Clinical Labor: Tissue Donors and Research Subjects in the Global Bioeconomy 9780822377009

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Clinical Labor

Experimental Futures Technological Lives, Scientific Arts, Anthropological Voices A series edited by Michael M. J. Fischer and Joseph Dumit

M e l i n d a C o o p e r & C at h e r i n e Wa l d b y

Clinical Labor Tissue Donors and Research Subjects in the Global Bioeconomy

Duke University Press Durham and London 2014

© 2014 Duke University Press All rights reserved Printed in the United States of America on acid-­free paper ♾ Designed by Courtney Leigh Baker Typeset in Whitman by Tseng Information Systems, Inc. Library of Congress Cataloging-­in-­Publication Data Cooper, Melinda. Clinical labor : tissue donors and research subjects in the global bioeconomy / Melinda Cooper and Catherine Waldby. pages cm — (Experimental futures) Includes bibliographical references and index. isbn 978-­0-­8223-­5608-­0 (cloth : alk. paper) isbn 978-­0-­8223-­5622-­6 (pbk. : alk. paper) 1. Human reproductive technology—Economic aspects.  2. Human reproductive technology—Moral and ethical aspects.  3. Medical care—Technological innovations. I. Waldby, Cathy.  II. Title. III. Series: Experimental futures. rg133.5.c669 2014 618.1′7806—dc23 2013025654

Contents

Acknowledgments vii

Part I.

What Is Clinical Labor? 1

One. A Clinical Labor Theory of Value 3 Two. The Historical Lineages of Clinical Labor 18 Industrial Order, Human Capital, and the Outsourcing of Risk

Part II.

From Reproductive Work to Regenerative Labor 33

Three. Fertility Outsourcing 37 Contract, Risk, and Assisted Reproductive Technology Four. Reproductive Arbitrage 62 Trading Fertility across Borders Five. Regenerative Labor 89 Women and the Stem Cell Industries

The Work of Experiment: Clinical Trials and the Production of Risk 117 Part III.

Six. The American Experiment 123 From Prison-­Academic-­Industrial Complex to the Outsourced Clinic Seven. Speculative Economies, Contingent Bodies 159 Transnational Trials in China and India Eight. The Labor of Distributed Experiment 195 User-­Generated Drug Innovation Conclusion 221  Notes 229  References 243  Index 273

Acknowledgments

The idea for this book occurred to us more or less simultaneously at the Bioeconomies and Biovalue conference at Lancaster University in April 2006. At that conference we first encountered the work of Kaushik Sunder Rajan, who presented from his then forthcoming book Biocapital. For each of us, this presentation crystallized a train of thought that was latent in our respective work on markets, neoliberalism, and biomedical research. While we had both contributed to the burgeoning critique of life sciences and contemporary capital in various ways, we had, like all the existing commentary, focused on the uncanny hybridities of money, speculation, financialization, and in vitro tissues. Listening to Kaushik’s presentation, we both realized that we, and the rest of the field, had neglected the question of labor. While there was an extensive body of work on the expert cognitive labor of the scientist and its centrality to the knowledge economy, the labor of those who provide the in vivo platforms for clinical experimentation and tissue provision did not figure in any account as labor. Or to be more precise, a burgeoning literature did name these activities in passing as kinds of labor, but did not probe what that might mean, how it might count, and what it might tell us not only about the organization of the bioeconomy but about the broader organization of labor and value today. So this became our task, and this book is the result. We have incurred many debts of gratitude to numerous colleagues, received generous grant support, and presented work at a number of seminars, conferences, and workshops. Catherine Waldby would like to thank Renee Almaling, Warwick Anderson, Kathrin Braun, Nik Brown, Katherine Carroll, Greg Clancey, Adele Clarke, Raewyn Connell, Gail Davies, Donna Dicken-

son, Maria Fanin, Peter Glasner, Herbert Gottweis, Erica Haimes, Elizabeth Hill, Linda Hogle, Klaus Hoyer, Isabel Karpin, Julie Kent, Ian Kerridge, Charlotte Kroløkke, Rob Mitchell, Michel Nahman, Brett Neilson, Pat O’Malley, Alan Petersen, Anne Pollock, Barbara Prainsack, Nikolas Rose, Brian Salter, Loane Skene, Kaushik Sunder Rajan, Fredrik Svenaeus, Steve Wainwright, Andrew Webster, and Clare Williams. For their essential personal support and love she thanks her family, David, Valerie, Gavan, and Jenny, and her partner, Paul Jones, who had to live with the inevitable psychic demands of the writing process. While there are too many seminars to list, she would like to particularly mention three that contributed strongly to the formation of the book’s argument; the Symposium on Biocapital and Bioequity Institute for Advanced Studies / Worldwide Universities Network, University of Bristol, 27 April 2011; The Body as Gift, Resource and Commodity workshop, Södertörn University, Stockholm, Sweden, 5–6 May 2011; and the Clinical Labour and the New Labour Studies seminar, University of Sydney, 21–22 May 2012. She thanks the participants in these workshops for their generous collegiality. Melinda Cooper would like to thank Lisa Adkins, Fiona Allon, Warwick Anderson, David Bray, Dick Bryan, Marina Cooper, Lucette Cysique, Jill Fisher, Louise Freckleton, Mark Gawne, Elizabeth Hill, Martijn Konings, Randy Martin, Angela Mitropoulos, Brett Neilson, Pat O’Malley, Anne Pollock, Michael Rafferty, Brian Salter, Kane Race, Kaushik Sunder Rajan, Miguel Vatter, Jeremy Walker, and Terry Woronov for their generosity in time, conversation, and intellectual support. Several workshops and conferences were crucial to the formation of the book’s argument. These include Experimental Systems, States and Speculations: Anthropology at the Intersection of Life Science and Capital, University of California, Irvine, 13–15 April 2007; Life (Un)Ltd, organized by Rachel Lee at ucla Center for the Study of Women, 9–12 May 2012; and the Clinical Labour and the New Labour Studies seminar, mentioned above. Catherine Waldby’s research was supported by two grants from the Australia Research Council: Human Oocytes for Stem Cell Research: Donation and Regulation in Australia, lp0882054, and The Oocyte Economy: The Changing Meanings of Human Eggs in Fertility, Assisted Reproduction and Stem Cell Research, ft100100176. She also received support from an Economic and Social Research Council International Visiting Research Fellowship and from the Regenerative Medicine in Europe: Emerging Needs and Challenges in a Global Context project, eu fp7 project. Melinda Cooper’s research was supported by an Australian Research Council Grant viii Acknowledgments

ft100100543, Experimental Workers of the World—the Labour of Human Research Subjects in the Emerging Bioeconomies of China and India. Generous additional funds were provided from the International Office and the Faculty of Arts and Social Sciences, Sydney University, and the Department of Sociology and Social Policy provided a stellar research culture and collegial environment for this work. Some sections of chapter 5 are adapted from an earlier paper: Catherine Waldby and Melinda Cooper (2010), “From Reproductive Work to Regenerative Labour: The Female Body and the Stem Cell Industries,” Feminist Theory 11(1): 3–22. A modified section of chapter 4 appears in Catherine Waldby (2012), “Reproductive Labour Arbitrage: Trading Fertility across European Borders,” in The Body as Gift, Resource and Commodity: Exchanging Organs, Tissues, and Cells in the 21st Century, ed. Fredrik Svenaeus and Martin Gunnarson, pp. 267–295, Centre for Studies in Practical Knowledge, Södertörn University. Sections of chapter 6 dealing with the history of informed consent and tort law appear in Melinda Cooper (2011), “Trial by Accident: Tort Law, Industrial Risks and the History of Medical Experiment,” Journal of Cultural Economy 4(1): 81–96. An abbreviated version of chapter 8 appears in Melinda Cooper (2012), “The Pharmacology of Distributed Experiment: User-­Generated Drug Innovation,” Body and Society 18(3–4): 18–43.

Acknowledgments ix

One

A Clinical Labor Theory of Value

What is labor? The question is increasingly salient to post-­Fordist economies, as forms of production and accumulation move further away from the mass manufacture model that defined twentieth-­century industrial capitalism. The post-­Fordist economies are dominated by the service sector, by knowledge creation and the culture industries, by financial markets and information capitalism—but also by new modes of biomedical production focused on innovation value and newly defined contractual rights in the body. These are forms of productivity whose output is no longer the standardized, mass-­manufactured commodity but, rather, less easily specifiable entities— brand equity, customer loyalty, trade marks, intellectual property. The industrial model of labor as exhaustible machine and entropic energy (Walker 2007), operationalized through the scientific management of discrete time and motion units, no longer accounts for the activity of most employees in the First World economies. As manufacture is decentered from the former industrial, advanced economies, the proliferation of these other forms of production throws into

question the established categories of economic analysis. In particular, it raises the question of how to understand the relationship between the labor process and the production of value when both domains are disentangled from mass manufacture, with its tangible use values and predictable economies of scale. While the financialization of economies has directed a great deal of critical attention to the ever more mercurial play of speculation in the creation (and more recently the destruction) of capital value, a growing body of scholarship is also engaged in rethinking the category and subjectivity of labor and its modes of productivity. Yet few have explored the new forms of embodied labor (surrogacy, the provision and sale of body tissues, participation in clinical trials) that have proliferated at the lower ends of the post-­ Fordist biomedical economy. This book intends to investigate these forms of labor as central to the biomedical innovation process, while reflecting, in turn, on how such a perspective might challenge some of the founding assumptions of classical, Marxist, and post-­Fordist theories of labor. Much of the sociological and political economy literature focuses on the structural changes that typify advanced economies since the late 1970s, particularly the decline in full-­time, permanent positions for the industrial, male worker that characterized the Fordist model of production. French sociologists Luc Boltanski and Eve Chiapello (2005) offer a detailed overview of the differences between Fordist labor regimes and post-­Fordist flexible labor. As firms restructured in the 1980s and 1990s to take advantage of economic deregulation and the transnationalization of supply and manufacture chains, they sought to divest themselves of their internal, permanent workforce and secure labor on the cheaper terms of just-­in-­time demand. Hence, companies increasingly resorted to subcontracting out administrative, service, and even professional activities to external contractors and consultants, substituting fixed-­term for long-­term labor contracts. The generic post-­Fordist worker is no longer the employee, tied to the firm by a long-­term contract of service, but the independent contractor, who moves from firm to firm and from client to client selling contracts for service. As the standard working day and week are supplanted by intermittent call-­work, night work, overtime, nine-­day fortnights, weekend shifts, and annualized work-­times, a plethora of new contractual forms have emerged to constrain labor to constant work-­readiness and volatile wages (Mitropoulos 2012). By divesting itself of the long-­term contract of employment, the post-­Fordist workplace frees itself of the burdens of social insurance and outsources risk to independent contractors, who become responsible for insuring them4 Chapter One

selves against the whole spectrum of life risks that were once taken in charge (albeit partially) by the welfare state. Under these conditions, the wage itself has become something of a speculative proposition—contingent, in many cases, upon unspecified hours of unpaid work-­readiness, conditional upon the achievement of performance indicators, or fully integrated into the volatilities of the stock market (as in the case of stock options as supplements to traditional wages). As the organizational form that emerged from the oil shocks and recessions of the mid-­1970s, post-­Fordism presides over the breakdown of the political and economic categories that structured the mid-­twentieth-­century Keynesian era. In response to the return of middle-­class women to the paid labor force from the late 1960s, and the corresponding disintegration of the breadwinner household with a full-­time, unpaid housewife, post-­Fordist economies blur the boundaries between the reproductive and productive spheres. Domestic tasks, sexual services, care provision, and, as we will see, the process of biological reproduction itself have migrated out of the private space of the family into the labor market and are now central to postindustrial accumulation strategies. The New Household Economics developed by Chicago School economist Gary Becker represents one of the first attempts to theorize this process within the limited framework of orthodox, neoclassical economics: not incidentally, its exponents have been some of the keenest champions of commercial markets in blood, organs, and reproductive tissues, alongside other forms of human capital (Posner 1989; R. A. Epstein 1995; Becker and Elias 2007). As both theorists of the New Household Economics and their critics have observed, post-­Fordist economies internalize the boundaries that the mid-­twentieth-­century social state placed on commodification, pushing back at the limits between production and social reproduction, production and consumption, production and circulation, to turn even the most intimate of bodily functions into exchangeable commodities and services (Becker 1981; Radin 1996). A wide-­ranging social science and humanities literature now recognizes the multifarious ways that the biotechnical processes of “life itself” (Rose 2007) are involved in networks of commercial transaction and capital accumulation. This literature has explored the speculative accumulation strategies of the pharmaceutical and biomedical industries (Parry 2004; Thacker 2005; Sunder Rajan 2007; Brown et al. 2011); the logics of biocommodification and commercial markets in tissues, organs, reproductive cells, organs, and dna (Franklin and Lock 2003; Parry 2004; Waldby and Mitchell 2006; A Clinical Labor Theory of Value 5

Brown et al. 2011); global markets in pharmaceuticals and genetic data (Thacker 2005; Petryna et al. 2006); and the political economy of clinical trials (Fisher 2009; Petryna 2009). Alongside this literature, and at a much more general level of analysis, theorists associated with the tradition of Italian autonomist or post-­workerist Marxism point to the ways in which “the time of life” (that is, the time reserved for nonwork or unpaid reproductive labor under Fordist conditions) has become ever more closely enmeshed in the circuits of capital accumulation. The transition to post-­Fordism, they argue, has undermined the conceptual and practical boundaries between the time of work and the time of life, inaugurating a transition from “capital-­labour” to “capital-­life” (Lazzarato 2004). Most recently, Andrea Fumagalli has proposed the term “cognitive biocapitalism” as a means of radicalizing the autonomist critique of political economy. For Fumagalli, “cognitive biocapitalism is bioeconomic production: it is bioeconomy” (2011: 12). Post-­Fordist capitalism puts life itself to work, “overcoming the separation between production and reproduction” to constitute a new form of “biolabor” (12). Under these conditions, any “theory of the value of work” must become “a theory of the value of life” (12). Suggestive as it is, the extreme generality of this literature means that it fails to pose the most salient question—what exactly was “life itself” under Fordist conditions of (re)production? What, in other words, were its gendered and racialized divisions of labor? And in what sense does the actual production of bioeconomic value in the knowledge-­intensive life science sector reflect or interact with these wider shifts in how the scene of reproduction is organized? Alongside these critical literatures, public policy discourse has identified the “bioeconomy” as a key site of strategic investment and a decisive stake in the nascent competitive standoff between the “advanced” postindustrial economies and the emerging economies of China and India. The Organisation for Economic Co-­operation and Development (oecd), the European Union (eu), and now the United States have all published policy directives designed to foster the emergence of a new long wave of postindustrial economic growth based on the integrated “bioeconomy” of the agricultural, medical, and industrial life sciences (European Commission 2005; oecd 2006; White House 2012). Echoing a discourse that is now at least four decades old, these directives call for a new generation of bio-­based technologies capable of transcending the limits of industrial, petrochemical production in agriculture, transport, and medicine. Much of the focus of this policy agenda is on the speculative value of as-­yet-­unrealized technological inno6 Chapter One

vation—biofuels, synthetic biology, experimental cell therapies—and their potential to propel the “advanced” economies out of economic recession. Yet despite the conceptual inflation of the “bioeconomic” in contemporary policy and theoretical discourse, few have explored the very material ways in which the in vivo biology of human subjects is enrolled into the post-­ Fordist labor process, through either the production of experimental data or the transfer of tissues.1 We contend that such forms of in vivo labor are increasingly central to the valorization process of the post-­Fordist economy. The pharmaceutical industry demands ever greater numbers of trial subjects to meet its innovation imperatives, and the assisted reproductive market continues to expand as more and more households seek fertility services from third-­party providers—gamete vendors and surrogates—and sectors of the stem cell industries seek out reproductive tissues. The life science industries rely on an extensive yet unacknowledged labor force whose service consists in the visceral experience of experimental drug consumption, hormonal transformation, more or less invasive biomedical procedures, ejaculation, tissue extraction, and gestation. In the United States alone, the epicenter of the global pharmaceutical industry, growing numbers of contingent workers engage in high-­risk Phase 1 clinical trial work in exchange for money, while uninsured patients may take part in clinical trials in exchange for medication that would otherwise be unaffordable. With the expansion of assisted reproductive technologies, the sale of tissues such as eggs and sperm or reproductive services such as gestational surrogacy has also emerged as a flourishing labor market, one that is highly stratified along lines of class and race. We refer to these forms of work as clinical labor. The terminology is novel because, generally speaking, tissue donation and research participation are not understood or analyzed as forms of work. Rather, these forms of productivity are regulated through the conceptual and institutional framework of bioethics,2 in which tissue providers—those who surrender blood, semen, oocytes, embryos, kidneys, and other forms of “live” tissue—are cast as altruistic donors who give for the public good, even in cases where they are paid a fee or their tissues are commercialized (Tober 2001; Waldby and Mitchell 2006). Clinical trial participants are understood to be volunteers who receive compensation rather than wages; nominally the compensation rates, set by Institutional Review Boards (irbs) and Human Research Ethics Committees, are kept low to discourage economic coercion, but in practice the rates are often higher than minimum-­wage rates for unskilled labor (Elliott 2008). The historical mission of bioethics, encoded in A Clinical Labor Theory of Value 7

its many national and international instruments3 and review processes, is precisely to protect research subjects and tissue donors from market forces, enshrining the principles of donation, voluntarism, informed consent, and freedom from coercion as the guiding principles of ethical research.4 State regulation of tissue donation and human subject experimentation routinely stipulate that the donor or volunteer should be compensated rather than paid a wage and that such compensation should not represent a form of coercion or undue influence. Nevertheless, as we demonstrate at length in this study, these key elements of bioethical regulation have proved remarkably adaptable to the task of governing an informal clinical labor market. In many of the cases we examine, the ethical insistence that the biological should not be waged only serves to facilitate atavistic (yet fully functional) forms of labor contract and desultory forms of compensation. Even in the mid-­twentieth century, we argue, bioethics served to place human subject experimentation and tissue donation under an exceptional regime of labor, one that justified various exemptions from the standard protections of twentieth-­century labor law. Ironically, as the protections offered by the statutory labor contract become more residual, the precarious nature of clinical labor increasingly resembles other kinds of informalized labor in today’s market.5 Throughout this book, therefore, we have sought to include bioethics within our field of analysis rather than presume its categories as points of departure. As such, we recontextualize the claims of bioethics by considering its historical relationship to labor law, contract, tort, and social welfare, and the particular ways it intersects with these more familiar instruments for regulating the economic risks of workers. We recognize that the category of labor cannot account for all the circumstances in which patients donate tissues or participate in clinical trials, particularly when these exchanges take place primarily within a well-­regulated and well-­insured therapeutic system, as does much solid organ donation and certain classes of hospital-­based clinical trials for cancer drugs, for example, which offer last-­resort, fully insured forms of care. Rather, we suggest that such services should be regarded as “labor” when the activity is intrinsic to the process of valorization of a particular bioeconomic sector and when therapeutic benefits to the participants and their communities are absent or incidental. Indeed, much clinical labor consists precisely in the endurance of risk and exposure to nonpredictable experimental effects that may be actively harmful, rather than therapeutic. We also include the situation where clinical labor is performed in exchange for health care, reconfigured as an 8 Chapter One

“in kind” compensation for service, comparable to “workfare,” where the payment of welfare benefits is made contingent upon the obligation to work. Our research focuses on two of the largest, best-­established, and transnational markets in clinical labor—those represented by assisted reproductive labor (including the sale of oocytes and sperm, and gestational surrogacy), on the one hand, and the labor of human research subjects engaged in pharmaceutical drug trials, on the other. By all estimates, these markets are vast.6 Clinical labor sustains some of the most patent-­intensive sectors of the postindustrial economy, yet most of this workforce intersects with the lowest echelons of informal service labor, recruiting from the same classes marginalized by the transition from Fordist mass manufacture to post-­Fordist informatic production. Human research subjects and tissue vendors occupy a liminal but critical position in the postindustrial biomedical economy. Unlike the service workers who provide cleaning, catering, and other kinds of low-­level contract work for the knowledge economy (Sassen 2002), their labor is fully internal to the value chains of the pharmaceutical and biomedical industries. The data generated by human research subjects is incorporated, in an immediate sense, into the investigational new drug application that needs to be submitted to regulatory authorities before a drug is approved for marketing. Egg and sperm vendors and gestational surrogates provide the living tissues and in vivo services that sustain a thriving economy of public and private fertility medicine and stem cell research. These forms of transaction, however, do not figure in economic analyses of labor in the life sciences. Almost invariably, such investigations concern themselves with the professional divisions of labor within the laboratory and clinic and do not extend to the in vivo labor that sustains the innovation process (Arora and Gambardella 1995; Nightingale 1998; Gambardella 2005). This oversight is all the more significant given that the life science business model is organized around a classical (Lockean) labor theory of value which identifies the cognitive labor of the scientist as the technical element necessary to the establishment of intellectual property in living matter. The scientist’s inventive step in isolating dna or creating a cell line from ex vivo tissues is treated in innovation economics and patent law as the moment that creates both property rights and appreciable commercial value from dumb biological materials (Boyle 1996). In this account, the bodily contribution of tissue providers and human research subjects appears as an already available biological resource, as res nullius,7 matter in the public domain, even while in practice the mobilization of these providers and subjects represents a growing logistical problem for the life science industries. A Clinical Labor Theory of Value 9

This constitutive blind spot regarding in vivo production is also to be found in contemporary critical studies of the labor process. Even the most interesting theories of postindustrial labor, those that point to the centrality of the immaterial, cognitive, or affective within post-­Fordism, ultimately paper over the divisions of labor that exist within the postindustrial innovation economies (Lazzarato 2002; Fumagalli 2007). In this book, we wish to explore the legal, social, and technical forms of value production that have converged to enroll in vivo biological processes (from metabolism to spermatogenesis and gestation) in a labor relation. In what follows, we turn to Marx’s labor theory of value and consider its potential usefulness (and limitations) for thinking through the question of bioproduction today.

Bioproduction and the Labor Theory of Value

For Marx, writing in the first volume of Capital, “free,” contractual wage labor is to be found wherever the worker seeks to sell, for a limited period of time, “the living-­power which exists in his own living body” (Marx 1990 [1867]: 272). Marx describes labor-­power as a “curious commodity,” unique in that it is “a source not only of value, but of more value than it has itself” (1990 [1867]: 301). It is this incipient temporal disjuncture that capital avails itself of when it distinguishes between the “socially necessary time” needed to maintain the life of the worker (hence the minimum wage payable for the worker’s time) and the labor time it appropriates free of charge, as a source of surplus value. Decisive for understanding the enigma of labor is Marx’s insistence that the determination of “socially necessary labor time” is the outcome of ongoing political struggles. It follows that there is no “law of value” in the sense of some transcendental or natural equilibrium regulating the relationship between price and labor. The calculation of the price of labor must be understood as historically contingent yet fully operative as an instrument of discipline. Here we follow those theorists who understand Marx’s theory of value as an immanent critique, not an extrapolation or revision, of the labor theory of value developed by his classical liberal predecessors (Rubin 1972; Elson 1979; Postone 1993). Adam Smith identified labor as the ultimate, transhistorical source of all social wealth, while David Ricardo, revising Smith, postulated that it was labor time that constituted both the source and measure of exchange value. For Marx, on the contrary, there is no intrinsic value to labor that we might want to recognize or valorize against the fetishisms of the market, and there is no automatic correspondence between labor time 10 Chapter One

and price. If it is labor time that constitutes value, as Ricardo argued, it is only by virtue of its abstraction from all particular use values of labor, its generic exchangeability as “abstract, socially average” time (Marx 1990 [1867]: 129). To “develop the concept of capital,” Marx writes in the Grundrisse, “it is necessary to begin not with labor but with value, and, precisely, with exchange value in an already developed movement of circulation” (1973: 259). It is not through some natural transformation of use value into price, but retroactively, through the abstraction of money in circulation, that the value of labor is determined. Having established the retroactive logic, however, Marx insists that the determination of the value of labor is a political decision, the outcome, that is, of ongoing conflicts between labor and capital. Labor’s value contains a distinct “historical and moral element,” manifest in the particular forms of temporal measure that govern labor in any given moment (Marx 1990 [1867]: 275). If exploitation is essentially a form of temporal discipline, it is not surprising that labor struggles have historically targeted the social organization of time—not only the length of the working day, as Marxists have traditionally pointed out, but also the division between the time of productive labor (work) and the time of reproductive labor (life), and the social distribution of accidental time or risk. Thus far, our reading of Marx is closely aligned with that of theorists such as Isaak Rubin and Moishe Postone, who point to the centrality of temporal abstraction in Marx’s labor theory of value. We differ from these perspectives, however, by insisting that the abstract and the material (indeed, embodied) dimensions of labor cannot be theorized in isolation. In their attempt to distinguish Marx’s theory of labor from the substantialist conceptions of the classical liberals, these theorists seek to divorce the concept of abstract labor time from the historically specific, physiological forms assumed by the concrete labor process in any given order of production. In so doing, however, they risk reinstating a reductive, ahistorical conception of the “physiological” in its place.8 In any event, we would suggest, the structural categories of Marx’s theory of value cannot be so easily abstracted from the biotechnical conditions of labor that characterized the mid-­nineteenth century. Far from representing a merely metaphoric aspect of Marx’s thinking, the technical vocabulary of early industrial production shapes the very conceptual framework of the theory of value, giving rise, for example, to the distinctions between dead and living labor, variable and constant capital. These distinctions rest on the assumption that the technical or machinic composition of capiA Clinical Labor Theory of Value 11

tal is necessarily inanimate and that the human or variable component of capital resides in the “living labor” of the worker’s body, conceived as an organic whole. Early twentieth-­century developments in biomedicine fundamentally challenge these categories by inventing what Hannah Landecker (2007) has called “living technologies”—in vitro tissues and cell lines that are both living and machinic in the sense that they can be cultured outside the body and form part of the technical composition of science. The twentieth century brings the production process inside the body and puts organs, blood, and cell lines into circulation outside the body, scrambling the classical Marxist distinction between the living and the dead (Cooper 2002). In earlier work, we theorized the emergence of living commodities (the commercial exchange of organs, blood, and cell lines outside the body) and living capital (the patented cell line as generative of surplus value) (Waldby and Mitchell 2006; Cooper 2008). In this book, we trace the relocation of the labor process to the suborganismic level of the body, via the mass experimentation of randomized controlled trials (rcts) and the contractualization of assisted reproductive services. What we are proposing here is not a “biological” labor theory of value in the classical, pre-­Marxist tradition, as if the ultimate use value and source of all wealth could be located in the intrinsic generativity of living biology. Rather, we understand “clinical labor” as the process of material abstraction by which the abstract, temporal imperatives of accumulation are put to work at the level of the body. The temporal abstraction that Marx identified as characteristic of exchangeable labor (and hence the defining feature of labor under the capitalist mode of accumulation) can also be detected in the long history of twentieth-­century interventions into the biological body. We would not be able to speak of “clinical labor” as such without the importing of mass production methods into the agricultural sciences in the early twentieth century, the development of instruments for culturing living cell lines outside the body, the use of statistics in the experimental clinical sciences, the invention of methods for suspending and freezing biological time (cryobiology) in the 1950s, and the perfection of infrastructures for the mass storage of tissues, organs, and cells (Clarke 1998; M. Edwards 2007; Gaudillière 2007; Landecker 2007). Developed in parallel with the European science of labor and American Taylorist methods of time management, each of these interventions render the biological newly pliable to the exigencies of abstract, exchangeable, or statistical time. At the same time, and increasingly so with the advent of post-­Fordist methods of flexible specialization, such biomedical infrastructures also serve to isolate and culture that which 12 Chapter One

is contingent, unpredictable, and plastic in the unfolding of biological temporality. The rct is rigorously Taylorist in its application of social statistics to the biomedical events affecting the massified body of the population, but it also serves to isolate the unpredictable or contingent biomedical event (the unexpected side effect, for example) against the background of the normal distribution. Increasingly (as we will see in chapters 6 and 8) it is the nonstandard temporality of the contingent event that has come to define the work of biomedical innovation. With the advent of stem cell biology, cell development is no longer understood to follow a predetermined path of progressively limited specializations but is cultured as a source of flexible, nonexclusive potentialities, any one of which can be materialized in practice. In this way, the statistical abstraction of labor that Marx saw as characteristic of the industrial mode of production now coexists with a form of speculative materialism, which demands that the contingent event be embodied in the unfolding of biological time.9 What we are proposing here is a theory of material abstraction that is neither dialectic nor representational in nature (pace the Marxist theorist of real abstraction [Colletti 1973]), but experimental and interventionist. As the “practical” turn in recent science studies might suggest, if the scientific hypothesis is effective, it is not as a theoretical proposition projecting itself onto an inert matter but as a method for inhabiting and modulating the already immanent possibilities of living matter (Hacking 1983; Simondon 1995; Rheinberger 1997b). The experimental intervention works to suspend, freeze, culture, replicate, reverse, accelerate, slow down, and amplify the already-­existing temporalities of the entities it works with (cell lines, metabolic processes, tissue cultures), prompting them to become other than they were in vivo or to “live differently in time,” in the words of Hannah Landecker (2005). Biomedical technology can be understood as a practice of controlled decontextualization that is able to provoke unsuspected or as yet unrealized actualizations from its living materials by exposing them to novel environmental conditions. In this respect it is always both an abstract and a material intervention into a spectrum of already available material abstractions; an attempt to modulate the multiple differentiations open to a particular cell, for example. In pointing to the importance of the material and experimental dimension of bioproduction, however, we do not wish to suggest that the creation of a market in clinical labor is reducible to its technical conditions. As we will explore in detail in this study, even when the necessary material premises have long been available, legal innovations such as the tort law concept A Clinical Labor Theory of Value 13

of informed consent, in the early twentieth century, and the contractualization of family law, in the late twentieth century, have played a critical role in determining when and how these biotechnical possibilities are realized as labor. In a similar way, the emergence of a financialized mode of biomedical and pharmaceutical innovation in the early 1980s was not so much the result of a technical revolution as a studied political maneuver on the part of private corporations, research universities, and policy elites. The financialization of the life science business model was enabled by a series of key regulatory and legal interventions into the realms of patent law, securities legislation, and consumer protection standards. We differ from most approaches to the field by understanding bioethics as a crucial component of the normative and legal infrastructure regulating the political economy of the life sciences, even when bioethics assumes a principled opposition to the body’s commodification. Whether it is framed in a liberal or a human rights register, we contend that bioethics as discourse and practice is internal to the political economy of the life sciences. Within the market for clinical labor, for example, we argue that informed consent plays much the same role that Marx ascribed to the doctrine of the “free” wage contract under classical liberalism. As such, we are not interested in improving “informed consent” by arguing for more or less “ethical” conditions of consent or for greater autonomy on the part of the consenting subject. Instead, we understand “informed consent” as an enabling regulatory condition for the market in clinical labor, one that has evolved alongside signal twentieth-­ century developments in labor law and social insurance to define the specific form of “unequal exchange” that governs commercial transactions in the clinic.

Organization of the Argument

In order fully to realize a historically contextual value theory of clinical labor, our study engages in a longue durée analysis, which considers the relationship between the modern history of labor as it is conventionally defined and the shadow history of clinical labor. In the next chapter, “The Historical Lineages of Clinical Labor,” we reframe some of the major transformations in the organization of twentieth- and twenty-­first-­century labor as moments in the organization of biopolitical risks and capacities—those associated with the life risks of illness, accident, and reproduction—as well as moments in the ordering of production. In particular, we track the move toward labor outsourcing, the contracting out of services, and the rise of human 14 Chapter One

capital theory, in which workers are constituted as entrepreneurs of their own productive, and indeed reproductive, capacity. These are crucial pivot points in the transformation from an industrial regime of statutory labor protections to a neoliberal regime of reprivatized contractual relations. We argue that the evolving institutional and legal forms of clinical labor bear witness to this transformation in the most material of ways. We then turn to a more specific investigation of the historical and contemporary conditions of clinical labor. As we will see, reproductive and experimental labor emerge from the margins of the Fordist industrial model and Keynesian welfare state, in the product-­testing regimes of the rct and the various forms of reproductive service performed by the unpaid housewife or the paid domestic servant (cook, nanny, or wet nurse). Our analysis traces the progressive spatial reorganization of clinical labor as reproductive and experimental services move from the sequestered spaces of the vertically integrated Fordist institution to the distributed spaces of post-­Fordist contract labor. Until the 1980s, clinical trials were conducted within the confines of the academic research hospital or the prison. During the same period, the unpaid reproductive labor of the housewife took place within the sequestered space of the Fordist household. Each of these categories of work blurred the boundaries between the “free” and the “unfree” contract of labor and involved more or less coercive forms of confinement or state financing.10 Unpaid reproductive labor was indirectly subsidized by the state through the institution of the family wage. Prison-­based clinical trials represented one of the few opportunities for earning a wage in prison at a time when there were severe restrictions on prison labor, and hospital-­based trials were subsidized by the introduction of social insurance for the elderly and the poor (Medicare and Medicaid) in the mid-­1960s. Located in the peripheral spaces of the household, the hospital, the warfront, and the prison, these experimental and reproductive forms of value generation were sharply separated from the scene of formal industrial labor. Since the 1980s, however, the institutional spaces of Fordist clinical labor have been subject to ongoing reform. At stake in the transition from Fordism to post-­Fordism, we argue, is not only the vertical disintegration of national production and the large firm but also the horizontal contractualization of services once performed in the confined spaces of the household, the hospital, and the prison. These once internalized labor forces have been supplanted by a model of contractual outsourcing that delegates clinical labor on a case-­by-­case basis to the independent contractor for in vivo services. It is during this period that we see the decomposition of the family wage, preA Clinical Labor Theory of Value 15

cipitated by women’s mass exodus from obligatory domesticity and into the workforce. As the unpaid domestic labor of the housewife is supplanted by an entire service sector specializing in contract-­based affective, sexual, and care labor, the biological process of reproduction is itself subject to a form of (legal, technical, and commercial) fragmentation. Once the technical repertoires of midcentury animal reproduction are adapted to human patients via the development of in vitro fertilization (ivf) and other assisted reproductive technologies (arts), the processes of ovulation, spermatogenesis, conception, and gestation are opened out to third-­party provision, drawing on surrogates and gamete suppliers outside the family proper. While many jurisdictions prohibited the commercialization of reproductive services, others, particularly in the United States, refused to frame regulations. As a consequence, particular jurisdictions have witnessed the emergence of a reproductive service sector framed almost entirely through private contract law. It is now possible to outsource discrete moments and functions of the reproductive process to independent contractors beyond the boundaries of the family and the nation without undermining the legal entity that is the post-­ Fordist family. It is this contradiction between the technological fragmentation of the family and the corresponding tendency toward its legal reassertion that we will address in the second part of the book, “From Reproductive Work to Regenerative Labor.” During the same period, the prohibition of prison-­based trials, followed by managed-­care-­inspired reforms of the academic research hospital, combined to push clinical trials into the private sector. The mass institutional trials of the post–World War II era have been progressively replaced by private-­contract-­based trials that are brokered and mediated by a new kind of research institution—the contract research organization or cro. The long-­term confinements required by Phase 1, first-­in-­human trials now take place in private research units, while later-­phase trials on patients are performed by private physicians under contract to the pharmaceutical industry. In keeping with these institutional shifts, the contractual conditions that shape clinical trial work have also changed, even while the racial and class profile of the clinical trial subject remains remarkably static. The pharmaceutical industry now looks for its research subjects outside the state-­subsidized spaces of the prison and the hospital, locating new sources of experimental labor in the various forms of risk exposure generated by neoliberal labor and welfare reform. Today, contract research organizations habitually recruit Phase 1 research subjects from among the underemployed, day laborers, ex-­ prisoners, and undocumented migrants, precisely those classes of worker 16 Chapter One

who routinely endure the most hazardous and contingent of labor conditions. Later-­phase trials are increasingly dependent on the growing numbers of underinsured, chronically ill patients who can access medicines only if they also agree to engage in clinical trials. Under post-­Fordist conditions of generalized labor informalization, clinical trial work is contingent labor par excellence—labor that is defined by the “freedom” to bear risks of the most visceral kind. It is this problematic of experimental labor that we will examine in the third part of the book, “The Work of Experiment: Clinical Trials and the Production of Risk.” In each section, we begin with a historical account that sets out the conditions for emergence of reproductive and experimental clinical labor in the twentieth century. We then give an account of the transnationalization of clinical labor, as both reproductive services and clinical trial work are offshored to less expensive locations beyond the borders of northern Europe and North America. We then consider the development of distributed, extensive forms of clinical labor in the more innovation-­driven sectors of the bioeconomy, examining the role of women as donors of “surplus” reproductive tissues in the stem cell industries and of patients as self-­experimental resources for pharmaceutical innovation. In what follows, then, we provide an account of clinical labor that simultaneously maps its historical conditions, its political economy, and its contemporary trajectory. We hope to show that this form of work, far from representing an exceptional or extreme manifestation of the underground economy, is emblematic of the conditions of twenty-­first-­century labor.

A Clinical Labor Theory of Value 17

Two

The Historical Lineages of Clinical Labor Industrial Order, Human Capital, and the Outsourcing of Risk

Clinical labor, in its current constitution, involves the worker’s assumption of biopolitical risks—the risks inherent in the experience of biological contingency and a precarious contractualism. The historical conditions that make this form of labor possible can be traced to particular biomedical developments, and in the following sections of the book we investigate this biomedical history in detail. These conditions also emerge from a broader twentieth-­century history of labor, in its close imbrication with the politics of the household and the social management of population. In this chapter, we examine the emergence of post-­Fordist clinical labor out of the shift from a mid-­twentieth-­century system of statutory labor protections reserved for the industrial male worker, to a far more precarious, late twentieth-­century regime of labor outsourcing to private contractors of “services in the self.” As we will see, post-­Fordist clinical labor is always, in some sense, outsourced labor, and the scale of contemporary clinical labor depends on an economy-­ wide, and indeed global, shift toward the constitution of labor as an external resource, rather than an internal element within the firm and its cognate

institutions, the prison, the household, the hospital. The constitution of the worker as a private contractor of his or her own labor power, rather than a collective agent understood to be in a relation of structural inequality with the employer, has not been lost on orthodox labor economics. As we will see, when the architects of human capital theory, Gary Becker and his colleagues at the University of Chicago, began in the 1960s to elaborate the concept of human capital, it was with direct reference to new or imagined markets in blood, solid organs, and surrogacy services. Hence the outsourcing of labor and the rise of new forms of clinical labor are not merely parallel historical developments but rather are deeply imbricated one with the other, and they act as the leading edge of late twentieth-­century neoliberal experimentation with new forms of accumulation.

The Outsourcing Business Model

Since Taylorist mass production reached its profitability limits in the 1970s, companies have sought flexible alternatives to the large, vertically integrated plant with a permanent, full-­time workforce and a national location. Outsourcing describes a series of business strategies; subcontracting, the lending out of a discrete component of production to a second-­party company; the use of service companies to maintain the workplace (cleaning, catering), rather than providing them in house; and the systematic casualization of the workforce. Permanent, full-­time positions in companies are more and more residual, as ever larger sectors of the workforce are engaged through temping agencies, through fixed-term and part-­time work contracts, through day hire and hourly rate employment (Hatton 2011). These forms of employment lack the predictability of income and conditions associated with permanent work. They also lack the extensive body of statutory protections that accrue to the permanent contract of employment: workers’ compensation, unemployment insurance, health insurance (in the United States), and rights to labor arbitration (Deakin and Wilkinson 2005). Outsourcing strategies have generated a flexible, networked organization for commerce, “wherein lean firms seek the resources that they lack from among a profusion of subcontractors, as well as a labor force that is malleable in terms of employment” (Boltanski and Chiapello 2005: 218). Small firms can undertake large projects, by outsourcing the expertise, plant, and labor power required on a project-­by-­project basis. Outsourcing effectively externalizes the workforce, freeing companies from the regulatory and fiscal costs associated with the maintenance of a permanent internal labor pool. The Historical Lineages of Clinical Labor 19

Instead, labor is constituted as a productive resource found outside the firm, one that can be drawn upon selectively and intermittently to tailor supply to demand. Casual relations between employer and employed serve to reduce downtime in the work process and to transfer the uncertainty of demand fluctuations from the firm to the workforce itself. If the market for a company product changes, casual workers can be hired, laid off, and given fewer or greater numbers of hours without statutory notice periods, and there are few restrictions on the length of their working day. As Boltanski and Chiapello summarize it, “Anything that is not directly productive is discarded as non-­working time, and the costs of maintaining the workforce are transferred onto the workers themselves or, in the event of unemployment or occupational disability, the State” (Boltanski and Chiapello 2005: 246). Beyond casualization, however, we can discern a more radical reordering of labor relations through the logics of outsourcing. Under current regulatory conditions in the United States, the United Kingdom, Australia, and other advanced industrial nations, the contract of employment, which sets out relations between employer and employee, can be readily replaced by a commercial contract with a service provider. As the legal academic Judy Fudge puts it, “The vertical disintegration of firms and the breakdown of internal labor markets [mean that] individuals who have once been treated as employees could easily be transformed into independent contractors who are outside the scope of labor protection” (2006: 612). She notes that in conventional labor and commercial law, the independent contractor, understood as self-­employed, is framed as the diametric opposite of the employee, who is contracted in a subordinate, service relation to an employer. The opposition is tendentious, however, both historically and as a description of the contemporary labor market. It tends to disguise the extent to which a contract of service, the ongoing, legally constituted relationship between an employer and employee, can be replaced by a contract for services, a project-­ based commercial contract for the provision of a good or service. The kinds of clinical labor that concern us here, the labor of commercial third-­party fertility provision and clinical trial participation, is organized, in the United States at least, as a contract for services, with specific implications for the men and women who provide gametes and gestational surrogacy to intending parents and the research subjects who undertake clinical trials on behalf of contract research organizations. To grasp these implications we need to understand the different ways that the formal employment contract (the contract of service with an employee) and the contract for services with an independent contractor work as biopolitical technologies, as ways to organize 20 Chapter Two

and distribute life risks and economic risks. We also consider the ways that these different contractual conditions of production have interacted with the social organization of reproduction and the relations between the workplace and the household through the course of the twentieth century.

Risk, Labor, Reproduction, and Contracting Out

Simon Deakin and Frank Wilkinson’s historical analysis of labor law demonstrates that the distinction between contracts of service and contracts for services is historically contingent. In Britain, it is stabilized over a protracted period between the 1880s and the advent of the National Insurance Act of 1946, which established the British postwar welfare state. With the decline of the welfare state after the 1970s, the distinction begins to unravel. The early history of industrialization and the move to factory manufacture did not initially involve the creation of direct, individual labor contracts between employers and employees, in either the United States or Britain. Rather, factory work was organized through a complex system of internal, private contracts, often verbal, and a range of workplace-­specific customs and practices (Stanley 1998; Deakin and Wilkinson 2005). Artisans contracted with an owner for the performance of a specified job, and they themselves recruited and subcontracted an assembly of artisans, apprentices, work gangs, and family members, who lacked any relationship with the factory owner. At the same time, at the historical high point of liberalism and contractual individualism, common law determinations through most of the nineteenth century failed to recognize claims by such workers to compensation for injury or standing-­down. Under the “fellow servant” rule, factory owners were functionally exempt from vicarious liability for harms visited by one worker upon another within their firms. Workers who labored in dangerous industries, such as metal foundries, were ruled, in both Britain and the United States, to have made a “voluntary assumption of risk” in accordance with the legal principle of volenti non fit injuria, “to the willing person no injury is done.” Thus they were understood to have relinquished rights to compensation (O’Malley 2009). In part 3 of the book, we examine how this principle of voluntary assumption continues to structure some forms of clinical labor, particularly clinical trial work. From the 1880s onward in Britain, a wave of social legislation was introduced, a response to growing organized labor unrest and the rise of unionism, which overturned the common law exemption of employers from liability. In its place, “the principle that the employer should assume responThe Historical Lineages of Clinical Labor 21

sibility for social and economic risks arising from the employment relationship began to take shape” (Deakin and Wilkinson 2005: 86–87). A series of Workmen’s Compensation Acts and National Insurance Acts introduced through the first half of the twentieth century “imposed liability on employers for workplace-­related injuries and disease, and prompted the widespread use of employers’ liability insurance to spread the risks in question. Social insurance spread the more general risks of interruption to earnings through illness, unemployment and old age throughout the working population through the device of state-­run insurance funds” (Deakin and Wilkinson 2005: 87). Through these measures, the enterprise became a site for the redistribution of social and economic risks at the behest of the state, which represents, in effect, the third party to the modern employment contract. The permanent contract of employment that emerges over the course of this history gives employers the right to an open-­ended duty of obedience and service in exchange for the provision of comprehensive social protections for employees. The British National Insurance Act of 1946, the foundational legislation for the postwar welfare state, consolidated the distinction between contracts of service and contracts for services because it required all contributors to be classified either as employees or self-­employed for purposes of determining employers’ liability for injury and social insurance. This consolidation of the permanent contract of employment also hastened the rise of the Fordist, vertically integrated firm, as the old internal contracting system was replaced with in-­house bureaucratic supervision and compliance costs began to favor large corporations. “Once the enterprise became a mechanism for the redistribution of social and economic risks, the resulting imposition of regulatory and fiscal costs on to employers created economies of scale which favored larger firms at the expense of smaller productive units. The welfare state extended its influence alongside increasingly vertical integration of production and the emergence of the public sector as a significant employer” (Deakin and Wilkinson 2005: 87). Hence, the crucial distinction between the contract of employment and the contract for services is that the state enforces a set of social obligations and risk-­sharing strategies through the former, while the latter remains in the domain of private law— regulated through court determination on contract, property, and tort. In the United States, however, the role of the state, particularly the federal government, in the regulation of labor has been far more attenuated and partial. Private contract retained a central role in the ordering of labor relations well into the twentieth century, upheld by a series of Supreme Court rulings that struck down individual state attempts to introduce minimum wages, 22 Chapter Two

maximum hours, or workers’ compensation statutes. The Supreme Court repeatedly overturned progressive and labor movement attempts to introduce minimum-­wage and conditions legislation along British and Australian lines, on the grounds that they violated the freedom of contract provisions of the Fourteenth Amendment, a post–Civil War Reconstruction amendment, and hence were unconstitutional.1 Amy D. Stanley, in her study of the relationship between the abolition of slavery and late nineteenth-­century labor relations in the United States, notes that “only in the United States did full scale industrial capitalism develop simultaneously with, and literally alongside, the consolidation and overthrow of chattel slavery. . . . The labor questions in the postbellum North and South were . . . ideologically framed by . . . the opposition between the principle of human chattel and the ideal of contract freedom” (1998: 60–61). Freedom of contract was, in other words, a key mechanism in a particular idea of free civil society and liberal social order, and the Supreme Court enforced this idea of freedom against progressive attempts to involve the state in labor protection. As we shall see, the political and economic centrality of private contract in the organization of labor was never fully displaced, and it continues to shape the conditions of US clinical labor in important ways. Several individual states nevertheless succeeded in establishing minimum wages for women working in sweatshop conditions, on the grounds that women, unlike men, were not equal parties to contract and so were in need of social protection. These wages were explicitly framed as sufficient to support a single woman but to exclude any claims for “breadwinner” status (Lipschultz 1996). Meanwhile, from 1910 onward, employers sought to ameliorate militant labor and progressive demands for improved conditions through corporate insurance and welfare measures, delivered by newly formulated group insurance policies to provide pensions, health coverage, and unemployment benefits. The convergence of employer and sectoral interests drove the development of the corporate industrial insurance sector, and the flourishing of large East Coast insurance houses such as Equitable and Metropolitan Life, as each party sought to preempt the development of social insurance and the state regulation of labor. Less-­skilled laborers and African American workers were excluded from these schemes and relied instead on poorly managed fraternal societies or union-­run plans which for the most part collapsed during the early years of the Great Depression (Klein 2003). It was not until the Franklin Delano Roosevelt administration introduced the National Industry Recovery Act (1933) and the Social Security Act (1935) as part of the New Deal that the federal government intervened to regulate The Historical Lineages of Clinical Labor 23

labor and to guarantee basic levels of social security at a national level. After Roosevelt appointed new justices to the Supreme Court, the Fair Labor Standards Act (flsa) was eventually passed into law in 1938, setting a national minimum wage and minimum conditions for both sexes (Mutari and Figart 2004; Neumark and Wascher 2008). So, in the United States too, a relationship was eventually created between social insurance provisions, state welfare, and labor regulation. The private industrial welfare sector nevertheless continued to provide additional protections for those employers who wanted corporate welfare benefits (Klein 2003). It is clear from the above that the British welfare state, the US New Deal, and the statutory organization of employment have functioned as key moments in the organization of mid-­twentieth-­century biopolitics. Each involves state investment in the vitality and security of workers, through management of the distributions of both embodied risks (accidents, ill health, old age) and market risk (unemployment). Nevertheless, it is evident that in the United States, the management of such risks depended far more on the internal industrial relations of individual firms and sectors, while the regulatory role of both the state and federal governments was far more attenuated than that of the British state, with its commitment to universal social insurance and the National Health Service. The US social insurance model was also more exclusionary, riven around questions of African American entitlement. As Robert C. Lieberman notes of the 1935 Social Security Act, while it was “the most important single act in the creation of the American welfare state,” it nevertheless “sorted Americans by class, classifying their target populations by occupation and work status. In so doing, [it] also sorted Americans by race” (1998: 5). All of its policies involved race-­laden exclusions, either by accident or by design.2 These social compromises institutionalized particular hierarchies of rights to labor protections and the valorization of particular forms of productive activity. They effectively protected the dangers and exposures associated with the white male industrial body and the mass production workplace and valorized a particular form of labor power, quantified in standardized skill levels, specified time expenditures, and production quotas. To this extent, the industrial contract of employment entrenches the most canonical elements of Marx’s labor theory of value, which differentiates sharply between productive (male, industrial, waged) and unproductive (female, domestic, service-­ based) labor, which is classified as reproduction (Marx 1990 [1867]).3 Other possible forms of production are excluded from these protections and sys24 Chapter Two

tems of valuation because they do not fall within the terms of the formal labor contract. This sharp differentiation of spheres is evident if we examine what kinds of labor fell outside such protections. In the US case, the flsa provisions did not extend to retail sales, agricultural work, or domestic service, occupations that included the majority of women and African Americans. Nor did it extend in practice to highly unionized sectors that preferred to retain their collective bargaining powers to obtain higher wages and improved conditions. Its primary focus was the white male unskilled workforce, which it provided with subsistence conditions, while allowing unionized labor to bargain for breadwinner wages. In the case of African Americans and white women, neither mechanism was available to secure a breadwinner wage, as neither were included in unions (Mutari and Figart 2004). While white women continued to be covered by weak state-­level subsistence wage legislation, African Americans had effectively no access to statutory protections, and the breadwinner wage was in effect never available to the majority of black men. In Britain (and elsewhere), the twentieth-­century evolution of statutory labor protections involved both customary and institutional exclusions of married women, understood to have their primary responsibilities at home and with childbearing, from full-­time employment, skilled employment, and the benefits associated with the industrial unionized workplace.4 From the early 1900s onward, with the advent of a social security rather than a “poor law” model of employment regulation, the male worker was positioned as the earner of a breadwinner wage, intended to support both himself and his dependents. Married women were understood to derive both their income and their rights to social security from the male breadwinner, while their primary responsibility lay with the household. In the process of finalizing the British National Insurance Act of 1946, William Beveridge made explicit that married women, as reproducers of the national labor force, were to remain sequestered from the labor market and to have a derivative entitlement to income and social insurance through their husband’s labor contract. The act, he wrote, “treats married women as a special class of occupied persons, and treats man and wife as a team on the understanding that the great majority of married women must be regarded as occupied on work which is vital though unpaid without which their husbands could not do their paid work and without which the work of the nation could not continue” (cited in Deakin and Wilkinson 2005: 172). In both the United States and Britain, then, women The Historical Lineages of Clinical Labor 25

are largely excluded, by omission or by statute, from full status as workers— particularly women engaged in the social and biological reproduction of children (Stanley 1998). The processes of reproduction (pregnancy, birth, and nurture, as well as the social reproduction of the household) were sequestered within the home and the private sphere and subsidized through the husband’s wage and welfare entitlements. In the United States, the exclusion of African Americans from industrial labor sectors and the benefits of unionization confined their employment to poorly paid and largely unregulated agriculture or domestic service. It is evident from this account that the historical specificities that stabilized and generalized the contract of employment to include most (white) male workers in the mid-­twentieth century, and to exclude women engaged in reproduction, have shifted decisively. As firms move from vertical integration to an outsourcing model, as the social protections configured around the male breadwinner and the dependent wife lose their relevance, and as states step back from postwar full employment policies and deregulate their national labor markets, the permanent contract of employment becomes increasingly marginal. Moreover, the state embrace of neoliberal models of governance and global competitiveness since the 1970s has seen a transformation in the ways governments manage economic and social risk across their constituencies. Postwelfare “competition” states have partially dismantled the institutions designed to socialize economic and health risks across the body politic, and to a large extent have devolved risk management to the level of the individual (Cerny 1997; Ericson et al. 2000). Postwelfare states have actively promoted labor flexibility through the proliferation of forms of work that exclude the worker from access to socialized risk management. Hence, work can be contracted out, without evoking the armature of state protections and corporate responsibilities built into the permanent contract of employment. Fudge (2006) points out that the term “independent contractor” includes both business owners who employ others, and “own-­account” contractors, who hire no one else. In 2000, the latter category comprised 65.5 percent of the self-­employed in the United Kingdom, and their income was significantly lower than that of average employees (Fudge 2006). Outsourcing also divests companies of responsibility in the event of illness or accident, making independent contractors personally responsible for providing themselves with adequate insurance against such contingencies. Hence independent contractors are frequently used to man26 Chapter Two

age the most dangerous aspects of a production process (Boltanski and Chiapello 2005). The spatial configuration of the Fordist household, which sequestered reproductive labor within the home, away from the dynamics of labor markets, has also been reversed. The various forms of equal employment legislation that washed through the advanced industrial economies from the early 1980s onward have seen the dismantling of institutional inequality in employment rights for women and the retrenchment of the division between married and single women. When white women exited the Fordist household en masse to join the paid labor force during the late 1960s, post-­Fordism put the “private” to work, newly restructuring the labor market around services (care, food preparation, cleaning) that were once performed as unpaid work in the private space of the home. During the same period, unprecedented numbers of African American women left their positions as paid household labor in white homes, progressively reducing the gap between their own and white women’s wages as they moved into better-­paid clerical and white-­collar jobs (Wallace et al. 1980). As we will see, the advanced industrial economies internalize the decomposition of the Fordist family wage by integrating women into a service economy that is stratified along the lines of gender and race. Meanwhile, the biology of reproduction, mediated by assisted reproductive technologies, is ever more tightly enmeshed in new forms of precarious service labor. In summary, labor outsourcing redresses the risk-­sharing strategies associated with the permanent contract of employment and shifts risks decisively from the firm to the contractor. These include economic risks associated with fluctuations in demand, the risks of lost productivity associated with accident or illness, and the profitability risks associated with collective bargaining rights and statutory obligations. Hence outsourcing is emblematic of precarious labor and invokes both the quantitative risks associated with fluctuating income and uncertain access to health insurance, and the precarious life of the vulnerable body: its exposure to the contingencies of loss, aging, and weakness and its openness to accident (Butler 2004). At the same time, certain social groups, notably women and, in the United States, African Americans, have historically been excluded from the protections associated with unionized, male labor or, in the case of childbearing women, have been subject to “protections” that involve their subsidized exclusion from the labor market. As we will see, these groups are key actors in the drama of clinical labor. They act as the independent contractors of their “bioThe Historical Lineages of Clinical Labor 27

logical capital,” yet they labor without labor protection. They are obliged to assume both the economic and corporeal risks of the biomedical innovation ­economy.

Clinical Labor and the Limits of Human Capital

To account fully for the biopolitics of outsourcing, however, we also need to consider its philosophical and economic articulation. The most eloquent advocates for outsourced labor are the Chicago School human capital theorists, who began in the late 1950s to articulate a set of propositions that provide conceptual scaffolding for the privatization of labor relations and the contractualization of biological “services” that was yet to come.5 The idea of labor as human capital has become synonymous with labor economics itself and is largely used as an anodyne term designating the social desirability of investment in an educated, skilled, or “flexible” workforce. Here, however, we return to the original arguments made by Gary Becker and his colleagues in the law and economics movement, because they are consistently concerned with the question of markets in biological tissues and other bodily services, markets that they link directly to both the privatization of labor and the contractualization of reproduction. We would suggest that the Chicago School’s special interest in biological commodities demands critical investigation if the emblematic status of clinical labor within contemporary service economies is to be fully appreciated. When Richard Titmuss (1997 [1970]) wrote his classic defense of the gift relation in blood in 1970, partially in response to the growing influence of neoliberal ideas in the United Kingdom, he argued that the noncommercialization of human tissues constituted a litmus test for the welfare state itself, serving as a marker for the existence of a normative distinction between commodifiable and noncommodifiable human relations. It is therefore hardly surprising that Chicago School economists and legal theorists were very quick to anticipate the commercialization of the biological and to advocate the complete contractualization of markets in human tissues. Both Richard Posner and Richard Epstein, leading figures in the law and economics movement, have called for the full enforcement of surrogacy contracts, with Epstein going so far as to recommend the exceptional contractual instrument of specific performance as a means of enforcing the transfer of a surrogate’s child to its intended parents, while Gary Becker has argued for monetary incentives to increase the supply of organs from cadavers and live donors (Posner 1989; R. A. Epstein 1995; Becker and Elias 28 Chapter Two

2007). Chicago School economists were also among the first to formulate a wide-­ranging (and now very familiar) critique of US federal drug regulations on the grounds that overly stringent consumer protection laws were responsible for the ongoing decline of new drug candidates (see Nik-­Khah, forthcoming [2014]; Landau 1973; Peltzman 1974, 1988 [1973]). What some have referred to as the neoliberal “counter-­revolution” in labor economics emerged from a position of marginality in the early 1950s, when Keynesian and neo-­institutionalist perspectives dominated the field of industrial relations, to establish itself as the dominant perspective in economic analysis during the 1980s (Kaufman 2010: 128). On the theoretical front, the early Chicago School neoliberals sought to reinvigorate neoclassical competitive price theory against the then dominant state-­interventionist theories of the Keynesians. In the political arena, they strove to undo the panoply of New Deal labor and social protections that constituted the very premise of Keynesian and neo-­institutionalist industrial relations. In practice this would mean returning the costs of social services to the consumer by reprivatizing the Keynesian social sphere (education, health, prisons) and reconstituting the domestic sphere of the Fordist household as a reserve of contractual services. Among the original Chicago School theorists, it is Gary Becker who most famously and consistently extended the analysis of neoclassical price theory to the domain of the household (he himself referred to his corpus as the “new household economics”; Mitropoulos 2012). By his own reckoning, Becker’s numerous interventions into the field of social economics were prompted by what he saw as the most significant shift in economic affairs to have taken place in the late twentieth century—that is, the profound overhaul of “household” relations that took place in the late 1960s and 1970s as a consequence of the massive return of middle-­class women to the workforce, the decline in average family size, and the relative desegregation of social space brought about by the civil rights movement. In a collection of essays published in 1981, Becker noted that the “family in the Western world has been radically altered, some claim almost destroyed, by events of the last three decades” (1981: 1). As we argued above, the Fordist/Keynesian welfare state had not only established a strict sexual division of labor between the masculine sphere of formal labor and the feminine sphere of reproductive, unpaid care (to be supported through the family wage); it had also relied, in the United States, on an implicit exclusion of African Americans from the household politics of welfare. It was the implosion of this entire architecture that Becker sought to theorize in his numerous studies on the economics of everyday life—studies that ranged from the economic effects of discriminaThe Historical Lineages of Clinical Labor 29

tion in the workplace to the cost-­benefit analysis of child-­rearing and spouse selection. Becker responded to the dissolution of the Fordist household by asserting that all social, domestic, and intimate relations should be incorporated, in theory if not in practice, within the space of rational economic analysis. Becker’s work evacuates all normative distinctions between productive and unproductive, productive and reproductive labor in favor of a general notion of the contractualized “service.” Within this perspective, the entire spectrum of activities that had once been performed as unpaid labor within the household are to be considered as potential assets, services that can be sold, valorized, and appreciated to generate a future return on investment. It is a logical consequence of this move that the interior of the body itself (its organs, attributes, and exposures) should be subject to a competitive price calculus on a par with any other market asset. Alongside their focus on reproductive services and the contractualization of the household, Chicago School neoliberals also mounted an early critique of the welfare state socialization of risks and its attendant forms of consumer protection. Even while recognizing the inefficiencies of private tort law as a means of litigating accidental harms, law and economics theorists have consistently argued that the moral hazards of social insurance constitute an intolerable affront to market freedom—understood as the freedom to bear and take risks (Landes and Posner 1987; O’Malley 2009: 150–154). Writing at the height of the consumer protection movement of the 1960s and 1970s, law and economics scholars launched an unrelenting attack on all collectivized models of public risk management (from social welfare per se to enterprise liability laws and no-­fault accident insurance), which they declared inimical to the ideal of consumer responsibility. In lieu of the welfare state ideal of social insurance, they called for a return to private tort litigation as an instrument for managing social and industrial risk, while at the same time advocating the adoption of entirely novel methods of privatized risk management, such as the financialization of social security. The philosophy of risk endorsed by the Chicago School law and economics movement can perhaps best be summed up by the nineteenth-­century tort doctrine of volenti non fit injuria (“to the willing person no injury is done”). It is this doctrine, we will argue, that has consistently informed the Chicago School perspective on federal drug regulation. In many ways, and no doubt because of its own considerable influence on government policy from the late 1970s onward, the Chicago School perspective on contemporary labor economics is descriptively astute. Albeit clothed in the simplistic terms of neoclassical equilibrium analysis, Chicago School 30 Chapter Two

law and economics reflects the changing (sexual and racial) composition of the labor market, the progressive displacement of the long-­term employee by the independent contractor and the ongoing expansion of the market in “contracts for service.” But Chicago School neoliberals are far from agnostic about the changes they are describing. While their analysis is attentive to the shifting boundaries between the household and the labor market attendant upon the civil rights movement and feminism, they are vociferously opposed to any kind of state legislation (antidiscrimination laws, for example) that might temper the sexual and racial divisions of labor that characterize the emerging service sector (R. A. Epstein 1983, 1984). They are also opposed to any form of labor collectivism (or “cartelization,” in their terms) that might address the changing contractual nature of labor in an economy now largely dominated by the service sector. Instead, they advocate a return to the kinds of private contract and tort law that dominated labor relations in the nineteenth century—precisely the kinds of law that predominate in the clinical services sector. Most significantly, perhaps, the very framework of “human capital” theory attempts to disarm any kind of labor politics adequate to post-­Fordist conditions by positing a formal equality between all independent contractors (capitalist and worker, experimental subject and entrepreneur) and equating all with the figure of the entrepreneur (Becker 1976). This maneuver was first performed by Frank Knight (1933), the founder of the Chicago School of economics, who in the 1930s argued that the traditional distinctions between the three factors of production—land, capital, and labor—were unfounded, since there was only one true value-­creating factor: capital. It would later be generalized by Theodore Schultz and Gary Becker, who reconfigure the worker as an investor in his or her own human capital—an entrepreneur of the self. And yet there exists a real and decisive difference between those who take immaterial, monetary risks to generate profit (risks that are in large measure underwritten by new laws protecting the financial investor) and those who bear the material, bodily risks of innovation in return for a wage or benefit. It is this division of labor, we will argue, that defines the current state of play of the biomedical innovation economy.

