Abstract

http://ssrn.com/abstract=2282014
 
 

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Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs


Donald W. Light


Rowan University, School of Osteopathic Medicine; Harvard University - Edmond J. Safra Center for Ethics

Joel Lexchin


York University

Jonathan J. Darrow


Harvard Medical School

June 1, 2013

Journal of Law, Medicine and Ethics, 2013, Vol. 14, No. 3: 590-610

Abstract:     
Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised Congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA’s prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication: independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few if any new clinical benefits; and the creation of a National Drug Safety Board.

Number of Pages in PDF File: 11

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Date posted: June 20, 2013 ; Last revised: September 12, 2014

Suggested Citation

Light, Donald W. and Lexchin, Joel and Darrow, Jonathan J., Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs (June 1, 2013). Journal of Law, Medicine and Ethics, 2013, Vol. 14, No. 3: 590-610. Available at SSRN: http://ssrn.com/abstract=2282014

Contact Information

Donald W. Light (Contact Author)
Rowan University, School of Osteopathic Medicine ( email )
2250 Chapel Avenue
Cherry Hill, NJ 08002
United States
Harvard University - Edmond J. Safra Center for Ethics ( email )
124 Mount Auburn Street
Suite 520N
Cambridge, MA 02138
United States

Joel Lexchin
York University ( email )
4700 Keele Street
Toronto, Ontario M3J 1P3
Canada
+416-736-2100 x 22119 (Phone)
+416-736-5227 (Fax)
Jonathan J. Darrow
Harvard Medical School ( email )
250 Longwood Avenue
Boston, MA 02115
United States
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