Relativity

We have discussed CCSVI and the Liberation procedure a lot (also see the web TV video of the recent MSF program, where there is a CCSVI discussion), but we need to remember the risks and benefits of immunomodulatory therapy (perhaps they will complement each other).

At the latest report (as of December 1, 2009), there are 28 "cases" of PML (progressive multifocal leukoencephalopathy) in post-marketing Tysabri (natalizumab) use. There have been, unfortunately, 7 deaths.

This makes the risk of PML as follows:

Overall (post-marketing): 0.43 per 1,000
=> 12 months: 0.76 per 1,000
=>18 months: 0.86 per 1,000
=> 24 months: 1.28 per 1,000
=> 30 months: 1.05 per 1,000
=> 36 months: 0.63 per 1,000


The utilization numbers (as of October -- so not the same time period) are:

Overall: 60,700
=> 12 months: 43,400
=>18 months: 23,000
=> 24 months: 13,400
=> 30 months: 6,400
=> 36 months: 3,00


So, what does this all mean?


We will have to wait and find out.

- Dr. Daniel Kantor, MD BSE
Medical Director
Neurologique

info@neurologique.org
www.neurologique.org