Ethics and Oncology: New Issues of Therapy, Care, and Research 9783495813430, 9783495485866

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ANGEWANDTE ETHIK

19

Monika Bobbert Beate Herrmann Wolfgang U. Eckart (Eds.)

Ethics and Oncology New Issues of Therapy, Care, and Research

VERLAG KARL ALBER

https://doi.org/10.5771/9783495813430

.

B

Monika Bobbert / Beate Herrmann / Wolfgang U. Eckart (Eds.) Ethics and Oncology

ANGEWANDTE ETHIK

A

https://doi.org/10.5771/9783495813430 .

The editors: Monika Bobbert, Prof. Dr. theol., Dipl.-Psych., Director of the Seminar of Moral Theology, University of Muenster. Beate Herrmann, Dr. phil., Institute for History and Ethics in Medicine, University of Heidelberg. Wolfgang U. Eckart, Prof. Dr. med., Director of the Institute for History and Ethics of Medicine, University of Heidelberg.

https://doi.org/10.5771/9783495813430 .

Monika Bobbert / Beate Herrmann / Wolfgang U. Eckart (Eds.)

Ethics and Oncology New Issues of Therapy, Care, and Research

Verlag Karl Alber Freiburg / München

https://doi.org/10.5771/9783495813430 .

ANGEWANDTE ETHIK Herausgegeben von Nikolaus Knoepffler, Peter Kunzmann, Reinhard Merkel, Ingo Pies und Anne Siegetsleitner Wissenschaftlicher Beirat: Reiner Anselm, Carlos Maria Romeo Casabona, Klaus Dicke, Matthias Kaufmann, Jürgen Simon, Wilhelm Vossenkuhl, LeRoy Walters Band 19

Originalausgabe © VERLAG KARL ALBER in der Verlag Herder GmbH, Freiburg / München 2017 Alle Rechte vorbehalten www.verlag-alber.de Satz und PDF-E-Book: SatzWeise GmbH, Trier Herstellung: CPI books GmbH, Leck Printed in Germany ISBN (Buch) 978-3-495-48586-6 ISBN (PDF-E-Book) 978-3-495-81343-0

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Contents

Introduction: Ethics and Oncology. New issues of therapy, care and research . . . . . . . . . . . . . . . . . . . . . . . . .

7

Caring for cancer patients Antonella Surbone Communication is the key: Can it be taught, learned and assessed? . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Doris Fölsch Ethical issues in nursing care in oncology . . . . . . . . . . . .

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Maren Goeckenjan and Bettina Böttcher, Ludwig Wildt, Thomas Strowitzki Medical and ethical issues of fertility preservation in female cancer patients . . . . . . . . . . . . . . . . . . . . . . . .

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Christoph Schickhardt Children as vulnerable patients in oncological medicine and treatment . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Christina Schües, Christoph Rehmann-Sutter Has a child a duty to donate hematopoietic stem cells to a sibling?

81

End-of-life decision making Christoph Rehmann-Sutter, Kathrin Ohnsorge and Heike Gudat Understanding terminally ill patients’ wishes to die. Significant narratives and a typology . . . . . . . . . . . . . . 103 5 https://doi.org/10.5771/9783495813430 .

Contents

Monika Bobbert Ethical criteria of treatment decision making for cancer patients no longer able to give consent . . . . . . . . . . . . . . . . .

121

Beate Herrmann Advance directives in oncological therapy . . . . . . . . . . .

133

Clinical cancer research: opportunities and risks Geraldine Rauch Why statistics matters. The ethical impact of biometrical issues in clinical trials . . . . . . . . . . . . . . . . . . . . . . . . . .

145

Vilhjálmur Árnason Responsible return: Consent for feedback from biobanks research . . . . . . . . . . . . . . . . . . . . . . . . . . .

154

Wolfgang U. Eckart New ›elixiers‹ : The problem of changing therapeutic target with Erbitux and Avastin . . . . . . . . . . . . . . . . . . . . . .

168

Authors and Institutions . . . . . . . . . . . . . . . . . . . .

174

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Introduction: Ethics and Oncology New issues of therapy, care, and research

Interdisciplinary and contextual ethical perspective The advances in oncological therapy, as well as the knowledge of the limitations to what is possible, pose major ethical challenges to health care teams and patients. As treatments in oncology are expanding continuously, patients are involved with increasingly complex treatment decisions, including end-of-life decisions. As a consequence, doctors must inform their patients adequately, deliver difficult news and advise patients and their relatives on treatment goals and changes to these, e. g. when changing from curative to palliative care. These initial challenges are embedded in different health care systems, research frameworks, social practices and expectations. Focusing on patient care while considering social and legal contexts was the concept of this anthology and its proceeding conference. Not so much questions of resource allocation and structures of health care for oncological patients, but questions of good care and communication were the starting points. However, cancer research and supporting structures for good patient care were also points of ethical reflection. Multiple actors and structures, scopes and perspectives in professions and disciplines had to be considered. Central concepts such as health, illness and suffering, the meaning and quality of life, medicine and nursing, cancer and society had to be integrated. Intense interdisciplinary literature research showed that ethical questions of cancer therapy and research are very seldom an object of discussion in medicine, nursing, theology, philosophy or social sciences. In view of such an obvious lack of ethical reflection and in view of the goal of good care for cancer patients, a conference and subsequent publication on »Ethics and Oncology« appeared more and more desirable. The first draft of »Ethics and Oncology: New Issues of Therapy, Care, and Research« was largely determined by the different disciplines and experience of the organizers. Wolfgang U. Eckart, director of the Institute of History and Ethics of Medicine, University of Hei7 https://doi.org/10.5771/9783495813430 .

Introduction: Ethics and Oncology

delberg, is specialized in the social history of medicine. Monika Bobbert, a former staff member of the Institute in Heidelberg, today director of the Seminar of Moral Theology at the University of Muenster, is specialized in ethics (with a focus on medical and nursing ethics) and psychology. Beate Herrmann, chair of the Clinical Ethics Committee at the University Hospital of Heidelberg and staff member of the Institute of History and Ethics of Medicine, is specialized in medical ethics, in particular in clinical ethics consultation. Thanks to the sponsorship of the Robert-Bosch-Foundation, Stuttgart, and of the German Research Foundation (DFG), Berlin, it was possible to invite experts from different disciplines to Heidelberg. The organizers thank the speakers of the conference for their presentations and their enthusiastic participation in the discussions at the conference. We would like to express our great gratitude to them for elaborating their papers for this anthology. The process of finalizing this book unfortunately was interrupted several times for reasons of jobs and families. We are grateful for the authors’ understanding.

New Issues of Therapy, Care, and Research A central question, which is always relevant in this context, is what constitutes good doctor-patient communication. Owing to new and in part complex means of diagnosis and treating tumours, health care teams have to consider which criteria are ethically relevant, i. e. which criteria should tip the scale when deciding on tumour-specific treatment (including in advanced stages of illness), or on therapies with marginal effectiveness or when dealing with patients in geriatric oncology. Both physical and cognitive limitations represent a particular challenge when communicating with the patient. Therapists have to be especially careful and thoughtful when supporting autonomous decision-making. Comorbidities and low functional reserves have a negative impact on patients’ quality of life, especially in the case of complex treatments with extensive side-effects. Genetic testing of the tumour genome is fast becoming a common part of routine diagnosis and treatment planning. In future it is to be extended to the healthy genome. How can the information that is obtained coincidentally or intentionally be used responsibly? Treatment often entails serious side effects, e. g. loss of fertility. In addition to the standard procedure of cryopreservation of sperm 8 https://doi.org/10.5771/9783495813430 .

Introduction: Ethics and Oncology

and embryos, research is currently being conducted on alternatives such as oocyte cryopreservation for single women or prepubertal girls. What is the risk-benefit analysis of this treatment and what ethical questions result from it? At a societal level, the question of a just allocation of resources arises. The proportion of cancer patients is on the rise because the population is ageing and new therapies enable cancer patients to live longer. On the other hand, these therapies are very cost-intensive and are expected to have an »explosive effect« on our health care system, which is solidarity-based. What price are we willing to pay for new therapies? Should these therapies be linked to effectiveness and what should a fair distribution look like? These controversial issues in medical ethics are not only important for oncology, but they are especially relevant in this field and have not been addressed in detail, and quite often not with an explicit ethical perspective. In contrast to formulating ethical questions as questions of science and medical expertise, in contrast to judging ethical questions by individual moral intuitions or institutional and cultural routines, the goal of the conference was to offer ethical reflection and argumentation based on philosophical concepts and methods – within an interdisciplinary dialogue. Planning the conference, we realized that in Europe – in contrast to North America – publications on ethics in oncology are very rare. Thus, we grasped the opportunity to bring together physicians, nurses, specialists in ethics from philosophy and theology, psychologists and health care chaplains, lawyers and administration staff from different European countries. Although it was not possible to cover the field of ethics in oncology comprehensively, the speakers invited offered deep insights, medico-ethical analyses, and perspectives. Additionally, the presentations showed decisive aspects of institutional and legal frameworks and deepened understanding of the specific qualifications and goals of participating professions and disciplines. The interdisciplinary discussions revealed at which points more communication, and what kind of communication and cooperation between involved professional groups and disciplines, is still a desideratum. This interdisciplinary European conference took place in Heidelberg in 2012, with experts from a wide range of fields, and deepened the discussion of the above-mentioned issues as follows.

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Caring for Cancer Patients In the first part of the book, »Caring for Cancer Patients«, interaction between patients and health care is examined from a medical, nursing, psychological and ethical perspective. Communication in oncology goes beyond the transmission of information, as it involves the process of sharing ideas, attitudes, feelings and objective behaviours. In her presentation »Communication is the key: Can it be taught, learned, and assessed« Antonella Surbone – familiar with the health care systems of Italy and the USA – shows that communication creates and shares meaning, fosters patient satisfaction and improves therapeutic results. Only a minor part of communication is verbal, whereas most is non-verbal, including gestures, body language, and tone of voice. Improper or insufficient communication increases patients’ and families’ emotional distress, deepens the patient’s existential suffering, and generates reciprocal mistrust. Three elements are key to good communication and need to be considered across cultures in clinical encounters: content (what and how much information is given), facilitation (setting and context variables), and support (emotional support during the interaction). With regard to teaching good communication, Surbone explains the evolution of truth telling attitudes and practices, communication in palliative and end-of-life care, and communication within families. She strengthens that cross-cultural encounters in oncology are increasing in multi-ethnic industrialized countries under the effect of globalization and major demographic shifts. Thus, she discusses how clinicians can integrate knowledge of the patient’s culture into encounters and treatment plans. In her presentation »Ethical issues in nursing care in oncology« Doris Fölsch from Austria, one of the rare specialists in the ethics of nursing in the German-speaking European countries, points out several conflicts in hospital health care and connected ethical problems of nursing. Nurses’ experience often conflicts with the patient, family members, other health-care team members or the health care organization. Very often these conflicts are about patient safety, informed consent, futility of treatment or dying with dignity, scarce resources, and recruiting patients for medical research. Inadequate staffing or incompetency of staff members can cause ethical problems. Caregivers in oncology can only do their best for the patient if they have 10 https://doi.org/10.5771/9783495813430 .

Introduction: Ethics and Oncology

a high level of professional knowledge. Only with specialized knowledge can oncology nurses act for the benefit of the patient. They should know how to use technical equipment and be informed about the current scientific state of nursing care in oncology. A skilled, experienced oncology nurse will not harm the patient by applying the wrong nursing standards, or by fundamentally misunderstanding the patient in his/her directly or indirectly articulated needs and worries. Management of symptoms from the cancer itself and side-effects from treatment, e. g. pain, vomiting, sleep disturbances, depression and nutrition problems, greatly influence the patient’s quality of life. With their expertise and experience, nurses can influence symptoms and alleviate discomfort. Furthermore, Fölsch points out how conflicts in health care teams, within the family or between the patient and health care professionals can lead to ethical problems of autonomy. Institutional obstacles and restrictions are also focused on with regard to direct consequences for patients’ well-being. Fölsch’s presentation highlights the contribution and expertise of nursing and points out ethical problems which are quite often overlooked. In their paper entitled »Medical and ethical issues of fertility preservation in female cancer patients« Maren Goeckenjan, Bettina Böttcher, Ludwig Wildt, and Thomas Strowitzki analyze the ethical implications of fertility preservation counselling for women with cancer. The authors emphasize the normative and communicative concepts of autonomy and authenticity. This implies that in the process of pre-treatment counselling, all different methods of fertility preservation and the related risks and benefits should be discussed with the patient and his or her partner. Counselling should also tackle ethical problems, such as the question of ownership of the gonads. This sort of counselling is supposed to enable patients and their partners to make an autonomous decision that meets all criteria of informed consent. However, it turns out that sometimes not all conditions of autonomy can be met, for instance, because a proper calculation of risks is not possible under the circumstances. In light of these difficulties, the paper supports the thesis that it is the concept of authenticity (cf. Böttcher and Paul 2012) rather than that of autonomy that is best applicable to decision making in this particular situation. It implies the patient’s arrangement of her own personality within her own biography, including values and norms, emotions, beliefs, desires, and life plans, and it considers the network of her personal relationships. 11 https://doi.org/10.5771/9783495813430 .

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The paper »Children as vulnerable patients in oncological medicine and treatment«, written by Christoph Schickhardt, offers a concept of children as »vulnerable« patients and identifies the following relevant moral principles that should be considered when children with cancer are under medical treatment: 1. children and their interests should be valued as equal in comparison with adults and their interests, 2. children have a right to adequate health care service, 3. as they grow, they have gradually increasing rights to become involved in the decision-making process. This implies that there are certain moral duties on the part of physicians and parents: the role of parents – according to Schickhardt – is that they have no special rights to decide about their children by virtue of being parents. Rather, the parental role in a certain treatment decision consists of the responsibility to choose and to guarantee the treatment which is best for the child. The doctor’s primary responsibility is to provide an adequate individual treatment and to protect and promote the child’s best interest in a concrete situation. The moral relations and the obligations between children, their parents and physicians are illustrated and analyzed in the framework of an exemplary case study. The study of »Nemo’s case« concludes with the proposal of concrete practical steps that can be undertaken by the medical staff to meet the challenges in this complex social interplay between children, their parents, and physicians. Numerous life-threatening oncologic diseases of the blood system require the live donation of bone marrow (BM) or peripheral blood stem cells (PBSC). In some cases it is a child’s sibling who is either the only available or the preferred donor. In their paper »Has a child a duty to donate hematopoietic stem cells to a sibling?« Christina Schues and Christoph Rehmann-Sutter consider cases where the sibling is a child and focus on the moral justification of such a procedure. In particular, they question the widespread assumption that the child has a moral duty to donate body tissue for a sick sibling. The paper supports the thesis that the assumption of such a duty is inconsistent and »obscures rather than elucidates the structure of the ethical conflict in which a child becomes a donor of blood stem cells for a seriously sick sibling«. This does not mean that a child should never donate for her sibling. The authors outline a normative framework for dealing with the problem. Their concept of »family solidarity« emphasizes that the whole family is involved in the decision to donate or not to donate. Considerations should start with concepts such as 12 https://doi.org/10.5771/9783495813430 .

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the »good life«, the quality of relationships, vulnerability, and trust. This means that harm and risks have to be weighed up. In any case, for Schues and Rehmann-Sutter, the question of a duty of the donor child is beyond consideration.

Ethics and end-of-life decision making Quite often cancer patients are healed or are able to gain life time by medical means. Their right to informed consent and self-determination is the leading ethical and legal norm. Special ethical questions arise if the end of life seems to be approaching soon. Rehmann-Sutter et al., Monika Bobbert, and Beate Herrmann discuss some of these problems. The paper by Christoph Rehmann-Sutter, Kathrin Ohnsorge, and Heike Gudat, »Understanding terminally ill patients’ wishes to die: Significant narratives and a typology«, is based on a study consisting of 116 qualitative interviews in three different palliative care settings in Switzerland. The paper supports the thesis that we should understand a wish to die as a complex and dynamic subjective phenomenon that should never be met with moral disdain and that can be justified even under the condition of excellent care. There can be multiple intentions regarding death that can be contained in a patient’s wish to die. For instance, we should distinguish wishes to die from the mere acceptance of dying. Some patients aim at palliative sedation or wish, for example, that death should be accelerated by refusing life-supporting treatment, while still opposing euthanasia. The authors show that a better and more nuanced understanding of the wish to die can lead to a more sensitive response to patients’ needs. They point out the need for better communication about patients’ wishes regarding death. In order to meet this requirement, the paper offers a typology of patients’ expressions regarding death that can support an essential dialogue between patients and their caregivers. Monika Bobbert, ethicist and psychologist, focuses on the »Ethical criteria of treatment decision making for cancer patients no longer able to give consent«. Even in the case of an unstoppable, progressive and incurable cancer, physicians, patients and their relatives often do not communicate with each other about decisions on treatment that may have to be made in future. What kind of ethical norms and

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criteria of consideration may justify termination of treatment when a critically ill patient is no longer capable of judgement? With regard to prognosis, variations in treatment should be anticipated and discussed, in particular the best possible and the worst possible course the illness may take. The principle of caution requires that all medical measures are to be applied to the point of obtaining great prognostic certainty in order to protect the moral and legal right to protection of life. Forms of argument referring to the alleged will and quality of life, as well as the value-dependent concepts of medical indication and futility, tend to be weak. They are weak because they are derived to a greater or lesser extent from the interests, moral intuitions, and evaluations of outsiders, which can contradict the individual rights of the patient to protection of life and self-determination, and individual ideas of a life plan and quality of life. When in doubt, physicians should and may continue treatment. Patients and relatives worried about excessive treatment should consider the questions that appear in connection with the end of life, and communicate their wishes and ideas to relatives and physicians, orally or in writing. The growing significance of advance directives results from the desire for a humane and independent life, in particular when it comes to illness and death. Although one’s own death cannot be controlled, after all, the process of dying or the final stage of life can be influenced by way of the growing possibilities of medicine and thus is a subject of human action and decision-making. In her paper »Advance directives in oncological therapy«, Beate Herrmann analyzes the specific function of advance directives for patients with cancer. She supports the thesis that autonomy being the leading principle for the patient’s decision does not simply mean »an unlimited choice when it comes to medical matters«. Rather, an autonomous decision by the patient requires the physician to bring in his/her expertise and estimation of the medical situation. Accordingly, the physician’s care may not be understood as competing with the patient’s autonomous decision, but as a necessary condition for its realization. This implies that questions about the best therapy for the patient cannot be answered with regard to medical assessment alone. Rather, there are always evaluative judgements involved (e. g. the term »medical prognosis« implies assumptions about the expected quality of life), and therefore the physician’s perspective on what she regards as the best therapy needs justification. Consequently, the author asks what fol-

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lows from these considerations with regard to advance directives counselling and supplies some recommendations.

Clinical cancer research: opportunities, risks, and perspectives As cancer diagnostics and therapy depend on reliable research with regard to the moral rights of human research subjects and animals, and with regard to limited resources, selected ethical aspects of clinical cancer research are presented as follows. As the genetic and neurological paradigms form the profile of much research in medicine, the question of »the right to know and the right not to know« have attained great importance. Biobanks for genetic research, in particular, raise several new and (in practice thus far) unresolved ethical questions, such as the guaranteed right of privacy of personal data and the problem of expected and unexpected findings – mostly in the form of probabilistic information. Iceland was one of the first nations to introduce a population database, in the 1980s – with the consequence of political and international ethical debates. From the beginning, the philosopher and ethicist Vilhjálmur Árnason from Iceland University has pursued these reflections. In Heidelberg he discussed the important, still unresolved question of unexpected findings in the context of biobanks research. In his paper »Responsible return: consent for feedback from biobanks research«, he evaluates three main options of returning information to individuals in a responsible way. Arnason argues in favour of the position that participants in genetic research only have strong autonomy claims for not knowing results, while they have weak autonomy to obtain information. Weak autonomy is understood in the sense that obtaining information should be limited by professional genetic counselling, as a researcher’s positive, but imperfect duties require contextual judgment and are limited by a sensible framework for conveying the results in a trustworthy and caring way. Authorization for return of genetic information could take two forms: those who prefer not to receive any findings could simply make that explicit once and for all; those who would prefer to receive information about unexpected findings could issue an authorization which would include the return of information by independent experts. In the case of findings that might help a con15 https://doi.org/10.5771/9783495813430 .

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tributor to avoid serious harm, the finding should be clinically actionable and have been validated clinically, and the unexpected finding should be provided in a context of clinical counselling. Geraldine Rauch, a biometrician and member of an Ethics Review Board for medical research, reflects on »Why statistics matters – the ethical impact of biometrical issues in clinical trials«. She focuses on a discipline sometimes underestimated by medical researchers. She shows not only that the scientific quality can be assured by biometrical consultation, but also the ethical quality of a study; she even strengthens the idea that good scientific quality defines the basis for ethically responsible research, as clinical trials always entail additional physical risks and increased efforts for the participant. Medical research in humans can thus only be ethically justified if a gain of information is guaranteed or at least highly probable. Study designs must be adequate to assess the research objectives, data must be correctly analyzed and interpreted, and the results published in a correct way. Important biometrical aspects which can interact with ethical issues are choice and definition of primary and secondary outcome variables, choice of the study design (number of treatment arms, blinding, randomization, interim analysis etc.), choice of statistical strategy (statistic tests, models, covariate adjustment etc.), and calculation of the required number of patients to detect treatment effects. Close cooperation with physicians and their medical perspective is essential, e. g. to find alternatives for problematic intervention designs or for small sample numbers – for example caused by narrow in- and exclusion criteria used in order to protect patients. Wolfgang U. Eckart, expert in the history of medicine, in »New ›elixiers‹ : the problem of changing therapeutic targets with Erbitux and Avastin«, addresses several problems concerning the new humanized monoclonal antibodies as an example for questionable cancer research and therapy. Referring to a palliative paradigm with the sole goal of stabilizing quality of life, he criticizes the use of preparations to prolong life minimally. These medications are questionable otherwise, too, being extremely expensive and showing comparatively poor outcomes. The basis of the application consists of the data of the so-called FLEX-study, in which improvement in the average total survival time of around one month was achieved. The sales of Erbitux and Avastin made great profits for pharmaceutical plants. Results of later studies have not agreed with other clinical data from older studies. Thus, some voices have called this cancer preparation a margin16 https://doi.org/10.5771/9783495813430 .

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ally effective medication and there seems to be reasonable doubt as to the new type of cancer medication. Eckart shows that undistinguished or even biased medical research can lead to applications that render healthcare systems worldwide unaffordable, even with no gain for patients at the end of life. By giving an example for interactions between medical research, therapy, and patient well-being, Eckart sensitizes researchers, physicians and patients to similar negative effects and issues of ethical decision-making in cancer research and therapy. One of the organizer’s main goals was to discuss new ethical questions in oncology which result from the expanding complexity of therapeutic decisions in cancer diagnostics, treatment, and research, e. g. genetic research and diagnostics, or the preservation of fertility in young women with cancer. Another goal was to bring together different disciplines and professions to develop comprehensive and persuasive solutions and to establish a network of expertise in Europe. The anthology »Ethics and oncology: new issues of therapy, care, and research« offers insights into complex interdisciplinary questions of helpful and responsible health care for cancer patients, placing the conference’s dialogue on a broader footing. In view of the extent of the volume, however, only a selection of perspectives, disciplines, actors and social aspects could be discussed. Many other topics and ethical problems remain open. For the sake of patients and their families, and also for the sake of health care professionals and researchers, we hope to stimulate a growing interdisciplinary exchange in Europe with the explicit focus on ethical issues. Monika Bobbert, Beate Herrmann, Wolfgang U. Eckart Heidelberg and Muenster, autumn 2016

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Caring for cancer patients

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Antonella Surbone

Communication is the key: Can it be taught, learned and assessed?

»We must learn to find the communication between one consciousness and another in one and the same world.« Maurice Merleau-Ponty, Phenomenology of Perception, 1954

1

Introduction

The importance of communication in oncology is underscored by the official statements of major US and international organizations. For the National Cancer Institute (NCI), communication is an extraordinary opportunity for health care workers; for the American Society of Clinical Oncology (ASCO), a key ability of any oncologist; for the Institute of Medicine (IOM), one of the six fundamental skills to provide adequate curative and supportive therapies to all cancer patients. Communication goes beyond the transmission of information and involves the process of sharing something in common (from the Latin communis). Communication is defined as the action to share, inform, join, unite, participate in; or the act or process of transmitting information about ideas, attitudes, emotions, or objective behaviors. According to the online 2012 Merriam-Webster Dictionary, communication entails personal rapport. The online 2012 Oxford Dictionary defines communication as the successful conveying or sharing of ideas and feelings, while the online 2012 Business Dictionary defines it as a two-way process of reaching mutual understanding, in which participants not only exchange information, but also create and share meaning. Communication in clinical medicine is a dynamic, bi-directional, process that evolves within the patient-doctor-family relationship in a specific socio-cultural context. The communication process is essential to establish and maintain trust among all partners involved, to foster patients’ satisfaction and compliance, and to improve therapeutic results. Contrary to common belief, it appears that only a minor part of communication is verbal, while most is non-verbal, includ21 https://doi.org/10.5771/9783495813430 .

Antonella Surbone

ing gestures, body language and tone of voice. Communication occurs both at cognitive and emotional levels: these are always intertwined, yet not superimposed. In clinical encounters, it is important to acknowledge these two levels of communication and to learn to master both, respecting cancer patients’ needs of knowing about their disease, but also of expressing their emotions. Good communication helps patients and families trust in individual physicians and also in institutions. Studies show that good communication makes patients and families feel treated with honesty and compassion, guided with respect of their own values and preferences, emotionally understood, and sustained in their hope. By contrast, improper or insufficient communication increases patients’ and families’ emotional distress, deepens the patient’s existential suffering, and generates reciprocal mistrust. Furthermore, poor communication limits physicians’ understanding of the patient’s physical and psychological problems and thus undermines the efficacy of the therapeutic relationship.

2

Basic principles of communication in the clinical setting

Communication does not occur in a vacuum, but rather in the specific socio-cultural and individual context of each patient-doctor relationship. Three elements are key to good communication and need to be always considered in clinical encounters: (1) content (what and how much information is told); (2) facilitation (setting and context variables); and (3) support (emotional support during the interaction). 1 The literature shows that, when information is provided, cancer patients’ needs and preferences are similar across cultures, with content ranking first in defining good communication. 2 Different methods of teaching communication have been published in the medical and oncologic literature, including the SPIKES model. 3 Few essential basic principles of communication, derived from the SPIKES model, are listed in Table I.

1 2 3

Parker PA et al. 2001. Surbone A 2006, Support Care Cancer. Baile WF et al. 2000.

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Communication is the key •

Ask-tell-ask

•

Listen carefully, while keeping conversation focused

•

Respond also at the emotional level

Table I. Basic principles of communication in the clinical setting. Due to the asymmetry inherent in the patient-doctor relationship, it is up to the oncologist to initiate and conduct proper communication with his or her patient, knowing how much, when and how to deliver medical information in a sensitive effective way. 4 In communication in the cancer care setting, where patients tend to be seen and treated by multiple specialists, oncologists must always inquire first about what their patients know and understand about their disease, and about how much information they wish to receive. Once additional information is provided, oncologists should always take the time to check their patients’ understanding and processing of what has been said. This may require encouraging patients to ask questions or directly suggest that patients summarize what they have learned during the medical encounter. Oncologists should listen carefully to their patients, never changing subject when they express concerns or emotions, while at the same time keeping the conversation focused on the issues at stake. It is important to learn not to overwhelm patients with statistical information, as this reinforces the physicians’ power while not addressing their patients’ real concerns. In fact, more than being interested in statistics that may not apply to their individual case, cancer patients share similar implicit questions, such as »What is happening to me?«, »How do I feel after knowing this?«, »What will change for me now?«, or »How will the life of my loved ones be affected by my illness?« These questions, while often not verbalized, are of utmost importance for cancer patients and oncologists. They should address them both at cognitive and at emotional levels. Patients should not be interrupted when they try to express their emotions, and the use of a teaching or preaching tone must be carefully avoided. Cancer patients are not interested in knowing about cancer in general, but rather they are concerned with their own can4

Surbone A & Lowenstein J 2003.

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cer, its treatments and possible outcomes. Any judgement about the reasons that may have led to the patient’s cancer are inappropriate. Furthermore, oncologists should never prematurely reassure patients or families, and should not hesitate in facing difficult issues or in admitting to the uncertainty that still surrounds the nature of cancer and its possible outcomes in individual patients. 5

3

Communication in oncology: education and assessment

Guidelines geared to clinical practice are emerging from empirical research in the field of communication and communication skills are now taught in medical schools and during oncology training in many countries worldwide. Different methodologies are used, such as specific or transversal teaching in medical school; training through intensive, interactive, courses; continuing medical education; and specific education and training for teachers. 6 The OncoTalk designed from M. D. Anderson’s I*Care program is an example of successful communication skill teaching. 7 In this model, the learning setting puts the learner’s practice at the center; the skill practice is structured as a reflective process; teachers engage the groups acting as facilitators, rather than coaches; and each learner’s feedback is encouraged as a key to learning. Finally, individual motivation and willingness to learn are optimized. 8

4

Difficult aspects of communication in oncology clinics

Communication with cancer patients can be especially difficult in particular circumstances, such as truth-telling about diagnosis and prognosis, discussions regarding palliative and end-of-life (EOL) care, involvement of family caregivers in information and decision-making, and cross-cultural communication.

5 6 7 8

Schapira L 2004. Back AL et al. 2009. Fallowfield L & Jenkins 2004. OncoTalk.

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4.1 Evolution of truth telling attitudes and practices »Truth-telling« is a major component of communication between oncology professionals and cancer patients and their families. 9 In the last two decades, a major evolution in truth telling attitudes and practices has occurred worldwide. 10 In most countries, cancer patients are now better informed of their diagnosis and treatment options, and more involved in decision-making. Cancer patients are asked about their information needs and preferences, and about their satisfaction with the communication process. Communication and information preferences vary with gender, age, education and degrees of truth-telling also vary with type of cancer, illness stage and status, rural or urban residence, treating institutions and culture. Furthermore, communication’s needs and preferences evolve over time and they need to be reassessed during the course of the patient’s illness. 11 Though some studies report that all cancer patients have similar information needs, there is an empirical evidence of differences with regard to the importance of content, setting and support. These are related to ethnic and cultural differences, as well as to gender, age and education. For example, while all informed patients value primarily the content of the information received, both in term of accuracy and comprehensiveness, men tend to give less importance than women to the emotional support provided by oncology professionals. 12 In some cultures, family members act as spokespersons for sick relatives in order to shield them from painful truths and physicians tend to withhold information about a cancer diagnosis and treatment options from their patients and rather inform their families. 13 Furthermore, families of patients treated in Western institutions may ask oncologists to withhold the truth from the patient: this practice challenges the Western notion of patient autonomy and requires cultural sensitivity in communicating and negotiating with patients and their families with regard to truth-telling and care planning. 14 Holland J et al. 1987. Authors Various in Surbone A et al. 1997; Elwyn TS 1998; Baile WF et al. 2001; Mystadikou K et al. 2004; Surbone. A 2004 Support Care Cancer; Surbone et al. 2012. 11 Butow PN 1997. 12 Surbone A 2006 Support Care Cancer cited; Surbone A 2006 Lancet Oncol. 13 Elwyn TS 2002. 14 Anderlick M et al. 2000; Ozdogan M 2004; Surbone A 2006 Support Care Cancer; Kagawa-Singer et al. 2010. 9

10

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4.2 Communication in palliative and end of life care Prognosis and risks, together with EOL issues are still not openly discussed even in Western countries. By contrast, awareness of illness status and of imminent dying seems to be associated with better quality of life of advanced cancer patients and of their families, delivery of care that is more respectful of patients’ wishes, and decreased incidence of complicated grieving in families and friends. 15 According to American Academy of Family Physicians Guidelines on End of Life Care, »Health professionals should recognize, assess, and address the psychological, social, spiritual and religious issues, and cultural taboos realizing that different cultures may require significantly different approaches.« 16 Other clinicians underline that oncologists should initiate and offer repeated discussions at different times, clarify prognosis and likely outcomes, identify patients’ goals for care, and develop care plans. 17 Following the publication of a study by Temel and colleagues in the New England Journal of Medicine on the benefits of initiating palliative care early in the illness trajectory of patients with advanced lung cancer, in 2011 ASCO established a new paradigm of care and communication for patients with advanced cancer that stresses the importance of engaging in early conversations about all available options, including palliative and EOL care. 18 The document issued by ASCO identified three main barriers to »candid conversations« with patients with advanced cancer: first, candid conversations can make oncologists feel like they are giving up or admitting failure; second, most of them have little or no training in how to engage in these conversations; and third, these conversations are typically very time-consuming, difficult to accomplish in a typical follow-up visit, and not sufficiently valued or compensated. 19 ASCO recommendations are addressed to both oncologists and patients and their families, and provide practical suggestions to all involved partners on how to initiate candid conversation about prognosis, impending death and palliative and EOL care options. The de-

15 16 17 18 19

Mack JW & Smith TJ 2012; Longo D & Smith TJ 2012; Smith TJ 2012. Searight HR & Gafford J 2007. Balaban RB 2000; Hagerty RG et al. 2005. Temel JS et al. 2010. Smith TJ et al. 2012.

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crease in administration of chemotherapy or other anti-cancer treatments in the last weeks or days of the patient’s life is one of the major benefits of having open conversations early on in the course of advanced cancer. Such treatments are not only futile and very costly, but they often constitute an impediment to the delivery of optimal care of patients with advanced cancer, which should rather consist in global, medical, psychological and spiritual supportive care. 20

4.3 Communication with families Cancer is a »family illness« that can only be understood in terms of the social, cultural, religious and family responses to the underlying disease, including the ways in which the patient and family conceptualize and elaborate it. A cancer diagnosis affects patients’ perceptions of their individual »self« and roles, as well as their family dynamics, even at the early stages of the illness. 21 Traditional families, community and religious values play a central role in determining people’s perceptions and attitudes toward life and death, as well as toward caregiving to a sick relative. 22 For this reason, it is now increasingly recognized that the fundamental unit of care in medicine is formed by the doctor, the patient and his or her family. 23 Consequently, in oncology practice there is a growing trend to assume broader responsibility toward cancer patients’ families during the illness course and in the grieving stage, as well as in cancer prevention, screening and genetic counseling. Oncology professionals need to acquire and master adequate communication skills not only with cancer patients, but also with their relatives, to effectively relate to the patient-family dyad and integrate and tailor interventions tuned to the needs of both care recipients and family caregivers. 24 Furthermore, due to the progressive shift from hospital to ambulatory or home cancer care, informal family caregivers of cancer patients are increasingly required to replace skilled healthcare workers

20 21 22 23 24

Surbone A et al, 2010 Support Care Cancer; ASCO 2011: Mack et al. 2012. Cooper CL et al. 2000; Baider L 2008. Baider L & Surbone A 2010. Baider L 2000; Surbone A & Baider L ASCO 2012. Surbone & Baider 2012, cited.

