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Medical journals to require public registry

/ Source: The Associated Press

The editors of 11 medical journals, including some of the most prominent ones in the United States, are adopting a policy meant to improve public access to study data, especially negative results that drug companies might want to keep to themselves.

The editors, who make up the International Committee of Medical Journal Editors, will require that studies be listed on a public registry at or before enrollment of human patients.

“Honest reporting begins with revealing the existence of all clinical studies, even those that reflect unfavorably on a research sponsor’s product,” the journals’ editors said in announcing the change.

The committee includes The New England Journal of Medicine, The Journal of the American Medical Association and Annals of Internal Medicine, as well as several foreign medical journals.

Policy designed to force hand of drug companies

Their new policy stems from concerns that drug company-sponsored studies with negative results rarely are submitted to medical journals. It follows recent revelations that unpublished data linked some anti-depressant drugs with suicidal behavior in children — a concern that also prompted the American Medical Association in June to call for a public research registry.

The journals prepared a formal announcement for Thursday to coincide with a congressional hearing scheduled on the anti-depressant issue.

The policy was prepared before Tuesday’s announcement from the pharmaceutical industry about its own new but voluntary Web-based registry of drug company studies.

Alan Goldhammer of the Pharmaceutical Research and Manufacturers of America said the industry group would examine the journals’ policy but remained committed to its own Web registry’s mission.

Registry must offer free public access

The journals’ policy doesn’t advocate for any particular registry but says any registry must offer free public access.

The policy applies to any clinical studies starting enrollment after July 1, 2005. Existing studies have until September 2005 to register, said Dr. Catherine DeAngelis, JAMA’s editor in chief.

The editors acknowledged that some drug companies could avoid the registry by trying to get research published elsewhere, but Dr. Jeffrey Drazen, editor-in-chief of The New England Journal of Medicine, said some researchers might not agree to participate if they knew their results would never reach the top journals.

Dr. Jerome Kassirer, a former New England Journal of Medicine editor who writes about ethical issues involving doctors and drug companies, said the new policy is “a pretty good idea” but that its success will depend on how much detailed information is made public and “how easy it is for the pharmaceutical companies to get away with doing the bare minimum.”

Dr. David Fassler, a Vermont psychiatrist involved in efforts to get the AMA to seek a study registry, called the journals’ policy “an extremely important step.”

“I expect that many other journals will readily follow suit and that this policy will quickly become the standard with respect to medical publication,” Fassler said.

The committee also includes The Lancet, Canadian Medical Association Journal; The Medical Journal of Australia; New Zealand Medical Journal; Croatian Medical Journal; Nederlands Tijdschrift voor Geneeskunde; Tidsskrift for Den Norsek Llegeforening; and Ugeskrift for Laeger.