Pharmacopolitics: Drug Regulation in the United States and Germany (review)

Arthur Daemmrich's book is first and foremost a workmanlike comparison of drug-regulation regimes during the half-century after World War II. Its focus is on the working of regulatory bodies, both in theory and practice, and the role of drug trials both in theory and practice is also explored. Germany and the United States make an interesting contrast. Germany was the traditional home of the drug industry and of scientific medicine before the 1930s. Since then, the United States has been dominant, even though a drug industry still flourishes in Germany. Continuities from the prewar days continue to color postwar experience, particularly in Germany. Both countries have come to share great individual wealth, but they differ radically in the way drugs are prescribed. Daemmrich provides a nice comparison of the approach that physicians take to the treatment of heart pain: in this country, this is seen as the result of a problem with the heart as an organ that requires, properly, a removal of the cause; in Germany, physicians have taken a more systemic approach.

The book's problematic is tightly delimited to the political science of regulation. The author expresses his intention to look at "therapeutic cultures" and defines these as "shorthand for relationships among the state (including legislature and regulatory agencies), the pharmaceutical industry, the medical profession, and disease-based organizations" (p. 4). Patients are of course admitted into the narrative: they are "constructed"—they protest, they combine. They do not, however, individually "consume" or negotiate with their physicians. As suspicious, gossiping, magazine-reading, sentient beings with their rich and complex strategies of interpreting and managing illness, patients are not included here. Nor do the media get much space. This is surprising in an age of direct-to-consumer advertising and television programs exposing drug scandals.

Where regulatory traditions were critical, as in the case of Interleukin, the international comparison is compelling. But the general treatment of case studies is too brief for the arguments they entail. The controversy over whether Propanolol was "a rational therapy" for heart disease is suggestive, but only half-raised, and the competing meanings of rational therapy are not fully explored. Elsewhere, the reader may be puzzled by the author's apparent unwillingness to explore the complexities of cultural differences—for instance, in the greater significance of litigation in the United States and its implications for the ways drugs are used.

There is a graph showing the massive difference in the incidence of AIDS in the two countries. In 1988, the new diagnoses were less than twenty-per-million population in Germany; in the United States, it was more than seven times greater. But the significance of this radical difference is neither explored nor interpreted. Daemmrich nevertheless points out that "German patients largely accepted approaches to treatment criticized as 'paternalistic' in the United States" (p. 102). He does map the greater attention given to safety and efficacy standards in this country than in Germany since 1970, but even here questions are left open. A new London-based regulatory body, the European Agency for the Evaluation of Medicinal Products, is reported to have largely taken over from the German Federal Health Office (Bundesgesundheitsamt) by the mid-1990s, and there is a short discussion of the degree to which this organization represented a break with the German regulatory tradition.

That an author does not have the reviewer's particular interests in mind is not, of course, a critique of any significance. Yet there may be more interesting structural reasons for what might seem to be surprising lacunae. The book concludes with an appendix called "Research Methods and Case Study Selection," which explains that the project is grounded in methods of qualitative research common to the social sciences. In other words, this is a particular take on history. It avoids the "cultural turn" and the user-focus characteristic of current historiography, and in its aspirations to rigorously examine it perhaps neglects...