A large study to test the safety of the controversial diabetes drug Avandia has been put on partial hold by the Food and Drug Administration. The FDA held a hearing on the safety of Avandia last week. Some scientists argue that the drug persistently, if modestly, increases the risk of heart attacks in diabetes patients. But other scientists, as well as the drug's maker, GlaxoSmithKline, challenge those results. The TIDE trial was designed to clear up lingering doubts about the drug but would take at least 6 years to complete. And today, FDA informed Glaxo that it was not allowed to enroll any new patients in TIDE, although patients already enrolled can continue.
Science will report on the TIDE trial in the 23 July issue, which appears online tomorrow.