Cheryl,

What is a RiskMAP? How does the actual RiskMAP actually aid in reducing risks to patients? I thought it was only some kind of thing where side effects are required to be reported, etc. or is that the TOUCH protocol which is different and is the reporting arm of this? But I've heard stories about people on T who appear to be having serious side effects aren't going through any special process. In fact, some are just continuing on with tx in spite of what sound like dangerous circumstances! From what I've gathered about the whole thing, it's not stringent or formal, it's pretty loosy-goosy.

If people testified at the FDA hearing (in support of the reintroduction of Ty), then they DO have an obvious bias. Why would they be involved, I assume regular every day consumers, in the development or monitoring of this RiskMAP? Wouldn't the FDA or Biogen be required to have its own PROFESSIONAL independent group responsible for overseeing this? It seems strange to me that laypeople such as yourself who only became known in any way because of their testimony at an FDA hearing to support Ty's return, are somehow involved in this process. That makes me uncomfortable. Are you being paid by someone?

I'm thinking about going on Ty. Is this RiskMAP something that would better help me make an information decision? I don't really understand your point about it highlighting the risks... obviously any doctor can access the study that shows Ty's efficacy. Isn't the whole point of this RiskMAP thing to properly characterize and delineate ALL the side effects to better gauge the risks? They are trying to make sure that people dying from Ty don't slip through the cracks like it did during the clinical trial. Aren't they?

I guess I'm a little confused by it all. And I take issue with the statement that "Biogen lost money because it was pulled". On the contrary, Biogen MADE money because it fast-tracked its little product so it could hit the market a year earlier. So it actually made money by doing so, just not as much because it had to be pulled for a while. I am annoyed that the cost of it has apparently gone up too... it already was outrageous. To think they are passing along these additional costs to the customer really irks me. They should have dropped the price to encourage customers to come back even though they forgot to properly evaluate its safety before putting it on the market to begin with. THEY should absorb these costs, not the consumers! (ok, wishful thinking I know!)