Quote:
Originally Posted by Riverwild
It now appears that Mr Baron's family has found a way, outside of the TOUCH program and outside of the P1 trial (only 12 trial patients) to get Tysabri and has been infused, despite Biogen Idec refusing to agree to the compassionate use granted by the FDA.
No one is saying how the family overcame the TOUCH program, but they did.
This case will bear watching, due to the unknown implication it will have, both on the trial for MM and for those who do not have influential friends to go to bat for them and have late stage MM, and on Mayo Clinic as one of the trial sites ( for allowing off label use without Biogen's permission)
To read more search on Frederick Baron or go to his son's blog at http://dembot.com/post/54498664/open...omment-3101930 |
Well, as you pointed out in a prior thread, we know there are many potentially very dangerous drugs being used off label, even for MS, so that's nothing new.
http://neurotalk.psychcentral.com/sh...hlight=Tysabri
I don't see that this will affect the current trial results in any way, since he is getting it off-label (and not as a trial participant).
I don't like that he got around the TOUCH program, but EVERYONE outside the USA (like in Canada) is getting Tysabri without the TOUCH program in place in their countries. NO!!! I don't like that at all . . . welcome to MY issue.
Cherie
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