New Study Questions Avandia's Heart Risk

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For example, in one major Avandia trial, patients did achieve much better blood sugar control -- compared to other drugs -- even though their risk for heart failure and heart attack rose, he pointed out.

"These data suggest that we urgently need to change the regulatory pathway for drugs for the treatment of type 2 diabetes to make clinical outcomes, not surrogates, the primary endpoints," he wrote.

And while many experts have pointed to "phase 4" post-marketing surveillance trials of new drugs as a possible means of preventing bad drugs from staying on drug store shelves, Rosen said these trials are observational only. That means their data fall short of the gold standard -- a randomized clinical trial -- so they "will neither solve the overriding problems of drug safety nor ultimately help a chronically underfunded federal agency," he said.

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More information

For more on diabetes drugs, visit the U.S. Food and Drug Administration.

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