Healthy Skepticism Library item: 362

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Publication type: news

Windham C.
AMA to Propose Broad Database For Clinical Trials
Wall Street Journal 2004 May 27

Full text:

Stepping up pressure to make public the results of unpublished medical studies, the American Medical Association is preparing to recommend the development of print and electronic databases of all clinical trials and their results.

The AMA will vote next month on the recommendations, presented in a report of its council on scientific-affairs committee, which would urge the U.S. Department of Health and Human Services to develop a registry for clinical trials, similar to databases used in HIV/AIDS and gene-therapy trials.

Developing a registry, the report said, will ensure the publication of negative as well as positive results, and help researchers review all the data from a particular subject.

Unpublished studies are at the center of the furor over antidepressants and potential suicide risk. In a study published in the Lancet, researchers found that unpublished research on some of the antidepressants included more negative findings than the published results, and they argued that the suppression of such research “can lead to erroneous recommendations for treatment.”

A separate review, in the British Medical Journal, “found disturbing shortcomings in the methods and reporting of trials of newer antidepressants” in children and adolescents. A study in this week’s Journal of the American Medical Association also found that trial outcomes are often reported incompletely and are biased.

In December British regulators said several antidepressants were “not suitable” for depressed patients younger than 18, because their benefits were limited or unproved and hadn’t been shown to outweigh risks that included self-harm and suicidal thoughts. The U.S. Food and Drug Administration has warned that depressed patients of all ages taking antidepressants should be watched closely, but it is still re- examining data from the trials Doctors say they need to have quicker and more direct access to such information.

Currently, the FDA doesn’t publicly disclose unpublished studies. The agency has sharp restrictions on its ability to reveal proprietary data it receives as part of drug applications. The Department Health and Human Services has declined to comment until it has formally reviewed the report. However, “any efforts to help the goal to use information technology to deliver health care, we welcome,” said Bill Pierce, an HHS spokesman.

Drug companies are likely to resist efforts to establish the database, researchers say. Court Rosen, a spokesman for the Pharmaceutical Research and Manufacturers of America, a trade group, yesterday said the organization “only received today the yet-to-be-finalized report and would comment once it’s finalized.”

To enforce the registry, the report called on institutional review boards, or IRBs, which are charged with monitoring the treatment of participants in clinical trials, to participation in the registry as a condition for approval to proceed with the clinical trial.

“If the IRBs say it has to be done, they have to do it,” said Eric G. Campbell, assistant professor at the Institute for Health Policy at Harvard Medical School.

“The database will only be effective as the strength of the mandating involved,” said Peter Lurie, deputy director of the health- research group for Public Citizen, a consumer group.

The report was drafted in response to a resolution introduced last year to the AMA House of Delegates by the American Psychiatry Association and the American Academy of Child and Adolescent Psychiatry. A related resolution asking the AMA to study the issue of enhancing access to FDA data was submitted earlier this month.

“I expect there will be a lot of interest in the issue,” said David Fassler, a clinical associate professor of psychiatry at the University of Vermont College of Medicine in Burlington and the AACAP’s delegate to the AMA’s House of Delegates. “I’m optimistic that the resolution will be passed.”