The controversy that has been haunting the FDA approval of Provenge (sipuleucel-T) still continues with major fireworks on all sides. I have written a number of pieces about Provenge in this blog, so if you are not familiar with this potential new treatment you might want to go back and read them. Pay particular attention to the piece posted on April 5.
Since Dr. Scher wrote his letter (posted April 17), Maha Hussain, M.D., the chairperson of the FDAâ€™s Oncologic Drugs Advisory Committee and a participant on the Cellular, Tissue and Gene Therapies Advisory Committee that did recommend the approval of Provenge at its March 29th meeting, has also written to the FDAâ€s commissioner, Andrew von Eschenbach. In her letter, she urges that the license for Provenge be held up until Dendreon completes additional clinical trials to more clearly establish both safety and efficacy of the treatment.
The response to these two letters was immediate. Groups of doctors, scientists, investors and of course advanced prostate cancer survivors have been meeting on the web and on the telephone. Many of them have posted point-by-point responses to both Dr. Scherâ€™s and Doctor Hussainâ€™s letters. (One of these many responses can be seen on my April 18th post).
In addition, the patient advocates continue to lobby for the approval of Provenge. Raise A Voice will also be making a formal response to the controversy. It is my understanding that 18 prostate cancer support organizations will be signing on to the support statement. I will post this statement when it is released.
The arguments continue and the pressure on the FDA is very significant. No matter what decision the FDA takes, there is going to be both happy and unhappy people.
Personally, I can only hope that the FDA approves Provenge so that patients, with the consultation of their doctors, will have the freedom to control their own bodies and make their own, informed decisions.
We are intelligent adults; we can understand the risks and the rewards. Let us make our own decisions.
Joel T. Nowak, MA, MSW
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