A dozen editors of prestigious medical journals jointly announced yesterday they will refuse to publish drug research sponsored by pharmaceutical companies unless the studies are registered in a public database from the outset -- a step designed to ferret out unpublished studies that find medications to be ineffective or dangerous.
The initiative creates a potent incentive for companies to register their drug trials and is expected to give physicians and the public a window on unfavorable studies that companies routinely suppress.
"When a pharmaceutical company sponsors a clinical trial and the results turn out not to be in the best financial interests of the company, it has been our experience these results are never made public," said Gregory D. Curfman, executive editor of the New England Journal of Medicine. "They are buried away."
More than two-thirds of studies of antidepressants given to depressed children, for instance, found the medications were no better than sugar pills, but companies published only the positive trials. If all the studies had been registered from the start, physicians would have learned that the positive data were only a fraction of the total.
The new requirement calls on companies to register their trials well before anyone knows whether a study will turn out positive.
The Journal of the American Medical Association, the Annals of Internal Medicine, the Lancet, the New England Journal of Medicine and several other international publications have signed on to the initiative, and their editors hope that more will join in.
Jeff Trewhitt of the Pharmaceutical Research and Manufacturers Association of America said several companies are already registering clinical trials on a voluntary basis and that a lot of information is already being made public. Individual companies, he said in a statement, "may have reservations about divulging proprietary information in clinical tests that are in very early phases. . . . [I]n the end it is their decision."
Responding to the growing outcry over suppressed medical studies, the House Energy and Commerce subcommittee for oversight and investigations plans today to ask executives of seven leading drug manufacturers whether they withheld information about the potential risks of suicidal behavior in children taking their popular antidepressant medications.
While companies could forgo publication in the journals and thereby avoid registration, the editors hope that preserving the opportunity to publish a positive study in a prominent journal, which can greatly boost the visibility of a new drug, will be a juicy enough carrot.
The medical editors' initiative also asks companies to report the studies' results in the database, but the editors acknowledged that if a trial turns out to be unfavorable, a company could decide not to. Still, they said, just knowing of the existence of the trial through the registration requirement would be telling.