Should drugmakers really conduct clinical trials when potential safety problems arise with a marketed drug? That's the question FDA Commissioner Margaret Hamburg asked the experts at the Institute of Medicine--and the IOM mostly said no.
Hamburg was looking for guidance on how to handle GlaxoSmithKline's (NYSE: GSK) TIDE trial of its controversial diabetes drug Avandia in advance of this week's advisory panel meetings. TIDE is designed to compare Avandia with Takeda Pharmaceutical's rival drug Actos; it was ordered by FDA back in 2007, when another advisory panel was charged with assessing Avandia's safety.
GSK has had trouble recruiting patients for TIDE--and recently some researchers have called that trial into question, saying it's unethical to enroll patients for a trial when new data already suggests that Avandia is riskier than Actos.
As for the broader questions on Avandia's safety, FDA staff is divided over whether to allow TIDE to continue. Some call the trial "unethical and exploitative" based on new studies done since 2007. Others say that the TIDE study "has the potential to address the question of the cardiovascular safety of [Avandia] more definitively" (as quoted by Reuters).
- check out the IOM's statement
- read the Reuters story
- get the coverage in the Wall Street Journal
- see the Pharmalot post