Hope everyone had a great Thanksgiving! Below is a copy of a post from IHUB’s falconer66a. I thought this as worth posting here,
Fletch
falconer66a Saturday, 11/28/20 10:46:51 AM
Re: ignatiusrielly35 post# 285406 0
Post # of 285414
The single-factor, pure response perspective.
In science research, it's called "reductionism." It's complex, but in full play with Anavex:
https://en.wikipedia.org/wiki/Reductionism
Study complex phenomena by reduction, reducing them to simplified, single-factor perspectives.
Quote:
“No, don’t take it, ma, we’re not sure yet if the data proves out the primary endpoint. Even though your condition will improve dramatically, it’s just not worth it.”
As a biologist (with recognized expertise and accomplishments in an area of field biology, the biology of a particular ecosystem complex) I note a particular, troubling perspective that various experts have on the medical research associated with the Anavex drugs. It's something they learned in grad school, often when doing Master's degree thesis research.
Simply, keep it simple, even stupid. Don't attempt to try to discern the interplay and consequences of a diversity of interacting factors or phenomena. Limit research to one single factor; which can then be definitively, accurately characterized. Research reductionism.
For example, determine the effect(s) of one particular synthetic molecule (drug) on one particular other molecule within a cell. To attempt to figure out the entirety of the new drug's many effects on a diversity of other molecules, organelles, and reaction cascades is simply too complicated. Too many things happening to get a clear understanding of the resulting chemistries. In fact, in organisms, organ systems, organs, tissues, and cells, the interplay of simple synthetic molecules with endogenous chemicals is too complex to understand. It can take decades, with thousands of researchers, in hundreds of labs, to gain even cursory understandings; as in the case of anti-cancer drugs, immune system treatments, and a host of others.
It is always the desire of the controlling, advising experts that a new drug should work both narrowly and completely. It should fix one specific symptom, with complete, universal efficacy; with few or no adverse events (side effects). That's the desire.
Of course, that seldom is the case. Organisms and their endogenous chemistries are too complex. It don't happen that way, no way.
But the desire for an idealized therapeutic mechanism is, nonetheless, the criterion against which new drug testing is demanded by the theoretical purists. "Whoa, you've got too many things going on there. No way to know which factors are causing which outcomes. Gotta simplify that trial."
Now, of course, at the same time, these folks will want a diversity of "endpoints," desired outcomes, to be defined and checked. That's against the keep it simple, one-factor perspective.
Therefore, unless a new drug sufficiently achieves each and every laid out endpoint, therapeutic outcome, it will be held in question. The "gotta be a cure" perspective, where the new drug has to, with safety, fix everything, causing no side effects.
But, finally, thankfully, there is one ultimate resolution of this problem. When the FDA approves the sale and therapeutic use of a new drug, all of the above no longer is in question. FDA approval answers, resolves virtually every question of efficacy and safety. End of the story. All is well.
Interestingly, all of this has been set aside when considering the several immunotherapies that continue to fail to treat Alzheimer's. Check out Biogen's aducanumab. Does it work well, simply, and with no side effects? Are clinical standards for blarcamesine the same as those for aducanumab?
https://investorshub.advfn.com/boards/read_ms...=159767855
Fletch
falconer66a Saturday, 11/28/20 10:46:51 AM
Re: ignatiusrielly35 post# 285406 0
Post # of 285414
The single-factor, pure response perspective.
In science research, it's called "reductionism." It's complex, but in full play with Anavex:
https://en.wikipedia.org/wiki/Reductionism
Study complex phenomena by reduction, reducing them to simplified, single-factor perspectives.
Quote:
“No, don’t take it, ma, we’re not sure yet if the data proves out the primary endpoint. Even though your condition will improve dramatically, it’s just not worth it.”
As a biologist (with recognized expertise and accomplishments in an area of field biology, the biology of a particular ecosystem complex) I note a particular, troubling perspective that various experts have on the medical research associated with the Anavex drugs. It's something they learned in grad school, often when doing Master's degree thesis research.
Simply, keep it simple, even stupid. Don't attempt to try to discern the interplay and consequences of a diversity of interacting factors or phenomena. Limit research to one single factor; which can then be definitively, accurately characterized. Research reductionism.
For example, determine the effect(s) of one particular synthetic molecule (drug) on one particular other molecule within a cell. To attempt to figure out the entirety of the new drug's many effects on a diversity of other molecules, organelles, and reaction cascades is simply too complicated. Too many things happening to get a clear understanding of the resulting chemistries. In fact, in organisms, organ systems, organs, tissues, and cells, the interplay of simple synthetic molecules with endogenous chemicals is too complex to understand. It can take decades, with thousands of researchers, in hundreds of labs, to gain even cursory understandings; as in the case of anti-cancer drugs, immune system treatments, and a host of others.
It is always the desire of the controlling, advising experts that a new drug should work both narrowly and completely. It should fix one specific symptom, with complete, universal efficacy; with few or no adverse events (side effects). That's the desire.
Of course, that seldom is the case. Organisms and their endogenous chemistries are too complex. It don't happen that way, no way.
But the desire for an idealized therapeutic mechanism is, nonetheless, the criterion against which new drug testing is demanded by the theoretical purists. "Whoa, you've got too many things going on there. No way to know which factors are causing which outcomes. Gotta simplify that trial."
Now, of course, at the same time, these folks will want a diversity of "endpoints," desired outcomes, to be defined and checked. That's against the keep it simple, one-factor perspective.
Therefore, unless a new drug sufficiently achieves each and every laid out endpoint, therapeutic outcome, it will be held in question. The "gotta be a cure" perspective, where the new drug has to, with safety, fix everything, causing no side effects.
But, finally, thankfully, there is one ultimate resolution of this problem. When the FDA approves the sale and therapeutic use of a new drug, all of the above no longer is in question. FDA approval answers, resolves virtually every question of efficacy and safety. End of the story. All is well.
Interestingly, all of this has been set aside when considering the several immunotherapies that continue to fail to treat Alzheimer's. Check out Biogen's aducanumab. Does it work well, simply, and with no side effects? Are clinical standards for blarcamesine the same as those for aducanumab?
https://investorshub.advfn.com/boards/read_ms...=159767855
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