What should be required for FDA new drug approval: (1) Comparison with placebos or (2) Comparison with current standard therapy?
Dear Dr. Weisenthal: I thought you’d like to read these articles, if you haven’t already. With your advocacy of revising the chemotherapy drug concession (n.b. the system wherein oncologists are paid for, in effect, running retail pharmacies, with a built-in incentive to choose drugs for patient treatment based on the “spread” between actual wholesale cost and reimbursement), I’m sure you are an advocate for “comparative drug testing” instead of “comparing new drugs with placebos”. One of the commonest methods to test a new drug is not against an already effective treatment but against a placebo. However, what matters most to patients is not whether a company’s drug is better than nothing, but whether it is better than established treatments. As this article explains, what a way to start off with comparative drug testing. In reference to Taxol for ovarian cancer, I’m sure if it were tested against tried and true drugs already on the market (like melphalan or carboplatin alone), instead
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