Is Glaxo Keeping Its Commitment To Releasing Paxil Trial Data?

For the past year, GlaxoSmithKline has vowed to usher in a new era of transparency by creating a system to disclose detailed clinical trial data, a widely publicized move that has been hailed by many critics of the pharmaceutical industry who have accused drugmakers of deliberately concealing vital information that should be accessible to others in order to confirm safety and effectiveness. Now, though, a group of researchers is putting the drugmaker to the test by requesting detailed data for an infamous study of its Paxil antidepressant, but are squabbling with the drugmaker over information being sought. In the process, the dispute is raising questions about whether Glaxo complied with a 2004 consent order with the New York State Attorney General to publicly disclose the Paxil trial data. At issue is data for Study 329. Glaxo participated in preparing, publishing and distributing what US authorities called a "misleading medical journal article" because the results reported that a Paxil clinical trial demonstrated efficacy in treating depression in patients under age 18, when the study actually failed to make the case. The trial missed its endpoints and also figured in a ghostwriting controversy (here is the study). For more than a decade, the study has haunted Glaxo after it became known that suicide risks in what was one of the best-selling antidepressants had been minimized. The episode, which led Glaxo to the 2004 consent order, factored into the $3 billion settlement w...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs