Avandia safety assessment at July meeting of joint FDA committees to lead to TIDE Trial decision.
When the FDA convenes a joint meeting of its Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory committees in July, the agency will assess the cardiovascular safety of Avandia and decide whether the controversial TIDE trial, comparing the heart risks of Avandia and Actos, will be permitted to continue. Diabetes patients, doctors, researchers and consumer drug safety advocates all eagerly await the decision, which may lead to an Avandia recall.
Shortly after the Senate Finance Committee Report on Avandia was released, co-author Sen. Charles Grassley sent a letter in February to FDA Commissioner Margaret Hamburg asking why the TIDE Trial Trial was allowed to continue. He cited the opinions of FDA researchers that Avandia has no proven health benefits over Actos, but confers an increased risk of heart attacks and heart failure compared to Actos. They concluded that “any proposed head-to-head trial of rosiglitazone (Avandia) vs. pioglitazone (Actos) would be unethical and exploitative” and, because of Avandia heart risks, “the safety of the study itself cannot be assured, and is not acceptable.”
In response, Commissioner Hamburg wrote, “I recognize that head-to-head safety trials pose challenging ethical questions.” She stated that a discussion at the July joint committee meeting about the cardiovascular safety of Avandia will lead to an assessment and decision by the FDA about Avandia and whether the TIDE Trial will be allowed to continue.