MR. GROVE: Good afternoon. My name is Ed Grove. I have no financial connection with the sponsor, and I would also like to thank Raise a Voice because if I hadn't heard from them I wouldn't be here, and I think it's just very, very important for me to be here along with the rest of you.
My name is Ed Grove and I'm a prostate cancer survivor for 14 years. I've been chairman of the INOVA Fairfax Virginia prostate cancer support group for 10 years, and we have about 60 members in our email
list. We are very active and have a monthly meeting with a very rich group of speakers. I am also on the board of the Virginia Prostate Cancer Coalition along with Jim Waldenfels.
In my situation I currently have a slow-growing recurrent prostate cancer. It is asymptomatic, but probably not metastatic, and certainly not now hormone refractory. However, I strongly believe Provenge could help me and my situation, and have tried to get on existing Provenge trials to no avail because they are only for men with very advanced disease. Those of us with recurrent disease must be warriors actively fighting this disease, rather than passive warriors, and this is the reason why I am sort of looking out towards Provenge right now, because I have the sense, and again this is just an intuitive sense, that for people with - and it may be in the data too, but for people with less advanced disease, Provenge might even work better, and it might even work better earlier. So again I'm, you know, I really firmly believe that those of us with recurrent disease must be warriors actively fighting it rather than passive survivors, and I am so glad to see so many active warriors here today. So and another way I look at this is I believe that prostate cancer warriors, we all need as many arrows as we can get for our quivers, and Provenge really could be one of them, particularly since it could strengthen our immune system with minimal side effects.
Indeed, I have a unique journey here. My immune system has played quite a critical role in my journey with prostate cancer. Diagnosed with early-stage disease in `92 and after having had what I call plain vanilla external beam radiation in early `93 I was doing fine with a nadir PSA of 0.06. However, I also had thyroid cancer in 1966 and it was in remission, but in 1997
it came back again after 30 years. And so what happened to me is when I had this recurrent thyroid cancer in 1997 I had to go off my thyroid medication. This substantially reduced my metabolism. Then I was zapped by a significant dose of radioactive iodine, which further compromised my immune system. The good news is that my thyroid cancer was driven into remission and has not returned. However, during and following this treatment my PSA rose, at one point tripling at only nine months. Fortunately, as my immune system recovered from the thyroid cancer treatment, the PSA rise slowed.
During the eight years from 1998 to 2006, I was able to slow further the rise of my PSA, and this is because I found three non-invasive arrows for my quiver. The first was the active form of Vitamin D called calcitriol. A small study by Dr. Thomas Stamey at Stanford showed that calcitriol markedly decreased the PSA doubling time of radiation in surgery patients with recurrent disease. Calcitriol did a good job for me of slowing my PSA for two years.
I then began to use the alpha 5 reductase inhibitors, first proscar and later avodart. The second arrow worked for an additional four years. However, after this time my PSA had reached the mid-teens, but then I saw a West Coast study on leukine by Dr. Eric Small which substantially increased the PSA doubling time of most men with recurrent prostate cancer in this trial. The immunotherapy leukine which I was able to be able to use kept my PSA stable for two more years before it reached 18. However, because of reaching this level and it looked like the leukine was having to work hard just to keep it there, last fall I went on triple hormonal therapy, adding casodex and lupron to the avodart I was taking. It is working well, and I hope to 2 stop it after a year.
However, when I go off hormonal therapy and knowing that Provenge, like leukine, also strengthens the immune system, would hope Provenge would at least be available then for men with advanced disease. This is especially true, since clinical trials of Provenge have shown significant additional survival for men with very advanced disease. Once Provenge becomes available, I believe there's a further possibility that men with less advanced disease and good immune systems like myself could conceivably benefit markedly from it. I would really like to see Provenge be the fourth arrow in my quiver. I appreciate the time this committee has taken for careful consideration of Provenge and I fervently hope that you approve its use now.
(Applause)