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in the delivery of complex care to their ill family members. These may include treatment monitoring; treatment-related symptom management; emotional, financial, and spiritual support; and assistance with personal and instrumental care. 25 When added to the other obligations and responsibilities that characterize caregivers’ lives, assisting cancer patients often results in a substantial physical, emotional and financial burden for the caregivers. 26 At the same time, the intimate and exclusive relationship between oncologist and patient may be diminished when family members are involved in providing care: oncologists should communicate with family caregivers respectfully and effectively, while always fostering their patients’ relational autonomy, based on acknowledging all contextual and relational aspects of the illness process. 27

4.4 Cross-cultural communication with cancer patients Cross-cultural encounters in oncology are increasing in multiethnic industrialized countries under the effect of globalization and major demographic shifts. Every culture has different styles and methods of communication, as well as different beliefs and attitudes toward matters of health and illness. 28 Communication is embedded within culture, yet we rarely see the western beliefs upon which we base our teaching of, and training in, communication skills, as culturally bound. 29 Lack of attention to cultural differences generates miscommunication and mistrust in the relationship among oncology professionals, patients and families 30, and it spoils the therapeutic relationship of the enriching dimension of cultural diversity. 31 The notion of culture is extremely complex and goes beyond ethnic and geographic boundaries, involving factors such as gender, age, socio-economic status, educational level, urban versus rural resiGiven B & Given CW 2001. Soothill K 2003, Surbone et al. 2010 ASCO; Baider L & Goldzweig G. 27 Blackhall L 1995; Carrese JA & Rhodes LA 2005; Surbone A 2006, Lancet Oncol, cited; Sherwin S 1998. 28 Kleinman A et al. 1978. 29 Surbone A 2007; Kagawa-Singer M et al. 2010 cited. 30 Kagawa-Singer K & Kassim-Lakha S 2005; Betancourt JR 2006; Crawley L & Kagawa-Singer M 2007. 31 Surbone A & Baider L 2013. 25 26

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dence, sexual orientation, disability and many others. 32 Culture and its influences vary with social, political, economic, and historical contexts. Cancer patients whose cultures value self-reliance tend to react differently to their illness from those who culturally value sharing all experiences, including that of a serious illness. Furthermore, in some cultures, cancer is still a source of »shame and guilt« or stigma. 33 Yet cultures are dynamic, evolve with changing environments and circumstances, and vary according to time and place. Personal dispositions may also be different in the same culture with regard to communication and decision-making styles. For cross-cultural communication to be possible, oncology professionals need to be aware of their own culture and of the culture of medicine to which they also belong. 34 Finding the right balance between understanding and respecting cross-culturally differences among cancer patients and families, while also adhering to Western principles of patient participation and self-determination, can be a very difficult task. Along with understanding and appreciation of different cultures, self-awareness of one’s potential biases is crucial to successful cross-cultural medical encounters. In the practice of oncology, prejudices tend to lead to major differences in quality and accuracy of information and communication with patients and families of different skin color or culture, perpetuating disparities in access to prevention, screening, optimal standard care and research, medical and psychosocial support and adequate end-of-life measures. 35 The skills required to improve cross-cultural communication and improve health outcomes for minority patients can be acquired in medical schools and through culturally based patient-centered practice. 36 Guidelines on how to negotiate cultural differences for the mutual benefit during clinical encounters can sustain the oncologist’s rational and emotional work of understanding and respecting of different cultural beliefs, values and practices. 37 In the culture-based approach, clinicians integrate knowledge of their patients’ culture into treatment plans to provide optimal cancer Surbone A 2004 & 2010 Ann Oncol. Kagawa-Singer M & Blackhall LJ 2001; Baider L & Surbone A 2010 J Clin Oncol cited. 34 Fox RC 2005; Kagawa-Singer M et al. 2010 cited. 35 Surbone et al. 2010 Support Care Cancer cited; Sabin J et al. 2009. 36 Dana RH 1993; Tervalon M 2003; Surbone A 2007. 37 AAMC 2005; Weinberg AD & Jackson PM 2006; Surbone A & Baile WF 2010. 32 33

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care based on their cultural beliefs and practices. 38 Clinicians should start by taking a cultural history as part of the social history of each patient, with extreme sensitivity in a non-inquisitional ways. The initial communication process needed to establish trust in cross-cultural medical encounters, requires a substantial time investment, yet it helps reducing future misunderstanding and conflicts. 39

5

Conclusion

Communication with cancer patients and their families today poses new challenges, such as the ones summarized in Table II. 40 •

virtual communication

•

computerized records

•

sharing scientific discoveries

•

exchanging information among peers/colleagues

•

conflicts of interest (COI)

•

medical errors

•

genetic risk

•

survivorship issues

Table II. Emerging issues in communication with cancer patients Information and communication are often thought of as synonymous. Yet, information is only a part of the larger dynamic process of communication with cancer patients and their families. Through information, oncologists disclose to their patients the medical truth about their cancer diagnosis and prognosis, the treatment choices and their benefits and risks. Beyond disclosure and mere information, sincere, accurate and reciprocal communication in clinical oncology is a dynamic evolving process, which helps cancer patients and their families make sense of their life with cancer and achieve better therapeutic results.

38 39 40

Kagawa-Singer M et al. 2010 cited. Kagawa-Singer M et al. 2010 cited. Surbone A et al. 2012 cited; Surbone A et al. 2013; Surbone A & Rowe M 2015.

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References Anderlik M, Pentz RD, Hess KR. Revisiting the truth telling debate: a study of disclosure practices at a major cancer center. J Clin Ethics 2000; 11:251–259. American Society of Clinical Oncology. Advanced Cancer Care Planning 2001. Available at http://www.cancer.net/coping/advanced-cancer-care-planning. (last accessed March 20th 2013). Association of American Medical Colleges. Cultural competence education for medical studies. Acad Med (2005) http://www.aamc.org.ezproxy.med.nyu. edu/meded/tacct/start.htm (23 February 2013, date last accessed). Authors Various. in: Surbone A, Zwitter M. (Eds). Communication with the Cancer Patient: Information and Truth. Ann New York Acad Sci, New York 1997. 2nd Edition. Baltimore: Johns Hopkins University Press, 2000. Back AL, Arnold RM, Baile WF, Tulsky JA, Barley, GE, Pea RD, Fryer-Edwards KA. Faculty development to change the paradigm of communication skills teaching in oncology. J Clin Oncol. 2009; 27:1137–41. Baider L. Communication about illness: a family narrative. Support Cancer Care 2008; 16, 607–611. Baider L & Goldzweig G. Exploration of Family Care: A Multicultural Approach. In Grassi L & Riba M. (eds) Clinical Psycho-Oncology: An International Perspective 2012. Baider L, Surbone A. Cancer and the family: the silent words of truth. J Clin Oncol 2010; 28: 1269–1272. Baider L, Surbone A. Universality of aging: family caregivers for elderly cancer patients. Front. Psychol 2014; 5:744. Baile WF, Lenzi R, Parker PA et al. Oncologists’ attitudes toward and practices in giving bad news: an exploratory study. J Clin Oncol 2002; 20: 2189–2196. Baile WF, Buckman R, Lenzi R, Glober G, Beale EA, Kudelka AP. SPIKES-A sixstep protocol for delivering bad news: application to the patient with cancer. Oncologist. 2000; 5: 302–11. Balaban RB. A physician’s guide to talking about end-of-life care. J Gen Intern Med. 2000; 15(3): 195–200. Betancourt JR. Cultural competency: providing quality care to diverse populations. Consult Pharm (2006) 21:988–995. Blackhall L. Ethnicity And Attitudes Toward Patient Autonomy. JAMA 1995; 274: 820–825. Butow PN, Maclean M, Dunn SM. The dynamics of change: cancer patients’ preferences for information, involvement and support. Ann Oncol 1997; 8: 857–863. Carrese, JA, Rhodes LA. Western bioethics on the Navajo reservation: Benefit or harm? JAMA, 2005; 274, 826–829. Cooper CL, Baider L, Kaplan Denour A (eds) Cancer and the Family. Vol. 1. Sussex, England: J. Wiley & Sons, Ltd., 1996. Second edition 2001. Crawley L, Kagawa-Singer M. Racial, Cultural, and Ethnic Factors Affecting the Quality of End-of-Life Care in California: Findings and Recommendations (2007) California Health Care Foundation. http://ehealth.chcf.org/documents

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Antonella Surbone /chronicdisease/CulturalFactorsEOL.pdf (23 February 2013, date last accessed). Dana RH Multicultural assessment perspectives for professional psychology. Boston, MA, USA: Allyn & Bacon, Inc. 1993. Elwyn TS, Fetters MD, Gorenflo W, Tsuda T. Cancer disclosure in Japan: historical comparisons, current practices. Soc Sci Med 1998; 46:1151–1163. Elwyn TS, Fetters MD, Sasaki H, Tsuda T. Responsibility and cancer disclosure in Japan. Soc Sci Med 2002; 54: 281–293. Fallowfield L, Jenkins V. Communicating sad, bad, difficult new in medicine. Lancet 2004; 363: 312–319. Fox RC. Cultural competence and the culture of medicine. N Engl J Med. 2005; 353: 1316–19. Hagerty RG, Butow PN, Ellis PM et al. Communicating with realism and hope: incurable cancer patients’ views on disclosure of prognosis. J Clin Oncol 2005; 23: 1278–1288. Holland JC, Geary N, Marchini A, Tross S. An international survey of physician attitudes and practices in regard to revealing the diagnosis of cancer. Cancer Invest 1987; 5:151–154. Given B, Given CW. Family support in advanced cancer. Can J Clin. 2001; 51: 213–231. Kagawa-Singer M, Blackhall LJ. Negotiating cross-cultural issues at the end of life: »You got to go where he lives«. JAMA (2001) 286:2993–3001. Kagawa-Singer M, Kassim-Lakha S. (2005) A strategy to reduce cross-cultural miscommunication. Academic Medicine 78, 577–587. Kagawa-Singer M, Valdez D, Yu M & Surbone A. (2010) Cancer, culture and health disparities: time to chart a new course? CA: Cancer Journal of Clinicians 60, 12–39. Kahnna SK, Cheyney M, Engle M. Cultural competency in health care: evaluating the outcomes of a cultural competency training among health care professionals. J Natl Med Assoc (2009) 101: 886–892. Kleinman A, Eisenberg L, Good B. Culture, illness, and care: clinical lessons from anthropologic and cross-cultural research. Ann Intern Med. 1978; 88:251– 258. Longo DL & Smith TJ. Talking with Patients about Dying. New Engl J Med 2012; 367:1651–1652. Lowenstein J. The Midnight Meal and Other Essays about Physicians, Patients and Medicine. Yale University Press 1997, University of Michigan Press 2005. Mack JW, Cronin A, Keating NL et al. Associations Between End-of-Life Discussion Characteristics and Care Received Near Death: A Prospective Cohort Study. J Clin Oncol 2012; 30: 4387–4395. Mack JW, Smith TJ. Reasons why physicians do not have discussions about poor prognosis, why it matters, and what can be improved. J Clin Oncol 2012; 30:2715–2717. Mystadikou K, Parpa E, Tsilika E at al. Cancer information disclosure in different cultural contexts. Support Care Cancer 2004; 12:147–154. OncoTalk Program, available at http://depts.washington.edu/oncotalk/modules. php (last accessed March 20th 2013).

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Communication is the key Ozdogan M, Samur M, Bozcuk HS et al. »Do not tell«: what factors affect relative attitudes to honest disclosure of diagnosis to cancer patients? Supp Care Cancer 2004; 12:497–502. Parker PA, Baile WF, de Moor C, Lenzi R, Kudelka AP, Cohen L. Breaking bad news about cancer: patients’ preferences for communication. J Clin Oncol. 2001; 19: 2049–2056. Razavi D, Merkaert I, Marchal S. How to Optimize Physicians’ Communication Skills in Cancer Care: Results of a Randomized Study Assessing the Usefulness of Posttraining Consolidation Workshops. J Clin Oncol 2003; 21: 3141– 3149. Sabin J, Nosek BA, Greenwald A, Rivara FP. Physicians’ implicit and explicit attitudes about race by MD race, ethnicity, and gender. J Health Care Poor Underserved (2009) 20: 896–913. Schapira L. Shared uncertainty. J Support Oncol 2004; 2: 14–15. Sherwin S. A relational approach to autonomy in Health Care. In S Sherwin, Coordinator, The feminist health Care Ethics Research Network, The Politics of Womens’ Health: Exploring Agency and Autonomy. Philadelphia: Temple University Press, 1988: 19–44. Searight HR, Gafford J. (2007) Cultural diversity at the end of life. American Family Physicians 72, 515–522. Smith TJ, Longo DL. Talking with patients about dying. N Engl J Med. 2012; 367:1651–1652. Smith TJ, Temin S, Alesi ER et al. American Society of Clinical Oncology provision: the integration of palliative care into standard oncology care. J Clin Oncol 2012; 30:880–887. Soothill K, Morris SM, Thomas C, et al. The universal, situational, and personal needs of cancer patients and their main carers. Eur J Oncol Nurs. 2003; 7: 5– 13. Surbone A. »Truth Telling To The Patient.« JAMA 1992; 268: 1661–1662. Surbone A, Lowenstein J. Asymmetry in the patient-doctor relationship. J Clin Ethics 2003; 14: 183–188. Surbone A. The difficult task of family caregiving in oncology: which roles do autonomy and gender play? Supp Care Cancer. 2003;11: 617–619. Surbone A. Persisting differences in truth-telling throughout the world. Support Care Cancer 2004; 12:143–146. Surbone A. Cultural competence. Why? Ann Oncol 200415, 697–699. Surbone A. Communication preferences and needs of cancer patients: The importance of content. Supp Care Cancer 2006; 14: 789–791. Surbone A. Family, autonomy, and cultural differences. In: 2006 ASCO Educational Book. Alexandria, VA: American Society of Clinical Oncology 2006: 156–159. Surbone A. Telling Truth to Patients with Cancer: What is the Truth? Lancet Oncol 2006; 7: 944–950. Surbone A. Cultural aspects of communication in cancer care. Supp Care Cancer 2007; 14: 789–791. Surbone A. Information to cancer patients: ready to ask new questions? Supp Care Cancer 2008; 16: 865–868.

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Antonella Surbone Surbone A, Baile WF. Pocket Guide of Culturally Competent Communication. I*Care, Houston: The University of Texas MD Anderson Cancer Center, 2010. Surbone A. Cultural competence in oncology: where do we stand? Ann Onc 2010; 21: 3–5. Surbone A, Baider L, Balducci L. Caregiving to elderly patients: clinical, ethical and psychosocial challenges. In: Govindan R, ed. 2010 ASCO Educational Book. Alexandria, VA: American Society of Clinical Oncology. Surbone A & Baider L. Are Oncologists Accountable Only to Patients or Also to Their Families? An International Perspective. In: Govindan R, ed. 2012 ASCO Educational Book. Alexandria, VA: American Society of Clinical Oncology; 2012: e15-e19. Surbone A, Baider L. Personal values and cultural diversity. J Med Pers 2013; 11: 11–18. Surbone A, Rajer M, Stiefel R, Zwitter M. (eds) New challenges in communication with cancer patients. Springer New York 2012. Surbone A, Annunziata A, Santoro A, Tirelli U, Tralongo P. Cancer patients and survivors: changing words or changing culture? Ann Oncol 2013; 24: 2468– 2471. Surbone A, Rowe M. (eds) Clinical oncology and error reduction. Hoboken, NJ: John Wiley & Sons, Inc. 2015. Temel JS, Greer JA, Muzikansky A, et al. Early Palliative Care for Patients with Metastatic Non–Small-Cell Lung Cancer. N Engl J Med. 2010; 363: 733–742. Tervalon M. Components of culture in health for medical students’ education. Acad Med 2003; 78: 570–576.

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Ethical issues in nursing care in oncology

1

Introduction

What is specific in oncology nursing? Cancer has more serious and far-reaching consequences than many other diseases. Like a patient said: »This illness isn’t like others, you always feel in your mind that the burden is heavier.« Main consequences of the diagnosis cancer are: • The patient has to go through an intensive medical treatment. This means recurrent hospital stays, and very often unpleasant, severe side effects of the treatment. • Most cancer treatments involve physical, psychological and social stress. • Cancer has a life threatening impact. In many cases the therapeutic outcome is open. Physicians can tell the probability rates of the expected therapeutic success, but what will happen to the individual patient in the next weeks, months and years is uncertain. The patient may feel like being under the sword of Damocles. • Cancer in many cases means a long-time illness. The cancer patient goes through different phases of the illness and treatment. Even though the patient seems to be healed the oncological disease can return. • Cancer means for some patients at a certain point a terminal diagnosis. To accompany an individual when he/she is going to die requires a lot of knowledge, skills and empathy by professionals and family members. The care of people with a diagnosis of cancer is influenced by the lifethreatening nature of this disease and mental, physical and social consequences. These far-reaching and serious consequences of cancer imply a high vulnerability of cancer patients. Due to the fact, that during the process of the disease the patient often gets weaker, he/she is in greater need of care. Thus, professional nurses and physicians have 35 https://doi.org/10.5771/9783495813430 .

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inevitably ethical responsibility for the possible ways of alleviation, support and cure.

2

Fields of action of the oncology nurse

Oncology nurses are confronted with ethical issues in the course of the diseases and different contexts. From the diagnosis or even before, until recovery or death of the patient nurses may experience conflicts with the patient him/herself, family members, other health-care team members or the organization. There are very often recurring issues like patient safety, informed consent, futility of treatment or dying with dignity. Conflicts occur in case of scarce resources, inadequate staffing or incompetency of staff members. 1 To systematize ethical issues of oncology nursing I introduce the different fields of action in professional nursing. I borrow the idea of classifying ethical issues by considering fields of action from Bobbert, as it is structures the goal of giving an overview of ethical issues of nursing. 2 The different fields of action are: • Direct care: The quality of care which the cancer patient gets, affects his quality of life. Therefore, it is of a great moral significance how the person with an oncological disease is nursed and accompanied during this time. • Health care team: How the nursing care team works together affects the quality of care and the well-being of the patient, but also the well-being of the staff. • Family: Many ethical issues also arise in interaction with relatives. Oncology nurses face ethical questions by having notice of the interactions between patient and family members, interactions within the family. Also the relationship between care team and family members influences the caring atmosphere and may have effects on the quality of difficult treatment decisions. • Institution: The organizational framework creates the condition which and how care can be provided. Financial resources are limited and question of fair distribution arise. The institution has to See Ekedahla/Wengströmb (2007), Nurses in cancer care – stress when encountering existential issues, p. 229. 2 See Bobbert, Patientenautonomie und Pflege (2002), p. 215, p. 334 ff. 1

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•

dispose, reflect and justify the framework of actions of all health care workers in regard to ethical standards. Research: In the field of nursing research, nurses have to comply with ethical guidelines. They also have to reflect on their role in medical research.

3

Direct Care

3.1 Professional care according to »state of the art« Caregivers in oncology can only do their best for the patient, if they have a high level of professional knowledge. 3 Only with specialized knowledge, oncology nurses can act to the benefit of the patient: 4 They should know the handling of technical equipment and they should be informed about the current scientific state of nursing care in oncology. This is necessary to have many possibilities to act adequate to the special physical and psychological needs of the patient (principle of beneficence). An experienced and skilled oncology nurse will not harm the patient (principle of nonmaleficence) by wrong nursing standards, or fundamentally misunderstanding the patient in his directly or indirectly articulated worries and needs. Research in psychology and nursing for example showed by interviews with oncology patients how important the above mentioned issues are for the patients themselves. Patients very often report feelings of safety and trust when they experience that the nurse who takes care is experienced and has professional knowledge. Also the technical competence, for example, handling with catheters and pumps, are mentioned by patients. »I knew the bone marrow transplant was such a risky procedure. The nurses were so knowledgeable. My confidence level was high.« 5 The trust to the nurse’s professional knowledge is described as an important factor of well-being. 6

See Fölsch (2012), 2. Aufl., Ethik in der Pflegepraxis, p. 107. See Charalambousa et al. (2008), Listening to the voices of patients with cancer, their advocates and their nurses, p. 439. 5 Radwin (2000), Oncology patients’ perceptions of quality nursing care, p. 184. 6 See Laurel (2000), Oncology patients’ perceptions of quality nursing care, p. 184; Rchaidia et al. (2009), Cancer patients’ perceptions of the good nurse, p. 537. 3 4

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3.2 Relationship between patient and nurse and the nurse’s attitudes Which kind of care cancer patient get and how nurses provide this care is essential for the patient’s quality of life. It is important, that the caregivers carefully listen to the patient’s needs instead of rushing around and not concentrating to the individual person. Patients also describe the importance of being looked after by a nurse, as they always have the opportunity to be helped if the patient’s conditions will get worse situation unexpectedly. One of the most important things is the relationship between nurse and patient. A patient said: »The nurses are the key to lowering anxiety and helping one to feel cared for and respected.« 7 Empathy, attentiveness and the way how the nurses communicate are crucial for the patient as they fell as counterpart who is cared for by respecting him as person. 89 If they are respected as a person and cared with empathy they feel more safety and comfortable and this improves mental health. Patients have more hope, trust and are more optimistic. From an ethical point of view this is what the principle of autonomy claims – to respect every person as individual and to respect his/her wishes and needs – to accompany the patient during his illness as an individual person. 10 In regard to information, understanding and informed consent nurses are very often the first person of contact if the patient has to take a difficult decision or if there are questions about treatment and potential side effects. To help the patient to understand information helps the patient to become a better expert of his/her disease, thus to gain control and autonomy within the boundaries which are given by his disease. Nurses empower the patient if they share their professional knowledge and explain why they think that special nursing measures, tests or treatment are necessary from a professional point of view. 11 Rchaidia et al. (2009), Cancer patient’s description of their nursing care, p. 164. See Charamlambousa et al. (2008), Listening to the voices of patients with cancer, their advocates and their nurses, p. 439. 9 See Dowling (2008), The meaning of nurse-patient intimacy in oncology care settings. 10 Cancer patients’ perceptions of the good nurse (2009), p. 536. 11 See Laurel (2000), Oncology patients’ perceptions of quality nursing care, p.185; Charamlambousa et al. (2008), Listening to the voices of patients with cancer, their advocates and their nurses, p. 440; Rchaidia et al. (2009), Cancer patients’ perceptions of the good nurse, p. 536 f. 7 8

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3.3 Symptom management and quality of life Another very important point of direct nursing care is the management of symptoms. Symptoms from the cancer itself and symptoms from the treatment and side effects, e. g. pain, vomiting, sleep disturbances, depression and nutrition problems. These side effects have a great influence on the quality of life. With their knowledge and experience, nurses can influence the intensity of the symptoms and alleviate the discomfort. 12 With adequate empathic care and creative approaches, nurses can increase the well-being a lot – for example by looking whether a reduction of drugs might be possible for the patient being more awake and taking part in daily course of life around him. Anyhow nurses also may contribute to the well-being of the patient by providing for immediate and adequate pain killing. Nurses may not ignore the patient’s wish for alleviation of pain or not take him seriously. Altogether the management of symptoms contains a wide range of caring aspects which are ethically relevant, not least, if patients encounter existential issues. 13

3.4 End-of-life care Oncology nurses can influence the quality of life and the comfort for the patient by direct nursing care. When there is no hope anymore and the patient is going or die soon nurses’ empathic and professional care matters even more. The oncology nurse supports the patient and ensures his wishes in the last phases of his life will be respected (principle of autonomy). With her experience she acts to the benefit of the patient and knows how to handle specific situations in the end-of-life care. Situations with a great moral impact are communication with the patient about dying, coping with symptoms, appropriateness of medical treatment and sometime even the patient’s request for euthanasia. 14

Cancer patient and staff ratings of cancer behaviors and their relations to patient anxiety and depression (1998), p. 859. 13 See Ekedahla et al. (2007), Nurses in cancer care – stress when encountering existential issues, p. 232; Germino (1987). 14 See Georges et al. (2002), Moral problems experienced by nurses when caring for terminally ill people: a literature review. 12

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3.5 Distribution of resources and justice It is ethically relevant how the oncology nurse distributes her/his resources. The resources of a nurse in the direct care are time and attention. She has to be aware of to what extent and to whom she gives benefit by nursing actions. 15 In this field of justice among several patients, the nurse can be at odds with different subgroups of patients or with all of her/his patients. Besides, there are demands not only of patients, but of family members, colleagues, teams and the institution. The nurse has to reflect the question of her moral responsibility. Is she mainly responsible for the patient? To which extend is she responsible for the surrounding conditions of nursing and medical care? Should she consider herself as patient advocate, thus try to protect and encourage the vulnerable cancer patient? 16 At the same time it should be kept in mind that justice also means that patients, relatives, colleagues and organizations have to respect the rights and the integrity of the nurse. 17

3.6 Cultural differences, beliefs and needs Ethical issues arise related to different cultures and beliefs. One of the most prominent ethical topics related to different cultures and beliefs are Jehova’s witnesses who deny blood transfusion. Another common topic in Western Europe are women from different cultures who are »not allowed« to decide for themselves, or don’t understand the language of the country where they are living. Nurses have to be sensitive for many issues in a multicultural world. For example, autonomy of the individual which is strengthened in Western Europe has sometimes not the same status in other cultures. Furthermore, in other cultures, the family as a whole is more relevant compared to a single person. Nurses have to reflect patients’ values and beliefs. They should be aware of not valuing decisions of patients and their relatives in terms of their own value system. 18 See Fölsch (2012), Ethik in der Pflegepraxis, p. 144 ff. See Olthuis et al. (2007), Why hospice nurses need high self-esteem, p. 64 f. 17 See Abma (2005), Struggling with the fragility of life, p.343. 18 Charalambousa et al. (2008), Listening to the voices of patients with cancer, their advocates and their nurses, p. 440. 15 16

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Nurses should respect and support patient’s needs and whishes regardless of different beliefs and cultural customs. This is important in the daily care, in the support during the process of treatment and in the end-of-life care.

4

Health care team

Ethics is not only an important issue in the direct care – it is an important issue within the nursing team and in the whole health care team. In the interdisciplinary team, the patient’s welfare must always take priority over differences between members. Within the health care team, nurses face ethical issues in the patient education process. In addition, in medical treatment decisions conflicts arise where nurses perceive the necessity and appropriateness of the prescribed medical treatments differently from other team members. Ethical conflicts arise when the patients’ autonomy and dignity are not respected or when the trust between patient and care givers is damaged by incorrect or insufficient information. If there are conflicts, power games and accusations, physicians and nurses will not listen to each other and important information will be ignored, will not be shared or get lost. Patients see and feel the cooperation between the team members and this influences his trust and comfort to the health care team. 19 Teamwork leads to more positive patient outcomes, thanks to more reasoned decisions developed through increased information-sharing and fewer mistakes. 20 Many oncology nurses report moral distress because of inappropriate communication within the healthcare team. On the other hand, the development of effective health care teams and a supportive work environment have protective effects against burnout. 21

See Laurel (2000), Oncology patients’ perceptions of quality nursing care, p. 185. See Drew, Why is teamwork important in nursing care. 21 See Penson et al. (2000), Burnout: Caring for the Caregivers, p. 430; Medland et al. (2004), Fostering psychosocial wellness in oncology nurses: Addressing burnout and social support in workplace, p. 49. 19 20

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4.1 Patient information and education It is the responsibility of the physician to inform and educate the patient about his disease and treatment. Nurses face morally difficult situations when the physician did not give adequate information to the patient. 22 It is difficult for nurses when they have the impression that the patient is treated in a way that they think is harmful for the patient and thus wrong from an ethical point of view. To communicate with a not well or even non-informed patient can be difficult because the nurse or the relatives know more about the disease and might feel obliged to hedge questions or even to lie. 23 This will not only undermine trust and offense to the patient’s right to true information. It might furthermore establish a sort of unauthentic communication which can cause isolation and diffuse despair.

4.2 Different views in regard to medical treatment One of the main problems, which nurses report, are situations when the caregivers have diverging views about the medical therapy. 24 Nurses will feel great moral stress in such a situation. For example, if they are convinced that a certain therapy or examination will put too much strain on the patient, however, they have to execute the physician’s instructions. Similar problems occur if the health care team doesn’t act in consensus and or the medical staff follows different therapeutic plans. Moreover, they will feel powerless as they have to be part of a therapeutic regime that they think it is not wellthought-out. Physicians and nurses are involved in different fields of functions, thus they have specific responsibilities. Compared to physicians nurses normally spend more time with the patient. 25 For the wellbeing of the patient, according to the principle of beneficence, nurses and physicians should create a culture where they try to understand Kuuppelomäki et al. (1998), Ethical dilemmas in the care of patients with incurable cancer, p. 287 f. 23 Fölsch (2012), Ethik in der Pflegepraxis, p. 114. 24 See Kuuppelomäki et al. (1998), Ethical dilemmas in the care of patients with incurable cancer, p. 289 f. 25 See Georges (2002), Moral problems experienced by nurses when caring for terminally ill people: a literature review, p. 163. 22

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each other’s point of view and to find ways to decide together for the well-being of the patient according to his wishes. 26

4.3 Nurses role of patients advocate and translator Because of the close relationship between nurses and patient, nurses feel the responsibility to act as advocate for the patient. 2728 If wishes of the patient are not heard, ignored or team member act in a harmful way, nurses very often try to support the patient. Nurses play an important role when patients need support to get access to the best care which is possible in an organization (for example transfer to a palliative care unit). Nurses are often the first person to whom patients address their questions when they don’t understand the given treatment information. Patients often communicate better with the nurse than with the physicians. 29 All this shows how important the cooperation within the nursing care team and the health care team is. It has serious consequences for the patient if the health care team doesn’t work together. Cooperation and teamwork increase the quality of treatment. This implies that every caregiver has the responsibility to contribute his part for a good relationship within the nursing team and the health care team. 30

5

The family

Every phase of an oncological disease has special psychological challenges as every patient reacts different. Nurses are confronted with patient’s feelings from hope to desperation. Not only the patient has to go through this difficult time; the whole family is affected. Nurses are very often confronted with the feelings of family members and See Goethals et al. (2012), Nurses’ ethical reasoning and behavior. A literature review, p. 647. 27 See Gadow (1998), An ethical case for patient self-determination, p. 99. 28 See Fölsch (2012), Ethik in der Pflegepraxis, p. 109. 29 See Charalambousa et al. (2008), Listening to the voices of patients with cancer, their advocates and their nurses, p. 439; See Larson et al. (1998), Cancer patient and staff ratings of the importance of caring behaviors and their relations to patient anxiety and depression, p. 860 f. 30 See Fölsch (2012), Ethik in der Pflegepraxis, p. 107. 26

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have to decide how to handle the dynamic of the family – while focusing on the best of the patient. Evidently ethical issues arise in interaction with relatives and patient. What is to do, if family members go about patient’s decisions? 31 How to intervene if relative’s behavior has a negative effect on well-being of the patient – for example, slowing down convalescence or inducing stress during the dying process. However, family members are very often in need, too. They are sad, afraid and desperate. Sometimes, if the patient is not able to decide for himself anymore, family members are asked for surrogate decision making although feeling overwhelmed by the ongoing. Family members need also support, but nurses have limited resources. Anyhow, what responsibility do they have towards the relatives? They face special family constellations that involve questions of charity, distributive justice, and balancing of different opinions, values and moral rights. 32 The company of and communication with relatives is ethically relevant from the beginning of the disease, since this has a major impact on the welfare of the patient and of the family members themselves who are under great stress. Difficult situations occur if patients or family members switch their own feelings into criticism or even accusation of nurses. A breast cancer nurse told me: »Sometimes the husbands behave as if we were guilty for the wife’s cancer – especially husbands who seem not having cared for their wife in healthy days. It’s a difficult situation for the team members. Sometimes you can handle the situation but sometimes you feel blamed, and it is psychologically very burdensome.« An ethical analysis on the basis of the principle of justice helps to recognize that caregivers do not have to take such unjustified accusations in any case. Shure, to argue with relatives will be unrewarding, but the staff can ask the health care institution for support like supervision, consulting service or training in special problems of patient communication. With this support, it is easier for everybody involved to understand and to handle such difficult situations and to respect each other.

See Kuuppelomäki M., Lauri S. (1998), Ethical dilemmas in the care of patients with incurable cancer. 1998 (p. 289) 32 See e. g. Carole (1999), Caring for patients and relatives: an appraisal of palliative care philosophy; McLeoda et al. (2010), Knowing the family: Interpretations of family nursing in oncology and palliative care. 31

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Another ethically difficult situation is when family members infringe the rights of a patient. For example, when not wanting to tell the patient the truth, not accepting the wishes of the patient or deciding about therapy without focusing on the patient’s wishes and values. Some relatives even put pressure on the patient by telling the patient what he has to do. An example: A couple was married for more than 40 years. The husband was used to make most of the decisions in the family and was an active man. Now he has cancer, he is getting weak and weaker, and his wife can’t accept this declining process. She forces him to eat and to get out of bed. But the husband cannot and does not want to eat any more and wants to stay in bed, as moving or getting out of bed causes him heavy pain and exhausts him. The wife puts a lot of pressure on him and expects him to be more active and convalescent instead of accept the husband’s situation. Here the nurses have to reflect on whether to interfere. The experience of many cancer nurses shows, that if they build up a relationship with the family from the beginning, keep them updated and talk with them, they can build up a really good relationship. During the time of treatment, in worst case scenarios or in the process of dying there will be fewer conflicts. It will attribute to the patient’s well-being, if family members and the caring team accompany the patient together. 33

6

The institution

The institutional framework of care in oncology is very important from an ethical point of view. Nurses work within an organization. The framework conditions are essential for how nurses can do their work. 34 The resources are limited. Quite often shortage of nursing staff leads to low quality of care or even to high risk care. 35 The patient’s well-being is shaped by the surroundings in which he will be cured or die. Do patients’ needs have high priority in a health care institution? Will the patient’s needs be recognized on all See Charalambousa A. et al. (2008), Listening to the voices of patients with cancer, their advocates and their nurses p. 441 34 See Ekedahla (2007), Nurses in cancer care – Stress when encountering existential issues, p. 234. 35 See Georges (2002), Moral problems experienced by nurses when caring for terminally ill people, p. 161. 33

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for human beings important levels, as to say physically, psychologically, spiritually and socially? How qualified and how quickly will be responded to patients’ needs in the treatment of severe symptoms? Are dignity and privacy during treatment and dying respected and protected? Is it possible for family members to accompany the patients continuously? As already mentioned, quality and quantity of the staff and structural procedures are significant. But also special and organizational conditions, e. g. distance to the toilet, number of patients in one room, noise level and visiting hours are important factors for patients’ wellbeing. Organizational structure, job conditions and communication style will also form the institutional climate and the interactions between patients, relatives and professional carers. 36

7

Research in Nursing and Medicine

In general, medical research programs must have an approval by an ethical research board (ERB). In Europe most countries have clear ethical guidelines for research in medicine. The research must be useful and may not harm the patient. Besides, the patient must be informed and give his consent. On the one hand, nurses who conduct nursing care research have to stick to their professional ethical codes of conduct. As soon as more research will be conducted in nursing potential research participants should be treated analogous to ethical standards of medical research. 37 On the other hand, they can face ethical conflicts when they observe that other health care members ignore these guidelines. 38 It may happen that a physician or another caregiver persuades the patient to agree to participate in a clinical trial although the patient was not well informed beforehand. 39

See Ekedahla (2007), Nurses in cancer care – Stress when encountering existential issues, p. 234; Fölsch (2012), Ethik in der Pflegepraxis, p. 132. 37 See among others World Medical Association, Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects, latest version from 2013. 38 See Ramfelt (1998), Patients with cancer: Their approaches to participation in treatment plan decisions, p. 150. 39 See Kelly (1998), Caring and cancer nursing, p.733; Jaspers et al. (2006), Inclusion practice in lung cancer trials. 2006, p. 658. 36

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8

Summary

In the care of oncological patients, nurses face ethical questions in all their activities. They need to consider the ethical implications of their provided daily care and of their actions within the interdisciplinary team. Medical and nursing research, new treatments and new technologies require analysis and consideration by caregivers on a case by case basis to ensure the maintenance of ethical principles and their justified application. The presented collection of ethical issues in oncology nursing is certainly not complete, but gives a first overview. It already shows a huge variety of ethical issues of caring for patient with cancer. It is important that oncology nurses know how to make ethical decisions and that they are sensitive to recognize ethical issues. More professional education will be necessary to increase competency in a complex and challenging field of nursing. Nurses should be able to explain their moral point of view and to reflect on their daily care. If all groups of caregivers in oncology know how to handle ethical issues and if they discuss ethical issues in a constructive and ethically informed way, the patient, the whole health care team, the organization and the caregivers itself will benefit a lot.

References Abma TA.: Struggling with the fragility of life: a relational-narrative approach to ethics in palliative nursing. Nursing Ethics 2005; 12 (4): 337–348. Bobbert M.: Patientenautonomie und Pflege. Begründung und Anwendung eines moralischen Rechts. Campus Verlag Frankfurt/New York 2002. Charalambousa A., Papadopoulosb R., Beadsmoore A.: Listening to the voices of patients with cancer, their advocates and their nurses: A hermeneutic-phenomenological study of quality nursing care. European Journal of Oncology Nursing 2008; 12 (5): 436–442. Dowling M.: The meaning of nurse–patient intimacy in oncology care settings: From the nurse and patient perspective. European Journal of Oncology Nursing 2008; 12 (4): 319–328. Drew B.: Why is teamwork important in nursing care. http://www.ehow.co.uk/ info_8190750_teamwork-important-nursing-care.html (Zugriff: 28. 01. 2012). Ekedahla M., Wengströmb Y.: Nurses in cancer care – Stress when encountering existential issues. European Journal of Oncology Nursing 2007; 11(3): 228– 237.

