Doctor Testifies that Merck Studies Showed Vioxx Risks

posted on:
December 1, 2005

author:
Heather Won Tesoriero

HOUSTON – Many of Merck’s own studies in Vioxx produced data indicating that the painkiller increase risks of hear attacks, even if taken over a short period of time, an epidemiologist testified on behalf of plaintiffs in a federal case here.

Having independently analyzed raw date from Merck & Co.’s studies, “the totality of evidence clearly indicates that Vioxx causes heart attacks and serious coronary heart disease,” said Wayne Ray, a professor of preventive medicine at Vanderbilt University in Nashville, Tenn. Taking Vioxx for less than a year increases heart attack risks by between 2.2 and 2.8 times, he said, adding that there was only a “one in a million” possibility that this finding was due to chance.

The professor, who studies the effects of drugs on populations, was testifying on the third day of a trial in U.S. District Court here, the first federal Vioxx case thus far.

Evelyn Irvin Plunkett is suing Merck over the 2001 death of her husband, Richard “Dicky” Irvin. He died of a heart attack after taking the drug for less than a month. Merck voluntarily withdrew the drug from the market last year. It pointed to the results of a study it was conducting that it said linked Vioxx to an increased risk of heart attacks and strokes in patients taking the drug for 18 months or longer. But it denies any increased risk for shorter periods.

Following the drug’s withdrawal, the Whitehouse Station, N.J., company, has been hit with a wave of some 6,400 lawsuits. Merck said that there is no conclusive scientific that Vioxx, when used in the short term, causes heart problems. The drug maker lost the first state Vioxx trial a few months ago when a Texas jury awarded $253.4 million to the widow of a man who died while taking the drug. The award will likely be reduced to $26 million under state damage caps. The company rebounded last month in an Atlantic City, N.J., courtroom.

Dr. Ray also provided testimony contradicting Merck’s explanation for why patients taking Vioxx in an early clinical trial known as Vigor showed greater incidence of heart problems than those taking another painkiller, naproxen. Merck had dismissed the results of the trial, concluding that rather than Vioxx causing heart problems, naproxen reduces the chance of heart attacks. “Naproxen has virtually no effect on heart attacks,” Dr. Ray said. “Doesn’t cause ‘em, doesn’t cure ‘em.”

Earlier in the day, attorneys for the plaintiff questioned Alan Nies, a retired Merck pharmacologist, about what Merck knew about Vioxx’s potential cardiovascular risks. Plaintiff’s attorney Jere Beasley tried to established that Merck had information that suggested Vioxx could adversely affect chemicals in the body that have a hand in blood clotting – which can lead to heart attacks—as far back as 1996, but rushed the drug market out of financial need.

Under questioning by Mr. Beasley, the former Merck scientist said that when he learned of the results of a study in the late 1990s that raise questions about Vioxx, Dr. Nies wanted to further explore the hypothesis but wasn’t overly concerned because the results weren’t conclusive. He said the company consistently acted in favor or patient safety and didn’t cut any corners in bringing Vioxx to market.

Under cross examination by Merck defense attorney Tarik Ismail, Dr Nies, who testified in the Texas state Vioxx trial, said that Merck did some 60 studies to test Vioxx’s safety. He said that following the results of the vigor study, Merck took several steps to try to understand the results, including convening a group of outside advisors.

Two other witnesses testified on behalf of the plaintiff yesterday. In addition to Dr. Ray, Thomas Baldwin, a cardiologist, told the jury of five men and four women that Mr.Irvin was at low risk for a heart attack.

Write to Heather Won Tesoriero at heather.tesoriero@wej.com1

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