Human Aspects of Biomedical Innovation [Reprint 2014 ed.] 9780674865464, 9780674865440

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Human Aspects of Biomedical Innovation

Harvard Studies in Technology and Society The volumes in this series present the results of studies conducted at the Harvard University Program on Technology and Society. The Program was established in 1964 by a grant from the International Business Machines Corporation to undertake an inquiry in depth into the effects of technological change on the economy, on public policies, and on the character of the society, as well as into the reciprocal effects of social progress on the nature, dimensions, and direction of scientific and technological developments.

Volumes in the Series Anthony G. Oettinger with Sema Marks, Run, Computer, Run: The Mythology of Educational Innovation, 1969 Emmanuel G. Mesthene, Technological Change: Its Impact on Man and Society, 1970 Anne P. Carter, Structural Change in the American Economy, 1970 Robin Marris and Adrian Wood, editors, The Corporate Economy: Growth, Competition, and Innovative Potential, 1971 Alan F. Westin, editor, Information Technology in a Democracy, 1971 Everett Mendelsohn, Judith P. Swazey, and Irene Taviss, editors, Human Aspects of Biomedical Innovation, 1971

Human Aspects of Biomedical Innovation

Everett Mendelsohn, Judith P. Swazey, and Irene Taviss, editors

Harvard University Press / Cambridge, Massachusetts /

1971

© Copyright 1971 by the President and Fellows of Harvard College All rights reserved Distributed in Great Britain by Oxford University Press, London Library of Congress Catalog Card Number 74-160027 SBN 674-41331-8 Printed in the United States of America

Foreword

When we first conceived this study in 1966, the subject of the social implications of biomedical technology represented relatively new and uncharted territory. Since that time, there has been no diminution either in the importance of the subject or in the challenge it presents to our social wisdom. On the contrary, such dramatic events as the advent of human heart transplants and breakthroughs in genetic research have served to increase public recognition of the importance and difficulty of the social and ethical problems involved. In .the academic year 1966-1967, the Harvard Program on Technology and Society established a small research group to begin to explore the subject. This group, which was headed by Everett Mendelsohn and included Judith Swazey and Stanley Reiser, convened a series of meetings and commissioned a number of papers dealing with various aspects of biomedical science and technology. In the following year, an expanded group under the direction of Seymour Kety (and including Mark Field, John Knowles, and Louis Lasagna in addition to the original members) continued discussions and study of these issues. Drs. Mendelsohn, Swazey, and Taviss then undertook preparation of this volume for publication. Since both scientific and social events moved quickly in the interval between research and publication, and because we were attempting more than another collection of symposium papers, the volume was revised and updated a number of times and required the skills of several editors. T o m Parmenter and Stanley Dry deserve warm acknowledgment for their contributions in this regard. T h e issues discussed in the volume have to do specifically with the social control of new biomedical technologies and with problems in the organization and delivery of medical care that have v

vi

Foreword

arisen in the face of technological and social change. Yet these questions are not unlike those that arise in other areas where technological change impinges on social institutions. They relate to how science and technology can be used to social advantage and how the negative consequences of new technologies can be controlled. What should social policy be with regard to the allocation of resources in this area? What value conflicts arise? What new types of regulatory mechanisms are needed? What have been the unintended consequences of deliberate social and technological changes? It is evident that what were once considered exclusively professional decisions are increasingly coming to be regarded as decisions that need to be made by the larger society. There are many reasons for this: new biomedical technologies can affect the health of entire communities; community action for dealing with contemporary health problems (e.g., pollution and highway safety) is taking on new importance; human experimentation and potential technologies of genetic and behavior control raise issues of individual freedom and privacy; there is an increasing shortage of medical manpower; and biomedical research and health care are more and more becoming public responsibilities financed out of the public purse. These various factors contribute to a growing need for social guidance. As Taviss notes in the first paper below, "where the profession is deeply divided (as in the case of human experimentation), where it is unaccustomed to the problems at issue (such as those raised by the large amounts of government money recently devoted to biomedicine and by current demands for better and more equitable distribution of health care), and where a very broad range of social issues is at stake (as in genetic and behavior control), the imposition of social controls seems to be required. On the other hand, where the problems are recurring ones for the profession (as in the 'experiment/therapy dilemma'), or where the issues demand biomedical expertise and must be solved if further scientific progress is to be made (as in the problem of the definition of death), the profession may take the lead in developing controls. The transition from informal to

Foreword

formal social controls usually takes place when the informal regulations provide insufficient guidelines and ineffective controls." But formal legal controls often raise major problems, as the PKU story by Bessman and Swazey amply demonstrates. While controls are surely needed, they must yet remain flexible, so as not to stifle research or lock in a given state of the art. Advanced medical technologies and the increased need for human experimentation also create new problems in medical ethics. Pellegrino discusses these problems in relation to the changing nature of medical practice—team practice and the emergence of the physician-investigator—and Lasagna looks specifically at human experimentation. Both of these papers touch on the dilemmas involved in balancing social against individual values, an issue that was central also in the conference on behavior control technologies reported on by the editors. The concluding section of the volume examines the problems for social and professional decision-making that arise as a result of changes in medical manpower and medical practice. Sidel's essay examines the effects of new diagnostic and treatment techniques on both the practice of medicine and the delivery of health care. Field's paper deals with the problems posed by medical specialization and the disappearance of the general practitioner and proposes some remedies. Knowles's paper details the medical manpower shortages in various geographical areas and in various medical specialties, as well as their effects on the health care of the nation. I am pleased to see this volume added to our series "Harvard Studies in Technology and Society" and I hope that it will contribute to an improved understanding of this important dimension of the technology-society relationship. Emmanuel G. Mesthene, Director Harvard University Program on Technology and Society.

Contents

v

Foreword Part I

Introduction

Problems in the Social Control of Biomedical Science and Technology 3

I R E N E TAVISS

Part II and

Toward a Social Policy for Biomedical

Science

Technology 47

Editors' Note PKU: A Study of Biomedical Legislation S A M U E L P . B E S S M A N AND J U D I T H P . SWAZEY

49

Physician, Patients, and Society: Some New Tensions in Medical Ethics E D M U N D D. P E L L E G R I N O

77

Some Ethical Problems in Clinical Investigation L O U I S LASAGNA

98

The Harvard Conference on Behavior Control Technologies E V E R E T T M E N D E L S O H N , J U D I T H P. SWAZEY, AND I R E N E TAVISS

Part HI

Science,

Technology,

and the Practice of

Editors'Note

111

Medicine 129

New Technologies and the Practice of Medicine VICTOR W . SIDEL

131 IX

Contents

The Health Care System of Industrial Society: The Disappearance of the General Practitioner and Some Implications MARK G. FIELD

Notes on Medical Manpower: Quantity, Quality, and Medicine's Current Efforts JOHN H. KNOWLES

Human Aspects of Biomedical Innovation

Part I

Introduction

IRENE TAVISS

Problems in the Social Control of Biomedical Science and Technology

The announcement of the first human heart transplant set off a flurry of concern and speculation about where advances in biomedical science and technology are taking us. The unforeseen adverse effects of such drugs as thalidomide provoked public demands for more thorough investigation and control over the products of our new biomedical knowledge. The suggestion that genetic research might soon provide us with the capacity to shape or alter the nature of the unborn child has brought a sense of both awe and fear. Yet these developments are but the most spectacular and dramatic examples of an ongoing process of change in the biomedical sciences that has already resulted in better health and increased longevity and that has at the same time generated new problems for social decision-making and control. Advances in the biomedical sciences and technologies, like advances in other scientific and technological areas, produce changes which are not always reflected adequately in the organizations, procedures, and values that govern their social utilization. Thus, advances in medical research and developments in human experimentation have not yet, by and large, been accompanied by changes in the training of medical personnel or by elaboration of a new Hippocratic Oath equal to the ethical problems of modern medical research and practice. The use of large-scale medical technologies has not yet resulted in any significant change in the organization of hospitals to allow them to pool resources and eliminate costly duplications and inefficiencies. Nor has the increased specialization of the medical profession been accompanied Irene Taviss is Research Associate, Harvard University Program on Technology and Society.

3

4

Introduction

by any substantial changes in the expectations of most patients concerning adequate medical care: a "family doctor" is still what most patients want, and the delegation of some medical tasks to nurses and other paramedical personnel is generally still looked upon with disfavor. The closing of such gaps or "cultural lags" between technological innovation and social response usually occurs through a gradual process. But the process is by no means automatic. Many thorny issues arise in the decision-making processes of private groups and organizations that are affected by the technological changes as well as in public deliberations about values, goals, and needed mechanisms of social control. Moreover, the rate of scientific change and its pervasive effects have occasioned a heightened concern about the need to anticipate the social problems which result from scientific and technological advances. Even though the precise direction of genetic and behavioral research cannot be predicted neatly, for example, it is considered not too soon to think about how society can see to it that the fruits of such research will not be misused. This concern inevitably forces us to attend explicitly to the values that we hold as a society and to the conviction with which we hold them. Considerations of values and mechanisms of social control also enter into the very processes by which new science and technology are generated. While the theoretical state of the art of any given scientific specialty is of course an essential determinant of scientific and technological progress, the amount of money and technical resources that go into a research area can make a critical difference in the rate at which that area advances. Hence, the social decisions which enter into the extensive governmental and private support of scientific research are highly significant. During 1971 the federal government will spend $1.66 billion for health research. At the present time, the federal government provides about 60 percent of all funds spent in the United States for health research. Industry contributes about 28 percent, and foundations, voluntary agencies, and others contribute about 11 percent.1 The power of the purse is only one aspect of increased governmental intervention in biomedical research, however. A second

Introduction

is the heightened welfare orientation of the government and society in general. While good medical care was once considered a privilege, it is now coming to be defined as the right of every citizen. In this transformation, the simple doctor-patient relationship has been superseded by a tripartite relationship, in which the society, or the state, bears ultimate responsibility for the care of the patient. Such intervention manifests itself at many different levels: in the establishment of public medical facilities, in the provision of health insurance, in the support of medical education, and in the financing of biomedical research. Medicare legislation authorizes the government to stipulate what kinds of medical services will be paid for. It thereby grants the government some measure of quality control and allows it to impose standards in matters of cost and organizational structure. Through support of medical education, the government may encourage the development of certain studies—public health and community medicine, for example. 2 The growth in size and complexity of the biomedical enterprise and increased governmental intervention have made problems of social control both more acute and more visible. Moreover, as biomedical technology continues to become more complex and biomedical knowledge more sophisticated, many traditional regulatory and legislative functions become more problematic. Our success in developing an adequate social response to these new developments and problems depends on first understanding the issues that arise in connection with the social control of biomedical science and technology.

Allocation of Resources The allocation of scarce resources is a crucial matter in the governance of any society or institution. It reflects both the priorities of the society and the peculiarities of its decision-making processes. Thus, it is the society at large that must ultimately decide what proportion of its total national resources it wishes to devote to biomedical research and the delivery of medical care. That is, society must decide how highly it values health as

5

6

Introduction

against other national goals, such as military security, material plenty, or economic equality. The many problems that arise concerning the criteria according to which, and the political processes by which, this first allocation decision is made are reflected in microcosm in the equally difficult decisions about how a given pool of resources devoted to health will be subdivided among the various claimants on it. In this microcosm, i.e., within the biomedical area, issues of resource allocation arise in connection with research support in the different biomedical specialties and with the delivery of medical care. The two are related, of course, since the results of research are eventually utilized in medical and health care. The two areas remain distinct, however. The major factors influencing the allocation of resources to research and development are the scientific state of the art in each specialty and the social importance of the problems under investigation. These two criteria are often in tension, since difficult trade-offs must be made between the desire to advance scientific knowledge in a particular field and the desire for direct social benefit. It is no easy matter to decide whether support should be given to research areas that promise a fast therapeutic payoff or whether to emphasize research in areas in which the advances may be slower but also more significant in the longer run. These difficulties are further compounded by the fact that the scientific state of the art and the social importance of a particular medical problem are not the only factors that affect allocation decisions. The values and interests both of the scientific researchers and of the relevant political authorities constitute an additional and highly significant element in this regard, as does also the tendency for patterns of allocation to persist even after changed social and scientific conditions have rendered them less useful than they were when first introduced. John Piatt has pointed to one of the ways in which the system of government grants tends to perpetuate scientific interests in a given field and can keep money flowing into it with little regard to the social importance of the research. He notes that "if the

Introduction

grand old man in a certain field was skilled in 'grantsmanship' just after World War II and got large grants or contracts for a few years, he was able to feed numerous undergraduate and graduate and postdoctoral students. As a result, within a few years he produced a dozen more trained scientists in the same field, specialists who had published papers and who knew how to apply for grants and who, as established experts, would recommend each other's grants and might even become agency officials." 3 As a result, "in every field of science . . . there are areas that are being overstudied . . . by men who might be doing something more valuable with their brains." 4 Piatt's proposed remedy for this situation is that government granting agencies should deliberately make judgments about the relative importance of different areas of research and should provide incentives for scientists to devote their attention to areas that are important but neglected at any particular time. "If government agencies do not want to point the finger at some areas as being overcrowded," Piatt continues, "they might at least consider giving wide publicity to the relative numbers of men and projects in different areas and to the ranking of the importance or promise of these areas by experts from nearby fields; and they might be able to take the lead in pointing out understudied fields and in soliciting grant applications in such fields." 5 There is certainly nothing objectionable in this suggestion. Scientists themselves, of course, exert considerable influence over the direction of research. Government attempts to do likewise by the use of such a policy might in fact prove quite valuable, as is suggested by the experience of some government agencies which have begun, in a limited way, to encourage grant applications in new fields. On the other hand, scientists and many nonscientists as well are very much aware of the danger that government control, if carried too far, could lead to a situation in which only certain areas of research were permitted and politically or socially unpopular research was stifled. To the extent that the "scientific establishment" functions as a lobby group, it is principally to assure adequate funding for their endeavors and to guard against this danger. How to avoid that danger while still granting the

7

8

Introduction

government's responsibility to exercise some control over and establish some priorities in scientific research poses a very difficult problem of resource allocation. Another frequent source of tension between the government and the scientific community is the question of the proper allocation of resources as between "basic" and "applied" research. Thus, the passage of the Heart, Cancer, and Stroke Act of 1965 and President Johnson's suggestion in launching the Medicare Program in June 1966 that it was time "to zero in on the targets" and "to get our knowledge fully applied" generated considerable concern among members of the biomedical community. They sparked the fear that the government would cut back on funding allocations for basic research—a particularly dangerous prospect, since much of the biomedical research remains in what Alvin Weinberg has called the "prefeasibility stage"; that is, the feasibility of application has not been demonstrated and therefore the link between "basic" and "applied" research is not as clear as it is in the physical sciences. 8 The desire of the President and the Congress to see tangible results from biomedical research in the form of improved health care is understandable, of course, and it is not easy to fault attempts to initiate large-scale efforts directed toward a cure for heart disease or cancer. The problem is that such otherwise praiseworthy attempts can often be scientifically premature and therefore wasteful. As Weinberg puts it: "I think it is fair to say that most basic molecular biologists would work directly on a cure for cancer rather than on what they are now doing, if only they knew how to make real progress. We don't cure cancer not because we don't want to, but rather because we don't know how to cure it." 7 Bearing in mind that science is not without its fads and fashions, however, governmental insistence on utilizable research can often serve as an indispensable corrective. Harvey Brooks has characterized the process of resource allocation in the biomedical area as follows: "The small feedback loops by which NIH controls its program are rooted in scientific criteria, but the large feedback loops which govern its budget and its broad allocations are primarily governed by the disease cate-

Introduction

gories and health problems, and what is perceived as their social importance. This hybrid system has on the whole been remarkably effective." 8 A less sanguine view of the matter is taken by Elizabeth Drew in her analysis of the "health syndicate," her name for the powerful lobby for medical research. She notes, for example, that as a result of the efforts of this group (which includes a number of aged legislators), resources devoted to research relating to the health of the elderly consume at least fifty percent of the federal health budget, despite the fact that almost half the population is under twenty-five and that infant mortality in the United States is higher than that of fourteen other countries. 9 That diseases of the elderly are receiving the lion's share of the health research budget is indicative of the kind of imbalance in resource allocation for medical care that has recently become a subject of much concern. If every citizen has the right to receive adequate medical care, how is this to be effected? Can the imbalances in favor of the old, the big-city resident, and the rich be rectified? How can this be done without sacrificing the high quality of medical care that has become available to the privileged as a result of the heavy investment in elite institutions and large-scale technologies? The dilemmas of resource allocation in medical care are illustrated most starkly by figures such as the following: The estimated cost for transplanting a kidney and providing follow-up care is $5,000, while $130 per year could give adequate routine health care to a poor American; $1 billion could buy enough kidney dialysis centers to serve the 25,000 or more people who will need them in the next decade, or it could buy comprehensive ambulatory health care for more than 1,250,000 poor people. 10 While such a juxtaposition of costs might not be the best way to examine the trade-off problems in the allocation of resources, it does point to a major issue in the medical care system, i.e., the heightened concern about the inadequate health services received by the poor. Recent breakthroughs in medical technology, such as dialysis machines, have become an irritation to those whose principal concern is with the general health of the poor; it is the

9

Introduction

same kind of irritation that is expressed in the frequently heard complaint that "We can put a man on the moon, but we can't get the rats out of Harlem." As in other welfare areas, real progress in providing better health care for lower-income groups depends only in part on making more resources available. Health is the third largest industry in the United States today, and annual health expenditures comprise approximately 6 percent of the gross national product. The spiral of rising demands and rising costs will not be significantly affected by more funds alone. To provide adequate distribution of medical care will require the kind of social dedication and purpose that will manifest themselves in changes in the organization of the health care system. But better organization and planning here, as elsewhere, meet with the resistance of vested interests and the lethargy of traditional habits and patterns. In the absence of such change, however, the health sector continues to be riddled with such anomalies as "two new hospitals, both half-empty standing] within blocks of each other" or "a halfdozen hospitals each equipped and staffed to do open heart surgery—one of the most expensive of all surgical specialties . . . [despite the fact that there are] barely enough cases to keep one of the centers busy." 11 These are examples of how the traditional patterns and reward system of the medical profession can lead to wasteful duplication of technological capabilities. The opposite problem arises in many new areas of biomedical technology in which the dilemma of how to allocate scarce technological resources becomes particularly acute. It has been estimated, for example, that at least 20,000 artificial kidney machines would be needed to keep pace with the 5,000 to 10,000 new patients each year who need hemodialysis. Yet, in the United States in 1968, only about 800 persons were being maintained by hemodialysis in 121 treatment centers.12 Since the availability of a dialysis machine usually means the difference between life and death for the patient, how will the selection be made of the people who will be allowed to live? It is obvious that the medical condition of the patient—his general health, age, medical history—must be one consideration.

Introduction

Since the requirements of treatment in chronic dialysis are often highly stressful, moreover, psychiatric examination of the patient might provide a second basis of selection. Beyond these two criteria, the possibilities are many and the dilemmas poignant. Shall we favor the young, who might be given more time to live if selected for treatment? Or shall we choose the old, since present capabilities cannot promise more than a year or two more of life anyway, which may mean more in the life of an older person? Shall we favor those with heavy responsibilities to others, since their loss would place a greater burden on society, or shall we adopt a "women and children first" policy? Shall we establish some kind of lottery or first-come-first-served system, or should we try to arrive at a more "rational" policy? More fundamentally, would attempts to develop such a policy boil down to service for those who can pay for the treatment and/or for those who meet the criteria of "social worth" that are prevalent in middle-class suburbia? In the Seattle Artificial Kidney Center, a committee was established to select patients on the basis of their "social worth." This experiment has generated much controversy, because of the obvious difficulties in specifying what is meant by "social worth" and the suspicion, therefore, that committee members defined it in accordance with their own particular values and biases. 13 This, in turn, has raised the question of how such committees should be constituted. Should they be composed of medical specialists, of medical and lay people together, of laymen alone? But if any arbitrary process of defining "social worth" is repugnant, then the composition of selection committees becomes less important than the specification of what the criteria for patient selection are to be. Another crucial question is who is to bear the cost for treatment. The idea that such life-and-death matters will continue to rest on individual ability to pay is becoming increasingly intolerable in American society. However, if society generally is to bear the cost, then the question of how much money, time, and talent should be devoted to such expensive experimental treatments as dialysis and transplantation becomes critical. As already noted,

Introduction

large investments in such relatively esoteric experimental care might seem extravagant in the face of the inadequacies of medical treatment received by large numbers of our poorer citizens. On the other hand, the promise that relatively inexpensive, effective, mass-produced technologies as well as new useful knowledge might result from such experimentation renders the question considerably more complex. The dilemmas raised in the process of allocating resources to medical research and medical care therefore converge at the point suggested at the start of this discussion: What proportion of our resources should we devote to areas that promise immediate payoff and large-scale social benefit and what proportion to longer-range and less certain developments? How much should be invested in those endeavors which have potential for broad applicability as opposed to those whose scope is narrower? While decisions about such matters ultimately must rest with the society at large, the nature and interests of the medical profession remain dominant factors in how the decisions are made, because it is the medical profession that has heretofore determined which technologies and treatments are developed and practiced. If changes in the present pattern of resource allocation are to be made, therefore, they will imply increased social control over the organization and functioning of the medical profession or increased social responsiveness by the medical profession.

Social Control of the Medical Profession Social control of the medical profession involves all of the difficulties inherent in the regulation of a special-interest group whose functioning directly affects the general welfare. Like any other professional group, doctors have control over their own licensing and regulatory procedures. In addition, their knowledge, wealth, and organization have given them a considerable amount of political power, especially in the United States. While this is not the place to analyze the politics of the American Medical Association, a discussion of social control of biomedical science and technology would be incomplete without some examination

Introduction

of the profession which translates biomedical advances into social use. Developments in science and technology have of course been responsible for significant changes in the nature of medical practice. As a consequence, they have created adjustment problems for the medical profession. To the extent that the profession's handling of these problems is deemed socially inadequate, the issue of social control arises. The medical advances which have allowed us to gain control over such diseases as pneumonia, tuberculosis, and smallpox have shifted the principal attention of medicine from acute to chronic illnesses. The treatment of chronic illness generally requires early diagnosis, health education, preventive medicine, and diagnostic procedures that can be applied to groups of people at a time rather than principally to the individual. 14 At the same time, social and technological complexity render individual health more and more dependent on community action, whether the problem is pollution control or highway safety. The practices of most doctors do not yet reflect these changed conditions. Indeed, the effects of scientific and technological progress on the practice of medicine seem to have been running in a direction counter to these needs. In the wake of new knowledge and technology, an increasingly complex system of medical specialization has developed. As a result, fewer physicians are available for the treatment of "the whole patient"; fewer doctors are available to provide the necessary health education, to make the early diagnoses, and to establish programs of preventive medicine. Moreover, the much-discussed decline of the general practitioner is a problem for many individuals who find it difficult to secure general medical advice and consultation and who miss the psychological comforts provided by the family doctor. 15 To some extent this problem is currently finding a solution in the tendency of specialists in internal medicine to assume some of the functions of the vanishing family doctor. But given the great demand for and the unabated proliferation of specialists, another possible solution to this problem is gaining favor: the training of upgraded medical assistants, such as the Medex or the

Introduction

nurse-practitioner. The role of this new type of health professional would be to deal with the "whole patient," thereby providing psychological comfort as well as serving as liaison between the patient and appropriate specialists. A second new type of generalist is the public health physician. As the focus of medical effort shifts from almost exclusive concern with the individual patient toward concern with community health, there is a growing need for physicians able to set priorities in the allocation of health resources within the community and to cooperate with other segments of the community to secure the social and economic prerequisites of good health. Such physicians would require training, not only in medicine but also in the social sciences and in such techniques as statistics and cost-accounting. The government could hasten the advent of such developments by making more funds available to hospitals and medical schools, by creating special programs, and by establishing community health centers. The need for social control of medical manpower is apparent also in the general shortage of medical personnel and in current imbalances among the medical specialties. In the absence of policy-making authorities with responsibility for anticipating medical manpower requirements, some specialties are seriously understaffed. 16 As in the case of scientific research previously discussed, government policies could provide special incentives to encourage medical men to enter these understaffed areas. The anticipation of medical manpower needs extends also to new types of specialists who will emerge as the role of computers in medicine continues to gain in significance. Despite some isolated successes in the use of computerized diagnosis, the role of computers in medicine has thus far been limited by and large to automation of hospital records and to use in medical research. Nevertheless, experiments across the country in using computers to gather medical information, to make diagnoses, and to monitor the medical condition of patients suggest that we should begin soon to train more physicians who can deal with the relationship between engineering and medicine. One important promise of computer technology in medicine

Introduction

is that it could provide a set of screening tests relevant to the patient's complaints that could be administered and processed almost immediately with the results instantly available to the diagnosing physician. The use of computers for actual diagnosis has many hurdles to overcome, of course, including the inability of most physicians to specify exactly and systematically what they do in arriving at a diagnosis. Reactions to such possible use of computers, incidentally, include both fear and hope. The principal hopes are that such a technological development might free the physician from technical chores and allow him to devote more attention to the nontechnical aspects of medical care and that it might make possible mass screening and health examinations. The principal fear is that it might routinize and depersonalize medical care. The assurance of proper use of this technology might thus become a major problem in the social control of medical practice. Aside from the special problems of financing medical care, which have received much attention of late, the proper use of advanced medical technology has been the major source of pressure for the adoption of new social controls over the medical professsion. The complexity and power of new technologies and techniques have made the consequences of medical decisions vastly more important. The decisions of a heart transplant surgeon or of a medical researcher experimenting on human subjects clearly become objects of social as well as medical concern. In addition, pressure for more regulation results from the rapidity of invention and dissemination of new techniques whose effects cannot be fully known in advance. By virtue of its expertise, the medical profession must of course play a role in the development of any proposed system of control. But the nature and extent of that role remain open questions.

Alternate Modes of Social Control The principal modes of social control over the use of biomedical science and technology may be categorized according to two axes: formal or informal and professional or social. In many instances, controls are formalized as a result of perceived in-

Introduction

adequacies in informal control mechanisms. Similarly, failures in a professional system of controls can call forth social controls. In some cases, finally, professional controls may be initiated only after informal social controls have begun to operate and exercise some pressure on the profession. Each mode of control has its own advantages and disadvantages, and each may be appropriate for some situations and not for others. A n examination of some major issues of contention over the control of biomedical science and technology serves to illustrate the problems involved in devising appropriate mechanisms. Human

Experimentation

Because of sheer increases in the volume of biomedical research, problems associated with human experimentation gain in importance. While laboratory work and animal experiments are important stages in the development of new medical knowledge and technology, experiments with human subjects are necessary at some point. This need raises very complicated questions of balancing the rights of patients against the need for knowledge and of choosing between social benefit and individual benefit. On the one hand, a patient must be protected against undue risk and manipulation. On the other hand, an experimenter must be protected against excessive restrictions on his work and against the paralysis that can result from an omnipresent threat of malpractice suits. While infringements of patients' rights and insufficient concern for the welfare of individuals are certainly not in the public interest, the social benefit derived from medical experimentation can be so great as to make the costs of failure to experiment very high. As Bernard Barber has put it, since even very careful and well-intentioned experiments may involve risks, "the public interest requires the public to take upon itself a certain measure of responsibility and burden for the risks which those who seek to benefit it must incur in its behalf. While researchers have no ethical right to make their subjects martyrs for society, society has no right to make martyrs of the experimenters who do harm in spite of their best and most conscientious efforts." 17

Introduction

Two concepts have emerged in the discussion about proper controls over the rights of the patient in human experimentation: "voluntary consent" and "informed consent." Opinions about the use of these two criteria range from the view that no experiments on uninformed patients can be justified morally on the basis of expected scientific gains, 18 to pleas for greater flexibility in the use of consent in order not to stifle necessary research. 19 The difficulties in applying these criteria are numerous. 20 First, there are different categories of human experimentation: experiments on patients which are directly related to the treatment they are receiving; experiments on patients which are not so related; and experiments on nonpatient subjects. Second, the nature of the risks involved and the degree of the experimenter's uncertainty vary widely. Third, different experiments have different degrees of importance for the advancement of medical knowledge. It may be, therefore, that different specifications of a general ethical code are necessary to cover such different experimental situations. Wolfensberger, among others, has suggested that a series of guidelines should be constructed to take into account the varieties of research and their accompanying risks. He argues, for example, that research for which the procedures are well tested and the outcomes predictable and which involve only limited invasions of privacy and sacrifices of time, energy, and dignity (as opposed to total surrender of autonomy or great risk of physical or emotional injury) might require only routine release forms, while more risky research would require more carefully worded release forms. 21 The currently existing codes of ethics—principally the Nuremberg Code and the code of the United States Public Health Service —specify only that subjects give their "voluntary" and "informed" consent before submitting to an experiment. However, these codes generally do not take account of differences in experimental situations of the kind cited above, except that the Nuremburg Code provides that "the degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment." 22 They provide no guidelines for how such a balancing of risk and benefit

Introduction

should be arrived at, however. Nor do these codes acknowledge the difficulties of defining consent. "The essential problem," as Barber has noted, "is to define in meaningfully concrete psychological and social terms what constitutes genuine 'voluntary consent'—or, as it is sometimes even more restrictively described, 'voluntary and informed consent'—in a particular research situation. The social and psychological distinction between 'voluntary' and 'coerced' behavior is often hard to make. For example, some doctors assert that charity patients who are asked, even before they are admitted to a hospital, to sign forms giving permission for the use of experimental drugs are, in effect, being coerced into giving that consent because they are afraid that if they do not sign they will not get the care they need. Are the laboratory assistants and medical or other students whom the clinical investigator or social scientist often use in their experiments genuine volunteers or a captive population? . . . How voluntary can be the consent given by those who are at least partly incompetent because of age (young or old) or illness (physical or mental)?" 23 There is good reason to doubt, finally, that "consent" really means the same thing when the subject is under the psychological duress of a serious illness as it does in the case of a healthy subject. Similar problems exist in defining "informed consent." Does it mean the same thing when outcomes can be predicted with a high degree of certainty as it does when they cannot? How much information must the patient be given in order for the consent to be "informed"? How technically knowledgeable does the patient have to be before his consent can be truly informed? Further, as numerous commentators have noted, might not the patient be harmed psychologically by being given full information about the nature of the experimental treatment and its risks? Might not some patients prefer not to have to make decisions about treatments whose nature they can understand only partly at best? Full disclosure of the nature and purposes of the research might also make certain kinds of experimentation impossible. How could one test for the effects of a drug in cases where the procedure requires checking for possible placebo effects if subjects were to

Introduction

be given full information? It could be argued that perhaps clinical experimentation need not follow all of the experimental procedures of the natural sciences and that there is a need for improving the metholology of mathematical or statistical assessment of outcome. Thus far the Nuremberg Code (and a number of analogs to it) has served as the principal basis for professional control of human experimentation. But the degree to which this code has been enforced and supplemented by such devices as hospital review committees differs in different institutions. Also, there is conflict within the professions, since the orientations of physicians and of clinical investigators are often divergent. While many clinical investigators are greatly concerned with protecting what they think of as their research rights, their physician colleagues are often swayed more by violations of ethical behavior that they have witnessed. Henry Beecher, for example, has compiled and published a set of twenty-two examples of ethical violations in human experimentation. His examples are drawn from leading medical schools, university hospitals, private hospitals, military departments, governmental institutes, Veterans Administration hospitals, and industry. Beecher suggests that however difficult informed consent may be, it must remain a goal. But the real safeguard remains the presence of "a truly responsible investigator." He suggests, therefore, that in order to discourage unethical experimentation medical journals should not publish data that have been obtained in an unethical fashion. Though he recognizes the loss to medicine that might ensue, he considers this less important than the "moral loss to medicine" which would result from the publication of such data. 24 Louis Lasagna argues that "although this is an attractive notion at first glance, one wonders whether in fact important data unethically obtained could or should really be buried in this way. If an unscrupulous investigator were to discover a cure for cancer, would it be ethical to keep this knowledge from being used by others for the benefit of cancer patients, in compulsive adherence to 'principle'?" 25 Lasagna's argument seems to ignore the fact that "adherence to principle" will not be established un-

Introduction

less some effective sanctions are imposed against unethical practices. Moreover, the gathering of medical information is generally a long-term process which seldom rests on the secret researches of one individual. Whatever the difficulties in establishing proper and effective codes of professional ethics, cases such as those reported by Beecher have led to supplementation of professional controls by overtly social controls over human experimentation, because the professional controls alone have been perceived as inadequate. One rather well-publicized case of ethical violation illustrates the process. In an experiment in the Jewish Chronic Disease Hospital in Brooklyn, New York, medical researchers injected live cancer cells into elderly patients without their knowledge. While the researchers claimed that little risk was involved, some of their colleagues objected and brought about a hearing. As a result, the New York State Board of Regents found the doctors guilty of fraudulent practice and formulated two general principles that were henceforth to govern such matters: (1) that a physician may not withhold any information that would influence the decision of the subject about whether to participate in an experiment and (2) that "when he is acting as experimenter," the physician "cannot claim those rights of doctor-patient relationships that do permit him, in a therapeutic situation, to withhold information when he judges it to be in the best interests of his patient." 26 Explicitly social controls as supplements to professional controls have also been applied by the National Institutes of Health and the Food and Drug Administration. The former requires that all its grantees receive written permission from the subjects of their investigations. FDA regulations require informed written consent from anyone who is given an investigational drug. Researchers like Lasagna fear that regulations such as those of the FDA will exact a high social cost, because proper investigation of drugs will not always be possible, with the consequence that development of new and better drugs may be hampered. Others, like Pappworth, argue that legislation is needed to enforce ethical principles.27 In other words, Pappworth believes that

Introduction

informal social controls operate ineffectively, and therefore he argues for the imposition of formal controls. The suggestion that legislation is required poses the dilemma of whether a system of ethics can or should be codified into law. At this point in time, there is no reason to believe that the law can yield precise answers to the ethical problems of medical experimentation. 28 Yet, "it is unreasonable to assume that the law can remain aloof from the issue; some degree of legislative codification will become necessary as more and more cases are brought before the courts and as the need to establish a basis for judicial decisions becomes more pressing . . . A codification of guidelines into law would have to recognize both the moral sensitivities of the community at large and the necessity to balance the rights of subjects against the rights of the investigator." 29 Close collaboration between the medical and the legal professions will be necessary to work out the many difficulties involved in translating general criteria into workable guidelines for specific clinical situations. The setting up of review and approval committees composed of doctors, lawyers, and social scientists might aid this process, especially if some coordination and sharing of information could be established among them. The problems of human experimentation are complicated by the fact that there is often a fine line between "experiment" and "therapy." As Renée Fox has expressed it, "all physicians trying out new procedures or drugs on sick persons . . . [face] the question of determining how experimental and/or how therapeutic an innovational treatment is, and in the light of that evaluation, deciding under what circumstances, and on whom, it may justifiably be used." Typically, there is a sequence of steps from work on animal subjects to "clinical trials with moribund, terminally-ill patients who are beyond conventional medical help, and thus can be said to have little to lose and much to gain. When the research physicians have achieved what they consider to be more adequate knowledge, skill, and understanding, they begin to try the new treatment on patients less desperately ill, advancing its application by degrees to persons in earlier, more benign phases of the medical conditions involved." The point at which the

Introduction

physician moves from work on animals to work on humans is always in some sense "an 'arbitrary' moment . . . This is a phase in clinical research, no matter what the nature of the procedure, which is inherently 'premature' and for that reason is often judged to be controversial and, sometimes, 'immoral'. . . . For, as a combined consequence of the many unknown and uncontrolled factors in this stage of experimentation, and of the drastic, complicated illness of the patients who undergo the clinical trials, successful outcomes are rare and ephemeral. Failure and death rates are high." 30 Organ

Transplantation

This is the stage that characterizes current work in organ transplantation. After the shock of the first heart transplant and the awe at its sheer technical virtuosity began to wear off, both the public and the scientific community became concerned about the ethics and efficacy of this new surgical procedure. Most of the patients died within a short time after the operation was performed. In addition, the publicity given to these operations and to the surgeons who performed them generated some public suspicion that fame and glory might have become more important motivations for these trials than expected benefit to the patient or the advancement of science. In March 1968, within a year after the first heart transplant, a special board of the National Academy of Sciences issued a report designed to serve as an informal mechanism of social control. The board concluded that "the procedure cannot as yet be regarded as an accepted form of therapy, even an heroic one. It must be clearly viewed for what it is, a scientific exploration of the unknown." 31 This report set forth criteria that should be met by any institution performing such operations and recommended that "only a relatively small number of careful investigations involving cardiac transplantation need be done at this time." 3 2 Half a year later, in part as a result of pressures exerted by such informal social control, informal professional controls began to operate in the same direction. From mid-September 1968 to March 1969, there appears to have been what Swazey and Fox

Introduction

have labeled a "clinical moratorium." 33 That is, a "spontaneous" and informal halt to further experimentation with heart transplants seems to have been called, largely as a result of a mortality rate that was both "too high and too immediate." 34 The sociology underlying the phenomenon of the "clinical moratorium" has been well expressed by Swazey and Fox: "A good deal of contemporaneous medical research is organized and carried out in a group. Membership in such a team may provide investigators with a way of sharing responsibility, and with the kind of day-to-day collegial counsel, support, and tension-release that helps them continue their research despite its concomitant strains and frustrations. However, the fact that by and large the solo investigator pattern has given way to a team model also means that research physicians are more immediately subject to being criticized, contradicted, or overruled by their collaborators. Thus, the sense of the group may be a powerful factor in compelling an investigator to call a moratorium on clinical trials which his colleagues believe ought to be discontinued." 35 The resumption of work on organ transplantation after March 1969 (albeit on a smaller scale) raises problems of social control beyond those pertaining to the ethics of experimentation. Foremost among them is the question of what constitutes death; i.e., the problem of defining the precise moment of death. If the criteria for determining death remain unclear, then there are no guidelines for when a physician may legitimately remove an organ for transplantation. Since deterioriation of organs occurs even while artificially sustained "life" still persists, a concern for the benefit of the potential recipient would dictate the earliest possible removal of the organ. For this reason, some commentators have maintained that it is ethically legitimate to remove the needed organs before the life-sustaining machines have been turned off, once it is determined that the patient cannot be saved. The relevant question would then become one of determining when there is no longer any possibility of restoring the patient to life, rather than of defining the moment of death. Supporters of this view note that patients who have been kept alive by means of artificial devices appear upon autopsy to have been dead for some

Introduction

time. Opponents fear that the use of any definition of death that does not include the traditional cessation of circulation would cause the whole transplantation procedure to fall into disrepute. 36 The effort to establish a new definition of death and thus allow for appropriate social controls over organ transplantation began within the profession, although it should be noted that Henry Beecher, who initiated and directed the Ad Hoc Committee of the Harvard Medical School, is a major critic of the profession from within. The report of this committee 3 7 received extensive notice and wide acclaim. It defined "irreversible coma as a new criterion for death," in persons "who have no discernible central nervous system activity," and recommended that four "characteristics of a permanently nonfunctioning brain" be used to determine whether death has occurred. It thus advocated that the irreversible cessation of brain activity should replace the cessation of respiratory and cardiac function as the definition of death. At the present time, it seems likely that if legal codification of this change in concept occurs it will follow the guidelines of the Beecher committee. Such legislation could help relieve the sense of uneasiness that surrounds the removal of organs. Another measure to the same end would be the presence of two teams in the operating room: one to try to resuscitate the patient and the other to take care of the transplantation if the patient could not be saved. 38 New legislation would also be required to allow persons to bequeath their body parts for use in transplantation. Many state laws concerning the disposition of the body of a deceased predate the advent of organ transplants. Moreover, although thirty-one states now allow prior organ donation, most physicians are reluctant to remove organs without specific permission from relatives of the deceased, because the laws have not been tested in the courts. Legal clarification of the rights of the deceased and his next of kin will no doubt be forthcoming. It might be noted in this regard that despite traditional notions of the sanctity of the body, a recent Gallup poll found that 70 percent of the persons questioned expressed a willingness to donate their bodies for medical purposes. 39

Introduction

It has been suggested that the problem of transplantation might be solved through the development of tissue banks, on the analogy of blood banks. In such a bank, tissues would be typed and relevant information about potential donors and recipients would be stored in a computerized system. Voluntary donors could be inconspicuously tattooed with their tissue type and blood group, and "because of the emergency nature of the service, laws will have to be revised so that such marks legally constitute proof of consent to the removal of organs after death. As a quid pro quo, donors will rate high on the list of potential recipients." 40 Organ transplants are the latest in a series of new life-prolonging techniques. The development of artificial circulatory and respiratory devices has enabled us to keep people alive after natural physiological processes have ceased to function. This has raised many ethical problems: When should artificial maintenance of life be employed and for how long? When might it be appropriate for the benefit of all concerned to unplug the machines? Though not legal, euthanasia has often been tolerated when it could be effected by simple acts of omission. The increasing reliance on artificial devices, however, means that euthanasia could no longer be effected except through deliberate acts of commission. If irreversible coma does become the formally accepted definition of death, the problem of euthanasia versus prolonging the "life" of a patient who is leading a vegetative existence will be virtually resolved. The problem of whether euthanasia is appropriate for those terminally ill patients who are in great pain would of course remain. But this has long been a problem and is often resolved informally by the parties concerned. While some have argued that it might be best to create provisions that would explicitly allow doctors to facilitate the death of such patients, it may be that situations of this type are best handled informally, despite the difficulties involved. Genetic and Behavior

Control

If some of the problems connected with such recent biomedical advances as organ transplantation seem to be on the way toward resolution, there are other areas of "frontier research" which pose

Introduction

some potentially grave questions that remain quite intractable. Despite many appeals for the development of what may be called "anticipatory social controls," we seem to remain incapable of devising any in the areas of genetics and of the psychological and physiological knowledge relating to behavior control. These areas of research touch man at his deepest and most intimate levels and also raise specters of totalitarian manipulation reminiscent of Brave New World and 1984. The main fear associated with these research areas is that, once sufficient knowledge is gained, techniques will become available that will allow men to manipulate other men. Most often, the potential manipulator is seen as the government; occasionally, as the scientists. Effective "manipulation" implies that the party being manipulated is powerless to affect the outcome intended by the manipulator. Since some form of cooperation would be required in most instances from the subject to be manipulated, however, the assumption underlying this fear is that people will be deliberately misled or coerced into allowing themselves to be manipulated. Another possible assumption is that people will willingly allow themselves to become objects of manipulation for purposes they consider important. On the analogy of the man who surrenders himself to the powers of a hypnotist in the hope of overcoming some of his problems, large numbers of men might allow the genetic composition of their children to be improved by genetic engineering or shaped in accordance with the specifications of a eugenics program. A mixture of the two assumptions yields the fear that some degree of voluntary submission to manipulation might lead ultimately to involuntary controls imposed in the interests of those who govern. Even if some degree of genetic or behavior control were to be achieved without coercion and for purely benevolent purposes, the unforeseeable and unintended consequences could be disastrous. At the same time, however, advances in our understanding of genetics and behavior could be extremely useful; they might, for example, enable us to eliminate certain forms of hereditary disease or certain types of mental illness. Given such alternative

Introduction

possibilities, members of the scientific community and the public at large are often ambivalent about such research. The central question for social control in this area is how to derive the benefits that are potential in this research while avoiding the deleterious consequences that are also latent in it. However, there is little agreement on what the benefits and dangers are, on how advanced the research is now or is likely to be in the future, and on what sorts of social control, if any, would be desirable. Disagreements among scientists as to the state of the art of genetic research were reflected in recent press reports about the successful isolation of a gene by Dr. Jonathan Beckwith and his colleagues at the Harvard Medical School. The New York Times reported that this achievement "probably brings much closer the day—less than 25 years off by some estimates—when it will be possible to cure human diseases or change inborn traits by injecting new genes. Because such methods could be misused, many scientists view this prospect with considerable ambivalence." 41 The Economist, on the other hand, noted that the isolation of the gene "hardly justifies the gloomy speculation about genetic engineering and sinister tampering with the natural order. The genes were in bacteria . . ." While conceding that "science moves so fast that it would be presumptuous to say the method could never be used to create specially engineered human beings," The Economist goes on to say that "the odds are so loaded against it, what with test-tube fertilization and all of a very complex organism, that it hardly seems worth the trouble this side of science fiction." 42 An interesting aspect of this latest advance in genetic research emerged in the public statements by the discovery team itself. One of the members was quoted as having said: "We do not have the right to pat ourselves on the back," for in the long run this work might "loose more evil than good" on mankind.43 What do they fear? " 'The more we think about it, the more we realize that it could be used to purify genes in higher organisms,' said Dr. Beckwith . . . 'The steps do not exist now but it is not inconceivable that within not too long it could be used, and it