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Doris Fölsch Fölsch D.: Ethik in der Pflegepraxis. Anwendung moralischer Prinzipien auf den Pflegealltag. Facultas Verlag Wien 2012, 2nd ed. Gadow S.: An ethical case for patient self-determination. Seminars in oncology nursing. 1998; 5(2): 99–101. Georges JJ., Grypdonck M.: Moral problems experienced by nurses when caring for terminally ill people: a literature review 2002; Nursing ethics 2002; 9(2): 155–178. Goethals S., Gastmans C., de Casterlé B.: Nurses’ ethical reasoning and behaviour: a literature review. International Journal of nursing studies 2012; 47 (5): 635–650. Germino BB.: Symptom distress and quality of life. Seminars in oncology nursing 1987; 3(4): 299–302. Jaspers P., van der Arend A., Wanders R.: Inclusion practice in lung cancer trials. Nursing Ethics 2006; 13 (6): 649–60. Kelly D.: Caring and cancer nursing: framing the reality using selected social science theory. Journal of advanced nursing 1998; 28(4): 728–736. Kuuppelomäki M., Lauri S.: Ethical Dilemmas in the care of patients with incurable cancer. Nursing Ethics 1998; 5 (4): 283–293. Larsson G., Widmark Person V., Lampic C., von Essen L., Sjöden PO.: Cancer patient and staff ratings of the importance of caring behaviors and their relations to patient anxiety and depression. Journal of Advanced Nursing 1998; 27 (4): 855–864. Laurel, R.: Oncology patients’ perceptions of quality nursing care. Research in Nursing & Health, 2000; 23(3): 179–190 McLeoda D. L., Tapp D. M., Moule N. J., Campbell M. E.: Knowing the family: Interpretations of family nursing in oncology and palliative care. European Journal of Oncology Nursing 2010; 14 (2): 93–100. Medland J., Howard-Ruben J., Whitaker E.: Fostering psychosocial wellness in oncology nurses: Addressing burnout and social support in the workplace. Oncology Nursing Forum 2004; 31(1): 47–54 Olthuis G., Leget C., Dekkers W.: Why hospice nurses need high self-esteem. Nursing Ethics 2007; 14 (1): 62–71. Penson R. T., Dignan F. L., Canellos G. P., Picard C. L., Lynch T. J.: Burnout: Caring for the Caregivers. The Oncologist 2000; 5 (5): 425–434. Ramfelt E., Lützén K.: Patients with cancer: Their approaches to participation in treatment plan decisions. Nursing ethics 2005; 12 (2): 143–155. Rchaidia L., Dierckx de Casterlé B., De Blaeser L., Gastmans C.: Cancer patients’ perceptions of the good nurse: a Literature Review. Nursing Ethics 2009; 16 (5): 528–542. Willard, C.: Caring for patients and relatives: An appraisal of palliative care philosophy. European Journal of Oncology Nursing 1999; 3 (1): 38–43.

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Maren Goeckenjan and Bettina Böttcher, Ludwig Wildt, Thomas Strowitzki

Medical and ethical issues of fertility preservation in female cancer patients Successful therapeutic regimens in women with cancer in childhood or early adulthood have offered cancer survivors the chance to reach the age of reproduction and active family-planning. But therapy induced infertility often counteracts this perspective of life. Therefore, with the diagnosis of a malignancy in a young woman or girl, discussion of fertility preservation should be undertaken prior to starting treatment. Various modern techniques of fertility preservation in women with cancer exist, but they are not yet evidence-based and standardized. They differ in efficacy of fertility preservation and achievable pregnancy rates, as well as in possible side effects and complications. The difficulties of interdisciplinary coordination of fertility preservation and oncological treatment, plus the confrontation with a lifethreatening diagnosis, combined with the necessity of reaching a decision in a short space of time create a special burden for the counseling required. Ethical implications of this special situation are discussed. The wide range of conflicts in the decision-making process is marked by the normative and communicative concept of autonomy and authenticity. Especially authenticity – based on the personal autonomy and biographical identity – is the main aspect of this challenging situation.

Introduction Preventive measures designed to preserve fertility following a cancer diagnosis in childhood or early adulthood became more and more common in the last 10–20 years. Children, young women, and men with a diagnosis of cancer have increasingly good chances to survive their disease. The data of the US-American national cancer registry show that the 5-year survival rates among children for all cancers increased from 58 % in the 70’s to 83,4 % for cancer diagnosed be49 https://doi.org/10.5771/9783495813430 .

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tween 2000 and 2011 (SEER 2015). The incidence of breast cancer at the age younger than 40 years is about 100/100.000 in Germany (GEKID 2015). It was estimated, that 1 out of 570 women or men between 20 and 34 years is a longtime survivor of cancer in childhood or adolescence (Henderson et al. 2010). About 7 % of women with breast cancer are younger than 40 years at the time of diagnosis (Hankey et al. 1994). Since the overall health of these female cancer survivors is roughly comparable to women not affected by cancer, the wish to have a child will occur after the disease while the woman is still in the reproductive age. In a German study, 70 % of 240 women and men who were survivors of cancer in adolescence expressed their desire to have children (Reinmuth et al. 2008). On the one hand, according to a survey by Schover et al. 1999, about 80 % of cancer survivors identified their illness as a life experience which would even enhance their ability to raise a child successfully. On the other hand, 20 % of the women in this study fear that pregnancy could trigger a reccurrence of the cancer. Canada et al. 2012 could also demonstrate that the unfulfilled desire for a child causes an ongoing psychosocial distress even 10 years after the first diagnosis and therapy of a malignant disease, e. g. invasive cervical cancer, breast cancer, Hodgkin’s disease, or non-Hodgkin’s lymphoma. Female cancer survivors face not only the risk of impaired fertility but also clinical signs of premature ovarian failure. After radiotherapy or chemotherapy in childhood, about 8 % of survivors have premature non-surgical ovarian failure (Green et al. 2009). Impairment of fertility is a long-term sequela of oncological therapy. It is recommended that this aspect and possible fertility preservation options should be addressed as part of the counseling before oncological treatment is initiated (Loren et al. 2013). Chemotherapeutical agents, individually or especially in combination, as well as radiotherapy may be gonadotoxic and may lead to amenorrhea and premature ovarian failure in a high percentage (Meirow et Nugent 2001). Lutchman et al. 2005 showed the effects of chemotherapy on the different parameters for fertility in women: Not a single clinical parameter for ovarian testing can reliably predict the effects of cancer therapy. The combination of biochemical and functional ovarian tests is useful.

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It is important to assess the individual risk for ovarian failure based on the age and individual characteristics of the patient and the oncological treatment before the treatment is initiated. In a consultation with a specialist for gynecological endocrinology and reproductive medicine, the individual parameters of ovarian reserve should be discussed. Currently, the proposed tests for ovarian reserve is the combination of vaginal ultrasound with the count of antral follicles (AFC) and the serum level of Anti-Müllerian-Hormone (AMH) (Fanchin et al. 2003). Serum AMH levels can be measured independently from menstrual cycle (Cook et al. 2000). Current studies propose nomograms for women with breast cancer to predict the individual effect of chemotherapy on ovarian reserve (Barnabei et al. 2015). In this counseling process, it is important to discuss family planning and anticipated perspectives for life with the patient and her/his partner. Individual demands should be addressed in an open consultation. Based on medical, psychological and social aspects, methods of fertility preservation can be offered (figure 1). Disease specific factors Type of Cancer Proposed treatment Actual threat of health Depression, fear Internal situation and beliefs

External factors

Sociodemographics Cultural background Spiritual beliefs Social structure Family situation and planning

Access to information and fertililty preservation methods Beliefs of consulting doctors Health policies Financial situation and possible demands

Figure 1: Factors influencing the counseling on fertility preservation in cancer patients

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Options of fertility preservation in cancer patients The cryopreservation of sperm samples by masturbation of sexually mature boys and men with cancer before cancer therapy is initiated has been offered for a long time. Sperm samples can be collected without complicated interventions and without time loss in comparison to methods of fertility preservation and cryopreservation in females. Therefore, there is an ongoing discussion concerning the best and most practical method to preserve fertility in women with cancer (Salama et al. 2012). Modern methods of fertility preservation for women are – pharmacological protection of the ovary with GnRH-analogues, – transposition of ovaries (method to protect from the effects of radiotherapy of the pelvis), – oocyte freezing after controlled ovarian stimulation with vitrification of unfertilized oocytes, – standard-in vitro fertilisation (IVF) mainly using intracytoplasmatic sperm injection (ICSI), followed by freezing of pronucleus cells or embryos, – ovarian tissue freezing followed by retransplantation, – maturation of oocytes from immature antral follicles (IVM). The special advantage of cryopreservation of ovarian tissue is the possibility to perform the intervention without delaying treatment (Burns et al. 2006). Recently retrospective reports of pregnancies after transplantation of cryopreserved ovarian tissue (Imbert et al. 2014, Donnez et Dolmans 2015, Dittrich et al. 2015) demonstrate that it is a realistic option to restore ovarian function after oncological treatment with a good chance of pregnancies. Other advantages and disadvantages of the different methods are shown in table 1. Especially for hormone-sensitive cancer, the risk of stimulation of tumor growth or increased risk of recurrence by hormonal stimulation and later pregnancies were postulated. A recent review with currently available data on pregnancy after breast cancer does not show an elevated risk of death in comparison to women without subsequent pregnancies (Litton 2012). Latest developments aim to reduce possible risks related to the controlled hyperstimulation to retrieve oocytes. In women with breast cancer high estradiol peaks under stimulation should be 52 https://doi.org/10.5771/9783495813430 .

Medical and ethical issues of fertility preservation in female cancer patients Method

Advantages

Disadvantages

Efficacy

Cryopreservation of ovarian tissue and reimplantation

No delay of oncological treatment Reducing side effects due to estrogen deficiency

Repeated laparoscopy with additional risks Possible re-implantation of residual cancer cells

Pregnancies are reported world-wide, chance of pregnancy about 30–50 % after retransplantation

Pharmacological protection (GnRH-a)

Possible protection of fertility and delay of premature ovarian failure Easy method, reduction of hemorrhage due to menstrual bleeding complications

Side effects of rapid pharmacologicallyinduced premature menopause

Effect questioned, divergent effects shown in studies, especially for pregnancy rates (Bedaiwy et al. 2011)

Transposition of ovaries

Indication is radioLaparoscopy needed therapy in the field of the ovaries

Rare indications, reduced ovarian function due to altered blood supply

Oocyte freezing Fertility preservation (slow freezing or offered to women vitrification) without a partner

Controlled ovarian hyperstimulation with delaying of cancer treatment, delay of 10–14 days Possible effect on hormone-dependent cancer cells

In vitro fertiliza- Fertility preservation tion (IVF/ICSI), offered to women cryopreservation with a partner of pronucleus cells embryos

Controlled ovarian Standard method, hyperstimulation modifications of stiwith delaying of can- mulation protocols cer treatment, delay of 14 days Possible effect on hormone-dependent cancer cells

In vitro maturation

No or only light sti- Only possible in few mulation necessary to centers retrieve oocytes. Possible use of cryopreserved ovarian tissue

Slow-freezing of oocytes with reduced pregnancy rates compared to embryos (Borini et al. 2007, Oktay et al. 2006), vitrification of oocytes is standard method

Experimental method

Table 1: Advantages and disadvantages of modern fertility preservation methods in women with planned cancer treatment

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Picture 1: Laparoscopy excision of ovarian tissue for cryopreservation (picture from university hospital of Heidelberg).

Picture 2: Laparoscopic transposition of left ovary before radiotherapy of the pelvis (pictures from University hospital of Heidelberg).

avoided by using gonadotropin stimulation in combination with the aromatase inhibitor letrozole this could be a benefit without impairment of the number of oocyte retrieved (Oktay et al. 2006). Another important modification of stimulation protocols is the start of hormonal stimulation in the late follicular and also luteal phase (von Wolff et al. 2009). This allows the initiation of follicle stimulation almost independently from the menstrual cycle of the women and therefore shortens the delay of cancer treatment. The duration of the stimulation is comparable to the start of stimulation in early follicular phase, but the required gonadotropin doses were increased and aspirated oocytes counts were 13.1 (follicular phase-stimulation) and 10.0 in luteal phase. Slightly higher fertilization rates were achieved. Even the combination of two techniques with oocyte retrieval and cryopreser54 https://doi.org/10.5771/9783495813430 .

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vation of ovarian tissue followed by controlled ovarian hyperstimulation and oocyte retrieval is a practical method without impairment of the oocyte retrieval (Dolmans et al. 2014).

Fertiprotekt: A network on fertility preservation in German speaking countries In 2006 a network in German speaking countries was founded to improve systematic evaluation and coordination of fertility preserving techniques. There are 75 centers and more than 30 university centers contributing to this network. Annual meetings, information brochures, a nationwide registry, and coordination of scientific studies and publications are provided (www.fertiprotekt.de). Current publications on the fertility protection network, for example, display the complications during ovarian stimulation in patients with cancer and ovarian tissue cryopreservation. von Wolff et al. 2015 published the data of more than 5000 women in the Fertiprotekt-consortium with fertility preservation counseling and treatment before chemotherapy was initiated.

Counseling on fertility preservation The counseling on fertility protection methods is part of an initiative of preventive medicine. Two aspects are important: preserving or restoring fertility and reducing or avoiding potential symptoms of early ovarian insufficiency. Cancer patients should be informed about established and available options for fertility preservation before informed consent to an oncological therapy is given. Furthermore, an interdisciplinary approach is necessary – aspects of medical, surgical and radiation oncology, pediatrics, genetics, psychology, ethics, and health law shall be parts of the decision-finding process (Böttcher and Paul 2012). In 2001 40 % of women were referred to the gynecologist for counseling on fertility preservation after (!), not before cancer treatment was initiated. This proportion switched by 2010 to 10 % counseling of oncological patients after potentially gonadotoxic cancer therapy; the vast majority of women was seen prior to the initiation of cancer treatment (Lee et al. 2011). Men with cancer were informed 55 https://doi.org/10.5771/9783495813430 .

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by an oncologist about sperm cryopreservation in about 50 to 60 percent of the cases (Schover et al. 2005). In a retrospective survey in California, more than 1.000 women of reproductive age with a diagnosis of various malignant diseases from 1993–2007 were asked about fertility counseling. About 50 % of the women recalled having received reproductive health counseling, whereas only 10 % remembered that they were counseled on fertility preservation (Niemasik et al. 2012). An analysis of women having received counseling on fertility preservation showed that women with higher socio-economic status and older age decided in a higher percentage for fertility preservation treatment (Kim et al. 2009). Another factor was an earlier cancer stage, which led significantly more often to the decision for fertility preservation techniques.

General ethical considerations As pointed out before, counseling on fertility preservation should be undertaken for women and men with cancer (ISFP practical commitee 2012). Nevertheless medical, ethical, and legal questions are still under debate (Patrizio and Caplan 2010). One psychological benefit from the discussion of fertility preservation with cancer patients and their family is the positive vision of the future after successful cancer treatment. Addressing fertility and family planning may give additional hope, especially for young women and girls (Wallace and Thomson 2003). Solely the assurance that ovarian tissue or embryos are cryopreserved can evoke hopeful feelings, which supports the patient psychologically during cancer therapy. The decision about fertility preservation must be made under the pressure of time and under the threat of a potentially lethal disease. The situation of the patient is influenced by existential fears of suffering and death in addition to a dramatic change of all former perspectives in life planning. Furthermore, the patient is confronted with problems of everyday life, like financial aspects, job perspectives, and care for existing children. She is confronted with the possibility of infertility all of a sudden. Financial aspects are not to be neglected as patients might not be able to afford techniques of assisted reproduction, and financial support by health insurance is often not provided. 56 https://doi.org/10.5771/9783495813430 .

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The situation of physicians is exceptionally complex as well. Facing the disease imminent clinical decisions on the health and the possible treatment are much closer to medical reality than uncertain, prospective future family planning aspects. They might hesitate to discuss and offer techniques for fertility preservation due to several reasons. For example, lack of time and insufficient knowledge can be limiting factors. Doctors might think that the prognosis of the disease is too uncertain, so fertility preservation is unnecessary. It is questionable if it is really possible to give understandable and adequate information on a future family planning aspect in this situation, considering the special situation of patients and physicians. Medical questions related to the proposed fertility protection techniques such as safety aspects related to the re-implantation of autologous cryopreserved ovarian tissue of a cancer survivor are still not answered. Actual data show an elevated risk of recurrence of the disease in leukemia, but not in lymphoma (Dolmans 2011). The experimental character of most of these techniques is another problematic aspect of counseling as success cannot be guaranteed (Frydman and Grynberg 2015). Risks of the methods, as well as the benefits, should be calculated and included into the process of decision making. The individual disposition to take risks might differ considerably. The option to deny any treatment should be taken into account (Cohen CB 2009). The impact on health of children born after cancer therapy also remains unclear up to now, although almost 2000 pregnancies and births of female survivors of cancer did not show an increased risk for low birth weight, preterm delivery, malformations, or mortality (Mueller et al. 2009). These results were confirmed in an Australian study with a comparable number of pregnancy of cancer survivors, no increased risk for congenital malformations and perinatal death was seen (Haggar et al. 2014). The risk of cancer for the offspring of female cancer survivors with fertility preservation treatment can only be analyzed as a longterm follow- up. Up to now, children born to cancer survivors after fertility preservation techniques are not more than 10 years old. Two risks for increased cancer development in these children can be assumed: the potential risk due to the mother’s treatment of the disease or due to offspring’s heritable cancer development, as in retinoblastoma or breast cancer. Another aspect concerning the next generation is the possibility 57 https://doi.org/10.5771/9783495813430 .

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that the children are raised as orphans in the case of early death of cancer patients. However, according to a statement of ASRM ethical committee 2005, the risk of being raised by a single parent is »not a sufficient reason to deny cancer patients assistance in reproduction« (Fallat et al. 2008, p. 1466). Another ethical question related to cryopreservation of sperm, ovarian tissue, and oocytes is the management of the material after the donor’s death (Dillon and Fiester 2012): Who is authorized to decide about it and can – besides reproduction – other ways of »utilization«, e. g. for future medical research, be legitimated? The management of cryopreserved material after death depends on national law. In German-speaking countries, posthumous reproduction is not allowed. Fertility preservation in children remains another open issue. Special comments on this difficult counseling with the parents and the child are made by the American Society of Pediatricians (Fallat et al. 2008): One reason for not discussing fertility aspects with parents of girls with cancer was the age (Anderson et al. 2008). The use of ovarian tissue of young girls is experimental, and the stimulation and oocyte retrieval in post-pubertal adolescent girls is not yet a standard procedure. An unfamiliar aspect of discussing fertility preservation is the emotional pressure related to the option to have a child after surviving cancer – possibly related to an internal and external demand to decide in favor of a child because the decision had been made earlier. This dilemma may be described with the duty to fulfill the reproductive prediction. But what happens if the woman does not wish to have a family and children, possibly due to the severe and life-threatening experiences of surviving cancer and cancer treatment? This scenario raises the question whether the freedom to decide against family may be impaired in a very subtle way. This for medical doctors interesting but unfamiliar thought of apodiction of fertility was raised by the lawyer DE Roberts at the symposium in Heidelberg in May 2012. The medical treatment may therefore lead to a diminished autonomy to decide over their future because of external demands, especially familiar and social, and internal desire. Fertility preservation may complicate the situation of a woman with cancer and cancer treatment. For she as a survivor is under pressure to fulfill the demand to have a child. This dilemma is especially difficult to be solved as the remaining question about safety of pregnancy for the women them58 https://doi.org/10.5771/9783495813430 .

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selves and their offspring are not clearly answered by now. Additionally, in case of cryopreserved embryos, the partner has to agree on the future transfer of the embryo. The woman depends on this agreement as the only way to fulfill her motherhood. This dependence might influence the couple’s relationship.

Discussion of autonomy and presentation of an alternative ethical concept Fallat et al. (p. 1464/2008) described the above illuminated particular situation as the »dilemma of counseling: fertility preservation may create both burden and opportunities for patients with cancer«. The capacity for decision making might be limited. Is an autonomous decision, as is often desired in clinical decision making, possible under these circumstances? Respect for autonomy as part of the ethical framework by Beauchamp and Childress 2009 is a key concept of decision making in clinical contexts. This normative concept might be overstrained due to the discussed characteristics of this setting: Respect for autonomy includes criteria for informed consent, which should be fulfilled to enable a person to an autonomous decision: Preconditions are the so-called threshold elements which are the competence to understand and decide and secondly determine the voluntariness in deciding. Information elements contain disclosure of information, recommendation of a plan, and understanding of the given information. Consent elements are the decision in favor of a plan and the authorization of the chosen plan. One condition for autonomous decision making is competence of the patient, which is relative to a particular decision to be made. This may vary over time and be intermittent. Another criterion for informed consent is disclosure: Disclosures should cover aims and methods of research, anticipated benefits and risks, any anticipated inconvenience or discomfort, and the subjects’ right to withdraw, without penalty, from the research (Beauchamp and Childress 2009, p. 121).

Research cannot be justified if significant risk is involved and patients are not informed that they are being placed at risk. Understanding need not be complete but certain conditions like diagnosis, prognosis, risks and benefits are essential. Voluntariness is another essential 59 https://doi.org/10.5771/9783495813430 .

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condition for informed consent. For an autonomous decision, it has to be assessed whether these criteria apply in this particular situation. First, strong emphasis is put on rational arguments. Fertility is not a pure rational desire; social expectations are in contrast to conditions of the body which might no longer be fertile. So this concept can be considered as in a way »disembodied«. The conflict which influences the decision making process is the mismatch between the desire for a child and future perspective with a growing family and the capability of the body with a fatal disease. Another critical point is that the concept of an autonomous decision-making process might be too individualistic. We focus on the female patient, on the woman, forgetting that she will hardly be able to become pregnant on her own, so the father has to be considered, at least as a semen donor, to be part of this decision. Furthermore, it has to be questioned whether we are responsible for the rights of the unborn baby as discussed above. Aspects of relationship between all persons involved, also in terms of positive influences, are neglected. In such a vulnerable situation, information is always limited, even more because of the experimental character of the techniques available. The condition to provide the patient with sufficient information is difficult to follow as the risk of the therapy itself and prognosis of the disease are not known. As no significant risks in research -as a condition for autonomy in this theory- may apply, it remains an open question as to who is responsible to calculate the risk; the physician himself might be overwhelmed. In this particular situation, the criteria for an autonomous decision can hardly be met. An alternative, but not necessarily paternalistic, decision making is needed. The concept of authenticity may be integrated into counseling. A few definitions of authenticity are illustrated: A widespread description of authenticity is made by Taylor: »It gives a new importance to being true to myself. If I am not, I miss the point of my life, I miss what being human is for me« (Taylor C 1991, p 29). Brudney D 2009 describes authenticity as a part of a decision on the basis of best interest. Holm S 2001 demands a careful analysis and interpretation of the patient’s history and the background interests. The caregiver or physician cannot be relieved of his obligation to personally assess the desires of the patient. For Schöne-Seifert et al. 1999, authenticity is a condition for autonomy. A conscious and reflective decision is required. She demands a directive counseling with 60 https://doi.org/10.5771/9783495813430 .

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inquiries and the offer of one’s own subjective judgment. Authenticity in the philosopher Quante’s work is a central term (Quante M 2002): Personality is a condition for authenticity leading to personal autonomy and includes a social self- concept. Background is an individual arrangement of one’s own personality within one’s own biography, including values and norms, emotions, beliefs, desires, and life plans. Development of personality is linked to a network of personal relationships. This includes communication and appreciation of others as individuals. Personal autonomy allows a partial surrender of autonomy. This means that a person may delegate certain actions and decisions to others, but under conservation of his personality and biographical identity and authenticity. Considering the critical points of the concept of autonomy and principalism, the concept of authenticity might be more applicable for decision making in this particular situation. An authentic decision making is suggested as an appropriate alternative concept in the context of fertility preservation (Böttcher and Paul 2012).

Conclusion The counseling of younger cancer patients on infertility and fertility preservation, and the decision-making process for techniques is a challenge in preventive medicine – both as a communicative and normative challenge. This counseling should be implemented in regular cancer treatment as a standard, even though methods of fertility preservation may be adapted in the next years. Aspects should be discussed in a tumor board among the interdisciplinary experts and together with the patient afterwards. The situation is unique for patient and physicians. Up to now, some of the modern techniques of fertility preservation are still not evidence based, but rather experimental. The individual outcome cannot be predicted. The counseling process includes information on the effects of the planned gonadotoxic cancer treatment, and information on possible fertility preservation methods: pharmacological protection, retrieval of oocytes to be cryopreserved as fertilized or unfertilized oocytes, cryopreservation of semen or ovarian tissue (figure 2).

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Diagnosis of cancer

Planning of oncological treatment

1. Information on fertility impairment as a sequelae of treatment (infertility rates, chemotherapy induced amenorrhea) 2. Assessment of funtional ovarian reserve (age, Ultrasound, AMH) 3. Objective presentation of medical options to preserve fertility 4. Evaluation of individual risks and benefits through fertility preservation 5. Informed consent in experimental treatments, possible psychological support and time for reconsideration Figure 2: Steps of counseling on preservation of fertility in oncological patients

The aim of the counseling process should be to assess the individual risk of infertility, techniques of fertility preservation, risks and benefits, and moral and psychological problems. Psychological counseling should also be offered additionally. The discussion of pending questions regarding special needs, desires, dreams, and life plans is the crucial aim of the counseling sessions. This should enable the patient to an authentic decision.

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Medical and ethical issues of fertility preservation in female cancer patients cryopreservation of ovarian tissue to preserve fertility: a 12-year retrospective analysis. Hum Reprod. 2014 Sep;29(9):1931–1940. doi: 10.1093/humrep/ deu158. ISFP Practice Committee, Kim SS, Donnez J, Barri P, Pellicer A, Patrizio P, Rosenwaks Z, Nagy P, Falcone T, Andersen C, Hovatta O, Wallace H, Meirow D, Gook D, Kim SH, Tzeng CR, Suzuki S, Ishizuka B, Dolmans MM. Recommendations for fertility preservation in patients with lymphoma, leukemia, and breast cancer. J Assist Reprod Genet. 2012 Jun; 29 (6): 465–468. Epub 2012 May 31. Kim J, Oktay K, Gracia C, Lee S, Morse C, Mersereau JE. Which patients pursue fertility preservation treatments? A multicenter analysis of the predictors of fertility preservation in women with breast cancer. Fertil Steril. 2012 Mar; 97 (3):671–676. Epub 2012 Jan 4. Lee S, Heytens E, Moy F, Ozkavukcu S, Oktay K. Determinants of access to fertility preservation in women with breast cancer. Fertil Steril. 2011 May; 95(6): 1932–1936. Epub 2011 Mar 3. Litton JK. Breast cancer and fertility. Curr Treat Options Oncol. 2012 Jun; 13(2): 137–145. Loren AW, Mangu PB, Beck LN, Brennan L, Magdalinski AJ, Partridge AH, Quinn G, Wallace WH, Oktay K; American Society of Clinical Oncology. Fertility preservation for patients with cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2013 Jul 1;31 (19):2500–10. doi: 10.1200/JCO.2013.49.2678. Epub 2013 May 28. Lutchman Singh K, Davies M, Chatterjee R. Fertility in female cancer survivors: pathophysiology, preservation and the role of ovarian reserve testing. Hum Reprod Update. 2005 Jan-Feb; 11(1): 69–89. Epub 2004 Nov 29. Meirow D, Nugent D. The effects of radiotherapy and chemotherapy on female reproduction. Hum Reprod Update. 2001 Nov-Dec; 7(6): 535–43. Mueller BA, Chow EJ, Kamineni A, Daling JR, Fraser A, Wiggins CL, Mineau GP, Hamre MR, Severson RK, Drews-Botsch C. Pregnancy outcomes in female childhood and adolescent cancer survivors: a linked cancer-birth registry analysis. Arch Pediatr Adolesc Med. 2009 Oct; 163 (10): 879–886. Niemasik EE, Letourneau J, Dohan D, Katz A, Melisko M, Rugo H, Rosen M. Patient perceptions of reproductive health counseling at the time of cancer diagnosis: a qualitative study of female California cancer survivors. J Cancer Surviv. 2012 Sep; 6 (3): 324–332. doi: 10.1007/s11764–012–0227–9. Epub 2012 Jul 3. Oktay K, Cil AP, Bang H. Efficiency of oocyte cryopreservation: a meta-analysis. Fertil Steril 2006; 86:70–80. Oktay K, Hourvitz A, Sahin G, Oktem O, Safro B, Cil A, Bang H. Letrozole reduces estrogen and gonadotropin exposure in women with breast cancer undergoing ovarian stimulation before chemotherapy. J Clin Endocrinol Metab. 2006 Oct; 91(10): 3885–3890. Epub 2006 Aug 1. Patrizio P, Caplan AL. Ethical issues surrounding fertility preservation in cancer patients. Clin Obstet Gynecol. 2010 Dec; 53 (4): 717–726. Quante, Michael (2002): Personales Leben und menschlicher Tod. Personale Identität als Prinzip der biomedizinischen Ethik. Frankfurt am Main.

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Maren Goeckenjan and Bettina Böttcher, Ludwig Wildt, Thomas Strowitzki Reinmuth S, Liebeskind AK, Wickmann L, Bockelbrink A, Keil T, Henze G, Borgmann A. Having children after surviving cancer in childhood or adolescence – results of a Berlin survey. Klin Padiatr. 2008 May-Jun; 220 (3): 159– 165. Salama M, Winkler K, Murach KF, Seeber B, Ziehr SC, Wildt L.: Female fertility loss and preservation: threats and opportunities. Ann Oncol. 2012 Nov 4. [Epub ahead of print]. Schöne-Seifert B (1999) Präimplantationsdiagnostik und Entscheidungsautonomie. Neuer Kontext – altes Problem. Ethik Med 11: 87–98. Schover LR, Brey K, Lichtin A, Lipshultz LI, Jeha S. Knowledge and experience regarding cancer, infertility, and sperm banking in younger male survivors. J Clin Oncol. 2002 Apr 1;20(7):1880–1889. Schover LR, Rybicki LA, Martin BA, Bringelsen KA. Having children after cancer. A pilot survey of survivors’ attitudes and experiences. Cancer. 1999 Aug 15; 86 (4): 697–709. Taylor C (1991): The ethics of authenticity. Harvard University Press, Cambridge, Massachusetts, London. von Wolff M, Dittrich R, Liebenthron J, Nawroth F, Schüring AN, Bruckner T, Germeyer A. Fertility-preservation counselling and treatment for medical reasons: data from a multinational network of over 5000 women. Reprod Biomed Online. 2015 Nov;31(5):605–612. doi: 10.1016/j.rbmo.2015.07.013. von Wolff M, Thaler CJ, Frambach T, Zeeb C, Lawrenz B, Popovici RM, Strowitzki T. Ovarian stimulation to cryopreserve fertilized oocytes in cancer patients can be started in the luteal phase. Fertil Steril. 2009 Oct;92 (4): 1360– 1365. Epub 2008 Oct 18. Wallace WH, Thomson AB. Preservation of fertility in children treated for cancer. Arch Dis Child. 2003 Jun; 88 (6): 493–496.

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Children as vulnerable patients in oncological medicine and treatment

1

Introduction

This article concerns the ethical questions surrounding the vulnerability of children as patients in cancer treatment. 1 Children are generally considered as a typical group of vulnerable patients. However, children are not all the same but instead form a heterogeneous group of patients. There are different kinds of reasons for children’s vulnerability and therefore different kinds of ethical issues. To deal with these ethical issues concerning children, it must be taken into consideration that children find themselves in a complex social situation when they are diagnosed with a severe disease such as cancer and supposed to get (in-patient) treatment. The social situation in which they find themselves involves three more parties other than children themselves: the parents, the doctors, and the state. This article will therefore not focus on children as isolated persons, but consider instead the ethical questions concerning children within that complex social framework. Before starting with the ethical analysis, a preliminary note has to be made with regard to the background of this article and its ambition. In the light of the terrifying nature of cancer in children and the dramatic nature of cancer treatment in children, I feel the need to say that I have no special knowledge or experiences with regard to clinical or specific pediatric treatment. Different from other thinkers in the field of bioethics, I am solely a »doctor« of philosophy without any medical training and praxis. Trying to be aware of the extraordinary human distress and the complexity of the topic I want to underline that the paper is only meant as a proposal of some analytical differentiations, ethical principles and ideas for practical steps – that has to be subject to further critical examination and discussion. I am grateful for comments and suggestions by Nelson Englert and Irene Schickhardt.

1

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2

Children

There is a widely accepted agreement on the matter that children are vulnerable patients. However, in order to deal adequately with the ethical questions arising with regard to children’s vulnerability, it is necessary to have a more detailed understanding of children and their vulnerability. First of all, it is necessary to clarify what we mean when speaking of »child« or »children«. In article 1 of the UN-Convention on the Rights of the Child all people below the age of eighteen or below the age of legal emancipation are defined as children. In this paper, I will henceforth use the terms »child« or »children« in that specific meaning defined by the UN. It is a formal definition which is completely based on age. This entails that the term »children« refers to neonates as well as to adolescents. Calling a certain person a »child« doesn’t depend therefore on that person’s lack of capacities or maturity. Individuals of very different cognitive capacities and of different states of mental and personal development can belong to the group of children. 2 At the bottom of the developmental scale, children, especially the youngest, will be completely without cognitive and social capacities, and therefore lack any understanding of their situation as patients. These children depend completely on others and are not able to understand and express what their needs are. The determination and satisfaction of their (medical) interests or needs, even of the most vital ones, depend on other protagonists of the pediatric scenario, first of all on their parents and doctors. At the top of the developmental scale, since individuals of the age of twelve, fourteen or seventeen count as children as well, there will be children who are mature like a normal adult with concern to their concrete medical situation. In addition – and this might hold for the majority of children – there is a large and complicated grey area between these two extremes. It is the area of development, the area of transition between the states of complete lack of capacities on the one hand and great mental and personal maturity on the other hand. Sure, many children will be in this area of transition and display individually one of all the possible and different degrees, which can be encountered during the complex process of developing from neonates into adults.

2

See also Gaylin (1982).

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3

Vulnerability

Vulnerability is a term which seems to have a clear meaning. When having a closer look at the term, however, the question about its precise meaning arises quickly and is not that easy to answer. 3 In the following, I will therefore point out three different possible nuances of the meaning of vulnerability. First, in comparison to »normal« patients, a vulnerable patient might be seen as a person with fewer skills and less power to defend her interests and to get what she wants or needs. In this sense, vulnerability refers to the world of social interaction where somebody might be more or less able to assert his interests and to assure that they are met and respected by others. Second and again in comparison with »normal« patients, vulnerability may be understood as a particular »fragility,« likeliness or inclination of being negatively affected or of undergoing harmful consequences by certain circumstances. In this latter sense, vulnerability can be understood in rather physical or medical terms. For instance, a neonate might be called vulnerable in this sense because not getting food for two days, being exposed to certain kinds of hospital bacteria or being dropped once from her bed can easily become life threatening – while the same incidents would have much less harmful potential for »normal« patients. However, vulnerability is not only a descriptive term referring to certain conditions of persons such as lacking social power or having a physiologically conditioned high risk of being negatively affected by something. Vulnerability, and that is the third nuance, may indeed also imply a normative aspect. Vulnerability often also refers to the risk that a person might not get what she is normatively supposed to have or what she is entitled to. 4 Thus, implying a normative aspect, the term vulnerability means that a person in certain circumstances is exposed to a particular risk of being wronged or of not getting what principles of justice or her rights entitle her to. At this point, it has to be mentioned that norma-

See for instance Kenneth Kipnis (2003). By pointing out the three different semantic nuances of the term »vulnerability« I do not intend to postulate them as necessary or sufficient conditions for a patient to be classified as vulnerable. Working out such a precise definition of vulnerability is beyond my purpose.

