13th Case of PML from Tysabri posted today; June 26th
 

Three cases of PML from the trials + 10 since the reintroduction; June 23, 2009, 30 months, MS, Ex-US:

http://investor.biogenidec.com/phoen...82&p=irol-TPME

That's 3 in June/09 alone.

Cherie

Sorry Cherie, but the link wouldn't work for me. :(

me either. link is broken or dead.

Can you edit and resubmit?

It works for me. If this helps anyone.

http://investor.biogenidec.com/phoen...82&p=irol-TPME

or try the product page for more..

http://www.biogenidec.com/site/tysab...on-center.html

You gotta be quick to catch anything on the internet about PML and Tysabri :winky:.

Not sure if the links are working for others, but here's the breakdown:

Progressive multifocal leukoencephalopathy (PML):

In the period between the reintroduction and approval of TYSABRI in July 2006 and June 26, 2009, the following cases of PML have been confirmed:

June 23, 2009 30 months MS Ex-US
June 19, 2009 34 doses MS Ex-US
June 10, 2009 35 doses MS Ex-US
May 18, 2009 24 doses MS US
April 15, 2009 31 months MS Ex-US
February 5, 2009 12 months MS Ex-US
December 10, 2008 26 months MS Ex-US
October 29, 2008 14 doses MS US
July 31, 2008 14 months MS Ex-US
July 30, 2008 17 months MS Ex-US

Cherie

Just to make the details better I've converted doses to months with the help of the detailed PML case summary

Ex-US Cases

Jul 30, 2008 - 17 months started Feb 07
Jul 31, 2008 - 14 months started May 07
Dec 10, 2008 - 26 months started Oct 06
Feb 5, 2009 - 12 months started Feb 08
Apr 15, 2009 - 31 months started Sep 06
Jun 10, 2009 - ~32 months started Nov 06
Jun 19, 2009 - ~31 months started Oct 06
Jun 23, 2009 - 30 months started Jan 07

US Cases

May 18, 2009 ~ 22 months started July 07
Oct 29,2008 ~ 13 months started Sep 07

Notice the clustering of cases in the group of Ex-US patients who started between Sep 06 and Feb 07. 6 out of the 8 cases.

Are you thinking there may have been a bad batch or something like that, Chris?

I think the length of time on the drug might have more to do with results than anything else. 6/9 were on for 22+ months, and ALL were on for 12+ months.

Cherie

I'm not a scientist so I don't know. Clearly something is different in Europe as the same drug batches are used in the US as in Europe. Length of time is certainly one variable but clearly not the only one as its not borne out in the US data which has more patients for longer durations. Do they withhold Tysabri infusions in Europe when there are active infections? Do they use different drugs in Europe to treat infections? Does it have to do with cleanliness habits in the US versus Europe? Sewage treatment? Again, I don't know and its just wild as speculation.