The Progress of Experiment: Science and Therapeutic Reform in the United States, 1900-1990

In a deeply researched, superbly structured, and lucidly written account, Harry Marks describes the attitudes and activities of a varied American group he terms “therapeutic reformers,” who during this century strove “to use the science of controlled experiments to direct medical practice” (p. 2). In the first half of the century, the controlling judgment rested in a group, the American Medical Association’s Council on Pharmacy and Chemistry, that drew its conclusions from the expertise of trusted individual researchers. The Food and Drug Administration borrowed the Council’s approach in regulating the safety of new drugs, an authority given the agency by the Food, Drug, and Cosmetic Act of 1938. In the second half-century, the judgment of experienced clinicians was replaced by trust in a more impersonal method—the double-blind, randomized, controlled clinical trial.

At both stages, reformers believed that their evaluative approaches would enhance clinical practice. They tended to be skeptical of business and dubious about the standards of rural general practitioners. Marks emphasizes the shifting assumptions that reformers held and the meanings that they gave to experimentation and to the roles of experimenters. Cooperative studies held precedence in the 1930s and 1940s, statisticians becoming indispensable research partners thereafter.

This is not a story of constantly evolving scientific triumph. Huge experiments went awry. Bitter disputes arose and persisted. “My postwar bureaucratic state,” Marks remarks, “is far less heavy-handed (or effective) in furthering the cause of a rational therapeutics than neoliberal critics of the regulatory state might allow” (p. 7).

The delight is in the details. Marks describes the operation of the Council on Pharmacy and Chemistry and of the FDA in the early years after enactment of the 1938 law. He examines the efforts of the Cooperative Clinical Group to evaluate methods of treating syphilis; a post-World War II study by the Veterans Administration of streptomycin as a treatment for tuberculosis; the Diet-Heart Study; and the University Group Diabetes Program study. None of these major efforts fulfilled initial hopes. This section of the book might have been strengthened by a more detailed account of the 1962 Kefauver amendments to the 1938 law, and the FDA’s development under the amendments of more precise standards for testing new drugs for efficacy prior to marketing.

Marks ends with a chapter on contemporary problems in making decisions as to therapeutic efficacy: continuing debates within the medical community and the rise in power of other elements—the Congress itself, HMOs, and social activists. His perceptive discussion of the pros and cons of such developments from the perspectives of science, politics, and ethics is well worth the attention of all participants in and observers of this complicated and crucial process related to the health of the nation.