Activist group Public Citizen doesn't want the FDA to wait until its planned July advisory panel meeting on Avandia--it wants an ongoing trial of the controversial drug stopped now.
The group has petitioned the agency to halt the trial, saying that continuing to enroll patients for the 16,000-participant trial puts people with diabetes at an unnecessary risk. "[The trial] is exposing thousands of high-risk patients with diabetes to a drug with an unfavorable safety profile and no clinical advantage over its comparator," the group--along with Canadian researcher Dr. David Juurlink--contend in a letter to FDA Commissioner Margaret Hamburg.
FDA officials say there's no need for immediate action and pledged to listen to its advisory committee's opinions in July before making any moves on Avandia. It was the agency that asked for the trial in the first place. After cardiovascular-safety concerns arose in 2007, the FDA directed GlaxoSmithKline (NYSE: GSK) to test Avandia against rival drug Actos, with an eye to the drug's long-term effects on heart health.
The agency says it's already reviewing all the data available on Avandia and hasn't yet come to any conclusions, Reuters reports. Hence the advisory panel slated for July: "Based on expert input and our own analysis," agency spokeswoman Karen Riley tells the news service, "FDA will reassess the rationale for the TIDE trial, review the trial's enrollment and respond accordingly."