Wednesday, September 08, 2004

Disclosure of Clinical Trials: Ongoing Debate

Today's New York Times provides a report about the ongoing debate concerning clinical-trials findings and the ability to balance favorable against unfavorable findings in an environment where unfavorable findings do not easily come to the fore:

Expected Call for Advance Registration of Drug Tests

By BARRY MEIER

The debate over the disclosure of clinical drug trials could reach a turning point this week, with editors of influential medical journals expected to call for fundamental changes in the way such tests are reported.

The journal editors, gatekeepers for the medical profession, are expected to begin requiring that drug trials be registered at the outset as a prerequisite for the subsequent publication of their results. Requiring such registration as a condition for reaching the journals' vast audience of doctors would make it difficult for drug companies to hide the results of unflattering tests - as some have been accused of doing.

The journal editors declined yesterday to discuss the new policy before the announcement, but the group said several months ago that it was considering such a step.

Details of the policy by the group - which includes prestigious publications like The Journal of the American Medical Association, The New England Journal of Medicine, The Lancet and The Annals of Internal Medicine - are to be presented Thursday at a House Commerce subcommittee hearing on disclosure of data from pediatric trials of antidepressants.

Meanwhile, both House and Senate Democrats say they expect to introduce legislation as early as Thursday that would require drug trials involving human subjects to be registered in a public database before the tests were allowed to proceed.

Congressional Republicans, though, have not announced any plans for such legislation. And an official of the drug industry's trade group, which yesterday announced a voluntary plan to disclose trial results, said his organization thought that legislation was not necessary.

Some academic researchers have long argued that drug companies unduly influence medical practice by highlighting positive trial findings while not publishing negative ones. The subject gained public prominence earlier this year with the disclosure that unpublished test data from trials of some widely used antidepressants had indicated that some adolescents and children who took the drugs had a greater tendency toward suicidal thoughts than those given placebos.

"People have been concerned for quite some time that nondisclosure of unfavorable studies has skewed the scientific literature and possibly medical practice," said Dr. Ronald M. Davis, a trustee of the American Medical Association. "But recently, tangible evidence of that concern has arisen."

Makers of antidepressants have denied concealing any data. But in recent months, they and other drug producers have scrambled to address criticism about disclosure in the industry of trial results.

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