• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Merck Exec Tells of Vioxx Market Removal

Posted on: Tuesday, 6 December 2005, 21:00 CST

By ANGELA K. BROWN

HOUSTON - 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. That was nearly a year after Irvin died at the St. Augustine, Fla., seafood distribution business he managed.

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.

In another study, the number of heart attacks was similar whether patients took Vioxx or sugar pills, which was "very, very comforting data," she said.

Under cross-examination, Reicin denied that the warning label change was delayed because Merck failed to timely submit more data to the U.S. Food and Drug Administration. She also said Merck resisted the FDA's initial label recommendation because the company disagreed that Vioxx caused heart attacks - not because such a label would hurt sales.

Earlier Tuesday, defense attorneys showed jurors an April FDA report saying "data ... do not clearly demonstrate" that Vioxx increases heart attack risks more than other painkillers. It says a small number of drug trials show Cox-2 inhibitors including Vioxx are associated with an increased risk of heart attacks compared with older painkillers, but "these observations raise serious questions."

Dr. David Silver, a Los Angeles rheumatologist, said because of that FDA document and several clinical studies, he does not believe Vioxx causes heart attacks.

"The FDA says it does not increase the risk at all ... and the overall benefits of Vioxx do outweigh the risks," said Silver, adding that Vioxx doesn't cause bleeding ulcers and other stomach problems the way older painkillers do.

Under cross-examination, Silver said he was a paid speaker for Merck and other pharmaceutical companies and had received research grants from Merck, but insisted he was not biased.

This is the first federal trial over Vioxx; Merck has already lost one state trial over the drug and won another, but it still faces about 7,000 lawsuits. The Irvin case was moved to Houston from its original venue of New Orleans because of destructive Hurricane Katrina.

Source: Associated Press/AP Online

More News in this Category