MR. CHIN: Good afternoon. I have no conflicts of interest to declare. I am here as the coordinator for the speaker's bureau of the Virginia Prostate Cancer Coalition, member of the planning group of the Fairfax INOVA prostate cancer support group and as a member of the Prostate
Pointers listserv.
I was diagnosed about three years ago, shortly after retiring from government service. I got my diagnosis shortly after retiring and I thought maybe I should have
gone to the beach and gotten skin cancer instead. But that was not my fate and I'm here today spending time with you, your valuable time and I thank you for that.
At my support group I meet some of those men who are metastatic, are hormone-resistant and are with or without symptoms. They become different people when they hear that they have moved to the next stage, a stage that takes them closer to their final hour. They are bewildered, they are often aimless and they are scared. That has been repeated. You've heard that before.
Noone wants to die a hopeless and painful death, and worst of all noone gladly accepts chemotherapy, the ultimate treatment now that you have run your course with the limited treatments available to men with hormone-resistant prostate cancer.
Typically you have suffered through surgery and/or radiation or cryoablation, and if the primary treatments fail you then have to face the fatigue, the mental exhaustion of hormonal therapy. Finally, with hormone resistance you are left with just chemotherapy where they burn the rest of your insides futilely, trying to kill the cancer cells. The side effects are so bad that men refuse to accept the treatment because they choose to have an improved quality-of-life in their final years.
But lo, on the horizon comes a vaccine which has few side effects, Provenge, because it is autologous and uses dendritic cells from one's own body to spark the body's own immune system. Hope is restored. Little or no side effects, and yet one is able to prolong life. I've spoken to many men and they want this. They want another option besides the pain of chemotherapy. They want something that will work and allow them to keep the quality-of life, especially if it is to be the last years of their life. It is important to them that they live it well. They and their families demand it. It is also important that they attempt to extend their lives. Provenge offers them this, and for the many men that have prostate cancer I ask that you recommend to the FDA that they approve this
revolutionary and historical prostate cancer
treatment.
At this point in my notes I would have - it says I would have introduced Andy. And I saw Andy, he's a member of my prostate cancer support group. I saw him last night, and I would have asked him to hold up his hands and picture this. He had Band-aids on each one of his fingertips. I don't know about you, but years ago I lost a thumbnail because I hit it with a hammer, and it was painful for months until another nail grew back. In his case all 10 of his fingernails fell off because of the Taxotere treatment that he's on. So it must be very painful for him, and he would have brought it home, but he had to leave early because he was feeling exhausted.
Anyway, I understand that Taxotere was approved as a primary chemotherapy when it extended life over placebo by only a couple of months. Provenge extends life more than twice as long without the pain. The loss of hair, fingernails, vitality, your dignity is something you don't lose with Provenge. Men will gladly trade the side effects of the present hormonal and chemotherapy side effects for the few and transient side effects associated with Provenge and gain more life in the process. The public perception is that Provenge is safe and effective and should be approved.
By recommending approval you will give up to 50,000 waiting men, maybe more, new hope and new life with an alternative treatment that works. You will be making substantial history today by approving this new alternative treatment, and I thank you from all those men that you will help today. Thank you.
(Applause)
DR. MULÃ: Thank you, Mr. Gillespie.
