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Merck Faces New Questions Over Vioxx Risks, Research

Pharmaceutical company Merck knew in 2001 that its arthritis drug Vioxx could harm patients and used staffers to "ghostwrite" favorable research on the drug, articles in the Journal of the American Medical Association report. Susan Dentzer examines the charges.

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  • JIM LEHRER:

    Now, developments today on the story about what the makers of the painkilling drug Vioxx knew and when they knew it. Vioxx was pulled from the market in 2004.

    Here now is our health correspondent, Susan Dentzer.

    And today's revelations or today's story has to do with the report in the Journal of the American Medical Association. What was its basic finding?

    SUSAN DENTZER, NewsHour health correspondent: There were actually three articles, Jim, with three different kinds of allegations, one of which was an allegation that Merck withheld from the Food and Drug Administration some data in 2001 that — the allegation is if the FDA had had this full data, it might have acted sooner against Merck and against Vioxx.

    Another allegation, and in fact…

  • JIM LEHRER:

    And this is data that related to Vioxx and the increase in risk, health risks involving the heart and strokes, right?

  • SUSAN DENTZER:

    Yes.

  • JIM LEHRER:

    OK.

  • SUSAN DENTZER:

    And specifically overall deaths in this one particular case.

  • JIM LEHRER:

    OK, all right.

  • SUSAN DENTZER:

    In addition to that, the charge has been made that Merck did not have a so-called data safety and monitoring board, an outside board specifically looking at some trials that Merck undertook to test Vioxx for use in patients with Alzheimer's to either prevent Alzheimer's progression or to prevent it altogether.

    And the allegation is that Merck did not have this board in place to watch what was going on in the trial and a board that could have called a halt to the trial and surface some of these data that are now in question.

  • JIM LEHRER:

    But the basic use — back to the first one — was not the — the primary use of Vioxx was not for Alzheimer's. It was for arthritis and as a pain reliever, right?

  • SUSAN DENTZER:

    That's correct.

  • JIM LEHRER:

    OK.

  • SUSAN DENTZER:

    It was approved for treatment as a pain reliever primarily for use in patients with arthritis.

  • JIM LEHRER:

    OK, now the third allegation?

  • SUSAN DENTZER:

    The third allegation was that Merck also systematically did what many pharmaceutical companies are said to do, which is that, when it was conducting these trials and accumulating data, when it came time to publish those in journals, like the JAMA, the Journal of the American Medical Association, what it did was either hire outside companies to write up these studies first or it had Merck employees, Merck researchers, write up those studies first.

    And then it went, the allegation goes, shopping around for outside academic scientists who would put their names on the studies so that they would, in effect, be prestigious enough to be published by medical journals.

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