re: /health/a-reminder-on-bone-health-and-osteoporosis

http://www.nytimes.com/2011/11/01/health/a-reminder-on-bone-health-and-osteoporosis.html?_r=1&scp=1&sq=bisphosphonates&st=cse

---------- Forwarded message ----------
From: barry levine
Date: Tue, Nov 1, 2011 at 4:09 PM
Subject: re: http://www.nytimes.com/2011/11/01/health/a-reminder-on-bone-health-and-osteoporosis.html?_r=1&scp=1&sq=bisphosphonates&st=cse
To: letters@nytimes.com


To the Editor:
  Before any new drug is approved for sale in the U.S. by the FDA, the manufacturer must submit evidence not only for safety and efficacy, but also how the drug is Absorbed, Distributed through the body's tissues, Metabolized and Excreted. In the case of the bisphosphonate drugs which are laid down in new bone and are never excreted, a sufficient safety trial would have to last to the grave. This study was never done for any of the drugs in this class. Once the FDA gave its approval, the Marketing divisions went into high gear and never looked back. The patients who have now been using these drugs for over a decade are therefore--wittingly or unwittingly--enrolled in this safety study. So far, the side-effects have been rare the risk/benefit ratio looks pretty good. As their patents run out, we will see the big companies flogging newer classes of drugs for osteoporosis. Until then, the very profitability of these drugs poses a barrier to R&D on something better.
Barry Haskell Levine