Scott, thanks for the visit.
I still have to digest all this, but a quick take may be that the most paranoid/pessimistic interpretation of Eddy's article would (1) take his as "official" position and (2) equate off-label with investigational. I do not think this is the most realistic interpretation.
Your conclusion seems to me a bit on the optimistic side, but is probably a lot more realistic than the extreme "paranoid" one given above. Clearly, a lot hinges on what is really needed, short of FDA approval, to establish that a particular treatment involving off-label use of a drug is "reasonable" and "supported by (phase II-like?) clinical data." I have not walked thru hospitals recently, but I do remember seeing material as you mentioned at UCSF or Stanford (a while back).
It will be interesting to consider this issue, for example, in the context of how the markets develop for Avonex, Rituxan, Avakine (if approved for Crohn's - will we see some early use for RA before CNTO moves for registration for that, larger, market?), and, one would hope, in the not too distant future, for anti-CD40L.
Thanks again for sharing your insights,
PB |