Conclusion

Our analysis reintroduces labor into the equation by investigating the embodied hierarchies and differentially material nature of the risks incurred in biomedical innovation. In particular, our analysis draws attention to the fact The Historical Lineages of Clinical Labor 31

that Chicago School legal scholars and economists endorse the return to two now largely obsolete principles of nineteenth-­century labor law—“specific performance” of contract, in the case of surrogacy law, and volenti non fit injuria in the case of biomedical experimentation. As we will see in chapter 3, “specific performance” represents an exceptional departure from classical liberal conceptions of contract in that it voids the possibility of monetary compensation and invokes the right to enforce the actual physical performance of the content of a contract. And as we will see in chapters 6 and 8, the assertion of volenti non fit injuria underlies the ethical construct of informed consent and constitutes the experimental subject as the bearer of certain kinds of noncontestable risk. We argue that these ostensibly atavistic legal forms are structural to the post-­Fordist economy in human services in the sense that they assert the necessity of embodied bondage at the heart of freedom of contract and render visible the hierarchies of embodied risk that sustain the speculative risks of innovation. Knight (1940 [1921]) famously defined the capitalist as one who takes uninsurable risks. We argue, on the contrary, that the biomedical innovation economy depends on the devolution of uninsurable, embodied risks to the clinical laborer. It is this asymmetry between the speculative risks of innovation, on the one hand, and the speculative but visceral risks incurred by clinical labor, on the other, that defines the unequal exchange of the contemporary biomedical economy.

32 Chapter Two

Pa r t I I

From Reproductive Work to Regenerative Labor

The term “labor” links two forms of action that are generally regarded as distinct, even oppositional, in conventional political economy. Women “go into” labor when they give birth, while workers labor to produce. The first kind of labor dramatizes the productivity of biology; the second kind supports the productivity of the economy. The labor of human reproductive biology produces children and is conventionally located in kinship relations and family formation. Hence, it is thought of as hors commerce, beyond market relations, while the worker’s labor is sold on the market. However, in what follows we argue that today the labor of human reproductive biology has become precisely a form of economic labor in certain key sectors of the bioeconomy. In a sense, this integration of human reproduction with production is nothing new. As feminist and postcolonial historians have demonstrated, in preindustrial plantation economies the reproductive capacities of the female chattel slave were pivotal sources of profitability. Cheryl Harris notes that in 1662 the Virginia colonial assembly adopted a statute classifying the children of Negro women impregnated by white men as slave or free according

to the status of the mother, an initiative quickly adopted by other colonial legislatures. She observes, “In reversing the usual common law presumption that the status of the child was determined by the father, the rule facilitated the reproduction of one’s own labor force” (C. I. Harris 1993: 37). In his history of female slavery in Barbados, Hilary Beckles points out that, unlike male slaves or laborers, the slave woman was valuable because she could “generate three income flows: from labor, prostitution and reproduction” (1989: 144). The practice of wet-­nursing, where working-­class women breast-­fed the children of the more wealthy for a fee, is another early example of the capacities of reproductive biology traded on an informal labor market (Golden 2006). Middle-­class women abandoned the employment of wet nurses only in the early twentieth century, after extensive public health campaigns to moralize breast-­feeding as an essential element in direct maternal care (Waldby 1984). The forms of reproductive labor we explore in the following pages are shaped by these earlier histories, particularly to the extent that postcolonial and class power relations are implicated. Nevertheless, the practices we examine—gestational surrogacy markets, gamete markets, and the provision of reproductive tissues (embryos, cord blood, fetal tissue, oocytes) for stem cell research—emerge from a distinctive set of contemporary socio-­ technical conditions. One of these is the development of a thriving clinical industry based on assisted reproductive technology (art), which has adapted the reproductive techniques developed in twentieth-­century livestock management to treat human infertility (Clarke 1998). art orders and standardizes reproductive biology and renders some elements ex vivo, so that fertilization takes place in vitro and embryos and oocytes can be disentangled from the female body and circulated through global space and between different subjects.1 A second condition is the denationalization of reproduction, the shift from a Fordist model of sequestered and subsidized reproduction within the gift economy of the family to a deregulated exposure to global precarious labor markets. Taken together, these developments see the formation of a global reproductive market, further supported by the mobility of elite populations, as they interact with the mobility limits of the urban poor (Vora 2008), and competition state pursuit of global bioeconomic advantage (Salter 2008). In chapters 3 and 4, we explore the labor involved in fertility outsourcing, in which elements of the reproductive process—particularly gamete production, gestation, and birth—are contracted out by intending parents and various kinds of fertility brokers to “third-­party” providers in exchange 34 Part II

for fees. Fertility outsourcing is enabled by the industrial logic of assisted reproductive technologies that break down reproductive biology into component processes. However, it also requires quite particular kinds of state policies and legislative environments, which have (so far) developed only in certain locales. We focus on the flourishing oocyte markets of California and the European Union and on the development of commercial gestational surrogacy in India. California is in many respects the global innovator for the contemporary reproductive labor market, the place where its value forms and property relations are developed and refined. While many other US states have stepped back from the task of creating a secure commercial environment for gestational surrogacy and oocyte vending, the Californian reproductive business model is being exported to other locations, particularly transitional economies, which compete on price for reproductive tourists. While reproductive tourists travel from all over the world and represent many ethnicities, the most lucrative market involves the reproduction of whiteness, and this desire shapes the geopolitics of fertility outsourcing to a considerable extent. In chapter 5, we examine another form of labor technically enabled by advances in reproductive biomedicine: women’s productive activity in the stem cell industries. Stem cell research diverts the capacities of reproductive biology away from the production of organisms and toward the production of regenerative tissues, with clinical applications in the treatment of organ failure and degenerative conditions. Women constitute the primary tissue providers in the new stem cell industries, which require high volumes of human embryos, oocytes, fetal tissue, and umbilical cord blood. We consider the diverse recruitment mechanisms that enroll different populations of women into this productive activity; these mechanisms range from a carefully regulated gift economy for “spare” embryos through private tissue banking for hematopoietic stem cells to an ever more bid-­driven transactional model for oocytes, which retain their scarcity value in the face of reproductive science’s limits. We consider what makes stem cell labor different from the labor of fertility outsourcing and the ways stem cell science is renegotiating the productivity limits of female reproductive biology.

From Reproductive Work to Regenerative Labor 35

Three

Fertility Outsourcing Contract, Risk, and Assisted Reproductive Technology

Fertility outsourcing refers to the commercial contracting out of a component of the reproductive biology cycle—the provision of gametes (oocytes and semen), or the gestation and birth of a child—to a third party in exchange for a fee. Highly profitable sectors of the bioeconomy, including sperm banks, fertility clinics, and oocyte and surrogacy brokers, secure these contracts on behalf of their clients, the intending parents. Fertility outsourcing is made biologically possible as an array of techniques—artificial insemination (ai), hormonal manipulation of the ovulation cycle, embryo transfer, freezing techniques for embryos and semen—developed primarily in twentieth-­century agricultural science for the management of animal herds were gradually applied to problems of human infertility in the 1970s and 1980s (Clarke 2007). Commercial sperm banks, which broker the transfer of semen between paid providers and purchasing recipients, were the first business foray into fertility outsourcing, and today such banks are highly corporate and sometimes transnational enterprises, with complex selection

and screening processes to maintain the capital value of their donor profiles and semen stocks. The securing of female reproductive capacities has proved far more technically and socially problematic. As we will see, it involves much more technical and biochemical invasiveness than semen production, and hence exposes providers to far greater bodily risk. For this reason, the commercial outsourcing of oocyte procurement and gestational surrogacy is prohibited or highly restricted in many jurisdictions. The state of California has historically had the most permissive legal and commercial environment for female fertility outsourcing, and in what follows we will examine the evolution of its business model (Spar 2006). More recently some particularly entrepreneurial competitors have set up business in less expensive international locations, notably southern and eastern Europe and the former Soviet Union for “white” oocyte vending (Waldby 2008), and India for gestational surrogacy. We explore these developments in chapter 4. In this chapter we will consider the development of fertility outsourcing as a distinctive form of reproductive, clinical labor. As a technical repertoire and set of contractual instruments, it redistributes reproductive risks and capacities not only between individual parties but also between different populations (both genetic and national) and different economic classes. Women engaged in such reproductive labor assume a significant burden of embodied risk, as well as effort, and different segments of the female reproductive labor market are exposed to different degrees of such risk, depending on their access to significant remuneration, good clinical care, and legal redress.

Sperm Banks

The first for-­profit sperm banks were operational in the United States by the late 1960s (Daniels and Golden 2004). Their business model involved the commercial reordering of a long-­standing clinical practice. Physicians have assisted conception with a husband’s semen since the nineteenth century. As reproductive science developed as a distinct medical field in the twentieth century (Clarke 1998) and knowledge of reproductive physiology and the causes of male infertility improved, physicians began to procure semen from other sources, often from medical students and residents, to assist with conception. The biology of semen—regenerative, ejaculable— makes it much more readily transferable than oocytes outside coital relations, and physicians relied on easy access to students or other male family 38 Chapter Three

members and quick turnaround times for the administration of fresh semen. Advocates of the practice countered criticisms regarding the immorality of masturbation and conception outside the marriage bond with claims that physician-­assisted conception would improve the eugenic composition of the gene pool by disseminating the semen of more intelligent men (Daniels and Golden 2004). For-­profit sperm banks, however, involved an extensive reorganization of both these face-­to-­face clinical relations and the logistics of sperm procurement and storage. Their viability as businesses depended on their adaptations of the extensive logistic and quality assurance innovations made in twentieth-­century livestock breeding. Artificial insemination techniques are the centerpiece of the scientific herd management practices that transformed animal husbandry during and after World War II. In Britain, ai research was given extensive public support as part of a national health strategy to improve the quality and seasonal availability of the milk supply. Techniques for preserving and transporting bovine semen were worked out during the 1930s in order to inseminate large numbers of cows dispersed across different small herds and improve herd exposure to high-­ yielding bulls. By the 1940s, with improvement in cryogenics, bovine semen logistics had come under direct state control, with large-­scale, centrally planned ai programs operated under the aegis of the Milk Marketing Board and the Ministry of Agriculture (Wilmot 2007). The national imperative supporting ai gave scope to more fundamental biological research on sperm physiology and biochemistry, and on storage and quality control techniques. These developments, which were of great interest to clinicians and reproductive scientists, focused on human reproductive biology and were part of a porous traffic between animal and clinical reproductive scientists that characterizes innovations in the entire twentieth-­century field (Clarke 1998). Bovine artificial insemination was then the first of what was to become a long list of technical innovations through the postwar years that changed the spatial relations and biological ratios of both human and animal reproduction. It permitted insemination without direct physical contact and scaled up both the number of inseminations from each unit and the distribution of units across geographical space. While under natural conditions a bull could fertilize thirty to forty cows per year, by 1947, using ai, one bull could fertilize five hundred to a thousand cows a year, and by 1979 the ratio had changed to one to fifty thousand (Clarke 1998). It facilitated quality assurance and quality improvement through the selection of better genetic sires and the exposure of far more cows to their gametes. Fertility Outsourcing 39

It is evident, then, as Adele Clarke argues, that ai, along with subsequent developments in reproductive technique, is designed to obtain industrial economies of scale in herd management and improve herds’ genetic composition. Artificial insemination was the first technique to organize animal reproduction along the lines of industrial mass production. It effectively Taylorizes biology, breaking living processes into subcomponents, standardizing them and rendering elements more interchangeable, in order to increase efficiency, produce greater yields and fewer losses, and make reproductive processes more predictable and open to further technical configuration (Clarke 2007: 330). As Jean-­Paul Gaudillière comments of the French and British experience, scientific management placed reproduction at the disposal of national development, both during and after the war. The ethos of increased yields, quality control, and rationalization became a matter of victory and defeat, and was later to be perpetuated in the postwar era as a condition of economic growth and social progress. The emphasis placed on reproductive control is therefore just one aspect of a more general search for bio-­productivity, which equated the management of both human and animal with industrial husbandry. The culture of standards and homogeneity inherited from the factory model of scientific management and rationalization was in this perspective as, if not more, important than the technical capacity to increase yields, that is, to deliver more numerous, less fragile and more rapidly growing newborns. (Gaudillière 2007: 525) In short, animal reproduction was remodeled as modern, industrial pro­ duction. Commercial sperm banking developed as companies gradually adapted these logistical and efficiency innovations to the procurement and storage of human sperm. While cryopreservation has been used for bovine semen since the 1950s, human semen proved to be more fragile, losing viability once it was frozen and thawed. Private sperm banking in the United States did not develop a secure profit base until the mid-­1970s, with the development of liquid nitrogen cryogenics, which better preserved the genetic viability and potency of human semen. While physicians continued to provide fresh semen to patients well into the 1980s, the advent of aids tipped the balance of patient preference and Food and Drug Administration (fda) recommendation toward frozen semen. Frozen semen could be retained while the donor underwent hiv testing, which involved a six-­month window period before the test result was entirely reliable (Almeling 2011). 40 Chapter Three

Cryopreservation allows banks to both accumulate and distribute units of semen, by removing time and space constraints on their use. Accumulation and distribution in turn move the transaction of semen beyond the direct, personal relationships involved in the physician’s procurement and administration of fresh semen described earlier. The doctor is no longer necessary as a face-­to-­face broker between provider and recipient. Instead, commercial banks create and manage semen markets, mediating between the supply of and demand for gametes—that is, between producers and consumers as economic agents. Semen producers are constituted in different ways in different regulatory jurisdictions. Donor insemination is the least restricted form of assisted conception. In a European study of thirty-­nine states (the eu plus Australia, Canada, New Zealand, and the United States) only one actively prohibited donor insemination (Council of Europe 1998). Nevertheless, the historical prohibition on the sale of human tissues means that in most western European and Commonwealth jurisdictions, regulations cap payment levels to producers and define it as compensation, in order to retain their voluntary status and their location within the health system. We examine the question of fertility compensation in chapter 4. In the United States, by contrast, the National Organ Transplant Act of 1984 classifies semen, along with blood and oocytes, as renewable tissues, and hence exempt from the act’s prohibition on the sale of solid organs. Both semen producers and oocyte producers are hence free to sell. Sperm banks and oocyte brokerage firms for the most part recruit gamete providers as independent contractors.1 The Internal Revenue Service code describes independent contractors as “people . . . who follow an independent trade, business, or profession in which they offer their services to the public” and who have control over the “means and methods of their work” and are paid by the job.2 Following our earlier discussion, then, gamete providers are not recruited as a reproductive labor force per se; rather, they are contractually retained by companies as the providers of a genetic resource, to perform as needed. The contractual conditions for sperm and oocyte provision are nevertheless somewhat different, and we will discuss each in turn. Semen production, in young men at least, is satirized as effortless and momentary, a transitory self-­pleasuring quite alien to the durational calculus and skill requirements of labor power as it is conventionally understood. As one recruitment advertisement put it, “uc men, get paid for something you are already doing! Call the Sperm Bank of California” (cited in Tober 2001). Nevertheless, the stringent exclusionary criteria used to select and rank Fertility Outsourcing 41

semen providers invoke an extended process of self-­investment, while the contractual relation created between the producer and the bank describes a series of temporal biological processes and bodily self-­management requirements pertaining to the quality assurance process that underwrites the capital value of sperm. While cryopreservation provides the material conditions for the accumulation of semen stocks, these stocks are worthless unless they are understood by potential consumers to transmit particular traits, and semen providers must embody these traits if they are to be accepted into the donor program. Sperm banks advertise the exclusivity of their donor program as an indication of the intrinsic value of their product. California Cryobank, for example, emphasizes that only 1 percent of applicants are accepted and details the array of medical, psychological, and educational assessments necessary to attain donor status. Applicants are meticulously screened for a wide range of health conditions (hiv, hepatitis, sexually transmitted diseases [stds], illicit drug use) and must provide detailed personal and family medical histories. They must provide blood samples for testing, undergo a physical examination, and meet requirements for desirable height, weight, appearance, educational attainment, dental regularity, ethnicity, religious denomination, and so on. The selection process also involves a tacit judgment about the reliability of the applicant and his propensity to stay in the program, justifying the investment represented by the recruiting and screening procedures (Almeling 2011). In the ranking of semen providers, educational attainment is particularly desirable. Banks routinely site branches near college campuses and recruit through college newspapers and social networks. Some banks insist on four-­year college degrees, some select according to the prestige of the university attended (mit, Harvard, Stanford, ucla), and some charge higher fees for “doctorate donors” (Daniels and Golden 2004). Banks free-­ ride on the institutional sorting and ranking processes that universities use to select their students, recruiting elite semen providers at a point in their lives when the comparatively low fees will be attractive. Once an applicant is accepted into a program, he enters into a contractual relationship with the bank that sets out a twelve- or eighteen-­month commitment. While semen production involves little in the way of bodily risk, particularly compared to oocyte production, typical contractual conditions are stringent. Contractors agree to conduct themselves in a way that maintains a high sperm count in their semen, to counter the spermicidal effects of cryopreservation. They agree to provide one or two units each week, and each visit must be preceded by a period of abstinence to ensure that sperm 42 Chapter Three

counts are high. They are expected to avoid or disclose any activities (sexual activity, recreational drug use, illness, medication) that might degrade the quality of semen. As a medium for genetic value, semen is also a potential transmitter of biological risk—of stds and genetic conditions. As independent contractors, then, semen providers are required to be “entrepreneurs of themselves” (Rose 2007), governing their conduct in a way that will not depreciate the capital value of their product. Unlike oocytes, which circulate on a highly stratified market with a wide distribution of negotiable fees, the fees for semen provision are comparatively flat. At time of writing, they were about �100 per unit, and contractors are not paid for units that fail to meet standards of motility and potency. Each unit is divided into multiple vials, frozen, and stored, and units are accumulated until the bank has sufficient inventory to begin marketing to potential purchasers. Units are sold under the anonymized profile of the contractor. Profiles describe height, weight, appearance, educational attainment, dental regularity, ethnicity, religious denomination, and so on. Profiles are listed on websites that allow potential consumers to browse for particular combinations of appearance and attainments, although the emphasis on privacy for semen donors prevents the use of adult photographs. Some sites show baby photographs instead. Ideally, the bank accumulates enough semen units to continue marketing long after the contractor has acquitted his obligations. It is commonplace for commentators to note that semen providers are systematically selected and marketed for traits that are nonheritable (e.g., Tober 2001; Daniels and Golden 2004), a practice usually attributed to popular misunderstandings of genetics. Certainly it points to the investment of desire and fantasy in the search for a semen provider (Waldby 2002). However, the process is also indicative of the ways in which an array of personal attributes (communicative ability, capacity for teamwork and networking, empathy) once considered extraneous to the skills that constituted industrial labor power are increasingly caught up in post-­Fordist production processes (Hochschild 1983). The ever-­widening ambit of interpersonal and psychological qualities and educational credentials associated with particular jobs drives much more detailed and stratified processes of selection and exclusion across the whole workforce (Boltanski and Chiapello 2005). Cast in this light, donor programs simply extend this kind of selection and exclusion process in their bid to accumulate what we might term “human genetic capital,” in the sense that each of its contractors brings a portfolio of desirable entrepreneurial, intellectual, physical, and psychological attainments to the task of gamete production. In this sense, human Fertility Outsourcing 43

genetic capital partakes of the broad terms of human capital that we discussed in the introduction. The donor is expected to demonstrate a portfolio of self-­investment—in health, good looks, expensive education, talent, discipline—and a general capacity for self-­appreciation. As Michel Feher (2009) notes, unlike the classical economic seller of labor power, split between a preexisting self and a set of alienable skills rented out on the labor market, and between the maintenance of self (consumption) and the production of commodities, the subject of human capital lacks a distinction ­between production and consumption. Hence activities and relations understood as socially reproductive—Feher gives the examples of dietary, erotic, religious—are readily enmeshed in the processes of self-­appreciation, part of an investment in the self. Enrollment in a donor program, understood in this light, quite literally puts the biology of reproduction to work, its market value enhanced and ranked by the portfolio of socio-­genetic qualities identified in the provider himself. Hence the reproductive labor involved in belonging to a commercial “donor” program is organized through two different productive logics. One of these is the industrial, Taylorist logic of ai, which renders components of reproduction ex vivo; selects for particular kinds of genetic value; accumulates, stores, and distributes semen; and multiplies the number of insemination events generated by each unit of production. The other logic here is that of human (genetic) capital accumulation, which in this case underwrites the process of class reproduction so evident in the recruitment and marketing strategies of sperm banks. Sperm providers are selected because they demonstrate the self-­appreciating ethics of expensive education as well as the highly invested, healthy bodies that connote a privileged background. So semen providers are contracted both to produce genetic material and to personify an embodied accumulation strategy.

Oocyte Brokerage

Semen provision is, biologically speaking, a relatively low-­risk activity, because it tracks processes (spermatogenesis, ejaculation) that are already in train in the normal course of (young) male reproductive physiology. Semen is also copious. The body readily regenerates it, and each ejaculation produces millions of spermatozoa, each with a full complement of the genetic material necessary to fertilize an oocyte and produce a conception. Hence, it lends itself easily to the constitution of a surplus, in excess of the reproductive capacity necessary to the man who produces it, and so compara44 Chapter Three

tively readily transferred to another. In this case, the risks associated with the process are to do with variation in quality rather than issues of quantity, and the contractual relations between providers and bank clearly allocate the costs for such variations to the contractor himself. Poor-­quality semen is discarded, and its donor is not paid. The provision of female gametes is much less biologically straightforward because it involves extensive biomedical intervention to scale up and externalize a process that is normally singular and in vivo. Oocytes are extremely difficult to constitute as a surplus, in either a biological or a social sense (Waldby and Carroll 2012), and hence involve far more complex forms of risk. In what follows we set out the biomedical and contractual instruments that are used to order oocytes as a surplus available on an open market in some US states. Like sperm banking, oocyte procurement has its technical origins in livestock breeding and attempts to scale up and coordinate the reproductivity of cows and ewes, as well as bulls and rams. Prior to World War II, US agricultural scientists had begun investigations of hormonal treatment to produce multiple births, synchronize estrus to facilitate artificial insemination, and transfer multiple embryos for herd management (Clarke 1998: 160). British and Australian scientists worked out the technique of ovulation induction in sheep during the 1950s, and by the 1970s a repertoire of new techniques for oocyte maturation, superovulation, embryo freezing, and embryo transfer were developed to manipulate and scale up the rate of ovine reproduction. Experiments with human ovarian stimulation began during the 1960s as clinicians and agricultural scientists tried to adapt animal reproductive techniques to human populations. By the 1970s ovarian stimulation was temporarily abandoned, as it appeared to be disturbing the hormonal milieu for embryo implantation (Hartshorne 2008). The first ivf births in 1979 and 1980 used the woman’s natural cycle, an approach that made oocyte recovery difficult to schedule in the hospital timetable. The timing of ovulation is unpredictable, and the collection process might take place any time during the day or night. ivf remained an unpopular and poorly funded activity while it made such difficult demands on hospital routines. Moreover, natural ovulation produces a single oocyte and a single chance at pregnancy for every cycle of collection. This approach thus lacked the capacity to improve the chances of conception for most women, because it could not alter the ratios already set by reproductive biology. In 1981, a scientific team at Monash University introduced hormonal stimulation cycles using human pituitary gonadotrophin and clomiphene Fertility Outsourcing 45

as a way to both increase the number of mature oocytes for harvest and to control the timing of ovulation and oocyte collection (Cohen et al. 2005). The production of multiple oocytes facilitated the fertilization of multiple embryos, which could be frozen for later use if the current round of ivf was unsuccessful. The technique benefited women whose infertility was caused by fallopian tube problems, but could make little difference to women whose problem stemmed from the oocytes themselves. However, once oocytes could be harvested and handled in a laboratory, they could also be transferred from one woman to another. In 1983, researchers at Monash University established that a woman with ovarian failure could sustain a pregnancy with an in vitro embryo created using a donated oocyte (Trounson et al. 1983). Prior to this development, gynecologists had assumed that the age of the uterus was also a factor in the difficulties of late conception and pregnancy, but now the way was open for older women to use ivf if an oocyte provider could be secured. The advent of this new suite of reproductive technologies, including new techniques for handling and researching human embryos as well as distributing gametes, produced a flurry of inquiries and regulatory activity around the world in the early 1980s. The Warnock Committee (United Kingdom, 1984), the Ontario Law Reform Commission (Canada, 1985), the Insemination Committee (Sweden, 1983), the Benda Commission (Germany, 1984), and the Waller Committee (Australia, 1983) all struggled to comprehend and embed the complex implications of these technical possibilities (Blyth and Farrand 2005). The new repertoires of ivf and oocyte donation abruptly expanded the number of potential participants in the creation of a child and radically redistributed the spaces in which ovulation, conception, pregnancy, and birth took place. They propelled existing understandings of the origins of life, women’s reproductive rights, and the structure of the family into potential disarray and hence demanded systematic social deliberation and legislative frameworks to manage the fallout. As Sheila Jasanoff observes, These technologies . . . split conception, now capable of occurring outside the womb, from implantation and gestation. A hitherto seamless biological process from conception to birth, entailing relatively little social or scientific ambiguity, became in this way fragmented, distributed among multiple agents, and subject to purposive human intervention. Additional participants made their way into what had once been, biologically, the exclusive preserve of one woman and one 46 Chapter Three

man—and had been cautiously expanded only to include artificial insemination by third-­party donors. The resulting novel linkages made close relationships of strangers, recombined generations in unexpected ways, and even cut across the line of life and death. . . . How, if at all, to render these unexpected relationships natural or unnatural, and how to adjust existing legal and moral dispensations so as to accommodate or disallow particular practices. (Jasanoff 2005: 148) A suite of complex legislation ensued in many countries: for example, the Human Fertilisation and Embryology Act (1990) in the United Kingdom, and the Embryo Protection Act3 (1990) in Germany, which set out terms or prohibitions for embryo research and handling, clinic licensing systems, and the management of gametes. For those nations that settled on a regulatory system, the majority favored managing gamete donation along the lines of organ and blood donation, as gift systems, albeit with provision for varying levels of compensation. In the United States, however, a set of particular political, commercial, and regulatory circumstances converged to open the way for an unregulated oocyte market to develop in California and several other states.

Beginnings of the US Oocyte Market

Public research funds for reproductive science were dramatically reduced during the Reagan and Bush administrations of the 1980s, under the political influence of anti-­abortion groups. Infertility research and fetal research were singled out for funding cuts, and entire university programs were abruptly dismantled (Clarke 1998). This withdrawal of funds and the absence of public subsidy for infertility patients pushed the field decisively into the private sector. At the same time, the federal government was silent on social regulation, in part because of a laissez-­faire attitude toward privately funded research, and in part because of political anxieties over the bitter abortion politics that fiercely polarized American society after the 1973 Roe v. Wade Supreme Court decision. As Jasanoff notes, this regulatory vacuum opened up a free space for entrepreneurial experimentation in the new medical and legal possibilities of fertility outsourcing: While the national trauma over abortion prevented any systematic federal regulation of reproductive technologies, their use and control developed in piecemeal fashion, through private enterprise, social experimentation, law-­suits, professional standard-­setting, and state-­by-­ Fertility Outsourcing 47

state regulation. Compared with Germany and even Britain, assisted reproduction in the United States remained largely free of formal state controls. As a result, media stories about the developing field convey the carnival air of a fairground where almost any imaginable approach to baby-­making is on offer: ivf, surrogate mothers, gestational mothers, artificial insemination for lesbian couples, frozen gametes from deceased donors, embryos for “adoption,” Jewish surrogacy and egg donation, and sperm and eggs from Ivy League donors, who are handsomely paid if they meet the buyer’s exacting selection criteria. (Jasanoff 2005: 165) It was in this libertarian environment that the highly stratified US oocyte market developed, with little regulation beyond that provided by contract law. As Rene Almeling (2011) demonstrates in her history of Californian gamete markets, the oocyte market emerged initially not from the semen-­ banking business model but from the surrogacy agency model. The availability of artificial insemination since the 1970s had opened up the possibility of contracting a woman to be inseminated with a husband’s semen and bear a child for the intending parents, to be surrendered for an agreed fee. In these early arrangements, prior to the technical ability to produce ex vivo oocytes, the contracted surrogate not only gestated the child but also contributed genetically, in the sense that the pregnancy depended on her normal fertility cycle, involving her own gametes. Through the late 1970s and early 1980s, surrogacy brokers had sprung up in states with lenient legislation around adoption, like Florida and California (Spar 2006). Agencies were set up not by clinicians but by attorneys, often in firms already working in the area of family law, whose clienteles were keen to pursue surrogacy as an alternative to adoption. Their viability depended on their ability to recruit women prepared to be surrogates and to secure contractual agreement between potential surrogates and intending parents in a legally untested and insecure area. While surrogacy contracts were widely assumed to be legally untenable, attorneys relied on psychological screening to identify women unlikely to renege (Spar 2006). Hence, agencies were already set up to recruit and screen women prepared to undertake reproductive labor in exchange for fees, with few barriers to expansion into recruitment of oocyte vendors. Moreover, these agencies built up a body of legal expertise in the volatile field of surrogacy contracts, and contracts for the delivery of oocytes appeared comparatively straightforward (Al­meling 2011). ivf clinics also began their own oocyte recruitment programs, but, Al­ 48 Chapter Three

meling argues, the surrogacy business model shaped even the way that clinics recruited. Rather than following the sperm bank model of recruiting students and capitalizing on class characteristics, both clinics and agencies initially recruited young women from local communities, through newspaper advertisements. Recruiters asked for women under thirty-­five who had children of their own and wished to help another couple have children. As several commentators note, the emphasis on altruism and maternal qualities that saturated both oocyte and surrogacy recruitment from this earliest point onward is absent from sperm bank recruitment (Spar 2006; Krawiec 2009; Almeling 2011). Oocyte vending also followed the surrogacy model in the creation of personalized relationships between vendor and purchaser, unlike the anonymized relations between semen donor and purchaser characteristic of sperm banks. Some early brokerage agencies required that vendor and purchaser meet as part of the selection process. Finally, unlike semen contracting, where the vendor signs a contract for services with the bank, the oocyte vendor signs a contract with the purchasing couple. The oocyte contract was hence to some extent modeled on the surrogacy contract, and this too was to have important effects in terms of the jurisdictional environment required for both forms of fertility outsourcing to flourish. By the early 1990s, the oocyte market began to fragment and stratify, as fertility clinics in California in particular gradually ceded recruitment functions to private agencies. Agencies in turn competed with each other by developing niche markets. Hence, consumer preference and escalating demand began to play a larger role in shaping gamete markets. While some agencies focused on appearance—recruiting young actresses from the Los Angeles entertainment industries, for example (Spar 2006)—the more common strategy was to adopt the sperm donation model and capitalize on class and educational prowess, as well as appearance. Hence, recruitment began to cluster around colleges and universities, seeking to attract oocyte vendors from good schools with high sat scores. This represented a decisive break with the class profile of surrogacy. By the mid-­1980s gestational surrogacy, using oocytes as well as semen provided by the intending parents or by separate donors, replaced so-­called traditional surrogacy, which uses the surrogate’s genetic contribution. Because gamete brokers had successfully established in the public imagination the relationship between genetic contribution and class acquisition, the class profile of the gestational surrogate, who does not contribute genetically to the child, became comparatively unimportant. The unbundling of uterus from oocytes in the process of third-­party conception effectively sorted oocyte vendors Fertility Outsourcing 49

into increasingly desirable class niches, packaging up accomplishments, intelligence, and appearance into upwardly tradable units, while allocating surrogates a comparatively flat class position in the reproductive labor market. While there are no large-­scale demographic studies of surrogates, a 2005 review of twenty-­seven empirical studies found that most surrogates are “in their twenties or thirties, white, Christian, married, and have children of their own. . . . Surrogate mothers’ family incomes are most often modest (as opposed to low), and they are from working class backgrounds” (Ciccarelli and Beckman 2005: 31). This profile is primarily indicative of agency screening protocols, designed to both identify psychologically and socially stable surrogates and “circumvent arguments that the process could be exploitive of poor, young, ethnic women” (Ciccarelli and Beckman 2005: 31). The number of births through gestational surrogacy remains comparatively low when compared to the number obtained through oocyte vending. The Centers for Disease Control (cdc) reports that in 2008, gestational carriers were used in about 1 percent of art cycles (915 cycles), while donor eggs were used in about 12 percent of cycles, resulting in 5,894 live births (Centers for Disease Control and Prevention 2010). Nevertheless, as we will see, contests over gestational surrogacy have had a decisive effect in shaping the contractual relations around fertility outsourcing, establishing both their exceptional status as contracts and their resemblance to much older, apparently superseded, kinds of labor contract.

Oocyte Vending as Reproductive Labor Outsourcing

Oocyte agencies in several respects create capital value in a fashion similar to sperm banks. They target and triage particular populations, recruit potential vendors, then screen and sort them according to a multiplicity of qualities—clinical, genotypic, phenotypic, educational, and disciplinary. Clinical requirements include age and body mass index (which influence physiological response to ovarian stimulation drugs) and family health history. As with sperm banks, phenotypic screening is central, because the appearance of the vendor is marketed as a synecdoche for the value of the oocytes—beauty, height, race, slimness, hair and eye color, and healthy appearance—are all assessed. Educational attainments are similarly treated as qualities that can be marketed to increase the value of the gametes, and recruits with high sat scores or qualifications from good schools attract higher fees (Al­meling 2007; Holster 2008). The agencies characterize each recruit according to the extent to which they embody such qualities, and they order 50 Chapter Three

the availability of the recruits’ gametes through databases that allow intending parents to search for their preferred combination of qualities. Hence, both oocyte agencies and sperm banks work by transforming latent genetic qualities dispersed throughout the population into a genetic capital, a reproductive resource ordered by price and sold into the gamete marketplace. Oocyte agencies nevertheless pursue a different kind of brokerage than sperm banks, and the labor process of producing oocytes is much more onerous than that of producing semen. As we will see, agencies facilitate a double form of outsourcing. They constitute an available pool of external genetic capital for clinics, freeing them of in-­house tasks, and they mediate contractual relationships between a vendor, who supplies an externalized element of the biological sequence necessary to produce a child, and purchasers, who are unable to complete this sequence without a third party. The agency supervises the contractual schedule that specifies the delivery of gametes and ensures that vendors meet their contractual obligations. Commercial oocyte production involves extensive hormonal and clinical intervention in the vendor’s body, to change its reproductive rates and rhythms. The vendor’s biology is effectively altered in the interests of the purchaser’s biology to coordinate her reproduction schedule with the intending mother’s cycle and to produce a surplus of reproductive potential to compensate for the intending mother’s deficit. The medical procedures are the same ones used to treat fertility patients, and in what follows we will use interview material from a study carried out by Waldby and colleagues with Australian patients and noncommercial donors.4 This is not to suggest that the experience is the same. It is evident when comparing Al­meling’s interviewees with interview material from Waldby’s and other studies of fertility patients (e.g., Franklin 1997; Throsby 2002) that being paid to provide oocytes is a qualitatively different experience from that of women using the same technology to try for pregnancy, a difference we will discuss below. Nevertheless, there are overlaps in experience in terms of logistics, self-­ management, the adherence to unfamiliar and rigorous timetables, and the endurance of pain and discomfort, and we draw selectively on material that illustrates such overlaps. To achieve ovarian stimulation, the woman must subscribe to a complex daily hormonal drug regime. Initially pituitary function, which normally regulates reproductive metabolism, is shut down. This involves approximately two weeks of daily hormone injections or use of a nasal spray, and blood tests and ultrasound to determine whether ovarian activity has been sufficiently suppressed. The process is in effect an artificially induced, Fertility Outsourcing 51

brief menopause, often including hot flashes and other symptoms. The next stage involves a daily or sometimes twice-­daily administration of follicle-­ stimulating hormone (fsh) to stimulate the production and maturation of multiple oocytes in the ovaries. fsh is administered by subcutaneous injection, and this is usually undertaken by the woman herself rather than at a clinic. The injections must be taken at the same time each day, and hence put something of a strain on women with work and family schedules. They also involve the management of awkward and potentially embarrassing drug paraphernalia. Throsby, in her study of British ivf patients, recounts women concealing injecting equipment from work colleagues and discreetly absenting themselves from meetings and workplace functions to keep to the timetable (Throsby 2002). The rate of oocyte production is monitored through transvaginal ultrasound and blood tests, so women also have to present for regular examinations. One noncommercial donor interviewed for the Australian study describes the difficulties of regular, timed self-­administration and clinic attendance while caring for small children. I guess because, having the boys . . . there was no need for them to know about it, and I think it’s a bit complicated for them to [have it] explained anyway, and having to have the injections at a certain time every day. . . . A couple of times we were away and I had to . . . take [the medication] with me and do it wherever I was, so I guess, yeah, just trying to stick to that routine with all the other demands of children and so on was [difficult]. . . . My youngest came with me for one of the scans . . . but he didn’t really know what it was all about. So yeah, that was a bit of a challenge. (Jenny, oocyte donor) There is no strict one-­to-­one relationship between the dosage levels of ovarian stimulation hormone and the number of oocytes produced, although higher doses tend to produce more oocytes. Large numbers of oocytes in the ovaries were associated with more discomfort, pain, and bloating for both the commercial vendors interviewed by Almeling and the patients interviewed by Waldby and colleagues. One ivf patient, who produced twenty-­ three oocytes, reported, “I was in a fair bit of pain. Because there was so many, I was having a lot of back pain, I was bloated. . . . So I had an idea what was going on before I even went in for that ultrasound, that there was going to be a lot, because I had a lot of really bad lower back pain, and I was getting really tender in my abdomen” (Mandy, fertility patient). An important difference between the two groups, however, is that vendors reported that some clinics prioritized the production of large numbers 52 Chapter Three

of oocytes over vendor comfort, and even over safety. If a vendor did not appear to be producing enough oocytes on schedule, some physicians would increase medication dosages, running a greater risk of ovarian hyperstimulation syndrome (Almeling 2011). This is an unpredictable response to ovulation induction that may involve pain, abdominal inflammation, renal failure, infertility, venous thrombo-­embolism, and cardiac instability. Between 2 percent and 5 percent of women in treatment develop hyperstimulation syndrome, which is occasionally fatal (Delavigne and Rozenberg 2002; Magnus and Cho 2005). About two weeks after initiating injections, blood tests and ultrasound scans indicate whether oocytes are mature enough to be collected. If they are mature, the clinic staff administer a trigger injection, which signals the ovaries to release the oocytes. Collection takes place thirty-­six hours later, in day surgery, under sedation, using a transvaginal procedure. Both patients and vendors stated that they recovered from the physical effects of the surgery quickly, within a day or two. However, at the point of retrieval, the experience of the vendors and patients radically diverged. Patients in the Australian study and in other reports (e.g., Franklin 1997) almost universally describe the process as intensely emotional and overwhelming, using terms like “a roller coaster” and “traumatic.” Their relationship with oocyte production is particularly fraught as, like most fertility patients, they are past the age of optimum fertility and may produce low numbers or oocytes with poor viability. Anxieties about fertility are largely absent from the accounts of oocyte vendors, who are paid their fee irrespective of the success or failure of the intending mother’s pregnancy. Almeling (2011) notes the straightforward way the vendors described the process—their minimization of discomfort and lack of reference to emotional involvement or mood swings.

Contract, the Stranger, and Price

The relationship between vendors and purchasers is managed through contract. The contract sets out the legal terms through which the process of producing and transferring the oocytes will take place. Such a contract typically includes clauses that specify the vendor’s agreement to undergo the medical and psychological tests and ovarian stimulation and retrieval cycle already described. It specifies the property rights of the intending parents over the oocytes, their “sole right to determine the disposition of the eggs,”5 and their exclusive claim to any child born as part of the process. It sets out behavioral requirements for the vendor: she must typically abstain from Fertility Outsourcing 53

sexual contact, the use of both illicit drugs and unprescribed medications, and smoking. It serves as a secondary informed consent in that the vendor acknowledges that she has been fully apprised of the medical procedures and risks of ovarian stimulation. She warrants that she has adequate medical insurance in the event of medical mishap during the treatment. In exchange, the intending parents agree to pay a specified amount on oocyte retrieval, sometimes a rising amount for subsequent retrievals, and a lesser amount if the medical practice or the couple for any reason discontinues the procedure. It sets out the terms for material breach—that is, noncompletion of the contract by the vendor—along with the costs to be reimbursed and the severing of obligations for payment to the vendor. Contract, then, is the legal instrument that binds the vendor’s reproductive biology to the commissioning couples’ intentions. Contract is defined in law as a form of private agreement, freely entered into by formally equal, consenting parties, a means of exchanging entitlements and a form of enforceable promise. Contract enshrines the action of the individual entering into relations with others through specified agreement. “Contract, under this conception, is the private law of the parties to the contract: their obligations flow directly from their agreement, not merely in the sense that they have agreed to be bound, but also in that they have agreed on specific terms that bind them” (Kreitner 2007: 6). How does the use of contract law shape the transaction of oocytes? At the most practical level, contract creates the legal condition in which individuals unknown to each other can secure agreement over the exchange of reproductive capacities, an exchange more usually governed by the laws and practices of family and kinship. Contract and the striking of price is one way to do this, because both money and contract facilitate the creation of binding, if temporary, relationships between strangers. Following Simmel’s late nineteenth-­century analysis of money (1990 [1900]), Pat O’Malley argues that both money and contract are technologies for the mediation of the social relations of modernity, where people come into constant anonymous contact with others on whom they are dependent—for goods and services, for example—but with whom they have no preexisting relationship. “If the world is increasingly a society of strangers,” O’Malley points out, “then it is in that measure also a society in which relations of contract come to predominate. In such settings the imagery of ‘normal’ relationships is of the ‘free and equal’ bargaining parties, and in contract law the default remedy for wrongs arising in the relationships between such parties comes to be that of money. We could say that 54 Chapter Three

money is the form of exchange befitting a society of abstract strangers, and the form of justice likewise reflects this imaginary” (2009: 9). Contract, then, is one way to answer Titmuss’s celebrated question, posed in his study of blood donation: “Who is my stranger in the relatively affluent, acquisitive and divisive societies of the twentieth century?” (1997 [1970]: 57–58). Titmuss’s 1969 study, The Gift Relationship: From Human Blood to Social Policy, gives a quite different answer to the question of how to secure the exchange of biological material between strangers. His study argued for the virtues of a system of voluntary gifting between civil equals and extensively criticized the system of private blood markets that had developed in the United States after World War II. He locates the donation and distribution of blood within a broader set of questions regarding the nature of the social contract and the power of the postwar British welfare state to produce egalitarian and communitarian relations between citizens. Blood, and by extension other human tissues, should be sequestered from market exchange because the circulation of gifts is crucial to the formation of collective social relations and mutuality among citizens. That is, while social democratic citizens are strangers to each other in a personal sense, they nevertheless recognize each other through the systems of formal equality, social inclusion, and distributive justice that underpin the social order of the welfare state.6 This vision of egalitarian distribution is still the central principle underpinning the regulation of most solid organ and whole blood donation in the world’s democratic nations, despite the erosion of welfare states that provided the original context (Waldby and Mitchell 2006). It is also the principle that controls the circulation of oocytes in many jurisdictions, limiting the role of money to minimal compensation for a donation proper, a free gift. Unlike blood donation, however, a strict donation system for oocytes has never been able to generate a surplus. So, for example, a survey of British art clinics found that 87 percent reported a shortage of oocytes for fertility treatment (Murray and Golombok 2000), and a recent survey of 2,269 Australian users of art services found that only 4 percent indicated a willingness to donate for fertility treatment (Access Australia 2008). In the United States, however, brokers and clinics have successfully produced a commercial oocyte surplus in part by building on a different tradition of contract and a different history of relations between bodies and markets. As we saw in the introduction to this chapter, the entire history of US labor is irrevocably marked by the social enthusiasm for contract as the opposite of chattel slavery, the most effective expression of a person’s right Fertility Outsourcing 55

to self-­ownership and civil freedom. Just as Titmuss’s argument for the gift relation is couched in a normative strategy for state-­engendered egalitarian social order, so the argument for freedom of contract is couched in a particular ideal of self-­regulated social relationships that take place without the intervention of the state (Yeatman 1996). As the historian Amy Stanley writes, “In postbellum America contract was above all a metaphor for freedom. In principle, contract reconciled human autonomy and obligation, imposing social order through personal volition rather than external force. To contract was to incur a duty purely by choice and establish its terms without the constraints of status or legal prescription. . . . As a relation of voluntary exchange, contract was premised on self-­ownership. In order to surrender rights and accept duties, parties to contracts had to be sovereigns of themselves, possessive individuals entitled to their own persons, labor and faculties” (1998: 2–3). Oocyte outsourcing thus contracts work to secure the reproductive capacities of young women by addressing them as the proprietors of their own biological capital and as calculating subjects who rationally and precisely exchange their capacities (Kreitner 2007). At the same time, reproductive contracts involving women’s, rather than men’s, reproductive biology, position the contracting parties in exceptional ways. First, both gestational surrogates and oocyte vendors are excluded from negotiations over price. While the agency will negotiate fees upward with intending parents if possible, the oocyte provider herself is actively discouraged from attempts to negotiate. Women who attempt to bargain on their own behalf are considered not psychologically appropriate to the task and may be excluded on those grounds (Almeling 2007). This paradox is generated by the marketing rhetorics used by brokerage companies, saturated with references to “the gift of life” and the maternal generosity of potential surrogates and oocyte providers. By imagining the transaction as a gift relation, the parties can experience the exchange in less starkly commercial and adversarial terms than those stated in the contract. Without this softening language, the spectacle of the oocyte vendor as the efficient negotiator of her reproductive capital threatens to contaminate the maternal generosity that has formed part of her market appeal. At the same time, the deployment of gift rhetorics responds to the concerns expressed in the guidelines of the American Society of Reproductive Medicine (asrm) and the Society for Assisted Reproductive Technology, the two professional organizations that have undertaken the task of industry self-­regulation in the United States. Both organizations explicitly argue 56 Chapter Three

against payment for oocytes on the standard bioethical grounds of undue inducement, and for a compensation model more in line with European and Commonwealth systems. Agencies have a strong stake in maintaining good relations with these bodies, and many have signed voluntary agreements to limit payment to levels approved as appropriate compensation. Aaron Levine, in an exhaustive study of the market price for oocytes at April 2006, found that mean level of payment hovered at the upper limit of asrm guidelines (�10,000), at �9,190 across 105 advertisements. The mean for “Ivy League” oocytes was closer to �20,000, with an advertised maximum of �50,000. Levine concludes that while “the majority of advertisements identified in [the survey] complied with asrm guidelines, a substantial minority did not” (2010: 35), suggesting that the price effects of voluntary regulation are moderating rather than determining.

Specific Performance, Intending Parents: Reproductive Contracts as Labor Contracts

Reproductive contracts have another exceptional feature, one more consequential for their consideration as labor contracts. The majority of states in the United States nullify surrogacy contracts (Lee 2009). States that prove willing to enforce such contracts are also those where commercial surrogacy agencies base their core business. In the United States this includes California, Arkansas, and Texas (Drabiak et al. 2007). California has perhaps the most developed reproductive business model, built on a body of contractual ordering that enforces specific performance7 by requiring that the tasks set out in the contract be fulfilled. Specific performance is an anachronistic requirement in modern contract law, a form of ordering that has largely fallen into disuse. O’Malley documents the steady substitution of money damages for specific performance during the nineteenth century, as the dynamics of liberal society and laissez-­faire economy come into historical play: The remedy of specific performance had come to be seen as involving the state in an unwonted degree of interference or even coercion. The court would have to stand over the plaintiff in a civil dispute to ensure that he or she behaved in conformity with the contract. A critical feature of the money sanction was its reduction in apparent coercion. . . . The liberty of the individual to elect not to perform a certain action in the domain of civil society or the economy is preserved. The price of this liberty is the amount the defendant would have to Fertility Outsourcing 57

pay in money for any harm to the expectations of contracting parties. (O’Malley 2009: 119–120) Nevertheless, while specific performance has largely been abandoned in determinations over commercial contract, it remained a feature of certain labor contracts well into the nineteenth century. Steinfeld (2001) notes that most legal history holds that wage labor in the nineteenth century was defined by the refusal of courts to enforce performance. The freedom to terminate contracts at will is understood to distinguish free wage labor from slavery and indenture, where specific performance was routinely enforced (Morris 1996). Nevertheless, Steinfeld (2001) demonstrates that in England employers had access to penal sanctions to enforce performance until 1875. Only progressive pressure, labor agitation, and resulting legislation finally overturned the practice. In the United States, employers used wage forfeiture and the practice of “entirety” (withholding pay until completion of the contract) to enforce performance until almost the end of the nineteenth century. While specific performance is rarely evoked in contemporary contract law, the area of reproductive contracts is a signal exception. It is notable that the human capital theorists, particularly Richard Epstein, have argued vigorously for the application of specific performance in surrogacy contracts on the grounds that state-­based regulation has no place in private law and that the intending father’s biological and legal rights to the child trump those of the gestational mother’s precisely because they are contractually enshrined. In his words, “In the abstract it is hard to determine whether the surrogate mother or the biological father has a greater interest in the child. But the genius of contract is to take this decision out of the public realm and to allow the parties to decide the issue for themselves. If specific performance is called for, then there has been a prior mutual evaluation as to who should have custody of the child, and there exists no reason for any court to reverse that judgment by refusing to enforce the contract as written” (R. A. Epstein 1995: 2337–2338). In cases where specific performance has been ordered, this logic is quite in evidence. The most important case here is Johnson v. Calvert (1993). In 1990, the Californian trial and appellate courts were called to decide between the claims of the gestational surrogate, an African American woman named Anna Johnson, and those of the white commissioning couple, the Calverts. While the Calverts had provided both sperm and oocytes, Johnson argued that her bearing and birthing of the child gave her superior claim to 58 Chapter Three

be its legitimate parent. The lower courts found in favor of the Calverts on grounds that Johnson was a host rather than a mother to the child and that the Uniform Parentage Act (1975) favored genetic parenthood over gestational parenthood (Cherry 2001). The California Supreme Court overturned the ruling on the grounds that neither the Uniform Parentage Act nor other adoption or family law statutes in fact gave clear guidance regarding the distinction between genetic and gestational motherhood. They noted that in the situation of oocyte donation, the nongenetic mother is treated in law as the natural mother. Instead the Supreme Court based its determination on contract law, looking to the intention expressed in the contested surrogacy contract, and by extension in oocyte contracts. The ruling states: [The Calverts] are a couple who desired to have a child of their own genetic stock but are physically unable to do so without the help of reproductive technology. They affirmatively intended the birth of the child, and took the steps necessary to effect in vitro fertilization. But for their acted-­on intention, the child would not exist. Anna [Johnson] agreed to facilitate the procreation of [the Calverts’] child. . . . We conclude that . . . she who intended to procreate the child—that is, she who intended to bring about the birth of a child that she intended to raise as her own—is the natural mother under California law. Thus, under our analysis, in a true “egg donation” situation, where a woman gestates and gives birth to a child formed from the egg of another woman with the intent to raise the child as her own, the birth mother is the natural mother under California law. (Johnson v. Calvert 1993) The court held that Johnson had been contracted to facilitate the Calverts’ reproductive intentions (Jasanoff 2005) and that this arrangement was indeed emblematic of a woman’s freedom of contract. “The argument that a woman cannot knowingly and intelligently agree to gestate and deliver a baby for intending parents carries overtones of the reasoning that for centuries prevented women from attaining equal economic rights and professional status under the law. To resurrect this view is both to foreclose a personal and economic choice on the part of the surrogate mother, and to deny intending parents what may be their only means of procreating a child of their own genetic stock” (Johnson v. Calvert 1993). Johnson was ordered by the court to complete the contract by relinquishFertility Outsourcing 59

ing the child, rather than to pay damages. Here we can see the exceptional status of reproductive contracts, considered from the perspective of either labor law or private law. As a kind of labor contract, gestation is at odds with industrial labor contracts because, unlike the industrial worker, the gestational mother literally embodies the means of production: the biology of parturition.8 One reason that factory owners rarely needed to assert specific performance by the late nineteenth century was simply that, as the owners of plant and productive technology, they could rely on the workers’ functional dispossession from these means of production to enforce labor discipline or to readily replace a terminating worker (O’Malley 2009). So, while assisted reproductive technologies Taylorize biology, externalizing and rationalizing its elements, gestation is one process that cannot (at least as yet) be either externalized or accelerated. The illiberal enforcement of gestational contracts comes into play because the surrogate cannot be biologically detached from her means of reproduction, so legal detachment is displaced to the postnatal child. Considered as a kind of private contract, a resort to money remedies is constrained by the nonfungible nature of the child, the promise that the contract is designed to enforce. The expectations of the intending parents cannot be met by a money equivalent, because the child cannot be exchanged for anything else. Effectively, the court enforces the family rights of the intending parents over the labor of the surrogate, which bears the imprint of the commissioning couple’s “genetic stock” or “procreative intent.” The surrogate’s labor does not belong to the surrogate herself; rather, it forms part of the commissioning couple’s biological inheritance. For this reason the surrogate’s productivity cannot be readily framed as fungible, abstract labor, and the normal terms of contractual adjudication are suspended in deference to the claims of family integrity.9 At the same time, specific performance means that the surrogate must accept a money equivalent for the child, framed as payment for the reproductive process, which she has agreed to bind to the intentions of the commissioning parents. This asymmetrical transaction most clearly expresses the property relations that surrogacy contracts enforce.

Conclusion: Production and Reproduction

We can see from this account that the US reproductive labor market emerged from a broad set of social transformations in the historical relations between production and reproduction, as well as from sets of more local contingencies. During the nineteenth- and twentieth-­century formation of modern 60 Chapter Three

industrial labor, reproductive biology and the reproducing women were excluded from the sphere of production, as necessary but external supports for the male worker. The Californian oocyte and surrogacy markets of the 1980s gain their momentum in part from the social energies unleashed by dismantling of this particular gender order, the Fordist household of public male breadwinner and private domestic housewife. We can say that the vertical disintegration of national production and the large corporation associated with post-­Fordism, the shift to horizontal outsourcing, was accompanied by the vertical disintegration of the Fordist household and the development of new kinds of contractual mechanisms to secure both biological and social reproductive capacity from outside the family unit proper. They have also gained momentum from a broader experimentation with the technical ordering of life, taking place not only within reproductive medicine but also in microbiology, genetics, virology, embryology, and the other disciplines that underpin the life science revolution of the late 1970s. This technical innovation is focused on mobilizing living processes from new sources of in vitro production, engineering entities like recombinant dna and oncogenic cell lines to generate new forms of biomedical and capital value (Cooper 2008). Ironically, it is precisely the bitter social disputes about the beginnings of life, the US abortion debates of the 1970s and 1980s, which created the regulatory vacuum in which libertarian experimentation with the generation of life could flourish. In the cases we have examined, both the processes and subjects of reproductive biology are gradually enrolled in a new kind of labor process, one that produces fertility surpluses as a form of fungible value, transacted through private contract. We can also see that this reproductive labor process tracks a larger experiment with outsourcing as a form of labor value and biopolitics. Like other forms of outsourcing, fertility outsourcing externalizes risk—in this case, the biological risks of technically assisted reproduction and the affective risks of surrogacy, assumed by reproductive vendors. The primacy of private contract and the absence of regulation have shaped the US fertility market, particularly the oocyte market, into a highly stratified sector, which tends to sort vendors upward, into more and more rarefied spheres of class accomplishment and fee levels, understood as forms of genetic capital. As we will see in the next chapter, fertility outsourcing is organized in quite different ways elsewhere, with different consequences for vendors, purchasers, and clinics.

Fertility Outsourcing 61

Four

Reproductive Arbitrage Trading Fertility across Borders

Assisted reproductive technologies open up the biology of fertility to flexible spatial possibilities and new productive ratios. Once the elements of conception take place ex vivo, reproduction can involve not only multiple bodies but also multiple locations. These scale effects are perhaps most evident in the contemporary market for Nordic semen, ordered online, frozen and shipped around the world (Kroløkke 2009). The elements of female reproductive biology have not so far lent themselves to this kind of frictionless circulation. Oocyte production and gestation remain far more time- and space-­constrained than semen, as they lack technologies for storage and deferral and gestation remains irrevocably in vivo.1 Nevertheless, art clinics in many parts of the world increasingly transact reproduction across national borders, procuring fertility from young women in one national location and selling it to older women or couples in another place. Unlike global semen markets, however, the parties to these arrangements must travel.2 As we saw in the previous chapter, different nations have adopted widely varying approaches to the regulation of donor-­assisted

conception, ranging from complete prohibition, through strict gift-­based regulation and compensation models, to a total absence of regulation. The consequent patchwork nature of national and provincial regulation creates distinctive geographies of permission and prohibition, so that intending parents may elude national regulatory restrictions and travel to a jurisdiction where oocyte or surrogacy markets are permitted. Women who work as oocyte vendors or gestational surrogates may need to travel to urban or provincial clinics, and sometimes from one country to another, and remain there for the duration of the process. In any case, the vendors, brokers, and purchasers of female fertility generally all have to be in one location at crucial points in the process. As Sven Bergmann notes, “Particular processes can be coordinated by e-­mail and telephone across national borders, but the decisive moments of ivf treatment [with oocytes] require human protagonists and substances to be on location; they must be fixed for a certain period of time to the local infrastructure of the ivf clinic and laboratory” (2011a: 284). The term “fertility tourism” is often used to describe this phenomenon, with its connotations of the leisured consumption of an exotic elsewhere. The term is considered derogatory by regulators and ethicists, who prefer the more neutral “cross-­border reproductive care” (Shenfield et al. 2010). However, our focus in this chapter is on the ways that market transactions organize cross-­border fertility chains, material transfers of fertility from one location to another.3 “Fertility tourism” gives a better sense of the relations between travel, purchasing power, and reproductive service labor that constitute the core of cross-­border oocyte and surrogacy markets. A significant proportion of fertility tourists travel because particular forms of reproductive labor are unavailable or unaffordable at home. As we saw in the previous chapter, the average price of oocytes in the United States is around �10,000, while gestational surrogates are paid fees ranging from �20,000 to �50,000 (Ciccarelli and Beckman 2005), and intending parents necessarily incur much higher costs associated with additional clinical procedures, legal fees, and so on. While the unregulated reproductive market in some US states has made it a primary destination for fertility tourists from Australia, Canada, Britain, and northern Europe, new fertility outsourcing centers are emerging, often in direct price competition with the United States. High costs at home are also seeing US residents travel to clinics in less expensive locations (Whittaker and Speier 2010). In this chapter, we will examine two fertility markets in some detail: the European oocyte market and the Indian gestational surrogacy market. We could discuss many other markets. Oocyte markets have developed in a Reproductive Arbitrage 63

number of regions—for example, between South Korea (vendors) and Japan (purchasers) until 2008, when the Hwang scandal provoked a tightening of regulations in Korea (Leem and Park 2008). In Latin America, Ecuador has developed an oocyte market featuring “light-­skinned” vendors, servicing neighboring countries (Roberts 2010), and in Southeast Asia, Vietnamese women sell oocytes and gestational surrogacy to intending parents in Thailand (Whittaker and Speier 2010). Oocyte markets tend toward regional footprints, because fertility clinics typically recruit vendors from populations phenotypically similar to purchasers, so that the resulting child will share the commissioning couples’ characteristics, particularly their skin color (although couples may also like to “trade up” to a lighter skin tone). Hence, clinics market a particular range of phenotypes and will attract clients who seek this phenotype across a regulatory border if similar services are prohibited in the country of origin. So, for example, German fertility tourists, unable to access oocytes at home, can drive a few hours to Prague, in the Czech Republic, where fertility clinics are heavily oriented toward an international clientele (Whittaker and Speier 2010; Bergmann 2011b). Gestational surrogacy is less spatially constrained, because the surrogate makes no genetic contribution, hence her ethnicity leaves no trace on the child. The burgeoning Indian surrogacy market relies on this feature of gestation, competing on price for US intending parents who cannot afford US fees, as well as for other nationals and nonresident Indians. The European oocyte market and the Indian gestational surrogacy market are of particular interest to us for a couple of reasons. First, they both play out broader trends in the contemporary feminized labor market in their respective locations, while also demonstrating the particular features of clinical labor. In Europe, a significant proportion of oocyte vendors are young eastern European women trying to navigate the insecurities of transitional postsocialist economies where formal labor options have retreated and national labor markets have dramatically restructured. Saskia Sassen (2002) and others (Ehrenreich and Hochschild 2003) have probed the relationships between the restructuring of the global economy since the 1980s and the restructuring of reproduction that concerns us here. As public funding for health and welfare is rolled back and formal work becomes more competitive in liberalizing economies, women are forced to invent new productive niches in the informal economy. In particular, women often support themselves and their children by recasting their feminine capacities for nurturance, maternity, and sexuality as negotiable assets, able to be traded for money in countries where they can find employment as maids and nan64 Chapter Four

nies, as cleaners and waitresses, and as sex workers of various kinds. In Sassen’s terms, they form the “lower circuits of globalization,” shoring up knowledge-­worker households with their high consumption patterns and need for household assistance and “wifely” services no longer performed by educated, professional women (Sassen 2002: 256). Women from the Czech Republic, Romania, Russia, and the Ukraine have adopted such options in significant numbers, traveling to western Europe to take up positions as care workers. In the same way, a proportion of this population may seek to supplement low, uncertain incomes with cycles of oocyte vending, either as part of immigrant life or as an income source in their home country. In India’s case, gestational surrogacy can be located both in the marketization of India’s fertility surplus—in the fecundity of its population, which has posed such a demographic headache for both national and international governance (Connelly 2008)—and in a more general policy of international labor outsourcing. India is at the forefront of developing nations that secure business investment and economic advantage by inserting their low-­cost workforce into global production and service chains (Suri 2007). While this outsourcing strategy has focused on it and business processing, the advent of gestational surrogacy and clinical trial work opens labor outsourcing to new forms of embodied service work. We term these “services in the self”: services that rely on in vivo, biological processing and the utilization of the worker’s living substrate as essential elements in the productive process. Second, both of these fertility markets involve themselves in the commercial reproduction of whiteness. Eastern European women are a particularly desirable oocyte vendor population because they share the characteristics of the northern European purchasers who travel from their more restrictive countries (Germany, Scandinavia, the United Kingdom) to the southern and eastern European clinics that facilitate matching. Oocyte markets create the conditions in which eastern European women can capitalize on their phenotypic assets. Indian gestational surrogates can be secured for a fraction of the price of their Californian counterparts, but because the gametes used in conception are not theirs, the resulting child will (ideally) look like the commissioning couple rather than the surrogate herself. Not all of the clients for Indian gestational surrogacy are fair-­skinned, but a significant proportion of such clients do travel from North America, Australia, and western Europe to take advantage of the capacity of Indian surrogates to reproduce white children at a discount. This reproduction of whiteness locates these fertility markets in a much longer history, in which older, prebiotechnical forms of feminized labor involved nonwhite women assisting Reproductive Arbitrage 65

in the creation and care of white children—through wet-­nursing, household servitude, and the (usually illegitimate) bearing of children (Glenn 1992). In what follows we will consider the dynamics of reproductive labor arbitrage, the trading of low-­cost fertility across borders, in these two regions but also more generally.

