Yes, PML signs are similar to those of MS, but no Lumbar punctures have been done in the detailed followup testing of the patients who have taken Tysabri. In fact, probably more is now being learned about PML and its differences from MS than ever.
Tysabri on monotherapy has a sterling record. The problem is quite evidently immunosuppressant synergies, which the label already warns against.
As this article brings out, the safety profile of other drugs in accepted use is far worse than anything associated with Tysabri. I believe the drug comes back with a warning label and becomes the standard of monotherapy in a short time. Neuros will undoubtedly demand waivers from patients, but patients will want the drug. From what I've read, the EDSS scores are not a particularly great way to guage actual quality of life.
You said:
"Tysabri on monotherapy has a sterling record. The problem is quite evidently immunosuppressant synergies, which the label already warns against"
I just don't know too many MS patients who are willing to write off steroids as their first line of attack during an exacerbation.
As far as the EDSS not being a way to gauge quality of life, it takes into account 8 different functional systems.
Most people think it only deals with mobility, but it does deal with other symptoms, or functional systems.
Here's a link to the expanded scale.
http://www.mult-sclerosis.org/expandeddisabilitystatusscale.html
Do waivers hold up in court? Sounds like the best tort reform right there.