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Monday, December 12, 2005

Tort Incompetence

In the Pipeline has a nice dissection of just what exactly Merck withheld from the VIGOR study published.

If the data were beyond the cutoff date for the study, then strictly speaking Merck did the correct thing by not including them in the analysis. Questions of propriety would arise only if Merck chose to include other data beyond the cutoff, such as some GI events. If the cutoff had altered the statistical conclusions, Merck would have been ethically obligated to disclose this, but that appears not to have been the case.

-- In the Pipeline Comment

Cries from attorneys for a mistrial and the probability that this will hurt Merck's outcomes at future trials shows nicely that lawyers and lay juries are incapable of digesting and understanding complicated medical data.

I really think what Merck did was within the realm of reason and shows no attempt to hide adverse data. From Point of Law, linked by In the Pipeline: the knowledge was out there (the FDA had it and it appeared on Vioxx's packaging), and the data deleted was inconsequential to VIGOR. What NEJM did without regard for the available context is sort of disheartening.
Why make a press release the afternoon of the closing argument? This looks like an attempt to affect the federal trial.

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