A sick agency in need of a cure?
Recall of a popular pain drug has focused attention on government drug regulation
When David Graham got his medical degree from Johns Hopkins University, he figured he'd opt for the comforts of an academic career in neurology. But he couldn't shake his other infatuation, with public health, so instead of heading to the lab he began what would become a 20-year government career at the U.S. Food and Drug Administration: "At the FDA," he says, "there seemed to be the possibility that you could have an effect that would benefit patients to a greater extent than at any university."
Today, that dream has turned sour. Indeed, Graham is now at the center of a national controversy over the FDA's ability to protect the public against unsafe medicines. As associate director for science and medicine in the FDA's Office of Drug Safety, Graham told Congress last month that FDA's problems with ensuring drug safety were "immense in scope" and left the nation "virtually defenseless" against the chance that unsafe drugs will reach consumers.
Graham was called before the Senate Finance Committee to explain why it took the FDA years to acknowlege that the pain reliever Vioxx increased cardiovascular risks. Merck, Vioxx's manufacturer, removed the drug from the market in September because of Vioxx-related heart attacks and stroke, which Graham and other researchers say may surpass 100,000 in the United States alone. The FDA has known of the risks since 1999, yet a warning was not added to the drug's label, which the FDA regulates, until 2002. According to Sandra Kweder, the deputy director of the Office of New Drugs, the FDA did not have enough leverage to force Merck to include a warning about heart risks; the agency negotiated with the company for some 14 months after the problem was first identified. When the warning was included, it was not a "black box" type, which might have reduced the flood of advertising directed at consumers. Vioxx remained a top seller for two more years.
High stakes. Product liability lawsuits, according to Merrill Lynch, may run as high as $18 billion, from patients and their families. And last week the New York State pension fund announced it was suing Merck, charging that the company concealed Vioxx's risks from shareholders, leading to a loss of $171 million by the fund. "Vioxx is a terrible tragedy and a profound regulatory failure," Graham told the Senate committee. It illustrates troubles at the FDA "that will make future Vioxxes inevitable." Graham, who is expressing his opinion, not that of the FDA, paints a picture of "an agency in denial," where bureaucratic wrangling has replaced scientific debate and a climate of fear stifles healthy dissent.
Many scientists believe that FDA's dual role of promoter and regulator of medicines is to blame. "The people in the agency who become the champion of a new drug can't be responsible for sustained surveillance," says Eric Topol, chairman of cardiovascular medicine at the Cleveland Clinic. "The position is just too awkward, and if they are critical of a drug, it makes them look like they made the wrong decision in the first place." As a member of the Institute of Medicine, Topol may serve on the committee the IOM is impaneling at the request of the FDA to sort out its drug surveillance system and make recommendations. "I believe the FDA is really trying to do the right thing," says Topol, "but they need more authority over the companies."
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