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How do we evaluate the safety and benefit of new drugs? What tasks do we hold the government responsible for and which ones do we leave to the medical profession? Harry Marks explores the origins of our contemporary system of drug regulation and the modern clinical trial. He shows that the story of modern drug regulation is synonymous with the history of therapeutic reform. Accompanying this history of public policy is a detailed account of changing experimental ideal and practices. Marks follows the history of therapeutic experimentation, from the 'collective investigations' of the last century to the controlled clinical trial which 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 which examines therapeutic experiments in a wide range of diseases, from syphilis and pneumonia to heart disease and diabetes.
Table des matières
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.
Résumé
This book explores the origins of our contemporary system of drug regulation and of the modern clinical trial. Harry Marks looks at the science and politics of drug evaluation and explores the influence of academic ideals on governmental drug regulation.
