Early Papers Suggested Vioxx Risk

posted on:
February 16, 2006

author:
Staff

NEW ORLEANS Merck & Co. (MRK) included the idea that its painkiller Vioxx might increase the risk of heart attacks in the first draft of a paper submitted to a top medical journal but dropped it because a reviewer found the section “awkward,” a company executive testified.

Alise Reicin, vice president of Merck’s clinical research, helped design, oversee and write up the study known as VIGOR. Plaintiffs’ attorneys say that study gave the first real indication that Vioxx might be bad for the heart, but Merck sidestepped the issue.

Reicin will be cross-examined Thursday in the retrial of the first federal Vioxx case, which ended originally with a hung jury. Attorneys hope to get through all remaining evidence Thursday, U.S. District Judge Eldon Fallon told jurors at the close of Wednesday’s hearing.

In this case, Evelyn Irvin Plunkett contends that taking the drug for a month caused the heart attack that killed her husband, Richard “Dickie” Irvin, in May 2001, and that Merck hid the drug’s dangers because it brought in billions of dollars.

On the day that the first jury began deliberations, the New England Journal of Medicine, which published VIGOR in November 2001, published an editorial criticizing VIGOR’s authors for omitting data about three patients who had heart attacks while taking the drug.

With or without those figures, the article noted a fivefold difference between the number of patients who had heart attacks while on Vioxx and those taking naproxen, the other drug used in the study, Reicin said.

In videotaped testimony played to the jury Monday, the journal’s executive editor criticized the study for suggesting only that the difference was because naproxen protects against heart attacks.

“The discussion section would have been better … if, instead of making the bald-faced statement that naproxen was protective, the equal possibility is that rofecoxib increased the rate of heart attacks,” Dr. Gregory Curfman said. Or, he added, both effects might have occurred.

Curfman, reached late Wednesday, said he could not comment about Reicin’s testimony.

Merck has said the three additional heart attacks all occurred after a cutoff date for reporting such events.

Curfman said he had not been told about such a cutoff date, and that authors are expected to update articles with late information.

Reicin said the date was set when, partway through the test, a committee of outside scientists set up to watch over the drug’s safety asked for a report on heart attacks, strokes and other “cardiovascular events.”

Reicin said that when she first saw VIGOR’s heart attack data, she worried that Vioxx might have caused the increase. However, she said, she looked at other studies and found nothing similar, and one showed about the same number of heart attacks among patients on Vioxx and those taking sugar pills.

Reicin testified that the original draft did mention the idea that painkillers including Vioxx and other “COX-2 inhibitors” might make heart attacks more likely by reducing production of an enzyme called prostacyclin, which helps keep blood from clotting.

“We talked about the theory that naproxen had a potential cardioprotective effect, and also mentioned … [the] hypothesis that COX-2 inhibition could cause prothrombotic events,” she said.

She said that section of the article was cut back because of a comment by one of the scientists who reviewed it for the New England Journal of Medicine.

Merck attorney Tarek Ismael read that comment from an e-mail sent from VIGOR’s lead author to Marshal M. Kaplan, an associate editor of the journal: “The conclusion is somewhat awkward. I understand that the emphasis on the apparent increased comparative rate of cardiovascular events in the rofecoxib group is relevant. However, this needs to be tightened up.”

The proposed revision followed that quotation, and was used in the published article, Reicin testified.

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