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Woman Says Merck Depended on Animal Study

Posted on: Thursday, 14 July 2005, 18:01 CDT

NEW YORK - In a new twist in the thousands of lawsuits filed against Merck & Co. over its now withdrawn pain reliever, Vioxx, a suit filed this week insists the pharmaceutical maker relied too heavily on animal studies to support the drug's safety.

Nancy Tufford alleges that taking Vioxx caused her to develop congestive heart failure and is seeking $1 million in compensatory damages plus punitive damages in a case filed Tuesday in the Superior Court of New Jersey. Tufford is a member of the Physicians Committee for Responsible Medicine, a nonprofit group which promotes alternatives to animal research. The group is providing Tufford's lawyer.

Tufford's suit says that "Merck relied upon data derived from animal testing that it knew or should have known were unreliable or scientifically unsound as a basis for predicting the effects of Vioxx in humans."

Merck withdrew Vioxx from the market last year after a study found it doubled patients' risk of heart attacks and strokes. The country's first Vioxx wrongful-death trial began Thursday in Texas.

One example cited in the suit concerned a 2000 study where Vioxx had five times the rate of heart attacks among users as naproxen. Merck said at the time that the difference was a result of naproxen's cardioprotective properties and not any defect in Vioxx.

But the suit says Merck relied on animals studies to make its claims about naproxen. It cited a never-published study involving 11 green monkeys that showed naproxen had cardiovascular protective qualities. The suit also noted a 2004 USA Today article that quotes Merck official Alise Reicin saying animals studies suggested naproxen was cardioprotective.

In a statement, Merck said it is "inaccurate to suggest Merck relied on a single animal study in concluding naproxen has cardioprotective effects." It said there were other human trials which supported the idea that naproxen was cardioprotective. Merck conducted the green monkey study at the suggestion of the U.S. Food and Drug Administration.

Other plaintiff lawyers have not raised the issue of animal studies when alleging Merck acted irresponsibly in promoting Vioxx. Instead, they cite various Merck internal e-mails, studies and promotions that show the company knew Vioxx was dangerous and marketed it anyway.

Daniel Kinburn, Tufford's lawyer who is also the Committee's associate general counsel, said he wouldn't ignore other elements of Merck's behavior but said he hoped the animal testing issue would raise additional questions about Merck's behavior.

"I don't think people think enough about the consequences of animal testing," Kinburn said. "Animal testing is just so common and accepted."

Merck says it acted responsibly at all times.

Source: Associated Press/AP Online

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