Banning a drug carrying some risk is not always best prescription
http://www.usatoday.com/news/opinion/editorials/2004-12-26-our-view_x.htm"This is a very confusing situation," a top Food and Drug Administration scientist, Sandra Kweder, said of the controversy over Celebrex and other popular pain relievers. If the FDA is confused, imagine the feelings of doctors and patients caught in the backlash.
The story so far: Celebrex, along with Vioxx and Bextra, were a new class of drugs that held great promise to relieve suffering from arthritis without causing the digestive discomfort and bleeding associated with older medications. They were heavily marketed, and sales reached billions of dollars.
Three months ago, a study confirmed fears that Vioxx increased the risk of heart attack and stroke. Now Vioxx is off the market, pulled by its manufacturer, and last Thursday the FDA urged doctors to limit prescriptions for Celebrex and Bextra.
---------snip-----------
Distorting the level of risk. Clinical studies often contradict each other, and wide-ranging conclusions are drawn from small samples. In the recently reported link between naproxen and cardiac risk, fewer than 3% of the 2,500 elderly patients suffered heart attacks or strokes over three years, a relatively small number for that age group. "We're being given flash results based on single trials that haven't been properly analyzed," says Michael Weber, associate dean of New York's Downstate College of Medicine. "There may or may not be a safety problem. At this point, we don't know."
---snip-----
Make no mistake: The FDA is badly off-track. It's not watching closely enough to see that the drugs it approves are safe as well as effective. But most often, the right solution will be to restrict a drug's use, not to ban it.