Here's what I believe to be a paradigm-shifting post from InvestorVillage (by paul_1149). I share it to hopefully begin a dialog between IV and IHub that can make a difference as we move into the approval process. Understanding what we have is one thing. Helping those who need it to shout it to the world is yet another.
~ yanqui
<<this article will be seen by many and could be important in rallying the patient population in support of approval.>>
You bring to mind an important point. Anyone familiar with Elan's Tysabri saga knows how crucial it was to have MS patients testify at the Advisory Committee meeting for the reapproval of T. The paid lawyer shills - from competitors as well as MS organizations - were there to put down the drug and insist it was too dangerous, but they were swamped by one moving testimony after another, by sincere, desperate people for whom Tysabri was the best shot for getting their lives back. An extra day was scheduled because of the volume of their testimony. One or two people were allowed to testify via videotape, apparently an unheard of protocol.
As they spoke of their difficult human and familial circumstances and what Tysabri would mean to them, minds were changed. The upshot was that the AC voted unanimously for the return of Ty. That was completely unexpected. There is no doubt that the patients demanding the right to make their own health decisions made all the difference. Trust me, it wasn't any action by Elan or BIIB - one often wonders which side they are on - that helped us make it over the top.
The outpouring was organized and sponsored by the Yahoo ELN board. We donated to transport the MS patients to Maryland. We let them stay in our houses there, or paid for accommodations. We organized MS Patients for Choice, with its own website. We secured group rates for the AC video feed - $20 instead of $200, if memory serves. I say "we" did this, and that's accurate, but one person in particular did much of the organizing.
One thing we learned is that we couldn't count on the big name MS organizations, despite their claims to serve the MS community. They were, quite frankly, pathetic at best, and seemed to more than a few to have corrupt motives. We had to take matters in our own hands. We did, and Tysabri is now back on the market.
Something we should be thinking about as the AC approaches. How do the prostate cancer organizations and the medical community view Provenge? How loudly, if at all, will they call for its approval? Is there a role we can play to expedite PCa sufferers getting to the meeting and being heard?
The philosophical issue with Tysabri is similar to the root issue here: when a drug is effective and its safety profile is known, should the government or the patient have the ultimate choice in whether the patient uses the drug? Tysabri's safety was wrongfully impugned, but that was not widely known at the time; in time it will be exonerated. But there's no reason to suspect Provenge has any safety problems. Why on earth then should the government have the authority to delay or deprive its use? Especially with such a devastating disease, the patient should have the right to choose.
I believe Eschenbach and Gottlieb understand the philosophical issue, and want to make fundamental changes in the role of the FDA. But then there's the political reality in which the Agency must function, and no one is blind to this aspect either. That's why the PC community could assume a crucial role in the approval of Provenge.
p.
AI
