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Authors Stand by Criticized Merck Vioxx Study

Posted on: Wednesday, 22 February 2006, 16:10 CST

BOSTON (Reuters) - Authors of a key study on the safety of Merck & Co.'s arthritis medicine Vioxx on Wednesday defended themselves from critics who claim the study inappropriately excluded three heart attacks among patients who took the drug, which has since been withdrawn.

Almost a dozen authors, who are not affiliated with Merck, took issue with highly publicized allegations lodged in December by the New England Journal of Medicine against the so-called VIGOR study.

The Journal at the time said it had determined that Merck deleted data about three heart attacks among Vioxx users, and other relevant data, prior to submitting its analysis from the so-called Vigor trial to the Journal in 2000.

The trial compared the safety of Vioxx with naproxen, a widely used rheumatoid arthritis drug.

But the authors and two Merck officials stood by the article in two separate letters to the editor of the Journal on Wednesday. They noted that the three heart attacks were not included in the study because they took place after a February 10, 2000 cut-off date for inclusion of heart-risk trial data.

"We stand by our original article," the non-Merck authors said in their letter, adding they do not believe the study needs to be corrected to include the heart attacks, as had been demanded by the Journal.

In an accompanying letter from Merck, Alise Reicin, an author of the VIGOR study who has testified in the company's defense in ongoing Vioxx product liability trials, and Deborah Shapiro said that Merck made "full and appropriate disclosures" of the cardiovascular risks.

Even if the data had been included, they would not have significantly changed the heart-risk conclusions of the trial, according to the authors.

Vioxx was withdrawn in September 2004 after being shown to double the risk of heart attack and stroke in patients taking it for over 18 months. More than 9,000 lawsuits have been filed against Merck in the United States, alleging Vioxx caused heart attacks and deaths.

The Vigor study appeared in the Journal in November 2000, soon after Vioxx was launched in the United States to great fanfare as a painkiller that is much gentler on the stomach than conventional treatments like aspirin and naproxen.

The Journal said in December that Merck had submitted its manuscript both on paper and on a computer diskette, but that the Journal's pre-publication review and editing of the story were completely on the printed version of the manuscript.

The Journal said it did not review the diskette until October 2004, several days after Vioxx was withdrawn.

Shares of Merck edged up 35 cents, or about 1 percent, to close at $35.94 on the New York Stock Exchange, amid moderate gains for the drug sector.

Source: REUTERS

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