Institutional harmonization and standard business practices are key issues in the current debate on globalization. Few business sectors are better suited for a study of global harmonization than the pharmaceutical industry. Although it is often heavily regulated by national institutions, the pharmaceutical industry also is strongly dominated by large multinational enterprises. The existence of organizations such as the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals of Human Use (ICH), which [End Page 712] works to coordinate the global introduction of new drugs by the United States, the European Union, and Japan, shows that major players strive to impose global harmonization within this field.
In this well-written and well-structured book on drug regulation in the United States and Germany, Arthur D. Daemmrich shows how history has created constraints to global harmonization. Inspired by the French scholar Bruno Latour, the author employs a concept of national therapeutic culture to analyze the development of the national regulation systems for drug testing and marketing in the twentieth century in the two nations. This concept describes at the national level the relationship among the state—including legislatures and regulatory agencies—the pharmaceutical industry, the medical profession, and disease-based organizations. Daemmrich argues that therapeutic cultures are active in three primary areas: legislative/ regulatory mandates, scientific testing in clinical trials, and oversight of adverse drug reactions. The Latourian influence is seen in how Daemmrich emphasizes the existence of networks between the actors that constitute the therapeutic culture.
After an introductory chapter in which the author presents the conceptual framework of the book, he analyses the development of drug regulation from 1906 in the United States and from 1943 in Germany. Based on this general overview, Daemmrich examines in detail in the next two chapters how different therapeutic cultures influenced testing and regulations in cases such as Terramycin (an antibiotic), thalidomide (a sedative), propranolol (a heart medication), interlujin-2 (a cancer therapy) and indinavir (an AIDS drug) from the 1950s to 2000. In chapter 5 he describes the development of different national systems to monitor side effects and collect reports about drugs, and in the final chapter he summarizes his findings and discusses them within the perspective of future global harmonization.
For those who are familiar with historical studies of different forms of national capitalism, it should be no surprise that the American and German therapeutic cultures are different. Daemmrich emphasizes especially the role of the medical profession as well as the tight networks among the actors within the therapeutic culture in Germany. Historically, German medicine developed into a guild-based profession long before the creation of the modern pharmaceutical industry. Based on its strong position in society, the medical profession gained a monopoly to speak for the patient in political settings, and commanded the authority to define drug safety and to oversee the use of pharmaceutical drugs. In the United States as well, physicians in the nineteenth century exercised controls over membership in the profession, spoke for their patients, and oversaw drugs on the market. However, during the twentieth century the American Medical Association [End Page 713] lost membership, and when the Food and Drug Administration (FDA) expanded its authority to define drug safety, the medical profession's control declined. The emergence of strong disease-based interest groups, which did not occur to the same degree in Germany, undercut the American profession's mandate to speak for the patient. While the German medical profession has served as a mediator between the public and the state, there has been a more direct relationship between the citizen and the state in the United States. Consequently, regulatory authority primarily has been concentrated in the state in the U.S, while in Germany it has been shared across a network of the state, the industry, and the medical profession.
Both in Germany and in the United States, the therapeutic cultures have evolved over time. However, Daemmrich shows that these changes have been slow and that they have not challenged...