Could Merck Have Known About Vioxx’s Elevated Cardiovascular Event Risks As Early as Late 2001?

This post hoc analysis of aggregated trials data from multiple sources, published just now, suggests so.

. . . .The association between Vioxx (rofecoxib) and risk of CVT adverse event or death strengthened with the additional of subsequently collected data. As of January 2002, 14,406 subjects had been observed for 7,806 patient-years and Vioxx (rofecoxib) was associated with a 39% increased risk of a CVT adverse event or death (RR 1.39; 95% Cl 1.07-1.80)(P=.02). . . .

So, by January 2002, there would have only been two chances in 100 that the 39% higher risk of cardiovascular events or death being seen in connection with Vioxx were the result of random chance.

That is fully two and a half years earlier than when Merck “folded the tent“, on this largely ineffectual, and more than occasionally-lethal drug. And to be clear, yes — it is true that several of the authors of the above-study served, at one time or another, as experts of various sorts for the plaintiffs’ consolidated federal court cases alleging injuries from Vioxx. Significantly, however, these findings have been independently peer-reviewed, and now represent rather stark evidence that the one entity with access to essentially all of this information — and likely in the best position to have “caught it” — would have been Merck, itself.

More in a moment, on the relatively low likelihood that all the FDA rules were being meticulously followed, in the reporting of Vioxx-related adverse events, by Merck.

Look above in a few moments.

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