Quote:
Originally Posted by yeahbut
I am that witness, Cherie what she said did come right from the rep's mouth!
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Quote:
Originally Posted by Riverwild
I am back to edit my previous post for a typo that I made.. I am not going to change the previous post, but make the change here so there is no question that the rest of the information stands as posted.
"They admitted that the monotherapy rate of PML is 2:35K+ at this point."
That statement should read 1:35K+
One patient, naive to ANY treatment outside of steroids, no interferons, no copaxone, no immunosuppressants, nothing. That is the ONLY patient who was truly a monotherapy patient out of every patient who has been diagnosed with PML and that is also the patient whose diagnosis is in question at this time.
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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
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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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