Editors of major medical journals joined forces on Wednesday to make researchers and companies register all clinical trials when they begin so that unflattering or unclear results cannot later be covered up.
The 11 top journals, including some of the most influential medical publications in the world, agreed not to publish any studies that were not registered when they began. They hope to force pharmaceutical companies in particular to make public even negative findings. “Honest reporting begins with revealing the existence of all clinical studies, even those that reflect unfavorably on a research sponsor’s product,” the International Committee of Medical Journal Editors wrote in a commentary appearing in all of their publications. “Unfortunately, selective reporting of trials does occur, and it distorts the body of evidence available for clinical decision-making.” The decision has been brewing for several years but it came to a head with the discovery that certain antidepressants may make adolescents more likely to commit suicide. Some companies were accused of covering up studies that could have shown this earlier. Last month, GlaxoSmithKline Plc agreed to release information on all its clinical studies to settle a lawsuit filed by New York Attorney General Eliot Spitzer, who had accused the firm of suppressing data on antidepressant Paxil. Forest Laboratories Inc. made a similar promise on Tuesday to disclose trial data on antidepressants Lexapro and Celexa, Spitzer’s office said in a statement. ‘PERSISTENT BIAS’ “One consequence of this lack of reporting is a persistent bias in favor of positive results and therefore in favor of the newer and more expensive treatments,” Dr. Drummond Rennie, a deputy editor of the Journal of the American Medical Association, wrote in a separate commentary. “Another consequence is that harmful effects found in unpublished trials disappear without a trace, since the U.S. Food and Drug Administration has no mandate to report them to the public.”Some companies, including Eli Lilly and Co., recently have pledged to make all research findings public and the industry announced on Tuesday it was setting up one database starting Oct. 1. The Internet-based registry will contain summaries of findings, both positive and negative, of studies completed since October 2002, according to the Pharmaceutical Research and Manufacturers of America, the drug industry lobbying group. Rennie expressed doubt that the industry itself could come up with anything that met all the journals’ requirements. “Progress is being made, but previous experience suggests that, because of inherent conflicts of interest, it is unlikely that industry will ever be able to establish a large, common, complete, useful, trustworthy, up-to-date, and easily accessible register maintained over the long term,” he wrote. The medical journal editors committee said any registry could be used that was accessible to the public for free, open to anyone, managed by a not-for-profit organization and with checks to ensure validity. The group said that only http://www.clinicaltrials.gov, sponsored by the United States National Library of Medicine, met the requirements. The 11 member journals include JAMA, the New England Journal of Medicine, the New Zealand Medical Journal, the Norwegian Medical Journal, The Lancet, MEDLINE, the Annals of Internal Medicine, the Croatian Medical Journal, the Dutch Journal of Medicine, the Journal of the Danish Medical Association, and the Medical Journal of Australia.(Source: Reuters Health News: Maggie Fox, Health and Science Correspondent, Additional reporting by Lisa Richwine: September 2004.)