Rosiglitazone, FDA under microscope after cardiologist finds increased risk of heart attacks with diabetes drug

06/06/2007

The firestorm set in motion by Cleveland Clinic cardiologist and Prescription Project Advisory Board member Dr. Steve Nissen, whose recent NEJM paper showed that patients taking GlaxoSmithKline's blockbuster diabetes drug Avandia are at a higher risk for heart attacks, continues to spread. 

Nissen, well-known for helping bring to light safety concerns around Vioxx a few years ago, found in a meta-analysis of published clinical trials that people taking Avandia, the brand-name for rosiglitazone, were at a 43 percent increased risk for myocardial infarction; heart attacks are already one of the major comorbid events associated with type-2 diabetes.

Nissen’s sleuthing was made possible by the public online clinical trial registry GSK created as part of the settlement with New York over Paxil—a website Nissen found while Googling, and called “a treasure trove.” The formation of mandatory, public and complete clinical trial registries are one of the Prescription Project’s major policy goals.  The New York Times looks at how this case may act as a deterrent for drug companies to make disclosure moves similar to GSKs in the future.  

An unplanned interim analysis of RECORD, the eight-year trial underway on the heart safety of rosiglitazone was published in this week's edition of the New England Journal of Medicine and found the data to be inconclusive, owing to low incidence rates.   The New York Times reports that the trial is in danger of going belly-up as many participants have dropped out in the wake of the NEJM paper.

 The June 5 edition of NEJM also contains editorials by diabetes experts, epidemiologists, and drug-safety experts underscoring the uncertainty around Avandia and its cardiovascular risks, as well as an editorial looking at the state of clinical trials registration nearly three years after the International Committee of Medical Journal Editors called for full registration of clinical trials prior to enrollment.

 The Times Gardiner Harris' analyzes the state of safety at the FDA, as commissioner Andrew von Eschenbach prepares to testify before Congress this week.  Businessweek looks at what to do about all those people taking Avandia, and the defense being staged by diabetes docs who say the scare isn't warranted.

 GlaxoSmithKline published a defense of Avandia last week in the British journal The Lancet.