Video: Vioxx trial under way

updated 7/18/2005 6:29:12 PM ET 2005-07-18T22:29:12

Merck & Co.’s top epidemiologist took some verbal punches Monday as the plaintiff’s lawyer in the nation’s first Vioxx-related lawsuit to go to trial said the company downplayed the drug’s safety for years before taking it off the market in 2004.

Nancy Santanello, executive director and head of Merck’s department of epidemiology and the New Jersey-based company’s representative at the trial, was the first witness to testify.

“It’s important that your company never minimize the risk of your drugs?” demanded Mark Lanier, the plaintiff’s lawyer.

“I think all the risks should be provided,” Santanello replied.

Lanier highlighted warning letters Merck received from the Food and Drug Administration about misrepresenting or downplaying concerns about Vioxx’s safety in aggressive marketing efforts that included glitzy television ads.

Among those was a letter Merck received in September 2001 — two years after Vioxx was introduced to the market with much fanfare — about Vioxx marketing in the aftermath of a 2000 study dubbed VIGOR. The study found some Vioxx users suffered five times as many heart attacks as people who used the older pain reliever naproxen, sold under the brand name Aleve.

The letter said Merck was engaged in a promotional campaign for Vioxx “that minimizes the potentially serious cardiovascular findings” observed in the 2000 study, and “misrepresents the safety profile for Vioxx.”

The letter also said that Merck’s campaign discounted the fact that patients on Vioxx “were observed to have a four- to fivefold increase in myocardial infarctions (MIs),” or heart attacks, compared to patients taking naproxen.

The FDA also challenged Merck’s attribution of the disparity to naproxen’s cardioprotective qualities, not a defect in Vioxx.

“That is a possible explanation, but you fail to disclose that your explanation is hypothetical, has not been demonstrated by substantial evidence and there is another reasonable explanation, that Vioxx may have pro-thrombotic properties,” or the ability to cause blood clots, the letter said.

“Would you agree the letter says you guys were doing something you shouldn’t be doing?” Lanier asked.

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“According to the FDA letter, yes,” Santanello replied.

Santanello, a scientist, also said she believes naproxen has a cardioprotective effect. But the FDA letter described as “simply incomprehensible” a May 2001 Merck press release that said Vioxx had a favorable cardiovascular safety profile.

“It wasn’t a lie sir,” Santanello said when Lanier pressed her about the release.

After two years of wrangling with the FDA, Merck added warnings about cardiovascular risks to Vioxx’s label in 2002. Merck removed Vioxx from the worldwide market last year after a study showed the drug doubled patients’ risk of heart attack or stroke if taken for 18 months or longer. About 20 million people took Vioxx before it was pulled from the market.

The trial centers on the May 2001 death of Robert Ernst, a 59-year-old produce manager at a Wal-Mart in Cleburne, near Fort Worth. Ernst also ran marathons and worked as a personal trainer. According to the plaintiffs, he took Vioxx for about eight months to relieve pain in his hands, and died in his sleep next to his wife, Carol, one month shy of their first wedding anniversary.

His autopsy report says he died of an arrhythmia, or irregular heartbeat, secondary to plaque buildup in two major arteries.

Whitehorse Station, N.J.-based Merck argues that no studies link Vioxx to arrhythmia, so the drug couldn’t have caused Ernst’s death. Lanier’s legal team argues that arrhythmia is most often caused by heart attack, but Ernst died too fast for his heart to show damage.

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