The Hidden Truth Behind A Medical Drug Disclosure
For Drug Makers, a Downside to Full Disclosure
When GlaxoSmithKline settled a lawsuit three years ago with the State of New York over the antidepressant medication Paxil, the company agreed to take an unusual step: publicly disclosing the results of its clinical trials for Paxil and other drugs. The company, which was criticized at the time for failing to publicize all pediatric trials of Paxil, not just the positive ones, made good on its promise. The first posting on a new Web site was about 65 studies involving its popular diabetes drug, Avandia.
The New England Journal of Medicine released its finding that Avandia posed a heightened cardiac risk. Many companies besides GlaxoSmithKline already post results from some studies or trials on their Web sites. Studies have found that the vast majority of drug and medical device studies are never published in medical journals. Some experts also believe that releasing the results of hundreds of studies involving drugs or medical devices might create confusion and anxiety for patients who are typically not well prepared to understand the studies or to put them in context. That’s just great! Other experts have argued that the relative efficacy or cost of competing drugs can be compared only when all study results, rather simply those that a company chooses to publicize, are available.
“I would be very concerned about wholesale posting of thousands of clinical trials leading to mass confusion,” said Dr. Steven Galson, the director for the Center for Drug Evaluation and Research at the F.D.A. But even before the recent Avandia episode, advocates were pushing lawmakers to take the next step by requiring that producers of drugs and makers of devices not only register trials but also publicly disclose study findings. Recently, a report issued by the Institute of Medicine, a part of the National Academy of Sciences, recommended that the F.D.A. release all summaries of study data it had collected in the process of approving new drugs as well as all post-marketing studies of those products. Then, there is also the question of who the audience for such information should be — scientists, consumers or both?
