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

[Link to this CHS article:]

Download the full paper here: Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs Journal of Law, Medicine and Ethics, Vol. 14, No. 3, 2013 Donald W. Light, Rowan University, Harvard University; Joel Lexchin, York University; Jonathan J. Darrow, Harvard Medical School

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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.

2 Responses

  1. I think the biggest problem is that the word “safe” is mistakenly thought of as the common use dictionary term by most people. In fact what it means is that the benefits outweigh the harm, which is quite a lower threshold and really is an opinion, since most problems with medications don’t appear until they are on the market. It’s hard to believe that any trusts their doctors if you just watch any commercial for essentially any drug.

    [ED: do you have a citation to support that definition of “safe”. In other words, who says so?]

  2. […] The EMA like other Government agencies has a track record of behaviour like this as reported in formal journal published research as this paper by authors from Harvard University’s Edmond J. Center for Ethics published in the Journal of Law, Medicine and Ethics Vol. 14, No. 3 (2013):  Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs […]

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