In recent times, the phrase personalised medicine has become the symbol of medical progress and a label for better health care in the future. However, a controversial debate has developed around whether these promises of better, more personal and more cost-efficient medicine are realistic. This book brings together leading researchers from across Europe and North America, from both normative and empirical disciplines, who take a more critical view of the often encountered hype associated with personalised medicine. Partially drawing on a four year collaborative research project funded by the German Ministry for Education and Research, the book presents a multidisciplinary debate on the current state of research on the ethical, legal and social implications of personalised medicine. At a time when future health care is a topic of much discussion, this book provides valuable policy recommendations for the way forward. This study will be of interest to researchers from various disciplines including philosophy, bioethics, law and social sciences.
Recenzijas
This volume is a landmark for demythologising the buzzword personalised medicine, critically differentiating between hype and false hopes on the one hand and realistic approaches and outlooks on the other. By comprehensively comprising a wide range of excellent normative and empirical studies, it empowers anyone interested in better understanding the presuppositions and consequences of the term personalised medicine to form a well-informed judgement on one of the most augured ideas in cutting-edge medicine. Peter Dabrock, University of Erlangen, Germany, and Vice Chair of the German Ethics Council and member of the European Group on Ethics in Science and New Technologies (EGE) 'The concept personalised medicine has become a buzz word in contemporary medicine. However, it is not at all clear what the concept entails. The suggestion is that treatment will be adapted to the individual patient. Yet, the basis is not knowledge of the individual patient, but statistical analysis of characteristics of patient groups. Moreover, individual patient wishes and preferences may become less relevant, if treatment options are seen in terms of chances of patient groups. This book contains critical discussions of the concept of personalised medicine, both from an empirical and a normative perspective. It provides a timely and needed contribution to the debate.' Guy Widdershoven, VU University Medical Center, Netherlands Gathering together a broad range of academics working in this important area, this book considers comprehensively the conceptual, ethical and practical issues associated with the ethics of personalised medicine. The editors are to be congratulated on this volume and for the way in which it carefully reflects on the issues involved in personalised medicine and its application in practice. Mark Sheehan, University of Oxford, UK "Contributors to this volumewho include researchers from across Europe and North America, from both normative and empirical disciplinespresent a multidisciplinary debate on the current state of research on the ethical, legal, and social implications of personalized medicine." Law and Social Inquiry Journal
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| Notes on Contributors |
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| Introduction |
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1 | (8) |
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PART I PERSONALISED MEDICINE -- MEDICINE FOR THE PERSON? CONCEPTS AND CONTEXTUAL ASPECTS |
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1 What is Personalised Medicine? Sharpening a Vague Term Based on a Systematic literature Review |
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9 | (16) |
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2 Alarming Symptoms of a Paradigm Shift? An Approach to Bridge the Gap between Hypothetical Ethics and the Current Status of Individualised Medicine Research |
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25 | (16) |
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3 Personalised Medicine: Getting Past the Controversies |
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41 | (12) |
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4 Patient as Person in Personalised Medicine: Autonomy, Responsibility and the Body |
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53 | (12) |
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5 The Authority of Corporeality and Emotions: The New Phenomenology and its Relevance to the German Debate on Personalised Medicine |
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65 | (12) |
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6 Towards Integration of `Personalised' and `Person-Centred' Medicine: The Concept of `Integrative and Personalised Health Care' |
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77 | (10) |
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PART II PERSONALISED MEDICINE IN CLINICAL AND PRACTICAL RESEARCH |
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7 Ethical Considerations for Developing a Best-Practice Guideline for Next Generation Sequencing in Oncology |
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87 | (10) |
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8 Practice Variation across Consent Templates for Biobank Research: A Survey of German Biobanks |
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97 | (16) |
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9 Individualised Medicine in the Diagnosis and Prognosis of Patients Younger than 65 Years with Normal Karyotype Acute Myeloid Leukemia: A Systematic Review and Meta-Analysis of the Impact of Fms-Related Tyrosine Kinase 3 Internal Tandem Duplication (FLT3-ITD) |
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113 | (16) |
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10 Taking it Personally: Patients' Perspectives on Personalised Medicine and its Ethical Relevance |
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129 | (20) |
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11 `Personalised Medicine' in Oncology: Physicians' Perspectives on Contributions to and Challenges for Clinical Practice |
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149 | (12) |
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12 Through Thick and Big: Data-Rich Medicine in the Era of Personalisation |
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161 | (14) |
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PART III PERSONALISED MEDICINE IN HEALTH-CARE SYSTEMS |
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13 Benefit Assessment of Personalised Interventions: Methodological Challenges and Approaches to a Solution |
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175 | (12) |
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14 The Relevance of the Analytic Validity of Genetic Biomarker Tests in Personalised Medicine in Oncology |
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187 | (12) |
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15 Approval and Reimbursement of Personalised Drugs: Interim Results of the Adjustment Process |
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199 | (12) |
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16 Criteria for Fairly Allocating Scarce Health-Care Resources to Genetic Tests: Which Matter Most? |
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211 | (20) |
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17 Personalised Medicine as Orphan Drugs? Legal and Ethical Questions |
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231 | (14) |
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18 Personalised Medicine: Priority Setting and Opportunity Costs in European Public Health-Care Systems |
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245 | (14) |
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PART IV PERSONALISED MEDICINE IN ONCOLOGY: RECOMMENDATIONS FOR FUTURE DEVELOPMENT |
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19 `Personalised Medicine': Multidisciplinary Perspectives and Interdisciplinary Recommendations on a Framework for Future Research and Practice |
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259 | (22) |
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| Index |
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Jochen Vollmann M.D. Ph.D. is Professor and Director at the Institute for Medical Ethics and History of Medicine and Chair of the Centre for Medical Ethics, Ruhr-University Bochum, Germany. Professor Vollmanns research interests include informed consent and capacity assessment, mental health ethics, end-of-life decision making, advance directives, personalised medicine, medical professionalism, clinical ethics committees, and clinical ethics consultation. Verena Sandow MA. is a researcher in medical ethics and applied ethics at the Institute for Medical Ethics and History of Medicine, Ruhr-University Bochum, Germany. She works in the field of human medical research and research ethics. Sebastian WƤscher MA. is a researcher in medical ethics, with a focus on social science aspects at the Institute for Medical Ethics and History of Medicine, Ruhr-University Bochum, Germany. His research interests are questions at the end of life, empirical ethics, personalised medicine and qualitative research methodology. Jan Schildmann M.D. MA. is a medical ethicist and physician. He is researcher at the Institute for Medical Ethics and History of Medicine, Ruhr-University Bochum, Germany. His research covers topics in clinical ethics (i.e. end-of-life decisions, ethics support services), research ethics (i.e. personalised medicine, conflict of interest) and methodological aspects of empirical medical ethics.
