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Pharmaceutical Firms Against Releasing Trial Results


Undoubtedly, patients and doctors alike would agree that pharmaceutical companies should be bound to revealing the results of clinical trials that suggest that their drugs don't work or may even be harmful. These admissions should come in good faith, but if not they should be nudged by a legal hand.

In response to legal pressures and a growing credibility crisis, some drug companies have agreed to disclose at least some of their trials and findings in public databases. Some companies also have put trial results on their Web sites.

The problem with these voluntary approaches is that decisions on what to report will be left to the companies. Too often, any negative results are suppressed or buried, and only glowing reports made public.

To combat such exclusions, a coalition of 12 leading medical journals made news this week with refusal to publish the results of any clinical trial that had not been registered at the outset in a public database. This registration would make it harder for companies to bury bad results. Since the journals include some of the most prestigious in the United States, the new policy should put great pressure on drug companies and researchers to register. Nonetheless, there are hundreds of other medical journals that would need to follow suit for this approach to be fully effective.

Drug makers are worried that calls for greater disclosure of early-stage clinical trials might lead to the release of scientific information that could help competitors. These industry groups will likely oppose efforts by medical journals to force companies to reveal the existence of the earliest studies, known as Phase I trials.

A leading suggestion – endorsed by the American Medical Association (AMA) – includes a law requiring that significant clinical trials covering drugs, medical devices and biological agents, be registered in a public database and results be made available.

Movement toward better disclosure gained momentum in recent months amid a controversy over the safety of antidepressants for children and teens. Manufacturers did not publicize findings from several studies that failed to prove most of the drugs worked primarily for pediatric patients.

Joi C. Ridley



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