The Daunting Quest for Drug Policy

While Bob Dylan was no doubt commenting on America's "other" drug problem in his 1965 song "Subterranean Homesick Blues," the theme of the relationship between the drugmaker, the patient, and the government is central to today's increasingly complex problem of ensuring the availability of safe and affordable drugs. Arthur Daemmrich's "Pharmacopolitics: Drug Regulation in the United States and Germany" investigates this complex relationship of codependents as they face the daunting task of establishing a global infrastructure for approving, pricing, and distributing new medicines.

As implied by the book's title, Daemmrich contrasts developments in the U.S. and Germany in the 20th century in laying out the challenges of the current century. His comparison hinges on distinctively different definitions of the patient, as well as on differences in the relative importance of physicians and government agencies in overseeing the drug approval process in the two countries.

Daemmrich, a policy analyst at the Chemical Heritage Foundation, argues that the German approach, informed in part by the dehumanizing aspects of Nazi Germany, defines the patient as an individual in need of guidance from a cadre of professional elites--that is, physicians. The U.S., on the other hand, has tended to define the patient as a statistic in a regime of clinical testing aimed at verifying the safety of drugs before their release to the public.

Steeped in the industrial reform sentiments stirred by Upton Sinclair's "The Jungle," the U.S. approach was motivated by disastrous harm to patients as a result of the improper testing of a formulation of the anti-infection drug sulfanilamide in 1937, which led to hundreds of deaths. This incident and subsequent problems, including the rash of birth defects from use of thalidomide, resulted in the Food & Drug Administration wresting control over testing from pharmaceutical companies and medical professionals.

Daemmrich argues that as the American Medical Association lost ground to government bureaucracy in the U.S., a less politicized regime was cultivated in Germany, where the medical profession has maintained certain forms of guild authority and what Daemmrich describes as "premodern" relationships of trust with the government, drugmakers, and the public.

In recent decades, the patient, represented by advocacy groups such as the AIDS activist organization Act Up, has weighed in on the process of developing drug approval policy. The result, Daemmrich says, has created a shifting battlefield--a kind of evolution toward the current realpolitik of "pharmacopolitics" in both countries.

In the 21st century, however, that battlefield is global, and a formal process of worldwide harmonization is already under way. During the past 15 years, U.S., European, and Japanese regulatory authorities and drugmakers have held a series of meetings called the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The group hopes to develop a system whereby drugmakers will be able to submit a single electronic dossier on a new drug to regulatory agencies in all three regions.

Daemmrich, however, contends that international efforts will have to progress beyond drug approval oversight to the issues of pricing and availability. Nowhere is the need to do this more important than in the effort to get affordable AIDS drugs to poor countries where infection has reached crisis proportions. And nowhere is the lack of global harmonization more evident than in the Bush Administration's hesitancy, despite its pledge of $15 billion to fight AIDS in poor countries, to fund the development and distribution of generic AIDS drugs, citing lack of approval by FDA.

"Pharmacopolitics" lays out an enormous challenge in the need "to design working institutions for a polity of unprecedented size and diversity." Daemmrich argues that success will require the establishment of transparent decision-making procedures that, above all, grant access to Dylan's man on the pavement--the patient.