Healthy Skepticism Library item: 48

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Publication type: news

Mangan K.
Medical Association Calls for End to Confidentiality Demands by Research Sponsors
The Chronicle of Higher Education 2004 Dec 9

Full text:

The American Medical Association approved a resolution this week that aims to eliminate from research contracts the confidentiality clauses that prevent medical scientists from communicating their findings in clinical trials.

The resolution, which was approved unanimously by the association’s House of Delegates, “will make it easier for physician-researchers to discuss both the methodology and the outcome of clinical trials with their professional colleagues,” without first having to get the permission of the company that paid for the research, said David G. Fassler, a clinical associate professor of psychiatry at the University of Vermont and a practicing psychiatrist.

“Ultimately, it will enhance the open exchange of ideas and information, which is the very foundation of scientific research and medical practice,” added Dr. Fassler, who worked on the resolution.

The measure calls on the medical association to work with the Pharmaceutical Research and Manufacturers of America, the American Academy of Pharmaceutical Physicians, and other groups to develop guidelines to eliminate the use of clauses “that interfere with scientific communication in agreements between pharmaceutical companies or manufacturers of medical instruments, equipment, and devices, and physician-researchers.”

The resolution adds that the association should act “to protect the rights of physician-researchers to present, publish, and disseminate data from clinical trials.”

The resolution was proposed by the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry.

If researchers are prohibited from publishing the results of studies whose findings are negative or inconclusive, “the scientific literature can become distorted, and this can affect medical practice,” said Ron Davis, a member of the AMA’s Board of Trustees.

That danger was illustrated in a recent New York Times article. The article described how researchers testing antidepressants in children and adolescents were not allowed to discuss their data with one another because of confidentiality agreements with their sponsors.

A spokesman for the Pharmaceutical Research and Manufacturers of America, Jeff Trewhitt, pointed out that the industry group had published principles 2½ years ago that call for “timely communication” of clinical-trial results, regardless of the outcome. He said the group would work with the American Medical Association and other organizations to ensure that that happened, as long as the results were released in a responsible way.

“The one major concern we do have is that data from a large, multisite trial not be discussed prematurely,” he said. “Data from only three or four out of eight or nine trial sites may not represent the actual, final outcome of overall testing.”