The European Oocyte Market

As we saw in the previous chapter, California has pioneered the creation of an entrepreneurial reproductive labor market, capitalizing in part on demand built up in less libertarian states. While California and some other US states have also been the original destination of choice for non-­US intending parents wishing to secure commercial oocyte vendors, an extensive European market for reproductive oocytes has emerged from the complex network of regulatory restrictions and aporias, national health insurance, cultures of tissue exchange, private medical initiatives, and phenotypic distributions that constitute the eu member nations and their neighbors. Regulations range from the complete prohibition of all forms of oocyte donation (Austria, Germany, Italy), through gift-­based systems that permit modest reimbursement for direct expenses (for example, Estonia), through specified levels of permissible compensation that might include wages lost (for example, the United Kingdom prior to 2011), or both time and inconvenience (for example, the Czech Republic and Spain), to nations that have no specific regulations (for example, Poland and Russia) (Hochschild 2001; European Commission 2006). eu member states are signatories to the Oviedo Convention and the eu Tissue and Cells Directive, as well as various national statutes that prohibit the exchange of body parts for money (Council of Europe 1997). They also belong to a broader European cultural commitment to the gift relation (Waldby and Mitchell 2006). Despite these anticommercial principles, Europe supports a vigorous intranational and cross-­border oocyte market, which has developed opportunistically to exploit the discrepancies and regulatory vagaries of various member states and their neighboring jurisdictions. The market is in part an effect of sheer demand and high volumes of treatment turnover. More than half of art procedures worldwide take place in the European area (de Mouzon et al. 2010).4 There are no reliable figures on the number of intending parents seeking cross-­border treatment, as registries do not record patients exiting their own country. Nevertheless, a recent survey of cross-­border patients conducted in forty-­six clinics in six European countries (Belgium, 66 Chapter Four

Czech Republic, Denmark, Slovenia, Spain, and Switzerland) estimates that those clinics alone performed fifteen thousand treatment cycles per annum for nonresidents (Shenfield et al. 2010). As we will see, the oocyte market forms a distinct circuit within the more general geography of European reproductive travel, where intending parents cross borders for a number of reasons. While many sought oocytes, others sought donor semen and intrauterine insemination. Some respondents traveled because as single women or gay couples they were excluded from treatment in their own countries, or because their age excluded them from subsidized treatment, and cheaper private treatment was available in other jurisdictions. These travel circuits are shaped not only by a regulatory patchwork but also by what, following Aiwha Ong (2006), we term “reproductive labor arbitrage.” Labor arbitrage describes a particular kind of outsourcing, where firms not only contract out their workforce but also seek the same skills for lower wages offshore. Ong writes, “Arbitrage is a term normally used in financial markets, referring to the practice of buying low in a market and selling high elsewhere. Arbitragers exploit price discrepancies between money markets in order to make a profit. . . . Until recently, the term arbitrage was not applied to labor markets. The global search for cheap labor in manufacturing, I argue, can be called a kind of industrial labor arbitrage that operates according to the logic of same skills, different prices” (2006: 160). As we noted earlier, the search for cheap labor has extended beyond the manufacturing sector that concerns Ong, and the globalization of informational and business service, to include the kinds of services in the self involved in third-­party fertility provision. In this respect, we can identify an arbitrage dynamic in the European oocyte market. Clinics procure cheap fertility produced by young, comparatively poor women in one national location and sell it to wealthier, older women and couples in another. Complex restrictions placed on oocyte procurement, both at the regional and member-­state levels, shape the geography of this market. In particular, it is shaped by the different ways member states have interpreted the European Union Tissues and Cells Directive (Directive 2004/23/ec), which forbids the exchange of human tissues for money but permits compensation “which is strictly limited to making good the expenses and inconveniences related to the donation” (Art.12[1]).5 Within the eu, this directive prevents the development of a fully monetized, contractual market like that found in California, where fees for oocyte vendors are determined simply by demand pressures. Instead, oocyte markets have developed in European states where compensation has adopted de facto features of monetization. Outside the regulatory Reproductive Arbitrage 67

space of the eu, a more frankly monetized market also operates, soaking up the demand for “white” oocytes but also operating under riskier clinical and recruitment conditions. In what follows, we can see the flexibility of the compensation principle in biomedical regulation and the impossibility of making an absolute distinction between money-­based compensation and monetization. As a bioethical principle, compensation is intended to recognize various, often codified costs incurred (expenses, inconvenience, time) as a result of research participation and to return the research subject to a position of social and economic equilibrium through equivalent payment or in-­kind services. It is intended to facilitate a gift economy by removing material barriers to voluntary participation without creating “undue inducement,” an instrumental incentive to participate in medical research. In the terms set out by the World Health Organization guidelines, “Payments in money or in kind to research subjects should not be so large as to persuade them to take undue risks or volunteer against their better judgment. Payments or rewards that undermine a person’s capacity to exercise free choice invalidate consent” (Council for International Organizations of Medical Sciences 2002: 46). Hence, compensation rates are in principle set at an ethical equilibrium point, sufficiently high that they are not exploitative but sufficiently low that they do not transform participation into a transaction. Actual rates are ideally a decision borne of formal deliberation by ethics committees (Council for International Organizations of Medical Sciences 2002). But in the European Union, we argue, compensation rates are currently being pushed toward market equilibrium, rather than ethical equilibrium, by the intense demand pressures for oocytes created by fertility patients and art clinics. While the prohibition on selling tissues for money is historically intended to protect the donor from predatory transactions (Waldby and Mitchell 2006), regulatory concern in the fertility medicine field is steadily shifting toward the protection of patients. In particular, regulators express concern over the risks patients incur when traveling outside national borders for treatment.6 Consequently, the existence of an intra-­European market is steadily eroding the ability of bioethics councils to keep compensation rates below an incentive level, as pressure mounts to improve intranational oocyte supply. The Compensation Market The geography of the European oocyte market, broadly speaking, involves purchasers from the North and West traveling to procurement clinics in the South and East. Countries with the most restrictive approach to oocyte 68 Chapter Four

donation (prohibited or permitted without compensation) cluster in northern Europe (Germany, France, Netherlands, Sweden), while those with liberal approaches, particularly to compensation, are Spain and the Czech Republic and, outside the eu, Russia, the Ukraine, and Cyprus. The exception to this northern European pattern is the United Kingdom, which has a comparatively liberal approach to oocyte donation, yet generates a considerable number of fertility tourists, for reasons we will explore below. Treatments classified as “oocyte donation” by the European ivf-­ monitoring consortium cluster in roughly this pattern. In 2006, as in previous years, Spanish clinics performed by far the greatest number of procedures involving donated oocytes (6,547), followed by the United Kingdom (1,763), Russia (1,110) France (573), Belgium (563), and the Czech Republic (511).7 In contrast, many reporting countries record no oocyte donation procedures (Netherlands, Switzerland, Italy, Germany) or very low numbers (for example, 22 in Iceland) (de Mouzon et al. 2010). These figures do not differentiate between treatment for residents or nonresidents, but there is reason to assume that the figures for France and the United Kingdom describe primarily intranational oocyte donation, as both countries are “sender” states for couples seeking oocytes, and France forbids compensation (Shenfield et al. 2010). Several country-­specific studies have found significant and often dramatically increasing numbers of residents traveling across borders for egg donation over the last five to ten years. For example, a Dutch study found a threefold increase between 2000 and 2008, both in the numbers of gynecologists approached to assist with cross-­border egg procurement and in the numbers of patients who actually traveled, mostly to Spain (Van Hooff et al. 2010). A British study of fifty patients who sought treatment elsewhere identifies lack of United Kingdom oocyte donors and waiting times as a major reason for travel, with Spain and the Czech Republic as the most popular European destinations.8 In the six-­country survey of 1,230 cross-­border patients, nearly a quarter—particularly German and British women—reported that they were seeking oocytes. While Germans preferred the Czech Republic, directly across their border, other nationalities preferred to travel to Spain (Shenfield et al. 2010). As the studies above suggest, Spain is at the forefront of European oocyte procurement, largely because of a specific history of liberal and light-­touch regulation of fertility medicine. The beginnings of ivf in Spain in the mid-­ 1980s coincided with a wave of post-­Franco liberal legislative reform around reproduction, family law, and women’s rights and a modernization policy intended to promote medical research. This low-­regulation approach has conReproductive Arbitrage 69

tinued into the present, creating the conditions for a flourishing, entrepreneurial private fertility industry. At time of writing there were around three hundred clinics operating in Spain, 90 percent private, clustered along the Mediterranean coast, in tourist sites or near airports offering cheap flights (Idiakez 2008, 2010). Multilingual websites and Internet communication have made international partnerships and patient bookings much easier. So, for example, the fertility company Nordica, with English, Danish, and Lithuanian web pages, offers oocytes through a Spanish clinic. Their website states, “At Nordica we offer treatment with egg donation. We have a co-­ operation [sic] with a fertility clinic in Spain. The clinic has a great experience with egg donation and also offers eggs to women with a Scandinavian look. If you want egg donation abroad, all consultations, preliminary examinations and the medical treatment take place in the Nordica Fertility Clinic. The fertilization of the egg and the transfer of the fertilized egg take place in Spain. After your homecoming the after-­treatment takes place at Nordica.”9 Spanish clinics are able to recruit significant numbers of oocyte vendors because of the way they administer donor identity and compensation. In Spain, clinics are obliged to anonymize gamete donation. Even when a patient finds her own oocyte provider, she will receive the oocytes of a second, unknown woman to preserve anonymity in the process, while the first woman’s oocytes will go elsewhere (J. Edwards 2008). This is in marked contrast to the United Kingdom and a handful of other eu nations (Sweden, Austria, Switzerland, the Netherlands, Norway, and Finland) which have banned anonymity (Idiakez 2010) and require donors to make their identity ­available through registries accessible to offspring when they reach a certain age. Donor registries have a generally depressing effect on donor numbers. In the United Kingdom, for example, both the numbers of women registered as egg share donors and the number of treatment cycles with donated eggs steadily decreased after the introduction of the legislation.10 Registers particularly deter young potential donors, for both sperm and oocytes (Glenn 1992). Spanish clinics also excel at recruitment because of the way they administer compensation. They have effectively monetized the process, so that it is paid as a de facto fee. First, they give relatively generous interpretation to the compensation required for time and inconvenience. Fees range from €900 to €1,200 (Dickenson and Idiakez 2008; Shenfield et al. 2010), a relatively substantial figure when compared to the £250 paid until recently in the United Kingdom (about a quarter of the Spanish rate). Until 2011, the UK system only compensated for time and a proportion of lost wages. How70 Chapter Four

ever, as we discuss in more detail below, this system has recently expanded to include the category of inconvenience, and the rate increased substantially. Second, Spanish compensation is a comprehensive rate, paid in cash. Oocyte providers do not have to document or itemize costs, as they did in Britain until 2011. In this sense, Spanish compensation takes on the liquidity and depersonalizing action that is a feature of monetization. In Simmel’s account (1990 [1900]), money facilitates exchange, changes in ownership, and the transfer of a surplus from one party to another. It does this precisely in its role as incentive, forcing the less willing party into trade once the price point is sufficiently high. To use Callon’s term, money disentangles objects from their owners by providing equivalence, while also facilitating impersonal circulation. Buyers and sellers strike price, complete their transaction, and are quits (Callon 1998). As Simmel puts it, “Exchange itself is embodied in money” (1990 [1900]: 293). As a consequence of this approach, Spanish clinics are able to recruit a steady supply of oocyte vendors from among groups of young women seeking anonymous transactional exchange, advertising through university notice boards and student magazines (Uroz and Guerra 2009), beauty parlors, and supermarkets and by word of mouth (France 2006). There are two primary vendor populations. The first is Spanish and international college students, who are trying to meet living costs and tuition fees. The second is migrants from Latin America and eastern Europe, working in agriculture or domestic service (Idiakez 2010; Bergmann 2011b). The post-­Franco Spanish state has been particularly active in enabling Spanish citizens to recruit women from the former Eastern bloc and from Spain’s old empire to provide private domestic assistance and care for children and the elderly, offering regular amnesties to undocumented workers and the possibility of citizenship, for example (Escriva and Skinner 2008). For migrant care workers focused on remittances to their own children and households back home, oocyte vending offers an intermittent source of additional, undocumented funds. The recruitment of both immigrant and Spanish vendors allows clinics to market a range of phenotypes, so that diverse populations of fertility tourists can find a match. Eastern European women in particular are highly desirable recruits for Spanish clinics, so that clinics can match their oocytes with northern European purchasers (Idiakez 2010). In his ethnography of a large clinic in Barcelona, S. Bergmann (2011b) found that both the demand for and supply of oocytes was so steady that the clinic did not wait to match a purchaser with a vendor before starting treatment. Rather, they eliminated waiting times and matched in the course of treatment. If a vendor responds Reproductive Arbitrage 71

well to ovarian stimulation and produces a large number of oocytes, clinics may invite her back for repeat procedures (Idiakez 2008). So it is evident that Spanish clinics can recruit oocyte vendors because they transact prices that constitute significant income for some populations of young women. The same liberal interpretation of compensation can be seen at work in clinics in the Czech Republic, the other destination of choice for eu fertility tourists seeking oocytes. Like Spain, the Czech Republic has specific legislation stating that gamete donation must be voluntary, gratuitous, and anonymous. Donors may be compensated, but not paid.11 Like Spain, compensation rates are set at a point that reflects the differential purchase power of international patients compared to young Czech women: around €600. This amounts to between two and three months’ salary for a woman working in the service sector (Whittaker and Speier 2010). Bergmann reports a preference for rural vendors among Prague clinics, facilitated by networks of gynecologists in small provincial centers. Rural vendors are both more in need of money and considered more “pure” than urban donors, less likely to be hiv-­positive and less likely to be “gypsies” (Romani) or undesirable migrants. As Bergmann notes, while the Spanish model caters to the requirements of a cosmopolitan, ethnically diverse clientele, the Czech model is more concerned with conserving the values of ethnic purity, untainted by the contaminations of globalization and urbanization (Bergmann 2011b). The international demand for Czech oocytes has seen the development of a two-­tier fertility industry. “The advent of a market oriented toward wealthy foreign patients has encouraged the development of clinics with access to the latest technology and procedures and has created an incentive for ivf specialists to remain in these countries. Yet it has also produced a division of elite clinics oriented to foreigners and the wealthiest local patients and other locally oriented clinics with crowded facilities, heavy caseloads, and poorer lab facilities” (Whittaker and Speier 2010: 374–375). Here we can see the ways in which transnational oocyte markets work as fertility chains. Not only do they transact fertility between individual purchasers and vendors, but they also displace fertility from one class and location to another and create new maps of reproductive surplus and deficit. Infertile Czech couples are excluded from assisted reproduction by the private clinic business model, whose focus is on the transfer of fertility to wealthier clients, to facilitate family formation elsewhere. Assisted fertility circulates across the eu according to the purchasing power of particular clienteles, moving from poor to rich, from South to North and East to West. 72 Chapter Four

The success of monetized compensation in disentangling fertile oocytes from young women is placing pressure on regulators in other member states to move toward a compensation market. This process is particularly evident in the United Kingdom, which uses two subsidization methods to encourage oocyte donation. One is “egg-­sharing,” set in place in 1998, where infertility patients may receive discounted treatment in exchange for giving a proportion of their oocytes to other infertile couples (Human Fertilisation and Embryology Authority 2005). The other is compensated gifting, as set out in the terms of the eu Tissues and Cells Directive. Between 2005 and 2011, the Human Fertilisation and Tissue Authority (hfea), which regulates reproductive tissue donation, set compensation levels for oocyte donation at £250, an amount intended to compensate for documented expenses and some loss of earnings, but not for the less easily specified “inconveniences related to the donation” (Art.12[1]). Despite these measures, British fertility patients constitute a significant proportion of European fertility tourists, particularly those seeking oocytes. They cite long waiting lists and the poor quality of gametes as a major reason to travel (Shenfield et al. 2010). In early 2011, the hfea launched a consultation on donor compensation. The consultation document listed the hfea’s major concerns as the shortage of donors, long waiting times for treatment, and the risks to British fertility patients if they use overseas services, including poor care in unlicensed clinics, and web-­based matching services. In other words, the consultation was concerned about the ways intra-­European market pressures affected British fertility patients. The options presented to meet these pressures include the expansion of compensation to include “inconvenience,” and the reduction of documentation, factors the hfea said would “remove a barrier to donation, rather than provide an incentive.”12 The consultation document repeatedly mentioned the much higher Spanish compensation rate and the fact that this was a blanket rate rather than one involving specific reimbursement. In October 2011, the hfea announced that compensation was hence set at a one-­off, low documentation fee of £750,13 a rate very close to current Spanish rates. We can see here how the terms of compensation are adjusted and expanded to manage the demand pressures created by both national queues and more transactional oocyte markets elsewhere. Compensation thus takes on more and more features of a regulated market, moving closer to monetized fees set by demand pressures and further from a notional equilibrium point set by bioethical deliberation.

Reproductive Arbitrage 73

Trans-­European Fertility Chains: Reproduction for Others Spanish and Czech clinics can recruit oocyte vendors because they have configured their payment systems to both meet the eu criteria for compensation and provide a cash incentive to particular populations of economically insecure young women. In this respect, it works in a similar way to the Californian market. However, there is also a very biopolitically significant difference between the two markets. In the United States, a wide range of vendor qualities (beauty, skin color, height, religion, Ivy League degrees, athleticism, musical accomplishments) become tradable units in a highly stratified market. Consequently, the US market tends toward ever more expensive niches, as the absence of regulation, the primacy of contract, and the scarcity of highly accomplished vendors push fees up. In the eu, clinics can match client phenotype (skin, hair, eye color), but they do not explicitly trade on class and cultural capital as the US clinics do. Moreover, the necessity to keep fees within the terms of compensation means that payment for oocytes is comparatively flat. There is little leeway for negotiation, or allocation of additional monetary values to particular donor qualities. These constraints mean that European fertility arbitrage depends not on large fee differentials to recruit ever more desirable cohorts of young women but on the differential risk exposures of young women. These risk exposures are simultaneously economic, civil, and bodily, arising from steep European hierarchies of earning capacity, human rights protections, and gendered value. Within the eu, earning power clusters in the northwestern states, where the residents of inner London, for example, have twelve times the income of residents in parts of Bulgaria. Regions with 75 percent of the eu average income are found in central and eastern Europe (Poland, Czech Republic, Romania, Bulgaria, and Hungary) and southern Europe (Italy, Portugal, and Greece) (Eurostat 2011). The oocyte compensation market has developed because these earning differentials mean that some populations of young women in Europe are more responsive to compensation-­level fees than others. In particular, the significant involvement of young women from eastern Europe, both in the eu oocyte centers like Spain and the Czech Republic and in clinics in Russia and the Ukraine, speaks to the relationship between economic vulnerability and oocyte vending. Certainly women as a group have faced more insecurity than male workers in the transition from state socialist to capitalist economies in eastern and central Europe. The end of state socialism in the early 1990s saw extensive unemployment throughout the former Eastern bloc, but women have been dispropor74 Chapter Four

tionately excluded from new employment in the expanding private sector and remain more likely to be unemployed or crowded in a shrinking public sector with poor salaries (Pollert 2005; Glass 2008). Hence women are increasingly involved in informal economic activity (Pollert 2005), as the old Soviet-era black markets expand into the entrepreneurial space created by marketization (Wallace and Latcheva 2006). Informal activity includes household subsistence (barter, food production) and work in black economies, “monetized but outside the law” (Wallace and Latcheva 2006: 81), in some cases illegal but in many simply nonlegal, unregulated as economic activity. While women may have public or private sector work, their salaries may be low or intermittent, and such workers will turn to second, undocumented jobs, paid in cash, outside taxation systems. “Black economy” earnings constituted about 20 percent of household income in central and eastern European countries in the late 1990s, while in some countries it is much higher (Wallace and Latcheva 2006). These disparities in earning capacity and economic security propel some young women into novel forms of self-­ capitalization, like oocyte ­vending. The European oocyte market is also an effect of a broader reorganization of reproduction in the region, changing relationships between states, markets, and household formation in both the former Soviet bloc and the industrial democracies in the West. On the one hand, the transition from state socialism to market societies in eastern Europe has involved the abrupt desubsidization of reproduction. Former state services for child care and health care have been withdrawn or privatized, and employers avoid statutory costs like maternity leave through dismissal or preferences for male employees (Pollert 2005; Glass 2008). Consequently, birth rates have fallen well below rates in northern Europe despite the introduction of shrill postnatalist policies restricting pregnancy termination and admonishing young women to reproduce for the good of the nation (Gal and Kligman 2000).14 In response to this situation, women have necessarily embarked on a search for forms of work that will help them sustain their families and care for children and the elderly. On the other hand, in western Europe, the mass movement of women out of the home and into professional and service work has seen a precipitant demand for assistance with child care and domestic duties since the 1980s. While the Nordic states publicly fund child care facilities and maternity leave, others, like the Netherlands, Spain, and France, subsidize private care, individualized care obligations, and migration policies that facilitate the employment of nannies, au pairs, and cleaners in the household (Lutz 2008). These transformations of household reproduction have seen Reproductive Arbitrage 75

the mass importation of care labor from eastern Europe to western, southern, and northern Europe. Households in the wealthier sectors of Europe rely on the care labor of often well-­educated, professional women who migrate from the Ukraine, Romania, Poland, and Russia, as well as from other parts of the world, to supply their need for child care, elder care, and housework (Lutz 2008). They in turn support their own children and households through remittances.15 To put it another way, households in Europe are increasingly formed through transnational relations, and reproductivity at all levels is more and more likely to involve the labor of women from outside the family proper. When these care chains are considered along with the oocyte market, we can see that eastern European feminized labor increasingly provides both the elements of biological fertility and the elements of nurture required to create and maintain families elsewhere, for others. Eastern European women provide both well-­educated care and fair-­skinned biological capital. Romanian Vendors We can see how these elements come together in the lives of eastern European oocyte vendors, documented in Michel Nahman’s ethnography of a Romanian art clinic (Nahman 2006; Nahman 2008; Nahman 2012). Romania is among the poorest of eu nations: incomes there are 47 percent of the eu average (Eurostat 2011). Only one-­third of household income is generated from the formal economy; the remainder comes from household-­level barter and food production and on undocumented work in the black economy (Wallace and Latcheva 2006). It is also a remittance economy, dependent on the income repatriated by emigrants to other parts of the eu (Eurostat 2007). The clinic in Nahman’s study is located in Bucharest and is part of an international chain, linked to a US-­based oocyte brokerage firm and a network of Israeli fertility clinics. At the time of the study (2002), Romania was not in the eu and not subject to the Tissue and Cells Directive. The clinic’s core business was to procure oocytes for Israeli women in fertility treatment. The model here was not typical of the European oocyte market because, in this case, the commissioning couple in Israel did not have to travel to the clinic. Instead, the clinic recruited young Romanian women to provide oocytes and fertilized them with the Israeli male partner’s sperm, which had been frozen and shipped. The resulting embryos were themselves frozen and transported back to Israel. Israel has a vigorous, publicly subsidized fertility industry, as part of a suite of pronatalist policies. The Israeli clients stated a strong preference for “European” oocyte providers, tall with 76 Chapter Four

pale skin, small noses, blue eyes, and European “refinement.” Nahman notes that this preference reflects the majority Ashkenazi identification with European culture but also a more general desire for Gentile, northern European norms of beauty (Nahman 2006). The twenty women Nahman interviewed were for the most part working, in poorly paid jobs in manufacture or service industries or involved in small-­ scale self-­employment. Some were students. Those with salaries stated that those salaries barely covered subsistence (rent, food), and they undertook oocyte vending as an additional, undocumented source of income. This was their only means of paying for clothing, study, basic home maintenance, or their children’s needs. Others were in debt and needed the fees to become solvent again. All the women interviewed stated that they sold their oocytes because of financial necessity. The clinic recruited by word of mouth and paid about US�200 in cash per procedure. The fee amounted to between two and four times the women’s monthly salary at that time. Some of the women interviewed had sold oocytes several times, or intended to sell again. The clinic permitted the women to go through six or seven cycles if they wished to. Nahman reported, “I asked the donors why they donate, what led them to donate their ova. They told me that they donate ‘out of desperation.’ They said they were desperate to get out of constant debt, so they can buy themselves basic ‘necessities’ such as clothes, new bedroom furniture, makeup, and cigarettes. One woman was behind on her rent for two months and so decided to sell her eggs rather than borrow money” (2005: 224). Many stated anxieties about the risks involved in the procedure but felt that they had little option, given debts and other financial pressures. Some wondered poignantly about the fate of the children conceived from their oocytes, where they would live and what they would look like. Several of the women stated that they did want children of their own but that they needed to establish themselves in careers first, or obtain some kind of income security, and that oocyte vending was one way to support themselves while they studied or improved their circumstances. While vending is a risky occupation, Nahman (2008) notes that it gave the women opportunities for consumption and self-­investment that they otherwise lacked, as they sought to position themselves in the globalizing Romanian economy of the early 2000s. Like other kinds of informal work in the cash-­based black economy, oocyte vending is here associated with a certain level of entrepreneurial drive and a desire to participate in the new world of consumption and technology, as well as simple economic desperation (Wallace and Latcheva 2006: 90). Reproductive Arbitrage 77

Indian Gestational Surrogacy

We can see an analogous situation for Indian women involved in the new transnational gestational surrogacy sector. Like oocyte markets, gestational surrogacy markets are shaped by sharp differences in national and provincial regulation and by the increasing willingness of intending parents to travel in order to obtain a child. However, unlike oocyte transactions, where issues of phenotypic resemblance tend to place regional limits on market footprint, gestational surrogacy is (potentially) truly global. The Indian business model relies on the fact that commissioning couples can utilize Indian women to reproduce their genetic child, or at least a child with their skin color, without leaving a trace of the gestational mother’s appearance. So while one transnational market for Indian surrogates is nonresident Indians, another is fair-­skinned North American or European couples. As we saw in the previous chapter, gestational surrogacy is a far more restricted practice than oocyte vending. Many national jurisdictions regard it as against public policy and place it under a comprehensive ban. India has developed as a surrogacy destination in part because it has adopted some key features of the Californian business model, while competing directly with California and other US states on price.16 While the Indian Council of Medical Research has developed nonbinding guidelines for the field (Indian Council of Medical Research 2005), private contract is at the moment the only legal instrument in play, and the Indian High Court has refused to frame statutes. In drawing up private contracts, clinics have adopted the terminology of intention to describe the commissioning couple (the intending parents), and clinics also undertake gestational surrogacy exclusively rather than so-­called traditional surrogacy (which uses the surrogate’s own gametes), to shore up the intending parents’ claims to the child in the case of legal contestation. A draft bill, the Assisted Reproductive Technologies (Regulation) Rules of 2010, that is currently before the Indian parliament would introduce statutory regulation into the area. As it is currently framed, the bill would support court enforcement of specific performance and uphold the contractual rights of intending parents over any claims by the surrogate. It stipulates that the birth certificate for the contracted child be issued in the name(s) of the individuals who commissioned the surrogacy and that the surrogate relinquish all rights to the child at birth (Indian Council of Medical Research 2010). There are no reliable national statistics, art registries, or well-­resourced monitoring bodies to provide an overview of the surrogacy sector in India, so it is impossible to estimate precise scale, and our account is necessarily 78 Chapter Four

impressionistic. The first international gestational surrogacy was carried out in 2003, at the Akanksha clinic, in Anand, Gujarat, and by 2009 there were 240 such births at that clinic, according to its director. Anand now supports a booming service industry in hostel accommodation for surrogates and brokers. During her 2008 fieldwork in a northern Indian surrogacy clinic, Kalindi Vora (2011) reports, the doctors there were aware of other clinics in the cities of Chennai, Mumbai, Hyderabad, and Ahmedabad. India has a well-­ developed, long-­standing, and quite unregulated private fertility industry, supported by the intense cultural stigma attached to infertility (­Bharadwaj and Glasner 2009), with an estimated 350 clinics (Carney 2011), so the clinical infrastructure to expand the gestational surrogacy sector is readily at hand. Medical tourism and surrogacy law companies in the United States are investing in the sector. For example, Proactive Family Solutions, Mumbai, a wing of BestMed Journeys, Florida, has opened to broker surrogacy arrangements between US commissioning couples, Indian fertility clinics, and Indian surrogates (Sarojini 2010). In an interview with the New York Times in 2008, the president of PlanetHospital, a Californian medical tourism agency, estimated that they would assist one hundred US couples that year to travel to India to secure a surrogate (Gentleman 2008). Different agencies make wildly varying claims about the net worth of the sector to the Indian economy. In 2008 the Economic Times estimated that the surrogacy business was worth US�445 million and that it would be worth up to �2 billion by 2012 (Economic Times, 25 August 2008). While the evidently rapid expansion of the gestational surrogacy sector is startling, in many ways its organization, particularly its international orientation, is consonant with other broad developments in the Indian economy and labor market. Since the early 1990s, India has moved from the national protectionist development model directed by the Congress Party after independence to an explicitly neoliberalized development model, involving the “flexibilization of labor and the informalization of economic activity” (Breman 2007: 3). Embracing World Bank (1989) advocacy of informal labor as the key to unlocking indigenous innovation and latent entrepreneurship, successive national administrations have reduced the availability of public sector and formal regulated work, while various forms of subcontracting and outsourcing have multiplied. Elizabeth Hill (2010) enumerates the varieties: home-­based work, sweatshop production, own-­account work, casual and day labor—all forms of work that fall outside official labor market statistics and labor law protections, yet provide employment for the vast majority of Indians. Reproductive Arbitrage 79

The expansion of the gestational surrogacy sector can also be located in a more general move to offshore service provision in the Indian economy. International trade in labor-­intensive services is a primary form of labor arbitrage, and both successive Indian administrations and enterprises have sought to attract it services and business-­process work with a well-­educated, low-­cost workforce (Suri 2007). Service outsourcing has effectively become the Indian national development model and driver of job creation, inserting Indian labor into offshored components of the it, communications, and pharmaceutical industries, in particular (J. Harris 2005). While offshoring services is advocated as an economic option for all developing nations, and indeed as a means of expanding services available to local populations as well as international clients (United Nations Conference on Trade and Development 2006), India has pursued this strategy most successfully, accounting for 80 percent of all such activity in developing countries (Majluf 2007). As signatory to the World Trade Organization (wto), India is also party to the General Agreement on Trade in Services (gats) negotiations, the multilateral agreement that governs and facilitates the international exchange of service labor. Trade in health services is rapidly developing as a lucrative form of labor-­intensive exchange in South and East Asia, attracting international investment and generating spin-­offs in tourism (Whittaker 2010). As part of its gats negotiations, sectors of the Indian state have actively promoted an economic and regulatory climate favorable to the development of an offshore medical sector and a medical tourism market. The Ministry of Health and Family Welfare encourages hospitals and clinics to market their service to international clients, and hospitals increasingly rely on revenues from international patient fees as public sector funding for health is withdrawn (Saxena 2011). The Ministry of Tourism has created a new category of medical visas that allow visitors to remain for twelve months rather than the six months permitted by a tourism visa (Hazarika 2010), and provincial states have provided infrastructural support for the development of international medical centers and tourism facilities (Saxena 2011). The Confederation of Indian Industries estimate that 150,000 patients traveled to India for treatment in 2005, and PricewaterhouseCoopers, in its evaluation of emerging markets in Indian health care, estimates that India has the potential to attract 1 million medical tourists each year, with sufficient state incentives and private investment (PricewaterhouseCoopers 2007). Within the gats definition of international health services, fertility tourism falls under “consumption abroad,” grouped together with other kinds of cross-­border patient travel in pursuit of affordable care or services unavailable at home. 80 Chapter Four

These strategies seek to capitalize on India’s educated workforce and well-­developed technology sectors and insert them into the global economy. At the same time, the various forms of clinical labor we discuss in this book enable a similar kind of strategy with regard to sectors of the uneducated or moderately educated population, in their capacity as experimental or reproductive bodies. Employed to bear and test medication risks, or to provide a component of fertility, research subjects and surrogates transform the Indian national burdens of disease and excess fertility into competitively priced commercial assets. In what follows, we turn to the organization of commercial gestational surrogacy in detail to consider the specific ways the surrogate’s reproductive capacity is put into transnational circulation as a form of service in the self. Informal Labor and Feminized Labor In many ways, the kind of labor involved in gestational surrogacy is continuous with other forms of feminized labor in India. The overwhelming majority of women are employed in the informal sector (Hill 2010)17 and may undertake a variety of unskilled, seasonal rural or home-­based work without ever gaining access to the formal worker identity-­card system that would entitle them to insurance, medical care, and other statutory labor protections. Informal workers may hold several kinds of low-­skilled occupation simultaneously, or they may move successively from one kind to another, all equally precarious. As Jan Breman, in his magisterial study of village-­level labor relations in Gujarat, puts it: The hierarchy of employment takes on the form of a continuum, and should be seen as a sloping gradient. After the transition point from informal to formal, the route rises steeply and is no longer visible to the enormous mass piled together in the lower zones. However, even at the foot, the slope does not flatten out. The informal sector is not a smoothly paved surface but a fragmented and undulating terrain with peaks and dips. In addition, the positions of the informal sector workers are not fixed, but subject to continuous fluctuation. They move back and forth through the landscape, manoeuvring themselves upwards or downwards. (Breman 2007: 72) In Breman’s account, lower-­caste rural labor, once employed through estate indenture and under customary obligations to landholders, now have far more mobility and far less security as they move from sector to sector and Reproductive Arbitrage 81

travel between village and city to find paid work. Similarly, former industrial labor, in the large textile mills or brick kilns, has been largely casualized and detached from the statutory protections once enjoyed by the almost exclusively male workforce. Since the 1990s, access to day labor or seasonal work is more and more channeled through subcontractors who undertake activities like road construction and maintenance using brokers (jobbers) who hire and oversee teams on piecework rates (Breman 2007). Most women in the informal economy adopt forms of work compatible with care of the home and children. So one form of feminized labor can be found in home-­based contract work in the garment industry, where contractors both supply the raw materials and purchase the finished items at piecework rates and the flow of work may both intensify and dry up without notice. While such women are participants in a complex production chain, they are themselves isolated and vulnerable to poor rates, penalties, and intimidation from contractors. Women also engage in own-­account work, home-­based artisanal production, or small-­scale vending, but often such apparently individual entrepreneurial activity becomes enmeshed in larger systems of production and distribution and workers are forced into procurement and distribution systems that disadvantage them (Hill 2010). The rates earned in much of the informal economy are insufficient to maintain household life, and Breman documents the structural necessity of credit to pay for both everyday costs (food, medicine) and expensive events like marriages. Much informal labor recruitment takes place through the advancement of wages as loans, so that, as he puts it, the worker works “under obligation of debt and for future credit” (Breman 2007: 231). Moreover, government strategies to alleviate poverty under the Hindu nationalist Bharatiya Janata Party and more recently Janita Dal (the rebranded Congress Party) now focus on microcredit and the creation of a class of microentrepreneurs. Breman documents the failure of such programs for the rural poor, who have no debt collateral other than their low-­value labor power and are unable to meet interest payments. So for the majority of village women who undertake surrogacy work, it has certain continuities with other kinds of feminized work. They are recruited through brokerage; the work may be undertaken at home, although many move to a clinic-­endorsed hostel for part of their pregnancy; and they service a component of a production chain while nevertheless falling outside the formal labor sector. Not all surrogates are drawn from this class background; at least one clinic in New Delhi, for example, recruits from among middle-­class and professional women.18 However, in the ethnographies 82 Chapter Four

undertaken by Kalindi Vora (2009a, 2009b, 2011) in northern India and Amrita Pande (2009a, 2009b) in Gujarat, the women’s usual occupations were as rural day laborers, home-­based workers, cleaners, small traders, or self-­described housewives, with education levels ranging from illiterate to middle school or high school. Pande (2009b) notes that thirty-­four of the forty-­two surrogates she interviewed reported family incomes below or around the official Indian poverty line and that the women’s husbands also worked primarily in the informal sector or were unemployed. However, gestational surrogacy also involves highly novel features, both as a form of labor (both embodied production and natal process) and as a form of labor value, and we now examine these features. Rentier Reproduction Women are recruited for surrogacy through local brokerage or word of mouth, and if they are accepted, they enter into a legal and medical process not unlike that followed by the Californian oocyte vendors and surrogates we discussed in the previous chapter. Clinics that follow the current guidelines (Indian Council of Medical Research 2005) or the mooted regulations (Indian Council of Medical Research 2010) use a combination of private contract, setting out the terms of exchange between surrogate and intending parents, and formal consent, which must be signed by both the woman and her husband. In both instances, the woman agrees to relinquish all parental rights over the child. Pande (2009b) reports that the contracts are in English, but some clauses are translated for the surrogates. The usual arrangement involves payment of a stipend at regular intervals during the pregnancy, and a final payment on delivery and relinquishment of the child. Once the contractual details are settled, the surrogate undertakes a course of hormonal intervention to both retime her ovulation cycle and prepare her body for pregnancy. Once pregnant, the women may stay at home or move to a hostel, where they may find access to self-­improvement activities like English lessons and computer skills. Clinics encourage hostel residence to stop women from undertaking other kinds of work, while most of the women interviewed by Pande (2009b) were concerned about neighbors thinking that they had conceived a child through adultery, a conflation of surrogacy with sexual infidelity that is in wide popular circulation. Surrogates generally have limited contact with the commissioning couple. The women who undertake this work receive a fee (US�5,000–�7,000) that amounts to between five and seven times their usual annual household income. In the normal course of events, as we described earlier, their labor Reproductive Arbitrage 83

power has little value, and they and their husbands are likely to move between a variety of low-­paid jobs without statutory protections and without ever gaining access to income beyond day-­to-­day subsistence and habitual indebtedness. Gestational surrogacy as a business model positions them in a quite different market and sets of transactional relations from those found in the local village. By becoming a surrogate, the woman takes on an entrepreneurial economic role, but in this case, her collateral is her own body. In order to realize its value, she enters into the surrogacy contract as the proprietor of her own reproductive capacity. In effect, she consents to the constitution of her uterus as an asset class, able to generate monopoly rent. In economic terms, monopoly rent is the revenue stream generated over time by virtue of the control the proprietor exercises over an asset that has some nonreplaceable quality or capacity. Control of the asset enables the extraction of rent from those who desire access to its qualities (Harvey 2012). The surrogate, by signing the contract, agrees to rent her excess reproductive capacity, which has little monopoly value at home in the village, into a global market where the comparatively prohibitive regulation of commercial surrogacy in most jurisdictions gives such capacity considerable scarcity value. Intending parents can thus lease access to the parturient conditions necessary to gestate a child, conditions provided by the body of a woman who may live thousands of kilometers away. These rentier dynamics operate at every scale level in the global surrogacy process. They are facilitated first of all by the way assisted reproductive technology orders reproductive biology into a set of modular units and processes, able to be rearranged and distributed between multiple bodies and over multiple temporalities. We have already investigated this capacity at some length in the earlier sections. In the case of surrogacy, the uterus is technically and legally isolated as a component that can be contractually ordered, detached from the selfhood of the surrogate and repositioned in a production chain at the behest of the clinic and commissioning couple. Vora explores the ways that the women working as surrogates are tutored in this new self-­relation: “The directors of the clinic are careful to explain to potential surrogates how the technology of ivf will allow them to temporarily house a baby that is actually someone else’s child. In the case of surrogacy at this clinic, there is an effort to train women into a new understanding of their bodies that allows them to conceive of their uterus as an empty space that is not being used, and therefore can be hired out. This training also situates them in a previously unimagined relationship (or lack of relationship) to the child they will bear” (Vora 2009a: 271). 84 Chapter Four

The surrogates and the clinic staff describe the uterus as an empty room or space, effectively a kind of vacancy that, by implication, should be occupied. Here we can see the way that gestational surrogacy both relies upon and reverses the idea of excessive fecundity associated with Indian femininity. While the national building associated with Indian postindependence governance was focused on birth control and reduction of the birth rate (Connelly 2008), the commercial surrogacy sector transforms the burden of uninterrupted parturition into a valuable surplus, an exportable potential. Moreover, if the uterus is an empty room, it can be imagined as a transactable space under the control of a proprietor, rather than a simple, unthematized aspect of the self. As empty space, it can be put to flexible kinds of use, while remaining somewhat detached from such uses. Vora further teases out the implications here: “The logic behind the genetic model of procreation that surrogate mothers are taught, where the womb becomes a place to rent out for use by someone else’s baby, figures her womb as property to use as she sees fit, and the fetus as belonging to the intended parents. The womb is understood as a place where the egg and sperm develop into a baby, and therefore when the baby is born it is ‘given back’ to its rightful owners” (Vora 2009a: 273). In short, the surrogacy contract requires both parties to agree that the surrogates’ parturient biology can be both (semi)-­detached and instrumentalized, in order to be rendered as an exchangeable, quantifiable entity. In the words of one clinician, “I inform [the surrogate] that . . . I only need her uterus” (cited in Kroløkke and Pant 2012). While the oocyte contract we discussed in the previous chapter depends on the actual detachment of the tissue and its transfer elsewhere, the surrogate’s biological capacities cannot be transferred. They remain irrevocably in vivo, and the commissioning couple establish their rights to this remote biology through lease. Hence the process of recruitment into surrogacy as reproductive labor is also a recruitment into the proprietal self, the subject who holds property in his or her body, which underpins the contractual individual in the European legal and civil tradition (Pateman 1988). The constitution of a proprietal self—able to rationally calculate the deployment of his or her body’s productivity, its risks and benefits, and enter into contract—is a corollary of a global market for biological services in the self, a moment in the ordering of particular embodied processes as fungible entities, tradable between strangers. The women who undertake this venture gain a capacity for both self-­investment and investment in the future that they would otherwise lack. Women typically say that they will use their fee to educate their children Reproductive Arbitrage 85

or build a house, aspirations that village-­level labor rates make difficult or impossible. Breman (2007), in his account of the village economy, repeatedly notes the ways that subsistence-­level incomes and ways of life preclude concerns about the future, focusing attention exclusively on the immediate needs of the day. The fee gives the woman and her family more capacity to organize their future, to accumulate assets and aspire to a more middle-­ class, urban way of life. At the same time, the property relations created by the surrogacy contract also dispossess the surrogate of the child and any claims to the child. While such contracts have yet to be tested in Indian courts, they are designed to shore up the intending parents’ rights over the child and to facilitate its repatriation. In practice, problems with repatriation have arisen not because of contractual contestation but because some states have refused to confer the intending parents’ nationality on the child, leading to some high-­profile stand-­offs and so-­called stateless children (Whittaker 2010). The surrogates themselves doubtless experience the relinquishment of the child in complex and variable ways. Certainly some informants in Vora’s (2009a) and Pande’s (2009b) studies described their suffering and expressed a desire for contact as the child grew up. Others were more pragmatic, focusing on the material benefits they have earned for their families and envisaging further surrogacies and more opportunities for their future. In the case of Indian surrogacy, we can also locate rentier dynamics at the level of the state. In international relations, a rentier state is one that derives substantial national revenues by renting indigenous resources to external clients. The term is used primarily to characterize the political formation of such states and distinguish them from those that rely on tax revenues from domestic production. Saudi Arabia, for example, is described as a rentier state, one where lavish levels of oil income provides some degree of autonomy from social forces and from demands for democratic participation (Luciani 1990). Clearly India, as a vigorous democracy, cannot be termed a rentier state in this sense. However, its promotion of gats health “consumption abroad” and its framing of draft regulations for surrogacy that would enforce specific performance suggest a form of rent-­seeking more akin to those identified by Christian Zeller (2008) in his analysis of intellectual property (ip) monopolies in US biotechnology. The establishment of ip rights in particular biological processes like gene sequences, in monoclonal antibodies, and in entire organisms gives the holder of such ip a capacity to lease use of the process to other laboratories and life science companies. Given the high de86 Chapter Four

gree of uncertainty in the life science development pipeline, establishing ip monopolies over platform processes, like human embryonic stem cell derivation, gives companies a dependable revenue stream, although in practice such monopolies are often contested in the courts (Gottweis et al. 2009).19 Zeller describes such monopolies as forms of rent-­seeking and argues that they effectively transform the processes of biological reproduction (he is referring to the cellular and molecular level here) into a means of “valorizing natural resources . . . in the form of rent-­based revenues” (2008: 88). The US federal government facilitates these revenue streams through the enforcement of the property relations that make them possible, primarily through the trips mechanism.20 In a similar move, transnational surrogacy can be described as rent-­seeking activity, which transforms the processes of indigenous reproductive biology into lease-­ready property available to external clienteles. While life science businesses work for the most part with in vitro biology and establish ip revenues based on in vitro processes, surrogacy creates rentier value from the lived biology of particular women.

Conclusion

We can see in our two case studies, the European oocyte market and the Indian surrogacy market, that the form of reproductive outsourcing that developed in California and some other US states during the 1980s and 1990s is now being exported to other locations. In the process, it has adapted to local constraints, like European ethical principles, and found new populations of women open to recruitment as fertility vendors at significantly lower rates than their US counterparts. Reproductive outsourcing is profoundly entwined with the post-­Fordist reorganization of other kinds of feminized labor and the rendering of formally domestic, privatized aspects of household reproduction as service labor, itself often transnationalized. It has gained dramatic momentum from multilateral economic developments like the wto promotion of global trade in human services. gats is a mechanism that facilitates cross-­border trade in feminized forms of production, precisely because it creates the conditions for intimate, bodily care and real-­ time exchange to take place between parties formerly separated in space. The ostensible focus of gats in the medical domain is hospital services and the globalization of clinical research and expertise. Nevertheless, it opens out the possibility of transnational access to low-­cost in vivo services, and dramatic escalation in the forms and scale of clinical labor as a means of employment for the less-­educated populations of the developing world. Reproductive Arbitrage 87

While there are numerous reproductive labor markets developing around the world, our two case studies are also notable because of the extent to which they are shaped by trade not only in raw fertility, but also in the genetics of white-­skinned reproduction. Eastern European women are not by any means the only group of women caught up in this more general economy, but they do provide the most salient example of ways that fair-­skinned women with precarious lives might capitalize on their karyotypic qualities and transform them into negotiable assets. The eu oocyte market is comparatively cosmopolitan, and “white” oocytes are not the only kind in demand; nevertheless, they form a privileged element in an ethnic dynamic where, outside eastern Europe itself, fair skin often designates purchase power and an ability to command medical and other resources in the pursuit of family formation. A similar dynamic underpins the explosion of the Indian gestational surrogacy market, a more truly global phenomenon than most oocyte markets, because the ethnicity and skin color of the surrogate is not at issue in the process. Rather, the surrogate can literally rent her uterus for the reproduction of white children, as well as those of other ethnicities, without leaving a genetic trace on the offspring. In each case women isolate and transact the desirable aspects of their fertility according to a map of regional and global economic power relations, which itself maps on to older histories of race and empire.

88 Chapter Four

Five

Regenerative Labor Women and the Stem Cell Industries

In the previous two chapters, we have explored the ways in which human reproductive biology, particularly women’s reproductive biology, is enrolled in new kinds of labor relations. In the cases we have analyzed so far, this reproductive labor involves the transaction of fertility and the creation of children. In this chapter, we consider another destination for women’s reproductive biology: the field of stem cell research and regenerative medicine. These new biomedical fields are rapidly expanding throughout the developed economies—the United Kingdom, North America, Japan, Australia, and western Europe, as well as India and the emerging innovation economies of East Asia—China, Singapore, South Korea, and Taiwan (Gottweis et al. 2009). Women constitute the primary tissue providers in the new stem cell industries, which require high volumes of human embryos, oocytes, fetal tissue, and umbilical cord blood. These industries rely on the maternal-­ embryonic nexus as a generative site. They divert material usually associated with reproductive biology along a different trajectory, the regeneration of existing bodies through stem cell therapies. The procurement of this ma-

terial involves onerous forms of donation, requiring (variously) superovulation, ivf procedures, pregnancy termination, or the birth process to disentangle it from the maternal body. Nevertheless, it is generally given for free in the advanced industrial democracies, constituted as a reproductive surplus (“spare” embryos) or waste (umbilical cord “afterbirth,” cadaveric fetuses) whose regenerative powers should not be withheld from others. The exception to this unremunerated donation is, again, oocytes, procured for stem cell research in a handful of jurisdictions through very substantial forms of compensation. In what follows, we argue that this largely unremunerated tissue donation should nevertheless be understood as a form of labor. In the previous two chapters, the more or less evidently transactional nature of oocyte vending and gestational surrogacy simplified the task of demonstrating their convergence with other kinds of informal, feminized labor. Here, however, we need to cast a wider analytic net to understand how activity formally located in the domain of altruism and the gift relation (Titmuss 1997 [1970]) can be considered as a labor relation. To do this we draw on two lines of analysis in feminist theories regarding the relations between reproduction and production. The first is the long-­standing socialist feminist strategy to rethink the gift relations associated with the family and private life as a form of unrecognized, unremunerated feminine reproductive labor (Barrett 1980; Delphy 1984). While our analysis broadly shares this strategy, its assumptions about labor process and the creation of value, as well as the gendered organization of the household, are embedded in a mid-­twentieth-­century industrial model of production and social security that cannot come to grips with the valorization processes of the contemporary innovation-­driven bioeconomy. Consequently, we draw on a second body of critique, concerned with the analysis of precarious labor and value creation in post-­Fordist economies, to consider more specifically how women’s bodily productivity is mobilized to support the stem cell industries, while its economic value remains largely unacknowledged (Dickenson 2007). We attend to the ways that the technical repertoires of stem cell research renegotiate the productivity limits of female reproductive biology, opening it out to novel and profitable forms of surplus value and enrolling particular groups of women in complex negotiations over their role in bioeconomic activity. We term this form of production “regenerative labor,” both cognate to the reproductive labor described in the previous chapters and describing a new productive trajectory for women’s bodies. 90 Chapter Five

Regenerative Medicine

“Regenerative medicine” (rm) is a blanket term that brings together a number of different biological and biomedical disciplines to treat clinical conditions like cardiac damage, osteoporosis, diabetes, and spinal cord injury, conditions associated with damaged tissues. The regenerative medicine method is still speculative, but it aims to promote in vivo tissue regeneration rather than relying on donated organs. In biology, “regeneration” describes the replacement of depleted specialized tissue with healthy specialized cells. Stem cells play a very significant role in this process, although rm also includes other techniques, such as gene therapy and bioscaffolds (Mason and Dunnill 2008). Stem cells are undifferentiated cells that can renew themselves and give rise to one or more specialized cell types with specific functions in the body. Stem cells are particularly important during embryonic and fetal development, but they also occur in adult tissues. They are abundant in the bone marrow, the developing brain, and two areas of the adult central nervous system: the hippocampus and the olfactory bulb. Mammals appear to contain some twenty major types of somatic stem cells that, for example, can generate muscle, blood, intestine, liver, and heart (McKay 2000). In human beings, the skin, gut, blood, and uterine linings are regularly replaced by stem cell activity, and stem cells play a crucial part in wound healing. However, this regenerative capacity is unevenly distributed in adult humans, and one of the aims of regenerative medicine is to harness the regenerative capacities of some forms of cells to repair sites and organs that otherwise have poor prognoses (Mason and Dunnill 2008). Stem cells are our focus here because many kinds of stem cells are derived from women’s reproductive biology. The most celebrated type of stem cell is “pluripotent,” meaning that it has the capacity to develop into almost all of the body’s tissue types. Recent research suggests that it may be possible to produce large numbers of pluripotent stem cells that differentiate on demand, providing an unlimited supply of transplantable tissue (Thomson et al. 1998). The major source of pluripotent stem cells is in vitro embryos. However, other types of reproductive tissues are also rich sources of stem cells. Umbilical cord blood, harvested at birth, has high concentrations of hematopoietic (blood-­producing) stem cells. Cord blood stem cells are capable of regenerating the entire blood system in patients with severe blood disorders, and their proponents claim that they have the potential for other kinds of regenerative action: assisting with cardiac repair, for example (Brown and Kraft 2006). Fetal tissue harvested from pregnancy terminations are important sources of stem cells. Scientists extract them from Regenerative Labor 91

the gonads, liver tissue, neural tissue, and mesenchymal tissue (Kent 2008). Oocytes, while not themselves sources of stem cells, are nevertheless essential components in Somatic Cell Nuclear Transfer (scnt) research, aimed at producing genetically matched transplantable tissues for clinical use. Each of these forms of stem cell tissue is valuable because it partakes of the generative nexus of the maternal-­fetal body, the ability to continuously produce organized tissue that develops along particular biological pathways. The stem cell industries have developed a repertoire of technical innovations that mobilize this generative potential. These include cryopreservation (freezing), which retains the material in a stable state, and stem cell lines, which are made by disaggregating embryos or fetuses into single cells and configuring them so that the cells reproduce themselves in the laboratory, galvanizing their developmental powers without producing actual organisms. The material can then, in theory at least, be transplanted into a human body, where its generative powers become regenerative, repairing damaged sites and restoring function. The rm methodology constitutes a significantly new approach to clinical treatment, particularly for conditions poorly served by existing small-­ molecule drugs or biologicals. Some commentators consider it a new “third arm” to medicine (Mason and Dunnill 2008). The rm industries are now well-­established sectors of the global bioeconomy. In 2011, 112 rm companies were operating in Europe, for example, while 392 firms worldwide were identified as working in the rm field in some capacity. Sixty-­five cell therapies were in clinical use or development. Almost all of the treatments in approved clinical use were autologous (using patient’s own cells), primarily relying on epithelial or cartilage cells to repair skin lesions and restore joints. However, among therapies in early stage development, a much higher proportion (fifteen out of forty-­seven) were allogeneic stem cell–based treatments (Webster 2011). While autologous treatments are considered safer and are easier to deliver to hospital-­based patients, they lack attractions for venture capital and pharmaceutical industry investment, as they fall outside intellectual property regimes. The establishment of intellectual property claims in biological processes is an essential element in the capitalization processes of pharmaceutical and biotechnology sectors, providing licensing revenue and underpinning stock market valuations (Zeller 2008). Allogeneic stem cell tissue is more attractive for corporate development because it is much more amenable to patent, particularly if lines can be standardized and scaled up to act as off-­the-­shelf treatments for large patient populations, a business model Andrew Webster and colleagues have termed 92 Chapter Five

the “cells-­as-­drugs” approach (Webster et al. 2011). Worldwide, just over one hundred patents are held in embryonic stem cells,1 and ten companies have allogeneic stem cell treatments in Phase 1 and 2 clinical trials, using tissue sourced from placentas, fetuses, oocytes, and blastocysts (Webster 2011).

