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

As more illnesses are managed with drug regimens rather than invasive treatments, drugs represent an ever-larger segment of rising medical costs. And as adverse drug effects rank, by some estimates, as the fourth leading cause of death in the United States, much is at stake in the assessment of the risks and benefits that drugs pose in individual clinical situations. In this volume, Arthur Daemmrich compares the drug-approval process in two countries that have been leaders in the development of scientific medicine and pharmaceutical research. He provides excellent historical analysis, while illuminating contemporary challenges that include globalization and the tensions that have erupted as pharmaceutical companies, focused primarily on marketing in wealthy industrialized countries, are called on the moral carpet to justify their pricing policies in developing countries wracked with infectious diseases.

Daemmrich argues that despite the scientific bases for safety and efficacy tests, and counter to the desire of pharmaceutical companies for uniformity of regulation across diverse markets, the drug-approval process is mediated by a host of social factors that characterize individual countries' "therapeutic cultures." Therapeutic cultures arise from "relationships among the state (including legislatures and regulatory agencies), the pharmaceutical industry, the medical profession, and disease-based organizations" (p. 4). Thus, they reflect institutional arrangements that change over time; they are characterized by different levels and forms of power of similar groups in different countries. Therapeutic cultures influence the kinds of negotiation, challenge, and accommodation that resolve disputes over whether to approve specific drugs and for what indications.

Daemmrich examines five case studies, each comparing the approval process for the same drug in the United States and Germany between 1950 and 2000. An early chapter sketches the legal and regulatory framework in each country over the twentieth century; a late one compares postmarket surveillance systems over the same period. But the sharpest insights come from the case studies, which illustrate not only important national differences, but also changing contexts for assessing the benefits and risks posed by new drugs. The cases focus on antibiotics, the medical miracles of mid-century; thalidomide, a sedative whose prescription for nausea during pregnancy reflected the expanding reach of medicine; and, as chronic diseases have become leading killers, an angina drug and an anticancer drug. Finally, AIDS treatments reflect the renewed importance of infectious disease as a cause of socially devastating mortality.

In the United States, the state mediated disputes among pharmaceutical manufacturers, physicians, and patient groups through FDA-mandated testing requirements. The FDA's role evolved in response to crises and, more recently, patient activism. Physician authority diminished as drug testing was conducted through premarket studies separated from regular clinical care. In contrast, the West German state was one actor among several, as it negotiated with a powerful medical profession and a long-established pharmaceutical industry to mitigate risks to patients, who were largely excluded from the negotiations.

In the United States, patient activists, most notably AIDS patients, changed both the speed of drug evaluation for terminal conditions and the formulas for the inclusion of diverse groups in test populations. This demand for diversity arose in the context of identity politics, as gays, women, and specific racial groups sought inclusion in clinical trials. In Germany, clinical pharmacologists retained control over drug testing, and testing methods relied on the qualitative assessment of individual patients rather than a statistical analysis of quantifiable effects. Reflecting a long-standing guild tradition, German physicians succeeded in sustaining a paternalistic role vis-à-vis patients—a paternalism in service of patient autonomy and functionality.

The broad outlines of the American story will be familiar to readers of Harry Marks, John Swann, and James Harvey Young. However, the comparative framework and the detailed case studies add significantly to our understanding of drug approval in the United States. The comparative framework contributes the analysis of Germany based on German sources; it also throws into relief...