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Drug Development, Regulation, and the Practice of Medicine
William M. Wardell, MD, PhD
JAMA. 1974;229(11):1457-1461.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings. |
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IN LESS than five decades, the "pharmaceutical revolution" has transformed therapeutics. The purpose of this report is to propose and examine the hypothesis that the process by which drugs are now developed and regulated has become a prototype for wider changes in the structure of medical practice.
Patients, Physicians, Government, and Industry
Before therapeutic drugs achieved their present economic importance, such development of useful new therapies as did occur (eg, quinine, digitalis, morphine, hypnotics, local and general anesthetics, cholinergics and anticholinergics, amyl nitrite, anthelmintics, antiscorbutics, hormones, and vitamins) stemmed mainly from the academic and professional communities. The main change of the past 50 years is the nearly total transfer of the responsibility for developing new drugs to the pharmaceutical industry, supervised by government. Industry's participation developed because of the enormous increase in the cost and complexity of drug development,1 and because of the profitability of the process. Government's entry
. . . [Full Text PDF of this Article]
Author Affiliations
From the departments of pharmacology and toxicology, and of medicine, University of Rochester Medical Center, Rochester, NY.
Footnotes
Reprint requests to Department of Pharmacology and Toxicology, University of Rochester, 260 Crittenden Blvd, Rochester, NY 14642 (Dr. Wardell).
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