3 4

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tive entitlements and principles of justice can belong to two different normative orders, the juridical one (the positive law) or the moral one. Many entitlements, rights and principles are recognized in both normative realms. For example, a child’s basic right to health care might be recognized by the social laws of a certain state as well as by moral theory. Generally, it is important for people working in the field of health care to be aware of the fact that there are two types of normative orders. Thus, returning to the term of vulnerability, it follows that in its normative sense the term can refer to two different kinds of normative orders. For example, a child might be considered as vulnerable because her legal rights or her moral rights might not be respected. Someone could argue that vulnerability is just about getting or – more precisely – about not getting what one »needs« or »really needs« and that it is of no use complicating the story by pointing to a normative (whether legal or moral) aspect in the meaning of vulnerability. In order to answer to this objection and to illustrate the frequent presence of a normative aspect in the meaning of vulnerability, let us look at the following hypothetical case of a 32-year-old patient who needs a heart transplantation. Unfortunately, the patient is highly unlikely to find a new heart because of a very specific and rare physiological characteristic of his organism which needs to be met by the donated heart. Because of that he is much more at risk of not getting what he really needs and what is of vital importance for him than almost all other people in need of heart transplant. Nevertheless, we probably wouldn’t call him a vulnerable patient. The reason for not classifying him as vulnerable appears to be that even though he has an urgent and vital need which probably won’t be met, he has no right of having his need met to have, the heart transplant where there is no matching donation available. The person might be in a lifethreatening situation and even die without being normatively wronged and without seeing any of his health care rights denied. We can summarize vulnerability as a »thick concept« (Williams 1985, 140 ff.) that might refer to matters of facts as well as to normative aspects. The matters of facts or factual circumstances referred to when considering for instance a neonate as a vulnerable patient might consist in the neonate’s lacking of social capacities to express her needs or in the particular harmful consequences, which false treatment might immediately have for the neonate because of her limited physiological resilience. The normative dimension of a child’s vulner70 https://doi.org/10.5771/9783495813430 .

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ability will be based on the assumption that the child is particularly likely not to have what she is entitled to; for example, that a doctor won’t care for her like he is supposed to do. That particular risk might arise from a specific matter of facts, for example from the child’s lacking intellectual capacities, which might make the doctor believe that the child as well as no one else will notice a negligence of his medical duty towards the child. Having so far illustrated the presence of a normative dimension in the meaning of the term vulnerability, the investigation of the normative question about how children should be dealt with will even shed more light on their specific vulnerability. In order to understand children’s specific risk of not getting what they are entitled to, it is necessary to clarify what children’s rights are and what people owe to them. In the following analysis and attempt of clarification, I will focus on the moral realm.

4

Children’s Rights

A fundamental and widely accepted principle of justice consists in the principle of equality of all human beings. This principle should also hold for children in relation to adults. Applying the principle of equality to children and adults means that children must not count less in comparison with adults just because of being children. If a child and an adult have the same kind of interests or needs, the child’s interests and needs should be respected and weighted in the same way as the adult’s needs. The normative principle of justice does of course not mean that children and adults should be medically treated in the same manner, for example with the same amounts of a pharmaceutical product. The principle of equality rather claims that if a child and an adult have needs of same (equal) importance for each of them, their interests should be weighted equally and the adult’s need must not have priority (Dworkins 1990, 370). Further, according to the basic and general principle of equality, other widely accepted bioethical principles such as the principle of non-maleficence or the principle of beneficence apply equally to children and adults. 5 A neonate has no minor right to not be harmed and See for the general bioethical principles of non-maleficence and beneficence Beauchamp/Childress (2009).

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to get help than an adult, even if she lacks the intellectual capacities to express and claim her rights and would not notice if her rights were violated. The general principle of equality is mainly a principle of justice against discrimination. With regard to children the principle’s basic function is to warrant that children are not simply discriminated or disadvantaged just because they are children according to their age. Children also have the right to adequate and good medical treatment and health care services. They have the right to have their health needs met and to get what is in their best (medical) interest – to the extent in which the necessary recourses are available and within the limits of feasibility. The general challenge of course is to determine what a child »really needs«, i. e. the child’s best (medical) interest. Another general bioethical principle, which is widely accepted, concerns the patient’s right to give or withhold informed consent. Mature and competent adult patients are commonly attributed the right to »informed consent« so that their general right to self-determination remains respected. Every doctor has the duty to inform his patient in order to allow the patient to determine competently (and in dialogue with the professionals) what his interests and needs are, what is best for him and what his medical treatment should consist of. Now, it is obvious that very young children cannot be warranted the right of giving or withholding informed consent since they are not able to determine competently their medical interest. Nevertheless, assuming that all children completely lack capacities to understand their situation would be a misconception. As mentioned above minors of very different ages and therefore of very different developmental degrees belong to the group of children. Thus, the different developmental degrees of children must be taken into account in order to answer the question of how children should morally be dealt with. It is unsatisfying to use age-based thresholds to resolve the problem of how children should be allowed to participate in their health decision making process. Looking purely at the age is very formal and does not leave room to consider the individual. Fixing, for instance, the age of twelve as threshold for giving children the right to be told what is at stake and the age of sixteen as threshold for attributing children the right to give informed consent would not be precise enough. Children must be assessed as individuals and respected according to the individual state of their developmental maturity. 72 https://doi.org/10.5771/9783495813430 .

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Instead of threshold depending on age, I would propose the gradual principle according to which gradually increasing rights to be heard, to be provided with information and explanations, to participate and finally to give informed consent should go hand in hand with the children’s mental, cognitive and personal development. As their mental capacities increase children should have increasing rights to have their say in determining and deciding what their best interest and best individual treatment consist of. The systematical relationship between what has been said about children’s rights and about the meaning of children’s vulnerability (as far as the moral dimension is involved) can be illustrated as follows. Compared to common adult patients, all children are vulnerable in the sense that they appear to be more likely to not have their best interest met and to not get what they are entitled to. However, they are so in different manners. A neonate might have her best medical interest not adequately determined or promoted by the professionals because of the neonate’s incapacity to explain her needs and to claim her rights. A sixteen-year-old girl, who is completely mature and competent with concern to her medical situation, might be at risk of not being considered mature and of not seeing her right to give or withhold informed consent respected. And many children who find themselves in the grey area between the two developmental extremes of a complete lack of intellectual capacities on one end and complete maturity on the other end are at risk that their gradual rights of being heard, of being informed, of having their say and of playing a role in the decision making process might be neglected – solely – because doctors or parents consider these »children« as very immature and ignore their rights to adequately participate in their health and treatment matters.

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The four-sided interplay

Every medical treatment and especially every clinical cancer treatment of a child takes place in a complex interplay which involves four different parties: the child herself, her parents, the doctors (and other medical professionals) and the state. Every party has legal and moral duties and rights towards every other party. At first glance, it might appear that three parties, namely the parents, the doctors and the state, simply have the (legal and moral) duty to protect and promote 73 https://doi.org/10.5771/9783495813430 .

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the child’s best interest. But from a closer and more analytical point of view things are not that simple. It is quite obvious that each of the three parties other than the child has a duty towards the child: the doctor, for example, has the duty towards the child to perform an adequate and good therapy. The parents have the general duty towards their child to take proxy decisions in the child’s best interest and the state has the duty towards the child to generally protect her from pain, harm and negligence. Furthermore, every single party among the four protagonists of this interplay can have duties, responsibilities and rights towards every other single party. For instance, the parents have the right towards the doctor to be informed and involved with respect to the child’s medical situation and treatment. It is a highly complex interplay because the manner in which a relation between two parties is handled can affect a third party. Take, for instance, the hypothetical case that informing the mother about her child’s medical situation is likely to cause her to have a hysterical attack, which could terrify and therefore harm the child. In this case, the doctor’s duty towards the mother to keep her informed might conflict with his duty towards the child to act in her best interest. 6 The role of the state is what in Anglo-Saxon law is called the parens patriae and what in German constitutional law is called the guardianship for the child’s welfare. While the parents and the doctors are the parties primarily responsible for the child’s best interest or welfare, the state is an actor of last resort. In the following case study, I will therefore focus on the parents and the doctors and consider the state as a background actor. It is time now to work through a case study. This will serve the purposes to exemplify and apply what has so far been said in rather theoretical and abstract terms, to illustrate concrete steps available to deal with emerging problems, and to investigate new questions which arise from the concrete case. The following case of Nemo is inspired by a real case, but has been modified and is therefore somewhat hypothetical.

For a more extensive analysis and a graphical representation of that interplay see (Schickhardt 2012, 278 ff.).

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6

The case of Nemo

Nemo is a one-year-old boy with a malign tumor. At a certain point after unsuccessful treatment the responsible doctor considers the tumor as incurable and suggests to end therapeutic efforts and to turn to palliative treatment. The parents don’t agree with the doctor. They believe in remaining chances and demand maximal therapeutic efforts and interventions, including surgical treatment. The doctor argues that there is no chance for therapeutic success and that further interventions will be useless and would just cause further pain to Nemo. The parents though demand the doctor to continue therapeutic treatment even against his personal conviction about Nemo’s best medical interest. Nemo’s case classifies as a representative case for those children who completely lack the intellectual capacities necessary to understand their medical situation. Nemo cannot be given any say in determining his treatment. Nemo’s specific vulnerability consists therefore especially in the risk that his best interest is not adequately determined, recognized, respected and implemented by those who are responsible for Nemo (first of all, his parents and the doctors). Furthermore, the case regards also the relation and occurring rights and duties between the parents and the doctor. Imagine for example that the parents claim that the doctor has the duty to sustain them and to carry out what they consider to be in Nemo’s best interest. The case prompts the following ethical questions in terms of three relationships: 1. parents-child: what are the parents’ rights and duties towards their child concerning child related treatment decisions? 2. parents-doctor: what rights and duties do parents have with respect to certain treatments for their child from the doctor? And what does the doctor owe to the parents? 3. doctor-child: what does the doctor owe to the child independently from or even against the parents claims and requests? In order to answer the question concerning parents’ rights and duties in deciding the medical treatment for their child, it is helpful to leave the medical context for a moment and to reflect – in a brief excurse – about the role of parents in general. What is the concept of parental rights and what are the morally most plausible meaning and function of parental rights? Dealing with this question requires considering the nature of rights. Rights have the function to protect in-

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terests or choices of persons. 7 The right to free speech of person A protects A’s interest to speak freely whenever she wants. When A wants to speak freely, A may speak freely, thus using her right to free speech. Usually, a right bearer may use or not use his right whenever and in any manner he wants to according to his own preferences. My basic moral thesis concerning the role of parents is that parents have no special rights towards their children by virtue of being parents in this strong and genuine sense of rights. There is no convincing moral justification for specific parental rights which would allow parents to behave arbitrarily towards their child. In their role as parents they are not allowed to pursue their own interests such as having fun or seeking the maximum utility for themselves. For example, parents appear to be »allowed« and to have therefore the right to catch their three-year-old child in order to hold her away from a busy street. However, in doing so, they don’t make use of a genuine right which would allow them to pursue their own personal interests freely; instead, they fulfill their duty to care for the child and protect him from potential traffic harm and danger. Indeed, by virtue of being parents they have the responsibility and duty to protect their child from danger and to take care of her. Returning to the medical context, the same holds for the so-called parental right to give or withhold consent to their child’s treatment. The parental right to give or withhold consent to treatment decision concerning their child is not a real right towards their child, but rather a responsibility they have to fulfill according to the child’s best interest. The parental role in treatment decision does not consist of the right to arbitrarily determine treatments for their child, but rather of the responsibility to choose and guarantee the treatment which is best for the child. Thus, with respect to Nemo’s treatment, his parents cannot refer to their parental rights or parental freedom in order to claim that they are allowed to decide whatever they want. Neither the parents nor the doctor have real and genuine rights towards Nemo with respect to the treatment decision, but instead they both have the duty towards Nemo to secure his best interest. The consequence for Nemo’s case from these reflections about the moral role of the parents and the doctors is that if there is a conflict between the parents and the doctor, See for the so called choice theory of rights, for example, Hart (1982, 183) and for the interest theory of rights, for example, MacCormick (1976).

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it only can be a conflict on the basis of diverging convictions about Nemo’s best interest: the only moral ground for such a conflict can consist in the parent’s and doctor’s diverging beliefs about how each of them should fulfill their duty to determine and to protect Nemo’s best interest. As to the doctors’ role, there can be little doubt that his main duty concerns the child and not the parents. The doctor’s primary responsibility is to provide Nemo with an adequate individual treatment and to protect and promote Nemo’s best interest in the concrete situation. With respect to the parents, the doctor has the duty to respect their role of being generally responsible for Nemo’s welfare and interests. Hence, the doctor has to respect the parents’ general task of taking proxy decisions for Nemo. The doctor has the duty to inform the parents and to make sure they can give or withhold informed consent to the child’s treatment. As an ideal, the relation between doctor and parents should work as a system of checks and balances among one party, namely the parents, with general responsibility for the child’s best interest, and the other party, namely the doctor, with specific knowledge and responsibility within the medical context. None of the parties is superior to the other, there is no hierarchy or structure of general subordination between parents and the doctor. The parents don’t have to give consent to whatever the doctor recommends and the doctor doesn’t have to carry out every treatment that the parents require. The doctor should count as an autonomous protagonist with a moral conscience of his own. Hence it is unacceptable – as it might happen in a case like Nemo’s that the parents consider the doctor to be a simple instrument of their will and view concerning the child’s best interest. The doctor does not have to follow the parents’ request if it is in contrast with what he believes to be the child’s best interest. In such a situation, he might find himself in a prima facie conflict of duties. Since his main duty, however, regards the child and compels him to help as well as not to harm the child, he is at least allowed, in case his opinion differs deeply from the parents’, to refuse to carry out the parents’ request for treatment. Since there is no hierarchy among the parents and the doctor with regard to a child’s medical treatment, the only inherent solution of their conflict is an eventual agreement despite their initial disagreement. If neither of them manages to convince the other and if they will not eventually agree on what is best for Nemo, there will be 77 https://doi.org/10.5771/9783495813430 .

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hardly any other solution than to call for state intervention. In order to avoid the escalation in form of calling on the state for intervention, it is useful to propose concrete steps that the doctor or the medical staff could take in order to convince the parents. The parents’ and doctor’s purpose must be to conceive and to agree upon a concrete treatment which both, the parents as well as the doctor, consider to be in Nemo’s best interest. This must certainly not be a compromise between the parents and the doctor at the expense of Nemo’s interests. Again in Nemo’s case, where the doctor is of the opinion that it is in Nemo’s best interest to not continue the treatment, there are various practical steps which can turn out to be helpful. The doctor should in a first step provide evidence for his diagnosis and for his negative conclusion and outlook drawn from the assessment of Nemo’s medical situation. Since there is so much at stake and the doctor’s recommendation is such a tragic one, asking the parents to give up struggling and hope without looking for more evidence wouldn’t be acceptable. It sounds reasonable to ask at least one other autonomous and highly specialized professional to give an independent assessment (including diagnosis and treatment proposals) of Nemo’s health situation. If the initial diagnosis is confirmed by at least one other doctor involved, and if the evidence is reasonably sufficient to appear reliable for the parents as well, then the doctor in charge should again explain to the parents his point of view. For the entire process, it is crucial to safeguard the possibility of further communication with the parents. For any further productive communication with the parents that could eventually make them change their minds, it is absolutely necessary to maintain a relationship of mutual respect that allows the parents to feel respected as dialogue partners. To maintain communication and mutual respect the doctor should not threaten to call for state intervention and hesitate to put formal or informal pressure onto the parents. Furthermore, once the doctor has made his point of view clear it should be the parents’ turn: »Audi alteram partem!« – Listen to the other side! Listen to the other story! This is a principle and sign of minimal respect and a condition for any further communication. The doctor should listen to the parents’ view and story. Listening to the parents and trying to understand their reasons might also open ways for other possible solutions. Understanding the 78 https://doi.org/10.5771/9783495813430 .

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reasons, fears and hopes of the parents enables the doctor to adequately react to them with specific arguments or procedures. For example, if Nemo’s parents belong to a social or ethnical minority it is possible that they are afraid to be discriminated. They might suspect that the doctor or the health system as a whole would just not care enough about Nemo’s life and would not find Nemo’s life worth all possible therapeutic efforts. In this case, the opinion and mediation of another doctor, who belongs to the same ethnical minority as Nemo and his parents and ideally independent from the first (and maybe even from the second) doctor might appear more trustworthy to the parents and convince them. Another possible way of convincing the parents is to show them that they have mistaken their own system of values and religious commands. If, for example, Nemo’s parents are Muslims and argue that their religion commands maximal treatment, it might be that they are inherently wrong and that an Islamic authority could explain to them that from an Islamic point of view palliative treatment were acceptable in Nemo’s case. If the parents instead hope for a miracle to heal Nemo, one might carefully remark that this could take place even without another surgical intervention unanimously considered to be without medical use and very painful by the involved doctors. With regard to communication, doctors in general should take into consideration that they are not all great communicators in all kinds of situations and with all kinds of people. The participation of other medical staff or people with special training and special communication and mediation skills might be helpful. Only after entirely all the doctor’s efforts to find an agreement have failed, further steps including the call for an authority intervention be mentioned or taken into consideration.

7

Conclusion

When talking about children as a group of vulnerable patients in the field of oncology, it is necessary to clarify the meaning of the words »children« and »vulnerability«. Because of their different developmental degrees, children form a heterogeneous group of patients. The term of vulnerability has (at least) three semantic nuances: a social, a physiological and a normative one. The normative nuance 79 https://doi.org/10.5771/9783495813430 .

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can only be fully understood when accompanied by an investigation into children’s rights and moral position within the field of health care services. The main moral principles applicable to the realm of children are: that children and their interests should be valued equal in comparison with adults and their interests, that children have a right to adequate health care service and lastly, as they grow they have gradually increasing rights to get involved in the decision making process. Children who are cancer patients find themselves in a complex four-sided social interplay. This interplay as well as related ethical questions such as those concerning the moral relations between children and their parents, between parents and the doctor, and between the doctor and the child are illustrated and analyzed in the framework of an exemplary case study (Nemo’s case). The study of this case concludes with the proposal of concrete practical steps that should be undertaken by the medical staff in order to deal with problems which might arise between parents and the doctors.

References American Academy of Pediatrics, Committee on Bioethics (1995): Informed Consent, Parental Permission, and Assent in Pediatric Practice. In: Pediatrics. Official Journal of the American Academy of Pediatrics, 95. 314–317. Beauchamp, Tom L./Childress, James F. (2009): Principles of Biomedical Ethics. 6. edition. New York/Oxford: Oxford University Press. Dworkin, Ronald (1990): Bürgerrechte ernstgenommen. Frankfurt am Main: Suhrkamp. Gaylin, Wilard (1982): The Competence of Children: No Longer All or None. In: The Hastings Center Report, 12(2). 33–38. Hart, Herbert L. A. (1982): Essays on Bentham. Studies in Jurisprudence and Political Theory. Oxford/New York: Oxford University Press. Kipnis, Kennth (2003): Seven vulnerabilities in the pediatric research subject. In: Theoretical Medicine (24), 107–120. MacCormick, Neil (1976): Children’s Rights: A Test-Case for Theories of Right. In: Archiv für Rechts- und Sozialphilosophie, 62(3). 305–317 Schickhardt, Christoph (2012): Kinderethik: Der moralische Status und die Rechte der Kinder. Münster: Mentis. United Nations: Convention on the Rights of the Child. Online available: http:// www2.ohchr.org/english/law/crc.htm (29. 01. 2013). Williams, Bernard (1985): Ethics and the Limits of Philosophy, London: Fontana.

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Has a child a duty to donate hematopoietic stem cells to a sibling?

Introduction Allogenic hematopoietic stem cell transplantations (HSCT), which are the state-of-the-art treatment for a series of life threatening oncologic diseases of the blood system, require the live donation of bone marrow (BM) or peripheral blood stem cells (PBSC). 1 A third possibility is the transplantation of cells from the umbilical cord blood. The person of need can be a patient suffering from acute leukemia, Fanconi anemia, or other blood related diseases. In some cases the only available person whose body can provide stem cells is the patient’s sibling. In other cases, despite the possible availability of an unrelated donor, the patient’s sibling is considered the donor of preference for medical or other reasons. Here we consider cases where the sibling is a child, 2 and we focus on the moral justification of such a procedure. Due to the peculiarity of a transplantation from a healthy sibling child, who can be as young as 1 or 2 years old and therefore cannot consent, justification is not without ethical problems. Donation involves injuring the child in a more than minimally invasive operation that is combined with burden and risks, which, although considered comparatively mild, are without any donor-related medical indication and without medical benefit to the donor. 3 The operation and the corresponding burden and risks depend on the chosen strategy (BMT or PBSCT) and on the specific operation procedures used. For instance, a central venous catheter, which may be required for PBSC donation, may not be suitable if the veins of young children are small. 4 In most cases, BMT is chosen, which is always accompanied

Cf. Jansen (2009). Miano et al. (2007). 3 German law provides that a medical intervention requires a medical indication to be justified. Other legislations are similar. See Laufs (2010), § 6. 4 Jansen (2009), Committee on Bioethics (2010), p. 393–404, Gratwohl et al. (2009). 1 2

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by the burden and risks of an anesthesia. Parents are legally required to judge whether their healthy child, if histocompatible, should act as a donor. Parents are required to give proxy consent (or not) before attempting an operation, which may be the only possibility, to save the life of their other child. In the case of adults, the donor’s voluntariness and his or her capacity for self-determination are moral and legal presuppositions that justify a donation. This is expressed by the concept of free and informed consent. Very young minors are considered not mature enough to decide on this matter for themselves, and they may not even have the capacity to assent or dissent. For this group of donors, the parents’ consent provides the only formal justification for the procedure. Some authors have claimed that the justification of stem cell donation by means of proxy consent is actually a form of ›forced altruism‹ of the donor child. 5 The argument is that because altruism is morally good, it is permissible to gently force somebody who cannot yet judge (but will become able to do so later in life) to do something as good as saving the life of a brother or sister. But can someone be forced to act in an altruistic fashion? Is that conceptually even possible? The question remains however whether the whole scheme is ethically sound. Two main justifying principles have been discussed in recent years: (i) the donor child, who does not benefit medically, can still expect a psycho-social benefit from saving the life of a family member; therefore HSCT is also permissible for small children. 6 (ii) The child has a moral duty to donate body tissue for a sick sibling; therefore undertaking HSCT (or consenting to it) is not just permissible but also, if medically possible, obligatory. 7 There are many ethical issues relating to these justifying principles that need to be discussed carefully. Is there enough evidence for assuming that the donor child will actually benefit psycho-socially? What does that mean concretely? In this paper, we focus on the second of these warrants: the assumption that the child is obliged in some way (even without possibly knowing the existence of such an obligation) and has the moral duty to donate. Has a child a duty to donate? In this article, we will explore how such a duty to donate could possibly be 5 6 7

Delany (1995), p. 240. Committee on Bioethics (2010), p. 393–404. Pentz (2006), p. 227–230.

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ascribed to a not-yet competent donor child. We will examine different constructs and evaluate them for consistency. Our conclusion will be that the assumption of such a duty is in fact inconsistent. It obscures rather than elucidates the structure of the ethical conflict in which a child becomes a donor of blood stem cells for a seriously sick sibling. 8

The construct of a child’s duty to donate The claim that a child has a duty to donate tissue for her or his sick sibling would be a suitable supposition because it says that no matter how complicated the situation of sibling donation might be, it is right to extract bone marrow or peripheral blood stem cells because it fulfills a moral duty the child would be aware of if she was already morally competent. This argument is used as a powerful legitimating principle to permit the harvesting of stem cells from a healthy child, even if the procedure involves burden and some risks. Thus, our discussion concerns not simply the permission of SCT but rather it focuses on the strategy of legitimizing this permission by way of assuming a duty for the child, regardless of how young and immature the child is and regardless of whether she or he feels the moral need to act in solidarity. This argument is based on the assumption that a minor actually has the duty to help her/his sick sibling and is not just said to have it. This idea of ascribing a duty to a child will be explained in two different contexts: 1. The child has an individual duty to act as a donor, because it can save the life of his/her sibling. The parents give proxy consent in the name of the child and represent the child’s own moral position. 2. The child has a duty out of solidarity because of family relationships and its role as a sibling within these relationships. Legally, the parents are required to give or refuse proxy consent; morally however, the construct of proxy consent is not so clear, since the child cannot be seen as just an individual that can be represented by a competent legal guardian. A family duty exists, regardless of whether or not a person is mature or has the capacity of self-determination. Adults have a duty of solidarity for instance to pay taxes or to do national services. All legal systems recognize duties of parents to care 8

An earlier version of the argument is published in Schües/Rehmann-Sutter (2012).

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for their children, but they do not contain any duties of children to provide medical support for their siblings. Even if the burden and risks are acceptable, if the child is in a good relationship with the sibling, and if there is a high chance of benefit for the ill sibling, the question must be answered: Do parents and physicians have the right to intervene in the healthy body of the potential donor child? If it could be affirmed that the child has a duty to donate, then giving permission to harvest stem cells would be unproblematic. If, however, that is not the case, then the question of legitimizing the permission of stem cell transplantations between siblings is still open. It does not imply that there is no legitimacy, but it would mean that it cannot be constructed in such a straightforward and easy way. Can a justification permitting children to undergo HSCT be based on the concept of duty? To answer this question, we need to first clarify the meaning of ›duty‹. In the first part of the essay we will discuss a concept of individual duty that is strongly influenced by a Kantian approach. We will start the discussion with those duties that parents have. Can they possibly be transferred to their child? In the second part of the paper, we will turn to the concept of familial duties. This idea implies that someone has the duty to do something beneficial for others in the family because he is morally (or legally) bound by solidarity within the family. The family, in this line of reasoning, provides a network of reciprocal help and support for each family member from each family member.

Parents’ duties Parents do have a legal and moral duty to care for their children. This is proscribed by civil law and common morality. Parents also have the freedom and responsibility to judge how best to protect their children from harm and how to fulfill their needs. Thus, it is generally agreed that parents are and ought to be the primary decision makers about the health of their children. 9 In the case of stem cell donation between siblings, however, the family consists of at least two children in the custody and care of the parents. The diagnosis of a fatal disease, for instance, acute myeloid leukemia in one child and the question how to decide about a possibly 9

Committee on Bioethics (1995), pp. 314–317.

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life saving stem cell donation from the sibling places the parents in countercurrent care obligations. For responsible parents, this is a psychologically and ethically difficult situation. Parents feel they have a duty to do everything they can for the survival and health of their sick child. This parental duty to care would be best fulfilled if one of the parents themselves could donate. But in many cases this is not medically feasible. 10 Parents face an emergency situation; often the child’s illness will be fatal if an HSCT is not undertaken; 11 thus, such a situation frequently leaves no realistic choice to the parents other than to agree to a transplantation of stem cells from their healthy son or daughter. Often they must make this decision in the face of possible death. Can they suppose that the child has a duty to help its sick sibling and in this way justify the infliction of an injury that is necessary but not medically indicated? If parents recognize their own duty to donate, if they could, could they somehow ›transfer‹ this duty to their daughter or son who is a matching potential donor? Would such a transfer of duty provide ›good reasons‹ and a moral justification for having their child, a minor, make a donation? ›Good reasons‹ must be so understandable, reasonable, sound and valuable such that they provide an obligatory justification. What are ›good reasons‹ however may be seen differently in different contexts; a ›good reason‹ in a public or political context may not be the same as a ›good reason‹ in a family context.

The child’s duty? We now discuss three different strategies how such a duty of a minor could be established. One strategy is that the parents transfer their parental duty to the child. Another is that since it is in the best interParents have a duty to care for their children, but legally this duty does not imply that they have the duty to donate stem cells for their sick child. The parents’ own bodily integrity and self-determination is, at least legally (in most countries), evaluated as higher ranking than the need of a sick child. This does not hold only for caring in cases of illnesses or in regard to a threat of infection. 11 An illness such as leukaemia or other diseases of the haematopoietic system can be fatal or chronic; the two are hardly comparable, but in both cases it is an emergency situation for the parents. If a disease is fatal, parents feel even more urgency to agree to a transplantation. 10

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ests for the child to donate s/he has the duty to donate for her/his sibling. These two strategies presuppose an individual notion of duty. The third strategy is based on a notion of solidarity or family duty. Concerning the latter, some authors start from the generally agreed assumption that intimate family relationships have a duty to help each other: »Siblings owe each other a duty to respect and care.« 12 This may include the donation of body tissue if it is life saving and does not seriously harm the donor. But before we go into this argument from relationships in detail we need to clarify the meaning of an individual duty.

Individual Duty The concept of a duty implies that it is always accompanied by a feeling of requirement or ›must do‹. 13 In order for this to make sense, to have a duty implies (a) the capability to decide, that is, it presumes the voluntariness and the possibility of the act to which the person is obliged. (b) It also requires at least a theoretical possibility of an alternative action (otherwise the violation of an obligation would not be thinkable and the ›must do‹ would be meaningless). And (c) it requires moral or legal permission for an action. Hence, the ethical ascription of duty always implies these three aspects. Immanuel Kant approached the key ethical question »What shall I do?« from a perspective of duties and made three key distinctions, which, within a deontological moral theory, form the basis of a conception of ›duty‹. The ascription of duty to either oneself or to someone else presumes that the question »What shall I do?« can be considered with the aim to clarify what it means to act from duty. For the Kantian account, the following distinctions are central: (I) action done from duty vs. action done from inclination, (II) perfect vs. imperfect duties, (III) actions done according to duty vs. actions done from duty. We briefly discuss each of these distinctions:

12 13

Weijer (2001), pp. 342–343, 343. Feinberg (1980), p. 134.

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(I) Action done from duty vs. action done from inclination For Kant duty means that an action is done out of respect for the universal lawfulness of the action and with the »will that my maxim should become a universal law«. 14 »An action done from duty has its moral worth, not in the purpose that is to be attained by it, but in the maxim according to which the action is determined.« 15 If it is a duty, the agent ought to will through the corresponding maxim that it should become a universal law. This is what Kant holds in his first formulation of the categorical imperative. 16 Hence, an action done from duty is done for its own sake, and must »exclude the influence« (den Einfluss ganz absondern) of any inclination other than the sense of its universal lawfulness and therewith every object of the will. 17 The idea of distinguishing duty from inclinations or feelings represents for Kant the distinction between the necessity of law and the contingency of feelings and interests. If a motive rests only on an inclination, it cannot count as dutiful because inclinations are contingent, vague or changing and so are not a reliable basis for a moral action. Kant acknowledges that this pure concept of duty can, if at all, only hold for negative duties, such as the requirement not to murder or not to steal and therefore introduces a category of ›imperfect‹ duties.

(II) Perfect vs. imperfect duties The duty to help someone is an example of an ›imperfect‹ duty, since it is contingent in the situation. 18 As an act of helping, a duty of HSC donation would fall into this category. The so-called imperfection arises from the thought that although the denial of an act of helping can easily be logically generalized, it is not desirable. In other words, the denial of helping donating is logically thinkable, but for many people not wishful. I do not want to live in a world where there is a

14 15 16 17 18

Kant (1981), p. 402. Kant (1981), p. 399. Kant (1981), p. 421. Kant (1981), p. 400. Almond (2011), pp. 464–470.

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general law that siblings are not required to help each other. Hence, Kant would consider the duty to donate to siblings as an imperfect duty. But this is still a duty that rests on the will to act out of respect for the sake of the universal moral law.

(III) Actions done according to duty vs. actions done from duty We concede that small children can already have some sense of duty. For instance, a 3-year-old toddler gives back a friend’s toys after playing with them and feels that he is supposed to do so. Children can clearly know that they are supposed to give a toy back. However, it is not possible to infer from this that the same child could also have a duty to donate HSC. Such a conclusion is illicit. The first reason for this is again related to Kant’s moral theory. Kant would not accept the idea of a 3-year-old acting from duty. Of course, children can act in accordance with duty and rehearse the role of having duties out of obedience or dependency on the family. 19 But acting from obedience or from feelings does not mean having a sense of duty. But if we would (contra Kant) allow a 3-year-old to have a duty to give the friend’s toys back, this would rest on the understanding of the act of lending and returning such toys. The same understanding cannot be assumed in the case of HSC transplantation. Of course all these considerations depend on the maturity of the child, how much insight she may have into a given situation and how stable her feelings and the relationships are. Older children, who can have at least basic elements of this insight, could then at least in principle be said to have a duty to donate but not younger children. We must now discuss the arguments how a child could be thought to become the bearer of such a duty. According to this interpretation of duty, persons who do not yet have decision-making competence in such a medical context and who do not yet have the rational reflectivity to think according to general principles cannot be taken to have the duty to act or the obligation to act from duty. Yet a deontological approach (as well as any other approach based on individual ethics) would clearly argue for protecting the individual integrity of the person and her body. Hence, one needs to have good reasons for legiti-

19

Kant (1968a), pp. 437–500.

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mizing the duty of a child to undergo a medical operation in order to donate body tissue for her sibling. Parents have the duty to care for their children. Are there good reasons to transfer their duty to their daughter or son in case they cannot fulfill their duty personally? Is the principle of voluntariness, which is a condition for adults consenting to a donation, made unnecessary by transferring the parental duty to the child, or by assuming that ascribing a duty is in the best interest of the child? The idea of ascribing duties to someone presupposes that it is possible to ascribe a duty regardless of whether or not this person can acknowledge a particular duty on the basis of insight into a moral law. Hence, the question is whether the parents (or whoever is the caretaker) may assume that the child ›has‹ the duty in a morally relevant sense even though the child herself might not recognize it. Now we shall discuss the three mentioned possible strategies of ascribing a duty to a child: 1. Parents transfer their duty to the child; 2. The best interest of the child implies his/her duty; 3. Siblings have duties toward each other because of their intimate family relationships. The third strategy uses a relational concept of duties, whereas the first two strategies rely on an individualistic concept of duties.

First strategy: Parents transfer their duty to the child The argument runs like this: If parents would recognize a duty to donate if they could fulfill it, then their child, who actually can, has that duty. Parents understand the moral implications of the situation. These considerations are valid not only for them but also for their children who could be put in their place to fulfill the donor role. Therefore, by means of proxy consent they are able to transfer their own acknowledged duty to their child. Thus, parents may sensitively persuade or even gently force the healthy child to donate HSC to the sick child. From a child’s rights perspective, 20 however, we need to ask: Do the parents have the right to interfere in this way with the bodily integrity of their child? Or do they not only have a right but even a duty to persuade or gently force their healthy child, who is bodily able but perhaps not actually willing to be operated on in a hospital, to agree and also to learn the lesson 20

Hagger (2009).

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(the »moral insight«) that he or she ought to donate body tissue to her otherwise dying sibling? If parents could base their actions on a child’s duty, the existence of which they can vindicate by insight, these questions would be much easier to settle because the duty of the child would then bend the protection rights of the child to bodily integrity. Parents’ persuasive strategies, which might conflict with the rights of the child, would for this reason be permissible, or even required. However, a closer look at the concepts used here shows that there is a problem with the idea of transferring a duty. If a child does not have the maturity of reason necessary to understand the objective concept of duty per se and the implications of the act of stem cell donation for the sick sibling, he does not act from reason, i. e. not from duty. Therefore, the parents’ insight into duty to help and care is not transferable to the child. The proxy consent by the parents leads at most to the allowance that their child becomes a donor. Such an allowance legalizes the possibility of a blood stem cell transplantation, but it cannot be based on some assumed duty of a child.

Second strategy: The best interest of the child implies his or her duty In the context of the question, whether and when a donation by siblings is allowed and whether the donation is perhaps even their duty, ethicists, psychologists, and also physicians often turn to the argument of best interest. This argument is based on the mutual relationship of implications between the assumed best interest of the child and a duty: (1) It would be in the best interest of the child to donate. This implies a duty to perform the act. (2) Because he has a duty to donate, he also wishes to donate. The child would want to donate if he could understand what it means (assumed consent). A justification to allow a transplantation of HSC between siblings to take place is often grounded in a weighing of the recipient’s medical benefits plus the donor’s psychological benefit on the one hand, with the burden and risks for both on the other. Since a child, so the argument goes, does not want to lose a sibling, it is in his best interest to donate. Thus, he has a duty. Several authors hold that children have duties in medical research contexts and those duties cohere with their interests. McCormick ar90 https://doi.org/10.5771/9783495813430 .

