"Control issues" are exactly the point of the FDA regulatory process - protecting both patients and non-expert clinicians from unscrupulous advertisement and proposed indications for pharmaceuticals. Based on your attitude throughout this thread, I assume it must sound odd to you that not everything that the pharma rep tells you when they bring lunch to your office can be taken at face value, but sometimes there really is deception there.
The standard of evidence for AA is the same as for full approval, just allowing use of a surrogate endpoint when a clinical endpoint is too difficult or time consuming to measure directly, and the surrogate endpoint is well-correlated to the clinical endpoint. In this case, both of these caveats were not true, as not only had the clinical endpoint data already been collected, but the surrogate endpoint had never been definitively correlated with the clinical endpoint. It was a bastardization of the process in multiple ways without even getting into the way that companies manipulate this process by dragging their feet in getting stage 4 data to the FDA to ensure they get a nice long period of sales before any potential threats arise to their approval.
You think the people drinking "kool aide" are the experts in the FDA scientific advisory committee, the vast majority of clinician-scientists, the laundry list of academic institutions refusing to adminster adu (many of which were core to the AB hypothesis in the first place), and anyone with fundamental skepticism regarding the interaction between government and industry -- but not those cheerleading press releases by the same company that recently created a Frankenstein's monster of a post-hoc study mash-up to justify accelerated approval with none of the usual standards being met? Yeah, I think we're done here. Everyone can see this exchange and come to their own conclusions about who is who.
You do not work for the FDA. You have no jurisdiction or expertise in this matter. While you may have delusions that you are in control of prescribing, this is exactly the same point of view
as the anti-thrombolysis ER doctors. Perhaps you can start
a blog with these guys.
What you need to do is quit your job, apply and get a job with the FDA, and then you can, with enough time and good choices, get into a directorship position, once Billy Dunn retires I suppose. From there you can control what drugs get on the market. You can apply YOUR thoughts to accelerated approval. Until then, frankly, you have zero control over what the FDA does.
The experts in the FDA advisory committee are advisors. While you are not at that level, you are free to start blogs, yell at clouds, and hold your own opinions. But before you do that, you might want to actually learn a bit. For example, you might want to learn about the accelerated approval pathway. Like you, I was ignorant of this pathway because it was never used in AD. But you are incorrect in the evidentiary standard.
Learn here. They are looking for reasonable likelihoods, not full approval, which always requires a confirmatory trial. You were wrong to be shocked above, they "made an additional post-market efficacy trial a condition of approval!" You are also not correct about Biogen, assuming they don't abandon the drug, has already enrolled the first person into aducanumab's confirmatory phase 3b/4 trial.
So now let's see, you've been wrong about
the science, and the
FDA approval process. I'm happy to help you learn, but as they say, I can explain it to you but I can't understand it for you.
I don't deal with pharma reps, although I love lunch. I deal with people in development. You clearly don't work in that role either.
