This statistician has doubts:
My question: was the cardiovascular risk real in all studies combined (p=0.03), but not in DREAM (p=0.22), ADOPT (p=0.27), or all small trials combined (p=0.15)? That seems to be a pretty bizarre statement to make, and is probably why the European agencies, the FDA, and Prof. John Buse of UNC-Chapel Hill (who warned the FDA of cardiovascular risks in 2000) have urged patients not to switch right away.The fact of the matter is if you look for something hard enough, you will find it. It apparently took 42 clinical trials, 2 of them very large, to find a significant p-value. Results from such a meta-analysis on the benefits of a drug probably wouldn’t be taken as seriously.
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{ 1 comment }
There is virtually no meta-analysis that should have generated the newsroom shark attack that this story has.
People don’t understand the many statistical errors inherent in combining many different studies like this.
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