Introduction

becomes more and more frightening, especially when we see work in biology used by our Government in Vietnam.' Dr. Shapiro concurred. 'The work we have done may have bad consequences over which we have no control,' he said, drawing a parallel to the development of atomic energy. 'The use by the Government is the thing that frightens us.' " 44 In this area, fear of the government is pervasive. Scientists rarely express concern about the uses which their colleagues might make of new scientific discoveries. In genetics one finds an exception to this rule, chiefly because some researchers in genetics have been associated with the eugenics movement. Scientists opposed to eugenics express concern about those of their colleagues who advocate it. They tend to argue that these scientists, though well intentioned, are misguided and are guilty of putting forth dangerous ideas. Leaving aside questions of present technical feasibility, what modes of genetic control might be possible? Three general types have been distinguished: ( 1 ) euphenics, i.e., the treatment of genetic maladjustments in the individual by alteration or control of the expression of the existing genes (as in the use of a special diet for the treatment of a hereditary disease such as phenylketonuria, a disorder which causes mental retardation); (2) genetic engineering, i.e., the change of undesirable genes through chemical or surgical intervention; and ( 3 ) eugenics, i.e., the recombination of genes already existing in the population, either by encouraging the reproduction of "favorable" genes and gene combinations or by preventing the reproduction of "defective" or "undesirable" genes. Of the three, euphenics seems to be both most feasible and least objectionable. Indeed, some euphenic techniques are already in use as an extension of medical care. As Edward Tatum has pointed out, "the simplest form of 'euphenic engineering' is already standard human therapy. This is the limitation of the production of an undesirable or harmful metabolite by dietary limitation of its source, as of the amino acid phenylalanine in phenylketonuria, or of galactose in galactosemia. It should also be pointed out that replacement of a missing or defective gene prod-

Introduction

uct also constitutes 'euphenic engineering.' Effectively used examples include substances readily carried in the blood, or missing normal blood constituents such as gamma globulin which is absent in the presence of certain mutant genes, or hormones such as insulin in diabetes or perhaps in the future, needed enzymes." 45 The other two types of genetic control are plagued by serious technical and social problems. Technically, eugenics would be difficult because it would require "the ability to identify the presence of an undesired gene even when it is not obvious from the phenotype." In microorganisms, mechanisms of gene recombination have been discovered; but, Tatum says, "it seems rather unlikely that any of these processes can be applied directly to higher organisms and to man." Nevertheless, he maintains, such gene transfers could conceivably be used indirectly even with man. Human cells can now be grown, and "studies of such human cell strains have shown that in some cases the cells retain the phenotypic (enzymatic) characters shown by the individual from whom they were derived. Thus, it seems feasible to attempt recombination and mutation studies." 46 In the case of genetic engineering, Joshua Lederberg points out that because of the inherent complexity of the human system, genetic alchemy (or "algeny") "is bound to fail a large part of the time, and possibly with disastrous consequences if we slip even a single nucleotide." 47 Moreover, negative eugenic programs are futile, because "most deleterious genes are represented and maintained in the population mainly by normal . . . heterozygous persons." 48 Even if such scientific and technical barriers could be overcome, the question remains whether genetic control should be instituted at all, and if so in what form. Those who advocate it argue either that it is or will become essential for survival or that it could provide great opportunities for human betterment. One of the foremost advocates of genetic control, H. J. Muller, argues that the natural process of human evolution by intergroup competition has been arrested by the agricultural and urban revolutions. "At the same time, intragroup natural selection, working via families and individuals, is also counteracted as much

Introduction

as our improving techniques can do . . . Our culture thus protects against elimination of mutations detrimental to bodily vigor, intelligence, or social predispositions." 49 Similarly, Paul Ramsey maintains that because our medical and technical competences have allowed us to preserve genes which would normally be eliminated by natural selection, "one can be sure that some future generation will begin to experience 20 percent genetic deaths. But . . . by then those who managed to stay alive will be generally and seriously impaired because of the genetic load they bear." 50 Theodosius Dobzhansky, on the other hand, rejects this idea. He points out that despite a continuing preponderance of cultural over biological evolution, mankind has not ceased to evolve biologically. Moreover, "the ideal of mankind free of all forms of genetic loads may not only be unattainable but also unacceptable, owing to the adaptively ambivalent effects of some of these load forms. Such a load-free mankind may turn out to be a dull stereotype, with no particular physical or mental vigor." Also, "an increasingly large part of mankind now lives in environments in which infectious diseases and old environmental hazards are being gradually brought under control . . . For this part of mankind, a source of genetic improvement may be . . . a weakening or elimination of resistances to environmental hazards . . ." 5 1 Opposition to any form of genetic manipulation has its source in the deleterious social consequences that many see implied by it. Advocates such as Muller, by contrast, argue that genetic manipulation would yield social betterment. It could and should be used, he maintains, to foster cooperativeness and general intelligence. He thus proposes that a system of storing semen (preferably for decades after the donors' deaths) should be instituted and that couples wishing to have children by artificial insemination should have knowledge and choice of donors. Such couples "should be guided to include [in their choice consideration] some of the more special gifts or predilections which tend to support or channel the two major ones of cooperative disposition and general intelligence." 52 Suggestions of this kind generate fear and antagonism among

Introduction

opponents of genetic control. Is there not a fine line between "guidance" and outright manipulation or control? Who is to determine what constitutes the components of such traits as cooperation or intelligence? Might these not come to be defined as passivity and obedience to rulers? What might be the consequences of widespread adoption of artificial insemination, for the family and other social institutions? As Dobzhansky has said, "a biologist should have the humility to recognize" that the questions involved "are more sociological than biological." 53 How, for example, could one reconcile the "contradictory requirements of uniformity for communication, and of heterogeneity for innovation? We have no idea where we stand on this scale." 54 Moreover, even if a set of traits to select for could be agreed upon, would not the assumption by man of such genetic control have the effect of "locking in" currently desirable traits that might not be desirable at some future date? What kind of anticipatory social controls could be instituted to insure agaiijst such negative social consequences of genetic manipulation? At least one sociologist, Kingsley Davis, has argued that there are what might be termed "inherent social controls" which militate against the very possibility of an effective program of eugenics. Davis argues that alteration of the biological capacities and traits of the human organism will not be attempted to any significant extent because of the "stubborn resistance to change inherent in human societies." 55 The social structures that would have to be changed in order to institute genetic control are especially resistant to alteration. The husband-wife and parentchild bonds are so strong and important in modern society, he maintains, that "the ethical feeling arises that marriage and procreation are somehow inalienable rights . . . The personal identity with 'one's own child' has the implication . . . that a child should, if at all possible, be biologically one's own . . . An effective system of eugenic control would . . . overthrow the existing system of emotional rewards and punishments, the present interpretations of reality, the familiar links between the person and the social status." 56 Thus, says Davis, genetic control appears unlikely to occur as an evolutionary process. It could oc-

Introduction

cur only as a revolutionary process if preceded by a genetic crisis such as one that might follow the use of nuclear weapons in a third world war. While Davis's arguments are persuasive, they are not entirely convincing. Might not genetic control be instituted in stages as people see advantages in it? Recent breakthroughs which could allow for determination of the sex of an unborn child provide an example. It is certainly not hard to imagine that many prospective parents might relish the possibility of being able to choose the sex of their children. As with other possibilities of genetic control, the results would be a highly mixed blessing; a curse, some would argue. On the positive side: "The conception of children of an undesired sex is often deleterious from a mental health standpoint, and might conceivably increase the incidence of overt homosexuality, or at least lead to sex role confusion . . . If control of sex were possible . . . the result would be smaller, and not larger, families, and the eventuality of parents 'trying for a boy, or girl' would be limited—a useful agent in population control. Not the least of beneficial consequences would be the control of genetic disorders that are sex linked—for instance hemophilia, one form of muscular dystrophy, and several enzyme deficiency diseases, all of which are many times more common in males than in females." 57 On the other hand, "complete free parental choice might result in dramatic change in sex ratio, with sweeping implications for personal, family and societal life . . . widespread voluntary or enforced celibacy of the 'majority sex' might come into vogue." 58 Of course, laws could be established to regulate such matters. For example, "laws could stipulate . . . that after a chance first birth parents could come to a government regulated agency to select the opposite sex of child as their second birth, or the law could stipulate that after two births of the same sex, parents could interfere with natural processes in choosing the sex of the third." 59 But would such arrangements be socially desirable? Would they result ultimately in more or less freedom of choice? Of course, even in the absence of genetic control, the problem of population growth coupled with the availability of sophisticated

Introduction

techniques of contraception might lead to establishment of measures to regulate freedom of choice in procreation. What is at issue is the proper balance between freedom and control in a complex technological society. While theologian Paul Ramsey has argued that the controls may be internalized through an "ethics of genetic duty," other commentators have argued that only socially imposed controls will be effective. Ramsey's argument is that "Christian teachings have always held that procreation is the place where one has to perform his duty to the future of the human species; this has not been a matter of the selfish gratification of would-be parents. If the fact-situation disclosed by the science of genetics can prove that a given person cannot be the progenitor of healthy individuals, or at least not unduly defective individuals, in the next generation, then such a person's 'right to have children' becomes his duty not to do so, or to have fewer children than he might want (since he never had any right to have children simply for his own sake)." 60 Garrett Hardin, however, has argued that appeals to conscience will be inadequate to control the population problem. The Darwinian argument suffices to demonstrate this, he maintains, since those who resist breeding because of conscience will die out, while those who breed against conscience will survive and eventually take over. In the shorter time range, the appeal to conscience would place man in conflict between attempts to satisfy both his personal interest and the collective good. "Responsibility," Hardin continues, "is the product of definite social arrangements." What is needed is "mutual coercion mutually agreed upon." Freedom will be impinged upon, but then "freedom is the recognition of necessity." Population controls are necessary if we are to preserve other, more precious, freedoms. 61 Issues of freedom and control are raised even more profoundly by the technologies of behavior control. In some ways the questions raised by behavior control are similar to those raised by genetics. And, as in the case of genetics, disagreement is rampant about the state of the art, the potential benefits and dangers, and what to do about them. But behavior control differs from genetic control in at least two important ways: ( 1 ) some degree of

Introduction

behavior control exists in all societies—whether it is called law, tradition, religion, or even simple human interaction; (2) some forms of behavior control are both easier to apply and less readily detectable than genetic control. Techniques of behavior control include what Perry London has called "control by information" (propaganda and education, psychotherapy, hypnosis, conditioning) and "coercive controls" (electric shock treatments, electrical and chemical stimulation of the brain, and mood-controlling drugs such as tranquilizers, energizers, hallucinogens, and narcotics). 62 Current methods of behavior control have not yet reached the level of precision of other highly sophisticated technologies. Nevertheless, the potential consequences of behavior control are so great that the potency of these techniques must not be underestimated, even if the present state of the art is comparatively underdeveloped. There appears to be a tendency among scientists working in these areas, however, to stress the beneficial uses of such techniques, to emphasize the technical difficulties involved, and to minimize the social consequences. Thus, José Delgado, one of the foremost researchers of electrical and chemical stimulation of the brain, argues that by discovering "the neuronal mechanisms of anger, hate, aggressiveness, or territoriality," investigators can provide "clues for the direction of emotions and for the education of more sociable and less cruel human beings." He considers the prospect of governmental control of the behavior of citizens to be "remote, if not impossible, not only for obvious ethical reasons, but also because of its impractability," for it would require "a detailed and complex exploration in each individual, because of the existence of anatomical and physiological variability. The feasibility of mass control of behavior by brain stimulation is very unlikely, and the application of intracerebral electrodes in man will probably remain highly individualized and restricted to medical practice." 63 Similarly, many practitioners of conditioning maintain, as does Roger Ulrich for example, that since men already can and do control behavior, our efforts should be devoted to developing less

Introduction

random, more intelligent, and more socially desirable forms of control. 64 B. F. Skinner goes even farther when he argues, albeit not convincingly to most people, that there is a degree of mutual influence between conditioner and subject in the conditioning process. "In noticing how the master controls the slave or the employer the worker," he comments, "we commonly overlook reciprocal effects and, by considering the action in one direction only, are led to regard control as exploitation . . . but the control is actually mutual." 65 Moreover, he continues, while the work of physical scientists is generally regarded as disinterested, "a disinterested consideration of cultural practices from which suggestions for improvement may emerge is still often regarded as impossible . . . When we can design small social interactions and, possibly, whole cultures with the confidence we bring to physical technology, the question of value will not be raised. So far, men have designed their cultures largely by guesswork . . . but we are not far from a stage of knowledge in which this can be changed." 66 The negative reactions to conditioning often hark back to Pavlov and his dogs. It is argued that to use the same techniques on men as Pavlov and numerous other researchers have used on animals is to "dehumanize" man. The skillful use of punishments and rewards and environmental stimuli to produce desired behavior seems to give the experimenter or therapist a degree of control over the subject that threatens to be considerably greater than that held by the more traditional psychiatric therapist. Yet, "there is an interesting irony in the evolution of control technology . . . Insight therapy cherishes self-consciousness and abhors manipulation. But its very emphasis on motivations, and on the higher brain processes as the means to discover them, anticipates the methods of control that are most capable of destroying self-consciousness altogether: surgery, radio, and chemistry, which go directly to the brain to capture motives there . . . action psychotherapy [conditioning], which begins its own polemic by vigorous disavowal of the self, yields, at its most effective, operant technology, whose cardinal principle is that

Introduction

mind alone must be left free to exercise itself as best its inner essence advocates, while all the stimuli around must be enslaved." 67 Whatever its relative merits as against the more traditional forms of psychiatric therapy or the philosophical assumptions which underlie them, conditioning raises new social problems because of its potential power and the desire of practitioners like Skinner and Ulrich to apply these techniques for purposes of social reform—in schools and communities, for example. Here they are clearly going beyond the realm of the usual experimenter-subject or doctor-patient relationship. The problems raised are akin to those raised by genetic control: the effects of such intervention could be large-scale and extending through several generations; the question of what traits it is desirable to inculcate is a crucial one; and there is the difficulty that even if a set of traits could be agreed upon, they would not necessarily continue to be desirable in the future. Also, just as in genetic control, largescale behavioral control could be instituted by a series of incremental steps. Thus, it is not hard to imagine that conditioning, which is already in use for treatment of alcoholism or drug addiction, might come to be used regularly for such socially beneficial purposes. But when the techniques are sufficiently perfected, might not such treatment become mandatory? Might there not then be a temptation or desire to extend their use to the "cure" of other forms of "anti-social" behavior, such as aggression or rebelliousness? Similar fears arise in connection with behavior control drugs. Tranquilizers and other drugs have been used with great advantage in treatment of the mentally ill and have allowed some people who previously would have been hospitalized to lead normal lives. But there is the danger that large numbers of people could be convinced or coerced into taking more potent drugs for purposes of social control. As noted earlier, however, behavior control is unlike genetic control in that it is subtler and often harder to detect and some forms of it are inherent in social interaction. Current debates about the proper use of the mass media as an agent of social influence reflect some of the difficulties involved. How deliberate

Introduction

and successful does persuasion have to be before it should be defined as "behavior control"? How can the fine line between education and "brainwashing" be drawn? Such problems are compounded by the fact that the use of behavior control threatens to eradicate the very distinction between the "voluntary" and "involuntary" behavior of subjects or patients. For, as London points out, "the ironic thing about chemical and surgical coercions . . . is that their main function can be said to be that of internalizing motives so that people will themselves desire what we want them to. This makes it necessary to resolve the practical issue of coercion before the pill is swallowed; afterward, the corpus delicti will testify only for the defense. The new technology thus creates a great conundrum: it makes possible the nullification of all those human rights which are predicated on individual consent. Once consent can be flawlessly engineered, then doctrines like the Nuremberg Code, which begin with 'The voluntary consent of the human subject is absolutely essential' to do medical research on him, become meaningless." 88 It is also frequently difficult to ascertain whether a given treatment is in fact necessary or beneficial for a given patient. While this is often a problem in all medical diagnosis and treatment, of course, it is peculiarly difficult here because the definition of the disorder which requires treatment may itself be uncertain. "The move from what are clearly physiological impairments to what are clearly not is a subtle one only because we are accustomed to the idea that what doctors treat, including head doctors, is illness, and illness implies, for most of us, physical malfunction rather than social malfeasance. The more the power to define disorder rests with people who are not the immediate victims of it, however, and the more the definitions rest on behavior rather than anatomy or physiology, the more tenuous [the definitions] become." 69 London has aptly summarized the problem: "The danger to a free society from behavior technology . . . is that even its most benevolent use runs the risk of eroding freedom when it takes place by the decision of anyone other than the person on whom

Introduction

it is used. And in a free but complex society, that decision must sometimes be made by other people, and even against the subject's wishes. The ethical challenge emphasized by behavior technology is that of how to preserve or enhance individual liberty under circumstances where its suppression will frequently be justified not only by the common welfare but for the individual's happiness." 70 This has been a problem for a long while in connection with the treatment of the mentally ill: Is involuntary commitment to a mental hospital necessary for the individual as well as the society or is it a form of social coercion against deviant behavior? With the development of more effective technologies for behavior control, such problems may be extended to the population at large. The magnitude of the problems associated with genetic and behavior control, and the current uncertainties about what form technical advances might take and how soon they are likely to be forthcoming, seem to overwhelm our capacities for social control. Several things would appear to be clear, however. First, professional controls alone are likely to be inadequate. The issues are too fraught with matters of social concern that are outside the scope of professional competence. Moreover, the understandable interest of scientists in pursuing their research without undue infringement, their tendency to see the benefits and minimize the costs and dangers of their research, and the inevitable professional disagreements about how to handle such problems make it unlikely that professional controls will be developed in the absence of a great deal of social pressure. Full professional consultation will be necessary for the development of any system of social controls, of course, since understanding of the nature of the techniques and their consequences is a necessary condition of a judicious solution. It also seems clear that controls must be flexible enough not to stifle research or inhibit achievement of the benefits potential in research. At the same time, they must provide adequate protection against undue invasions of privacy and unwarranted manipulation. Societal planning and decision-making processes will have to be responsive to the need to prevent dramatic social

Introduction

changes until proper safeguards and adequate controls can be established. As with codes of ethics for human experimentation, such general guidelines will be extremely difficult to implement and apply to concrete situations. In the meantime, careful scrutiny and monitoring of ongoing research are called for, along with public discussion and public education about the issues. A fully informed citizenry could in the long run be the best protection against the abuses potential in genetic and behavioral control. What general conclusions can we draw about the operation of alternative modes of social control in biomedicine? It is clear, first of all, that many problems have yet to be solved. But it is also clear that the biomedical professions do not remain an island unto themselves; there is feedback between the professional sector and other social institutions. Generally, where the profession is deeply divided (as in the case of human experimentation), where it is unaccustomed to the problems at issue (such as those raised by the large amounts of government money recently devoted to biomedicine and by current demands for better and more equitable distribution of health care), and where a very broad range of social issues is at stake (as in genetic and behavior control), the imposition of social controls seems to be required. On the other hand, where the problems are recurring ones for the profession (as in the "experiment/therapy dilemma"), or where the issues demand biomedical expertise and must be solved if further scientific progress is to be made (as in the problem of the definition of death), the profession may take the lead in developing controls. As noted earlier, the transition from informal to formal social controls usually takes places when the informal regulations provide insufficient guidelines and ineffective controls. Since the legislative process is often intricately tied to particular political pressures, however, legislation can also be drawn up in the absence of such cause. While formalization is often clearly necessary, in other words, there remain some particular problems in the relationship between biomedical science and legal control that bear examination.

Introduction

The Legislative Process There would seem to be an inherent tension between science and law stemming from the fact that the law tends to be conservative while science is dynamic. Hence, the legal structure at any given moment is often likely to reflect the scientific state of the art of an earlier time. Furthermore, the adversary procedures by which laws are generated and tested are often not well suited to scientific matters. Nor is the system of safeguards surrounding our legal system—the promulgation of laws by the Congress or state legislatures followed by a series of tests in the courts-— always able to keep pace with the rapidity of scientific developments. While few would want to abolish the system of checks and balances built into our legal system, there is often a sense of frustration resulting from the slowness of the process. On the other hand, occasions arise in which laws are rushed through the Congress—and more often through various state legislatures— without adequate consideration of their merits. This conservatism and slowness of the law can raise problems in the use of legislation for control of biomedical science and technology. In attempting to protect the health and well-being of the citizenry, legislators face the danger of freezing the existing scientific state of the art into law. Therefore, in matters pertaining directly to scientific knowledge, such as the treatment of a given disease, lawmakers need to tread a fine line between taking no action (where intervention may be desirable or necessary) and enacting legislation which is ultimately self-defeating (by requiring specific actions that science later discovers to be deleterious). The case of legislation which required the use of certain diagnostic tests and treatments for phenylketonuria (PKU) illustrates the dangers of the latter course. 71 While the legislation was pending and after it was passed, much evidence was uncovered to indicate that the tests are faulty and the treatment harmful in cases in which an inaccurate diagnosis of PKU is made. As a result of cases of this sort, a consensus appears to exist in favor of risking sins of omission rather than of commission. Alterna-

Introduction

tively, it might be possible to include review mechanisms or cutoff dates in legislation of this type. The PKU legislation is an example, also, of legislation that was passed too quickly. By contrast, laws pertaining to organ donation and to the regulation of drugs are often painfully slow in developing and changing. A second problem in the relationship between law and science stems from the use of adversary procedures. The growth and diffusion of science and technology present lawmakers with an ever-expanding body of highly complex scientific developments about which they are called upon to legislate. To cope with this challenge, a vast network of information and advisory bodies has been developed to counsel the Congress. But adequate information provides only part of the solution. Problems of communication between scientists and lawmakers often arise as a result of the differing outlooks and constraints of the two groups. The goals and interests of the Congressman and the scientist may be convergent or contradictory, depending on the specific issue involved, so that lawmakers, though relying on testimony from scientists, may and often do interpret this information to suit their own purposes and predilections. In the controversy over possible legislation on cigarette smoking, for example, many Congressmen exaggerated and capitalized upon the disagreements among scientists in order to support their disinclination to enact strong regulatory measures. In the case of legislation calling for the diagnosis and treatment of phenylketonuria, by contrast, state legislators downgraded or disregarded existing disagreements among scientists. Scientists, in turn, may slant their testimony for purposes of demonstrating their success and appealing for more research money. To what extent communication failures between scientists and legislators are unavoidable and to what extent they result from deliberate distortion remains an open question. In either case, it would seem incumbent on both parties to assume greater responsibilities for communication and cooperation. As a result of such difficulties, it is probably well to be cautious about instituting legislation in cases where informal control mechanisms are operating fairly effectively. In dealing with such thorny matters as the ethics of human experimentation, it is

Introduction

probably good to experiment first with various types of informal control. This allows for enough time to air the issues in their full complexity and, it is to be hoped, to "debug" the systems before they are set into law.

Value Dilemmas Decision-making with respect to any aspect of the control of biomedical science and technology—in the allocation of resources, in the ethics of human experimentation, in the issues arising from possible genetic and behavior controls—is fraught with value questions. Indeed the consequences of science and technology for our values and social structures are of such significance that they have led to demands for institutionalization of some form of "technology assessment." In 1966, Representative Emilio Daddario introduced a bill to establish a Technology Assessment Board, which would advise Congress on the desirable and undesirable effects of certain technological programs and engage in policy research to help determine appropriate courses of action. In 1968, Senator Walter Mondale proposed establishment of a fifteen-member Commission on Health Science and Technology charged with "setting goals, suggesting programs, recommending priorities, suggesting legislation, and formulating models for the evaluation of our national health science effort within the context of the needs of society as a whole." 72 Even if such legislation were passed, the difficulties of assessing modern technologies and of formulating policies for dealing with them are great. Part of the difficulty stems from inadequate knowledge, i.e., from inability to predict the consequences of technological developments with precision. There is the further and in some senses prior problem of a lack of clarity about values and goals. It is extraordinarily difficult to assign priorities, to weight the various desiderata against each other. Clearly, the two problems—lack of knowledge and lack of clear values and goals—feed each other. If we knew what the effects of making no deliberate genetic interventions would be, for example, it might be somewhat easier to weigh the values of individual freedom

Introduction

and dignity against the values of human improvement. On the other hand, it is conceivable that such better knowledge of outcomes might serve to exacerbate value conflicts. The value dilemmas that appear throughout the issues discussed above may be characterized as: (1) short-range versus long-range considerations, (2) balancing individual and social benefits, and (3) containing the negative effects of science and technology versus allowing freedom of research and inquiry. Such dilemmas are not unique to problems emanating from the biomedical sciences and technologies. They appear in numerous other aspects of life in a complex technological society. If they appear to have a special poignancy in the biomedical area, it is because of the close and readily apparent relationship between biomedicine and the physical and psychological health and wellbeing of man. The problem of balancing short- versus long-range considerations is crucial in matters of technology assessment. Any given scientific and technological development might be highly desirable currently although its long-term consequences (often only dimly seen) might be disastrous. As has been noted, for example, some possibilities of genetic and behavior change that might be desirable now might also have the effect of "locking in" certain traits that could be highly problematic in the longer run. Conversely, a recurrent problem in the allocation of resources is that some investments that seem questionable today might result in substantial longer-term benefits. It is probably safe to say that present-day concern with the future ramifications of science and technology makes us more willing to consider the long-term consequences than we might have been in the past. Thus, despite a vital interest in improving medical care today, we are willing to invest large sums in more speculative research for which the payoff might not be visible for some time to come. The problem of unexpected and unintended consequences of technological development remains a major difficulty in any attempt to forecast and anticipate long-term effects. Few people, for example, foresaw that the obvious benefits resulting from better nutrition, sanitation, and health care would result in a vast

Introduction

growth of population that now threatens to outrun society's ability to deal with it. Nor did we recognize until recently that our technology and affluent life style would result in threats to the ecology of the planet. Current concerns about genetic and behavior control are often based on just this sense that the unforeseeable consequences of such techniques are likely to be harmful. It is felt, therefore, that we must be cautious in our efforts to apply them. The longer-term consequences of some drugs or of organ transplantations are also problematical. What, for example, might be the social consequences of removing the technological, ethical, and legal constraints on transplantation and of establishing a system of organ banks? In the short term, the beneficial effects on the health of the nation could be great. But how is one to assess the possible long-term consequences of a technology that would allow for the indefinite preservation of life through the replacement of vital organs? The power of modern technology to create large-scale and sometimes irreversible change makes such questions urgent. The problem of balancing individual and social benefits was discussed above primarily in connection with the ethics of human experimentation. It leads to the conclusion that while small risks to the individual for the benefit of the society are likely to be tolerated, jeopardy to the person will not, no matter how great the potential social benefit. Society has not yet begun to face this issue in such matters as population control, however. While the need to limit population growth is recognized as urgent, the idea of placing restrictions on the freedom of individuals to procreate is still anathema to many people. Given the high degree of interdependence that characterizes a complex technological society, however, the welfare of the individual and the welfare of society are more closely related than in the past. Whether and how quickly appropriate value changes will be forthcoming to accord with this changed social situation remains to be seen. In the absence of such change, it is likely that some social controls will have to be exercised over individual freedom in order to prevent social disaster.

Introduction

The idea that "frontier research" in genetics and behavior control could also turn out to be disastrous has led some people to advocate what might be called a "stop technology" movement. Even members of the Harvard Medical School team that isolated the gene structure of bacteria have proclaimed that they would not pursue that line of research if they had it to do over again. Aside from the fact that one man's refusal to do such research does not mean that the same discovery will not be made by another, the issue cannot be dismissed so simply. There are numerous methods that might be employed to control science and technology. But it is to the uses of such science and technology that our control efforts must be devoted, not to the ability to do research and to engage in inquiry. Some control over the research process is of course required in order to prevent unethical practices, but the idea that some kinds of research should be forbidden entirely could lead ultimately to the very thought control that the critics of genetic and behavior control research fear! The complexity of the issues involved in the social control of biomedical science and technology and the uncertainties attached to them make any attempt at a definitive statement appear foolish. Yet discussion of the issues is vital. The papers that follow seek to contribute to such discussion.

Part II Toward a Social Policy for Biomedical Science and Technology EDITORS' N O T E . Innovations in biomedical science and technology create the need for mechanisms of social regulation and control. These mechanisms take many forms, ranging from informal selfregulation by physicians and scientists to formalized governmental controls. Generally, the mechanisms may be classified as formal or informal, professional or social. The essays in this section examine various regulatory and control mechanisms in specific areas of biomedical science and technology. A case study by Samuel P. Bessman and Judith P. Swazey points up the interaction between biomedical science and the legislative process in a recent campaign to enact state legislation requiring the testing of newborn infants for phenylketonuria ( P K U ) . The study serves to illustrate a variety of problems associated with the formalized regulation of sensitive and complex biomedical issues. The informal-professional approach to the regulation of applied biomedical science is discussed in essays by Edmund D. Pellegrino and Louis Lasagna. The Pellegrino essay examines changes in biomedical technologies as they affect traditional codes of medical ethics, with particular emphasis on ethical problems resulting from the emergence of the "physician-investigator." Louis Lasagna discusses the ethical questions raised by human experimentation, focusing on the problem of how best to protect the rights of the subject without hampering medical research. Both Pellegrino and Lasagna caution against overly restrictive regulations that might inhibit scientific research. Finally, the summary paper of the Harvard Conference on Behavior Control Technologies prepared by the editors highlights many of the problems associated with the utilization and regulation of these technologies.

SAMUEL P. BESSMAN AND JUDITH P. SWAZEY

Phenylketonuria: A Study of Biomedical Legislation

As the most powerful society ever to inhabit the earth, we have come to expect perfection in our lives, but we have found that perfection is not easily gained and may indeed be unattainable. We grow dissatisfied with the slow development of useful knowledge. In the case of medicine, this dissatisfaction has resulted in a great increase in public interest in the process of science. This public influence has been useful to medicine, often accelerating the development of a field of interest by assuring increase'd support, focusing scientific curiosity, and even providing volunteer patients for research. The force of public opinion has not always had a salutary effect, however. By taking a very active role in an important field of medicine, a small group of determined and highly motivated parents of mentally retarded children, together with a few equally dedicated physicians, needed less than three years to persuade forty-one states to pass laws requiring the testing of newborn children for phenylketonuria ( P K U ) , a rare and imperfectly understood cause of mental retardation. In many ways, these laws are innovations in the practice of medicine, in the orderly development of research, and in the relations between medicine and the state. The implications and consequences of these laws could not have been seriously considered in the short time between proposal and implementation. The haste implied an urgent need to protect the health and Samuel P. Bessman is Professor and Chairman of Pharmacology, Professor of Pediatrics, University of Southern California School of Medicine. Judith P. Swazey is a Research Associate with the Program on Technology and Society and a Lecturer, History of Science Department, Harvard University. 49

Samuel P. Bessman and Judith P. Swazey

safety of the people at large against a sudden threat. But these laws in fact concern a hereditary, noncontagious disease affecting, at most, one person in ten thousand. The story of these PKU laws is the paradigm of a crusade. There was a simplified and incomplete understanding of the objective situation, a singleminded campaign which trumpeted successes and ignored failures, and most of all a failure to consider the harm that might be done by seeking to do good. PKU is a metabolic disorder. A genetic flaw inhibits the synthesis of the liver protein phenylalanine hydroxylase. This protein controls the conversion of the amino acid phenylalanine into the amino acid tyrosine. The phenylalanine builds up in the system, and at the same time mental impairment appears. No cause and effect relationship between high blood phenylalanine levels and retardation has been established. The only accepted treatment for PKU, however, is a diet low in phenylalanine, the efficacy of which is in considerable doubt. Laboratory tests do not detect PKU but rather high blood phenylalanine levels, which can have causes other than PKU. Furthermore, the tests suitable for the mass screening required by law are subject to misinterpretation and error. Where does this leave the researcher and the individual practitioner? The law requires that the diagnosis of PKU be made. According to the state legislatures, the PKU tests are accurate; many of the laws say so directly, and none of them would have been passed if the legislatures had believed otherwise. Furthermore, in requiring the diagnosis, the legislatures clearly expected that some treatment would follow a positive test. Both medical ethics and the chance of a negligence suit call for treatment following a diagnosis. But the tests are not accurate; they miss a number of cases of PKU and yield false positive reactions in an even greater number. Given a positive test, the physician will very probably put the child on a low phenylalanine diet. Phenylalanine is an essential amino acid; the body can neither produce it nor survive without it. Phenylketonuric children have more phenylalanine in their systems than they need. Even if the diet were to be proved completely worthless, it is

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assumed that they would not have been harmed. But a child who does not have PKU is actively endangered by the diet and can suffer physical deterioration at the least; a number of children have died from being treated for PKU, and it is likely that they did not have the disease. Finally, we have a critical lack of information about almost every aspect of PKU. We do not know the cause of the retardation. We do not know if every individual with the genetic defect is in danger of retardation. We cannot be completely confident of our diagnostic tools. We do not know with certainty how to treat it. Yet the states have endorsed a simplified model of the disease which reflects none of this scientific doubt. The forty-one laws were designed with this possibly false, certainly incomplete model in mind. We will consider some of the scientific issues later in this paper, but the question now at hand is simpler: How did forty-one states come to require the diagnosis of an obscure and noncontagious disease when the social and individual benefits were in such doubt and while the dangers were so clear?

How the PKU Laws Were Passed The laws of this country are usually passed after an adversary procedure resembling in many respects a court trial. Those who believe there will be some benefit to society or to themselves from a law propose it and even draft model statutes for consideration by the legislature. Those who foresee an injury or loss marshall testimony and evidence to defeat the proposal. The legislature sits in judgment and decides in the best interests of the public. Of course, neither a trial nor the passage of a bill is quite so simple, but this is the basic model of the process, a process that appears to work in most circumstances. It did not work for PKU. Biomedical legislation in this country falls into two general categories: attempts to solve the economic problems of medicine through such programs as Medicare and Medicaid and attempts to regulate the nature and practice of medicine. Included in this second class of legislation are licensing of health personnel,

Samuel P. Bessman and Judith P. Swazey

drug-control measures, abortion laws, and laws mandating testing, preventive measures, or treatment for certain diseases, such as the laws requiring smallpox vaccination, premarital venereal disease testing and treatment, quarantine, and PKU detection and treatment. Most compulsory health measures—required examinations, immunization, isolation and quarantine, hospitalization or detention—have been enacted to control and prevent the spread of disease. Although PKU is a hereditary, noncontagious disease, the laws aimed at controlling it have the same legal basis: the state's power "to enact and enforce laws to protect and promote" the health and general welfare of the people, the police power. 1 In dealing with the first type of biomedical legislation, such as Medicare, legislators are on firm and familiar ground and the usual mode of political discourse is adequate to the situation. But in passing the second sort of laws, the legislature can only follow the best advice of experts. As we shall see, neither experts nor best advice are always available to legislators. Since the PKU laws are a recent and particularly provocative case of the second type of biomedical legislation, we have attempted to discern just how the power of the law was called upon to force entire populations into a highly questionable medical experiment. There are no heroes or villains in this story. The "villains" are those who sought most earnestly to do good, and the "heroes" simply arrived too late or went unheeded. In the late 1950's the data on diagnosis, treatment, and followup of PKU in the literature were minimal, in spite of a large number of reports on individual cases. These case reports were poorly documented, and most indicated failure of the low phenylalanine diet to cause significant change in patients. The results usually were explained in the case reports as being due to finding the children too late or to inadequate control of the diet. A number of deaths of children on the diet were reported, and warnings were sounded on the use of the highly abnormal diet necessary to control the blood phenylalanine. Cases of patients with normal IQ's and all the chemical signs of PKU also were reported, but these reports were either ignored or minimized. No attempt was

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made to explain why many normal people escaped retardation even though their blood contained great excesses of phenylalanine. Many serious observers were already skeptical of the value of the diet and the accuracy of the blood phenylalanine level as a predictor of mental retardation. They were ignored, for they presented no mass of data equal to the many, albeit poor, observations proffered as proof of the dietary hypotheses. One gets the impression, when reading the literature now, that physicians who had little positive evidence of their own to communicate nevertheless tried to lend their encouragement to others, on the basis of their hopes and their conviction that the diagnosis and therapy were good. Stimulated by the deceptive enthusiasm of these reports, lay organizations interested in mental retardation could not understand the lack of interest within the medical profession. T h e confusion of the reports plus the rarity of the disease probably contributed to this attitude. The average practitioner of medicine, who sees mainly adults, knew that he might never see a case of P K U in his lifetime, and the pediatrician, who might see a couple of hundred newborn children a year, could expect to turn u p one or two cases in his entire career. A number of pediatricians began to test urine by a simple but often inaccurate test in their office and clinic practices, but in general physicians were bewildered by the great emphasis of lay organizations on such a rare disease. To their minds, the problems of handling many other diseases were much more pressing. A new phase in the campaign of lay pressure for compulsory case finding began after Knox's publication in 1960 of a retrospective statistical analysis of the results of diet therapy for PKU and the mental deterioration to be expected in untreated patients. 2 The paper was a compilation of heterogeneous data, the best available, but admittedly inadequate. Knox was tentative in his conclusions and in particular expressed reservations about the diet therapy in the light of known cases of high blood phenylalanine content and sound intelligence. His caveats were ignored by laymen, who seem to have read only the statistics on apparent progressive deterioration of mental function in untreated PKU.

Samuel P. Bessman and Judith P. Swazey

Nor did the well-known artifact of intelligence testing, in which deterioration appears to occur with age in most forms of mental retardation, enter into consideration. It was proposed that phenylalanine or something chemically involved with phenylalanine was causing the minds of the children to deteriorate. The idea was established that at least this form of mental retardation could be treated by diet: The child could eat its way to mental health. The primary assumption of this simplified model was that phenylalanine or some product derived from it was toxic. The second assumption was that the developing brain suffered increasing damage with time because of this excess phenylalanine. The third assumption was that all children who had excess phenylalanine in their blood were imminently in danger of mental retardation. And the final assumption was that a low-phenylalanine diet would halt and even reverse mental deterioration. This model has a good deal of logic on the surface, though the scientific evidence in favor of any of its assumptions is at best inadequate. But to committed laymen, most of them relatives of retarded children, it seemed negligence of the worst sort that the medical profession was not doing more to find and treat PKU. They were joined in this concern by a number of dedicated physicians interested in furthering research in the general area of "inborn errors of metabolism." These scientists felt that compulsory mass screening for PKU was the best way to turn up enough cases of this rare disease to permit further intensive study that might lead to a model for investigating and understanding the nature and management of other diseases of this class. As they saw it, any advance in knowledge of PKU might lead to advances in knowledge of the more than twenty other diseases which seem to be rooted in genetic and metabolic defects. Other physicians involved in the pressure for the compulsory mass screening laws were attached to the lay groups seeking them, primarily the National Association for Retarded Children and the Joseph P. Kennedy, Jr. Foundation. Completing what has been called "the PKU establishment" 3 was the Children's Bureau of the Department of Health, Education and

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Welfare. Joseph Cooper, a political scientist who has studied the PKU laws, has stated: "Although the officials of the Children's Bureau deny they were working for PKU legislation, I have copies of their literature and dispassionately feel that it can be interpreted no other way. There was a mixture of motives—the Children's Bureau people undoubtedly felt they were doing a societal good, and also establishing their niche in the health sector." 4 None of these groups pressing for laws on PKU appear to have been acting in bad faith; they simply identified their own interests with the public interest. Research on PKU was clearly stimulated by their efforts. Before a single law concerning PKU was passed, there were voluntary screening programs covering several hundred thousand newborn infants each year. 5 The first PKU law was passed in Massachusetts in July 1963, but in the year before the law was passed, all Massachusetts maternity hospitals were actively engaged in a voluntary mass screening and treatment program run by the maternal and child health division of the state department of public health and financed by the U.S. Children's Bureau. Even before this program began, Massachusetts had an active commitment to PKU work. The Children's Bureau had set a quota of 10,000 infants to be screened under state supervision, but the department of public health set as a goal the testing of all infants born in the state, approximately 112,000 annually. "It was quite logical for the state to embark on a fullscale program," Robert MacCready, then director of the state diagnostic laboratories, has written. "The division of maternal and child health was already encouraging well child conferences to test for PKU, and had been furnishing the services of a district nutritionist to assist the families of known cases." 6 But at the time the Massachusetts law was passed, only a handful of children had been treated and the results had not been uniformly successful. Both the administrative action and the compulsory law were based on minimal information. Although the voluntary program might have produced more information, the Massachusetts legislature was unwilling to wait. Nor were other legislators willing to wait. Within eighteen months of the

Samuel P. Bessman and Judith P. Swazey

passage of the Massachusetts law, before any f o r m a l report o n the Massachusetts experience h a d been published, thirty m o r e states had passed similar laws. W e m a y note that the Massachusetts law was brief and, c o m p a r e d to laws passed later in other states, unrestrictive: The physician attending a newborn child shall cause said child to be subjected to a phenylketonuria test. The Department of Public Health shall make such rules pertaining to such tests as accepted medical practice shall indicate. The provisions of this section shall not apply if the parents of such child object thereto on the grounds that such test conflicts with their religious tenets and practices. This "unrestrictive" law requires a test for P K U , thus assuming that there is an unequivocal test for the disease, and authorizes the state health d e p a r t m e n t to define "accepted medical practice." T h e r e are facts and facts. T h e legislative "facts," i.e., that there is a test and that there is accepted practice, r u n counter to the scientific "facts." Short of liver biopsy or the troublesome phenylpyruvic acid test, there is n o clear, unequivocal test for P K U . Of the available tests, all were in use in Massachusetts at the time the law was passed, hardly demonstrating that there was any accepted practice. 7 Although the Massachusetts legislators apparently felt that individual physicians needed to be forced into action against P K U , they did not believe they were defying a respectable b o d y of scientific opinion in doing so. T h e law they passed was perfectly in accord with the information they were given on P K U , b u t their information was not complete. T h e r e a p p e a r to have been two m a j o r reasons why scientific opposition to the P K U laws was sporadic and ineffective. Neither reason gives any cause for optimism a b o u t present or f u t u r e legislation of this type. First, the legislative hearing is an inappropriate f o r u m for the discussion of scientific questions. A d versary proceedings customarily deal with matters that are m o r e or less c o n c r e t e — a n indictment to be proved beyond the shadow of a doubt in court, or not proved; a bill to be passed, amended, voted down, or tabled. In this case the concrete matter was a bill

Phenylketonuria

which stated that PKU retardation was caused by an accumulation of phenylalanine in the blood. Opponents could not have then and cannot now state that PKU retardation is not caused by an accumulation of phenylalanine in the blood. They can say only that there is no conclusive evidence that this is so, that there are anomalies to be explained, but also that there is even less evidence that phenylalanine did not lead to retardation. 8 The natural reluctance of scientists to testify under such constraints was reinforced by a second major block to opposition testimony, the emotional intensity of the law's proponents. We may take the passage of the law in Maryland as an example. One of the authors of this paper (Dr. Bessman) was engaged in PKU research in Maryland at the time of passage. Joseph Cooper, who has also studied the Maryland experience, stated, "At least in Maryland, the medical testimony given the legislators was from a homogeneous source. No opposition voices were heard . . . The testimony was largely organized by persons with substantial connections with the Kennedy Foundation and with research grants in this area." 9 At the time the Maryland law was passed, a voluntary screening program in operation for eighteen months was testing 80 percent of all newborn babies in the state. Although three different groups in the state, two at the National Institutes of Health in Bethesda and one, including Bessman, at the University of Maryland, were active in PKU research at the time, not a single individual who had done original work in the biochemistry of PKU was asked to testify on the law. Several did make public statements that the legislation was premature, but these statements went largely unanswered. The proposed Maryland bill, which gave jurisdiction to the state board of health and mental hygiene, was opposed by the chairman of that board. In response to this challenge, the concerned parent associations sought support from the state medical society. The medical society refused and stated that it favored only the voluntary PKU program. The medical society witness at the legislative hearings on the bill testified that the society's members were neither for nor against the proposed law. The society representative was asked if all the state's doctors were

Samuel P. Bessman and Judith P. Swazey

participating in the voluntary program. H e replied that 80 percent were, whereupon one of the members of the legislative committee stated that if all doctors and all newborn infants were not involved it was necessary for the legislature to act. The law was passed. Joseph Cooper and other investigators have maintained that arguments against the P K U laws should have been forcibly brought to the attention of the legislatures. However, given the difficulty of carrying a complex scientific argument before any audience, the special constraints on argument imposed by the legislative setting, the superficial logic of the P K U model, and the political and emotional power of the proponents (who gave the legislators the feeling that they were meeting a medical emergency), it is difficult to see how uninvited medical witnesses opposing the bills could have contributed anything but rancor to the situation.

