Vioxx Victim said at low Risk for Heart Attack

posted on:
December 1, 2005

author:
Staff

The deceased at the center of the first federal Vioxx trial was at low risk for a heart attack and his blocked artery didn’t need invasive treatment, according to a doctor who testified Thursday.

Richard “Dicky” Irvin lacked many of the factors associated with heart attacks, such as high blood pressure and diabetes, said Dr. Thomas Baldwin, a cardiologist in Kansas City.

Jurors will be asked to decide if Merck & Co.’s now withdrawn pain reliever Vioxx contributed to the fatal heart attack Irvin suffered in May 2001. The 53-year-old manager of a seafood distributor had been taking the drug for about a month to alleviate back pain when his colleagues found him dead at his desk.

Irvin’s widow, Evelyn Irvin Plunkett, is suing Merck, which has scored a loss in Texas and a win on its home turf of New Jersey in the first two state-level Vioxx cases. Merck faces about 7,000 state and federal lawsuits, and analysts have estimated its liability could reach $50 billion.

Plunkett alleges that Vioxx—which inhibits an enzyme that promotes inflammation and thins the blood—led to the clot formation. Merck says that plaque, or fatty deposits in artery walls, ruptured and caused the clot that lead to Irvin’s death.

Baldwin said the clog in the major artery wasn’t significant enough to treat. According to testimony, the artery was 60 percent clogged, but Baldwin said the condition appears worse after death so it probably wasn’t as constricted as believed.

Irvin had a “low-risk profile” for a heart attack, and he would have prescribed aspirin as a precaution because of the clogged artery, said Baldwin, who was receiving $1,000 an hour for his testimony. Aspirin is known to reduce the risk of heart attack.

A Merck lawyer asked Baldwin a series of mostly yes or no questions to establish he was not a clinical researcher or a Vioxx expert.

Whitehouse Station, N.J.-based Merck withdrew Vioxx from the market in September 2004 after a long-term study showed the drug doubled risk of heart attack or stroke if taken for 18 months or longer. By then, more than 20 million Americans had used Vioxx.

A series of letters and e-mails from doctors in and outside of Merck that raised concerns about Vioxx’s safety were not a “red flag” highlighting risk but rather “scientific discussions”, a former company executive said.

Dr. Alan Nies, who was senior vice president of clinical research at Merck before leaving in 2002, said he believed Vioxx was a safe drug.

Plaintiffs showed a 2000 e-mail in which Dr. Ed Scolnick, former head of research at Merck, said “the CV (cardiovascular events) are clearly there” and that they were “mechanism-based,” meaning they were caused by the way the drug works in the body. Nies said that Scholnick changed his mind after reviewing additional data.

E-mails and letters also suggested outside experts thought Merck should conduct tests to investigate Vioxx’s cardiovascular safety, but the company never did.

“There was no clinical evidence it was important,” Nies said.

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