Wednesday, May 23, 2007

Is There Something in the Water?

I don't know what it is, but it's been ridiculously busy around here. It's like someone put something in the water... Blogging, unfortunately, has suffered. I'll be back as time permits. I realize there's lots of controversy about the Avandia meta-analysis that showed up in the New England Journal of Medicine this week.

Unfortunately, I can offer litle to what's already been said. I only know that if I had submitted a meta-analysis to the New England Journal of Medicine regarding any other drug, it likely would have been summarily rejected due to methological flaws inherent to such studies. While the study certainly raises important questions, it still leaves open the possibility that there might be one or more confounding variables to explain the cardiovascular risks with this drug reported.

But it is also important to realize that people much wiser than me had an opportunity to critically review the study and, perhaps due to the inability of the investigators to acquire the raw ("patient-level") data, felt the implications of the findings were important enough to publish. There can be no denying that the Journal is taking a stand on how to manage patients with heart disease taking this drug. But I question whether these results really required an "Online First" designation (meaning the results were important to disseminate quickly). I could see this if there were a prospective randomized trial sufficiently powered to make a claim about changing treatments, but a meta-analysis as "Online First?" Have we lost our minds?


Addendum: 2158PM 23 Mar 07: Some saner minds prevail:
To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of rosiglitazone is needed. Alarmist headlines and confident declarations help nobody.
22:23PM 23 Mar 07: Hmmm... it seems some folks are happy with the way this study was presented. And we wonder why the cost of healthcare is skyrocketing?

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