The Nature of the PKU Laws Specific provisions of the forty-one statutes are summarized in Table 1. A number of the provisions are of scientific interest, particularly the distinction between the earliest laws, which mandate testing for P K U only, and the later laws, which also mandate testing for "other metabolic defects." Senators Winston L. Prouty (R., V t . ) and Edward M. Kennedy (D., Mass.) sought to extend the screening principle to all metabolic disorders through a federal law in 1967. Their bill (S2402, 89th Congress) did not pass, but the idea appealed to the lay forces who were pressing state legislatures, and similar wording appears in at least eighteen subsequent state laws. Specific provisions for P K U testing are made in thirty-nine of the forty-one state laws, which often include requirements for the establishment of state diagnostic facilities, for reporting the test results to the state board of health, and for noting the performance of the test on the child's birth certificate. Twenty-seven of these states require that a P K U test be performed on all newborn infants, rather than only in births attended by a

State and year of enactment

Alabama-1965

Louisiana-1965

Maryland-1965

/

Alaska-1965

Connecticut-1965 Arkansas-1967

y y

California-1965

y y y

Colorado-1965

y y y

y y

y

Kansas-1965

y

Kentucky-1966

y

Maine-1965

y

Massachusetts-1963

y

Michigan-1965

y

PKU Testing

y

y y

Florida-1965

y

Georgia-1966

y y

Hawaii-1965

y y

Idaho-1965

y y y

Illinois-1965

y y y

Indiana-1965

y y y

Iowa-1965

y

y

y

Minneso ta-1965

y

y

y

Missouri-1965

y

y

y

y

y

Treatment Provisions

y

y y

y

Penalty: failure to follow laws is a misdemeanor

State responsible for educating health personnel and general public

State maintain facilities for diagnostic, preventive, and treatment research

State supply treatment control tests State provide treatment if necessary

State establish regulations for care, including treatment

Exemption for other parental objections Test for other metabolic defects

I At request of parent or doctor 1 I Religious exemption 1

In all newborns In those born in hospital, maternity home, and/or attended by a physician

Table 1. A Digest of PK.U Legislation

y

y y

y

y

y

y

y

y

y

y

y

y

y

y

y

y

Montana-1965

J

Nebraska-1967

y

Nevada-1967

y

New Hampshire-1965

y yb

y y

y

New Jersey-1965

y

y

y

New Mexico-1966

y

y

y

New York-1965

/

Ohio-1965

y

y

ya

y y

Oklahoma-1965 • Oregon-1965

y

Pennsylvania-1965

y

y

Rhode Island-1965

y

y

South Carolina-1965

y

y

y

Utah-1965

y

Virginia-1966

y

Washington-1967

y

West Virginia-1965 ' Wisconsin-1966

y

y

y

Texas-1965

Penalty: failure to follow laws is a misdemeanor

M c

State responsible for educati health personnel and general public

Treatment Provisions State provide treatment if necessary State maintain facilities for diagnostic, preventive, and treatment research

Exemption for other parental objections

Religious exemption

In all newborns

State and year of enactment

In those born in hospital, maternity home, and/or ! attended by a physician I At request of parent or doctor I

P K U Testing

Test for other metabolic defects

(continued)

State establish regulations for care, including treatment State supply treatment control tests

Table 1

y

y

y

y y

y y y y

y y

y

y y y

y

y

y

' State law establishes provisions for but does not require prenatal testing. The Nevada law does not explicitly mandate the provision of treatment but states that the Department of Health shall "follow the development of all children carrying the syndrome of any metabolic disease to insure that those persons responsible for the care of the child are fully informed of accepted medical procedures for the detection, prevention, and treatment of such conditions." b

Phenylketonuria

physician. To ensure as complete compliance as possible, they state, variously, that it is the responsibility of the person in charge of the institution in which the child is born, of the child's physician or other person attending the birth, or of the parents or guardians, to have the test administered. In another ten states, the law is slightly less comprehensive, stipulating that a test must be performed on any infant born in a hospital or maternity home or otherwise attended by a physician. A third class of legislation on P K U testing, found in West Virginia and Oklahoma, establishes provisions for testing but does not require it. P K U testing is not explicitly cited in two laws. Kentucky law states broadly that every infant under twenty-eight days old shall be given "a test for inborn errors of metabolism in accordance with rules or regulations prescribed by the Commissioner of Health." Similarly, Maine's law requires testing of newborn infants for "metabolic abnormalities which may be expected to result in subsequent mental deficiencies." Twelve states direct their state health officers to maintain education programs both for health personnel and the general public. Oklahoma's law, for instance, reads: " T h e State Board of Health shall institute and carry out an intensive educational program among physicians, hospitals, public health nurses, and the public concerning phenylketonuria and related inborn metabolic disorders. This educational program shall include information about the nature of the diseases and examinations for the detection of the diseases in infancy in order that measures may be taken to prevent the mental retardation resulting from these diseases." 10 T h e last aspect of these laws which we shall note in this review is their position on treatment. Although the low-phenylalanine diet is clearly implied as the accepted treatment in all states where diagnosis of P K U is compulsory, only nine state laws make any explicit provisions regarding treatment. These provisions fall into four overlapping categories. T h e most common treatment provision, found in seven state laws (Illinois, Kansas, Louisiana, Texas, Nevada, Washington, and West Virginia), is that the state has a responsibility to care for children with phenylketonuria. Thus, the Illinois Department of Public Health is required to:

Samuel P. Bessman and Judith P. Swazey

Supply the necessary treatment product where practicable for diagnosed cases for as long as medically indicated, when the product is not available through other state agencies. Arrange for or provide public health nursing, nutrition and social services and clerical consultation as indicated.

Three states (Texas, Louisiana, and West Virginia) have established PKU research programs under their state health departments. These laws appear to cast some doubt on the beliefs about PKU which supported the passage of the PKU laws. The Texas law, for instance, states: "The Department shall establish and maintain a diagnostic laboratory for conducting experiments, projects, and other undertakings necessary to develop tests for the early detection of phenylketonuria; for developing ways and means of discovering methods to be used for the prevention and treatment of phenylketonuria in children; and for other such purposes considered necessary by the Department to carry out the program." The most direct form of legislative mandate is found in the laws of two states (Virginia and Alabama). The less strict Virginia law states: "Further treatment of infants found to have phenylketonuria—The State Board of Health shall recommend procedures for the further treatment of all infants who are detected to have phenylketonuria." Alabama's law is the most explicit. The state board of health is directed to "promulgate such rules and regulations as it considers necessary to provide for the care and treatment of those newborn infants whose tests are determined positive, including but not limited to advising dietary treatment for such infants." Finally, the law in Kansas, in addition to prescribing the supply of treatment products—low-phenylalanine "milk" primarily— charges the department of health with providing "treatment control tests for which laboratory services are required." What any of these laws says, of course, is less important than the manner in which they are implemented. Even the most direct of the laws, Alabama's, does not require the dietary treatment but merely requires treatment. The language of the bill does not exclude experimental therapeutics, but since the low-phenylalanine diet is the only accepted treatment, it is difficult to imagine what other

Phenylketonuria

response to the diagnosis of PKU a physician could make, particularly if those administering the law are committed to the diet. In addition to these state laws, two federal laws have been proposed, though neither got out of committee. The KennedyProuty bill, which led to the inclusion of other metabolic diseases in many state laws, has been mentioned. The other (HR913, 90th Congress), introduced in January 1967 by Representative John E. Moss (D., Calif.), was: "A bill to amend the Public Health Service Act in order to promote the detection of phenylketonuria and other inborn errors of metabolism leading to mental retardation or physical defects." The Moss bill proposed a two-year program of grants to states for PKU testing programs under the Public Health Service. To qualify for grants, the states would have had to conform to regulations prescribed by the Surgeon General. This national standard could have had an impact on research and treatment far beyond that of even fifty state laws on PKU. In order to understand the difficulties that such laws have created, it is necessary to explain more completely the state of our knowledge of PKU. We do not mean to suggest that the legislators who passed these laws should have been geneticists, psychologists, biochemists, or specialists in public health; we suggest only that the meaning of this accumulation of conflicting evidence should have been considered by them. If there were conclusive evidence that methods of diagnosis and treatment of PKU were sound, safe, and efficacious, then perhaps the other areas of doubt could have been ignored by the legislators. Sanitation laws appeared long before germs were discovered. London chimney sweeps were counseled to bathe regularly to avoid cancer of the scrotum centuries before the carcinogenic nature of soot was discovered. But the kind of knowledge in these two cases is absent with PKU.

What Is Known About PKU There have been four major areas of uncertainty and dispute about PKU, each of which bears on the enactment of the screening laws. They are given here in the form of affirmative state-

Samuel P. Bessman and Judith P. Swazey

ments (in italics) followed by some discussion of the scientific evidence for each proposition. 11 There is a mass screening test for PKU which is not prohibitively expensive and which is reliable in the sense of yielding few false positive or false negative results. There are also confirmatory diagnostic tests which can be used to verify presumptive positive results identified by the mass screening test. The first PKU test, one that is still used occasionally, was part of the laboratory routine which led to the recognition of the disease itself. The Norwegian physician and biochemist Ashborn F0lling was examining two retarded siblings who had been brought to him because of an unusual body odor. He ran a series of tests on their urine and found that the test with ferric chloride gave a peculiar green color that had not been previously reported. This induced him to survey several hundred institutionalized retarded children. He found eight more whose urine gave the same reaction. These eight included two more pairs of siblings. Thus, recognition of the disease, the test, and the suspicion of genetic origin came at the same time. The ferric chloride test does not detect phenylalanine itself, but a metabolite, phenylpyruvic acid, which is found almost exclusively in the urine of persons with phenylketonuria. A more sensitive and reliable detector of phenylpyruvic acid in the urine is dinitrophenylhydrazine. Although it is more sensitive, it is much less accurate. The ferric chloride urine test is popularly known as "the wet-diaper test," a homey name that is part of the simplistic approach to PKU. And diapers are often used, along with urine-soaked filter paper, commercial dipsticks, and test tubes. These are simple, inexpensive tests and were routinely used in the first mass screenings of newborns, usually in .conjunction with a second test intended to provide confirmation of any diagnosis of PKU. The urine tests have a number of inadequacies. First, there is the delay in the appearance of phenylpyruvic acid in the urine. It may not be detectable until six or more weeks after birth, but the requirement that PKU must be found as early as possible is often written into the laws. Hawaii, for instance, requires testing

Phenylketonuria

within two weeks of birth. Second, phenylpyruvic acid may not be detectable in the urine of infants with phenylketonuria. When phenylketonuria is present, the phenylalanine content of the blood ranges from 5 milligrams per 100 cubic centimeters to 60 mg./lOO cc. ( 1 - 2 mg./lOO cc. is normal). But if the blood Table 2. Major Clinical Features of Patients with Phenylketonuria

Finding Agitated behavior EEG abnormalities Muscular hypertonicity Microcephaly Hyperactive reflexes Blond hair, blue eyes Inability to talk Hyperkinesis Inability to walk (and usually incontinent) Tremors Eczema Seizures

Frequency, percent 90-32 80 75 68 66 62 63 50 35 30 19-34 26

Occurrence in patients with low-grade PKU a

+ — —

+ + —

+ + + + —

+

Source: W. Eugene Knox, "Phenylketonuria," in John B. Stanbury, J. B. Wyngaarden, and D. S. Fredrickson, eds., The Metabolic Basis of Inherited Disease, 2nd ed. (New York: McGraw-Hill, 1966), p. 263. a Each " + " indicates features occurring more frequently or severely in low-grade disease.

phenylalanine content falls below 15 to 20 mg./lOO cc., phenylpyruvic acid may not be excreted in the urine. 12 For this and other reasons, the test is estimated to give up to 20 percent false negative results, that is, missing one out of five cases of phenylketonuria. Finally, the presence of fecal contaminants or

Samuel P. Bessman and Judith P. Swazey

other urinary metabolites, or both, can cause the test to yield an unknown number of false positive results; that is, giving normal infants a diagnosis of phenylketonuria, which can have serious consequences if they are then deprived of essential phenylalanine in their diets. 13 In 1961, Robert Guthrie reported on a new method of semiquantitative analysis which was adaptable to mass screening. The Guthrie blood test uses a disc of filter paper soaked in blood— a pinprick in the baby's heel produces enough—which is then placed on the surface of a bacterial culture. If the blood sample contains excess phenylalanine, phenylpyruvic acid or phenylacetic acid (other metabolites found in the systems of persons with abnormally high blood phenylalanine levels), the culture will grow. The test produces a number of false positive results, 14 and its developers urge that "any positive test by this method should be confirmed by repeated tests upon new blood specimens, and also by at least one independent method of testing blood phenylalanine." 15 The sensitivity and precision of the independent methods Guthrie advocates have been well established; they do not give the false negative results and particularly the false positive results that plague all the mass screening tests; but they also do not give a certain diagnosis of PKU. They are used primarily for the purpose of diagnosing high blood phenylalanine levels. The National Collaborative Study on PKU has found that parallel testing for a low tyrosine level—a metabolic factor in PKU that has been little investigated—is very rare and that blood samples are very often contaminated. 16 Tyrosine is as closely related to the fundamental liver defect in PKU as phenylalanine. If the liver were normal, phenylalanine would be turned into tyrosine. In persons with phenylketonuria, this conversion does not take place, leaving the system high in phenylalanine and low in tyrosine. While the consequences of high phenylalanine levels have been traced with doggedness, the effects of tyrosine deficiency have attracted little interest. This research imbalance plays a significant part in the matter of diet treatment. To summarize the state of PKU testing: (1) Absence of the

Phenylketonuria

protein phenylalanine hydroxylase in the liver is the only absolutely clear physiological indicator of PKU, but this lack cannot be determined except through liver biopsy, which is inappropriate to any but the most highly controlled experimental situations. (2) Presence of phenylpyruvic acid in the blood or urine is a clear indication of PKU, but the acid does not appear until some time after birth, and the laws and medical convention prohibit waiting. In addition, all persons with phenylketonuria do not produce the acid. (3) All other tests are tests for hyperphenylalaninemia, not PKU. Inclusion of a test for low blood level of tyrosine would improve the chances of correctly diagnosing PKU but would not eliminate all false positive results. ( 4 ) All mass screening tests for PKU are known to produce some false positive and false negative results. Retardation in PKU is caused by an accumulation of phenylalanine in the system. The notion that phenylalanine is somehow toxic is at the heart of the simplistic model of PKU which won the legislators over to the PKU laws. There is, of course, a strong association between hyperphenylalaninemia and PKU, but why the inability to convert phenylalanine to tyrosine should lead to severe retardation and the other symptoms of PKU (see Table 2) is not at all clear. Nor does present knowledge of PKU explain why some patients with phenylketonuria show little or no intellectual impairment. 17 In a review of thirty such cases in 1963, Knox commented that although "most of the recorded patients would . . . appear to be typical phenylketonuric patients, both genetically and biochemically, no explanation can be given for their mild intellectual defect." These patients studied by Knox were not retarded, but neither were they normal. Knox continued, "The results in differential development tests are scattered, showing dissociated psychic development typical of organic defect . . . They frequently constitute behavior problems because of their acute anxieties and disruptive emotional outbursts." 18 There are other reported cases of older individuals with high phenylalanine levels who have presumably had these levels all their lives and yet are mentally normal. Most curious of all, many

Samuel P. Bessman and Judith P. Swazey

premature infants suffer metabolic disturbance which causes temporary tyrosine accumulation. The phenylalanine is not used for conversion to tyrosine, and thus for one to two weeks at the period when the brain is at its greatest period of growth the phenylalanine level is very high. Yet these children do not suffer any brain damage and do not have PKU in any form. 19 There are no clear indications from animal studies that phenylalanine itself is toxic to the brain, and such studies would be inconclusive in any case because the human metabolic system is more complex than that of experimental animals. Nor is there conclusive evidence that any of the various metabolites characteristic of PKU are toxic to the brain in the amounts occurring in PKU. 20 There are also indications that some persons have persistent, mild phenylalaninemia, that some have early and persistent high phenylalanine levels, and that some persons have increasing tolerance for phenylalanine as they grow older. 21 Further study of hyperphenylalaninemia among institutionalized retardates and of infants with high phenylalanine levels indicates that excess of phenylalanine alone may not play a significant part in retardation. 22 Nor is there any clear correlation between the amount of phenylalanine or its metabolites in the system and the severity of retardation. A low-phenylalanine diet started early enough and continued long enough will prevent retardation in individuals with the genetic defect of PKU. This is perhaps the most debated aspect of PKU. First, and most obvious, since there is no conclusive evidence that excess phenylalanine or its metabolites are toxic to the developing brain and no correlation between phenylalanine levels and severity of brain damage, there is ample reason for doubts about the efficacy of a diet low in phenylalanine. Second, the effects of the diet are difficult to assess because there has never been a well-controlled study using comparable populations and adequately assessing the factors affecting mental function. For instance, few studies do more than recognize the Hawthorne effect (the beneficial effect of the attention given the subjects of an experiment), yet some studies have attempted to compare children

Phenylketonuria

under dietary treatment, who are constantly being tested, checked, and watched over, with an untreated population which has been institutionalized. Experience with mongoloids suggests the significance of the institutionalization. Once, such children were labeled hopeless idiots at birth and "put away." Now, many mongoloids are raised at home with normal siblings. Mongoloids institutionalized at birth have profoundly low IQ's, while mongoloids raised at home often have IQ's well within the educable range. Although there are differences between mongolism and PKU, it is clear that it is not enough to mention the social or environmental factors; they must be measured as well. There are some interesting results from the studies that have been done, however. Two of the best, most fully reported, studies are those by P. W. Berman and his associates and that of A. A. Baumeister. 2 ' 1 Berman reports on twenty-two children who were treated with the low-phenylalanine diet for an average of twentyseven months each. This group included four children who had been given a diagnosis of PKU through routine mass screening, eight whose condition was discovered when they were tested after a sibling or cousin was found to have PKU, and ten who were tested and given a diagnosis because retardation had already begun. The control group was 111 unaffected siblings of these children. Berman found that response to treatment seems to depend on the age at which it is initiated. The children treated earlier had higher IQ scores both at the beginning and end of the test period, from which Berman concluded that these children "had, in general, suffered less impairment at the time treatment was initiated." In his review of 167 cases, Baumeister also concluded that the effectiveness of the diet in preventing severe retardation depends on the age at which treatment is begun. Baumeister reported a strong correlation ( — .61) between the beginning age and the final IQ, a moderate correlation (—.41) between the final IQ and the degree of control of phenylalanine during the test period, and no correlation between the duration of treatment and either final IQ or IQ gain. Sutherland and other researchers have found the duration of the diet to be of little importance in comparison to the age at

Samuel P. Bessman and Judith P. Swazey

which it is begun, but others have argued that there is no clinical evidence for or against continuing the diet for life (Langdell; 2 4 Berry and Wright 2 5 ). Almost all the data indicate that IQ is unaffected by termination of the diet, but there is disagreement about the behavioral and emotional effects of termination. There are reports of no change (Berry and Wright; Hsia 2 6 ), of improved behavior following termination (Solomons 2 7 ), and of deterioration (Baumeister; 2 8 Langdell). The conclusions of the Berman group have been subjected to a detailed analysis by Herbert G. Birch and Jack Tizard. 29 They argued that the Berman data did not warrant the conclusions that the diet prevented retardation or that the earlier it was begun, the better. Their first point is that the evidence that the diet raises IQ is not clear. Taking the group as a whole, over two years, mean IQ went from 64.3 to 71.8, only 7.5 points. Birch and Tizard state: "For children, most of whom are backward, who live in above-average families, and who have brighter-thanaverage sibs, such average gains . . . in early childhood are not exceptional. It is relevant that two of the three untreated children who remained at home also gained in IQ—one by 17 and the other by 6 IQ points." Birch and Tizard also argued that the bias of the sample was such that the data could be reanalyzed to show that the diet is ineffective. The primary bias in the sample was in the forcing of comparisons of IQ between children who had been picked out by mass screening tests (and who may not have had PKU at all) with children who had been shown to be retarded. Renée Fuller, in a study of 112 children with phenylketonuria, found that when the group was considered as a whole, the earlier the diet was begun, the better the results. But taken singly, some children started on good dietary control shortly after birth showed marked retardation, while others started after they were three years old improved to the point of little or no retardation. Finally, in the matter of diet, we should note that the "mirror" of the low-phenylalanine diet—a high tyrosine diet—has hardly been tried, although there are indications that additional tyrosine has an effect on the physiological symptoms of PKU. Proof of efficacy of any particular treatment is difficult, as Knox has pointed out: "If we wish to frame the worst possible

Phenylketonuria

evaluation of our present practices, we could say that one-half the children with elevated phenylalanine may not become retarded in any case, and another one-quarter may be added as a result of bad screening tests. Therefore, one is left with approximately one-fourth of the children with high phenylalanine levels who may possibly become retarded if they were not treated. So, after treatment of all these children, three-fourths have a near-normal IQ. It looks like a magnificant result. Yet the treated group is salted with three-fourths who would be normal anyway." 3 0 Thus, forty-one state legislatures have mandated diagnosis of a disease for which there is no accepted treatment of undisputed value. Lofenalac, a low-phenylalanine "milk" commonly used for treating PKU, is a prescription drug licensed by the Food and Drug Administration. Herbert L. Ley, director of the FDA Bureau of Medicine, has stated that Lofenalac "is subject to the new provisions of the [Food, Drug, and Cosmetic] Act since it is not generally recognized as safe and effective for its recommended uses. [Italics added.] A new drug application was made [in 1958] prior to the 1962 Kefauver-Harris Amendments of the Act, and thus was evaluated on the basis of safety only rather than safety and effectiveness. All new drugs cleared through the new drug procedure between 1958 and 1962, including Lofenalac, are now under evaluation by the National Academy of Science/National Research Council to determine if there is evidence that the drugs are effective for the conditions claimed in their labeling. 31 PKU generally produces retardation. There appear to be several patterns of PKU affliction, although, as we have seen, our tools of diagnosis and treatment are by no means subtle enough to distinguish any forms of PKU. If there were several forms, we might be able to understand some of the difficulties in the etiology of PKU and the lack of correlation between blood phenylalanine levels and the degree of retardation.

The Consequences of the PKU Laws Although it would be foolish to say that the PKU laws have frozen research, the bad effects probably outweigh the good.

Samuel P. Bessman and Judith P. Swazey

Affirmatively, one can argue that PKU screening programs have yielded important data on the incidence of the disease, have stimulated work on more accurate diagnostic methods, have provided information on the practicality of large-scale screening programs for detecting other hereditary disorders, and have led to the discovery that hyperphenylalaninemia is not the same thing as PKU. Conversely, the PKU screening programs will not yield any other scientific information of much value. As it now stands, every child born in forty-one states must be tested in some way for "PKU." Some of these will be found to have "positive" tests. This group will be "treated" with the low-phenylalanine diet. Some patients will be normal in the end. Some will have behavior problems. Some will be mildly retarded. Some will be severely retarded. A few will die. There is no convincing proof that it would have been any different without the laws. The laws have made a difference in establishing and reinforcing through daily practice the conventional view of PKU. The statement on PKU by the subcommittee on legislation of the American Academy of Pediatrics in testimony on the Moss Bill to promote detection of inborn errors seems an entirely appropriate comment on almost all the PKU laws: "In our view, this is a poor piece of legislation, one with noble aims, but based upon unwarranted medical assumptions. We do not believe that, at this time, we have sufficient knowledge concerning either the correct and early diagnosis of inborn errors of metabolism, nor their effective management, to warrant this kind of public health programming. The funds needed to support this legislation would be much better utilized to further research in the field." 32 There have been about half a dozen malpractice suits involving PKU, but there is no reason to believe that there will not be more. A variety of legal issues are involved. No one can predict how a court would treat a death from phenylalanine deprivation after a false positive test for PKU. Or even if the child survives, who is responsible for the anguish and suffering caused the parents? Who is responsible for the false negative results? While actions for negligence might be defended in voluntary programs,

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when the entire population is compelled by law to be screened, would the patient not be justified in demanding a higher degree of accuracy than is now attainable? There are other legal problems as well. The confidential relationship between doctor and patient is violated by the administrative procedures required by these laws. Not only are records of tests filed in several different places in the state health department but the entire preventive medicine apparatus of the state, including psychology, nursing, statistics, social services, nutrition, and education, is alerted to the condition. In this process, information which could seriously affect an individual for life is passed about among nonprofessional, nonmedical personnel who have no legal or moral responsibility to the individual. This invasion of privacy is compelled by the state. What harm could there be? There is recent, impressive evidence that even unretarded persons with phenylketonuria have certain behavior problems and that many are in fact psychotic. It is common practice, in assessing an individual's fitness to enter college, take a job, take a military commission, or even to receive a promotion to the executive level in industry, to take his health into consideration. Can the people making those decisions ignore a diagnosis of PKU? Such a diagnosis, made today with inadequate definitions and seriously inadequate tests, will be filed in semipublic records, a brand of potential psychosis. The only way to right the wrong would be to expunge the records. The compulsory laws, combined with the unwritten sanctions of society leveled at "psychotics," could constitute together a bill of attainder. The laws themselves have not been subjected to the scrutiny of higher courts, but just as there was no appropriate mode of opposition in the legislatures, there is no appropriate stance for opposition in the courts. Sanford Jay Rosen of the University of Maryland Law School has commented as follows on the approach to the PKU laws likely to be taken by an appellate court: If the basic question put to the court concerns the existence of a rational medical basis for the P K U laws, then a fairly well drafted law is probably valid. Since the constitutional developments beginning in the 1930's with respect to socio-economic legislation, a

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court reviewing the validity of the legislation has generally asked the question, "Has the legislature been proven wrong?," not, "Is the legislature right?" This is obviously a very important distinction. If the first question is the one answered by the court, many PKU laws are likely to be sustained. On the other hand, there is a tendency now on the part of the courts to look more closely at governmental actions which may impinge on what are known as critical democratic rights, starting with the first amendment rights and moving into the area of privacy. When you are in this critical realm, and I don't know if you are in it with PKU, the courts start to ask additional questions. First, the courts ask whether there is a substantial governmental interest justifying invasion of the individual's or group's rights. If you could show an overall economic gain (on a simplistic model of the costs of mass screening v. the costs of institutionalizing expected numbers of phenylketonuric retardates) there might be a substantial government interest. But even if the court is able to find a substantial government interest that may justify invasion of critical democratic rights, another question must still be asked, i.e., "Is there some more limited way the legislature may achieve these appropriate goals without impinging so directly and so deeply on individual rights?" This is a very complicated process, and one that I have difficulty in evaluating in the case of PKU. I tend to think that with respect to the mass screening laws per se, the proponents are likely to come out on top. A carefully attuned legislature can draft a law mandating screening which would avoid many of the legal problems. 33 It is possible that the PKU laws will go the way of an earlier attempt at genetic legislation, the eugenic sterilization laws which cropped up around the country in the early decades of the twentieth century. None of these laws is now enforced, but pressure to strike them from the books is rarely attempted, for fear of giving them a second wind. On the other hand, a legal requirement like that still on the books in California—that sexual deviants be immediately sterilized upon discovery—remains a threat, however passive or remote it may seem. We can take some comfort in the observation that laws like these are comparatively rare, but that comfort should be tempered with the knowledge that the PKU laws were passed by forty-one legislatures in less than two years and that they were passed on minimal scientific information. Most of the detailed knowledge

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we have about PKU was brought to light after the PKU-law movement had started. The PKU laws have frequently been cited as an example of the benefits to be derived from the application of social, governmental, and scientific forces to a problem. If they are accurate examples, then we can predict that the benefits of future such joint efforts will be slight, unexpected and hard-won. These laws are better characterized as symptomatic of the conflict between the scientific commitment to unfettered research and the public commitment to social betterment, however construed. We have been increasingly aware of this kind of difficulty since World War II, but most often the conflict, as the case of the current national debate over the military-industrial complex illustrates, has strong economic and ideological overtones. In the case of PKU the ideological and the economic play almost no part, yet we find that the dilemmas of the scientist, the policymaker, and the citizen remain much the same. We are not prepared to hand down verdicts on the legislators, pressure groups, and scientists whose interests in PKU we have been discussing, but there are some questions to be asked. First, where the responsibility lies for informing the legislatures of the true state of knowledge about PKU is not at all clear. Scientists associated with the lay groups which promoted these laws felt that present knowledge was sufficient to warrant legislative action. Scientists and physicians in the state health departments made no claims to expertise on PKU, but any cursory reading they might have done would not have given them pause, because most survey articles on PKU in the popular and scientific literature give the clear impression that the etiology, diagnosis, and treatment of PKU is a settled matter. 34 And, as we have seen in our discussion of the Maryland experience, scientists who attempted to remain neutral or to bring up difficult questions were ignored or frightened off. Certainly, as Cooper says, they might have pushed harder to get their views before the legislature, but there is every indication that they would not have been received with gratitude. The parents of the National Association for Retarded Children took up PKU with determination. Their emotional

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commitment to ending mental retardation, while completely understandable, led them to create an atmosphere of emergency in which any discussion of the gaps in our knowledge of genetics and metabolism would have seemed irrelevant and even obstructive. Were the "outside" PKU researchers expected to hire public relations men and lobbyists to take their views to the legislatures? We can say that they should have, but we can also say that individual scientific researchers simply do not react that way. It would not have been impossible for the legislatures to call these men, but not every legislature has staff of the quality and quantity to devote to seeking out experts in every scientific field that happens to come to the attention of the legislature. We can expect the situation to arise more often in the coming years. Those who cite PKU as an example of what can be achieved by concerted action by the public, science, and the state have neither studied the problem in detail nor considered the consequences of present activities. What we have done so far with PKU should give us no cause for pride or self-satisfaction. If we examine the situation in which we now find ourselves, we may be able to construct a more intelligent and effective approach to the application of science to social questions. The doleful story of PKU teaches us that political methods are more likely to achieve conformity than knowledge, that consensus is not truth, and that action is not always better than inaction.

EDMUND D. PELLEGRINO

Physician, Patients, and Society: Some New Tensions in Medical Ethics

For Plato, medicine epitomized the way in which practical knowledge, when applied to man, must be modulated by moral imperatives. 1 In its long history, medical ethics has, to its lasting credit, heeded this prescription, promoting the good of the person as the proper end of every medical transaction. Today, as a consequence of its own unparalleled effectiveness and the concurrent socialization of every aspect of human life, medicine is compelled to an equal and specific concern for the social dimensions of human existence. Societal and individual values are increasingly counterpoised in almost every medical act. Some rational and just order must be established between these values to ensure the good of society while safeguarding the traditional rights of the person. This is the central ethical issue before contemporary medicine. It is an issue which arises, as Jacob Bronowski has said, "when men try to fit together their need to be social animals with their need to be free men." 2 Can we make optimal use of medicine as an instrument of social good without illicit intrusion on individual human rights? Reconciliation of these opposing values can be accomplished only by the progressive evolution of medical ethical codes open to the matrix of legal, philosophic, and theologic thought characterizing our times. Simplistic repetitions of the Hippocratic oath as a sufficient base for all medical actions can only mean abrogation of our responsibility for the consideration of some painful, but urgent, questions. Traditional medical codes are statements of ideals to be preserved, not immutable guides Edmund D. Pellegrino is Vice President for the Health Sciences and Dean, School of Medicine, State University of New York, Stony Brook, New York. 77

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through all the new complexities generated by medical progress. To endure as viable instruments they need continuing revision and greater specificity. They must reflect more accurately the cultural values which define the ground within which physicians and patients carry out their relationships today. Examination of the potential conflicts between values which impinge upon each other is common in ethics. Resolution evolves from a critical ordering of each value to the other. In medicine we are called upon to define those personal values that society will not relinquish for any material good and those which can be invaded for a worthy social purpose. This definition must be carried out concurrently with continuing experimentation and the application of new techniques as they appear. In no other way can public expectations be fulfilled. This ordering of the individual and social good in medical acts requires consideration on three distinct levels.3 First, and this is the usual level of most discussions of medical ethics, is the level of morals: the statement of what is, and what is not, right action. The next level is more abstract and involves a consideration of ethics proper, the language and logic of moral discourse. The last is the level of metaethics, which attempts to define the good and presumably provides the basis for the "ought" and "should" of ethical codes. To have meaning today, an analysis of these levels of moral discourse must involve many disciplines in addition to medicine. To assign the stewardship for defining individual and social rights in medical actions solely to the physician, as some still insist should be done, is no longer defensible. To do so is to create the conditions for an increasingly restrictive public policy concerning medical acts. This in turn will redound to the detriment of society itself, since such restrictions inevitably inhibit the creative work of legitimate investigators and innovative clinicians. To preserve his freedom to explore better ways to practice his art, the physician must willingly submit his acts and cogitations to the scrutiny of educated laymen in a wide variety of fields. As René Dubos has emphasized, "the time will come when scientists will have to accept the higher criticisms of science formulated by enlightened non-scientists." 4 More urgently than at any time in its

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long history, medicine is today required to encourage this intersection with every aspect of contemporary culture. Medicine will always be essentially a relationship of persons, and every traditional medical code is designed to safeguard certain fundamental rights of the human person—the right of freedom of assent to procedures, and the right to competent care, to humane and dignified treatment, and to confidentiality. These rights are rooted in certain assumptions about the nature of man, and the physician's responsibilities flow therefrom. It is these human rights which are in danger of compromise owing to medical and social progress, and it is the very personal nature of the medical transaction that is in process of the most profound transformation. This essay will deal with four well-established trends which are altering the ethical dimensions of the medical relationship: (1) the remote consequences of medical acts; (2) the institutionalization of medical care; ( 3 ) the emergence of the physician as .clinical scientist; and (4) the evolution of medicine as applied biology.

The Social Impact of Medical Acts The emphasis of traditional medical codes on the personal responsibilities of the physician to his patient is, of course, still vital. These codes were sufficient to meet contemporary problems when medical acts had effects predominantly upon the patient, with few implications for persons removed from the immediate circle of his illness. Under such circumstances the rights of the individual patient could be placed above all other considerations and could form the absolute and exclusive basis for the physician's actions. The simplicity of this arrangement has been drastically altered by medical progress and the ever-increasing interdependence of men and societies. When applied on a worldwide scale, modern medicine can eliminate certain diseases entirely in addition to curing and preventing individual episodes in single patients. As he treats pneumonia or tuberculosis with antibiotics, immunizes against tetanus or influenza, subjects his patient to renal dialysis or organ transplantation, or simply

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advises on chemical methods of contraception, the physician inexorably alters the ecology of the human race. Each life prolonged, each neonatal death prevented, each epidemic forestalled contributes to changing the number, kind, and distribution of human beings. The competition for living space, food, and personal conveniences increases, and the possibility of lowering the conditions and satisfactions of living for all becomes a real one. We must increasingly assess the social costs of significantly altering mortality and morbidity statistics and so modulate our social planning as to make the added years more satisfying and less a burden to individual and community. Clearly, the individual physician is rarely in a position to measure the remote and additive effects of his own individual medical acts. Nor can such considerations influence the care of his individual patient. The individual physician is unfaithful to the trust the patient places in him if he withholds a specific therapeutic agent in anticipation of some eventual perturbation of human ecology. Society, therefore, cannot possibly delegate such decisions to each physician. As a responsible public servant the doctor can be expected to anticipate the remote effects of the cumulative medical acts of his profession. He must indeed raise the significant question of choices, no matter how painful, and suggest specific ways to ameliorate and forestall them. In short, he must provide verifiable and expert testimony upon which public decisions can be based. At the same time, the physician must honor the implied contract with every patient to help and not to injure by omission or commission. The doctor thus finds himself increasingly at the intersection of social and individual ethical values, impelled to act responsibly in each sphere without specific guidance from existing medical codes. This overlap of individual and social good demands close and conscious scrutiny by physicians, public officials, and the general public. Equally vexing ethical questions complicate the decisions about how to allocate resources optimally among the many new possibilities generated by medicine and technology. Is it socially preferable to expend large sums to develop open heart surgery

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which can, at best, alter the life expectancy of a limited few? Or should this same amount of money be put into public education to eradicate streptococcal infection—the root cause of most damaged heart valves? Voluntary health agencies which decide not to finance expensive care for a limited number of patients but choose instead to put their resources into research or public education do in fact make such decisions. Similar decisions are inherent in recent federal legislation to encourage regional medical programs for heart disease, cancer, and stroke rather than to support more basic research or education in other categories of illness. Even in an affluent society, limitations of resources will prevent the application of all the knowledge we have, even now. In the allocation of funds and effort, a costbenefit analysis weighing the relative gains to society and to the individual is unavoidable if truly ethical decisions are to be made. Establishing general policy in such questions is a social and public responsibility. The doctor can participate as a member of society and as an expert witness in certain aspects of the issues. He is an expert in the technical substratum of decision-making; he has no special expertise in the choice of values and policies for the polity. In this, the physician is a participant essential to a rational decision but not the final arbiter of that decision. When the value judgment or policy decision is made, the physician must maintain his traditional relationship with the patient—that of helper and guardian of individual rights. Now, however, this guardianship takes place in a "field" of value decisions established by social mandate and rooted in, but not limited by, professional advice.

The Institutionalization of Medicine A second contemporary challenge to the personal dimensions of the medical transaction derives from the growing institutionalization of all aspects of medical care. The character of the patient-physician relationship is becoming complicated in a way that cannot have been foreseen in traditional medical ethics.

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Increasingly, the contract inherent in medical care is made with an institution or a group of physicians rather than with an individual physician. The patient comes to the hospital or clinic rightfully expecting to receive all the care he needs. The institution and its representatives then decide for him such things as the choice of physician or consultant. The responsibility for the quality and quantity of the care he receives is in the hands of a board rather than an identifiable single physician, as in the past. This trend will inevitably increase, since there are distinct advantages to group practice and institutionalized medical care. An institution under these circumstances inevitably must undertake considerable responsibility to preserve the rights of the patient in the same way the individual physician has always done traditionally. Ethical responsibilities are thus imposed upon the hospital, which in turn can only be exerted through institutional policies and a corporate ethical responsibility vested in a board of trustees as well as a professional staff. Responsibility is consequently more diffused, more difficult, and, at times, impossible to fix. Despite its more complicated apparatus, the institution must share the physician's responsibility to safeguard the same personal rights of the patient defined in traditional ethical codes. We are far from defining the precise conditions under which the ethical responsibilities for medical care can be assumed by institutions. This is a subject to which legal and ethical inquiry must be directed in the immediate future. Characteristic of the institutionalization of medicine is the provision of patient care by a team of experts made up of physicians and variable numbers of members of the other health professions. The effects of institutionalization are thus compounded, since many professionals share the responsibility of preserving the traditional rights of the patient formerly vested in a single identifiable physician. 5 The competence, confidentiality, integrity, and personal attention must somehow be derived from a group of diverse individuals enjoying variable degrees of personal contact and involvement with the patient. Individual responsibility is inevitably attenuated as more tasks are assigned to more people. Many who provide critical services may have no personal contact

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with the patient, yet their opinions and work form the basis for clinical decision-making. Care by a team of experts is essential if medicine is to make optimal use of the benefits of a technological and organized society. But the team approach profoundly changes the physician's role. He becomes the coordinator of a group. He must now make sure that the group assessment of the patient's needs is accurate, that a rational plan of management is elaborated, that mutually assigned responsibilities are carried out, and that the result brings satisfaction to the patient. No current code of medical ethics defines how the individual rights of the patient can be preserved in the complicated nexus of relationships which characterizes team care. Clearly, no one of the health professions can fabricate a code of ethics for itself without the cooperation of the other professions which together constitute the "team." We have as yet no mechanism in this country which will enable physicians, nurses, pharmacists, physiotherapists, and other health personnel to elaborate a common code of ethics. Yet, we are entering an era in which "medical" ethics will be supplanted by "health care" ethics—a broad set of principles defining the responsibilities and duties of a team of disparate health workers united by the needs of the patient and constrained by his rights as a person.

Emergence of the Physician-Investigator For most of medical history the approach to new knowledge was empirical. Careful reasoning and accurate clinical observations constituted the major methodology of medical investigation. The physician did not face a conflict of values in treating his patient and learning from him. In the past fifty years, clinical investigation has become a true science, and it now must proceed by controlled experiments designed to answer specific questions. This implies the manipulation of observation and treatment in deliberate ways. The physician is now forced to face the issue of gathering verifiable information in humans and, at the same time, safeguarding the inviolable rights of the experimental subject.

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The physician's traditional role as helper and his new role as scientist are of necessity brought into potential conflict. There is an overlapping of two sets of values—the scientific and the personal—which continually must be ordered to each other. There can be no serious question of abandoning scientific investigations of clinical problems. Every useful operation, drug, and vaccine was at one time untried. The immediate and longterm good of the individual and of society depend heavily upon controlled observations in humans. The focal issue is a more precise definition of the conditions under which experimentation is legitimate and the extent to which the individual may yield some of his rights for possible benefit to himself or his fellows. Certain values, essential to the good of the individual and of society, cannot be sacrificed without peril: the right of informed consent, of freedom to refuse to participate in any experiment, the right to veracity on the part of the investigator, and of justice which would guarantee redress and compensation to the subject for an ill-advised or immoral experiment. The terrifying consequences of subversion of these rights is before us in the records of the Nuremberg trials. The current problems fortunately do not involve the major moral aberrations perpetrated on humans in the name of the state and science by the Nazi physicians. Rather, we are now concerned with the more delicate questions which bear on the potential conflict between the good of the experiment and the good of the patient and the subject. The public and the scientific community are genuinely concerned with how legitimate human experimentation can best be pursued in a democratic society without loss of personal rights and dignity. The issues focus generally on whether the subject has given free and informed consent, whether the risks are warranted by the probable good to be achieved, and whether privacy is violated in the collection and use of personal and psychologic data. 6 Elsewhere in this volume Louis Lasagna discusses the complex matter of informed consent, particularly as it applies to drug trials. In this essay, it is appropriate to mention only a few selected issues relating to experimentation with humans, particularly when they

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are subjects and not patients, for in this circumstance the conflict between personal and social good is most starkly presented. Experimentation on volunteers for the potential good of others but with no immediate benefit to the subjects themselves is an important means of medical progress. When the subject is a patient and the experiment is designed to benefit him, a crude cost-benefit analysis is at least possible. When a normal volunteer submits to infection with the hepatitis virus or the malarial parasite or undergoes cardiac catheterization, he exposes himself to consequential risks and discomfort solely for the good of others. The only benefit he can derive is the satisfaction of possibly helping others. The resultant configuration of moral questions is very complex. Some hold that we never have the right to risk injury of one person for the benefit of another. Others would permit small risks if the benefit is large enough or redounds to a large number of people. Unfortunately, final questions about man's biologic nature must ultimately be resolved in man. Data on normal physiologic processes are the indispensable benchmarks against which disease is measured. Experiments in normal man are among the most important, therefore, and must be conducted if medicine is to advance. Exposure of the subject to some hazards under such circumstances appears justifiable. The subject and investigator are, in fact, opening up new frontiers to exploration. Our current system of morality permits the voluntary risking of life in war and emergencies. Is not a similar principle involved in human experimentation for the potential benefit of mankind? Provided the volunteer is not reckless, misguided, psychotic, or under duress, and the investigator has devised a significant experiment with appropriate safeguards, experiments on normal volunteers for the general good are not inconsistent with the values we hold as individuals and as a society. But in any human experimentation, with patients or well volunteers, the attempt to weigh risks against benefits becomes meaningless if the research question is trivial, the control inadequate, or the investigator incompetent. The investigator cannot ask himself too often whether the experi-

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ment is worth doing, whether it has already been done adequately, or whether his protocol will answer the question he has set for himself. As one reviews experimental protocols involving human subjects, it is impressive how often this dimension of morality is ignored. Better surveillance over experimental design and purpose is a first step in reducing vulnerability to informed public criticism. It is certainly immoral to ask a patient to run even a slight risk to obtain information that is redundant or trivial. Moral culpability is shared by the institutional committees on human experimentation. The members of such committees share the investigator's responsibility, and they become abettors of injustice if they give a careless or superficial review to research proposals and the questions of values they pose. Institutional controls must be conscientiously applied to safeguard the patient's rights and to assure that the experiment is scientifically worth doing. One may also err morally by an excessive adulation for scientific rigor and random selection in experimental design. At what point does the investigator abandon the random selection of patients for a new treatment when it appears to be having a salubrious effect? There is precedent for too early abandonment of the random method. For example, in the early studies of the effects of anticoagulant treatment of cerebral vascular disease and myocardial infarction, the initial results appeared so favorable that random selection was abandoned as unfair to the untreated patients. Subsequent studies by other investigators, however, showed that the treatment was of questionable or no value. There are also instances in which the experimental protocol is so rigidly applied as to deprive patients of a beneficial treatment. Here the good of the patient must be expertly balanced against the importance of a well-substantiated result which will preclude the necessity of repeating the experiment and subjecting another group of patients to the same risks and discomforts. Prudent clinical judgment must always be available to modulate the interplay of scientific rigor and patient welfare. 7 Wolf Wolfensberger has suggested a useful classification of the levels of clinical research. 8 He refers to one level which is almost universally practiced unknowingly by most clinicians. It is not

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recognized as research and consists of those widely used procedures which are considered justifiable by one's peers but which have never been experimentally validated. Many common diagnostic and therapeutic practices are in this category. When critically examined they often do not satisfy the criteria of utility or safety. Some of our most cherished clinical practices may be in the realm of gratuitous assertions. Here is a neglected realm of medical morality, accentuated by the rapidity with which new procedures appear and become part of the baggage of common usage. Procedures are often eagerly accepted by a physician on the recommendation of his peers lest he appear unprogressive. Every physician should feel impelled to examine his own practices to see how much unrecognized experimentation he is perpetrating. A crucial issue in the emergence of clinical investigation is the stress it places upon the traditional role of the physician as the patient's helper and friend. Otto Guttentag has perceptively analyzed this dilemma. 9 He is of the opinion that in experiments designed to arrive at a basic fact and not at directly helping the patient it is not reasonable to expect the same physician to be both scientist and helper. The implication is that one physician should be assigned the care of the patient and another the care of the experiment. However, other dangers are introduced if two physicians are involved, each with different responsibilities. The physician assigned to care for the patient cannot really protect him without full knowledge of the experimental design and method. Without this knowledge, the physician would always be in danger of being seriously misled by the patient's responses or the investigator's wishes. He can easily succumb to subtle pressure for the investigator or, to ease his own anxieties, he might obstruct legitimate procedures in the name of patient safety. When responsibility is divided, the investigator is too easily let off. He can excuse himself from personal concern, since another physician has been assigned to be the advocate for the patient. The relationship is far too complex to trust to divided responsibility. The patient-subject is better served if the double ethical responsibility of physician and scientist is vested in one person. The investigator must reconcile the two ethical dimensions. Institutional con-

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trols and ethical codes are both needed to monitor the way in which these double responsibilities are satisfied. Another serious threat to the traditional relationship of the physician to the patient resides in the connection between clinical investigations and academic advancement. We have here a modernized and more sophisticated version of Shaw's "Doctor's Dilemma." The unconscious conflict is precipitated not by pecuniary interest but by academic ambition—a no less effective seductress. The mores of clinical academia are built on recognition of "elegant" clinical investigations. The data so accumulated are essential to our understanding of human disease, but excessive adulation for this mode of scholarship can easily blur the ethical sensitivities of even the most dutiful physician. The necessity for conducting human experimentation in a context of institutional and peer review and control is manifest. These few instances of tensions created in the relationship of physician and patient are typological. A more detailed consideration of some of the ethical challenges in human experimentation is presented elsewhere. 10

Medicine as Applied Biology The biological sciences are experiencing today the same exponential burst of knowledge that has characterized the physical sciences in the last half-century. As the potentialities of modern biology are applied for individual and social purposes, man will face the most fundamental challenges to traditional values. 11 It is now conceivable that man may consciously modify the nature of his own species and control its behavior. Manipulation of the genetic material by a variety of means and perfection of methods for long-term contraception and for controlled fertilization, together with application of known principles of eugenics, could bring the entire reproductive process under explicit control. To achieve given social goals, the right to procreate could be limited to those with the most favorable confluence of genes. The reproductive function could be separated from marriage and even from the family. Drugs and psychologic manipulation can be used

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to modify the behavior of humans in predictable ways. Humans could be "programmed" to adapt to specific social roles and accept specified goals. Aggressive impulses against the "system" could be reduced by appropriate behavior modification with drugs or psychologic means. Such measures could make the number, kind, quality, and "utility" of human beings in future generations a determinable factor. If man's current exploitation of atomic power is any indication, there is little doubt that he will also explore the potentialities of his new biologic knowledge and thereby create profound and unparalleled stresses between social and individual good. As medicine conquers acute diseases, the physician's energies may be directed elsewhere. He will delegate many of his present manipulative functions to programmed technical assistants. The doctor himself will soon become the practitioner of much of the new applied biology. Society will expect him to undertake this new function, since he will continue to be the member of society best prepared to deal with the total human being. The physician will then face some of the most vexatious questions and the most direct challenges to his role as protector of the person of his patient: Who shall determine what the future species will be like? What characteristics of intellect and behavior should be bred into future generations and which bred out? Who should be allowed to procreate or to have the benefits of transplanted or artificial organs? What changes in behavior should be induced and in whom? Tension is inevitable between the personal rights physicians are bound to protect and the hopes of society for a better existence, which the new biology could promote. As an agent of the new biology, the profession of medicine will be compelled to rethink the whole series of assumptions that underlies its actions. Medicine can derive the guidelines for meeting these new questions only by a deeper analysis than has hitherto characterized medical ethics. The individual physician would be presumptuous indeed to attempt to provide his own answers, even if society would tolerate it. Medicine must instead enter into ethical discourse with colleagues in the humanities, the social sciences, and the law. It is only from this exchange that an ex-

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panded and new medical ethics can be fashioned which will be equal to the new opportunities for good and evil in the new biology. Such an ethics will require exploration of the philosophical bases for medical ethics and explore what, for the physician, is unfamiliar language of metaethics and axiology.

