Vioxx Caused Heart Attacks In Two Weeks!

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heart-attack.pngThis is one study many people have been waiting three years to see - except Merck people. Known as Victor, the study suggests that increased heart risks associated with Vioxx began immediately after people took the painkiller. That contradicts Merck’s assertion, since it withdrew Vioxx in September 2004, that the drug caused serious heart risks only after 18 months of use.

The yet-to-be-published study, called Victor, was conducted by researchers at Oxford University in England. A Merck defense attorney sent a copy of the study to New Jersey Superior Court Judge Carol Higbee along with a letter saying that it was “our understanding that this manuscript has been accepted” for publication by the New England Journal of Medicine. A prepublication version of the study was reviewed by The Wall Street Journal (subscription required).

The study, which was designed to see whether the drug would curb progression of colon cancer, compared Vioxx with a placebo in 2,434 patients who were followed for two years. The study was halted when Merck pulled Vioxx from the market after another study, known as Approve, linked the drug to an increased risk of heart attacks and strokes. The new report includes only information about cardiovascular findings, the paper writes.

According to the manuscript, 16 of the 23 cardiovascular events occurred in the Vioxx patents, and half of those occurred in patients within 12 months of taking the drug. “It would appear…that patients do not need to take rofecoxib for 18 months to be at increased risk of a cardiovascular thrombotic event,” the authors wrote. The study also suggests that by 14 days - not months, days - after patients stopped taking the drug, the risk of heart and stroke went away.

In a statement, Merck’s outside counsel Ted Mayer pooh-poohs the study: “We will wait until publication of the study before going into detail about what the data show or do not show. The data have been previously presented last year at a scientific meeting, and at that time it was noted that there were limitations in it related to the premature termination of the study together with the fact that events were collected after patients had been unblinded. The reported findings with respect to confirmed thrombotic events in short-term use are not supported by the data found in the other available large placebo studies with Vioxx, including Alzheimer’s studies, ViP and Approve.”

A spokeswoman for the New England Journal of Medicine, citing publication policy, declined to discuss the status of the manuscript.

Merck faces about 28,000 lawsuits. Of those that have gone to trial, the company has won 10 and lost five.

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  1. I thought you might be interested to see the statement from Ted Mayer, Outside Counsel for Merck in the Vioxx litigation.

    “We will wait until publication of the study before going into detail about what the data show or do not show.

    The data have been previously presented last year at a scientific meeting, and at that time it was noted that there were limitations in it related to the premature termination of the study together with the fact that events were collected after patients had been unblinded.

    The reported findings with respect to confirmed thrombotic events in short - term use are not supported by the data found in the other available large placebo studies with Vioxx , including Alzheimers’ studies, VIP and APPROVe.”

  2. “there were limitations in it related to the premature termination of the study together with the fact that events were collected after patients had been unblinded”

    Am I getting this? His contention is that since the study ended early, DUE to the problems, those problems shouldn’t be included as part of ths study? Wow, talk about spin!

  3. Laurie,

    The study was not stopped because of the events in that study, but stopped after Merck pulled Vioxx after because of results from the Approve study.

    I haven’t seen the results of this study (Victor), but if they already unblinded as they were still getting results, then yes, it does cast doubt on the results. In the same way, if Merck saw something positive after unblinding but still collecting data, people would have a collective fit over the soundness of that data.

  4. One other part of the article that you did not quote is that in this study all the CV effect difference between drg and placebo is attributed to the first 14 days. From what I understand, if the patient did not have an event in the first 14 days, they did not end uyp having one.

    This may be a blow to all the plaintiffs who claim effects way after patients stopped taking the drug.

  5. Hi Peter,

    I did include that point. If you click on the words ‘Read more,’ you will see more information along with a comment from Merck’s attorney.

    Cheers
    ed

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