Testimony Begins in Vioxx Case

Merck & Co.’s top epidemiologist took some verbal punches Monday as the plaintiffs’ lawyer in the nation’s first Vioxx-related lawsuit to go to trial said the company downplayed concerns about 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 Whitehorse Station, N.J.-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?” asked Mark Lanier, the plaintiffs’ 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 in aggressive marketing efforts that included glitzy TV 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. 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 study and “misrepresents the safety profile for Vioxx.”

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

The FDA also challenged Merck’s attribution of the disparity to naproxen’s cardio-protective qualities: “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.

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

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

Santanello also said she believed naproxen had a cardio-protective effect. But the FDA letter described as “simply incomprehensible” a May 2001 Merck news release that said Vioxx had a favorable cardiovascular safety profile.

Merck is being sued by the family of Robert Ernst, who died in 2001 after taking Vioxx for about eight months.