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Capitol Health Call
April 9, 2008

Surrogate End Points Queried

JAMA. 2008;299(14):1657. doi:10.1001/jama.299.14.1657-a

The Government Accountability Office (GAO) will review a drug approval process used by the Food and Drug Administration (FDA) that evaluates safety and efficacy based on surrogate end points in clinical trials.

The review comes at the request of Sen Chuck Grassley (R, Iowa), who said March 4 that the FDA had approved several drugs that appeared to have little to no effect in protecting lives and improving health. Grassley singled out bevacizumab (Avastin, Genentech), rosiglitazone (Avandia, GlaxoSmithKline PLC), and ezetimibe/simvastatin (Vytorin, Merck/Schering-Plough Pharmaceuticals). Grassley said the FDA had approved the drugs based on their effectiveness in achieving surrogate end point goals (such as limiting tumor growth) without determining whether the drugs improved health.

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