Lawyers Argue about the true meaning of Vioxx Research

posted on:
November 15, 2005


Lawyers for Merck and Co. and for a woman whose husband died of a heart attack a month after he began taking Vioxx cited the same studies Monday in attempts to convince a judge that the other side has no acceptable evidence to buttress its key arguments.

Attorneys for Richard Irvin Jr.’s family contend that numerous studies show an increase in heart attacks and other cardiovascular problems within weeks after people began taking the drug.

Merck’s attorneys contend that their analysis _ and often their data _ is so fundamentally flawed that it shouldn’t be allowed in court. They say scientific studies show it is dangerous only after at least 1 1/2 years on the drug, a claim the other side wants kept out of court.

The question before U.S. District Judge Eldon Fallon was only whether the evidence is acceptable in court. Jurors in the trial scheduled Nov. 28 in Houston will decide whose interpretation they believe.

“Each of you are referring me to the same studies. You’re just interpreting them differently. … I’m faced with a focus more on conclusions than on methodology. At least, that’s the way I see it,” Fallon told Merck attorney Philip Beck at one point.

The judge is overseeing pretrial coordination of more than 1,800 federal Vioxx lawsuits to streamline document gathering and other steps common to the cases. The hearing is expected to resume Tuesday.

Irvin, a Florida man whose case will be the first in the trial, was taking Vioxx for back pain when he died in May 2001. Paul Sizemore, a plaintiff’s attorney, said Vioxx makes heart attacks more likely by cutting production of prostacyclin, a hormone-like chemical which lowers blood pressure and thins the blood. That puts it out of balance with another chemical which narrows blood vessels and promotes clotting, he said, raising and lowering his hands as if they were pans on a balance scale.

He quoted a number of memos and letters in which Merck employees or consultants spoke about its effect on prostacyclin or concerns that Vioxx might make heart attacks more likely. One analysis of numerous studies, never sent to the U.S. Food and Drug Administration, found that it doubled the risk, he said.

Without saying anything about the total number of patients in each study _ a major point in drug research _ he cited several studies in which five or eight patients had heart attacks or other cardiovascular problems soon after starting Vioxx, while those on placebos had one or none.

Those studies were among 58, involving 10,000 patients, conducted before the U.S. Food and Drug Administration approved Vioxx in 1999. The only studies that meet the “gold standard” for drug research prove Merck’s stand, and some of the studies Sizemore cited don’t meet those standards, Beck said.

No study shows that the dose Irvin took could cause a heart attack in a month or less, Beck said.

If the drug doesn’t accumulate in the body “and it’s just a question of balance,” that could support the plaintiffs’ position, Fallon said.

The studies they cited were small and had other major problems, Beck said. “They don’t prove anything about causation.”

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