Procuring Regenerative Potential

Since the late 1990s, fertility clinics, hospitals, laboratories, ethics committees, and regulators with an interest in the promotion of stem cell research have experimented with different ways to source reproductive stem cell material and negotiate with potential female donors. In the case of embryo donation, national and provincial states have taken the lead by providing regulatory frameworks and encouraging bioethical oversight. Since the early 2000s a number of the oecd countries have developed regulatory systems that permit ivf clinics to solicit so-­called spare embryos. When a woman undertakes in vitro reproductive procedures in order to have a child, she enters into a treatment regime very similar to the one we described in chapter 3: several weeks of daily hormone injections, clinic visits and tests, and a day surgery procedure to produce a number of oocytes for fertilization. For women working as vendors, egg collection is the end of the medical process. However, for women undergoing fertility treatment, collection is the beginning of a much more drawn-­out and contingent period. They and their partners wait to see whether the clinic can cultivate viable blastocysts, and whether they develop sufficiently to become transferable embryos. If successful, some may be frozen for later use, while one or two may be introduced into the woman’s uterus. The in vivo embryos then need to become stable pregnancies and carried to term and birthed as children. The logic of the procedure thus means that more embryos are created in a treatment round than are routinely used to establish a pregnancy. It is these embryos that have been designated as potentially “spare” and framed by stem cell scientists and regulators as the waste of a precious resource if not donated for stem cell science (e.g., Chief Medical Officer’s Expert Group 2000). For women undergoing ivf and for clinical staff working with them, designating an embryo as “spare” is a complex and often fraught process. It depends on a multitude of factors, including the clinic’s freezing policies, its facilities for blastocyst culturing, grading procedures, the woman’s age and risk for pregnancy complications, and the extent to which the woman’s or couple’s wishes are taken into account by clinic staff (Scott et al. 2012). Nevertheless, as a locution, the idea of “spareness” renders nonimplanted Regenerative Labor 93

embryos as a valuable surplus that should be given so their value to others can be actualized. This formulation has largely been successful in securing donations of embryos to stem cell research from women who are often knowledgeable about stem cell research and feel a moral obligation to contribute (Parry 2006). In research conducted by Waldby and colleagues,2 we found that women in fertility treatment were ultimately prepared to consider embryos as “spare” if they had completed their own families and still had some cryopreserved embryos left. Such embryos could be diverted from the reproductive pathway to the research pathway (Waldby and Carroll 2012). Women were far less willing to donate “fresh” embryos, which still had reproductive potential for themselves (Ehrich et al. 2010). Cryopreservation of embryos is a routine part of ivf treatment throughout the world (Cohen 2009), and several studies have confirmed the willingness of women to donate such embryos to stem cell research (Bangsbøll et al. 2004; Lyerly and Faden 2007). Women in ivf also express a strong preference for research donation rather than donation to another couple. While much of the initial controversy around embryonic stem cell science revolved around the special status of the embryo as an entity with a potential biographical life, the women interviewed by Waldby and colleagues (Waldby and Carroll 2012) and women in other studies (Access Australia 2008) preferred to give embryos to research. They felt that giving to research was a more responsible way to divert the life of the embryo, rather than placing their genetic child at risk of neglect from unknown parents. A second source of stem cells, perhaps the least publicly known, is found in fetuses. Fetal material has been harvested from pregnancy terminations for medical research since abortion was decriminalized in the United Kingdom, western Europe, Australia, and the United States between the mid-­ 1960s and mid-­1970s.3 In Britain, the use of fetal tissue for research is governed by the Polkinghorne Guidelines, drawn up in 1989 in response to the use of fetal neural tissue to treat Parkinson’s disease. Julie Kent notes that, compared to the well-­regulated, standardized, and documented procedures that govern the procurement of embryonic tissues for stem cell research in the United Kingdom, the harvesting of fetal tissue is something of a shadow economy, lacking public records to indicate the number of fetuses used for research or which laboratories use them (Kent 2008). Usually a research nurse initiates donation, approaching women planning a termination. Under the Polkinghorne Guidelines, they receive little information about the kinds of medical research that this might involve. The donation process is rela94 Chapter Five

tively unceremonious, in contrast to the elaborate protocols that govern embryo donation for stem cell research, a difference that reflects the very different degrees of public attention given to these two kinds of stem cell donation.4 Researchers need high volumes of fresh fetal tissue because of the technical difficulties of creating viable stem cell lines. The terminated fetus is classified as a cadaver, and, as Kent found, scientists and nursing staff understand donation as a way to secure social and medical value from what would otherwise be shameful waste. She notes that this idea of waste emerges from a more general tendency to consider women’s reproductive biology as a teleological system, ordered to produce life; any diversion from this aim appears as waste. She writes, “The reproductive labor of women is closely tied to notions of wastefulness; for example, constructions of menstrual blood as waste, and women ‘wasting’ eggs and embryos which have the potential for life, mobilizes specific cultural values about what their role is and reinforces social obligations of women to be productive in specific ways. . . . Following this analysis, women who terminate a pregnancy are especially ‘wasteful’” (Kent 2008: 1752). Donation avoids the problem of waste, diverting the fetuses’ truncated biographical life into in vitro life. Once donated, a single fetus can be efficiently transformed into multiple use values and destinations. It may be disaggregated into different cellular materials and diverted to various research programs concerned with conditions like Parkinson’s disease, Type 1 diabetes, Huntington’s disease, and stroke. Two of the ten allogeneic stem cell clinical trials currently in train involve such fetal tissue, one trialing a treatment for stroke, the other for spinal cord injury.5 In her research with women who had donated fetal tissue, Naomi Pfeffer (2008) found that this diversion of different elements of the fetus into cellular treatments and stem cell lines provoked the most unease. Women initially expressed general support for donation to medical research, along similar lines to the clinical staff cited above—as the redemption of shameful waste. However, the more they found out about stem cell research, the more concerned they became about the complexities of life, regeneration, and death that these technologies present and the difficulty of separating the biographical life of a potential child from the in vitro life of a cell line created from the same tissue. Pfeffer writes, “What makes stem cell research more troubling is its association with renewal, regeneration, and immortality. . . . Stem cell research introduces the understandable confusion between ‘life’ at the cellular level and ‘life’ in terms of a conscious human being. . . . Perplexity about ‘life’ led on to worries about fetal death. [In the words of one participant,] ‘You’d want to know Regenerative Labor 95

whether it was dead as well. . . . You wouldn’t want for it to be living for ages not knowing if this thing that you produced is still alive or not, would you?’” (Pfeffer 2008: 2551). To put it slightly differently, we can see here some indications of the complex feelings women have toward the new potentials and medical destinations that stem cell research elicits from their bodies, and the impossibility of neatly separating out the everyday life of reproduction, mothering, and kinship from the uncanny laboratory life of the immortalized cell line. Cord blood constitutes a third source of stem cells, and cord blood companies like Pluristem and Cordlife have developed a novel, although increasingly mimicked, business model. Through various types of advertising, they solicit pregnant women to open a private cord blood account for their child. Umbilical cord blood, the hundred or so milliliters of blood retained in the placenta and cord after birth, is an accessible source of hematopoietic (blood-­producing) stem cells. It has become therapeutically valuable tissue over the last twenty years because it can substitute for bone marrow transplant in the treatment of blood disorders and is able to regenerate the entire blood system. While cord blood stem cells do not display the same pluripotent repertoire as embryonic stem cells, they are nevertheless the objects of extensive research programs designed to increase their flexibility and become useful for other forms of regeneration. Paul Martin and colleagues estimate that cord blood companies constituted 35 percent of all stem cell companies in 2006 (Martin et al. 2006). Because of this association with broader stem cell research, cord blood companies emphasize the possible future uses of a private cord blood account, as well as current clinical applications. Blood is collected during birth, and the account is retained for an annual fee, available in case the child or another compatible family member requires treatment for a blood disorder or for conditions that may become treatable with stem cell therapies in the future. Private cord blood banking is neither a gift system nor an exchange system; rather, it is structured more like a form of investment. Banks create their markets in part by inviting clients to invest in the future of their child by investing in the future of regenerative medicine and by hedging against future embodied risk (Brown and Kraft 2006; Waldby 2006). Such private tissue-­banking services are set to expand as stem cell research identifies more and more sites of adult stem cell concentration (e.g., baby teeth, menstrual blood) that may provide sources of self-­regeneration in the future (Fannin 2011). Oocytes are our final example of the ways women’s reproductive tissues 96 Chapter Five

are used in stem cell research. They themselves do not give rise to stem cells, but they are nevertheless essential elements in a type of stem cell research termed somatic cell nuclear transfer (scnt), sometimes called therapeutic cloning. In scnt, a nucleus from a patient’s body cell, such as a skin cell, is introduced into an unfertilized oocyte from which the original genetic material has been removed. This creates an embryo with the genome of the adult from whom the nucleus was taken. Such an embryo could (theoretically) be transformed into an embryonic stem cell line that could act as a source of perfectly histocompatible, transplantable tissues for the person who donated the nucleus. This technique is the highest aspiration of stem cell research, because it would solve the logistical problems of organ shortages and mismatching and would also facilitate treatments for currently untreatable degenerative conditions. scnt research is highly experimental at this stage, and while it is now used with several kinds of mammals, it is unclear whether the technique can be successfully adapted for human biology. To date, only one human scnt line has been derived (Tachibana et al. 2013). Research oocyte procurement has proved to be a much more volatile affair than research embryo procurement. The reasons for this volatility are complex, but to some extent they relate to the US and European reproductive oocyte market that we have already described. Simply put, once a transactional market has developed for oocytes, it is far more difficult to procure them voluntarily. At the same time, the extreme social sensitivity around stem cell research, its controversial nature, and the protracted and elaborate process of ethical regulation that various nations have put in place (Gottweis et al. 2009) mean that issues of commodification or transaction are particularly intractable. Hence, regulatory systems are still in flux as to the best way to secure a sustainable, nonexploitative supply for scientists wishing to work in the scnt area. The 2005 Hwang scandal in South Korea served to bring the ethical and sheer logistical difficulties of research oocyte procurement to widespread public attention. Professor Hwang Woo Suk and his team, in an attempt to create the world’s first human scnt cell lines, obtained 2,221 eggs from 121 women, most procured from brokers that normally sold Korean oocytes to Japanese fertility tourists. The rest were donated, and the donors included two research assistants from Hwang’s own laboratory team (Leem and Park 2008). When Hwang was subsequently exposed for falsely claiming success in the creation of patient specific cell lines, the world’s media were also alerted to the scale of oocyte procurement and the potential for exploitation if regulation was weak or absent. Since then, there has been a fierce global debate and little regulatory or scientific consensus about what ethical Regenerative Labor 97

model should be used to procure research oocytes, or indeed whether they should be procured at all (Dickenson and Idiakez 2008). Different jurisdictions have adopted widely varied regulatory options. In the United States, for example, California’s Reproductive Health and Research Bill (SB1260) of 2006 specifies that “no payment in excess of the amount of reimbursement of direct expenses incurred as a result of the procedure shall be made to any subject to encourage her to produce human oocytes for the purposes of medical research.” While this approach is consonant with widely shared regulatory principles about the procurement of gametes, it is rather paradoxical in California, which, as we have seen, has one of the most lucrative and entrepreneurial unregulated reproductive oocyte markets in the world (Almeling 2011). Meanwhile, the state of New York has defied US National Academies of Science guidelines (Human Embryonic Stem Cell Research Advisory Committee and National Research Council 2010) to mandate a �10,000 compensatory fee for research oocytes, funded through public or private research grants, effectively meeting the US market rate for reproductive oocytes (Levine 2010). In Britain, the Medical Research Council has funded an egg-­sharing program at the North East England Stem Cell Institute in Newcastle-­on-­Tyne, which gives women a £1,500 rebate on their ivf fees in exchange for providing a proportion of their oocytes to research (Roberts and Throsby 2008). Oocytes must be diverted prior to the determination of their fertility, and it is this feature of oocyte procurement that distinguishes it sharply from embryo procurement. While embryos can be classified and ranked for viability, the only way to tell whether an oocyte is fertile is to fertilize it. There is no laboratory test that can tell clinicians which ones to use and which ones to discard. Moreover, unlike embryos, oocytes must be used while they are fresh. There are no routine, secure options for preserving oocytes. This obduracy is particularly difficult for fertility patients, who cannot know whether they are giving away their most fertile oocytes, and in Waldby’s and colleagues’ research, no women in active treatment were prepared to donate to stem cell research (Waldby and Carroll 2012). These intractable features of oocytes are additional barriers to donation, as they cannot be readily ordered into necessary and surplus moieties. In most of Continental Europe scnt research is forbidden. Sweden, Belgium, and Spain permit scnt, but at the time of writing only Spain supported an active research program, at the Centro de Investigación Príncipe Felipe (cipf) in Valencia and the Centro de Medicina Regenerativa de Barcelona (cmrb) in Barcelona. In those programs, research oocytes were pro98 Chapter Five

cured primarily by diverting oocytes initially obtained from reproduction, via the generous compensation regime we described in the previous chapter. Nevertheless, laboratories found the logistics of procurement burdensome, primarily because of the competition for “young” oocytes from the reproductive sector, and both of these programs were in the process of winding up (Braun and Schultz 2012). In summary, fertile research oocytes are procured in significant quantities only through transaction. The resort to frank payment for these tissues is particularly startling because, so far, it forms the only instance of a radical departure from the normative bioethical principle that guards against undue inducement for research tissues (Hyan 2006). Moreover, it introduces an industry cost at a point in the procurement pipeline which has historically been provided for free—the point of “donation” (Waldby and Mitchell 2006; Hayden 2007). This regulatory controversy and the logistical problems of procurement have led many aspiring laboratories to abandon human scnt work altogether and focus on the less ethically vexed area of induced pluripotent stem cells (ips), which create pluripotent cell lines from somatic cell nuclei (e.g., skin cells). However, worrying evidence continues to emerge that ips lines are oncogenic (Knoepfler 2009), and some scientists in the field consider that scnt research should be retained as an active option in order to advance basic knowledge of stem cell biology. So we can see that particular groups of women are being integrated into the lower echelons of the stem cell industries as essential productive agents through various contractual mechanisms, institutional arrangements, and regulatory systems. The stem cell industries have found ways to procure reproductive biological material from women in the developed nations without entering into direct forms of transaction. Embryos, fetal material, and cord blood have been configured, in both regulations and rhetorics, as a wasted form of vitality if they are not given to stem cell research. In each case, maternal responsibility for the life of the child (cord blood) or potential child (embryo, fetus) is evoked to solicit procurement of tissues. It is particularly striking that in the latter two cases, stem cell research has been successfully positioned as an ethical, worthwhile destination for the embryo or fetus, even though the life of the in vitro stem cell line is so radically at odds with the biographical, kinship life of a child (Waldby and Squier 2003). Such appeals to maternal responsibility have not succeeded in securing access to oocytes, however, and the most advanced bioeconomies, the United Kingdom and (one state of) the United States, have resorted to more or less frank forms of transaction (egg sharing and market exchange, respectively) to secure supplies. Regenerative Labor 99

Labor and the Stem Cell Industries

We want to argue that women who donate or transact their biological material to the regenerative medicine industries are engaged in a form of labor. As we noted in the introduction, when the bioeconomy is analyzed in terms of labor, attention invariably turns to the value created by highly skilled, scientific labor, understood to perform the work of creative innovation necessary to transform biological life into industrial, therapeutic, or agricultural processes (Ashish and Gambardella 1994; Gambardella 1995). The organization of intellectual property in the life sciences recognizes the cognitive labor of the scientist and the clinician, but not the constitutive nature of the biological material or the collaboration of the donor (Pottage 1998). The business model of the corporate regenerative medicine sector relies on the establishment of intellectual property in allogeneic (donated) tissue, and a significant proportion of current clinical trials and patents revolve around the regenerative powers of women’s reproductive biological material. It is evident, then, that the recognition of labor here is structured by a mind/ body split, wherein the embodied productivity of the tissue donor does not figure. In our analysis, however, this embodied productivity is given a central place. Stem cell researchers require access to women’s in vivo reproductive biology, the living interior processes of their bodies, as a generative site for biological materials. The donor’s participation in this process is generally conceptualized as deliberative and contractual. They participate insofar as they make an informed decision to consent to donation. The act of consent is central to the transaction of property relations in the life sciences, the moment when the donor is understood to transfer nonreversible rights of ownership to the recipient, without being able to claim prior property rights in their own tissues. But the recipient—the scientist, laboratory, or company—can establish intellectual property rights in donated tissue through the addition of scientific labor, the inventive step that distinguishes found matter from patentable matter in intellectual property law (Waldby and Mitchell 2006). However, we would contend that donor participation should be understood as a thoroughgoing collaboration that involves not merely the legal disposal of surplus biological material but the generative energies of the donor’s biology and selfhood, sustained over time. While the moment of donation takes place after ivf, superovulation, termination, or birth, the genesis of the materials takes place through a drawn-­out and complex interaction between the woman’s subjectivity, the trajectory of her reproductive biology, 100 Chapter Five

the regulatory environment, and the technical repertoire of stem cell research, which redirects the developmental pathways of fertility, embryogenesis, fetal development, and birth. In the process of this collaboration, the donor is caught up with various forms of effort, compliance, self-­care, and drug administration, in vivo risk and transformation (Throsby 2002; Nahman 2005). The donor is also involved in affective labor: the work of care and custodial responsibility for the conceptus. Corporeal vulnerability, maternal responsibility, and social flexibility are the elements technically and socially configured to the requirements of stem cell research. Nevertheless, the labor involved in this collaboration goes largely unrecognized, valued as a gift of natural, reproductive surplus rather than a process of embodied production. How can this contribution to the valuation processes in the life sciences be properly conceptualized?

The Reproductive Labor Debates

In many respects, our proposal to cast these interactions as a form of labor is not new, and several other feminist commentators have made similar moves with regard to the stem cell industries (Lock and Franklin 2003; Dodds 2004; C. Thompson 2005; Dickenson 2007). This critique, for the most part, works off a more general feminist analysis of the historical exclusion of reproduction, in both the social (nurture, care, household consumption) and biological (conception, pregnancy, parturition) senses, from the sphere of production. As we have demonstrated earlier in the book, this exclusion is articulated in orthodox political economy, from Marx to Beveridge, and until the 1980s it was a structural feature of both twentieth-­century labor regulation (the breadwinner wage) and the Keynesian welfare state (the married woman’s derivative entitlement to social insurance) in most of the advanced industrial democracies. This exclusion has been the subject of extensive feminist critique, beginning with the Marxist feminist analyses of reproductive labor developed between the late 1960s and early 1980s. This critique aimed to recognize the productivity of domestic work as an important contribution to the economy and “to expand existing notions of work” (Weeks 2007: 235). Feminists such as Christine Delphy (1984), Michelle Barrett (1980), and Nancy Hartsock (1998) argued that the Fordist/Keynesian model of economy and society both relied on the relegation of women to the domestic space of reproduction and failed to extend proper recognition to the productive work performed there. Women were expected to perform a multitude of tasks—childbearing, child care, housework—that were not Regenerative Labor 101

paid but were in fact essential to the whole regime of Fordist labor relations and the organization of the welfare state. The family in this analysis was not a realm of natural, voluntary feminine activity, and private relationships but, rather, an obscured component of the wage system, “a distributive mechanism through which wages could be imagined to extend to the non-­waged, under-­waged, not-­yet-­waged and no-­longer-­waged” (Weeks 2011: 121). The care and domesticity provided by the housewife was a way of extending the boundaries of the working day and securing services that would otherwise be prohibitive if purchased in the marketplace. By reconfiguring the realm of the family and the activity of the housewife/mother as “unpaid domestic labor,” the materialist feminist tradition points to the foundational economic role of reproduction within the Fordist/Keynesian social contract—its significant yet uncounted contribution to the valorization process. It is this repositioning of reproduction within production that has been adopted as a strategy by the much more recent body of feminist commentary on the stem cell industries. These analyses locate reproductive biology at the heart of production in the bioeconomy. So Charis Thompson, in her ethnographic work on North American fertility clinics, develops the idea of a “biomedical mode of reproduction” akin to the industrial mode of production. In the biomedical mode, “reproduction [is made] productive in an industrial sense,” with its product being standardized molecular entities like clones and cell lines (C. Thompson 2005: 253). She draws an analogy between the alienation of labor in industrial capitalism and the alienation of tissues in fertility clinics: “[An economic] characteristic of the biomedical mode of reproduction concerns the nature of exploitation and alienation. Whereas, under capitalism, workers risk being alienated from their labor, in the biomedical mode of reproduction, patients risk being alienated from their body parts” (C. Thompson 2005: 255). The reference to alienation follows Marx’s analysis of the social relations of industrial labor and refers to the way the worker’s labor power, expended over time, is embodied in the commodity. The worker lacks a property right in the product of his labor, because he lacks control over the means of production, the plant and materials used to create commodities. He receives a wage for his labor, while the factory owner, the capitalist, retains control of the exchange value of the commodity, its value on the market. Hence labor power is alienated in an object over which the worker has no control (Marx 1887 [1867]: 46–52). Thompson goes on to draw an analogy between the workers’ lack of property rights in the commodity they produce and the patients’ risk of losing control of their reproductive materials, or 102 Chapter Five

being forced into exploitative exchanges because of economic need (e.g., surrogacy). Margaret Lock and Sarah Franklin draw on Thompson’s formulation6 in their analysis of the contemporary life sciences, placing the processes of reproduction at the center of capitalized biosciences as the “primary generator of wealth, agency and value” (Lock and Franklin 2003: 7). They note that “Thompson’s proposal for reconceptualising the way biocapital is generated draws on a long history of feminist critiques of Marxist approaches, which overemphasise production at the expense of reproduction” (Lock and Franklin 2003: 9). They argue that “reproduction—like gender, nature and kinship, often feminized—has been wrongly marginalized in accounts of economic change and development” (Lock and Franklin 2003: 10–11). Donna Dickenson has gone furthest in reworking the materialist feminist concept of reproductive labor to gain analytic traction on the stem cell industries. Like Thompson, she draws on the idea of alienated labor. She argues that the neglect of women’s contribution rests on a historical lack of recognition for the work of maternity more generally, an indication of women’s lack of property rights in their own reproductive labor. Here she builds on Carole Pateman’s (1988) analysis of the difference between the housewife and the worker. In a complex historical analysis, which we can only sketch here, Pateman argues that women as political subjects lack the apparently universal civil status of the (implicitly masculine) possessive individual, who commands property in his person and can freely enter into contract for the transaction of that property. Women are, rather, subject to what she terms the “sexual contract,” enacted in contracts that explicitly involve women as sexed beings—she cites the marriage contract, the prostitution contract, and the surrogacy contract. Each of these instances transacts capacities specific to the feminine body—reproduction and sexual services—to give men mastery over such capacities, which they themselves lack. In the case of the housewife, Pateman makes an apparently sharp distinction between domestic labor and industrial labor, with regard to self-­possession. She writes, A housewife is not a worker who happens to be located outside the workplace and who is subject to her husband; she is not a worker at all. The work of a housewife—housework—is the work of a sexually subject being who lacks jurisdiction over the property in her person, which includes labor power. But sale of labor power, in contrast to sale of labor or the person, is what makes a man a free worker; the ability to contract out a piece of property in exchange for a wage Regenerative Labor 103

is, it is held, what distinguishes the . . . wage laborer, from unfree laborers and slaves. A housewife does not contract out her labor power to her husband. She is not paid a wage—there is no token of free exchange—because her husband has command over the use of her labor. . . . The marriage contract is a labor contract in a very different sense from the employment contract. The marriage contract is about women’s labor, the employment contract is about men’s work. (Pateman 1988: 135–136) Elsewhere, however, Pateman argues that the distinction between the labor contract and the marriage contract (which gives the husband control over the housewife’s free labor) is not absolute. The worker, as an embodied being, cannot treat his labor power as an externalized possession; rather, he must give the employer a time-­limited command over his person, subject to direction for the duration of the working day, in exchange for a wage. In this respect, the labor contract, like the sexual contract, creates relations of authority and obedience rather than the equal exchange attributed to the act of consent. At the same time, the male worker’s capacity to earn a wage and meet his employer’s demands depends on his access to a wife, to support his need for care, reproduction, and sex in exchange for economic protection (Pateman 1988). It is this absence of the housewife’s property rights in her own labor that Dickenson uses to analyze the lack of property recognition for women’s contributions to the stem cell industries. She notes the history of feminist analy­ ses that have “extended the logic of alienation into the home,” insisting that wives’ domestic labor is actually external and forced, including the creation of the most intimate “product,” children. Carole Pateman’s notion of the sexual contract is the most sophisticated of many feminist critiques . . . which [draw] our attention to the way in which women, unlike workers in Marx, are not viewed as possessing property in their labor. If reproductive labor in the home can be viewed as alienated, then certainly alienation can be applied to reproductive labor outside the home, and to a situation where there need be no inverted commas around “product.” Although children are neither property nor truly a product, stem cells are both. When women labor to produce the intermediate product used in the stem cell technologies, ova available for enucleation, there can be no question that their labor is neither natural nor performed in a realm ex104 Chapter Five

traneous to capitalism. Their reproductive labor has entered into the very heart of one of the most thriving applications of modern biotechnology, and they are liable to oppression in that site. (Dickenson 2007: 76) So, in each case, these commentators have introduced the idea of industrial production and feminized labor to counter the relegation of feminized donation to the domain of altruism and gift relations, a domain, like the family, understood to be beyond the transactional relations of commerce (Titmuss 1997 [1970]). Like the materialist feminists of the 1970s and 1980s whom they invoke, they want to relocate this feminized, unwaged productivity within the circuits of economic value, as do we. However, while this work is enormously suggestive, we consider that it remains too embedded in the mid-­twentieth-­century model of the relations between reproduction and production that we have already interrogated to some extent in this study. In particular, it relies on an industrial model of labor and value—alienated labor, expended over metric time, which produces commodities for market exchange—which is unable to fully delineate the valorization processes at work in the life science industries. Nor is this model able to thematize the more general matter of post-­1970s reproductive labor and its transformation into feminized precarious care and service work. Here we can see the limitations of the socialist-­feminist reproductive labor debates, teetering as they were on the historical cusp of the move from Fordist to post-­Fordist organization (Weeks 2007). On the one hand, they served to open up the possibility that apparently intangible, naturalized activities like care and nurture could be reconceptualized as aspects of production. To this extent they can be considered the opening gambit in the attempt to grasp the specificity of post-­Fordist feminized service labor, whose beginning is more usually attributed to Arlie Hochschild’s The Managed Heart (1983). On the other, these debates were eventually disabled by their attachment to an industrial model of labor and valorization and their inability to conceptualize forms of productive activity that did not involve expenditures of metric time or produce tangible commodities. Hence, the later debates revolved around forced comparisons between factory production of commodities and the housewife’s production of use values like meals and cleanliness, for example (Weeks 2011). To put it another way, the 1970s reproductive labor debates were exhausted by their ideological commitment to a form of production and family formation that was rapidly becoming obsolete in the advanced economies. Regenerative Labor 105

In what follows, we will draw on theorizations of labor that directly address this transformation in production/reproduction and value creation, particularly as it relates to innovation, in order to think more precisely about the ways women are positioned in the stem cell industries.

Post-­Fordism and Reproduction

As we have already seen in the earlier chapters, the domain of both social and biological reproduction has been radically deterritorialized in the advanced industrial economies since the 1970s. With the decline of the breadwinner wage and the dramatic increase of women in the paid workforce, the shift to post-­Fordism undermines the very separation of spheres that was constitutive of the Fordist middle class. What was once unpaid housework, performed by the full-­time housewife, is now unquestionably labor, a service contracted out and sold on the market. The neoliberalization of former welfare state domains like health care has actually increased the demand for care, but middle- and upper-­class professional women increasingly employ other, less credentialed women as nannies, private nurses, and cleaners to carry out such care (Bakker 2003), or use the burgeoning service sector to purchase meals, elder care, and child care. As we saw in the previous chapter, the entire lower end of the service sector is disproportionately dependent on the labor of local racial minorities and migrants, most of whom are female (Sassen 2002). Hence a major difference between Fordist uncompensated reproductive labor in the home and the contemporary relations of reproduction is a deprivatization and denationalization of the reproductive sphere and its exposure to global precarious labor markets. As we saw in the previous chapter, in Europe the women who leave their country to provide care labor in another are often the same women who engage in clinical reproductive labor, providing oocytes to fertility clinics as another income stream to supplement remittances to their own families in their country of origin. Global care chains can readily become global fertility chains as well. This shift to high labor participation rates for women and to precarious reproductive labor also undoes to some extent the gendered power relations that characterize the mid-­twentieth-­century household. Housework is less about the housewife’s provision of multiple forms of unremunerated care and task completion in exchange for male economic support, and more about emerging class relations between women, as well-­paid professional women employ other women to provide care. As Linda McDowell (2008) demonstrates in her study of care labor in contemporary Britain, national 106 Chapter Five

economic policy now advocates the obligation for all citizens, including mothers, to work, and the normative model of the good mother is now the working mother. She writes, The good mother now is a mother who enters the labor market to raise her income for the benefit of her children and who no longer occupies the home as a continuous presence but hands over the care of her children to another (woman) for part of the day. [The aim of labor market policy] is paid work for women, especially single mothers and so, of necessity, childcare has become a key economic issue. Childcare has been recast through a substitution lens into a commodity form, reconstituted as a social responsibility enacted though the market and performed by the labor of socially unrelated others, either in state- or market-­provided specialist facilities, or in the homes of individual families. This has the effect of transforming the home into a site of commoditized interactions, rather than a locus in which social relationships were assumed to be based on ties of love and affection. (McDowell 2008: 156) So care in the advanced industrial democracies is no longer provided predominantly by an unwaged housewife through a household gift economy, although these arrangements are not entirely displaced. Certainly, time use surveys and labor market statistics still describe households where mothers provide more care than fathers and are more likely to work part-­time (Offer and Schneider 2011). Nevertheless, some elements of the burden of care are likely to be outsourced and transacted, and women are more likely to be employers or employees of such care, and often both. However, in order to fully appreciate the qualitative difference between the reproductive labor of women as maternal producers and providers in Fordist society and the bioeconomic labor performed by women today, it is necessary to move beyond the transformations in broad political economy. We will now turn to consider in more detail the form of value produced by regenerative labor for the stem cell industries, and the kind of action it implies. While the feminist accounts of biomedical reproductive labor discussed earlier revolve around a dynamic of alienation, we will suggest that regenerative labor is about the transaction of biological potential and the creation of experimental relations. We contend that the renegotiation of bodily limits and productive possibilities has become the core business of bioeconomic innovation. Regenerative Labor 107

Potential, Experiment, Regeneration

Recent analyses of postindustrial or post-­Fordist economies, particularly those with strong innovation sectors, argue that their modes of value and accumulation are oriented toward the organization of potential, toward prospecting for new sites of possibility, vitality, and future commercial energies (Adkins 2008). Nigel Thrift (2006) proposes that post-­Fordist knowledge economies, oriented to the relentless search for new techniques, value-­ added commodities, modes of communication, and ways to orient and treat the body, as essentially experimental economies. As he puts it, the post-­ Fordist mode of accumulation attempts to “squeeze every last drop of value out of the system by increasing the rate of innovation and invention through the acceleration of connective mutation. . . . Instead of being thought of as a passive store, knowledge is thought of as a set of continuously operating machines for activating competences, risk taking and readiness to innovate” (Thrift 2006: 281). Connective mutation here refers to the emergence of unpredictable and potentially valuable relationships between expertise, technical capacity, commodity forms, and consumer demand. The experimental economy is concerned with both the provocation of unpredictable synergies and the capturing of value potentials that emerge from such synergies. This experimental orientation involves r�d and valorization processes dispersed beyond the confines of laboratories and companies, across the social body more generally. The ever-­expanding use of consumer databases and data-­mining and data-­tracking programs and the astronomical stock valuations of companies that successfully aggregate large numbers of users (Google, Facebook) point toward this distribution effect, enabled by the mass adoption of information and communication technologies as essential for work and private life. In the field of bioeconomic innovation, this network effect is evident in the enrollment of significant proportions of national populations in genetic biobanks, for example, so that the everyday life of populations (dietary habits, smoking, exercise) can be linked in real time to both genetic profiles and clinical outcomes (Waldby 2009; Mitchell and Waldby 2010). In chapter 8, we examine another example of this bioeconomic network effect, in the field of pharmaceuticals and user-­generated innovation. Here online patient groups experiment with off-­label drug consumption, in the process producing experiential and clinical data treated by pharmaceutical companies as potential alternatives to the structured clinical trial. This distributed, experimental production process also lends itself to more porous, less bounded forms of labor relations than those which char108 Chapter Five

acterized Fordism. Work in the innovation sectors of contemporary economies is less and less distinct from practices of consumption and (apparently) private creativity. Rather, cultural consumers may simultaneously operate as cultural producers, “not just a passive terminus but a complicit and creative relay in the reproduction of capitalism” (Toscano 2007: 74). Maurizio Lazzarato’s (1996) work on “immaterial labor,” for example, investigates the proliferation of what he terms mass intellectual work and innovation in the knowledge and culture industries, and its displacement of “material labor,” the industrial production of mechanical commodities. He writes, Immaterial labor . . . is defined as the labor that produces the informational and cultural content of the commodity. The concept of immaterial labor refers to two different aspects of labor. On the one hand, as regards the “informational content” of the commodity, it refers directly to the changes taking place in workers’ labor processes in big companies in the industrial and tertiary sectors, where the skills involved in direct labor are increasingly skills involving cybernetics and computer control (and horizontal and vertical communication). On the other hand, as regards the activity that produces the “cultural content” of the commodity, immaterial labor involves a series of activities that are not normally recognized as “work”—in other words, the kinds of activities involved in defining and fixing cultural and artistic standards, fashions, tastes, consumer norms, and, more strategically, public opinion. (Lazzarato 1996: 133) Such labor is highly distributed and networked, not bound by the walls of a factory or plant, and often organized on a project-­by-­project basis. The productive capacity of immaterial labor is intermittently mobilized and is latent in social and professional networks that often exist outside workplaces. Lazzarato argues, “Small and sometimes very small ‘productive units’ (often consisting of only one individual) are organized for specific ad hoc projects and may exist only for the duration of those particular jobs. The cycle of production comes into operation only when it is required by the capitalist; once the job has been done, the cycle dissolves back into the networks and flows that make possible the reproduction and enrichment of its productive capacities. . . . Industry does not form or create this new labor power, but simply takes it on board and adapts it” (Lazzarato 1996). Tiziana Terranova (2000, 2004) further develops this account of latency, mobilization, and precarity in her analysis of work in the digital media industries. She characterizes the digital economy not only as the formal corporate Regenerative Labor 109

sector, but also as a system of experimental valorization that trawls for talent, content, subcultural chic, innovation, design, and new communicative forms across the social body. She describes the digital economy as a specific mechanism of internal “capture” of larger pools of social and cultural knowledge. The digital economy is an important area of experimentation with value and free cultural/affective labor. It is about specific forms of production (Web design, multimedia production, digital services, and so on), but is also about forms of labor we do not immediately recognize as such: chat, real-­life stories, mailing lists, amateur newsletters, and so on. These types of cultural and technical labor are not produced by capitalism in any direct, cause-­and-­ effect fashion; that is, they have not developed simply as an answer to the economic needs of capital. However, they have developed in relation to the expansion of the cultural industries and are part of a process of economic experimentation with the creation of monetary value out of knowledge/culture/affect. . . . Incorporation is not about capital descending on authentic culture but a more immanent process of channelling collective labor (even as cultural labor) into monetary flows and its structuration within capitalist business practices. (Terranova 2000: 38–39) Terranova gives particular importance to the place of what she terms “free labor” in the provision of content and innovation for the digital economy: the web designers, software writers, and bloggers who effectively work in the knowledge industries but are not formally employed. As she puts it, in this field “labor is not equivalent to waged labor” (Terranova 2000: 46). While some forms of digital production may be waged, others, often highly labor intensive and skill-­based—open-­source code writing, for example, or website construction—may circulate within a collegial gift economy that nevertheless feeds into corporate capitalization. Free labor emerges at a point of “experimental compromise between the historically rooted cultural and affective desire for creative production . . . and the current capitalist emphasis on knowledge as the main source of value added” (Terranova 2000: 38), part of a kind of corporate commons. The term “immaterial” is highly problematic for any discussion of clinical labor, given the absolute centrality of embodiment and living matter in the production processes of the bioeconomy. Nevertheless, Lazzarato’s and Terranova’s accounts give contemporary context to some of the dynamics of the biomedical knowledge economy that we have already described, par110 Chapter Five

ticularly the relentless scanning of the social body for ways to involve the productivity of human biology in life science experimentation. As we saw earlier in this chapter, regulators and university and corporate researchers are constantly modifying and developing new ways to gain legal and technical traction on human biological processes and to incorporate different kinds of tissue donors or clinical research subjects into research programs. In the case of regenerative medicine, the fertility and maternity sectors, the clinics and wards concerned with reproductive care, are sites where regenerative potential, framed as reproductive surplus or waste, can be solicited, mostly without resort to transactional procurement. Rather, women are approached in terms of the responsible disposal of excess life, asked to consent after the fact of reproduction or its termination. The exchange of money for tissues only comes into play when regulators and researchers fail to define particular tissues as excess, most obviously in the case of oocytes, which retain a recalcitrant scarcity value in virtually all jurisdictions. As with other areas of innovation economies (Adkins 2005; Thrift 2006), we would argue that this quest for tissue procurement is driven by the intense competition in the biomedical sciences to identify new forms of vital potential, new possibilities for in vitro productivity and in vivo therapeutic applications. This orientation toward potential derives in part from the uncertainty of the life science r�d pipeline and reflects the centrality of financial forecasting and market projection in stock market valuation of firms. The identification of vital potential is crucial to the establishment of corporate promissory value, particularly intellectual property rights, which secure licensing controls over the possible future uses of an invention (Brown and Michael 2003; Waldby 2006; Cooper 2008). However, it also derives from the vitality and open-­ended performativity of the biological itself, provoked by new ways of bringing technical and experimental systems into relation with living bodies. This last point is crucial for understanding what is at stake in an analysis of women’s labor in the stem cell industries.

Clock Time, Innovation Time, Biological Time

As we saw, existing accounts of reproductive labor rely on a Marxist theory of alienated labor and commodity value, located in the industrial, Fordist mode of production. We contend that this account of labor lacks traction on feminized labor for the stem cell industries, in part because it is committed to an equation of productive work with the industrial expenditure of clock time, and the value of the commodity as an accumulation of this expendiRegenerative Labor 111

ture. In Marx’s account, the relationship between labor and the commodity form is retroactive: the living labor of force expended in the present is congealed as past or dead labor in the exchangeable commodity. Labor is alienated because the value produced through its expenditure, above and beyond the clock time necessary for workers to support themselves, accrues in the commodity as the source of profit for the capitalist. We know that the value of each commodity is determined by the quantity of labor expended on and materialised in it, by the working-­ time necessary, under given social conditions, for its production. . . . In determining the value of . . . yarn, or the labor-­time required for its production, all the special processes carried on at various times and in different places, which were necessary . . . to spin the yarn, may together be looked on as different and successive phases of one and the same process. The whole of the labor in the yarn is past labor. (Marx 1887 [1867]: 129) Lisa Adkins (2009) argues that this mechanical account of value creation and the assumption of clean, specifiable relations between expended labor power and commodity value is unable to describe either the reproductive labor of the Fordist household or the more dispersed processes of innovation labor today. Rather, the Fordist household was organized to sustain the capacity of the male body to engage in such mechanical labor, while operating outside its industrial temporalities. She writes, “Socially reproductive labor functioned to sustain and reproduce labor power, a reproduction which was critical since the labor power of industrial capitalism was organized and functioned as a form of energy or force with the work process involving expenditure of this energy, energy which was then replaced via the reproductive activities associated with the private sphere. While socially reproductive labor was not subject to the rules of clock time and hence not amenable to standardization and homogenization, nonetheless this work therefore ensured that the social energy required of productive activities was replenished on a daily basis” (Adkins 2009: 333). She goes on to argue that this specifiable relation between time expenditure and retroactive value has become unmoored and uncertain and that in contemporary innovation economies there is no necessary connection between value creation and abstract labor time. A feature of the “immaterial” labor processes explored by Terranova (2000) and Adkins is the irrelevance of the formal working day and the absence of contractual control over labor time. Adkins suggests that this disarticulation of production from clock 112 Chapter Five

time points to the ways that some features of private reproductive labor in the household, particularly its concerns with care, affect, and relationality, have become more generalized across the social body as new forms of transactional labor. Hence, to properly conceptualize reproductive labor in the stem cell industries we need to develop a conceptual repertoire that does not rely on a logic of alienation and commodity production, precisely because such concepts are grounded in both an inapplicable industrial model of retroactive value and a particular implicit idea of the mechanical, working male body. Nor can we precisely extrapolate from the accounts of biological, reproductive labor we have described in the earlier chapters. Rather, we need to account for the specific forms of value creation at work in the stem cell sciences. Here we can see how existing clinical sites and practices around birth, assisted reproduction, and pregnancy termination have become locations for the mobilization of new biological potentials, the diversion of biological processes associated with the production of children toward much more open-­ ended, experimental kinds of vitality. Stem cell technologies are methods of investigating cellular potential beyond the confines of an organism. This orientation toward experimental potential distinguishes regenerative labor in the stem cell industries from either reproductive labor or industrial labor. We can explicate our claim by comparing the biology of assisted reproduction with the biology of stem cell technologies, and the different forms of productivity they engage. As we saw in chapter 3, for the greater part of the twentieth century, assisted reproductive technologies were devoted to the mass reproduction of animal life for industrialized agriculture (Rabinow 1999). Human art involves not the reordering of cells’ developmental biology, but the facilitation of fertilization—the creation of embryos in vitro only as a preliminary to their transfer into the woman’s uterus and the unfolding of the developmental pathways that may eventually produce a child. The process is organized precisely to preserve the ontogenic and teleological potentials of the germinal cells, their trajectory toward the reproduction of the organism in interaction with the maternal body. Stem cell technologies, however, are concerned with the disruption of this teleology and experimentation with cellular potential. They rely on art to disentangle reproductive material from the maternal body, yet as the oocyte or embryo passes from the clinic to the stem cell laboratory, it also passes from one institutional, legal, and scientific context to a dramatically different one. Former reproductive tissue enters into another epistemological space where the potentiality of the germ cell is defined in radically difRegenerative Labor 113

ferent ways. One of the prime innovations of stem cell science is to have reworked formerly orthodox understandings of cell potentiality. This is true of both somatic (nonreproductive) and germinal (reproductive) cells, such as the egg or sperm. In each case, a notion of potential that formerly limited their future possibilities of division and differentiation to the evolving organism now detects a quite different, even incommensurable spectrum of possibilities in the same tissue specimen. In scnt, an oocyte is used to reactivate the pluripotency of dedicated somatic cells. That is, a somatic cell (a skin cell, for example) can be taken back along its developmental pathway so that it regains its former embryonic ability to unfold into all tissue types. scnt is the process used to clone Dolly the sheep in 1996. Prior to Dolly, it was assumed that the nuclei of adult mammalian cells had lost their pluripotency; once programmed to produce a particular kind of cell, they lost their ability to produce different kinds of cells (Keller 2000). Human embryonic stem cells are disaggregated from the blastocyst, the elementary level of organization that begins the production of the organism. Their pluripotency is diverted into the production of a cell line, a technique that both immortalizes the tissue and facilitates its self-­perpetuating potential in vitro. The embryonic stem cell line can produce any of the specialized, fully differentiated cells that constitute a developing organism, while continuing to divide and produce more stem cells in an uncommitted, ex-­ organism state. In each case, the cell’s potential is at stake; their future possibilities of differentiation always exceed the finite possibilities available to the developed organism. Hence, their scientific value resides in their promised capacity to provide “inexhaustible” reserves of flexible, transplantable tissue, the promise (and the fantasy) of an endlessly self-­regenerating, frictionless biology. It is therefore not only the infrastructure of contemporary biomedicine that is being reorganized around an economy of promise, potentiality, and expectation, but also the temporality of the cell. In the words of two cell biologists, “The main attributes of stem cells relate to their potential in the future. . . . All statements that we can make [about stem cells] will be necessarily probabilistic statements about the future behaviour of the cell under consideration” (Loeffler and Potten 1997: 13–14). In this model, the “stemness” of the stem cell “is not a property but a spectrum of capabilities from which to choose” (Loeffler and Potten 1997: 1). According to this reworking of bodily potentiality, the cell is no longer determined by its specific lineage, nor committed to a path of progressive differentiation and loss of potency. 114 Chapter Five

Its capacity can be imagined outside the teleology of reproduction, organism development, and the perpetuation of species being. Rather, all cells retain the embryonic capacity for unrestricted proliferation and indefinite regeneration, independently of the chronological trajectory of the organism.

Conclusion

Through the mechanism of informed consent, women who donate their tissues to the stem cell industries contractually engage their bodies with these experimental systems and promissory economies, giving not so much the surplus products of reproduction as technical and legal traction on their bodily potentials for regeneration. The technologies of stem cell research directly engage these capacities and extend them well beyond their historical use values for sexuality, reproduction, and nurture into an experimental realm of potential and regenerative action whose social and biological limits are presently unknowable. It is poignant that such an engagement often takes place through appeal to the woman’s sense of responsible custody for the vital status of prenatal life, the sense that stem cell technologies offer a way to reanimate and revalorize what might otherwise be wasted life, channeling it into uncanny potentials. So, rather than simply adding an additional reproductive capacity to a female body already committed to reproductive labor, the stem cell industries require us to acknowledge the mutual constitution of politico-­economic and technological conceptions of potential itself. If different modes of technical production, scientific speculation, and economic calculus call forth different capacities from the body, it is the very conception of what the body is capable of doing—the work it is capable of rendering and the experimental systems in which it can play a part—that is under negotiation in the encounter between reproductive and regenerative medicine. While reproductive medicine demands a literal labor of reproduction from the female body, regenerative medicine is interested in the body’s capacity for embryonic self-­regeneration, prior to and apart from any process of development. Bodily potentiality is itself being reconfigured at the interface of new labor relations and the biological sciences.

Regenerative Labor 115

Pa r t I I I

The Work of Experiment Clinical Trials and the Production of Risk

Before being marketed, all prescription drugs need to be approved as safe and effective for consumption. This approval is granted by a regulatory agency such as the Food and Drug Administration, or fda (in the United States); the European Medicines Agency, or ema; or some other national administration. As consumers who ingest ever greater numbers of drugs in ever more complex combinations, we rarely pause to consider the many hundreds and sometimes thousands of research subjects who have taken part in randomized controlled trials (rcts) to determine the safety and efficacy of these everyday products. Even more rarely do we consider the fact that many research subjects, indeed the majority, undertake clinical trials as a form of paid work or work for health care. Human research subjects, however, have been engaged in the regulated production of therapeutic drugs and biological and medical devices since the mid-­twentieth century. Their numbers have increased dramatically over the past few decades, as clinical trial protocols have become more complex and provable drug innovations more elusive. While the United States continues to house the greatest number of

clinical trials—including the majority of high-­risk, Phase 1 trials—over recent decades, a growing proportion of clinical trials have migrated offshore to the newly liberalized and postsocialist zones of the world economy. The drugs we consume may have been tested on Phase 1 recruits in New Jersey and Shanghai, and uninsured Phase 2 or 3 recruits in California, Beijing, and Ahmedabad. The pharmaceutical industry relies on a transnational, informal labor force of industrial-­scale proportions, one that largely escapes public scrutiny as a form of labor. In the chapters that follow, we offer a theoretical and historical analysis of the evolving forms and contexts of clinical trial work both in the United States and offshore. The formal methodology of the rct, the gold standard of clinical research, was established in 1946 when Austin Bradford Hill of the British Medical Research Council published the results of streptomycin studies for tuberculosis. In practice, however, clinical trials had been conducted for much longer; physicians on both sides of the Atlantic had performed statistically controlled trials throughout the 1930s and 1940s, with a particular spike during the war years (M. Edwards 2007: 21). It is to the mass experimentation of World War II that we owe the breakthroughs of mid-­twentieth-­ century pharmacology. Under the emergency conditions of war, participation in clinical research was considered a kind of national service, on a par with the “unfree labor” of the conscripted soldier. As infectious diseases struck down thousands of soldiers on the front lines of war, British and American research councils, philanthropic organizations, and pharmaceutical companies joined forces to accelerate the development of new therapeutic agents. New drugs were tested not only on cadets and soldiers but also on the inmates of state prisons, public hospital patients, the institutionalized, orphans, and employees of vital wartime services such as the post office, government ministries, and even factories (Stanton 2003). With the support of the Rockefeller Foundation, a combined British-­American research effort administered hundreds of thousands of influenza vaccine doses to members of the Royal Navy, the raf, the Ministry of Health, and the post office during the winter of 1940– 1941, while American researchers administered several thousand doses to inmates in correctional institutions in the United States (M. Edwards 2007: 124–125). In the United Kingdom, other vaccine trials were carried out on volunteers in the various Home Commands, medical students and nurses, conscientious objectors, and hospitalized arthritis patients (Stanton 2003; M. Edwards 2007: 126). In the United States, even greater use was made of institutionalized subjects. The Committee on Medical Research (cmr) ad118 Part III

ministered highly toxic dysentery vaccine to teenage boys and girls in the Ohio Soldiers and Sailors Orphanage, provoking severe side effects. The vaccine was also tested on patients in public hospitals; state wards at the Dixon Institute for the Retarded, in Illinois; and residents at the New Jersey State Colony for the Feeble-­Minded (Rothman 2003: 36). A cmr grant allocated to Dr. Alving of the University of Chicago authorized him to purposely infect patients with malaria before administering investigational antimalarial drugs. To this end, he set up a sixty-­bed clinical research unit at the Manteno State Hospital in Illinois, where he infected psychotic patients, and transformed an entire floor of the Stateville prison hospital into a clinical research unit, where he infected and tested five hundred prisoners (Rothman 2003: 36). The cmr authorized similar experiments for research on influenza vaccine. Dr. Werner Hernle of the University of Pennsylvania Medical School received a grant to transmit influenza to thousands of patients from the Pennhurst state institution for the retarded and a correctional center for young offenders. Six months after infection, the patients were administered an experimental influenza vaccine. An even more ambitious testing program was carried out by Dr. Jonas Salk, who transformed the entire Ypsilanti State Hospital for the criminally insane in Michigan into a research site for influenza inoculation (Rothman 2003: 38–39). The emergency conditions of war—with its mass mobilization of regimented bodies and its legal exceptionalism—had offered the ideal conditions for perfecting the experimental methods of the rct, so much so that many of those involved in the wartime trials thought demobilization represented a real loss to medical progress. They were now faced with the logistical problem of how to replicate the mobilization of docile bodies on a smaller scale, without diminishing the scientific validity of their experiments (M. Edwards 2007: 127–134). It is perhaps not surprising, then, that Cold War trials on cancer patients treated the latter as “proxy soldiers” (Kutcher 2009). The problem of demobilization, however, would ultimately be resolved by other means, notably the displacement of the clinical trial into the carceral space of the state prison. During the pharmaceutical boom years that followed World War II, American prisons would provide the bulk of human research subjects for drugs and cosmetics, in what proved to be a highly lucrative alliance between academic science, the pharmaceutical industry, and the state correctional system (Hornblum 1998). Human subject experimentation remained unfree labor par excellence—both legally and spatially excluded from the unionized, Fordist workplace. The forms of experimental labor we explore in the following pages are The Work of Experiment 119

shaped by this history of prison-­based, high-­risk labor. Nevertheless, the period we focus on—from the late 1970s onward—is marked by the prohibition of prison-­based trials and a corresponding movement toward the decentralization of the clinical trial process itself. Today clinical trial work lies at the intersection of the professional knowledge economies and the contingent labor market and is shaped by ongoing transformations in the structure of the household, the prison, and health insurance. During the past few decades, the bulk of clinical trials have moved from the total institution of the state prison and academic research hospital to the private physician’s office (for later-­phase trials) and the dedicated Phase 1 unit (for toxicity studies). The vertical disintegration of the prison-­industrial-­pharmaceutical complex has given rise to a new, and quasi-­ubiquitous mediating agent—the contract research organization—which places and sometimes organizes clinical trials on behalf of the large pharmaceutical companies. The prohibition of prison-­based trials has refashioned the research subject as an independent contractor in personal services, a move that also characterizes the organization of assisted reproductive labor and is in keeping with the evolution of post-­Fordist labor in general. Clinical trial work, however, continues to be shaped by the legacies of race, labor, and class, as Phase 1 trials recruit a disproportionate number of impoverished Latino and African American men. In the meantime, the evolving institutional form of later-­phase clinical trial work is intimately bound up with the process of neoliberal health care reform. For the growing numbers of nominally middle-­class Americans who are both chronically ill and uninsured, the selective erosion of health insurance has become for many an impetus to undertake clinical trials—and a novel form of workfare. The past few decades have also seen a dramatic recalibration of the clinical research complex away from its traditional location in western Europe and the United States (still the world’s leading clinical trial market) to newly emerging destinations in Asia, Latin America, and eastern Europe (Sunder Rajan 2007, 2008; Petryna 2009; Prasad 2009; Kuo 2012). During the 1960s and early 1970s, even European drug companies were conducting many of their clinical trials in US state prisons. Today US-­based and European pharmaceutical companies are outsourcing a growing proportion of clinical trials to the postsocialist and newly liberalized zones of the world’s economy— eastern Europe, the former Soviet Union, Latin America, China, and India. In chapter 7, we focus on the clinical trial sector in China and India—two of the fastest-­growing clinical trial markets in the world. Far from reflecting a simple continuation of colonial experimental medicine, or a predict120 Part III

able outcome of long-­standing health inequalities, the rise of a clinical trial sector in these countries was enabled only by very recent “reforms” of the health sector, the hospital system, and collectivized labor. Both the Indian and Chinese states, moreover, have made concerted efforts to promote the cross-­border trade in clinical services, transforming the public hospital into an experimental export zone par excellence. As the pharmaceutical industry offshores a growing proportion of clinical trials to cheaper destinations such as China, India, the former Soviet Union, Latin America, and elsewhere, evidence-­based medicine is being globalized and scaled up as never before. Yet the very forces that are driving the pharmaceutical industry to relocate clinical trials offshore are also leading many within the industry to rethink the epistemological premises of the clinical trial itself. In chapter 8, we turn to emerging new configurations of clinical research and clinical labor. As the pharmaceutical industry confronts declining innovation rates and rapidly expiring patents, many are beginning to question the very assumptions of the three-­phase rct. With the support of regulatory agencies, both industry and academic researchers are experimenting with new formulations of the clinical trial (Phase 0 and adaptive trials), or rethinking the very boundaries between the lab, the clinic, and the consumer public. Of particular interest here is the turn toward models of user-­generated innovation, which outsource the practice of experimental drug consumption to the public at large. Despite their ambivalent relationship to neoliberal philosophies of risk, we argue that such models of distributed experiment can be traced to the critical interventions of aids-­ treatment activists in the early 1990s, who mounted a wholesale critique of the consumer protection model of drug testing. Today we are left to grapple with the complexities of a critical health politics that has been incorporated into the very strategies of commercial drug development. Our study examines forms of clinical labor—assisted reproductive work and clinical trial work—that have themselves been organized around a long-­ standing sexual division of labor. Historically, the labor and welfare protections that have been reserved for women (most notably the family wage) have served as means of subsidizing or valorizing their reproductive roles (Wikander et al. 1995). A similar logic is at work in late twentieth-­century clinical trial regulations. While women are considered naturally suited to the biological labor of gestation and reproductive gift giving, since the mid-­ 1970s they have been routinely excluded from Phase 1 clinical trials for the very same reasons. In 1977, the fda issued a new rule prohibiting pharmaceutical trial sponsors from including pregnant women and women of childThe Work of Experiment 121

bearing age in Phase 1 clinical trials (McCarthy 1994). It was not until the 1990s that this sexual division of experimental labor would be seriously challenged, when women suffering from hiv/aids demanded to be included in trials that represented their only hope of treatment. Today, the division between reproductive and experimental labor is being further challenged by the fact that regenerative medicine is moving into the experimental space of Phase 1 clinical trials. The final chapters of parts II and III of this book point to the emerging scenes of production, where experimental and reproductive labor are becoming increasingly difficult to distinguish.

122 Part III

Six

The American Experiment From Prison-­A cademic-­Industrial Complex to the Outsourced Clinic

The vertically integrated pharmaceutical firm, which rose to prominence after World War II and culminated in the blockbuster model of drug development in the 1980s, is now experiencing an organizational crisis.1 The so-­called blockbuster drugs—patented prescription drugs generating more than US�1 billion a year—are rapidly encountering the limits of their patent terms, but the pharmaceutical industry has yet to find a reliable source of new innovations to replace its established portfolio of products. Increasingly, pharmaceutical companies look for their new drug leads and potential new market-­makers outside the walls of the in-­house research unit in the world of small academic research centers, public-­private spin-­off companies generated by university research institutes, and small biopharma start-­ups. The promise of these companies is inherently speculative—what they have to offer has not yet been realized and exists in the form of experimental drugs or therapies that have yet to travel the long path from laboratory assay and animal testing, through human subject testing, to final market approval. What they have to sell is a portfolio of patent claims on drug compounds

or biologicals whose clinical effectiveness has yet to be demonstrated. Their business model is highly financialized. It is premised on the willingness of venture capital funds, and the pension funds that sustain them, to underwrite the initial and most speculative phase of product development; the highly promissory regime of patent protection that was introduced under President Ronald Reagan in a bid to sponsor a new long wave of postindustrial growth; and the Bayh-­Dole Act of 1980, which facilitated the creation of commercial spin-­off companies from publicly financed basic science research (Coriat and Orsi 2002). Different kinds of investors enter into alliances with the small biopharma company at successive stages of the product development process. Venture capital funds sustain the company at its most speculative, experimental stage, exiting the contract and recouping their investments when the company is publicly listed on the stock market via an initial public offering (ipo) and is acquired or partnered by a large pharmaceutical company. Big Pharma intervenes at a later stage, acquiring licensing or patent rights to a drug in order to steer it through the three phases of human testing (Lazonick and Tulum 2011). The speculative model of investment that animates the small biopharma company has had an enduring effect on the institutional structure of Big Pharma itself. As long-­ term pipeline strategies give way to the promissory economy of shareholder value and vertical integration is replaced by continuous restructuring, both the business model and organizational culture of Big Pharma have become increasingly volatile. Today the market valuation of a publicly traded pharmaceutical company relies less on its actual profits than on the promise of yet-­to-­be-­approved but nevertheless patented experimental drugs. The fact that the pharmaceutical industry is currently experiencing a conspicuous crisis of productivity has only intensified the tendency of stock markets to look toward experimental product portfolios rather than established consumer markets. In his famous study Risk, Uncertainty and Profit, Frank H. Knight (1940 [1921]), the somewhat unorthodox founder of the very orthodox Chicago School of economics, argued that profit was the entrepreneur’s reward for bearing uninsurable risks in a radically uncertain environment. As we will see, this logic is loudly endorsed by the pharmaceutical industry as a justification for high drug prices in the domestic consumer market but belied by the actual regulatory and legal protections that accrue to speculative innovation in the post-­Fordist American economy. Much of the commercial risk of pharmaceutical r�d is concentrated in the clinical trial stage of drug development. In order to preempt competition, pharmaceutical companies 124 Chapter Six

routinely file patents on a drug before it enters human trials. Any lag in the clinical trial process is therefore clocked up as a subtraction from the standard patent term of twenty years, which in turn translates as a huge dent in future profits. After a period during the 1980s when intellectual property rights and their violation represented the major concern of drug company executives, today the pharmaceutical industry is obsessed with the idea of shortening, accelerating, and rationalizing the clinical trial process as a way of reviving profits. Maddeningly, however, the “translation” from investigational new drug to federally approved and marketable product remains fraught with obstacles and beset by routine failure. The transition from preclinical testing on animals to clinical testing in humans is highly uncertain; in addition, most new drugs also fail to complete the three stages of human clinical trials that are required before approval for marketing. There is a 60 percent chance that a drug in Phase 1 testing will fail; a Phase 2 drug has only a 50 percent chance of making it to Phase 3; and the probability of failure in Phase 3 can be as high as 50 percent, depending on its therapeutic indication (Pisano 2006: 57). In the words of Gary Pisano, the process of drug r�d, unlike that of microelectronics, for example, “is highly risky due to profound and persistent uncertainty. This uncertainty is rooted in our currently limited knowledge of human biological systems and processes” (2006: 55). “Due to the absence of strong prior knowledge and high-­fidelity testing models,” he goes on to note, “drug r�d is inherently an iterative and inductive process in which high levels of uncertainty persist throughout the process” (Pisano 2006: 59). Above and beyond the scientific uncertainties inherent in the clinical trial process, however, the pharmaceutical industry is also faced with the practical task of identifying, recruiting, and retaining the research subjects needed to complete a clinical trial. In recent years, the logistics of human subject recruitment have become increasingly daunting as clinical trials grow in number and the specifications for selecting appropriate trial subjects become ever narrower. Human subject recruitment now consumes the highest proportion of overall drug r�d costs (J. P. Walsh et al. 2003). For all of these reasons, the successful completion of each phase of clinical testing represents an important milestone in the development of an investigational new drug and a powerful catalyst for movements in financial asset prices. As Daniel P. Carpenter notes, “Unexpected changes in clinical trial results can induce tremendous swings in company-­wide stock prices. When the findings are surprisingly bad ones, their announcement can erase individual and organizational fortunes within minutes. So heavily do invesThe American Experiment 125

tors cling to the structure of phased experimentation for their news that it has become customary for companies to publicize results from each phase of experiment well before they are published in a medical or scientific journal” (2010: 294). Patent protection on an investigational new drug functions something like a promise whose reality awaits confirmation, or dismal failure, during the lengthy clinical trial process. When a drug successfully completes one of the three stages of the clinical trial process, it is a sign that expectation has been realized, that the high risks incurred in the drug r�d process have paid off as higher-­than-­average returns. Yet despite the highly uncertain fortunes of any one investigational new drug, the overall business portfolio of the pharmaceutical industry is remarkably risk averse. The pharmaceutical industry produces very little true innovation of its own. Most new drug discovery is conducted outside the commercial drug sector in academic research centers publicly funded by the National Institutes of Health (nih) or in the private-­public partnerships formed by small biotech start-­ups. For the most part, the pharmaceutical industry intervenes after the drug discovery stage, licensing the most promising fruits of publicly funded research in order to take them through the clinical testing and drug review process. Nothing predisposes the pharmaceutical industry to take an “in-­house” risk with unusual or entirely novel therapies, unless it is completely convinced of market success. As Joseph Dumit (2012) notes in his compelling reinterpretation of Marx’s thesis on capital, the late twentieth-­century pharmaceutical industry is oriented not so much toward health as toward surplus health—the self-­ valorization of capital through the generation of new therapeutic markets. Many best-­selling new drugs respond to the creation of chronic conditions, indicated by the moving thresholds of officially recognized risk factors rather than current symptoms, while a sizable number of newly branded products are in fact “me-­too” drugs, slight variations of an existing formulation that promise to capture a market without incurring too much commercial risk in the drug-­testing stage. And many of the feted “inventions” of recent years have been legal innovations, ingenious ploys for stretching patent coverage beyond its original terms by (for example) testing the drug on a new population or filing for a new therapeutic indication for an old drug. In these and other ways, the pharmaceutical industry has developed multiple ways of hedging against the intrinsic uncertainties of the drug development ­process. Estimates of pharmaceutical r�d costs are highly contested. A much publicized and frequently cited study produced by a group of economists, 126 Chapter Six

headed by Joseph DiMasi of the Tufts Center for the Study of Drug Development, cited a figure of US�802 million as the average pretax cost of new drug development (DiMasi et al. 2003). Marcia Angell, former editor of the New England Journal of Medicine, has challenged this figure, pointing out that the Tufts Center study was limited to new molecular entities (nmes)—a very small percentage of all new pharmaceutical drugs (2005: 40–43). Others have proposed an after-­tax figure of �110 million as the average cost for each drug approved, but this figure may also need to be revised downward given that it is also based on estimates for nmes (Public Citizen Congress Watch 2001). But whatever the true costs of pharmaceutical r�d, the exceptional profits earned by the pharmaceutical sector remain indisputable. Even as rates of “true” innovation have declined, prescription drug prices have tripled since the early 1980s. The United States is the only major world economy that does not intervene directly in the regulation of drug prices and leaves private health insurers, hmos, and pharmaceutical companies to negotiate prices among themselves. Consumer drug prices in the United States are among the most inflated in the world and a disproportionate share of overall drug industry profits derive from US sales (Finkelstein and Temin 2008). The commercial risks that plague the clinical testing and drug approval process for each individual drug are therefore offset, many times over, by the possibility of continually raising drug prices. Most importantly, perhaps, the act of making a commercial promise has been purged of its traditional legal consequences following significant changes to US securities law under the Clinton administration (but opposed by Clinton himself). In 1995, Congress passed the Private Securities Litigation Reform Act (Pub. L. No. 104–167, 109 Stat. 737 [1995]), an amendment to New Deal securities legislation that included a controversial safe harbor for “forward-­looking statements.” Under this amendment, “forward-­looking statements”—the promissory claims that publicly traded companies include in press releases, annual reports to shareholders, and filings with the Securities and Exchange Commission—are to be considered exempt from litigation as long as they are framed in language that signals their conditional, speculative, or future subjunctive nature.2 The press release of a large pharmaceutical firm, for example, will include language such as “expects,” “looks forward to,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and “projects,” and will explicitly reference its use of such language as a means of preempting future litigation. With the passage of the 1995 Safe Harbor clause, publicly traded pharmaceutical companies were free to make speculative projections about their future portfolios without bearing actual The American Experiment 127

legal responsibility for the risks and uncertainties of the innovation process. The exceptional legal protections afforded to so-­called innovation risks suggest a fundamental reworking of Knight’s (1940 [1921]) classic formulation of the logic of high-­risk enterprise. In today’s innovation economy, the profit generated by high-­tech firms is to be understood not as a return on essentially uninsurable, radically uncertain risks, but as the income stream accruing from the generation of (legally) risk-­free promises. By contrast, the risks borne by the experimental subject are material and structural to the process of regulated drug innovation, since it is the systematic risk-­exposure of the clinical trial process that transforms the therapeutic compound from investigational new drug into a regulated, marketable product. For the Phase 1 clinical trial subject, who is subjected to a series of dose-­escalation studies to determine drug toxicity, these risks are of an immediate, visceral kind. The Phase 1 clinical trial is a product-­testing procedure, but one that uses living human subjects rather than animals or crash-­ test dummies to ascertain risks and thresholds of toxicity. The risk induced by the Phase 1 clinical trial are by definition unknown and unknowable before the test has been carried out. Many would argue that these risks are uninsurable. For the chronically ill patients who undertake Phase 2 and 3 clinical trials in lieu of affordable health care (a large percentage of overall candidates in the United States), the risks involved are of a less immediate but no less tangible kind. When participation in clinical trials becomes a means of primary health care, health itself becomes a highly speculative proposition, contingent not only on one’s selection into a trial but also on one’s assignment to an effective (nonplacebo) arm of the trial. The guaranteed benefits of social insurance are here replaced by the aleatory and competitive returns of a double-­blind trial on an experimental new drug. In this way, then, the research subject’s bodily assumption of uninsured (perhaps uninsurable) risks constitutes the structural premise of the pharmaceutical innovation economy. Pace Knight, it is the clinical laborer who acts as risk bearer of last resort to the speculative innovation economy of the contemporary life sciences. By all accounts, the overall number, size, and complexity of pharmaceutical clinical trials have increased dramatically over the last few decades. In an effort to capitalize on the competitive advantages of new molecular entities developed in academic research institutions, not only are pharmaceutical companies initiating more drug studies, but trial sponsors are also recruiting far more subjects per trial (US Department of Health and Human Services 2000). This trend can be attributed in part to the increasing im128 Chapter Six

portance of chronic and degenerative diseases within the pharmaceutical industry’s portfolio. When compared to the therapies for acute and infectious diseases developed in the post–World War II era, these conditions require longer and more complex trials to yield statistically significant results (Grabowski 2002: 90; Kaitin 2008). It can also be attributed to the fact that pharmaceutical companies are sponsoring more trials for so-­called “me too” drugs—slight variations on already-­existing treatments that can yield large commercial profits but that also require a much more intensive trial process to prove their effective superiority to preexisting alternatives. In 2006, according to research conducted by the nih and the Center for Information and Study on Clinical Research Participation, 775,000 Americans participated in government-­funded clinical trials, 880,000 enrolled in industry-­ funded Phase 1, 2, or 3 clinical trials, and 750,000 people were recruited in industry-­funded Phase 4 trials (ciscrp 2011). On average, more than 4,000 research subjects are required for the fda to approve an investigational new drug for marketing (Krall 2011). It is clear from recent empirical studies that most research subjects take part in clinical trials either for money (in the case of Phase 1 trials) or in exchange for health care (in later-­phase trials) (Dickert and Grady 1999; Lemmens and Elliot 1999, 2001; Anderson and Weijer 2002; Dickert et al. 2002; Grady et al. 2005; Fisher 2009; Folayan and Allman 2011). The risks incurred in human subject experimentation are intrinsic to the process of regulated drug innovation. Without it, there would be no guarantee of consumer safety—and no innovation value. Human subject experimentation, then, represents not only an integral step in the biomedical innovation chain but also a massive component of the post-­Fordist labor process—yet it escapes conventional analyses of both the informal service and high-­tech knowledge economies. In this chapter, we follow a small but growing number of critics who argue that the clinical trial is in fact organized along the lines of a labor relation, albeit an informal one (Dickert and Grady 1999; Lemmens and Elliot 1999, 2001; Anderson and Weijer 2002; Sunder Rajan 2008; Folayan and Allman 2011). James A. Anderson and Charles Weijer, for example, compare the fate of the serial drug trial recruit to that of the sweatshop worker during the Industrial Revolution, noting that much as “industrialisation created a profusion of meaningless work, turning the skilled artisan into a ‘spoke in the wheel’ of industry, the shift in location of drug research from the academy to contract research organisations (cros) threatens to turn the research subject into a ‘cog in the machine’ of pharmaceutical production” (2002: 372). Neal Dickert and Christine Grady (1999) argue for the introThe American Experiment 129

duction of a standardized minimum wage, comparable to that of other unskilled wage laborers, while Trudo Lemmens and Carl Elliot (2001) make a case for unionization. While we are in accord with the spirit of these critiques and share their desire to break from the stranglehold of bioethics as the sole available language for addressing human subject experimentation, we are not necessarily in favor of a specific form of labor recognition (in the current context, for example, unskilled wage laborers may earn far less than the average Phase 1 research subject—labor recognition without prior contestation does not in general yield an interesting labor politics). Nor do we agree with the proposition that clinical labor is directly comparable to Fordist industrial labor. Rather, we will argue that the legal and institutional infrastructures of human subject experimentation evolved in opposition to the formal standards of unionized, risk-­compensated Fordist labor throughout the twentieth century, making clinical trial work an exception to conventional and canonical Marxist understandings of work. In this respect, our understanding of the specificity of human subject experimentation qua labor comes closest to that of Kaushik Sunder Rajan, who defines clinical trial work by its intrinsic relationship to “risk” (2008: 160–161). The chapter will begin by examining the regulations that govern and shape the clinical trial enterprise, before defining the different categories and echelons of clinical trial work today. We will then move on to a more nuanced account of the full repertoire of clinical trial work and the various levels of transaction that human subjects enter into when they enroll in a clinical trial. We will argue that clinical trial work in general can be conceptualized as a form of “risk-­bearing” labor, subject to what we call the “evental time” of metabolic exposure rather than the measurable, “socially average” time postulated by Marx’s classical labor theory of value (Marx 1990 [1867]: 129). We then go on to discuss the exceptionalism of clinical trial work with respect to mid-­twentieth-­century, Fordist ideals of regulated industrial labor, pointing to the complex debates around tort law, risk, and workplace injury that gave shape to the legal convention of informed consent. Here we adopt a longue durée perspective on the history of the clinical trial and suggest that the “bioethical” conventions incorporated into regulated clinical research would be fruitfully analyzed alongside wider developments in risk regulation and tort law. We then turn to the recent history of clinical trials in the United States, still the world’s largest clinical trial market. Over the last two to three decades, the clinical trial process has evolved from a carceral model of highly regimented, mass-­produced experimentation based in the public prison and university research hospital to a more decentralized, 130 Chapter Six

contract-­based model in which drug testing is outsourced to private research organizations and nonacademic clinicians. We argue that the reorganization of clinical trial labor along the lines of flexible, contract-­based work, reflects the evolving intricacies of race, gender, and labor relations generated by deindustrialization and welfare reform. As the anthropologist Roberto Abadie (2010) notes, the burgeoning of the labor market in high-­risk, Phase 1 work is a product of the deindustrialization of the North American economy, which has seen a corresponding intensification of investment in the pharmaceutical and biomedical industries. Many of the former manufacturing hubs of the North American Rust Belt have replaced their industrial precincts with postindustrial “high-­tech” corridors specializing in it, pharmaceuticals, biotech research, and other medical technologies. Phase 1 work resides in the margins of the formal pharmaceutical economy, recruiting from a permanently casualized, informal labor force, from among populations that reside either in the borderlands of social citizenship (racial minorities and the urban underclass within the United States) or at the literal, geographical border of the US economy (the US-­Mexico border, for example). Phase 2 and 3 work, by contrast, operates in the margins of the formal health consumer market, recruiting among a population of chronically ill but underinsured patients. While Phase 1 and 2 trials on healthy subjects recruit low-­ wage workers who participate in remunerated trials as a form of occasional or routine service labor, growing numbers of uninsured patients are enrolling in Phase 2 and 3 trials as a means of gaining access to vital health care and medical treatment. We refer to the first kind of clinical trial as informal, contingent, transactional labor and categorize the latter as a qualitatively new form of “work for health care.”

