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Journal Questions Vioxx Study

Editorial Notes Three Unreported Heart Attacks in Vioxx Users; Drugmaker Responds

Drugmaker Responds

Merck disputes the notion that those three heart attacks substantially affected the study's results.

The company states that it "believes it is important to emphasize that the company promptly and appropriately disclosed the results of the VIGOR study."

"Merck correctly communicated about the benefits and possible risks of Vioxx and extensively disclosed the VIGOR data to the scientific and medical communities, and in the press," the statement continues.

Merck's statement also notes that the results were "fairly and accurately described" as of a prespecified cutoff for analysis. The three other heart attacks happened after the prespecified cutoff date and therefore weren't part of the study as published in the journal, states Merck.

However, Merck stresses that it disclosed those heart attacks to the FDA in 2000 and 2001 and to doctors, the public, and the media.

The drug company adds that it only recently learned of the editorial and "looks forward to providing a more complete response" to it.

Researcher's Statement

WebMD emailed Claire Bombardier, MD, who worked on the original study, for her response to the journal's editorial.

Bombardier, who works at the University of Toronto, replied by email. Her statement reads:

"In response to the editorial that appeared today in the NEJM, I believe that the Vigor paper appropriately disclosed the data as per the prespecified plan of analysis. Events that occurred after the pre specified cut-off date have been publicly known since the FDA advisory committee in February 2001. The authors of the paper will be preparing a response to the editorial but given the very short notice from the NEJM we have not had the time to finalize it yet."

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