Date:Â Â Â Fri, 7 Sep 2007 20:02:32 EDT
From:Â Â Â Gary Takata <GTTakata@AOL.COM>
Subject: off topic -F D AÂ post marketing studies
The F D A has no rational system for post-marketing surveillance. After the
agency approves a drug for sale its authority is markedly diminished. The
ball
is left in the manufacturer's court. As a result, most post-marketing studies
have never been started. And guess what, nearly three-quarters of those
started remain incomplete. In the case of O N J it was clinicians and patient
advocates that identified this adverse event.
Gary
Dr. Sid Wolfe has been extremely vocal about the potential dangers of the FDA's lack of oversight once a drug has been approved. He has written about questionable drugs for many years in his publication, Best Pills, Worst Pills. This is his attempt to alert consumers about potentially dangerous drugs and their side effects. In many cases, he has predicted a drug's downfall several years before its recall, but not before many people had died from the drugs.
See:
http://www.citizen.org/hr...
This is a far reaching issue and one that may be beyond survivors/caregivers as we have enough to think about. But it does remind us that we need to look out for ourselves (I am not bashing the fda here). I have never faulted conventional oncology- if oncs depend on the fda and the fda doesn't have the resources for post marketing studies, then no one is keeping an eye on conventional therapies- onj is a prime example. David
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