Wednesday, July 16, 2008

Round Up The Usual Suspects

Senator Grassley's investigation of the connections between Big Pharma and psychiatry continues to target individuals who have been featured on this blog. The latest, according to Pharmalot: Martin Keller of Brown University. Those of you who have any familiarity with GlaxoSmithKline's work with Paxil in youth will recall that Keller was the "lead author", using the term as loosely as possible, of the infamous Study 329 paper which claimed inaccurately that Paxil was safe and effective in treating depression. Recently, a team of researchers published a bombshell of a paper that pointed out in detail how the Study 329 manuscript was doctored to paint an unrealistically favorable picture of the study's findings.

A recent transcript became available in which Keller discussed his role in "authoring" the Study 329 paper (pgs. 242-266 in particular). The CliffsNotes version: Keller claimed on one hand that he couldn't recall what happened and on the other hand said that he always played a key role in developing the main points to be communicated in every manuscript on which he was lead author. If we take Keller at his word, that he really developed the main ideas for the paper, then he was either a) negligent of the actual study data or b) actively participating in covering up the unfavorable results from the study. I noted earlier that Keller indicated earlier that he did not seem particularly familiar with the actual study data, so I suppose option A may be more likely. In any case, being the lead author on a study that claims a drug is safe and effective when the study data show that the drug is dangerous and ineffective -- that's nothing to brag about.

An interesting coincidence: There is a new Dean of Medicine (Edward J. Wing) at Brown University. Aubrey Blumsohn of the Scientific Misconduct Blog wrote a letter to the incoming Dean. So far, Blumsohn says he has received no reply. Blumsohn expressed concerns with Keller and with the handling of David Kern, a Brown University faculty member who was canned for apparently nefarious reasons. My bet: Nothing will change. Keller brings in a boatload of money to the university and is hence highly valued by the administration. He is also a "big name" in psychiatry, though between Study 329 and ARISE-RD, another strange study in which Keller seems to have designed a study after it was already completed, his standing is certainly not spotless. Let me be clear: I'm not advocating that the new Dean do anything in particular. I'm not calling for Keller to be canned or anything of the like. However, if I were a Dean (God forbid), then I would be concerned about well-documented issues with one of my big-name faculty, particularly because these issues go to the heart of scientific integrity.

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