New Cautions About Long-Term Use of Bone Drugs

http://well.blogs.nytimes.com/2012/05/09/new-cautions-about-long-term-use-of-bone-drugs/?ref=todayspaper

---------- Forwarded message ----------
From: barry levine 
Date: Thu, May 10, 2012 at 10:11 AM
Subject: re: New Cautions About Long-Term Use of Bone Drugs
To: letters@nytimes.com


To the Editor:

    Twenty years ago, when Merck sought FDA approval for the first bisphosphonate drug, its terminal half-life was already  known to be very long. Now it's reported to be ten years. Logically therefore the safety studies would have had to run at least sixty years i.e. until the drug had cleared from the body. That would have been an extraordinarily expensive Clinical Trial.  Of course that was not done and a slew of similar drugs were approved with no more scrutiny. So now the FDA is trying to fix what it didn't do right the first time.  We wish them well. But the American public looks to the FDA's approval to mean that a drug is safe. That's a conclusion that can't be rushed for the manufacturer's convenience.

Barry Haskell Levine