Drug Regulation and the Clinical Trial Process

The fda, created by the Food, Drug and Cosmetic Act of 1906, is the agency responsible for regulating all prescription drugs, over-­the-­counter medicines, biologics, medical devices, cosmetics, nutritional supplements, and, with the exception of meat and poultry, all food in the United States. In the words of Arthur Daemmrich and Joanna Radin, products regulated by the fda “are ubiquitous in modern life and act as critical components of nutrition and health. . . . Put in economic terms, the fda regulates some 25 cents of every dollar spent by consumers; the total annual sales of products falling under the agency’s mandate exceed �1.5 trillion” (2007: 3). The fda is one of the few American agencies to exercise national jurisdiction: no new drug The American Experiment 131

can be legalized in the United States without first passing its approval process. The fda not only holds veto power over all potential products before they go to market, but in large measure also defines the shape of pharmaceutical r�d, clinical testing, and product development. “Regulation” and “innovation” are not opposed, then, as some libertarian critics of the fda would have it. Rather, fda drug regulation shapes the pharmaceutical product before it goes to market and, in an important sense, adds value in the form of an implicit guarantee of safety and efficacy. The current rules governing clinical research in the United States can be traced in large measure to the Kefauver-­Harris Amendments of 1962. Introduced in response to the thalidomide scandal, whose worst effects had been averted in the United States, these amendments not only strengthened existing drug regulations (compelling drug manufacturers to prove both the effectiveness and the safety of a product before it could be marketed) but also established the standard methodological, ethical, and regulatory structure of the clinical trial process as it is practiced today. The new regulations, which demanded “adequate and well-­controlled investigations” before any “new drug” could enter interstate commerce, normalized the rct as the gold standard of clinical research and introduced the novel concept of a three-­ phase (1, 2, and 3) testing process, which would move from initial toxicity tests (1 and 2a) to efficacy tests (2b and 3) before submission of a final drug application (Carpenter 2010: 260–292). Not only did the Kefauver-­Harris Amendments institutionalize the rct; they also gave shape to what we now consider the standard bioethical norms of clinical research. The 1962 rules required trial investigators to obtain the consent of patients or their representatives before undertaking research. In 1966, a further specification to these rules embedded the term “informed consent” in federal regulations and required investigators to inform patients of the dosage of the drug to be administered, all reasonably foreseeable risks, and the possibility of being assigned to a control or placebo arm of the trial (Carpenter 2010: 549). In 1969, federal legislation specified that all investigational new drug applications for undertaking trials had to be reviewed and approved as safe and ethical before being submitted to the fda. In 1974, the US Congress passed the National Research Act, which required all federally funded research institutions to set up an internal institutional review board (or irb) to review and approve trials (Stark 2012). “The need for specialists to staff these academic irbs,” notes Philip Mirowski, “gave rise to the job category of the ‘bioethicist,’ with one of the few academic growth areas in the discipline of philosophy in recent decades, ‘medical ethics’” (2011: 230). With the exception of 132 Chapter Six

the phased division of trials, none of these requirements—the informed consent form, the rct, or the irb—were novel to clinical research in the United States. The expanding administrative role of the fda, however, meant that these practices would become standard elements of clinical research both in the United States and internationally. The Kefauver-­Harris Amendments profoundly reshaped the regulatory powers of the fda. Under the terms of the 1906 act that created the agency, the fda had few powers over the testing of drugs before they went to market. Instead, the fda was endowed with ex post facto law enforcement powers that authorized it to prosecute food and drug manufacturers for launching faulty or toxic products onto the consumer market (Hutt 2007). By the 1920s, the fda was bringing close to one thousand criminal prosecutions and several thousand seizure actions against companies per year. Its powers were extensive. In 1943, a landmark Supreme Court decision established the principle of strict criminal liability for manufacturers of food or pharmaceuticals, meaning that the fda did not have to prove criminal knowledge or intent to prosecute a company. Beginning in the 1950s, however, the rise of consumer protection regulations governing everything from food additives to pesticides displaced the burden of proof from postmarketing criminal prosecution to premarket testing. During this period, the high point of Fordist mass consumption, consumer protection laws for all kinds of products gained support on both sides of the political spectrum. Increasingly, courts chose to disregard the established common law immunities reserved for large corporations, while new enterprise liability laws held manufacturers directly responsible for defects and failures to warn of potential product risks (Priest 1985; Witt 2003). Mass product testing—using dummies, animals, and humans—became a requisite component of commodity production.3 The Kefauver-­Harris Amendments, which granted the fda unprecedented powers to regulate and veto the testing of products before they went to market, can be seen as part of this trend. The trade-­off between criminal prosecution and premarket regulation has remained more or less stable, although in chapter 8 we will investigate recent trends toward the retrenchment of strict consumer protection rules in favor of postmarket surveillance. Today the drug approval process follows a well-­established sequence of events. After the identification of a promising drug candidate or other therapeutic product (medical device or “biological”), testing is first carried out on animals. This phase of the drug development process is known as preclinical testing. Once a sponsor is confident that a therapeutic product is ready to undergo testing in humans, an investigational new drug application must be The American Experiment 133

lodged with the fda. This grants the fda a thirty-­day period within which to suspend the proposed investigation (approval is implicit if no suspension order is issued). The first phase of the testing process is primarily concerned with establishing the safety of a drug through the use of dose escalation. All Phase 1 studies of investigational new drugs (also referred to as first-­in-­ human studies) involve considerable and largely unpredictable risks, since they progressively escalate drug dosage to the point of toxicity (Shamoo and Resnik 2006). Phase 1 studies use pharmacodynamic testing to document how a drug is absorbed and metabolized, how it moves through the body, and how it binds with molecules. Pharmacokinetic testing describes similar processes over a longer period of time, documenting how a drug is metabolized, distributed throughout various tissues, built up, and excreted. These studies generally recruit a small number of otherwise healthy subjects (between twenty and eighty), although recruits for aids and cancer drug trials are generally patients suffering from the disease. They take between nine and eighteen months to complete. Once the initial safe dosage of a drug has been established, Phase 2 studies can be undertaken to provide further evidence of safety and preliminary evidence of efficacy in the target patient population. Phase 2 studies generally recruit a small population of research subjects (between one hundred and three hundred) and can take between one and three years to complete. Phase 3 studies recruit a much larger and more diverse spectrum of patient subjects (between several hundred and several thousand) and seek to confirm the therapeutic effects of a drug by comparing them with standard available treatments or placebos. (The fda has more recently introduced two new phases of testing—Phase 0 or exploratory ind studies and Phase 4 or postmarketing studies—at either end of the existing clinical trial process, and we will discuss these two phases in chapter 8.) The standard three phases of testing can take between three and five years to complete. In practice, sponsors will conduct multiple trials of any one phase in order to yield a significant trial result. At the end of this sequence, the sponsor submits a New Drug Application to the fda, which will grant marketing approval if it believes that sufficient data has been collected on the drug’s safety and efficacy.

Clinical Trial Work as Risk-­Bearing Labor

The work undertaken by a clinical trial participant is intensive, high-­risk, and eminently physical, yet it demands a very different kind of bodily investment from that required of the industrial laborer. Human subject ex134 Chapter Six

perimentation can be described as a form of transformative exposure, where the recruit is called upon to both experience the sometimes unpredictable metabolic effects of pharmaceutical compounds and perform a number of second-­order tasks, such as adhering to a strict regime of diet and drug administration, self-­monitoring, and recording of information. This is a depiction of labor that blurs the boundaries between passive and active participation, the subject and object of labor. A Phase 1 study of the neurophysiologic correlates of anesthesia might require that healthy volunteers undergo several electroencephalograms, serial blood tests, and multiple diagnostic tests after the administration of a different anesthetic during a two-­week clinic confinement. A study evaluating an investigational agent for aids-­related diarrhea could involve a four-­day hospital admission during which stools and blood will be collected. A randomized placebo-­controlled trial of an experimental agent for gastroesophageal reflux might require a three-­day admission, an endoscopy, a stomach biopsy, and three or four nasogastric tube insertions. Trial participants undergo a strict washout period prior to the commencement of trials, during which they are unable to consume a designated range of other drugs. Once the trial has begun, they must adhere to a specific diet, sleep regimen, and other protocols and are required to carefully monitor and record the effects of drug compounds on their body. Hooked up to machines, monitored, scanned, and examined, the clinical trial recruit undergoes a process of intensive biochemical exposure involving greater or lesser degrees of risk, discomfort, and endurance. Unlike the industrial laborer, he or she participates in a labor of ingestion and metabolic self-­transformation rather than expending energy in transforming the physical object. One self-­identified professional “guinea pig” has described this as “pissing, bleeding work” (Burrill Report 2001). What this pissing and bleeding produces, from the perspective of the pharmaceutical industry, is a symptomatology of metabolic events that can be analyzed according to pharmacokinetic and pharmacodynamic criteria and transformed into clean, readable data, ready for insertion in the drug application process. Within the category of clinical trial work, we distinguish between different levels and kinds of transaction. In the current US context, Phase 1 studies on healthy subjects are the most blatantly transactional form of clinical labor in that the research subject is generally motivated by financial reward alone and does not expect to receive any therapeutic benefit from the trial. These trials involve varying degrees of risk and pay accordingly. As Jill Fisher explains, first-­in-­human studies of investigational new drugs are “time intensive, require multiple doses of varying quantities of the experimental drug, The American Experiment 135

and carry higher and oftentimes unknown risks,” whereas bioequivalence studies, which compare brand-­name medications to a generic, involve considerably less risk (2009: 149). Phase 1 studies generally require a period of confinement in a clinic that can last anywhere between a week and more than a month. Longer confinements generally pay more. The fda does not classify participation in clinical trials as a form of labor and therefore is at pains to distinguish the “compensation” received by the research subject from a “wage.” Information sheets published by the fda insist that fees are not a “benefit, [but] a recruitment incentive” and advise institutional review boards to “review both the amount of payment and the method and timing of disbursement to assure that neither are coercive or present undue influence” (cited in Dickert et al. 2002: 368). However, payments for Phase 1 studies (often several thousand dollars for a month-­long confinement) remain attractive when compared to average wages for other kinds of informal, high-­risk service labor. The author of a popular online information portal on clinical trials, Just Another Lab Rat, calculates that in the seven years he has been doing studies, he has “spent an average of 108 nights a year in-­house, . . . had over 1500 blood draws, taken over 750 pills and [made] an average of �13.68 an hour based on a normal 40 hour a week job” (Just Another Lab Rat 2011). Just Another Lab Rat forms part of a growing class of so-­called “professional guinea pigs” who undertake successive clinical trial confinements throughout the year, alternating them with the month-­long washout periods that are required before one can be selected into a new trial. By contrast, Phase 2 and 3 trials recruit patients who are already ill and therefore might possibly receive some kind of medical benefit. Many bioethicists make a sharp distinction between Phase 1 and later-­phase trials, arguing that only the former can be considered a transactional relation. Lemmens and Elliot (1999, 2001), for example, who are strongly in favor of configuring Phase 1 trials as a form of labor, draw a line at Phase 2 and 3 trials on healthy subjects, which they prefer to see along the lines of a humanitarian model of last-­resort or experimental patient care. However, the distinction between these kinds of research participation is not so clear-­cut in practice. Although it is true that many later-­stage studies offer patients the prospect of direct care, others (notably Phase 3 trials) are conducted for purely research purposes and require a similar contribution of time and effort from both patient and healthy groups (Dickert et al. 2002: 372). Moreover, although the intensive confinement periods associated with Phase 1 trials may make them more lucrative as a work option, recent studies indicate that cumulative payments for patient subjects are comparable to or higher than those 136 Chapter Six

offered to healthy subjects (Grady et al. 2005). Finally, we would argue that patients who participate in Phase 2 and 3 studies are often involved in a less immediate, although no less coercive, form of labor relation that we would call “work for health care.” It is increasingly the case in the United States that uninsured or underinsured patients will enroll in a clinical research study in order to receive the medical care they would not otherwise be able to afford. In this case, their motivation for participating in a trial comes not from an informal and unrecognized “wage relation” but from the invisible impetus of lack of health insurance. While their participation in the trial resembles a form of work, it comes closest to the peculiar method of coercion associated with “workfare” regimes, where welfare recipients are required to work in exchange for social welfare benefits or health care (Peck and Theodore 2000; Peck 2001; Krinsky 2007). In both cases, clinical trial participants are engaged in a peculiar kind of risk-­bearing labor. For the healthy recruits in a Phase 1 first-­in-­human study, this is the immediate bodily risk of exposure to more or less dangerous pharmaceutical compounds, whose effects on their metabolism are by definition unknown. As the bioethicist Paul McNeill notes, it is this element of unknown risk which distinguishes Phase 1 clinical trial work from other, more routine forms of low-­wage labor: “The risks of being harmed in our work are usually known in advance and can be minimized by adopting safe practices. The situation is not comparable to research. By definition, research, which involves experimentation on human subjects, exposes those human subjects to risks of harm and those risks cannot be known in advance. If the outcome was known to be safe, prior to the experiment, then it would not be an experiment by definition” (1997: 391). While many kinds of labor are hazardous or unprotected by workers’ compensation, very few derive their intrinsic value from the worker’s ability to bear bodily risk. (Possible exceptions to this rule might be the labor performed by stuntmen and -­women, test pilots, and the human crash-­test dummies who were once employed in lieu of mannequins.)4 But this is the case for participants in a drug study, who truly labor only inasmuch as they subject themselves to the possibility of metabolic transformation. The process of transformation may be therapeutic or high-­risk in its effects, but in either case its temporality is always highly contingent, unpredictable, and eventlike. Uninsured patients who participate in later-­phase efficacy studies may not face the same immediate physical risks from the ingestion of a compound, since its safety has already been partially established. Nevertheless, they are very often exposed to the more diffuse, but real, risks that come The American Experiment 137

from lack of health insurance. While Phase 2 and 3 efficacy trials are routinely marketed to potential recruits as a way of obtaining access to free medical care and drugs, they are often no more than a gamble on the chances of treatment, since patients may be receiving either an investigational drug or a placebo, and in any case the treatment will be discontinued at the end of the trial (Fisher 2009: 136). Again the temporality of clinical labor in these later-­phase trials can be described as evental or aleatory, since the patient’s access to treatment is entirely randomized and precarious. Here we can see how clinical trial work, like reproductive labor, appears anomalous from the perspective of a canonical Marxist theory of labor time.5 Marx’s value theory of labor, outlined in the first volume of Capital, posits abstract, “socially averaged” (that is, statistical) time as the socially necessary measure of labor’s exchange value (1990 [1867]: 129). Implied in this definition of labor, as Moishe Postone notes, is the exclusion of other evental or (we would argue) contingent modes of temporality. In the modern industrial organization of labor, argues Postone, “abstract time” as “uniform, continuous, homogenous” and “independent of events” displaces and marginalizes a notion of time as “a function of events, occurrences or actions,” whose unit of measure is “not constant but itself varies” (1993: 202). Modifying Postone’s analysis somewhat, we would argue that the salient distinction here lies not so much between the secular time of industrial modernism and the sacred time of religious history as entirely within the purview of capitalist labor relations—that is, in the distinction between productive, measurable, industrial labor time and unproductive, immeasurable, contingent time: in a word, the time of the accident. In this respect, clinical trial work eludes canonical Marxist and Fordist definitions of standard industrial labor. The mid-­twentieth-­century formalization of industrial labor was in a crucial sense premised on the marginalization of risk, in the form of both accident prevention laws and the introduction of various forms of social insurance. Whereas Fordism sought to eliminate the industrial accident from the unionized work process, the controlled production of unexpected events—or accidents—was always intrinsic to the clinical trial. In the mid-­twentieth century, the expansion of clinical trials represented a palpable challenge to emerging conventions of labor protection and workers’ compensation. In what follows we will trace the process through which the clinical trial was formally excluded from the purview of Fordist labor law.

138 Chapter Six

Risk, Labor, and Tort: The Exceptionalism of the Clinical Trial

The legal principles governing work-­related risk underwent a significant transformation in the first decades of the twentieth century. Up until the late nineteenth century, legal disputes arising from work-­related injuries were governed by the law of torts. Closely associated with the expansion of commercial contract, tort law (derived from the French word for “wrongs”) addresses itself to civil (i.e., noncriminal) wrongs that do not arise out of explicit terms of contract. Whereas criminal law covers offenses against the state and requires the state to act as plaintiff, torts apply to injuries to the private person (White 2003). Within the framework of mid-­nineteenth-­century tort law, workers and employees had very little room for redress or compensation in the event of a work-­related accident. Nineteenth-­century civil law favored a vision of equal and independent contractual parties, each endowed with the proper foresight to manage the hazards he or she might encounter in the course of daily life. During this period, tort law was dominated by the notions of individual fault and negligence. If an employee wished to bring a tort action against an employer, he would need to prove fault or negligence on the part of his employer. As Pat O’Malley explains in some detail, nineteenth-­century law assumed that workers had made a voluntary assumption of risk, according to the legal principle of volenti non fit injuria or volenti (2009: 124). The principle of volenti made the worker personally responsible for all the risks he or she incurred in the workplace and precluded compensation—unless a specific fault on the employer’s part could be proved. Nowhere do we find a clearer expression of nineteenth-­century tort law than in the work of the American pragmatist and legal theorist Oliver Wendell Holmes Jr. (Witt 2004: 43). Holmes’s theory of torts rests on an ultraliberal philosophy of the accident, in which freedom is defined as the individual’s ability to take risks. All free action, Holmes asserts, generates unforeseeable events; to make the individual liable for the entire chain of consequences he sets off would be to cancel out freedom itself. Where there is no intentional wrong or breach of contract (damnum absque injuria), there is no fault. Holmes’s plea in favor of the radical freedom to generate (and bear) risk is based on an argument from foresight and expectation. Where consequences cannot be foreseen, no person can be held liable for the unintended effects of her actions. Like fate, the “wrong” of the accident cannot logically be held to account. “The general principle of our law,” Holmes wrote, “is that loss from accidents must lie where it falls, and this principle is not affected by the fact that a human being is the instrument of misfortune” (1991 [1881]: The American Experiment 139

94). Yet even as Oliver Wendell Holmes wrote these words, in the later years of the nineteenth century, the liberal philosophy of accident, fault, and responsibility was beginning to be seriously challenged. Industrial workers suffered deaths, amputations, and injuries with much the same regularity as foot soldiers in the front lines of war. The kind of accident that Holmes had ascribed to fate—the non-­negligent act involving strangers—was beginning to reproduce itself on an industrial scale, with what seemed like statistical regularity. While tort law was in principle an option for injured workers, the costs of litigation were beyond the reach of most industrial laborers, and the onus of proving fault on the part of an employer practically ruled out the possibility of a successful trial. By the end of the century, the commercial and managerial burden of industrial accidents was becoming too great even for managers to ignore. The law of torts, essentially a means of responding to private disputes between persons, proved unable to respond to the collective amplitude of the problem. By the turn of the century, an alliance of unions and industries came together to fight for the general reform of accident laws, resulting first in a series of firm-­specific accident insurance funds and later in the passage of state-­level industry-­wide workers’ compensation statutes. In 1910, New York enacted the nation’s first workers’ compensation statute. Forty-­two of the nation’s forty-­eight states would introduce similar statutes over the next decade; only the less industrialized southern states failed to follow suit, meaning that African American agricultural workers were not covered by compensation (Witt 2004: 127). In many respects, American workers’ compensation statutes followed the example of European no-­fault workers’ accident law. In both cases, the introduction of collective accident insurance laws marked a far-­reaching shift in legal understandings of tort, contract, and risk. In marked contrast to the contractual, individualist, and fault-­based vision of tort that had prevailed in the mid-­nineteenth century, these laws shifted the onus for industrial accidents from the worker to the firm, and from the courts to the state, which thereby took charge of the collective insurance of all industrial accidents. In the process, the punitive and individualizing framework of nineteenth-­century tort law was replaced by the managerial, redistributive logic of social insurance. Henceforth, the incidence and distribution of costs related to industrial accidents was to be managed through actuarial principles derived from the laws of probability and the empirical evidence of statistical data. Inherent in this shift toward an actuarial mode of calculation was the idea that the accident was not to be considered an exceptional event interrupting the normal routine of contractual relations but was instead, in some sense, to be expected—and taken in 140 Chapter Six

charge as such (Figlio 1985). Within such a framework, the question of determining “negligence” or “fault” became increasingly irrelevant, and what nineteenth-­century tort law had considered a residual and problematic category of accident law—damnum absque injuria, or “loss without a direct intent to harm”—came to be considered the very paradigm of the industrial accident (Witt 2004: 142). The field of clinical medicine was not impervious to contemporary developments in the industrial law of accidents. The historian Sydney Halpern (2004) notes that medical accidents were the subject of intense public debate during the first decades of the twentieth century. Within the medical profession, these debates were generated by a growing awareness of the shift from private tort law to the administrative regulation of industrial risks via social insurance. Yet in many ways the evolution of medical tort law, particularly in relation to human experimentation, was diametrically opposed to that of industrial workplace law. William Curran (1970) points out that prior to 1935 US tort law had not explicitly dealt with the issue of deliberate medical experiment. In the arena of health care, tort law established its normative categories around the relative notions of standards of care. At this stage, tort law made no distinction between the nonstandard administration of medical care and medical experiment as such. Indeed, the term “experimentation” was used to designate any departure from standard of care in the clinic and was automatically classified as a form of medical malpractice. Beginning in the 1930s, however, tort law was forced to confront the growing importance of deliberate, statistically controlled experimentation in medicine and to make allowances for the kinds of accident (injurious or otherwise) that were routinely and necessarily generated in the course of the large clinical trial. Almost unheard-­of in previous decades, the number of statistically designed clinical trials rose dramatically in the 1930s and 1940s, with a sharp escalation of infectious disease research during World War II. By the time Austin Bradford Hill of the British Medical Research Council defined the standard rct methodology in his streptomycin studies of 1946, less rigorous statistical trials had already been practiced for many years (M. Edwards 2007). The legal and political problem raised by human experimentation was self-­evident—the medical experiment represented a deliberate departure from the standards of clinical practice. In an era in which industrial accidents were beginning to be taken in charge as social risks by the nascent welfare state, through both workers’ compensation laws and health and safety reform, the methodology of the clinical trial necessitated the industrial-­scale production of biomedical accidents. The language The American Experiment 141

of turn-­of-­the-­century tort law was unforgiving in its classification of such experiments—as deviations from standards of care, clinical trials seemed to constitute the very definition of a legal wrong. In the first decades of the twentieth century, the medical profession could no longer afford to ignore the threat of tort actions. Sydney Halpern has carried out a minute investigation of the various solutions contemplated by the medical profession during this period, arguing that the “informed consent” form arose out of these early efforts at institutional risk management.6 The Schloendorff case of 1914, involving a plaintiff who accused her physician of carrying out an operation she had not consented to, represented a watershed event in the history of medical accident law. In his decision on the case, Justice Benjamin Cardozo ruled that a medical procedure without consent amounted to an intentional tort: “The wrong complained of is not merely negligence. It is trespass. Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent, commits an assault, for which he is liable in damages” (Schloendorff v. Society of New York Hospital, 1914). It was not until 1935, however, that a direct ruling on medical experimentation as such was made. In Fortner v. Koch, a ruling by the Michigan Supreme Court included the following statement: “We recognize the fact that, if the general practice of medicine and surgery is to progress, there must be a certain amount of experimentation carried on; but such experiments must be done with the knowledge and the consent of the patient or those responsible for him, and must not vary too radically from the accepted method of procedure” (cited in Halpern 2004: 108). In general, the medical establishment did not wait for these explicit rulings to undertake its own risk-­containment strategies. As early as the Schloendorff case, medical institutions were beginning to anticipate the threat of tort actions for clinical experiments and were choosing to adopt consent forms as a way of safeguarding themselves from liability claims. The informed consent form, then, was the medical profession’s first-­line defense against the increasing political clout of the antivivisectionist movement (opposition to animal and human “vivisection” was closely linked in the early decades of the twentieth century). When the American Medical Association created a Council for the Defense of Medical Research in 1908, it appointed a director, Walter Cannon, who vigorously lobbied medical journals, medical practitioners, and researchers to advertise the use of “consent” contracts in their publications (Halpern 2004: 98). By the 1940s and 1950s, notes Halpern, the large institutional sponsors of clinical research, such as the 142 Chapter Six

Rockefeller Institute, the Committee on Medical Research, the American Epidemiology Board, and the National Foundation, were requiring written consent as a matter of course. The informed consent form, then, emerged out of tort law and fears of litigation before it was elevated to the status of “human right” by international bioethics conventions. It was designed, moreover, as a risk-­management strategy for the medical profession, not an instrument to protect the rights of patients. The banal effect of the consent form, as noted by the legal theorists Jerry Menikoff and Edward Richards, was to reduce rather than expand the rights of the participant in medical experiment. Referring to the current state of play in medical malpractice law, Menikoff and Richards point out that the patient who has not signed an informed consent form enjoys far greater rights to initiate a legal claim than does the consenting participant in a clinical trial (2006: 51–55). In the United States, state tort laws ensure that all patients are assumed to have a right to standard medical care, without having to sign a consent document. While departures from standard of care are not in general considered to be a form of trespass (as in the early Schloendorff case), they are certainly classified within the less serious tort category of negligence. The informed consent form, on the other hand, effectively invalidates the right to standard medical care and exculpates the medical institution from the usual risks of malpractice suits. As the legal scholar Joel Feinberg (1986: 115–117) has pointed out, informed consent is premised on the notion of voluntary assumption of risk or volenti non fit injuria, the very tort law principle that governed labor relations up until the late nineteenth century. Before the introduction of workers’ compensation statutes in the early decades of the twentieth century, the principle of volenti made the industrial worker solely responsible for the injuries he might suffer in the workplace, attributing industrial risk to personal negligence or fault rather than the social laws of the “normal” accident (O’Malley 2009: 124). As workers’ compensation and other forms of social insurance progressively displaced the principle of volenti, medical practitioners and their professional organizations began to grapple with the potential legal issues raised by medical experiments. The very nature of medical experiment confronted them with a legal conundrum. While the industrial workplace proliferates in accidents, the contingency of the accident is not structural to the generation of industrial value—indeed, it is often counterproductive, as late nineteenth-­century industrial reformers had found. Medical experiment represents a case apart in the sense that the production of contingent events represents its very raison d’être. Experimental risk canThe American Experiment 143

not be eliminated from the clinical trial and cannot be insured against with the same ease as industrial accidents. Medical practitioners responded to this conundrum by placing clinical trials under a legal state of exception— enshrined in the bioethical principle of informed consent. The Fordist/Keynesian consensus, it might be said, relegated the contingency of the accident to the margins of the productive process and defined standard labor as insurable labor—labor subject to the socially averaged time postulated by Marx’s labor theory of value or the Euclidean geometry of measurable risk invoked by John Maynard Keynes.7 In so doing, it did not eliminate the industrial accident or hazardous labor conditions—far from it; rather, it reserved them for Fordism’s peripheral subjects. In the United States, women were not directly covered by workers’ compensation laws until 1980 (in this respect, American workers’ compensation laws represented a variant of the family wage) (Witt 2004: 127–134). And even in the heartlands of American Fordism, African American workers were routinely assigned to the most accelerated and hazardous components of the production line, up until the dying days of the Fordist “golden age.”8 The exceptionalism of the accident was nowhere more apparent than in the realm of clinical research. As a form of in vivo product testing, the very obverse of standard commodity production, human subject experimentation could only be defined as nonstandard labor par excellence. This exceptionalism was reflected in the institutional and legal forms of the mid-­twentieth-­century clinical trial. During and after World War II, research subjects were recruited from the ranks of the socially marginalized—orphans, state wards, indigent public hospital patients, conscripted soldiers, and prisoners. After World War II and up until the late 1970s, American prisons would provide the bulk of experimental research subjects to both US and European pharmaceutical firms. Excluded from the administrative protections of welfare and industrial rights, these research subjects were nevertheless instrumental in producing the experimental data necessary to the rise of mass health care, a national health service (in the United Kingdom), and a powerful pharmaceutical industry in the aftermath of World War II (in the United States). Their exclusion points to the constitutive aporia of a social insurance model that must produce uninsurable risk in one part of the population to secure the health of another. In the wake of World War II, the question of the legal and contractual nature of experimental research in humans had apparently been resolved. Even after the war, however, a surprising number of legal scholars continued to address clinical trial recruitment as a labor issue, calling for the applica144 Chapter Six

tion of workers’ compensation laws to human research subjects injured in the course of their “work.” As early as the 1960s, the medical law specialist Irving Ladimer proposed a no-­fault compensation system based on voluntary contract for all clinical trial participants, while the celebrated tort law scholar Guido Calabresi voiced his support for a similar plan in an influential special issue of Daedalus (Ladimer 1963, 1970, 1988; Calabresi 1969). The proposal was not unknown to federal regulators. In 1975–1976, the Department of Health, Education, and Welfare (the predecessor to Health and Human Services) created a task force to investigate the use of compensation plans for injured research subjects (US Department of Health, Education, and Welfare 1977). Noting that the number of research subjects enrolled in federally supported research studies alone approached 600,000, the task force recommended the adoption of a federal no-­fault compensation plan (US Department of Health, Education, and Welfare 1977: viii–ix). Despite these recommendations, however, the introduction of a workers’ compensation scheme for experimental research subjects has remained far from the official agenda until this day.9 Ironically, perhaps, the post-­Fordist erosion of labor protections for all classes of workers means that the position of the human research subject appears less exceptional today than it did in the middle of the twentieth century. As we saw in chapter 2, the number of long-­term employees covered by standard contracts of employment, replete with welfare benefits, has declined dramatically; instead, growing numbers of workers (skilled and unskilled, professional and service-­level) are engaged as independent contractors. Unlike the unionized male industrial worker covered by mid-­ twentieth-­century labor laws, the independent contractor is held individually responsible for insuring him- or herself against life’s contingencies. In this respect, the Phase 1 research subject occupies much the same structural relationship to risk as any other contractor in personal services, even though the risks of clinical research are more immediate and visceral in nature than those encountered in most workplaces. As if in recognition of this structural proximity, the Internal Revenue Service, the US government agency responsible for tax collection, has in recent decades intervened in several disputes to stipulate that the human research subject should be classified as an “independent contractor,” not as an “employee.”10 Taking note of these decisions, in 1996 the US Department of Labor issued a ruling on unemployment compensation which clarified the status of human research subjects employed by federal agencies: in no cases should these workers be considered employees with rights to workers’ compensation or unemployment benefits; instead, The American Experiment 145

the research subject should be treated as an “independent contractor” who does not provide a product as such but, rather, “samples of blood and normal bodily functions” (US Department of Labor 1996: viii–ix). In what follows, we will trace the institutional process by which the unfree labor of the incarcerated research subject was replaced by the independent contractor model of clinical trial work.

Scenes of Experiment: From Prison and Hospital Trials to the Private Outsourced Trial

In order to fully grasp the import of recent developments in pharmaceutical research, one needs to recall that prison-­based clinical trials were once the norm in the United States (Petryna 2009: 61–66). The mass recruitment of prisoners as research subjects began in earnest during World War II. As so often in the history of public health, it was a state of war that justified the use of uncommon means to initiate scientific progress. With large numbers of troops suffering from infectious diseases on the war front, prisoners were called upon to participate in large-­scale drug trials and blood transplant experiments in order to accelerate the development of new cures. The practice was not suspended after World War II, however, and continued to grow steadily throughout the following decades, as the nih increased research funding and pharmaceutical companies (often in collaboration with academic coinvestigators) expanded their research operations into state prisons (Hornblum 1998: 83). During the high-­growth years of the 1960s, pharmaceutical companies in North America were conducting most of their Phase 1 clinical trials among prison populations, even going so far as to build state-­of-­the-­art clinical trial laboratories on prison grounds. Their concern was not only to recruit prisoners as human subjects but also to train inmates as clinicians, capable of carrying out tests at a fraction of the cost outside prison walls. For prisoners themselves, taking part in a Phase 1 clinical trial represented a relatively remunerative option. Prison labor had been subject to severe restrictions during the New Deal, and what little inside work was available paid very poorly (as little as fifteen cents a day to make shoes and clothing). A pharmaceutical or cosmetic test, by contrast, could pay between ten and thirty dollars, while clinical assistants were paid between forty and fifty dollars a month (Hornblum 1998: 5). Even so, prisoners were aware that their participation in research could be obtained at much lower costs than in the outside world, with no compensation for risks: in 1968, a group of prisoners from Holmesburg state prison in Philadelphia, Pennsylva146 Chapter Six

nia, brought a lawsuit against the state Department of Corrections, claiming that the companies had obtained hundreds of thousands of dollars of labor for free (Hornblum 1998: 103). Others attempted to sue for injuries but discovered that they had waived all legal rights by signing informed consent forms (Hornblum 1998: 5). The rapid expansion of Phase 1 prison trials during the 1960s was an unintended consequence of the 1962 Kefauver-­Harris Amendments to fda regulations. As we have seen, the 1962 guidelines recommended that three phases of human clinical trials, including Phase 1 safety trials on healthy subjects, should be conducted before a drug could be marketed. This meant that the small number of patients that had hitherto been required for clinical trials was suddenly insufficient. And as Allen Hornblum points out, state-­controlled prisons seemed to offer the perfect conditions for both industrial-­scale labor and the requirements of standardized clinical experiment—highly regimented, isolated living conditions and a workforce that was “cheap, available and confined,” not to mention already highly stratified along class and race lines (1998: 108). In the meantime, the academic health center (or ahc), an institutional complex consisting of a medical school or teaching hospital and its closely affiliated facilities, established itself as the prime site for conducting Phase 2 and 3 efficacy studies on patients. Academic health centers experienced a rapid growth in funding during the 1960s when nih research grants and federal support for medical training increased. As Eli Ginzberg notes, “In 1950, the nation’s total expenditure for medical research amounted to only �160 million, with foundations still a significant contributor. But shortly thereafter, the reorganized and expanded National Institutes of Health became the major conduit for new funding for biomedical research, and most of their grants went to the medical schools that were beginning to be transformed into ahcs” (1990: 60). These new streams of funding were augmented by the passage of Medicare and Medicaid legislation in 1965, which reimbursed long periods of hospital confinement for the poor and the elderly who were not otherwise covered by the employment-­based policies that have always dominated in the United States. Many inner-­city ahcs had long provided free care to the poor. As noted by Ginzberg, the introduction of these new forms of social insurance transformed poor and uninsured patients from a financial liability into a financial asset (Ginzberg 1990: 61). By encouraging hospitalization, they also provided the medical hospital with a readily available source of research subjects. Today, as ahc drug trials are marginalized in favor of private sector The American Experiment 147

studies, there is a tendency to romanticize the conditions of academic research. Yet historians of the academic research hospital remind us that there once existed an “implicit contract” between the public ward patient and the health profession, a contract that implied a fair exchange between free or state-­subsidized health care for poorer patients and the requirement that they serve as clinical research subjects and teaching material (Ehrenreich and Ehrenreich 1970: 25; Byrd and Clayton 2002: 330). By the late 1960s, however, the academic research enterprise had expanded to such an extent that both private clinic and public ward patients were requisitioned into service as teaching material and clinical trial subjects (Rogers 1998: 206; Opdycke 1999: 108–109). At this point, the class distinction between Medicare and Medicaid patients, on the one hand, and private clinic patients, on the other, came to be reflected in the kinds of research to which patients were assigned. In an early sociological study of the professional dilemmas facing biomedical practitioners in an academic hospital setting, Bernard Barber and his coauthors noted that studies involving a greater degree of therapeutic benefit, as well as the more scientifically rigorous studies, were more likely to be offered to private patients (Barber et al. 1973: 55). They went on to draw the following pointed conclusions about the divisions of labor governing hospital research: Our data, then, throw light on . . . [an] assumption that is held by many biomedical researchers, the assumption that, in order for medical knowledge to grow, some people have to serve as subjects for risky but important research. Those people, it is assumed, should rightly be the ward and clinic patients who receive their medical care either free or at a reduced charge. In return for cheaper care they will provide the crucial ingredient for medical knowledge to grow. While the studies with the poorest Risks-­Benefits Ratio for Subjects more frequently involve ward and clinic patients than more favorable studies do, a fact consistent with the assumption in question, it is not at all clear from our data that researchers intend the sacrifices these patients make to provide important scientific or other benefits, as the rest of that assumption implies. The problem of the ethics of the differential treatment of ward and clinic patients as against private patients has not been adequately faced by the medical research profession. There is a moral inadequacy here that cannot be blamed entirely on the established system of payment for medical care, as it sometimes is. Even within the established system, biomedical re148 Chapter Six

searchers might well require, at least in this respect of medical treatment, full equality for all their patients. (Barber et al. 1973: 57) From the early 1960s to the early 1980s, then, most clinical research in the United States took place in the institutional context of the prison (for Phase 1 trials) or the academic research hospital (for Phase 2 and 3 trials). Both of these institutions provided the ideal environment for what we might define as the Fordist mode of experiment—reliable and ongoing access to research subjects, cheap or free labor, standardized living conditions, and a highly centralized space for overseeing the course of treatment. In 1981, however, this symbiotic system of prison and academic hospital trials came to an abrupt end when the fda officially outlawed the practice of prison-­ based trials.11 Over the following decade, Phase 1 clinical trials were conducted either in academic research centers or in-­house by the major pharmaceutical companies. More recently, the institutional context for drug trials has again shifted, this time from academic research hospitals and in-­house r�d clinics to the private, nonacademic medical sector. Since the mid-­1990s, the growing influence of “managed care,” a philosophy of health care rationalization that seeks to reduce insurable health costs, has had a devastating impact on the clinical research programs carried out in academic health centers. Academic hospitals had funded their clinical research by taking on a high caseload of Medicaid and Medicare patients. They had also relied on their inpatient care programs and the long-­term hospitalization of patients to provide a readily available population of human research subjects. By the late 1980s both of these enabling conditions were under threat, as managed care reforms began to discourage hospitalization and a number of states introduced regulations designed to restrict the freedom of Medicaid and Medicare patients to choose higher-­cost providers such as academic research hospitals (Ginzberg 1990: 57–59). Anticipating the decline of the academic research center, a new kind of private research enterprise emerged to take its place, often founded by former academics and drug company employees (Browning 1995). In 1991, 80 percent of research funds spent by the pharmaceutical industry went to ahcs. By 1998, the figure had dropped to 40 percent (Goldner 2008: 21). The industrial-­academic-­carceral research complex that dominated until the mid-­1990s has gradually undergone a process of vertical disintegration as established institutional capacities have been relocated in private investigative sites and outsourced to an array of private service providers. These sites may be based in small clinics that otherwise The American Experiment 149

serve as medical practices, while other larger sites are exclusively dedicated to clinical research and oversee a large number of clinical trial contracts. In the process, the human research subject is no longer the subject confined (the prisoner or indigent public hospital patient) but is now much more frequently interpellated as an independent contractor in services, one whose identity is captured by the figures of the occasional or professional Phase 1 “guinea pig” or the uninsured patient. Most Phase 1 trials now take place in dedicated private research clinics that represent a curious hybrid between the hospital and the research production site.12 The institutional architecture and infrastructure of these sites are indistinguishable from those of the hospital. Research subjects are housed in wards lined with hospital beds or seated in rows in treatment rooms similar to a chemotherapy suite, although the people who are confined here are not patients receiving health care but producers of clinical data. All clinical research units have an intensive care room in case of adverse events. In an era in which long hospital stays are exceptional and deinstitutionalization is the norm, Phase 1 research subjects are obliged to undertake long periods of confinement ranging from a few days to a few months. Meals are standardized, and research subjects are required to respect strictly controlled mealtimes. The recent evolution of the clinical trial sector, then, has reconfigured the hospital as a site of production, one that is modeled, in organizational terms, on Fordist principles of shop-­floor standardization, but nevertheless utilizes post-­Fordist methods of contractual informalization. In much the same way that Fordist industrial production was relocated to the world’s peripheral economies, minus labor rights, the Phase 1 research unit adopts the regimented architecture of the Fordist hospital to house an overwhelmingly contingent labor force of high-­risk workers. Many Phase 1 research subjects move from trial to trial on a contract-­by-­contract (or, rather, consent-­by-­consent) basis in what is a highly itinerant life. Like other contingent laborers in the United States, these self-­styled “professional guinea pigs” are remarkably “organized” in ways that escape conventional understandings of labor organization. Highly active web-­based information sites and chat rooms offer detailed listings of upcoming trials; insider information about trial sites; offers of travel, accommodation, and carpools; advice on which sites to avoid; and tips on how to endure and sometimes “cheat” on trials—for example, by avoiding washout periods. Phase 2 and 3 efficacy trials have also been outsourced—not to dedicated research units, but to small clinics and private physicians’ offices that otherwise serve as medical practices. In large part due to the pressure of managed 150 Chapter Six

care–driven budget constraints, private medical practices now compete for contracts with pharmaceutical drug sponsors as a way of compensating for declining professional incomes (US Department of Health and Human Services 2000: 15). Medical practices may advertise their high patient caseloads, extensive patient databases, and high enrollment rates as “services” that can be sold on, via an intermediary contractor, to the pharmaceutical trial sponsor. As clinical research has migrated outside the institutional walls of the state prison and academic research hospital, a growing number of private physicians have begun to assume a dual role as medical practitioners and independent contractors on behalf of the pharmaceutical industry. Facilitating this shift is a qualitatively new kind of private service provider, the contract research organization (cro), which acts as an intermediary between the sponsors of clinical trials (the large pharmaceutical companies) and private medical centers. Once marginal to the r�d process, cros now account for the bulk of all outsourced clinical research and aspire to cover all aspects of the drug development process, from drug discovery, preclinical testing, and clinical trials per se to marketing and “bioethical services” (Mirowski and van Horn 2005). In industry literature, the rise of the cro is routinely attributed to the fact that academic research centers and university hospitals were too rigid, expensive in terms of labor costs for clinicians, and not responsive enough to commercial timelines. cros have progressively taken on much of the more standardized, fungible work formerly conducted in academic settings, which means that the professional labor costs of their workforce tend to be lower. They tend to elude many of the regulatory requirements that were originally designed to oversee very different kinds of research organizations (Mirowski and van Horn 2005: 513; Shuchman 2007). The trend toward the contractualization of r�d is one of the symptoms of the vertical disintegration of the pharmaceutical industry itself, which in recent years has steadily reduced its in-­house research investments and outsourced its professional labor costs to cheaper, often less-­qualified contract research providers. cros are responsible for “placing” trials in private clinics or research centers, where medical practitioners now take on the role of clinical investigator. They are also becoming involved in the search for suitable patient recruits (indeed, some cros, referred to as Patient Recruitment Organizations or pros, are exclusively devoted to the task of locating and recruiting suitable experimental subjects). As patient recruitment levels drop, the area of “recruitmentology” has itself become a kind of quasi-­science, according to Steven Epstein (2008), consuming an ever-­growing portion of the clinical trial budget. The professionalization of patient recruitment The American Experiment 151

means that cros employ increasingly sophisticated methods for locating, screening, and retaining potential volunteers. These include direct marketing through television and newspaper advertisements, notices placed on dedicated clinical trial alert sites (of which there are a growing number), intensive database searching, the targeting of patient advocacy groups for later-­phase trials, and recruitment websites with e-­mail alerts for occasional Phase 1 studies. In many ways, the methods employed by contract recruitment organizations to locate recruits with the right patient profile are indistinguishable from the consumer demographic studies conducted by marketing companies. But cros must also be alert to the factors motivating recruits to enroll in trials, which may include lack of health insurance, undocumented migrant status, or simply the need to make money. In this respect, they employ many of the demographic targeting methods of temporary-­job recruitment agencies. Research subjects fall into several distinct categories, depending on the trial phase in which they are enrolled. The regular participants in Phase 1 studies include students, ex-­felons, artists, squatters, day laborers, and other precarious workers of various kinds (Abadie 2010). After the subprime mortgage crisis of 2008 and the ensuing recession in the United States, the ranks of potential Phase 1 recruits expanded considerably to include former professionals, retirees, and the recently foreclosed (abc News 2008; Mosedale 2009; Zaragoza 2009; O’Brien 2011). Nevertheless, the clinical labor force continues to reflect distinct race, class, and gender fault lines. In her extensive empirical research into the state of the clinical trial enterprise in the United States, Jill Fisher notes that the majority of Phase 1 recruits are low-­ income minority men. In the Southwest these recruits are mostly Latinos, who otherwise might work as day laborers in the urban informal economy, while in other parts of the country most are African American. These relatively high-­paying studies, which are not classified as labor and are therefore not contingent on resident status, appear to attract a high proportion of undocumented migrants (Fisher 2009: 131). Phase 1 studies require that patients check in to a clinic and remain there for lengths of time ranging from a few days to several weeks, where they can be closely monitored for side effects and treated if necessary. In general these trials take place in private trial centers that specialize in one particular kind of study and patient recruitment profile. By contrast, Phase 2 and 3 studies that test the effects of experimental drugs on patients suffering from the targeted illness tend to recruit a majority of white middle-­class women, most of them un- or underinsured, while discouraging poorer women on the pretext that they are less 152 Chapter Six

reliable. These studies involve frequent visits to private clinics during working hours and require participants who are flexible, reliable, and mobile (Fisher 2009: 130). Fisher comments that many of the middle-­class women who participate in these trials in order to receive access to drugs and medical care describe their participation as a form of altruism or volunteer work. While it is highly probable that the demographics of the clinical trial participant will continue to evolve, given the industry’s history of continuous restructuring, the convergence between the current profile of participant and the lower echelons of the US labor force is striking. In Phase 1 studies on healthy subjects, in which the clinical trial contract is most obviously transactional, research studies target precisely those populations that are overrepresented in other areas of high-­risk, informal, and seasonal labor in the US economy. These populations can be said to inhabit the borderlands of “biological citizenship” (Rose and Novas 2004), either in the literal sense of their being undocumented migrants or through their historical overrepresentation in the US prison system. In this respect, rather than insisting on a sharp discontinuity between the prison-­based system of clinical labor, which lasted up until the 1970s, and the current situation, it might be more illuminating to examine the concurrent mutations of clinical trial work and prison labor over the same period. A longue durée historical perspective reveals that the regulations governing routine prison labor and prison clinical trials have coevolved in such a way that the one alternates with and presupposes the other. Industrial labor had been the norm in American prisons before the 1930s but was subject to severe restrictions during the New Deal, when unions began to contest the unjust competition represented by cheap prison labor (H. A. Thompson 2011). These restrictions, which limited but did not abolish prison labor, endured up until the late 1970s. Crucially, however, they did not extend to clinical trials, which were not conventionally considered a form of work. As a consequence, it was during this period of limited prison commerce that clinical trials flourished as a full-­fledged industrial complex. As we have seen above, inmates themselves rarely distinguished between their participation in pharmaceutical trials and the other kinds of low-­paid, often hazardous labor they undertook in prison. (When inmates sued the Department of Corrections for their participation in clinical trials, it was on the pretext that they had not been paid for their “labor.”) Indeed, the politicization of prison trials can be seen as part of a larger movement of labor struggles that erupted in and outside American prisons during the 1970s. It was during this period that prisoners (overwhelmingly African American) formed unions and staged strikes across the country, calling for The American Experiment 153

workers’ compensation and the minimum wage—until prison unions were banned and the prisoner movement crushed in the late 1970s (H. A. Thompson 2011). It was also during this period that Detroit, the epicenter of Fordist mass production, witnessed a series of wildcat strikes initiated by African American workers in protest against their hazardous work conditions and tenuous rights to workers’ compensation (Georgakis and Surkin 1975). The Black Panther Party briefly but incisively made the connection between these economies (clinical, industrial, and carceral) when it campaigned against the extension of a clinical research program to Vacaville in California, an institution where many African American political prisoners were housed (Nelson 2011: 167–169). Both within and outside the walls of the prison, the most dangerous and accident-­prone forms of labor were reserved for racial minorities. The subsequent spate of prison reform reversed the relationship between carceral labor and clinical trial work. In 1979, the New Deal legislation restricting prison labor was overturned, ushering in a new era of prison-­based industry that has endured to this day (Wacquant 2009). Prison-­based trials, on the other hand, were banned shortly thereafter; these trials were moved from the carceral space of the correctional clinic to the academic research hospital or in-­house pharmaceutical clinic and more recently the private Phase 1 research unit. The spatial relationship between routine prison labor and clinical trial work has been reversed, then, but without any significant alteration of the class or race composition of the low-­wage labor force. Mass incarceration has only increased the workforce available to both sectors. A combination of factors—including the war on drugs, the offshoring of permanent industrial jobs, and soaring unemployment levels at the end of the 1970s—led to a sharp increase in the number of African American men in US prisons. Over the following decades, many states reauthorized prison labor in an effort to respond to a shortage in low-­wage laborers within the US service sectors. Thus the politico-­economic transition that delivered young African American men en masse into US prisons also primed them as a contingent workforce for a newly evolving postindustrial service economy. The criminologist Robert Weiss comments that the relationship between prison labor and “free” wage labor in the outside world is a fluid one: “Adding prisoners to the contingent labor force would not only bring the entrepreneur back into the prison, but through post-­release programs also extend the prison into society” (2001: 254). The clinical trial has undergone a similar evolution, even while it has moved in the opposite direction, from inside to outside the institutional space of the prison. While the transitional 154 Chapter Six

period of the early 1980s saw the prohibition of prison-­based clinical trials, it also led to their gradual reorganization along the lines of decentralized, contract-­based labor, to be performed preferentially by the very same underclasses who are now engaged in private contract work in US prisons. The widespread use of criminal record checks in vetting prospective job candidates means that ex-­prisoners, much like undocumented migrants, are marginalized from formal employment. Phase 1 clinical trial work is one activity that does not demand either a criminal record check or proof of citizenship (although it does require a Social Security number). There is a close, often competitive relationship between prison labor, undocumented migrant workers, and offshore labor forces, all of which can be maneuvered against each other to depress wage levels in general. As the labor historian Alex Lichtenstein notes, “The half million prisoners now released into the labor market annually constitute ‘a large volume of marginal laborers who can be superexploited at will,’ ideally suited to temporary and contingent employment. In essence, this is akin to a guest-­worker program in which vulnerable laborers travel across the border from incarceration to freedom, always in danger of repatriation to the world behind bars. This disciplinary function of the carceral state of the labor market works at the other end too, especially as the functions of the federal prison system and Immigration and Customs Enforcement become ever more integrated” (2011: 11). Perhaps it would be apposite to conceive of the class dynamics of Phase 1 clinical trial work in similar terms, with African American and Latino trial recruits vying for similar positions within the US contract research market and potentially pitted against Phase 1 recruits in locations such as China, where Phase 1 multinational trials are beginning to be introduced. In any event, it is clear that for many participants in Phase 1 trials, the risks associated with drug studies are continuous with the risks they routinely incur in their everyday efforts to make a living. One study of African American drug users engaged in paid hiv prevention trials found that participants considered recruitment in pharmaceutical trials a less risky option than stealing or trading sex for drugs, both of which might lead to incarceration. The study investigators go on to observe that “payment for research participation appears to be part of the ‘informal economy’ in economically disadvantaged communities. . . . [This economy] includes illegal transactions (e.g., drug dealing, prostitution—referred to by some as the ‘underground economy’) and systems of barter. Interviewees viewed participating in research as an alternative to other riskier ways of making money” (Slomka et al. 2007: 1408). This small but telling study demonstrates just how closely The American Experiment 155

the illegal and legal drug economies are entwined for those who act as producers at the lower ends of the clinical research chain. The rise in incarceration rates consequent on the war on drugs and the heavy criminalization of illegal-­drug users has also created a (legal but informal) labor market for those who would sell “risk exposure” for a living. In the meantime, the recruitment of uninsured patients in later-­phase efficacy trials reflects the evolving relationship between labor and welfare in the United States, particularly as it affects the racial and gender politics of the former, Fordist middle classes. The rise in the number of uninsured Americans—45.5 million people in 2007—is itself closely attuned to transformations in labor, class, and the gendered politics of the “household wage” in the United States, where historically most insurance coverage was sponsored by large, industrial employers. In the postwar period, an alliance of convenience between unionized labor, private health insurers, and the state meant that mutual, subsidized health insurance was limited to those employed under a permanent, full-­time contract by unionized industries. Unlike its western European counterparts, North America never adopted a form of universal health insurance but instead forged a limited model of insurance based on “a white male model of participation in the [industrial] work force: the full-­time, full-­year worker” (Klein 2003: 229–230). African American men were disadvantaged by the fact that they often worked irregular hours or in seasonal employment, while almost half of African American women worked as agricultural or domestic laborers and were therefore excluded from health coverage. For many middle-­class white women, health insurance was only ever accessible through the intermediary of the husband’s “family wage.” As industrial manufacture has moved offshore and greater numbers of workers have become engaged in casual, small-­scale service work, the breadth of coverage has declined accordingly. The erosion of health insurance no longer applies only to low-­income workers or the unemployed, since growing numbers of middle-­income contract workers in highly skilled professional, academic, and technical forms of employment are also unable to afford access to high-­cost individual premiums, particularly after the age of forty-­five (Swartz 2006). As employment-­related insurance becomes the exception, growing numbers of uninsured, chronically ill Americans are turning to clinical trials as a means of covering their health care costs (Kolata and Eichenwald 1999; Pace et al. 2003; Shoemaker 2005; Anonymous 2008). Not all, however, have an equal chance of being selected. As the work of Fisher (2009) makes clear, the historically gendered nature of health consumption and volunteer work plays a significant role in determin156 Chapter Six

ing the profile of patients recruited into these later-­phase trials. Most of the participants who end up in these studies are white middle-­class women, subjects who are presumed to have access to transport and are flexible enough to attend appointments during the week. Nonwhite women, Fisher notes, are routinely excluded because of their perceived unreliability (2009: 142–143). This particular form of clinical labor, we would argue, is best categorized as a type of “workfare,” in which wages for clinical trial work are received in kind, in the form of free drugs, health care, and tests. Work for health care can thus be seen as part of a larger trend in the reorganization of feminized, contingent labor markets in the United States—one that has seen a growing number of former welfare recipients compelled to take part in workfare programs since the passage of President Bill Clinton’s Personal Responsibility and Work Opportunity Reconciliation Act of 1996. It is often forgotten that Clinton’s welfare reforms included a form of “work for health care”— former recipients of welfare, for the most part African American and Latina single mothers, are obliged to work not only for welfare benefits but also in order to receive continuing access to Medicaid (a federal-­state program that provides health coverage to certain classes of low-­income people, including pregnant women, children, the disabled, and parents of eligible children). Perhaps, then, we should distinguish between two classes of “workfare” or “work for health care” in the United States: one that is primarily reserved for low-­income minority women on Medicaid and one that is increasingly reserved for uninsured white women on middle-­class incomes. President Clinton’s promise to end welfare as we know it (ratified by the Personal Responsibility Act of 1996) not only blurred the boundaries between welfare and work; it also introduced significant class and race divisions into the category of “workfare,” restricting the moral value of charitable work (itself significantly revalorized) to white women in particular. In light of this dubious but relative privilege, middle-­class white women may be more inclined than others to see “work for health care” as a form of altruistic volunteerism and to consider themselves health care consumers when they are also acting as producers at the lower ends of the pharmaceutical innovation chain.

The Limits of the US-­Based Clinical Labor Market: Toward Offshored Trials

This, then, has been the recent history of the clinical trial process in the United States: during the past four decades, the clinical trial has moved from the highly centralized context of the state prison and university teaching The American Experiment 157

hospital toward a more decentralized system of contract-­based clinical trial work located primarily in the private sector. The current model is not without problems of its own, even from the vantage point of the pharmaceutical industry, which routinely bemoans the costs of US-­based contract clinical trials; the length of time required for recruiting suitable patients; and the patients’ unreliability, high dropout rates, noncompliance, and lack of clinical legibility (Tufts Center for the Study of Drug Development 2008). While the relocation of clinical trials to the private sector has no doubt cut the costs of clinician salaries, it seems that the deskilling of clinical investigators and study coordinators has also contributed to the inefficiencies of the trial process (Christel 2008). In the case of later-­phase trials that recruit from relatively small private health care clinics, the process of patient recruitment has become too decentralized and haphazard to keep up with the accelerated rhythms of pharmaceutical innovation. In other words, at the very moment that the pharmaceutical sector vaunts the flexibilities of decentralization, subcontracting, and the decollectivization of labor and its risks, it finds itself confronted with the problem of excessive flexibility—and how to rechannel it toward productive ends. Research subject recruitment, we would suggest, has become a labor supply issue—but one that is not avowed as such. Even while the pharmaceutical industry intensifies its outsourcing contracts within the United States, the drive to push the clinical trial process offshore represents one way of resolving this problem—at least in the short term. In this respect, it is no accident that some of the fastest-­growing markets for Phase 2 and 3 clinical trials are located in the former socialist economies of China, central and eastern Europe, and the former Soviet Union, where the institutional remnants of once well-­funded public hospitals provide a more workable combination of centralization, infrastructure, and professional training to offset the excessive flexibility of the US recruitment process. Another favored destination is India, where the dismantling of a unionized industrial labor force has delivered a population of potential research subjects to the newly emergent clinical trial sector. In the following chapter, we will turn to the expansion of multinational clinical trials in China and India, demonstrating how the phenomenon of transnational trials is attuned to both the internal transformations of the US clinical trial market and the recent innovation strategies adopted by emerging economies themselves.

