Ethics and the Pharmaceutical Industry
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《新英格兰医药杂志》
The Law and Ethics of the Pharmaceutical Industry
By M.N. Graham Dukes. 409 pp. Amsterdam, Elsevier, 2006. $129.95. ISBN 0-444-51868-1.
Hardly a day passes without the appearance of headlines related to the pharmaceutical industry. Whether such stories herald successes (such as advances in drug therapy) or probe unsavory issues (such as problems in drug development, pricing, or availability), considerable attention is focused on the industry. Such attention isn't terribly surprising, given the high medical, monetary, and moral stakes involved. There are obvious medical needs for new and better pharmaceutical products, yet the development of these products can take, and make, substantial amounts of money.
Although few observers would argue against fair profits for the creation of valuable and sometimes lifesaving products, the tensions that can arise from mixing medical or scientific goals with financial pursuits have rightly engendered concern. Will the rights and interests of research participants be protected if investigators or sponsors stand to profit on the basis of the results of research? What are the human and societal costs attributable to the pricing of pharmaceutical products? When is it justifiable to override corporate interests in order to satisfy unmet medical needs? How should the research-and-development agendas of pharmaceutical companies be properly structured to maximize the promotion of human well-being while also maintaining a profitable business and corporate integrity? What are the appropriate constraints on intellectual property?
The raising of such questions doesn't imply that the entire enterprise should be dismantled. After all, it would be naive or even absurd to assume that the vast majority of discoveries of pharmaceutical drugs could or should occur in a financial vacuum. It is perhaps paradoxical to the readers of the stories beneath the headlines, and to some recent scholarship on related topics, that corporate goals may actually enhance the quality, safety, and efficiency of drug development. Making sense of the moral quagmire presented in these stories requires an in-depth understanding not only of the facts of a particular case but also of the pharmaceutical industry and the context in which it operates.
The two books reviewed here begin this important latter task; both provide the reader with a sense of the complexity of the industry and of the tensions that seem to be inherent in the creation of products that ideally have laudable goals for the treatment or prevention of human disease.
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.
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.
Forecasting is always a treacherous task, but it seems reasonable to predict that we will witness many more headlines related to the pharmaceutical industry, both positive and negative, in the future. For those who are involved in health care and health care policy, it is essential to be able to put these headlines into the appropriate context and to interpret them accurately. It is possible to become a more careful reader by having access to relevant information about the industry, its context, and the stakeholders. Both of the books discussed here are suitable resources for doing so.
Jeremy Sugarman, M.D., M.P.H.
Johns Hopkins University
Baltimore, MD 21205(Edited by Michael A. Sant)
By M.N. Graham Dukes. 409 pp. Amsterdam, Elsevier, 2006. $129.95. ISBN 0-444-51868-1.
Hardly a day passes without the appearance of headlines related to the pharmaceutical industry. Whether such stories herald successes (such as advances in drug therapy) or probe unsavory issues (such as problems in drug development, pricing, or availability), considerable attention is focused on the industry. Such attention isn't terribly surprising, given the high medical, monetary, and moral stakes involved. There are obvious medical needs for new and better pharmaceutical products, yet the development of these products can take, and make, substantial amounts of money.
Although few observers would argue against fair profits for the creation of valuable and sometimes lifesaving products, the tensions that can arise from mixing medical or scientific goals with financial pursuits have rightly engendered concern. Will the rights and interests of research participants be protected if investigators or sponsors stand to profit on the basis of the results of research? What are the human and societal costs attributable to the pricing of pharmaceutical products? When is it justifiable to override corporate interests in order to satisfy unmet medical needs? How should the research-and-development agendas of pharmaceutical companies be properly structured to maximize the promotion of human well-being while also maintaining a profitable business and corporate integrity? What are the appropriate constraints on intellectual property?
The raising of such questions doesn't imply that the entire enterprise should be dismantled. After all, it would be naive or even absurd to assume that the vast majority of discoveries of pharmaceutical drugs could or should occur in a financial vacuum. It is perhaps paradoxical to the readers of the stories beneath the headlines, and to some recent scholarship on related topics, that corporate goals may actually enhance the quality, safety, and efficiency of drug development. Making sense of the moral quagmire presented in these stories requires an in-depth understanding not only of the facts of a particular case but also of the pharmaceutical industry and the context in which it operates.
The two books reviewed here begin this important latter task; both provide the reader with a sense of the complexity of the industry and of the tensions that seem to be inherent in the creation of products that ideally have laudable goals for the treatment or prevention of human disease.
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.
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.
Forecasting is always a treacherous task, but it seems reasonable to predict that we will witness many more headlines related to the pharmaceutical industry, both positive and negative, in the future. For those who are involved in health care and health care policy, it is essential to be able to put these headlines into the appropriate context and to interpret them accurately. It is possible to become a more careful reader by having access to relevant information about the industry, its context, and the stakeholders. Both of the books discussed here are suitable resources for doing so.
Jeremy Sugarman, M.D., M.P.H.
Johns Hopkins University
Baltimore, MD 21205(Edited by Michael A. Sant)