Quote:
Originally Posted by the_busy_ant
it is merged...I was actually just being imprecise by saying "tysabri", when what I actually meant was "tysabri OR natalizumab"
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Cool!
So why is it that when I type in "natalizumab" a seperate database comes up
:
http://www.fdable.com/search/aers/ad...y/2fcb1d403a66
Also, do you know why reports for Avonex, Betaseron, etc. all pop up in the database when I request only Tysabri?
http://www.fdable.com/search/aers/ad...y/9eb4fec4b9b6
Quote:
Originally Posted by the_busy_ant
short answer: no. Long answer: no. never. I work in biotechnology.
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So, curiousity got the cat . . . why are you responsible for updating the FDAble AERS then? Moonlighting?
Quote:
Originally Posted by the_busy_ant
you are correct in thinking they are "POTENTIAL" cases. Since anyone can file an AE report, the reports themselves span a wide range of 'quality of verification'. I believe the makers of Ty have explicitly stated that while AERS shows a # of suspected PML cases with Ty, there are only a small # that have been confirmed independently.
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So are all cases of PML that are reported through AE SENT for independant confirmation then?
It would seem to me that people reporting PML cases shouldn't be doing so willy nilly. They must have some convincing evidence to venture such a "guess". . .
You might remember when the Crohn's patient died from what was reported as some other condition, and eventually his cause of death was re-evaluated. Not sure how they did this
, but they determined in the end that it was PML. That was before the days when they "looked" for PML, of course, but clearly the dx isn't cut and dry even now.
Do you have any idea what happens when a AE reported PML case is "suspected"? Are all of these cases flagged and sent for independant analysis, or ?
Quote:
Originally Posted by the_busy_ant
There may be a separate reporting system (in the U.S.) specifically designed for Ty...I think you are referring to the Touch(tm) risk minimization system. However, anything that goes into Touch should ultimately also makes its way into AERS as well.
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That reminds me, TOUCH is only in the US and about 1/3 (I think) of the patients currently on Tysabri are from outside the US.
Is the AE system only for US reporting too, or does it include all countries?
Yes, I guess it would the the "risk minimization system", but I've not been able to find anything that describes the established procedures for reporting through that system.
Quote:
Originally Posted by the_busy_ant
I think skepticism is a good rule for any bit of information...and your comfort level may vary depending on the specific source and the specific information.
So far, I am the only person who has added to the wiki and my information has come exclusively from government data...so it's a matter of trusting me...and the US government.
the way that I look at Wikis in general is that they should be a "jumping off point" for additional study. But they *can* be rather informative.
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Yeah, I just thought it was interesting to see a government site hook up to Wiki, but that's cool.
Quote:
Originally Posted by the_busy_ant
p.s. I read the other day about a woman with MS who is planning to climb Everest!
pretty impressive considering that you can't get me to climb a chair in my kitchen without a handful of tranquilizers.
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Do you have MS too?
You've been a big help, thanks!
Cherie
__________________
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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