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

11 Pages Posted: 20 Jun 2013 Last revised: 12 Sep 2014

Donald W. Light

Rowan University School of Osteopathic Medicine ; Center for Migration and Development; Institute for Advanced Study

Joel Lexchin

York University

Jonathan J. Darrow

Harvard Medical School

Date Written: June 1, 2013

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.

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: https://ssrn.com/abstract=2282014

Donald W. Light (Contact Author)

Rowan University School of Osteopathic Medicine ( email )

Cherry Hill, NJ 08003
United States
6092160071 (Phone)

Center for Migration and Development ( email )

200 Wallace Hall
Princeton, NJ 08544
United States
6092160071 (Phone)

Institute for Advanced Study ( email )

1 Einstein Drive
Princeton, NJ 08540
United States
(609) 734-8000 (Phone)

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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