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Journal challenges Canadian-led Vioxx study

Dec 9, 2005 | Canadian Press

The prestigious New England Journal of Medicine publicly alleged Thursday that some of the authors of a landmark Canadian-led study withheld adverse events linked to use of Vioxx from their submitted manuscript.

Failing to include the three heart attacks led to an understatement of the difference in risk of adverse cardiovascular events between Vioxx and naproxen, a generic pain relief medication to which Vioxx was being compared in the VIGOR study, published in the journal in late 2000, three editors said in an editorial released online.

Other relevant adverse events were deleted from the manuscript two days before it was first submitted to the journal, the editorial added.

"Taken together, these inaccuracies and deletions call into question the integrity of the data on adverse cardiovascular events in this article," the editorial states.

"We have asked the authors to submit a correction to the journal."

Dr. Claire Bombardier, a prominent researcher at Toronto's Mount Sinai Hospital, was the lead author of the study, which was published in the Nov. 23, 2000 issue of the journal. Bombardier was not immediately available for comment Thursday.

The journal editorial did not specify which of the 12 named authors of the study had known of the three additional myocardial infarctions that were not included in the manuscript submitted to the journal.

The editorial said the journal learned of the additional adverse events in 2001 when the U.S. Food and Drug Administration released additional data on Vioxx, a one-time giant in the pain relief world that was pulled from the market in September of 2004.

Sales of the drug, made by Merck & Co., were suspended when data showed it increased the risk of heart events in some users. It is currently the subject of a number of ongoing lawsuits.

The journal said until last month, it had believed the events came to light too late to be included in the article. But it has since learned at least two of the authors knew of the events 4 1/2 months before the manuscript was published.

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