Abstract

Several high-profile episodes have recently thrust drug safety and the pharmaceutical industry's practices into the spotlight. Merck's recall of the drug Vioxx, for instance, was a major news event. GlaxoSmithKline's suppression of data linking suicidal behavior among children to Paxil also galvanized tremendous public attention. What differentiates these events from the usual evolving process of scientific knowledge, and marks them with an aura of “scandal,” are questions about the propriety of corporate behavior. Who knew what, and when did they know it? Concerns are growing about the potential for industry sponsors to suppress negative results from clinical trials research. Scientists, medical journal editors, legislators, and the public have called for greater transparency in the conduct of clinical trials and the drug approval process.