Quote:
Originally Posted by komokazi
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.
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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.
Quote:
Originally Posted by Debbie D
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.
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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
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I am not a Neurologist, Physician, Nurse, or Hairdresser ... but I have learned that it is not such a great idea to give oneself a haircut after three margaritas
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