Denialism by Michael Specter Read Free Book Online Page B

members of the sales force were instructed to refer doctors with questions to the card, which claimed—falsely—that Vioxx was eight to eleven times safer than other similar painkillers. The sales reps were told to produce the card only when all else had failed, to help “physicians in response to their questions regarding the cardiovascular effects of Vioxx.” The FDA, realizing that doctors needed to understand the gravity of the findings from the VIGOR trial, issued a strongly worded letter instructing Merck to correct the record. “Your claim in the press release that Vioxx has a ‘favorable cardiovascular safety profile,’” the letter read in part, “is simply incomprehensible, given the rate of heart attack and serious cardiovascular events compared to naproxen.” The company reacted swiftly: “Do not initiate discussions of the FDA arthritis committee . . . or the results of the . . . VIGOR study,” the sales force was told. If doctors proved too querulous, the Merck representatives were instructed to respond by saying, “I cannot discuss the study with you.”
    In the summer of 2004, the Lancet asked Topol and the gastroenterologist Gary W. Falk, a colleague of Topol’s from the Cleveland Clinic, to sum up the state of knowledge about Vioxx and similar drugs known, as a class, by the name coxibs. Their editorial was published that August under the title “A Coxib a Day Won’t Keep the Doctor Away. Topol was taken aback when he realized how little had changed. “It was amazing to see that nothing had been done in three years,” he recalled. “It was not even clear that Vioxx protected the stomach. It cost four dollars a day for these darn pills.” On September 29 of that year, Topol happened to dine with Roy Vagelos, Merck’s much-admired former chief executive, who had been retired for nearly a decade. Topol was visiting a New York-based biopharmaceutical company called Regeneron whose board Vagelos chairs. There were few people in medicine for whom Topol had as much respect. “We started talking about Vioxx,” he said. “It was the first time I ever spoke to Roy about it. I remember that conversation well: it was at Ruth’s Chris Steak House in Westchester. Roy went on for a while. He was entirely opposed to the Merck approach to Vioxx. And he didn’t mince words.”
    The following morning a Merck cardiologist called Topol and told him the company was removing Vioxx from the market. Another trial had shown that patients taking the drug were at increased risk of heart attack and stroke. That study, APPROVe, began in 2000 as an attempt to discover whether Vioxx helped prevent the recurrence of colon polyps. It didn’t. “I was shocked,” Topol said. “But I thought that it was responsible for them to pull it. And Steve Nissen came down to my office, also very pleased, and said, ‘Isn’t that great? They are pulling the drug.’ We both thought it was the right thing to do.”
    For Topol, that could well have been how the story ended. But Merck began to mount a press offensive. The message never varied: Merck put patients first. “Everything they had ever done in the course of Vioxx was putting patients first. All the data was out there,” Topol said, still stunned by the brazen public lies. “This just wasn’t true. It wasn’t right. I called and tried to speak to Ray Gilmartin”—Merck’s chief executive. “Neither he nor anyone else returned my calls.” (That itself was significant: after all, Topol ran one of the most important cardiology departments in the country; he was also the director of a Merck drug trial.) “This was a breach of trust that really rocked the faith people have in institutions like those,” Topol said. “We are talking about thousands of heart attacks. There were simply gross discrepancies in what they presented to the FDA and what was published in journals. I took them on. I had to.”
    That week, Topol wrote an op-ed piece for the New York Times .