Quote:
Originally Posted by ewizabeth
Wow RW, I hope it will work for him at this late stage.  Too bad he couldn't have received it sooner.
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While I certainly hope that it works out for this man, it brings up some very interesting questions, Wiz.
For instance: what if he dies anyway.
Does Tysabri again get listed as the cause of death?
If he does die, does it affect the stats for the P1 trial despite his obtaining it outside of the trial and outside of the TOUCH program?
Should a very well off man who has a history of huge lawsuits against drug companies and who has influential friends get a drug that others with the same disease and at the same point who are NOT well off and well connected have no chance of obtaining?
Should a trial center be suggesting or allowing treatment with a drug that they have agreed to run a Phase 1 trial for, after the person hasn't met the criteria for the trial, the trial is full, and his inclusion may skew the trial results since it is only a 12 patient study, especially when the drug in question is NOT allowed to be prescribed off label for ANY reason by the requirement of the FDA, who wouldn't allow that drug back to market without strict guidelines and monitoring?
The family had stated that they would NOT sue or hold Biogen liable for anything that happened, but the history of this man and his law firm precludes me believing anything.
I just do NOT want any chance of Tysabri being pulled or maimed further by off label use regardless of who or why. I for one cannot afford further disability or relapse, and I won't be happy if something happens to endanger any of us on Tysabri. We've already been through this once and it didn't go well for a whole lot of patients who are now disabled because of it.