Thread: Seminar notes
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Old 11-12-2008, 08:34 PM
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Join Date: May 2007
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Quote:
Originally Posted by lady_express_44 View Post
Perhaps the Biogen rep said 2:35K, or perhaps he said 1:35K . . . but since I was not there, I will not attempt to debate what was said or interpreted from that Biogen sponsored seminar.

Before we try to get into the “hearsay” that is out there though, let’s see if we agree (or if disagree) on the published “facts” to date, as I know them:

1. SIX people have been identified as having gotten PML while on Tysabri; two in the MS trial, one in the Crohn’s trial, two from Europe, and one from the USA.

2. The acceptable ratio of PML (from when it was brought back on the market) was determined on the basis that 3 people in the trials, of the approx 3000 people that participated, came down with PML; 3:3000 (or 1:1000).

3. The “mean” length of treatment, whereby PML surfaced in the trials, was determined to approx an 18 month period.

4. There were a cumulative 6600 people (including those in the trials) who have/had been on Tysabri for 18+ as of Aug/08.

5. The latest number cumulative (including those in the trials), that has been published for those who’ve been on Tysabri 18+ months, is 9500 patients.

I have links to all of the above statements, but if anyone has contrary written evidence, please provide it.

Once we determine where there are misconceptions on those points (above), we can rectify our perceptions and then can go forward with any further debate on "hearsay" and number crunching from there. P

Cherie

Thanks Cherie. Once again you have all the facts!
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