Pharmacopolitics: Drug Regulation in the United States and Germany

by Arthur A. Daemmrich (Author)

Editorial Reviews

From the New England Journal of Medicine, May 20, 2004
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.

Journal of the American Medical Association
"[Should] interest a broad spectrum of readership since the regulation of
prescription drugs is an enduring political topic."

Product Details

Hardcover: 264 pages
Publisher: The University of North Carolina Press; 1 edition (March 3, 2004)
Language: English
ISBN-10: 0807828440



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