Pharmacogenomics: Social, Ethical, and Clinical Dimensions.

Edited by Mark A. Rothstein. Hoboken, NJ: John Wiley & Sons, 2003. 320 pp. ISBN: 0 471-22769-2, $59.95 cloth.

This interesting and timely book presents a multidisciplinary analysis of the scientific, clinical, economic, ethical, social, and legal implications of pharmacogenomics research and treatment. Some of the individual chapters analyze societal issues against an incomplete understanding of what pharmacogenomics is and what it is not. However, the major strength is the comprehensive approach (both in topics covered and in their authors) that is rarely found in a single book. The multidisciplinary author and topic coverage is quite enlightening and required reading for those who focus only on the science and do not consider the societal implications of their research. Many scientists are so focused on their research that they do not appreciate the larger issues. This book will help them understand the implications of this research for society at large and for different subsets of society. Readers can evaluate for themselves which implications are realistic and which are not, but scientists need to be aware of all the societal implications that well-educated nonscientists describe from their unique and more global perspectives.

Pharmacogenomics is commonly defined both as the genetic basis for differences among individuals in drug response and/or toxicity (often referred to as pharmacogenetics) and the use of genomic information for the discovery and development of drugs with new and more specific targets. Many chapters describe the economic, ethical, social, and legal implications of genetic differences among individuals in drug toxicity or drug response. Knowledge of these genetic differences is relevant for the administration of certain drugs; such differences should be resolved by substitution of another drug or dose as health care providers are better informed. Although pharmacogenetics is an important subset of genetics research, there clearly are different societal implications for an individual exhibiting genetic susceptibility to an adverse reaction or inadequate response from a drug as opposed to genetic predisposition to disease. The other important aspect of pharmacogenomics--the use of the genomic information to identify new and more precise drug targets-does not fit the general public perception of "genetic" research, and the societal implications of identifying these new drug targets from genomic information are not covered as well in this book. Some chapters conclude that "pharmacogenomics-based" drugs will be more costly, so their use will have wide-ranging economic, ethical, and social implications. However, other chapters argue that pharmacogenomics has clear potential to lower development costs for new drugs compared to those for new drugs derived from empirical approaches, and conclude that it has the potential to change the course and outcomes of many morbid and fatal diseases that generate enormous economic costs in health care expenditures, human suffering, lost productivity, and human suffering. Most scientists would agree, logically, with the latter view.

The multiauthor text is divided into five parts. Part I is an introductory section that describes public attitudes about pharmacogenomics and provides a scientific primer on the subject. The first chapter describes the results of a public survey on pharmacogenomics and might be better placed as an appendix to the book. The second and third chapters are well-written overviews of pharmacogenomics built upon the two fundamental scientific disciplines of pharmacology/toxicology and population genetics. Part II describes consequences of pharmacogenomics on minorities, drug development, drug regulation, genetically guided therapy, and intellectual property. Part III describes clinical applications, medical liability, and applications for health care delivery by pharmacists. Part IV describes economic, social, and constitutional implications of pharmacogenomics. Two chapters focus on the implications for minorities. Part V includes an exceptionally well-written epilogue that provides context and unifies the book as a whole. Readers might be well advised to skip the first chapter (the public survey) and to read the final epilogue both first and last.

David W. Hein is the Peter K. Knoefel Professor and Chairman of the Department of Pharmacology and Toxicology, Distinguished University Scholar, and Director of the Molecular Epidemiology Group of the James Graham Brown Cancer Center at the University of Louisville School of Medicine.