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gued in 1974 that a parent’s consent is ethically sufficient for knowing about the coherence between the decision and the will of the child: »[t]he child would wish this therapy because he ought to do so.« 21 He claims that children have a duty and therefore also an interest to participate in research for the sake of a benefit for all. The problem with this claim is however that we would need either to assume that the child has the duty anyway (and then the wish to fulfill the duty would follow). But this is exactly what is in question; the argument is circular. Or we would need to assume that if an action is in the best interest then this person always has a duty to perform the action. This is clearly wrong, since people also have a right to refrain from doing everything that is in their best interest. If an act is in the best interest of A, this does not establish that A has a duty to perform the act. Interestingly enough, in reference to children and their donation of BMT or PBCT for a family member, we frequently find a hermeneutical shift to the question of weighing risks and benefits. Only in the case of children it is emphasized that the slight discomforts and risks of donation are easily outweighed by the psycho-social benefit of helping a family member and not losing, for example, a beloved sibling. Therefore, so this line of argument, the donation is not merely done for the benefit of the other but also done for one’s own benefit, and hence it must be in the best interest of the donor child, who then has a duty. 22 There are, however, three problems with this argument: a) The argument conflates motivations and justifications. The tactic of weighing medical risks and psychological benefits follows a utilitarian logic by using psychological motives to find the best outcome for the donor. However, the duty of the child suddenly plays a role within an ethics of weighing risks or burdens and benefits. Hence, a balance between risks and benefits only could establish that it is in the best interests of a child to donate, which, as we have said, cannot be solid bases for a duty as already explained above. To conclude from best interest to a duty would clearly misinterpret the notion of best interest because following it as a duty is not part of its conception. b) It imputes certain assumed long-term interests as ›best interests‹ to both children. Benefits for the sick are treated as benefits for 21 22

McCormick (1974). Schmidt-Recla (2009), pp. 567.

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the healthy child. This would have rather harsh implications for the donor child. In an extreme form, this strategy could also legitimize much more invasive practices of transplantation of body parts, as long as they do not result in the death of the donor (since the life of the sibling is the standard of comparison). This would be the case because the donor’s interests take the value of the saved life of the sibling into account. An analogous argument would not hold for adult siblings as their legitimized donation rests on voluntariness. c) There is a general objection against the ascription of duties to children who cannot assent or dissent. If an adult feels she has a duty to donate, she can still think critically about it and affirm the duty or reject it. Children who are considered to be non-mature minors do not have this option of affirming or rejecting. Thus, the question of rights and duties turns back to a medical or psychological ›expert‹ who then decides whether a child is mature enough to act voluntarily on the basis of rational decisions. In such a scenario a minor who is not considered to be mature enough to dissent plainly must undergo the donation. This necessity is neither based on a Kantian ›will‹ nor on an ›ought‹.

Third strategy: Siblings have duties toward each other because of their intimate family relationships This strategy uses a relational concept of duty that stems from the kinds of relationships a particular child is living in. A child’s duty to donate is often referred to from a perspective of familial solidarity. The argument runs like this: Duties are embedded in intra-familial obligations. Intra-familial obligations mean that family members have responsibilities for one another’s welfare simply because they share an intimate family relation. The minor has the duty to help other family members and to bear responsibilities for them regardless of his own benefit. This position demands that a minor has a duty of an HSC donation based on an obligation towards his family members. This argument captures much of the intuitive appeal of the moral rightness, even on the necessity of an HSC donation and transplantation that can save the life of a sibling. The intimate family bonds, as well as the expected future intimacy of these bonds, demand that family members hold strong moral obligations towards each other. The strength of family relationships is expressed in the enactment of 92 https://doi.org/10.5771/9783495813430 .

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a system of duties. These duties are supported by solidarity; insofar as they are derived from the existence of a mutual beneficence in the family, they are based on a different normative ground than individual duties. The relation of solidarity always contains both a subjective and an objective perspective: The collective, here the family, is a reciprocal relationship that is objectively perceivable and can be described as subjectively meaningful. Its individuals understand themselves not just as individuals but foremost as members of a family. Hence, a great deal of their self-understanding depends upon belonging to their family. If one would destroy such a family relationship, one would also destroy some of this individual self-understanding. Thus, solidarity transfers decision-making into the realm of the family, which is – at least partially – beyond the realm of individual rights and claims. A measure for this is the emotional strength of belonging and of being related and the objective fact of membership, which is expressed, for instance, in substituted consent or in the removal of medical confidentiality. Solidarity contains an expectation of being helped in cases of emergency, illness, or in other situations in which help is needed. Solidarity is thus related to ›emotional obligation‹, to the ›feeling of being obliged‹, of having ›no choice other‹ than to help a family member. 23 It presupposes a belief in a latent reciprocity among family members and a belief in the goal of promoting the well-being of all members of the family. Rebecca Pentz, in a reference to case reports, writes that »These reports suggest that the obligation to donate a kidney to a family member is so obvious, the decision takes no thought or consideration.« 24 Certainly, such cases might make it intuitively appealing to argue that donation is legitimized by a duty of children. However, such reports do not effectively or sufficiently justify that a child really has a duty to donate body tissue where other family members do not see the existence of such a duty as self-evident. Normative statements cannot be based merely on a description of cases where minors actually did donate. Cases of refusal also occur but are rarely

Hume (1978), p. 481. Hume thinks about the solidarity between equals next to each other. If one considers the children as non-equal to the parents (which would be correct) concerning their capacity to give consent or dissent), then one would speak rather of a child’s loyalty. 24 Pentz (2004), pp. 149–155. 23

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documented or discussed. The first objection we have against this line of reasoning does not aim at the heart of this argument but it seems nevertheless important. No matter how intuitively appealing they may be, descriptions of cases suggesting that donation is the right thing to do cannot sufficiently demonstrate that whether a duty to donate exists. The observation that families act this way and that in practice a child’s participation in donation for its sibling is often taken for granted does not entail that there is a theoretically sound basis for a child’s duty. Clinical ethicist Lainie Ross seems to firmly believe that children have a duty to donate regardless whether they are able to give consent or not. She writes, »parents can override (a child’s) present-day autonomous refusal in order to shape him into the type of person who will come to accept Good Samaritanism and family obligations as integral to his own well-being.« 25 For Ross, parental autonomy also includes taking decisions for the child with regard to educational objectives and accordingly to the ascription of family duties. Last but not least, a part of the argument for duty is also the observation that if one refuses to help an extremely sick child, one needs really strong reasons, while if one actually helps a sick child, no reasons of support seem necessary. The burden of proof seems then to be on the side of those who refuse the life-saving donation and not on the side of those who allow it to take place. Hence, the justification for permitting a donation means – if there are no reasons against it – factually an imperative, an ›ought‹, and this is what we mean when we say there is ›a duty‹ to donate. However, if we ask whether the duty to donate belongs to the social role of being a sibling and living within the familial relationship, 26 or being able to become a histocompatible ›sister’s keeper‹, 27 then we are referring to a rather broad and relatively weak notion of duty. It is questionable whether this concept can fulfill the special task of justifying permission for blood stem cell transplantation from a minor. When appealing to family duties, the strategy of justification is reversed. The argument from a solidarity duty is not searching for ›good reasons‹ for justifying a minor’s donation. Rather, the oppo25 26 27

Ross (1998), p. 118. Merton (1968), p. 422 ff. Picoult (2005).

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nents and critics are asked to find ›good reasons‹ against the minor’s donation for her sibling. Hence, taking the child as a donor would be the self-evident practice of solidarity and therefore above all need for justification; but to hesitate or to dissent to the child’s body becoming therapeutic material would demand strong reasons. The position that the strength of the family relation is represented by the enactment of just such a system of duties is put forward by Kesselheim et al. (2009) In an essay with the catchy title »Is Blood Thicker than Water?« they write, »The most plausible justifications for donation by minors are the best-interest standard, the intimateattachment principle, and the appeal to intrafamilial obligations.« 28 The advantage of these three justifications is taken to be that none of them would legitimize a donation by »a nonintimate biological sibling«. 29 The concept of family relations is based here on social and psychological relationships, not on biological kinship. Evidence from case descriptions seems to support this thesis, for example, a case about a 6-year-old daughter who refused to donate for her biological mother because she was unknown to her. 30 Charles Weijer gives a further argument in support of the idea that children also have this sort of duties. He believes that rights rule relations between strangers, whereas duties order relations among family members. 31 Rights could never rule, for instance, the confidentiality required within a family, but duties can. Thus, for Weijer either rights or duties regulate particular kinds of human relations. The argument is of a dualistic, either-or nature. If rights do not regulate an action, then duty does. However this is an implausible claim. Even if we agree on the point that rights alone cannot regulate family relations, this does not entail that confidentiality, love, and care are only regulated by duty. For family members this would imply regulation by reason and not by caring for each other from the heart, out of love and respect. In sum, the reference to family solidarity duty contains the view that the donor child is a family member and the duty of donation is inscribed into its material bodily membership in a family. In this view,

Kesselheim/Lehmann (2009), pp. 413–416, 415. Kesselheim/Lehmann (2009), pp. 413–416, 415, Ross L. F. (2009), pp. 1065–1066. 30 Pentz (2004), pp. 149–155, Pentz (2006), pp. 227–230, Opel/Diekema (2006), pp. 207–219. 31 Weijer (2001), pp. 342–343. 28 29

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donating body tissue cannot be interpreted as an act of violence to his body that is inflicted on him by parents or physicians. The child’s individual well-being is unquestionably subordinated to the wellbeing of the family. However, the child’s own perception of the donation may, perhaps in retrospect, differ. Will the child perceive the donation as helping or being harmed, or as something ambivalent or even hurtful, something that with reference to a supposed idea of ›family‹ was pre-decided by proxies, most often his parents, with their power to define the family’s well-being and to give consent.

Conclusion: Difficulties of the assumption of a duty of a child to donate If we hold that young children have a duty to donate HSC to a sick sibling, three things become obscure: a) Where would the limitations of such duties be? If the child has no morally justified ground for refusing, then there are no clear and strict limits of the alleged duties that could be imposed on her. Consequently, obligations within families could be used to justify excessive sacrifice. 32 Kesselheim et al. discuss the case of a girl who had been assaulted by her older brother and who was later asked to donate for him. The description of the emotional and psychological stress the girl went through makes it plausible that the criterion of intimacy must have its limits. »When intimacy does not exist, there is no obligation.« 33 »But even if one admits that putting a family donor at risk is morally justified, there are limits.« 34 Where are these limits? In order to identify these limits, risks and opportunities should be weighed. A negligible benefit would not even justify taking a minimal risk, but a higher benefit would. However, what would be acceptable on the risk side of the equation if survival were on the benefit side? Such a benefit would surely justify taking a significantly higher risk. b) Why should hopes of future family intimacy on the part of the parents or the recipient determine the moral considerations about a duty of the child? It is unclear why and how hopes for a particular

32 33 34

Kesselheim (2009), pp. 413–416. Ross/Glannon (2006), pp. 220–226, 222. Pentz (2004), pp. 149–155, 151.

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future necessarily bear upon the potential present duties of the donor. 35 c) Adults or older minors have the possibility to dissent to a donation because they also have the right of self-determination, but minors do not have this right. Thus, an obligation for them would represent a greater imposition than for older family members. Minors would be supposed to enact family duties that in similar cases might actually be rejected by older children or adults. d) Individual duties and solidarity duties are located on very different dimensions of moral justification and of moral insight into such ambiguous and conflict-laden situations. The difference between the two forms of duty is grounded on the basic belief about privileging individual rights over collective goods or needs. This is very evident regarding the same medical situation discussed above but in reference to adults. The individual’s bodily integrity is not to be harmed for the sake of someone else or the family, unless it has been voluntarily agreed upon by the medically suitable donor. We conclude that the duty to donate body tissue for siblings cannot be reasonably ascribed to minors. The capacities of autonomous reasoning and of grasping the implications of an act within a given context are necessary conditions for doing an act from duty. Young children do not have all the capacities needed to understand the context and then to make a decision on the basis of general moral values. They can and do perform acts of helping others and at least older children do have a concept of duties, but younger children can only donate stem cells according to duty (if one presumes there is a duty at all). To expect a voluntary donation and to ascribe a corresponding duty to a child contradicts the idea that the child’s parents are autonomous decision-makers acting in the best interests of their children. If a person is supposed to have a duty, then she must also have the ability to decide for herself and must also have the freedom to reject that duty. This supposition is also contained in the subjective and objective perspective of a concept of family solidarity. We have seen that individual duties and solidarity duties can be distinguished in three respects: the concept of individual duty presupposes the capacity of decision-making and autonomy as central. Hence, it values the principle of voluntariness higher than someone else’s benefit. It needs ›good reasons‹ for a transplantation and for 35

Pentz (2006), pp. 227–230.

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injuring a healthy person. And it cannot properly justify donations by minors and, hence, alternative strategies for legitimizing proxy consent are necessary, such as best interest concepts, or solidarity duty. The switch between moral approaches, that is, from the principle of voluntariness to a model of best interest (ascribed by someone else) would not be considered acceptable in the case of adults. Solidarity duty contains a subjective and an objective perspective of belonging and membership, which potentially subordinates the individual’s decision to the well-being of the family. Thus, the question of self-determination, autonomy, or decision-making capacity does not play a central role. Even more so, denying the existence of a duty for a child demands ›good reasons‹. Under the construct of family solidarity, we conclude that not weighing risks and benefits between the siblings and not giving permission for an act improving the well-being of the whole family could only be justified by strong reasons. The language of duties should be kept for those who have the autonomy to decide. The moral question whether parents should allow stem cells be taken from the body of their healthy child cannot be answered using an argument from the duty of the child, whether individual or solidarity duty. The situation remains ethically more complicated. The parents have to balance their duties of care, their love and their responsibilities. Both of their children with their sick or healthy bodies are vulnerable to what is done or not done to them, to how this is done or not done, to how their own perceptions and memories are heard and how they are talked about with their children after the fact. 36 Solely referring to a psychological benefit of the donor child misses the question of how burden and risks can be justified. Children’s rights and health cannot be successfully protected on the basis of a supposed duty. Young children may be habituated to act according to duties; they even may say that there are things they ›must do‹ for their siblings, but this neither implies that they ought to donate nor that the question of duty is a basis for legitimizing the transplantation of stem cells from children. If children are to be ›altruistically‹ involved in such a medical context, ethics should refrain from delivering a quick and easy solution to a complex moral problem. It should rather start from considerations about the ›good life‹, about the qual36

See Schües/Rehmann-Sutter (2015).

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ity of relationships, about vulnerability, or trust. When discussing the ethics of involving young children in donating programs the question of a duty of the donor child is beyond consideration. Acknowledgment: The paper is part of a study on the well-being of the child in stem cell transplantation, which is funded by the Fritz Thyssen Foundation and the German Ministry of Education and Research (BMBF). Our thanks also go to the Colleagues in The Network on Ethics of Families (www.familyethics.net), funded by the Dutch NWO, where parts of the argument have been discussed.

References Almond, B. (2011), »Pflicht«, in: Düwell, M. / Hübenthal, C. / Werner, M. H. (eds.), Handbuch Ethik. Stuttgart, 3rd ed., pp. 464–470. Baron, M. (2006), Acting from Duty (GMS, 397–401), Horn, C. /Schönecker, D. (eds), Groundwork for the Metaphysics of Morals, Berlin/New York, pp. 72– 92. Committee on Bioethics (2010), American Academy of Pediatrics: Policy Statement – Children as Hematopoietic Stem Cell Donor, lead author: L. F. Ross, Pediatrics 125, pp. 393–404. Committee on Bioethics (1995), Informed Consent, Parental Permission, and Assent in Pediatrice Practice, Pediatrics 95, pp. 314–317. Delany, L. (1995), »Protecting children from forced altruism: the legal approach«, in: BMJ, 312, p. 240. Feinberg, J. (1980), Rights, Justice, and the Bounds of Liberty, Princeton. Gratwohl A. et al. (2009), Risk score for outcome after allogeneic hematopoietic stem cell transplantation: a Retrospective Analysis for the European Group for Blood and Marrow Transplantation and the European Leukemia Net. Cancer 115:47, pp. 15–26. Hagger, L. (2009), »The Child as a Vulnerable Patient. Protection and Empowerment«, Farnham / Burlington. Hume, D. (1978), »A Treatise of Human Nature« (1739), P. H. Nidditch (ed.), Oxford. Jansen, S. (2009), Die gerichtliche allogene hämatopoetische Stammzellspende bei Kindern und Jugendlichen. Ein Vergleich von peripheren Stammzell- und Knochenmarksspendern, Düsseldorf: Medizinische Fakultät der Heinrich Heine Universität. Kant, I. (1968), Grundlegung zur Metaphysik der Sitten«, in: Kants Werke. Akademie-Ausgabe, Bd. IV, Berlin, pp. 387–463. Kant, I. (1981): Grounding for the Metaphysics of Morals, transl. by James W. Ellington, Indianapolis / Cambridge.

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Christina Schües and Christoph Rehmann-Sutter Kant, I. (1968a), Pädagogik (1803), in: Kants Werke. Akademie-Ausgabe, Bd. IX, Berlin, pp. 437–500. Kesselheim, J. C., Lehmann, L. E., et al. (2009), Is Blood Thicker than Water? Ethics of Hematopoietic Stem Cell Donation by Biological Siblings of Adopted Children, in Archives of Pediatrics & Adolescent Medicine, Chicago, Vol. 163 (No. 5), May, pp. 413–416. Laufs, A. (2010), Die Elemente der Rechtfertigung ärztlichen Handelns, in Laufs, A./ Gänzel, H. / Kern, B.-R. et al. (ed.), Handbuch des Arztrechts, 4. ed., München 2010, § 6. McCormick, R. A. (1974), Proxy Consent in the Experimentation Situation, in Perspectives in Biology and Medicine, Autumn, Baltimore, pp. 2–20. Merton, R. K. (1968), Social Theory and Social Structure. 1968 enlarged ed. New York/London. Miano, M./ Labopin, M. /Hartmann, O. et al. (for the Paediatric Diseases Working Party of the European Group for Blood and Marrow Transplantation) (2007), Haematopoietic stem cell transplantation trends in children over the last three decades: a survey by the paediatric diseases working party of the European Group for Blood and Marrow Transplantation, Bone Marrow Transplantation, 39, pp. 89–99. Opel, D. J. / Diekema, D. S. (2006), The case of A. R.: the ethics of sibling donor bone marrow transplantation revisited, in Journal of Clinical Ethics, Hagerstown, Md., 17(3), pp. 207–219. Pentz, RD. (2006), Duty and altruism: alternative analyses of the ethics of sibling bone marrow donation, in: Journal on Clinical Ethics, Fall, 17(3), pp. 227– 30. Pentz, RD. / Chan, KW (2004), Designing an Ethical Policy for Bone Marrow Donation by Minors and Others lacking Capacity, in Cambridge Quarterly of Healthcare Ethics, 13, pp. 149–155. Picoult, J. (2005), Beim Leben meiner Schwester, München. Ross, L. F. (1998), Children, Families, and Health Care Decision-Making, Oxford. Ross, L. F. (2009), The Ethics of Hematopoietic Stem Cell Donation by Minors, and reply by Jennifer C. Kesselheim, in Archives of Pediatrics & Adolescent Medicine 163 (11), pp. 1065–1066. Ross, L. F./Glannon, W. (2006): A Compounding of Errors: The Case of Bone Marrow Donation between Non-Intimate Siblings, in The Journal of Clinical Ethics, vol. 17 (3), pp. 220–226. Schües C, Rehmann-Sutter C (2012), Hat ein Kind eine Pflicht, Blutstammzellen für ein krankes Geschwisterkind zu spenden? in Ethik Med (online first Mai 2012: DOI 10.1007/s00481-012-0202-z) Schües C, Rehmann-Sutter C (2015), Einleitung. In Schües C, Rehmann-Sutter C (eds.), Rettende Geschwister. Ethische Aspekte der Einwilligung in der pädiatrischen Stammzelltransplantation. Paderborn: Mentis, pp. 7–24. Schmidt-Recla, A. (2009), Kontraindikation und Kindeswohl. Die »zulässige« Knochenmarkspende durch Kinder, in GesR, 11, pp. 565–572. Weijer, C. (2001), Family duty is more important than rights, in West J Med, May, 174(5), pp. 342–343.

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End-of-life decision making

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Christoph Rehmann-Sutter, Kathrin Ohnsorge and Heike Gudat

Understanding terminally ill patients’ wishes to die Significant narratives and a typology For those involved in palliative and end-of-life care, to be confronted with a wish to die by terminally ill patients can pose a serious emotional and also moral challenge. It requires sensitive and empathetic understanding and a particular respect for the patient’s subjectivity. Palliative care doctors are aware of this challenge, even though opinions differ on how to respond to such a wish in practice, especially if it also involves a request for assisted death. How far should medical care go, and what can medical institutions endorse as ethically appropriate and responsible? There is, however, an underlying question which needs to be clarified before we can reasonably discuss which responses are morally acceptable and which are not: what does the patient actually want when she or he expresses a wish to die? How can we understand a wish to die as a complex subjective phenomenon at the end of life? Is a wish to die self-contradictory – even necessarily so, since one cannot logically want not to exist, since wishing presupposes existing? This rather theoretical way of framing the issue, which is found in the tradition of Augustine and Immanuel Kant, is clearly rather abstract. It is not commensurate with the concerns of real patients who wish to die; indeed, it implies that their own thinking cannot be trusted. 1 The problem with this framing of the wish to die is that it assumes a subject which is abstract from the reality of embodiment Hannah Arendt, in her book on the history of the will (1978; II, p. 91), recounts the discussion in Medieval philosophy where Augustine argues that wishing one’s own existence to end is impossible: »A will directed not only against a counter-will but against the very existence of the willing or nilling subject […] cannot be trusted, since while he is saying it he is still alive.« Kant famously said that suicide is morally wrong because it is a violation of a duty to oneself. Suicide even infringes a perfect duty, he claims, in the sense that permission to commit suicide cannot be thought as a general law.

1

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and therefore does not reflect on dying. It lacks the memento mori. This abstract subject of wanting is not the one present at the end of life, where death is a reality, and in which a subject is challenged to acknowledge an inevitable death in all its embodied concreteness. It is not wishing death in the midst of life. Real people relate differently to that event of dying, and real people do not always reject death in every situation when they are close to it. To bring an end to living involves planning and foresight, including a judgement about when it is the right time to go. Overwhelming personal decisions must be taken, not only about medical treatments. And these decisions also involve interpretation of the meanings in the present situation. And the words, which are found to talk about the challenges, involve being interpreted by others. For caregivers, however, being confronted with a patient who wishes to die can be frustrating and both emotionally and ethically difficult to handle. Christof Müller-Busch, in his book on the ethics of dying, which builds on decades of experience in palliative care and is written with a thorough respect for the patients’ perspective, reports on this difficulty. He suggests that a patient who articulates a wish to die might in fact not want what he or she says explicitly, i.e. to bring about a more rapid end to life. The patients might instead desperately want to change their situation also in such a way that the unavoidable process of dying, which will come in due course, can be accepted (Müller-Busch 2012, p. 73). In this view, acceptance is the real challenge, and the wish to die is a step towards accepting. This might be true, and if changes that improve the situation are possible they should be made, in order to facilitate acceptance of an inevitable departure in due time. However, it is probably not true for all situations and all patients. Some patients may really want to die, full stop. They would reject having their wish to die explained away (›interpreted‹) as the expression of something behind their wish, that makes their wish to die itself dismissible in the eyes of others. There is an important lesson to be learned from this for end-oflife research as well. When we interpret a wish to die, however benevolently, there is always an intrinsic risk: the risk of explaining it away, or of explaining it in a way that makes it less contradictory and brings it closer to our own values. There is an epistemological gap between person A, who experiences a wish to die, and person B who hears person A expressing a wish to die. Things can get even more complicated as soon as we, as persons who may also be in the 104 https://doi.org/10.5771/9783495813430 .

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position of A, examine the constitution of a wish to die. How does one know that oneself wishes to die? Is the wish a feeling, which is there or not there, that sums up a whole life situation with its past and present? Is it a real desire, even a ›decision‹? Is it active or is it rather a passive experience of something that is somehow ›there‹? Recent years have seen a growing number of empirical studies investigating the phenomenon of the wish to die in the medical context. 2 Despite these efforts, it is still an open question what patients actually might experience and mean when they express such a wish. There are studies that focus on the causal factors leading to a wish to die (see for instance Rurup et al 2011). However, they cannot clarify what it might signify in the context of a persons’ own life to have such a wish, to know of it, to grapple with it, and what impact it should have in the planning of end-of-life care. Many of the earlier studies also started from the assumption that a wish to die as a subjective mental phenomenon simply should not occur under good medical care, and would disappear if the patient was properly cared for. This assumption, however, has proven problematic. First, it is contradicted by evidence that the wish to die occurs relatively frequently even under good palliative care. Data collected in the United States by the Oregon Department of Human Services show that 88.2% of terminally ill patients who used the state’s Death with Dignity Act of 1994 to end their lives by physician-assisted suicide from 1998 to 2009 were receiving high quality palliative care, yet clearly still wished to end their lives. This figure increased to 95.1% from 2008 to 2009 (Campbell 2010). Data collected by Arnold et al. (2004) suggest that the desire to hasten death is not uncommon among hospice patients and is particularly prevalent among patients diagnosed with cancer. 3 In our own empirical study with oncological patients in three different palliative care settings in Switzerland, one of them a very well equipped hospice offering first-rate palliative care, patients expressing a wish to die were not difficult to find. Second, if studies are based primarily on a biomedical model, they focus on death as the final disintegration of the functional biological system of the human body. In consequence, this type of reSee Rehmann-Sutter et al. 2015, a comprehensive meta-analysis by MonforteRoyo et al. 2012, and a summary with many references Stiel 2010. 3 Cf. Ohnsorge/Rehmann-Sutter 2010. 2

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search proposes explanatory accounts of wishes to die composed of observable biomedical factors and their subjective correlations, while it fails to integrate the full range of subjective experience, which is immensely more complex and includes questions of meaning, hope and fear. A biomedical account of dying reduces lived experiences to an extreme extent and misses important aspects in human reasoning and meaning-making that are needed to grasp the complexity of what persons are saying when expressing such a wish. If we attest intentionality with regard to one’s own life’s ending, this intentionality should be well theorized and examined, also in its subjective expression. Many existing studies (see many of them mentioned in Monforte-Royo 2012) focused on one specific form of the wish to die: the wish to hasten death. But not all patients who wish to die also wish to hasten death. This narrow focus of some studies reduces the richness and variety of the ethical senses that may be contained within a concrete wish to die. For the person confronted with death in one way or another, deciding exactly what to wish for presents fundamental and existential questions. People are forced to deal with these questions and to existentially relate to the act of dying: what is dying in my life that I have lived together with all the other people I know? Should it be feared, or is it feared now under these particular circumstances? Do I need to accept it now (or later)? Can I accept it? What are the losses? How much suffering do I want to bear? What about my relationships and important commitments in life? Am I allowed to go, and if so, how? Questions about hastening death or not hastening it, which are extensively treated in the bioethical literature, then might arise too. In a larger interview-study on the phenomenon of the wish to die, we included patients with all kinds of wishes and ideas about dying. We conducted 258 qualitative interviews in different palliative care settings in Switzerland, with 62 terminally ill cancer and noncancer (neurological diseases, organ failure, frailty) patients, their close relatives and their caregivers. 4 Special attention was paid to the temporal and relational dimensions of a wish to die. The data were analysed and interpreted using phenomenological and hermeneutical methodology based on Grounded Theory. The results show that terminally ill persons can experience and mean a wide variety of things when expressing a wish to die, and that 4

Main results so far are published as Ohnsorge et al. 2012, 2014a, 2014b.

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deeper knowledge of this diversity is ethically relevant. A wish to die is not always a wish to hasten death, nor is it always stable over time, nor does it always carry the same meaning. The wish to die can be conceptualized in an ideal-typical way as a process of agency, which is multidimensional, dynamic and interactive. It contains at least one of several possible intentions toward dying, which may range from the pure acceptance that death will come and welcoming it, desiring to die without the wish to hasten it, to suicidal ideation, or to the request for assisted suicide or euthanasia. A wish to die also contains meanings, such as a wish to relieve others, or to relieve oneself from a life that is experienced as futile or burdensome, or to preserve a sense of autonomy. A wish to die has reasons, which explain its presence from the viewpoint of the patients. And a wish to die can have a function that goes beyond what is expressed in the wish. In this chapter we discuss the resulting model for understanding wishes to die and the corresponding typology. We start with two stories from patients.

1

Klara and Kurt

Klara 5 was a 65-year-old widow with terminal pancreatic cancer, which had been diagnosed 14 months previously. We interviewed her on her ninth day in the hospice. She said she felt very well treated. She was in a cheerful mood when we first talked to her, but less than a minute into the interview she said: »It’s just too slow. I think now it is [time]. Those up there should say straight off: come on now!« She refused to eat, partly in order to make it possible to die, but also because any kind of food repelled her and she had a complete loss of appetite. She said that she wondered that she was still alive. She told us how she had fought her »silly cancer« for one and a half years, with operations and chemotherapy, »as long as there was just a little bit of hope, even a tiny bit.« When the doctors said that they would no longer try to cure the cancer, she said »Okay, now it’s finished, I am tired of fighting, I want to go now.« She then organized her funeral and gave instructions to her local minister. Repeatedly she insisted on giving a moral justification for her attitude. Right at the beginning of the interview she said she wanted to leave this world »decently«. And later: »With a clear conscience I can say: I have 5

Klara and Kurt are not their real names.

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fought until the end. I didn’t chuck it all in right away, and say, oh no, this is too difficult, this I cannot do. […] I really did everything, a horrible operation down in Lausanne, which was not pleasant at all […] always as long as there was a millimetre of hope. […] I enjoy being here, but there is no point in it any more.« But she was very careful about what she wished for. She was »absolutely against euthanasia« and found suicide undignified. »No, I’d like to have a natural death, but it should just come more quickly. It [death] shouldn’t dawdle like someone from Bern.« 6 Even without food she was not hungry. The lack of hunger and the disgust when faced with food she interpreted as a corporeal will to die: »And this means the body doesn’t want food any more.« She also refused tubefeeding. But for her, assisted suicide was not an option. In the interview she explained this attitude through the story of an earlier suicide attempt she had made after her husband died. She took an overdose of sleeping pills and had been rescued, but the attempt had resulted in the paralysis of one of her arms. »I regard my arm as punishment, because I did what I have done; I always think, God is punishing me for this.« She had also lost both of her children. Kurt, 86 years old, was a spirited, humorous old man. He suffered from bile duct carcinoma, which had been successfully treated with surgery, but had metastasized to the lung. He was nursed at home and treated palliatively. He had been married for nearly 62 years. He said that his wife had progressive dementia, and that in terms of his death he was primarily concerned about her: »But I worry more about my wife who is getting more and more forgetful. When she is on her own afterwards, life for her will be difficult.« Their daughter had died when she was 50, also from metastatic cancer. And he gave a terrifying account of her dying in appalling pain. He said that when he learned about his own diagnosis he had been quite composed. »I thought, now it is time. […] I am an old man and I know that at some point one must stand down, so I thought it’s not so bad. I just need to accept it. At some point, one dies.« He refused suicide or assisted suicide (»for ethical reasons«) even though he remembered in his youth having thought about killing himself if he should ever get cancer. But that was long ago and no longer relevant. He was not afraid to die, but did fear what might come before, which he obviously saw as mirroring the final painful days of his daughter. 6

In Switzerland, people from Bern are jokingly said to speak and act slowly.

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The memories of his daughter’s death shaped his own projections into the future. If he ended up like her he would not want to continue living: »If I were to be lying here like that, completely weak and filled with pain, like I saw my daughter in her last days, I would be thinking I would be glad for it to be over. […] now I think, I just want to help my wife as long as I can.« He did not forcefully wish to die, but was open to the coming end, and said it may come sooner. Rather than positively wishing to die, he accepted that his life would end sooner. From his perspective, this made a big difference. The fears he expressed were linked to the experience of his daughter’s painful death, and to the situation of his wife who would not thrive without him, not to what he projected as his own life’s end. Later in the interview he reacted very positively when asked for his opinion about the option of palliative sedation if he were to suffer from unbearable pain. He stated clearly, »That would be the solution for me, I think now.«

2

A model of what it can mean to wish to die

For both, the wish to die (in the case of Klara) or the acceptance of dying (in the case of Kurt) was not just an idea they ›found‹ within their mind and that they could feel and describe, like the presence or absence of pain. The interviews contained a story about their wish, with subtle reasoning for why they wished this and not something else. The phenomenology of wishes must start from the position that it is not possible to separate the wish from the self who is wishing. We can say that the wishing self lives the wish through, or expresses itself by the wish. Therefore, for the wishing self, it is important to find and form a precise wish that makes sense in the context of life history, values and self-understanding. For instance, the fine difference between ›just accepting and not resisting death‹ and ›positively wishing to die‹ is crucial for the person expressing the wish. For the caregivers, the difference might not matter so much, as long as their own decisions do not depend on recognising it. But for the wisher, who will be the dying person, it matters very much what to wish in the first place and how exactly to wish it. Wishing is a way of responding that includes both being active and receptive. This is of course not only true at the end of life. The person who wishes to die (think of Klara) relates herself in a certain 109 https://doi.org/10.5771/9783495813430 .

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distinct way to the object of her wish, which is death. This is active in two ways: first, alternative ways of wishing to die are excluded. And second, the wish itself is an activity: a kind of hoping, desiring or willing. A person who accepts death (for example, Kurt) continues to relate her- or himself to the life that might end soon, but through a new mode of activity. Patients (all 62 whom we have interviewed) were much concerned about what kind of wish they had and should have. It was therefore a complex and dynamic process involving the patient as an active self who has responsibilities (e.g. Kurt’s concern for his wife) and who is in important relationships. In more than one way, then, a moral component is intrinsic to wishing. A wish implies a value statement regarding the object of the wish. What is wished is desirable, at least for the person who wishes it in that moment. To have a wish therefore implies reflection on the desirability of the wish’s content. This can include considerations of what is licit in moral terms, and it can also include considerations about what contributes to their idea of a ›good‹ death (Hagger/Woods 2013). However, the wish also contains a passive, receptive dimension. The patients did not describe their wishing as a matter of deliberate choice, but as a matter of fine perception of themselves living with progressive illness and as embodied beings incorporated in a social network. This can involve a kind of moral perception. 7 The active and the passive cannot be separated in the wish to die, but rather can be seen as two complementary strands. 8 Patients needed to find the right wish: the one that was appropriate, and therefore adequately represented their agency. Intentions. How can wishes to die differ from each other? One crucial set of differences that we found in our sample refers to the multiple intentions about death that can be contained in a wish to die. Klara wished that death might proceed more quickly, but she did not intend to interfere actively. However she interpreted her disgust about food and her lack of appetite as ›her body not wanting food‹ any more. Accordingly, she rejected the tube feeding that might have sustained her life for a while. Kurt, on the other hand, did not really wish death

On moral perception see Martha Nussbaum (1990) and Blum (1994). On the connections between the active and the passive in moral agency see Soran Reader (2007).

7 8

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to come, in the basic sense of the term wishing, but he was ready to die sooner. When we went through the cases we found persons who wished to live and not to die, others who were accepting that death would come, and still others who positively wished to die. Among those who wish to die, their wishes differed in many respects: First, a wish to die can be a wish that does or does not involve hastening death. Second, a wish to die can be a wish that does or does not involve practical steps that lead to dying. We found examples of each of these groups and therefore proposed that there are basically three groups of escalating intentions expressed by patients in their wishes to die: those that do not involve hastening death, those involving hastening death, but do not undertake practical steps, and those involving active practical steps that lead to hastening death. When looking into the cases more carefully, these groups could be further split into three subgroups each. Table 1 shows a typology of 9 idealized forms of intentions towards dying that can be contained in terminally ill cancer patients’ wish to die statements. To distinguish wishes to die from the mere acceptance of dying seemed necessary because the term ›wish‹ implies a kind of hope that something will happen that is actually not (yet) realized. A ›wish‹, according to the Webster’s Dictionary (1981, p. 2625) implies an »unfulfilled desire«. This is a feeling that you want to have something or do something. You hope for something that is not easily attainable, whereas in accepting you agree with a course of events that you may foresee. If a patient just says he or she is not refusing or resisting dying, it might not involve actually wanting death to come. Another terminological explanation of the suggested difference between wishing (in a narrower sense) and willing may be helpful. Some patients wished to die in the sense that their wish was directed to an imagined death to which they aspired. Dying was foreseen, and a process leading towards death might also have started. But neither death nor dying had yet happened to be objects of their intentional acts. Other patients wished to die in the sense that they were actively doing something that led to death, which they hoped would come. Some in this group had voiced an active request for one of the possible forms of assistance that would lead to a quicker death, others refused life sustaining support, such as operations, chemotherapies, food, drink, tube feeding, or infusions, with the explicit intention that this would accelerate death. And some acted towards dying in a more di111 https://doi.org/10.5771/9783495813430 .

