Responding to growing public and scholarly concern that pharmaceutical companies may be hiding unfavorable results of clinical trials, the American Medical Association last week called on the federal government to create a central registry for the experiments.
At its annual meeting, the medical association’s House of Delegates voted to ask the U.S. Department of Health and Human Services to create a database that would allow doctors and members of the public to learn of the existence, at least, of all human trials of novel therapies. Now pharmaceutical companies can run many clinical trials without publicly disclosing their existence, let alone their results.
The medical association also called for institutional review boards to require all research involving human subjects to appear in the registry as a condition for approval. The boards oversee such research at universities and hospitals and must affirm that the studies meet legal and ethical standards for them to proceed.
Controversy Over Paxil
The association’s vote came hard on the heels of a controversy involving Paxil, an antidepressant made by GlaxoSmithKline. The company had publicized favorable results from one trial of the drug in children and adolescents, but it did not release the negative results of other clinical trials until after New York’s attorney general, Eliot L. Spitzer, sued it earlier this month.
In a news release, an official of the medical association said he hoped that a central registry would reduce the pharmaceutical industry’s influence on publishing.
“Studies with positive findings are more likely to be published than studies with negative or null results,” said Joseph M. Heyman, a trustee of the medical association. “We are concerned that this pattern of publication distorts the medical literature, affecting the validity and findings of systematic reviews, the decisions of funding agencies, and, ultimately, the best practice of medicine.”
The association’s new proposal stopped short of requiring that clinical trials be registered in order for reports of their findings to be published in its prestigious journal, The Journal of the American Medical Association, known as JAMA.
The New York Times reported last week that the International Committee of Medical Journal Editors was considering such a requirement. A representative of the medical association said that if JAMA were to take such action, the decision would have to be made by the editors, not the association.
Last July JAMA published an essay by Kay Dickersin and Drummond Rennie, researchers at the Brown University Medical School and the University of California at San Francisco, respectively, that strongly urged the creation and use of such registries.
“The result of not knowing who has performed what,” they wrote, “is loss and distortion of the evidence, waste and duplication of trials, inability of funding agencies to plan, and a chaotic system from which only certain sponsors might benefit, and which is invariably against the interest of those who offered to participate in trials and of patients in general.”
The American pharmaceutical industry has generally opposed such a registry, although some companies say they voluntarily release results of all their clinical trials.
http://chronicle.com Section: Research & Publishing Volume 50, Issue 42, Page A25