Three Essays: Ethics Medico-Industrial Complex

 As medicine has come under the pharmaceutical industry’s control, research report conceal the most serious hazards–simply to protect profits.

Two articles in the Journal of the Royal Society of Medicine (Volume 99,  August 2006):

1. "From Optimism to Disillusion About Commitment to Transparency in the Medico-Industrial Complex" Sir Ian Chalmers, past Director of the Cochrane Centre, describes the historical context for that optimism followed by disillusion. http://www.jrsm.org/cgi/content/full/99/7/337

In 1998 he thought he had reason to be optimistic when it appeared he had persuaded the pharmaceutical industry to meet its responsibility toward upholding scientific integrity by reporting the outcome of clinical trials.

In 1998, the Ethics Committee of the Faculty of Pharmaceutical Medicine and several drug companies–including GlaxoWelcome– issued a declaration of intent to report all clinical trial outcomes.

"I had become optimistic that the industry really was beginning to address the problems that I had urged should be addressed at our meeting eight years previously. Although the response was not nearly as good as the ABPI had hoped, AstraZeneca, Aventis, MSD, Novartis, Roche, Schering Healthcare and Wyeth did begin registering retrospectively those of their trials that had involved UK patients."

However his optimism was short-lived when the incoming CEO of (the newly merged) GlaxoSmithKline unceremoniously cut the project without so much as a response to his (naïve?) overture.  Chastened by reality Chalmers acknowledges that Eliot Spitzer’s (even) brief appearance on the scene had the only real persuasive power over Glaxo (and by extension the industry).

Chalmers quotes Andrew Herxheimer, emeritus fellow, UK Cochrane Centre, whose 2004 editorial in the BMJ recognizes the fleeting nature of industry declarations:

 ‘Last month GlaxoSmithKline announced that it would publish summaries of all its clinical trials of a new product once it had been launched. The decision followed news of a lawsuit brought by New York State alleging that the company had concealed the results of paroxetine because they might have spoiled marketing plans. GSK said it had been considering the move for some months. A similar sounding policy was announced by Glaxo Wellcome in 1998, but seems to have been quietly abandoned in 2000 after the merger with SmithKlineBeecham.’

2. An editorial by Richard Smith, former editor of the BMJ, "Lapses at the New England Journal of Medicine," http://www.rsmpress.co.uk/0607JRSMSmith.pdf

holds the NEJM editor, Jeffrey Drazen, fully responsible for the journal’s failure to correct the VIGOR (Vioxx) report.
The report was published in the NEJM in 2000, failure to report three additional deaths, enabled the authors to misinterpret the results.
"Jeff Drazen knew about these extra deaths long before the end of 2005. Indeed, the Wall Street Journal  has discovered that Drazen was told about them in August 2001. Jennifer Hrachovek, a pharmacist who had reviewed the data on the FDA website, told him on a phone-in to a Seattle radio show. She also submitted a letter to the journal, which was rejected."

See: http://www.ahrp.org/cms/content/view/168/94/

Smith argues that:  If the journal had corrected the data then the dangers of the drug might have been highlighted much earlier."
Thus the NEJM may be accused of contributing to preventable human casualties.

3. "Ethical issues in psychopharmacology" by Leemon McHenry in the Journal of Medical Ethics, http://jme.bmjjournals.com/cgi/content/full/32/7/405#BIBL

is a review of corrupt practices in psychopharmacology–in particular the selling of disease to increase sales of  antidepressants:

"Marketing departments employ a strategy they call ‘‘evergreening’’ by beginning with one indication of a use for an SSRI and then moving on to explore other ‘‘green’’ pastures for potential markets. In order to convince people something is wrong with them that requires SSRI therapy, the marketing departments hire public relations firms to raise awareness of a newly approved indication, sometimes using celebrity spokespersons to pitch the idea.

SSRIs were first marketed for depression, then for panic disorder, obsessive compulsive disorder, post traumatic stress disorder, seasonal affective
disorder, generalised anxiety disorder, and social anxiety disorder. Other potential indications in the marketing strategy that show up in clinical trials include premature ejaculation and paedophilia (since we know SSRIs cause sexual dysfunction), premenstrual syndrome, writer’s block, obesity, alcoholism, cocaine addiction, compulsive shopping, and smoking cessation."

"Corporate psychiatrists become coconspirators by accepting a paradigm uncritically and by adopting the language game of chemical imbalance that entirely satisfies this purpose…. A behemoth pharmaceutical industry has created corporate psychiatry along with industry sponsored clinical research, direct to consumer marketing of antidepressants, ghost writing for medical journals and a major war for the market share. All the trappings are in place for marketing the disease rather than the cure."

 
Contact: Vera Hassner Sharav
veracare@ahrp.org