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.