Wednesday, September 16, 2009

Where Cancer Progress Is Rare, One Man Says No

---------- Forwarded message ----------
From: barry levine 
Date: Wed, Sep 16, 2009 at 9:03 AM
Subject: re: Where Cancer Progress Is Rare, One Man Says No

To the Editor:
   In most disease areas, the FDA requires evidence of both safety and efficacy before one can launch the first study in humans. In the Cancer area, only evidence of safety is required, because animal models of cancer correlate only weakly with the disease in humans. It  therefore seems obvious that the FDA must require evidence of efficacy coming out of these clinical trials, before approving a new therapy.  The definition of efficacy however is vexing.  If the only measure of efficacy is the extension of life, then patients will be chosen for these studies who are already near death. These patients are the least likely to respond to treatment. The consequence is that we have probably disallowed many drugs that would have shown efficacy if they had been tested against younger cancers.
Barry Levine

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