This book explores the origins of our contemporary system of drug regulation and the modern clinical trial. Marks illustrates the symbiotic relationship between the history of modern drug regulation and the history of therapeutic reform. Accompanying this history of public policy is a detailed account of changing experimental ideals and practices. Marks traces the history of therapeutic experimentation, from the "collective investigations" of the past century to the controlled clinical trial that emerged after 1950 as the paradigm of scientific experimentation. The result is the first general history of clinical research in the United States, a book that examines therapeutic experiments in a wide range of diseases, from syphilis and pneumonia to heart disease and diabetes.
Part I. Of Institutions and Character: The Era of Organisational Reform: 1. A rational therapeutics; 2. Memories of underdevelopment: therapeutic research in the US 1900–1935; 3. Playing it safe: the federal Food, Drug and Cosmetic Act of 1938; 4. War and Peace; Part II. Of Statistics and Institutions, or the Triumph of Method: 5. Managing chance; 6. You gotta have heart; 7. Anatomy of a controversy: the University Group Diabetes Program study; 8. The dreams of reason.
