most popular new medications was killing people. “Then I was angry, and eventually I became outraged.”
At the time, Topol was chairman of the Cleveland Clinic’s cardiology department, which he more than any other physician had transformed into one of the finest in American medicine. His research into how to prevent and treat heart attacks was highly valued and constantly cited. As perhaps the clinic’s most visible face, Topol was already prominent. But it was his role in helping to expose the grave risks posed by the anti-inflammatory drug Vioxx that turned him into one of the country’s best-known doctors. It also made him one of the most controversial, in part because he repeatedly stressed how little regard the Food and Drug Administration seemed to have for the hundreds of millions of people it had been created to protect.
The cloak of invincibility had long before been stripped from any government agency, replaced by the constants of doubt and denial; politicians, scientists, doctors, and lawyers are held in lower esteem today than at any time in decades. Yet no previous incident—not the explosion of the space shuttle Challenger , Ford’s willingness to dump a death trap called the Pinto on the American public, not even the nuclear accident at Three Mile Island—demonstrates more vividly why that mistrust has become so pervasive.
Vioxx was introduced by Merck with great enthusiasm in 1999, one of a new class of drugs called cox-2 inhibitors, which were designed to interfere with an enzyme called cyclooxygenase-2, which, among more beneficial duties, produces chemicals that cause inflammation (and pain). Before Vioxx appeared, hundreds of thousands of people who suffered the debilitating effects of arthritis and other chronic ailments faced an unpleasant choice every day: they could take drugs like aspirin or Advil, or they could endure agony in order to avoid the bleeding ulcers and other serious stomach complications those drugs can cause. Vioxx was referred to as “super aspirin,” which didn’t seem like much of an exaggeration: in early studies it offered better pain relief than any traditional remedy, and was far less likely to disturb the stomach. The drug quickly came to be seen by those who needed it most as a kind of magic potion, one that only the tools of modern medicine could have produced. Driven in part by one of the most aggressive advertising campaigns in medical history, more than twenty million Americans took Vioxx at one time or another. In 2003 alone, Merck sold more than $2.5 billion worth of the drug.
Topol, who suffered from an arthritic knee, loved Vioxx. Even now he readily attests to its effectiveness. “Nothing worked as well for me before or since,” he said. “Vioxx truly dulled the pain.” One February morning in 2001, though, he noticed a report that struck him as odd. Topol had been invited to deliver a lecture about the future of cardiac care to a gathering at the Medical College of Georgia in Augusta. Over breakfast at his hotel, he started to page through the copy of USA Today that he found on his doorstep. One particular story leapt out at him. “It was about Vioxx,” he said, “and this study,” called VIGOR—Vioxx Gastrointestinal Outcomes Research—“which was intended to determine whether Vioxx really was easier on the stomach than other, less powerful nonsteroidal anti-inflammatory medication.”
Between January and July 1999, researchers had followed eight thousand patients with rheumatoid arthritis. Half took Vioxx to control their pain; the other half took naproxen, which is sold over the counter as Aleve. (It was a large and fairly conventional randomly assigned, double-blind study—which meant that the patients had no idea which of the two drugs they were taking, and neither did their doctors.) The first time the safety committee assigned to monitor the study looked at the data, it found exactly what one might have expected: people in the Vioxx