American Medical Association May Ask HHS To Develop New Registry of Clinical Trial Data
The American Medical Association House of Delegates will vote at a meeting starting Saturday on a resolution asking HHS to create a registry of all private and public clinical trials and their results, the Philadelphia Inquirer reports (Burling/Loyd, Philadelphia Inquirer, 6/9). The resolution would follow a lawsuit filed last week by New York Attorney General Eliot Spitzer (D) alleging that GlaxoSmithKline concealed negative clinical trial data related to the antidepressant Paxil. The lawsuit alleges that GSK concealed data from trials that indicated Paxil is no more effective in adolescents and children than a placebo, and in some cases could cause suicidal thoughts. The lawsuit is the first to allege that the suppression of negative trial results is illegal (California Healthline, 6/3). GSK currently is developing a clinical trial registry that will provide summaries of all trial protocols and results but will not describe the underlying data in studies. The AMA resolution is supported by the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry.
A report by the AMA Council on Scientific Affairs supporting the resolution states, "No comprehensive system for tracking, organizing and disseminating information about ongoing clinical trials currently exists." Drug makers and medical device manufacturers in 2002 provided 80% of the $5.6 billion spent on clinical trials with human subjects, "prompting concerns" about the companies' willingness to publish negative study results, the Inquirer reports. According to FDA Associate Commissioner Peter Pitts, companies must submit results of all clinical trials when they apply to sell a new treatment, but FDA considers such information proprietary, the Inquirer reports. During the testing process before applying for approval, firms only are required to report any safety issues to FDA, according to the Inquirer. Some clinical data may be released on labels or during public FDA hearings. Dr. Jeffrey Drazen, editor of the New England Journal of Medicine, said, "One of the problems with the whole system of reporting is that the people who design and report the trials are not dispassionate. They have a fiduciary interest in it." Alan Goldhammer, associate vice president for regulatory affairs at Pharmaceutical Research and Manufacturers of America, said PhRMA is "examining whether we need to take any new position [on the issue]" (Philadelphia Inquirer, 6/9).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.