Heated Exchanges In Vioxx Trial

Merck & Co.'s former top scientist in charge of Vioxx studies bristled repeatedly Friday when pressed about whether the pharmaceutical giant's eye was on its bottom line in rushing the once-lucrative drug to market.

Dr. Alan Nies, testifying as Merck began its defense in the nation's first Vioxx-related civil trial, insisted the New Jersey company wasn't in a race with Pfizer's Celebrex. He grew angry when questioned about his own written 1996 Vioxx product development plan that said Merck was concerned about a "significant negative impact" on financial projections if Celebrex made it into medicine cabinets first.

In a bruising cross-examination, plaintiff's lawyer Mark Lanier showed jurors where the document said Merck could lose up to $611 million in potential revenues if Vioxx lagged behind Pfizer's goal of selling Celebrex by late 1998, allowing the competitor to snag critical market share.

"You wanted to get the drug out for the money?" Lanier demanded, his voice raised.

"Not me!" Nies snapped. He told Lanier he knew nothing about "financial modeling" at Merck, and then conceded that his product development plan had a marketing aspect.

"Six hundred and eleven million dollars is the value of being first rather than second?" Lanier demanded a few minutes later.

"You don't have to yell at me; I can hear you," Nies snapped.

"I don't mean to yell at you, I just wanted to make sure Mrs. Ernst can hear you," Lanier said, gesturing toward plaintiff Carol Ernst, who is suing Merck over the 2001 death of her husband.

"So the reason y'all are rushing to market is for the almighty dollar" and to help pain sufferers like Robert Ernst, Lanier asked.

"Those two things go hand in hand. If you get the drug out earlier, it will help more people," Nies said.

Merck pulled Vioxx from the market last year when a study showed it could double risk of heart attacks or strokes if taken for 18 months or longer. Robert Ernst died in his sleep after taking Vioxx for eight months to ease pain in his hands.

Merck has relied heavily on his autopsy, which says he died of an irregular heartbeat secondary to clogged arteries, and no studies link Vioxx to those conditions. The coroner testified earlier in the trial that a heart attack was likely behind those conditions, but Ernst died too fast for his heart to show damage.

Neis finished testifying Friday, and Monday Merck intended to question Dr. Thomas Wheeler, an expert coroner and head of the Baylor College of Medicine's pathology department.

Lanier and Carol Ernst also have targeted Merck's aggressive marketing of Vioxx, contending the company cut corners on studies and downplayed safety concerns in a horse race with Pfizer to market what became a multibillion-dollar seller.

Merck claims the company acted responsibly, disclosed research, and believed Vioxx to be safe until the study that prompted the drug's withdrawal from the market came up.

In 2000 a study showed Vioxx users suffered five times as many heart attacks as users of the older painkiller naproxen, sold under the brand name Aleve. Lanier showed jurors a September 2001 internal Merck e-mail that said the American Heart Association, the National Stroke Association and the Arthritis Foundation had called for the company to study cardiovascular effects of "coxibs," or painkillers like Vioxx.

In early 2002 Merck canceled a study intended to focus on Vioxx's effects on the heart. Nies, who initially approved the study, said it was deemed unethical because patients would have had to stop taking other needed pain medication to participate.

Before Lanier began drilling Nies, he told Merck lawyer Joseph Piorkowski that there was no race to get Vioxx on the market before Celebrex. Nies, who retired from Merck in 2002 three years after Vioxx went on the market, also told Piorkowski it was "absolutely false" that Merck minimized safety to rush Vioxx to consumers.

However, Nies' 1996 plan identified the Celebrex market goal of late 1998 and set the same goal for Vioxx. The document also noted an "accelerated and compressed" drug development strategy, or beginning some studies before others were finished.

"That's called efficiency," Nies said.

"It's called recklessness," Lanier countered.

"It's not reckless," Nies said.