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rect way, for example by having the barbiturate stored at the right-todie organisation, or by undertaking a suicide attempt. These we grouped in the category of ›will to die‹. If you ›will‹ something to happen, a common dictionary says, »you try to make it happen by using mental effort rather than physical effort.« (Collins/Cobuild 2003, 1667) Willing means using effort, mostly mental. Mental effort can be intimately connected with doing things that lead to the intended goal. 9 Somebody who prepares assisted suicide and not only hopes for somebody who could be ready to assist but actively looks for somebody would also fall into this category.

Wish to live Acceptance of dying Wish to die Not considering hastening death 1 Looking forward to dying 2 Hoping that death happens more quickly 3 Wanting to die (but hastening death is not considered) Considering hastening death 4 Hypothetically considering hastening death (in the future, if certain things happen) 5 Actually considering hastening death, but at the moment (for moral or other reasons) it is not an option 6 Actually considering hastening death which is at the moment a (moral) option Will to die 7 Explicit request 8 Refusing life-sustaining support (such as food or treatments) with the intention of hastening death 9 Action towards dying (such as suicide or assisted dying) Table 1: Intentions towards dying 10

For a more elaborate discussion of the wish-will-distinction in the context of Wittgenstein’s Philosophical Investigations see Rehmann-Sutter (2013). Examples of this distinction can be found in Martin Heidegger (1927, § 41) and Ernst Bloch (1959, pp. 49–52). 10 Reproduced from Ohnsorge (2014a). Copyright © 2014, the authors. Psycho-Oncology published by John Wiley & Sons, ltd. 9

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Motivations. Klara and Kurt gave different motivations when asked to explain why they whished for or accepted what they did: While ›wishing to die‹ for Klara was wishing to be able to go in peace and in what she understood as decency (»anständig«), which is a wish for a good death, Kurt did not wish to die but accepted it by giving the explanation that he knows that death would come, but he still hoped to be able to assist his wife as long as possible. We have therefore found different meanings that people state to explain what they are wishing for at the end of life: These meanings are figurations used when the patient explains in significant terms what she/he wants when wishing to die. Meanings were frequently embedded in a larger life narrative. Many patients, for example, said that they wished to die because they wished to stop being a burden to others. Others wanted to bring unbearable suffering to an end, and death was a way of realizing this. Others said that they wanted to move onto another reality after death. Some wanted to be an example to others of how one could die decently. Still others saw the dying process as inevitable and did not want to wait all the time until death occurred naturally. 11 In addition to meanings we also need to consider the patients’ own narrative of the reasons behind their wishes to die. Reasons are different from causes. Causal factors would be those influences that can be described in a third-person account as possibly leading to or contributing to the emergence of a wish to die. Reasons, on the other hand, are the explanations given by the patients themselves of why their wish to die emerged or why their wish to die is what it is now. Reasons therefore are factors or conditions from which a patient suffers and which are seen by the patient as explaining the presence or occurrence of her/his wish to die. Examples of reasons include overall poor quality of life, feelings of shame, loss of sensory function (such as eyesight and hearing), loneliness, being too much of a burden to others, hopelessness, or pain of many sorts. The motivations for wishes to die however include a third component: their functions. Sometimes the message »I would rather die« has and is intended to have multiple effects both on the wisher and on others. Sometimes a wish to die statement is an appeal to others, triggers personal interaction or dialogue, or is seen as a cry for help. It can also be an expressive medium, a means of communicating something that is very important to the speaker but is something 11

For examples see Ohnsorge et al. 2014 b.

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more than the content of the wish to die, i.e. not just the message that she or he wants to die. In some cases, we had the strong impression that expressing a wish to die was also a way of re-establishing agency in a situation where everything is falling apart and in which agency seems to be under threat. In yet other cases, expressing a wish to die seemed to have a manipulative function, for example to get extra attention, to test others’ reactions, or to test others’ love. Functions should be differentiated from meanings and reasons, since they contain the effects, sometimes intended, sometimes unintended, of a wish to die, or of statements expressing it, either within the internal emotional and mental ›household‹, or on other people in a larger social network. Social interactions. Next to intentions and motivations, there is a further component that needs to be taken into consideration when one wants to understand a wish to die: A wish to die is also always coined by the context it is experienced and expressed in. In our study we found that the way people see themselves within their social relationships, the norms and values they perceive to be important to others, relatives, friends, but also their health professionals, to a great degree influence what they allow themselves to wish for or what they risk to express. Their consideration and love for significant others and their own values and commitments in relationships often make an important point in people’s reflections about their dying. But wishes to die also often reflect dominant ›cultural scripts‹ (Seale 1998), which persons sometimes consciously or unconsciously internalize. Not few elderly persons for example feel their existence to be ›useless‹ or of having a life ›without value‹ referring indirectly to the strong value that is socially ascribed to productive activity and youthfulness. So a wish to die cannot be understood in abstractum outside the context it is expressed in. Figure 1 is a very rough scheme of how we suggest that a wish to die can be seen as composed of these three different components (intentions, motivations and social interactions), and how they are related to the dimensions of time and space.

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Interactions with the social environment: relationships, significant others Motivation

Functions Reasons Meanings

Wish to die

Intention

Why

How?

Figure 1: Components of a wish to die and its contexts. 12

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Ethical implications of wish to die statements

Our close observation and mapping of wishes to die of terminally ill patients indicates some notable philosophical and ethical implications, some of which we will now discuss. The first and most important point is that a patient who wishes to die is not doing a morally wrong thing in having and expressing, explaining or even defending this wish. A wish to die in the end of life situation can be entirely understandable, and therefore the response, from the point of view of the others, should not be one of moral disdain, but should be met with openness and willingness to listen. The wish to die is one among many responses to the situation at the end of life, a response that can be seen as appropriate by a patient who is carefully reflecting on the personal ethic of his or her wish. However, some patients also struggle with their own wishes, and may try to transform them into a form that is acceptable to them. A patient who expresses the wish to die in a certain way is not being disloyal to caregivers; neither is she necessarily giving up, or expressing an impulse to self-destruction, to commit suicide out of self-hatred for example. A wish to die is therefore not per se an indication of a psychiatric condition where appropriate treatment would then make the wish to die disappear. This may be true in some cases, but not in general. In our sample, only a small minority of patients who expressed a wish to die had a diagnosed clinical depression. And Reproduced from Ohnsorge (2014b). Copyright © 2014, the authors. biomed Central ltd published by Springer under the Creative Commons attribution license.

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also in those who had it is not clear that the wish to die can be explained away as a symptom of the depression. A further point is that patients make ethical end-of-life decisions in many more ways than solely in regard to refusing treatments, to euthanasia or to assisted suicide. The bioethical perception of end-oflife decisions, which has been developed in an extensive literature, is very often oversimplified. The fine-tuning of wishes by patients, including wishes to die and how to die, which we have observed here, is part of the ethics of life’s ending. The patient is at the centre of this reflection. Patients’ views are necessarily local ones; they are not abstract but are very concrete and embedded in life. And since the decision primarily affects the patient her- or himself, others (including bioethicists) need to be very careful not to overstate their role as advocates of objective moral truth. Ethics is practiced in these patients’ reflections and dialogues. If professional ethicists, or clinical ethics consultations, can connect to these reflections in a respectful, clarifying and supportive way, they are supportive in the clinic. One conclusion is of particular importance for clinicians. A wish to die expressed in some way by a patient should not be the end of a conversation, rather the beginning. Clinicians need to listen to their patients, to hear at least the most important parts of the story. The typology that we have suggested here (and which may be elaborated by further studies) provides a vocabulary for verbalizing and better understanding wishes to die in all the richness of their detail. It can perhaps help to bring a finer-tuned language into end-of-life situations. Without understanding the details of the precise intentions, the specific meanings, reasons, functions of and the social interactions around a wish to die in the context of a patient’s narrative, it is difficult to understand what the patient actually wants and is asking for, and why that particular wish is important. The recognition and empathic understanding of wishes to die are therefore part of ›good‹ end of life care. Wishes to die are complex spaces within which agency at the end of life develops. They are closely related to patients’ personal life stories, and to all the questions of autonomy and self-determination that arise at the end of life. They contain the experience of illness within the personal lifetime with the past and the expected future. They are connected to the search for meaning in the face of death. And they are also intimately woven into a morality, and how the person concerned perceives moral responsibilities, values, and duties. 116 https://doi.org/10.5771/9783495813430 .

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A closer look at the phenomenon of wishes to die at the end of life shows that in most cases they must be distinguished from suicidal ideation, which has been extensively studied in psychology and suicide research (see for instance Gliatto/Rai 1999). By contrast, these wishes to die develop in a situation where death is imminent, and the topic of dying is inevitable. The patient is challenged by the situation to make up her or his mind about dying. It is not a pathological disorder that makes her or him think about death. A better understanding of the wish to die, perhaps aided by the distinctions that we have suggested here, can support a more subtle and sensitive response to patients’ needs. Poor communication about wishes regarding death, including no communication at all or attempts to communicate that are too late, deprive patients of the opportunity to enter into an essential dialogue with caregivers. It can contribute to an internalization of the wish to die, which in itself can contribute to the total pain (Saunders 1963) of dying patients. We also hope that the topic of wishes to die will be included in curricula of continuing professional development in oncology. Structured training courses on good communication and palliative care could substantially improve clinical practice (see also Gudat et al. 2013). The wish to die at the end of life also has implications for how we think about death. Death is more than the end of life. It is a rich experience and a space of practices. For those who are dying, their death is like a mirror in which they see their whole life, and what was and is important in it. The mirror can reveal things to the dying person that were unknown or less obvious before. This mirror is therefore challenging, illuminating, and can be immensely important for the person who faces it. When I watch the living meet And the moving pageant file Warm and breathing through the street Where I lodge a little while, If the heats of hate and lust In the house of flesh are strong, Let me mind the house of dust Where my sojourn shall be long. Alfred Edward Housman (1859–1936). A Shropshire Lad, XII (first two stanzas)

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These verses could be read as relativizing: everything we experience so strongly in life is ephemeral; this is death’s message. But they can also be read as giving sense and depth to life before death by reminding us that we must finally die. To mind ›the house of dust‹ means to mind the life that ends. This means to see it more fully for what it is. It means to cherish and to deeply respect these ›heats of hate and lust‹ and to try to come to terms with what remains. If death is like a mirror, then what is a wish to reach death? What meanings of a wish to die are revealed by this metaphor? In dying we see our life coming to an end and how we relate to the end of our life. In anticipating dying we anticipate seeing our life as it comes to an end and how we will relate to the end of our not-yet finished life. In all these respects, the finale of our life can be good or bad. It would therefore be surprising if the phenomenology of relating to one’s life’s end could be told by a single story. We think that a wish at this crucial time in life must contain something of what is most existentially important to the person concerned. If a patient in terminal care makes a statement about whether and how he or she wants to die, something of such importance may be represented in this expression and in the communication that follows. We do not want to paint too romantic a picture. Wishes to die can reveal severe suffering and/or inadequate palliative care. Too many patients are driven to want their life to end because of unbearable physical symptoms, such as pain, which could perhaps be better treated. Some wishes to die might then disappear, or at least change into less acute forms. One patient we interviewed wanted to die with the help of the organization Exit by committing assisted suicide; this wish persisted as long as he was in a large hospital, where he was unhappy. As soon as he moved to the hospice and received specialized palliative care, he changed his mind. He still wanted to die soon, but he preferred to live through his last few days. In this new situation he saw that that some juice could still be squeezed out of his time. 13 A wish to die is complex and dynamic. It should therefore neither be reduced to its face value without an attempt at deeper understanding, nor be dismissed as an undesired effect of triggering factors, which, if removed, would make the wish simply go away. The phrase ›squeeze juice out of one’s life’ is from Terry Pratchett. See his documentary Choosing to Die made in 2011 for BBC (https://vimeo.com/140956431; accessed on Jan 31, 2017).

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References Arendt, Hannah: The Life of the Mind. II: Willing. Orlando: Harcourt 1978. Arnold, Elizabeth M. et al. (2004): Consideration of hastening death among hospice patients and their families. Journal of Pain and Symptom Management 27: 523–532. Bloch, Ernst (1959): Das Prinzip Hoffnung. Bd. 1, Frankfurt aM: Suhrkamp. Blum, Lawrence A. (1994): Moral Perception and Particularity. Cambridge: Cambridge University Press. Campbell, C. S., & Cox, J. C. (2010): Hospice and Physician-Assisted Death. Collaboration, Compliance, and Complicity. The Hastings Center Report, 40 (5), 26–35. Collins Cobuild (2003): Advanced Learner’s English Dictionary. Glasgow: HarperCollins, 4th ed. Gliatto, Michael F. / Rai, Anil K. (1999): Evaluation and treatment of patients with suicidal ideation. American Family Physician 59: 1500–1506. Gudat, Heike / Rehmann-Sutter, Christoph / Ohnsorge, Kathrin (2013): Sterbewünsche – weit mehr als ein Hilferuf. Schweizer Krebsbulletin Nr. 1/2013, pp. 33–35. Hagger, Lynn / Woods, Simon, eds (2013): A Good Death? Law and Ethics in Practice. Farnham: Ashgate Heidegger, Martin (1927): Sein und Zeit. Tübingen: Niemeyer 1986. Monforte-Royo et al (2012): What lies behind the Wish to Hasten Death? A Systematic Review and Meta-Ethnography from the Perspective of Patients. PLoS ONE 7/5 e37117. Müller-Busch, Christof (2012): Abschied braucht Zeit. Palliativmedizin und die Ethik des Sterbens. Frankfurt: Suhrkamp. Nussbaum, Martha (1990): Love’s Knowledge. Essays on Philosophy and Literature. New York: Oxfort University Press. Ohnsorge, Kathrin / Gudat Keller, Heike R. / Widdershoven, Guy A. M. / Rehmann-Sutter, Christoph (2012): ›Ambivalence‹ at the end of life: How to understand patients’ wishes ethically. Nursing Ethics 19 (2012): 629–641. Ohnsorge, Kathrin / Gudat, Heike / Rehmann-Sutter, Christoph (2014 a): The intentions in wishes to die: analysis and a typology. A report of 30 qualitative case studies of terminally ill cancer patients in palliative care. Psycho-Oncology (2014), DOI: 10.1002/pon.3524. Ohnsorge, Kathrin / Gudat, Heike / Rehmann-Sutter, Christoph (2014 b): What a wish to die can mean: reasons, meanings and functions of wishes to die, reported from 30 qualitative case studies of terminally ill cancer patients in palliative care. BMC Palliative Care 2014 13:38. Reader, Soran (2007): The Other Side of Agency. Philosophy 82: 579–604. Rehmann-Sutter, Christoph (2013): Sterben als Teil des Lebens und als Handlungsraum. Ethische Überlegungen. In: Hajo Greif, Martin Gerhard Weiss (eds.): Ethics, Society, Politics. Proceedings of the 35th International Wittgenstein Symposium, Kirchberg am Wechsel, Austria, 2012. Berlin/Boston: DeGruyter Ontos 2013, S. 483–518.

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Christoph Rehmann-Sutter, Kathrin Ohnsorge and Heike Gudat Rehmann-Sutter, Christoph / Gudat, Heike / Ohnsorge, Kathrin (eds.): The Patient’s Wish to Die. Research, Ethics, Palliative Care. Oxford: Oxford Univ. Pr. 2015. Rurup ML et al. (2011): Wishes to die in older people: a quantitative study of prevalence and associated factors. Crisis 32 (2011): 194–203. Saunders, Cicely (1963): Distress in dying. British Medical Journal 2: 746. Seale, Clive (1998): Constructing Death. The Sociology of Death and Bereavement. Cambridge: Cambridge Univ. Pr. Stiel, S. et al. (2010): Wunsch nach vorzeitigem Lebensende. Was steht dahinter? Schmerz 24: 177–189. Webster’s Third New International Dictionary of the English Language (1981): Chicago: Merriam-Webster.

Acknowledgments Our greatest thanks goes to the persons near the end of life, their families and health care givers who shared so kindly and openly in the interviews their experiences, thoughts and intimate stories. We also thank all the institutions that collaborated in the study and that made the interviews possible. We are grateful to Oncosuisse (grant 01960-10-2006) and to the Gottfried und Julia Bangerter-Rhyner Stiftung for funding the first part of the study (oncology) and to the Swiss National Science Foundation/NRP 67 »End of Life« (grant 406740 145089) for funding the second part of the study (non-onco). We thank Nina Streeck who joined our group with her own dissertation project in the non-onco-part. The pilot study was made possible by the Förderstiftung HOSPIZ IM PARK, Arlesheim and the Freiwillige Akademische Gesellschaft Basel (FAG). Special thanks to participants at the Ethics and Oncology symposium in Heidelberg in May 2012 and at a roundtable at the Department of Social Science, Health and Medicine at King’s College London in February 2013, and to Monica Buckland and Jackie Leach Scully for English revision and for many clarifying questions.

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Ethical criteria of treatment decision making for cancer patients no longer able to give consent 1

Introduction

People with cancer frequently have a long history of illness, diagnosis, and therapy. Operations, radiation treatments, and pharmacological therapies alter body and mind. The threat to life becomes the clearer, the more the medical therapy intervenes and the faster the tumor tissue grows back again. But even in the case of an unstoppable, progressive and incurable cancer, physicians, patients, and relatives often do not communicate with each other about decisions on treatment that may have to be made when the patient is no longer able to say anything, nor do they talk about the approaching end of life. On the one hand, a high degree of specialization, the division of labor, and considerable pressure of time in the care of patients combine to hinder a trusting, continual relationship between physician, patient, and relatives. On the other hand, those involved often avoid difficult, fearridden discussions and thoughts about the near future. Thus, repeatedly physicians, relatives, or those carers provided by law must act as proxies and make decisions on carrying out or not carrying out medical measures for the most severely ill cancer patients, when the latter are no longer capable of judgement. What are the ethical questions that then pose themselves, and what norms and criteria of consideration are then relevant?

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Essential but not sufficient concepts in treatment decision making

2.1 Diagnosis and prognosis In ancient time Hippocrates already pointed out the professional helpfulness of prognosis: »I hold that it is an excellent thing for a physician to practice forecasting. For if he discover and declare un121 https://doi.org/10.5771/9783495813430 .

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aided by the side of his patients the present, the past and the future, and fill in the gaps in the account given by the sick, he will be the more believed to understand the cases, so that men will confidently entrust themselves to him for treatment. Furthermore, he will carry out the treatment best if he know beforehand from the present symptoms that will take place later.« 1 But at the same time it always will be an approximation. The formulation »treatment at the end of life« presupposes something that has not yet happened, and that must not necessarily happen soon: the death of the patient. The uncertainty attached to every diagnosis and prognosis implies methodical and ethical questions. A diagnosis is a statement based on medical knowledge and pathological findings, that refer to the patient’s current condition. However, subjective complaints on the part of the patient, observations on the part of the physician, and examination findings are combined into one analytical concept of illness. 2 Ultimately it is about the subsumption of a single case into what is for the most part the probabilistic corpora of knowledge in medicine. Only by means of a diagnosis, that permits comparison with other cases, can any further diagnostic or therapeutic procedure corresponding to the state of medical knowledge be derived. Against this, prognosis represents a plausible, but as yet uncertain statement about the future development of the patient’s state of health. The frequency with which a certain course of some illness has been observed yields the measure of probability for the occurrence of a development within the group of all those who are ill. In addition, the prognosis is not based on empirical studies, or only partially; rather, it is based on the experience of the individual physician treating the patient. Therefore to some extent it depends on his area of expertise, his professional experience, and his individual knowledge. Apart from these variable influences, a prognosis can never state the individual probability for any particular patient of expecting any particular course of illness. In any case, in view of a »poor« or »infaust«, i. e. unfavourable or unfortunate prognosis, one must ask to what the prognosis actually Hippokrates, Corpus Hippocraticum, Prognosis 1, transl. by Jones, W. H. S. (Loeb Classical Library), London/Cambrige 1923, 3rd ed., Vol II, 1952, p. 7. 2 See Paul (2006), p. 143 ff., Lanzerath (2000), 62 ff., Leder (1990), Agich (1983), Wieland (1975). 1

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refers to the further survival of the patient, to his or her foreseeable mental condition, or the quality of life for the patient? A primary medical task for the physician thus consists in recognising and accepting the scientific prerequisites and limits of diagnosis and prognosis, as well as striving for a certainty as great as possible in diagnosis and prognosis, while at the same time perceiving the extent of uncertainty as far as possible, and communicating this uncertainty. Diagnosis and prognosis should be based on the best possible expert knowledge, i. e. in complex or disputable cases on medical counsel by colleagues of many areas of expertise, as well as on scientific research. With regard to the prognosis, variations in treatment should be anticipated and discussed, in particular the best possible and the worst possible course the illness may take.

2.2 Medical indication Many definitions of »indication« in everyday clinical work and in the literature suggest that the question of diagnostics and therapy represents an empirical and scientific judgement. It is implicitly assumed that the biomedical functioning of an organism or an organ system represents the sole and unquestionable goal of medical action. However, because every medical intervention is always connected to a diagnostic or therapeutic goal, indeed, it is only legitimated by such a goal, a medical indication represents a so-called »mixed judgement«, constructed of value judgements and judgements of fact. 3 Since both establishing the goal of therapy and the choice of means are connected to ethically relevant evaluations, there can be no »indicated« medical measures per se. Reference to the »indication« of a measure, when this is about treatment decisions at the end of life, cannot provide sufficient reason for medical action or inaction. Apart from this, there is a mutual relationship between means, i. e. diagnostic and therapeutic instruments, and the goals aimed at. Thus a goal found to be good entails a decision on what means to use in order to attain it, e. g. the goal of saving life, extending life, or relieving symptoms, and whether the goal is realistic at all, or whether it can be reached only by accepting considerable side-effects or risks. In the case of decisions on treatment made at the end of life, 3

See in detail Lanzerath (2008); Bobbert (2012), esp. pp. 185–195.

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the physician must make the goal of treatment explicit, and adjust it to the ideas of the patient involved. 4 The central point is thus establishing the goal of therapy.

2.3 Therapeutic »futility« From a certain point in the course of an unsuccessful curative therapy there is a tendency to refer to »medical futility«. 5 But the use of this concept may hide some open questions. A so-called »futile« therapy is not a delimitable and definable entity; rather, it is located at one end of a range of therapies that have little effect. Like the concept of »medical indication«, the concept of medical futility represents a mixed judgement. It is essential, then, to agree on the goal of therapy and to describe the chances of success for a therapy with an empirical foundation. Finally, the decision must be reached, on ethical criteria, as to whether a given procedure should actually be used in view of a foreseeably slight chance of success. 6

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Goals of medical therapy from an ethical point of view

3.1 The prima facie goal: Saving life If a patient is limited in his or her ability to make decisions, or is no longer able to judge, the physician must increasingly rely on the medical state of the patient – in the form of diagnosis and prognosis. The more limited the patient’s ability to make decisions, the more weight must be placed on the observation of the current state of health and the remaining medical possibilities. 7 If a chance to save life, to extend it, or even the chance of a cure exists, then the patient Lanzerath (2008) and Neitzke (2008) discuss this problem and thus, introduce the evaluative term »physician’s indication«. 5 See Jecker (2007), Pellegrino (2005), Joralemon (2002), Youngner (1988), Truog (1992), Davis (1960); in german see Illhardt (2005), Marckmann (2003). 6 E. g. Shapiro (2008). 7 See in detail about ethics and end of life decision making for critically ill patients who are no longer capable of giving consent Bobbert (2012), Birnbacher (1999), Schöne-Seifert (2007), esp. pp. 109–136. See for professional guidelines Bundesärztekammer (2011). 4

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will be treated to the maximum extent at first, under the assumption that the patient wants to be saved. In the case of an irreversible, progressive, and lethal illness, or that of an »unsuccessful« curative therapy, it is, however, possible that otherwise common medical procedures are no longer regarded as helpful, and other kinds of help are seen to be better (nursing care, spiritual guidance, social aids). If needed to be repeatedly adapted to new real situations, the following issues with reference to medical measures must be discussed.

3.2 Responsible dealing with prognostic uncertainty Dealing with prognostic uncertainty is an ethical question that can be answered in various ways. A legally-based approach with basic, individual moral rights assumes a duty on the part of the physician to protect and preserve life. 8 The principle of caution requires then that all medical measures are to be applied to the point of obtaining great prognostic certainty in order to protect basic moral »assets«. In clinical practice, this procedure may correspond to »patient waiting« or »further treatment« within a particular period of time.

3.3 Weighing potential burdens and damage, relief and benefit The norm of non-damage has particular importance when a patient is approaching the end of life, because the »benefit« for the patient of any kind of intervention taking time and representing a strain is increasingly limited. As the possibilities for preserving the life of the patient become fewer, the obligation to save life on the part of the physician can only be fulfilled in an ever more limited way. In view of this situation, the more important thing is to provide cancer patients with relief for the time remaining to them, and to concentrate on treating burdensome and wearing symptoms. For this reason, the question has to be clarified of what is burdensome and its damages on the individual patients, and on the other hand what will provide relief and what will benefit the patient. Severe side-effects may, under the circumstances, no longer be worth the 8

See Gewirth (1978).

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slight extension of life. In other words, the question arises of whether or not potentially longer life includes considerable stabilisation or improvement of the quality of life. Although the concept of quality of life suggests a view above and beyond mere physiological survival, it is, nonetheless, essential to clarify the aspects of the complex concept of quality of life that are important to the individual patient, and to provide an evaluation of the hoped-for improvements oriented towards the patient’s preferences. As a rule, not only the extension of the absolute duration of life is important, but also the psychological, social, and spiritual levels. These considerations, however, harbour difficulties when the patient is no longer able to judge.

3.4 Resistence against ideas of quality of life Many case discussions end at the point of assumptions on the »quality of life« which will foreseeably result in cases of successful or unsuccessful treatment, respectively. But what can be considered reasonable and what is desired can, in the final analysis, only be articulated by the patient. Nobody has the right to decide whether another person’s survival is sensible or not. Even when extensive healing is impossible or when permanent handicaps must be expected, treatment that extends life may still be desired, e. g. to regain consciousness in order to say goodbye to people close to one, or to be able to stay alive just a few days longer. But regaining consciousness may be felt to be a burden, too. Since these decisions are serious ones, and both physicians and relatives are in danger of transferring their own valuations and anxieties to the patient, basing such a decision for treatment on the alleged will of the patient to any great extent is problematic. Ideas of »quality of life« should be reformulated in narrow, primarily physical burdens or damages in regard to pain, breathing, spasms, hunger, thirst and temperature.

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of the patient’s general condition, then queries should be made with regard to the alleged will of the patient. A written patient’s provision is seldom present; naturally, if it is realistic, it should be obeyed as the patient’s free and informed will. If expressions of will have been made orally by the patient recently, they may possibly be taken as an indication of the patient’s will. But a prearranged written decision making such as a written living will rarely exists. Usually, the physicians involved will turn to close relatives, friends, or the general practitioner for information in this regard. However, oral expressions which may have been made in a specific context and spontaneously, rather than carefully thought out, often yield only vague indication, similar to the cases with interpretations by external persons of the patient’s attitude to life or the manner in which he or she has dealt with crises in life. Since questions of limiting treatment are mostly ones of life or death, the argument of the alleged will of the patient can only represent an additional argument, not the decisive one. This shall be emphasized in what follows on the paradox of handicap.

3.6 Attention to the »paradox of handicap« as empirical phenomenon The paradox of handicap designates the empirical phenomenon, that outsiders attribute a worse quality of life to those who are ill or handicapped, than these do themselves. 9 This indicates that physicians, nursing staff, or relatives may not »suppose« correctly about the quality of life of the patient. Thus, for example, in a study with more than 1400 severely ill patients, half of whom had a life expectancy of no more than six months, relatives and physicians estimated the state of health and the quality of life of the patients as significantly worse than did the patients themselves. 10 The authors of the study emphasised the result, namely that those ill do not evaluate their current state of health according to medical aspects or the degree of bodily limitation, in contrast to outsiders. Albrecht and Devlieger point out that, starting from the saluto9 10

See Ubel (2001), Albrecht/Devlieger (1999), Wright (1998). See Tsevat (1994).

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genetic model proposed by Antonovsky, the quality of life must comprise more than merely the concept of »quality of life according to health«. A more holistic concept allows »quality of life« to be extended past daily activities and categories of illness, aiming in a more comprehensive way at social, psychological, and spiritual well-being. From the point of view of those concerned, the following contribute to the quality of life: a certain degree of control over the body, the mind, and life itself, despite physical or mental handicap or impairment. The ability to deal with daily life was rated as more important than the patient’s own appearance. Many said that faith and spirituality were important, as these gave them strength and allowed them to see a meaning in life. For 45 percent of those with a handicap, who said that their quality of life was bad or poor, the following factors were burdensome: pain, fatigue, loss of control of bodily functions, and no longer being able to carry out certain activities. Pain, in particular, reduced the quality of life. The authors comment on this latter point as follows. People in pain lose not only the control over their bodies, but also over their social lives and their environment. For the body becomes the dominant centre of attention, and its new unpredictability and vulnerability continuously threaten the one concerned. People with a handicap also report a poorer quality of life when they have no central purpose in life, clear values, or level of spirituality. Albrecht and Devlieger point out that many of the impairments associated with handicaps are conditioned by an interplay between individual and environment. Those who do not have a command of knowledge, resources, and social contacts are at a disadvantage, but without acceptance and the support of others, and a helping environment, the adaptation to new conditions and the process of mastering a crisis can hardly succeed. Altogether it is clear that a description cannot match the experience of those concerned. 11 Secondly, in healthy people there is the phenomenon of focusing on certain negative effects of an illness, while many positive aspects in other areas of life are ignored. Thirdly, the importance attached to individual limitations owed to illness varies among those concerned, and is determined as well by the point of reference. Fourthly, healthy people overlook processes of adaptation and are not able to predict how these might be for any particular patient. Ubel et al. conclude that many illnesses have far fewer effects 11

Ubel (2003), Albrecht/Devlieger (1999).

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on the satisfaction with life or the subjective quality of life than many of us suppose. 12 The »paradox of handicap« can be explained by understanding that ill or handicapped people evidently attach a different degree of importance to certain aspects of the quality of life; different dimensions and levels of integration of the quality of life become relevant, and, in addition, chronically ill people or handicaps pass through a course of adaptive and coping processes that can have a positive effect on the subjective quality of life. 13 For ethical decision making at the end of life reflection and correction of potential biases are needed in order not to follow arbitrary valuations. 14

4

Prerequisites for limitation of treatment from an ethical point of view based on rights

4.1 The right of self-determination in questions of therapy A reason for thoughts about the limitation of treatment in cases of patients no longer able to make decisions could be a decided prohibition of treatment, well thought-out, on the part of the patient – supposing that a very close relationship to the right of self-determination can be described. In all other cases argued by physicians or relatives, two conditions must be fulfilled. Firstly, the patient must be in very poor condition, either characterized by an irreversible, progressive, incurable and lethal basic illness, in addition to which further complications or co-morbidities appear. Alternatively, the patient has the severest impairments caused by an accident or an acute illness. Secondly, the critical state of health must have been preceded by unsuccessful or only slightly effective maximal treatments, so that the effectivity of the measures is rightly questioned, or so that one can even speak of all measures being exhausted. The condition of a very critical state of health and the condition of the ineffectivity of the measures taken indicate an extremely low chance of improvement, so that the application of any remaining medical means to extend life needs to be discussed. 12 13 14

Ubel (2003), p. 605. See Staudinger (2000) esp. pp. 185 f.; Menzel (2002). See Wright’s early claim (1988).

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4.2 The norm of non-damage Less of a problem from an ethical point of view than the argument with external judgements of the quality of life is the norm that prescribes not injuring the patient by medical intervention more than he or she is being helped. For this reason, the empirical task exists of recognizing stress caused to the patient, especially through the sideeffects of a treatment, and to weigh this against potential usefulness. A deliberation of use versus damage thus carried out can, in the end, only be justified from the perspective of the patient concerned. The assumptions of the current state of the patient should, for this reason, be based on concrete, empirically verifiable evidence. Moreover, in view of the possibilities provided by medicine, the norm of non-damage and especially the duty to help, require particularly careful treatment of pain and relief of symptoms.

5

Conclusion: The value of ethical norms and rules

The principle of caution, or the rule of attempting to achieve the greatest possible certainty in prognosis, before any limitation or cessation of treatment is put into practice, is to be assigned. On the one hand, to the individual norm of the protection of the life of a human being. On the other hand, to the forms of argument referring to the alleged will and the quality of life, as well as the value-dependent concepts of medical indication and futility, all of which tend to be weak. They are weak because they are derived to a greater or lesser extent from the interests, moral intuitions, and evaluations of outsiders, which can contradict the individual rights of the patient to protection of life and self-determination. When in doubt, physicians should and may continue treatment. Patients and relatives worried about excessive treatment or who do not wish by any means to be kept alive with medical means for a longer period of time should consider the questions that appear in connection with the end of life, and communicate their wishes and ideas to relatives and physicians, orally or in writing.

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Ethical criteria of treatment decision making for cancer patients

References Agich, G. J. (1983), Disease and Value: a Rejection of the Value-Neutrality Thesis, in: Theoretical Medicine 4, 27–41. Albrecht, Gary L., Devlieger, Patrick L., The Disability Paradox: High Quality of Life against all Odds, in: Social Science and Medicine, Bd. 48 (1999), 977–88. Birnbacher, Dieter (1999), Grenzen der Intensivmedizin aus ethischer Sicht, in: Brudermüller, Gerd (Hg.), Angewandte Ethik und Medizin, Würzburg, S. 119–130. Bobbert, Monika (2012), Ärztliches Urteilen bei entscheidungsunfähigen Schwerkranken. Geschichte – Theorie – Ethik, Münster. Bundesärztekammer (2011), Grundsätze der Bundesärztekammer zur ärztlichen Sterbebegleitung, in: Dt. Ärzteblatt 108, Heft 7, A 346–347. Davis, F. (1960), Uncertainty in Medical Prognosis. Clinical and Functional, in: American Journal of Sociology 1 (66), 41–47. Fuchs, Robert (Hg.) (1895), Hippokrates, sämtliche Werke, Bd. 1. München. Gewirth, Alan, Reason and Morality, Chicago 1978. Hippokrates, Corpus Hippocraticum – Prognosis 1, transl. by Jones, W. H. S. (Loeb Classical Library), London/Cambridge 1923 (1953; 3rd ed.), Vol II, 1952. Illhardt, Franz-Josef (2005), Wer hat wann warum das Recht, eine aussichtslose Therapie zu begrenzen?, in: Ders. (Hg.), Über das Recht sterben zu dürfen, Freiburg i. Br.: Universität Schriftenreihe, S. 56–66. Joralemon, D. (2002), Reading Futility: Reflections on a Bioethical Concept, in: Cambridge Quarterly of Healthcare Ethics 11, pp. 127–133. Lanzerath, Dirk (2000), Krankheit und ärztliches Handeln. Zur Funktion des Krankheitsbegriffs in der medizinischen Ethik, Freiburg/Br. Lanzerath, Dirk (2008), Was ist medizinische Indikation? Eine medizinethische Überlegung, in: Charbonnier, Ralph, Dörner, Klaus, Simon, Alfred (Hg.), Medizinische Indikation und Patientenwille. Behandlungsentscheidungen in der Intensivmedizin und am Lebensende, Stuttgart: Schattauer, S. 35–52. Leder, D. (1990), Clinical Interpretation: the Hermeneutics of Medicine, in: Theoretical Medicine 11, 9–24. Marckmann, Georg (2003), Medizinische Nutzlosigkeit. Einführung, in: Marckmann, Georg, Liening, Paulus, Wiesing, Urban (Hg.), Gerechte Gesundheitsversorgung. Ethische Grundpositionen zur Mittelverteilung im Gesundheitswesen, Stuttgart: Schattauer, S. 251–253. Menzel, Paul, Dolan, Paul, Richardson, Jeff, Olsen, Jan Abel, The Role of Adaption to Disability and Disease in Health State Evaluation: a Preliminary Normative Analysis, in: Social Science and Medicine, Bd. 55 (2002), 2149–58. Neitzke, Gerald, Unterscheidung zwischen medizinischer und ärztlicher Indikation. Eine ethische Analyse der Indikationsstellung, in: in: Charbonnier, Ralph, Dörner, Klaus, Simon, Alfred (Hg.), Medizinische Indikation und Patientenwille. Behandlungsentscheidungen in der Intensivmedizin und am Lebensende, Stuttgrt: Schattauer, S. 53–66.

