You don't see many articles in the medical literature titled "Expression of Concern". But that's how yesterday's release from the New England Journal of Medicine starts out (PDF).
The editors are expressing their concern over the published VIGOR trial data from 2000. It turns out that some time ago, the journal's editors had found a disk which had been part of the submission of the paper, and it contained earlier versions of the manscript. These had a blank table for cardiovascular events, and in what looks like another example of the wonders of the "track editing changes" function, it appeared that the table had been deleted by Merck two days before the final version. The journal wasn't sure what to make of this, and kept quiet (for four years) until their editor, Dr. Gregory Curfman, went through a deposition during this latest trial. He then saw a complete version of the earlier manuscript, which seemed to show more adverse cardiovascular data than appears in the final published version. (Forbes is all over this story; check that link for the full details).
This comes after the jury in the first Federal Vioxx trial had started deliberations. (For updates on how that's been going up until now, take a look at some of the Merck entries on Point of Law). What's it going to mean? Well, I would assume that the jury can't hear about this, for one thing, since none of this was introduced in testimony during the trial. It would seem to be fodder for a mistrial motion, though, if the verdict doesn't go the plaintiff's way. Should it be?
I've gone both ways on that question in the last few hours, but now I don't think so. While this story makes Merck look bad, idiotically bad, on closer inspection there isn't as much here as you'd think. The data in question are three heart attacks in the final weeks of the VIGOR trial. But the adverse cardiovascular event data in the paper, as published, didn't reach statistical significance, and they don't seem to reach it with these added in, either. On top of that, these data were submitted to the FDA during the drug's approval process, and (according to Point of Law) are on the Vioxx package insert itself.
So Merck might be guilty of making their data look better for the New England Journal of Medicine, but they're not guilty of hiding it from the world. And I'm not sure about that first charge, either. The lead author on the VIGOR study, Claire Bombadier of Toronto, told Forbes that the paper accurately disclosed the data and the she and the other authors are working on a response to the journal. But the headlines today are going to be variations on the theme of "Merck Hides Data". But as far as I can tell, they should be "Merck Looks Like Gang of Idiots, Blasts Away At Own Foot For Fourteenth Time". But that's not a crime. Yet.