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Saturday, September 17, 2005

Vioxx likely leads to heart problems-expert witness

By Jon Hurdle

ATLANTIC CITY, N.J., Sept 16 (Reuters) - The probability that Merck & Co. Inc.'s (MRK.N: Quote, Profile, Research) arthritis drug Vioxx could lead to heart problems or stroke is very high, an expert witness told a court hearing a closely watched product liability lawsuit.

Fredrick Humeston, a 60-year-old postal worker and Vietnam War veteran, is suing the drug maker, blaming Merck's painkiller for his 2001 heart attack.

The trial in Atlantic City, which got underway this week, is the second such case against Merck, which withdrew its blockbuster Vioxx drug, a so-called COX-2 inhibitor, from the market last year.

The drug company is hoping for a victory after losing the first Vioxx trial in Texas last month. Merck faces a slew of suits following its voluntary withdrawal of the drug in September 2004.

"The probability is very high that Vioxx and other COX-2 inhibitors, but mostly Vioxx, can lead to the development of thrombo-embololic events," said Benedict Lucchesi, professor of pharmacology at University of Michigan Medical School.

Lucchesi, responding to questions from the plaintiff's attorney Christopher Seeger, added: "Based on my medical knowledge, there is a very good probability that Vioxx does pose a risk to patients with underlying disorders."

The plaintiffs produced a letter written in 1999 by John Oates, a professor of pharmacology at Vanderbilt University and former scientific advisor to Merck, warning the company to be careful about marketing COX-2 drugs.

"He is telling Merck that you have to be careful. You can't just give (Cox-2s) to everybody," Lucchesi said.

"They are trying to tell the leadership (about the risks) before they go out and launch this drug to millions and millions of people," Lucchesi told the court, referring to a May 1998 report issued by Merck's scientific advisors to Management.

Merck withdrew the drug after its own research showed increased risk of heart attack and stroke in some patient who took Vioxx for at least 18 months.

Lucchesi broke down in court when asked about an internal Merck email in February of 1997 in which Merck scientists expressed concerns about the marketability of Vioxx in light of clinical trials.

"I became enraged," Lucchesi said when asked about his reaction to the email. He was unable to continue for several moments in the courtroom as he was overcome with emotion.

"These are my colleagues," he said, referring to the Merck scientists. "They put profits before life."

Jim Fitzpatrick, a lawyer representing Merck, said the email had been misinterpreted and that his side would be clarifying the company's position later in the trial.

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