The National MS website reported on 10/23/09 that Europe, unlike the US, has no unified risk management strategy for the administration of Tysabri. As of 09/14/09 (Elan/Yahoo news), 2 new cases were reported in Europe. The BIIB website reported that in July, 2009, there were 11 PML cases with only 3 in the US. Since these cases are the only ones currently discussed, the chances are that the great majority of the new PLM cases are in Europe and its no wonder that the EMA is considering further steps to improve safety. Wouldn't this mean that they would adopt the US strategy because of its success in avoiding PML? The new cases could just be a tempist in a teapot if they could have been prevented.
I did get an email from the EMEA press office that stated as follows:
"The number of cases has changed since the press release was issued on Friday 23 October, and we are now confirming 24 cases following the receipt of an additional report over the weekend. The number relates to the number of confirmed cases since the approval of Tysabri in the European Union in June 2006."
There may be a case per week with as many patients as there are on Tysabri at this point.
The portion of my post referring to more sensitive tests was based on rowerx's post to that effect and a reading of teh manufacturer's press release, so please do not think that I arrived at that speculation independently. I have asked the EMEA if that may be a factor, and will report anything I hear back.
since you have a pipeline into EMA, a better question to ask them.... given the number of confrimed cases in Europe is over 1200% greater then in the US and the number patients taking it over 18 months is 400% more, medically speaking how do you account for this. If you can't, do you think maybe you should look into it.
Remember, you are talking about europe. the majority of which is lying, muslim, and wrong most of the time. as soch, they will withdraw the treatment ( to save medical expense outlay ) during the investigation period - then decide to implement the us system asap. go figure !!
I really doubt that they would withdraw Tysabri even for a temporary period. First they already reinstated it once. Second, the US model shows that PML is not a significant problem with a proper strategy.