It is easy to superficially link the Fosamax®, Vioxx® and Avandia® debacles to the below analysis, but Ms. Kolata does an admirable job (while quite properly noting the obvious connections) of setting it all in the context of a broader narrative. Do go read it all, in this morning's New York Times -- but here is a bit:
. . . .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.”
Dr. Jason Karlawish, a University of Pennsylvania ethicist who studies the ways new treatments are developed and disseminated, expressed a similar concern.
“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,” he said. . . .
Indeed. We need to focus, at FDA, on this plainly emergent trend.
