Putting GlaxoSmithKline to the test over paroxetine.

When the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) published study 329 in 2001, its editors could have had no idea that the paper would spark a controversy, not only about the use of the antidepressant paroxetine in children but also about secrecy in clinical trials. It is a controversy that rages to this day and that goes to the heart of recent campaigns to gain access to drug companies’ trial data. By most accounts, GlaxoSmithKline is leading the pack in its efforts to liberate access to its clinical trial data. It was the first major pharmaceutical company to sign up to the international AllTrials petition calling for all trials to be registered with the full methods and the results reported. Whereas companies like AbbVie and InterMune have lodged lawsuits aiming to block access to clinical trial data, GSK has forged ahead with a new website enabling third party access to deidentified participant level data “because it is the right thing to do, both scientifically and for society.” GSK’s website states that five requests have been approved up to 20 September. None have been rejected. One is under review. But one group’s request for data is testing the limits of GSK’s commitment to full transparency. Jon Jureidini, clinical professor of psychiatry at the University of Adelaide, is leading a team to reanalyse and republish the results of GSK’s study 329—a randomised, double blind, placebo controlled trial of paroxetine for the treatment of depression in adolescents. For over a decade, Jureidini has been critical of how the study was reported in JAACAP in 2001. In 2003, Jureidini and Tonkin wrote to JAACAP: “We believe that the Keller et al study shows evidence of distorted and unbalanced reporting that seems to have evaded the scrutiny of your editorial process.” They noted that “on neither of [the study’s two primary outcome] measures did paroxetine differ significantly from placebo”—yet the Keller et al paper concluded that “paroxetine is generally well tolerated and effective for major depression in adolescents.” Jureidini was subsequently contracted to provide expert advice as part of a class action lawsuit against GSK in 2004. Through this legal action, some internal company documents were released into the public domain, and Jureidini and colleagues reported that study 329 had an additional six secondary outcomes specified in the protocol. Paroxetine was not more effective than placebo on any of these outcomes either. Troubled history