Open Access News

News from the open access movement

Wednesday, July 20, 2005

Why we need OA to clinical trial data

From a posting on yesterday's POGO blog from the Project on Government Oversight:
The birth control patch Ortho-Evra may be more dangerous than people once thought. After filing a FOIA [Freedom of Information Act] request for federal drug safety reports on the birth control patch, the Associated Press discovered that "the risk of suffering a survivable blood clot while using [Ortho-Evra] was about three times higher than while using birth control pills." What's alarming isn't so much the findings of the FDA study, but rather the fact that the AP had to submit a FOIA request to obtain them. Why weren't these studies made available to the public? How can a person be expected to make a decision about their health if they don't have all the facts? In order to help protect the public (and in order to regain some of the credibility lost in the past year) the FDA needs more transparency. Unfortunately, legislation that would help to remedy this problem, such as the Fair Access to Clinical Trials Act (some information is currently and more will hopefully be posted at, is held up in the Senate Committee on Health, Education, Labor, and Pensions. What are they waiting for?