Glaxo to post trials on Web

By Theresa Agovino
The Associated Press

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The company's move Friday comes amid mounting pressure on drug companies to make all trial results more widely available. Doctors receive much of their information on clinical trials at medical meetings, by reading journals and through drug-company marketing, but there long has been concern that negative information is largely absent from those channels.

Glaxo was sued over the issue two weeks ago, and the American Medical Association (AMA) last week passed a resolution calling for a comprehensive, government-run registry for all drug-study results so that unfavorable results aren't buried. Meanwhile, international medical journals are considering not publishing studies conducted by drug companies unless the trials are listed in a public registry.

Doctors largely were unimpressed with Glaxo's announcement, saying they need one central place to obtain information rather than having to scour multiple sites. They also criticized Glaxo's decision not to disclose when it is starting a trial — because then it won't have to account for what happened in the study if the results are negative.

Glaxo said it shouldn't take longer than six months for the information to be posted.

"I think this is the right thing to do. We think more transparency is better," said chairman and chief executive Jean-Pierre Garnier, who added he supported a comprehensive registry. "We don't want to be accused of anything about the way we deal with trials. I think it too important a subject."

Garnier said the company had been considering the Web site for months and the decision to announce it was a reaction to the AMA resolution, not the lawsuit. Still, he said he hoped it would persuade Attorney General Eliot Spitzer to drop the lawsuit.

Glaxo already has posted on its Web site the studies Spitzer accused it of hiding, along with what Garnier said was proof that the trial results had been made public.

The lawsuit, filed in New York State Supreme Court, said Glaxo suppressed four studies of its anti-depressant Paxil that failed to demonstrate the drug was effective in treating children and adolescents, and that suggested a possible increase in suicidal thinking and behavior. It also said an internal 1999 Glaxo document showed the company intended to "manage the dissemination of data in order to minimize any potential negative commercial impact."

A Spitzer spokeswoman said officials were examining Glaxo's proposal.

Copyright © 2004 The Seattle Times Company

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