Ethical Issues in Drug Testing, Approval and Pricing: The Clot-Dissolving Drugs

This comprehensive analysis gives an ethical perspective of the entire drug development process, comparing American and European approaches. It describes new approaches to the testing and pricing of drugs, while giving accounts of the development of thrombolytic therapy for heart attacks, and of the current rules for the approval of drugs adopted by the Federal Drug Authority in the USA.

Review :
"The first comprehensive treatment of the entire process of drug development from the perspective of ethics and public policy....Baruch Brody's book is a thoroughly interesting and engaging account that deals intelligently and insightfully with one of the most critical health care issues of pur time....Sets a high standard for bioethics case studies....Because Brody has so carefully laid out the important questions about drug development and so thoroughly evaluated alternative approaches to each, readers will profit from his analysis for some time to come."--Journal of Legal Medicine "Smooth and even entertaining reading...Brody's discussion is scholarly, dispassionate, and even-handed....His critique...is relentless and, ultimately, brutally effective....Brody's discussion of the ethical issues in drug testing and his description of the history of the cloth-dissolving drugs are first-rate. There is much to learn from the material on drug approval and pricing. His writing is lucid and lively. His book is an important contribution to the literature..."--Medical Humanities Review "This is a very fine book. This is sound scholarship, carefully researched, and very well-written."--Robert J. Levine, Yale University School of Medicine "Well-written, current and correct in its description of the political issues surrounding the introduction of the three major thrombolytic therapies. Its writing style is narrative but concise and reads well. In a positive sense, the book captures the readers' minds, and reads almost as a detective novel. Depth to the analyses is provided by the many sources used by the author to document the story. The author really has searched, evaluated and included all the relevant literature including the Federal Register, FDA meeting reports....Truly provides a unique, detailed, historical account."--Abraham G. Hartzema, Pharm.D., M.S.P.H., Ph.D., Director, Center for Pharmaceutical Outcomes Research, University of North Carolina-Chapel Hill "Provides a remarkable compendium of historical information leading to the present state of affairs regarding thrombolytic therapy, and it aggressively tackles head-on the ethical aspects of drug development, regulatory issues, and clinical trials. So rich and detailed is this scholarly text that even well-informed readers will want to read it more than once."--Philip B. Dobrin, MD, PhD (Loyola University), Doody's Journal