Won't It Be Interesting...
If or when Australian medical officials shortly authorize the sale and therapeutic use of Anavex 2-73, for either Rett syndrome or Alzheimer's disease, won't it be informative to read from our several experts just why this was a mistake. What will it be?
Oops, trials not long enough, especially for the Rett girls. Real chance that after they've been on Anavex 2-73 for some time, severe toxicities will show up, embarrassing the medical officials down there. Or, the positive treatment outcomes will be predicted to be short-lived, with the girls suffering even more after a course of Anavex 2-73. The big one, of course, will be the lack of a placebo arm in the short, tiny study. Results were all placebo effects. No basis for safe approval.
For Alzheimer's, what will be the comments? "Way too early to know if Anavex 2-73 is both safe and effective. Not enough data to support sales authorization. Australian Alzheimer's patients now at great risk with this unproven drug."
Of course, the comments and thoughts of medical officials and practitioners (and patients) around world will be even more interesting when, after a few weeks or months of Rett and Alzheimer's Anavex therapies in Australia any number of profoundly good results begin to appear. Little girls with Rett begin to sleep rather normally; able to gain near-normal neuromuscular coordination; seizures subside or disappear. Dozens of Alzheimer's patients begin to live normal lives, unassisted. They sleep well, begin to think normally, and are no longer burdens on family members and caregivers. What happens in the US and Europe when ever-increasing numbers of such stories from Down Under become known in the Northern Hemisphere?
"No, we are the FDA. We have RULES about drug approvals. That Anavex drug must conduct several more years of big double-blind studies before we will consider any sales approval."
"Sir, this is the President. Get your FDA people over here tomorrow morning, so you can be here when I make an executive order to promptly begin sales of that Anavex drug right here in America. We want to make American medicine great again."
