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    Sunday, December 11, 2005

    Much Ado: The New England Journal of Medicine sprung a surprise on Merck, maker of Vioxx and defendant in many lawsuits over it, at the end of the week. The Journal published an "Expression of Concern" over the way data was submitted/not submitted when this paper was accepted for publication. The journal editors say they had to go over all of the original submission data when they were depositioned by lawyers for the plaintiff in the latest and most current Vioxx trial. In that data, they found a disk they hadn't looked at before, which included editing changes to a table that included the number of heart attacks suffered by Vioxx users compared to Naprosyn users. Three heart attacks among Vioxx users had been edited out of the table.

    Merck says they weren't included because they occured after the cut-off period for follow-up of the trial. The editor of The New England Journal told Forbes "We're not buying into that".

    But, in the original article, published five years ago, the authors acknowledge exactly that:

    When the data showing a reduction in the rate of myocardial infarction in the naproxen group became available after the completion of this trial, Merck, the manufacturer of rofecoxib, notified all investigators in ongoing studies of a change in the exclusion criteria to allow patients to use low-dose aspirin.

    Those words are from the original article, written five years ago, before the Vioxx trials, before the deposition, before the New England Journal's suprise late-week editorial. It appears, in this case, that Merck and its researchers are telling the truth.

    The table in question never appeared in the original study. The study itself was concerned entirely with the rate of gastrointestinal bleeding in people who used Vioxx for rheumatoid arthritis, in doses higher than normal. The information about heart attacks is one small paragraph, almost an aside, and as I mentioned, it not only points out that there were more heart attacks after the trials completion, but that Vioxx users had more heart attacks even during the study's run. And, as Derek Lowe points out, three missing heart attacks don't appreciably change the risk.

    One of Derek's commentors says that the missing data only changes things for the "innumerate." He's right. Unfortunately, we physicians are largely innumerate - even those of us who hold editorial positions at influential medical journals.

    posted by sydney on 12/11/2005 12:08:00 PM 2 comments


    Don't you think that the NEJM is just "covering its behind" to prevent it from being drawn into the spree of lawsuits should Merck declare bankruptcy? The lawyers are looking for all possible "deep pockets" including the Massachusetts Medical Society and the NEJM. This is just basic risk management.

    By Anonymous Anonymous, at 5:58 PM  

    Yes, I suspect you may be right. They certainly seem to have been scared witless by their deposition. And wouldn't it be likely a plaintiff's lawyer would insinuate that they, too, might be culpable?

    By Blogger sydney, at 10:30 PM  

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