The Philosophical Bases of Medical Ethics Whitehead pointed out very aptly that "the pursuit of philosophy is one avocation denied omniscience." 12 But it is in this uncertain realm of philosophy that many of the newer ethical questions raised by medical progress must be considered. Our discussion thus far has been confined to the first level of moral discourse—the "ought" and the "should" of medical actions. We have said nothing of how we can judge medical acts to be right or wrong, good or bad. These are matters of ethical theory, as are the even more fundamental questions of what we mean by the words "good" and "bad" as predicates. Ethics and metaethics require the kind of philosophical discourse to which physicians have, in general, been antipathetic. Yet every ethical code derives its justification from the position it takes on certain philosophical questions, chiefly those relative to philosophical anthropology. Without ever explicitly saying so, existing medical codes are designed to protect the rights of man as defined in the JudeoChristian and Greek concepts of man as "person" with a certain special destiny. The philosophical assumptions underlying the practical directives of ethical codes are rarely specified. The codes have instead concerned themselves with how to act. They set forth duties without concomitant examination of the values which determine those duties. They were devised at first chiefly to limit quackery and regulate professional relationships.13 As Donald Konold points out, in the nineteenth century, the American medical profession used its ethical code as an argument against even the meager clinical research of the times. An "ethical" spirit was then interpreted as justification for an antiscientific bias. While such an eventuality seems unlikely in our time, there is always

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sufficient suspicion of science dormant in society to make it a possibility. It is striking how infrequently codes of medical ethics provide the philosophical substratum for the rules they promulgate. Equally impressive is the assiduous avoidance of medical questions by contemporary ethical theorists. In the English-speaking countries, ethics itself has been confined largely to analyses of the language of ethics and its logic—the second level of ethical discourse. Metaethics, in whose domain many problems of medical ethics ultimately reside, is out of favor among ethical theorists today. It is inappropriate to enter here into a discussion of ethical theory. Yet most of the truly significant ethical issues raised by medical advances are adequately explored only by a closer contact with ethical theory. We should continue, as at present, empirically revising our traditional codes to meet the new challenges in medical progress. Ultimately, we must confront the deeper questions: How do we test the validity of an act—its Tightness and wrongness? How can we measure what is "good" for the individual and what is "good" for society? The history of modern ethical theory provides a confusing array of critical factors against which to measure the Tightness of human acts, medical or otherwise. 14 They include whether the act induces pleasure in the person performing it, whether it promotes the good of the many rather than the few, whether it can become a logically sound universal rule of action, or whether it fits the nature and the ends of man as a spiritual being as defined in Aristotelian-Thomist analysis. Some ethicists propose that the Tightness of an act is intuitively self-evident, and thus they dispose entirely of the need to seek logical substrata for ethical judgments. Some biologists, like Huxley and Waddington, measure the Tightness of a human act in terms of its ability to foster desirable trends in the evolution of the species. 15 This congeries of philosophical criteria for Tightness of an act is forbidding and confusing to the practical or positivist-minded physician or investigator. Yet each criterion contains some facet of reality and provides some glimpse of the bases for moral behavior. A serious attempt must be made to bring ethical theory

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into closer conformity with the reliable first-order data which medicine, sociology, and psychology can now provide. The ethical questions posed by medical progress are of fundamental interest. They should more frequently be used to test out theoretical formulations. While the language barrier between ethical theorists and physicians is formidable, it should not prove insurmountable. Universities with medical centers provide valuable laboratories of human experience in which philosopher and physician can collaboratively inquire into the most basic ethical questions. Even more difficult to approach are the metaphysical questions. What do we mean by the words "good" and "evil," and what do we understand as the "nature" of man? These are unpopular questions in a positivist, analytically oriented world, but they persistently return whenever we try to choose between what can be done and what should be done. They assume the greatest practical significance now, when modern biology, if applied widely, could alter the present ecology and the future evolution of man. The widest divergence of opinion is expressed among biologists on what are the ends to which our new knowledge should be directed.16 What are the highest human values? What constitutes the good life? What freedoms are we willing to sacrifice in the name of progress? Who shall decide? On what grounds? Some consider these questions meaningless and so dispose of them easily. But we must derive at least proximate answers, or our new knowledge of biology will be as mindlessly deployed as have other technological advances. The more our means for modifying the world multiply, the more exquisite is the need for a definition of ends. After all, every attempt to establish norms of right behavior or to define the ends to which technology should be put must be made from some conviction of what is "good" for man. This is true whether the "good" is regarded as scientifically determinable, or logically deducible, or a mere expression of feeling. The definition of the "good" has generated as much philosophical conflict as the definition of what is right.17 But the difficulties cannot excuse us from the effort to generate socially

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acceptable operational definitions which will give some direction to the way in which medicine and biology are applied. Science and medicine are competent to determine what is and what can be, but traditionally they have stopped short of what should be and what must be. With such powerful means as biology will place at man's disposal, we are impelled to explore the intersections of medicine and philosophy and cultivate the ground between them. The impending conflicts between the good of the one and of the many and the determination of the ends to be sought with new technology are only soluble by an interpénétration of the scientific and philosophical attitudes of mind. In seeking a scientific or biologic humanism, Dubos is asking for such an interpénétration, as are Bronowski, Glass, and Waddington when they stress the ethical dimensions of science. Through such a synthesis, scientist and humanist can arrive at some rational bases for actions in the new and unexpected situations created by the application of new knowledge and technology. Contemporary medicine, in its emergent role as applied biology and sociology, must seek energetically to effect this synthesis of the scientific and humanist spirit.

Some Implications The complexity of the moral issues will necessarily impel medicine and its practitioners to an intensive dialogue with those professional and nonprofessional laymen outside medicine who must contribute to the definition of ends and purposes. While the physician will retain his expertise in the technical aspects of medicine, he will increasingly serve as expert witness, but not final arbiter, of how medical resources are to be deployed. The balance between these responsibilities will be difficult to strike. The dangers to the individual consciences of patients and doctors will be considerable as the medical transaction becomes more public and more systematized. Medicine will find it increasingly difficult to claim uniqueness or to expect freedom from reasonable review by those it purports to serve. To resist such

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review on the basis of traditional prerogatives or even traditional medical ethics is to ignore the profundity of the changes occurring in the social milieu and to incur overly restrictive regulation by society. Rather, the physician should encourage the participation of nonphysicians in the establishment of institutional and national goals and policies. He should seek the collective wisdom of his colleagues in law, philosophy, theology, and the social sciences. Some of the sensitivity of the educated public to the preciosity and the mystique of medical issues can be dispelled by genuine participation in decisions of broad concern to the entire community. Such participation will require better public education on medical issues. But the physician can hardly expect continuing support for his efforts in a democracy unless he makes a real effort to define social issues in his work as clearly as possible. We can expect such issues to become part of general university education as medicine becomes even more effective and more focussed on enhancing the conditions of human existence. Even more concrete are the implications for the education of the physician himself. Though he will function in a health care system far more complex than ours, the future physician will continue to be the major agent through whom society will channel its aspirations for health. The physician's ethical reflexes have always been as important as his technical capabilities. But as the tools at his disposal become more powerful, more dangerous, and further-reaching in their effects, his ethical education will become even more critical. To date, there has been little deliberate effort to sensitize each physician to the modalities of ethical discourse or to acquaint him with the complexities of the value decisions he makes daily. Indeed, medical faculties are inclined to see ethical and metaethical questions as vague and insubstantial. The recourse is too often to apodictic statements and simplistic solutions. Customarily, we have depended upon the admirable but insufficient guidelines of the Hippocratic ethic and the more contemporary codes which are derived from it. The answer is not to be found in additional coursework in medical ethics or more "humanities" in college. These facile

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prescriptions have failed repeatedly to make physicians more humane or more moral. Fortunately, today's medical students have taken the initiative in demanding discussion of social and ethical issues which arise in the uses of medical knowledge. More concrete opportunities can be provided for discussion with clinicians, lawyers, theologians, sociologists, and others in the clinical setting. Students need to see in the actions of their teachers a concern for ethical questions equal to their concern for mechanisms of disease and their management. The opportunity to serve as observers and participants in institutional committees on human experimentation, drug usage, bed utilization, and others would be salubrious in this regard. Student involvement in community action also provides practical experience in discerning conflicts in values which may attend the application of medical knowledge. Some education in the history and sources of medical morals seems indicated, as well as some knowledge of the technical methods of logical analysis and moral discourse. The metaethical questions of the "good" and the "right" are best explored in the context of specific problems encountered in providing care for individuals or communities. These same discussions must also become a feature of continuing education of all practicing physicians, who are the most challenged by the changing ethical frame within which they must pursue their work. All of this calls for a deeper involvement of social scientists and humanists in medical education. This will not be easy to effect. Social scientists and humanists are too inclined to think in terms of "courses," when what is needed is involvement in concrete clinical situations and the exchanging of views with clinicians and students. The social scientist and the humanist must become practitioners of their disciplines, to a certain extent. This type of involvement will create the demand for a special group of social scientists and humanists with certain characteristics—a desire to communicate their disciplines to those in the health professions, an interest in providing in-depth experiences for medical students who wish it, and interest in the use of the

Edmund D. Pellegrino

resources of health sciences centers and their hospitals as laboratories for research. To be most effective, these social scientists and humanists must also retain intimate contact with their basic disciplines. In essence, they must be willing to involve themselves in some of the major problems of man, as they are encountered in the modern medical center. Social scientists and humanists of this stamp are not plentiful at present, but the excitement and the pertinence of health and medicine are attracting more of them into close association with health sciences centers. The prospects for deeper involvement in the future are good, provided the appropriate administrative and academic rewards can be elaborated. As the social dimensions of medicine assume increasing importance, medical schools will consciously elect a larger aliquot of entering students from undergraduates who have demonstrated an interest and some training in social and ethical questions. In this way, the medical school can broaden the mix of physician attitudes in the future and develop a deeper interest among future practitioners in some of the problems discussed here. We need also to develop a small but special cadre of physicians to occupy the uncomfortable but exciting gray zone between medicine and the relevant university disciplines in the humanities and social sciences. There is a clear precedent in those physicians who have learned the techniques of biochemistry or physiology and use them to investigate clinical problems. We must develop an additional group who choose similarly to enrich their medical educations by a knowledge of the language and methods of philosophy, theology, sociology, anthropology, and other disciplines. As future faculty members or practitioners, they might help to diminish the barriers in communication which now isolate medicine from other university disciplines. Such physicians are essential in the future if research and teaching in the social and ethical dimensions of medicine are to become an integral part of medical education. More importantly, these physicians could effectively enlarge the horizons of medicine to make it not only a biological science but also a social science and a liberal study.

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Summary The simple, personal, one-to-one medical transaction of the past can no longer endure. The intrusions of experimental science, technology, and social organization have immeasurably enlarged the capabilities of medicine as a social instrument. They have opened up new ethical questions not soluble by traditional codes of medical ethics—questions which deal with new intersections of personal and social values. Our age is dominated by a political and cultural crisis arising out of our effort simultaneously to expand man's existence as a person and as a social being. Medicine, as a manifestation of this culture, epitomizes the crisis of values more acutely than almost any other human endeavor. From its unique position dealing with man's most intimate problems, medicine could catalyze a new humanism which would optimize both the personal and the social dimensions of human life. To do so, medicine must reexamine that most personal of experiences, the medical relationship, in the light of its emergent social and technological transformations. By expanding its traditional ethic to encompass the social as well as the personal, medicine might become the most human of the sciences and the most scientific of the arts.

LOUIS LASAGNA

Some Ethical Problems in Clinical Investigation

One potentially important source of tension in clinical investigation is the fundamental discrepancy in outlook between the clinical investigator and the physician. The two positions are rarely identical. One reads that medical experimentation takes place continually in every doctor's office and that the therapy of disease is an experimental aspect of medicine, but in point of fact, the practice of medicine and the pursuit of a scientific problem are not equivalent. The physician is primarily concerned with the patient qua patient, with getting him well as quickly as possible and with a minimum of discomfort, inconvenience, risk, and cost to the patient. In the practice of his art the doctor has to use any and every measure he considers justified, and he is concerned with what measure (if any) works, not with what contribution (if any) he makes to the body of scientific data. For the investigator, the primary emphasis is on the research question. This does not mean that he need be callous or lacking in caution; indeed, patients who are in an experiment are likely to be more carefully observed and cared for than if they were not research subjects. (In fact, carefully designed experiments result more often in improved patient care than in exciting new scientific information.) There are good reasons for the preferred status of patients in an experiment. Physicians in a research ward or research institution have usually had the advantage of intensive training, experience, and the intellectual discipline of an academic atmosphere. Further, the patient is, paradoxically, often better served by the restraint observed in the therapeutic approach of the critical experimentalist. The uncritical use of many therapeutic measures can be less desirable than the wise Louis Lasagna is Chairman, Department of Pharmacology and Toxicology, University of Rochester School of Medicine. 98

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use of a few well-chosen ones; in medicine two and two sometimes add up to minus four, as the patient finds his medications working at cross purposes and yielding iatrogenic illness to boot. Often in controlled trials, for example, the placebo-treated patients turn out to be the lucky ones, as the new "remedy" proves to be toxic or therapeutically ineffective. Notwithstanding the admirable qualities of many researchoriented physicians, however, there still remain important differences in orientation between the physician and the investigator which may affect the individual patient to a significant degree and which deserve discussion. Take, for example, the patient with metastatic cancer. Here is a serious disease for which we lack good treatment. There would seem to be no ethical problem in giving a desperately ill patient a new compound which may do some good. Yet the situation is only superficially simple. The first cancer patients to receive an investigational drug often fail to obtain significant therapeutic benefit, and the dose exploration and tolerability studies involved in such early pharmacologic trials are likely to entail a certain amount of serious risk because of the powerful drugs generally required to treat malignant disease. In such a situation, therefore, the physician might well say " N o " to the earliest trial of a new drug in cases where the investigator might say "Yes." If one then moves to a problem such as the treatment of pain or of insomnia, where we have remedies which, while not perfect, are for most purposes excellent and reasonably safe, what is the physician to say? Statistically, there is no doubt that the patient has a better chance of adequate relief if given a standard and accepted drug rather than an untried one, no matter how impressive a case for research can be made from the standpoint of society's long-term needs. Another difficulty stems from the use of both patients and volunteer subjects in medical research. This practice tends to blur the fundamental distinction between these two kinds of subjects. The volunteer (or the patient who is being studied in a way unrelated to his disease) is truly an experimental subject and usually stands to gain little or nothing medically—at least

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in the near future—from the experience of being exposed to an investigational compound. He may run considerable risk. It seems to me that such a volunteer must be handled quite differently from the patient who is also contributing to research goals but who may derive considerable benefit in the immediate future. To the degree that this distinction is blurred, ethical difficulties will be compounded. It may be useful to consider the currently controversial issue of obtaining "informed consent" from subjects participating in drug investigation. The new Food and Drug Administration ( F D A ) regulations governing experimentation on human subjects make it clear that except in rare instances informed written consent must be obtained from anyone who is being given an investigational drug. 1 The FDA has spelled out in great detail the kinds of information that must be supplied to subjects of such experiments. It is interesting to contrast this approach with the usual practice of medicine, in which drug administration also plays an important role, and where patients almost certainly suffer more harm (some avoidable, much of it not) from the use of old drugs than experimental subjects suffer from the prescribing of new drugs by experienced investigators. In ordinary practice, consent is usually not informed, and it is almost never written, except for surgical procedures. In favor of obtaining informed consent in clinical investigation is the reasonable (and generally held) belief that a person should know what is being done to him and what the risks of participation in an experiment may be. Of course, there are also important legal implications in procedures which—in the absence of consent—may be construed as civil or criminal assault on a person's body. There is a strong common law tradition in this regard which goes back at least as far as Justice Cardozo. In addition, unless a physician or committee other than the investigator is making the final decisions, the patient's informed consent represents a check on the motives of the investigator, motives which may be generally admirable but specifically undesirable, or at least questionable, for the individual patient. What are the arguments against informed consent? To begin

Some Ethical Problems

with, there are instances in which it would seem clearly not in the patient's best interest to discuss matters with full candor. A person dying of terminal cancer who has been given the few weakly effective available drugs, and whose condition is deteriorating, may gain little from an excessively detailed and frank discussion of the situation when a new drug is available which might possibly provide some benefit. Investigational drug use in psychiatric patients poses similar psychic hazards, including the special risk, if the use of drugs is made to look too much like an experiment, of permanently damaging or destroying the patient-doctor relationship. One may also argue that obtaining informed consent involves the assumption that the investigator knows the risks of giving the drug, of withholding it, and the alternative risks f r o m the use of other, older agents that might be used instead. The language of The F D A regulations does, it seems to me, imply all this. In fact, this information is available only in small measure. 2 One also assumes that the investigator is capable of the exposition required to present this information to the patient and that the patient is capable of grasping the information. One would also like to think that the patient is capable of making a decision in keeping with his own best interests after hearing the information, although a competent adult should, I suppose, have the freedom to make the wrong decision in the hospital or doctor's office no less than in the voting booth. All of these considerations are not, to be sure, so much arguments against informed consent as examples of the difference between the wish and the achievement. Some important arguments against consent revolve around the possibility of impeding scientific progress if such consent is routinely obtained. (One could, for "scientific progress," substitute "providing benefit to others, including future generations.") There are some trials that will be impossible if a truly candid explanation has to be provided. One prominent investigator has evinced his skepticism about convincing people to participate in a trial that will last for years and in which some individuals are given drugs to lower their blood pressure and others receive

Louis Lasagna

placebos. Since it is not clear that all patients with hypertension should receive drugs, it would seem unethical not to perform the trial, but there is disagreement as to whether it is ethical to inform the patients of the nature of the trial while they are participating in it. With postpartum patients, we found in one experiment that if women were approached while they are actually having pain and asked to sign a consent form to participate in an experiment in which they might also receive inert preparations, some 80 to 85 percent refused to participate. (In work conducted on patients of this sort without written consent over a decade or so, we have never seen any evidence of serious harm or discontent; indeed, it is reasonably certain that these patients have received closer attention and better medical care than they would otherwise have received.) This would result in such an idiosyncratic selection of the population that we refused to conduct the trial, not only because of the time that would be required to complete it but because of the very real possibility that the results in such a minority of the population might not provide legitimate basis for predicting effects in the majority. There is also the chance—even if patients consent to participate—that one may destroy the validity of a trial by inducing introspection of various kinds, producing a sort of Heisenberg effect. Some patients, when they know they are in a trial, will try to outwit the investigator by guessing which medications they are receiving. Other patients will be troubled by the nontherapeutic aspects of the experience, so that one may have difficulty in relating the responses to the usual clinical situation. Although investigators quite rightly tend to emphasize, the difference between clinical practice and rigorous clinical investigation, it is nevertheless true that those studying new drugs experimentally wish very much to collect data applicable to the use of the drugs in patients treated by "ordinary" doctors in "routine" medical practice. Finally, there are some experiments which lose their entire point if all the cards are laid on the table. Take, for example, the investigation of the impact of a placebo. Although some

Some Ethical Problems

patients report benefit from placebos even when they are told they are receiving "sugar pills," the full power of suggestibility and the patient-doctor relationship would almost certainly be affected by a discussion of the experiment with the subjects. This would be the medical equivalent of "bugging" a jury room to study the jurors' deliberations and then showing the jury the hidden microphones.;i Are there alternatives to "double-blind" placebo trials? (It is assumed that the obtaining of consent will be more feasible if patients do not have to agree to receive placebos.) One possibility, in drug investigation, is to demonstrate differences between a new drug and a standard drug. If the new one is significantly better, there is no problem. But what if it is significantly worse? This could mean that the drug is ineffective or merely that it is a less effective one—an important distinction. Another possibility is the use of dose-response relationships. If such relationships can be-shown for new and old drugs in the same experiment, potency estimates can be made which are in no way dependent on the use of placebos. This is quite possible in a situation such as alleviation of postoperative pain, where the challenge is severe, the response to powerful analgesics is reasonably predictable, and placebos are thus rarely needed or used. In postpartum pain, however, dose-response relationships are rather difficult to elaborate, and the same may be true in studies of hypnotic drugs. This phenomenon has important implications for the admission of new drugs to the marketplace. If placebo studies are abandoned, will the F D A accept clinical comparisons where no dose-response relationships are evident? Not to do so may keep an effective drug off the market, but accepting at face value experiments where no difference is demonstrated between doses or drugs will surely result in the occasional admission of ineffective agents to the market. Is some less formidable and stylized consent approach acceptable? It is apparently not, in regard to investigational drugs, unless one is willing to flaunt the F D A regulations. On the other hand, it may be possible to modify these regulations so as to make the consent provisions more flexible. If one eliminates the

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written aspects of the present informed consent regulations and substitutes verbal discussion (perhaps even placed on tape for the record) it may be possible to avoid some of the threats to experimentation discussed above while at the same time insuring that a certain amount of discussion with the patient has occurred. 4 I believe that the degree of candor utilized in obtaining consent should be related not only to the specific psychological and clinical problems but also to the expected risks of the experiment. There is also the possibility of monitoring experimentation by use of peer committees or lay-scientific review boards which go over protocols, checking them carefully for flaws of various kinds, including ethical ones. No investigator should be engaged in research that he would be ashamed to have judged by his scientific colleagues or by a responsible group of laymen and scientists. There is at least theoretical advantage to sharing problems of conscience and morality with individuals not directly involved in the research, and of course ample precedent exists in society for delegation of important decision-making powers to others, although I doubt the legal acceptability of such review as an alternative to informed patient consent. It should be remembered, however, that a peer review mechanism may safeguard a subject more efficiently than informed consent; some people will agree to undergo risks that an expert committee would veto on their behalf. It has been suggested that one way of discouraging unethical research is for editors to prevent the publication of data obtained in unsavory experiments by refusing to accept such manuscripts. Although this is an attractive notion at first glance, one wonders whether in fact important data unethically obtained could or should really be buried in this way. If an unscrupulous investigator were to discover a cure for cancer, would it be ethical to keep this knowledge from being used by others for the benefit of cancer patients, in compulsive adherence to "principle"? Although it is often affirmed that the ends do not justify the means, our society often functions as if they do. One way of improving the present situation would be to ac-

Some Ethical Problems

quaint the public, the regulatory agencies, the governmental granting agencies, and hospital committees with the needs and problems of experimentation. The present F D A regulations on informed consent, for example, quite clearly are the result of a particular climate of opinion. The law is susceptible to change. I heard one distinguished Baltimore judge say recently that the purpose of the law is to harmonize progress with stability. Years ago a property owner possessed the land underneath his feet as far as it went and all of the air directly above his property. With the coming of the airplane, this concept has changed. Similarly, educational facilities once considered "separate but equal" are no longer considered "equal." The law reflects the needs and desires of society as society sees these needs and desires, and it is entirely consistent with history to expect an appropriate legal response from society if it becomes educated to the needs of science and the social benefits of research. 5 One wonders how many of medicine's greatest advances might have been delayed or prevented by the rigid application of some currently proposed principles to research at large. Even physicians were in a sense intellectually and emotionally unprepared for the earliest triumphs of cardiac surgery. What, then, would have been the layman's reaction to a full exposition of the problems involved in the original Blalock-Taussig shunts? And what of cardiac catheterization? The benefits of this technique have, quite appropriately, won Nobel Prizes for three of the physicians who pioneered in its use, but is it difficult to imagine lay journalists dubbing the early experimentation of these men barbaric and Nazi-like? ("and then, dear readers, these monsters have the temerity to thrust a tube down the length of one's arm into the very chambers of the human heart! The mind of anyone not completely brutalized by prolonged immersion in the bloody charnel houses of Science boggles at the thought.") I doubt, on the other hand, that the public would back—provided they had the facts—legislation like that originally proposed by Senator Thaler in New York State, which would have prohibited pediatric research of all kinds .in the absence of court orders. Others have already pointed out that such legislation would have

Louis Lasagna

rendered impossible the development of the poliomyelitis and other vaccines. If society is to be educated, there are many items that might be put on the agenda for discussion. The desire to involve the patient in the decision-making process in regard to details of medical care implies that there should be fuller and franker discussion about the use of everything from drugs to surgical techniques. Whether the public wants this is a matter for debate; I personally doubt it. In my own experience as a physician and investigator, not only are patients usually incapable of making the decisions in question (which is not surprising) but they are usually not desirous of making such decisions. In considerable anxiety a lay friend once called me to say that his physician had disclosed to him the controversy over the long-term use of anticoagulants in the management of patients who had recovered from a cardiac infarct. My friend protested that he was in no position to judge whether his wife should receive anticoagulants and that he really would have preferred his physician to make this judgment. In many complex decision-making situations in medicine, the patient is really more in the position of being on an airplane that has defective landing gear, is running out of gas, and whose pilot has to make some sort of landing in one of several alternate places than in the position of a passenger who is asked whether he wishes to board a plane whose pilot indicates that he is about to fly for the first time with his eyes closed and "no hands." How much should be told to a patient by a surgeon who is requesting permission to perform an established operation, but one he personally is attempting for the first time? How much should be told to a patient about the hazards of a debilitating series of diagnostic abdominal X-rays, which may subject him to days of restricted food and fluid intake, as well as repeated cathartics? How much should be told to individuals exposed to radiation of any kind, for diagnosis or therapy, in view of the evidence in both insects and mammals that no amount of radiation is innocent in regard to genetic damage? There are many other points that require consideration. What

Some Ethical Problems

special safeguards are required for the study of prisoners? Of children? Of the psychiatrically ill? Of the mentally retarded? Of the dying patient? If an experimental live virus vaccine is to be given to subjects, should consent also be obtained from neighbors or schoolmates who may pick up the virus from the volunteers and come down with the disease? Should the patients in the adjoining beds be asked for permission when a new antibiotic is given to a patient, in view of the ability of antibiotics to disturb the ecology of the normal bacteria resident in the body and cause the development of resistant strains which can then spread to these patients? Should individuals be recompensed for damage suffered in the course of research, without any attempt to establish blame? The patient or volunteer who is injured by an experimental drug and loses his earning power thereby is entitled to compensation. The children of a patient who dies as the result of unanticipated mischief from a new diagnostic technique under investigation perhaps ought to expect financial remuneration. This implies not that the investigator must shoulder this burden alone but that the burden must be borne somehow. Who, then, shall pay the bill? In seeking an answer to this question, we should perhaps ask, "Who reaps the benefits of research?" While it is true that the investigator will gain when research is successful, and that with new drugs the pharmaceutical industry will profit, in the final analysis the beneficiary is really society as a whole. It would therefore seem incumbent on society to seek means of walking safely the narrow ledge between the twin abysses of hampered research and uncompensated patient injury. Scientists must not be reckless in their research; neither can they operate in an atmosphere of perpetual fear of disabling economic loss (or destroyed reputations) if unavoidable harm is the result of a well-planned experiment. Patients must not seek court settlements capriciously; neither must they silently suffer pain, injury, or death in the course of research. The problem is both subtle and complex and deserves an honest and equitable solution. What should be society's attitude toward harm to the individual in return for benefits to the population as a whole? Mass

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chest X-ray surveys to detect treatable tuberculosis or other pulmonary diseases may cause leukemia in a few. Is the benefit worth the risk? Who shall decide? What means should be taken to safeguard the rights and health of individuals approached to participate in such a survey? Should a simple majority decide whether an entire community's water supply should be fluoridated? We have become reconciled to the ability of a governmental agency to expropriate our land or homes in order to build a new school or a new bridge, but it is not traditional to force anyone to participate in research. Yet society frequently tramples on the rights of individuals in the "greater interest." One can object, but can we deny the existence of the phenomenon? Should we have different guidelines for individual sacrifice when health or life is at stake, rather than property? Finally, a word about the effective implantation of an ethical conscience in the minds of physicians and clinical investigators. The doctor becomes increasingly accustomed to a life which does not allow for leisurely contemplation. He is by trade a nonagnostic. Even when he makes a decision not to treat, for example, he is not suspending judgment but expressing the belief that "no treatment" is better than treatment. He must continually choose between remedies even when he has poor basis for making a choice. The doctor is likely to be propelled increasingly in the direction of quick decisions which at times resemble reflex responses. In this pragmatic, frenetic existence he may quickly absorb the moral atmosphere around him without questioning it. It is my conviction, therefore, that ethical problems must be integrated into the doctor's life at the earliest possible moment. I do not believe that it will be effective to bring up such matters relatively late in the medical career, although the doctor will certainly require constant reinforcement throughout his professional life. The medical student must be made, from the beginning, to consider the ethical aspects of medicine, in regard to both practice and research. Many a liver biopsy or laboratory test is now performed in the name of science, with little benefit to the patient. A medical student made emotionally immune to the casual performance of risky procedures by the tacit accep-

Some Ethical Problems

tance of such procedures by his mentors is unlikely to be excessively concerned as a physician or investigator with the subtleties of ethical and moral issues. Some way must be found to incorporate these matters so firmly into his moral fabric that he cannot avoid the ethical implications of his acts. I submit that the successful development of such an ethical conscience, combined with professional skill, will protect the patient or experimental subject much more effectively than any laws or regulations. I have previously said that for the ethical, experienced investigator no laws are needed and for the unscrupulous incompetent no laws will help, except to allow the injured subjects to obtain compensation or to punish the offending scientists. Between these extremes there still remain many investigators who will unquestionably be constrained in some way by legislation. But it is unlikely that subjects will be optimally protected from h a r m without additional safeguards imposed by the scientific community itself. These safeguards will range all the way from exercise of wisdom and judgment to the invoking of statistical monitoring techniques to halt experiments that were ethical at the outset but cannot ethically be continued. Some are fond of quoting Claude Bernard when he said, in An Introduction to the Study of Experimental Medicine, " T h e principle of medical and surgical morality, therefore, consists in never performing on man an experiment which might be harmful to him in any extent, even though the result might be highly advantageous to science, i.e., to the health of others." 6 This statement is irrelevant to much of clinical investigation, where patients usually are involved in procedures that may be of considerable benefit to them, although they necessarily involve some risk (like almost everything else in this world). One might point out that Claude Bernard also said, "So, among the experiments that may be tried on man, those that can only harm are forbidden, those that are innocent are permissible, and those that may do good are obligatory." 7 The investigator is responsible not only to the patients currently under his care but also to the many that will never be seen by him. Is this responsibility to

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mankind less noble than that of the physician concerned with the care of the individual patient? Bernard's statement is—like my own remarks—full of ambivalence. As J. Bronowski has put it, one of society's major tasks is to reconcile the welfare of man with the welfare of men. 8 In clinical investigation, as in other societal activities, the good of the individual and the good of society are often not identical and sometimes mutually exclusive. I believe it is inevitable that the many will continue to benefit on occasion from the contributions—sometimes involuntary—of the few. The problem is to know when to say "Halt!" There are some societal "gains" that may only be available at an excessively high price. We cannot afford to have the cancer of moral decay that comes from frequent and flagrant disregard of human rights gnawing away at the body of science. We should, therefore, in a very real sense welcome the present and continuing debate on ethics in clinical investigation. That harm has come from exaggerated stories is unquestioned, as is the possibility that additional harm to patients may occur, but I believe that in the long run both the public and science will benefit from a searching analysis of the roots of our ethical conduct.

EVERETT M E N D E L S O H N , J U D I T H P. SWAZEY, AND IRENE TAVISS

The Harvard Conference on Behavior Control Technologies

On March 18, 1967, the Harvard University Program on Technology and Society brought together a group of seventeen scholars for a one-day conference on the social implications of behavior control technologies. The conference participants— whose names and institutional affiliations are listed at the end of this chapter—were drawn from a wide range of disciplines: psychology, psychiatry, biophysics, physiology, demography, history of science, history, philosophy, political science, and law. Prior to the conference, working papers prepared by Jose M. R. Delgado, Roger E. Ulrich, and Sanford Unger were circulated to the participants. The papers, which summarized the authors' own work, were intended primarily to familiarize the conference participants with the scientific state of the art and to serve as a "data base" for the conference discussion. Brief summaries of the papers are presented below, followed by a report of the conference discussion.

Jose M. R. Delgado—"The Manipulation of Behavior by Direct Stimulation of the Brain" Dr. Delgado asserts that "the ability to manipulate cerebral, mental, and behavioral mechanisms should not increase the control by civilization over the individual. On the contrary, this knowledge should enhance personal freedom and social relations Everett I. Mendelsohn is Professor of the History of Science, Harvard University. Judith P. Swazey is a Research Associate with the Program on Technology and Society and a Lecturer, Department of the History of Science, Harvard University. Irene Taviss is a Research Associate, Program on Technology and Society, Harvard University.

Ill

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by liberating man from many genetic and environmental unknowns and by allowing him the intelligent selection of elements which determine personality and individual behavior, just as medical sciences have liberated modern man from many forms of illness and pain and enabled him to improve the nourishment and hygiene of his body." The postulates underlying Delgado's research are: " ( a ) mental and behavioral activity are necessarily related to specific physical and chemical events located within the brain, ( b ) experimental investigation of these events is possible, (c) the results of these experiments are predictable, and (d) we can intelligently manipulate the cerebral determinants of behavior." Delgado further states: "The great historical handicap to investigating the functions related to mental activity was the fact that the brain was well protected, not only by philosophical taboos, but also by a shell made up of membranes, skull, and skin which could not be penetrated without seriously disturbing local functions and general behavior. Fortunately, a combination of recent technological advances in surgery, electronics, and chemistry of plastics has permitted the long-term implantation of electrodes inside the brains of animals and men for research and therapeutic purposes." Research on the effects of such electrical stimulation of the brain shows that "most autonomic functions may be influenced by direct excitations of specific structures . . . Many motor responses have been elicited in monkeys, cats, and other species by stimulation of specific cerebral structures; and the animals have been induced to turn the head, wiggle the ears, chew, eat, walk around, close the eyes, lie on the floor, and perform a wide variety of movements which were generally well organized and often appeared directed by the animals' will toward some useful purpose. For example, when licking was evoked in cats by excitation of the motor cortex, they looked actively for something to lick such as milk in a cup, the floor, their own fur, or even the experimenter's hands. These stimulations were not uncomfortable, and on the contrary the cats seemed to enjoy the at-

Behavior Control Technologies

tention paid to them and usually rubbed against the observer's hands and purred happily . . . "Behavior depends not only on the activation of some motor mechanisms, but also on the inhibition of many other unrelated responses. T o act is to choose one motor pattern from among the many available possibilities, and as we are well aware, inhibitions are continuously acting to suppress inappropriate or socially unacceptable behavior . . . Various types of inhibition have been evoked in different situations, including loss of leadership by a boss monkey who was tamed, and his hierarchical rank within the monkey colony reduced following [brain] stimulation . . . In some cases, a submissive monkey learned to press a lever which triggered radio stimulation of the dominant animal in the group, diminishing his aggressive behavior. The fact that one animal is able to control the behavior of another by instrumental means has obvious social implications . . . "Electrodes have been implanted in the brains of patients for diagnosis and treatment of illnesses such as epilepsy as well as for intractable pain and involuntary movements. This work has provided an opportunity to confirm many results obtained in animals, and especially to investigate changes in emotions and in the thinking process evoked by intracerebral stimulations. These studies have produced many results, including recollections of the past, sensations that the present has already been experienced in the past, sensations of fear and threat of unknown danger, increasing friendliness, feelings of pleasure and happiness accompanied by giggling, laughter, and humorous comments, perception of words and phrases, and blocking of thoughts. The available literature demonstrates that the study of mental functions can be approached by well-controlled and repeatable experimentation. Many patients have already been helped by the new methodology and far greater benefits should be expected in the near future . . . "It would be inappropriate to discuss whether physical control of the mind should be accepted or ignored, because history suggests that when technology is available it will be used and

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developed regardless of possible dangers or moral issues. It is therefore preferable to face reality, evaluating ethical implications, establishing limits, and using our new power wisely. One objective should be the liberation of man from some undesirable ancestral instincts—like the tendency to retaliate to a threat with physical violence—which had an adaptive function when survival depended on physical power, but could be dangerous in present civilized life where reason should prevail over instincts . . . Ultimately, we should be able to influence the genetic, environmental, and intracerebral levels in order to substitute, at least in part, human intelligence for natural chance in the formation and education of individual mental activities . . . If we could intelligently modify mental mechanisms, the consequences would be far more important than the consequences of extending man's lifespan or limiting his birthrate, because to influence mental processes is to influence the source of all human activities."

Roger E. Ulrich—"Behavior Control: Technology and Social Implications" * Dr. Ulrich's paper begins with a brief history of psychology leading to the development of the behaviorist school, which was initiated by the work of John B. Watson and E. L. Thorndike. Thorndike's work "led to formulation of the Law of Effect, a behavioral law desirably operational in nature, parts of which have been impervious to the ravages of time. The law states that whenever an act results in a satisfying state of affairs, the act is likely to recur; whenever an act results in a discomforting state of affairs, it is likely to be discontinued. In other words, the consequences of an action change the organism in such a way that its future behavior is altered." The work of Thorndike and subsequently that of B. F. Skinner "have led us to concentrate on the consequences of behavior, vernacularly known as rewards and punishments . . . There are classes of environmental events that have the property of * With the assistance of Neil D. Kent (Professor of Psychology, Western Michigan University)

Behavior Control Technologies

increasing the frequency of occurrence of the behaviors they follow. We discover empirically what these environmental events are, noting that they differ from individual to individual primarily because of the differences in their past histories. In order to scrutinize only the particular variables that we immediately wish to examine we attempt to study behavior in situations in which extraneous variables can be controlled. For this reason, a great deal of initial work is done with lower organisms whose genetic backgrounds and behavioral histories can be controlled in order to increase the sensitivity of experiments to the single factor in which we are currently interested. We can also investigate the effects of variables which practically or ethically are not possible with humans. "The usual experimental procedure involves isolating a single response for study, such as a bar press with a laboratory rat, or a key press or a verbal response with a human subject . . . "As a more specific example of the type of work upon which our present technology is built, we may briefly examine research on aggression . . . In early studies of aggression it was noted that animals fought in response to painful stimulation and that painful pinches, intense heat, and electric shock were all effective as stimuli that would produce what appeared to be unconditioned attacks. The fact that this phenomenon occurred in a number of species and especially in monkeys suggested its possible generalization to humans as well. Of particular interest, in terms of potential applicability, was the fact that 'pain' produces aggression. This finding suggested the necessity for re-examination of commonly used punishment procedures employing 'painful' or aversive stimulation . . . "The principles of behavior derived from these studies are not idle theoretical assumptions that society has viewed as merely academic. Education, the mental institution and outpatient clinic, advertising, industry, and the military have all felt the influence of the technology of behavioral control . . . "In consistently increasing numbers mental institutions have shown the success of making certain 'desirable' consequences (such as social approval or tokens which can be traded for food,

Mendelsohn, Swazey, and Taviss

privileges, etc.), contingent on 'appropriate' responding. From extensive controlled investigations we are now certain that the traditional 'tender loving care' distributed independent of 'normal,' 'desirable' behavior is inefficient and perhaps dangerous. Outpatient clinics for the emotionally disturbed routinely counsel parents and relatives of patients in the theory and method of preventing a recurrence of the behavioral difficulty. Implicit in the rationale of these sessions is the assumption that changing the environmental conditions apparently causing or controlling problematic behavior will produce a different, perhaps less 'deviant' mode of responding . . . "Current means of behavioral shaping, such as by education and advertising, have not usually produced much concern, perhaps because the techniques used by many controlling individuals or agencies are not aversive in nature. People do not appear to be as opposed to behavioral control that involves the use of positive reinforcers contingent upon a response, and are likely to explain that they engage in the behavior because they 'want to.' However, if a behavior is controlled by presenting a noxious stimulus for failure to respond, many individuals are likely to say that they engage in the behavior because they 'have to' or are 'forced to.' "Yet current behavioral shaping should be the subject of our concern. We impose controls that leave children to grow up in slum environments where there are poor educational interests and facilities, and later punish them because they act like uneducated slum dwellers. Society continues to allow religious and cultural dogma to dictate practices inhibiting the control of a population expansion which, if not checked, will guarantee society's own extinction. And when a controlling government manipulates men's passions so that they gladly rush to war against other men with similarly manipulated passions, there is, indeed, cause for great concern . . . "The thought that some day human behavior might be brought under scientific control in the same manner that other natural events have been is repugnant to some because it seems to imply a corresponding loss of freedom of choice that human beings

Behavior Control Technologies

are supposed to possess. Another basis of apprehension is the tendency to think of behavioral control in terms of Brave New World or 1984; that is, in terms of control by coercion, punishment, or restriction, technically called, 'aversive stimulus control.' A third general basis for concern is the fear that people will lose individuality or dignity. "Ostensibly these are all legitimate concerns; but let us examine them more closely. When we visit a mental hospital and observe the despair of patients for whom reality is so unpleasant that they can no longer respond to it, can we honestly say that these people would be deprived of dignity if their environments were controlled in such a way as to make their lives meaningful? When we read daily of youngsters who, for reasons beyond their control—accident of birth, cultural deprivation, and so on— drop out of school or commit delinquent or criminal acts, is it meaningful to say that we have deprived them of freedom of choice if we can manipulate their environment in such a way as to make them more productive citizens? Does it make sense to become preoccupied with what may be pseudo-problems of dignity and self-determination when we consider what might be done for the millions of so-called mentally retarded children presently destined to live in institutions as 'vegetables'? . . . "Although the potential dangers of behavioral control certainly require careful consideration, the majority of debates about behavioral control actually miss the point. Too much time is consumed by the question of whether behavioral control can or should be effected. Men can and do control the behavior of other men. Our culture must accept the assumption that man is an organism which obeys certain laws of behavior and that the control of human nature is a ubiquitous fact. Questions of goals, methods, and choice of practitioners are of extreme importance, but are premature if used as arguments against the implementation of behavioral control . . . If we refuse to apply our knowledge of behavior we are not simply taking a neutral position. Rather, we are endorsing other forms of control that gain in potency as we withhold the competition offered by our methods."

