Those who have been reading tdaxp over the past few months will know why this story is personal.
My first reaction is that the 43% higher risk of heart attacks
Pooled results of dozens of studies on nearly 28,000 people revealed a 43 percent higher risk of heart attack for those taking Avandia compared to people taking other diabetes drugs or no diabetes medication, according to the analysis published online Monday. The study, published by the New England Journal of Medicine, also found a trend toward more heart-related deaths.
Presumably means that .30 of the variation in heart attacks is explained by taking Avandia. This is a “large effect size.” It should show up in smaller sized studies. Unless the most recent study is an outlier, it’s strange that the effect has not been seen before.
Among worst cases, the increased risk is 64% (presumably, .38 of the variation is explained by taking Avandia). And indeed, apparently the FDA has known about this since 2002:
In 2002, U.S. Food and Drug Administration staff scientists called for reports of congestive heart failure to be included on the label of Avandia as well as Actos, made by Takeda Pharmaceutical Co. Ltd., the group said, citing an internal FDA document.
The group released the memo one day after researchers reported Avandia, or rosiglitazone, raises the risk of cardiovascular-related death by 64 percent and the risk of heart attack by 43 percent.
To me, though, blaming the FDA is like blaming the traffic police for a hit-and-run.
Glaxo strongly objected to the results and defended use of the drug, which treats type 2 diabetes.
I imagine I’ll be following this for a while.