Why did the New England Journal of Medicine come out with their "expression of concern" last Friday? The more I think about the situation, the more I'm coming to agree with a speculation that I first saw over at Medpundit.
Don't get me wrong: I think Merck had every intention of making their VIGOR data look as good as possible when the study was published. Companies do that, and they should be punished when they push things too far. But if these three MI cases that we're disputing really did occur after the cutoff date for the study, then Merck had every right to exclude them from the data. (They had to be reported to the FDA, though, which is exactly what happened when it came time for approval). So why is the journal so worked up?
I don't know if this was a deliberate attempt (as some have speculated) to affect the outcome of the first Federal Vioxx case (now declared a mistrial). I hope not. But what I do think is that it was an attempt to clear the NEJM as a target of future lawsuits. Look at the sequence of events: the journal discovers the editing discrepency four years ago, but does nothing. Vioxx goes to the FDA for approval, goes on the market, sells in huge amounts, is hit with concerns over cardiac safety, is withdrawn from the market and is the subject of FDA and Congressional hearings. During this whole time, the journal and its editors say. . .nothing. Merck is hit with hundreds, then thousands of lawsuits. The first case goes to trial, and Merck loses with a huge jury award. But they win the second one, as the weeks and months go on. And the New England Journal keeps quiet.
Then the first Federal case starts up, and the journal's editor is brought in to give a deposition. And now the editorial staff springs into action, rushing out an unprecedented comment on a paper from their own journal that manages to publish on a Friday afternoon. All of a sudden, somehow, things couldn't wait.
Could it be that the plaintiff's attorneys, while questioning Gregory Curfman, mentioned that there could be more targets for litigation than just Merck? You run a prestigious journal there. . .probably influenced a lot of physicians to prescribe Vioxx, eh? Didn't see anything odd in the cardiovascular data, you say? Why, that's nearly a tort right there. . . I don't like to think that this is what happened. But it's not impossible, either. The journal's actions look like those of an organization that fears the legal discovery process. And why would you fear that, unless you fear that you'll be sued?