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    Wednesday, August 09, 2006

    CYA at NEJM? Remember the highly unusual and highly publicized statement of concern published by The New England of Journal several months ago, that basically accused the authors of a paper on the safety of Vioxx of scientific fraud? They were accused of deleting data from their paper to make the drug look safer than it was. At the time, there were many questions about the NEJM's timing and motives, as well as their methods. The statement of concern came out after the editors had been deposed by the plaintiff's attorneys in a Vioxx case. (More here.)

    A former editor of the British Medical Journal says the New England Journal was no innocent:

    But is the New England Journal of Medicine blameless in all this? It published the expression of concern at the end of 2005 because the problems with the study had emerged as evidence was gathered for a court case against Merck brought by patients who allege that they have been damaged by rofecoxib.

    It is clear, however, Jeff Drazen knew about these extra deaths long before the end of 2005. Indeed, the Wall Street Journal has discovered that Drazen was told about them in August 2001. Jennifer Hrachovek, a pharmacist who had reviewed the data on the FDA website, told him on a phone-in to a Seattle radio show. She also submitted a letter to the journal, which was rejected. With hindsight the failure of the journal to publish a correction—and probably a reinterpretation of the cause of the excess cardiovascular side effects—is lamentable. If the journal had corrected the data then the dangers of the drug might have been highlighted much earlier.

    Derek Lowe has more on the aforementioned Wall Street Journal article here, including this revelation about the missing data:

    In reality, the last-minute changes to the manuscript were less significant. One of the "deleted" items was a blank table that never had any data in it in article manuscripts. Also deleted was the number of heart attacks suffered by Vioxx users in the trial -- 17. However, in place of the number the authors inserted the percentage of patients who suffered heart attacks. Using that percentage (0.4 percent) and the total number of Vioxx users given in the article (4,047), any reader could roughly calculate the heart-attack number. . .

    Looks like the original authors were telling the truth when they defended themselves.

    What about the impact of the Journal's statement?

    Many news organizations, including The Wall Street Journal, misunderstood the ambiguous language and incorrectly reported that the deleted data were the extra three heart attacks -- which, if true, would have reflected badly on Merck. The New England Journal says it didn't attempt to have these mistakes corrected.

    And why would they? They were more concerned about covering themselves from potential litigation than with upholding scientific integrity. Sigh. Is there any corner left in medicine with a shred of dignity?

    posted by Sydney on 8/09/2006 11:50:00 PM 3 comments


    It's almost to the point that if someone did stand up for truth, they'd enjoy a ticker-tape parade.

    By Blogger beajerry, at 4:01 PM  

    ". Sigh. Is there any corner left in medicine with a shred of dignity?" No. I draw your attention to the Aug. 8 WSJ page B1, Cleveland Clinic Defends Gift From a Vendor article. One of the more chilling aspects of recent revelations is that they include major medical centers and doctors of national prominence.

    How can patients, or doctors, put faith in findings or standards when there is so much conflict and financial dealing of questionable merit?

    Steve Lucas

    By Anonymous Anonymous, at 8:43 AM  

    I think the lay-public needs to remember there is a reason certain drugs are labeled "propriatary" (prescription only). We in the medical professions need to step up to the plate and demand full info about the drugs and treatments we prescribe. And patients need to be informed fully about the risks. I'm one of those who did very well on Vioxx and am now doing very poorly without it. I have a number of patients and friends in the same predicament. I'd take the risks with Vioxx - I have no other cardiac risk factors except overweight - if I could just get pain and inflammation reduced sufficiently to exercise enough to lose at least some of the weight.


    By Blogger Elizabeth, at 9:44 AM  

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