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GlaxoSmithKline PLC, which was sued by the New York attorney general for fraud for withholding critical clinical information, said Friday it will post the results of all of its drug trials on the Web. The move 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 has long been concern that negative information is largely absent from those channels. Glaxo was sued over the issue earlier this month, and the American Medical Association passed a resolution last week 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 were largely unimpressed with Glaxo’s announcement, saying they need one central place to get 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 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 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 that 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 and the information about the Paxil trials posted on the Web to see if they would affect the lawsuit. The controversy over prescribing antidepressants to children has magnified the issue of whether there is adequate disclosure of clinical trial information. Garnier said both the Web site and any future public registry present problems not only for drug companies, but for doctors and patients. “Some studies need to be seen in the entire context of all the research,” Garnier said. “There is always a risk of junk science through isolating just one trial.” He said the part of the problem is that journals don’t publish negative news. “They have difficulty getting excited about negative news. They favor the positive,” he said. Medical editors say that is because they receive more favorable studies than unfavorable ones. “We can only publish what we get, and we get far more positive than negative,” said Dr. Catherine DeAngelis, editor in chief of the Journal of the American Medical Association. Editors also want complete news. New England Journal of Medicine Editor in Chief Dr. Jeffrey Drazen said when a company started eight trials but only talks about three, it signals that something may be amiss. “We want to give your readers complete information,” he said. Drug companies have made similar announcements in the past, but they haven’t improved disclosure. In 1998, Glaxo Wellcome started a registry that listed the purpose and parameters of its trials with links to publications carrying the results. It hasn’t been updated since the company merged with Smith Kline Beecham in 2000. “I’ve congratulated companies before and their efforts haven’t been worth anything,” said Dr. Drummond Rennie, a deputy editor at JAMA. There are several public and private clinical trials registries, but doctors say they are not standardized or complete. One of the largest is ClinicalTrials.gov, which was started in 2000 by the National Library of Medicine. It lists about 10,000 studies. Federal law requires that companies that have conducted studies for serious or life-threatening treatments post them there. The FDA is investigating whether the companies are doing so, said Alexa McCray, the library’s director for biomedical communications. Merck & Co. said it supports expanding that site to add more trials and information — but spokeswoman Janet Skidmore could not say whether Merck would list of all its trial results on the Web. Copyright 2004 Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.

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