In a lengthy, but most illuminating, post Roy M Poses MD takes us through both the JAMA/Pargluva issues and also a JAMA editorial by Brophy in which the following phrase rings in Insider's ears:
"Generically, there are specific methodological decisions in the sponsor’s FDA application that may foster an illusion of safety. The following are several, perhaps unintended but nevertheless disingenuous, methods observed in the application that may have contributed to an overestimate of the safety profile:"
A list of 8 "methods" then follows.
BMS with their "partner" Merck were due to co-promote Pargluva.
http://hcrenewal.blogspot.com/2005/11/muraglitazar-case-new-window-on.html
The above old post came to mind when I read this today!
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