Mendelsohn, Swazey, and Taviss

Sanford Unger—"Psychedelic Therapy: A Brief Overview" Dr. Unger's paper discusses the uses of LSD (lysergic acid diethylamide) in facilitating "a variety of psychotherapeutic objectives." The procedure involves "a specialized set of techniques for programming and guiding the reaction to LSD (or an LSDtype drug) within the context of ongoing psychedelic therapy . . . Psychedelic therapy has developed largely as a series of strategies and tactics of treatment; overall theory development has been sketchy. In general, pathological functioning in the patient is presumed to have been determined by a reinforcement history which would have predisposed toward root 'defects' in the self-system (self-image, self-esteem, self-trust, sense of basic worth). Once the pathogenic elements in the history have been identified the major focus of psychedelic therapy turns to reconstruction of the self-system . . . "The primary purposes of the high-dose LSD session are not conceived as diagnostic or uncovering but rather as corrective and remedial . . . The psychedelic procedure is designed to elicit and guide the evolving episodes of experience so as to achieve deep catharsis, reciprocal inhibition of anxiety, conflict resolution, emotionally validated insight, attitude redirection, elevated self-esteem, and deepened philosophical perspective. "The rapidity with which major changes in certain aspects of a patient's psychological picture may be accomplished is one of the unique advantages of psychedelic therapy . . . The shortterm consequences of a stabilized psychedelic reaction are often quite remarkable. Mood is elevated and energetic; there is a relative freedom from concerns of the past and from guilt and anxiety. The disposition and capacity to enter into close interpersonal relationships is enhanced. This psychedelic 'after-glow' often persists for from two weeks to a month and then gradually fades. The therapeutic challenge has revolved, first, on reliably producing the psychedelic reaction, and then, more importantly,

Behavior Control Technologies

on learning to utilize this extraordinary, 'paranormal' phenomenon as a fulcrum of enduring personality reconstruction . . . "The significance of a rapid and radical benign alteration in the patient's pattern of functioning, while it would seem of general value, is of special importance in the treatment of alcoholism. . . . The apparent effectiveness of psychedelic therapy with culturally-deprived patients of low intelligence has emerged as another advantage." Following this exposition of the nature of the treatment, Unger presents an illustrative case history.

Conference Discussion All three researchers argue the case for continued and more intensive exploration of their methods of behavior control. They see them as being socially beneficial and assert that our abilities to control behavior will be enhanced in the future. While recognizing that there may be some social dangers involved, they take an optimistic view about the progress of such techniques. The conference participants did not all share their optimism. While the discussion did not concern itself with the rate of progress of such techniques, it did consider the promises and dangers involved. The focus was on such questions as: Could we use such techniques wisely? Should they be used at all? For what ends and with what constraints? Individual Freedom and Images of Man One major source of contention was the issue of random versus deliberate behavior control. Ulrich argued that since behavior control is constantly occurring in any culture, we should apply it more intelligently and deliberately for humane and social purposes. In his view, the question in not whether to use behavior control techniques but how to use them wisely. While it was easy enough for most participants to accept the fact that the environment, the educational process, in sum the entire culture, shapes human behavior, many could not accept

Mendelsohn, Swazey, and Taviss

the contention that the planned scientific shaping of human behavior is but a further refinement on the same level. The objection to the use of conditioning and electrical stimulation of the brain was based, in the first instance, on their deliberateness. As Jacques Barzun expressed it: "What bothers me about your ways [of controlling behavior] in contradistinction to mine, is that yours are systematic, that they have a mechanically tested base, and perhaps they are more powerful. Believing as I do that man is infinitely plastic, I am worried about the limitation of something that comes from systems and mechanics. The saving grace about what I won't even call my methods is that they are fitful and uncertain and in one important sense not deliberate. The individual responds very differently to what is done deliberately than to what happens accidentally, and the more we go in for deliberate manipulation, the more we must expect sideeffects which come not from the technique, but from the deliberateness of the technique." The use of such techniques, Barzun continued, results in "the reducing of possibility, even the possibility of disaster, and we don't know what we lose with it." The deliberateness of scientific behavior control also implies some degree of coercion or restriction of individual freedom. Opponents of behavior control argued that the child who is scientifically conditioned to behave in a certain way has less freedom of choice than one who is not. In response, Dr. Delgado argued that it is a fallacy to say "leave the child in freedom" because babies "are not free. They are going to accept what we give and then they are going to react, accepting, correcting, modifying the values that we give them; they are not going to invent values." The purpose of creating an intelligent behavior system, Delgado continued, is a dual one: to increase both social integration and individual differentiation. "If we teach the mechanisms which determine our social integration, then we will give the individual the power to select the elements for his own integration, and in this way we reinforce individual differentiation." Those who find the notion of deliberate control repugnant were not satisfied even by a technique which has individual freedom as one of its goals.

Behavior Control Technologies

The restriction of individual freedom is more apparent in the case of electrical stimulation of the brain than it is with various forms of conditioning. As Barzun argued, when you implant electrodes into the brain for whatever purpose, "it is a form of coercion," the individual "cannot resist it." Delgado responded that in implanting electrodes "the only thing I am trying to do with these pieces of metal is to understand how behavior is done, and then to apply these facts to normal education and to human behavior. What I am doing is adding one element to determine behavior which will compete with the behavior mechanisms within the brain. I am only waking up physiological mechanisms within the brain . . . and the main objective of the whole thing is not to direct behavior by push button control." While this is not the objective, Dr. Delgado did concede that such techniques could be used for push button control. In addition to the fears associated with the deliberateness of behavior control technologies and the restrictions they place on individual freedom, some concern was expressed about the possible irreversibility of such methods. As Dr. Mesthene pointed out, "you can change a law, what can you do if you once altered a brain?" Ulrich and Delgado did not agree that their methods are any less reversible than the traditional methods of shaping behavior. In fact, Delgado asserted, "in education you implant your ideas and your ethical codes" in a way that is "by far stronger than the very clumsy method that I am using." While some demurred that the education process is not an irreversible one, Professor Rosenblith noted that "there is a great deal of evidence today that if you deprive' children in their very young years of the ability of interacting with the environment in a rich way, then you have done irreversible damage." This is a technique of behavior-shaping too, he argued, though it may perhaps "seem to us more acceptable because it is something that we have lived with for a long time." Yet another major objection to the use of behavior control techniques stemmed from conceptions of the nature of man which are incompatible with scientific behavior-shaping. Jacques Barzun touched off a discussion of this issue by noting that the

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scientists tended to "divide and subdivide" what they call "behavior," while he looks at "man as a whole and man in groups." Addressing himself to Dr. Delgado, he said that "when you told us that you could implant an electrode and make somebody cheerful, in the first place I believed you. In the second place, I would see that you could reduce the organism's capacity to adapt intelligently and rationally to its environment by this manipulation. You could have somebody lose a member of his family and render him jolly, if it suited your convenience or that of the group or any other criterion that you set up. And if we go far enough along this line of speculation, we see that what we have called rationality, of which there is precious little in history, would diminish perceptibly and that almost all the social and political problems would then be as atomized as you would have made the behavior that you could control. To put the same thing differently, what we now see is partly the result of the total disappearance of any model for man. We have no notion of what a man should be." Professor Mendelsohn observed that the assumption was implicit in this discussion that most means of controlling behavior, through schools and the church, for example, have developed institutional forms, whereas "now we are seeing an accelerating pace of existing modes, and new modes, of controlling behavior, which we are not sure how to build into institutional patterns." Dean Barzun said that he would go farther and argue that these problems are upon us precisely because such traditional institutions for controlling behavior as the family, the church, and myths have broken down. Behavior-conditioning involves the selection of specific behaviors to be rewarded or punished. The procedure would thus be to take a socially desirable outcome such as law-abiding behavior and reward it. What both Barzun and Mesthene objected to was that this procedure leaves little room for creativity and change. As Mesthene said, "for man to be man, what you want is people who are going to change the law, who are going to make a different culture." Professor Dershowitz entered the discussion at this point to

Behavior Control Technologies

say that he saw both Barzun and Mesthene as "agreeing, for example, that if two people pick somebody out of a puddle, one man does it because of the reward, one man does it because he is a good man. It is the same act, but the act has a very different quality to it. I think the middle ground answer is that there are certain levels of conduct which are so important in a society and so intolerable for a society to exist without that we may have to sacrifice that general character and offer bribes." Dean Barzun countered that though the bribe system has been operating in our schools for about forty years now, "we have at the present time the worst taught collection of young people with the greatest amount of native intelligence that perhaps the world has ever seen." Both Unger and Ulrich argued that the objection to behavior control techniques often rests on the unwarranted assumption that human beings are treated like circus animals or machines. What is needed, Dr. Quarton suggested, is to achieve certain desirable patterns of behavior by a method which allows for greater maturity or choice on the part of the individual. Indeed all participants seemed to agree with Dershowitz's suggestion that the aim should be "to train a man who will not respond exclusively or even primarily to external stimuli, to train a man who will respond to what is right and wrong from within." The Selection

of

Goals

Beyond this general goal, no consensus could be reached on any specific goals that one might want to foster through the use of behavior control. Despite Ulrich's repeated prodding, the participants could not agree on any specific behavior that they would like to see inculcated in all children. In part, this reflected a belief that there are few behaviors which one should like to see all men share; different individuals ought not to be shaped in the same ways. In part too, it reflected the absence of a model for man that Barzun had noted. Without such a model it is difficult to achieve agreement on social goals and values. Finally, there was the fear that if once such goals could be chosen they might become mandatory and come to be imposed on all people.

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Thus, the state or the scientific community might come to have greater power than we now consider to be warranted. As Dershowitz expressed it, the real problem is that of determining what kinds of goals would be appropriate "for the state to have an influence on. The way I would put the legal question would be: what areas that you presently deem illegitimate for negative sanctions should be regarded as legitimate for control by positive sanctions?" Although there are many types of behavior that society would currently like to encourage through the educational process and by persuasion, there are relatively few types of behavior that society feels should be discouraged by institutionalized legal punishment. "I think the feeling is," said Dershowitz, "that if positive conditioning were used only in instances where punishment is now used, there would be no legitimate concern and no legitimate objection, but the fear is that positive sanctions, positive conditioning, might be deemed justified to control areas of activity and behavior for which we have come to agree that negative punishment would not be authorized." As an example of the problem, he cited narcotics addiction. Society has a stake in the control of narcotics addiction and seeks to discourage the use of narcotics by its citizens. The prevailing view, however, seems to be that a person should not be imprisoned simply because he is an addict. Now if we developed scientific techniques that enabled us to "program" individuals in such a way that they would never become narcotics addicts, would that be considered a proper area of control? Does society have a large enough stake in the control of narcotics addiction to employ the kind of affirmative sanctions provided by science to control behavior? One must ask, Dershowitz continued, whether there are some things that society has such a great stake in that it will permit almost any devices to be used to prevent them from occurring, whereas in other matters although punishment might not be authorized today, one might consider "authorizing some affirmative conditioning sanctions which would achieve the goal without totally or significantly reducing the area of choice available to the individual."

Behavior Control Technologies

Mendelsohn suggested that a different line of questioning might be: how long do you hold back the means of altering behavior that is currently deemed punishable? "If society will jail an alcoholic, how long do you hold back the therapy or drugs which might alter the condition?" Mesthene responded that "you hold it back until the society has made a political decision to employ it." But Dershowitz demurred, saying: "you don't prevent all things which you would punish if they occurred . . . One has to weigh very carefully the costs of prevention." There are some areas, he contended, in which there is a fine line between what is acceptable behavior and what is not. Free speech, for example, is an area in which we "carefully and precisely punish people only after they go over the line, whereas the only way to prevent wrong behavior is to prevent more than you want to punish." There is social benefit, he argued, in allowing for the choice of good and evil. Mendelsohn asked whether this combination of freedom and controls might be "attempting to manipulate the behavior in perhaps a very ineffectual way?" Dershowitz replied that "sometimes the use of ineffectual mechanisms in an area as delicate as this one is a virtue." That statement seemed to express the feeling of most conference members who were skeptical about the use of behavior control technologies. The Problem

of Social

Control

Though the problem of "who controls the controllers" was an underlying theme throughout much of the conference discussion, little attention was devoted to it explicitly. The issue was raised by Mesthene as he questioned Ulrich's assumption that it is the duty of scientists to apply their knowledge of behavior to affect cultural ethics. He maintained that the social consequences of behavior research are too important to be left in the hands of scientists alone. "So long as the scientist stays in the test tube, there is still an interference with nature, but very few people really are going to deny him the right to do anything he wants in the test tube. But as soon as he starts exploding nuclear bombs in the atmosphere or trying to gain control of the local school system, then it seems to me that the society

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begins to have a stake in what is done initially for scientific purposes. As soon as the consequences become other than just scientific, you raise questions of the structure of attitudes and social controls within which the enterprise of science can be conducted." Dershowitz added a footnote to this by reciting a discussion that occurred within the American Psychiatric Association. A proposal for community psychiatry—for "curing communities" and preventive psychiatry—had provoked the response that the psychiatrist advocating such a program should run for public office on that platform and see whether he would be acceptable to the community. He should not try to do this under the guise of psychiatric or medical intervention. While the rights and freedoms of scientific investigation must be maintained, some social control is obviously necessary. The balance between social and scientific freedoms is not an easy one to strike. Mesthene suggested that the more effective a scientist's methods for controlling behavior, the less freedom he should have to implement these methods outside the laboratory. If we accept the proposition that in various ways and using various methods, individuals and groups attempt to influence the behavior of others, and if the scientific techniques being developed are more powerful and effective than traditional methods of influencing behavior, then the scientist is at a distinct advantage. He has the upper hand, so to speak. Mesthene's suggestion would put the scientist more closely on a par with the nonscientist. Ulrich's response to this suggestion was that the way to establish social control over the works of scientists is to "give more people knowledge about the methods," to educate the people "so that they are adept at understanding behavior control and using the principles of behavior control. In this way, when I try to get you to do something, you have information which puts us more on a par with each other. I think that this will be the best guarantee that we may be going into situations as equals." Delgado argued that scientists "have a great responsibility in the social and political repercussions of their own discoveries,"

Behavior Control Technologies

though they have not always exercised such responsibility. Mesthene questioned whether the scientist is necessarily in the best position to understand and deal with the social and political consequences of his work. The science-society relationship is a complicated one and still in the process of evolution. The democratic political system has not yet developed appropriate mechanisms for dealing with issues like the social control of behavioral technology. Dershowitz noted that the extremes of "immediate vote"—as in the case of overhasty legislation authorizing the use of sterilization without appropriate safeguards—or of "no vote at all"—as in the case of the atom bomb development—ought not to prevail. Rather, we must "begin to articulate the jurisprudence of the appropriate influence and counter-influence of scientist and democracy." Quarton suggested that we need more information about this interaction process. "Some of the resistance that is immediately felt when a new technique for modifying behavior comes up becomes a phenomenon that needs to be studied in its own right. We should understand a lot more about how society comes to accept or reject new technologies, or to reshape them. If a technology is going to be slowly introduced, I suspect that most of us would not want to decide just how it is going to be. We would want a system that permitted reshaping." The development of a wise and flexible system for adopting and controlling new technologies was probably the one aim that all participants could wholeheartedly agree on. It is to be hoped that public and private discussion and planning will help to avert the evils that behavior control technologies could portend and to stimulate the benefits that might accrue from their use.

Conference Participants Jacques Barzun, University Professor, Columbia University Jonathan O. Cole, Professor of Psychiatry, Tufts Medical School José M. R. Delgado, Professor of Physiology, Yale University School of Medicine Allen Dershowitz, Professor of Law, Harvard Law School Judith Favell, Research Associate, University of Kansas

Mendelsohn, Swazey, and Taviss

Everett I. Mendelsohn, Professor of the History of Science, Harvard University Emmanuel G. Mesthene, Director, Harvard University Program on Technology and Society Robert Nozick, Associate Professor of Philosophy, Rockefeller University Gardner Quarton, Program Director, Neurosciences Research Program, Massachusetts Institute of Technology Stanley Reiser, History of Science, Harvard University Roger Revelle, Director, Harvard University Center for Population Studies Walter Rosenblith, Professor of Communications Biophysics, Massachusetts Institute of Technology Harvey Sapolsky, Assistant Professor of Political Science, Massachusetts Institute of Technology Judith P. Swazey, Research Associate, Harvard University Program on Technology and Society Roger Ulrich, Chairman, Department of Psychology, Western Michigan University Sanford Unger, Chief, Psychological Research, Maryland State Psychiatric Research Center

Part III Science, Technology, and the Practice of Medicine EDITORS' N O T E . Advances in biomedical science and technology have brought about fundamental changes in the organization and delivery of medical care. The essay by Victor W. Sidel discusses a number of these biomedical advances, their impact on traditional forms of medical practice, and the new (and unresolved) problems they are creating for both physician and society. The essay by Mark G. Field examines the division of labor and specialization that have come to characterize the medical profession, relating the rise of the medical specialties to the demands occasioned by advances in biomedical science and technology. Field foresees even further specialization within the profession (and the attendant increase of paramedical personnel) as biomedical science and technology become increasingly complex and sophisticated. At the same time, however, he finds a very real need for the emergence of a class of medical generalists who could serve to integrate the outputs of medical specialists and who could provide the "pastoral" or compassionate element of medical care that, he feels, is too often neglected. Finally, John H. Knowles examines the manpower shortages that plague many of the medical specialities, relating these shortages to the need for improved medical care for the poor. He finds that there are no effective mechanisms within the profession either to anticipate or to alleviate manpower shortages. He argues that we are entering a new era in which the medical profession will become more conscious of, and responsive to, the social problems of medicine.

VICTOR W. SIDEL

New Technologies and the Practice of Medicine

Introduction Almost every technological advance affects health and disease and consequently affects medical practice. The technological revolution in industry, for example, is almost certain to lead to increasing demands for a guaranteed annual wage of workers and to a progressive redefinition of "work" and "leisure." 1 The probable consequent redefinition of "illness," which in many cultures means in large part "inability to work," will have profound effects on medicine. The new leisure resulting from technological advances may itself create new illness as well as new patterns of reaction to illness. A group of physicians from Maine were asked which advance in medicine in the past half century they considered most important. Some suggested insulin, some penicillin, some cortisone. One physician, however, stated that the most important advance in Maine had been the development of better roads, bringing patient and physician together and making hospitals more accessible. The development of better roads and of faster and more powerful vehicles has surely been a force for good, and bad, in the health of the society and has markedly changed medical practice. The incandescent lamp, telephone, radio, television, and countless other inventions have had immeasurable effects on medical practice and on society as a whole; however, since it is impossible to enumerate and discuss all technological advances which affect medical practice, we might start with some changes which have occurred in health, disease, and medicine and attempt to find their technological roots. In 1900, the leadVictor W. Sidel is Chief, Department of Social Medicine, Montefiore Hospital and Medical Center, and Professor of Community Health, Albert Einstein College of Medicine, Bronx, New York. 131

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ing causes of death in the United States were (a) influenza and pneumonia, (b) tuberculosis (all forms), (c) "gastroenteritis" (which probably included much that is presently diagnosed as acute myocardial infarction or other specific diseases), and (d) heart disease. Over the past decade, the leading causes of death in this country have been (a) heart disease, (b) cancer, (c) stroke (cerebrovascular disease), and (d) accidents. 2 This change in the "top four" reflects changes in society and in medical practice, some due to medically related technical advances such as the introduction of antibiotics in the treatment of pneumonia, and others, such as the disappearance of tuberculosis and the rise of accidents (and probably the rise of some kinds of cancer), due to social and technical advances which have little to do with the traditional concerns of medicine. This paper will single out a few techniques—from several different areas of medicine—and discuss their effect on society and on the practice of medicine, now and in the future. There has been no attempt to choose on the basis of the magnitude of the effect; if there had been, techniques for waste disposal and water purification would have had to be included. Rather the hope is that from these arbitrarily chosen examples it may be possible to form some generalizations applicable to a broader range of technological change.

Technologies in the Maintenance of Health and Prevention of Disease Contraceptives One of the most widely discussed technological advances of the past decade has been the development of improved techniques to prevent conception. The scientific knowledge on which these improvements are based ranges from the most ancient to the relatively new. The scientific advance has proceeded from the seer, lost in prehistory, who first noted the causal relationship between copulation and procreation, to the most recent (and still incomplete) studies on the reproductive hormonal cycles of

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the human female. The technological revolution occurred when it became possible to provide contraceptive devices which were relatively reliable, inexpensive, easy to use, and acceptable in the culture in which they were to be used. Older methods such as abstention, coitus interruptus, or castration, and relatively more recent ones such as "rhythm," the condom, or diaphragms and jellies, failed on one or more of these grounds. The two newest are the "pill" (a generic term for a variety of hormonal preparations which, taken regularly by the female on a prescribed cycle, prevent ovulation and therefore conception) and the intrauterine contraceptive device, IUCD (a generic term for a variety of objects which, placed inside the uterus by a health professional, prevent successful implantation of a fertilized egg or otherwise interfere with reproduction). Both of these meet many of the tests of a successful technique; they are relatively reliable (the pill more reliable than the IUCD); they are easy to use (the IUCD easier than the pill); and they are relatively acceptable. In- addition, further technical development seems imminent, ranging from a hormone preparation which may be implanted under the skin, thereby eliminating the necessity of depending on the memory or habit pattern of the user, to IUCD's which are easier to insert and which are less likely to be expelled from the uterus. Effects on Society. The most obvious social effects of contraceptives stem from reducing the number of children born. Such well-discussed consequences as reduction in the pressing demand for food, increased ability to provide educational opportunity, and potential lessening in the drive for territorial expansion have been listed as advantages; consequences such as the increased propensity for the better-educated to use contraceptive methods —and potential negative eugenic effect—have been counted as disadvantages. Only slightly less discussed are some of the potential positive and negative effects of contraceptives techniques on the people using them. These include the physical (positive: the prolongation of the life and health of the mother by reduction in number of pregnancies; negative: the suggestion of in-

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creased risk of thrombotic disease, 3 and the as yet unproved suspicion of liver disease or of certain forms of cancer from the "pill"); the emotional (positive: the ability to plan one's life and the freedom from fear of pregnancy; negative: the guilt of preventing conception in the face of religious or social taboos); and the sociological (positive and/or negative: the effect on the society of the independence of women from their traditional prolonged child-rearing role, of the increasingly powerful role of women in controlling their own procreative destiny, and of the sexual freedom thus permitted). The political effects of contraceptive devices are more widely discussed in other countries than in ours. In a country such as Brazil, with an annual population growth rate of about 3.1 percent (compared with 1.6 percent in the United States), 4 population expansion is looked upon by some as the means of further national development and as one way of "catching up" with the overdeveloped countries. In other countries contraceptives are viewed by minorities (Moslems in India, the Bantu in South Africa, and certain black and Puerto Rican groups in the United States, for example) as another form of tyranny of the majority. Effects on Medical Practice. The change in the age distribution of the population which might result after several decades from widespread use of contraceptives is very great, if they are used for "population control" rather than simply "birth control" in which the "ideal family" might, for example, be two children rather than four. For example, although the differences are probably due only in small part to contraception use thus far, in Brazil in 1965 approximately 30 percent of the population were under age ten and 3 percent over age sixty-five; in the United States 20 percent were under ten and 10 percent over age sixty-five.5 The spectrum of disease which the physician treats in a given society is determined, in large part, by the age of the population. If contraceptive techniques are to be generally useful in the underdeveloped countries, they will have to be introduced on a mass "public health" basis; in countries such as the United

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States, the prescribing of contraceptives has traditionally remained the province of the individual medical practitioner. Archaic laws and religious constraints have confused the issue, and moral questions often arise. Should (or may) the practitioner prescribe such methods when the patient asks for them (particularly if she is unmarried)? Or, more important, what is the responsibility of the physician in bringing such technological improvements to his patient's (or the population's) attention when the patient has not asked for them? If the contraceptive fails, should abortion be made available? What is the role of surgical sterilization for either males or females who wish their reproductive potential to be terminated? The reaction of physicians in underdeveloped countries is a special one, ranging from the support of many physicians in India to the negative reaction of the Guanabara Medical Association in Brazil (which states that birth control programs are being backed by the United States "to keep Brazil from growing" and which is preparing to draft legislation that would prohibit the production and sale in Brazil of contraceptive pills and devices). 6 It may be that in these countries the relatively few practicing physicians will have much less to do with the program than will public health physicians, nurses, and technicians. Transferring the responsibility from the private practitioner to the public practitioner still leaves crucial problems. It is relatively easy to deal with mosquitoes, which cannot talk or vote, or with vaccinations, in which an arm must be proffered for fifteen seconds; it is more difficult to convince a population to cooperate with such a fundamental change in their social and habit patterns. There are several approaches that might be considered: (1) education (how do you teach the pill cycle to the uneducated when some college coeds do not realize that taking the pill over the weekend is not enough?); (2) the carrot (does one provide financial incentives for those who have only a certain number of children?); (3) the stick (does one tax—or sterilize—those who have over a certain number of children?); (4) mass treatment (will a contraceptive be developed which can be added to water or food supply, like flouride to water or iodide

Victor W. Sidel

to salt or vitamin D to milk?). The last technique is particularly worrisome, not only on social and ethical grounds but sometimes on pharmacological grounds. For example, despite the known serious toxic effects in some patients, 7 Brazil added chloroquine to cooking salt to prevent malaria. 8

Vaccines Over the past few decades, four diseases have been nearly eradicated by vaccines in the United States: smallpox, whooping cough, diphtheria (although onset of the fall in incidence of diphtheria appeared to precede the immunization program), and poliomyelitis. At present we are in the middle of an exciting campaign that gives fair promise of wiping out measles within a few years. The implications of immunization for society and medical practice depend in part on the disease involved. For certain diseases there is a so-called herd immunity: the protection of a significant fraction of the population breaks the humanhuman transmission chain and prevents epidemics (as in smallpox and measles). For other diseases there is no herd immunity; the transmission pattern is not human-human and the protection of even a very high percentage of humans offers little or no protection to those not immunized (as in tetanus and yellow fever). Effects on Society. There are obvious positive and negative effects that result from the use of vaccines: eradication of certain forms of communicable disease leads to decreased morbidity and mortality, to increased life expectancy, and to population increase and shifts in age distribution. The better educated, high socioeconomic class is more likely to be protected than the lower socioeconomic classes. Experience with the Salk polio vaccine provides two kinds of evidence. Surveys were conducted in a Virginia county of mothers of second-graders who did and who did not receive the vaccine. 9 In the highest socioeconomic class, 86 percent consented to their children participating in the poliomyelitis trial, as opposed to 84 percent of the middle socioeconomic class, and only 43 percent of the lowest socioeconomic

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class. In terms of what they had read or heard about the poliomyelitis trial, 43 percent of both the highest and the middle socioeconomic class had read or heard "a good deal," as opposed to only 16 percent of the lowest socioeconomic class. Only 10 percent of the highest socioeconomic group reported hearing or reading "little or nothing" about the trial, as opposed to 23 percent of the middle class, and 55 percent of the lowest socioeconomic class. The practical consequence of the socioeconomic factor is demonstrated by one of the last great epidemics of poliomyelitis (in Providence, Rhode Island), which occurred during the period when the vaccine was being given; it was centered among children of lower socioeconomic class rather than having the usual egalitarian, or somewhat upper-class distribution. 10 There are, of course, some risks attached to the use of vaccines. A good example is the smallpox vaccine, with a complication risk of about 5 in 100,000 primary vaccinations. 11 This danger seems small enough in comparison with a disfiguring and often fatal disease, which caused an approximately 4 0 percent fatality rate among unvaccinated persons in outbreaks in England and Sweden in 1962-63. 1 2 The risk is surely small enough to be borne in countries in which smallpox is endemic. But is it a worthwhile risk in the United States, where there has not been a case of smallpox contracted within the country since 1947? On the one hand, Kempe and other authorities argue for the early cessation of routine vaccination except for certain "high risk groups" such as workers at ports of entry and hospital personnel. On the other, the Public Health Service Advisory Committee on Immunization Practice on October 11, 1966, said: "Until eradication is achieved or, at least, nears realization, vaccination, although not wholly without risk, clearly represents the only currently practicable approach for community protection in the United States. Considering the comparative risks of smallpox to the United States contrasted with the risks of vaccination, it is therefore important, at this time, to continue the present practice of widespread, routine subsequent revaccination." 13 In addition, there is the risk of reintroduction of a disease for which a high level of herd immunity has been achieved but is gradually lost by failure of people, as they grow older, to

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continue receiving booster immunization. Thus, if an adult who was immunized in childhood with a vaccine which does not give lifelong immunity enters an area in which the disease is still endemic—or is exposed to a reported case—he may develop the disease. For example, if the oral polio vaccine does not give lifelong immunity, and someone who received this vaccine in childhood enters an area where the disease is endemic, he may develop severe paralytic polio. Effects on Medical Practice. As with contraception, issues arise as to the relative roles of public health departments and practicing physicians in advocating and administering vaccinations. With a few significant exceptions, particularly among pediatricians, practicing physicians have not distinguished themselves in this area. In short, vaccines have not had a strong impact on physicians' practice patterns. The question therefore arises whether "well care" and "sick care" should be combined in the same professional role. Is a different temperament or self-image required? How should recruitment and professional education differ for the two roles? There are also questions relating to the financing of medical services; fee-for-service is probably not the best method for financing vaccinations. Does this mean that there should be (as there are for many public health services today) different ways of paying for different elements of new technology as they are introduced? Are there inferences to be drawn from these difficulties which may be valuable in restructuring the financial relationship between physician and patient for all types of medical services including the traditional ones?

Technologies in Uncovering Disease and Disability Two groups of diseases must be distinguished in a discussion of screening techniques. In the first group—communicable disease—early detection may prevent the disease from spreading. In the second group—diseases with serious consequences for the individuals who have them—early discovery of the disease may

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lead to an increased possibility of cure or at least a delay of the onset of symptoms or the progression of complications. An example from each type of screening will illustrate some of the technological problems and their consequences. Case Finding in Tuberculosis Technological improvements both outside and within medicine have, as noted earlier, significantly diminished the importance of tuberculosis as a cause of death and disability in the United States. However, new cases continue to appear, both among those known to have a higher risk, such as those in poverty areas and those exposed to the disease, and among those in whom no higher risk is suspected until after the development of the disease. Early discovery is essential, not only for the protection of others but because present techniques make it possible in most instances to treat early-discovered disease successfully. Furthermore, such treatment can be given with relatively little cost or social disorientation to the individual compared to the relatively unsuccessful, expensive, and demoralizing techniques of two decades ago. Effects on Society. There are two means of detecting early cases (the tuberculin test and the chest X-ray), a fairly effective means of prevention (Bacillus Calmette-Guerin [BCG] vaccine), and excellent drug treatments. All have their flaws. A positive tuberculin test indicates past or present tuberculosis infection, not necessarily active disease; after it has become positive it is useless as a simple screening test for new active disease in that individual. Chest X-ray carries with it the dangers of radiation-—dangers not yet measured (or measurable) at the relatively low dosage levels involved. BCG vaccine is not completely effective, carries a slight risk, and, by making the patient tuberculin positive, eliminates the tuberculin test as a screening device. Since most children and young adults in the United States are now tuberculin negative, tuberculin testing is the most widespread screening technique. However, BCG vaccine is being used in certain high-risk populations (among nurses, for ex-

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ample) 14 and in certain sections of New York City. 15 Drug treatment, which is now used on most people who have newly become tuberculin positive as well as on those with evidence of active disease, also carries its own risks. The marked decrease in the "white plague" can be attributed in very small part to screening techniques; almost certainly of more importance have been improvements in social and economic conditions and improved chemotherapeutic techniques for treatment after discovery. Nonetheless, cases continue to occur and screening must continue. The decreasing incidence requires initiation of continuing cost-benefit analysis so that the economic and social costs of screening can be balanced against the economic and social benefits of early detection. Tuberculosis, a disease which used to be one of families or endemic in the population, has become one of individuals. This disease, which usually carried a death sentence, has become curable if recognized and treated in time. Yet, TB still carries some of the image conveyed by E. L. Trudeau, writing in his autobiography about the day on which he was told he had the disease: I think I know something of the feelings of the man at the bar w h o is told that he is to be hanged on a given date, for in those days pulmonary consumption was considered as absolutely fatal. I pulled myself together, put as good a face on the matter as I could, and escaped from the office after thanking the doctor for his examination. When I got outside . . . I felt stunned. It seemed to me that the world had grown suddenly dark. The sun was shining it is true and the street was filled with the rush and noise of traffic, but to me the world had lost every vestige of brightness. I had consumption—that most fatal of diseases! Had I not seen it in all its horrors in m y brother's case? It meant death and I had never thought of death before. Was I ready to die? H o w could I tell my wife w h o m I had just left in unconscious happiness with the little baby in our home? And my rose-coloured dreams of achievement and professional success in N e w York? They were all shattered now and, in their place, only exile and the inevitable end remained. 1 6

Society's picture of the disease has not changed with the reality.

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Effects on Medical Practice. Again the issue of public versus private responsibility is reflected in the role of the professional who will detect and treat. Detection and treatment have often gone together as a public health responsibility. Now treatment moves increasingly into the private sector and can be done by general doctors at home or in general hospitals. Who has responsibility for seeing that treatment is completed and that contacts are followed? Even if the private practitioner wishes to assume this obligation, does he have the legal authority to insist on certain procedures? The multiple, conflicting methods of screening for, vaccinating against, and treating the disease illustrate the complexity of such choices. What may be reasonable for the individual, e.g., an annual chest X-ray, may be unreasonable for the population for medical or economic reasons. What may be reasonable for the population, e.g., treatment of all newly positive tuberculin test patients, may be unreasonable in the individual case. The physician has few guidelines to help him in these choices. Periodic "Health

Examination"

Since the American Medical Association first advocated the "periodic health examination" in 1923, 17 periodic screening for disease has become more and more common. These programs range from the "Fight Cancer with a Check-up and a Check" of the American Cancer Society to the rest plus Executive Health Examinations at the Greenbriar Hotel and the extensive programs of the United States Army and other large employers. The value of screening techniques for noncommunicable diseases depends on the validity of the assumption that early detection (and preferably detection in the asymptomatic phase) leads to a greater chance of cure and delay in progression and complication. For certain diseases, such as carcinoma of the cervix and glaucoma, there is reasonably good evidence that early detection and treatment are valuable: there are good techniques (vaginal cytology and tonometry) for early detection, and good techniques (surgery and medication) for treatment. For other

Victor W. Sidel

diseases, such as most cases of diabetes mellitus or many cancers, there is little evidence that early detection in the asymptomatic phase permits the physician to alter radically the progression of the disease. There are several new techniques that facilitate the screening process, of which the best example is the Automated Multiphasic Screening Program at Kaiser-Permanente Health Program in San Francisco. 18 Patients are given a preprogrammed, highly automated battery of tests which include a symptom questionnaire, chest X-ray, tonometry for glaucoma, and laboratory studies on blood and urine. The blood tests, for example, are done by an "auto-analyzer" technique which permits multiple tests to be done almost as efficiently and inexpensively as one test; the symptom questionnaire is scored and evaluated by machine. Most of the results are fed into a computer, and a set of instructions is issued while the patient waits—for example, "return for a medical appointment," or "have the blood sugar measured after a test meal." 19 A constructive alternative to periodic examination or screening for disease is a combination of health education—whether performed by physicians or not—and the early elucidation of symptomatic disease. There are two elements in this process: The patient must be willing to bring the symptoms to the physician for evaluation, and the physician must be prepared to deal with early symptoms. This model is not incompatible with the health screening technique but emphasizes a different approach. In screening, the patient has little responsibility except to present himself for examination and to answer questions as accurately as he can; in early symptom evaluation the patient must choose the appropriate moment to bring his complaints to the physician. Effects on Society. In those cases in which early detection leads to increased opportunity for cure, reversal, or slowing of progression, the opportunity cannot be realized unless the detection program leads to a program for medical or other attention to the problems uncovered. Society must therefore build a therapeutic

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potential into every screening program and must be prepared to allocate increased resources for this purpose. For example, in the Martin County, Kentucky, screening program performed by the United States Public Health Service in 1966, a large number of patients were told to see their physicians for newly discovered illnesses, with the result that available facilities for diagnosis and treatment were overloaded. A particular problem was the number of patients having a positive tuberculin test and scarring of the lung apex who then required an intensive workup to be assured that they did not, in fact, have active tuberculosis. 20 In those cases in which early detection provides no opportunity to help the patient significantly or to help his family or his community, or in those cases in which disease is uncovered but no facilities exist to care for the patient adequately, the question arises whether the uncovering of the disease does more harm than good. There is increasing evidence that the change from the "well role" to the "sick role" is a significant one in the life of the individual. A well-known example is that of the asymptomatic, or relatively asymptomatic, patient who is told he has coronary heart disease and becomes a "coronary cripple." For both screening and for symptom evaluation there is evidence that people of lower socioeconomic status will make less use of available facilities. 21 In addition, data such as those cited previously for lower immunization rates among lower socioeconomic groups suggest that these groups will participate less in asymptomatic screening programs unless special efforts are made. This tendency for the lower socioeconomic groups to participate less is magnified by the fact that certain types of diseases, some of which are thought to be better diagnosed early than late, are more common among these groups. An example of such a disease is cervical carcinoma, for which an effective screening test is available, which appears to be better treated early, and which appears to be associated with such social factors as low socioeconomic status, early intercourse, and early pregnancy. 22 The group which most needs these new screening techniques may be the last to get them.

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Effects on Medical Practice. Physicians and others have increasingly questioned the value of the "periodic health examination." 23 The repetitive nature of these examinations, the infrequency of positive findings, the dilemma of uncovering abnormalities which are either unimportant or about which nothing can be done—but which would be disturbing to the patient if disclosed—have all been cited as disadvantages. The advantages —the opportunity to perform some health education, the opportunity to build a relationship and a "baseline" from which further changes can be measured and handled, the chance to cure or halt progression of an illness discovered "early"—often do not appear to outweigh the disadvantages. Even if it were felt that periodic health examinations are worthwhile, sufficient medical manpower simply does not exist to offer an annual or even biennial examination to everyone. The automated alternative has the major disadvantage of impersonality and does not even offer the advantages of health education. Financing of early detection of disease is a difficult problem, especially with regard to early reporting of symptoms. At present the cost of the individual consultation is a barrier to free consultation on symptoms. If this barrier is completely removed by a prepayment mechanism, what other threshold can be substituted to screen the "significant" complaints from the "insignificant"? Periodic health examinations can be scheduled and budgeted, but the actuarial problems resulting from encouragement of the patient to report early symptoms have yet to be solved. Finally, the oft-heard argument that early detection and treatment of disease will reduce the total cost of medical care to society is probably spurious.

Technologies in the Treatment of Disease and Disability Most of the highly publicized "new technologies" of medicine relate to treatment: for example, antibiotics, the artificial kidney, the laser beam, high-voltage irradiation, ultrasound, and modern techniques of anesthesiology and surgery. These are

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what most people are talking about when they speak of the "wonders of modern medicine," and these are the things for which they may be willing to give up an increasing portion of their income, an increasing cut of the gross national product, and even some of the attributes of the personal physician. These techniques are for the most part administered and chosen by the individual physician, although it is widely recognized that for some expensive, long-term treatments social decision-making is required. In fact, for all of these new technologies there is extensive social decision-making in the background (e.g., by the Food and Drug Administration in the development and distribution of drugs, the National Institutes of Health in the development of research techniques, and by hospital trustees and administration in the allocation of hospital resources), but they are made to appear relatively unimportant in relation to the proximate decision-making power of the individual physician. Drugs The vast expansion in the number and types of new drugs is well known. It includes the development of totally new formulations, the modifications of old ones, and the combination of old drugs into new forms. The potency of the new agents has raised both new hopes for cure and for amelioration of symptoms and new dangers of complications. Because of antibiotics, pneumonia is no longer "the old man's friend"; diabetes and adrenal cortical insufficiency and other specific hormonal deficiencies can be met by substitution therapy; phenothiazines are bringing the mental patient from the asylum back into the community. The instances of the damage done by these agents are likewise familiar; cases of phocomelia with thalidomide have dramatized the picture, but there are many less dramatic or lessknown instances. The aplastic anemia caused by chloramphenicol (Chloromycetin) is another example of direct toxicity. In addition, there are many types of indirect dangers: the development of resistant strains of organisms and of superinfections in patients receiving antibiotics; the dangers of addiction and of misuse; or the danger of a drug having an unexpected effect on

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a pilot or a gasoline truck driver or an astronaut or a man in control of thermonuclear weapons. Effects on Society. As new, effective drugs become available new means of distribution must be found. In the United States, except for the cost factors mentioned below, distribution methods are excellent; in other parts of the world new or expensive drugs simply are unavailable. Efficacy of treatment implies life extension, which may create new problems for patients with painful or incapacitating chronic illness. Yet withholding the treatment once it has been made available requires special considerations by physician and family and raises new ethical issues. In addition, as with most of the new technologies discussed, life extension leads to larger population, changes in age distribution, and possible changes in the gene pool which may raise increasingly difficult issues.24 There are several types of drug dangers: (1) direct immediate danger (within days or weeks) or "adverse reaction" or "unexpected effect" to the individual taking the drug (e.g., "carcinogenicity" or the production of cancer); (2) delayed effects on the individual or on his offspring (e.g., "teratogenicity" or the production of malformations in the fetus) from the use of drugs, with the possibility of an overall "population effect," such as life-shortening or decrease even where no individual effect can be demonstrated; (3) dangers of addiction or misuse either in the individual for whom the drug is prescribed or by those who may come upon the drug (children eating flavored aspirin) or who may easily obtain it (adolescents taking benzedrine or hallucinogenic agents). The widespread use of relatively mild drugs such as barbiturates, "tranquilizers," and "stimulants," and the therapeutic use of hallucinogens and other powerful agents raises the vision of Brave New World. As use of the milder agents becomes more universal, and as more of the powerful agents come into existence, there is increasing potentiality for the control of human emotions. The high cost of drugs raises other types of distribution problems. Prepaid medical care plans have run into severe actuarial

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problems in attempting to include drugs, and recent data suggest that less than a million people in the United States have full coverage for drugs under health insurance plans. Also, the cost of drugs may fall unequally on the segments of the population which can least aiford them. 25 Effects on Medical Practice. As the number and the power of drugs multiply, means must be found for keeping physicians informed about them. Two kinds of information are necessary: knowledge of the potentialities for good so that a physician will not overlook an application of the drug because he is ignorant; knowledge of the potentialities for harm so that a physician will not use the drug without full awareness of possible untoward consequences. The dangers of leaving the diffusion of such information entirely in the hands of the manufacturers are well known. The physician must be aware of special risk situations. Which drugs must he not use because his patient is likely to combine them with alcohol? Which must he not use because they might dull his patient's faculties at some critical moment? The physician must be aware of the relative cost of several equally effective, or almost equally effective, agents and include this cost in making his decision among agents. The American Medical Association has recently urged that cost be included as a factor in choosing among drugs and that "medical judgments be supplemented with cost considerations in prescribing drugs for patients." 26 Artificial and Transplanted

Organs

There is increasing evidence that organs can be successfully transplanted from one human being to another despite the body's immunologic defense against such intrusion. There is also increasing evidence of ability to construct artificial organs which will function for considerable periods of time, such as the artificial kidney and the artificial heart. Transplantation raises issues both for the donor and for the recipient. 27 Implantation of artificial organs raises issues for the recipient. Both raise issues for the society and for the physician. There are some ethical or

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social issues, such as expense, use of scarce resources, and religious dictates (Jehovah's Witnesses or Christian Scientists), even when artificial organs are used simply to tide the patient over a temporary crisis which prevents his own organ from functioning normally. Examples are the use of dialysis in the patient with temporary renal shutdown following shock, poisoning, or infection, and the use of a pump oxygenator to bypass the patient's heart during heart surgery. Even more difficult problems arise when organs are implanted in the hope of their being "permanent" (or at least "replaceable") for the life of the patient. The cost of artificial organs to the individual, or to the society if these programs extend to the entire population, is staggering. Estimates as high as a half billion dollars or more per year for a full-scale national long-term dialysis program have been given (estimates based on 5,000 new patients per year; patient life expectancy of ten years; and annual cost of $10,000 per patient). 28 While a society which spent $75 billion during 1967 on defense can presumably afford to spend a great deal on the health of its citizens, the number of such programs, and the increasing proportion of the GNP devoted to them, must at some time approach an asymptote. Who will decide where the asymptote is to be? And what part of the cost, if any, should be borne by the patient or his family? Finally, what of the "opportunity cost"—the loss of alternate benefits in medicine or other social programs because there is insufficient manpower, money, or other resources? As long as the resources devoted to such programs are limited, choices must be made among individuals who need them. Who in the society will make such lifeand-death decisions? The use of panels of laymen, as attempted in Seattle, has drawbacks, but in certain respects it may be preferable to leaving such choices to physicians. The psychological problems involved in such procedures are just being explored. What are the effects on the identical twin if he gives or receives—or does not give or receive—a kidney from his twin? This is far from a sophistic question: the negative psychological effect on the donor of not giving has been used as

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the legal justification, under a directive from the Massachusetts Supreme Court, for removal of a kidney from a healthy identical twin under age 21. 29 What are the problems for a wife who must tend a long-term dialysis unit at home for her husband? What are the effects on their children? What are the reactions of the patient whose life depends on a not entirely foolproof cardiac pacemaker which is implanted in his chest? Effects on Medical Practice. A number of ethical dilemmas are posed for the physician who must advise both the potential donor and the potential recipient in the case of transplantation and the recipient in the case of artificial organs. How shall the physician advise the donor or the recipient on the risks of giving and not giving and of receiving and not receiving? Use of most of these techniques is far beyond the capability of the individual physician. They must be used in complex, well-equipped medical centers. Efforts to establish the proper number of such centers and to find rational referral patterns are just beginning. How much of any given institution's resources should be used for transplantation? As the patient's life is entrusted more and more to gadgetry, the "maintenance man" becomes increasingly important. Who will remember to replace the batteries at the right time, discover mechanical flaws early enough to remedy them, replace an old model with a newer one, or prevent power failures? A recent accident during dialysis (failure in the central dialyzate supply, which permitted distilled water to enter the unit) killed three patients undergoing dialysis at the Community Dialysis Center, Minneapolis. 30 It is an example which indicates that this consideration is not an idle one. With increasingly powerful techniques, the physician's dilemma heightens with regard to the patient who refuses or, more important, who refuses for his child—a lifesaving technique. The refusal by the Jehovah's Witnesses of blood transfusion is a well-known example; does the judicial power to compel a parent to permit transfusion extend to the use of dialysis on a temporary basis for transient renal failure?

