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GSK to Post All Study Results On Web Site

Under threat of a major lawsuit, Paxil's manufacturer agrees to alter the way it handles findings from clinical trials of all its drugs.

One of the world's largest pharmaceutical manufacturers, GlaxoSmithKline (GSK), has agreed to post on its Web site the results of all its clinical trials of its medications conducted after December 27, 2000.

This major change in the way the company informs physicians and the public about its products is the key element in GSK's settlement of a potentially damaging civil suit filed in June by New York Attorney General Eliot Spitzer (Psychiatric News, July 2).

That suit charged the company with fraud for concealing findings of Paxil clinical trials that indicated that the antidepressant had little if any efficacy when used to treat children and adolescents and could in fact pose safety risks. Spitzer maintains that GSK released findings only from the minority of studies that suggested Paxil's success in treating this population. He also charged the company with using marketing tactics in which its sales representatives urged physicians to use the drug for indications not approved by the U.S. Food and Drug Administration.

In addition to agreeing to post all of its clinical trials data on the Web—which it said it would do by December 2005—GSK agreed to pay $2.5 million to the state of New York to settle the suit, though the company noted that it was doing so to "avoid the high costs and time required to defend itself in protracted litigation" and believes that Spitzer's charges are "unfounded."

GSK voluntarily began posting its Paxil studies on children and adolescents on June 10.

Eli Lilly and Company has already announced that it will begin publishing all clinical trial results on its Web site; there is no evidence yet, however, of a drug-company bandwagon on this issue.

Details of the settlement are posted online at <www.oag.state.ny.us/press/2004/aug/aug26a_04.html>. Findings from GSK's Paxil studies are posted at <www.gsk.com/media/paroxetine.htm>.

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