Calculate it however you choose, Chris . . . the numbers are all there, so if reducing it by three (or taking out the German cases) makes YOU feel better, go ahead. Whatever floats your boat.

The original risk ratio of 1:1000 was calculated on the basis of how many had used it for 18+ months. They calculated the mean amount of time that everyone in the trials had been on it, and there were 3 cases of PML, so that gave a ratio of 3:3000, or 1:1000.

We don't have a 'mean' of 18 months on the market yet, so the best numbers we can use for comparison is how many have simply been on for 18+ months. I provided those numbers, which is 24,400 people with 9 cases of PML to date, or 1:2711.

Cherie

ummmmmm

careful with the tone of these responses please

"apples and oranges" and "deserve honest information" and "whatever floats your boat" are bordering flaming each other and not conducive to an intelligent discussion of the topic, but reduce it to a spat.

if you must disagree, please do so agreeably

we really dont want to have to intervene here but if the guidelines are broken we have to

thanks

All I know is that those numbers don't mean squat to most of us...my eyes cross when I see ratios, etc. I truly get brain fog...
What the discussion needs, as far as I'm concerned, is how those who are on Ty feel about the risk/benefit ratio...
I have talked to a few people who are on Ty, and they feel it's worth the risk...they feel so much better as far as their quality of life is concerned. So many of us on DMDs have side effects or do not get relief from our sxs.

If a patient feels that the quality of life is worth the risk, and is fully informed, then that is the barometer I wish to go by.

EACH of the PML cases has it’s own individual “story”, and I'm really not interested in re-hashing each case with you again.

I think it suffices to say that some were on Avonex, some had/were treated with steroids, and yet others were only ever previously on DMD’s or NOTHING before starting Tysabri. Some come from America, others are from the UK. Some lived & some died. All very sad.

All 9 got PML, and they wouldn’t have gotten it without Tysabri.

Fully informed means understanding the risks . . . at least it does in my opinion.

This information is NOT posted for the benefit of those who've already decided 1:1000 is a comfortable risk ratio. It is an update for those who HAVEN'T yet decided.

Cherie

What's sad is what MS does to people physically and mentally and the corresponding impacts on family and friends.

Sorry, but the PML cases do have to be looked at at least in groups - PML risk and outcomes in the trial where they were using other immunnosuppressants/weren't looking for it/treating it and PML risk and outcomes in commercial use where they are using it in monotherapy/they're looking for PML and trying to treat it.

As I've said before risk is a function of chances of occurring and outcome of occurrence. If your concern is to fully inform patients considering Tysabri please give them the full and accurate information.

Tysabri scares the crap outta me! I dont believe I would ever consent to be on it. Just way too scary for me. I think those that do chose it are incredibly brave, and have boat loads more courage than I could ever muster. I think it has much much more to prove before I would even think about it. But thats just me.

Stay tuned. Biogen and Elan are working on new ways of detecting PML earlier and identifying those most at risk.

[QUOTE=lady_express_44;498927]Calculate it however you choose, Chris . . . the numbers are all there, so if reducing it by three (or taking out the German cases) makes YOU feel better, go ahead. Whatever floats your boat.


The apples and oranges comparison is easily supportable. In the original trials ,which drove the 1:1000 label (3 pml cases:3000 patients), the PML cases occurred in patients who were on other immunosuppressants (Avonex/1 recently had Remicade and Imuran). In the post-marketing setting, concommittant immunnosuppressants are specifically contraindicated i.e. shouldn't be being given. Different usages (apples vs oranges) can clearly affect the relative risks of an opportunistic infection.

In no way do I exclude the 4 PML cases from the 6 post-marketing cases confirmed. It does suggest given the patient numbers in the US and other countries excluding Germany and only 2 confirmed cases versus the patient numbers in Germany and the 4 confirmed cases that this isn't just random chance and normal distribution. I don't know how the Germans are using this drug compared to US Touch (although the husband of PML patient #5 postmarketing said that Germany had no periodic MRI monitoring) but I would certainly investigate to see if there are any identifiable differences that may explain this.