As most of you know, Tysabri trials have been started for Multiple Myeloma (a form of cancer) The P1 trial started a few weeks ago.

There is a man, Frederick Baron, who is dying of MM. His family has asked for Tysabri. The Mayo clinic doc who is treating him said he only had a few days to live, and told them his only chance at recovery is Tysabri. Mayo happens to be one of the trial sites, even though they are not advertising it, due to the overwhelming number of patients who want in on this trial)

Mr. Baron also happens to be a lawyer who has sued a lot of drug companies and manufacturers ( think Merck and Vioxx, mesothelioma and asbestos) and a huge Democratic fundraiser.

He has had some big friends go to bat for him ( Clinton, Kennedy, Lance Armstrong, etc) and begged the FDA to allow him to have Tysabri. The FDA said ok. Then the family went to Jim Mullen ( the CEO of Biogen Idec) Jim Mullen said NO.

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