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This is a fact. Tysabri was reapproved as a monotherapy treatment only because when combined with Avonex, PML developed in 2 MS patients. This is documented in the FDA Sentinel trial. The FDA Affirm trial with Tysabri as a monotherapy had NO cases of PML.
I am very disturbed that medical professionals never uncover these facts and continue to spread the FEAR of Tysabri when it is so desparately need by those afflicted.
http://www.fda.gov/cder/dsn/2007_fall/2007_fall.pdf
Rituxan is listed as the cause in the above 24 cases of PML. As there is no documented FDA cases of Tysabri as a monotherapy causing PML, why is Tysabri so maligned?
Just out with no mention of the dreaded word. A master of deceit at work? I do not like to take such a vindictive approach, but show me my error. I am on a mission to clear Tysabri's name so that MS and Crohns's patients won't be deathly afraid of the safest and most effacious drug for their condition. I dare all to find the PML warning here in this new release:
http://biz.yahoo.com/bw/080125/20080124006309.html?.v=1
I realize health professionals are often overworked and face a myriad of new medical developements. The above facts are there to be acertained. Those patients afflicted with these 2 horrible diseases deserve to know the truth.
My mum had a colostomy bag fitted an was told half of her large intestine had been removed an that it would most probably be able to be reversed. since having it fitted she has become depressed, suicidal an now is a borderline alcoholic. i was wondering if there's any knew pioneering technology that would be able to reverse this colostomy bag as i'm at my wits end and want my mum to sort herself out an live a normal life????? HELP!
A worried son.
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I am a MS patient and have had 17 Tysabri infusions to date. There are many CD patients that post on a CD forum that are not afraid of Tysabri. For example, here is one post:"My take on it: I was in the Phase II and Phase III clinical trials for this medicine. In Phase III, I had an infusion every month or two (can't remember the exact schedule) for 18 months until the drug was yanked by the FDA. As I understand it, 3 people (out of about 3000 in the study) had the neurological illness, and 2 of them died. Everyone in the study was asked to get an MRI of the brain...To my knowledge, it has never really been confirmed that the drug had anything to do with this terrible tragedy. But for me, even if it was the cause, I would still want Tysabri for my CD...Why? Because it is the ONLY medicine I've ever had that gave me terrific results for Crohn's. I measured an 80% improvement in my symptoms. By that, I mean that prior to Tysabri, I was in a full-on flare up roughly 25 days out of a 30 day month. After a couple of months, I only had bad days maybe 5 days per month. A very dramatic improvement. Would I risk a 1% chance of death to get those results again?...Yep. In a New York minute."
Respectfully submitted, Lauren (MS patient & current Tysabri user)