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Lawyer: Merck Downplayed Vioxx Safety

Posted on: Wednesday, 27 July 2005, 21:00 CDT

ANGLETON, Texas - The plaintiff's lawyer in the country's first Vioxx-related civil trial grilled Merck & Co.'s top epidemiologist Wednesday about whether Merck deliberately minimized the drug's safety issues while promoting it to doctors in 2000.

Mark Lanier, who represents the widow of a Texas man who died in May 2001 after taking Vioxx for eight months, told jurors about the results of 1999 clinical trials of Vioxx on osteoarthritis patients.

The so-called "CV cards," intended to show cardiovascular effects of Vioxx, indicated little difference between Vioxx and sugar pill groups. Dr. Nancy Santanello, head of Merck's epidemiology department, has repeatedly said that such trials conducted before Vioxx went on the market in 1999 consistently showed little difference in effects on patients.

Lanier alleged Wednesday that Merck's math didn't add up. He handed Santanello a calculator, and she came up with a lower rate of cardiovascular problems in the 783 patients on sugar pills than noted on the card that the company sent to doctors.

Lanier alleged the wider difference was correct, but Merck pumped up the sugar pill rate to be closer to that of Vioxx to make the painkiller appear safer.

Santanello said the calculation she came up with in court was skewed because it didn't account for the actual number of days patients took the sugar pills during the trials. Osteoarthritis patients can't do without their regular pain medication for an entire six-week or six-month trial, she said, and her in-court calculation assumed they took only sugar pills throughout the entire trials.

Lanier said the lower rates were based on information Merck provided the U.S. Food and Drug Administration.

"It may be murky math on your part," Santanello told Lanier.

"With all due respect, ma'am, you did the math," Lanier retorted.

Santanello later addressed why Merck added warnings about cardiovascular risks to its label in 2002, two years after a study found that some Vioxx users suffered five times as many heart attacks as people who used the older pain reliever naproxen.

At the time, Merck said the disparity was because naproxen had qualities that protected the heart, rather than because of a defect in Vioxx, and got a rebuke from the FDA for making that assertion without scientific proof.

Lanier asked Santanello why the label wasn't updated to reflect findings of the Vioxx/naproxen study sooner than 2002.

She said Merck sent the FDA revised label data for approval three months after the Vioxx/naproxen study results were known. But the government and the corporation negotiated language and placement of the new labels for nearly two years, she said.

"You could have strengthened the warning language two years earlier?" Lanier asked.

"Yes, but we didn't believe the data warranted putting a warning in when naproxen may have a cardioprotective effect," she replied.

The case centers on the death of Robert Ernst, a marathon runner and personal trainer who worked as a produce manager at a Wal-Mart near Fort Worth. He died in his sleep next to his wife, Carol, who is suing Merck.

Lanier alleges Ernst died of an arrhythmia brought on by a heart attack caused by Vioxx. He also alleges Merck aggressively marketed the drug knowing it could be dangerous years before Merck pulled the painkiller from the market last year when a study showed Vioxx could double risk of heart attack or stroke if taken for 18 months or longer.

Merck contends the company acted responsibly, disclosed studies and possible risks and believed Vioxx was safe until the study last year showed otherwise.

The case on trial in Angleton, about 40 miles south of Houston, is the first of more than 4,200 state and federal lawsuits filed across the country to go before a jury.

Source: Associated Press/AP Online

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