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US group: Merck wrongly relied on Vioxx animal data

Posted on: Thursday, 14 July 2005, 15:15 CDT

By Lisa Richwine

WASHINGTON (Reuters) - Merck & Co. Inc. knowingly put patients at risk by relying on limited animal studies to claim its arthritis drug Vioxx would not harm the heart and ignoring human data that suggested otherwise, a U.S. advocacy group said on Thursday.

The Physicians Committee for Responsible Medicine, which promotes alternatives to animal testing, filed a lawsuit against Merck on Tuesday on behalf of a member who claims Vioxx caused her congestive heart failure.

The group said at a news conference on Thursday that it believed the suit, filed in New Jersey, was the first against a U.S. pharmaceutical company for relying on animal tests.

Merck, based in New Jersey, disputed the allegations in a statement issued on Thursday, saying it based its analysis of Vioxx on "multiple sources involving extensive human trials."

Merck pulled Vioxx from the market in September 2004 after a study showed the drug doubled heart attack and stroke risk in patients who took it for at least 18 months.

A June 21 memo from Merck to the physicians group detailed a study of African green monkeys designed to compare the ability of various pain relievers to prevent blood clots. In the study, the drug naproxen appears similarly effective to aspirin, which has been shown to reduce the risks of heart attacks and strokes.

The physicians group said it received the memo from Merck in response to a request for information about the effects of naproxen in animal studies. The group released the memo to reporters on Thursday.

The group said in its lawsuit and at the news conference that Merck relied on the animal research when a 2000 human study called Vigor linked Vioxx to more cardiovascular problems when compared to naproxen.

Merck has argued that Vioxx patients had more cardiac problems only because the drug did not have the heart-protective effects of naproxen.

At least nine of 11 other studies in rats and mice showed Vioxx helped the heart, the physicians' group said at the news conference.

But Dr. John Pippin, a cardiologist and consultant to the physicians' group, said that human studies had shown no heart-related benefit from naproxen, and that Merck was aware that animal studies often do not predict what will happen in people.

"Merck was wrong to rely on data from mice, rats and African green monkeys when faced with compelling evidence that human patients are at risk," Pippin said.

Merck, in its statement on Thursday, said it was "inaccurate to suggest that Merck relied on a single animal study" to demonstrate naproxen protected the heart.

The company pointed to human tests published in the 1990s and in 2000 that showed anti-clotting effects for naproxen and similar compounds.

"We believed that the weight of the evidence supported naproxen's ability to provide a cardioprotective effect by blocking platelet aggregation," or clotting, Merck said.

Vioxx does not stop blood clots from forming, and that was noted on the drug's label and labels of similar medicines, Merck said.

Source: REUTERS

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