There is so much misinformation on this thread, it's amazing. I have a loved one with MS and so I know ALL about Tysabri-- I've been following it closely since Phase II trials.
"I might be the 1 in 200 who's brain wacks out doesn't bother me in the slightest."
That number is coming from someone who is on your side of this debate. I do believe though that its use is to say that even if the number were that high that Severin would still be willing to try it.
Even though you mean well, this is false. This was the IMPUTED rate of PML (progressive multifocal leukoencephalopathy, the disease everyone is referring to that MIGHT be tied to Tysabri plus the use of other immunosuppressives) during the last Phase III trial. Since then Tysabri was approved by the US FDA + EU to treat MS patients, of which 26,000 are now ACTIVELY on the drug WITHOUT A SINGLE ADDITIONAL DETECTED CASE OF PML.
The folks who developed PML did it after exposure to multiple immunosuppressants-- lowering their body's ability to fight a very common pathogen, leading to the brain-wasting disease PML.
As a safety precaution, a restriction was placed on Tysabri sales that EVERY ONE taking it must register with the drugmakers, Elan + Biogen, and be consistently screened (including MRI) for any symptoms that might indicate PML. If your doctor doesn't know about that, or suggests you take additional immunosuppressants (like Remicade or azathioprine) then I'd stop and find another doctor, otherwise you're not going off the deep end as most people here seem to suggest.
And here is the same concern most of us have for James. His doctor wants to start the injections within a week from his original post.
Actual quote from his original post:
"-I get my first infusion next week. We'll know within a week if it's working."
A quick glance at his signature will let you know the medicines that he is probably still using. He just got off of Remicade and is still on Imuran (by his signature line). His doctor has never done this before (inexperienced) and is already going against the recommended use of the medicine.
I'm amazed at how rabidly people are suggesting removing an organ over trying a drug that is in WIDE RELEASE and is highly monitored by the FDA. There's a risk of dying on the surgery table or of the pouch failing that is probably far greater of contracting PML (disclaimer:conjecture). You can try Tysabri for 3 months (make sure to have a nice wash-out period for any of your previous therapies like Remicade) and make your decision then. Everyone has different risk tolerance, but that's how I would be thinking as it's not like you're taking some concoction from his back closet or taking a drug that is in limited clinical trials.
James was the first to say he was ready for surgery,(quote from his original post "-I pleaded my case for surgery now.") if that is how he wants to treat (cure) his disease then who am I to say he has to try every drug on the market (to include ones that are not approved for UC, just Crohn's and MS) before he can do that, considering I had surgery without trying Remicade or Tsyabri because I already had enough near death experience from immunosuppressants (ICU for 7 days, yeah there is a fatal side to immunosupressants they can promote sepsis along with other potentially fatal problems). There are approximately 1,000,000 people in the US who have IBD (Crohn's and UC) and around 25% to 40% of those who have surgery. This means that would account for 250,000 to 400,000 people who have successfully had surgery and are still alive today (that would be for ostomy and j-pouch combined). Surgery being used up to 40% of the time means it has to be one of the main treatments for UC but Tsyabri is not used by 25% to 40% of UC sufferers so surgery is more readily accepted. Next can you produce the statistics of how many people die on the surgery table? I have been searching for those numbers since that is the first thing anti-surgery people use to combat having surgery but I have yet to find a credible source (actually any source) for these numbers.
Total Colectomy with End Ileostomy May 27th, 2008