Researcher calls FDA 'shortcuts' into question

A high-profile researcher has issued what is now one of many public challenges to the manner in which the FDA speeds approval of certain drugs. Researcher Dr. Clifford J. Rosen is concerned, in particular, about shortcuts the FDA is using to approve drugs treating type 2 diabetes, particularly in light of questions about the safety of diabetes drug Avandia. His remarks, which were published in a recent edition of the New England Journal of Medicine, are bringing additional attention to an issue which has recently become much higher-profile.

Rosen is suggesting that approvals should only go through if drug makers can offer proof that a drug saves lives and improves patient health, as measured by such impacts as reductions in stroke, heart attack or mortality rates. Where diabetes drugs are concerned, he suggests, FDA officials should prove that the drugs improve patient quality of life and cut risks for side effects.

- read the Boston Globe article
- and see this FierceHealthcare report

ALSO: Not only did a new study in the Journal of the American Medical Association find that the diabetes drug doubles the risk of heart failure and boosted heart-attack risk by 42 percent, another JAMA study showed that Actos, a rival drug, actually lowered the risk of heart attacks, strokes, and death (though risk of heart failure did rise). Report

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