Using a big black, red and yellow chart labeled “Merck Knew But No Warning” to emphasize his points, a plaintiff’s attorney cross-examined a top scientific executive for the drug company Thursday, as the first federal Vioxx trial neared its second closing.
U.S. District Judge Eldon E. Fallon, who is retrying a case that ended with a hung jury, told jurors that attorneys hoped to wind up evidence Thursday. In this case, Evelyn Irvin Plunkett contends that taking the drug for a month caused the heart attack which killed her husband Richard “Dickie” Irvin in May 2001, and that manufacturer Merck & Co. hid the drug’s dangers.
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.
Reicin said the company did report them to the FDA, but didn’t feel it had to tell the journal because they didn’t significantly change the results. With either set of figures, she said, rounding would have made the “relative risk” figure the same.
The figures reported to the journal were 17 heart attacks among patients on Vioxx and four among those taking another drug, called naproxen, or 4 1/4 times as many. The additional three changed that to 20 and four, or five times as many.
Merck, saying that the difference was probably because naproxen kept blood clots from forming, framed it as a reduction in the likely risk. Rounding off made that the same in either case, Reicin said: “a fivefold difference.”
“And we highlighted those results in that paper,” she said.
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,” Reicin said.
“You never gave it to them,” Birchfield said.
That was because the earlier analysis already showed a significant difference, Reicin said. “Had these changed the conclusions, I think we would have thought differently about it. But it didn’t change the conclusions.”
She also repeated Merck’s contention that it asked the FDA that year to approve a new label, but the approval process took two years.
A plaintiff’s expert testified earlier that a label’s warning can be strengthened without getting approval first from the FDA. Reicin said she wasn’t aware of that.