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House berates FDA, drug makers

US Congressional subcommittee holds hearing on clinical trial disclosure rules

By | September 10, 2004

At a day-long hearing in Washington, DC, yesterday (September 9), the House Energy and Commerce Subcommittee on Oversight and Investigations repeatedly took both Food and Drug Administration (FDA) and pharmaceutical company officials to task for failing to fully disclose clinical trial results.

The charge was led by committee chairman Rep. Joe Barton (R-Texas), a long-time FDA critic. Barton chided the agency for stonewalling committee requests for more data on studies of antidepressants in children, saying that FDA "actually stands for 'foot-dragging and alibis.'"

The subcommittee's ongoing investigation of what has–or has not–been disclosed about these drugs' efficacy and side effects was the hearing's main focus. But panelists also closely questioned FDA and drug company witnesses about whether they intended to support various proposals to create centralized registries and databases that would contain both positive and negative trial results.

Janet Woodcock, FDA's acting deputy commissioner for operations, said, "I strongly support the goal of transparency and availability of information on human subjects," and noted that the agency was contributing to ClinicalTrials.gov, the central trial registry maintained by the National Library of Medicine.

But Woodcock also said the agency is prevented from disclosing certain trial information by "legal restraints." "We can't compel companies to reveal this information," she said of negative trial data. Panelists repeatedly demanded that she cite the rules preventing that disclosure. Woodcock demurred, saying she could provide the statutes at a later date. Several members said they expected the information when the committee meets again on September 23.

The hearing came a day after the International Committee of Medical Journal Editors (ICMJE) issued a call for more open reporting of clinical data. In a statement published in the New England Journal of Medicine and the Journal of the American Medical Association, the ICMJE said it would bar data from trials that had not been registered–before enrolling any patients–in a free, open-to-the-public database that is managed by a nonprofit organization. Each trial file would include: protocols; definitions of outcomes; key trial dates; target number of subjects; funding source; and contact data for the principal investigator. According to the ICMJE, ClinicalTrials.gov comes closest to its ideal.

Although the editors' statement was not discussed at the House hearing, panelists asked for input on registry proposals by the American Medical Association (AMA) and the Pharmaceutical Research and Manufacturers Association (PhRMA). Drug makers were also asked individually about plans for disclosing trial data.

Rep. Diana DeGette (D-Col.) called the PhRMA registry, which would be voluntary and will be online at www.clinicaltrialresults.org beginning October 1, "a commendable first step," but asked how meaningful and available the data will be to physicians and patients.

Rep. Henry Waxman (D-Calif.) slammed the proposal, saying that, "if it's voluntary, it's voluntary not to do it."

Representatives from GlaxoSmithKline, Forest Laboratories, Wyeth Pharmaceuticals, Eli Lilly, Bristol-Myers Squibb, Pfizer, and Organon USA all said they supported the PhRMA proposal and would participate. All the officials also said they had not had time to digest the AMA proposal, but were open to participation. Most said they were in the process of disclosing trial results on their own Web sites.

Both Forest and GlaxoSmithKline have been forced to create online registries through recent consent agreements with New York State Attorney General Eliot Spitzer.

John Hayes, an Eli Lilly product team leader, said Lilly will disclose full information about phase I, II, III, and post-marketing trials within a year of each study's completion. The company was motivated in part by bad press, he said: "There's a societal crisis in terms of the credibility of drug company results."

But, he said, there is a limit to what makes sense to make publicly available, noting that the company recently submitted a new drug application to the FDA that contained 417,000 pages, much of it raw data.

Waxman said he and colleague Edward Markey (D-Mass.) would not wait for voluntary efforts to pan out, but instead will soon introduce legislation to make it mandatory to register trials at ClinicalTrials.gov. The bill would also incorporate recommendations from the ICMJE and the AMA.

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