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Members of Congress blast FDA, drug makers

Mayo Clinic
Food and Drug Administration (FDA)
Health Organizations
Bart Stupak

WASHINGTON (AP) -- Drug manufacturers acknowledge 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.

Dr. 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 Dr. David Wheadon, senior vice president of regulatory affairs for Philadelphia-based GlaxoSmithKline. "We always want to make sure we're serving the good, the right purpose," he said.

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Controversy first flared last summer with the disclosure that unpublished studies made that link.

"I think these hearings are evidence of the fact there is a great deal of mistrust," Hayes told reporters during a break.

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. An FDA 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," Food and Drug Administration psychiatric drugs chief Dr. 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 from the panel's vice chairman, Rep. Greg Walden, R-Oregon.

Adopting FDA's wording was a "reasonable compromise," Dr. Joseph Camardo, senior vice president of medical affairs for Wyeth, testified.

Earlier in the hearing, Walden asked Dr. Janet Woodcock, FDA deputy commissioner for operations, whether the agency pressured drug companies to not issue such warnings.

Woodcock began to say the agency cannot compel companies to reveal information about clinical trials for drugs pending review.

Walden interrupted. "But some of them have asked you for the ability to release that information, and you said no."

"I don't have information on that," Woodcock said.

The panel's acting chair, Rep. Joe Barton, R-Texas, had already sharply criticized the FDA for what he described as the agency's reluctance to release records, which he said hampered the subcommittee's ability to investigate.

Because of the volume of records, the FDA had offered to have records reviewed at the agency, an offer that still stands, Woodcock said.

Subcommittee members said the FDA and drug companies have provided scant details of pediatric clinical trials for antidepressants. And, when the agency last month did publish five summaries, it did not include crucial details, such as links between antidepressants and heightened suicidal thoughts among children, said Rep. Bart Stupak, D-Michigan.

Stupak has been a harsh critic of the acne drug Accutane since his son committed suicide while using the drug, which has been linked to depression in some people.

Reps. Edward Markey and Henry Waxman will propose legislation that would create a mandatory registry for drug trials. The drug industry this week also announced a new Web site where companies could voluntarily summarize clinical trial results for drugs approved by the FDA.

Among the potential legislative solutions being considered by the panel: Resuscitating an amendment from Stupak requiring clinical trial publication and label changes before drug manufacturers receive six-month patent extensions for drugs they test in children.

Such exclusive marketing to children yielded an extra $4 billion for drug makers of such leading antidepressants as Prozac, Zoloft, Paxil, Luvox, Celexa and Effexor, data released by the committee indicates.

Copyright 2004 The Associated Press. All rights reserved.This material may not be published, broadcast, rewritten, or redistributed.

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