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Merck & Co. Inc. Message Board

  • qed_2005 qed_2005 Dec 11, 2005 11:33 AM Flag

    WSJ on study

    from WSJ, Dec9, page A1:
    ...
    Published in November 2000, the Vigor study has been a central piece of evidence debated in the three Vioxx trials conducted so far.

    The study, which began in early 1999 and was paid for by Merck, wasn't specifically designed to look at heart-attack risk, but at gastrointestinal problems. Its main goal was to determine whether regular use of Vioxx would cause fewer ulcers and gastrointestinal bleeding in rheumatoid arthritis patients than another widely used painkiller, naproxen, and thus give Vioxx a marketing advantage. The study did conclude that Vioxx performed better.

    In its editorial, the medical journal said it learned late last month that the data had been withheld when its executive editor was deposed by plaintiff's attorneys. It said it had learned that

    [ IMPT POINT: ]
    at least two authors of the study knew about the three omitted heart attacks in July 2000, more than four months before the article was published and before the first of two revisions of the article were submitted to the journal. It didn't identify the two authors.

    The medical journal said it had discovered from a computer diskette submitted along with the article that some data were deleted from the manuscript just two days before it was initially submitted for publication in May 2000.

    In an interview, Gregory Curfman, executive editor of the New England Journal, said that while the overall findings of the study weren't invalidated,

    [ IMPT POINT: ]
    one of its conclusions, that the cardiac risk from Vioxx was seen only in the higher-risk subgroup of patients, did become invalid. He said all three new cases came from a different group of patients who were at lower cardiac risk.

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