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Technologies in the Organization of Medical Practice A host of new methods for organizing and delivering health care services have come into being over the past two decades. These include the introduction of pre-payment plans such as the Health Insurance Plan of Greater New York and the KaiserPermanente Health Foundation, the wide expansion of group practice, and the introduction of new management and communication techniques, the most important of which is automatic data processing. Automatic Data Processing There has been relatively little use of modern computer technologies in medical applications. There are many reasons for this: ( 1 ) The capital outlay required for computer "hardware" (the machines needed for computing) is very large. ( 2 ) The highly trained personnel required for the design of computer "software" (the programs which make the "hardware" do the job required) are usually unavailable in medical institutions and demand salaries outside the normal salary scale. ( 3 ) The interrelationships within medical institutions are complex and require considerable codification and simplification before being adaptable to computer techniques. ( 4 ) Computers seem to represent depersonalization, a process about which there is much fear in medicine. ( 5 ) The confidential nature of much medical material leads to concern about the unauthorized spread of the information to those with access to the computer. Despite these difficulties, the application of the computer to medicine has proceeded in two broad areas: in "diagnosis" and in organizing and in communicating within medical institutions. For the first application, that of diagnosis, the computer program can be no better in its logical structure than it is in the mind of its human programmer. However, the ability of the computer to retain a vast amount of data and manipulate it extremely rapidly and reliably allows logical strategies to be used that cannot be used by human diagnosticians. For consistency the computer can-

New Technologies

not be equalled by the human, and when the human's "intuitive" processes are better understood and some of the data input problems solved, the machine will beat him at diagnosis. Thus far, these methods remain in their infancy. Developing at a much faster rate is the application of computers to the transfer of information. Much of medicine consists of making decisions on the basis of bits of information gathered from a variety of sources—in short, a problem in effective management. As the relevant data becomes more numerous and as the institutions in which the data are collected become more complex, the collection, storage, retrieval, and analysis of the data become progressively more difficult. Computers, as has already been demonstrated in other management situations, can contribute much to this process. Most hospital accounting departments already use computers extensively, and their use is spreading to medical records analysis, transmittal of laboratory data, and the ordering of drugs. It seems inevitable that within the next decade a very large investment will be made in computer hardware and software by most large medical institutions. Effects on Society. There is considerable fear that reliance on automatic data processing will increase the depersonalization which many already see occurring in medicine. Although this is not necessarily a consequence of computerization, computers may hasten the process. On the other hand, computers properly used may simplify the paperwork and bookwork of medicine and give the physician more time to spend with his patients. The vast expenditures of money and personnel required for computer introduction may further widen the gap between the have and have-not areas of medical care. This will not be the case if there is a conscious infusion of federal funds into areas in which help is most needed; but since those institutions which already have good facilities can usually make the best use of new computer facilities, it is likely that the rich will get richer. The computer may, however, improve the diffusion of expert knowledge from one area to another through the use of remote terminals and other techniques.

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The issue of confidentiality is a critical one. The computer lends itself to the development of data banks in communities so that there can be rapid exchange of information among hospitals and other social institutions. 31 While such a data bank may be a boon for emergency treatment of individuals or for the collection and analysis of data for regional planning, it carries with it great dangers of loss of privacy and of the power to control. 32 Looked at another way, these data have always been subject to misuse, albeit on a lesser scale; the computer may provide means of maintaining better supervision of confidentiality. Effects on Medical Practice. The physician will have to be very explicit in his use of the computer as a diagnostic instrument. If he has built-in biases favoring one diagnosis over another, these should be built into the program. For example, diagnosis in the hands of the skilled physician is directed toward making those diagnoses which can be most helpful for the patient, that is, diagnoses about which something can be done. The physician reserves until last diagnoses which might be more probable, but which carry a hopeless prognosis. If the computer is not so programmed, the problem lies not with the computer but with the physician who uses it. Since it would be unwise to force physicians to learn in detail a technology for which most are unprepared by undergraduate or medical school training, much development will have to take place at the "man-machine interface": the physician must be permitted to communicate with the computer in the simplest language available, and input and output must be made as simple as possible. Even so, an approach far more disciplined than that currently used will be necessary if computers are to be effective. As a consequence, the physician will have to adapt to increasingly structured definitions and formats for recording medical data and ordering tests, medications, and procedures. This is not likely to be easily acceptable in a profession that prides itself on its individuality of approach and technique. However, insofar as it forces the physician to become more explicit and precise in his formulation of problems and in his decision-making, the adapta-

New Technologies

tion may be worthwhile. With comparability of definition and format, and ease of storage and retrieval, the computer becomes a powerful tool in review of utilization of resources and in quality control. T h e danger again lies in unthinking application, for the exceptions may be more interesting than the statistical rule. Team Approach

to Medicine

A number of streams have come together during the middle third of the twentieth century to change the course of the solo practitioner approach to medicine. These include the increases in medical knowledge, in specialization in medical practice, in shortage and maldistribution of physicians relative to demand, in importance of the hospital in medical practice, and in professionalization of the nurse and social worker. The number of techniques which have been used to integrate medical practice is almost as large as the number of groups which have developed. Most group practices are predominantly physician-oriented, and some, such as the Mayo Clinic and the Lahey Clinic, have been in existence for a long time. Others have laid great stress on the nonphysician members of the team; an example is the Family Health Care Maintenance Demonstration conducted by Dr. George Silver in New York City. 33 Programs have been initiated to train "physician assistants" and "nursepractitioners" to act as suppliers of primary care. 34 Large hospitals have become important as the focus of medical activity and have become progressively more concerned about the interrelationship of their traditional goals of patient care, teaching, and research with community health needs. There have been paradoxically conflicting responses to the changing methods of practice in the United States. On the one hand, there is satisfaction with increasing technical competence and specialization; on the other, dissatisfaction with decreasing availability and increasing depersonalization. There is general satisfaction (at least as expressed in surveys) with the individual's own physician, but dissatisfaction with "medicine" and with "doctors." And at the same time that all these changes in practice have occurred, the mean number of visits per person per year

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to a physician has increased from about 2.5 in the 1930's to about five now. 35 In short, there has been a greater demand for the product even as it is more and more criticized. The trend toward use of nonphysician personnel necessitates great reeducation on the part of people who feel that the "doctor" alone can meet their needs. Considerable education will be required before the nurse can be generally accepted as a better purveyor of well-baby care than is the highly trained pediatrician. Until this reeducation is accomplished, there will be demands for care from fringe professionals such as chiropractors whose members carry some of the aura of "doctor." The removal of much medical care to the hospital may increase the distance of some groups in the society from the source of care. Yet the alternative, the development of "satellite" centers in the community, may be unacceptable to many hospitaloriented physicians. Bridging the gap is, together with rising costs and shrinking space, one of the key problems facing hospitals. Effects on Medical Practice. The physician must learn to act as a member of a team in a number of ways: (1) with physician colleagues in group practice; (2) with nonphysician colleagues, such as nurses, social workers, physician assistants, and possibly midwives; (3) with a progressively more complex institution, where each day of care is extremely costly to the patient and to society and physician behavior must at times be subordinated to the needs of the institution or colleagues. There is little in the tradition of medicine, and less in medical education, which teaches the physician how to adjust to the less-than-individual role. Physician satisfaction—and certainly physician income—is correlated with superspecialization and with the degree of association with the hospital. 36 There are few incentives and fewer models which would encourage students to enter a role providing primary medical care, yet there is no obvious professional waiting to assume that role. As medicine is increasingly financed by third-party payers the physician may spend more and more of his time justifying his treatment in forms and reports and less time giving it. The al-

New Technologies

ternative extreme—carte blanche for the physician—is dangerous, because with the patient's individual pocketbook no longer acting as a brake there must be some institutional control. A middle ground must be found which provides adequate fiscal control with reasonable freedom for physician and patient.

Summary Attempts to draw general principles from such diverse examples as have been discussed here are difficult. One principle which clearly emerges is that technological advances always carry the potentiality for harm as well as for good. On the one hand, they may amplify many of medicine's current problems in goals and methods which remained hidden in the absence of powerful new techniques; there may, therefore, be a tendency to blame new technologies for the problems rather than to attack the fundamental underlying causes. On the other hand, new technologies may indeed cause new problems: the most disadvantaged in the population may be left even more disadvantaged by technological change. The divergence between society's image of disease, and of medicine, and the reality produced by the new technologies may increase. In all probability, the solo physician will increasingly be unable to handle many of the new technologies; new organizational forms and institutions will be required. Medicine, along with the society it serves, will be forced by technological advance to examine critically its current dogmas and methods, including increased attention to "preventive" as opposed to "curative" approaches, to new methods for organization and delivery of medical services, to innovations in financing care, to educating medical students for new physician roles (including tapping new pools of students), and to training new types of health personnel. Most important will be the need to solve ethical dilemmas which will be quantitatively and qualitatively different from those of the past. More and better research is urgently needed to evaluate the consequences of the new technologies, and the means of responding to them, so that their challenge may be effectively met.

MARK G. FIELD

The Health Care System of Industrial Society: The Disappearance of the General Practitioner and Some Implications

The purpose of this paper is to set forth some ideas and hypotheses concerning the medical enterprise of the contemporary, large-scale, industrial, and urban society. Although it is based primarily on the American situation, it has drawn heavily on a detailed study of the Soviet system of socialized medicine. The central theme is that the health systems of all modern societies undergo a similar process of internal differentiation and evolution so that, in spite of differences of historical and cultural origins, these systems tend to converge in their major contours, structure, and requirements, and thus increasingly to resemble each other. The general approach I have taken is macro-sociological, with the society as the unit of analysis, and structural-functional in that it seeks to locate the health care (or medical) system as part of the social structure for which it performs functionally significant tasks and services and from which, in turn, it must receive specific "inputs." These inputs are always problematic, since they are "scarce" resources. The paper also attempts to identify sources of strain in the relationship between society and the health care system, particularly insofar as the increased use of technology and the effective demand for medical services lead to the inability of medicine to satisfy traditionally expected needs of the population. It explores the question of the "prices" society has had to pay for medical effectiveness and for better distribution of services. Mark G. Field is Professor of Sociology, Boston University; Associate, Russian Research Center, Harvard University; and Assistant Sociologist, Department of Psychiatry, Massachusetts General Hospital. 156

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The Medical "Needs" of the Social System The adequate functioning of any social system depends in large part on the ability of the individuals within it to perform their various roles. Because physical or psychological incapacity may impair or destroy the ability of individuals to perform their social roles, illness is a potential threat to the social system. Incapacity or premature mortality also affects the "investment" in time, human efforts, education, and economic outlays and supports which the society has placed in the individual from birth on. F o r example, of every 100 males who reach the age of fortyfive in the United States, only 90 will survive to the age of fifty-five, whereas in Sweden the comparable figure is ninety-five. Thus, during the critical period, when most men are at the peak of their working and earning capacity, twice as many die in the United States as in Sweden—a mortality rate that is also higher than that of almost every Western nation. 1 Thus, from the viewpoint of society, health maintenance, because it is "capacity maintenance," has a functional significance that far transcends personal unhappiness, suffering, and the anxieties that are related to illness, injury, and death. The linkage between health and society can be demonstrated in many areas, such as the production losses and other costs caused by absenteeism due to illness, traumatism, and epidemics (540,000 man years annually in the United States through heart disease alone, worth $2.5 billion), the number of people declared unfit for military or other services (half of those rejected by the military in the United States are rejected for medical reasons), the percentage of the population affected by mental illness or retardation (half of all American hospital beds are psychiatric b e d s ) , and the inability of underdeveloped countries to modernize because of high birth and death rates, lowered stamina, and low life expectancy. In industrialized society, morbidity presents a threat primarily because of the complexity and interdependence of that kind of structure. As a recent Canadian Royal Commission Report stated, " A modern industrial and increasingly automated

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society is highly vulnerable as long as significant segments of the population remain unprotected by a comprehensive system of health services." 2 The significance of the health service or medical system of a society may thus no longer be solely a question of privilege or income, nor even a question of "rights." It tends to become, in the modern, industrialized society, an aspect of social policy with important "functional" implications. If we focus on illness or premature death as a major threat to the functioning and indeed to the very existence of a society, we must also specify the nature of societal responses to that threat in terms of mechanisms and roles addressed to mitigating, neutralizing, and, if possible, eliminating the impact of "incapacity" on the society and its members. By and large, we may distinguish four analytically distinct responses to the "needs" associated with illness, incapacity, and the ever-present possibility of death. The magical response is man's attempt to come to grips with, to understand, and to control or affect the course of illness, which is conceived as the result of the action of certain forces, such as deities, that he tries to propitiate through rituals. The magical response must be seen in the light of the uncertainty of outcomes and man's attempt to procure favorable outcomes. The magical response often embodies a perspective on causality that is anthropomorphic: for example, gods must be "placated" through offerings and sacrifices. This type of response is action-oriented: it answers to the need "to do something" in the face of illness and uncertainty. "If you want the patient to recover, pray for him like you never prayed before" is the kind of familiar verbal formula that epitomizes this response. The religious response stems from man's attempt to get at the "meaning" of illness, disability, and eventual death. It is an attempt to reconcile him to the existence of phenomena that remain mysterious but which he must accept as the work of some higher purpose and providence. The formula "The Lord giveth and the Lord taketh away" reflects this need; otherwise, the death of a loved child, although it can be described in scientific terms, remains essentially meaningless. The religious answer, as defined here, is "passive"; it is oriented toward acceptance or resignation

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and cannot satisfactorily be derived solely from a "scientific" or "rational" viewpoint. The compassionate or pastoral response stems from the need for comfort, reassurance, love, "therapy," support, consolation, and "tender loving care" that the suffering, anxiety-ridden, frightened, and often psychologically disturbed or regressed patient, and sometimes those near him, need in the course of illness, suffering, or disability. The "optimistic bias" so often displayed by members of the health profession is part of an attempt to provide psychological reassurance that "everything will be all right!" The compassionate response is an intensely human and personal one that only another human being can provide (it cannot be automated), and in evolutionary terms its prototype is probably the mother-child relationship. The technological response is the application of "empirical" or "scientifically grounded" knowledge, techniques, and technology in a rational approach to the alleviation or elimination of pathological states. It is, of course, what is often defined as "medical treatment" or "services": that is, primarily an active, interventionist approach such as stopping bleeding, massaging the heart, giving an injection, or reducing a fracture. The usual verbal formula for this kind of activity is that "the doctors are doing everything in their power to save the life (or limb) of the patient." Illness gives rise to these four "needs," and the maximization of one response at the expense of others may create a critical imbalance detrimental to the patient and society. The magical and religious responses are more, though not by any means exclusively, the province of religious specialists or philosophers, and the compassionate/pastoral and technical responses are more the central responsibilities of medical (including nursing) personnel. One might add not only that there is a great deal of "magical" behavior among medical personnel but that in the past, and to an important extent in the present, a great deal of medical care was provided under religious auspices, indicating the closeness of these needs. "Comforting" in its etymological meaning of "strengthening" is thus one of the essential tasks of medicine

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and of the physician, as R. M. Magraw has pointed out. 3 Comfort is a function that is perhaps even more important than that of curing or providing specific therapy, and yet it is one that has tended to be overshadowed as a result of overemphasizing technology and the application of science. It is thus with the balance of the compassionate/pastoral and the technical responses that this paper will be centrally concerned, since they constitute, in my opinion, the core of contemporary medical responsibilities.

Societal Response to Illness: Structural Differentiation and the Medical Care System A comparative, evolutionary, and historical look at societal and individual response to illness and premature mortality suggests that, in primitive societies, this response was unspecific and undifferentiated, as were the social roles, collectivities, and facilities concerned with morbidity and mortality. There were, in these societies, no health "specialists" any more than there were full-time teachers and agricultural experts, nor clinics and sanatariums any more than schools, factories, temples, or parliaments. To the degree then that "medical" functions were performed, they were performed by practically everybody (especially members of the family or kinship group) or not performed at all. Even today in our highly specialized and complex society, the family still retains some residual "medical" functions such as the care of sick children by the mother. By and large, however, the provision of medical care has shifted to medical specialists and to settings outside the home. Modern society has a fully differentiated medical care system (or subsystem) that can be identified in the same way as the educational, economic, political, religious, family, and other systems can be identified and conceptualized. William Kissick has pointed to the amazing diversity of the medical care system: It is represented by a multitude of resources, both human and material, and a myriad of services derived from these resources. It is composed of programs dealing with people and programs concerned with the facilities, programs related to services, research and edu-

Health Care System

cational activities. It requires the labors of physicians, dentists, nurses and other professional and technical health manpower, as well as clerical workers, janitors and so on. It encompasses hospitals, nursing homes, rehabilitation centers and health departments. It includes environmental control and biomedical research programs, the pharmaceutical industry, hospital and medical insurance plans, large national voluntary health agencies, small areawide planning councils. It is an interest of the federal, state and local governments and requires the participation of uncounted individuals from all walks of life . . . It involves many secular endeavors—education, agriculture, commerce, recreation and conservation . . . Finally it requires vast and increasing expenditures. 4

The expression "medical" or "health care system" is thus meant as conceptual shorthand to designate that totality of efforts and resources, human and material, which a society sets aside for services centered around the health concern. In order to function, the medical system must receive specific inputs or resources from the society. There are at least four analytically distinct inputs from society: mandate and trust, knowledge, personnel, and instrumentalities. Mandate and Trust The medical system must receive a mandate from society "to care" for the health of its population and must enjoy the trust of that society. A "charter" is therefore granted to the medical system specifying its legitimate obligations and privileges. This charter often amounts to a monopolistic license but also implies that the medical system will perform its functions to the best of its abilities. This fiduciary commitment also implies, in many instances, that medicine will police its own house in return for a relatively free hand in most professional matters. Knowledge The medical system cannot operate without a body of knowledge and techniques. That is, it requires accumulated "cultural" resources, the "state of the art," which must be transmitted from one generation of health personnel to another through an educational system which is itself tied to the general education of the

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society; and it must be added to, revised, and altered through the discovery of new or more advanced knowledge (research). This knowledge may be of a general scientific type, technical, or socialorganizational, and is affected not only by developments and research within the medical field but also to a very significant extent by the state of science, technology, and management in society at large. Personnel The medical system also requires a contingent of specialized individuals or personnel (physicians, nurses, orderlies, and so on) whose central occupational concern is health. These personnel must be motivated, recruited, taught, trained, socialized, and allocated. They apply the results of research as well as the accumulated fund of knowledge, techniques, and technology to the solution of the society's health problems (prevention, diagnosis, clinical care, and rehabilitation), and, in the aggregate, they must be involved in research and education as well as services. Instrumentalities In order to perform their mandate, health personnel must be provided with the necessary supports, powers, and instruments. Generally we can distinguish two broad categories of such instrumentalities: political instrumentalities or the ability to use legitimate power and exercise authority; and economic instrumentalities that may range from an aspirin to a medical center, from the fee paid a physician to the fraction of the gross national product devoted to health. It is thus possible to conceive, at the most general level, of the medical subsystem as providing a certain level of output ("services rendered by physicians, dentists, and other health professionals, plus all the goods and services consumed in connection with their work and under their direction"), 5 provided it receives certain inputs or investments of the types outlined above. Of the four major "inputs" described earlier, two seem to play a major role in the changing nature of the medical system and medical services. The first is that of science, knowledge, and bio-

Health Care System

medical technology. This force is truly revolutionary and accounts for many features of the contemporary medical system. The other factor, which is equally significant, is the sheer increase in the effective demand by society for the application, distribution, and delivery of medical knowledge and technology in the form of medical services to an ever-increasing proportion of the population. This broadened mandate, most often backed by political pressure, not only has ideological components, such as equality of access for all citizens to medical care, but also has significant functional (particularly economic) correlates. These two forces account, to a large extent, for increased pressures on the two other inputs mentioned earlier—economic allocations as a percentage of the GNP and the demand for medical personnel as a percentage of the national labor force—particularly since health services, unlike industry, tend to be labor rather than capital intensive. It often happens that the development of knowledge and technology, instead of reducing the costs of medical services and the demand for labor, increase them as more personnel are needed to operate, monitor, and service the costly technology. As a result, the role that the society, through the polity, is called upon to play at the national, regional, and local levels gradually and significantly expands. This expansion occurs particularly in the establishment of priorities between competing systems, such as allocations to health as against education, welfare, transportation, housing, defense, and industrial expansion, and in planning, administration, and the collection and redistribution (primarily via taxation) of the necessary monies to finance these services. The medical care system today is in a process of accelerated internal differentiation and is moving from a relatively simple to a highly complex state. This process has important implications for the nature of the medical "output" available to the society and the individual recipients of that output, who "pay" for it in economic resources, manpower, and political capital. Parallel to the qualitative process of differentiation through the specialization of medical and allied roles and facilities, there is a quantitative expansion as the demand for services and hence

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for personnel increases. More and more personnel are called upon to perform more, and more differentiated, medical tasks. The complexity and the size that result from differentiation and expansion may be deemed "functional" or beneficial only to the degree that they improve the medical system's ability to fulfill the mandate with which it has been entrusted: to deliver an effective "product" enabling the society and its members to better cope with the environment by better dealing with its "medical" problems. It is difficult, and probably impossible, to make precise and categorical statements on the subject, given the vagueness of the term "mandate" and the lack of control situations that would permit one to test for two situations, one of a relatively simple medical system, the other of a relatively complex one. This is more, perhaps, a problem for the imagination. The question would be: what would be the state of modern society, all things remaining equal, if instead of having the kind of medical care system it has today, it had a relatively simple and small one, consisting primarily of physicians trained for general and solo practice as they were, let us say, a hundred years ago? Note that I am not asking what would happen to contemporary society if, through some kind of strike, disabling illness, or widespread catastrophe that would affect health personnel, the health care system simply ground to a halt and stopped functioning altogether. Such a question might be easier to answer within, of course, gross limits. The point at issue here is that it is presumed that the differentiation and the increased size of the contemporary medical care system permit it to save more lives, to lengthen life expectancy, to reduce disability and suffering, to eliminate and mitigate many pathological conditions, to increase the satisfaction of patients, and so on. It is my contention that such an assumption cannot, in any way, be made. Differentiation and expansion, in turn, exact prices of their own that make the advantages of such a process problematic or dependent, in turn, on other arrangements. I will return to these problems and dilemmas in greater detail in a later section. In brief, they are the problem of the "assembly" of ever-increasing narrow outputs into a comprehensive medical product, the increasing chance for technical

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errors as the system becomes more complicated, and the depersonalization of medical services that goes with an advanced division of medical labor and the mounting bureaucratic nature of the medical system. But before these can be examined, it will be necessary to document briefy the evolution of the American medical system toward greater complexity.

The Specialization of Medical Roles and Collectivities Specialization appears to be a hallmark of the contemporary medical system and accounts for its phenomenal success in the technical aspects, as well as its equally disturbing failures in the area of compassionate care and the therapeutic or psychological support of the patient. Medical Roles At an earlier, simpler stage of the medical system, the physician, sometimes assisted by a nurse and a pharmacist, was at the center of the medical stage. Physicians, as such, constituted the vast majority, almost the totality, of the medical contingent. By virtue of his mandate the physician, although a specialist when compared to the other members of the population, was a generalist in medicine and provided almost the entire gamut of medical services. In the last fifty to seventy-five years, the rise of specialty practice within the medical profession has led to a process of differentiation among doctors and to the rise of a large contingent of medical personnel who are not physicians themselves, so that, at present, medical doctors constitute only a small fraction of those working in the medical system. The first specialty board for physicians was established in 1916, and there were in 1966 over thirty specialties certified by some twenty boards, although legally a physician can simply declare himself a specialist and practice as such if he chooses. Equally significant is the fact that very few medical school graduates go into general practice today. In 1931 four-fifths of all American physicians were in general practice; in 1966 threefourths of physicians were in specialty practice. According to

Mark G. Field

R. M. Magraw, the specialization of the entire physician population within another fifteen to twenty years, and perhaps sooner, is likely.6 One of the major reasons for this trend is the increasingly scientific nature of medicine and the growing application of technology. In this context, general and unspecialized practice promises few intellectual challenges to bright, scientifically oriented medical students. This dim view of general practice is further reinforced by the nature of contemporary medical education and its emphasis, ever since the Flexner report, on research and science rather than the delivery of health services. Allied Health Roles The traditional characteristic of the physician's role was that he was a solo general practitioner. With the changes in the medical system outlined earlier, the physician now works with a team of other physicians and a whole array of allied health personnel. For example, the volume of medical services provided under the direction of physicians increased 81 percent between 1955 and 1965 in the United States, while the increase in the number of medical doctors has barely kept up, if at all, with population increases. This is due to the existence of an ever-increasing number of different allied health personnel, many of whose occupations are due to new biomedical technologies which did not exist before World War II. Similarly, the fact that the "health industry" is now the third largest out of seven industries defined by the Bureau of Census is due not to a radical expansion of the medical contingent but to the increased numbers of allied health personnel. Between 1900 and 1960 the total number of such personnel has increased almost six-fold (5.78), while the number of physicians has not quite doubled (1.96). "Other health personnel" (all such personnel except physicians), on the other hand, increased more than twelve times, with the most dramatic rise among professional nurses: in 1900 there were 640 professional nurses in the United States and in 1960 there were over half a million professional nurses, an increase of almost 80,000 percent (787.5 times). In these years, the proportion of physicians per

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100 persons in all health professions has dropped by two-thirds (from 63 to 2 1 ) . In 1960, physicians constituted less than 12 percent of all health workers (rather than only those in selected health professions). 7 Nonmedical Roles in the Medical Care System A third category of individuals who play a role of increasing importance in the health system are the nonmedical employees, whose activities are essential to the operations of the health system. The list of these personnel would be extensive. D. D. Rutstein mentions the following few: "drug manufacturing employees, pharmacists' clerks, ambulance drivers, the electricians, plumbers, other maintenance workers, the housekeeping staff members in the hospital, and the secretaries of physicians. For obvious reasons, the boundaries of this group are difficult to define." 8 Problems of definitions make specification of health system personnel difficult. According to Lerner and Anderson, of the estimated total of 2.5 million in the health service industries in 1960, 1.75 million belonged to what the census calls health occupations, of which there are eighteen distinct types (nurses and student nurses, physicians and surgeons, dentists and medical and dental technicians, as well as others classified as professional, related, or kindred). The balance of about 750,000 would thus be in supportive occupations not specific to health, such as clerical personnel, maintenance workers, laundry employees, janitors and service employees. 0 In 1965, it was estimated that the health manpower of the United States was between 2.87 and 2.90 million, distributed in no less than thirty-five fields. As professionals and other health personnel begin to specialize, either because of knowledge and technology or because there is a need to manage an ever-increasing number of personnel employed in the health system, many of them cease being "generalists" and upgrade themselves (or are promoted) to more specialized roles and occupations. As "specialists" or managers (i.e., health "administrators") they acquire a scarcity value, and their status and rewards increase as the scope of their concerns is

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narrowed and deepened and as their contribution to the efficiency of the medical enterprise is enhanced. As a result, the span of health personnel lengthens on the vertical axis from the topmost superspecialist or administrator to the lowliest attendant or orderly, and it widens on the horizontal dimension as more specialists at about the same level of the hierarchy are added to perform new and numerous tasks. As those who formerly were generalists move into specialties and thereby "limit their practice," their previous less specialized functions are vacated, although the need for such functions is in no way eliminated. Indeed, as will be suggested below, the very process of specialization seems to require a parallel process of de-differentiation that is complementary to specialization. The "vacancies" created by specialization are filled in a variety of ways. Personnel down the line, so to speak, may move up a notch and take over some of these functions: this occurs, for example, when nurses are entrusted with tasks that until then only physicians would perform; personnel may be imported from another society, as when physicians and nurses immigrate to the United States. Some specialists engage in a kind of general practice, as internists and pediatricians sometimes do; or the job may go by default, as when the general practitioners disappear from the ghetto areas and are not replaced by any functional equivalent. The process described here often involves both a downward transfer of responsibilities (physician to nurse, nurse to licensed practical nurse, licensed practical nurse to nurses' aide, and so on) and a downgrading of jobs to permit those with less formal training to perform tasks previously done by more skilled personnel. In New York City, for example, a training program has been instituted to permit nurses' aides to upgrade themselves to the level of licensed practical nurses because of the severe shortage of professional nursing personnel. As it is, in some of the municipal hospitals of that city, "unlicensed and untrained nurses' aides now administer oxygen, perform deliveries, work as obstetrical, radiological and operating room technicians and supervise wards in the city hospitals." 10

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In the face of continued expansion of knowledge and technology and the demand for medical services, these trends are unlikely to be reversed. For example, while the total civilian labor force increased by about 15 percent in the decade 1 9 5 0 - 1 9 6 0 , and while the number in agriculture declined by 38 percent and those in construction by 10 percent, those in the health service increased by 54 percent. There is reason to believe that the health services are now the fastest growing segment of the total economy and will continue to be in the future. 1 1 T h e same phenomenon is also visible in Canada, where "the health service industry, one of the biggest in Canada, employs one Canadian in twenty, and ten other persons for each doctor." 12 Projections into the future are even more striking. By 1975, according to Dr. Darrel J. Mase of the American Medical Association's Council of Education, physicians will constitute only 4 percent of those employed in health services, and health may then employ 6,000,000 persons and constitute the nation's biggest industry. 1 3 At the same time, as an index of the "industrialization," or, as some call it, the "institutionalization" of medicine, it should be noted that currently about three-fifths of all persons employed in health occupations are employed by hospitals or related institutions. 14 Indeed, the strategic role played by the hospital and other medical facilities in the medical system deserves much more attention than can be given in this paper. The modern hospital has become, in the last 50 years, the center of the medical world. T h e process of specialization that has taken place in the medical profession may also be seen if the hospital is visualized as a kind of "collective physician." Specialization and differentiation of functions between a community hospital and a research or special-diseases hospital, for example, will also require mechanisms such as regional cooperation and planning to make a more rational use of scarce facilities. In the words of Cherkasky and Pines, the hospital will have "to limit itself to functions that cannot be performed elsewhere. It will concentrate on definitive diagnosis and treatment, delegating all other medical care to closely associated but less expensive satellite facilities." 15

Mark G. Field

Differentiation and Depersonalization: Technology and the Alienation of the Patient As the medical care system, under the impact of the twin factors of increased differentiation and quantitative expansion, becomes increasingly large and complex in its internal structure, certain consequences and problems result. One of the prime implications of specialized functions and decreased generalist activities in the necessity for mechanisms that will integrate the increasingly narrow discrete outputs of specialized roles and collectivities into a comprehensive and effective product through planning, organization, integration, management, traffic control, transportation, and communication. The more costly the specialized outputs are, the more strategically important is the rational use of these resources to ensure the most equitable functionally adequate deployment of personnel and facilities. Thus, the first major prerequisite of a differentiated system is the appropriate "assembly" of the specialized outputs. This entails management, hierarchy, lines of authority, subordination and superordination, and eventually some kind of bureaucratization. The seeds of several important problems are inherent in such needs. One of these, and perhaps from the traditional medical viewpoint (with its Hippocratic legacy of individual responsibility) the most vexing, is that organization and management imply a process in which the physician becomes part of a larger bureaucratic structure and sees his independence and status threatened by outside forces. At the same time, he himself becomes the manager of a team of professional, semiprofessional, and nonprofessional medical and allied health personnel. The net result, particularly of the second process, is to reduce the time available for direct patient contact. In the aggregate, the proportion of physicians in administration has risen in the last few years. It will presumably continue to rise as the "managerial" functions of doctors expand at about the same rate as the size and complexity of the medical system, unless doctors become increasingly willing to delegate these tasks to nonphysicians, which would be a fur-

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ther process of differentiation with its own problems and dangers. Organization and management have further implications for the two medical needs of the patient outlined earlier, the compassionate and the technical. The technical aspect of medical care, as a result of specialization, differentiation, and allied phenomena, allows an ever greater possibility for error in the chain of activities (the "medical assembly line") as the number of individuals involved in the care and treatment of patients increases. Potential conflicts may arise from the need to reach quick decisions (as when a private patient is under the care of the hospital staff, and the patient's physician cannot be reached immediately, or when the staff hesitates on whether to bother that physician with what might be considered a trifle), or from the manner in which the "orders" of the physician are carried out (for example, in medications), or from errors that are overlooked in the process, and so on. At the same time, the increased number of personnel who handle a patient also has serious implications for the fate of that patient, and particularly for the pastoral element which I hold as a fundamental component of good medical care. We can dispose, at the outset, of the argument that in a lifeor-death situation the impersonal but effective physician and machine are to be preferred over the tender ministrations of a physician who can only sit through the night at the bedside of a dying patient and who is powerless to affect the course of illness but wise in the ways of comforting the dying. In most instances one can presume that the situation is not that dramatic and that short shrift often will be given to the patient's emotional needs, though everyone seems to agree that these needs are important. This phenomenon is already highly visible in the heavily instrumented hospital of today. The hospital is, in essence, a kind of medical factory in which the patient, because he has the lowest seniority on the hospital totem pole, is sometimes handled as an object to be processed, as a disease inside a human skin, as an interesting diagnostic or scientific problem, or as good teaching material, but not necessarily as a flesh and bone individual. This malaise is compounded by the fact that the patient is manipu-

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lated, percussed, exhibited, trundled, cut into, connected to tuhes, swabbed, wrapped, all the while moving from one person to another as on an assembly line. Thus, paradoxically, as the health care system becomes more technologically sophisticated and as more personnel become involved in medical care, that care becomes increasingly unsatisfactory to the patient, at least at the personal, emotional, psychological level. From sharing the center of the medical stage with the physician, the patient now often occupies a small corner, outnumbered and overwhelmed by a multitude of white-coated people who speak a cryptic jargon of vaguely reassuring phrases. The increased application of science and technology in medicine, the growing "industrialization" and "institutionalization" of medical care thus produce, in turn, a depersonalization of the patient somewhat akin to the alienation that has been noted, for a century or more, for industrial workers. It is an alienation, however, of a special medical kind, intensified by association with the pecularities of illness and disability and the anxieties related to suffering and possible death. In describing the "maze" through which "consumers wander in search of services to meet their own ideas of need," observers of the contemporary American medical scene have noted that this fragmentation not only detracts from the quality and the continuity of care but also substantially adds to the overall costs. 16 At the same time, to the degree that general practitioners upgrade themselves into specialty practices and to the degree that no functional equivalents take their place, the loss of the general practitioner is likely to present a serious problem to the patient. It is, of course, the opinion of some that what patients really want is the best technical medical care available and that they will be satisfied with that. It is my contention, on the other hand, that the general practitioner (sometimes referred to as the family doctor or primary physician and defined as the individual responsible for primary care, continuity of care, personal health services, and reassurance to the patient) 17 or some appropriate functional equivalent has, by no means, been made obsolete by the increased differentiation, technological orientation, and com-

Health Care System

plexity of the contemporary medical care system. Indeed, he may be needed now more than ever. The process of "upgrading" has already been noted both for professionals, as when physicians limit their practice to a specialty, and for semiprofessionals, as when a nurse decides that her role is to see that nursing is done rather than doing it herself. This process depends, naturally, on the availability of less skilled personnel who can with some ease move upward into the vacated slots, such as nurses' aide to licensed practical aide, to whom "deskilled" functions are transferred downward. The process is not quite the same for physicians as it is for semiprofessional personnel for the reason that there is no one with medical professional training who stands below the general practitioner. If one reaches below the general practitioner to scoop up someone with medical training who could fit into the physician's shoes, there is, in truth, no one with these qualifications. The upshot is that the functions of the general practitioner are often not being performed by a medical person, or that someone else, without appropriate professional qualifications, steps into that role and performs like a generalist. This is what, to some degree, is taking place in the medical system. It is necessary, however, to attempt to justify why, in an era of specialization and superspecialization, in a system that increasingly relies on automation, computers, and machinery and thus will become technologically increasingly efficient, the generalist role or some adequate functional substitute is important and may not be easily disposed of. I have already examined, or at least adduced, some reasons for the continuing need for some kind of general practitioner. In the most general terms, illness, by its very nature, gives rise to the need for psychological support and pastoral or compassionate care, and the specialist, by the very nature of his "limited" mandate, even though he has had the standard medical training of all physicians, is simply not ready nor perhaps equipped to provide that kind of care. And perhaps, in the age of specialization, there is a tendency on the part of physicians faced with an anxious or demanding patient to suggest that he go to another specialist in

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these matters—the specialist in psychological matters, the psychiatrist—a suggestion the patient may well feel is a rejection. But there are other issues, of a more structural or organizational nature, that come to the fore as a result of the disappearance of general practice. Briefly, they are the following. Access, Diagnosis, and Primary Care One major characteristic of medical practice in the community was the physician's visiblity and availability. The hanging of the shingle was a symbolic act, signifying that at this location, at almost any time, one could find a doctor, and that medical ethics dictated that claims for primary medical care would be honored. Thus, even though in most instances the physician was in private practice as a member of a liberal ( " f r e e " ) profession, he was a "public servant." In most instances people in the community knew where to find a doctor. The "open door" also meant that the patient could get into the medical system with the least amount of fuss, bother, and barriers, and that he could obtain preliminary diagnosis and care and any further steps which were needed. The patient was thus "introduced" by the general practitioner to the health care system, however rudimentary that system might have been. With the absolute and proportional decline of general practice in the community, particularly in the underprivileged neighborhoods (the core city and ghettos), and with the exodus of physicians to the suburbs, the potential patient has lost this important portal of entry into the medical system, although substitutes have tended to develop. Moreover, it seems to be a growing phenomenon that even those physicians who remain in general practice in the community often make themselves unavailable during evenings and weekends, a phenomenon described as "5 o'clock medicine." 18 The importance of the role of the generalist has also been emphasized, as when Badgley and Wolfe commented of the general practitioner in Great Britain, " N o health service, private or public, can succeed unless careful attention is paid to the doctor who provides primary care in the community. All other decisions depend on what he decides when the patient is first

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seen." 19 In the United States, as R. T. Jensen and many others have observed, despite high annual expenditures on health care— in 1969, the figure was more than 60 billion dollars—the nonavailability of primary care is a common complaint. Although the population has become accustomed to the miracles of modern medical technology, for most people "the greatest medical need is for someone to provide primary medical care for the common maladies." 20 Allocation

or Triage

A further, though analytically distinct, aspect of the access and diagnosis problem is particularly important in a highly differentiated and complex medical care system: the possibility, after preliminary diagnosis, of allocating or directing the patient to the appropriate facilities and specialized personnel who can help him best. This function is seen, perhaps in its sharpest form, during disasters or on the battlefield in the role of the triage officer, who makes a summary judgment as to where the patient must be sent next. The absence of such a role often means that patients who need care may not get the right kind of care at the right place at the right time. Thus, the allocative functions appear to be a necessary complement to specialization. For the general practitioner (or triage officer, or whatever one might call this role) has, or should have, a fairly accurate cognitive map of the medical care environment, its resources, strengths, weaknesses, and gaps, and can refer patients to the appropriate personnel and facilities. If this role is not performed, available medical resources will be misused, overused, or not used at all. The problem is compounded by the multiplicity of jurisdictions in the medical system and the inclination of some hospitals to select only those patients who contribute to their research and teaching functions. Comprehensiveness

and

Continuity

The general practitioner did not only "care for" an individual rather than a condition, organ, or organ system; he often also cared for the patient's family. In addition, through his familiarity with the community in which he lived and worked, the physician

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could obtain a good picture of the social, economic, and psychological environment in which his patients lived and the kinds of general pressures and demands they were subject to. The increasingly "scientific" nature of medicine, with its search for the etiological agent in chemical or biological terms, has contributed to deflecting the physician's attention away from the total social and psychological situation of the patient. Further, shifting the locus of medical care to the hospital presents the patient to the physician as an isolated specimen rather than as a person involved in a multiplicity of social relationships, some of which have a bearing on the illness process. Finally, general practice permitted, in theory at least, some continuity of care through the different and changing phases of illness, a continuity that often gets lost in the shuffle caused by specialization and by having the same patient treated by various personnel. Orchestration, Integration, and Reassurance or

Compassion

Insofar as the general practitioner considered the patient as "his" patient, that is, his personal medical responsibility, he could play the role of director or supervisor of the different and specialized medical services his patient was receiving. In general he could be aware of his patient's medical progress while at the same time informing and reassuring him. The hospital was the physician's own workshop, replacing either the patient's home (and the somewhat unsatisfactory kitchen table as operation room) or the physician's ill-equipped office or private clinic. What happened to the patient, inside or outside the hospital, was his responsibility, and he had the opportunity to supervise closely what other medical personnel were doing to, or for, his patient. And if he used the services of a consultant, or later on of a specialist, he was still personally orchestrating the care of his patient. The disappearance of the generalist threatens this function, and failure to replace it by an appropriate functional substitute increases the possibility of error, duplication, and the alienation of the patient. 2 1 Space and time do not permit a consideration of the substitutes

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for the vanishing general practitioner that have tended to arise nor of the controversy surrounding proposals for the training of several types of physicians, including a new, sophisticated, comprehensive physician who would provide the primary care that is part of general practice. But it may be added that the greater the technological sophistication of medicine, that is, the greater its differentiation, the more important is the process of dedifferentiation in the structure of the medical system to permit it to perform satisfactorily its mandated task of "care" in the dual sense of efficiency of treatment and compassion toward the patient. Finally, it has not been my intent, in any way, to idealize or romanticize general practice, especially since the basic quality and the medical competence of the traditional general practitioner have often been questioned. Rather, my aim has been to point to two important phenomena: ( 1 ) In dealing with health personnel, from top to bottom, we are not dealing with a typical hierarchical and bureaucratic structure in which the promotion of an incumbent from one rank or position to another is followed automatically by promoting a replacement from the rank immediately below. Unlike the procedure in which a first lieutenant is chosen to become a major when a captain is promoted to major, nurses do not become physicians as a rule. ( 2 ) The increased specialization of medical practitioners, regardless of its hierarchical implications, creates a functional need for a new and complementary role, rather than a retread of the old general practitioner. Indeed, it seems that a systems approach to this question makes the creation of this role unavoidable. The only remaining question is whether this will be a largely unplanned phenomenon or whether a more rational approach will be used in formulating the dimensions of such a role, the qualifications for entrance, the training for it, and the nature of that training. The efforts of the American Academy of General Practice represent an attempt to train medical personnel for this role; programs for "assistants" or "associates" in medicine represent another.

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The Present and Continuing Malaise in the SocietyMedicine Relationship If every advance made by man also exacts a price from him, it can then be said that one of the major consequences or "prices" of the introduction of science and its technological applications into medicine has been the depersonalization, alienation, or estrangement of the patient. In one sense, the problem of alienation is endemic in a highly differentiated society of the industrial or postindustrial type, and the individual in his role as a patient is confronted with the same general phenomenon in many of his other roles. Yet it might be proposed that the alienation of the individual qua patient is perhaps more difficult to bear than that in most other roles because of the peculiarities of illness and the precariousness of the patient's psyche. The pastoral or compassionate element that had loomed, traditionally, as so important in medicine has diminished under the onslaught of biomedical progress and has tended to be relegated to still another specialty, psychiatry. It is truly tragic when the patient, in whose interest the medical system has supposedly been established, subjectively feels that he is the low man on the medical totem pole, the forgotten man of medicine, even though one might argue that objectively he receives far better care than he would have fifty or a hundred years ago. The distance between the patient and the doctor, the lack of communication and compassion, cannot but have a negative impact on the medical enterprise. This problem comes precisely at a stage when society is becoming, or has become, increasingly impersonal. The physician, traditionally, has been the one professional with whom the individual could establish a relationship of intimacy outside his family. The withdrawal of the physician, through specialization, from that role means a further decrease of "lightning rods" for personal problems and may well affect the emotional balance of society. The ambivalence of the public toward medicine and the medical profession is a revealing aspect of that dislocation.

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On the one hand, admiration is directed at the scientific and technological achievements of medicine and its "miracles"; on the other, there is a fair amount of hostility toward the medical profession in terms of the kinds of incomes and other rewards they are able to garner and display, their apparent decreasing interest in their individual patients, their unwillingness to make house calls, their brusque behavior, crowded waiting rooms, and so on. To some extent, the efforts of the "radical physicians," the increased social consciousness among medical students, the opening of store-front clinics, the different programs to "bring health care to the people," and the increased national awareness of the question of the delivery of health care rather than medical research are symptomatic responses to some of the problems outlined here. One might add that to the degree to which the medical care system fails to provide the supportive element, however well instrumented, .automated, and "cyberneticized" it may have become, the medical product provided by that system will be unsatisfactory, or at best incomplete. The fissure that runs between the human and the technological-scientific aspects of medicine may well reflect, in essence, two "cultures," each with its peculiar orientation. One might be called the Hippocratic culture, the other the "scientific" culture. This dichotomy runs like a leitmotif through a great deal of the literature concerned with these matters. Furthermore, it should be reiterated that attention to the pastoral or compassionate aspect of medical care may not be a "luxury" or a "frill" but a basic aspect of adequate "care." Finally, in examining the impact of biomedical technology and demand on medicine and then on society one must ask, given the functional need for medical services, how does the contemporary medical care system acquit itself of its mandated task, and more precisely, what is the balance in the final analysis of the following factors: ( 1 ) need for medical care, ( 2 ) demand for medical care and societal response through the medical care system, ( 3 ) impact of science and technology on that medical care system, (4) fulfillment both of society's needs and of patients' medical (technical) and emotional demands, and (5) changes

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in the society (demographic, political, legal, economic) resulting from the intervention of the medical care system. Or, seen from a somewhat different vantage point, have the means of medical production and the exchange of medical products been so affected by science and technology that they have altered the patientdoctor relationship to the dysfunctional point, to the point of revolt?

