Journal Questions Vioxx Study
Editorial Notes Three Unreported Heart Attacks in Vioxx Users; 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
"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.
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
"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