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Originally Posted by Grammie 2 3
I had #44 Mon; same as the 43 before it 
Yesterday I spoke with my case manager to get switched back to CO from AZ. He confirmed the 42 pml cases thru 3/10, 15 in the U.S and stated there are 60,000+ users (37,000 U.S.). I then asked how many infusions the 2 newest pml cases had-didn't know and then asked how many people had been on it over 3 yrs didn't know that either. Told him since the risk is higher the longer on it (as Biogen reported) we want to know how many cases of pml over 3 yrs and how many people on it (still on it) since 7/2006.
He did say the FDA still approved the 1/1000 ratio. I want the info like we got it before 7/24/09 and told him so.
Linda
I just read new info on pml cases 41 and 42. One had 30 infusions the other 34. |
Hi Linda!
Glad to hear that 44 went as well as all your previous infusions!
I can't help with the new cases of PML and the count of infusions right now but will see what I can find out when I see my doc next week.
The last time I saw him he explained the numbers and length like this: There are less people who have had more than 36 infusions than people who have had lesser number of infusions. The cohort is smaller and it cannot be compared to the greater number with less infusions. He said the data does NOT show more people with greater number of infusions coming down with PML at a higher rate than people with lesser number of infusions. He said the data actually shows that the rate seems to be trending down rather than up after 36 infusions.
He cautioned that since there is NOT a lot of data available since the number of people in our group is smaller, that the rate may change, but it is not being seen at this point. I believe that the last count I saw for people at 36-48 infusions was around 6400 people worldwide. If someone went out on a drug holiday, they restart at 1, so they are disqualified from the group. He said a drug holiday is considered as missing more than three infusions in a row, but that there are people like me, who missed one infusion or were late on an infusion due to some other reason than actually choosing drug holiday, that mess up the numbers too, but still get counted as being in a group. He also said there are people like Natalie, who are extending the time between infusions, but still receiving infusions, who are counted as being part of a group despite their changed schedule and that changes the group data, or who move from one group to another after being on a changed schedule for a longer time, due to the number of infusions missed despite being on Tysabri for a certain number of years
He said it is getting more confusing as time goes by and the numbers of people on Tysabri go up and that since he is not a statistician, he can't keep track either, but that some poor bugger at Biogen is keeping track of it all with a computer modeling system.
Biogen received a letter from the FDA just the other day, citing them for a webcast that didn't give enough detail/info/bad news about PML. According to Biogen, this webcast was for health professionals only and NOT for general population, and they can not control who releases the info to the general public. This may shut off some of the information that we, as searchers for info, have been getting from outside of "approved sources for patients"
As usual, only time will tell.
As an aside, there is still Alex's site for info but it almost seems like maybe the info train is slowing for him also:
http://chefarztfrau.de/?page_id=716
One thing I found as strange on his site was post # 40! It's what appears to be a sale of Tysabri on ebay/de ! Click on his one line comment and it takes you to the supposed page!
It's my sincere hope that the work being done on assays and biomarkers will help to clarify risks in the future, for all of us!
