Open Access News

News from the open access movement


Thursday, June 17, 2004

OA to drug trial data

Barry Meier, Medical Journals Weigh Plan for Full Drug-Trial Disclosure, New York Times, June 15, 2004 (free registration required). A good overview of a large, emerging story. In short: there is a growing call for drug companies to deposit data from their drug trials in a central public registry. No one is calling the registry "open access", but that seems to be presupposed. The purpose is to give researchers, doctors, and patients access to negative results, which are often suppressed, in order to fill out the picture and qualify positive results, which are often trumpeted one-sidedly both in company advertising and in peer-reviewed journals. The penalty for not registering a drug trial would be that a group of prominent medical journals would agree not to publish any results from the trial. Another penalty proposed by the AMA is that hospitals and universites would agree not to host experiments with unregistered drugs.

The registry proposal was endorsed today by the American Medical Association (AMA). It is now under consideration by the International Committee of Medical Journal Editors (ICMJE), which represents journals like The Journal of the American Medical Association, The New England Journal of Medicine, and The Lancet. The Pharmaceutical Research and Manufacturers of America (PhRMA) initially opposed the proposal but now says it "might reconsider" its position. More coverage.

(PS: If the registry would be OA, this is an excellent idea. If it wouldn't be OA, then those who need these data will face the same access barriers that we now see for those who need access to research literature. It won't be enough to give access to university-affiliated researchers and practicing physicians. Patients who take medicine and those who act for them will also need access. The AMA and the ICMJE also need to consider that if public health requires public access to medical information, then the same principle entails open access to peer-reviewed research literature.)