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Data Missing from Vioxx Study, Medical Journal Finds

December 9, 2005

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The prestigious New England Journal of Medicine said that data about three Vioxx patients who suffered heart attacks was removed from a Merck & Co. study, making the painkiller look safer than it should have.

Merck is fighting more than 6,500 lawsuits filed on behalf of patients who allegedly suffered heart attacks after taking Vioxx, withdrawn from the market in September 2004 after a study found an increased risk of heart attacks after 18 months of use.

The medical journal said the omitted data "call into question the integrity of the data." But Merck said in a statement that the omitted cases were not included in the study because they occurred after a "pre-specified cutoff date." It said the study "fairly and accurately" described the results of the drug trial.

The data about the three heart attacks was included in information provided to the Food and Drug Administration (FDA) and in other materials. Merck insisted that the missing heart attacks did not change the overall conclusions of the study published in the New England Journal.

The journal said in its editorial that adding the missing cases back into the study data would mean that Vioxx patients were five times more likely to suffer a heart attack than those taking naproxen. As originally published, the study presented the relative risk as 4.25 times greater.

The development came as a jury in Houston began deliberating on evidence presented in the third Vioxx trial.

In the Houston case, Evelyn Irvin Plunkett alleges that Vioxx caused the 2001 fatal heart attack of her husband, Richard, who took the drug for less than a month to treat back pain.

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