Skip to content

    Arthritis Health Center

    Font Size
    A
    A
    A

    When Did Merck Know Vioxx Was Deadly?

    Study Finds Danger Signal in Early Merck Data; Merck Says Study Flawed
    By
    WebMD Health News
    Reviewed by Louise Chang, MD

    Nov. 23, 2009 - Merck should have known Vioxx was deadly years before they pulled the drug from the market, a study of Merck's own data suggests.

    The study, published in the current issue of the Archives of Internal Medicine, is by Joseph S. Ross, MD, of Mount Sinai School of Medicine, and colleagues. The study authors were paid consultants to plaintiffs' lawyers in Vioxx lawsuits -- in which much of the Merck data first was revealed.

    "By our analyses, the association is clear that by June 2001 -- more than three years before the drug was eventually taken off the market -- the risk could have been known," Ross tells WebMD.

    Merck took Vioxx off the market in November 2004, after the "APPROVe" study conclusively demonstrated that Vioxx users had more heart attacks and strokes than patients receiving a placebo.

    In their study of data from Merck-sponsored clinical trials, Ross and colleagues found that:

    • By December 2000, data from 21 trials showed that the risk of a heart- or stroke-related adverse event (a cardiovascular thromboembolic event or CBT) or death (from all causes) was twice as high in Vioxx patients -- but the finding was just shy of statistical significance, meaning it could have been a chance finding.
    • By June 2001, pooled data showed Vioxx increased the risk of a CBT adverse event or death by 35% -- a statistically significant finding, meaning it is unlikely to be a chance finding.
    • By April 2002, adding new studies to the pooled data showed Vioxx increased the risk of CBT or death by 39%, a statistically significant finding.
    • By September 2004, adding new studies to the pooled data showed Vioxx increased the risk of CBT or death by 43%, a statistically significant finding.

    In a written statement and in an interview with WebMD, Merck says the study is flawed. It maintains that the company acted responsibly both in conducting safety studies and in pulling the $2 billion per year drug from the market as soon as it was aware that the drug increased the risk of heart attack and stroke.

    Today on WebMD

    Mature woman exercise at home
    Hint: Warming up first is crucial.
    feet with gout
    Quiz yourself.
     
    woman in pain
    One idea? Eat fish to curb inflammation.
    senior couple walking
    Can you keep your RA from progressing?
     
    xray of knees with osteoarthritis
    Slideshow
    close up of man wearing dress shoes
    Slideshow
     
    feet with gout
    Quiz
    close up of red shoe in shoebox
    Slideshow
     
    salad
    Video
    two male hands
    ARTICLE
     
    Woman massaging her neck
    Quiz
    5 Lupus Risk Factors
    Article