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March 16, 2009

On Conflicts of Interest & Atypical Antipsychotics

In few areas of modern medicine are the forces at work relating to COIs more stark than in psychiatry.  There are some particularly good sources for discourse on these matters in the blogosphere, and among the very best is the anonymous blogger at Clin Psyc Blog.  Not content, like most of us, with simply noting and commenting, CP makes a habit of what em terms "research blogging."  The Professor himself, as well as Kalman Applbaum, are other good examples for those of us hoping to do more in the blogosphere than note and comment, but CP's latest research blogging addresses a recent article discussing the use of aripiprazole (branded as Abilify) for unipolar depression.

Here is a taste:

One of psychiatry's big-name academics, Michael Thase, signed on as lead author. I'm hoping that he didn't actually write the paper. Actually, there are eleven authors of the paper, which seems a little ridiculous given that the paper is an analysis of data which had already been collected for two previously published clinical trials. Seven of the authors are employees of Bristol-Myers Squibb (BMS) or Otsuka, which both market Abilify. Wait... If you look closely, you can see my favorite disclosure... In the fine print on the first page...

In case you can't read the fine print: In defense of Thase and the other academic authors, they may have not actually written any of the paper. Much or all of the writing appears to be creditable to Ogilvy Healthworld Medical Education.

Ghost-writing, of course, is an enormous problem in the biomedical literature, and is intimately related to COIs.  It also seems a basic violation of publication ethics, though admittedly such violations are, both in my view and according to the best evidence, rampant.

My favorite portion of CP's post is when he discusses the article's "analysis" of safety:

The authors note that "adjunctive aripiprazole is relatively well-tolerated in patients with MDD." Relatively? Relative to what -- being hit with a baseball bat repeatedly? They note that akathisia occurred in 25% of patients on Abilify compared to 4% of patients on placebo. Restlessness: 12% vs. 2%; insomnia: 8% vs. 3%; fatigue: 8% vs. 4%; blurred vision: 6% vs 1%. The authors report that akathisia resolved in 52% of patients by the end of the study, which would also mean that for 48% of patients with akathisia, they were stuck with it at the end of the study. But don't worry, it's "relatively well-tolerated."

Mmm, yes.  Quite.

Go read the whole thing.


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