GlaxoSmithKline PLC, which has been sued by the New York attorney general for fraud for withholding critical clinical information, announced today it will post the results of all of its drug trials on the Web.
Glaxo's announcement comes two weeks after the lawsuit was filed and three days after an American Medical Association resolution called on the government to create a public registry for all drug-study results so unfavorable results also get attention.
Glaxo couldn't say when the information would be posted but said it shouldn't take longer than six months.
"I think this is the right thing to do. We think more transparency is better," said Glaxo Chairman and Chief Executive J.P. Garnier. "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 that the decision to announce it was not a reaction to the lawsuit, but to the AMA resolution. Still, he said he hoped the announcement would persuade New York state Attorney General Eliot Spitzer to drop the lawsuit.
Glaxo has already published on its Web site the studies Spitzer accused it of suppressing, along with what Garnier said was proof that the trial results had been made public.
Filed in New York State Supreme Court, the suit said Glaxo suppressed four studies of its antidepressant Paxil that failed to demonstrate the drug was effective in treating children and adolescents and that suggested a possible increase in suicidal thinking and acts.
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."
Doctors receive much of their information on clinical trials through attending medical meetings, reading journals and drug company marketing. There has long been widespread concern that negative information isn't communicated through those channels, and such worries have been magnified recently over the issue of prescribing antidepressants for children.
Last year, after reviewing some of the Paxil studies, British medical authorities said the drug should not be prescribed to treat depression in those younger than 18 because of concerns about potential suicidal behavior. At a Food and Drug Administration meeting in February to discuss suicidal tendencies in children taking antidepressants, doctors saw studies they had never seen before.
Garnier said both its Web site and any future public registry present problems not only for the drug companies, but also for doctors and patients.
"Some studies need to be seen in the entire context of all the research. There is always a risk of junk science through isolating just one trial," said Garnier. "But we think it is a risk worth taking."
Meanwhile, Merck & Co. said it supports expanding an existing government clinical trial registry, which is currently just for studies of serious and life-threatening diseases, to include all drugs. But Merck spokeswoman Janet Skidmore said she was not prepared to comment on whether Merck would list of all its trial results on the Web.
