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

"So which country is better?" was a question that Arthur Daemmrich apparently heard frequently while researching this book on the recent history of the regulation of therapeutic drugs in the United States and the Federal Republic of Germany. Readers of this journal may not be surprised to learn that Daemmrich does not consider the question very relevant. Drug regulation is a complex system, Daemmrich argues, and his central aim is to demonstrate how "the institutions that govern this system are nationally and historically specific" (p. ix). His case studies are the antibiotic terramycin in the late 1940s and 1950s, the infamous sedative thalidomide a decade later, the beta blocker propranolol in the 1960s and 1970s, the biotechnologically produced interleukin 2 in the 1980s, and the AIDS drug indinavir in the 1990s. Looking at the debates around the market introduction of these drugs and the emergence of new regulatory tools, Daemmrich aims to explain how what he calls the "therapeutic cultures" of both countries have given rise to different systems. In the United States the federal Food and Drug Administration (FDA) assumes most of the control over drug regulation, whereas in Germany the market for pharmaceuticals is overseen by a decentralized network dominated by physicians, leaving the Federal Health Administration to play a comparably minor role. Daemmrich uses the term therapeutic cultures as shorthand for the (institutionalized) relationships among the state, the pharmaceutical industry, the medical profession, and disease-based organizations that shaped the political negotiations on drug laws, testing methods, and market surveillance.

Why draw the comparison between (West) Germany and the United States? The choice seems slightly arbitrary at first and might have its origins in the contingencies that shape every research project. But as reformers on both sides of the Atlantic look to the other side for help, this comparison also holds relevance. Health care in the United States is perceived as "a private good associated with individual choice" (p. 4), but in Germany—which in this respect can be seen as representative of most Western European nations—health care is viewed as primarily "an entitlement" (ibid.). The principal actors shaping drug regulation in both countries are comparable, but as the American Medical Association progressively lost influence over the twentieth century, German physicians remained highly organized, and the German counterpart of the AMA continues to act as the main mediator between patient interests, the state, and the pharmaceutical industry.

The different therapeutic cultures also shaped the preferred tools for testing and regulating. The FDA, Daemmrich argues, has historically preferred to rely on clinical trials rather than postmarket testing, because trials offered government regulators more control over physicians and patients. In Germany, in contrast, the strong self-regulatory position of the medical profession prevented a strict division between pre- and postmarket testing. The preference for qualitative data in the drugs commission of the German medical profession also resulted in less attention to formal testing methods like double-blinding and clinical controls. The German system continues to rely on qualitative reports by physicians, an approach that failed in the United States but worked reasonably well in Germany and led to a more flexible approach to the introduction of new drugs.

Daemmrich argues that both systems responded to different constructions of "the patient." In the United States, in response to a series of drug scandals, politicians and a wider public came to conceive of patients as needing protection from harmful or mislabeled drugs and from abuse as human guinea pigs, which helped the FDA assume an increasingly central position in the regulation of drugs. In the 1980s, as a consequence of the AIDS epidemic and the emergence of powerful groups of patient activists, the FDA found itself confronted with patients who demanded quick access to new, and often not fully tested, experimental drugs rather than protection from them. In cancer, too, the American public no longer viewed experimental subjects in therapeutic trials as passive human guinea...