FDA Avandia Fight-Testing Ground For Drug Evals

The FDA’s decision yesterday to keep GlaxoSmithKline’s Diabetes drug Avandia on the market, may be just an early battle in a long war as we appear to be at a new point in defining FDA powers and the standards for drug testing. So far, regulators have been reluctant to pull a major drug off the market once it had previously been deemed safe. When the FDA yanked Merck’s Vioxx, it cost the company billions of dollars. The panel looking at Avandia this week voted to require the company to add warnings to the drug which defines the dangers of cardiovascular events. The FDA as well as the nation’s cardiologists will likely remain vigilant on the dangers of the drug if and when they prescribe it. In today’s Wall Street Journal, there was an interesting lead editorial suggesting that the real debate concerning Avandia is actually about statistical techniques and the design of randomized clinical trials versus metastudies like those done by Steve Nissen of The Cleveland Clinic critical of Avandia. Those studies, say Glaxo, are not at all as good on drug safety and are a blunt instrument. If this drug is the inflection point in our efforts to create credible studies on drugs, then the decisions about to be made on these issues cry out for a braoder involvement of the medical research community including and especially scientists at NIH. Pharma and biotech leaders should welcome this debate is it would seem that a clarification in the kind of studies to be performed as well as the statistical modes of analysis would help their cause, rather than harm it. To clear the presnt “fog of war”. In addition, this kind of clarification should be a clear examination of the science. There are some things, such as drug safety, which should not be determined by the particular political whim of who is in the White House or Congress.