My question is what is your honest opinion of the fda ?
First, thank you for your comments of appreciation. I was an accomplished biology teacher and learned how to make complicated biochemical and biological processes understandable for students. I can't do the differential equations of calculus (well, not even binomial algebra of any complexity anymore). Now those things are complicated; no way to make them easily understood.
But most of what happens in biochemistry, in the cell, is not so difficult. It's all pretty straightforward stuff. Someone just needs to break down each of the components or factors, then tell how they all relate and operate. That's what I strive to do in explaining Anavex biology. When properly presented, it can be understood, even by those with little training in biology or medicine.
The FDA? My opinion? I think it's some federal agency that's supposed to check and assure the safety of foods, and the safety, efficacy, and sales and therapeutic uses of drugs. Right?
Does it actually do any of that? Well, all of it. But, sufficiently, accurately, and usefully? In one case (Aduhelm) all of that comes into question.
Teddy Roosevelt started it, in 1906, after various books and articles described the unsanitary and fraudulent practices in meat processing. When the public learned what was being inserted in their sausages, the agency was promptly authorized.
As a student, in the last century, I recall thalidomide. Great new drug; ameliorated the upset stomachs, headaches, and other discomforts sometimes encountered during pregnancies. But, of course, it also had previously unknown or undiscovered teratogenic effects; disruption of normal embryonic development. Kids were born without arms or legs; all because the drug was never tested for teratogenicity. Easily done, in lab rats and mice; even lab roundworms. But never required.
The thalidomide crisis mandated modern drug testing, the various preclinical and clinical "phases." Was and is this appropriate? Absolutely.
But, as in the cases of either Aduhelm or blarcamesine, should there be reduced testing, either because there is such a great need for a particular drug (as with Aduhelm and Alzheimer's), or, because all of the early preliminary data showing overwhelming safety and multitudes of efficacy (as with blarcamesine)? Nope! There should be no exceptions. Incongruously, Adulelm was allowed to sneak out of the lab, onto pharmacy shelves, without adequate data supporting either safety of efficacy. Everyone, even FDA insiders (who, then in protest resigned) recognized the absurdity of the Aduhelm approval.
It will prove so bad that I doubt it will ever happen again. Before Aduhelm, FDA critics held up thalidomide as the necessity for deep and thorough drug testing. Henceforth, after thousands taking Aduhelm suffer brain hemorrhages and their Alzheimer's symptoms continue to progress (after expending hundred of thousands of dollars), Aduhelm will be the new drug testing poster child.
FDA will continue to await Anavex's submission of clinical trial results for blarcamesine treating Rett syndrome, Parkinson's disease dementia, and finally, Alzheimer's itself. I'm confident results in each of those will be definitive, mandating sales and use approvals. It will take longer than wished, but it will happen.
Of course, things might be complicated, hastened even, if, per chance (well, per evidence), that Australia's Therapeutic Goods Administration, their FDA, comes out with some sort of blarcamesine authorization before the FDA. Won't it be interesting to see how all of that might play out in both the northern and southern hemispheres of the globe?
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