158 Chapter Six

Seven

Speculative Economies, Contingent Bodies Transnational Trials in China and India

The business of drug testing in human subjects has undergone extensive restructuring over the past two decades. Most clinical trials, until very recently, were conducted in the major drug consumer markets of western Europe, North America, and Japan, with the notable exception of drugs for infectious disease.1 Since the mid-­1990s, however, a growing percentage of trials for chronic or acute conditions (notably cancer) have been relocated offshore to the newly postsocialist or liberalized economies of India, China, East Asia, Latin America, central and eastern Europe, and the former Soviet Union (Sunder Rajan 2007, 2008; Petryna 2009; Prasad 2009; Kuo 2012). While the United States and western Europe continue to house the greatest proportion of Phase 1 clinical trials, close to one-­fifth of all US registered trials, most of them in Phases 2 and 3, are now being conducted in central and eastern Europe, Latin America, and Asia (Thiers et al. 2008). Today trials may be conducted simultaneously in multiple locations around the world, in response to fluctuating recruitment demands and calculations of cost arbitrage. Later-­stage trials that have been initiated in North America

and fail to fulfill recruitment goals can be “saved” at the last moment by relocating to offshore zones where “suitable” patient populations can be found. Over the past few years, China and India in particular have reported extremely high growth rates in clinical trials as their governments have made concerted efforts to build up research infrastructure and internationalize regulations. This process of market expansion is in constant flux, as pharmaceutical companies feverishly speculate on the next frontier to be opened up and the next institutional and regulatory barriers to be overcome and remade in their efforts to find ever-­expanding pools of experimental research subjects. Pharmaceutical companies that have been established in China and India for barely more than a decade are already beginning to anticipate the new opportunities opening up in rural China, Vietnam, and Sri Lanka. Just as the contract research organization facilitated the vertical disintegration of the pharmaceutical firm in the United States, the cro has also emerged as the principal broker of transnational clinical trials, constantly mediating between pharmaceutical trial sponsors, offshore clinical research sites, and patient populations to locate the most cost-­effective sites for conducting a particular study. In many respects, the expansion of drug testing into these new markets is an artifact of the International Conference on Harmonization (ich), a consortium created in 1995 at the behest of the International Federation of Pharmaceutical Manufacturers’ Association. Under the umbrella of the ich, the regulatory authorities and pharmaceutical industries of western Europe, North America, and Japan have developed Good Laboratory Practice (glp) and Good Clinical Practice (gcp) guidelines designed to harmonize the drug development process across national economies (Abraham and Reed 2002; Daemmrich 2004: 151–166).2 These guidelines have subsequently been taken up by regulatory authorities worldwide in an effort to take advantage of the expanded commercial opportunities of multiple market registration for new drugs. The creation of these harmonized standards for drug testing follows in the wake of the wto’s adoption of the gats, a treaty that authorizes the cross-­border trade in health services (including clinical trials), and the trips (or Trade-­Related Intellectual Property Rights) Agreement, which enforces the global protection of patented pharmaceuticals (Drahos and Braithwaite 2002; Sell 2003; Saxena 2011). Together, these efforts at forging global standards have transformed the experimental results of clinical research into fully exchangeable data, whose translatability across regulatory borders and drug consumer markets is rendered as smooth as possible. As a consequence of regulatory harmonization, drug companies have 160 Chapter Seven

moved toward a model of “global concomitant registration” in which the data generated in multisite trials dispersed throughout several countries can be simultaneously registered and approved for sale in multiple consumer markets around the world. Driving this process are the growing problems associated with patient recruitment in the United States, which nevertheless continues to host the largest number of clinical trials relative to all other countries. The recent adoption of techniques of so-­called rational drug design, such as high-­ throughput screening and combinatorial chemistry, have greatly increased the number of new candidate drug compounds available to pharmaceutical companies. The number of drugs in US Phase 1 clinical trials grew from 386 in 1990 to 1,512 in 2000, and continues to grow (J. P. Walsh et al. 2003). Yet the translation from in vitro drug innovation to marketable in vivo results has been slow. In the meantime, the length and complexity of the clinical trial process has also increased, as trial sponsors seek ever finer statistical differences to capture markets for “me-­too” drugs and the fda requires more specific patient selection criteria to meet statistical end points. It is increasingly difficult for trial sponsors to locate, recruit, and retain the research subjects they need to successfully complete a trial. The Tufts Center for the Study of Drug Development estimates that research subject selection rates dropped from 75 percent in 1999–2002 to 59 percent in 2003–2006, while retention rates also declined substantially (Tufts Center for the Study of Drug Development 2008). The recruitment of suitable human subjects now rates as the major cost incurred in the clinical development phase of new pharmaceutical drugs. It is largely in response to these intractable problems of research subject recruitment that clinical trial sponsors have moved offshore. In non-­ US and non–western European locations, trial sponsors report saving up to six months on recruitment times even when regulatory approval times are slower. Compensation for patients and salaries for on-­site personnel (trial investigators, clinical research associates, and statisticians) also cost considerably less. Administrative lags in the processing of trial applications remain problematic in countries such as China and India, where regulatory agencies have only recently taken on enormous trial approval caseloads; yet for the moment at least, the speed and low cost of patient recruitment outweighs these concerns and continues to exercise a strong gravitational pull on multinational drug sponsors. When compared with their American counterparts, patients in India and China have typically consumed far fewer pharmaceuticals and are therefore less susceptible to Speculative Economies, Contingent Bodies 161

the drug-­drug interactions that can cloud clinical results. In industry parlance, these patients are praised for their “compliance” (their adherence to protocols and study schedules) and treatment naïveté (the relative lack of exposure to drugs, which means that trial data are “cleaner” and easier to read). The Indian and Chinese consumer markets, moreover, are growing at a vertiginous pace: by placing an arm of their multinational trials in these countries, pharmaceutical companies gain rapid access to the local market. Increasingly, competitive pressures to dominate these new sites of accumulation means that the major players cannot afford not to move some of their trials offshore. In the previous chapter, we investigated the recent evolution and current status of the US clinical trial market, which remains the largest in the world. We also explored some of the problems associated with the decentralization of contract clinical trials—problems that are pushing the pharmaceutical sector to seek out the remnants of hospital and manufacturing infrastructures overseas. This chapter will take a closer look at the emerging clinical trial market in China and India, the two fastest-­growing clinical trial hubs in the world. We are particularly interested in the expansion of contract clinical trials into the large urban hospital in metropolitan China (Shanghai and Beijing) and the emergence of both private and public sector trials in the city of Ahmedabad, Gujarat, considered to be the contract clinical trial capital of India. In many respects, the rise of a clinical trial market in these locations is comparable to the developments traced by Adriana Petryna in her groundbreaking work on the expansion of clinical trial markets into Latin America and the former Soviet Union (2009). However, we have chosen to focus on Ahmedabad and the urban centers of China because, unlike the countries of the former Soviet Union, both the Indian and Chinese governments are simultaneously positioning themselves as contenders in the global market in biomedical innovation and intellectual property rights. For a brief moment during the 1980s and early 1990s, China and India were positioned as the criminal outliers to the postindustrial knowledge economy embraced by the United States in the early 1980s—condemned to produce cheap counterfeits of the exquisite software and pharmaceuticals emanating from the more knowledge-­intensive sites of the world economic system. Yet having embraced trade liberalization and acceded to the wto rules on intellectual property rights protection, the Indian and Chinese governments have adopted a remarkably different and in some respects more threatening tactic, choosing to compete within rather than contest the postindustrial regime of 162 Chapter Seven

innovation first embraced by the United States. No doubt this transition is neither clear cut nor final (India, in particular, remains heavily invested in generics and continues to mount strong opposition to the most egregious patent claims of multinational pharmaceutical companies). Nevertheless, what interests us here is the emerging tension between the scientific and technical ambitions of the postcolonial or postsocialist state and the constitution of a contingent labor force in contract clinical trial work, one that has largely been facilitated by the very same governments. In other words, we seek to understand the structural interdependence between an economy of speculative innovation and a labor market that constitutes “risk exposure” itself as a tradable service. Much of the critical public health literature has tended to address the politico-­economic questions of global clinical trials through the prism of human rights and its revised ethical categories, as if the transnationalization of trials were entirely separate from the general dynamics of global labor restructuring that have accompanied economic liberalization. Adriana Petryna, for example, locates her critique of transnational trials in the geopolitical “variability of ethical standards,” pointing to the crisis conditions of public health that may be invoked to justify withholding treatment from the control arm of a placebo trial in an impoverished environment (2009: 35).3 It is not clear to us, however, that such practices depend on the “variable” interpretation of ethical standards. Indeed, as Sunder Rajan (2008) points out, it is the generalization of bioethical standards, not their variability, which underwrites the exceptional medical interventions of the clinical trial, and it is ethical standardization that has transformed human subject research into an exchangeable commercial service. Moreover, the exceptional practices identified by Petryna are not limited to clinical trial sites in the developing world: uninsured trial subjects in the United States, for example, are regularly subject to randomized trials in which they may receive a placebo depending on the trial arm they are assigned to (Larkin 2000). Theorists of global health who appeal to a human rights framework seek to go beyond the restricted understanding of rights contained in gcp guidelines—currently the standard form of ethical oversight adopted in global clinical trials. In lieu of the classical liberal right to take risks, they argue in favor of a social democratic right to protection—of the body, health, and life itself (Farmer 2005; Mills and Singh 2007; Petryna 2009: 33). In its most rigorous form, contemporary human rights discourse substitutes the universal biological citizen for the national citizen, thus overcoming the contradiction between state citizenship and extra-­territoriality that Hannah Speculative Economies, Contingent Bodies 163

Arendt (1973: 270–302) identified as the aporia of mid-­twentieth-­century human rights discourse. Judith Butler (2004) evokes an ethical subject who is vested with a “right to have rights” by virtue of his or her mere biological existence, making “life’s precariousness” and bodily “vulnerability” the common foundation of all human rights. Butler’s philosophy of precariousness is remarkably consonant with recent directions in human rights discourses: the appeal to “vulnerability” has thus become ubiquitous in critical understandings of bioethics and human subject protections. This expanded, extra-­territorial understanding of human rights belongs to a historical moment in which philanthropic foundations and ngos have come to replace the nation-­state as the prime provider of welfare services in the postcolonial world (Dezalay and Garth 2002; Moyn 2012). And yet the bioethics of human rights can be subject to the same critique that Marx (1970) addressed to the rights of man—in its affirmation of formal equality among biological citizens, an equality grounded in one’s bodily vulnerability, human rights discourse can be considered the fetishized form of the actual social relations that shape the contemporary organization of health care and clinical labor. Like classical rights discourses, human rights confines politics within the realm of representation or mediation, as if the protections legislated from above could resolve the inherently asymmetric distribution of risks constitutive of the clinical labor relation. We would argue, instead, that the persistent inequalities that continue to shape the consumption and production of health care cannot be forcefully addressed unless we also confront the nature of the capitalist labor relation itself—a labor relation that, in the current conjuncture, crucially depends on the exposure of certain bodies to uninsured risk. What our investigation highlights is a remarkable degree of synergy across clinical labor markets: the transnational organization of clinical research is highly stratified according to phase and therapeutic indication, yet these stratifications traverse national borders. For example, one well-­known Phase 1 contract research organization has clinics located on the US-­Mexico border, in Madrid, and in a private-­public partnership located in a nominally public hospital in Shanghai. Another major contract research organization oversees multiple locations around the world, including sites in Mexico, Beijing, and Ahmedabad. In each of these locations, Phase 1 recruits tend to belong to the urban and rural-­migrant underclasses of contingent and contract day laborers who regularly undertake high-­risk labor to make a living. Participants in Phase 2 and 3 trials tend to be chronically ill patients with little 164 Chapter Seven

or no health insurance. What distinguishes these sites are their divergent, nonsynchronous histories of institutional reform (a long-­standing model of stratified health care in the United States; a more recent history of market liberalization in China and India). These histories have produced specific institutional infrastructures (the large urban hospital in China; the generic drug sector in India), residual architectures of the developmental and socialist state that can be selectively reanimated to resolve some of the deficiencies of research decentralization in the United States. In each instance, recent trajectories of reform have converged to produce a population of subjects defined by their structural exposure to risk (the absence, that is, of adequate health insurance), an exposure that is both a liability and a newly defined asset. As in the United States, the mobilization of a “ready to recruit” population of offshore research subjects is tightly connected to recent histories of deindustrialization (in India), labor informalization (in China and India), and welfare reform (in China). The labor of such overexposed subjects is readily exchangeable with that of the uninsured and precariously employed in the United States. In what follows, we unfold the recent history of labor, welfare, and health care in urban China and Ahmedabad in order to understand the conditions under which bodily risk has become an exchangeable service and a newly productive form of labor.

Indigenous Innovation and Human Capital: Postsocialist Science in the Hu Jintao–Wen Jiabao Era

In a speech delivered at the opening of China’s Fourth National Conference on Science and Technology in January 2006, President Hu Jintao spoke of China’s need to “adhere to a new path of innovation with Chinese characteristics and strive to build an innovation-­oriented country” (Salter 2009a: 402). President Hu’s speech reflected a decisive rethinking of the three-­ decade-­long process of scientific modernization pursued by China during the reform era. His message was consonant with China’s changing vision of its place in the world economy. If China was to maintain its position among its closest competitors such as India and the other rising economies of East Asia, it could no longer rely on the economies of scale offered by the low wages of a mostly industrial labor force. The era of economic growth based on cheap labor and the mass reproduction of foreign innovations was coming to an end. Henceforth, China would need to develop its capacity for “indigeSpeculative Economies, Contingent Bodies 165

nous innovation” (zizhu chuangxin) and learn to compete within the global economy of patented high technologies. President Hu’s strategy of indigenous innovation was subsequently reflected in the “Medium- and Longterm Science and Technology Development Plan” of 2006—a fifteen-­year blueprint designed to establish China among the top five countries in the world in terms of international patents for “indigenous” innovations and citations in international science journals (Jacobson 2007: 4). Biomedical innovation, including pharmaceutical r�d, figured prominently among the sectors targeted by the new plan. Viewed within a regional perspective, China’s new science and technology policy reflected a wider dissatisfaction with the developmental strategy pursued by its East Asian neighbors (Singapore, South Korea, Thailand, Malaysia) during the 1980s and 1990s, a strategy that focused on the cheap, mass production of commodities for well-­established or known consumer markets. As these countries have joined the wto and acceded to its regulations on intellectual property (trips), protectionist measures have become redundant as a long-­term growth strategy. Along with its neighbors, China is now turning its attention from established mass consumer markets for cheap goods to highly uncertain, speculative markets for experimental products such as new life science technologies (Salter 2009b: 50). No longer content to play host to offshored industrial production, China now aspires to compete with the United States, Japan, and Europe as a postindustrial innovation economy, one in which intellectual property plays a key role in securing the speculative value of future markets. Under the policy aegis of the “Harmonious Society,” the Hu Jintao–Wen Jiabao administration has popularized the idea that China must cultivate the “human capital” of its labor force in order to produce a middle stratum of professional workers and high-­income consumers (Greenhalgh 2009). According to a monumental report published by the Chinese Academy of Social Sciences in 2002, China’s future middle stratum (the word “class” is conspicuous by its absence) would ideally include “the group of people who do knowledge-­based work, earn salaries, and possess not only the capacity to find a profession that is relatively high-­paying, with a good working environment and conditions, but who also have the capacity to consume and maintain a quality of life in leisure” (Chinese Academy of Social Sciences 2002: 252). Marking a subtle but decisive move away from the purely economic discourse of experimentation associated with Deng Xiaoping and his immediate successors, the “Harmonious Society” envisages a new social contract, one that promises to mitigate some of the harsh social asperities 166 Chapter Seven

of the reform era without doing away with class stratification per se. Although it decries the excesses of economic liberalization and sets itself the explicit task of defusing the most egregious of its social antagonisms, the Harmonious Society agenda is far from advocating a return to the collectivized risk insurance structures of the socialist era. Instead, the Hu–Wen administration has implemented a number of juridical and policy reforms (including but not limited to the introduction of labor contract law, a national statute on tort law, and the ongoing project of universal basic health insurance) designed to enable at least one class of citizens to manage their own risks on a private, contractual basis. The middle stratum is defined by the ability to bear risks and manage losses, with minimal assistance from the state (Hai Ren 2010: 122–128). As noted by Lisa Rofel (2007), the will to experiment has become a defining feature of China’s newly emerging middle-­class self. By the same token, we will argue, experimentation has also come to define the subject positions of those classes of labor that are marginalized from the ideal projection of China’s future middle stratum. For these classes, the freedom to experiment is also the obligation to take risks, either in the form of highly contingent, often dangerous forms of work, or the inability to pay for health care. The obligation to bear risks is nowhere more literally embodied than in China’s growing class of experimental research subjects who undertake contract clinical trial work in China’s Phase 1 research units or engage in clinical trials in exchange for health care. For these research subjects, the consumption of innovative drugs is simultaneously a form of productive labor and the risks of experimental innovation are visceral ones.

Speculative Drug Innovation and the Experimental Worker: China’s Clinical Trial Industry

With the help of the central government’s economic stimulus policies, China’s domestic health care consumption has grown at an astonishing rate. In 2011, China became the world’s third largest prescription drug market, after the United States and Japan, and it is estimated that it will be the second largest by 2020 (Ribbink 2011). As the government rolls out a series of experimental health insurance schemes designed to subsidize part of the costs of prescription drugs, it is expected that a new middle-­class consumer market will emerge, on a grand scale, in the next few decades. In anticipation of these trends, most of the larger multinational pharma comSpeculative Economies, Contingent Bodies 167

panies have established major r�d centers in China or are planning to do so within the next few years, with small to medium biotech companies following in their wake (Goodall et al. 2006; Humphries et al. 2006; Hughes 2010). Technology parks such as Zhongguancun Life Science Park in Beijing and Zhangjiang Biopharmaceutical Park in Pudong, Shanghai, host an extraordinary concentration of multinational research facilities and allied support companies, rivaling (in scale at least) the regional research clusters that have been credited with fueling the US pharmaceutical economy (Cao 2004; Zhou 2005; Scott 2011; Zhang and Wu 2012). Several of the major pharmaceutical companies are pursuing r�d programs targeted exclusively at China’s projected future consumer market (Astra Zeneca, for example, recently set up a US�200 million global r�d center for Asian disease in Zhangjiang Biopharmaceutical Park). The development of new drug compounds on Chinese soil means that multinational companies are able to conduct first-­ in-­human Phase 1 trials in Chinese hospitals—a strategic move if one is to establish one’s product in a newly emerging consumer market. Thus far, however, Chinese life science institutions have produced very little in the way of patented drugs. While China hosts many leading research centers in basic life science and biotech research, including genomics, and holds a large share of the world market in bulk drug manufacturing, until recently it has lagged behind its closest regional competitors in commercial drug innovation. It is this situation that the Chinese government is trying to remedy by encouraging its domestic science laboratories to engage in novel drug development and joint research ventures with multinational pharmaceutical companies (Liang et al. 2010; Qi et al. 2011). The eleventh Five-­Year Plan (2007–2012) includes a budget for “major new drug creation” that provides finance for the development of innovative drugs for ten major disease categories.4 The program, which hitherto privileged returned overseas Chinese scientists, was expanded under the twelfth Five-­Year Plan (2011–2015) to include joint ventures between Chinese and foreign partners. In recognition of the high costs and uncertain prospects of the translational component of pharmaceutical research (the passage, that is, from novel molecular entity to investigational new drug ready to enter clinical trials), both the Chinese state and local governments have initiated successive programs to fuel domestic venture capital investment in early stage research (Salter 2009a). Such programs date as far back as 1986, when the China New Technology Venture Investment Corporation (a state-­owned enterprise intended to reproduce the role of private venture capital in Silicon Valley) was created, and 168 Chapter Seven

they have been replicated many times over, with varying levels of success. Metropolitan high-­technology parks often oversee their own research development funds. Shanghai’s Zhangjiang Biopharmaceutical Park, home to the most concentrated life science cluster in the country, operates both a grant system intended to finance r�d through the clinical trial stage and a venture capital subsidiary which invests in early-­stage drug development (Interfax 2009, 2010). In the absence of a strong private investment sector comparable to that of the United States, these programs represent a novel form of state-­funded (or part state-­funded) speculative capital investment and have helped a growing number of Chinese life science enterprises to launch ipos (initial public offerings) on the Shanghai stock exchange. Yet these speculative investments only illuminate one aspect of China’s “indigenous innovation strategy.” For even while the state seeks to reposition its domestic science laboratories as centers of high-­tech innovation and contenders in the world ip market, it is also promoting its hospitals as potential clinical trial sites and experimental service providers for domestic and foreign pharmaceutical sponsors (Bailey et al. 2007: 58). Over recent years, the government has made concerted efforts to transform China into an attractive destination for multinational clinical trials. It has established drug approval and gcp regulations conforming to global standards; created an accreditation system for clinical trial sites in hospitals, specialized training centers for clinicians, special technology zones for contract research organizations (Zhongguancun Life Science Park in Beijing and Zhangjiang Biopharmaceutical Park in Shanghai); and pursued a high-­profile corruption case against the former head of the State Food and Drug Administration (he has since been sentenced and executed). One regulatory intervention in particular has been decisive in transforming China into a global clinical trial site. Prior to 2003, new drugs could be marketed in China only if they had already been approved for marketing in Europe and in the United States. They also needed to be subject to a Phase 3 trial in China before receiving approval for consumption in the Chinese market. Changes to domestic regulation in 2003 made it possible to include China in multinational drug trials without a time lag (Humphries et al. 2006). As a result, clinical trial data collected in China is now being used not only for the domestic approval of drugs already accepted in the United States but also as a platform for developing new drugs for the international market. China has seen a rapid proliferation of domestic and foreign contract research organizations (cros) mediating between the interests of large pharmaceutical companies, clinical trial cenSpeculative Economies, Contingent Bodies 169

ters in hospitals, and the cfda (China Food and Drug Administration), and now has the highest annual growth rate of all clinical trial markets, both emerging and established (Thiers et al. 2008: 2). The postsocialist hospital represents an attractive production site for the multinational pharmaceutical sponsor precisely because it retains at least some of the features of the socialist work unit, or danwei: a qualified work force, centralization, massive case loads, and a concentration of specific patient profiles in specialized departments. In contrast to the United States, all Chinese clinical trials (Phases 1, 2, and 3) take place in large urban-­based government hospitals, often affiliated with a medical school, and must be accredited by the cfda.5 Despite recent efforts to create a local gp system, hospitals remain the destination of choice: patients don’t need a referral to visit a hospital, and regularly travel from remote rural destinations to consult the more qualified staff that can be found in the large urban centers. These hospitals have multiple specialty departments and can house between one thousand and two thousand beds, making them considerably more efficient than the current US model of later-­phase trials run from private physicians’ offices. As of 2011, the cfda had accredited 278 clinical trial institutions, more than double the number it had approved in the late 1990s (Djali 2011). While China’s first generation of multinational trials were in Phases 2 and 3, more recently the central government has heavily invested in infrastructure for Phase 1 trials and has allocated grant funding to approximately half of existing Phase 1 units with the clear ambition of attracting foreign sponsors (indeed, by some accounts it has overinvested, as state-­of-­the-­art labs are often left unused by local drug producers whose protocols don’t yet extend to sophisticated pharmacological tests) (Zhu et al. 2011).6 All Phase 1 units in China are based in hospitals and are either run by hospital staff or cooperatively organized with a private cro or smo (a site management organization, or cro specialized in the on-­site running of trials) (D. Zhang 2011). Shanghai Clinical Research Center, for example, is a fifty-­six-­bed unit located within the confines of Xuhui Central Hospital. Much like comparable institutions in the United States, the unit has a small intensive observation ward equipped with twelve beds, an entertainment area for trial subjects, a blood-­drawing room, an emergency room for “adverse events,” and state-­of-­the-­art electromyography and electrocardiography facilities. The unit’s website includes a recruitment page featuring pastel-­colored, airbrushed photos of smiling families, a mother and baby, and a mother and two children against a verdant backdrop of trees. Below them a caption reads, “Here you help to create a better future!”7 Other units are located in govern170 Chapter Seven

ment hospitals but run by international Phase 1 groups, who typically manage a chain of similar Phase 1 units in strategic locations around the world. One such company, the US-­based FrontageLab, has a seventy-­two-­bed Phase 1–2a clinical trial unit in New Jersey and a 130-­bed, hospital-­based Phase 1–2a facility located in the First Affiliated Hospital of Zhengzhou University, a 6,000-­bed facility considered to be one of the top hospitals in China. Another private US-­based clinical trials company, start (South Texas Accelerated Research Therapeutics), which already operates Phase 1 units on the US-­Mexico border and in Madrid, has recently opened a Phase 1 unit in Fudan University Cancer Centre, Shanghai’s largest cancer center (Carlson 2011). A private-­public partnership between Fudan University, start, and Cenova Ventures, a health investment fund backed by local and central governments in China, this operation is unique in China; it testifies not only to the PRC’s willingness to experiment with new institutional forms but also to the transnational synergies between Phase 1 labor markets. Taken together, these examples of multinational investment in China are representative of an emerging global production chain in clinical research, one that aspires to leverage a 24/7 network of public and private clinics, physicians’ offices, and hospital wards for the production of data that can be lodged with multiple regulatory agencies. The harmonization of regulatory, clinical, and ethical standards has made it possible for cros to set up operations in multiple strategic locations around the world, in each case taking advantage of the changing social and economic conditions that have served to repurpose the historical legacies of the specific medical institution (the private doctor’s office or the socialist hospital) and pushed local populations into high-­risk work or welfare-­labor hybrids such as work for health care. It is perhaps not surprising, then, that we find considerable similarities between the kinds of research subject ­recruited into clinical trials in China and the United States. In some Phase 1 units, especially those based in hospitals affiliated with medical schools, most Phase 1 subjects are medical students who undertake trials to supplement their incomes. However, as in the United States, China has recently witnessed the emergence of an urban labor force of “professional” human research subjects who alternate between clinical trial work and other forms of contingent, informal, and sometimes high-­risk work (Liu Zuoxiang 2008). These research subjects are recruited through adverts placed in hospital and medical school grounds, in newspapers, on websites and (it is reported) through job recruitment agencies who act as brokers on behalf of research hospitals (Wemos 2010; Lin 2011; Interview 2013). As in Speculative Economies, Contingent Bodies 171

the United States, participation in a Phase 1 clinical trial pays relatively well compared to other kinds of low-­skilled labor, with some research subjects claiming to collect up to several thousand yuan for one month’s confinement (higher than the average income) (Liu Zuoxiang 2008). Not surprisingly, then, the domestic clinical trial sector is beginning to face some of the same difficulties that foreign sponsors thought they had left behind in the United States. In one industry conference, we heard a prominent figure in the Chinese clinical trial sector speak of the problem of “professional guinea pigs” who move from trial to trial without respecting the required thirty-­ day washout time (Zhu et al. 2011). Another participant complained that research subjects were motivated only by the money. A discussion ensued as to whether local cros should collaborate to set up a database of Phase 1 research subjects that would allow trial investigators to distinguish between genuine “volunteers” and “professional guinea pigs.” There seemed to be little appreciation of the fact that the entire industry might cease to exist without such highly motivated test subjects. Later-­phase efficacy trials (2 and 3) may take place on an outpatient or inpatient basis, depending on the indication. The failures of insurance coverage are the key motivating factor for patients who undertake therapeutic studies, and since randomization is less commonly practiced in China, participation in a trial may well be a more promising way of receiving health care than in the United States. As part of the Harmonious Society agenda, the PRC has recently piloted a basic medical insurance program that it aims to extend to the entire population. This insurance coverage remains minimal, however, and only reimburses a restricted list of essential drugs (Duckett 2010). Even under this new regime, many drugs and treatment protocols that are considered standard of care for insured patients in wealthier countries are not easily accessible in China unless one is able to pay out-­of-­pocket. This difference in standards of care represents a strategic opportunity for clinical (and commercial) expansion by the pharmaceutical industry. Two examples of such commercial opportunities are prostate and breast cancer (Limbach 2010). Both have a relatively low incidence in China, yet due to the absence of public prevention programs, patients tend to present at an advanced stage of illness. Drugs that would be the standard of treatment for insured patients in wealthier countries are not reimbursed by China’s basic medical insurance. This means that trial sponsors can expect to find a population of patients who have no “standard of care” to forgo and are therefore more than willing to test experimental new cancer drugs as their only hope of treatment. From the perspective of the trial sponsor, the clinical trial is a useful 172 Chapter Seven

means of habituating clinicians to the use of their product and creating a potential market for commercialization: testing a new drug formulation on an underinsured patient population is also a strategic pathway to market expansion. In its navigation of transnational regulations and geographies of health care, then, the pharmaceutical economy relies on the existence of disparities in health coverage that create a demand for access to experimental drugs. The speculative value of future pharmaceutical markets, in other words, depends on the absence of risk prevention and remediation strategies for entire segments of the world’s population and the willingness of experimental subjects to expose themselves to the contingencies of untested drug compounds, often in the absence of any realistic alternative. In this economy of exposure, the patient’s uninsured body is both a liability and a tradable asset—a form of labor constituted by its ability to sustain and translate risk into data in exchange for either money or health care. In many respects, the conditions that have given rise to a “ready to recruit” population of research subjects in China are not unique. In China, however, these conditions are relatively recent. In what follows, we will investigate the history of health and labor reform that has transformed urban China into an emerging destination for multinational clinical trials.

The Postsocialist Hospital: From Danwei to Experimental Export Zone

The liberalization of health care was one of the first and most comprehensive of market reforms undertaken by Deng Xiaoping in 1978. Its effects were all the more resounding given the astonishing success of China’s Communist-­ era campaigns to improve public health through a combination of traditional and Western medicine, preventative, basic health care interventions, and collectivized health insurance. In the decades following the founding of the PRC in 1949, China massively reduced the incidence of infectious disease and increased life expectancy from an average of thirty-­five to over sixty in the 1970s. During the 1970s, the World Health Organization hailed China’s health care system as a model for the entire developing world (Wang 2004; Zhan 2011). After 1949, the urban hospital, like other work sites in the urban centers, was organized as a danwei—an administrative unit that allocated and managed work for a relatively stable internal labor force while also providing for the welfare, family planning, and health matters of its employees (Bray 2005). In their study of an urban hospital in the years immediately following the Cultural Revolution of 1966–1976, Gail Henderson and Speculative Economies, Contingent Bodies 173

Myron Cohen found that the hospital danwei combined egalitarian principles of welfare distribution and shared educational opportunities with a vertically integrated structure of authority “reminiscent of a feudal estate” (1984: 143). Even after the Cultural Revolution, they observed, promotion was “egalitarian” but for this very reason more often than not resembled a political decision rather than a reward for professional advancement. Physicians and other staff members had few opportunities to move between organizations. Despite its limitations, however, the centrally funded hospital danwei managed to offer relatively affordable health care to all classes of the population throughout the Communist era. All this changed in 1978, when the central government began an incremental process of shifting responsibility for medical services onto provincial and local authorities (Blumenthal and Hsiao 2005). The enduring effect of these reforms has been a growing disparity between the coastal, urban centers, where tax revenues can be called upon to compensate for at least some funding shortfalls, and the impoverished hinterlands of rural China, where no such alternative sources of income are to be found. Yet even the large urban hospital, the epicenter of China’s highly centralized health system, has not fared well under reform and has abandoned the collectivist principles of the socialist work unit or danwei in favor of an entrepreneurial model of health care “services” (Zhan 2011). Hospital reform accelerated after 1989 when the central government formally capped its support for public health care and demanded that hospitals become responsible for covering their own operational costs. In exchange, it was decided that hospitals were to be free to generate income through the sale of drugs and other health care services such as diagnostic tests (Gu and Zhang 2006). For the most part, these reforms have taken the form of institutional marketization—on the model of the so-­called new public management—rather than outright privatization (Urio 2012). The PRC did authorize the return of private practice in medicine in 1980, and a small number of private hospitals have been set up, yet public hospitals remain the major player in the hospital sector (Tam 2010: 64). These institutions, however, have been radically transformed from within, as the central government has authorized them to turn previously “nonproductive” health care services into lucrative commodities and erstwhile public spaces into rent-­making assets. In the process of marketization, the vertically integrated, paternalist structures of the hospital danwei so vividly described by Henderson and Cohen (1984) have given way to a complex array of horizontal contractual relations between individual wards, services, practitioners, and various ex174 Chapter Seven

ternal clients. Hospital managers now fix revenue targets for individual departments, setting up different sectors of the institution in competition with each other and rewarding medical practitioners as a function of their revenue-­raising capacities. In the popular media, it is the intensely commercial and increasingly antagonistic nature of the doctor-­patient relationship that has come to signify all that is wrong with the postsocialist hospital, and indeed the reform process itself. The introduction of performance-­linked (or “floating”) wages means that medical practitioners are now paid as a function of their ability to extract fees from their so-­called clients (Bray 2005; Yang 2006; Tam 2010: 66). State regulation in this area has had counterproductive effects: in an effort to place at least some limits on prices, the Ministry of Health regulates fees for “basic services” but allows hospitals to charge extortionate fees for pharmaceuticals (sometimes manufactured on-­site) and high-­tech diagnostics such as scans and X-­rays. As a result, Chinese hospitals routinely overprescribe and overcharge for pharmaceuticals while also subjecting patients to an unnecessary number of tests. The consequences for the relationship between the patient and the medical profession are chilling: in their dual role as providers of health care and revenue raisers for an underfunded institution, medical practitioners are more or less compelled to triage among low- and high-­cost patients. There is evidence (and more important, perhaps, a widespread perception) that doctors need to be bribed to deliver minimal health care to underinsured patients (Yang 2006). Yet the intrusion of informal and sometimes outright illegal contractual relations into the space of the clinic extends well beyond the immediate encounter between the doctor and the patient. Waikeung Tam (2010: 68–69), for example, recounts that the leasing out of entire clinical departments to outside contractors has become common practice since the 1990s, despite repeated efforts by the Ministry of Health to ban it. Other institutions have resorted to the practice of creating vip floors that offer private rooms, personal toilets, and other exclusive amenities to patients willing to pay more (Cong and Hu 2005). During the past decade, the contract clinical trial has emerged as an alternative, even more lucrative source of income for the underfunded Chinese hospital and an informal means of resolving ongoing conflicts between patients and medical staff (Interview 2008b). Physicians in urban China are highly qualified yet poorly paid in comparison to other urban professionals, and by acting as principal investigators on a pharmaceutical industry–­ sponsored drug study, doctors not only receive a sizable bonus or “floating wage” but also the chance of being published in a reputable international Speculative Economies, Contingent Bodies 175

medical journal.8 In the meantime, the uninsured or underinsured patients derive an at least relative benefit from the arrangement by receiving medicines that are both foreign-­manufactured (and thus considered “safer” than Chinese-­manufactured products) and free of cost, along with free health care for the duration of the trial. The revenue-­raising imperative that now weighs on hospitals means that clinical trials are becoming an essential source of income for the Chinese health services sector as a whole—an export service market that deploys both the low-­cost professional labor of the medical practitioner and the materially contingent labor of the experimental research subject. Alongside the restructuring of the hospital, then, the steady evisceration of health insurance, particularly during the pivotal decade of the 1990s, has created the ideal conditions for a flourishing clinical research market. Rural health insurance in socialist China was always less extensive than that available to urban residents; but when the PRC abandoned the system of agricultural collectives in the late 1970s, rural residents lost all access to the coverage offered by cooperative medical systems. Urban residents, whose rights to health insurance were tightly linked to full-­time employment, have fared only slightly better, as the institutional structure of the danwei has been dismantled and work itself has become increasingly precarious. Introduced as a temporary measure in 1948 and codified in 1951 under the national Labor Insurance Regulations, the PRC’s urban welfare system provided members with cradle-­to-­grave social protection administered by individual industrial enterprises or danwei. As comprehensive in its scope as western European social welfare, China’s social insurance regime covered everything from health care expenses to medical accidents, workers’ compensation, retirement benefits, maternity leave, and child care (Bray 2005; Guthrie 2008: 137). Urban medical insurance extended beyond formal workers per se to all “productive” members of society through two official schemes—the laobao yiliao (labor insurance medical care), which offered full coverage to the employees of state enterprises along with partial coverage to their immediate family members, and gongfei yiliao (publicly funded medical care), which provided for civil servants, workers in universities, handicapped military officers, and students. During the reform period, however, the progressive dismantling of the work unit has meant that many urban residents have lost most if not all access to social welfare. The promulgation of the 1995 Labor Law officially put an end to the danwei regime of statutory lifetime employment (the so-­called “iron rice bowl”) and replaced it with a system of contractual labor relations, in many cases operative even within the institutional 176 Chapter Seven

confines of the old work unit. The effect on health care was devastating. At the beginning of the twenty-­first century, only half of urban residents, most of them formal sector workers, were covered by medical insurance. Workers’ dependents, the self-­employed, informal workers, and urban-­rural migrants were not covered at all (Yip and Hsiao 2009). Dorothy Solinger (2009) has documented how closely ill health is connected to the rise of the urban underclass in China, noting that those who have remained without work since the mass redundancies of the late 1990s are distinguished by low levels of education, their age (most are over thirty-­ five), and their poor health. The sudden and dramatic deproletarianization of a whole sector of the former working class (now going under the label of dibaohu, that is, households receiving the minimal livelihood guarantee or dibao) is in many cases a function of enduring medical problems. Even for those assured of a position in a state-­owned enterprise, job security is now seriously threatened by the experience of ill health or medical negligence. In 1986, the State Council adopted regulations that allowed employers to dismiss employees who were disabled due to non-­work-­related causes, with the result that increasing numbers of employers were no longer offering lifetime economic support and care to workers who had experienced medical problems. The 1995 Labor Law extended this measure to all employers and workers (Harris and Wu 2005: 461). Deemed unfit to adapt to the new economic conditions of China’s urban labor market, these welfare recipients are nevertheless required to engage in mandatory workfare, much of which amounts to menial community service work such as street-­cleaning, handing out government propaganda, and monitoring traffic (Solinger 2009). Health care is even more precarious for the large, “floating” population of rural-­urban migrants, whose very mobility makes them unaccountable to China’s highly territorial administrative system. A permanent labor underclass defined by its exclusion from urban residential (hukou) status, the floating population is overwhelmingly employed in the informal construction and service sector, and more recently in short-­term contract positions in China’s newly restructured state institutions (hospitals, universities, state-­ owned enterprises). According to official statistics, urban-­rural migrants are exposed to an extremely high rate of workplace accidents, disabilities, and fatalities, yet they are least likely to be covered by any form of accident or health insurance (Zhao Tiechui 2005). While official rhetoric adopted under the leadership of Hu Jintao and Wen Jiabao calls for a mitigation of the disparities between urban and rural populations via an extension of new welfare schemes, so far such policies either exclude the floating poor by virtue Speculative Economies, Contingent Bodies 177

of their extreme mobility or are not implemented in practice (H. X. Zhang 2012). Because they have no stable residential status, labor migrants are excluded even from the minimum livelihood guarantee or dibaohu that now protects the nonmobile urban and (in some cases) rural poor. These, then, are the structural conditions that have impelled growing numbers of Chinese to participate in clinical trials. For healthy participants in a Phase 1 clinical trial, recruitment in a trial represents a form of casual, high-­risk, yet relatively remunerative labor, interchangeable with other forms of precarious work in the urban informal economy. Although not recognized as such, this labor market is mediated by smos that act as informal recruitment agents in the identification and selection of appropriate research subjects (Wemos 2010; Lin 2011). The later-­phase trials (2 and 3) attract another class of recruit—uninsured or insufficiently insured patients who cannot afford treatment or may have commenced treatment they are unable to continue unless they enroll in a clinical trial (Berton 2006; Xu et al. 2006: 371; Vaidya et al. 2007: 23; Interview 2008a, 2008b). In the absence of alternative means of accessing drugs, many patients have jumped at the chance to participate in trials, even though the therapeutic usefulness of the drugs is by no means assured and the actual distribution of drugs (as opposed to placebo) in a double-­blind randomized trial is unknown to both the investigator and the patient. How should this novel experimental relationship between the patient and the hospital be understood? In lieu of state-­assured health care, the patient enters into what is implicitly, although not contractually, a labor relation, undertaking a form of productive service on behalf of the pharmaceutical industry with the hope (never guaranteed) of receiving some kind of suitable health care in exchange. Here consumption and production blur into each other: the experimental consumption of an untested drug represents a highly contingent, in-­kind “wage” for the patient and a form of productive (data-­generating) labor from the point of view of the pharmaceutical industry. In the previous chapter, we argued that this relationship can be interpreted as a novel form of “workfare”—for which we have adopted the expression “work for health care.” In China, as in the United States, there exists a tight, mutually determining relationship between the risk economies of welfare, health insurance, and employment, on the one hand, and the constitution of a potential class of “ready to recruit” experimental subjects, on the other. Despite recent attempts to mitigate the violence of postsocialist welfare reform, the inadequacies of health insurance remain structural to 178 Chapter Seven

the reform-era innovation agenda, constituting the underinsured patient-­ consumer as a de facto producer in the lower echelons of the global pharmaceutical economy. Having abandoned the collectivist model of the danwei or socialist work unit, the postsocialist hospital now survives as a hybrid institution in which the formal structures of the socialist health care complex are maintained in place by artfully recombining forces with the multinational, private research sector. As David Stark (2001) argues with respect to the former Soviet Union, the postsocialist transition to a neoliberal model of growth has not, in practice, involved the rapid and all-­encompassing implementation of market reform and privatization, nor has transition taken place on the virgin ground of a pure socialist economy. Far from introducing a wholesale privatization, postsocialist reform has blurred the boundaries between organizational forms, legitimating principles, and standards of valuation, making it impossible to distinguish between private and public ownership in any final way. As Stark points out, the resultant ambiguity of assets means that the one institution is able to deploy its infrastructure toward multiple ends (2001: 82). The postsocialist Chinese hospital offers the perfect example of such a strategy of “organizational hedging”: operating within the general legitimating principles of collectivist public health care, it has also transformed itself into an experimental export zone, leveraging its patient population as an experimental asset and source of commercial data. In the case of the clinical trial industry, however, Stark’s thesis needs to be extended still further, since it is not only the institutional ambiguity of the postsocialist hospital that comes into play but also the social ambiguity of the postsocialist “citizen” who at one and the same time is both a citizen-­patient and an experimental subject, both a newly constituted “consumer” of health care “services” and a de facto producer. At stake here, then, is not only the recombination of property forms and heterogeneous norms of legitimation but also hybridized notions of political and legal personhood, with their attendant relationship to risk and welfare. As the risk protections of the socialist danwei have been selectively eliminated, risk exposure itself has become a tradable service— and, ironically, for some, an alternative means of accessing health care. It is in light of these ongoing shifts in the nature of public risk management that we can understand the recent introduction of bioethics as discourse and practice into the Chinese clinic. The Chinese Ministry of Health and State Food and Drug Administration have been assiduous in their efforts to enforce the use of institutional review boards, gcp regulations, and bioSpeculative Economies, Contingent Bodies 179

ethical standards that respond to the requirements of the global pharmaceutical sector (Döring 2004; Xu et al. 2006; Li and Cong 2008; Wang and Henderson 2008). The global exchangeability of clinical data requires a rigorous (albeit purely formal) respect for ethical standards of treatment in the conduct of clinical trials. Although the discipline of bioethics is barely more than two decades old, then, it is hardly surprising that bioethics is flourishing in China. Rather than a sui generis development, however, the expansion of bioethics into China should be seen as continuous with wider shifts in the civil and administrative governance of work, health, and welfare during the same period. The implementation of labor contract law in 1995, for example, reconstituted the urban Chinese worker as an individual contractor and was instrumental in undermining the collectivist model of the social work unit or danwei. As one would expect given its historical connections to contract, private tort law regulations have also emerged in China, most notably as a response to medical malpractice disputes (one of the most explosive sites of social contention in reform-era China). Regulations established in 2002 to cope with the growing number of medical negligence and accident cases in Chinese hospitals included a provision for “informed consent”—the standard means for waiving liability in accident law (Harris and Wu 2005; Ding 2012). Together, these legal innovations have displaced the danwei as an institutional form guaranteeing collective accident insurance in both the workplace and the hospital. In its place, they have given shape to an individual legal subject who is empowered to assume and litigate risks on an exclusively private basis—a figure we might characterize as the experimental subject of law. The highly experimental model of social reform undertaken by China during the 1980s and 1990s has only been partially successful, however, and has in turn generated political risks that are beginning to threaten the stability of the postsocialist state. The problematic of the “accident” looms large in contemporary Chinese life. It can be encountered in the proliferation of industrial accidents among China’s mostly rural construction workers and coal miners, in the dramatic road toll statistics that have accompanied rapid urban development, and in everyday encounters with dangerous, faulty, and toxic products, including “life-­saving” pharmaceuticals and rampant incidents of medical negligence (Wright 2004; Human Rights Watch 2008; Suttmeier 2008). In response to a pervasive sense of structural overexposure, protests, riots, and other so-­called mass group incidents (群体性事件— Qunti xıng shıjian) have proliferated. It is a sign of the intense politicization of 180 Chapter Seven

health care in contemporary China that these mass group incidents extend beyond the more familiar form of labor disputes and wildcat strikes to include popular protests against hospitals (and violent attacks against medical staff) after alleged cases of medical malpractice and mistreatment.9 Until the late 1970s, the PRC relied on a model of collectivized insurance to deal with the social and economic costs of accidents (medical, industrial, or life risks). The reforms that were undertaken by Deng Xiaoping and his successors have restratified and reprivatized risk, with only a very small percentage of the urban population able to hold on to the welfare guarantees of the old danwei system. In short, China has progressively abandoned the administrative model of risk insurance, without, until recently, providing any viable alternative other than the recourse to civil litigation. In what follows, we will examine the PRC’s recent policy efforts to mitigate the political risks of mass group dissent and examine its implications for the evolving structures of the clinical research enterprise.

Regulating Risk in the Harmonious Society: The Eleventh Five-­Year Plan

In October 2006, the Hu Jintao–Wen Jiabao administration declared its intention to pursue a new social policy agenda, that of the Harmonious Society. Among the “disharmonious” elements allegedly afflicting contemporary Chinese society, the Chinese Communist Party’s Central Committee listed serious socioeconomic imbalances between urban and rural areas; the intensification of environmental and population problems; the failure of national welfare provisions, including unemployment benefits, education, health care, housing, occupational health and safety, and public order; the slowness of democratic and legal reform; and the corruption of public officials. This was the first time during the reform era that official discourse had placed “social harmony” above “economic development” in planning for China’s future. The change in tone was more than rhetorical: the new discourse represented an admission that the growing inequalities in China’s social fabric were beginning to pose a political threat that could undermine its vertiginous economic growth. The eleventh Five-­Year Plan explicitly recognizes that the social asperities of China’s reform process need to be mitigated by selective government intervention, if the plan is to have any hope of succeeding. What is envisaged here, however, is something other than the full social insurance offered by the Maoist state. Instead, the doctrine of the Speculative Economies, Contingent Bodies 181

Harmonious Society proposes something like a Third Way politics with “Chinese characteristics,” midway between Mao’s philosophy of class struggle and Deng Xiaoping’s emphasis on purely economic growth (L. Zhang 2010: 215). Efforts to improve risk management lie at the heart of the Harmonious Society program (Greenhalgh 2009). Speaking at a conference organized by the International Risk Governance Council in September 2005, Li Yizhong, the minister for the State Administration of Work Safety, noted that China’s economic reforms had exposed it, perhaps inevitably, to a “growing number of risks and challenges in areas ranging from nature, economy and politics, to human health, safety and environment” (2005). “Risk identification and control” had therefore become “one of the issues to which the Chinese government attaches great importance amid efforts to build a harmonious society.”10 Pivotal to the political vision of the Harmonious Society has been the experimental introduction of basic medical insurance schemes in cities throughout China. These schemes, which are designed to provide a nominal level of insurance to those not covered by existing insurance programs, were expected to cover 90 percent of the population by 2011 (Duckett 2010). Alongside these targeted reforms of the health insurance system, the central government has also intervened to consolidate and reinforce the partial provisions contained in already-­existing tort and contract law. In 2008, the PRC replaced existing labor regulations established in 1995 (widely thought to favor the employer) with a new national labor contract law specifying uniform, national requirements for contractual relations between employers and employees (Wang et al. 2010). According to the text of the law, the new labor contractualism is designed to promote “harmonious” relationships between employers and workers and to protect the “lawful rights and interests of workers” by limiting the continuous use of short-­term contracts and granting greater powers of enforcement to China’s government-­sponsored trade unions (Order of the President of the People’s Republic of China 2008). In fact, it does little more than enforce the transparent use of classical contract law by granting workers a private right to legal action in local courts or employment arbitration bureaus. At the same time, it strongly discourages the strikes, protests, marches, and other forms of unregulated mass public protest that have plagued China’s leadership over the past few decades. More recently, the PRC has enacted a comprehensive new tort law that codifies and extends existing statutes relating to tort in specific sectors of the economy, including health and medicine (Neumann and Ding 2010; Ding 2012). The aim of these reforms is not so much to return to the collective state-­ 182 Chapter Seven

based administration of risks characteristic of the Communist era as to formalize the legal status of a new kind of subjectivity—that of the individual risk-­bearer and contractor in personal services. Thus, even while promising health care coverage for all, the new health insurance schemes piloted by the government do not guarantee anything more than a minimum level of health care coverage (Duckett 2010). What the government has ratified, instead, is a raft of new legislation designed to consolidate the right of the individual contractor to litigate medical negligence or labor disputes under private tort and contract law and the right of the underinsured patient to enter into a clinical trial “protected” by the informed consent provisions outlined by the new tort law. In its efforts to mitigate the harsh exposures of contemporary life in China, the Hu-­Wen administration has opted for the juridification of risks. This is a solution that provides legal channels for risk compensation, while placing the onus of pursuing such options squarely on the shoulders of the individual. It is possible that the long-­term effect of these reforms will be to criminalize the kind of mass group incident that has afflicted both the workplace and the hospital over recent years. After all, if the government claims to have nullified the urgency of protest through its provision of extensive legal reform, does not protest signify a rejection of social harmony itself? As Li Zhang has noted, “Privileging harmony can potentially foreclose the field of contestation, thus delegitimizing and stigmatizing the social struggles of laid-­off workers, migrants, peasants,” and, we would add, underinsured hospital patients or experimental subjects (2010: 214). By conferring on the individual Chinese citizen the right to bear, contractualize, and contest risk, the “harmonious society” potentially redefines all collective contestation of risk as a “disharmonious” threat to social order.

Indian Clinical Trials: From Generics to Contract Research Services

Unlike China, India has a long-­established domestic pharmaceutical industry and is now striving to revive the infrastructures of this industry in the service of a new commercial environment. In independent India, notes Rohit Chopra, “science was authorized as a ‘reason of state.’ It would not be an exaggeration to say that science was invested with a quasi-­religious sanctity” (2008: 14). Under the rule of Jawaharlal Nehru, India’s scientific “reason of state” rested on the ideals of centralized planning, state-­financed education, and national protectionism, the latter to be achieved through a politics of import substitution and strict tariff controls (Prakash 1999: 187–200). The Speculative Economies, Contingent Bodies 183

generic pharmaceutical sector remains one of the most successful of the industries fostered by the Congress Party in the wake of independence. Immediately after its accession to power, the government established a network of state-­owned pharmaceutical manufacturing companies (among them Hindustan Antibiotics Ltd. and Indian Drugs and Pharmaceuticals Ltd.) that in turn produced a host of private, often highly successful spin-­off companies (Dr. Reddy’s is one of the most famous). It also set up a number of national research institutes specializing in the pharmaceutical sciences (Reddy 2007: 58). Designated as an industry of critical importance to the nation’s health, the pharmaceutical sector was singled out for state protection under two special regulations—the Drug Price Control Order of 1970, which limited the profits of pharmaceutical companies and set prices on more than half of marketed drugs, as well as the Patent Act of 1972, which disallowed product patents for drugs and placed a seven-­year time limit on process patents (Chaudhuri 2005). These regulations would define the shape of the Indian pharmaceutical company for the following decades, giving rise to a domestic market based on the mass manufacture of apis (the active pharmaceutical ingredients used in bulk drugs) and the mass reproduction of generic versions of patented drugs through the use of alternative processes such as reverse-­engineering. Following the passage of India’s restrictive legislation, multinationals exited the market en masse, leaving Indian companies to dominate a domestic market entirely focused on generics and bulk pharmaceuticals and uninterested in the development of new drugs. Yet since the turn to a politics of economic liberalization in the early 1990s, India’s pharmaceutical industry has been obliged to restructure around a very different vision of entrepreneurial futurism. In the wake of liberalization, the quasi-­religious qualities attributed to science have not diminished, least of all for the newly ascendant Hindu Right (Chopra 2008). However, economic liberalization has profoundly altered the Indian scientific enterprise. The cultural nationalism of the Hindu Right now coexists in a tense but working relationship with a new economic strategy premised on the dismantling of national trade barriers, the mass migration of professional knowledge workers, and an international trade in formerly protected services such as health and telecommunications. The turn toward economic liberalization has favored a newly privatized model of science, affecting even those institutions that were created at the height of the protectionist era. With World Bank assistance, the director general of the Council of Scientific and Industrial Research has been at the forefront of efforts to reorganize public sector science around the American univer184 Chapter Seven

sity model of intellectual property rights and commercial returns (Lofgren and Benner 2011: 168). The Ministry of Commerce and Industry has identified biopharma as one of the indigenous industries most likely to succeed under the new conditions of global competitiveness imposed by membership of the wto, while in 2007 the Department of Biotechnology (established within the Ministry for Science and Technology as early as 1986) published a National Biotechnology Development Strategy closely modeled on the bioeconomy policies of the oecd and eu (Lofgren and Benner 2011: 165, 169; Department of Biotechnology 2007). In an attempt to emulate the trajectory of software development in the 1990s, whose success was due in no small part to public funding of technology parks and communications infrastructure, the Indian government is now investing heavily in the creation of special economic zones for life science research and development (Vaidyanathan 2008). As a member of the wto, India has been obliged to lift import restrictions and lower tariffs on trade in pharmaceutical products. Since 2005, it has also been subject to the wto’s specific rules on patent protection, under the trips Agreement (Reddy 2007). The effect on the pharmaceutical industry has been profound. Indian companies are no longer able to “reverse-­ engineer” patented drugs and now have to wait for the expiry of patents in overseas markets before they can mass-­produce generic copies. As expected, India’s accession to wto regulations has lured multinational companies back into India’s domestic market. But it has also changed the focus of both the Indian pharmaceutical industries and the profile of their domestic consumer market. India remains dedicated to the generics market, but perhaps ironically its sights are now set on vastly increasing exports of generics to Western consumer markets, where a host of major blockbuster drugs are poised to lose their patent protection. In the meantime, the domestic market for patented drugs is expected to rise significantly. Once vaccines and anti-­infective drugs dominated the market, but now medicines for chronic diseases represent one-­quarter of sales—and a potentially lucrative, middle-­ class consumer market for both domestic and multinational pharmaceutical companies. As a result, several of the more successful Indian pharmaceutical companies (Ranbaxy, Dr. Reddy’s, Glenmark, and Piramal Healthcare) are now investing in the development of new drug candidates, with the aim of putting their own patented drugs into clinical trials, while others have forged licensing alliances with multinationals for the development of early-­ stage compounds (Reddy 2007: 66–67). In rhetoric, at least, the focus of the Indian pharmaceutical industry has expanded from the mass production of Speculative Economies, Contingent Bodies 185

generics toward new strategies of accumulation based on drug development and patent protection, although so far the material outcomes of such strategies remains extremely limited (Sariola et al. 2012). In the meantime, the wto-­administered gats agreement has been instrumental in transforming India into a prime destination for multinational clinical trials. The gats agreement prohibits all but the most exceptional limits on trade in services, including so-­called health services such as medical tourism and clinical trials, within its expanded list of legitimately tradable commodities (Saxena 2011). The government has been tireless in its efforts to promote India as a clinical trial destination. Its most significant intervention to date has been to overturn time restrictions on the implementation of clinical trials in India. The regulation of clinical trials in India falls under Schedule Y of the Drugs and Cosmetics Rules, which are enforced by the Drugs Controller General. Until 2005, this regulation required a phase lag for clinical trials conducted on foreign drugs: a Phase 2 trial on a foreign drug could be carried out in India only after a Phase 3 trial had been completed overseas. In January 2005, the Drugs and Cosmetics Rules were amended to allow concurrent multinational trials: a Phase 2 trial being conducted in the United States could now be simultaneously carried out in India (Srinivisan and Nikarge 2009: 6). Investigational new drugs that have been developed in India need to undergo Phase 1 first-­in-­human studies. The Drugs and Cosmetics Act does not currently allow Phase 1 trials of foreign-­ developed drugs unless the drug is of local relevance (exceptions are therefore routinely made for hiv/aids and oncology drugs). However, permission to repeat Phase 1 trials already under way overseas can be granted, and by sustaining a certain ambiguity around the extent of such tests, the law allows pharmaceutical companies to conduct Phase 1 first-­in-­human studies by default (Prasad 2009: 10). Most of the large multinational cros, such as Quintiles, Parexel, pra International, and icon, have now established a presence in India, while a host of local cros provide Phase 1 bioequivalence studies to domestic generics’ producers (Drabu et al. 2010; Chin and Bairu 2011: 143; Sariola et al. 2012). The government’s strategy of promoting multinational clinical trials must be understood in the context of declining levels of funding for health care in the wake of liberalization (Qadeer et al. 2001; Baru 2005). Public hospitals are severely underfunded, and many now seek to cover persistent budget shortfalls by offering medical tourism services or bidding for contracts to conduct multinational clinical trials. The rapid informalization of the workforce since the 1980s means that already limited levels of health insurance 186 Chapter Seven

have plummeted. With little over 10 percent of the population covered by any form of health insurance at all, many patients are unable to afford health care even in public hospitals, where they are required to pay for certain procedures, tests, and drugs. By allowing the hospital to bid for multinational clinical trial contracts, the gats-­mandated liberalization of trade in health services has opened up an alternative revenue stream for the resource-­ starved public health sector. Uninsured public hospital patients who undertake clinical trials are spared lengthy waiting times and are provided with treatment that may otherwise have been unaffordable (Interviews 2012a, 2012b, 2012c). Most Phase 2 and 3 multinational trials are carried out in public teaching hospitals and target therapeutic areas for which Indian patients have little history of treatment (drugs targeting diabetes and cardiovascular conditions are heavily represented in Phase 2 and predominate in Phase 3 trials) (Frost & Sullivan 2012: 28). However, some of the new private hospital conglomerates such as Apollo and Fortis (which cater to the domestic and international middle-­class market) are also seeking to attract a portion of the clinical trial market, especially for complex trials of cancer drugs or new stem cell therapies (where the patient has a high personal investment in the promissory nature of the treatment) (Patra and Sleeboom-­Faulkner 2009; Shukla 2010). While some Phase 1 trials are conducted in hospitals, India differs from China in having a large network of private Phase 1 clinics located outside the hospital system (Interviews 2012b, 2012c). Many of these clinics conduct relatively simple bioequivalence studies on generic drugs produced by local manufacturers. However, some of them are dedicated to more complex trials such as Phase 1 first-­in-­human oncology trials, which involve significant risk to the patient. India is fast becoming a favored destination for cancer trials, accounting for almost 20 percent of overall cro revenues in 2012 and the greatest source of Phase 1 revenues, because of the large numbers of patients at varying stages of illness who have not received any prior treatment (Frost & Sullivan 2012: 19, 28). In an illuminating study of the rise of the clinical trial market in Bombay, anthropologist Kaushik Sunder Rajan has explored the conditions under which the labor of drug testing has come to replace the mass textile industries that once flourished in the same location (2008). Sunder Rajan’s analysis is exemplary not only because it points to risk exposure as the defining element of clinical labor—the clinical trial recruit occupies “a subject position that is based neither in ‘working on oneself in a continuous fashion,’ nor is ‘efficient and adaptable,’ but is rather merely risked” (2008: 160–161)— Speculative Economies, Contingent Bodies 187

but also because it locates the rise of a clinical trial market as the symptom and outcome of a process of industrial transition, one that has moved from the mass industrial labor of the textile mills to the speculative land investments that made such labor unprofitable, to an emergent form of corporeal labor in which bodily risk itself becomes the object of speculation. It is at the intersection of these economies—industrial, speculative, and clinical—that a new labor market in pharmaceutical services has arisen, recruiting former mill workers and other marginal workers into drug studies that fuel a burgeoning market in clinical data for domestic and multinational pharmaceutical companies.

Labor Reform, Risk Economies, and the Rise of Clinical Labor: The Case of Ahmedabad

The case of Ahmedabad is exemplary of the process of labor transition outlined by Sunder Rajan. A former center for textile production situated in the western state of Gujarat, Ahmedabad has been at the forefront of industrial restructuring throughout the twentieth century and was one of the first cities to undertake labor reforms during the 1980s. Ahmedabad has been described as the “shock city” of twentieth-­century India. Following Indian independence in 1947, it became a model of Nehruvian modernization, excelling in textile production and initiating some of the first multinational ventures in chemical and pharmaceutical production. Ahmedabad was also home to the Textile Labor Association, a union inspired by Gandhi that eschewed strikes in favor of negotiation and arbitration and also provided its members with an extensive social welfare network, including insurance, a bank, and educational services. By the 1960s, Ahmedabad was the most industrialized city in India—one-­third of the city’s male population worked in the textile mills, most of them members of the Ahmedabad Textile Labor Association (Spodek 2011: 6). Ahmedabad, however, was also one of the first cities in India to experience deindustrialization. It was in the mid-­1980s, well before the official liberalization policies adopted by Rajiv Gandhi in 1991, that the state of Gujarat adopted a new economic regime promoting the informalization of labor (Breman 2004: 144, 235). Although mill closures would soon occur across India, sharply accelerating after the failure of the Bombay mill strike in 1982, it was in Ahmedabad that the evisceration of the textile mills had their most far-­reaching social and economic impact. By the end of the 1990s, a total of 125,000 formal sector jobs had been lost, along with an incalculable number of contract positions associated with tex188 Chapter Seven

tile production. Since 2001, the controversial chief minister of Gujarat, Narendra Modi, has overseen an unholy alliance between Hindu Nationalism and economic liberalism that has only intensified the ongoing restructuring of the local labor market. In one respect, the “deindustrialization” of India must be understood as a euphemistic term for the informalization of industrial labor. Many of the specific tasks that were formerly carried out in the large composite mills have not been eliminated; rather, they have been outsourced to small-­scale workshops where they are no longer subject to workplace regulation or labor laws (Breman 2004: 144, 235). In the meantime, other kinds of informal, industrial labor have flourished after the demise of the composite mills— these include contract work in the petrochemical, plastics, pharmaceutical, cement, and denim industries, as well as casual work in diamond-­cutting and -­polishing workshops. In another respect, however, the closure of the textile mills in Ahmedabad, as elsewhere, has reflected a general shift in the locus of the economy from industrial production to the tertiary sector, comprising both formal (often professional and scientific) labor and informal, highly contingent service labor. As textile production underwent restructuring, Ahmedabad became host to a burgeoning new “clinical services” sector comprising several dozen Contract Research Organizations and employing both formal professional workers (clinical trial monitors, biostatisticians, data managers, nurses) and an informal workforce of human subjects. The closure of the textile mills has resulted in a process of rapid deproletarianization for all but the most skilled clerical workers. Not all mill workers were employed on a full-­time, contractual basis; and not all textile work was equally qualified. But those workers who had been employed on full-­time contracts (almost exclusively men) had enjoyed “permanent, skilled work, relatively high wages, the comfort of leisure, insurance against illness and other risks, the capacity to accumulate financial reserves, access to cheap loans, and lastly, the possibility to defend their interests through collective action and the political awareness that comes with it” (Breman 2004: 218). With few exceptions, laid-­off workers have since moved into the urban, informal economy of casual service labor, contract industrial work, or outsourced piecework at massively reduced wages. Most earn less than half what they earned in the composite mills, and far less than the minimum wage for unskilled labor established by the government of Gujarat (Breman 2004: 184). Former mill workers have become rickshaw drivers, street vendors, repairmen, security guards—and clinical trial recruits in the burgeoning local clinical research economy. Speculative Economies, Contingent Bodies 189

The abrupt interruption of workers’ rights to health and accident insurance has been instrumental in pushing them toward the clinical labor market as both consumers and producers of experimental drugs. Before the mass redundancies of the 1980s, both state and private sector mill workers had been automatic members of the Employees State Insurance Scheme (esis), which covered the costs of compensation in the event of a worker’s illness, accident, or disability (Breman 2004: 208). Created by the postindependence government in 1948, the esis oversaw a system of district hospitals offering medical care to employees and their families before and after retirement, in exchange for a relatively small contribution from their wages. All this changed abruptly with the mass mill closures. Since the mill workers had not retired but had been made redundant, they were no longer covered by insurance. Refused access to the esis hospitals, former mill workers were now obliged to go to the Ahmedabad Civil Hospital, where they would be examined free of charge but needed to pay for drugs that, on their drastically lower wages, had now become unaffordable. The informalization of the Indian labor force has led to diminishing opportunities for savings and investment, turning health risk into one of the principal liabilities facing the urban poor. The regular incomes and secure employment of male textile workers once assured them access to the low-­ interest loans of union-­run cooperative banks; informalization consigns them to highly unfavorable terms of credit (Breman 2004: 215). Creditworthiness, then, has declined along with the predictability of employment. In less than a generation, these formerly unionized workers have moved from a regime of prudential savings to one of speculative everyday investment, in which high risks must be taken in order to meet the most mundane contingencies of daily life. Health care expenditures are among the most frequent and crippling sources of personal indebtedness (Gumber and Kulkarni 2000). It is little wonder that clinical research has flourished under these conditions. Promising to turn the liability of health risk into an asset and source of income, contract clinical trial work represents one way of putting risk exposure to work—and one way of making bodily contingency pro­ ductive. The state government of Gujarat has played a critical role in enabling Ahmedabad’s postindustrial transition. Under the leadership of Narendra Modi of the Hindu Nationalist Bharatiya Janata Party, the state government hosts an annual “Vibrant Gujarat” investment summit and has accumulated a growing number of international contracts with largely uncritical foreign partners.11 Unlike other Indian cities such as Bangalore, Ahmedabad has not 190 Chapter Seven

focused on developing business process outsourcing and back-­office call centers. Instead, the state government has capitalized on already-­existing skills in pharmaceutical and chemical production to steer these sectors toward the newly liberalized trade in clinical services. In 2004, the Department of Science and Technology of the government of Gujarat created the Gujarat State Biotechnology Mission with the aim of promoting industries across the entire pharmaceutical value chain in the region. Ahmedabad had already established a cluster of small to medium pharmaceutical manufacturing firms in the 1970s and 1980s, which serviced a wave of generics exports to countries in the Soviet Union and Africa (Spodek 2011: 127, 231– 232). These firms have now been joined by a host of local and multinational contract research organizations, as well as a large multinational clinical trial supplies plant, ThermoFisher Scientific Inc., the first of its kind in the region (Bharadwaj Chand 2008; Nair 2009; Dave 2010). Identified as key economic actors by the State Biotechnology Mission, many of these firms are protected by Special Economic Zone status, which grants them generous tax benefits, including five-­year exemptions on export income. The State Biotechnology Mission has undertaken several other initiatives to promote the growth of clinical research in the region, from the provision of seed funding to new companies to the establishment of biotech parks in Ahmedabad and other urban centers. Most importantly, perhaps, it contributed to the creation of the Shivrath Center of Excellence in Clinical Research, a public-­private venture now affiliated with Gujarat University, which aims to redress the shortfall in qualified clinical research staff for the local cro industry. Ahmedabad is now considered the focal point for contract clinical research in India, followed closely by Mumbai, Bangalore, Hyderabad, Chennai, and New Delhi (Dave 2010; Frost & Sullivan 2012: 64). As of 2010, Ahmedabad counted more than a dozen cros, many of which boast their own on-­site Phase 1 trial clinics.12 In general, Phase 1 studies are conducted outside the hospital sector in dedicated private clinics.13 Many of the cros based in Ahmedabad have had prior experience in bioequivalence studies for generic drugs and are now undertaking all types of Phase 1 trials on behalf of both domestic and multinational pharmaceutical companies. First-­in-­human studies are less common than in China, where almost all of the major multinational pharmaceutical companies are engaged in on-­site drug development. But at least a few Indian Phase 1 centers specialize in higher-­risk first-­in-­human studies for oncology and hiv/aids drugs. Unlike hospital sites, Phase 1 units do not recruit directly but use brokers (often former research subjects paid by the cro) to locate and transport trial subSpeculative Economies, Contingent Bodies 191

jects from the poorer areas and ghettos of the city (Jenkins 2010; Parmar 2012). Unlike both China and the United States, the Ahmedabad Phase 1 sector recruits a large number of female subjects, and several local Phase 1 units have wards reserved for women—a sign not only of the kinds of trials the sector is performing (there is a high preponderance of trials for breast cancer and drugs targeting postmenopausal women) but also of the specific labor histories of the region (women have long engaged in both industrial and service labor in the informal sector) (Outsourcing Pharma 2010; SIRO Clinpharm 2012). Research subjects currently earn between 7,000 and 10,000 Indian rupees for a study, with 105 Indian rupees paid up front for an initial assessment test (to give some sense of the relative value of this, the national minimum wage has been legislated as 115 rupees per day since April 2011, although many informal sector workers in fact earn much less than this (Jenkins 2010; Parmar 2012). Phase 2 and 3 trials take place in the large urban teaching hospitals, where physicians may see several hundred patients per week. The Indian hospital clinical trial sector has evolved in much the same way as its Chinese counterparts—in part in response to the demand of multinational trial sponsors who are looking for a more centralized, higher-­volume method of recruitment than that which they find in the United States, and in part as a result of funding cuts in the Indian hospital sector, which has impoverished public hospitals and compelled them to seek alternative sources of income in medical tourism or clinical trials (Interview 2008b). As in China, the multinational contract clinical trial has become an integral part of the Indian hospital infrastructure and a primary source of health care for growing numbers of patients. The fact that a large segment of the local population has been divested of its former employment-­related rights to free medical care and insurance means that the patient demand for clinical trials is immense. Economic liberalization, then, has not only abolished the risk protections implicit in the formal contract of labor; it has also introduced a fundamentally new form of labor—one premised on the exposure to uninsured and (perhaps in the long run) uninsurable risks. The profile of clinical trial recruit is strongly inflected by the class, caste, gender, and ethnic/religious stratification of the local population as it has evolved in the wake of economic liberalization and the rise of a violent Hindu nationalist politics. Not only do former textile mill workers frequently undertake clinical trial work as a form of occasional contract labor or work-­ for-­health care; contract workers in other sectors also routinely turn to clinical trial work as a stop-­gap measure in tough economic times. For example, 192 Chapter Seven

workers in the newly flourishing diamond-­polishing sector (an import from nearby Surat) turned en masse to Phase 1 clinical trials when employment became scarce after the 2008 financial crisis (Rahman 2009). Ahmedabad’s Phase 1 clinical trial sector also recruits an unusually high proportion of women—a sign, no doubt, of the prominent role of women in the informal sector. The economic reforms of the 1980s not only compelled many unionized male workers to move into the informal sector but also scrambled (and to a certain extent redressed) the gendered division of labor established by the Gandhian textile unions. Like its counterparts in western Europe, the Gandhian Textile Labor Association made the family wage one of its primary demands, with the result that the rationalization of textile production during the 1930s and 1940s forced most women workers back into the home and the informal economy, with little or no commotion on the part of the union (Breman 2004: 212–213). Following economic liberalization, however, women have returned to their positions as prime economic actors in what is essentially an economy of informal labor. As Phase 1 trial work proliferates at the margins of the formal economy, it is not surprising that women are represented there in high numbers. Again, it needs to be specified that the resegregation of urban space in Ahmedabad following the closure of the textile mills and the ascendance of Hindu Nationalism in Gujarat has been decisive in determining which populations are compelled to engage in contract clinical trial work. The pogroms instigated by Hindu nationalists in 1992 and 2002 pushed the Muslim population of Ahmedabad into Juhapura, a ghetto on the outskirts of the city where there are very few opportunities for employment. Muslim women living in Juhapura, many of them widowed by the riots, have subsequently turned to Phase 1 clinical trials as one of their few remaining sources of income (Kaur 2008). To varying degrees, then, labor informalization, the loss of health insurance, and the communal segregation of urban space have turned health risk into one of the principal liabilities (and potential assets) of the urban poor.

