New reviews of these two books appear in the July 27 issue of the New England Journal of Medicine. See the excerpts below.
Ethics and the Pharmaceutical Industry. Edited by Michael A. Santoro and Thomas M. Gorrie, 492 pp, $40, ISBN 0-521-85496-2, New York, NY, Cambridge University Press, 2005.
JAMA excerpt: [full text by subscription]
The pharmaceutical industry has had a prized business role in society because of its ability to provide tools for treating illness and alleviating human suffering. However, in recent years public perception of pharmaceutical companies has become increasingly negative. While the title Ethics and the Pharmaceutical Industry may suggest a paradox, Michael Santoro and Thomas Gorrie have compiled a series of essays that provide a fair, balanced, and insightful examination of an increasingly troubled relationship between the pharmaceutical industry and society. They highlight that much of the challenge in this relationship is driven by an imperfect alignment of objectives. Society wants affordable, effective, and safe drugs. Businesses want to maximize profits. The free market brings these two sets of objectives together while providing powerful incentives for creativity and innovation but also for businesses to restrict access to products and distort medical priorities.
NEJM excerpt: [full text by subscription]
Santoro and Gorrie have woven together a rich collection of perspectives in Ethics and the Pharmaceutical Industry, with contributors ranging from activists and academicians to regulators and representatives from the industry. Santoro, an academician, and Gorrie, who has a background in the industry, bring different conceptual orientations to the work. In their words, Gorrie believes “that healthcare is a commodity” and Santoro believes “that healthcare is a fundamental human right that circumscribes the exercise of intellectual property.” They also hold differing views of the proper role of government in the oversight of the pharmaceutical industry. These conflicting outlooks are reflected in the contributed chapters, which provide accessible and nuanced descriptions of the views of various stakeholders. The range of topics that are covered is quite broad, much like the reach of the industry itself. These topics include drug development and clinical testing, marketing and the availability of health care resources, and intellectual property and fair pricing. Because the contributors come from different camps, it would be imprudent to read a single chapter with the assumption that it offers a complete picture of a particular problem or issue. Rather, the book may prove to be the most useful in offering chapters with competing perspectives. As such, the integrative work is left in large part to the reader, although introductory material written by the editors preceding each major section provides an overview.
The Law and Ethics of the Pharmaceutical Industry. by Graham Dukes, 409 pp, $129.95, ISBN 0-444-51868-1, San Diego, Calif, Elsevier, 2006.
JAMA Review JAMA excerpt: [full text by subscription]
The preface of this book begins, “Any sector of society has both its written and unwritten rules of behaviour, which develop and change as time goes by.” Graham Dukes, professor emeritus of Drug Policy Studies at the University of Groningen in the Netherlands, builds the entire book around that sentence. He traces the origins of laws, regulations, and codes of behavior developed around the world to guide the pharmaceutical industry. In this regard, the book is very ambitious. It describes the history of the pharmaceutical industry and the definition of standards for that industry. It goes on to document the acceptance and implementation of those standards in areas such as safety, demonstration of efficacy, and ensuring quality. It describes the behavior of the industry in terms of pricing and profits and its role in innovation and marketing. It covers the industry in both the developed and developing world and even deals with issues such as animal studies and the role of generic manufacturers.NEJM excerpt: [full text by subscription]
Dukes’s book, The Law and Ethics of the Pharmaceutical Industry, reflects the author’s background in medicine and law. In mapping the wide range of policies and laws that relate to the pharmaceutical industry and the associated ethical issues, Dukes presents an important set of background conditions. Commensurate with the relevant conditions at hand, the scope of the book is vast and includes sections on business standards; standards for drug quality, safety, and efficacy; marketing and its relationship to education; drug pricing; pharmaceutical innovation; issues in the developing world; special situations (such as animal and human research, self-medication, controlled substances, alternative medicines, orphan drugs, and veterinary drugs); the manufacture of generic drugs; and areas of social controversy (such as the use of contraceptives and abortifacients and the patenting of biologic materials). Although Dukes doesn’t attempt to catalogue all relevant laws, he provides categories and examples that serve as a useful starting point for understanding the types of policies and laws that should be considered in particular cases. In addition, Dukes includes stories that led to the adoption of some of the laws and policies, which helps to make the process more accessible to the reader.