In today's JAMA, (http://jama.ama-assn.org/cgi/content/extract/299/12/1474 ), Drs. Psaty and Lumley echo many of the points on this blog over the last six months about ezetimibe and torcetrapib (see posts below.) While they stop short of calling for a boycott of ezetimibe, and their perspective on torcetrapib is tempered by Pfizer's early conduct of a trial with hard outcomes as endpoints, their commentary underscores the dangers inherent in the long-standing practice of almost unquestioningly accepting the validy of "established" surrogate endpoints. The time to re-examine the validity of surrogate endpoints such as glycemic control, LDL, HDL, and blood pressure is now. Agents to treat these maladies are abundant and widely accessible, so potential delays in discovery and approval of new agents is no longer a suitable argument for a "fast track" approval process for new agents. We have seen time and again that such "fast tracks" are nothing more than expressways to profit for Big Pharma.
Psaty and Lumley's chronology of the studies of ezitimibe and their timing are themselves timely and should refocus needed scrutiny on the role of pharmaceutical companies as the stewards of scientific data and discovery.
Do you have previous posts on torcetrapib? I couldn't find them.
ReplyDeleteWould you require a clinical trial with hard endpoints before FDA approval?
Thanks
Marilyn
Hi, Marilyn - Here is the link to the Torcetrapib post "Torcetrapib Torpedoed: When the hypothesis is immune to the data"
ReplyDeletehttp://medicalevidence.blogspot.com/2007/11/torcetrapib-torpedoed-sunk-by-surrogate.html
And to answer your question, yes, I WOULD require hard endpoints for any drug for a disease where alternatives forms of treatment exist. If it were my world, I would also not allow non-inferiority trials for "me too" products, nor would I allow companies to design and conduct their own trials. But, alas, it is clearly NOT my world.