Restructuring the Clinical Trial: Alongside and Beyond Globalized Trials?

In this and the previous chapter, we have explored the recent, symbiotic evolution of the clinical trial industry in the United States and the emerging offshore locations of India and China. The globalization of clinical trials, we suggested, was one solution adopted by the pharmaceutical industry to what it perceived as a crisis in patient recruitment. More recently, however, Speculative Economies, Contingent Bodies 193

the pharmaceutical industry has begun to look for new, internal solutions to what it perceives to be a crisis in drug innovation—a crisis manifested by slow drug r�d pipelines, rapidly expiring patents, diminishing returns on r�d investment, and increasing pressures to moderate prices. One must be wary of the pharmaceutical industry’s perpetual evocation of crisis—­ deployed, more often than not, as a pretext for the inflated drug prices it imposes in the United States. Yet it is clear that after a rapid spike in new drug innovations in the post–World War II era, the pharmaceutical industry has experienced ever-­declining rates of new drug development. Most new drugs are “me-­too” drugs, slight variations on already-­existing chemical formulations, or new authorizations to market a drug for an alternative condition. The pharmaceutical industry has advanced various more or less plausible explanations for the decline in genuine drug innovation. In the following chapter, we will focus on those clinicians and industry representatives who have identified the standard clinical trial process itself as an impediment to true experimentation—and hence innovation. With increasing insistence, these critics have argued that the current gold standard of clinical testing—the rct—does not allow for true innovation (that is, experimental surprise) but merely permits one to test an already-­existing chemical compound. They have also suggested that the current division of labor between lab-­based pharmacology and the clinic has led to the neglect of “translational medicine”—that is, the passage from in vitro innovation to clinically viable innovation. In short, the current protocols of clinical testing do not allow for enough genuine experiment in the clinic. This is a potentially explosive conclusion, but one that has received a considerable degree of support from the fda, the nih, and the ema. National research councils in both the United States and the eu have increasingly turned their attention and funding to the area of “translational medicine,” hoping to promote closer and more productive interaction between the lab and the clinic, while the fda has voiced its support for new, more experimental trial methods (the Phase 0 trial, flexible trial designs) that permit riskier, more invasive research or allow for trial designs to be modified as they evolve. In the meantime, the pharmaceutical industry has been exploring the possibilities of social media as a means of tracking the semi-­regulated, off-­label consumption of drugs among patients. What is at stake here is an outsourcing of the drug development process from the institutional clinic to the “distributed clinic” of the drug-­consuming public. It is this novel form of outsourcing that we will explore in the following chapter. 194 Chapter Seven

Eight

The Labor of Distributed Experiment User-­Generated Drug Innovation

What is experiment? The science historian Hans-­Jörg Rheinberger (1997a, 1997b) argues that much of what we take to be scientific experiment in fact constitutes a test. Karl Popper offers the classic formulation of the experiment as test when he asserts that the “theoretician puts certain definite questions to the experimenter, and the latter, by his experiments, tries to elicit a decisive answer to these questions, and to no others. All other questions he tries to exclude” (2004: 89). For Rheinberger, on the contrary, the proof of a true experiment lies in its ability to generate entirely new questions from the conjuncture, recombination, or hybridization of old ones. In his own words, “experimental systems must be capable of ‘differential reproduction’ in order to behave as devices for producing scientific novelties that are beyond our present knowledge, that is, as ‘generators of surprise’” (Rheinberger 1997b: 3). Taking up the argument that “experimentation has a life of its own” (Hacking 1983: 150), Rheinberger develops a “speculative materialist” perspective on scientific invention. His epistemology is both rigorously focused

on the materialities of practice and unusually attentive to the production of nonreductive “events” from within the very fabric of practice. Far from imposing merely material limits on the creative spirit in science, insists Rheinberger, the complex infrastructure of the experiment is what enables new connections to arise in the production of scientific knowledge. The real, in this sense, is not that which grounds all truth but, rather, that which has the capacity to interrupt or confound our expectations of what “matter can do.” In Rheinberger’s words, “We should recognize that, properly analysed, the details and particulars of practice, far from imposing limits on our knowledge, are prerequisites for, and provide the very means of, achieving scientific knowledge. In particular, it is in the fabric of properly ‘tuned’ experimental systems that scientific events materialize. . . . Novelties are always the result of spatiotemporal singularities. Experimental systems are precisely the arrangements that allow scientists to create epistemic spatiotemporal singularities. They allow researchers to arrive at unprecedented, surprising results. In this sense, such systems are ‘more real,’ if you will, than ordinary reality” (1997a: s245–s246). It is this ability to generate material surprise which, for Rheinberger, ultimately distinguishes the experiment from all other models of verification, including the test. Where the testing device aims to reproduce and measure degrees of uncertainty, only the true experiment is capable of generating uncertainties of its own. Rheinberger’s philosophy of the experiment is corroborated by theorists associated with the Harvard Business School, who place experimental surprise at the heart of contemporary business strategies, albeit with the much more limited aim of generating new markets and greater margins of profitability (Pine and Gilmore 1999; Thomke 2003). For these theorists, the modus operandi of post-­Fordist innovation is experimental in the sense that it aims to elicit and capture the unexpected event rather than accumulate elapsed time in the congealed form of commodities. What distinguishes this economy of innovation is not only its orientation toward the unexpected but also its indifference to traditional boundaries between production and consumption, consumer public and labor market. Value is no longer to be generated through the mass reproduction of standardized form; rather, it emerges from the constant solicitation of new and unexpected configurations of experience. In the words of these theorists: “The new information provided by a trial-­and-­error experiment to an experimenter are those aspects of the outcome that he or she did not (was not able to) know or foresee or predict in advance—the error” (Thomke et al. 1998: 316). If we turn our attention from these theoretical reflections on the nature 196 Chapter Eight

of scientific invention to the actual practice of clinical pharmacology, what is immediately striking is how little Rheinberger’s paradigm of experiment has applied here. Until very recently, the gold standard for experimental design in medical research has been the double-­blind rct, a method that corresponds much more closely to the test than to the experiment as defined by Rheinberger. Developed in the mid-­twentieth century, the rct seeks to answer a scientific question (framed as a hypothesis) through the progressive measurement of uncertainties. Like many of the risk-­management strategies of the mid-­twentieth century, the rct works on the assumption that “risk” can be standardized: its aim is to assign a probability distribution to uncertainty, to confirm or nullify a hypothesis, not to generate new uncertainties of its own.1 Recently, however, the established conventions of the clinical trial have come under increasing scrutiny as the pharmaceutical sector indicts what it sees as the rising costs and diminishing returns of drug development. This chapter will look at the ways in which pharmaceutical companies and regulators have attempted to reform the clinical trial, arguing that these developments represent a far-­reaching shift in the dynamics of human subject experimentation. In the first part of the chapter, we will investigate recent efforts (associated with the discourse of “translational medicine”) to rethink the interface between experimental lab-­based science and the clinic. We will also look at closely associated efforts to reintroduce an element of experimental surprise into the clinical trial process itself, through the adoption of novel trial designs (including Phase 0 trials and flexible trial techniques). Both of these reforms strive to break down the barriers between lab-­based science and clinical care, making the clinic itself more open to unpredictable risk—and experimental surprise. In the second part of the chapter, we will move from the experimental clinic to what we call the distributed experiment. Here we will focus on efforts to outsource pharmacological innovation to a distributed public of patients through the use of social networking software. These platforms allow drug developers to escape the limits of the conventional clinical trial by tracking the experimental practices taking place in the distributed clinic of unregulated drug consumption. Within the business literature, this model of product development is known as “user-­ generated innovation” (von Hippel 2005). It refers most frequently to the business model of social networking sites such as Facebook, Myspace, and Wikipedia, which generate value through the unpaid technical contribution, freely shared data, and personal details of their users. Increasingly, however, the pharmaceutical sector is also experimenting with models of “user-­ The Labor of Distributed Experiment 197

generated innovation” through the development of patient-­based social networking sites such as PatientsLikeMe. While theorists in the autonomist tradition of Marxism have amply documented the role of distributed, immaterial labor in constituting “user-­generated” value for the digital, creative, and media economies (Lazzarato 2002; Terranova 2004), this chapter investigates the less familiar process of user-­generated drug innovation, exploring the ways in which patients are enlisted—in corpore—into the coproduction of pharmacological value. Delving into the prehistory of user-­generated innovation, we contend that the model of patient participation in the innovation process finds its precedent in the aids activism of the late 1980s, when activist-­patients involved with act up demanded access to highly experimental, potentially high-­risk new antiretroviral drugs (S. Epstein 1996). Well versed in the scientific research on aids and often working in close political and clinical alliance with medical practitioners, these activists forced the boundaries between patient, experimental subject, and researcher. The aids activism model resonates with other minoritarian movements (feminist and antiracist) that have called for the expansion of clinical research protocols beyond the “standard” (white, adult, male) experimental subject (S. Epstein 2003). Quite independently of the pharmaceutical companies, these groups have campaigned against the regulation and standardization of the clinical trial process, often appealing to their democratic “right” to participate, as nonstandard subjects, in highly experimental research and nonstandard care. Paraphrasing Isabelle Stengers and Didier Gilles, we might say that the new health-­based movements have articulated a right to “take risks” (Stengers and Gilles 1997). Today, however, the ambivalence of this process of inclusion is becoming increasingly apparent. The “democratization” of clinical research has also functioned as a means of expanding into new drug consumer markets (for example, the marketing of mood disorder drugs to children; niche markets for the elderly or drugs aimed at particular ethnicities) and new markets for clinical labor. In an era marked by declining rates of drug discovery, pharmaceutical companies have responded to the challenge of patient activists by incorporating them into the innovation process itself, in the form of distributed networks of self-­experimental labor. What was once a clandestine practice of self-­experimental pharmacology is now being promoted as a novel method of commercial drug production, one that in the long run may profoundly reshape the contours of pharmaceutical drug development.2 As an emerging (although still quantitatively marginal) reorganization of 198 Chapter Eight

the clinical trial process, user-­generated drug innovation can be usefully compared to other forms of distributed labor described by theorists of late post-­Fordist work—it shares much in common, for example, with the “playbour” of recreational gamers who contribute high-­value (but unremunerated) modifications to proprietary games (Küklich 2005); the “free labor” of open-­source software development and other forms of collaborative digital production (Terranova 2004); and, most pertinently, the distributed labor of those who contribute tissues and medical data to national biobanks (Waldby and Mitchell 2010). The labor of distributed experiment, however, differs from these other forms of work in the sense that it involves a visceral, metabolic assumption of the risks of innovation. The role of the clinical trial subject reminds us that the speculative promise of medical innovation must also be embodied as a labor of ingestion and metabolic self-­transformation, if its value is to be realized at all. It is here that the cognitive bias of recent autonomist theory reveals its limits. The perspective we offer on this topic conceptualizes labor as a process of material abstraction—that is, labor as the process through which the speculative event must be experienced as a moment of bodily transformation. The articulation of a “right to take risks,” moreover, is in perfect accord with wider shifts in the organization of welfare, tort, and liability law. As Pat O’Malley (2009) has remarked, the generalization of the independent contractor model of employment means that we are witnessing something of a return to late nineteenth-­century conceptions of risk, injury, and tort. We are also seeing the resurgence of the principle of volenti non fit injuria within neoliberal philosophies of law (Goodin 2006). The principle of volenti implies that self-­experimentation, even when diverted toward commercial ends, is freely assumed and a fortiori deserves no special state protections. The return of the principle of volenti, however, is complicated by the fact that the clinic, like the post-­Fordist workplace, has become so expansive as to coincide with the entire social body. It is this question that we will discuss in the concluding part of the chapter.

Translational Medicine: From the Experimental Clinic to the Distributed Experiment

For the past three decades, the pharmaceutical industry has been experiencing a decline in the absolute numbers of workable new drug discoveries and truly novel drug innovations. This slowing of productivity has been attributed to many different factors, from excessive regulation of clinical trials to The Labor of Distributed Experiment 199

insufficiently rationalized drug discovery and dwindling recruitment rates for clinical trials (Wurtman and Bettiker 1995; Pisano 2006). It remains true that the rate of new drug discovery (the discovery, that is, of new chemical compounds of proven efficacy) has slowed considerably over the last three decades, despite successive waves of hype about and investment in new, more rationalized drug discovery technologies (combinatorial chemistry, high-­throughput screening, and so-­called rational drug design) and the commercial promise of new biotechnologies. Innovation, it would seem, has remained purely speculative, failing to materialize as workable therapy when introduced into the human body. It is in response to this perception of crisis that academic institutions, regulators, and funding agencies have turned their attention to the neglected area of clinical research, figured as the moment of “translation” between bench and bedside, or between in vitro and in vivo science. In the United States, the nih launched three new thematic areas in 2003 as part of its Roadmap for Medical Research, one of which is dedicated to “reengineering the clinical research enterprise” through a renewed focus on “translational research” in the clinic. Recognizing that the research potential of clinical science has been devalued and that interactions between basic scientists and clinicians have become increasingly distant, the funding initiative seeks to elevate “translational medicine” to an institutional status on a par with that of lab-­based research. It also calls for a reprofessionalization of clinical science that would reorient at least some clinicians toward research work rather than patient service (Zerhouni 2005). In the United Kingdom, a review of UK health research funding commissioned by the Treasury in 2006 found that pharmaceutical companies were being tempted to disinvest from the United Kingdom because of the excessive regulation of clinical trials and neglect of applied research (Cooksey 2006). The report recommended, among other things, the allocation of greater research funds to “translational medicine” and the creation of a new Translational Medicine Funding Board. In 2008, the National Institute for Health Research announced funding for twelve hospital-­based clinical research units designed to open up an institutional interface between the clinic and experimental research (Adams 2008). While the field of translational medicine rapidly takes on institutional form, many have questioned the very use of the term “translation,” arguing that it obscures the specificity and unpredictability of research in the clinic. As pointed out by the editors of the newly created Journal of Translational Medicine, most people understand the translation from in vitro to in vivo as 200 Chapter Eight

“a uni-­directional effort to test in human novel therapeutic strategies developed through [lab-­based] experimentation” (Mankoff et al. 2004: 14). The very concept of translation, that is, seems to suggest a simple predictive relation between in vitro lab-­based experiment, preclinical animal models, and the results of early-­stage clinical trials in humans. On this model, the results of in vitro studies would be progressively scaled up and refined in vivo but would not undergo any substantial phase change in the process. In practice, however, critics point out that this is far from being the case. Human metabolism is notoriously unpredictable: the “translation” from laboratory to animal studies to clinic may give rise, at each step, to entirely unexpected results. Yet efforts to promote translational medicine do not in general envisage a return traffic of information from the clinic to the basic biomedical research of the laboratory. Others argue that the dearth of pharmacological innovation can be attributed to the institutionalized division of labor that relegates invention (and true experiment) to the laboratory and testing to the clinic. This division, it is true, is enshrined in bioethics conventions such as the Belmont Report, which insists that clinical treatment is fundamentally distinct from research and that all clinical innovation should be conducted within a proper research protocol (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1978). Quite apart from bioethical principles, however, the distinction is also inscribed within the very terms of the gold standard of clinical research, the rct, which is designed to respond to and measure a limited number of hypothetical uncertainties, not to generate new uncertainties of its own (Gelijns et al. 1998: 693). The traditional clinical trial can only verify or nullify a hypothesis; it precludes the identification of new or unexpected questions in the course of investigation. The problem here is that such unexpected events represent a significant source of experimental innovation in practice. It is not that clinicians do not innovate, then (there is considerable scope for off-­label use of drugs and therapeutic interventions), but that the current regulations on clinical trials exclude such innovation from the scope of legitimate experimentation. The paradoxical result, according to critics of the current status quo, is that clinical innovation proceeds in a completely unregulated fashion, without feeding into formal research protocols. Yet historically, the vast majority of new drugs have been discovered through innovation in the clinic (Gelijns et al. 1998: 693; Ghaemi and Goodwin 2007: 4). Alongside calls for a greater investment in “translational medicine,” then, a number of critics are demanding a much more radical reform of biomediThe Labor of Distributed Experiment 201

cal experiment. In their view, an effective new research paradigm should not only strive to blur the boundaries between clinical care and clinical research but should also refashion the clinical trial along much more speculative lines (Johnston and Hauser 2007: a7). Clinical science must aspire to become much more than an effective means of translation; it must also generate innovation in and of itself. In the words of prominent health policy analysts, “We need to find a way of ‘capturing the unexpected’ effects of clinical intervention” (Gelijns et al. 1998: 693). It is in the context of these multiple calls for reform that clinical scientists (often working in close affiliation with pharmaceutical companies) have begun to develop a number of novel clinical trial methodologies. Most prominent among these new methodologies are “Phase 0” and “flexible” trial designs. Deploying Bayesian statistical techniques, the “flexible” or “adaptive” trial allows investigators to check results as they accumulate during the trial and change the trial design accordingly. While the traditional trial design required the trial to run to its end before a new hypothesis could be formulated, the “unexpected” event is here incorporated into the trial in process, as a way of reformulating the trial’s original question (Scott and Baker 2007). Phase 0 trials (also known as exploratory investigational new drug or ind trials) differ from traditional Phase 1 trials in that they do not respond to a predetermined hypothesis but instead seek to generate new hypotheses by screening for as many effects as possible (Garner and Lippin 2006; LoRusso 2009). In Phase 0 trials, a small number of experimental subjects are administered microdoses of an investigative substance before undergoing intensive screening for possible results. The wager here is that the relatively intense level of screening will allow investigators to pick up potentially interesting, unexpected results that can then be taken as leads to undertake a traditional clinical trial. The intensive information gathering of the Phase 0 trial may also be useful in telling researchers when not to go ahead with a given experimental drug. Both innovations have received support from regulatory authorities such as the ema and the fda. While regulators have been rethinking the nature of medical experiment in the clinic, others have been pursuing a very different strategy—one that would move the experiment outside the walls of the institutional clinic into the distributed clinic of the consumer public. Following the example of social networking software, drug developers are beginning to look toward models of “user-­generated innovation” to track and capture new modes of drug consumption taking place outside the clinic. Unlike the previously discussed methods of reform, the concept of user-­generated innovation can 202 Chapter Eight

be said to have originated outside the pharmaceutical industry itself, in the practices of patient-­activist groups who for many years have been calling for radical changes to the drug development process. Before we undertake a more extended discussion of user-­generated innovation, then, we will first look at the legacy of aids treatment activism in formulating a minoritarian critique of biomedical research. The aids treatment movement emerged at the height of the hiv/aids epidemic, at a time when US federal regulations governing clinical research were still relatively strong. Its critique of federal drug regulations has subsequently been taken up, in sometimes perverse ways, to facilitate a new model of pharmacological innovation.

AIDS Treatment Activism: Experiment in Extremis

Although the pharmaceutical industry has been subject to various forms of oversight since the 1930s, by far the most stringent regulations were established at the height of the pharmacological boom years of the 1960s. In chapter 6, we noted that the Kefauver-­Harris Amendments of 1962 radically restructured the fda drug approval process around a three-­phase model of premarket testing, mandatory irb oversight, and standardized ethical safeguards. In the aftermath of the thalidomide debacle, it was more or less accepted that slower rates of drug development were the necessary price to pay for greater safety standards. It was no doubt to be expected that the pharmaceutical sector would contest the growing regulatory powers exercised by the fda. Many of the specific complaints that have now become standard features of the pharmaceutical critique of the fda were formulated as early as 1972, when, at the prompting of George Stigler, the Chicago School of Economics organized a conference on the effects of the new drug regulation (Landau 1973; Nik-­Khah, forthcoming [2014]).3 Both here and in follow-­up articles, it was argued that time-­consuming drug-­testing requirements would slow or deter innovation and lead to a “drug lag,” a claim that would resonate loudly throughout the conservative business press over the following decades (Peltzman 1974, 1988 [1973]). It would be misleading, however, to suggest that opposition to fda regulations and oversight emanated entirely from the pharmaceutical industry and conservative economists. Indeed, it is arguable that the most effective campaign against the established regulation of clinical trials was mounted by the coalition of aids patients and activists who organized in response to the pressing needs of people living with, and dying of, aids in the early years of the epidemic (Edgar and Rothman 1990; The Labor of Distributed Experiment 203

S. Epstein 1996, 2003). These activists railed against the state prudentialism that prohibited the terminally ill from taking experimental new drugs prior to the completion of the trial process, obliged them to participate in clinical trials in which treatments were distributed on a randomized basis, and prevented them from combining treatments as they chose. In a context where treatment options were extremely limited, federal regulations designed to ensure consumer protection had begun to seem impossibly cruel. The aids treatment movement (which included quite a few medical practitioners) found ways to circumvent these obstacles by illegally importing experimental, unapproved drugs and organizing underground trials of their own. It has been remarked that the Kefauver-­Harris era was characterized by a certain ambivalence on the part of the Left with regard to the consumption of drugs: on the one hand, the more progressive sectors of the American public demanded the stringent regulation of mass-­market drugs; on the other, this attitude coexisted with a hedonistic, even experimental ethos with regard to recreational drugs. Within the gay community, this willingness to experiment did not preclude the development of a certain counterculture of care with regard to how, when, and with whom drugs were taken (Stengers and Gilles 1997; Race 2009). Many have detected a certain continuity between the recreational drug culture of the pre-­a ids era and the activism that grew out of it. When the aids treatment movement began to campaign against the longueurs of the federal drug approval process, it brought this cultural ethic of experimental drug use to bear on the question of therapeutic consumption. The aids treatment movement was remarkably successful in its efforts to reform official drug regulations. In May 1987, the fda issued new rules permitting the sale of investigational new drugs (inds) to terminally ill patients. The reforms meant that a drug could be put on the market if early results from Phase 2 trials looked promising, as long as the trial sponsor continued to evaluate the drug’s effectiveness after it went to market.4 Accelerated drug approval, followed by postmarketing surveillance, now became possible for a restricted class of drugs for the terminally ill. The 1987 reforms were followed, in October 1988, by a further series of amendments designed to fast-­track the evaluation of drugs and other therapeutic products targeting serious and life-­threatening illness. These rules put a swift end to the arm’s-­length relationship the fda had traditionally maintained vis-­ à-­vis the drug industry, since the acceleration of the drug approval process was to be achieved through a closer collaboration between the drug manufacturers and the fda in the actual design of the clinical trial process. The 204 Chapter Eight

aids amendments of 1988 gave shape to a radically new kind of relationship between the fda and patients. The amendments mandated the creation of a data bank of publicly accessible information on controlled clinical trials and obliged the government to conduct clinical trials on whatever therapeutic drugs aids patients were currently experimenting with. What had once been a guerrilla economy of illegal, community-­based trials was now, at least partially, integrated into the official process of drug development (Edgar and Rothman 1990: 127–133). The official response to aids treatment activism marked a turning point in the history of drug regulation in the United States. But before examining the long-­term consequences of this move, we will first discuss the specific challenge posed by women and minority activists to the classic configuration of pharmaceutical protectionism.

Against Protectionism: Women, Minorities, and HIV/AIDS Activism

Perhaps the most radical challenge to fda regulations came from the women’s and minority caucuses working within the aids treatment movement, since these groups were concerned not only with the exclusion of women from clinical trials but also with the fact that most women affected by hiv/aids were poor, nonwhite, and uninsured. Their opposition to fda regulations is not surprising given the history of special protections reserved for “women of childbearing potential,” protections that were for the most part designed to protect the fetus rather than women themselves (McCarthy 1994; Baird 2011). In the early 1970s, pharmaceutical companies took the initiative in excluding women from clinical trials due to fears of future litigation by children affected by thalidomide and des (another pregnancy-­ related drug, given to women to prevent miscarriage; it was subsequently found to cause vaginal cancers in young girls). These preemptive forms of self-­regulation were later reinforced from above by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which in 1975 promulgated additional protections for pregnant women and their fetuses. In 1977, the fda followed suit by prohibiting pregnant women and “women of childbearing potential” from participating in Phase 1 research. In interpreting these measures, observes McCarthy, pharmaceutical companies routinely erred on the side of caution, so in practice very few premenopausal women were invited to take part in experimental research. He goes on to note that “little thought was given to the fact that greater potential harm and greater potential responsibility resulted from The Labor of Distributed Experiment 205

the ingestion by pregnant women and women of childbearing potential of prescribed drugs that had never been tested in these women in controlled studies” (McCarthy 1994: 697). As a result of these prohibitions, the numbers of women able to participate in hiv/aids treatment trials (even when these women were sterilized, were taking contraceptives, or did not want children) were extremely low (Christensen 2011: 61–62). The problem was compounded by the fact that women infected with hiv/aids, most of them nonwhite, had very little access to health care in the first place and were most likely to present at a physician’s office in the advanced stages of illness. At a time when aids activism was overwhelmingly focused on the problems facing middle-­class white gay men, the women’s and minority caucuses within act up challenged the movement to examine the entanglements of gender, race, and class. Not only did they fight for the inclusion of women and minorities in clinical trials for new hiv/aids drugs; they also called for an expansion of the very definition of hiv/aids to incorporate the indicator diseases most commonly found in women at the time. In many cases, women infected with hiv were not being diagnosed or encouraged to take hiv/aids tests because their specific symptoms and opportunistic infections were not recognized under the Centers for Disease Control’s official classification criteria for the syndrome. One consequence of this exclusion was that official aids statistics were hopelessly flawed. Another, more immediate consequence for women suffering from hiv/aids was the inaccessibility of health benefits (Christensen 2011: 62–65). Pushing at the limits of aids treatment activism, targeted interventions by act up’s women’s and minority caucuses, including direct-­action protests against the fda and cdc in the early 1990s, met with some success. By 1993, they had persuaded the cdc to officially recognize a range of indicator diseases affecting women and convinced the Social Security Administration to use these symptoms as a basis for assigning Medicare and disability benefits (Christensen 2011: 66–67). The women’s and minority caucuses also managed to modify participation criteria for clinical trials. Under pressure from both the women’s caucus in act up and the wider women’s health movement around breast cancer, in 1990 the nih agreed to establish an Office of Research on Women’s Health, with the express mandate of increasing the participation rates of women in nih-­funded clinical research. These regulations would soon be codified into law under the nih Revitalization Act of 1993. Under the terms of this act, all clinical research funded by the nih was required to include women and minorities as research subjects. The fda did not go quite so far in modify206 Chapter Eight

ing the rules governing private sector research—to this day, it does not require women to participate in all stages of research (and as we have seen, the presence of women in Phase 1 research, at least in the United States, remains minimal), although it has lifted the explicit prohibition (passed in 1977) against the inclusion of women of childbearing potential in experimental drug trials (Baird 2011: 40–42). Both the nih and fda now require researchers to categorize human subjects according to sex, race, ethnicity, and age and to report pharmacological differences for nonstandard subjects. The nih Revitalization Act inaugurated what Steven Epstein has called the paradigm of “inclusion-­and-­difference” in clinical research: increasingly, “an identity-­centered redefinition of US biomedical research” focuses attention on distinct bodily subtypes and postulates the existence of inherent biochemical differences along the lines of gender, race, and age (S. Epstein 2007: 6). For Bernadine Healy, former director of the nih, women and minorities had formulated a valid critique of the representative value of clinical research performed on the standard white male subject; the systematic inclusion of women and minorities promised to put an end to the “orthodoxy of sameness and the orthodoxy of the mean” in clinical research (cited in S. Epstein 2007: 1). Yet the notion that the white male subject constitutes the standard experimental subject is far from true. At best, the white male subject is overrepresented in the most sought-­after, late-­stage therapeutic trials for critical illnesses. In early-­stage, nontherapeutic trials, it is the impoverished African American or migrant male who predominates, while middle-­class uninsured women are overrepresented in later-­phase trials for non-­life-­saving drugs (Fisher and Kalbaugh 2011). Notwithstanding this discrepancy between representation and practice, the expansion of the paradigm of “inclusion-­and-­difference” has had profound effects on the understanding of recruitment imperatives and criteria. In what follows, we will examine the sometimes ambivalent long-­term consequences of aids treatment activism on drug regulation in the United States, noting how the imperative of “niche standardization” has come to play a role in the creation of new markets for the pharmaceutical industry. Not surprisingly, the Chicago School theorists who were once loudly opposed to the interventions of consumer activist and patient advocacy groups now present themselves as the champions of patient freedom against the paternalism of the fda.

The Labor of Distributed Experiment 207

Beyond Protectionism: From Premarket Testing to Postmarket Surveillance

No one could deny that the tactics of the aids treatment movement have been a resounding success. Yet since the early 1990s, the deregulation of the drug approval process has gone much further than the original demands made by aids activists (Abraham 2007: 53). Under pressure from the pharmaceutical industry, subsequent reforms have generalized the expedited approval process from aids drugs to new drugs targeting non-­life-­threatening chronic or lifestyle conditions. The Prescription Drug Users Fee Act of 1992 and the fda Modernization Act of 1997 promised accelerated review times for all classes of drugs, in exchange for industry fees and (in some cases) a commitment to undertake Phase 4 trials after the drug had been marketed (Abraham and Davis 2005: 890). Phase 4 trials, sometimes called pharmacovigilance trials, are designed to track the long-­term effects of drugs among the consumer public and can include several thousand subjects. Because of these large cohorts, Phase 4 trials also have the potential to monitor the side effects of drugs in particular subpopulations (children, the elderly) that were not included in the first three phases of premarket testing. Under the terms of the fda Modernization Act, however, the fda has no power to enforce Phase 4 trials, and not surprisingly, many of the promised trials are still pending. One of the effects of this reform has been a partial devolution of the risks of the trial onto the consumer public, even for conditions that are non-­life-­threatening. The fda now permits riskier, shorter trials for all classes of new drugs, postponing much of the monitoring of dangerous side effects or “adverse events” to the period after the drug has been marketed, where a combination of Phase 4 trials and voluntary reporting are expected to compensate for shortfalls in regulatory oversight (Abraham and Davis 2005). The rise of postmarket surveillance, notes philosopher of science Niklas Langlitz (2009: 399–400), marks a shift away from risk prevention as the guiding principle of drug regulation toward strategies of preparedness, which refocus attention on the unexpected event or unpredictable risk as it emerges in the consumer market. It is assumed here that rigorous product testing can no longer hope to circumvent all the potential risks associated with a product before it goes to market. The market itself must therefore function as a testing site, reporting back to manufacturers the risks that become visible only in the process of consumption. In the words of Arthur Daemmrich, “data collection shifted from the clinical trial to the market; at the same time, the market was forcibly reconfigured as an extension of the clinical trial” (2004: 118). Whether the pharmaceutical companies have 208 Chapter Eight

been sufficiently alert to postmarketing risks or sufficiently conscientious about reporting them is a matter of some debate (McGoey 2009). In any event, it is clear that as the focus of drug regulation has shifted somewhat from premarket testing to a still-­evolving system of postmarketing surveillance, the consumption of pharmacological compounds has, by default, become more experimental. Interestingly, it is precisely at this moment in time that calls have been made to assert a positive right to take experimental drugs. The aids activist movement had for the most part operated in semi-­clandestine conditions, eschewing the rights-­based language of democratic inclusion that would also have entailed state surveillance of its sometimes illegal practices. It is only in recent years, as the drug approval process has become less stringent, that patient groups have demanded formal recognition of the right to self-­ experiment. While subjects who were once excluded from late-­stage therapeutic trials (women, minorities, and children) are demanding to be represented in clinical research, prompting interventions by the nih and fda to redress alleged historical biases against nonstandard subjects, others are seeking a formal exemption from the standard clinical trial process itself. In what follows, we will discuss the exemplary case of the Abigail Alliance—the patients’ rights group that has gone furthest in its efforts to redefine the circumstances under which the normal clinical trial can be legally abrogated.

The Right to Self-­Experiment: The Abigail Alliance, the Law and Economics Movement, and the Return of Volenti Non Fit Injuria

In 2006, the Abigail Alliance for Better Access to Developmental Drugs brought a lawsuit against the fda, citing the “constitutional right” of seriously ill patients to take unapproved drugs in the first stages of testing (Dresser 2006; Okie 2006; Romano and Jacobson 2009; Schüklenk and Lowry 2009). The Abigail Alliance was formed in 2001 by Frank Burroughs, whose daughter Abigail died of squamous-­cell carcinoma of the head and neck that same year. Burroughs had tried unsuccessfully to obtain two new drugs that were undergoing clinical trials at the time. Since neither of the drugs was being tested for head and neck cancer, access was denied, although one of the drugs has since been approved for that indication. Frank Burroughs’s legal and media actions have been supported by the right-­wing libertarian Washington Legal Foundation, which has strenuously lobbied to reintroduce the principle of volenti non fit injuria into compassionate-­use programs—a move many perceive as the first step in an effort to underThe Labor of Distributed Experiment 209

mine the entire consumer protection model of drug regulation established in the 1960s. In chapter 6, we saw how the remit of the fda had moved from the realm of postmarketing litigation and criminal sanctions against individual manufacturers to that of premarket regulation. Before the Kefauver-­Harris Amendments of 1962, the fda was bringing to court several thousand criminal prosecutions and seizure actions for toxic or misleadingly advertised products per year (the number today is much lower, between twenty and thirty) (Hutt 2007). The high number of prosecutions was the inevitable trade-­ off for inexistent premarket regulation. After the passage of the Kefauver-­ Harris Amendments, tort litigation against pharmaceutical companies survived only as a supplementary form of redress for adverse events. As the consumer protection model of socialized risks and preventative regulation rose to ascendance, the principle of voluntary assumption of risk (or volenti non fit injuria) was progressively marginalized from both the regulated consumer market and the professional ethos of the scientific researcher. It is by no means coincidental that in 1953, at a time when public opinion was hardening in favor of the consumer regulation model, the nih issued a formal memo to prohibit self-­experimentation by in-­house researchers (Halpern 2004: 128). It is well known that many of the most famous drug discoveries of the late nineteenth and early twentieth centuries were the result of self-­experimentation by individual researchers: in the absence of organized clinical trials, and often prior to the inception of a formal clinical trial, scientists had used their own bodies as a first-­line instrument of research (Altman 1998). But with the consolidation of the consumer protection model, the principle of voluntary risk assumption was prohibited outside the limited context of a formal research protocol—the statistically controlled, randomized clinical trial. Under the premarket testing regime, the unknowable risks of experiment were considered legitimate only if they were devolved upon the socially marginal figure of the research subject (considered distinct from both the professional scientist and the average consumer) whose formal assumption of risk now needed to be confirmed by the legal device of the informed consent form. Today, however, the space of contestation opened up by aids activism has challenged the marginalization of volenti. In a curious turn of events, it is the consumer-­patient who is now demanding a right to assume unknowable risks and a partial exemption from the standard rules of drug approval. It is the Abigail Alliance that has been most assiduous in its efforts to formalize the principle of volenti as a constitutional right. Together, the reform efforts of the Abigail Alliance and the Washington 210 Chapter Eight

Legal Foundation have met with a certain degree of success. In 2006, a three-­ judge panel of the US Circuit Court of Appeals for the District of Columbia ruled that terminally ill patients have a constitutionally protected right to access experimental therapies that have passed Phase 1 testing but not yet received fda approval.5 In support of their decision, the judges evoked the principle of volenti non fit injuria, arguing that “an individual must be free to decide for herself whether to assume any known or unknown risks of taking a medication that might prolong her life” and asserting the patient’s right to make the decision about her life free from government interference.6 The full Court of Appeals reversed this decision in August 2007, holding that terminally ill patients do not have a fundamental right to access investigational drugs, while in early 2008, the Supreme Court denied the Abigail Alliance’s petition for further appeal. Nevertheless, the 2006 decision has had a resounding effect on public and legal opinion in the United States, and the demands of the Abigail Alliance have subsequently been taken up in a number of congressional bills, the latest of which is the Compassionate Access Act of 2010 (hr 4732). In line with the principle of volenti, the Compassionate Access Act of 2010 proposes a number of changes to fda regulation that go well beyond the existing exemptions provided by treatment ind and compassionate-­use programs. Present exemptions apply only to drugs that have passed through Phase 2 testing; the Abigail alliance demands access to drugs that have successfully completed Phase 1 testing. Moreover, the Compassionate Access Act would allow drug sponsors to set any price on investigational new drugs and stipulates that patients who obtain access to experimental Phase 1 drugs must permit collection of their clinical data and waive the right to sue the manufacturer—provisions that may be of particular interest to pharmaceutical sponsors wishing to accelerate or bypass the normal drug approval process without incurring liability (Schüklenk and Lowry 2009). Neoliberal and libertarian legal scholars associated with the Chicago School law and economics movement have seized upon the demands of the Abigail Alliance as a means of undermining the entire framework of premarket testing and enterprise liability established in the 1960s. Most prominent among these is Richard A. Epstein, who has written the definitive libertarian critique of the fda (2006a) and has expressed his support for the Abigail Alliance in numerous newspaper reports and articles (2009). While the Kefauver-­Harris model of drug regulation has not been abrogated (far from it), there now exists an array of exemptions, fast-­tracks, and options for postmarketing surveillance that have undermined the full force of the conThe Labor of Distributed Experiment 211

sumer protection model. As a consequence, some of the risks that were once reserved for the research subject are now visited upon the consumer public, whether or not they know it, and certainly without their formal consent. Unsurprisingly, the acceleration of drug approval has led to a higher rate of postmarketing adverse events (Abraham 2007). In all logic, one would also expect that the partial relaxation of premarket testing would lead to an increase in tort cases against pharmaceutical companies, drug manufacturers, and perhaps also the fda. The fact that the consumer-­patient has not signed a consent form releasing others from liability means that he or she potentially represents a much greater legal threat to the fortunes of the pharmaceutical industry than the “consensual” research subject. It is this possibility that conservative and libertarian advocates of pharmaceutical deregulation are strenuously seeking to preempt. Richard Epstein, for example, arguably the most libertarian of the Chicago School law and economics scholars, has argued not only that premarket testing for all investigational new drugs should be limited to Phase 1 trials (and even these should perhaps be eliminated in the long run), but also that individual tort litigation against pharmaceutical companies for adverse events sustained after marketing should be severely restricted (2006b; 2009: 14–15). In other words, libertarian critics of the fda consumer protection model would like to abrogate federal regulations on pharmaceutical products while also making it impossible to pursue individual tort actions against a pharmaceutical company. If realized, this program would signal not only a return to the early model of de facto postmarket testing on the consumer public but the erasure of the one means of redressing the risks of drug consumption within this model—tort litigation. So far, the Abigail Alliance’s proposed congressional bill has not been successful. However, the fda has responded to pressure from the Abigail Alliance and other patient groups by greatly expanding access to investigational new drugs for the terminally ill. New rules introduced in October 2009 clarified the process of applying for compassionate use, allowed drug sponsors to charge limited fees for providing access, and redefined the term “serious illness” to include a much broader range of disease categories (Korieth 2010). Although not as radical as the changes demanded under the Compassionate Access Act, the fda’s new rules have more than doubled the number of requests for unapproved drugs. In the meantime, pharmaceutical companies have started to explore alternative options for capitalizing on experimental drug consumption. In the following section we will consider these options. What the Abigail Alli212 Chapter Eight

ance is asserting as a constitutional right to self-­experiment, we will suggest, is fast becoming a new business model and a novel condition of labor.

The “Democratization” of Experimental Drug Use: User-­Generated Innovation

In the face of probable death, what aids activists had demanded was an exemption from the normal procedures of drug testing and regulation. These patients did not so much assert the right, as make the decision, to take incalculable risks. Today the stakes have changed. What was once an extralegal decision is now being reformulated as a right. And what was once an exception to the standard rules of drug testing is now being investigated as one among several alternative models of drug development for a pharmaceutical sector in dire need of new sources of innovation. In recent years, the model of user-­generated innovation (variously referred to as “open-­source innovation” or “distributed cocreation”) has been vigorously championed as the solution to the productivity woes of the pharmaceutical sector (von Hippel 2005; Ogawa and Piller 2006; Eysenbach 2008; Allison 2009). This literature looks to the example of open-­source software and online content developed by distributed communities of unpaid users (Linux, Mozilla Firefox, Wikipedia) to conceptualize a model of drug development that relies on the peer-­to-­peer exchange of information about pharmaceutical compounds and their side effects.7 Increasingly, it would seem, the pharmaceutical sector is seeking innovation in “public” practices of experimental drug consumption rather than “rational” interventions into the hardware of industrial chemistry. In the process, commercial drug innovation is moving closer to the recreational-­experimental model of drug production pioneered by the aids treatment movement. Thus far, one of the most successful platforms for soliciting “user-­ generated innovation” in the clinical sciences is represented by PatientsLikeMe, a social networking site that boasts several thousand registered users divided into sixteen distinct disease categories ranging from Parkinson’s, aids, and multiple sclerosis to depression and anxiety (Marshall 2008; Allison 2009; Brownstein et al. 2009). Launched in 2006, PatientsLikeMe provides a social networking infrastructure where patients can informally exchange information about their illness, treatment possibilities, and experience of drug side effects. The site actively promotes transversal communication among patients by classifying their illness into stages and alerting The Labor of Distributed Experiment 213

them to the existence of other patients at similar states of progression, inviting them, in effect, to constitute themselves as a distributed community of fellow patients. The site also provides patients with standardized metrics to record their symptoms, their chosen drug treatment, the dosage, and the progression of their illness, which are then translated “free of charge” into visuals outlining expected outcomes and treatment options. The software uses the same rating scales that are found in clinical trials, which means that the patient-­reported data is also of considerable value to pharmaceutical companies, who are increasingly turning to such sites as a way of short-­ cutting the time and costs associated with traditional methods of data collection and patient recruitment.8 Espousing a philosophy of “open-­source innovation,” the company reserves the right to sell anonymized patient data to pharmaceutical companies, researchers, and others. The business model of sites such as PatientsLikeMe effectively reverses the usual trajectory from product development to marketing to dissemination, by using targeted software to “solicit” or encourage the self-­organization of online communities that will then serve as ready-­made consumer markets (and coproducers) of the product to come. In practice, this means the clinical trial sponsor is able to wait for a cohort to informally self-­recruit before it makes the expensive decision to proceed with the development of a drug. It also means the prospect of dedicating funds to develop an orphan drug, destined for a relatively small public of consumers, may become a viable commercial option for companies who have already identified and captured the consumer market they wish to target. The social networking platform artfully sidesteps the privacy regulations contained in the Health Insurance Portability and Accountability Act (hipaa) of 1996 by using only information that has been directly entered by users (Brownstein et al. 2009). For “user-­generated innovation” to work as a business model, the patient/user must be unaware of or indifferent to the fact that he or she is laboring toward the production of a commercial drug—one that will be potentially unavailable to the producers themselves, if the results of recent disputes between patient groups and pharmaceutical companies are anything to go by (Hayden 2007). The patient-­reported data collected on the site functions as a source of information on practices and experiences of consumption that escape the purview of the conventional clinical trial process. These may include the “off-­ label” consumption of drugs that have been approved for another use or the side effects (“adverse events”) that may arise after long-­term consumption of a drug, both of which lie in a gray zone between the unregulated (since un214 Chapter Eight

approved) and legal use of drugs. The consumption of drugs “off-­label”—that is, for medical indications that have not yet been tested—is a widespread, and not formally regulated, practice. The fda has little jurisdiction over the actual practice of medicine, leaving the doctor free to make decisions with regard to how drugs should be consumed once normal standard-­of-­care options have been exhausted. It appears, in fact, that off-­label indications constitute a huge proportion of overall prescriptions in the United States, with some estimates suggesting that over 60 percent of legal drugs are prescribed for nonstandard use. There are many different forms of off-­label drug use. Most patients with life-­threatening diseases such as aids or cancer, for example, are prescribed at least one drug off-­label. Few prescription drugs have been tested on children or pregnant women; therefore many of the drugs taken by these populations are prescribed off-­label. These examples, however, only constitute a small percentage of overall off-­label prescriptions. In the early stages of development, many chemical compounds show promising signs of clinical effectiveness for several different indications. Drug companies regularly make calculated decisions to conduct clinical trials and seek approval for one indication only—generally the indication that will be easiest to prove, or most remunerative in terms of patent life (for example, it would be more logical to seek approval for an as-­yet-­untreatable or “orphan disease,” for which the fda grants longer patent terms). Once approved for the one indication, the drug company then has several options for promoting the off-­label use of its drug for other, untested indications.9 These nonstandard indications of already-­approved drugs also represent a growing proportion of new drug approval applications to the fda, since it is much cheaper to seek approval for drugs that have already been manufactured and tested for another use than to develop a successful drug from a novel pharmaceutical compound (commercial drug innovation is as cautious in practice as it is adventurous in rhetoric) (Menikoff 2008: 1067–1073). PatientsLikeMe has openly publicized the potential of its electronic data records to track the benefits (or lack thereof) of off-­label drug consumption, a method that may serve as a useful first step in prompting drug companies to sponsor further, fully randomized and blind trials. Researchers associated with the site have thus far conducted one observational study on the off-­label use of lithium carbonate by patients diagnosed with the fatal neurodegenerative disease amyotrophic lateral sclerosis, using a specifically developed algorithm to compensate for the confounding effects of nonrandomization. Their findings indicated that the treatment was not effective. Commenting on the potential The Labor of Distributed Experiment 215

for further such studies, the researchers suggest that drug developers would do well to avail themselves of “increasing level[s] of self-­experimentation” among patients (Wicks et al. 2011). Alongside this focus on nonstandard, off-­ label drug consumption, PatientsLikeMe also advertises its superior ability to track the side effects or “adverse events” that occur after a drug has gone to market. The patient-­ reported data offered by PatientsLikeMe represents a significant advance in postmarketing surveillance not only because it offers a potentially more thorough mode of adverse event reporting than the current one but also because the standardized format of electronic data makes it more amenable to statistical data mining. It is often pointed out that many of the most spectacular leads of recent pharmacology have come not from primary drug development but from the unexpected “insights”—that is, side effects—­ generated by the long-­term consumption of a drug. (The most notorious example in recent history is that of Sildenafil, a drug that was initially intended to treat hypertension but eventually became Viagra. Thalidomide, the drug that inspired the entire framework of US pharmaceutical regulation, constitutes a less well known example. After being withdrawn from the market in the 1960s, thalidomide was accidentally discovered to be uniquely effective in treating both leprosy and multiple myeloma. It is now marketed for these uses under the trade name Thalomid.) As a result, clinical researchers and drug developers are beginning to think of postmarketing surveillance of adverse events as a potential source of new drug leads, over and above their risk-­management function (Boguski et al. 2009; Pulley et al. 2010). Implicit in this move from surveillance to innovation is the recognition that a chemical compound has no inherent therapeutic valence, whether curative or toxic: “Drugs can be regarded as chemicals with a series of effects. Which effect is the beneficial intended one and which effects have to be considered as the adverse unwanted effects depends on the indication for which a drug is used” (Jong-­van den Berg 1995: 177). The bodily effects of a drug lie in the soft science of consumption, not the hard science of biochemistry. Or, rather, biochemistry itself produces effects that are contingent upon the art of consumption. Novel as its methods may appear, PatientsLikeMe represents one platform among many in a much more diffuse trend toward the use of patient-­ controlled electronic health records in drug innovation. Most significant among these is the fda’s new Sentinel Initiative, a national program of active postmarket surveillance that relies entirely on the data mining of electronic health records (US Department of Health and Human Services 2008).10 The 216 Chapter Eight

amount of data captured by open-­source innovation systems is critical to their effectiveness: by drawing on a public, nationwide network of standardized electronic patient records, the Sentinel Initiative multiplies the research potential of private platforms such as PatientsLikeMe many times over. By the same token, however, it also magnifies the already-­existing tensions that exist between the ostensible ethos of open-­access information and the reality of commercial appropriation (Hayden 2007). Given the public character and regulatory mission of the fda, the uses to which such a large-­scale surveillance program will be put pose compelling—and as yet unanswered— questions. Will publicly accessible and freely shared patient health information constitute an open-­source database of drug development leads for the pharmaceutical industry? And if so, to what extent will the end products of such research be freely available to the public? Thus far, the fda has signaled its intention to conduct active surveillance studies of adverse events, as well as comparative effectiveness research that evaluates existing treatments against each other rather than a placebo. But as the business model of PatientsLikeMe demonstrates, such studies could well be used to generate new drug leads and other commercially valuable information (Tabarrok 2009). As one commentator points out, the fda’s Sentinel Initiative, once fully operational, will be “analogous to a continuous, massive post-­approval ‘clinical trial,’ many times larger, and much more subtle in it ability to detect statistically significant results, than the average Phase 4 trial” (Gordon 2008: 303). The Sentinel Initiative constitutes the entire health-­consuming public as an experimental population. It remains an open question whether or not the fruits of such continuous, real-­time experimentation will be freely available to those who helped produce it.

The Distributed Labor of Experiment

The Fordist model of industrial biomedicine has been criticized for its tendency to exclude the “public” from the process of scientific deliberation, establishing a strict division of labor between the scientific expert and the patient. It has also been taken to task for assuming an overly standardized public, with the result, for example, that drug innovation is directed toward mass consumer markets (to the neglect of orphan drugs) and tested only on the white male research subject, to the exclusion of nonstandard subjects (S. Epstein 2003). As a result of these critiques, calls for the reform of biomedical science have tended to focus on the need for a more democratic model of public participation in science, one that would include minority The Labor of Distributed Experiment 217

publics in the coproduction of knowledge by and about communities. The model of user-­generated drug innovation, it must be conceded, responds point by point to the various critiques of industrial drug production formulated by minority groups during the last decades of the twentieth century. What is proposed here is a method of drug development in which value is rigorously “cocreated” by clinicians, pharmaceutical companies, and patients through the solicitation of nonstandard practices of drug consumption and semi-­regulated spaces of public experiment. In practice, the “democratization” of science has led to an alternative business model, one that demands the direct participation of the patient, “user,” or “consumer” in the coproduction of scientific knowledge. The open-­source innovation model is neither averse to public participation in the production of knowledge nor blind to the particular demands of nonstandard subjects. As Steven Epstein notes, “If the existence of a single standard human was the presumption of Fordism (the early twentieth-­century system of producing mass commodities as standardized as the Model T), then niche standardization moves us squarely into the world of post-­Fordist manufacturing—niche marketing of diverse products to well-­defined subgroups” (2007: 178). User-­generated innovation “democratizes” research not only by mobilizing new patient communities of nonstandard subjects, but also by enlisting these “publics” as so many niche markets, ready-­made for the commercialization of the product they are themselves engaged in producing. The “public” is not only interpellated as a potential consumer market, then, it is also configured as an unwaged, highly skilled labor market, expert in the minutiae of consumer pharmacology.11 In recent years, the clinical trial has undergone a process of gradual “deinstitutionalization.” The mass trials of the mid-­twentieth century (which favored the homogenous, regimented living conditions of total institutions such as the state prison, the teaching hospital, the orphanage) are being progressively displaced by the contract trial conducted in the private clinic or Phase 1 unit and, more recently and tentatively, the distributed clinic of user-­generated experiment. The classic division of labor within the trial has also shifted in line with the transition from Fordist to post-­Fordist modes of production. User-­generated innovation blurs the lines between experimental “line work” and clinical management, subject and object of research, demanding that the research subject become expert in his or her condition, capable of administering and monitoring the experiment on her own behalf. The privilege of scientific expertise is no longer reserved for the scientist alone but is increasingly outsourced to peer-­to-­peer networks of producer-­ consumers. In the newly opened frontiers of drug innovation, peer-­to-­peer 218 Chapter Eight

enabled self-­experimentation has become the paradigm of clinical labor. No longer is it possible, then, to assume that invention takes place in the laboratory only, that the production of novel pharmacological compounds is distinct from the scene of consumption, or indeed that the distinction between recreational and therapeutic drug use is an adequate one for conceptualizing the actual practice of product development in the pharmaceutical sector. The frontiers that shaped the scene of mid- to late twentieth-­century pharmacology are breaking down and reforming in unprecedented directions. At the same time, the very nature of the “experiment” has changed as it has moved outside the walls of the clinic. The user-­generated experiment has abandoned the scientific and regulatory ideal of calculable risks and measurable uncertainties. The experiment, it might be said, has become speculative, embracing risk as such, outside any standard distribution. The point is no longer to delimit risks and standardize probabilities but to generate entirely unexpected events—as sources of innovation. After a period in which federal drug regulations sought as far as possible to reduce the riskiness of drugs before they went to market (the Kefauver-­Harris Amendments representing the culmination of the consumer protection model), we now have a situation in which pharmaceutical companies are scouring for sources of innovation in the high-­risk practices of the consumer public. By what right, then, do pharmaceutical companies retain the sole privilege of intellectual property over an experiment that has been so rigorously outsourced? How can the unregulated drug prices of the American pharmaceutical market be justified when the risks of drug development are increasingly borne by the drug-­consuming public? Far from resolving the problems of risk distribution associated with the traditional model of human subject experimentation, the outsourcing of clinical trials to the drug-­consuming public merely generalizes them. The protocols of experiment and expertise have become so thoroughly distributed that drug users may well begin to ask (as others have already done) by what subterfuge the unknown, visceral risks of self-­experimentation return in the form of speculative profits and inaccessible drug prices.

