Monday, July 26, 2010

Enrollment in TIDE trial halted by FDA

The FDA has decided to halt further enrollment in the TIDE trial, a clinical trial sponsored by GlaxoSmithKline (GSK) to compare Avandia (rosiglitazone) to Actos (pioglitazone).  Avandia has come under a lot of fire recently, due to safety concerns, including increasing Congressional scrutiny.

The FDA released the following statement, which reads, in part:

The FDA has instructed GSK to update investigators, institutional review boards (IRBs) and ethics committees involved in the TIDE trial regarding new safety information presented at the joint FDA Advisory Committee meeting held on July 13 and 14, 2010, along with information regarding the deliberations and votes of that meeting.

The decision by the FDA is somewhat surprising given that the same FDA Advisory Committee meeting suggested keeping Avandia on the market, despite uncertainty over its safety profile.  

All in all, I think this is a smart, and surprisingly bold, move by the FDA. It is really advocating for patient safety, though a lot of this may be directly related to bi-partisan pressure from Congress and public perception that the FDA is too closely aligned with the pharmaceutical and medical device industries.  

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