Washington Editor

WASHINGTON - A pair of House Democrats on Thursday vowed to introduce legislation that would require drug companies to publish information on ongoing clinical trials and the results, whether positive or negative.

During a House Energy and Commerce Subcommittee on Oversight and Investigations hearing, Rep. Henry Waxman (D-Calif.), an author of the pending legislation, said the bill would expand the FDA's current clinical trial registry to ensure that physicians, patients and the public have access to information learned in all studies.

"The legislation will also prevent pharmaceutical companies from withholding clinically important information about their products," Waxman said. The bill will be co-sponsored by Rep. Ed Markey (D-Mass.). The drive to force biotechnology and pharmaceutical companies to disclose clinical trial information is the outgrowth of a report published more than a year ago suggesting that paroxetine (generic for GlaxoSmithKline plc's Paxil) appeared to increase the risk of suicidal thoughts and actions in children.

Prozac, made by Eli Lilly and Co., of Indianapolis, is the only antidepressant approved by the FDA for pediatric use. However, other selective serotonin reuptake inhibitors, including Paxil, have been prescribed off-label to children.

Last year, the Medical Health Regulatory Agency, the British equivalent of the FDA, pulled from public sale all antidepressants except Prozac for people under 18 years of age with depression. The FDA took up the issue in June 2003, Janet Woodcock, the agency's acting deputy commissioner for operations, said in her testimony before the subcommittee Thursday. Sometime thereafter, former subcommittee Chairman James Greenwood (R-Pa.), launched an investigation into the question of disclosure of clinical studies and the use of antidepressants in children, Energy and Commerce Committee Chairman Joe Barton (R-Texas) said. (Greenwood resigned as subcommittee chair after accepting the position of president of the Washington-based Biotechnology Industry Organization.)

Barton said the committee's investigation has been hindered due to the FDA's failure to cooperate in providing requested documents and materials.

"Unfortunately, over the last several months, the committee has been met mostly with stonewalling, slow-rolling and plain [incompetence] from the FDA," said Barton, adding that FDA actually stands for "Foot-Dragging and Alibis."

Whatever the case, Barton said if he doesn't get cooperation from the FDA soon, "we'll send our people over [to the FDA] with the Capitol Police and we'll start going through documents ourselves."

Specifically, Barton is interested in 15 placebo-controlled, randomized studies submitted for an indication in children with depression. He said the FDA found that 12 out of the 15 studies showed no efficacy. "I also note that only three out of these 15 studies have been published as stand-alone articles in peer-reviewed journals," he said. "Therefore many people want to know what was in the other 12 studies."

Indeed, Waxman said when clinical trials end poorly, drug companies simply hide the data because they are not compelled by the FDA or the public to publish them. But Rep. Cliff Stearns (R-Fla.) warned that publication of poor data could be used against companies in litigation.

Under the Best Pharmaceuticals for Children Act of 2002, the FDA has the authority to publish the results of pediatric clinical trials after a firm's 180-day market exclusivity expires. Congress guarantees the exclusivity period to companies that agree to conduct pediatric trials in adult drugs used in children.

Woodcock confirmed that the law does allow the agency to publish trial summaries, a point that annoyed several lawmakers who said all the relevant data should be made public. Pressure to publish trial results is surfacing within other areas of the medical community. A day in advance of the subcommittee hearing, the International Committee on Medical Journal Editors (ICMJE) released an editorial saying its 11 member journals will require, as a condition of consideration for publication, clinical trial registration in a public registry. Trials must register at or before the onset of patient enrollment, said the editorial, posted on the Journal of American Medical Association's website.

The policy applies to any clinical trial that starts enrollment after July 1, 2005. For trials that began enrollment before that date, the member journals will require registration by Sept. 13, 2005.

The initiative to start a national clinical trials registry to ensure that all trials, negative or positive, are published, got off the ground in June when the AMA's House of Delegates called on the Department of Health and Human Services to establish the registry. (See BioWorld Today, July 2, 2004.)

Currently, only the FDA's registry (www.clinicaltrials.gov) meets requirements for publication set by the ICMJE, the group's editorial said.

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