Then, What of the Political Pressures for Anavex?
Yes, a number of very moderately effective drugs have been approved to treat various cancers. I have noted the “fine print” disclaimer in small typeface in one cancer drug’s advertisements on the evening TV news, something to the effect, “This drug is not a cancer cure, and will only slightly delay the disease’s lethal outcome.”
I also contemplated (but did not actually determine) the surely very high cost of this drug. FDA approved a drug with giant, short-term treatment costs, with assured lethality. No cure; very poor treatment.
Ponder then, if you will, what might be the public perceptions and comments should it “leak out” early in the new Anavex 2-73 Phase 3 study that about half (figure out which that might be) of the Alzheimer’s patients in the trial were now sleeping well and had stabilized or improved thinking (cognition) abilities. Family members and care-givers would be telling friends about how Aunt Millie, after just a few weeks taking this new pill, is feeling so much better; talking sensibly to everyone, and no longer having problems getting or staying asleep each night.
“Hey, why can’t my husband be on that pill? We are gonna have to put him in a nursing home. I can’t take care of him any more? Why is the government keeping this drug from us?!!”
The social and political pressures for early, compassionate approval of Anavex 2-73 for Alzheimer’s (and also for Rett and Parkinson’s Disease) may be strong.
I will not be surprised if FDA is pressured (by you know whom — it would be YUGE), or congressional members, to terminate the trial and grant immediate compassionate use, once Anavex 2-73 performance levels leak out of the study. If they are anywhere as good as what happened in the Phase1/Phase2 Australian study, there will be no possible way to hide or mask the data. The word will get out; with, perhaps, some remarkable and early FDA approval outcomes.