The Labor of Distributed Experiment 219

Conclusion

Clinical labor, as a set of productive relations, emerged from the margins of the Fordist workplace and the mid-­twentieth-­century social state. Its experimental and reproductive forms of value developed in sequestered spaces sharply separated from those of industrial mass production—not the shop floor but the prison, the orphanage, the asylum, and the household. While these spaces were excluded from the national economy proper, they nevertheless involved more or less coerced forms of labor; the involuntary participation of patients and prisoners in the mass clinical trials of the mid-­ twentieth century, and the compulsory gift work of the housewife, who provided biological, affective, and task-­oriented capacities to her husband in exchange for his waged support. These forms of sequestered labor were understood as the diametric opposites of the industrial labor process, organized around the predictable manufacture of the mass commodity and the rights and protections afforded to the white male body. Operating as they did outside the Taylorist clock time intrinsic to twentieth-­century industrial labor, their aleatory, evental, cyclical, or elastic temporalities rendered their forms of productivity opaque to the calculus of national economic production. Experimental and reproductive labor was an essential element in the social and health care systems that supported the mid-­twentieth-­century national economy, but they never appeared in estimates of the labor force or quantifications of gross domestic product. As the vertically integrated Fordist firm and its fully employed internal workforce disintegrate into the contemporary horizontal landscape of multilateral contracts and innovation outsourcing, so too do these carceral and familial institutions begin to unravel, unleashing latent capacities into a

rapidly deindustrializing economy and a deregulated, precarious labor market. When women leave the confines of the home and seek waged employment, they precipitate what we have described as the vertical disintegration of the Fordist household. The reproductive labor of the unpaid housewife has been supplanted by an entire service sector (child care, food preparation) and various horizontal contracts for formally domestic service, including the care and nurture provided by (often undocumented) migrant labor. At the same time, as life science innovation expands to fill the economic space left by mass manufacture, the newly deprivatized reproductive capacities of young men and women are mobilized in new ways, as clinicians and agencies in California and elsewhere experiment with the legal and technical reordering of fertility. In the cases we have discussed, the actual biological elements of reproduction have been fragmented into a suite of in vivo services that can be performed by independent contractors outside the legal unit of the ­family. As a consequence, it is now possible to outsource discrete moments and functions of reproductive biology, without undermining the legal entity that is the post-­Fordist family. Assisted reproductive technology (art) has led to a proliferation of biological-­technical relations between bodies, outside established norms of kinship. At the same time, fertility contracts reaffirm the legal privilege of the commissioning couple’s rights to the child, and hence the legal integrity of the conventional family, over those of the fertility contractor. It is not surprising that these juridical forms emerged first in the United States, with its more contested and privatized relations around property in the body and its greater willingness to resort to contract as a way to settle such issues. However, they are also being exported to new locations, as business models and legal forms designed to deal with the complex implications of denationalized reproductive labor. Cross-­border art denationalizes and disaggregates the family in space and time. This is less critical in the case of oocyte vending, where vendors and purchasers themselves cross borders, but becoming increasingly complex in the case of surrogacy, where some states (France, Australia) contest the civil status of any child born to a surrogate beyond its borders. In return, the most permissive surrogacy jurisdictions (California and other US states, and potentially India) have undertaken various legal and civil initiatives to repatriate the child and restore the ­family. In the domain of experimental labor, as civil rights legislation in the 1970s and 1980s introduced new protections into prisons and see the dismantling of forced hospitalization, the burgeoning pharmaceutical industry lost ac222 Conclusion

cess to institutional experimental conditions and had to develop other, more transactional ways to recruit. As we have seen, it has found new testing sites among the uninsured and unemployed, the precariat of deindustrialization. Here again outsourcing and contractualization prove remarkably flexible organizational and legal techniques for gaining traction on in vivo capacities, mobilizing both the economic and biological risk exposures of human research subjects to produce the fungible experimental data and compliance status necessary to get a drug to market. Pharmaceutical experimentation has come to depend on the recruitment effects generated by casualized labor conditions, both underemployment and the absence of medical insurance (in the United States) for ever wider sectors of the population. These conditions propel the underemployed into the risk work of Phase 1 trials and drive the chronically ill to seek temporary, contingent care through Phase 2 and 3 participation. This dynamic has become more transparent in the United States, where the downturn precipitated by the global financial crisis of 2008 has seen the unemployed turn to clinical trial and fertility work with renewed enthusiasm. We have seen the ways that the flexible bioethical principles that de jure govern clinical trial participation and gamete “donation” can operate de facto to organize an informal clinical labor market. The principle of informed consent has evolved historically in a complex, often overlapping, yet largely undocumented dialogue with the act of contractual consent, which renders a promise enforceable. Their conflation is particularly evident in US and Indian fertility markets, where there is no clear way to separate the oocyte vendor’s or surrogate’s consent to medical procedures and their legally enforceable consent to facilitate the commissioning parent’s intentions to have a child in exchange for a fee. As we saw in chapter 3, if the contracting parties go to law, medical consent to undergoing hormonal and surgical procedures is treated as evidence of intention, and hence of contractual consent. Contractual consent is enforceable in some jurisdictions through the otherwise rarely used recourse to specific performance, the court ordering of contractual completion by surrendering the child. Informed consent also works to exclude both experimental subjects and fertility contractors from the social protections available to those (increasingly few) covered by permanent labor contracts. We saw that informed consent procedures were adopted in the 1940s and 1950s in the United States in response to fears of litigation from those involved in trials. It reactivates from nineteenth-­century labor law the atavistic principle of volenti non fit injuria, the principle that the worker, by consenting to the labor contract, also Conclusion 223

consents to bear all the risks associated with the workplace. While the power of organized labor eliminated volenti from the late nineteenth-­century shop floor, and workers’ compensation and other kinds of social insurance have muted the risks of industrial accidents, the experimental subject is understood to consent to the risk that is the very matter of the clinical trial itself. The work of the Phase 1 trial is entirely the work of enduring experimental accidents, and consent in these circumstances exempts clinics and pharmaceutical companies from broad liability for the biological contingencies to which the experimental subject is exposed. The bioethical principle of compensation, too, has proved singularly adaptable to multifarious recruitment and procurement conditions. As we saw in chapter 4, the transnationalization of reproductive labor in the eu has involved opportunistic interpretations of compensation principles so that they facilitate an informal labor market. Sharp differentials in earning capacity and monetized administration ensure that even comparatively low compensation payments can work to recruit significant numbers of fertility vendors from among the ranks of indebted students, legitimate and undocumented migrants, and eastern European “tourists.” In short, bioethical principles are highly adaptable to the regulation of informal labor markets. While their stated aims are to protect research subjects and tissue donors from “undue inducement” and to foster truly voluntary participation, in practice they tolerate and incorporate not only transactional recruitment but also atavistic features of labor law—volenti and specific performance—that characterized the unprotected labor conditions associated with the high point of nineteenth-­century contractual individualism and the laissez-­faire state. We have sought to show that the implicit contractualism of bioethical administration, the immense weight placed on the act of consent to indicate noncoercion and voluntary acceptance of risk, is entirely consistent with the conditions of post-­Fordist labor and the prevailing norm of employment-­at-­will. While voluntarism and gift relations may be justifiable in some spheres (for example, blood and solid organ donation within national boundaries), they have very different effects when extended to populations who seek to transact their experimental or reproductive labor as a necessary source of subsistence. At the very least, the conceptual categories used in bioethics, particularly compensation, inducement, and consent, need extensive critical reevaluation and open dialogue with the history and categories of labor if they are to adapt themselves to the conditions of the contemporary bioeconomy. Indeed, some have already argued that bioethical protections need to assume some of the features associated with the statutory contract of labor, particularly those concerned with 224 Conclusion

a just wage and social insurance (Lemmens and Elliot 1999, 2001; Anderson and Weijer 2002). Without rejecting such normative arguments outright, what we have proposed here, instead, is a critical history of contract and tort law as they have evolved at the interface of social and biomedical regimes of production, reproduction, and welfare. Ultimately, we have suggested, the transformation of labor relations depends on radical political critique rather than juridical reform, and social protections do not engender but follow in the wake of such disruptions. Even the social and workplace protections afforded by the Fordist labor contract were premised on strict demarcations of race and gender, and were only disrupted by the wave of antinormative politics that surged forth at the end of the 1960s. The invocation of a new social protectionism, then, even the expanded protectionism of human rights discourses, must be cognizant of the limits of such normative and rights-­based claims. We have seen that the ranks of clinical labor are multiplying, driven by both quantitative and qualitative developments in the life science industries. The twenty-­first-­century bioeconomy has expanded to fill some of the productive spaces abandoned by the Fordist manufacturing nations, and in the process has repurposed some of the unskilled labor capacity that might otherwise have been absorbed by industrial work. In the process, it has introduced a far more speculative, evanescent, and unstable business model into the economy, and an entirely informalized and disavowed employment model into the labor market. The nature of the life science industries is also changing, in ways that place more onerous recruitment and procurement demands on clinics, brokers, and cros. The move to translational medicine, to clinical rather than laboratory applications of innovation, requires far higher rates of in vivo exposure and experimental enrollment. The move to regenerative medicine demands much more intensive negotiations with female tissue providers, whose reproductive tissues can be accessed only through prolonged and invasive procedures, as well as more complex and regulated forms of consent. These negotiations stand in stark contrast to laboratory innovation using res nullius tissue during the early years of the life science revolution, when the property rights of life scientists could be exercised in simpler ways. Meanwhile, the fertility industry continues to expand with apparently infinite demand elasticity, and developing economies outside North America and Europe are now competing in the life science innovation sector. In response to this expansion, recruitment of clinical labor has become more distributed, in two senses of the term. First: recruitment has become Conclusion 225

more extensive in transnational space. cros specialize in the identification of subpopulation vulnerabilities and disease burdens that would lend them to clinical trial recruitment, and the spatial flexibility of outsourcing has produced a highly internationalized sector where the extreme life uncertainties of the unskilled in the transitional economies of China, India, and elsewhere propel them readily into experimental and reproductive labor. Selling the ability to endure experimental risk is now a major source of income for significant sectors of the urban poor and lower middle class in these countries, as is selling or renting fertility. These developments are facilitated through industry initiatives like the International Conference on Harmonization (ich) and state initiatives like accession to the wto’s gats Agreement, and the promotion of a medical tourism market. These initiatives help to standardize what is rapidly becoming a global clinical labor market in in vivo services, rendering experimental experience, gamete vending, and gestational surrogacy as outsourced capacities with tradable terms that can be secured across borders with a minimum of friction. The export of clinical labor to these developing economies helps to service productivity demands while depressing labor costs, so that the demand for fertility services, for example, can be met with both more capacity and lower expenses for intending ­parents. At the same time, we have shown how recruitment into clinical labor in these developing economies also involves the diffusion of contractual individualism. In China, the former PRC collectivist systems for worker protections are being displaced by the introduction of comprehensive private law around labor contract and tort. These reforms effectively formalize the legal status of the worker as a private contractor and lend themselves to the formation of a service labor sector where risks are both more individualized and more contestable through private adjudication. These reforms pave the way for large-­scale recruitment into contract clinical trials, both outsourced from European and US companies and operated by the burgeoning Chinese pharmaceutical innovation sector. In India, gestational surrogacy contracts address the surrogate as the proprietor of her own body, as a rational calculator of risk and fertile capacity who can rent these capacities into an international marketplace ordered through private law. At the same time, contract enforces the property and custodial rights of the commissioning parents, assuring them that their intended family form will be upheld in court. As we saw, such contracts are yet to be tested in the Indian courts, so their legal force is at present unclear. Nevertheless, we can see that they introduce a contractual property relation and a potential for both capitalization 226 Conclusion

and dispossession into the ordering of Indian women’s fertility, in a fashion startlingly at odds with former nation-­building strategies to contain fertility. Second: new, less intensive forms of recruitment are more extensively distributed across the social body. Drawing on the free labor strategies of social media and the extreme deregulatory rhetorics of some US health economists, patient network sites aggregate the off-­label dosing and side-­effect data of thousands of people, whose self-­experimental experience is used by pharmaceutical companies as a source of new drug and patent leads. In the regenerative medicine field, reproductive tissue surpluses are discreetly accumulated in the private tissue banking sector, where women can store cord blood and menstrual blood (Fannin 2011) as forms of familial and self-­ investment in stem cell technologies. These forms of accumulation involve less intensive negotiations than those required to procure fetal tissue, embryos, and oocytes. In general, regenerative medicine researchers are interested in identifying potentials in tissues that do not carry problematic associations with the beginnings of life, hence the enthusiasm for hematopoietic stem cells (as in the cord blood and menstrual examples above), and for induced pluripotent stem cells, which can be derived from ordinary somatic, adult tissue. Other extensive forms of distribution are evident in national biobanks, where whole sectors of the population are enrolled in genomic platforms that data-­mine donated blood samples for small genetic differences and link them to the donor’s clinical data. While the burgeoning bioeconomy cannot operate without intensive access to in vivo clinical labor, we can see that these less invasive, distributed strategies are likely to become both more common and more ingenious, free-­riding particularly on the aggregation capacities of mobile communication networks and the social enthusiasm for private tissue banking. We can see here how clinical consumption converges more and more with production, in a fashion similar to that evident in the digital economy. Finally, we would like to comment on the biopolitics of value generated by clinical labor. As a form of production it draws on early and mid-­twentieth-­ century Taylorist rationalization in the logics of the mass experiment and the technical ordering of fertility, while at the same time mobilizing in vivo temporalities at odds with industrial clock time—the temporalities of ingestion, metabolism, endocrinal cycles, excretion, and parturition. It orders the experimental, reproductive, and regenerative potentials of these living processes to render them exchangeable and negotiable, calculable as standardized experimental data or as capacities transferable between different bodies. The commercial terms of this exchange have been largely set by Conclusion 227

the practices of outsourcing and the constitution of the clinical provider as an independent contractor of his or her own biological capital. These legal forms frame the contractor’s generative biology as proprietary asset, open to multiple forms of negotiation and transaction. To this extent, clinical labor has become a more obviously economic phenomenon as it converges with other kinds of casualized personal service labor and is framed by the terms of human capital more generally. At the same time, however, the contractor’s in vivo capacity cannot be exhaustively stabilized as an asset form, because the contracting self cannot be separated out from this capacity. While this inseparability is of necessity true for all forms of labor power (Pateman 1988) because all work engages the body of the worker to some extent, it has particular implications when the labor involved is entirely concerned with the living processes that sustain the contracting self. The biology of species-­ being is the capacity at stake in clinical labor, and in its current form the contractor must both risk this biology and assume the consequences. Under these terms, the plastic potentiality of biology, its openness to both transformation and trauma, is a condition of clinical labor’s productivity, and the contractor who undertakes clinical labor has little recourse as the independent proprietor of his or her own living being. This irreducible asymmetry belies the apparent suspension of power relations articulated by ideas of human capital. The proprietor of the self is not like other proprietors, because he or she cannot, after all, realize value by liquidating bodily capital, or exchange it for another, more desirable asset (Bryan et al. 2009). Rather, the contracting self is hostage to its own embodiment, and to the calculus in which risking that embodiment becomes, paradoxically, a way to live. In the words of one Indian surrogate, “I have earned this [money] putting my body at stake” (cited in Kroløkke and Pant 2012). It is these terms of exchange that must be redressed if clinical labor is to be undertaken in more equitable ways.

228 Conclusion

Notes

One.

A Clinical Labor Theory of Value

1 The exceptions here are recent fieldwork studies that have provided important accounts of particular sectors, including gamete vending (Almeling 2011; Vora 2011) and Phase 1 clinical trial work (Sunder Rajan 2008). 2 Bioethics is a broad discipline, as well as a regulatory discourse, and we acknowledge that a critical and feminist bioethical scholarship has pursued some of the questions and issues we raise in this book (e.g., Elliot 2008; Dickenson 2007; Baylis and McLeod 2007). 3 For example, the Nuremberg Code (1949), the Declaration of Helsinki (World Medical Association 1964), the Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1978), and the European Convention on Human Rights and Biomedicine Council of Europe (1997). 4 The Belmont Report, for example, stipulates that “informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance” (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1978). 5 This resemblance is not lost on popular current affairs media, where more and more documentaries and news items feature sensationalized accounts of impoverished students or the newly unemployed selling eggs or signing up for Phase 1 clinical trials to make ends meet in the post–financial crisis world. Indeed, the self-­evidence of such clinical labor is treated in the news media as an index of the new economic realities faced by young people in particular. Nevertheless, it remains opaque to most bioethical analysis. 6 Here we limit ourselves to a brief survey of figures available for assisted reproduc-

7

8

9

10

tive markets and clinical trials in the United States, taking into account the fact that little data exists for some of the less-­regulated kinds of clinical labor, such as the sale of oocytes and sperm. According to research conducted by the National Institutes of Health (nih) and the Center for Information and Study on Clinical Research Participation (ciscrp), in 2006, close to 800,000 Americans were enrolled in government-­funded clinical trials and close to 900,000 in industry-­ funded trials (Phases 1–3) (ciscrp 2011). The market value of the US infertility services sector was estimated to have reached �4.4 billion in 2008 (Marketdata Enterprises 2009). As of 2008, the United States housed more than 100 sperm banks and 483 fertility clinics, most of them run by small medical practices or hospital-­based clinics (although there is one large provider chain, IntegraMed, that operates several dozen clinics). The Centers for Disease Control and Prevention (cdc) reported that 17,697 donor eggs were transferred to infertile women in 2009 (Centers for Disease Control and Prevention 2011). art produced more than 50,000 children per year via 142,000 ivf procedures (Marketdata Enterprises 2009). According to the common law doctrine of res nullius, persons do not have property rights in their own bodies and cannot sell a part of themselves. The human body and its parts are considered beyond commerce and outside of contract, and once tissue has left the body, it is understood to belong to no one. Patent law in the life sciences relies in turn on a notion of property right derived from Locke—property rights can be established by adding labor to unimproved or natural land or materials, transforming them into useful entities. For an extended treatment of the Lockean idea of labor and property see Waldby and Mitchell 2006. This move is most flagrant in Rubin (1972), who dismisses the “energetic” conception of labor as an ahistorical reading of the labor theory of value. What Rubin misses is the very historicity of the concept of “energy,” its close connection to the thermodynamic science of industrial production, and its deployment as a category of labor discipline. In other words, a historically sensitive perspective on the material abstraction of labor would need to investigate how “energy” (or, for example, affect) come to constitute the socially determined measure of labor value within a given order of production. See Vatin 1993 for an example of this kind of perspective. We use the term “speculative materialism” in a critical sense. From our perspective, much of the current philosophical literature on “speculative materialism” substitutes ontology for critique and fails to engage with its proximity to the contemporary form of capital’s “material abstraction.” See, for example, Bryant et al. 2011. Throughout this work, we deploy the concept of “free wage labor” in the critical sense intended by Marx. In other words, we insist that Marx’s theory of labor was a critique of liberal political economy—and therefore a critique of liberal theories of freedom of contract—not a continuation of Ricardian political economy, as the more technocratic and statist elements in the Marxist tradition would later come to interpret him. We recognize that Marx made “free wage labor” the target of his critique precisely because it escaped the critical purview of nineteenth-­century liberals, who were quite happy to denounce the unfree labor of the slave but

230 Notes to Chapter One

stopped short of examining the exploitation involved in freedom of contract. However, Marx’s almost exclusive critical focus on the free wage contract means that he neglects the various forms of unfree labor—bondage, indenture, and coverture—that continued alongside the expansion of industrial labor throughout the nineteenth century. At his most reductive, Marx dismisses such forms of unfree labor as residues of an archaic feudal order, destined to be overcome by the long march of history. We argue instead that free and unfree labor presuppose each other and are equally constitutive of the capitalist labor relation. For an extensive and illuminating discussion of this question, see van der Linden 2008.

TwO.

The Historical Lineages of Clinical Labor

1 The Court interpreted the Due Process Clause of the Fourteenth Amendment, a post–Civil War Reconstruction amendment, as enshrining freedom of contract. 2 Lieberman writes, “Southern Democrats, committed to preserving both racial segregation and the distinctive regional labor market, found themselves in a majority coalition during the New Deal with urban Northerners and organized labor, who were demanding a social democratic program of national social and employment policy. This coalition . . . created a national welfare state aimed at its constituent class groups, industrial workers and white Southern planters, and it did so by building new institutions on a foundation of racial inequality. . . . [The act created exclusions,] in some cases by excluding the occupations in which most African Americans worked [agricultural and domestic workers], in others by drawing strict eligibility criteria that many African Americans could not meet, and in still others by preserving local autonomy” (Lieberman 1998: 24–25). 3 What we are referring to here is the “canonical” version of the labor theory of value expounded in the first volume of Capital. We recognize that, in other texts, Marx proposes a more nuanced understanding of the full spectrum of contractual and social conditions at play in capitalist labor relations. In his Theories of Surplus Value, for example, Marx argues against Adam Smith that “productive” (surplus-­ value-­generating) labor extends beyond the material production of commodities to include the processlike performance of “personal services.” By this definition, all kinds of service work ranging from the lowest forms of menial, domestic, and sexual labor (“the mass of menial servants,” “cooks,” “prostitutes”) to the highest forms of professional, bureaucratic, or scientific labor (“state officials, military people, artists, doctors, priests, judges, lawyers”) can potentially be considered “productive” labor if they enter into a labor relation that generates surplus value. See Marx 1969: 165, 174. Here again, however, Marx fails to account for the persistence of domestic servitude within the capitalist order of production, by classifying tasks performed on a personal basis within the household as feudal remnants. 4 In Australia, the Commonwealth Court of Conciliation and Arbitration awarded the first male breadwinner wage in the Harvester Judgement of 1907. 5 For a detailed account of the various theorists associated with Chicago School neoliberalism, see Horn et al. 2011. Notes to Chapter Two 231

Part II

1 Semen is also a crucial material in art but for the most part does not involve technical intervention to render it ex vivo.

Three.

Fertility Outsourcing

1 Almeling (2007) reports one oocyte brokerage company that frames the payment of oocyte providers as gifts from the intending parents. 2 See http://www.irs.gov (accessed 5 February 2010). 3 Gesetz zum Schutz von Embryonen (Embryonenschutzgesetz, or ESchG), as promulgated on 13 December 1990, Federal Law Gazette I, p. 2746. 4 C. Waldby, I. Kerridge, and L. Skene, “Human Oocytes for Stem Cell Research: Donation and Regulation in Australia,” Australian Research Council Linkage Project, lp0882054 2008–2011. 5 “Egg Donor Contract” template, Family Beginnings, http://www.ivf-­indiana.com (accessed 16 October 2010). 6 For an extended account of Titmuss’s argument see the introduction to Waldby and Mitchell 2006. 7 Our thanks to Donna Dickenson for pointing this out. 8 Our thanks to Pat O’Malley for this point. 9 The logic that informs these decisions can usefully be compared to the precedent of specific enforcement in slave contracts in nineteenth-­century America. In American legal history, the invocation of specific performance is not incidentally bound up with the notion of indissoluble familial ties between the slave and the slave owner (Morris 1996). During the early decades of the nineteenth century, a number of slave owners called for the enforcement of specific performance on the grounds that the slave represented a unique, incommensurable property, one that could not readily be exchanged for a monetary equivalent in the event of breach of contract. Many of these cases involved disputes around wills and testaments in which slaves had been bequeathed in trust to future generations. In more than a few cases, it was argued that the slave was not just any property, but family property (Morris 1996: 103–120). The slave could therefore be legitimately inherited, but not exchanged for a sum of money (for which no equivalent could be found). Decisions in favor of specific performance of slave contracts were instances in which the law of familial succession took precedence over the horizontal laws of contract, which reduce all commodities and services to exchangeable equivalents. In the specific case of family slaves, the genealogical claim to property in the (other’s) body overrode freedom of contract.

FOur.

Reproductive Arbitrage

1 It is possible to freeze oocytes, and cryopreservation techniques have been developed over the last twenty-­five years primarily for oncology patients, whose treatment will compromise their ability to have children. However, success rates for 232 Notes to Chapter Four

2

3

4

5

6 7

8 9 10

viable pregnancy using frozen oocytes are not high. Due to their high cytoplasmic volume, oocytes tend to develop intracellular ice crystals in the thawing process, which produces misaligned chromosomes and other forms of tissue damage. While about 75 percent of embryos survive cryopreservation, the rate is only 50–65 percent of oocytes (Barrett and Woodruff 2010). Many clinics internationally offer patients the option of oocyte cryopreservation, but fees are very high (Rudick et al. 2009; Martin 2010). A small number of clinics use a different business model that avoids the need for patient travel. The male partner’s semen is transported to an oocyte procurement clinic; the blastocyst is created on site, frozen, and then shipped back to the commissioning clinic. See, for example, a program operating between an Irish and a Ukrainian clinic (A. P. H. Walsh et al. 2010). This is an adaptation of Arlie Hochschild’s (2001) “global care chains,” which describe the ways care labor (nannying, cleaning, elder care) is transferred from one place to another, as women migrate to better-­paying locations, often in order to pay for the care and education of their own children back home. According to the European ivf-­monitoring consortium, which collates data from national registers, in 2006, 458,759 treatment cycles were reported from 998 clinics in thirty-­two countries, including 12,685 involving oocyte donation. Directive 2004/23/ec states: “Member States must encourage voluntary and unpaid donations of tissues and cells. However, donors may receive compensation strictly limited to making good the expenses and inconveniences related to the donation (e.g., travel expenses). No promotion and publicity activities are allowed in support of the donation of human tissues and cells with a view to offering or seeking financial gain or comparable advantage. The general rule is that Member States must endeavor to ensure that the procurement of tissues and cells is carried out on a non-­profit basis.” See, for example, the terms of the 2011 hfea consultation on egg donor compensation, http://www.hfea.gov.uk/6177.html (accessed 14 November 2011). These figures are indicative rather than exhaustive, as not all clinics report or keep precise registries. The authors state that the proportion of reporting clinics is 86.0 percent (998 out of 1,160 clinics), but participation still remained very low in two countries (Greece and Serbia) and limited in four others (Bulgaria, Hungary, Poland, and Spain). Moreover, a study of voluntary donor registries in Spain found that information on oocyte donation was patchy and poorly kept compared to other procedures (Luceno et al. 2010). This suggests that the number of oocyte donations performed in Spain may in fact be considerably higher. “Trans-­national Reproduction: An exploratory study of UK residents who travel abroad for fertility treatment,” http://www.transrep.co.uk. http://www.nordica.org/composite-­361.htm (accessed 15 February 2011). The numbers of newly registered egg share donors per year are as follows: 504 in 2004; 417 in 2005; 339 in 2006; 471 in 2007; 377 in 2008. hfea, “Egg Share Donors and Non-­patient Egg Donors” (2009), http://www.hfea.gov.uk/3412.html (accessed 6 May 2010). The number of patients treated with donated eggs deNotes to Chapter Four 233

11 12 13 14

15

16 17 18 19

20

clined from 1,794 in 2004 to 1,416 in 2007. hfea, “Donor Conception—Treatments” (2009), http://www.hfea.gov.uk/donor-­conception-­treatments.html (accessed 6 May 2010). Legislative Act No. 227/2006 Col. http://www.hfea.gov.uk/6177.html (accessed 12 November 2011). “hfea Agrees New Policies to Improve Sperm and Egg Donation Services,” 19 October 2011, http://www.hfea.gov.uk/6700.html. In 2007, the average fertility rate for eastern European countries was 1.31, while the average in northern Europe was 1.8. Population Reference Bureau, “Fertility Rates for Low Birth-­Rate Countries, 1995 to Most Recent Year,” http://www.prb .org/Reports/2009/tfrtable.aspx (accessed 6 May 2010). The migration of care labor has also come in for criticism from eastern European nationalists, who regard such developments as undermining the reproductive capacities of the nation. Pronatalist policies are effectively strategies forcibly to channel young women’s reproductivity back into the national economy. In the United States, a gestational surrogacy arrangement costs the intending parents around �80,000–�100,000, while in India it costs around �20,000. Estimates place the proportion as high as 96 percent (Hill 2010: 49). Personal communication with Elizabeth Hill, March 2011. For example, see the case of the Wisconsin Alumni Research Foundation patent over all primate and human embryonic stem cells and the various resultant international machinations (Gottweis et al. 2009). trips is the Agreement on Trade-­Related Aspects of Intellectual Property Rights. Created in 1994, trips sets mandatory harmonizing standards of ip law for two major technologies—digital technology and biotechnology—and has the power to enforce these standards for all members of the wto.

Five.

Regenerative Labor

1 The breakdown for kinds of human embryonic stem cell patent at 2011 is embryonic (n = 67); embryonic/pluripotent stem cells (n = 35); induced embryonic / dedifferentiation of cells (n = 6); induced pluripotent cells / dedifferentiation of cells (n = 1); and induced pluripotent stem cells / reprogramming of cells (n = 3). The United States is the leading patenting region, with over half of all patents, followed by Japan, Korea, Germany, and Canada (Webster 2011). 2 C. Waldby, I. Kerridge, and L. Skene, “Human Oocytes for Stem Cell Research: Donation and Regulation in Australia,” Australian Research Council Linkage Project Grant lp0882054 2008–2011. 3 For example, with the Abortion Act (1967) in the United Kingdom, Roe v. Wade (1973) in the United States, and Bundesgesetzblatt Tiel 1 (1976) in West Germany. For more details see Herzog 2009. 4 The highly controversial and contested nature of the ethics of embryonic stem cell research during the early 2000s ensured an unprecedented level of public oversight and regulation in many jurisdictions. In several countries the difficulties 234 Notes to Chapter Five

of managing these controversies provoked the formation of national-­level ethics bodies where none had existed before (Gottweis et al. 2009). 5 The stroke trial is being run by ReNeuron and the spinal cord trial by Stem Cells. 6 From an earlier version of her argument.

Six.

The American Experiment

1 For an illuminating discussion of the changing business model of the large pharmaceutical firm, see the discussion of GlaxoSmithKline in Froud et al. 2006. 2 For a full account of the reform and its effects on biomedical innovation, see Ripken 2005 and Fortun 2001. 3 A more extensive treatment of the history of the clinical trial would need to investigate the parallel development of product and safety testing for the mass consumer market. It would also need to look at the mass enrollment of standardized, experimental animals into both product testing and “pre-­clinical” trials of pharmaceuticals during the same period. We are unable to pursue that history here. Suffice it to say that the use of animals to test the safety of food, drugs, and chemicals also expanded considerably in the wake of World War II, particularly in the United States. Andrew N. Rowan (1984: 192–196) thus points to a sharp increase in animal testing for cosmetics, vaccines, hormones, pharmaceuticals, and chemicals between the late 1940s and the 1970s, due to the introduction of successive food and drug safety regulations. See also Birke and colleagues (2007: 35–55) on the history of the standardized experimental animal. 4 Perhaps the closest historical analogy to the medical research subject is the human crash-­test dummy. Between 1947 and 1975, researchers at the National Highway Safety Bureau and Wayne State University filmed themselves and their students in hundreds of rapid deceleration tests, before reverting to the traditional mannequin, cadaver, and animal studies. See Beckman 2008. Both mass clinical trials and human crash-­tests emerged in response to consumer protection regulations in the mid-­twentieth century. Both mobilize a form of product-­testing labor. 5 We do not wish to suggest, however, that the most canonical version of Marx’s labor theory of value represents his entire thinking on the subject. As we pointed out in note 3 of chapter 2, Marx provides a much more subtle definition of the different kinds of labor relation (subsuming both commodity and service production) in his Theories of Surplus Value. See Marx 1969: 165, 174. 6 Sydney Halpern (2004: 102–103) notes that as early as the 1940s, scientists and sponsors were also discussing the possibility of purchasing liability insurance to cover the costs of injuries to research subjects. According to Halpern’s archival research, federal agencies generally had three responses to these requests: “First, officials viewed the cost of insurance for subjects—whether life, accident, medical or disability coverage—to be prohibitively expensive. Second, in the hands of government lawyers to whom such issues were referred, questions about insurance coverage for subjects were translated into questions about the liability of researchers, their employers, and the US government. If insurance was to be purchased, it Notes to Chapter Six 235

7

8

9

10

11

would be coverage for institutions and investigators, not for research subjects. . . . But the government’s third and preferred solution was not to provide insurance for researchers, much less for subjects, but rather to rely on the indemnification of federal contractors and on waiver provisions included in consent statements.” These early debates about the feasibility of compensation for injured research subjects remain highly relevant in the United States today, where researchers and clinical trial sponsors are still not required to provide compensation to injured research subjects. A history of informed consent that covers the same period as Halpern 2004, but does not make the same connections with technologies of risk management and insurance, can be found in Faden et al. 1986: 114–150. Keynes writes that the “classical theorists resemble Euclidean geometers in a non-­ Euclidean world who, discovering that in experience straight lines apparently parallel often meet, rebuke the lines for not keeping straight—as the only remedy for the unfortunate collisions which are occurring. Yet, in truth, there is no remedy except to throw over the axiom of parallels and to work out a non-­Euclidean geometry. Something similar is required in economics” (1987: 366). For an extended discussion of the hazardous work conditions experienced by African Americans, migrant Arab workers, and women workers in the automobile plants of late Fordism, see Georgakis and Surkin 1975. Robert Steinbrook notes that “the situation in Europe is much different, in part because many countries have universal health insurance. The 2001 European directive on the conduct of clinical trials states that a trial may be undertaken only if ‘provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor.’ Some countries—such as France, Germany, and Spain— have compulsory insurance laws” (2006: 1873). These interventions are contained in private letters sent by the irs and cited in a ruling of the US Department of Labor (1996). According to this ruling, “On August 2, 1990, the Internal Revenue Service (irs) ruled in a non-­precedential decision that human test subjects in medical tests conducted by the Food and Drug Administration are not employees and do not receive ‘wages’ for income tax withholding or Federal employment tax purposes. Priv. Ltr. Rul. 91-­06-­004 (Aug. 2, 1990)” and “On January 24, 1994, in a Federal Employment Tax Determination letter mailed to the Bionetics Corporation, the irs ruled that an individual’s participation as a human test subject in usda-­sponsored research was as an independent contractor and not an employee of the firm conducting the research. This letter was obtained from the ars on August 16, 1996.” For details on the prohibition see Code of Federal Regulations (1981), Restrictions on Clinical Investigations Involving Prisoners, 21, part 50, 44. The formal prohibition of prison-­based trials followed a series of investigations and media inquiries throughout the 1970s. The investigative journalism of Jessica Mitford, originally published in the Atlantic Monthly, was particularly influential in mobilizing public opinion against prison-­based trials. Her articles were subsequently published in book form (Mitford 1973).

236 Notes to Chapter Six

12 Significantly, however, more-­complex trials—those involving new cell therapies, for example—continue to take place in academic settings.

Seven.

Speculative Economies, Contingent Bodies

1 Here it should be noted that transnational clinical trials, conducted most often in Asia, Africa, and Latin America, have long been the norm in biomedical prevention trials for infectious disease research. These trials trace their historical origins to “tropical medicine and global health services, experimentation in ‘island nations,’ and post–World War II international development in Africa, Asia and Latin America. From Walter Reed’s Yellow Fever Commission in Cuba and Mauritius in the sixties to present aids and malarial vaccine research and clinical trials, most have involved government sponsorship and have often blurred lines between research experiment and provision of health services” (Petryna 2009: 215). Today these government-­sponsored research programs have been supplemented by a panoply of private actors, including Global Health Partnerships and philanthropic foundations such as the Bill and Melinda Gates Foundation. After more than thirty years of neglect, there has been in the last decade a veritable explosion of biomedical prevention trials seeking to test and develop vaccines, antimicrobials, and antivirals for infectious diseases. See, for example, Nguyen 2010; Rushton and Williams 2011; McGoey et al. 2011; Pollock 2011: 106–118; and Peterson 2012. These trials are sometimes called “public health trials”; because of the nature of their sponsorship, however, they would be better characterized as “humanitarian” trials. The relationship between the commercial pharmaceutical industry and this new humanitarian health care complex represents a significant new development in biomedical innovation and an expanding frontier of clinical trial activity. However, for reasons of space, we do not address this particular aspect of the clinical trial enterprise in our study. Instead, we focus on “traditional” clinical trials for chronic or lifestyle diseases, or for chronic treatment of infectious disease, which are organized within a very different political economy. 2 According to critics of the ich, it has in general opted for the lowest common denominator among existing regulatory standards, choosing, for example, to set a low minimum of six months’ toxicity testing in animals as a prerequisite for human clinical trials (Abraham and Reed 2002). 3 Adriana Petryna (2009: 33) represents the most sophisticated exponent of an expanded conception of bioethics founded on a critical, social democratic understanding of human rights. Drawing on the work of Paul Farmer, her perspective on health ethics goes beyond a purely liberal conception of individualized rights and is cognizant of the ways in which judicial notions of the right to health can be harnessed to the ends of commercial expansion. 4 In principle, such initiatives are designed to catapult the Chinese life science sector from its current status of low-­cost service provider to full-­fledged participant in the global patent regime. Whether their benefits will devolve to the Chinese re-

Notes to Chapter Seven 237

5

6

7 8

9

10

11 12

13

search sector or to multinational pharmaceutical companies remains to be seen. What is certain is that the multinational pharmaceutical sector has reaped significant rewards from the Chinese government’s investments: several foreign companies have acquired or entered into joint ventures with domestic Chinese pharmaceutical research companies, allowing them to develop innovative new drugs from Phase 1 onward (Hughes 2010; Ribbink 2011). Since the late 1990s, only hospital centers and clinics accredited by the cfda (formerly the State Food and Drug Administration, or sfda) and compliant with international gcp regulations have been authorized to conduct clinical trials. The rapid expansion in Phase 1 clinical trials in China is a symptom of the fact that multinational companies have set up drug r�d facilities on Chinese territory (therefore allowing them to bypass the rule that only compounds discovered in China can be tested locally), but also a sign that domestic science laboratories are producing their own novel chemical entities and entering into collaborative alliances with multinational pharmaceutical companies. “Volunteers at scrc,” http://www.scrcnet.org/Volunteers_en.asp (accessed 15 February 2012). According to interview data, typically about 70 percent of the clinical trial budget goes to the hospital while 30 percent is allocated to the clinical investigator. However, the distribution of payments can vary between hospitals (Interview 2008b). Between 2000 and 2003, there were more than five hundred reports of such acts of violence in Beijing alone. In ninety of these cases, health care workers were injured or permanently handicapped. See Harris and Wu 2005. In other provinces, health care workers have been killed and the numbers of overall acts of violence have been even higher. The workplace has become so dangerous for China’s doctors and medical staff that many hospitals have hired permanent security forces to protect them from the ire of patients. Corroborating this position, a swath of academic articles have explored the relevance of Ulrich Beck’s (1992) Risk Society thesis for the “transitional economy” of contemporary China. See http://www.vibrantgujarat.com (accessed 20 February 2012). The Gujarat State Biotechnology Mission maintains a list of the ten major cros at the following site: http://btm.gujarat.gov.in/btm/pharm-­bio-­clinical-­research.htm (accessed 11 February 2012). Some multinational cros, however, are now setting up Phase 1 units in India’s new private hospitals.

Eight.

The Labor of Distributed Experiment

1 Our argument here is an epistemological one. The rct is designed to measure the statistical uncertainties arising from a given scientific question or hypothesis, not to generate entirely new questions replete with their own uncertainties. This is not to suggest that rcts do not produce uncertainties in practice. On the contrary, as David Armstrong (2007) has argued, evidence-­based medicine has tended to re238 Notes to Chapter Eight

2

3 4

5 6 7

locate uncertainty from the actual performance of the rct to the statistical interpretation of the data it produces. And as Linsey McGoey (2010) has shown, these uncertainties of interpretation lead, more often than not, for calls to perform further rcts. No doubt these innovations remain marginal in quantitative terms when compared to the mass of pharmaceutical clinical trials that continue to be conducted in the “old-­fashioned” manner, according to the precepts of the rct. As the pharmaceutical industry offshores a growing proportion of clinical trials to cheaper destinations such as China, India, the former Soviet Union, Latin America, and elsewhere, evidence-­based medicine is being globalized and scaled up as never before. Yet the very forces that are driving the pharmaceutical industry to relocate clinical trials offshore are also leading many within the industry to rethink the epistemological premises of the clinical trial itself. Some of the innovations we discuss in this chapter are being adopted as routine components of clinical trials worldwide (Phase 4 and adaptive trials are being introduced into new clinical trial markets in India and China, for example), while others, especially the user-­ generated model of drug innovation, are confined primarily to the United States. Although limited geographically, then, these developments are far from parochial, given that the US Food and Drug Administration exercises such a disproportionate influence on pharmaceutical regulation worldwide (Carpenter 2010). We offer no predictions about the future evolution of drug development. Whether or not the distributed experiment will displace the mid-­twentieth-­century paradigm of the rct remains an open question. We limit ourselves here to investigating the novel forms of labor that are being generated at the margins of the formal clinical trial process, while pointing to the emerging political tensions that haunt the business model of open-­source innovation. For secondary accounts of the Chicago School critique of federal drug regulations, see the analyses by Carpenter (2010) and Nik-­Khah (forthcoming [2014]). Prior to this, the fda had granted compassionate-­use ind (investigational new drug) exemptions to treat serious illness on a case-­by-­case basis only. The program required a formal request from the patient’s physician and was notoriously bureaucratic. The new “treatment ind” program allowed the fda to grant expanded access to an entire class of drugs, thereby sidestepping the mediation of a personal physician. Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 445 F.3d 470 (DC Cir. 2006). Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach; italics added. Researchers and pharmaceutical companies are also exploring open-­source innovation models for the early-­stage development of drug compounds. In 2011, the National Institutes of Health (nih) launched an initiative to create a freely accessible database and a full physical collection of molecules that have been approved for human testing but were abandoned at the research stage. The initiative is designed to promote drug rescue research that exploits the wealth of already accuNotes to Chapter Eight 239

mulated data on abandoned drug compounds for new clinical hypotheses. See Collins 2011. Within the private sector, drug companies have entered into mutual contractual arrangements to offer each other free access to their proprietary databases in the early stages of development. The strategy of “precompetitive collaboration” allows pharmaceutical companies to share data in the early stages of development and does not preclude, but selectively restricts, the scope of intellectual property protection to the later stages of drug development. The move toward precompetitive collaboration stems from the recognition that very few of the speculative promises of “rational drug design” (the cornucopia of new therapies anticipated as a result of the introduction of high-­throughput screening, combinatorial chemistry, and alliances with biotech) have actually come to fruition as workable products. This failure, as even drug companies have begun to realize, is at least partially due to the fact that overly stringent patent protection on molecular compounds or other basic elements of drug production (such as gene sequences) makes effective innovation more difficult for all contenders in the pharmaceutical market. 8 The business model of the site rests on the premise that future revenue streams will be generated from contractual arrangements to supply market research, clinical trial data, and recruitment information to pharmaceutical companies, health care providers, and health insurers. The site already has several partnerships with major pharmaceutical companies, and the founders claim that ultimately their goal is to directly partner with industry in the discovery and development of new therapies. 9 The fda prohibits direct-­to-­consumer marketing of “off-­label” pharmaceuticals but, under the right to commercial free speech, allows drug companies to distribute “educational” material to physicians and to publish academic research on “off-­label” drug use in scientific journals. For an insight into the many methods the pharmaceutical industry has developed to avoid fda restrictions, see Fugh-­ Berman and Melnick 2008. 10 In 2007, Congress passed legislation—the Food and Drug Administration Amendments Act, or fdaaa—designed to overhaul the existing system of postmarketing surveillance. The fdaaa requires the fda to create an integrated data system of electronic health records from at least 25 million patients by 2010 and 100 million patients by 2012—many times the number of patients enrolled in premarket clinical trials (Gordon 2008). It also instructs the fda to collaborate or contract with private and public organizations to conduct observational, longitudinal, and surveillance studies using the data it collects. It was in response to these demands that the fda launched the Sentinel Initiative in 2008. 11 In this respect, the diffusion of “user-­generated innovation” must be understood as a parallel development to discourses of “public participation” in science, as exemplified most notably in Britain. Charles Thorpe and Jane Gregory (2010) offer an incisive reading of the conceptual fit between the ethos of public participation and the demands of post-­Fordist labor, suggesting that “participation can be understood as a form of immaterial labor which gains currency in this phase of 240 Notes to Chapter Eight

capitalism, blurring the distinctions between production and consumption, and between the economy and the political or communicative public sphere. Participation operates both in the production and consumption of goods and in the legitimation of social and political relations. Public engagement exercises instantiate the way in which immaterial labor is both productive and political” (2010: 274).

Notes to Chapter Eight 241

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Interviews

All interviews conducted by Melinda Cooper. Interview. 2008a. cro representative. Beijing. 14 November. Interview. 2008b. cro representative. Beijing. 18 November. Interview. 2012a. Clinical investigator in public hospital. Mumbai. 28 November. Interview. 2012b. cro representative. Mumbai. 29 November. Interview. 2012c. cro representative. Hyderabad. 11 December. Interview. 2013. Academic Phase 1 Center assistant director. Beijing. 25 June.

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Index

Abadie, Roberto, 131 Abigail Alliance for Better Access to Developmental Drugs, 209–13 academic health centers (ahcs), 147–49 act up, 206 Adkins, Lisa, 112 ahcs. See academic health centers Ahmedabad, labor reform, 188–93 Ahmedabad Civil Hospital, 190 ai. See artificial insemination aids. See hiv/aids clinical trials Almeling, Rene, 48, 51, 53 Alving, Alf Sven, 119 ama. See American Medical Association American Epidemiology Board, 143 American Medical Association (ama), 142 American Society of Reproductive Medicine (asrm), 56–57 Anderson, James A., 129 Angell, Marcia, 127 Arendt, Hannah, 163–64 art. See assisted reproductive technology artificial insemination (ai), 39–40, 44 asrm. See American Society of Reproductive Medicine assisted reproductive technology (art), 34, 47–48, 60, 62, 66, 76–77, 222 Barber, Bernard, 148–49 Barrett, Michelle, 101 Bayh-­Dole Act (1980), 124

Becker, Gary, 5, 19, 28–30, 31 Beckles, Hilary, 34 Belmont Report, 201, 229n4 Benda Commission, 46 Bergmann, Sven, 63, 71–72 BestMed Journeys, 79 Beveridge, William, 25 Bharatiya Janata Party, 82, 190 bioeconomy: clinical labor in, 8, 33, 100, 110, 227; innovation in, 17, 90, 99, 108; knowledge economy, 110–11; policy directives on, 6–7, 185; profitability of, 34, 37; regenerative labor in, 107; regenerative medicine sectors, 91–93, 225; reproductive biology in, 102 bioethics: in clinical trials, 7–8, 14, 130, 136, 151, 163–64, 179–80; compensation and, 56–57, 68, 73, 224–25; informed consent, 13–14, 115, 132–33, 142–44, 147, 183, 223; regulation, 93, 201 Black Panther Party, 154 Boltanski, Luc, 4, 20 Breman, Jan, 81–82, 86 Burroughs, Frank, 209 Butler, Judith, 164 Calabresi, Guido, 145 California Cryobank, 42 California Supreme Court, 59 Capital (Marx), 138 capital value, 4, 5, 37–38, 42, 43, 50, 61

Cardozo, Benjamin, 142 Carpenter, Daniel P., 125–26 cdc. See Centers for Disease Control Cenova Ventures, 171 Center for Information and Study on Clinical Research Participation, 129 Centers for Disease Control (cdc), 50, 206 Centro de Investigación Príncipe Felipe (cipf), 98–99 Centro de Medicina Regenerative de Barcelona (cmrb), 98–99 cfda. See China Food and Drug Administration Chiapello, Eve, 4, 20 Chicago School, 28–32, 124, 203, 207, 211–12 China Food and Drug Administration (cfda), 169–70 China New Technology Venture Investment Corporation, 168–69 Chinese Academy of Social Sciences, 166 Chopra, Rohit, 183 cipf. See Centro de Investigación Príncipe Felipe civil rights movement, 29 Clarke, Adele, 40 clinical labor/trials, 117–22; in Ahmedabad, 190–93; aids activism and, 205–7; in bioeconomy, 8, 33, 100, 110, 227; bioethics, 7–8, 14, 130, 132–33, 136, 151, 163–64, 179–80; in China, 167–81, 226; compensation for, 7–8, 17, 117, 120, 122, 129, 136–37, 155–56, 167, 224; defined, 12; experimentation in, 197, 217–19, 223; gender/race/class in, 131, 152, 192; globalization of, 193–94; historical context, 14–17; human rights and, 143, 163–64; independent contractors in, 145–46; in India, 183–93; innovation and, 123, 127–28, 158, 161, 166, 167–73, 194, 200–201, 239–40n7; legal innovations and, 13–14, 223; locations of, 15–16, 117–18, 120– 21, 130–31, 146–58, 159–61; outsourced, 18–19, 150–51, 219, 226, 227–28, 239n2; patents and, 124–25; phase definitions, 134; prison-­based, 118, 120, 146–47, 149, 153–55, 218, 221; r�d costs, 126–27; recruitment costs, 125; regulation in, 8, 131–34, 160–61, 163, 179–80, 186, 200, 203–4; reproductive, 9, 38; risks, 18, 21, 32, 38, 81, 128, 130,

274 Index

134–38, 164, 187–88, 235–36n6; risks, right to, 198–99; self-­experimental, 198–99, 210, 216, 218–19, 227; statistics, 229–30n6; stem cell, 95, 100; success rate of, 125; tort law, 139–46; translational medicine and, 199– 203; transnationalization of, 17, 160, 164, 225–26, 237n1; trials as labor, 9, 135–36, 138, 190; use of term, 7; women in, 121–22, 152–53, 193; as workfare, 157, 178 Clinton, Bill, 127, 157 cmr. See Committee on Medical Research cmrb. See Centro de Medicina Regenerative de Barcelona cognitive biocapitalism, use of term, 6 Cohen, Myron, 173–74 Committee on Medical Research (cmr), 118–19, 143 Compassionate Access Act (2010), 211 Confederation of Indian Industries, 80 Congress Party, 184 contract research organizations (cros), 129, 151–52, 169–70, 186, 191, 226 contractual consent, 223 Cordlife, 96 Council for the Defense of Medical Research, 142 Council of Medical Research (India), 78 Council of Scientific and Industrial Research, 184–85 Court of Appeals, 211 cros. See contract research organizations cryopreservation, 40–41, 233–34n1 Cultural Revolution (1966–1976), 173 Curran, William, 141 Daedalus (journal), 145 Daemmrich, Arthur, 131, 208 Dal, Janita, 82 Deakin, Simon, 21 Delphy, Christine, 101 Deng Xiaoping, 166–67, 173, 182 Department of Biotechnology (India), 185 Department of Health, Education and Welfare (US), 145 Department of Labor (US), 145–46 Dickenson, Donna, 103 Dickert, Neal, 129–30 digital economy, 110–11 DiMasi, Joseph, 126–27

Dixon Institute for the Retarded, 119 donor registries, 70 Drug Price Control Order (India, 1970), 184 drug regulation, 30, 117, 131–32. See also Food and Drug Administration Drugs Controller General (India), 186 drug trials. See clinical labor/trials Dumit, Joseph, 126 Economic Times (newspaper), 79 egg procurement: cross-­border, 69; for stem cell research, 98; vendors, 9 Elliot, Carl, 130, 136 ema. See European Medicines Agency Embracing World Bank (1989), 79 embryo procurement, 93–94 Embryo Protection Act (Germany, 1990), 47 Employees State Insurance Scheme (esis), 190 Epstein, Richard, 28, 58, 211, 212 Epstein, Steven, 151–52, 207, 218 Equitable and Metropolitan Life, 23 esis. See Employees State Insurance Scheme eu. See European Union European Medicines Agency (ema), 117, 194, 202 European Union (eu), 6, 66, 74, 185 Exchange Commission, 127 experimentation: defined, 195–97; distributed labor of, 217–19, 223 Fair Labor Standards Act (1938), 24–25 family law, 13–14 fda. See Food and Drug Administration fdaaa. See Food and Drug Administration Amendments Act (2007) Feher, Michel, 44 Feinberg, Joel, 143 fertility outsourcing, 27–38, 61. See also gestational surrogacy; oocyte procurement; sperm banks fertility tourism, use of term, 63, 69 Fisher, Jill, 135, 152, 156–57 flsa. See Fair Labor Standards Act (1938) Food, Drug and Cosmetic Act (1906), 131–34 Food and Drug Administration (fda), 40, 117, 121–22, 131–34, 161, 194, 202, 206–7, 208, 216 Food and Drug Administration Amendments Act (2007), 240n10

Fortner v. Koch (1935), 142 Fourteenth Amendment, 23 Franklin, Sarah, 103 FrontageLab, 171 Fudge, Judy, 20, 26 Fumagalli, Andrea, 6 gamete procurement: anonymity in, 70; biomedical intervention, 45; clinical labor in, 20, 226; markets, 34, 49, 51. See also oocyte procurement Gandhi, Mahatma, 188 Gandhi, Rajiv, 188 gats. See General Agreement on Trade in Services Gaudillière, Jean-­Paul, 40 gcp. See Good Clinical Practice General Agreement on Trade in Services (gats), 80, 87, 160, 186, 188, 226 gestational surrogacy, 9; class profile, 49–50; clinical labor in, 20; fecundity and, 85; fees, 56, 63, 64–65, 234n16; as feminized labor, 81–83; implications of, 20–21; Indian, 65, 78–88, 226; markets, 34–35, 64–65, 84; outsourced, 35, 38, 87, 226; parental claims, 58–60; prohibitions on outsourcing, 38; vs. traditional surrogacy, 49; travel requirements, 63 Gift Relationship, The (Titmuss), 55 Gilles, Didier, 198 Ginzberg, Eli, 147 glp. See Good Laboratory Practice Good Clinical Practice (gcp), 160, 163 Good Laboratory Practice (glp), 160 Grady, Christine, 129–30 Gujarat State Biotechnology Mission, 191 Halpern, Sydney, 141–43, 235n6 Harmonious Society, 166–67, 181–82 Harris, Cheryl, 33–34 Hartsock, Nancy, 101 Harvard Business School, 196 Health Insurance Portability and Accountability Act (1996), 214 Healy, Bernadine, 207 Henderson, Gail, 173–74 Hernle, Werner, 119 hfea. See Human Fertilisation and Embryology Authority

Index 275

Hill, Austin Bradford, 118, 141 Hill, Elizabeth, 79 hipaa. See Health Insurance Portability and Accountability Act hiv/aids clinical trials: in India, 191–92; treatment activism, 198, 203–7, 210 Hochschild, Arlie, 105 Holmes, Oliver Wendell, Jr., 139–40 Holmesburg Prison, 146–47 Hornblum, Allen, 147 hospital reform in China, 173–81 Hu Jintao, 165–66, 177, 181, 183 human capital theory, 19, 31. See also Chicago School Human Embryonic Stem Cell Research Advisory Committee, 98 Human Fertilisation and Embryology Act (UK, 1990), 47 Human Fertilisation and Embryology Authority (hfea), 73 Human Research Ethics Committees, 7 Hwang Woo Suk, 97 ich. See International Conference on Harmonization icon, 186 independent contractors: in China, 180; in clinical trials, 145–46; post-­Fordist, 4–5, 18–20, 27–28; risk and, 26–28. See also outsourcing Indian High Court, 78 inds. See investigational new drugs informed consent, 13–14, 115, 132–33, 142–44, 147, 183, 223 Insemination Committee, 46 institutional review boards (irbs), 132 intellectual property (ip) rights, 86–87, 92, 111, 219 Internal Revenue Service (irs), 41, 145, 236n10 International Conference on Harmonization (ich), 160, 226 International Federation of Pharmaceutical Manufacturers’ Association, 160 International Review Boards (irbs), 7 investigational new drugs (inds), 7, 125–26, 128–29, 132–35, 186, 202, 204, 211–12 in vitro fertilization (ivf): development of,

276 Index

45–46, 69–70; embryo procurement from, 93–94; oocyte recruitment and, 48–49 ip rights. See intellectual property (ip) rights irbs. See International Review Boards irs. See Internal Revenue Service ivf. See in vitro fertilization Janita Dal, 82 Jasanoff, Sheila, 46–47 Johnson, Anna, 59 Johnson v. Calvert (1993), 58–60 Journal of Translational Medicine, 200–201 Just Another Lab Rat, 136 Kefauver-­Harris Amendments (1962), 132–33, 147, 203–4, 210–11, 219 Kent, Julie, 94–95 Keynes, John Maynard, 144, 236n7 Knight, Frank H., 31, 32, 124, 128 labor: alienated, 102–5, 107, 111–12; contracts, 57–60, 103–4; control and, 102–3; feminized, 81–83, 105; flexibility, 26; immaterial, 109, 112; legislation, 22–24; models, 3–4; reform in India, 188–93; theory of value, 24–25, 31, 144, 231n3, 235n5; unions, 22–23; use of term, 33. See also clinical labor/trials; regenerative labor; reproductive labor Labor Law (China, 1995), 176–77 Ladimer, Irving, 145 Landecker, Hannah, 12–13 Langlitz, Niklas, 208 Lazzarato, Maurizio, 109 Lemmens, Trudo, 130, 136 Levine, Aaron, 57 Lichtenstein, Alex, 155 Lieberman, Robert C., 24 Li Yizhong, 182 Li Zhang, 183 Lock, Margaret, 103 managed care, 149 Managed Heart, The (Hochschild), 105 Manteno State Hospital, 119 Mao Zedong, 182 Martin, Paul, 96 Marx, Karl, 24, 102, 111, 138, 164, 230–31n10 McDowell, Linda, 106–7 McNeill, Paul, 137

Medicaid, 147–48, 157 Medical Research Council (UK), 98, 118, 141 Medicare, 147–48 “Medium- and Longterm Science and Technology Development Plan,” 165–66 Menikoff, Jerry, 143 Michigan Supreme Court, 142 microcredit, 82 migrants: in clinical trials, 16–17, 152–53, 164, 207; oocyte vending and, 65, 71, 76, 106; risks for, 177–78, 224 Milk Marketing Board (UK), 39 minimum wage, 22–23 Ministry for Science and Technology (India), 185 Ministry of Agriculture (UK), 39 Ministry of Commerce and Industry (India), 185 Ministry of Health (China), 175, 179–80 Ministry of Health (UK), 118 Ministry of Health and Family Welfare (India), 80 Ministry of Tourism (India), 80 Mirowski, Philip, 132 Modernization Act (1997), 208 Modi, Narendra, 190 Monash University, 45–46 Nahman, Michel, 76–77 National Academies of Science (US), 98 National Biotechnology Development Strategy, 185 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 205 National Foundation, 143 National Industry Recovery Act (1933), 23–24 National Institute of Health Revitalization Act (1993), 206–7 National Institutes of Health (nih), 126, 129, 146, 194, 200, 206–7, 210, 239n7 National Insurance Act (UK, 1946), 21–22, 25 National Organ Transplant Act (1984), 41 National Research Act (1974), 132 National Research Council, 98 Nehru, Jawaharlal, 183 New Deal, 2, 24–25 New Household Economics, 5

New Jersey State Colony for the Feeble-­ Minded, 119 New York Times (newspaper), 79 nongovernmental organizations (ngos), 164 Nordica Fertility Clinic, 70 North East England Stem Cell institute, 98 oecd. See Organisation for Economic Co-­ operation and Development Office of Research on Women’s Health, 206 Ohio Soldiers and Sailors Orphanage, 119 O’Malley, Pat, 54, 57–58, 139, 199 Ong, Aiwha, 67 Ontario Law Reform Commission, 46 oocyte procurement, 44–47; compensation market, 68–73; contracts, 53–57; European market, 66–76; intervention in bodies, 51–53; markets, generally, 63–64; origins of, 45, 47–50; prohibitions on, 38, 66; recruitment, 71–72; risk exposure, 74; Romanian, 76–77; scarcity value, 111; in stem cell research, 96–99; surplus, 55; surrogacy model for, 48–49. See also gamete procurement Organisation for Economic Co-­operation and Development (oecd), 6, 185 outsourcing: business model, 19–21; of clinical labor, 18–19, 150–51, 219, 226, 227–28, 239n2; fertility, 27–38, 61; of gestational surrogacy, 35, 38, 87, 226; human capital theory on, 28–31; of oocyte procurement, 38; risk and, 27–28. See also independent contractors Oviedo Convention, 66 Pande, Amrita, 83, 86 Parexel, 186 Parkinson’s Disease, 94 Pateman, Carole, 103–4 Patent Act (India, 1972), 184 patents, 124–25, 126, 184–86 Patient Recruitment Organizations (pros), 151 PatientsLikeMe, 197–98, 213, 216 Pennhurst State School and Hospital, 119 Pennsylvania State Department of Corrections, 146–47 Personal Responsibility and Work Opportunity Reconciliation Act (1996), 157 Petryna, Adriana, 162, 163, 237n3 Pfeffer, Naomi, 95

Index 277

pharmaceutical industry. See clinical labor/ trials Pisano, Gary, 125 PlanetHospital, 79 Pluristem, 96 Polkinghorne Guidelines, 94–95 Posner, Richard, 28 post-­Fordism: clinical labor, emergence of, 18; independent contractors and, 4–5, 18–20, 27–28; reproduction and, 106–7; service sector and, 3; time of work/life in, 6 Postone, Moishe, 11, 138 pra International, 186 Prescription Drug Users Fee Act (1992), 208 PricewaterhouseCoopers, 80 prisons. See under clinical labor/trials Private Securities Litigation Reform Act (1995), 127 Proactive Family Solutions, 79 pros. See Patient Recruitment Organizations Quintiles, 186 Radin, Joanna, 131 raf. See Royal Air Force randomized controlled trials (rcts), 117–18, 119, 132, 141, 194, 201, 238–39n1. See also clinical labor/trials rcts. See randomized controlled trials Reagan, Ronald, 124 regenerative labor: in bioeconomy, 100, 225; in stem cell technologies, 107, 113; use of term, 90 regenerative medicine (rm), 91–93, 115 rentier state, 86 reproductive contracts: as labor contracts, 57–60; for oocytes, 53–57 Reproductive Health and Research Bill (2006), 98 reproductive labor, 9; arbitrage, 67, 74; clock time and, 111–15; debates, 101–6; as economic labor, 33; in Fordist household, 27, 112, 222; post-­Fordist, 106–7; risk in, 38; types of, 34. See also gestational surrogacy; oocyte procurement; sperm banks reproductive tissues, 34, 55, 90. See also oocyte procurement res nullius, 9, 225 Revitalization Act (1993), 206–7

278 Index

Rheinberger, Hans-­Jörg, 195–97 Ricardo, David, 10–11 Richards, Edward, 143 risk: Chicago School on, 30; in clinical labor/ trials, 18, 21, 32, 38, 81, 128, 130, 134–38, 164, 187–88, 235–36n6; employer liability, 22; independent contractors and, 26–27; regulation, in China, 181–83; reproductive labor, 38; volenti non fit injuria, 21, 30, 32, 139, 143, 199, 209–11, 223–24 Risk, Uncertainty and Profit (Knight), 124 rm. See regenerative medicine Roadmap for Medical Research (nih), 200 Rockefeller Foundation, 118 Rockefeller Institute, 143 Roe v. Wade (1973), 47 Rofel, Lisa, 167 Roosevelt, Franklin Delano, 22–24 Royal Air Force (raf), 118 Royal Navy, 118 Rubin, Isaak, 11 Safe Harbor clause (1995), 127–28 Salk, Jonas, 119 Sassen, Saskia, 64–65 Schloendorff v. Society of New York Hospital (1914), 142 Schultz, Theodore, 31 scnt. See Somatic Cell Nuclear Transfer semen: capital value of, 41–42; cryopreservation, 40–41; fees, 43; Nordic, 62; sperm count, 42–43. See also sperm banks Sentinel Initiative, 216–17 Shanghai Clinical Research Center, 170 Shivrath Center of Excellence in Clinical Research, 191 Sildenafil, 216 Simmel, Georg, 54, 71 site management organizations (smos), 170, 178 skin color in reproduction, 64, 78, 88 slavery, 33–34, 232n9 Smith, Adam, 10, 231n3 social insurance, 24, 30, 128, 140–41, 143, 147, 176, 224–25 social networking, use of, 197–98, 213–14 Social Security Act (1935), 23–24 Social Security Administration (ssa), 206

Society for Assisted Reproductive Technology, 56–57 Solinger, Dorothy, 177 somatic cell nuclear transfer (scnt), 92, 97–99, 114 Special Economic Zones, 191 specific performance, 58–60 sperm banks, 37, 38–44, 49, 51; capital value, 42; vendors, 9. See also semen ssa. See Social Security Administration Stanley, Amy D., 23, 56 Stark, David, 179 start (South Texas Accelerated Research Therapeutics), 171 State Food and Drug Administration (China), 179–80 Steinbrook, Robert, 236n9 stem cell research, 34; allogeneic tissue, 92–93, 100; as controversial, 95–96, 234–35n4; from cord blood, 96, 227; from embryos, 93–94; from fetal tissue, 94–95; from oocytes, 96–99; pluripotent cells, 91, 227; procurement, 93–99; somatic cell nuclear transfer, 92, 97–99, 114; value creation and, 113–15; women as providers for, 89–92, 100–101 Stengers, Isabelle, 198 Stigler, George, 203 Sunder Rajan, Kaushik, 130, 163, 187, 188 Supreme Court (US), 22–24, 133, 211 surrogacy. See gestational surrogacy Tam, Waikeung, 175 Terranova, Tiziana, 109–10 Textile Labor Association (Ahmedabad), 188, 193 thalidomide scandal, 132, 216 ThermoFisher Scientific Inc., 191 Thompson, Charis, 102–3 Thrift, Nigel, 108 Tissue and Cells Directive (eu), 66–67, 73 Titmuss, Richard, 28, 55 tort law, 13–14, 139–46, 180, 182–83 Trade-­Related Intellectual Property Rights (trips), 87, 160, 166, 185 translational medicine, 125, 199–203, 225 Translational Medicine Funding Board, 200 trips. See Trade-­Related Intellectual Property Rights

Tufts Center for the Study of Drug Development, 126–27, 158, 161 Uniform Parentage Act (1975), 59 unionization, 22–23, 130 United States Circuit Court of Appeals for the District of Columbia, 211 user-­generated innovation, 213–17, 218, 240– 41n11 Vacaville Prison, 154 volenti non fit injuria, 21, 30, 32, 139, 143, 199, 209–11, 223–24 Vora, Kalindi, 79, 82–85 wages, 22–23, 25, 129–30 Waller Committee, 46 Warnock Committee, 46 Washington Legal Foundation, 209–11 Webster, Andrew, 92–93 Weijer, Charles, 129 Weiss, Robert, 154 Wen Jiabao, 166, 177, 181, 183 who. See World Health Organization Wilkinson, Frank, 21 women: aids activism and, 122, 205–7; in clinical trials, 121–22, 152–53, 193; embodied risk by, 38; feminized labor, 81–83, 105; property rights and, 104; return to workforce, 29; sexual contracts and, 103–4; as stem cell providers, 89–90; unpaid productive work by, 101–2, 105, 222; worker status, 24–25, 74–75 workers’ compensation statutes, 22, 140, 143 World Bank, 79, 184 World Health Organization (who), 68, 173 World Trade Organization (wto), 80, 160, 185–86 wto. See World Trade Organization Xuhui Central Hospital, 170 Ypsilanti State Hospital, 119 Zeller, Christian, 86–87 Zhangjiang Biopharmaceutical Park, 168, 169 Zhengzhou University, First Affiliated Hospital, 171 Zhongguancun Life Science Park, 168, 169

Index 279