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Originally Posted by lady_express_44
It’s probably true of many countries with a “universal health care” system, as access to diagnostic testing is limited and prioritized. That might seem like all the more reason to NOT approve the drug in our countries to begin with . . . however, all that REALLY means is that they might not be able to catch (diagnostically) the PML in timely fashion to save people from death. It isn’t going to change the fact that people may get PML (in any of our countries) though.
Cherie
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I don't know too much about universal health care systems and the quality of care. But, you are absolutely right. People still have a risk of PML. And that is something a patient needs to take into account before going on Ty. (weighing the risk v. the benefit in the face of the facts, or at least as close as you can get). A patient takes a calculated risk in deciding to go on the drug. The protocol is not designed to prevent you from getting PML. The only thing you can do is mitigate
the effect of the risk if it manifests itself. It sounds like at least one of the doctors trusted his gut (and made the diagnosis based on the MRI and clinical signs) and did the plasma exchange on one of the cases very early -- this is the person who is stable, at home, and ambulatory. A protocol is better than NO protocol and I feel relatively confident in the ability of my MS Clinic to catch it early. But I thoroughly acknowledge there is still a risk of getting PML. And I guess you could say there is a risk that my clinic might not catch it early. But aren't there all kinds of risks in life? To each his own...some are more comfortable with risk than others. The nice thing is we have the choice.
Quote:
Originally Posted by JJLL411
Have any of you spoken with your neurologist regarding Biogen's report of the two new cases of PML - and what was your doctor's response regarding continuation of Tysabri?
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I didn't speak with my neurologist but I spoke with the head research nurse at the clinic where they have 150 people on Tysabri. In fact, this clinic had one of the 3 initial PML cases in the early Tysabri trials--it was the guy who lived, albeit very disabled. She and the docs have been discussing it and will meet next week again. They don't intend to pull anyone off. I asked about the "12 suspected cases of PML" that were reported. She claimed the clinic had been in touch with the FDA and that in fact these cases were not PML. Doctors are just being hyper vigilant which can lead to over reporting. I can't say I know this to be true. It's reassuring to hear her say this but you can't know for sure. I imagine there is a lot of hearsay and misinformation floating around as well.
Maybe we should move this discussion back to the Tysabri link announcing the 2 new cases of PML that was started yesterday? It's good of Cherie to post the link to that thread here so people can have access to it. But I don't want to hijack this thread. What do you all think?