PML cases now reach 423
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HarryZ
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PML cases now reach 423
PML cases have jumped 5 more from last month...up to 523. Not known if any additional deaths took place.
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cheerleader
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Re: PML cases now reach 423
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
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
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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HarryZ
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- Location: London, ON, Canada
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Re: PML cases now reach 423
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.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
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cheerleader
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- Joined: Mon Sep 10, 2007 2:00 pm
- Location: southern California
Re: PML cases now reach 423
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
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
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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HarryZ
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- Location: London, ON, Canada
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Re: PML cases now reach 423
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
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