PML cases now reach 423

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

PML cases now reach 423

Postby HarryZ » Fri Dec 20, 2013 11:44 am

PML cases have jumped 5 more from last month...up to 523. Not known if any additional deaths took place.
User avatar
HarryZ
Family Elder
 
Posts: 2454
Joined: Tue May 25, 2004 3:00 pm
Location: London, ON, Canada

Advertisement

Re: PML cases now reach 423

Postby cheerleader » Fri Dec 20, 2013 8:09 pm

Harry--
I also recommend that patients consult the eHealthMe.com site, to see what the FDA, doctors and patients are reporting.
EHealthMe has reports from 90,286 patients on Tysabri, with 2,583 patients reporting PML.
http://www.ehealthme.com/ds/tysabri/pml
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
User avatar
cheerleader
Family Elder
 
Posts: 5015
Joined: Mon Sep 10, 2007 3:00 pm
Location: southern California

Re: PML cases now reach 423

Postby HarryZ » Fri Dec 20, 2013 9:04 pm

cheerleader wrote:Harry--
I also recommend that patients consult the eHealthMe.com site, to see what the FDA, doctors and patients are reporting.
EHealthMe has reports from 90,286 patients on Tysabri, with 2,583 patients reporting PML.
http://www.ehealthme.com/ds/tysabri/pml


Mind boggling!! How can there be such a huge difference in what is being reported on the German site?! That would place the risk factor much higher than what Biogen has been telling us. I knew Tysabri was dangerous but this is beyond dangerous.
User avatar
HarryZ
Family Elder
 
Posts: 2454
Joined: Tue May 25, 2004 3:00 pm
Location: London, ON, Canada

Re: PML cases now reach 423

Postby cheerleader » Sat Dec 21, 2013 12:05 pm

Harry--

I compiled this information on PML reporting, because I wanted to understand how adverse effects were tabulated. Here is what I learned.

Biogen is not required by the FDA to keep tabulation or a compilation of all deaths or side effects due to Tysbri--they are only required to record adverse effects directly reported to them by doctors, utilizing a particular protocol.
http://www.tysabrihcp.com/pdfs/PML_Brochure.pdf

This is why they are being sued by patients who now have PML, who believe they were not told of the true risk.
http://www.bostonglobe.com/business/201 ... story.html

The FDA has a self-reporting system for patients and physicians to report adverse affects to drugs. It is called the FDA Adverse Event Reporting System. It is not for consumer use, and therefore, it is not possible to search for specific drugs (like Tysabri) and find out adverse events. IT IS NOT A USER FRIENDLY SYSTEM. You cannot just seach "Tysabri" and get deaths....you get a 25 MB file, and have to go thru it with a fine tooth comb. And right now, the records only go thru 2012.
That means that adverse effects for 2013 are not even included yet.
http://www.fda.gov/Drugs/GuidanceCompli ... 082193.htm

What does this mean? We have no clue how many cases of PML exist right now.
The EHealthMe site is very important, because it keeps track, in real time, of reported adverse effects, and is updated regularly by patients, doctors and the FDA.

Hope this explains why the numbers are so different, depending on the source.
cheer
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
User avatar
cheerleader
Family Elder
 
Posts: 5015
Joined: Mon Sep 10, 2007 3:00 pm
Location: southern California

Re: PML cases now reach 423

Postby HarryZ » Sat Dec 21, 2013 2:22 pm

Thanks Cheer...

As usual, you've done your research!

It would be nice for every potential Tysabri patient be given this kind of information but we know in the world of big pharma that just won't happen. Too much potential interference for revenue generation!

Harry
User avatar
HarryZ
Family Elder
 
Posts: 2454
Joined: Tue May 25, 2004 3:00 pm
Location: London, ON, Canada


Return to Tysabri (Antegren or Natalizumab)

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: No registered users