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Monika Bobbert Paul, Norbert, Diagnose und Prognose, in: Schulz, Stefan, Steigleder, Klaus, Fangerau, Heiner, Paul, Norbert W. (Hg.), Geschichte, Theorie und Ethik der Medizin, Frankfurt: Suhrkamp, 143–152. Pellegrino, E. D. (2005), Futility in Medical Decisions: the Word and the Concept, in: HEC-Forum, pp. 308–318. Schöne-Seifert, Bettina (2007), Grundlagen der Medizinethik, Stuttgart: Kröner. Shapiro, Gary R., Are there Limits to Oncology Care? (Futility), in: Angelos, Peter (Ed.), Ethical Issues in Cancer Patient Care, Boston 2008, 2nd Ed., 137– 57. Staudinger, Ursula M., Viele Gründe sprechen dagegen, und trotzdem geht es vielen Menschen gut. Das Paradox des subjektiven Wohlbefindens, in: Psychologische Rundschau, Bd. 51 / 4 (2000), 185–97. Tsevat, Joel, Cook, Francis E., Green, Michael L, Matchar, Davfid B., Dawson, Neal V., Broste, Steven K., Wu, Albert W., Phillips, Russell S., Oye, Robert K., Goldman, Lee, Health Values of the Seriously Ill, in: Ann Intern Med, Bd. 122 (1994), 514–20. Ubel, Peter A., Loewenstein, George, Hershey, J., al., et, Do Nonpatients Underestimate the Quality of Life Associated with Chronic Health States because of Focusing Illusion?, in: Medical Decision Making, Bd. 21 / 3 (2001), 190–99. Ubel, Peter A., Loewenstein, George, Jepson, Christopher, Whose Quality of Life? A Commentary of Exploring Discrepancies Between Health State Evaluations of Patients and the General Public, in: Quality of Life Research, Bd. 12 (2003), 599–607. Wieland, Wolfgang (1975), Diagnose. Überlegungen zur Medizintheorie, Berlin u. a. Wright, B., Attitudes and Fundamental Negative Bias: Conditions and Corrections, in: Yuker, H. E. (Hg.), Attitudes toward Persons with Disabilities, New York 1988, 3–21. Youngner, Stuart N. (1988), Who Defines Futility?, in: JAMA 2060, pp. 2094– 2095.

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Beate Herrmann

Advance directives in oncological therapy

1

Introduction

The growing significance of patients’ provisions results from the desire for a humane and independent life, in particular when it comes to illness and death. Although one’s own death cannot be controlled, after all, the process of dying or the final stage of life can be influenced by way of the growing possibilities of medicine and thus, is a subject of human acting and decision-making. For those concerned, this is connected to both, the opportunity and the responsibility to make autonomous decisions about medical care at the end of life. By a written advance directive the individual person may state her ideas of a humane life. Nevertheless, precisely this phase of life also is subject of care and responsibility of physicians and nurses. A few decades ago it was more or less no question that the physician, to the best of his/her belief, had to decide about the diagnostic and therapeutic measures for the patient’s welfare. However, nowadays there is wide consensus that the patient’s informed and free decision about her medical care is the guideline and legitimate foundation of medical practice (Erbguth 2003, 652). Advance directives may be considered as expression of a change of paradigm – from a paternalist to an equal relationship between physician and patient. As autonomy being the leading principle for the patient’s decision, for the context of advance directives must be mentioned that autonomy does not simply mean an »unlimited choice when it comes to medical matters« (Erbguth 2003, 652). Within the framework of health care the physician is legally not obliged to use any kind of medically inappropriate therapy by order of patients or their relatives (see verdict by LG Karlsruhe 30. 08. 1991, AZ: 10 O 291/91). Rather, an autonomous decision by the patient requires the physician to contribute his/her expertise and estimation of the medical situation. The patient will only be able to make an autonomous deci133 https://doi.org/10.5771/9783495813430 .

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sion if he can rely on well-grounded medical information and capability to judge. According to this understanding of an autonomous decision, even statements of an advanced health care directive concerning the ending or not starting of artificial respiration are connected to certain conditions. And it always depends on judgements of the physician: beside surrogate decision makers it is him, who is crucial for question if the initiating conditions are met, e. g. if the patient is »in the final stage of a fatal illness«. Accordingly, the physician’s care may not be understood as competing with the patient’s autonomous decision, but as a necessary condition for its realization (cf. Dörner 2000, Eibach et al. 2001, 21–28). Especially in the case of cancer, numerous patients are faced with the decision which kind of treatment would make sense for them. Many malignant diseases are untreatable. Thus, at some point, a switch should take place from curative care to palliative care. With respect to the question when and how this change should be managed, advance directives play a prominent role. They might be especially helpful if patients cannot utter their own opinion any more at a certain point of time (Jox 2008).

2

Medical indication, aim of treatment and will of the patient

Under which circumstances is it possible to change the aim of a therapeutic regime and to stop certain medical interventions? The answer to this results from the general conditions under which medical treatment should take place. These conditions are: • There is an indication for a certain therapeutic intervention. This means, the intervention has to bring about more benefit than harm for the patient. • The patient has to agree to a certain intervention. He can give his informed consent after having been provided with sufficient information. It should be noted that not only stopping treatment but also continuing requires justification. Accordingly, medical interventions can be ended under the following conditions: • The intervention has no benefit or does more harm than benefit to the patient. • The patient refuses treatment. 134 https://doi.org/10.5771/9783495813430 .

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Of primary concern is the question of an intervention’s benefit. If a treatment is useless in the sense that it either has no physiological effect nor the aim of treatment can be reached, the treatment is not necessary. As the patient has only a right to medically indicated treatments, in this special case the informed consent of the patient is not effective (Thöns et. al. 2008, 126). The question whether a certain intervention has any benefit for the patient cannot be answered with regard to medical assessment alone. Rather, there are always normative judgments involved. The term »medical prognosis«, for example, contains not only objective medical parameters but also normative assumptions (therefore requiring justification): What is the patient’s expected quality of life? Is the patient’s age relevant for the prognosis? Another aspect of normativity is involved in the term »benefits of therapy«: It is easy to agree upon the position, that the patient’s benefit of a course of therapy should primarily be considered. However, what does »benefit« mean in this context? By asking whether a particular therapy is beneficial for the patient in the above-mentioned sense, two kinds of judgements are involved: such based on medical expertise as well as normative judgements. Judging the benefits based on medical expertise predominantly concerns the physiological effectiveness of a therapy. However, not every therapy, physiologically effective in the sense that it prolongs life for a particular period of time, is actually beneficial to the patient (c.f. Marckmann 2004, 380). The concept of »therapeutic benefits«, in the sense that therapy is beneficial for the patient, moreover implies normative suppositions, for example, judgements of quality of life: Does this special therapy offer the patient a worthwhile and desirable end result? Will there be an acceptable quality of life after the end of therapy? What are the chances of success? Is the anticipated benefit for the patient greater than the disadvantageous aspects of the therapy? For instance, the life-prolonging effect of artificial ventilation is certainly to be taken for granted. However, it may be uncertain whether an aim of treatment can be reached that is acceptable for a patient – for example with respect to the patient’s mobility and his/her ability to communicate with family and partner. If the patient cannot speak for herself anymore, an advance directive offers an alternative to find whether and how she would have been wanted to be treated. Advance directives are meant to guarantee

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that patients can autonomously decide about treatment themselves, even if they cannot utter their opinion any more. If there is no written statement, the patient’s presumed will must be investigated by those in charge of medical treatment in cooperation with family members. Patient’s earlier explicit statements about attitude towards life, values and preferences, but also non-verbal statements must be considered. All possibly relevant information should be collected in order to respond to the question how the concerned person would decide in the given situation (Marckmann 2005, 332–336). Notwithstanding all difficulties when it comes to investigating the presumed will as a basis for deciding about further therapeutic steps, existing studies indicate that a great majority of persons is very stable in their preference concerning the rejection of life support measures in the final stage of an illness (Garrett et al. 1994, Emanuel et al. 1994). The situation is even more difficult if the patient’s presumed will cannot be investigated, e. g. if the concerned person has never made any statement on the issue or if there are no relatives who might inform about her preferences. Also in the case of small children and newborns it is usually not possible to investigate any presumed will. In these cases one must refer to those general values we may believe to serve for the patient’s »objective« welfare. Given the plurality of values of our society, this construct may be problematic. Thus, when it comes to weighing harms and benefits for a patient resulting from the discussed medical measures one must be even more careful (Marckmann 2004). Such a weighing may refer, among others, to the following criteria: • Extent of the capability to perceive both, one’s environment and one’s own person. • Capability of interacting with others. • Extent of current and expected pain and suffering. • Prognosis of the illness while taking the possible therapeutic options into consideration. Even if the patient’s autonomy is a precious good and the foundation of any medico-therapeutic decision-making, such difficult situations make obvious that such decisions cannot be taken without medical and nursing expertise. In such borderline cases one cannot doubtlessly assume a generally recognized agreement on values. Thus, all professional groups participating in the care of the patient as well as the relatives should be included into the decision about limiting a 136 https://doi.org/10.5771/9783495813430 .

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therapy. In this case, the German Respiratory Society recommends explicitly the consultation by an ethics committee (Randerath et al. 2008, 308). The appropriate situative judgement on what is the best treatment option for the patient requires to unite and evaluate all available views: medical and nursing aspects, as well as religious and biographical aspects, among others personal attitudes towards life and personal values. This extended procedure can improve the judgement of bystanders if and in how far the individual will benefit from the possibilities of modern (intensive care) medicine.

3

The German law for advance directives of 2009: The normative perspective

In Germany, since 2009, there is a law about advance directives that regulates (among other points) the conditions of the validity of patients’ advance directives. This law gives very high priority to the autonomy of the patient: The written will of the patient is immediately binding for the physician under the following conditions: • The advance directive is indeed applicable to the patient’s situation in which the decision has to take place. • The advance directive does not demand anything illegal from the doctor, e. g. killing on request. • The advance directive has not been written while the patient was subject to external pressure or due to errors or manipulation. The most important alteration of the law is that patients may at any time make the decision not to receive any form of life-sustaining treatment – independent of the state of her disease. In the eyes of many critiques of the law, the emphasis of the patient’s autonomy went too far. According to them, the physician should not be regarded as the mere henchman of the patient’s wishes, independent of whether or not her wishes make any sense. It was criticized that the physician’s fiduciary duty requires his or her autonomous assessment of the situation. The following example points out the underlying conflict: During a case of fire, a young man suffers from a gas poisoning. He needs transitory artificial ventilation. In his advance directive, he had previously objected to any form of artificial ventilation. If one follows the law closely, the physician commits a crime if he saves the man’s life via artificial ventilation. According to the critiques, this is a counter-intuitive consequence. The physician rather always has to act 137 https://doi.org/10.5771/9783495813430 .

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in the patient’s best interest. This holds especially for cases with unforeseeable consequences and with outcomes, the patient had probably not wished. In our example, this had indeed been the case: Afterwards, the young man was extremely happy that his life had been saved via artificial ventilation.

4

Empirical results

Up to this point, we have dealt with the normative conflict between autonomy of the patient and physician’s duty of care. In light of this, it is important to consider the practical use advance directives have for cancer patients. Below, we will have a look at some selected studies that deal with the following questions. What do cancer patients think of the use of advance directives, and how important they are for guaranteeing patient’s autonomy? An Austrian study asked hospitalized patients with malignant diseases for their attitudes towards advance directives. About one third were in first line treatment, the others in second and third line treatment or in additional treatment lines for solid cancer (Kierner 2010): Only 5 % of the patients had signed an advance directive, 85 % did not wish to broach the issue of advance directives. (One has to notice that in Austria legally binding advance directives have to be attested by a notary.) The main reasons for disinterest were the following aspects: • They felt optimistic about their prognosis (15 %). • They were confident that their physician would make the correct decision (22 %). • They feared undertreatment of their disease (8 %). • They hold that family members should decide (7 %). In a study by Oorschot et al. from 2012, cancer patients who had to undergo radiotherapy were asked about their attitudes towards advance directives. The study included 658 patients, 23,6 % had already signed an advance directive, 53,3 % thought they were likely to sign. One of the most important results was the following: Independent of the question whether an advance directive was issued, 50 % of the patients said that their view of advance directives was to facilitate consultations rather than serving as a directive in a concrete situation (Oorschot 2012, 2729–36).

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Who should take the initiative for setting up an advance directive? The majority of patients with a malignant disease wished that their physician would bring up the issue of an advance directive as early as possible. The majority of patients and control groups felt that physicians should point out the possibility of an advance directive to their patients (Oorschot 2012). This can be interpreted as an expression of patients’ trust towards their physicians that he or she will know the right time to bring the issue up. Physicians, on the other hand, prefer this to be delegated to the patient’s family or to members of other health care professionals.

Bindingness of advance directives In order to strengthen cancer patients’ autonomy and to improve quality of palliative care, it is necessary to know what patients’ preferences are in regard to treatment at the end of life. In the case of written advance directives, it is questioned whether the patient’s preferences, uttered in the advance directive, are still in accordance with his/her current wishes and needs, presumed that he or she finds herself in the situation described by the advance directive. The study of Sahm et al. asks whether a change of perspective takes place if people are confronted with life-threatening diseases. In order to investigate this question, cancer patients as well as healthy persons (hospital professionals) were asked about their wishes with respect to different treatment options at the end of life. There was a significant difference between patients and other groups regarding the application of antibiotics and aggressive treatment measures such as chemotherapy or dialysis. The patients’ group wanted both types of treatment significantly more often. (Sahm 2005, 211) This result indicates a general problem of advance directives. Numerous studies show that people are very bad in anticipating their future will and action in situations that they have never faced before and that they find hard to imagine. For instance, as long as we are healthy, it is difficult – if not impossible – to anticipate how we would decide once we had a life-threatening disease. Among patients with amyotrophic lateral sclerosis, preference with regard to resuscitation changed within a few months (Silverstein 1991) from original rejection to acceptance of resuscitation. Apparently, often a change of per139 https://doi.org/10.5771/9783495813430 .

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spective takes place. This means that a patient changes her attitudes from rejection of treatment into the wish for a particular type of treatment if she is confronted with a serious disease. This may be due to the ability to adapt oneself to difficult situations.

5

Consequences for counseling with regard to advance directives

What are so far the consequences for the advance directives counseling? The physician’s counseling and his or her medical assessment of the patient’s condition is of utmost importance. Good counseling is a pre-condition for the patient’s ability to formulate her wishes and preferences clearly (Vetter 2009, 76–77). Furthermore, studies showed that the support of the physician when signing an advance directive reduces fear and depression (Jones 2011, 3 ff.).

Combination of advance directive and health care proxy If patients lack the capacity to decide for themselves, the solution should not be to follow a written document in a prescriptive manner. In addition to advance directives one should designate a health care proxy for discussing decisive questions (Sahm 2005, 211). For the case of later incapacity for consent (e. g. as a result of grave illness or agerelated mental degeneration) the concerned person in her healthy days entitles a trusted person to decide on her behalf and in her best interest about further medical treatment. The health care proxy is an important supplement to the advance directive, because a patient’s family members are important conversation partners for the health care professionals if the patient cannot express her own wishes any more. In the ideal case, family members are well informed about the treatment wishes of the patient and are able to communicate them to the health care professionals. If they act as proxies, they are in a position to bring in the patient’s interests in a legally binding way. Advance directives should primarily be seen as an enhancement for the patient physician relationship. They should not be regarded as instruments for surrogate decision making or as a substitution for communication in the first place. Rather, they are important tools to

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facilitate the communication between patients, their relatives and the health care professionals.

References Dörner, K., Der gute Arzt. Lehrbuch der ärztlichen Grundhaltung, 2000, Schattauer. Eibach, U., Schäfer, K., Patientenautonomie und Patientenwünsche, Medizinrecht 2001; 1: 21–28. Emanuel, L. L.; Emanuel, E. J., Stoeckle, J. D. et al., Advance directives. Stability of patients’ treatment choices, Archives of Internal Medicine 1994; 154: 209– 217. Erbguth, F. J., Ethische und juristische Aspekte der intensivmedizinischen Behandlung bei chronisch progredienten neuromuskulären Erkrankungen, Intensivmedizin 2003; 40: 646–657. Garrett, D. M., Harris, R., Patrick, D. L., Stability of choices about life-sustaining treatments, Annals of Internal Medicine 1994; 120: 567–573. Jones L, Harrington J, Barlow CA et al, Advance care planning in advanced cancer: can it be achieved? An exploratory randomized patient preference trial of a care planning discussion. Palliat Support Care 2011, Vol. 9(1): 3–13. Jox RJ, Heßler H-J und Borasio GD, Entscheidungen am Lebensende, Vorsorgevollmacht und Patientenverfügung, Nervenarzt 2008, Vol. 79(6): 729–739. Kierner, K., Hladschik-Kermer, B., Gartner, V., Watzke, H., Attitudes of patients with malignancies towards completion of advance directives, in: Support Care Cancer 2010, Vol. 18:367–372. Marckmann G, Lebensverlängerung um jeden Preis? Ethische Entscheidungskonflikte bei der passiven Sterbehilfe, Ärzteblatt Baden-Württemberg 2004, Vol. 59(9): 379–382. Marckmann, G, Patientenverfügungen. Vorsorge für das Ende des Lebens, Ärzteblatt Baden-Württemberg 2005; 60 (8): 332–336. Oorschot van, B., Schuler M, Simon A, Flentje M, Advance directives: prevalence and attitudes of cancer patients receiving radiotherapy, Support Care Cancer. 2012 (11): 2729–2736. Randerath, W. et al.: Betreuung von Patienten mit maschineller Beatmung unter häuslichen und heimpflegerischen Bedingungen. Stellungnahme der Deutschen Gesellschaft für Pneumologie und Beatmungsmedizin e. V. (DGP) und der Arbeitsgemeinschaft für Heimbeatmung und Respiratiorenentwöhnung e. V., Pneumologie 2008; 62: 305–308. Sahm, Stephan: Imperfekte Autonomie und die Grenzen des Instruments Patientenverfügung, Zeitschrift für Medizinische Ethik 2005, Vol. 51, 265–275. Sahm S, Will R, Hommel G., What are cancer patients’ preferences about treatment at the end of life, and who should starttalking about it? A comparison with healthy people and medicalstaff. Support Care Canc 2005, Vol. 4, 206– 214.

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Beate Herrmann Silverstein, M., Stocking, C., Antel, J., Beckwith, J. Roos, R., Amyotrophic Lateral Sclerosis and Life-Sustaining Therapy: Patients’ Desires for Information, Participation in Decision Making, and Life-Sustaining Therapy, Mayo Clinic Proceedings 1991, Vol. 66, (9), 906–913. Thöns, M., Marckmann G., Kutzer, K., Zenz, M., Ende einer Heimbeatmung. Rechtliche, ethische und palliativmedizinische Aspekte, MMW-Fortschritte der Medizin Originalien Nr. III 2008; Vol. 150: 123–127. Vetter, M. (2009): Selbstbestimmung am Lebensende. Patientenverfügung und Vorsorgevollmacht, Stuttgart: Boorberg.

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Clinical cancer research: opportunities and risks

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https://doi.org/10.5771/9783495813430 .

Geraldine Rauch

Why statistics matters The ethical impact of biometrical issues in clinical trials

1

Introduction

Medical progress in general is substantially based on findings and results from clinical trials which are defined as »any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product […]« (ICH E6, 1999). For example, the market approval of drugs is directly related to the results of corresponding phase III efficacy trials. A good scientific quality thereby defines the basis for an ethical research (Victor, 1999) as clinical trials always go along with additional physical risks and increased efforts for the participant. Therefore, medical research in humans can only be ethically justified if a gain in information is guaranteed or at least highly probable. Apart from the protection of the participants, it should also be noted that clinical trials usually require a substantial financial support. Spending the existing financial resources only for valid and constructive research only can also be regarded as an important ethical issue. For these reasons, it is necessary that clinical trials are carefully planned, and that this plan is documented in a study protocol which is reviewed and approved by an independent ethical committee and which must be strictly followed by all members of the study team. These requirements promote the interest of the society in medical progress on the one hand but protect the rights of the participants (patients or healthy probands) on the other hand. In general a scientifically valid trial ensures that • • •

the study design is adequate to assess the medical research objectives, the data are correctly analyzed and interpreted, the results are published in a correct way, regardless of whether they are positive or negative, expected or unexpected.

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These aspects are essentially guided by a valid biometrical methodology (ISI, 2010). The impact of medical biometry in clinical trials has steadily grown during the last decades. Today, a biometrician is involved in all well planned clinical trials. Moreover, medical ethics committees often involve a biometrical expert. Finally, biometrical aspects usually undergo a separate and intense review process when publishing the results in medical journals. In the present overview, we demonstrate the importance of biometrical aspects for an ethically sound medical research, discussing general aims and interests in chapter 2, presenting the role of ethics committees and the role of biometricians within these committees in chapter 3, and finally discussing biometrical aspects of medical research and their relation to ethical issues in chapter 4.

2

Aims and interests of medical research

The general aim of medical research is to improve diagnostic, prognostic or therapeutic methods, tools and strategies and to maintain or improve quality of life and prolong life expectancy. New diagnostic, prognostic and therapeutic methods, especially new drugs are first tested in healthy volunteers (probands) and later on in the development process in patients in order to assess safety, practicability, and efficacy. These general goals are population based interests but they are not automatically in accordance with the particular interests of the individuals participating in a clinical trial. The interest of a patient in general is to receive the best possible treatment with a minimum of additional risk. In a clinical trial, however, the benefits and harms of the new intervention are usually not known yet. This problem results in conflicting interests between researchers who are interested in extending their scientific knowledge, the society aiming a rapid medical progress and the study participants demanding a positive benefit-risk ratio. An ethically sound medical research therefore has to find an adequate balance between these positions. There exist a number of laws and guidelines to deal with this sensible issue. For example, the ICH E6 Guideline for Good Clinical Practice (1999) and the GCP ordinance (2004) formulate general requirements for the conduct of clinical trials. The Declaration of Helsinki (2013) states explicit recommendations for medical research projects in order to protect the safety of the participants. On this basis 146 https://doi.org/10.5771/9783495813430 .

Why statistics matters

the general rule is that »benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s)« (Declaration of Helsinki 2013). This rule intends to insure that study participants are not deliberately treated worse than the current standard in order to enlarge the potential treatment effect. In general, it depends on the research objective and the study design whether there exists a potential individual benefit for the participants, a group benefit (for example when testing the validity of a new diagnostic instrument compared to the current standard) or whether the potential benefit is exclusively related to a third party, which is the case if a new drug is tested on healthy volunteers (phase I studies). For clinical studies concerning drug development and medical devices, there exist explicit laws delineating and regulating standards of study design, risk management, information and protection of study participants and ethical approval (the corresponding German laws are AMG 2012, MPG 2011). However, there exist numerous additional medical research fields which are not covered by these laws. These are for example psychotherapeutic therapies, physiotherapeutic or ergotherapeutic approaches, surgery techniques, preventive and rehabilitation strategies etc. In these latter cases, the responsibility for an ethical research exclusively lays in the hand of the clinical trial team and the local ethics committee.

3

Ethics committees in medical research

The general task of ethics committees is to assess and control the scientific and legal validity of medical research projects in humans under ethical aspects in order to enable medical progress on the one hand and thereby protecting patient’s safety on the other. Moreover, the ethics committee has an advisory function. For clinical trials concerning drugs or medical devices, the decision of the ethics committee is binding. For all other medical research project the comments of the ethics committee exclusively have an advisory character. The decision of the ethics committee thereby is essentially guided by a thorough review of the study protocol. The members of ethics committees are mainly medical experts from different fields. This medical expertise guarantees that the research project is well planned from a clinical point of view and that 147 https://doi.org/10.5771/9783495813430 .

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the medical risks and benefits for the participants are correctly declared and ethically justified. Additionally to medical experts, ethics committees should always include a lawyer, an expert in medical ethics or a theologian and finally a biometrician. These latter recommendations, however, are currently not mandatory, although for a clinician it is simply impossible to provide the knowledge for a correct assessment of the legal, the ethical and the biometrical aspects of a clinical trial. In particular, in many clinical trial situations the statistical aspects can only be judged by a biometrical expert with a certain mathematical background. The following section therefore will demonstrate the diversity of biometrical aspects and their relation to an ethically sound research. As all the items described below have to be carefully checked by the responsible ethics committee, the need for a biometrican within any medical ethics committee becomes obvious. Moreover, the following section will illustrate why it is important to include a biometrican in the study team when planning, analyzing and publishing a clinical trial.

4

Biometrical aspects of study planning

As outlined above, the market approval of drugs and other medical products depends on the results of previous clinical trials. The results of clinical trials, however, are essentially influenced by the choice of the study design and the statistical analysis method. Thus choosing an inappropriate study design or analysis strategy may lead to serious misinterpretations and thereby has potentially serious consequences for patients and for the medical progress in general (Mannsmann et al. 2004). Although there exist a number of well-established standard study designs and statistical methods, which can be easily implemented, biometrical research is rapidly growing and new aspects continuously have to be considered. New strategies in design and analysis have the potential to considerably improve medical research. In order to understand the impact of biometrical aspects and the need for a constant research in statistical methodology, we will now describe the key biometrical issues in a clinical trial. It thereby has to be noted that an appropriate biometrical study planning only is possible in close cooperation with the responsible medical expert. The most im148 https://doi.org/10.5771/9783495813430 .

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portant biometrical aspects in the planning stage of a clinical trial can be summarized as: 1. Choice and definition of primary (and secondary) outcome variables, 2. Choice of the study design (number of treatment arms, blinding, randomization, interim analyses etc.), 3. Choice of the statistical analysis strategy (statistical tests, models, covariate adjustment etc.), 4. Calculation of the required number of patients to detect an existing treatment effect. The different biometrical aspects are also stated and discussed in the ICH E9 Guideline »Statistical Principles for Clinical Trials« (1999). In the following, these four main aspects will be discussed in more detail and exemplary clinical scenarios will be presented to illustrate the importance of these items.

Choice and definition of outcome variables Every medical research project starts with an open medical question to be answered. The first important medical and biometrical task is to define an adequate outcome variable which enables the assessment of the research question. By choosing an appropriate primary endpoint the following considerations should be taken into account: • • •

•

The outcome variable must be relevant for the medical research question and surrogates should be avoided if possible. An objectively measurable outcome variable should always be preferred to subjectively assessed endpoints. The outcome should be measurable and assessed within reasonable time limits, also taking into account potential financial limits. Multiple primary endpoints of interest should be avoided if possible.

Although, these recommendations might seem trivial at a first glance, they may be difficult to be followed in many cases. For example, many studies in oncology or cardiology focus on death as primary 149 https://doi.org/10.5771/9783495813430 .

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endpoint. Although death defines an objective and relevant outcome, it may be difficult to assess if the disease under consideration progresses only slowly. The expected long and potentially expensive observation period therefore may be shortened by preferring a surrogate endpoint, e. g. tumor-progress or a composite endpoint like progression-free survival. However, these alternative endpoints must be strongly correlated to the endpoint of primary interest in order to guarantee a correct interpretation of the results which might be difficult to verify in the planning stage. Therefore, additional consistency analyses should be carefully planned in advance to guarantee a valid outcome interpretation. This exemplary situation illustrates that the choice of an adequate outcome criteria is not solely a medical task but also includes important biometric considerations.

Choice of the study design Apart from the definition of the primary and secondary endpoints, the choice of the study design is a major biometrical aspect. For clinical phase III drug efficacy trials, the gold standard is a randomized, controlled, double-blind design. However, there exist many other possible designs depending on the intention and the context of the clinical trial. For example, in the early development phase of drugs (phase I), the new agent is first tested on a small number of patients to determine safety and tolerability. As in these phase I studies the new agent is often applied for the first time in humans the knowledge concerning benefit and harms is limited and has to be extrapolated from animal studies. Therefore, only a very limited number of study participants are acceptable for ethical reasons. From a statistical point of view, however, observations based on a small number of patients refer to a high uncertainty. There exist special step-wise study designs to solve this problem by increasing the number of participants only in case that the very first results support an adequate safety. In phase II and III studies, there exist so called sequential designs, which allow an early interruption of the trial either for futility or as efficacy has been demonstrated earlier as anticipated. By these approaches, the number of patients might be reduced considerably. In general, new study designs follow the general aim to minimize the required number of patients and to improve the level and quality

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of information gained from the study results. Statistical research on new study designs is thus done for ethical reasons in a global context.

Choice of the statistical analysis strategy The statistical analysis strategy is closely related to the choice of the primary endpoint(s) and the study design. Moreover, the total number of required patients is essentially driven by the analysis strategy. Although some standard statistical tests and models are well established, there always exist a number of alternative possibilities to analyze a specific outcome. The choice of the analytical method depends (among other aspects) on the underlying statistical model assumptions and on confounders that must be taken into account. Usually, there exist more than one approach to analyze the same data, which correspond to different advantages and limitations. For example, robust statistical tests have the advantage of being less dependent on the underlying data distribution and could thus prevent misinterpretations of results. On the other hand parametric approaches that depend on a number of distributional assumptions usually require a smaller sample size to be efficient which also defines an ethical advantage. Choosing an optimal statistical analysis strategy is therefore only possible by a biometrical expert who knows how to judge advantages and disadvantages of different analysis strategies for a specific clinical situation.

Calculation of sample size A major biometrical task closely related to ethics is sample size calculation. Medical research can only be ethically justified if the number of study participants is correctly specified. If the sample size is too low the study will not be effective in the sense that existing treatment effects cannot be detected. As the research question cannot be answered patients are unnecessarily exposed to the study related risks. If the sample size is too large, it might happen that patients are recruited although a relevant treatment effect has already been proven. In a controlled trail design, this would mean that some patients are still randomized to the reference treatment although it has already been demonstrated that the new treatment is more effective. 151 https://doi.org/10.5771/9783495813430 .

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The sample size formula depends on the specific trial design, the definition and the number of primary endpoints and the choice of the analysis strategy and some other statistical and medical parameters. The calculation of sample size usually is not trivial and should always be performed by a biometrical expert in closed cooperation to the responsible medical expert. In summary, the definition of outcome variables, the specification of the study design and the strategy of the biometrical analysis as well as a valid sample size calculation define the most important biometrical aspects when planning a clinical trial. All these aspects can be difficult and complex from the point of biometrical methodology and therefore require the expertise of a professional biometrican.

5

Conclusion

The biometrical aspects of clinical trials presented above demonstrate the importance of a valid statistical planning. An incorrect or inappropriate biometrical design may lead to misinterpretations or even wrong results, thereby potentially leading to inadequate treatment recommendations. In the medical literature, there exist a number of clinical trial examples with substantial limitations concerning the biometrical design. This could generally be avoided by consulting a biometrical expert when planning the study and when analyzing and interpreting the results. Moreover, it is of strong importance to include a biometrician in every ethics committee in order to guarantee a sound control of all important statistical aspects in medical research projects. However, the biometrical aspects are always strongly related to the medical context. Without knowledge of the medical background, it is impossible to give general recommendations for any biometrical aspects. Therefore an intense cooperation between biometricians and medical experts defines the basis for an ethically and scientifically sound and thereby successful medical research.

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References Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz – AMG) 24. 08. 1976, neugefasst am 12. 12. 2005, BGBl. I 2005, S. 3394, zuletzt geändert am 19. 10. 2012. Gesetz über Medizinprodukte (Medizinproduktegesetz – MPG) vom 02. 08. 1994, neugefasst 07. 08. 2002, BGBl. I – 2002. S, 3146, zuletzt geändert am 08.11. 2011. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (1999): Guideline for Good Clinical Practice (E6). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (1999): Statistical principles for clinical trials (E9). International Statistical Institute (ISI) (2010): Declaration on Professional Ethics. Mannsmann U., Jensen K., Dirschedl P. (2004): Good Biometrical Practice in Medical Research – Guidelines and recommendations. Informatik, Biometrie und Epidemiologie in Medizin und Biologie 35: 63–71. Verordnung über die Anwendung der Guten klinischen Praxis bei der Durchführung von klinischen Prüfungen mit Arzneimitteln zur Anwendung am Menschen (GCP-Verordnung – GCP-V) vom 09. 08. 2004, BGBl. I – 2004, S. 2081, zuletzt geändert am 19. 10. 2012. Victor N. (1999): Prüfung der wissenschaftlichen Qualität und biometriespezifischer Anforderungen durch die Ethikkommissionen? Medizinrecht 9: 408– 412. World Medical Association (1964, 9th Revision 2013): Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects.

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Responsible return Consent for feedback from biobanks research

1

Population database and unexpected findings

When population database research started, it was intended to provide basic general knowledge and not to reveal information about individuals. This has shaped the policies and ethical frameworks for population database research. Recently, much attention has been focussed on return of unexpected findings that could be of great relevance for individual contributors. In this paper, I deal with the question how this information could be returned to individuals in a responsible way. First, I consider this in the case of participants who never expected return of individual findings. I evaluate three main options for this task. I argue that participants only have strong autonomy claims for not knowing results while they have weak autonomy claims for obtaining information. It is weak autonomy in the sense that it should be limited by professional responsibility of health care professionals and researchers. In order to secure that, I argue that return of individual findings should only take place in a context of genetic counselling. Conducted in the form of dialogue, counselling provides the proper conditions for autonomy in this context. I then address the task of designing an appropriate consent for return of unexpected findings about individuals. In this context I ask how useful the ideas of restricted informed consent, open consent and wide authorization for conditions of use of samples in biobank research are for the challenge of managing feedback of research results to individual contributors. I argue that the most fitting way is to formulate an authorization for conditions that need to be met. In all cases, regardless of whether participants have consented to receiving individual results or not, researchers have perfect duties only to respect the right of those who prefer not to know. In the task of returning results, they have imperfect duties which require contextual judgment limited by a sensible framework for conveying the results in a trustworthy and caring way. 154 https://doi.org/10.5771/9783495813430 .

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2

Iceland’s population database research

When population database research started in Iceland by deCODE genetics in the late 1990’s, it was emphasized in the discussion that there was no interest in information about individuals. The research was described as genetic epidemiology carried out in order »to create new knowledge in medicine« (Gulcher and Stefansson 1999). This was used to argue against a policy of obtaining restricted informed consent for participation in population database research and for a policy of broad consent. »With broad consent to use the genotypic information to study the genetics of health and disease it would be possible to use the combinatorial analysis systematically to seek the best fit between all regions in the genome and all phenotypic variants recorded in the database« (Gulcher and Stefansson 2000: 1828). These authors point out that consent for genetic research has three components: first, for the acquisition of the biological material, second, to the genotyping of the DNA, and, third, to the use of the genotypic information that results. In all cases, they argue, »the consent requested is for the use of genotypic data to generate knowledge about the nature of the group, rather than knowledge about the individual person« (Gulcher and Stefansson 2000: 1829). Nevertheless, Gulcher and Stefánsson (2000) were also aware of the possibility that population database research might bring benefit to individuals and they address this point specifically: »The Icelandic legislature decided that the protection of privacy was more important than the possibility of immediate benefits to individuals. However, if the appropriate authorities granted permission, it would be relatively easy to identify and contact all persons in Iceland who had a particular risk for disease« (p. 1829). The authors point out that it would be possible to ask participants whether they would prefer to reduce the emphasis on privacy and »wish to be notified about any association between alleles they carry and specific diseases or predispositions to the development of disease« (Gulcher and Stefansson 2000: 1829). This, however, has never been done in Icelandic population database research. The company deCODE genetics works only with personally unidentifiable information collected for basic genetic research in cooperation with primary researchers and physicians. In the wide consent for biobanks research, participants in research give deCODE permisson to store their biosamples in a biobank and use them for medical research in search for causes, improved diagnosis and treatment 155 https://doi.org/10.5771/9783495813430 .

