Merck & Co. Chief Executive Officer Raymond Gilmartin said Monday his first indication that the painkiller Vioxx carried a heart risk came on Sept. 23, and the company withdrew the medicine a week later.
Gilmartin laid out Merck’s defense against mounting criticism from lawmakers, trial lawyers and doctors who say Merck should have known as early as 2000 that Vioxx was dangerous. He plans to appear at a Senate hearing this week as attorneys prepare lawsuits on behalf of thousands of people who say they or their relatives were hurt or killed by
"We did the right thing every step of the way," Gilmartin, 63, said Monday. "The question is not who is responsible, but did we act responsibly, and we did. Our record is impeccable."
Merck, the No.2 U.S. drug maker, pulled Vioxx on Sept. 30 after a three-year company study found that patients taking it for more than 18 months faced twice the risk of heart attack and stroke as those getting a placebo. Since then, Merck’s market value has plummeted by more than $40 billion.
"It’s important to keep in mind that it was only after 18 months of continuous use on the drug that we even began to see a difference in cardiovascular risk," Gilmartin said. "The risk for anyone individual of having a heart attack or a stroke is very small. We will defend ourselves vigorously against these claims."
Vioxx generated $2.5 billion in sales for Merck last year, about 11 percent of total revenue. Gilmartin had been banking on Vioxx to help compensate for the eventual loss of US. patent protection on the company’s biggest drug, the Zocar cholesterol pill, in June 2006. Zocor had $5.01 billion in worldwide sales last year.
Even if Merck acted quickly after getting the results of the latest study in September, the company dragged its feet in the preceding years, said Andy Birchfield Jr., an attorney in Montgomery, Ala. His firm, Beasley, Allen, Crow, Methvin, Portis & Miles has filed 61 suits alleging injuries caused by Vioxx and is reviewing thousands of other claims.
Court documents show that Merck was concerned about the potential for a heart risk before the drug was even approved, Birchfield said. The company had warnings from earlier studies that should have changed how it marketed the medicine, he said.
"All of those signals went unheeded and Merck continued a very significant marketing campaign, spending hundreds of millions of dollars in direct-to-consumer advertising," Birchfield said. "Certainly, that is not the course of action of a responsible pharmaceutical company."
Dr. Eric Topol, the Cleveland Clinic’s chairman of cardiovascular medicine,-told-the-CBS news program "60 Minutes" on Sunday night that data from a 1998 Merck clinical trial called "Study 090" found that serious cardiovascular events occurred about six times more often in patients taking Vioxx than in those taking other arthritis drugs or a placebo. The study was never published, Topol said.
The combination of "Study 090" with a larger trial performed a year later should have raised alarms at Merck in 2000, Topol told the show.
The doctor said that when he tried to express his concerns about Vioxx to top Merck officials, including Gilmartin, they refused to take his calls.
Gilmartin said Monday that he had no recollection of those calls. He also said the company reported the results of the "090" study to the Food and Drug Administration and to the medical community.
U.S. regulators estimate that Vioxx may have contributed to 27,785 heart attacks and deaths before it was pulled in the biggest drug recall ever. Merck’s liabilities may range from $4 billion to $18 billion, Merrill Lynch has estimated.
Gilmartin, who has less than two years before reaching Merck’s mandatory retirement age of 65, said he has no plans to step down early and the company doesn’t need a merger to survive.
"We’ve been very clear that a large-scale merger doesn’t make sense," Gilmartin said. ”It doesn’t add to our pipeline, and it doesn’t add to growth."
The U.S. Justice Department has launched a criminal probe and the Securities and Exchange Commission has started an informal investigation, Merck said Nov. 8.
Gilmartin said the probes followed a Wall Street Journal report that was based on documents under court seal that were leaked "and deliberately represented out of context." The Journal report suggested that Merck aggressively downplayed
negative data from earlier Vioxx studies through sales tactics, lobbying and legal measures.
A criminal probe isn’t worrying "when you do the right thing. That’s the thing to point to – we did the right thing every step of the way," Gilmartin said.
Gilmartin, the former head of syringe maker Becton Dickinson and Co., became Merck’s CEO in 1994, the first outsider to get the post in a century. The board has yet to name his successor.
Merck, a 117-year-old company that won top honors for corporate stewardship from the U.S. Commerce Department and the U.S. Chamber of Commerce last year, ran full-page newspaper advertisements in the Wall Street Journal and New York Times last week saying its integrity is being unfairly questioned.