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19 Oct 2010

Should long-term drugs get greater scrutiny?

Drugs for these chronic diseases present a novel set of challenges about how to assess their safety.

Is it a "wide-scale institutional failure" that drugs for chronic diseases--drugs that today's aging population takes for decades--are only evaluated by shorter-term clinical trials? That's what some experts are telling the New York Times in an article inspired by two recent drug-safety episodes. First, Avandia, the GlaxoSmithKline diabetes drug now sharply restricted because of evidence linking it to heart problems. Second, bisphosphonates, the popular osteoporosis drugs that recently got a new warning that they may increase the risk of a rare-but-serious type of leg fracture.

Drugs for chronic illnesses are often used by large swaths of the population. They're taken for years, not days or weeks like drugs for acute illnesses. And so they warrant a different approach, some say. "The point is not that the drugs are bad, but that drugs for these chronic diseases present a novel set of challenges about how to assess their safety," ethicist Dr. Jason Karlawish tells the Times.<

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