Posted 1/18/2008 7:34 PM (GMT -6)
Hi everyone, just thought I'd stop by and drop off a link where you can read the CD testimonies of the following patients: Melissa Arnett, Dr. Doug Wolf and Dr. Bruce Sands (both gastroenterologists), and posted below is the most powerful testimony of Lisa Casanova, all which were given at the Tysabri trials in March, 2006 (in which I testified via videotape for MS) Take good care everyone, Lauren:
"MS. CASANOVA: Good afternoon. My name is Lisa Casanova. I own no stock in Biogen Idec or Elan Pharmaceuticals. My trip here was paid for with my credit care.
There has been a lot of talk at this meeting about the patient, the Crohn's patient. I am 29 years old and I have had Crohn's disease since I was 7.
I was a participant in the Phase III clinical trial and open label trial was natalizumab at the University of North Carolina, Chapel Hill. I am here to tell you to bring Patients [Tysabri].
When I enrolled in the [Tysabri] trial, it was because I was looking for options. I had a very inflamed stricture and my colon was making me verysick. I knew that I was going to need surgery to remove it. That was inevitable, but I was looking for choices to allow me to delay that.
When I enrolled in the [TY] clinical trial, it was a wonderful drug. I started to get better almost immediately. I know objectively that I was getting better, because my gastroenterologist would examine the stricture, I knew that it was getting less inflamed, and I felt better, my quality of life improved.
I was able to do things like get through an entire day of work without trip after trip to he bathroom. Most people take that for granted and don't know what it is like when you are everything and run off to the bathroom because, of course, you have a mental map in your head of where every single one is, and hope that it is available, so that you have a place to wait out the pain and the nausea just so that you can go back to work and get through the day.
[With TY] I was able to work, I was able to make significant progress toward my Ph.D., and do the things I wanted to do like be able to sit through an entire class lecture, to be able to play a string instrument because I could last through a whole concert.
When Tysabri was taken off the market, I couldn't have it anymore, I started to get worse again, I was getting sicker, I was in pain, the inflammation was getting worse, and I knew it was time for surgery.
So, I went under the knife in November of last year . I had a sigmoidcolectomy, and I ended up with an anastomotic leak and an abdominal abscess that took six months to heal. I was let out of the hospital with a pick line and an abdominal drain that drained the contents of my intestine into a little container that I carried around in my pocket in any attempt to heal it.
I was so sick my mother came to live with us, and she would pat me and tell me what a good day I had had on the days when I could get up, take a shower by myself, and push the grocery cart around the store while she shopped. That is what recovery from surgery was like for me.
Did I know the risk before I went under the knife?
Yes, I did. I understood the risks just like I understood the risk when I enrolled in a clinical trial of an experimental drug [TY], and if I could go back and do it again, I would make the same choices. I would do it again.
The risks that I took are the reason that my life is moving forward and it is always going to be that way for me. I mean I am 29, I am going to have Crohn's disease for the rest of my life, and I am facing that continual choice between one risk and another. I would love to have completely effective treatments that had no dangerous side effects, but that only exists in some fantasy world. In the real world, like I said, I do ok
Remicade, which has its risks of infection. I maintained on azathioprine, which has its risks of liver damage, of infection. Both those drugs have long-term risks of lymphoma that we understand only poorly. Right now I use biphosphonate with all their attendant risks to treat the osteopenia that
I have from years of corticosteroid therapy. I dropped below the fracture wrist threshold when I was 25. So, that is what it is going to be like for me, a tradeoff of one risk for the benefit that I can get out of any given drug.
If you bring Tysabri back on the market, are the risks significant? Yes, they are. If that means that it has to be in a strictly regulated program like the RiskMAP that they have described here, then, that is the way it should be, because that is an acknowledgment of reality that risk can never be eliminated, it can only be managed, and we deserve the chance to assume that risk in exchange or the benefit that we can get."