Originally Posted by komokazi

The apples and oranges comparison is easily supportable. In the original trials ,which drove the 1:1000 label (3 pml cases:3000 patients), the PML cases occurred in patients who were on other immunosuppressants (Avonex/1 recently had Remicade and Imuran). In the post-marketing setting, concommittant immunnosuppressants are specifically contraindicated i.e. shouldn't be being given. Different usages (apples vs oranges) can clearly affect the relative risks of an opportunistic infection.

In no way do I exclude the 4 PML cases from the 6 post-marketing cases confirmed. It does suggest given the patient numbers in the US and other countries excluding Germany and only 2 confirmed cases versus the patient numbers in Germany and the 4 confirmed cases that this isn't just random chance and normal distribution. I don't know how the Germans are using this drug compared to US Touch (although the husband of PML patient #5 postmarketing said that Germany had no periodic MRI monitoring) but I would certainly investigate to see if there are any identifiable differences that may explain this.

Originally Posted by Debbie D

If a patient feels that the quality of life is worth the risk, and is fully informed, then that is the barometer I wish to go by.