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group were less likely to experience significant stomach distress than those who took Aleve.
    The trial also showed something that had not been anticipated, and the news there was disturbing: participants who already suffered from heart disease were far more likely to have heart attacks if taking Vioxx than if they had been given Aleve. Nobody was sure why, and because Merck had never expressed concern about the drug’s effect on the heart, there were no cardiologists on the safety committee (which was not unusual since that wasn’t the purpose of the trial). Scientists wondered if the difference might have been due to the fact that people in the trial were required to stop taking aspirin, since it can lower the risk of heart attack or stroke. It was also possible that something previously unrecognized about the chemical composition of Aleve itself helped protect the cardiovascular system. (That would have provided a benign explanation for the differing rate of heart attacks, and Merck endorsed the hypothesis with great enthusiasm.)
    “I was not a drug safety expert and I never even had any interest in the issue,” Topol said. “My principal research was in heart disease and heart attacks, and that dates back more than twenty years.” Topol had made a name for himself as a postdoctoral researcher at the University of California at San Francisco. He then took a job at Johns Hopkins University, where he became the first physician to treat heart attacks with the powerful clot-busting agent known as tPA; he also directed a pivotal study that compared the efficacy of that drug with an older treatment, streptokinase, in saving lives. In 1991, Topol moved to the Cleveland Clinic, where for the next fifteen years he served as chairman of the department of cardiovascular medicine.
    What Topol saw in USA Today that morning in Augusta made no sense to him. “Why would a new anti-inflammatory agent prove less protective against heart attacks than the one you can buy at a pharmacy with no prescription?” he wondered. Yet, the newspaper report suggested that patients taking Vioxx were more than twice as likely to have heart attacks as those taking Aleve. For people with a history of heart disease, the risk was far higher. (Risk numbers don’t mean much unless they are accompanied by some assessment of the statistical probability that those risks could occur by chance. In this study, which at the time was the largest ever conducted using Vioxx, that number was .002—two in one thousand. In other words, if the study were repeated a thousand times, results like those would appear by chance twice.) “I thought, that is interesting, they are saying a highly touted experimental drug was not as good as the one you buy in the drugstore,” Topol said. “They weren’t saying anything about Vioxx causing heart attacks, just that Aleve seemed better at preventing them.”
    The distinction was crucial because after the data was made public, Merck asserted, as it would for the following three years, that Vioxx posed no increased risk of heart attack or stroke. “It did seem strange,” Topol said, “but I didn’t give it a lot of thought. After all, that’s why you do clinical studies—and so it looked like maybe Aleve had some protective effect we didn’t know about. Surprising as that would have been, it certainly wasn’t beyond the realm of possibility. Still, it wasn’t my thing and I didn’t dwell on it.”
    Topol delivered his address and returned to Cleveland, where Debabrata Mukherjee—“one of my fellows and a brilliant scientist”—had also seen the report which showed that people using Vioxx were far more likely to suffer from heart attacks than those taking over-the-counter pain medication. Mukherjee became intensely curious about the reasons for such surprising results. He dove into the data that Merck had been required to provide the FDA, and soon realized that the initial report failed to include all the