The New York Times ran a news analysis recently that discussed the increasingly common situation in which drugs designed to prevent a medical condition actually cause the condition. Here are excerpts:
One is bisphosphonates, which is widely used to prevent the fractures, especially of the hip and spine, that are common in people with osteoporosis. Those drugs, like Fosamax, Actonel and Boniva, will now have to carry labels saying they can lead to rare fractures of the thigh bone, a surprising new discovery that came after another surprise — that they can cause a rare degeneration of the jawbone.
The other is Avandia, which is widely prescribed for diabetics, whose disease puts them at risk for heart attacks and heart failure. Two-thirds of diabetics die of heart problems, and a main reason for taking drugs like Avandia is to protect them from that. But now the F.D.A. and drug regulators in Europe are restricting Avandia’s use because it appears to increase heart risks.
In the case of bisphosphonates, the benefits for people with osteoporosis still outweigh the risk, bone experts say. And no one has restricted their use. But the fact remains that with decades of using drugs to treat chronic diseases, the unexpected can occur.
Something new is happening, said Daniel Carpenter, a government professor at Harvard who is an expert on the drug agency. The population is aging, many have chronic diseases. And companies are going after giant markets, huge parts of the population, heavily advertising drugs that are to be taken for a lifetime.
And the way drugs are evaluated, with the emphasis on shorter-term studies before marketing, is not helping, Dr. Carpenter said.
“Here is a wide-scale institutional failure,” he said. “We have placed far more resources and requirements upon premarket assessment of drugs than on postmarket.
The difficulty is in figuring out how to assess the safety of drugs that will be taken for decades, when the clinical trials last at most a few years.
Today’s system, which largely consists of asking doctors to report adverse reactions and of researchers’ attempts to look at patient experiences in a variety of diverse databases, like records of large health plans, is ineffective, medical experts agree.
Congress recently gave the drug agency the power to require studies after drug approval, but the agency has used it sparingly.
