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

As an integrative medicine doctor, for many years I’ve heard rumblings in the integrative medicine literature about the tight connection between the FDA and the pharmaceutical industry-like a revolving door. In addition, from the same sources, I see articles claiming how many deaths there are from pharmaceuticals and how many side effects are from pharmaceuticals.

Most of the articles I have seen were not from what I would call “reputable sources” Sometimes they were from websites with no licensed medical doctors and an obvious agenda. Sometimes I saw it on websites from practitioners who cannot prescribe drugs and whose opinion therefore seemed quite biased.

However, now, this week I bring to your attention a relatively new article from an unquestionable and undeniable source.

This is the article that appeared in the Journal of Law, Medicine and Ethics (JLME) edited by Mark Rodwin, and written by Donald W. Light, from the Edmond J. Safra Center for Ethics at Harvard University. The co-authors were Jonathan J. Darrow of Harvard Medical School and Joel Lexchin, of York University.

The title of this article is “Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs”.

The article points out that “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”.

Some of the shocking statistics in this article include that “About 90% of all new drugs approved by the FDA over the past 30 years are little or no more effective for patients than existing drugs.”

It also points out that the bar for safety has also been dropped over the past 30 years and that approved drugs have caused an epidemic of harmful side effects, even when they were properly prescribed. They estimate that “Every week about 53,000 excess hospitalizations and about 2400 excess deaths occur in the United States among people taking properly prescribed drugs to be healthier.”

They also point out that one in every five drugs approved ends up causing serious harm.Furthermore, only one in 10 drugs provide a substantial benefit compared to already existing established drugs.

And shockingly they point out that prescription drugs are The fourth leading cause of death in our country. They estimate that American patients suffer from approximately 80 million mild side effects every year.

I urge all of my patients and readers to read the original of this article which you can find HERE

Also please see the references listed below for further information.

Please let me know your thoughts on this new information

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References

1. Lexchin J. New drugs and safety: what happened to new active substances approved in Canada between 1995 and 2010? Archives of Internal Medicine 2012 (Nov 26);172:1680-81.
2. Hilts PJ. Protecting America’s Health: The FDA, Business and One Hundred Years of Regulation. New York: Alfred A. Knopf; 2003.
3. Rodwin M. Conflicts of interest, institutional corruption, and Pharma: an agenda for reform. Journal of Law, Medicine & Ethics 2012;40:511-22.
4. Rodwin M. Reforming pharmaceutical industry-physician financial relationships: lessons from the United States, France, and Japan. Journal of Law, Medicine & Ethics 2011(Winter):2-10.
5. Sismondo S. Ghost management. PLoS Medicine 2007;4:1429-33.
6. Sismondo S, Doucet M. Publication ethics and the ghost management of medical publication. Bioethics 2010;24:273-83.
7. Schondelmeyer S, Purvis L. Rx Price Watch Report. Washington DC: American Association of Retired Persons 2012.
8. Kozauer N, Katz R. Regulatory innovation and drug development for early-stage Alzheimer’s disease. New England Journal of Medicine 2013 (Mar 13);DOI: 10.1056/NEJMp1302513
9. Young JH. The Toadstool Millionaires: a social history of patent medicines in America before federal regulation. Princeton, NJ: Princeton University Press; 1961.
   
10. Schiff G, Galanter W, Duhig J, et al. Principles of conservative prescribing. Archives of Internal Medicine 2011;171:1433-30.
11. How Pharmaceuticals Came To Be The 4th Leading Cause Of Death In America;November 20, 2013 by Lisa Bloomquist
12. Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs The Original Article as PDF.
13. Risky Drugs: Why The FDA Cannot Be Trusted, Donald Light from the Edmond J Safra Center for Ethics, Harvard University