Dr. Pazdur and his allies like to suggest that accelerated-approval advocates risk throwing science out the window. But in truth, there's no scientific reason to believe that large placebo-controlled trials -- in which treatments are tested against nothing, i.e., the proverbial sugar pill -- should be considered the "gold standard," as Dr. Pazdur believes. Withholding treatment is unethical in terminal diseases, and we have enough historical data about how cancer patients fare to judge new treatments without the need for placebo control groups.
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