Merck disclosed Vioxx heart risks, court told

Boston Globe  |  March 8, 2006

By Jon Hurdle

ATLANTIC CITY, New Jersey (Reuters) - Merck & Co. Inc. <MRK.N> disclosed a report showing that its pain drug Vioxx had heart attack risks and did not try to hide results that could have hurt sales, the company's former head of marketing told a New Jersey state court on Wednesday.

David Anstice said Merck sales representatives and scientists talked openly to physicians, regulators and the media about a large study that found Vioxx users suffered five times as many cardiovascular events as those taking naproxen, another pain-reliever from a different class of drugs.

In his third day on the witness stand at the second Vioxx state trial in New Jersey, Anstice said Merck sales people were candid about the reasons for a change in the drug's labeling in April 2002 that drew attention to heart risks associated with the arthritis medicine.

"They were actively discussing the Vigor data after the label change," Anstice told the New Jersey Superior Court in Atlantic City in a reference to the 8,000-patient study published in March 2000.

Merck is being sued by two men who blame the drug for their heart attacks. Thomas Cona, 59, had a heart attack in June 2003 after using the drug for 22 months. John McDarby, 77, who has appeared in court in a wheelchair, took Vioxx for four years and suffered a heart attack in April 2004.

The trial is being closely watched as it is the first involving long-term Vioxx users and could provide a clearer view of what Merck is up against as it wades through nearly 10,000 Vioxx-related lawsuits.

Merck withdrew Vioxx from the market in September 2004 after a study showed it doubled the risk of heart attack and stroke after 18 months of use. All the previous Vioxx cases to come to trial involved patients who took the drug for less than 18 months, enabling Merck lawyers to argue that there was no evidence of increased risk with short-term use.

Under questioning from Merck attorney Mike Brock, Anstice said that a U.S. Food and Drug Administration panel which evaluates drugs for the market had voted unanimously to approve Vioxx, and that Merck scientists had had extensive discussions with regulators about the drug before that decision.

All the drug's effects, not just its benefits, were disclosed, Anstice said. "Any adverse experiences were also described to the FDA," he testified.

On Tuesday, Cona's attorney Mark Lanier accused Anstice of trying to hide the heart risks of Vioxx because Merck needed a major new drug to replace the sales of six others on which patents were soon to expire.

Brock showed the jury the Vioxx label that was updated to include data from the controversial Vigor study.

He pointed out that it warned doctors to exercise "caution" in using Vioxx for patients with heart disease and contained tables of data showing the higher rate of "serious cardiovascular thrombotic events" for Vioxx users compared with those on naproxen.

Merck has said it believed the Vigor results signaled heart protective qualities of naproxen rather than increased risks from Vioxx -- an assessment questioned by many critics.

The Merck attorney highlighted a press release announcing the results of the Vigor study that also showed Vioxx caused fewer gastrointestinal problems than other pain killers.

"Are you telling them only about the GI data? You are telling the whole thing, aren't you?" Brock asked Anstice. "Yes, we are," the Merck executive replied.

(Additional reporting by Bill Berkrot in New York) -