Boston, MA -- For years, pharmaceutical companies have sought to restrict public access to drug safety data collected in clinical trials on the basis that it is proprietary information, arguing that competitors could use that information in the development of their own products. However, a number of recent cases of drugs found to have dangerous side effects after coming to market, such as the anti-inflammatory drug rofecoxib (Vioxx), have raised concerns about safety data being treated as confidential. A new analysis by researchers at the Harvard School of Public Health (HSPH) and Brigham and Women’s Hospital (BWH) of laws and regulations governing public disclosure of clinical trial data submitted to the Food and Drug Administration (FDA) suggests changes should be made to the way the FDA implements its policy regarding the confidentiality of those data. Allowing greater access to safety data would enable researchers to independently evaluate risks, resulting in more timely risk detection. The review and commentary appears in the March/April 2007 issue of Health Affairs.>>> Discuss This Story
