What's the FDA's primary mission? Getting new drugs onto the market quickly, or safeguarding patients? That's the question, say experts troubled by increasing adverse events. One reform advocate, Dr. Clifford J. Rosen, recently called for regulators to require proof that new diabetes remedies definitely cut risks of long-term side effects like heart attacks, eye and kidney problems, and so forth--but that proof would require years-long clinical trials. In the case of Avandia--which Rosen reviewed as chief of an FDA advisory panel--the drug would have had to be tested in at least 5,000 patients for at least four years to satisfy Rosen's requirements.
Rosen's New England Journal of Medicine commentary spawned lots of criticism. The FDA said such an approach would keep potential life-savers off the market for years. But in light of new studies highlighting Avandia's risks--and reports that serious side effects, including death, caused by prescription drugs have more than doubled since 1998--the debate is sure to rage on.
- read the article from the Boston Globe