Hear Alison Bass (author of side Effects, the story behind the deceptive marketing of Paxil) interviewed about her book and corruption in the medical profession. As Alison reveals in Side Effects, GlaxoSmithKline hired a ghostwriting firm, Scientific Therapeutics, to write the first draft of the controversial Paxil study 329. That draft concluded that Paxil was effective and well tolerated in adolescents, even though the actual data in the clinical trial showed otherwise. See back story here.
Indeed, in its re-examination of clinical trial data for all the antidepressants, the FDA labeled study 329 a negative study, finding that Paxil was no more effective than placebo in treating depression in adolescents. Yet Martin Keller, the principal investigator of the Paxil study, and his co-authors, did not object to the ghostwritten version of the study and despite its inaccuracies (which were flagged by peer reviewers), the study was published in The Journal of the American Academy of Child and Adolescent Psychiatry in 2001 and used by GlaxoSmithKline to heavily flog the drug for use in children and adolescents.
Why were the authors of study 329 so lax in attaching their names to a study they didn’t write? Could it have had anything to do with the fact that Keller and several of his co-authors were getting paid huge amounts of money in consulting and speaking fees by GlaxoSmithKline?
Some of my related posts to Study 329 and Marty Keller can be found here.