Institutional Corruption and the Myth of Safe and Effective Drugs
What turned the drug companies into the FDA's prime clients? The authorization of user fees in 1992, during the Reagan administration.
The FDA no longer purely serves the public interest.
http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2282014
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, Vol. 14, No. 3, 2013, Forthcoming
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.
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