INSTITUTIONAL CORRUPTION OF PHARMACEUTICALS AND THE MYTH OF SAFE AND EFFECTIVE DRUGS

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, 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. 
Number of Pages in PDF File: 11 
Accepted Paper Series 

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