View Single Post
Old 12-31-2008, 03:38 PM
komokazi komokazi is offline
Member
 
Join Date: Dec 2008
Posts: 192
15 yr Member
komokazi komokazi is offline
Member
 
Join Date: Dec 2008
Posts: 192
15 yr Member
Default

Cherie,

I read through your link and all I can say is that the issue is as clear as mud. My link to Biogen's charts clearly shows that they did not include the prior clinical trials in their safety numbers reported there. With your link it is impossible to tell if the numbers exposed to Tysabri include the prior clinical trials or not.

With it being as clear as mud, it is clearly up for interpretation. I still believe my interpretation is correct as evidenced by my example but this is clearly not enough to sway you. (At the end of the day I live with this risk, literally as I'm taking the drug) We don't have to agree. The only takeaway we both should have from this discussion is that posting PML risk numbers is fraught with potential for error/misinterpretation. Is this fair for someone contemplating using this drug? The label says 1 in 1000 with new wording that the rate in monotherapy appears to be less than this. Let's let the regulators decide what the PML risk is in monotherapy based on the correct patient exposure data in monotherapy.

Chris
komokazi is offline  
"Thanks for this!" says:
Becca44 (12-31-2008), SallyC (12-31-2008)