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Vioxx Heart Risk Similar to Other Drugs: Doctor

Posted on: Tuesday, 28 March 2006, 15:05 CST

By Jon Hurdle

ATLANTIC CITY, New Jersey -- A series of studies on Merck & Co.'s pain drug Vioxx showed no significant difference in the rate of heart attacks among its users and those taking similar drugs or placebos, a doctor testified on Tuesday.

Dr. Barry Rayburn, a cardiologist from the University of Alabama, Birmingham, told a jury at the latest Vioxx product liability trial that the studies, covering a total of about 28,000 patients, contained no evidence that Vioxx exposed users to a higher rate of heart attacks and other cardiovascular events than comparable drugs or sugar pills.

"The pooled analysis doesn't show any evidence that there is an increased risk of these kind of events in patients taking Vioxx," Rayburn told the court.

Merck is being sued by Thomas Cona, 59, and John McDarby, 77 -- both long-term Vioxx users who blame the drug for their heart attacks.

Under questioning from Merck attorney Christy Jones, Rayburn said a study published in 2000 of some 8,000 rheumatoid arthritis patients showed a higher rate of heart attacks among Vioxx users because of the protective effect of naproxen -- a common pain drug to which Vioxx was being compared -- and not because Vioxx increased cardiovascular risk.

"The best explanation is that this was a combination of the benefits of naproxen and also some play of chance," Rayburn told the court.

Another study of some 5,500 osteoarthritis patients showing five heart attacks among Vioxx users compared with one for those taking naproxen was "not statistically significant," he said. That study also found six strokes among naproxen users and none for Vioxx patients.

"The numbers are very small," he said. "Six strokes out of 5,500 patients is just too small to make a decision on."

Merck pulled its $2.5 billion-a-year pain drug off the market in September 2004 after a study showed it doubled the risk of heart attack and stroke in patients who took it for at least 18 months.

The current trial -- the first to involve long-term Vioxx users -- is one of about 10,000 lawsuits that have been filed against Merck over Vioxx. Plaintiffs allege the company knew the drug increased heart risks long before it withdrew the medicine from the market, but failed to adequately warn users because it placed profits ahead of safety.

Rayburn told the jury of seven women and two men that he does not believe Vioxx caused McDarby's heart attack.

"What did?" Jones asked him. "Atherosclerotic heart disease," Rayburn replied.

Source: REUTERS

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