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of illnesses and/or preventive measures. Until 2007, there was no mention of return of information. In the consent form used currently by the Research Service Center for deCODE, there is a clause to the effect that participants give permission to have information personally identified and that they may be contacted with personal information with the permission of the National Bioethics Committee in order to introduce to them further research with their participation. This option, however, has never been used in order to inform individuals about their particular results and is not intended for that.

3

Return of results to individuals?

In recent years, the tide has markedly turned and the discussion has centred around return of results to individuals. This discussion had been taking place in closed circles for some time before it broke out into the open in the wake of reports about Angelina Jolie’s decision to undergo a double mastectomy. The actress wrote about her decision: »The truth is I carry a »faulty« gene, BRCA1, which sharply increases my risk of developing breast cancer and ovarian cancer. My doctors estimated that I had an 87 percent risk of breast cancer and a 50 percent risk of ovarian cancer, although the risk is different in the case of each woman. […] I am writing about it now because I hope that other women can benefit from my experience« (Jolie 2013). Stefánsson, the founder and CEO of deCODE genetics, used the opportunity created by the Jolie case to inform the Icelandic public about certain kind of knowledge generated in the course of research by the company. He has stated that the company has information about approximately 7000 lcelanders who have 75–80 % likelihood of getting serious diseases related to genetic mutations. According to Stefánsson, about 1200 Icelandic women are at about 80 % risk of getting breast cancer of the type BRCA1 og BRCA2. »If it is not duely detected, they will die from this disease« (Morgunblaðið 2013) and says that the primary duty should be to save their lives. Stefánsson points out that researchers at deCODE genetics could find the individuals in its database in no time if they were granted the permission which has been rejected by the Icelandic health authorities. »I have told them that I find it ruthless not to at least contact these women and offer them that they will be under close surveillance. I am convinced that it is possible to prevent premature death 156 https://doi.org/10.5771/9783495813430 .

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in this group of women« (DV 15. May 2013). In a public meeting held on June 11 2013, the opinion was raised that the responsible reaction to the situation was to have an informed social discussion about this and then the women could themselves take the initiative and inquire whether the information applied to them. To this position Stefánsson responded: »This is what the controversy is about. Is it sufficient that we tell the society that this information is obtainable or should we approach these women? As an old fashioned physician, I am of the opinion that we have to approach them because the likelihood that they will get cancer and die from it is far too high for us to simply stand by and watch« (RÚV 2013).

4

Ethical evaluation of three options

It is clear from the above description that Icelandic society is facing an ethical dilemma. Researchers have unidentified information about several participants at relatively high risk for getting serious diseases, such as breast cancer, but have no channels for conveying the information to the outside world. This raises the question whether information should be returned to individuals from database research and, if so, how that return should be managed. In dealing with this question, I will discuss three main options and evaluate them from an ethical perspective.

4.1 Do nothing The first option in this situation is simply to do nothing. There are two main arguments for this position. The first has to do with the purpose of population database research: »Seemingly, return of individual fundamental research is impossible and nonsensical as the very purpose of this type of research is not the production of individual but generalizable knowledge« (Knoppers et.al. 2006, 1172). To this one could respond that even though this was undeniably the purpose of the research, it has nevertheless revealed information about participants that could be of clinical significance for them. It seems to be an overly rigid position to deny possible avoidance of serious harm to individuals simply for the reason that their participation in research had another purpose. One argument against return of individual re157 https://doi.org/10.5771/9783495813430 .

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sults is that such practices invite therapeutic misconceptions. The words of DeCODE’s CEO that »as an old fashioned physician« he recommends that participants be actively approached is a clear case where the roles of fundamental research and clinical activity are confused. This argument is certainly an important reminder of being most careful in building bridges between fundamental research and the clinic, but it should not be used to trump all attempts in that direction. The second argument for the »do nothing« position is that in those cases where return of results was not part of the consent for participation in database research there is no justification for getting back to the participants. »However handled, the issue of notifying (or not) participants of results should be disclosed and agreed to in advance (ie on the consent form)« (Knoppers et.al. 2006, 1176). This is a major issue and raises the question whether return of results should not even be considered in those cases where that possibility was not raised on the initial consent forms. I will argue against such a rigorous position provided that all other relevant conditions for disclosure are met. There seems to be a growing consensus in the literature about the conditions for disclosure which can be summarized in the following way: »findings that are analytically valid, reveal an established and substantial risk of a serious health condition, and are clinically actionable should generally be offered to consenting contributors« (Wolf et al. 2012, 361). Let us look at two examples of such conditions. The former is from World Health Organisation (WHO) and lists three conditions that have a direct reference to the ethical principles of beneficence, non-maleficence and autonomy, in this order: (i) »the data have been instrumental in identifying a clear clinical benefit to identifiable individuals«; (ii) »the disclosure of the data to the relevant individuals will avert or minimize significant harm to those individuals«; (iii) »there is no indication that the individuals in question would prefer not to know« (WHO 2004, 81). Another example of criteria for sharing information with research participants provided by Cassa et.al. (2012, 422) marks a somewhat different approach but has similar moral implications: »1. The genetic finding has important health implications for the participant and the associated risks are established and substantial. 2. The genetic finding is actionable; that is, there are established therapeutic or preventive interventions or other available actions that have the potential to change the clinical course of the 158 https://doi.org/10.5771/9783495813430 .

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disease. 3. The test is analytically valid and complies with all applicable laws. 4. During the informed consent process or subsequently, the study participant has opted to receive his/her individual genetic results.« It is interesting to compare the autonomy clauses in these two examples of criteria for disclosure. In one we find a positive formulation and an explicit mentioning of informed consent, while in the other there is a negative formulation and no requirement of an explicit consent to know: »there is no indication that the individuals in question would prefer not to know«. This is an important difference which can guide us in the effort to manage return of information to participants who decided to participate in research without expecting any return of individual results. The positive formulation is stricter and could be compatible with the »do nothing« position. The negative formulation, on the other hand, is more flexible and primarily protects the right not to know of those who have indicated that preference. In all other cases, it could be justifiable to approach participants with individual results if all the other conditions were fulfilled. As I will discuss below, I don’t think that these conditions are sufficient for contacting the participants, but I think that they provide a weighty argument against the »do nothing« position.

4.2 Giving option of knowing The second option in a situation where no consent is for return of information to individuals is to contact participants and give them the option of knowing about findings relevant for their health. As mentioned above, this has been suggested by the CEO of deCODE genetics who has appealed both to benefit of patients, saving them from immediate danger, and to their autonomy since a person with information has a stronger basis for self-determination than a person who is ignorant about the same. Both the appeals to benefit and autonomy raise complex questions which I can only briefly address here. As regards benefit, this is already addressed in the conditions for disclosure but this requires that prior to approaching individual participants there has been a careful selection of the type of information that is ›returnable‹ to them. The notion of returnability implies a responsible screening of information in the light of conditions or criteria for disclosure. This could be done by a committee with a broad 159 https://doi.org/10.5771/9783495813430 .

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professional background; »Including in the committee not only expertise on the scientific data in question (genetic and nongenetic), but also clinical expertise from professionals such as genetic counsellors, ethics expertise, and representation from the biobank contributor population allows robust analysis of the values questions involved« (Wolf et al. 2012, 375). The selection of returnable information in this manner already implies that the appeal to participant autonomy for return of information is relatively weak. The contrast between strong and weak autonomy is informative in this context. By a strong autonomy I have in mind relationships of the kind where preferences of a receiver of services are determinant for the result, limited only by availability of products. The paradigm example of this is a commercial relationship between a shopkeeper and a customer. »The customer is always right« because the main obligations of the service provider is to meet his preferences and not restrict them. The notion of weak autonomy, on the other hand, is characteristic of a relationship where the options of the receiver of services are restricted by the responsibilities of the service provider. While negative preferences of the client are important, positive preference only have weight with regard to options already selected as »offerable« by a responsible professional. The weak notion of autonomy is fitting for the context of therapy and research which is shaped by the special relationship between the agents. Professional responsibility of health care professionals and researchers limits the autonomy of patients and participants. In the case of research this is done by regulatory agencies which mediate the interaction between researchers and participants, e. g. by deciding which research projects are »offerable« for prospective participants whose choice is usually limited to taking part in the research or not doing so. This could be compared to the role of a professional committee which had the role of determining what kind of genetic research results are »offerable« to individuals whose autonomy would be restricted to receiving them or not. This requires a framework for responsible return within which the weak autonomy of the participants can be properly exercised. A major question relating to this framework is »to whom the finding should be communicated—the contributor or the contributor’s primary care physician (PCP)« (Wolf et al. 2012, 376). In a previous paper (Wolf et al. 2008), these authors argued »that offering the return of findings to the research participant was ethically justifiable to 160 https://doi.org/10.5771/9783495813430 .

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insisting on return to the PCP« (Wolf et al. 2012, 376). The ethical justification rested on respect for autonomy and concerns for privacy of the participant. The main problem with communicating such finding directly from biobank research to contributors has been well described by Gulcher and Stefánsson (2000, 1829): »Notifying participants in research of the results as they apply to them as individuals before the results have been confirmed and put in the appropriate clinical context is always problematic. For example, the discovery of a mutation in a gene that is found in 100 percent of patients with a certain disease does not tell us how large a proportion of patients with the mutation the disease develops, nor how reliable the test for the mutation is. A basic discovery should always be validated clinically before it is made known to individuals.«

4.3 Make availability of information publicly known The third option in a situation where no consent has been obtained for return of information to individuals is to make it publicly known that this information is available. Those contributors who would prefer to find out whether this information applies to them could then visit a genetic counsellor who would discuss the information with the individual. From the viewpoint of autonomy this would be a good way to handle the information. Genetic counselling is conducted in the form of a dialogue which can provide optimal conditions for individual self-determination in this context. This is because the situation has both epistemological and emotional aspects that need to be properly dealt with. The information is complex and requires professional interpretation if it is to enhance the individual’s understanding of her situation. The information can also be sensitive and have serious implications for the life of the individual receiving them. This requires empathy and emotional support which can also be provided by genetic counselling. In this way, the communication that takes place can provide freedom both from ignorance and confusion and from fear and anxiety induced by the information (Gottfreðsdóttir and Árnason 2011, 57). This is why the conditions for returnable information described above are not sufficient. In addition to the criteria of clinical utility and validity, beneficence and autonomy, it is a responsible requirement that the information be provided only in a context of clinical 161 https://doi.org/10.5771/9783495813430 .

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counselling. This requirement squares well with the idea of weak autonomy described above and, paradoxically, presumes that in this kind of context weak autonomy can facilitate more meaningful and in fact stronger self-determination than strong autonomy. The notion of weak autonomy is relational in the sense that it presumes a communication between a professional and a client. The idea of strong autonomy, on the other hand, implies that the receiver of information or services is best left alone so as to ensure that she is free from paternalistic interference. The rhetoric of empowering individuals by enabling them to have direct access to genetic data that has characterized the discourse of personalized genomic medicine (Juengst et al. 2012) is a case in point. It has been claimed that by giving people direct access to genetic information about themselves they are regarded as active citizens who are empowered by increased health literacy and can better manage their own health (Brand and Brand 2011). From the perspective of weak autonomy and professional responsibility that I have drawn upon, these ideas of empowerment and individual health management by direct access to genetic information are misleading. It is not empowering to have access to maximum quantity of information. Massive information can be bewildering and confusing and does not facilitate understanding which is a condition for self-determination. This is why I have emphasized that a responsible return of information to individual contributors needs to be mediated by genetic counselling. The task is to translate the genetic information being generated in basic genetic research into helpful tools in the context of clinical counselling, increasing the knowledge of genetic mutations and the accuracy of the information provided to individuals who are seeking help, information or advice in the context of health care and counselling. »This would for example provide us with information about genetic mutations in families that we are now unaware of« (Private conversation with a genetic counsellor). The option that we are discussing – making it publicly known that information which may have relevant health implications for individuals, could be made available to them in a context of genetic counselling – faces, however, several practical challenges. As one researcher says, (Private conversation 2012): »Those most likely to make use of this knowledge already know that they belong to a family where genetic diseases have been prevalent. But these are the people who already visit the genetic counsellors. Some of the most serious genetic diseases are so rare that people are not aware of the fact that 162 https://doi.org/10.5771/9783495813430 .

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they are hereditary. These individuals can be detected by using knowledge already obtained in the genetic cancer research at deCODE genetics and it is imperative to make them aware of the risk.« Is it possible to word a public announcement in such a way that these individuals’ interest is ignited without getting the entire population into the clinic for genetic testing and counselling? I have no solution to this practical problem but I believe that this is a challenge that we need to live with in the case of those contributors who decided to take part in genetic research at the time when return of individual results was not mentioned in their consent forms. The task is not limited to conveying information to those who donated without expecting return; it is also about designing consent for a responsible return of results from future genetic research. The problem of conveying individual research results generated in research that was intended for generalizable knowledge will only increase in inductive discovery research where the whole genome is under scrutiny rather than driven by concrete hypothesis (Wolf et al. 2012).

5

Three types of consent for database and biobank research

The discussion about consent for participation population database and biobank research has an instructive history by now. This history has some lessons that we could learn from when dealing with the new challenge of designing consent for return of individual results. At the risk of oversimplification, one could say that three types of consent have been discussed: (i) a restricted informed consent, (ii) an open consent, and (iii) a wide consent or a dynamic authorization. The question is how useful these ideas are in the task of managing a responsible return in the spirit of the ideas outlined above. I will now briefly discuss each possibility as a consent option for possible return of individual results from population database research.

5.1 Restricted informed consent Restricted informed consent implies that specific consent would be obtained for return of unexpected genetic findings at the beginning of every study by recontacting each donor. This policy is subject to similar criticism as restricted informed consent for participation in 163 https://doi.org/10.5771/9783495813430 .

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population database research generally. It is cumbersome, expensive and not in accordance with participants’ wishes (Árnason 2004, Hoeyer et al. 2004). While this could be necessary in the case of participants who contributed without expecting feedback, the situation is quite different when participants have the chance of voicing their preferences in advance.

5.2 General open consent General open consent would imply that participants would simply decide whether they would or would not prefer to be recontacted concerning individual findings deemed relevant for their health. This policy has been criticized for being morally inadequate because it does not provide conditions for meaningful consent (Árnason 2004; Holm 2009). Since it opens the possibility of preferring to have all healthrelated findings returned, it would also be subject to problems of strong autonomy discussed above.

5.3 Authorization and dynamic consent The main reason why ideas of authorization and dynamic consent were introduced (e. g. Greely 1999, Árnason 2004, Caulfield et al. 2003, Kaye, 2004) was the inadequacy of the other two consent forms. Even though they are radically different, they share the common limitation of an exclusive emphasis on the initial consent. The authorization idea recognizes the unforeseeability of research projects in database research which cannot be specified in advance and emphasizes that participants should initially be asked for consent to conditions for use of their samples or data. This overcomes the main shortcoming of a restricted informed consent. The authorization idea has gradually developed into a dynamic consent (Árnason 2009) which implies that participants or their proxies will be regularly informed about the research practice and can opt out of particular research projects. This overcomes the main shortcoming of an open consent which simply places trust in regulatory agencies to make decisions about the use of samples. Such dynamic authorization is sufficient to serve the moral purposes of informed consent, that participants are not coerced, deceived or exploited in some other way. 164 https://doi.org/10.5771/9783495813430 .

Responsible return

5.4 Authorization for return: two forms It seems to me that the authorization model is fitting for the task of designing conditions for a responsible return of individual research findings. It has been well said that the sensible approach is to »create a clear set of rules upon which researchers and potential donors may rely« (Alessi 2013). Authorization for return could take two forms. On the one hand, those who prefer not to receive any findings could simply make that explicit once and for all. For those, on the other hand, who would prefer to receive information about unexpected genetic findings, an authorization would need to describe the following factors: Information will only be returned to individuals if (i) according to independent experts (ii) it might help a contributor to avoid serious harm, (iii) it is clinically actionable, (iv) it has been validated clinically, (v) it will not violate individual privacy, and (vi) will be provided in a context of clinical counselling.

6

Conclusion

There is an increasing discussion that biobank researchers have an obligation to return individual research findings to individuals (Cassa et al. 2012; Knoppers et al. 2006; Wolf et al. 2012). In light of the preceding discussion, it is important to remind ourselves of the distinction between perfect negative duties or obligations and imperfect obligations. As regards return of individual information from population database research, there is a perfect duty not to return information to those who have made it explicit that they prefer not to know. My argument is an autonomy based approach only in the negative sense, i. e. if the participant does not want to know results, her liberty right not to should be respected. I have rejected autonomy based claim rights for return of information and argued that it should be limited by professional responsibilities. This implies that researchers have imperfect positive duties which require contextual judgment, related to possible benefits and sensible framework for conveying the results in a trustworthy and caring way. The conditions for interpreting these obligations towards participants could be made quite clear by an authorization for return, but the main challenge that we are facing now is how return can be managed in the case of those who never expected any return of individual 165 https://doi.org/10.5771/9783495813430 .

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information. It follows from my argument that the same general principles should apply as we could agree upon for a prospective authorization of return. The main difference is that those contributors who have not authorized return should not be approached directly but could take the initiative themselves. A precondition for this is an informative public dialogue and announcements which make it clear that the information is available. An informed and extensive social discussion is also needed for the democratic legitimacy of introducing new technology that may »revolutionize« the practice of medicine. Such public debate is particularly complex in the case of a »promissory science« (Hedgecoe 2004) which tends to build high expectations in the population. But that is another story and raises issues quite different from those that have been addressed in this paper (Árnason 2012).

References Alessi, S. A. (2013). »The Return of Results in Genetic Testing: Who Owes What to Whom, When, and Why?« Available at SSRN: http://ssrn.com/ abstract=2227667. Árnason, V. (2004). »Coding and Consent. Moral Challenges of the Database Project in Iceland«, Bioethics 18 (No. 1), 39–61. Árnason, V. (2009). »Scientific citizenship, benefit, and protection in population based research.« In: Solbakk, J. H., Holm, S., Hoffman, B. eds. Ethics of research biobanking (Dordrecht: Springer Verlag), pp. 131–141. Árnason, V. (2012). »The Personal is Political: Ethics and Personalized Medicine.« Ethical Perspectives 19 (1), 103–122. Brand, A. and Brand, H. (2011). »Health Literacy and Public Health Genomics: Innovation Management by Citizens.« Public Health Genomics 14 (no. 4–5), 193–194. Caulfield T, Upshur REG, Daar A. (2003). »DNA databanks and consent: A suggested policy option involving an authorization model.« BMC Medical Ethics (4). Available at http://www.biomedcentral.com/1472–6939/4/1. Cassa, A. C. et.al. (2012). »Disclosing pathogenic genetic variants to research participants: Quantifying an emerging ethical responsibility.« Genome Research 22, 421–428. DV [Icelandic newspaper] (2013). »1200 íslenskar konur semeru með yfir 80 % líkur á að fá brjósta-krabba-mein« (1200 Icelandic women are at about 80 % risk of getting breast cancer), May 15. Available at http://www.dv.is/lifsstill/ 2013/5/15/ef-thad-er-ekki-greint-naegilega-snemma-tha-munu-thaerdeyja/. Visited June 20 2013. Gottfreðsdóttir, H. and Árnason, V. »Bioethical concepts in theory and practice:

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Responsible return An exploratory study of prenatal screening in Iceland«, Medicine, Health Care and Philosophy 14 (no. 1), 53–61. Greely H. (1999). »Breaking the stalemate: A prospective regulatory framework for unforeseen research uses of human tissue samples and health information.« Wake Forest Law Review 34, 737–766. Gulcher, J. and Stefansson, K. (1999). »An Icelandic saga on a centralized health care database and democratic decision making.« Nature Biotechnology 17 (July), p. 620. Gulcher, J. and Stefansson, K. (2000). »The Icelandic Healthcare Database and Informed Consent«. The New England Journal of Medicine 342 (No. 24), 1827–1830. Hedgecoe, A. (2004). The politics of personalized medicine. Pharmacogenetics in the clinic. Cambridge: Cambridge University Press. Holm, B. »Broadening Consent and diluting ethics?« J. Med. Ethics 35, 125–129. Hoeyer, K., Mjörndal, T., Olofsson, B. O., Lynöe, N. (2004). »Informed Consent and Biobanks: A Population-Based Study of Attitudes Towards Tissue Donation for Genetic Research.« Scand J Publ Health 32, 224–229. Jolie, A. (2013). »My Medical Choice«. The New York Times, May 14 2013. (http://www.nytimes.com/2013/05/14/opinion/my-medical-choice.html?_r= 2&). Visited June 20 2013. Juengst E. T., Flatt M. A., Setterstein R. A. (2012). »Personalized Genomic Medicine and the Rhetoric of Empowerment.« Hastings Center Report 42 (no. 5), 34–40. Kaye J. (2004). »Broad Consent—the only option for pulation genetic databases.« In: Árnason G., Nordal S., Árnason, V. eds. Blood and data. Ethical, legal and social aspects of human genetic databases (Reykjavik: University of Iceland Press), 103–109. Knoppers, B., Joly, Y., Simard, J. and Durocher, F. (2006). »The emergence of an ethical duty to disclose genetic research results: international perspectives«. European Journal of Human Genetics 14, 1170–1178. Morgunblaðið [Icelandic newspaper] (2013). »ÍE vill ná til allra arfbera« [deCODE genetics wants to contact all BRCA2 carriers], May 15. Available at: http://www.mbl.is/frettir/innlent/2013/05/15/e_vill_na_til_allra_arfbera/. Visited June 28 2013. RÚV [Icelandic state radio] (2013). »Vill láta konur í áhættuhópi vita« (Wants to alert women at risk). June 11. Available at http://www.ruv.is/frett/vill-latakonur-i-ahaettuhopi-vita. Visited June 20 2013. WHO (2004). »Genetic Databases: Assessing the Benefits and Impact on Human and Patient Rights«. European Journal of Health Law 11, 79–84. Wolf, S. et al. (2008). »Managing incidental findings and research results in human subject research: analysis and recommendations.« J Law Med ethics 36, 219–248. Wolf, S. et al. (2012). »Managing incidental findings and research results in genomic research involving biobanks and archived data sets.« Genetics in Medicine 14 (no. 4), 361–384.

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New ›elixirs‹ : The Problem of changing therapeutic target with Erbitux and Avastin

By far the most difficult part of palliative treatment is not at all, as most would assume, the task of terminal care. That can be learned, and the burden is distributed among many people in the palliative team and the pain centres. The real problem is to be found in the initial phase of palliation; it has to do with the highly complex, extremely sensitive decision to change the goal of therapy. After all, this decision has to do with many things: • it is the culmination of the epicrisis of the physician (accompanied by critical assessment of the course of, in the end, an unsuccessful curative therapy); • the professional crisis on the part of the physician resulting from the need to give up the curative therapy and to define other goals of therapy with regard to the dying state of the patient; • the beginning of the crisis of grief on the part of the palliative patient (beginning of the phase of grief); • the loss of hope for a cure on the part of the patient, and his or her reflection on new tasks in the phase of dying. As early as at the point of the change in therapy, then, a highly sensitive and vulnerable phase of patient care begins. The central interests are now not in cures, but only the consistent organisation of the quality of life, influencing comorbidity, and the psychosocial and spiritual reorientation of hope. In this phase of life, one might say on the palliative home stretch, the use of preparations to prolong life minimally should, indeed must be avoided, for this will unjustly and unjustifiably revive hopes of a cure that had already been relinquished; in this way, such use severely disrupts the process of palliation, already underway, or even causes it to be questioned. In the following, this problem will be illustrated by the example of the new monoclonal antibodies Cetuximab and Avastin. During the past 15 years, the medicational therapy of ENT (ear, nose, and throat) tumours has gained enormously in significance. 168 https://doi.org/10.5771/9783495813430 .

New ›elixirs‹

Until the 1990s, cytostatic chemotherapy was used only in cases of inoperable recurrent tumours or the presence of distant metastasis. In contrast to this situation, chemotherapy today is not only used in palliative cases, but also within the context of multimodal therapeutic concepts, especially when organ preservation is desired, or a high risk of recurrence following resection has been established. Important new finds over the past few years include the optimisation of inductive chemotherapy, which is used not only in cases where preservation of organs is desired, but also, and increasingly, is seen as the standard approach in cases of inoperable local tumours. Beside this method, the approval of monoclonal antibodies – in ENT tumour therapy especially Cetuximab – appeared, and still appears from some points of view, to be pioneering in the treatment of recurring and locally progressive tumours. But I have chosen the example of Cetuximab – and, as a complement, Avastin – because, in the meantime, doubts have become audible about the advisability of using this preparation. These doubts extend not only to the question of whether these preparations are effective at all, but also to the problem of whether such preparations should, or may, be used at all in cases of infaust prognosis in the context of palliation, or directly prior to this. In addition in this context, the ethical permissibility of any further clinical testing of the preparations named is currently under discussion, and finally, as I would like to emphasise, the matter of economics with regard to the ratio of cost and efficiency. Altogether, a highly complex area of problems has become visible here. Quite recently, the medications Cetuximab and Avastin have entered the discussion in connection with the customary treatment of therapy-resistant or recurrent ENT tumours, but also with regard to other tumour types. Cetuximab, also known under the brand name of Erbitux® (ImClone Systems, Eli Lilly, Bristol-Myers Squibb, Merck KGaA), is a therapeutic chimeral monoclonal antibody of the type IgG1 against the epidermal growth factor receptor (EGFR), and applied in oncology for cancer immune therapy. After a series of successful clinical trials, Cetuximab was approved in 2003 in the USA, in 2004 in the EU, and in 2008 in Japan for therapeutical use in cases in which the cytostatic chemotherapy hitherto used had failed. Bevacizumab, produced by Roche under the brand name of Avastin, is a humanised monoclonal antibody of the group of immunoglobulins (IgG1), which is also used in cancer immune therapy, and, apart from this, in ophthalmic therapy for new vascular growth in the choroid of 169 https://doi.org/10.5771/9783495813430 .

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the eye. Through selective binding to the Vascular Endothelial Growth Factor (VEGF), the growth of new vessels is inhibited. Approval for first-line therapy of advanced or metastasised non-smallcell bronchial carcinomas, for instance, was applied for by the manufacturer on 11 September 2008. The basis of the application consisted of the data of the so-called FLEX study, in which improvement in the average total survival time of patients was achieved, using the addition of Cetuximab to a standard therapy containing platinum, the improvement being around one month, whereby the survival rates since undulate within a rather broader temporal range. The sales of Erbitux, by the way, led to a worldwide turnover of some 1.7 billion dollars in 2009. Avastin, used for the treatment of various cancers, brought the Swiss concern of Roche some six billion dollars in 2009 alone, which corresponds to an increase of more than 20 %. Altogether, over the last five years alone, the money spent on cancer medications has increased by 285 per cent. The two preparations named above are really blockbusters of oncotherapy, relevant both for profit and costs – depending, naturally, on where one stands. Compared with cytostatica of the usual sort, Cetuximab has few side-effects, but it is not free of them by any means. The most frequent such side-effect appears to be a skin rash resembling acne, which, in turn, apparently correlates to a good response to the therapy. In about 5 per cent of patients, however, the treatment can also entail hypersensitive reactions; approximately half of these cases are severe. Systematic medication with Avastin can have these side-effects: osteochemonecroses of the lower jaw, disruptions of wound healing, arterial hypertonia, intracerebral haemorrhage, thromboembolism, polyneuropathies or epileptiform fits, to name but a few. Quite apart from the effect of extending the life of the patient, yet – and that should be emphasised here – with no change to an unfavourable prognosis, an effect deserving of critical discussion in any case, there are additional factors besides the side-effects mentioned which should be heeded. They are, on the one hand, related to the hoped-for effect of the extension of life, which appears by no means so undoubted, as the manufacturers would have us believe. A study on Erbitux, carried out in Norway and published in 2010, clearly places the use of the preparation in question. Thus, of 566 patients examined, who had been treated with Erbitux and a triple chemotherapy, no reproducible clear indication of any actual extension of life could be observed. Already in 2009 the British study COIN could find 170 https://doi.org/10.5771/9783495813430 .

New ›elixirs‹

no significant improvement in survival time. The results with regard to Avastin are similarly sobering. A Greek study with 222 patients came, in fact, to the conclusion that those patients treated with Avastin and chemotherapy did even worse than those who received only chemotherapy. The Medical Service for Public Health Insurance (MDK) in Baden-Württemberg, in May 2010, called this cancer preparation ›a marginally effective medication‹. Merck and Roche have declared, as can be expected, that the two new studies allegedly do not agree with other clinical data from larger, older studies. On the other hand, experts at the Congress of the European Society for Medical Oncology (ESMO) pointed out that the most recent results had obviously demonstrated in how complex a way new cancer medications work under the conditions involved in each case. Thus, in the two studies mentioned, accompanying factors may have had an influence. The Medical Service for Public Health Insurance (MDK) in Baden-Württemberg remained doubtful too in view of this, and criticised, as well, that the effectivity, at least in the case of Avastin, by no means justifies therapy costs of EUR 5000 per month, apart from the doubts as to the life-extending effects. There was no doubt that ›considerable toxicity‹, with some fatal complications, existed. Roche, in turn, reacted sharply to these allegations and denied them, citing the evidence: Avastin was the most-tested cancer medication worldwide, some 1000 clinical studies having been carried out on more than 40 000 patients. Hitherto over three-quarters of a million patients had been treated with Avastin, and health insurances had accepted the costs everywhere. Also, the survival advantages for a number of tumour types had been proven. I cannot and will not go into details here that I cannot judge, but there seems to be reasonable doubt of the new types of cancer medication produced by the firms named, so that the general question must be posed as to just how reliable the evidence for borderline preparations is, and whether apparently objective effectivity studies do not suffer from certain distortions, when they are studies financed by pharmaceutical concerns (CRYSTAL®, EXTREME®, etc.), as could be gathered from the comments on this area by the Pharmaceuticals Commission of the German Medical Association. As far as their president of many years, Wolf-Dieter Ludwig, is concerned, Avastin is yet another example of the debated use of many medications, among others Erbitux, which are used against cancer, rheuma, HIV, or in transplantation medicine. Their uncritical application threatens to render the health systems 171 https://doi.org/10.5771/9783495813430 .

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worldwide unaffordable. Ludwig calls for an early warning system, such as those existing in the UK and Austria. In this manner, the senseless use of expensive medications could be stopped. Now, I do not wish to be misunderstood. Examining the current state of research on the medications named cannot be the business of the medical historian or investigator of medical ethics. That is the province of the pharmaceutical and clinical researchers. The current significance of these medications for the patient with an infaust prognosis and a low further life expectancy, however, belongs firmly and squarely in the province of medical ethics within palliative medicine. All clinicians admit that such patients who are treated, for example, with the medication Erbitux, are no longer responsive in the classical sense of a causal therapy, and that these patients find themselves, equally indubitably, in the last stage of their lives. From this, there are evident questions that appear with regard to a change in the goal of therapy, from the curative to the palliative: • What exactly is the survival advantage gained for such patients by the use of the substances mentioned? Is there a survival advantage in the sense of palliation, i. e. significant stabilisation or improvement in the quality of life, measured against the situation resulting from a continued and burdening application of causal therapy? • Is achieving a comparatively slight survival advantage really commensurable with the palliative quality of life and comorbidity of the patient? • In what relation do the side effects and the slight lengthening of life stand to each other? The situation of palliation is exactly where it is of decisive significance to not only chronologically win time, but to do so in such a way that it appears worthwhile mentally and psychologically. • What psychological effect do final therapies of this kind have on patients? Do they even in some way suggest hope that cannot be fulfilled by the medications, and thus by the physicians involved? • What is the ethical situation for clinical research? If we provide patients unable to make free and voluntary decisions with special protection as far as clinical studies are concerned, should we not do this for patients in palliation as well? • And finally, a question for those bearing the costs and for the legislative powers: is it not proper to require particularly stringent reasons of the pharmaceuticals industry with regard to ex172 https://doi.org/10.5771/9783495813430 .

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tremely expensive medications with a comparatively poor outcome for a patient group at the end of the therapeutical course, as measured in success? That the idea of a Therapia causalis finalissima is favoured with particularly high hopes and expectations by researchers, clinicians, and especially by patients, and that this is specific to this extremely lucrative market segment, is, naturally, well-known to the marketing departments of the manufacturing firms. However these questions may be answered in detail, for palliative medicine the unqualified demand must be that the first and only goal is to stabilise the quality of life, if possible to improve it, and to favourably influence comorbidity to the benefit of the patient. Palliative medicine may not shorten the process of dying, as that might be considered manslaughter; but it may not extend this process either, whether just for the sake of lengthening or for the benefit of associated research or financial interests, unless the palliative situation itself is de facto improved; anything else would be deceiving patients in a highly vulnerable situation.

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Authors and Institutions

Prof. Dr. Vilhjálmur Árnason, Department of History and Philosphy and Centre of Ethics, University of Iceland, Gimli, IS–101 Reykjavik, [email protected] Prof. Dr. Monika Bobbert, Seminar für Moraltheologie, Universität Münster, Johannisstr. 8–10, D–48143 Münster, [email protected] Dr. med. Bettina Böttcher, Universitätsklinik für Gynäkologische Endokrinologie und Reproduktionsmedizin, Anichstr. 35, A–6020 Innsbruck, [email protected] Dr. med. Maren Goeckenjan-Festag, Universitätsklinikum Dresden, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Fetscherstr. 94, D–01307 Dresden, [email protected] Prof. Dr. Wolfgang U. Eckart, Institut für Geschichte und Ethik in der Medizin, Universität Heidelberg, Im Neuenheimer Feld 327, D–69120 Heidelberg, [email protected] Mag. Phil. Doris Fölsch, Gaisbergweg 5B, A–5400 Hallein, [email protected] Dr. phil. Beate Herrmann, Institut für Geschichte und Ethik der Medizin, Im Neuenheimer Feld 327, D–69120 Heidelberg, beate. [email protected] Dr. Kathrin Ohnsorge, Institut für Medizingeschichte und Wissenschaftsforschung, Universität zu Lübeck, Königstr. 42, D–23552 Lübeck, [email protected]

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Authors and Institutions

Prof. Dr. Geraldine Rauch, Institut für Medizinische Biometrie und Informatik, Universität Heidelberg, Im Neuenheimer Feld 130.3, D–69120 Heidelberg, [email protected] Institut für Medizinische Biometrie und Epidemiologie, Universitätsklinikum Hamburg-Eppendorf, Martinistr. 52, Geb. W34, D–20246 Hamburg, [email protected] Dr. med. Heike Gudat, Klinik für Palliativmedizin, Hospiz im Park, Arlesheim, Stollenrain 12, CH–4144 Arlesheim, [email protected] Prof. Dr. Christoph Rehmann-Sutter, Institut für Medizingeschichte und Wissenschaftsforschung, Universität zu Lübeck, Königstr. 42, D–23552 Lübeck, [email protected] Dr. Christoph Schickhardt, Universitätsklinikum Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT), Im Neuenheimer Feld 460, D–69120 Heidelberg, [email protected] Prof. Dr. Christina Schües, Institut für Medizingeschichte und Wissenschaftsforschung, Universität zu Lübeck, Königstr. 42, D–23552 Lübeck, [email protected] Dr. Antonella Surbone, New York University, Department of Medicine, Division of Haematology and Medical Oncology BCD 556, 550 First Avenue, New York, NY 10016, USA, [email protected] Prof. Dr. med. Thomas Strowitzki, Universitäts-Frauenklinik, Abtlg. Endokrinologie und Fertilitätsstörungen, Im Neuenheimer Feld 440, D–69120 Heidelberg, [email protected] Prof. Dr. med. Ludwig Wildt, Universitäts-Frauenklinik, Abtlg. für gynäkologische Endokrinologie und Reproduktionsmedizin, Anichstr. 35, A–6020 Innsbruck, [email protected]

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