Quote:
Originally Posted by komokazi
Please stop mixing apples and oranges by including the original trial data with the post marketing experience. Patients deserve honest information about their potential risks. 6 PML cases in the post marketing setting with almost 25,000 at 12 months or greater and 14,400 at 18 months as of the end of Mar 31, 2009. It is also important to note that 4 of the 6 PML cases appear to be in German patients which begs the question of whether the German usage of Tysabri is outside the US TOUCH procedures. I'll leave the calculation of the PML risk to the biostatisticians.
|
Personally, I really don't think it makes any difference to the number of PML cases as whether it happened during the trials or afterwards. The bottom line is that the patient being treated with Tysabri ended up getting PML and that IS the concern.
I also don't think that it makes any difference that the German cases happened outside the Touch program. The German medical system, the last time I heard, was excellent. I read on another MS forum that the German's were being very honest when it came to reporting problems with Tysabri use.
I fear that the PML count for Tysabri users will continue to climb and make the MS patient's decision to try the drug even harder to make.
Harry