Should long-term drugs get greater scrutiny?

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.

How can drugmakers possibly figure out how safe a drug is over decades when it's tested for two or three years at most? And should they be required to foot the bill for that? One approach favored by Karlawish is electronic tracking of drug use and outcomes; mining electronic medical records and insurer databases, for instance. Seems reasonable, especially given that some pharmacy benefits managers are doing similar monitoring already.

But some fear that risk warnings can curtail treatment for those who need it. Consider the fracture risk with bone drugs: Even with long-term use of the meds, the particular fracture the FDA warns against is still quite rare. We'd err on the side of favoring more information on risk. It's the interpretation that can be a doozy.

- read the NYT piece

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.