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Replies to #45682 on Biotech Values

Biowatch

04/24/07 11:06 PM

#45696 RE: blackcat #45682

BIIB >they really fought hard to not have to give up "Combo", in spite of knowing that it caused problems.<

They may have, but it was behind the scenes or not obvious to me at the meeting.

Regarding Tysabri approval for Crohn's disease, I don't think that will ever happen, and I don't see it getting used off label for that indication, although one of the public speakers had taken Tysabri for Crohn's and was asking that it be made available for MS patients.

There were so many people that wanted to speak at the meeting that they had a strict three minute limit per person, so many people could not finish their speech because they were in tears or had difficulty speaking due to their MS.

Since you know people who were there, perhaps you could answer ghhm's question about how common PML is, and in what patient populations. My impression was that it is fairly common but benign in people with a normal immune system. My impression was also that it can cause brain lesions which can be confused with MS if not diagnosed properly, but that it is a rare event.

As a side note, anybody who thinks that the FDA or advisory committee members do not realize that real people die and suffer from diseases that they are asked to review drugs for safety and efficacy have lost touch with reality in my opinion. They know it very well, and face many conflicting pressures. (e.g., How many Vioxx lawsuits are out there?)