JOHN H. KNOWLES

Notes on Medical Manpower: Quantity, Quality, and Medicine's Current Efforts T h e b o l d outlines of a national crisis in health h a v e b e e n clearly d r a w n in the past d e c a d e in a spate of reports, c u l m i n a t i n g with the Report power.

of the National

Advisory

Committee

T h e introduction to the Report

on Health

Man-

gives a capsule definition

of the crisis: T h e indicators of such a crisis are evident to us as commission members and private citizens: long delays to see a physician for routine care; lengthy periods spent in the well-named "waiting r o o m " ; and then hurried and sometimes impersonal attention in a limited appointment time; difficulty in obtaining care on nights and weekends, except through hospital emergency rooms; unavailability of beds in one hospital while some beds are empty in another; reduction of hospital services because of a lack of nurses; needless duplication of certain sophisticated services in the same community; uneven distribution of care as indicated by the health statistics of the rural poor, urban ghetto dwellers, migrant workers, and other minority groups which occasionally resemble the health statistics of a developing country; obsolete hospitals in our major cities; costs rising sharply from levels that already prohibit care for some and create major financial burdens for many more. 1 A l t h o u g h I o b j e c t to the priority w h i c h is a f f o r d e d to the p u r e service and c o n v e n i e n c e aspects of health c a r e

( d o e s , for ex-

a m p l e , a l o n g waiting list or a c r o w d e d waiting r o o m really represent part of a " c r i s i s " ? ) , this priority does reflect the

value

that our culture places on service and e c o n o m i c s and thus it stands as an e p i t o m e of life in A m e r i c a n m e d i c i n e t o d a y .

Not

only are there not e n o u g h doctors and other health w o r k e r s but, as w e are told constantly, the existing, i n a d e q u a t e health system is itself inefficient in the use of scarce health w o r k e r s and in the allocation of e x p e n s i v e facilities and e q u i p m e n t . John H. Knowles is General Director of the Massachusetts General Hospital and Professor of Medicine at Harvard Medical School. 181

John H. Knowles

The key to the American health system is the physician, notwithstanding the well-recognized symbiotic relationship of men, machines, professions and trades, and institutions. It is through the physician that the consumer gains entry into the system. It is the physician who deploys other health workers. It is he who controls the organization, distribution, and utilization of health services. It is he who ultimately determines the cost of most medical services and the allocation of health expenditures. Finally, it is the physician who controls the numbers recruited, trained, and retained in his own profession through his membership on medical faculties, teaching hospital staffs, and public and private commissions, and through his membership in professional organizations, in particular the American Medical Association, the Assocation of Medical Colleges, and the official specialty boards. Given all this, still, one cannot agree with the commonly encountered assertion that "in a way unparalleled in any other industry, the physician controls and influences his field and all who venture near it." 2 The physician's power as a professional is no greater and no less than that of the lawyer, the priest, or the scientists, and that of their respective organizations. With the increasingly important social role of knowledge and technique, the expert or professional and his organizations assume greater authority because of their central importance in the provision of services and in the resolution of problems. The match between authority and responsibility becomes critical to both professional and public satisfaction. If the professional assumes authority without responsibility, the public is frustrated. If the public demands responsibility on the part of the profession without giving commensurate authority the professional becomes dissatisfied. The contemporary scene finds both physician and consumer frustrated. Assessments of manpower needs by various professional medical groups have generally been inadequate. Such studies suffer from a view of the professional which is lopsided because it excludes other relevant disciplines (such as economics, sociology, psychology, education, political science, management, and administration) which can help view the problems objectively and

Notes on Medical Manpower

rigorously. The combination of studies by the medical profession and by other relevant disciplines should give the best information for planning purposes. Such comprehensive studies are generally lacking in the field of health, and relevant information is widely scattered. As a result, those who are responsible for planning in medical institutions are lacking in sufficient information to make rational decisions, both short- and long-range. I shall review the issue of physician shortages under four headings: (1) how the shortage is determined; ( 2 ) the staggering needs and underestimated future demands of the urban poor; (3) the available information and studies planned or completed by the various professional groups, including the American Medical Association; (4) suggestions as to what medical schools, teaching hospitals, and professional organizations might do regarding the quantity and quality of medical manpower.

The Analytic Framework Ever since the classic study of Lee and Jones in 1933, the ratio of physicians per 100,000 population has been used to define and estimate the need for doctors. 3 Their estimate of the ratio at that time was 134.7 to 100,000. Although useful for global estimates, the concept has restricted rather than enlarged the perspective of medical planners. The supply of doctors and the demands of the population must be analyzed in detail if the ratio is to have meaning. Manpower research requires analyses of both supply and demand, and it is here that the economist becomes important. The viewpoint of the economist has only recently been represented in the health field and its manpower requirements, an area which traditionally was reserved for the medical profession itself. In addition to Rashi Fein's monograph, The Doctor Shortage, and the Report of the National Advisory Commission quoted earlier, a variety of recent publications have considered the economics of health manpower. 4 When demand outstrips supply in a free market economy, the price for services (or commodities) rises. In health, as prices increase, the corresponding in-

John H. Knowles

crease in medical indigency results (and has and will result) in political intervention, for this country professes that health is the birthright of all its citizens. As tax money is added to the medical field and increased public awareness and expectations are generated by the new legislation, demand again increases and further outstrips supply, leading to another increase in prices. At this point, the net benefit to the public of new legislation and new money (contrasted with the benefit to physicians and their institutions) becomes an overriding concern of politicians and economists, as witnessed by recent voluminous reports in the wake of Medicare. Although doctors frequently assert that a free-market, freeenterprise system is the American way of life, many economists have questioned whether free-market forces can balance supply and demand in the health field, since the consumer has no way to judge quality and almost no direct influence on the supply of physicians or the mode of meeting demand. Physicians, singly and collectively, plead for free enterprise (and small medical school classes) while controlling not only the supply but also the effectiveness of demand and the standards used to determine and meet medical need. Consumer influence has so far been exerted through political channels and resulting state and federal legislation. If the situation does not improve, the public's only recourse could be the type of violent intervention recently seen in the universities. When the public fully recognizes that medicine is a social instrument and not just a technical one, the demand could become staggering and violent. With demand exceeding supply, the social problem is to increase the supply while containing and stabilizing the prices. The supply can be increased by expanding educational and training facilities and increasing the productivity of present manpower. Both solutions imply a reduction in standards and a lowering of quality. The question then is whether some service of possibly lower quality is better than none. (We must also recognize that the quality of services of the presently overworked physician is open to question.) The problem of stabilizing prices in the face

Notes on Medical Manpower

of manpower shortages and increasing demand remains a difficult one in a free economy, and one which I have not the expertise to discuss. Analysis of physician supply and population demand requires consideration of a multiplicity of variables. The physician-population ratio has meaning only if both numerator and denominator are analyzed. The study of physician supply must include: ( 1 ) specification of the type of physician involved (for example, general surgeon, neurosurgeon, dermatologist, or radiologist), the actual use of his time (in practice, research, or administration), and the location of his practice (rural, urban, hospital, or medical school); ( 2 ) analysis of the effectiveness of recruitment of workers into the field, including the social, psychological, cultural, and economic reasons for entry or lack of entry (the position of women and the special problems of minority groups bear study); ( 3 ) evaluation of the capacity and utilization of the training system (medical.schools and hospitals); ( 4 ) study of the limiting or facilitating functions of state and specialty board licensing; ( 5 ) a detailed analysis of expense of training as contrasted with ultimate income; ( 6 ) analysis of the degree of retention of doctors once they are in school, hospital, or practice (including studies of attrition through retirement, death, changes of career, and migration). Once the above factors are determined, the activities of such physicians in their chosen fields must be broken down and analyzed in regard to: the productivity of the physician (as private practitioner, salaried hospital employee, or member of a group practice); limitations to productivity imposed by organizational and institutional controls; influence of the technology needed to meet health-care demands, its costs, utilization, and availability; the effects of mobility, sex, and general environment on turnover rates; the accessibility and availability of physicians, involving geographic, commercial, cultural (work patterns, public expectations versus professional, etc.), and transportation factors; the relations of complementarity and substitutability among professionals and between professionals and "paramedical" workers,

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in the estimate of supply and future need; and finally, the rate of substitutability of other health workers for tasks done by the physician. Turning to the denominator, demand for health services is influenced by age, sex, color, region and residence, education, and income; by the dissemination of health information; by the availability of physicians and other health workers and of equipment and facilities; and by legislation designed to facilitate and encourage the use of health services. Most of these variables may be altered at a moment's notice by scientific and technological discoveries, the setting of new standards of need and of quality by both the public and the professionals (a convenient and relatively rapid way to maintain or alleviate shortages for one reason or another), changes in the utilization of high-cost facilities such as hospitals, and further social legislation and changes in the financing of health services by private and public plans. We have said little about need as contrasted to demand. Health needs are staggering in certain segments of our population, but as yet there has been ineffective and minimal demand. The economist and the social planners are currently much more concerned with demand than with need, for effective demand influences supply and price while unmet need without demand has relatively less influence on the economy and the political world. Some observations and statistics on health manpower will highlight the comments above. The number of active physicians increased 22 percent between 1955 and 1965 while population growth in the decade was only 17 percent. The productivity of physicians increased even more rapidly, at an average annual rate of 4 percent. The improved productivity was due to greater use of other health personnel, particularly technologists in diagnostic laboratories, and of special care facilities in hospitals and other health institutions. Doctors also took advantage of their increased productivity by spending less total time with patients, meaning shorter office visits and less night and weekend work. The number of physician-directed hospital services increased 81 percent in the same period, while the number of physicians in private practice increased only 12 percent. 5

Notes on Medical Manpower

Services have increased while personal contact between doctor and patient has decreased. Over the past thirty years the average number of contacts of a white person with a doctor has doubled to over five per year, and the proportion of the population that fails to see a doctor each year has fallen from one-half to less than one-third. 6 During the same period, the number of patients the physician sees has increased markedly, as much as 300 percent in the case of general practitioners. There is, however, some recent evidence of a decline in hours worked and patients seen, particularly in the Midwest, the area of highest net earnings. 7 With the physician's greater dependence on other health workers, the shortage of paramedical personnel has become of central importance. While the total labor force grew 11.4 percent between 1950 and i960, employment in the health professions grew 50.5 percent (total population growth was 18.5 percent). This trend is expected to continue with even more marked growth in numbers of health workers. Meanwhile, the percentage of total health manpower constituted by doctors (including osteopaths but not psychiatrists) was 13.48 percent in 1950, 10.93 percent in 1960, and will be an estimated 8.14 percent in 1970. 8 While the number of professional nurses in practice has increased 44 percent from 1955 to 1965, nonprofessional nurses 63 percent (licensed practical nurses 55 percent and orderlies 68 percent), and medical auxiliary personnel 63 percent (radiologic technicians 56 percent and clinical laboratory workers 70 percent), shortages of these workers seem even more severe than the shortage of physicians. 9 To provide "optimum care," hospitals need 257,000 more professional and technical workers immediately in addition to the 1,332,000 employed in 1966, an increase of 19 percent. 10 The number of supportive personnel behind each physician was one in 1900, is thirteen today, and will be an estimated twenty per physician by 1975. 11 Availability of other technical and professional personnel has become a limiting factor in the productivity of the physician. If the supportive manpower were available in existing hospitals and if the national utilization of hospitals were to increase from the present annual occupancy average of 80 percent to greater

John H. Knowles

than 90 percent, I believe existing physicians could increase their workloads by 10 percent. We may note that a 4 percent increase in physician productivity would add the equivalent of 11,700 physicians to the existing supply, greater than the current annual output of all medical schools in the United States. 12 A recent survey reported that 21 percent of 700 doctors surveyed could see 99 or more additional patients per week. Older doctors in general practice and rural practice are least able to see more patients. The surgeons reported that 42 percent could see more patients. Of all the doctors surveyed, 33 percent reported that they could see more patients under present circumstances and 44 percent reported they were limiting their practices (least likely for surgeons, most likely for general practitioners). 13 With an increasing number of physicians entering the specialties (less than 2 percent of today's graduates go into general practice), the advantages of group practice both to patient (in quality, comprehensiveness, continuity, and cost control) and to doctor (in economic security, intellectual satisfaction, increased efficiency, productivity, and convenience) should attract increasing numbers of graduates. Yet the numbers entering group practice have decreased or remained stationary. Only 12 percent of private physicians are in group practice of all kinds (roughly 28,000 of 228,000), and only 6 percent of physicians in private practice are full-time members of comprehensive, group practice clinics.14 The figure will remain low as long as physician shortages exist. 15 The proportion of the population receiving its care from practitioners in prepaid groups remains low, at 2 percent, and did not grow between 1955 and 1965. 16 In a recent projection of physician shortages, Fein estimates that the demand for physician services will grow by 22 to 26 percent by 1975, and by 35 to 40 percent by 1980, at the lower limit. Increase in population and income account for over 85 percent of the growth in demand for physician's visits. Fein estimates at 19 percent growth in numbers of physicians by 1975, from 305,000 in 1965 to 362,000 in 1975, which assumes continued immigration of foreign-born physicians. Without the foreign supply the estimated growth in total numbers would be 13 percent. Although this exceeds the estimated population growth

Notes on Medical Manpower

of roughly 13 percent, it is not sufficient to meet increasing demand as a result of income growth. 1 7 T h e difficulties of projecting the production of physicians have been outlined by Ruhe. Uncertainties surrounding the expansion of existing schools as a result of recent federal legislation, the building of new schools, the attrition rate among medical students (currently estimated at 10 percent), the numbers of foreign graduates (between 20 and 30 percent of the total doctor population), and the projection of an irregular growth curve of medical graduates, compound the problem. 1 8 With all these variables considered, present projections show 369,000 or 382,000 physicians by 1975, depending on the increase in new unlicensed foreign graduates each year ( 5 0 0 versus 1,500 per year with a constant supply of 1,500 new foreign licentiates each y e a r ) . Current estimates give a population of 230 million people by 1975, which will mean a physician-population ratio of between 160 and 166 per 100,000. On the surface, a physician-population ratio of 160 to 166 per 100,000 represents a marked increased from the level of 149:100,000 population in 1959 and 153:100,000 in 1966. As shown by Fein, however, projected demand for physician visits will outstrip the improvement in physician-population ratio, and I agree that his estimates of demand lie at the lower limits. One should also note that the rate per civilian population in 1965, when one considers only physicians in active practice, was 9 7 : 1 0 0 , 0 0 0 , or 62.5 percent of the total number of physicians. This is a continuation of the decrease from 1950, when the figure was 109:100,000, representing 72.2 percent of the total number of physicians. 19 The trend to increasing numbers of medical graduates who enter research, teaching, industrial, administrative, and institutional careers continues, as does the preference for specialty practice versus general practice. It is difficult to determine the ideal physician-population ratio on the basis of existing figures. There are, for example, marked geographic differences (a total of 178 per 100,000 in the Northeast, with 134 physicians in active practice per 100,000 in New York, and 113 per 100,000 in the South, with a national low of 58 physicians in active practice per 100,000 in Mississippi in

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1965). Another index comes from the average number of physicians—109.4 per 100,000 population served in six medical groups providing prepaid medical services (Table 1). If we estimate that only 60 percent of all physicians will be in private practice in 1975, we will have a ratio of approximately 100 practicing physicians per 100,000 population. 20 Table 1. Number of Physicians per 100,000 Population Served, in Six Medical Groups Providing Prepaid Medical Services, by Specialty Specialty Internal medicine Allergy Dermatology Pediatrics Obstetrics Orthopedics Ophthalmology Otolaryngology Surgery Urology Radiology Physical medicine a Anesthesiology a Pathology » Neurology Psychiatry Total b

Mean

Median

45.2 1.6 2.8 18.0 9.1 3.2 3.7 4.6 6.5 1.9 4.4 1.3 1.5 1.8 1.0 2.8 109.4

44.9 1.4 2.5 15.8 8.0 3.0 3.3 3.5 6.7 1.5 4.0 1.0 1.5 1.6 1.0 1.5

Source: U.S. Department of Health, Education, and Welfare, Bureau of Health Manpower, Health Manpower Perspective, 1967, Washington, D.C.: U.S. Government Printing Office, Appendix, Table 6, p. 75. a Physical medicine based on three groups; anesthesiology based on two groups; pathology and neurology based on four groups. These services are provided in the remaining groups in other ways. b Exclusive of interns and residents in hospitals.

Notes on Medical Manpower

Should we assume that these figures given in Table 1 represent the ideal? It is impossible to say, for several reasons common to the numbers game of manpower shortages: ( 1 ) the quality of care is not known accurately; ( 2 ) the efficiency of the system is not known, although the cost is; and ( 3 ) the populations served generally represent actively employed, middle-class individuals whose level of income and education result in better health, lesser need for prolonged hospitalization, less complicated illnesses, and more effective demand as compared with the poor. The difficulties of measuring quality and efficiency combined with the multiplicity of variables listed earlier make global estimates of the needs for physicians crude at best. We do know that in prepaid group practices cost is reduced and quality of care at least compares favorably with other forms of practice. While efficiency experts are stymied by the problem of providing for personal encounters between physicians and patients, which are as much affairs of the heart as they are of the head, it is recognized that quality control is enhanced in group practices, as well as in teaching hospitals (versus community hospitals), and in voluntary (versus proprietary) hospitals. 21 The ability of the consumer to buy or utilize services is the key determinant in any discussion of manpower needs. Since that ability is a function of education, cultural values, and access, it is the urban poor who are least able to buy or utilize medical and other services and whose needs have thus been grossly underestimated. This group of some 40 million people has staggering needs but has, as yet, voiced little or no effective demand. With all our other known problems in medicine, we have not yet been either blessed or burdened with the horrors of the health needs of our under-developed urban "colony." I say "blessed" because the dilemma offers us opportunities to change and improve the system of medical care. I say "burdened" because we in the medical world are ill equipped to assume our rightful place in the resolution of larger issues that beset our country today. We profess the need for more science and more knowledge, yet we make little attempt to use existing knowledge for the benefit of 20 percent of the population lying the shadows of our urban medical

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institutions who are most in need of our knowledge and our services but who cannot afford us, cannot find their way to us, and do not know they even need us. Small wonder we are greeted initially with hostility. Small wonder the medical world is excluded from the Kerner Commission and from the decisions that set priorities and allocate resources for conflicting demands of health versus housing versus food versus education and schools versus the police versus transportation versus urban renewal. We experts have been excluded from the mainstream and play little part in the large issues surrounding causation, prevention, or alleviation of discontent (dis-ease). We should not be excluded, for I believe we have much to offer and much to gain in the efforts to improve the American system.

Health Problems of the Poor There are today some 40 million people in the United States who are classified as poor, following the Social Security Administration's definition of an urban family of four with less than $4,345 annual income. A recent analysis by Department of Health, Education, and Welfare projects the number of such people so defined to 44 million in 1969 and 41 million in 1973. This report, entitled Delivery of Health Services to the Poor, should be read in its entirety by every doctor, medical school dean, teaching hospital director, and faculty member in the United States, to say nothing of any and all other concerned Americans. I shall summarize some of its findings. It is true that an individual's health is the product of his total environment, including the air he breathes, the family in which he grows, the education he receives, the religion he adopts, the work he does, the income he receives, the genes he inherits, the recreation and leisure he enjoys, the place he lives, the food he eats, the health care he receives, and the identification and position his culture gives him. All of this should be part of the physician's total knowledge and efforts to improve his caring and his ability to prevent dis-ease. For my purposes, however, I will list only the factors relating dis-ease to one variable, poverty.

Notes on Medical Manpower

Poverty affects all the variables listed above in an adverse way, the sum total of which is an increase in somatic, psychic, and social dis-ease. (1) Twenty-nine percent of the people with family income of less than $2,000 have chronic conditions limiting activity, as contrasted with less than 7.5 percent for families with incomes of $7,000 or more. Heart disease, arthritis, mental disease, high blood pressure, visual impairment, and orthopedic impairments are all more common among the poor. Between the ages of 17 and 44, the poor suffer such conditions at twice the rate of the non-poor, and between the ages of 45 and 64, the rate for the poor is five and one-half times greater. The rate for mental and nervous conditions is 26.4 per 1,000 population for those with incomes under $2,000, compared to 4.2 per 1,000 for those with a family income greater than $7,000. (2) Males in the working-age group of 45 to 64, in the $2,000 income level, have three and one-half times as many "disability days" (49.5 days per year) as the over $7,000 group (14.3 days per year). (3) Poor families have more multiple hospital admissions, are more often hospitalized for nonsurgical conditions, and stay in the hospital longer (10.2 days per hospital stay for under $2,000, 7.2 days for over $7,000). (4) Using color as a surrogate measure of economic position (nonwhite people, 90 percent of them Negroes, experience poverty at three times the rate of white people), life expectancy at the time of birth is 63.6 years for nonwhites and 70.19 years for the white population. Thus, reduction in life expectancy may be a reflection of poverty per se. ( 5 ) Maternal mortality rates in 1965 were 90.2 among nonwhites, compared to 22.4 maternal deaths per 100,000 live births among white mothers. (6) Death rates due to tuberculosis, syphilis, influenza and pneumonia, vascular lesions of the central nervous system, and homicide are more than twice as great for nonwhites as for whites. Cancer of the cervix, which can be cured if diagnosed early, has a higher nonwhite mortality. ( 7 ) The children of families with under $2,000 income aver-

John H. Knowles

age two physician visits per year, compared with 4.4 visits in the above $7,000 families. (8) Of nonwhite children ages one to four, 22.5 percent have not received immunization for diphtheria, whooping cough, and tetanus, compared with the 8.6 percent of white children who have been missed. ( 9 ) Of members of families with under $4,000 income, 22 percent have never seen a dentist, compared to 7.2 percent of the members of over $10,000 income families. (10) The oft-quoted figures relating to infant mortality and life expectancy in the United States compared with the other countries of the world bear repeating here, if only to make final the plea that we stop proclaiming our superiority in medicine to the world. In 1965, the United States ranked eighteenth among the countries of the world in infant mortality (we were eleventh in 1959); twenty-second in male life expectancy in 1965 (thirteenth in 1959); and tenth in female life expectancy (seventh in 1959). 2 2 Turning from the national condition to a local survey will perhaps make the point more forcefully. Let me give some facts about Boston', cradle of American liberty, wellspring of American medicine, the home of great hospitals and medical schools, which boasts one of the greatest concentrations of doctors and other health workers per capita of the entire Western world. In 1955, Boston ranked first in the nation for morbidity and mortality due to tuberculosis among cities with populations over 500,000 (and ranked second only to San Francisco in alcoholism). All this in the shadows of the Massachusetts General Hospital and the Boston City Hospital! Today we rank eleventh in morbidity and twelfth in mortality. In Roxbury (black Boston), the infant mortality rate is 32.1 per 1,000 live births as compared with the citywide rate of 24.6. Infant mortality rates are as high as 79.5 per 1,000 live births in some areas of Boston. The Youth Health Program which provided medical services to individuals between 16 and 21 years of age who were participating in various Office of Economic Opportunity programs reported that 364 (31 percent) of 1,191 youths examined has "one or more medical conditions requiring more definitive diag-

Notes on Medical Manpower

nostic and/or treatment services." 23 Ninety percent needed some form of dental care. A list of medical problems discovered is given in Table 2. How can these problems exist in twentiethcentury America, what can we in the medical world do, and what has all this to do with medical manpower shortages? Table 2. Findings in 1191 Youths, Ages 16-21, from Boston Area Classification Asthma Blood dyscrasias Cardiac Diabetes Ear, nose, throat Endocrine-thyroid Eye refractive errors Fracture-orthopedic Gastrointestinal Hypertension Genitourinary Medical a Neurological Nutritional Obstetrics-gynecology Obesity Prenatal Psychiatric-psychological Renal Respiratory Skin Speech Surgical Tumor Venereal (syphilis-gonorrhea) Total (representing 364 patients)

Number 18 34 87 10 92 13 150 22 13 20 21 23 39 3 46 82 50 50 57 8 27 6 24 3 29 927

Source: Office of Economic Opportunity survey. Data supplied by Dr. Andrew Sackett, Boston City Hospital. a Undiagnosed symptoms.

John H. Knowles

The Causes The poor are unable to gain access to the present health system because there are few individuals or local facilities to serve as points of entry. The usual entry occurs with acute crisis, more often than not through the police. In addition, the poor are also uneducated as to their needs and therefore can make no effective demands. (Spokesmen for the Poor People's March on Washington in 1968 placed jobs as their greatest need, far ahead of health in the traditional sense.) The poor have no political power, save for the recently found self-destructive negative power of collective action and violence. Urban medical centers, with isolated exceptions, have made no attempt to extend themselves to their communities but instead have remained self-satisfied with their traditional, acute-curative (and passive) functions. We say, "If you can get here, you'll get the best!" The best is available, but they have to know how to get it. The poor distrust our medical establishment. Note the militant demands of the Negro poor in Newark, New Jersey, who insisted there would be no urban renewal of their blighted area with location of a new medical center in their midst unless the center guaranteed care and a decent ambulatory clinic for their use— a telling and ironic comment on the medical establishment. 24 It is important to review the behavior of the Newark poor and the ultimate influence they exerted, for I believe the experience represents a bellwether for the future. The report in Science said in part: This 630-bed institution (Newark City Hospital), which adjoins the college site and is soon to be taken over by the college, is known to most Negroes as the "butchershop." The college's plan has been to upgrade the hospital, once administrative control has been achieved, and use it as a clinical resource for its teaching program and a principal means of providing community health care. The new 272-bed teaching hospital, on the other hand, will be a referral hospital for the entire state. The black community's negotiators were afraid that City Hospital would not be much improved and would be a buffer between the college and the community. "What we really wanted was a total redesign of the college, with

Notes on Medical Manpower

City Hospital becoming the teaching hospital," one of the negotiators told Science. "But they just weren't going to do that. They would have pulled out first." The black community did get assurances that $2.5 million will be spent immediately on the rehabilitation of City Hospital. It was also promised an ambitious "outreach" program whereby the college, by setting up the neighborhood health centers and by other means, would develop new ways to combat such community health problems as the high incidence of tuberculosis, venereal disease, maternity and infant mortality. Most of the things the college has agreed to do to improve community health services, it would have done anyway, D e a n Cadmus says, though there is little evidence of much past interest by the faculty in improving the health of the poor. Because of the negotiations, if for no other reason, community medicine is now assured a high priority. 25

The poor are discovering new ways of exerting effective demand! In fiscal year 1968, $5.1 billion of federal money was spent on health care for the poor (compared with $1.6 billion in 1966), of which $4 billion was in payments under Medicare and Medicaid. The expenditure is partly a result of efforts of specific programs such as the Comprehensive Health Services Program, Children's Bureau programs, and programs to deal with such problems as migrant workers and venereal disease. All these programs have helped. But federal financing for Medicare has removed (or replaced) the state's burden, and with the recent reluctance to implement Medicaid fully in various states, the net increase in aid falls far short of the mark. As the H E W report says, "Despite recent legislation, inability to pay for services remains an important barrier to the poor's quest for health care." 26 Medical facilities and manpower are scarcest in those areas where they are most needed. T o verify this statement, one has only to look at the municipal hospitals of urban America to know that facilities are inadequate to the task and to note the mass exodus by practicing physicians and other health workers to the clinics and laboratories of voluntary teaching hospitals or to the suburbs.

John H. Knowles

The Solutions

As the successes of medical science and technology burgeon, there is an accompanying increase in the subdivision of medical labor, discontinuity of care, manpower shortages, and costs. These considerations, coupled with the present defensive isolation of the medical world in its hospitals—bastions of acute, curative, specialized, technical medicine—prevent the giving of comprehensive, preventive care and the development of the true health center for community health care. Obviously, our system of medical education and our notion of the scope of necessary medical knowledge must be considered deficient; its context avoids the study of the social and economic dis-ease which is manifested everywhere in increasing numbers of what we call the mentally ill, in the uneven distribution and utilization of health services, in our increasing difficulty in financing the care of the chronically ill, in the wretched conditions of those who most need our aid, the impoverished, the children, and the aged. What, then, is needed? Let us start with what we have, the "health center." These centers as they now exist are restricted to the treatment of established, somatic disease by teams of specialists. Specialists in public health or preventive medicine are rarely included. Many hospital "health centers" have no social service at all; the best that is often available is a poorly developed outpatient clinic. No honest attempt to provide continuity of care or extension of services to the community and into the home is made. There is little communication or cooperation with other community institutions which affect health. Where is the "health center" that works regularly and imaginatively with community nursing homes, visiting nurse associations, homemaker services, the churches, the schools, the courts, the urban renewal department, city hall, to name only the most obvious institutions affecting community health? The care of the mentally ill has long been segregated into distant asylums. The urban hospital has the name of "health center" in the medical profession only because by and large the medical profession sees "health" as the treatment of somatic crises, an area of health in which the hospital has the central position.

Notes on Medical Manpower

But the health of a community must inevitably be affected by its economic condition, its education, its recreation, its housing, its general social conditions. Somatic and psychic disease is most prevalent in urban communities of the poor where, hand in hand, one finds the poorest living conditions, the highest unemployment rates, the worst schools and the worst schooling, and, not surprisingly, the greatest unrest. That these matters are not included in the "learning field" of medicine does not make them nonmedical. Medicine inevitably must concern itself with the larger field of social welfare; it must develop a complete concept of a community's health. The role of medicine is to prevent disease and maintain health and part of that role is to enhance the quality of individual life and to contribute to the national welfare. If we see medicine in this role we will be able to place it in its rightful position in the larger field of social welfare and enhance the learning experience of all health personnel. From this concept should flow study and experimentation leading toward the better use by the health professions of scarce personnel and the more rational use of health services by the community. The costs, although increased absolutely when services are initially provided to those who have lacked them, will be more than justified by the economic advantages of preventing disease, rehabilitating the disabled, and making better use of all health facilities. We already have a base for extending the medical interest in the ways I have suggested in the urban, university-affiliated, teaching hospitals. These can be developed into comprehensive health centers accessible to the poor, and they can conduct rapid research on the present system of medical care and needed improvements in it, particularly in the area of manpower utilization. They can recruit people from impoverished areas to work in health. Through these extensions of interest, the health system of the country can be changed and the three major issues of cost, quality, and equality will be productively engaged. Federal legislation and funding must be simplified, increased, and stabilized against politics if such programs are to be undertaken. Uncovering the needs and stimulating the demands of

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40 million Americans will certainly strain existing health manpower and facilities. This factor has been consistently underestimated. Any success will create new problems, but planning should involve research on the system and on development of more health workers of more kinds so that more effective use can be made of the doctor and the nurse. And may I also state the simple fact that such development must be acceptable for all social classes. After all, most of the complaints and effective demands of today are coming from the middle and upper classes, where most of the political and economic power politicians respond to is found. This proposal for a reconsideration of the definition of health by physicians and hospitals is not my exclusive property, and I am glad to say that it has moved well out of the oratory stage. A variety of experiments and programs is already underway, such as the Columbia Point project of Tufts University; the Yale Studies in Ambulatory Care; the plans of Meharry Medical College for determining whether a comprehensive, family-oriented program in a neighborhood health center using multiphasic screening actually reduces morbidity and mortality and whether it actually increases demand and utilization; the new comprehensive services program of the Massachusetts General Hospital. Perhaps the most inclusive of these programs is the work of the Chicago Health Research Foundation, the research arm of the city's Board of Health, which has contracted with voluntary teaching hospitals and medical schools in the area to provide comprehensive health services for the ghetto poor. These attempts should be evaluated both from the standpoint of the recipients and from that of the institutions which are providing it. Much research is needed into the ultimate medical and economic effects of various types of approaches to this problem of the health of the urban poor.

A Survey of the Medical Specialties I would like to turn now from these general matters to more specific concerns relating to doctor shortages with a discussion

Notes on Medical Manpower

of present and projected shortages of manpower in the medical specialties. General practitioners are declining in number; specialists are increasing. By the second year after graduation twothirds of recent medical graduates have chosen a specialty, and the proportion increases gradually to about three-quarters of those who have been out of school seven years. The general practitioners of today are mostly men of middle age or older; very few new ones are coming along. There are nineteen recognized specialties in medicine, 27 each centered on a particular field of medicine with a special body of knowledge and practice concerning a particular organ system (as in obstetrics and gynecology) or a particular method of diagnosis and treatment (as in psychiatry). The various specialty boards work under broad guidelines set down by the Advisory Board for Medical Specialties, which also has the responsibility with the Council on Medical Education of the American Medical Association for approving proposed new specialties. According to the statement of the Advisory Council in its Directory of Medical Specialists, "The primary objective of approved specialty boards is to provide comprehensive qualifying examinations for physicians who fulfill requirements and to certify those who are successful. In this manner an attempt is made to ensure the public, both lay and medical, that physicians professing to be specialists possess proper capabilities." Other responsibilities are "to aid in improvement of general standards of graduate medical education and facilities for special training" and to "establish minimum standards for graduate training, thus allowing maximum flexibility to institutions, preceptors, and to physicians in training." The specialty boards' chief aim is to promote the public welfare and improve medical care. While nothing in any of these statements of the general policy expected of specialty boards can be construed as requiring the boards to concern themselves with manpower, neither is such concern excluded. Indeed it seems obvious that specialty boards and their requirements must exert considerable influence on ultimate shortages of manpower. The influence is at present great, but not complete. A report on the specialties in 1966 numbered

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full-time specialists at 122,711, of whom only 9 4 , 1 8 4 ( 6 8 . 9 percent) were board certified. Only 5 2 percent of anesthesiologists and 53 percent of internists are board certified, while 93 percent of radiologists and 9 4 percent of pathologists are diplomats of their respective boards (see Table 3 ) . The boards, however, have great influence over standards of practice and training in their specialties whether or not the individual specialist holds his diploma. Table 3. Numbers of Specialists and Percentage Certified by Respective Boards in 1966

Specialty Internal medicine General surgery Obstetrics/gynecology Psychiatry Pediatrics Radiology Anesthesiology Ophthalmology Pathology Orthopedic surgery Otolaryngology Urology

Full-time specialists

Diplomates, number

Diplomates, percentage

28,617 19,717 13,313 13,117 11,939 7,483 7,164 7,018 5,875 5,738 4,412 4,056

15,110 13,400 7,380 7,000 9,300 6,963 3,691 4,952 5,551 3,992 3,946 2,899

53 68 55 53 78 93 52 71 94 70 89 71

Source: Medical Economics, Dec. 26, 1966, p. 63. Copyright 1966 by Medical Economics, Inc., a subsidiary of Litton Publications, Inc., Oradell, N.J. Quoted by permission. In order to find out what the various specialty interests had done or not done about manpower, I wrote the executive secretaries of the nineteen specialty boards stating my purposes and interest as follows : I am trying to review the thoughts and plans of the various specialty groups vis-à-vis shortages in their fields of interest. Specifically, has your Board (or your professional college, academy, association, or society) :

Notes on Medical Manpower

1. made a study of manpower (professional and/or technical) shortages? 2. planned to make a study? 3. made no plans to study the situation and if not, why not? (e.g., there are no present or anticipated shortages!) 4. Are there any existing private or public (e.g., governmental commission or study group, state or federal) studies which you recommend as valid statements of the problem within your field—and if so could you give me the pertinent references? 5. Have you issued any policy statement or taken any official position on the subject and if so could I have it?

The results of the survey are summarized in Table 4. Certain modern composers say that silences in their compositions are as important as the sounds. I am forced to say the same thing about the results of my survey. American medicine is subdivided into large numbers of specialized organizations. For instance, the American Board of Otolaryngology is made up of representatives from each of the following groups: the American Laryngological Association; the American Otological Society; the American Academy of Ophthalmology and Otolaryngology, the Section on Laryngology, Otology and Rhinology of the A.M.A.; the American Bronchoesophagological Association; and the American Society for Head and Neck Surgery. Consequently, it is difficult to divine in any particular case which organization might take an interest in the manpower supply in any medical field. I started with the specialty boards because they are charged with certification of new specialists and approval of hospital training programs, which, on the face of it, seems to imply at least some interest in manpower. Therefore, it was of considerable interest to me to find in answer to my inquiry to the nineteen specialty boards (counting psychiatry and neurology as one, and ophthalmology and otolaryngology as one) that either explicitly (eight boards) or implicitly, by virtue of no sponsorship of appropriate studies (five boards), the majority of specialty boards considered it quite outside of their area of interest or responsibility to consider the broad question of manpower shortages. The apparent lack of knowledge of, interest in, or responsibility for manpower short-

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Notes on Medical Manpower

ages nonetheless was surprising, particularly when the specialty boards have been given the power to protect the public interest. Some substantial studies have been done on manpower shortages in pathology, psychiatry and neurology, and dermatology, and some very promising studies are under way in the fields of pediatrics, orthopedic surgery, and urology. Studies in obstetrics and gynecology, radiology, and anesthesiology seem skimpy at best for such obviously important areas. Generally speaking, the studies lack uniformity and are notable for their lack of the kinds of data that the experts of discipline such as economics and the other social sciences would wish to know. Furthermore, few concrete recommendations for relieving the problems have been offered. It is particularly noteworthy that no formal studies have been attempted in either of the two broadest specialties, internal medicine, where there is a definite shortage, and general surgery, where there is apparently no shortage at the present time. In internal medicine, the problem will be alleviated by increasing the numbers of medical students, since internal medicine attracts a high proportion of each graduating class. In general surgery, although no study has been undertaken, the American College of Surgeons has expressed concern about the sudden decline in the number of American candidates for certification and the corresponding sharp increase in the number of foreign medical graduate applications. (It would be of interest to know what the effect of the free-market economy has been on "prices" where present supply is sufficient.) A recent expansion of requirements of a year each by the specialty boards in pediatrics (if straight internship is not taken, three full years in training are required) and anesthesiology (if three years of residency are taken instead of two, the board examination can be taken a year earlier), is arresting in view of the existing shortages in both fields. One can only surmise that the additional requirements have magnified shortages at least transiently and wondered whether this effect was even considered at the time of the action.

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Action by the American Medical Association In 1966 the board of trustees of the American Medical Association appointed a Committee on Health Manpower, which reported, in a statement on medical manpower in June 1967, an increasingly "critical need for more physicians, for a better distribution of physician resources, and for allied health personnel in all categories." The committee recommended expansion of existing medical schools as well as recognizing the need for new institutions. Continuing study of the "effect of new roles for health personnel and new interrelationships and interdependencies between health professionals, as well as the impact of innovative concepts on the organizational structure evolving in the general system of health care delivery," was recommended. The committee published its critique of the Report of the National Advisory Commission on Health Manpower in the Journal of the American Medical Association.28 Subsequently, on what might be termed an historic occasion, a joint A.M.A.-A.A.M.C. statement on health manpower was issued on March 5, 1968. The two associations emphasized "the urgent and critical need for more physicians" and stated that "both associations endorse the position that all medical schools should now accept as a goal the expansion of their collective enrollments to a level that permits all qualified applicants to be admitted." In addition to encouraging an increase in enrollment across the board, the statement called for curricular innovations and "other changes in the educational programs which would shorten the time required for medical education and minimize the costs." Furthermore, the associations said, "the development of schools of quality whose primary mission is the preparation of able physicians for clinical practice as economically and rapidly as possible is to be encouraged. Such schools may have less emphasis on fundamental biological research than is appropriate for a number of other schools," which is a remarkable and earthshaking departure from the conventional viewpoint. Finally,

Notes on Medical Manpower

the joint statement called for support through public as well as private financing. This statement was amplified and expanded in a further joint statement issued on April 16, 1968, which urged that "increased emphasis be given to support of the educational component of academic medical center activities with the intent that the production of physicians and other health personnel by such centers be assigned the highest possible priority." On April 6, 1968, the A.M.A. gave a charge to its new Council on Health Manpower, with ten specific areas of interest to be pursued. The American Medical Association has assumed its full share of responsibility for the resolution of the current crisis of manpower shortages in medicine. It is to be congratulated for its joint work with the A.A.M.C. and for the broad charge of its new council.

Conclusions The health needs of some 40 million impoverished Americans, living largely in urban but also in rural ghetto areas, are staggering. As effective demand increases from this group, manpower shortages will become even more acute. Nevertheless, medicine must inevitably concern itself with the larger field of social welfare and develop a holistic concept of a community's health if it is to prevent disease, maintain health, and enhance the quality of life. Medicine is a social as well as a biological science. Through active extensions of the interests and resources from the base of the urban university-affiliated hospitals, easily accessible comprehensive health centers can be developed which will provide medical care while they enlarge the learning field of medicine and allow significant research in the system of medical care—its organization, its efficiency, its workers, and its institutions. The reluctance of many specialty boards to concern themselves with manpower shortages within their field is paradoxical and cannot be defended rationally from the point of view of respon-

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sibility to the community and national interest, particularly since these boards have been given the power to protect the community interest. A combination of interests is needed in each specialty field in order to provide comprehensive, discriminating, objective, and uniform studies for the use of medical faculties, administrators, and national public and private organizations. Represented in such a study should be the specialty board, specialty professional association or academy, the A.M.A., the A.A.M.C., the National Institutes of Health, the Bureau of Health Manpower, and the Center for Health Services Research and Development and should include economists and other social scientists. The essential role of consumer groups in such a pooling of interests should not be underestimated. The experience in psychiatry is a case in point. Merely increasing the numbers of physicians will not necessarily solve the problem of shortages related to geographical distribution (urban now in addition to rural), nor those in particular medical faculties (radiology, anesthesiology, pathology, urology, orthopedics, neurosurgery), and fields of practice (radiology, anesthesiology, pathology, psychiatry, pediatrics, obstetrics, physical medicine, urology), as well as the field of medical administration generally. I believe we are approaching the end of a great cycle in American medicine which began with the Flexner Report (1910) 29 and has seen an incredibly successful and beneficial expansion of science and technology in the life of the doctor, his institutions, and his patients. We are beginning a new cycle which will see us pay equal attention to the social problems of medicine—those within the profession and those within the community. Some would ask, are we the solution or the problem? Our successes in utilizing our magnificent body of knowledge will be no less demanding, no less rewarding, and no less exciting than its acquisition has been over the past fifty years. I believe a new Flexnerian revolution has already begun which will involve us all as we struggle to reach a system closer to Utopia and farther from the destructive polarization of the Ocean Hill-Brownsville School District in New York City.

Notes

Notes

Problems in Social Control 1. Washington Science Trends, 23 (February 2-9, 1970), 100. 2. Irene Taviss, "Introduction," Implications of Biomedical Technology, Research Review No. 1 (Cambridge, Mass.: Harvard University Program on Technology and Society, Fall 1968), 2. 3. John R. Piatt, "Diversity," Science, 154 (December 2, 1966), 1133. 4. Ibid. 5. Ibid. 6. See Alvin Weinberg, "Prospects for Big Biology," in Research in the Service of Man: Biomedical Knowledge, Development, and Use. A conference sponsored by the Subcommittee on Government Research, Committee on Government Operations, United States Senate, October 24-27, 1966 (Washington, D.C.: U.S. Government Printing Office, 1967), pp. 3 2 ^ 3 . 7. Ibid., p. 38. 8. Harvey Brooks, "The Federal Establishment for Science and Technology: Contribution to New National Goals," Research in the Service of Man: Biomedical Knowledge, Development, and Use, p. 62. 9. Elizabeth B. Drew, "The Health Syndicate: Washington's Noble Conspirators," The Atlantic Monthly, 22 (December 1967), 7 5 82.

