Today I heard back from a representative of the FDA about my concern and complaints surrounding the treatment of the public at FDA advisory committee meetings (my post of 11-20-07). It was explained to me that at the time of the advisory committee meeting for Satraplatin when the public was relegated to the rear of [...]
On November 19, 2007, the FDA posted a consumer update entitled "New Steps to Improve Advisory Committee Processes." The stated goal of these actions is to strengthen its advisory committee process in ways which are consistent with recommendations of the Institute of Medicine. "One of FDA's strengths is that we routinely enlist the nation's leading [...]
I have had the privilege of working with Leslie Mulkey, an independent video producer on a short "You Tube" video about Provenge. Our hope is that our question, "Should terminally ill patients have access to promising new therapies?" will become a part of the next national presidential debate. You can view our video by clicking [...]
Often, the FDA limits access to clinical trials to patients who have failed all other approved therapies. This means that we only evaluate potential new drugs on individuals who are already very sick and have been weakened by their disease as well as their prior treatments. Cancer cells "learn" how to survive treatments by mutating. [...]
The Life Extension Foundation has a series of "Alerts", one of which is about the problems at the FDA that I have been writing about recently. If you go to their alert web page at www.lef.org/lac you can have the following letter electronically sent to your individual congressperson (Senators and House Representative). It will take [...]