A controversial new diabetes drug has led some physicians to question the way new drugs are approved in the United States.
Avandia (rosiglitazone) is a glycemic control drug that was approved by the FDA after six months of clinical trials in 1999. Produced by GlaxoSmithKline, Avandia is the top-selling diabetes drug in the United States and generates around $3 billion worth of revenue each year. Though the drug appears to be effective, studies have shown it may double a type 2 diabetic’s already-high risk for ischemic heart disease. According to Clifford J. Rosen, M.D., an endocrinologist at St. Joseph Hospital in Bangor, Maine and acting chair of the FDA Advisory Board, the overall incidence of cardiovascular events in previous studies was low because researchers studied small samples of patients, and these patients were followed for relatively short periods of time.
“[Avandia] got on the market quickly,” Dr. Rosen told Ivanhoe. “It sold a billion a year or more. It was really expensive drug, and I think the expectations were huge. The concern is if we’re going to put somebody on a drug for a long period of time, we’d better make sure it’s safe.”
After facing a great deal of scrutiny from various members of the medical community, the FDA mandated all Avandia products bear warning labels to raise awareness of the drug’s potentially life-threatening side effects.
According to Dr. Rosen, the FDA is generally quick to approve any diabetes drug that promises to give patients increased glycemic control, and a substantial number are approved within six months to a year.
“I think we need better criteria for approving drugs such as this, besides just lowering blood sugar,” Blank said. “I think what may have to happen is, [the FDA] may have to look at patient outcomes and say, ‘Look, after two years, what happens with this drug in terms of quality of life?'”
Dr. Rosen said one of the best ways the FDA could educate doctors and patients about the benefits and drawbacks of certain drugs would be to broadcast all FDA drug hearings. “It’s so educational for patients and physicians,” he said. “There’s no reason everybody shouldn’t be exposed to the discussion we had last week.”
SOURCE: Ivanhoe interview with Clifford Rosen, M.D.; 357: 1-3
