You and I are seeing the same situation is different ways.
You make the safety and effectiveness point. Which by the way explains why there are almost no drugs available for treating AD. The trial designs approved by the FDA, have not shown effectiveness. I also agree that the FDA does consider the scientific rational for the drugs and their MOA in their decisions. We can argue safety as a separate point later.
As I understand your point you are saying that the FDA failed to tell the drug companies what research they should be pursuing. Do I have that right?
As to bio's well done post earlier. About the mouse models. I agree they were flawed. At the same time you are pointing out the model flaws, please remember that there were no other animal models to choose from. They can't go poking around in people's brains, there weren't any petri dish models to work with. What other choices were available at the time?
I liken the situation the researchers were and are in to that of investing. The issue of "The hard right edge of the chart". You can collect all the data, charts, PE ratios, etc. you want, but when it comes time to place an order you are attempting to predict the future.
The AD researchers had and still do have very incomplete data to make their predictions with. There is a lot more known now than 10 - 20 years ago. The tools they have to work with are better. The understanding of the brain biology and biochemistry is better. Not to mention that it has now has been shown what was obvious is no longer obvious i.e. plaque and tau tangles.
By way of comparison, how long has cancer research been a high priority, well funded field? Compare that with the AD research funding and time frame. Yeah the cancer guys are doing precision medicine. That is based on many years of research about gene and biochemical pathways that have been developed over long periods of time with many different well funded research groups working the problems.
And remember that the cancer guys don't need murine models for much of their research. They have cancer cell lines they can grow in petri dishes to work with and have had them for many years. AD researchers are just beginning to get tools like that to work with.
I have been involved with troubleshooting in one form or another most of my life. When I think about what Doctors do and the tools they have to work with I am impressed that they get as much right as they do. The human body is unbelievably complex with so many systems interconnected. We tend to think that Dr's have so many tools and tests available to them that how could they not get this stuff right. It is true that there are many tests and tools available, but compared to the complexity of the body the tools are really quite limited. Half the time just figuring out which test might yield useful information is a big challenge. There are so many feedback loops in the human body that a disturbance in one can affect several others. That is one reason that AVXL took a look at the gut biome when looking for the reasons that different people responded to 2-73 differently. Maybe some people have different bacteria in their gut that affects they way 2-73 is absorbed or metabolized. Maybe some bacteria themselves can metabolize 2-7? They are working at the hard right edge of the chart.
Consider what Anavex has done with the KEM genetic testing and data analysis. That process took a lot of time, data from 25 or so people, and significant computer analysis to generate the hypothesis that two gene variants are responsible for the different responses to 2-73. That is new data and if it proves out in the upcoming trial may provide new insights into the AD disease process.
Don't forget that the genetic variations are correlations with response. They do not explain why the responses are different or why the biochemical pathways are different. What that does is tell researchers where there is a good place to look.
Medicine is hard. CNS is even harder.
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