Pharmacogenomics: Social, Ethical, and Clinical Dimensions - Hardcover

Hardcover

ISBN 10: 0471227692 ISBN 13: 9780471227694

Publisher: Wiley-Liss, 2003

Synopsis

Through analyses of the complex underlying issues, this interdisciplinary volume frames the agenda for dealing with genetic variation and incorporating pharmacogenomics into health care. The three sections of this book, Research Issues, Clinical Issues, and Social Perspectives  address key elements integral to a comprehensive discussion of this emerging field.

This groundbreaking text…

• Examines new research strategies, methodologies, and ethical and social considerations of pharmacogenomics
• Addresses practical considerations of anticipated changes in education, training, oversight, guidelines and protocols, and continuing education requirements
• Provides analyses of the potential enormous impact of pharmacogenomics, such as in the standard of care and treatment, including perspectives from the fields of anthropology, law, ethics, and economics

About this title

About the Author

Mark A. Rothstein holds the Herbert F. Boehl Chair of Law and Medicine and is Director of the Institute for Bioethics, Health Policy and Law at the University of Louisville. He has appointments in the Departments of Medicine and Family and Community Medicine at the School of Medicine and at the Louis D. Brandeis School of Law. Professor Rothstein is a leading authority on genetics, privacy, and health policy. He has served as an advisor to the NIH, CDC, DOE, Institute of Medicine, National Conference of State Legislatures, and numerous other public and professional entitles.

From the Back Cover

"In this remarkably broad and far-reaching work, editor Mark Rothstein and his distinguished list of contributors have laid out an impressive framework for the field. Beginning with a survey of public attitudes, and progressing through scientific, clinical, governmental, legal, economic, and societal issues, the text builds to a final provocative epilogue on consequences for public policy."
-from the Foreword by Francis S. Collins

Pharmacogenomics promises to revolutionize medicine by enabling the prevention, diagnosis, and treatment of diseases at the genome level. While a substantial amount of public and private research focuses on new pharmacogenomic applications, notably less attention has been directed to the ethical, legal, and social implications of "individualized medicine." Mark Rothstein's timely anthology reduces that scholarship deficit, presenting a multidisciplinary analysis of the scientific, clinical, economic, ethical, social, and legal implications of pharmacogenomics.

Assembling an all-star cast of bioethical scholars, medical researchers, legal scholars, and social scientists, Mark Rothstein examines the promises, questions, and concerns these revolutionary therapies implicitly present. Among other features, Pharmacogenomics:
* Reports for the first time the results of the first detailed, national survey of public attitudes regarding pharmacogenomics
* Covers informed consent, privacy, confidentiality, and risk-benefit evaluations
* Analyzes the potentially enormous changes in the standard of care and the approach to treatment with the development and application of pharmacogenomic technology
* Addresses practical considerations of education, training, oversight, guidelines and protocols, and continuing education requirements
* Recommends approaches to respond to the more complex issues of safety, efficacy, and quality in the distribution and development of individualized therapies
* Explores the new legal standards and implementation challenges
* Offers a policy framework that balances the benefits and risks and considers the wide range of legislative, regulatory, and professional options

Biotechnology and pharmaceutical researchers and regulators, health care professionals and students, and academics and policymakers will find Pharmacogenomics to be a valuable resource.

Reviews

This collection of essays focuses on all aspects of the emerging field of pharmacogenomics except the science that underpins it. This omission is understandable because the science of pharmacogenomics is currently clouded by uncertainty. Pharmacogenomics refers to the use of genomic tools to understand differences among people in their responses to drugs, either in terms of efficacy or in terms of adverse effects. It is assumed that many of these differences derive from specific DNA-sequence variants. Yet this assumption is largely unproved. Moreover, we have little understanding of the nature or frequency of such functionally important variants or of their distribution in different populations. Still, the paucity of data has not prevented prominent academics and executives in the biopharmaceutical industry from making sweeping statements about how pharmacogenomics will bring about the era of "personalized" medicine. Such statements offer an irresistible starting point for considerations of the social and ethical implications of pharmacogenomics. Scientific uncertainty does not provide much on which to build an essay. The one indisputable fact about pharmacogenomics is that it offers a possible solution to immense clinical problems that currently have no solutions -- namely, serious adverse drug effects and the poor response of considerable numbers of patients to the available treatments for a given condition. It is therefore not surprising that the chapter called "Integration of Pharmacogenomics into Medical Practice" is the crispest essay in the book. The authors of this chapter offer concrete examples of success stories in which pharmacogenomics may have helped identify subgroups for specific cancer treatments. Other chapters offer fascinating glimpses into fields that may not be familiar to geneticists, genomicists, or clinicians and that have yet to be defined in relation to the anticipated effect of pharmacogenomics. For example, there are two detailed chapters about the legal implications of pharmacogenomics, one on intellectual-property law and the other on potential liability issues. These chapters show that it is possible to be prepared for a variety of alternative scenarios, depending on what the science indicates. What is really striking is the diverse ways in which the prospect of pharmacogenomics is influencing social science. Several forceful chapters focus on race -- what it means, how it is defined, and how pharmacogenomics may influence its relation to issues of social justice, such as discrimination and equality of access to health care. These chapters are particularly speculative, and their conclusions may change as the science of pharmacogenomics progresses, particularly if this science does not result in personalized medicine within the next several years. Still, they will be informative for geneticists or genomicists and provide a reminder that many people outside this field are going to be paying a lot of attention as discoveries about human genetic variation and drug response are reported. Nelson B. Freimer, M.D.
Copyright © 2003 Massachusetts Medical Society. All rights reserved. The New England Journal of Medicine is a registered trademark of the MMS.

Edition details

• Publisher: Wiley-Liss
• Publication date: 2003
• Language: English
• ISBN 10: 0471227692
• ISBN 13: 9780471227694
• Binding: Hardcover
• Edition number: 1
• Number of pages: 384
• Editor: Rothstein Mark A.