Saturday, July 28, 2018 6:07:41 PM
FDA recalcitrance regarding any sort of prompt approval of Anavex 2-73 may be caused by a number of factors — things that may not be so entrenched or controlling in, say, Australia.
By whatever mechanism or arrangement, let it occur so that those who choose to be treated by Anavex 2-73 for their Alzheimer’s dementias can be. If that happens in the US (no indications that it will), all well and good.
But there will be a much better chance that the first population to gain Alzheimer’s treatment (and prevention) access to the drug will be the Australians. The up-coming Phase 3 clinical trial will be centered down there. Local medical officials and physicians will see results first-hand, as they progress, even, per chance, in the early months of the trial.
With any sort of positive data early in the trial, the arithmetic of any 13-yr old will instantly reveal the profound national and institutional cost savings resulting from widespread use of the Anavex drug in a national population.
Here’s the central question. Where is Anvex 2-73 most likely to first gain governmental approval for generalized medical use? Is the US FDA set up for and promoting such an outcome? Or, perhaps, are things more propitiously arranged and aligned in Australia?
If it’s the latter (I think it is), it will be interesting to follow the involved social and economic factors that would then play out here in the US. “Hey, how come we are reading about how Australia has conquered the Alzheimer’s problem, but the FDA says [As they always do.] ‘Not enough data yet for Anavex approval in the US’?”
Gonna be really interesting to watch the eventual approval of Anavex 2-73 play out, no matter by what means, no matter where. If the drug provides even the most minute therapeutic benefit; say, holds Alzheimer’s patients at a start-of-treatment baseline (just keeps patients from getting worse), the diverse economic impacts will be in the billions of dollars. Moreover, if the drug performs as all of the cogent information predicts, that it not only stops the lethal progression of Alzheimer’s but either reverses or prevents the disease, the economic impacts are even greater, by an order of magnitude.
Who, per chance, could be against either of those outcomes? Let’s see. Large legacy institutions that “treat” and care for Alzheimer’s patients; nursing homes, hospitals, neurology clinics, others. Ponder whose life styles, incomes, and professional careers might be threatened by a successful, global termination of the “Alzheimer’s problem.”
Might any of those parties “express great concern about the inadequacies and safety hazards of this unproven new drug?”
On the other hand, who would welcome it’s availability? Foremost, of course, would be national governments and their taxpayers, who bear most of the diverse costs of those with senile dementias. Social, citizen groups would support widespread use. Private health insurance companies?
Let’s watch. The Anavex 2-73 story is not opening on an American stage. A new production is about to begin in Australia. A cast of 450. Get your tickets now. Australian medical cost officials have theirs; will be sitting right in front of the stage. News reporters and cameras in the seats just behind them. House lights soon to dim; let the curtain rise. To be one of the greatest stories in two millennia of medicine.
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