The former top scientist at Merck testified Monday that he initially concluded an internal study of Vioxx linked the drug to an increase in heart attacks and strokes less than a year after it was approved for sale.
In a videotaped deposition shown to a Houston jury, Dr. Edward Scolnick, the president of Merck Research Labs until 2002, acknowledged writing a company e-mail in which he noted that the cardiovascular links to Vioxx were “clearly there.”
He said he changed his opinion just 18 days later after reviewing other data and literature, joining company officials in their position that there was no such link. Still, the cardiovascular issue continued to bother him even after Merck’s marketing department put out a press release reaffirming the drug’s safety, Scolnick said.
“I will tell you that my worry quotient is high,” he wrote in an e-mail to the Vioxx project team. “I am actually in minor agony.”
Vioxx, a blockbuster painkiller, was approved in 1999 after the FDA deemed it safe and effective. But it became dogged by public safety concerns the next year after Merck released the results of the so-called VIGOR study. And in September 2004, Merck pulled it from the market after another study showed it doubled the risk of heart attack and strokes in patients who took it for 18 months or longer.
Merck now faces an estimated 7,000 lawsuits by former Vioxx users or their families. In August, a Brazoria County jury awarded $253 million to the widow of a former marathon runner who died of a heart attack after taking the drug. But last month, a New Jersey jury found no wrongdoing in the case of an Idaho postal worker who suffered a non-fatal heart attack.
The Houston case is the first federal suit to go to trial. At issue is whether Vioxx contributed to the blood clot and death of 53-year-old Richard “Dicky” Irvin, a Florida seafood salesman and former college football player.
Also Monday, Scolnick acknowledged in his deposition that he called federal regulators “bastards” in an internal e-mail because they were considering adding a warning label to Vioxx after the VIGOR study’s release.
Scolnick said he strongly disagreed with the U.S. Food & Drug Administration’s concerns that the label should be added to Vioxx.
“Be assured, we will not accept this label,” Scolnick said in an e-mail to other Merck officials in October 2001.
Of regulators asking for additional safety information, he said, “They are bastards.” Later he called them “devious.”
Scolnick said in his deposition, offered by plaintiffs attorneys, that he took issue with regulators’ push for a warning label in the fall of 2001 because an advisory committee to the FDA had not recommended such a labeling change earlier that year.
That committee was formed after Merck released the VIGOR results, which showed that patients who took the popular painkiller had five times as many heart attacks and strokes as those who took naproxen, another painkiller.
Merck officials have said they believe the reason for that discrepancy is that naproxen protects against cardiac events, not that Vioxx causes them. Scolnick said he wanted that position, as well as the study results that Vioxx was easier on the stomach than naproxen, reflected in the labeling.
He said he asked the team to devise a large, long-term study specifically looking for cardiac events in arthritis patients who took Vioxx against those on Tylenol.
But the team said the study could not be done because arthritis patients could not be asked to take just Tylenol for a long period of time, he said, so such a trial was never done.
Scolnick also testified that at the time Merck was developing Vioxx, patents were running out on two of the company’s largest revenue-producing medicines. Asked if that put pressure on Merck to come up with a big drug to fill the void, Scolnick said, “Vioxx was going to fill the void.”
Also, Monday, Irvin’s widow Evelyn Irvin Plunkett testified that her husband of 30 years was a healthy, hard-working man who rarely got sick and took Vioxx for a back strain he got from lifting a box of shrimp.
She said she was stunned when she received a call from her husband’s boss on the morning of May 15, 2001, telling her that Irvin had suffered a heart attack and had been rushed to the hospital. Shortly after arriving there, she said, a doctor visited her and two of her four children in the waiting room. “She said, ‘We worked on your husband for over an hour and we couldn’t save him'”, said Plunkett, who has since remarried. “It was like my whole life went up in the air,” she said.
Her attorneys rested their case after Plunkett testified. They also withdrew two of their five lawsuit claims: fraud and breach of warranty.