ORLANDO, Fla. (Ivanhoe Newswire) -- 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
