---------- Forwarded message ----------
From: barry levine
Date: Thu, Oct 9, 2014 at 10:07 AM
Subject: re: Finding Clues in Genes of ‘Exceptional Responders’
To the Editor:
in 2014, the U.S. FDA still classifies cancers by tissue of origin. E.g. a thyroid cancer is one disease; a uterine cancer is another. This puts our regulators at odds with the researchers, who know that all the body's cells have the same genes and can be driven berserk by the same molecular defects. This mismatch has real consequences. Researchers on a drug that blocks e.g. mTOR would have to run two different clinic studies against "uterine cancer" and "thyroid cancer" even when they are driven by the same mutations and could be expected to respond to the same drugs. Richard Pazdur (head of FDA, oncology) acknowledged this much by 2005. We need to bring our regulatory framework into line with the best modern understanding of the science.
Barry Haskell Levine