Loophole in New FDA Law: Reporting Failed Trials

Barry Meier of the New York Times has an eye-opening article this morning pointing out a major flaw in the recently passed Food and Drug Administration reform law. Clinical trials that are halted because their products will not meet the FDA's safety and efficacy standards probably won't have their results registered in the government's clinical trials database because the results are never compiled. The story cites a failed silicone breast implant trial by Inamed as one example. The trial's existence and protocols presumably were registered at ClinicalTrials.gov because the company usually wants a successful trial published in a medical journal, and most of the good ones conform to the International Committee of Medical Journal Editors guidelines that require registration of clinical trials before the first patient gets enrolled if the results are to be published.

But negative results? That's the blackhole in every field of science. And, as today's story points out, this black hole in the medical information system has very real and negative consequences for public health.