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Drug Makers Explain Trials to Congress

Thu Sep 9, 6:32 PM ET


WASHINGTON - Drug manufacturers acknowledged Thursday that they face a crisis of credibility they hope to remedy by releasing information about their clinical trials.

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At a contentious congressional hearing, company representatives also said they are concerned the information will be so unwieldy that it will confuse doctors and patients.

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

Overwhelming 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 hearing of a House Energy and Commerce subcommittee was intended to give seven drug companies a chance to explain how they did — or did not — disclose studies that suggested links between antidepressant use and suicidal tendencies in children.

Unpublished studies disclosed last summer made that link.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 in the lengthy hearing.

The subcommittee chairman, Rep. Joe Barton (news, bio, voting record), criticized the Food and Drug Administration (news - web sites) for what he described as the agency's reluctance to release records. That hampered the subcommittee's ability to investigate, said Barton, R-Texas.

"FDA (news - web sites) either does not hear the wake-up call ... or they're choosing to ignore it," Barton said.

Addressing Dr. Janet Woodcock, the agency's acting deputy commissioner for operations, Barton said: "What can you tell me that will give some comfort that we are going to get cooperation? I do not want to have to subpoena records."

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

Federal health officials are preparing stronger warnings for some antidepressants that children use. But it is not clear what those warnings will say and which drugs will be affected. 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," Dr. Thomas Laughren, the FDA's psychiatric drugs chief, wrote the advisory panel last month.

Subcommittee members said the FDA and drug companies have provided scant details of pediatric clinical trials for antidepressants.

When the agency last month published five summaries, it did not include details such as links between antidepressants and heightened suicidal thoughts among children, said Rep. Bart Stupak (news, bio, voting record), D-Mich.

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

Woodcock said the FDA cannot, by law, disclose clinical trial information until the drug is approved.

Under questioning, Woodcock said the agency cannot compel companies to reveal information about clinical trial.

"But some of them have asked you for the ability to release that information, and you said no," said Rep. Greg Walden (news, bio, voting record), R-Ore.

He was referring to an August 2003 warning letter sent by Wyeth Pharmaceuticals to doctors warning about possible links between suicidal thoughts and hostility in depressed children taking Effexor. The company's proposed label change was rejected by the FDA, Walden said.

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

Among the potential legislative solutions under consideration are reviving Stupak's plan to require clinical trial publication and label changes before drug makers 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.

The only antidepressant approved by FDA for use in children is Prozac. Woodcock said the agency has not approved the other drugs because "the jury is still out" on whether the other drugs work for children.

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