10. Senator Walter Mondale, Introduction of Joint Resolution to Establish a Committee on Health Science and Society, Congressional Record, 114, no. 19, February 8, 1968. 11. Harold M. Schmeck, Jr., "Spiraling Medical Costs Reflect Tangle of Conflicting Problems," New York Times, April 28, 1968. 12. David Sanders and Jesse Dukeminier, Jr., "Medical Advance and Legal Lag: Hemodialysis and Kidney Transplantation," UCLA Law Review, 15 (February 1968), 357-419. 13. See Ibid, for evidence that the overwhelmingly suburban middle-class committee members do define social worth in this way. 14. See Roger M. Battistella and Richard McK. F. Southby, "Crisis in American Medicine," The Lancet, 1 (March 16, 1968), 581-586. 211

212

Notes to Pages 13-24

15. See the paper by Mark Field in this volume for a discussion of this problem. 16. See the paper by John Knowles in this volume for a discussion of this problem. 17. Bernard Barber, "Experiments with Humans," The Public Interest, 6 (Winter 1967), 101. 18. See for example M. H. Pappworth, Human Guinea Pigs: Experimentation on Man (London: Routledge & Kegan Paul, 1967). 19. See for example Louis Lasagna, "The Clinical Pharmacologist as a Servant of Society," The Canadian Medical Association Journal, 97 (July 15, 1967), 109-113, and his essay in this volume. 20. See the paper by Louis Lasagna in this volume for a discussion of these difficulties. 21. Wolf Wolfensberger, "Ethical Issues in Research with Human Subjects," Science, 155 (January 6, 1967), 47-51. 22. Cited by Barber, "Experiments with Humans," p. 97. 23. Ibid. 24. Henry K. Beecher, "Ethics and Clinical Research," New England Journal of Medicine, 274 (June 16, 1966), 1354-1360. 25. See his paper in this volume. 26. Barber, "Experiments with Humans," p. 93. 27. See M. H. Pappworth, Human Guinea Pigs. 28. See Paul A. Freund, "Is the Law Ready for Human Experimentation?" American Psychologist, 22 (May 1967), 394-399. 29. Taviss, "Introduction," p. 6. 30. Renée C. Fox, "A Sociological Perspective on Organ Transplantation and Hemodialysis," New Dimensions in Legal and Ethical Concepts for Human Research, Annals of the New York Academy of Sciences, 169, 2 (January 1970), 410-411. 31. Board on Medicine, National Academy of Sciences, "Cardiac Transplantation in Man," NAS-NRC-NAE News Report, 18 (March 1968), 2. 32. Ibid., p. 3. 33. See Judith P. Swazey and Renée C. Fox, "The Clinical Moratorium: A Case Study of Mitral Valve Surgery," in Paul A. Freund, ed., Experimentation with Human Subjects (New York:' George Braziller, 1970), pp. 315-357. 34. Fox, "A Sociological Perspective," p. 411. 35. Swazey and Fox, "The Clinical Moratorium," p. 339. 36. Taviss, "Introduction," p. 7. 37. "A Definition of Irreversible Coma. Report of the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death," Journal of the American Medical Association, 205 (1968), 337-340. 38. See Joseph E. Murray, "Organ Transplantation: The Practical

Notes to Pages 24-34

Possibilities," in Gordon Wolstenholme and Maeve O'Connor, eds., Ciba Foundation Symposium, Ethics in Medical Progress, with Special Reference to Transplantation (Boston: Little, Brown, 1966), pp. 54-77. 39. See Science News, 93 (March 2, 1968), 220. 40. Donald Longmore, "Implants or Transplants?" Science Journal, 4 (February 1968), 83. 41. New York Times, November 23, 1969. 42. "Genes and Consciences," The Economist, 233 (November 29, 1969), 87. 43. See Robert Reinhold, "The Gene: Isolated for Good or Evil?," New York Times, November 30, 1969. 44. New York Times, November 23, 1969. 45. Edward L. Tatum, "The Possibility of Manipulating Genetic Change," in John D. Roslansky, ed., Genetics and the Future of Man (New York: Appleton-Century-Crofts, 1966), p. 60. 46. Ibid., pp. 55-58. 47. Joshua Lederberg, "Experimental Genetics and Human Evolution," Bulletin of the Atomic Scientists, 22 (October 1966), 9. 48. Ibid., p. 5. 49. H. J. Mjuller, "What Genetic Course Will Man Steer?," Bulletin of the Atomic Scientists, 24 (March 1968), 8. 50. Paul Ramsey, "Moral and Religious Implications of Genetic Control," in Roslansky, ed., Genetics and the Future of Man, p. 111. 51. Theodosius Dobzhansky, "Changing Man," Science, 155 (January 27, 1967), 411—412. 52. Müller, "What Genetic Course Will Man Steer?," p. 10. 53. Dobzhansky, "Changing Man," p. 413. 54. Lederberg, "Experimental Genetics and Human Evolution," p. 10. 55. Kingsley Davis, "Sociological Aspects of Genetic Control," in Roslansky, ed., Genetics and the Future of Man, p. 177. 56. Ibid., pp. 190 and 195. 57. Miriam Moore-Robinson, *'. . . And Puppy Dogs' Tails," New Scientist, 44 (November 13, 1969), 351. 58. Ibid. 59. Ibid. 60. Ramsey, "Moral and Religious Implications," p. 111. 61. Garrett Hardin, "The Tragedy of the Commons," Science, 162 (December 13, 1968), 1243-1248. 62. See Perry London, Behavior Control (New York: Harper & Row, 1969). For a more extensive discussion of the types of behavior control and their social implications see the summary of the Harvard conference in this volume. 63. José M. R. Delgado, Evolution of Physical Control of the

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Notes to Pages 35-49

Brain, James Arthur Lecture on the Evolution of the Human Brain (New York: The American Museum of Natural History, 1965), pp. 46, 49-50. 64. For discussion of Ulrich's views and the reactions to them see the behavior control paper in this volume. 65. B. F. Skinner, "The Design of Cultures," in Roger Ulrich, Thomas Stachnik, and John Mabry, eds., Control of Human Behavior (Glenview, 111.: Scott, Foresman and Company, 1966), p. 335. 66. Ibid., p. 338. 67. London, Behavior Control, pp. 104-105. 68. Ibid., p. 178. 69. Ibid., p. 165. 70. Ibid., p. 208. 71. For a discussion of the issues surrounding the PKU case see the paper by Samuel Bessman and Judith Swazey in this volume. 72. Mondale, "Introduction of Joint Resolution," Congressional Record, February 8, 1968. Phenylketonuria The interest of the Research Group on Biomedical Sciences in phenylketonuria began with a short paper, "Legislation and Genetics," by I. Herbert Scheinberg, professor of medicine at Albert Einstein College of Medicine and chairman of the National Genetic Alert Program. This paper reflects in many ways the scientific and social concerns of Dr. Scheinberg, and the authors are greatly in his debt. As part of the work of the research group, Dr. Swazey prepared a detailed analysis of the disease and the laws concerning it, which led to the decision to convene an interdisciplinary conference on the diagnostic and therapeutic state of the art on PKU and to consider the medical and social issues engendered by the legislative actions on PKU. Dr. Bessman prepared a position paper for that conference. The present paper draws heavily on the conference discussion and on the insights of the discussants, whether cited specifically or not. The conference, held on May 19, 1968, in Cambridge, Massachusetts, was chaired by Dr. Seymour Kety. Discussants were: V. Elving Anderson, a geneticist; Dr. Bessman; Joseph Cooper, a political scientist; Geoffrey Edsall, an immunologist and public health official; Mark G. Field, a sociologist; Renée Fuller, a psychologist; Park S. Gerald, a geneticist; Charles Hampden-Turner, a social psychologist; Dale E. Harro, a public health official; W. Eugene Knox, a biochemist; Louis Lasagna, a pharmacologist; Harvey L. Levy, a neurologist; Robert A. MacCready, a microbiologist;

Notes to Pages 5 2 - 5 4

Stanley Joel Reiser, a physician and historian of science; Sanford Jay Rosen, a professor of law; Dr. Scheinberg; and Dr. Swazey. 1. Frank P. Grad, Public Health Law Manual (New York: American Public Health Association, 1965), p. 5. 2. W. Eugene Knox, "An Evaluation of the Treatment of Phenylketonuria with Diets Low in Phenylalanine," Pediatrics, 26 (1960), 1-11.

The Children's Bureau has organized and is now supporting the first long-term cooperative study program on PKU which may be expected to yield some definitive answers. It involves more than twenty centers in seventeen states and will cover more than half of the cases of PKU in children born in the United States over a period of more than five years. 3. Joseph Cooper, "Creative Pluralism, Medical Ombudsman," Research in the Service of Man, hearings before the Subcommittee on Government Research of the Senate Committee on Government Operations, 90th Congress, 1967, pp. 46-66. 4. Harvard University Program on Technology and Society, PKU Conference, transcript, p. 32. The Children's Bureau has provided us with a statement on these assertions, dated December 16, 1968. After a brief recapitulation, the Bureau states: "In formulating a judgment on the Bureau's action and involvement in this matter, it might be well to keep the following points in mind: (1) The Children's Bureau is not a recent newcomer to the Federal establishment that needs to 'carve out a niche.' This agency was established in 1912 with a broad mandate 'to investigate and report upon all matters pertaining to the welfare of children and child life among all classes of our people.' Both we and Congress by their continuation of this agency apparently feel that we have been fulfilling this mandate . . ." "(2) Our interest in PKU stems from our concern about the conditions facing children with special problems and the need not only to provide leadership in preventing, but also in alleviating, the problems and the circumstances under which these children live." "(3) The problems of mentally retarded children have been one of the concerns of the Children's Bureau from the beginning. Since 1956, Congress has earmarked Children's Bureau funds which can be used by the States only for prevention and treatment programs relating to the problem of mental retardation." "(4) The need for the Children's Bureau to specifically explore and provide some leadership in the area of PKU was first raised by a Bureau advisory committee in 1957. This Committee at its meeting in September of 1958, reviewed what was known about various methods of early detection and treatment of this condition and reviewed beginning programs in seven States. Specific recommenda-

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tions were made to the Bureau, including use of earmarked funds for the support of screening efforts, laboratory facilities and dietary treatment. The Bureau accepted these recommendations and proceeded to implement them in the following years. Other constituent agencies of HEW were at this time also supporting some specific basic research projects relating to inborn errors of metabolism." "(5) Between 1958 and 1962 the Bureau supported a variety of screening and management programs (chiefly screening of well-baby populations with the 'wet diaper' test and high-risk groups such as retarded children in institutions and children seen in seizure clinics, to detect families with the condition). This experience essentially demonstrated that urine screening was an inefficient method and that broad screening could not be achieved by relying on well-baby populations that could be reached. During this period also, evidence was accumulated which pointed to the potential efficiency of utilizing blood from newborns for an effective screening program." "(6) From early 1962 through December of 1963, the Bureau supported an effort on the part of 29 States to field-test a method of screening newborn infants. Over 400,000 infants were screened, 39 cases of PKU were confirmed, and the particular technique was judged to be practicable, efficient and effective. It was recommended to the States as an available, practicable approach that could be used in developing statewide screening programs." "(7) As practicable screening methods and confirmatory, diagnostic, and management facilities have become available, the Bureau has encouraged States to set up screening programs, but we have never suggested that these screening programs be developed through State legislation. How a State can best achieve screening of all children in any area can be determined only by a State. The Bureau has, in its effort to encourage States to develop screening, facilitated the exchange of information and ideas among States regarding newer screening and confirmatory techniques, data on treatment results, etc. Because of the popular interest in the subject, compilations of laws have been issued for informational purposes. In its work on PKU, as in its other work in mental retardation, the Bureau maintains liaison and furnishes this same type of information to groups such as the National Association for Retarded Children, the American Academy of Pediatrics, the American Association on Mental Deficiency, the State and Territorial Health Officers Association, etc. We do not consider this as establishing a 'consortium' with any one of these groups for the purpose of promoting legislation." "(8) The Children's Bureau plans to continue, as in the past, to support efforts to help mentally retarded and other handicapped children, and, as scientific knowledge becomes available, to work to-

Notes to Pages 55-66

ward prevention of conditions leading to retardation and handicapping." Points 4, 5, 6, and 7 demonstrate quite clearly the bureau's commitment to the therapeutic model of P K U which led to the movement to encourage passage of P K U screening laws. 5. Public pressure accounts for only part of the increased interest in mass screening of the early 1960's. The displacement of the "wetdiaper" tests for P K U by the Guthrie blood test was another important factor. Both tests are economical and suitable for large-scale use, but the Guthrie test is also considerably more reliable. 6. Robert A. MacCready and M. G. Hussey, "Newborn Phenylketonuria Detection Program in Massachusetts," American Journal of Public Health, 54 (1964), 2075-2081. 7. Some researchers make a direct assay of liver phenylalanine hydroxylase by needle biopsy, but this operation can only be undertaken with the greatest care. It is in no way suitable for mass screening. Without the special attention and controls of the experimental situation, the large-scale application of needle biopsy of the liver could cause much more damage than any cases of P K U that might otherwise be missed. The primary advantage of this technique is that researchers can use it to differentiate true P K U from other instances of high blood phenylalanine level in difficult cases. 8. It is for this reason that the PKU laws are likely to survive any court test. 9. PKU Conference, transcript, p. 32. 10. Oklahoma, as noted, does not require neonatal testing, but allows it if physician or parents request it. Given the broad language quoted here, the law is unobjectionable, constituting little more than the opinion of the legislature that parents and physicians should be concerned about PKU and other metabolic disorders. 11. These four areas were delineated by Seymour Kety as chairman of the P K U conference. They have been slightly adapted for use here. 12. Some patients suffer severe retardation at the 5 mg./lOO cc. blood phenylalanine level; others appear relatively unaffected at much higher levels. Thus, no particular level is considered diagnostic of P K U . Most diagnoses are made on the basis of a blood level set arbitrarily by the hospital or laboratory making the test. Often this level is set at 20 mg./lOO cc., which finesses at least part of the problem with phenylpyruvic acid. 13. For discussion of the flaws of urinary analysis, see W. R. Centerwall, R. F. Chinnock, and A. Pusannt, "Phenylketonuria: Screening Programs and Testing Methods," American Journal of Public Health, 50 (1960), 1667-1677; Arnold R. Kaplan, "Phenylketonuria: A Review," Eugenics Quarterly, 9 (1962), 151-160; and

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Notes to Pages 6 6 - 7 0

David S. Kleinman, "Phenylketonuria: A Review of Some Deficits in Our Information," Pediatrics, 33 (1964), 123-134. 14. Robert Guthrie and S. Whitney, Phenylketonuria: Detection in the Newborn Infant as a Routine Hospital Procedure, Children's Bureau Publication no. 419 (State University of New York at Buffalo, 1964). 15. Robert Guthrie and Ada Susi, "A Simple Phenylalanine Method for Detecting Phenylketonuria in Large Populations of Newborn Infants," Pediatrics, 32 (1963), 338-343. 16. PKU Conference, Transcript, pp. 7-8. 17. W. Eugene Knox, "Phenylketonuria," in John B. Stanbury, J. B. Wyngaarden, and D. S. Fredrickson, eds., The Metabolic Basis of Inherited Disease, 2nd ed. (New York: McGraw-Hill, 1966), ch. 11; "Legislation and Advances in Knowledge—Acceleration or Inhibition?," Journal of Pediatrics, 70 (1967), 150-154; B. S. Sutherland, H. K. Berry, and H. C. Shirkey, "A Syndrome of Phenylketonuria with Normal Intelligence and Behavior Disturbances," Journal of Pediatrics, 57 (1960), 521-525. 18. Knox, "Phenylketonuria," p. 263. 19. The high phenylalanine count can lead to a diagnosis of PKU, however. Withholding an essential amino acid from these children is an extremely dangerous procedure of no possible benefit. 20. Kleinman, "Phenylketonuria"; S. W. Wright and G. Tarjan, "Phenylketonuria," American Journal of Diseases of Children, 93 (1957), 405-419. 21. Charles R. Scriver, "Diagnosis and Treatment: Interpreting the Positive Screening Test in the Newborn Infant," Pediatrics, 39 (1967), 764-768. 22. Margaret E. O'Flynn, et al., "Hyperphenylalanemia without Phenylketonuria," American Journal of Diseases of Children, 113 (1967), 22-30. 23. P. W. Berman, H. A. Waisman, and F. K. Graham, "Intelligence in Treated Phenylketonurie Children: A Development Study," Child Development, 37 (1966), 731-747; A. A. Baumeister, "The Effects of Dietary Control on Intelligence in Phenylketonuria," American Journal of Mental Deficiency, 71 (1967), 840-847. 24. John I. Langdell, "Phenylketonuria: Eight Years Evaluation of Treatment," Archives of General Psychiatry, 12 (1965), 363-367. 25. Helen K. Berry and S. Wright, "Proceedings of Conference on Treatment of Phenylketonuria" (Cincinnati, Ohio, January 7, 1966), Journal of Pediatrics, 70 (1967), 142-147. 26. David Y. Y. Hsia, "Phenylketonuria: A Study of Human Biochemical Genetics," Pediatrics, 38 (1966), 173-184.

N o t e s t o Pages 7 0 - 7 8

27. Gerald Solomons, et al., "Evaluation of the Effects of Terminating the Diet in Phenylketonuria," Journal of Pediatrics, 60 ( 1 9 6 6 ) , 592-602. 28. Baumeister, "The Effects of Dietary Control on Intelligience in Phenylketonuria," pp. 840-847. 29. Herbert G. Birch and Jack Tizard, "The Dietary Treatment of Phenylketonuria: Not Proven?" Developmental Medicine and Child Neurology, 9 ( 1 9 6 7 ) , 9 - 1 2 . 30. P K U Conference, Transcript, p. 9. 31. Personal communication, April 1968. 32. "New Child Health Legislative Bills Proposed-—Academy Subcommittee Issues Guidelines," Bulletin of Pediatric Practice, 1 (April 1967), 1-2. I. Herbert Scheinberg has added this comment to the statement quoted: "And, one might add, such funds should also go to educate physicians, legislators, and the public about the results of such research and the need for caution in applying them clinically. The education must be provided not only by foundations and associations devoted to one disease or area of disorders, but also by institutions with the broadest interest in providing balanced educations, including the gloomy as well as the bright facts. Physicians need this information for their profession and should want it. Legislators apparently also need it for their profession but the motivations to sponsor public health legislation do not always create an urge to acquire the necessary scientific and clinical background. One legislator, just prior to filing a bill similar to the P K U legislation, breezed through my laboratory with a cameraman and public relations assistant and would not even sit down. The public needs and seems to want the information if it is to evaluate its legislators' acts intelligently." "Legislation and Genetics," Paper prepared for the Research G r o u p on Biomedical Sciences, Harvard University Program on Technology and Society, 1968. 33. P K U Conference, Transcript, pp. 22-23. 34. See, for example, Jerry Bishop and Douglas M. Davis, New Horizons in Medicine (Princeton, N.J.: Dow Jones Books, 1966), ch. 3; and John F. Henahan, Men and Molecules (New York: Crown, 1966), pp. 32-41. Physician, Patients, and Society 1. Werner W. Jaeger, Paideia: The Ideals of Greek Culture, Gilbert Highet III, trans. (New York: Oxford University Press, 1944). 2. Jacob Bronowski, Science and Human Values, rev. ed. (New York: Harper and Row, 1965). 3. This is a modification of the division used by V. J. Bourke for

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moral discourse in general. Vernon J. Bourke, Metaethics and Thomism, Etienne Gilson Tribute (Milwaukee: Marquette University Press, 1959), pp. 20-22. 4. René Dubos, "Humanistic Biology," American Scholar, 34, no. 2 (1965), 179. 5. Edmund D. Pellegrino, "The Ethical Implications of Changing Patterns of Medical Care," North Carolina Medical Journal, 26, no. 2 (1965), 73-76. 6. Edmund D. Pellegrino, "The Necessity, Promise and Dangers of Human Experimentation," in Experiments with Man, Hans-Ruedi Weber, ed. World Council of Churches Studies, No. 6 (New York, Geneva: World Council of Churches and Friendship Press, 1969), 31-56. 7. A. Bradford Hill, "Medical Ethics and Controlled Trials," British Medical Journal, 5337 (April 20, 1963), 1043-1049. 8. Wolf Wolfensberger, "Ethical Issues in Research with Human Subjects," Science, 155 (1967), 49. 9. Otto E. Guttentag, "The Physician's Point of View," Science, 117 (1953), 207. 10. Pellegrino, "The Necessity, Promise and Dangers of Human Experimentation," pp. 31-56. 11. H. Bentley Glass, What Man Can Be. Address, Thomas Alva Edison Foundation, 1967 International Edison Birthday Celebration, Science Youth Day, Dearborn, Mich. (Detroit: Thomas Alva Edison Foundation, 1967). 12. Alfred North Whitehead, Modes of Thought (New York: Capricorn Books, 1958), p. 233. 13. Donald Ensloe Konoid, A History of American Medical Ethics, 1847-1912 (Madison, Wis.: State Historical Society of Wisconsin, 1962). 14. Raziel Abelson, Ethics and Metaethics (New York: St. Martins Press, 1963), pp. 183ff. 15. Conrad Hal Waddington, The Ethical Animal (London: Allen and Unwin, 1960). Thomas H. Huxley, Touchstone for Ethics (New York: Harper, 1947). 16. Gordon E. W. Wolstenholme, ed., Man and His Future (Boston: Little, Brown, 1963). 17. Abelson, Ethics and Metaethics, pp. 300ff. Some Ethical Problems in Clinical Investigation 1. While the FDA rules apply only to investigational drugs, the issue of consent is relevant to all clinical investigation because of both legal implications and current National Institutes of Health

Notes to Pages 101-131

policies on human experimentation which affect the conduct of grantees. 2. It is surrealistic to read, in an editorial in a leading American medical journal, the statement: "How much more important it is to have informed consent, when the potential risk is unknown!" 3. Dinnerstein et al., in an interesting paper, have reviewed some of the literature on the differential effects of drugs in different experimental settings. Their desire to study the effects of drugs "in a completely concealed form, with the subject not even knowing when he has been drugged" and under situations with different "cover stories" would be out of the question if rigid application of this principle of "total disclosure" were made. Albert J. Dinnerstein, Milton Lowenthal, and Bernard Blitz, "The Interaction of Drugs with Placebos in the Control of Pain and Anxiety," Perspectives in Biology and Medicine, 10 ( 1 9 6 6 ) , 103-117. 4. It is important to remember that there is no necessary relation between a consent procedure that satisfies the law and one that safeguards the patient. 5. John Dewey once warned that part of the public protest against experimentation is related to old misunderstandings and dreads about science. He was talking about animal experimentation, but it may be useful to remember his warning to be "on the alert against every revival of the spirit of animosity to discovery and to the application of the fruits of discovery." One does not need to accuse everyone who is concerned about the ethics of clinical investigation of being antiscientific to believe that at least some of the hue and cry can be traced to antiscientism. 6. Claude Bernard, An Introduction to the Study of Experimental Medicine (New York: Dover Publications, 1957), p. 101. 7. Ibid., p. 102. 8. J. Bronowski, Science and Human Values (London: Hutchinson & Co., 1961), p. 78. New Technologies and the Practice of Medicine This paper was originally presented at a conference on "New Technologies and the Practice of Medicine" sponsored by the Harvard University Program on Technology and Society, January 28, 1967. 1. Ad Hoc Committee on the Triple Revolution Report, "The Triple Revolution" (Santa Barbara, Calif., 1964). 2. U.S. Department of Health, Education, and Welfare, Life and Death: Selected Statistics of the Nation's Health and People (Washington, D.C.: National Center for Health Statistics, 1965) ; President's

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Notes to Pages 134-140

Commission on Heart Disease, Cancer, and Stroke, Conquering Heart Disease, Cancer, and Stroke (Washington, D.C.: U.S. Government Printing Office, 1964). 3. Since the presentation of this paper, evidence has been published further strengthening the association between use of the pill and thromboembolic disease; the risk, while apparently greater than that associated with other forms of contraception, appears to be less than the risk of complications during pregnancy itself. 4. U.S. Information Service, Population Reference Bureau, World Population Data Sheet (Washington, D.C., December 1966). 5. United Nations, Demographic Yearbook (New York, 1966), pp. 182-183. 6. "Leftist Brazilian Doctors Open a Drive against Birth Control," New York Times, December 5, 1966. 7. Joseph R. DePalma, "Chemotherapy of Protozoan Infections I: Malaria," in J. R. DePalma, ed., Drill's Pharmacology in Medicine, 3d ed. (New York: McGraw-Hill, 1965), p. 1380. 8. M. Pinotti, "The Addition of Antimalarial Drugs to Cooking Salt," Triangle, 4 (October 1959), 10-13. 9. L. C. Deasy, "Socio-economic Status and Participation in the Poliomyelitis Vaccine Trial," American Sociological Review, 21 (1956), 185-191. 10. U.S. Department of Health, Education, and Welfare, Communicable Disease Center, Epidemiology Branch, Statistics Section, "Poliomyelitis Epidemic: Rhode Island, 1960" (Washington, D.C.: U.S. Government Printing Office, undated). In addition, it began to be noted in 1970 that epidemics of measles had shifted to low income areas. 11. John M. Neff, et al., "Complications of Smallpox Vaccination," New England Journal of Medicine, 276 (January 1967), 125132. 12. U.S. Department of Health, Education, and Welfare, Communicable Disease Center, Epidemiology Branch, CDC Status Reports, Donald A. Henderson and Leo Morris, compilers (Washington, D.C., 1965). 13. U.S. Department of Health, Education, and Welfare, Communicable Disease Center, Morbidity and Mortality, no. 47 (November 26, 1966), 405. A more recent evaluation of this problem was published by J. Michael Lane and J. D. Millar, "Routine Childhood Vaccination Against Smallpox Reconsidered," New England Journal of Medicine, 281 (November 27, 1969), 1220-1224. 14. Sol R. Rosenthal, et al., "BCG Vaccination and Tuberculosis in Students of Nursing," American Journal of Nursing, 63 (November 1963), 88-93. 15. New York Tuberculosis and Health Association, "BCG Vac-

Notes to Pages 140-149

cination in New York City: February 18-19, 1964," Conference Report of the Advisory Committee. 16. E. L. Trudeau, An Autobiography (New York: Doubleday, 1916), quoted in Selman A. Waksman, The Conquest of Tuberculosis (Berkeley, Calif.: University of California Press, 1964), p. 241. 17. "Streamlining Health Examinations," Journal of the American Medical Association, 137 (May 15, 1948), 244. 18. Morris F. Collen, "Periodic Health Examinations Using an Automated Multitest Laboratory," Journal of the American Medical Association, 195 (March 7, 1966), 830-833. 19. The issues involved in multiphasic screening have recently been reviewed by R. M. Thorner, "Whither Multiphasic Screening?," New England Journal of Medicine, 280 ( 1 9 6 9 ) , 1037-1042. 20. Robert Huntley, personal communication, 1967. 21. E. L. Koos, The Health of Regionville (New York: Columbia University Press, 1954). 22. U.S. Department of Health, Education, and Welfare, Socioeconomic Distribution of Cervical Cancer, Public Health Monograph no. 73 (Washington, D.C.: U.S. Government Printing Office, 1965). 23. Gordon S. Siegel, "An American Dilemma—The Periodic Health Examination," Archives of Environmental Health, 13 (September 1966), 292-295. 24. For a recent discussion of some of these problems, see Louis Lasagna, "The Pharmaceutical Revolution: Its Impact on Science and Society," Science, 166 (December 5, 1969), 1227-1233. 25. A study published since this paper was written suggests that the poor may actually be charged higher prices than middle- or upper-class consumers for the same prescription. G. E. Hastings and R. Kunnes, "Predicting Prescription Prices," New England Journal of Medicine, 277 (November 21, 1967), 625-628. 26. "M.D.'s Urged to Survey Drug Costs," AMA News, January 9, 1967. 27. Certain of these issues are intensified in the case of human heart transplantation such as the definition of death in the donor (since the heart must be removed as soon as possible after death), the vast use of resources for the treatment of a few individuals while many with other kinds of relatively simple or preventable disabilities go untreated, and the introduction in humans of a technique which many observers believe is still in the unperfected experimental stage (particularly with regard to prevention of immunologic "rejection" of the transplant by the recipient). 28. Roy Penchansky and G. Rosenthal, "Productivity, Price and Income Behavior in the Physicians' Service Market," Medical Care, 3, no. 4 (October/December 1965), 240-244. 29. Edward Hager, personal communication, 1967.

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Notes to Pages 149-160

30. "Three Kidney Patients Die as Machinery Fails," Medical World News, 8, no. 5 (February 3, 1967), 23. 31. A study of the problems and potentialities of such a system in the Boston Metropolitan Area was conducted by the Joint Center for Urban Studies of the Massachusetts Institute of Technology and Harvard University. D. P. Moynihan, V. W. Sidel, and J. M. Beshers, "Problems and Perspectives in the Design of a Community Health Information System," 1969 (mimeo.). 32. U.S. Congress, House Committee on Government Operations, The Computer and Invasion of Privacy: Hearings, 89th Congress, 1966. 33. George Silver, Family Medical Care: A Report on the Family Health Maintenance Demonstration (Cambridge, Mass.: Harvard University Press, 1963). 34. A number of recent developments have occurred in this area. Some of these are summarized in Education in the Health-Related Professions, Annals of the New York Academy of Sciences, 166 (December 31, 1969), 821-1059. A comparable role in the Soviet Union was described in V. W. Sidel, "Feldshers and 'Feldsherism,'" New England Journal of Medicine, 278 (1968), 934-940, 981-992. 35. Odin W. Anderson and Monroe Lerner, Measuring Health Levels in the U.S., 1900-1958. Research Series 11 (Chicago: Health Information Foundation, 1960), 27. 36. Penchansky and Rosenthal, "Productivity, Price and Income Behavior," pp. 240-244.

The Health Care System of Industrial Society This paper is based on a larger monograph entitled Technology, Medicine and Society: Effectiveness, Differentiation and Depersonalization, written while the author was a member of the Research Group on Biomedical Sciences, Program on Technology and Society, Harvard University. This work was also partly supported by PHS Research Grants CH 00406, Division of Community Health Services, and HS 00272, National Center for Health Services Research and Development. The paper was first presented at the First International Conference on Social Science and Medicine, Aberdeen, Scotland, September 4-6, 1968. Mrs. Judith H. Koivumaki provided the essential editorial touches to bring the manuscript to acceptable standards for publication. 1. U. R. Fuchs, "Basic Factors Influencing the Costs of Medical Care," in Report of the National Conference on Medical Costs (Washington, D.C.: U.S. Government Printing Office, 1968), p. 18.

Notes to Pages 161-175

2. Robin F. Badgley and Samuel Wolfe, Doctors' Strike (Toronto: Macmillan, 1967), p. 135. 3. R. M. Magraw, "The Purchase of Health Care—Payments, Controls, and Quality," in Report of the National Conference on Medical Costs (Washington, D.C.: U.S. Government Printing Office, 1968), p. 290. 4. W. L. Kissick, "Foreword" to "Dimensions and Determinants of Health Policy," The Milbank Memorial Fund Quarterly, 46 (January 1968), 7. 5. Fuchs, "Basic Factors Influencing the Costs of Medical Care," p. 17. 6. R. M. Magraw, Ferment in Medicine (Philadelphia: W. G. Saunders, 1966), pp. 145-149. 7. U.S. Public Health Service, Chart Book on Health Status and Health Manpower (Washington, D.C., 1961), pp. 28-30. 8. D. D. Rutstein, The Coming Revolution in Medicine (Cambridge, Mass.: MIT Press, 1967), p. 55. Of the somewhat over 1.6 million people employed in the health service industries in 1950, about 500,000 were in occupations nonspecific to the health field. These occupations included about 70,000 stenographers, typists, and secretaries; 75,000 other "clerical and kindred" workers; 12,000 mechanics and repairmen; 18,000 laundry and dry cleaning operatives; 16,000 janitors and sextons; 30,000 cooks; almost 70,000 other service workers, as well as many persons in other occupations. M. Lerner and O. Anderson, Health Progress in the United States, 1900-1960 (Chicago: University of Chicago Press, 1963), 2. 9. Lerner and Anderson, Health Progress in the United States, p. 221. 10. New York Times, October 17, 1967, p. 51; March 30, 1966, p. 31. 11. Magraw, Ferment in Medicine, p. 166. 12. Badgley and Wolfe, Doctors' Strike, p. 134. 13. Quoted in Time, March 1, 1968, p. 36. 14. Lerner and Anderson, Health Progress in the United States, p. 219. 15. Martin Cherkasky and Maya Pines, "Tomorrow's Hospitals," in M. K. Sanders, ed., The Crisis in American Medicine (New York: Harper, 1961), p. 116. 16. W. H. Stewart, "The Challenge to the Nation," in Report of the National Conference on Medical Costs (Washington, D.C. : U.S. Government Printing Office, 1968), p. 158. 17. Rutstein, The Coming Revolution in Medicine, p. 132. 18. Milton Helpern, "Inaugural Address to the Medical County of New York," New York Times, Oct. 6, 1962.

225

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Notes to Pages 176-187

19. Badgley and Wolfe, Doctors' Strike, p. 134. 20. R. T. Jensen, "The Primary Medical Care Worker in Developing Countries," Medical Care, 5 (Nov.-Dec. 1967), 382. 21. This is reflected in the following familiar story: A caller phoned the hospital asking the condition of a Mrs. Brown in room 550. After calling the correct hospital floor and getting a report from the nurse the hospital operator said, "Mrs. Brown is progressing quite well. Her behavior is normal. As a matter of fact, she will be discharged in a few days. May I know who is calling?" The caller answered: "This is Mrs. Brown in room 550 whose doctor never tells her anything." "Smiling Psychiatry," American Journal of Psychotherapy, 22 (October 1968), 736. Notes on Medical Manpower The research for this paper was done in 1967-68 while the author was a Research Associate with the Biomedical Sciences Group, Harvard University Program on Technology and Society. A version of the paper was presented at the 79th Annual Meeting of the Association of American Medical Colleges, Houston, Texas, November 2, 1968, and was published in the Journal of Medical Education, February 1969. Many individuals were helpful in supplying the information summarized in this paper. 1. Report of the National Advisory Commission on Health Manpower (Washington, D.C.: U.S. Government Printing Office, 1967), I, 1-2. 2. D. L. Hiestand, "Research into Manpower for Health Service," Milbank Memorial Fund Quarterly, 44, no. 4, part 2 (1966), 148. 3. R. I. Lee and L. W. Jones, The Fundamentals of Good Medical Care (Chicago: University of Chicago Press, 1933), p. 115. 4. For example, Hiestand, "Research into Manpower for Health Service"; S. E. Harris, The Economics of American Medicine (New York: Macmillan, 1964); H. E. Klarman, The Economics of Health (New York: Columbia University Press, 1965); Report of the National Conference on Medical Costs (Washington, D.C.: U.S. Department of Health, Education and Welfare, June 1967); Irene Butter, "Health Manpower Research: A Survey," Inquiry, 4 (December 1967), 5-41; H. M. Somers and A. R. Somers, Doctors, Patients and Health Insurance (Washington, D.C.: the Brookings Institution, 1961); H. M. Somers and A. R. Somers, Medicare and the Hospitals (Washington, D.C.: the Brookings Institution, 1967). 5. Report of the National Advisory Commission on Health Manpower, II, 237-238.

N o t e s to Pages 1 8 7 - 2 0 1

6. Somers and Somers, Doctors, Patients and Health Insurance, p. 182. 7. Ibid., p. 48. 8. Butter, "Health Manpower Research," pp. 5 - 4 1 . 9. Report of the National Advisory Commission on Health Manpower, I, 87. 10. Manpower Resources in Hospitals (Chicago: American Hospital Association, 1966). 11. Hospital Tribune, July 15, 1968, p. 15. 12. Report to the President: Medical Care Prices (Washington, D.C.: U.S. Department of Health, Education and Welfare, February 1967), p. 25. 13. "Productivity Survey," Medical Economics, Sept. 30, 1968, pp. 63-154. 14. Report of the National Advisory Commission on Health Manpower, II, 576. 15. Alex Gerber, "The Surprising Truth about Groups," Medical Economics, May 15, 1967, pp. 219-228. 16. Report of the National Conference on Medical Costs, p. 204. 17. Rashi Fein, The Doctor Shortage: An Economic Diagnosis (Washington, D.C.: The Brookings Institution, 1967), pp. 60, 135. 18. D. A. Johnson and E. B. Hutchins, "Doctor or Dropout? A Study of Medical Student Attrition," Journal of Medical Education, 41 ( 1 9 6 6 ) , 1116. 19. Health Resources Statistics: Health Manpower, 1965, U.S. Public Health Service, Publication no. 1509 (Washington, D.C.: U.S. Government Printing Office, 1966), p. 100. 20. Report of the National Advisory Commission on Health Manpower, II, 235. 21. M. A. Morehead, et al., A Study of Quality of Hospital Care Secured by a Sample of Teamster Family Members in New York City (New Y o r k : Columbia University School of Public Health and Administrative Medicine, 1964); L. Rosenfeld, "Quality of Medical Care in Hospitals," American Journal of Public Health, 47 ( 1 9 6 7 ) , 856-865. 22. D. D. Rutstein, The Coming Revolution in Medicine (Cambridge, Mass.: M I T Press, 1967), pp. 9, 15, 16, 22, 23. 23. A. P. Sackett, M.D., Commissioner of Health and Hospitals, Boston, Mass., personal communication, May 1968. 24. L. J. Carter, "Newark: Negroes Demand and Get Voice in Medical School Plans." Science, 160 ( 1 9 6 8 ) , 290-292. 25. Ibid., p. 292. 26. Delivery of Health Services for the Poor (Washington, D.C.:

227

228

Notes to Pages 206-208

Office of the Secretary, U.S. Department of Health, Education and Welfare, December 1967). 27. The number increased to twenty in 1969 when the Advisory Board for Medical Specialties approved the application of the Academy of General Practice for a Board of Family Practice. 28. "Committee on Health Manpower Critique: Report on the Health Manpower Commission," JAMA, 203 (1968), 157-164. 29. Abraham Flexner, Medical Education in the United States and Canada, A Report to the Carnegie Foundation and the Advancement of Teaching, bulletin no. 4, Boston, 1910.

Index

Index

American Academy of Pediatrics, 72 American Board of Otolaryngology, 203 American College of Surgeons, 205 American Medical Association, 12, 141; on drug costs, 147; on health manpower, 206-207 American Psychiatric Association, 126 Anderson, Olin W., 167 Artificial insemination, 30-31 Artificial Kidney Center, 11 Badgley, Robin F., 174-175 Barber, Bernard, 16, 18 Barzun, Jacques, 127; on behavior control, 120, 121-122, 123 Baumeister, A. A., 69, 70 Beckwith, Dr. Jonathan, 27-28 Beecher, Henry, 19, 20, 24 Behavior control, 33-39, 111-128; compared with genetic control, 33-34; through electrical stimulation of brain, 111-114; conditioning, 114-117, 120-123; drugs, 118-119. See also Genetic control Berman, P. W., 69, 70 Bernard, Claude, 109-110 Berry, Helen K., 70 Birch, Herbert G., 70 Birth control, see Contraceptives Brain, investigation of, as related to behavior control, 111-114 Brave New World, 26, 117, 146 Bronowski, Jacob, 77, 93, 110 Brooks, Harvey, 8-9 Canadian Royal Commission Report, 157-158

Carcinoma, cervical, 141, 143 Cherkasky, Martin, 169 Children's Bureau (HEW), and PKU legislation, 54-55 Codes of ethics, 17-21, 90-91 Cole, Jonathan O., 127 Computers: application of, to medicine, 14-15, 150-151; effects of, on society, 151-152; effects of, on medical practice, 152-153 Conditioning, 34-36, 114-117, 120123 Contraceptives, 132-136; effects of, on society, 133-134; effects of, on medical practice, 134-136 Cooper, Joseph, 55, 57, 58 "Cultural lags," 4 Daddario, Emilio, 42 Davis, Kingsley, 31-32 Death: definition of, 23-24, 25; leading causes of, 131-132 Delgado, José M. R., 111-114; on behavior control, 34, 120-121, 122, 126-127 Delivery of Health Services to the Poor, 192 Dershowitz, Allen, 127; on behavior control, 122-123, 124, 125126, 127 Diabetes mellitus, 142 Diet, low-phenylalanine, 50-54, 61; and prevention of retardation, 68-71. See also Phenylalanine hydroxylase Diphtheria, 136 Disease: vaccines against, 136138; types of, 138-139; treatment of, 144-145 Dobzhansky, Theodosius, 30-31 Donation of body parts, 24-25 231

232

Index

Drew, Elizabeth, 9 Drugs: use of, in treatment of mentally ill, 36, 118-119; addiction to, 36, 124; use of, in human experimentation, 100-104; use of, in treatment of disease, 139, 140, 145-146; effects of, on society, 146-147; effects of, on medical practice, 147 Dubos, René, 93 Economist, The, on isolation of a gene, 27 Elderly, diseases of, and federal health budget, 9 Electrodes, use of, for diagnosis and treatment, 112-113 Ethical violations, in human experimentation, 19-20 Eugenics, 28-29; defined, 28 Euphenics, 28-29; defined, 28 Euthanasia, 25 Experimentation, human, 16-22, 83-88, 99-110; and "voluntary consent," 17-18; and "informed consent," 17-19, 100-110 passim; ethical violations in, 19-20; legislation for control of, 20-21, 109; patients and volunteers for, 99-100 Family doctor, see General practitioner Favell, Judith, 127 Federal government, expenditures of, for health research, 4-5, 6-7 Fein, Rashi, 183, 188, 189 Ferric chloride urine test, 64-66 Flexner Report, 208 F0lling, Ashbòrn, 64 Food and Drug Administration (FDA), 20, 145; on human experimentation, 100, 101 Fox, Renée C., 21, 22-23 Fuller, Renée, 70 Gallup poll, and donation of body parts, 24 Gene, isolation of a, 27-28

General practitioner, 4; decline of, 13, 165-166, 172-177; defined, 172. See also Physician Genetic control, 3, 25-34, 39; compared with behavior control, 33-34. See also Behavior control Genetic engineering, 28-29; defined, 28 Glass, H. Bentley, 93 Glaucoma, 141 Guthrie, Robert, 66; blood test of, 66 Guttentag, Otto, 87 Hardin, Garrett, 33 Harvard Medical School, 24, 45 Health care system, components of, 160-165 Health examinations, 141-144 Health Insurance Plan of Greater New York, 150 Heart, Cancer, and Stroke Act, 8 Heart transplants, see Transplantation, organ Hippocratic Oath, 3, 77 Hsia, David Y. Y„ 70 Huxley, Thomas H., 91 Illness, responses to, 158-160 Industry, contributions of, to health research, 4 Jensen, R. T., 175 Jewish Chronic Disease Hospital, ethical violation at, 20 Johnson, Lyndon B., and Medicare Program, 8 Jones, L. W., 183 Journal of the American Medical Association, 206 Kaiser-Permanente Health Foundation, 142, 150 Kennedy, Edward M., 58 Kennedy, Joseph P., Jr. Foundation, 54, 57 Kennedy-Prouty bill, 58, 63 Kent, Neil D., 114n

Index

Kidney: dialysis centers, 9; (artificial) machines, 10. See also Transplantation, organ Kissick, William, 160-161 Knox, W. Eugene, on PKU, 53, 67, 70-71 Konoid, Donald, 90

National Institutes of Health, 89, 20, 145 New York Times, on isolation of a gene, 27 1984, 26, 117 Nozick, Robert, 128 Nuremberg Code, 17-18, 19, 37

Lahey Clinic, 153 Langdell, John I., 70 Lasagna, Louis, 19-20, 84 Law of Effect, 114 Lederberg, Joshua, 29 Lee, R. I., 183 Legislation: proposed, concerning transplantation, 24; proposed, concerning genetic control, 32; relation of, to science, 40-42 Lerner, Monroe, 167 Ley, Herbert L., 71 Lofenalac, 71 London, Perry, 34, 37-38 LSD, 118

Pappworth, M. H., 20-21 Pavlov's dogs, 35 Phenylalanine hydroxylase, 50-54, 57, 61; detection of, 64-67; correlation between mental retardation and, 67-68. See also Diet, low-phenylalanine Phenylketonuria (PKU), 28, 6370; legislation concerning, 4041, 51-63, 71-76; defined, 49, 50 Phenylpyruvic acid, 64-67; test, 56 Physician: responsibility of, toward patient, 79-80; as member of society, 80-81; effects of institutionalization on, 81-83; as scientific investigator, 83-88; future role of, 89-90, 93-96, 182; compared with clinical investigator, 98-99; ethical conscience of, 108-110; as team member, 153-155; alienation of patient from, 172-177, 178; supply and demand, 183, 185-192. See also General practitioner Pines, Maya, 169 PKU, see Phenylketonuria Placebos, 102-103 Plato, 77 Piatt, John, 6-7 Poliomyelitis, 136, 137, 138 Population control, 33, 44, 134 Poverty, and health, 192-200 Prouty, Winston L., 58 Psychedelic therapy, 118-119

MacCready, Robert, 55 Magraw, R. M., 159-160, 165-166 Mase, Darrell J., 169 Mayo Clinic, 153 Medex, 13-14 Medicare Program, 5, 8 Mendelsohn, Everett I., on behavior control: 122, 125, 128 Mental retardation: and PKU, 4954 passim, 57; correlation between phenylalanine and, 67-68 Mesthene, Emmanuel G., 128; on behavior control, 121, 122, 123, 125-126, 127 Mondale, Walter, 42 Mortality rate, 157; infant, 9 Moss, John E., 63 Muller, H. J., 29-30 National Academy of Sciences, Board on Medicine, 22 National Association for Retarded Children, 54, 75-76

Quarton, Gardner, 123, 127, 128 Ramsey, Paul, 30, 33 Reiser, Stanley, 128

233

234

Index

Report of the National Advisory Committee on Health Manpower, 181, 183 Research, health, federal and industrial expenditures for, 4-5, 6-7 Revelle, Roger, 128 Rosen, Sanford Jay, 73-74 Rosenblith, Walter, 121, 128 Rutstein, D. D., 167 Sapolsky, Harvey, 128 Science, 196-197 Silver, Dr. George, 153 Skinner, B. F., 35, 36, 114 Smallpox, 136, 137 Solomons, Gerald, 70 Specialization (of medical roles), 165-169, 200-205 Sutherland, B. S„ 69 Swazey, Judith P., 22-23, 128 Tatum, Edward, 28-29 Thalidomide, 3, 145 Thorndike, E. L., 114 Tizard, Jack, 70 Transplantation, organ, 22-25, 147-149; cost of, 9, 148; ethics and efficacy of, 22-23; and def-

inition of death, 23-24; proposed legislation for, 24; longterm consequences of, 44; effects of, on medical practice, 149 Trudeau, E. L., 140 Tuberculosis, 139-141 Tyrosine, 50, 66, 67, Ulrich, Roger, 128; on behavior control, 34-35, 36, 119-126 passim Unger, Sanford, 111, 118-119, 123, 128 United States Public Health Service, code of, 17-18 Vaccines, 136-138 Waddington, Conrad Hal, 91, 93 Watson, John B., 114 Weinberg, Alvin, 8 Whitehead, Alfred North, 90 Whooping cough, 136 Wolfe, Samuel, 174-175 Wolfensberger, Wolf, 17, 86-87 Wright, S„ 70