The Avandia saga grows curiouser and curiouser. A new analysis of the data that originally provoked fears that the diabetes drug causes heart failure and heart attacks shows that there's perhaps no greater risk at all.
Led by a cardiologist and professor at UCLA, the new study examined the same data that led Dr. Steven E. Nissen to peg a 43 percent increase in heart-attack risk for patients taking Avandia. The UCLA doctor, Sanjay Kaul, found that Nissen excluded data from Avandia trials that he should have included--and that this data would have watered that increased risk down to nil. In his study published by the Annals of Internal Medicine, Kaul says the trials in question were too short to establish long-term cardiac risks; he called for long-term studies designed specifically to assess the drug's influence on the heart.
Bottom line, though, is that Kaul thinks the FDA's advisory panel did the right thing in calling for warnings to be attached to the drug.
- see this article from Forbes