Originally Posted by lady_express_44

Since we have to go to the Tysabri thread to read your notes . . . and then refer to this convo (about your notes) HERE . . . I'll cross reference the two threads:



As far as the ratio of PML cases they are "admitting" too, I'm not sure how they can make such a claim.

A very large % of that 35,000 have not been on Tysabri for 18+ months, but the "acceptable" PML ratio was determined on the basis that those “who received a mean of approximately 18 monthly doses of Tysabri" . . . "it was estimated that the incidence of PML was 1 case per 1000 patients over 18 months”.

http://www.pubmedcentral.nih.gov/art...medid=18360634

At that point they were suspicious/hopeful that the PML cases occurred only because of combined therapy, but unfortunately we know that those same people in the trials may have gotten it from Tysabri alone now ...

Last I heard, there were about 9,500 people (which isn't a mean, but the only # we have to work with) who are (or have been) on Tysabri for 18+ months. That is a cumulative number, which includes all the people that were on Tysabri in the trials, plus since 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 be now be closer to 6:9500 (or 1:1583).

They can't add in the people who've been on just a few doses to determine the current ratio 2:35,000 . . . when the original "estimation" of acceptable PML cases was based on an average of 18 doses.

They also can't include the number of people in the trials who were on 18+ months (giving a total of 9500). . . but then drop counting the three PML cases from the trials because a few weren't on monotherapy when they got it.

Cherie