New Study Questions Avandia's Heart Risk

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"There was not a statistically significant difference between serious and non-serious events, which is exactly what we found," Kaul said. "There was substantial uncertainty associated with those risk estimates. You couldn't say one way or the other whether the risk was increased or decreased. When they looked at myocardial infarction [heart attack], they did not find a statistically significant increased risk," he added.

Kaul agreed that there is a heart-attack risk with Avandia, but the size of the risk is uncertain. "It's no longer statistically significant when you look at myocardial infarction," he said. "But, if tomorrow there is evidence to suggest increased risk, we will be the first ones to acknowledge it."

The Avandia saga has a "lesson" for the FDA, according to an article released online Wednesday by the New England Journal of Medicine and scheduled for publication in the journal's Aug. 30 print edition.

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The article was written by Dr. Clifford Rosen, of the Maine Center for Osteoporosis, who headed the recent FDA advisory committee panel that recommended Avandia stay on the market, albeit with stronger warnings.

Rosen said the Avandia story "quickly became obvious to the advisory committee: a new 'wonder drug,' approved prematurely and for the wrong reasons by a weakened and underfunded government agency subjected to pressure from industry, had caused undue harm to patients."

He wrote that, all too often, so-called "surrogate" endpoints are used in studies aimed at estimating a drug's safety and effectiveness, with an eye toward approval. In the case of Avandia, researchers focused on the durability of the patients' blood sugar control ("glycemic durability"), even though blood sugar control is "a relatively poor surrogate for cardiovascular outcomes in type 2 diabetes," Rosen said. In other words, such trials would probably miss the real heart dangers posed by these types of drugs, he wrote.

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