Tuesday, April 03, 2007
GSK -- More Documents. Oh boy. The good folks at Healthy Skepticism have posted a slew of documents pertaining to the infamous GSK Study 329, in which Paxil was described in a 2001 journal article as safe and effective, yet the data showed some rather heinous side effects occurring much more frequently in the Paxil group (such as significant aggression and suicidal behavior) than in the placebo group. The data also showed, at best, a small advantage for Paxil over placebo, an advantage that was more than outweighed by the significant incidence of serious side effects.
I've looked at a few of the newly posted documents and hope to post my take on them in the near future. In the meantime, I refer you to the documents on Healthy Skepticism's excellent website.
Hat tip to Philip Dawdy at Furious Seasons for beating me to the punch and linking to the above documents. Also beating me to the story, he mentioned that in the latest American Journal of Psychiatry, there is an editorial on adolescent bipolar disorder written by Boris Birmaher, one of the articles on the now discredited GSK 329 study. Birmaher states that it is quite important for bipolar disorder to be increasingly recognized and treated in youth.
Dawdy essentially asks why we should trust Birmaher given his involvement in the scandalous GSK Study 329 (please read this link for background info). Despite several years passing since the publication of the study's results, not a single one of the "independent" academic authors have apologized or spoken out against the way the data were manipulated and misinterpreted.
Key Opinion Leaders or Used Car Salespeople? If academic psychiatry wants some credibility, then it is high time for the so-called opinion leaders to issue a mea culpa -- it's time to admit some fault. Here's my message to the the big-name academics in psychiatry, which likely applies to the academic bigwigs in many other branches of medicine as well: Rather than pimping drugs in corporate press releases, taking cushy consulting gigs, and rubber stamping your name on ghostwritten articles (based on data you have never actually seen) and infomercials labeled as "medical education," turn over a new leaf. Have you been used? Are you really performing science or are you just a tool of a marketing division? What good is your research actually doing for patients? Does selectively reporting only positive data and burying the negative data really help people struggling with mental anguish?
How is it different to hide the faulty mechanics on a 1986 Ford Tempo as a car salesperson versus, as a researcher, to hide safety and efficacy data on a medication? The same rule is applying -- Tell to Sell. In other words, if it ain't going to help sell (the car or the drug), then keep your mouth shut.
Must...take..."broad spectrum psychotropic agent"...too outraged to function...