Merck & Co. pulled its blockbuster drug Vioxx off the market last year although an “overwhelming majority” of scientists and outside consultants disagreed, a company executive testified Tuesday during the first federal trial involving the drug.
Dr. Alise Reicin, vice president of Merck’s clinical research, said the decision was made in September 2004, soon after researchers were shocked by results of a long-term study showing the drug doubled risk of heart attack or stroke if taken for 18 months or longer.
“The overwhelming majority thought we should have Vioxx on the market but change the label; we elected to be very conservative and take Vioxx off the market,” she testified, adding that she still does not believe Vioxx causes heart attacks.
The widow of Richard “Dicky” Irvin, 53, who died in 2001 after taking Vioxx for back pain for a month, is suing Merck. Evelyn Irvin Plunkett says Whitehouse Station, N.J.-based Merck failed to issue safety warnings and that Vioxx caused his heart attack.
The Vioxx warning label wasn’t changed until 2002 to reflect study results showing increased risk of heart attacks and strokes .
Merck argues that problems with Vioxx do not surface after just one month of use, and that Irvin’s heart attack was caused not by the drug but by plaque that ruptured in his artery.
Reicin testified that she initially was concerned with a 2000 study showing Vioxx users suffered five times as many heart attacks as users of the older painkiller naproxen. But Reicin said she and many others did further study and soon found an explanation: that naproxen, similar to aspirin, protects against heart attacks not that Vioxx causes them.