Merck Stresses Concern for Vioxx users Safety

posted on:
December 6, 2005

author:
Staff

In the first full day of defense testimony at the federal Vioxx trial in Houston, witnesses for drug manufacturer Merck presented the company and its scientists as careful, methodical and, above all, concerned about the safety of the users of its drugs.

Speaking in soft and measured tones, Alise Reicin, Merck’s vice president of clinical research, told jurors, “We take the safety of medications that we give to patients extremely seriously.”

The trial involves the fatal heart attack of a 53-year-old Florida man, Richard “Dicky” Irvin. Irvin died in 2001 after taking Vioxx for less than a month.

Plaintiff lawyers have argued that Merck knew Vioxx could cause fatal heart attacks long before it withdrew the drug from the market last year. They have cited a study known as “VIGOR,” which found that patients on Vioxx had five times as many heart attacks as those on an older painkiller, naproxen. Merck learned of those results in 2000.

Reicin told jurors she was “quite concerned” when she first heard about the VIGOR findings.

She said scientists at the company immediately went back to data from previous Vioxx studies to see if they contained signs of risk, but found nothing. “We wanted to make sure we hadn’t missed something. We redid the analyses,” she testified.

Reicin said, at that point, she and others looked at data from ongoing studies of Vioxx’s ability to slow and prevent Alzheimer’s. But Merck found no sign in those studies that Vioxx posed a cardiac risk.

“And I must tell you it was very, very comforting data,” Reicin told jurors.

The Alzheimer’s studies used Vioxx and a placebo—unlike the VIGOR study, in which Vioxx was being compared to naproxen.

Reicin said that Merck, in its consultations with outside scientists about how to interpret the excess heart attacks on Vioxx, “overwhelmingly” was told naproxen was “cardioprotective.” In other words, there were more heart attacks in the Vioxx group, not because Vioxx was bad for the heart, but because naproxen was good for it.

Reicin told jurors, “I truly believed (then) and believe today” that Merck’s interpretation of the VIGOR trial was the correct one.

Plaintiff lawyers have produced several witnesses, including prominent medical researchers, who reject that explanation. Further, they have told jurors that if Merck had interpreted the results of the VIGOR study correctly for doctors and the public, Irvin and his doctor would have known that Vioxx posed a risk to the heart—and Irvin would not have taken the drug and died.

At the end of the day, Andy Birchfield, a lawyer for the plaintiff, began his cross-examination of Reicin. He asked why Merck had fought the FDA’s efforts to place a prominent warning about heart attack risks on Vioxx’s label and whether adding such information might have had a financial impact.

“It certainly might have,” Reicin replied, “but it didn’t affect what I thought was right.”

Jurors also heard from California rheumatologist David Silver, who testified that Vioxx’s benefits outweighed its risks.

Silver told jurors that earlier this year, the Food and Drug Administration had determined that there was nothing in the scientific data to show that newer painkillers such as Vioxx and Celebrex were riskier for the heart than older painkillers, such as ibuprofen.

In fact, the FDA says it is difficult to make that comparison because comprehensive studies haven’t been done with most of these drugs.

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