Pharmacopolitics: Drug Regulation in the United States and Germany
http://www.100md.com
《新英格兰医药杂志》
The development of therapeutic drugs is accomplished through a complex series of interactions among government regulators, medical professionals, and the pharmaceutical industry. In declaring that a drug is suitable for marketing, this triumvirate must strike a compromise between ensuring the absolute safety of the product and meeting the immediate needs of patients. In Pharmacopolitics, Arthur Daemmrich examines the interplay among the three key players involved in the regulation, pre-market testing, and post-market surveillance of drugs in the United States and Germany in the 20th century, with an emphasis on events that occurred between 1950 and 2000. The scope of the material covered is ambitious in a book containing only 163 pages of text.
Brief histories of key pieces of legislation concerning the regulation of drugs in both countries provide the necessary context for discussion of the changing roles of government, physicians, and industry over time. Case studies of the development and approval of oxytetracycline, thalidomide, propranolol, interleukin-2, and indinavir are used to illustrate reactions to both opportunity and crisis by the U.S. and German systems. Daemmrich, a policy analyst at the Chemical Heritage Foundation, argues persuasively that the effects of varying historical influences (notably World War II) and divergent "therapeutic cultures" in the two countries ultimately led to the development of very different systems. The United States established a powerful, centralized regulatory authority that valued quantitative analysis of pre- and post-marketing data, whereas Germany maintained a more balanced system in which the medical profession exerted the dominant influence, with an emphasis on qualitative analysis of data.
Daemmrich identifies one additional key player, the disease-based organization, which entered the scene in the 1980s, though this type of group wielded much more influence in the United States than in Germany. The author notes that Americans tend to embrace social protest as a means of countering restrictive conditions that are imposed by legal entities or by the status quo. Indeed, participation by AIDS activists and other special-interest groups was probably inspired by a U.S. tradition of social protest, which was used to win women the right to vote in 1920 and to champion civil rights and protest the Vietnam War in the 1960s.
Several elements are notable for their absence from the book, though the exclusions are excusable in the light of the complexity and broad scope of the topic. Missing is an analysis of the effects of medical research that was funded by the U.S. National Institutes of Health (NIH), especially in regard to the agency's influence on the design of clinical trials and on the general availability of drugs. The NIH is mentioned tangentially in the case study of interleukin-2 (although the amount that the agency spent on studies is mentioned without a corresponding figure for corporate funding) and as a sponsor of a workshop on clinical trials of drugs for AIDS. Less forgivable is the omission of a discussion about how the creation of the European Agency for the Evaluation of Medicinal Products as a regulatory authority in 1993 affected key players in Germany.
Despite some weakness in the analysis of current events, Pharmacopolitics takes a broad look at the history of drug regulation, clinical studies, and post-marketing surveillance in the United States and in Germany, and it will be of interest to those seeking a general overview of the topic.
Janice M. Reichert, Ph.D.
Tufts Center for the Study of Drug Development
Boston, MA 02111
janice.reichert@tufts.edu((Studies in Social Medici)
Brief histories of key pieces of legislation concerning the regulation of drugs in both countries provide the necessary context for discussion of the changing roles of government, physicians, and industry over time. Case studies of the development and approval of oxytetracycline, thalidomide, propranolol, interleukin-2, and indinavir are used to illustrate reactions to both opportunity and crisis by the U.S. and German systems. Daemmrich, a policy analyst at the Chemical Heritage Foundation, argues persuasively that the effects of varying historical influences (notably World War II) and divergent "therapeutic cultures" in the two countries ultimately led to the development of very different systems. The United States established a powerful, centralized regulatory authority that valued quantitative analysis of pre- and post-marketing data, whereas Germany maintained a more balanced system in which the medical profession exerted the dominant influence, with an emphasis on qualitative analysis of data.
Daemmrich identifies one additional key player, the disease-based organization, which entered the scene in the 1980s, though this type of group wielded much more influence in the United States than in Germany. The author notes that Americans tend to embrace social protest as a means of countering restrictive conditions that are imposed by legal entities or by the status quo. Indeed, participation by AIDS activists and other special-interest groups was probably inspired by a U.S. tradition of social protest, which was used to win women the right to vote in 1920 and to champion civil rights and protest the Vietnam War in the 1960s.
Several elements are notable for their absence from the book, though the exclusions are excusable in the light of the complexity and broad scope of the topic. Missing is an analysis of the effects of medical research that was funded by the U.S. National Institutes of Health (NIH), especially in regard to the agency's influence on the design of clinical trials and on the general availability of drugs. The NIH is mentioned tangentially in the case study of interleukin-2 (although the amount that the agency spent on studies is mentioned without a corresponding figure for corporate funding) and as a sponsor of a workshop on clinical trials of drugs for AIDS. Less forgivable is the omission of a discussion about how the creation of the European Agency for the Evaluation of Medicinal Products as a regulatory authority in 1993 affected key players in Germany.
Despite some weakness in the analysis of current events, Pharmacopolitics takes a broad look at the history of drug regulation, clinical studies, and post-marketing surveillance in the United States and in Germany, and it will be of interest to those seeking a general overview of the topic.
Janice M. Reichert, Ph.D.
Tufts Center for the Study of Drug Development
Boston, MA 02111
janice.reichert@tufts.edu((Studies in Social Medici)