You are not grasping the concept.
It is not the FDA's job. The tax payers resources are not at risk. That money is being spent by the drug development companies, because they think it is good use of their resources.
If anyone it to be held responsible for the money being spent it is the executives of the drug companies and that job of holding to accountability falls to the shareholders of the drug companies.
The FDA does not "manage the process". It evaluates drug trial proposals brought to it by drug companies.
What seems to be missing in this discussion is the realization that it is hindsight that is telling us that the plaque approach does not work. We know that ONLY because there have been many trials that have approached the disease by managing, controlling, or removing plaque and they have not succeeded.
Accept the fact that the science about AD is not very well developed. The root cause is not known. The path from the root cause to full blown disease is suspected but not proven. The few things that are definitively known are plaque build up, tau tangles, and diminished brain volume. Most of those things have been learned at autopsies. Only recently have diagnostic techniques been developed that begin to allow for what may be definitive diagnosis prior to advanced disease.
There are HUGE amounts of money at stake for the first company that can successfully slow or stop the progress of AD. The rewards are even larger for the company that can prevent the development of the disease.
The companies that are working on developing AD drug treatments know this. They are spending $ billions on research and trying to get to the successful drug first. They spent money on the plaque approach because based on the weak science available at the time, that looked like the best approach to achieve success.
AVXL is taking a different approach to AD treatment. It may work out to be a better approach. There are other companies using different approaches. Only time will tell which ones will be the better one. Until the root cause is understood, it is likely that ALL current drug approaches will turn out to be stop gaps. Even more likely (to me anyway) is that AD will turn out to be a common set of symptoms with a number of different causes. Each of which will require a different drug approach.
Rant over.
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