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Expected Call for Advance Registration of Drug Tests


Published: September 8, 2004

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.

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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 The subject gained public prominence earlier this year with the disclosure that unpublished test data from trials of some widely used antidepressants had indicated that some adolescents and children who took the drugs had a greater tendency toward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.

Three leading companies, GlaxoSmithKline, Eli Lilly and Merck have recently announced plans under which they would provide more public information about their drug tests and the results. Yesterday, the industry trade association, the Pharmaceutical Research and Manufacturers of America, said it was creating a Web site on which its members could voluntarily post the results of trials of their medications.

Also yesterday, the New York State attorney general, Eliot Spitzer, said in a telephone interview that his office had reached an agreement with another drug maker, Forest Laboratories, for it to disclose the results of clinical trials. Mr. Spitzer had sought information from Forest about how it marketed and disclosed test results for its antidepressant Celexa and other drugs, but his office has not begun a formal investigation or accused the company of wrongdoing.

This past spring, Mr. Spitzer sued GlaxoSmithKline, contending that it misled doctors by playing down negative pediatric test information about its popular antidepressant Paxil. And soon thereafter, the American Medical Association called for the federal government to create a database in which drug companies would be required to register clinical tests of their medications at the outset and report the results.

In June, the group from the medical publications, calling itself the International Committee of Medical Journal Editors, said it was considering requiring companies to publicly register tests in order for them to be published later.

Yesterday, two journal editors declined to discuss the details of that plan before its public release on Thursday. But both editors said they supported calls for mandatory drug trial registration and reporting, apparently signaling by their comments that the group planned a major shift in publication policy.

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. Glaxo Begins Posting Drug Trial Results (September 1, 2004) 
. Glaxo Agrees to Post Results Of Drug Trials on Web Site  (August 27, 2004)  $
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