In other words we are killing too many people so we need to add additional safety language. Rather than just reading the news article I went to the FDA website to look at the new disclosure. Additional Information for Patients. The change revolves around testing for JCV antibodies, but even negative you can still end up getting PML.
What immediately struck me was that “201 cases of PML have been reported among approximately 96,582 patients treated with Tysabri worldwide through January 4, 2012.” Or a little over .2% of the patients.
The other thing I learned about Tysabri is that it is a “risk” to take it longer than two years. This puts it into the category of the most aggressive chemotherapy drugs because if you take them longer than that they definitely start causing cancer. Tysabri is an immune suppressant so does it definitely cause cancer after more than two years or something else (e.g. death)?
I know Tysabri is effective, but taking everything into account I do not see it as a net gain.