Using a big black, red and yellow chart labeled "Merck Knew But No Warning" to emphasize his points, a plaintiff's attorney cross-examined Dr Alise Reicin, a top Vioxx executive for the drug company Thursday, as the first federal retrial neared its second closing.
For nearly four hours, Andy Birchfield asked Alise Reicin, vice president of clinical research at Merck, about two studies in which patients taking Vioxx had more heart attacks than those in comparison groups, and about related events.
The first study, called VIGOR, was reported to the U.S. Food and Drug Administration in 2000, but the heart attack information was not added to the Vioxx label until 2002. The second study, called APPROVe, prompted Merck to pull the drug from the market in September 2004.
The New England Journal of Medicine criticized VIGOR's authors in an editorial published online the day that the first jury began deliberations, saying they failed to mention three heart attacks among patients who were taking Vioxx. These were found amongst hidden "metadata" on the diskette which Merck submitted, along with other changes to the draft paper.
Reicin said the company did report the deaths to the FDA, but didn't feel it had to tell the journal because they didn't significantly change the results.
In earlier videotaped testimony, the journal's executive editor, Dr. Gregory Curfman, said the numeric difference was of great interest to the journal and its readers, and should have been reported to keep the article up to date.
"You withheld these three myocardial infarctions from the New England Journal of Medicine," Birchfield said.
That was "mischaracterization" said Dr Reicin.
Source: Janet McConnaughey at AP
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