Quote:
Originally Posted by Riverwild
As I posted on the MS forum, Yabbit and I attended a seminar sponsored by Biogen/ MSActiveSource. This is going to be a long post!
I was specifically interested in the Tysabri questions people asked. I also got to speak to the two Biogen reps about my concerns and get some answers to some questions.
I took some rough notes on questions and this is what I got:
They admitted that the monotherapy rate of PML is 2:35K+ at this point.
There is some thought that Pt. #1 back in September may not have had PML at all!! He was the one who had no JCV showing in his CSF after first LP and an extremely low level after LP # 2. His MRI was reviewed by a number of neurologists and radiologists and most of them feel that it wasn't PML.
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Since we have to refer to this thread to read your notes from the seminar. . . and then another thread for the ensuing discussion . . . I'll cross reference the two threads.
Last I heard, there were about 9,500 people who are (or have been) on Tysabri for 18+ months, including those in the trials. From what we've been told publically to date, there were 3 cases of PML in the trials, 2 in Europe, and now one in the US. Hence, the ratio should now be closer to 6:9500, or 1:1583 . . . (not anywhere near 2:35,000 they are “admitting” to
.)
Further discussion is here though, so as not to bog down this thread:
http://neurotalk.psychcentral.com/thread59295-2.html
Quote:
Originally Posted by Riverwild
Biogen has stated that they will no longer be reporting PML cases the way they have in the past. They reported the EU cases because they were the first since return to market. They reported on the US case because the SEC required them to file an adverse event report (8K) with the SEC because it could affect the value of shares, and it was the first US patient since the return to market. They will be leaving it to the doctors to file adverse event reports with the FDA, since the labeling already reports the rate of 1:1000 chance of PML, and the rate so far is well below that.
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Do you happen to have a link to this information?
Thanks
Cherie
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I am not a Neurologist, Physician, Nurse, or Hairdresser ... but I have learned that it is not such a great idea to give oneself a haircut after three margaritas
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