Among the 30 or so physicians at two dozen universities that the Senate Finance Committee is probing concerning disclosure of grants from drugmakers is Martin Keller, a psychiatrist at Brown University who is a controversial figure for his role in studying Glaxo's Paxil antidepressant. The committee, according to sources familiar with the investigation, sent a letter to Brown as part of its investigation. We are awaiting a reply from Brown and will update you shortly.
In recent weeks, the committee has acknowledged focusing on three academic psychiatrists - Harvard University's Joe Biederman, Stanford University's Alan Schatzberg and the University of Cincinnati's Melissa DelBello. Last week, Chuck Grassley, the ranking Republican on the committee, also asked the American Psychiatric Association to open its books (read the e-mail here).
Keller, you may recall, was the lead author of an infamous study published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry that Paxil, which is known as Seroxat in the UK, was “generally well tolerated and effective for major depression in adolescents.” Known as study 329, the findings were used to widely promote the drug, which became a huge seller.
However, the study was later held in disrepute after it was learned the results didn’t tell the whole story. In fact, 329 was one of three studies cited by former New York Attorney General Eliot Spitzer, who filed a suit charging Glaxo with “repeated and persistent fraud,” alleging the drugmaker had promoted positive findings, but hadn’t publicized unfavorable data (back story).
As it turns out, study 329, which already had a sordid history that included ghostwriting charges (here’s some background), were worse than imagined. A recent study in the International Journal of Risk & Safety of Medicine disclosed that, after sifting through some 10,000 documents that surfaced during Paxil litigation, highly selective reporting was used to skew the results favorably.
Curious to hear how Keller explains the process by which study 329 was drafted? Then feel free to wade through this lengthy deposition from September 2006 in which he discusses the role played by Scientific Therapeutics Information in preparing the study (see pages 242-266). You can also read more about Keller in the recent book about Paxil, Side Effects, by Alison Bass.