Watchdog Group Urges FDA to Suspend Avandia Study on Safety, Ethical Concerns

Consumer advocacy group Public Citizen has asked the Food and Drug Administration to stop a clinical trial that compares two drugs for treatment of type 2 diabetes, citing evidence of an increased risk of heart failure associated with the drugs.

Sidney Wolfe, director of Public Citizen’s Health Research Group, and Dr. David Juurlink, a Toronto researcher who led a large study in 2009 which concluded that Avandia carried more risk than Actos, sent a letter May 11 to FDA Commissioner Margaret Hamburg asserting that continuation of the trial, “Thiazolidinedione Intervention in Vitamin D Evaluation (TIDE),” is unethical and dangerous.

According ...