MS. MANARITE: I'd like to ask you all to close your eyes for a moment because I want to paint you a picture. PSA 7,096.0. Prostate cancer to the bone, including hips, pelvis, spine and skull. Bone metastasis to the entire spinal cord, including the thoracic 7, 8 and 9, which included complete marrow involvement and spinal cord compression. This patient had to be totally sedated for MRI and bone scan because of undiagnosed pain. He did not know his PSA was over 7,000 because he had never had one. He was 58. This patient named Dominic awoke from sedation for his
imaging. He looked at his wife and said, "Baby, did they cut me because I'm so cold?" "No, honey," I said, "they didn't cut you. You're okay." Dominic was paralyzed from the waist down and his entire left side. This man is my husband.
My name is Jan Manarite. I am the Florida educational facilitator for the Prostate Cancer Research Institute. I am here on behalf of a grassroots initiative for advanced prostate cancer patients called Raise a Voice. Today, I am one voice. We went to a leading cancer institution for a second opinion. By the way, my husband did recover and four days later, after bilateral laminectomy he walked out of that hospital. I want you to know that. I am told that that doesn't always happen. So we went to a leading cancer institution in Florida, about two hours north of Fort Myers, very close to St.
Petersburg for a second expert opinion. They wrote my husband off and offered no treatment options. The one doctor we saw was a urologist who specialized in geriatric medicine. My husband was only 58. He said, "I would not give a bisphosphonate to my brother." He said something about efficacy, which I didn't fully understand at the time and an endpoint which was never proven at his institution. It made no sense to me even though I was not a physician and I knew little about prostate cancer at the time, so we fought for a bisphosphonate. We fought for Aredia because Zometa was not yet
approved. We fought the doctor, we fought the insurance company. My poor husband was just trying to fight his cancer. We won.
Dominic went seven years without a fracture, pathologic or because of osteoporosis, induced by hormone therapy which gave him no testosterone for seven years. That is because of the bisphosphonate that we fought for. The bisphosphonate is what he needed. A miracle is what we fought for and what we received.
I forgave that institution because God had bigger plans for this family. That was March of 2000. Today Dominic's PSA is about 2.7. Our son is 16. He's preparing for varsity football in his senior year in high school. He was nine when my husband was diagnosed in fourth grade. We purchased new memories because we fought. I forgave that institution because it is not the nature of science to be perfect. It is the nature of science to provide for humanity with excellent probabilities. One famous scientist said,
"It runs as follows. The state is made for man, not man for the state. The same may be said of science." Science is made to serve humanity, not humanity to serve science. This scientist went on to say, "These are old sayings, coined by men for whom human personality has the highest human value. I should shrink from repeating them were it not that they were forever threatening to fall into oblivion." That was Albert Einstein. It was 1931.
Dr. Mulé, you know more about immunology than most of us in this room will
ever hope to forget or pronounce. We are thankful for that and we are thankful to all of you because all of you here do something that we cannot. I forgave that institution.
Dr. Mulé, I'm going to ask you to forgive me because I'm about to quote you. You have a commentary that was published with Jeffrey S. Weber in the Journal of Clinical
Investigation, March, 2001. It was entitled, "How Much Help Does a Vaccine-Induced T-Cell Response Need?" The commentary was about breast cancer
immunotherapy, including HER-2/neu. At the conclusion, trial design was discussed, including this statement. "A secondary endpoint would be to correlate immune
response with survival, the ultimate challenge to the cancer vaccine field." If that be the case, then hasn't Provenge met the ultimate challenge?
Today there are things we know and there are things that we do not know. Here's what I do not know. Can Provenge be single-handedly responsible for reducing the
prostate cancer death rate of 27,000 per year, 520 a week? Since I got here 24 hours ago, 74 more men have died and their families are mourning right now. I don't
know if that's possible, but I wonder. Will you make history today by approving the first therapeutic immunotherapy for cancer? I don't know, but I wonder. Will other cancers eventually benefit from Provenge being approved, melanoma, breast cancer, lymphoma? I don't know, but I wonder.
It is not the nature of science to be perfect. No studies are perfect. None yield 100 percent results. It is the nature of science to be sound, to give us excellent probabilities with honest representation and to serve humanity. Today you bring us the science. We bring you humanity. Thank you.
(Applause)
DR. MULÉ: Thank you, Mrs.
Manarite. On behalf of the committee, I'd
like to thank all the speakers for sharing
your personal experiences and stories with
us. At this juncture, we'll break for lunch
and we'll plan to reconvene at 1:45.
