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Posted on Sat, Sep. 11, 2004

Dispute intensifies over disclosures in drug study

The Associated Press

WASHINGTON — Drug manufacturers acknowledge that they face a crisis of credibility that they hope to remedy by releasing information about their clinical trials in multiple locations.

But at a contentious congressional hearing Thursday, representatives of the companies said they also are concerned that releasing all of the information will be so unwieldy that it could confuse doctors and patients.

John R. Hayes, product team leader at Eli Lilly and Co., said a single report about a drug can number more than 400,000 pages.

Flooding a Web site with 120,000 clinical trials may dilute the usefulness of the information, said David Wheadon, senior vice president of regulatory affairs for GlaxoSmithKline. “We always want to make sure we're serving the good, the right purpose.”

The two testified at a House subcommittee hearing designed to give seven drug companies an opportunity to explain how they did — or did not — disclose studies that suggested links between antidepressant use and suicidal thoughts in children.

Controversy first flared last summer with the disclosure that unpublished studies made that link.

Federal health officials are preparing stronger warnings for some antidepressants used in children. But exactly what those warnings will say, and which drugs will be affected, hasn't been settled. A Food and Drug Administration advisory committee will consider the issue next week.

“While there remains a signal of risk ... for some drugs in some trials, it is important to note that the data are not black-and-white in providing a clear and definitive answer,” FDA psychiatric drugs chief Thomas Laughren wrote the advisory panel last month.

At the House subcommittee on oversight and investigations hearing Thursday, tempers flared, tears flowed, and a major drug company, Wyeth Pharmaceuticals, found itself pitted against the FDA.

As early as 2002, Wyeth attempted to add warning labels to its antidepressant Effexor, but ran into FDA opposition. The ultimate label changes mandated by the FDA dropped references to increased hostility seen with Effexor, Wyeth acknowledged under questioning.

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