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Should public see results of all drug tests?



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By Gregory M. Lamb, Staff writer of The Christian Science Monitor / June 21, 2004

It took some legal arm-twisting from New York State's attorney general, prodding from the American Medical Association (AMA), and threatened action by medical journal editors. But finally, the healthcare industry looks to be on the verge of asking the government to set up a comprehensive registry of clinical drug tests.

The registry would include not only positive trials that drug manufacturers like to tout, but also any tests that show drugs to be harmful or ineffective. The move could go a long way toward addressing public concerns that such studies are being suppressed, especially after recent revelations about the effects of an antidepressant on children and teens, observers say. But by itself, a registry won't counteract the influence drug companies hold on the marketplace, they add.

"We should not delude ourselves into thinking it will overcome the enormous promotional clout that the companies already have," says Jerry Avorn, a professor of medicine at Harvard Medical School and author of the forthcoming book "Powerful Medicines: The benefits, risks, and costs of prescription drugs." Even if such a registry were magically in place tomorrow, Dr. Avorn says, "the companies would still have a very large say in what published information is brought to the doctor's office in a convenient, colorful, glossy, well-illustrated package."

Concerns about clinical trials arose earlier this month after Eliot Spitzer, New York's attorney general, sued GlaxoSmithKline. The suit charges, among other things, that the British drug firm had suppressed clinical studies showing that its antidepressant drug Paxil was ineffective in children and teenagers and possibly could cause suicidal behavior. Glaxo released the studies.

Then last week, apparently reacting to growing public concerns that negative trials were being hushed up, the AMA called for a comprehensive government registry of all clinical trials, ensuring that information on trials with negative results would be widely available. The AMA proposal followed on the heels of news reports that the International Committee of Medical Journal Editors was considering a requirement that any articles published in its member publications be based on trials listed in such a database. That could pressure drugmakers to register all their trials, since they count on reports in prestigious medical journals to influence the choices physicians and patients make when choosing prescriptions.

The drug industry's trade organization, the Pharmaceutical Research and Manufacturers of America (PhRMA), has yet to decide whether to endorse the concept of a registry. It is waiting to see a final draft of the AMA proposal and to learn whether the medical editors formally act, a spokesman says.

Drug companies are already committed to communicating negative trial results, says Alan Goldhammer, PhRMA's vice president for regulatory affairs, noting that PhRMA is on record with a general expression of support. That statement calls for "timely communication" of the results of clinical trials "regardless of outcome."

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