AMA calls for total drug-trial disclosure

Seeking to prevent drug companies from suppressing research with negative outcomes, the nation's preeminent physicians group yesterday called on the federal government to create a public registry of clinical trials that would ensure the results of all medical experiments would see the light of day.

Pharmaceutical companies sometimes withhold results that reflect poorly on their products, leaving doctors without a full picture of the risks and benefits of certain drugs.

''Studies with positive findings are more likely to be published than studies with negative or null results," said Dr. Joseph M. Heyman, a trustee of the American Medical Association, which called for the registry. ''We are concerned that this pattern of publication distorts the medical literature, affecting the validity and findings of systematic reviews, the decisions of funding agencies and, ultimately, the best practice of medicine."

A coalition of medical journals, the conduits between researchers and practicing doctors, is working on a similar proposal.

''We as journals and physicians only know about the good news, only the news that drug companies want to see out there," said Dr. Jeffrey Drazen, editor in chief of the New England Journal of Medicine. ''Physicians want to see the totality of the work out there . . . right now, they're not getting the whole story."

The New England Journal and 11 other major journals are considering publishing only studies that are listed in a public registry, such as the one recommended yesterday by the AMA. The plan under discussion by the International Committee of Medical Journal Editors was first reported yesterday by The New York Times.

Federal health officials, which the AMA called on to run the registry, did not comment yesterday.

Some scientists have long complained about the practice of withholding studies, and their cause got a boost in court last month. In a first, New York Attorney General Eliot Spitzer sued drug giant GlaxoSmithKline, alleging the company suppressed research on the antidepressant Paxil that showed the drug might have limited effects on children.

''We owe a lot to Spitzer," Drazen said. ''Academics have been harping on these kinds of issues for a long time. But we haven't been able to influence the drug companies."

The AMA decision was the product of complaints from its members, who are worried that studies of antidepressant use in children have been suppressed, according to AMA officials.

An AMA scientific committee concluded that positive studies were more likely to be published, especially those testing new drugs against placebos, experiments that are more likely to show a positive effect. The panel also found that researchers themselves are more inclined to submit positive studies for publication because scientific journals tend to favor such studies, which often cause a change in how medicine is practiced.

Under the AMA proposal, every clinical trial would have an identification number and be posted in an electronic database run by the federal government.

Raja Mishra can be reached at rmishra@globe.com.