All this even after criticisms of futility for Aducanumab. even after evidence of malfeasance from the FDA, and even after fraudulent findings in Alzheimer's research warrant an overhaul to the field.
Jan 7, 2023·edited Jan 7, 2023Liked by Modern Discontent
I’m a bit confused- wasn’t the first drug found to not be effective because the root cause of Alzheimer’s is still unknown (eg its not the plaque build up?) And hence, the first drug was dangerous and ineffective and this second drug makes the same assumption that Alzheimer’s is from plaque build up, when it isn’t? Isn’t this a parallel to antidepressants where they had to admit that low serotonin levels are not the root cause of depression and they don’t know exactly what antidepressants do? Disclaimer- not sure I even understood those concepts correctly either...
So this requires a bit of an assessment of the timeline to answer. There will be a tl;dr if you want the short answer at the bottom.
First, both Aducanumab and Lecanemab are immunotherapies intended to target the amyloid beta plaques that form during Alzheimer's, so they both have similar mechanisms of action.
Prior to Aducanumab the field of Alzheimer's was struggling with figuring out what role the amyloid plaques played. One school of thought assumed that the amyloid plaques are the causative agent for the neurodegeneration, and therefore by targeting them you can reduce the neurodegeneration. Aducanumab's retrospective assessment added on another assumption, in that removal of the amyloid plaques would also improve cognition, which was unheard of based on the inconsistent evidence in the plaque's actual role.
The other school of thought, and one my amateur brain heads towards, is that the plaque formation is actually a consequence of cellular dysregulation, in that they are a symptom of a cell's inability to control several processes such as protein formation, among other factors. And so if this thought were to be true, then the targeting of the amyloid plaques wouldn't do much good because the neurodegeneration would be due to the cellular dysfunction with the plaques just being an indication that cellular dysfunction is occurring.
Then that leads us to Aducanumab in the summer of 2021. Prior to the accelerated approval the FDA halted Biogen's studies due to lack of futility (i.e. both studies didn't meet their primary endpoints), as the reduction in cognitive decline was seen to be either minimal or modest at best. However, Biogen looked back to one clinical trial and noted that in a select few patients neurocognition improved. Of course, this raises red flags given what was listed in the prior paragraphs.
However, this retrospective analysis led the FDA to accelerate its approval under the guise that Biogen had to produce information showing futility, and because there was no real effective treatment for Alzheimer's so far.
But nearly everyone on the approval committee voted against it's approval, and so the FDA's ruling was seen as so egregious that 3 members of the committee left.
Then that brings us to Summer 2022, where Science releases an investigative report. The report was spurred on by a scientist who was hired by an attorney for two scientists with investments in a biotech company. The scientists were concerned that the company may have been manipulating data, leading the hired scientist to dig into available information on said company.
The researcher found some concerning evidence of data tampering, however as he dug deeper and reexamined old studies he noticed that one of the most widely cited studies on these amyloid plaques may have tampered with their blots, essentially copying and pasting over bands from different blots to manipulate their data. In short, this raised questions as to whether the specific plaques from this heavily-cited study were related to Alzheimer's, or if they even existed.
But the findings were so monumental that other Alzheimer's researchers used it to find treatments that targeted these plaques, even though several labs reported they couldn't find these specific plaques themselves.
So given the fact that one of the most widely cited studies in Alzheimer's may be fraudulent, it puts these immunotherapies in a new light because now you have to deal with the fact that you are attempting to target either a red herring or something that may not exist.
So then that leads us to Lecanemab and the findings from the press release in September 2022. With everything that came before the results of Lecanemab (the controversies with Aducanumab and the recent Science report) this press release should have been met with skepticism, especially given the fact that Lecanemab's initial results were comparable to Aducanumab (in my opinion). So my criticisms of Lecanemab were based on the mounting evidence criticizing these immunotherapies given everything that has been coming out.
Then, right at the end of 2022 a joint congressional committee releases a report noting that Biogen may have been in talks with people at the FDA in order to get accelerated approval.
Essentially, the regulatory agency that should have shown impartiality actually showed a pharmaceutical company how to maneuver the accelerated approval process to get their immunotherapy to market.
So with this report that should tell us that both Biogen and the FDA should not be trusted with these accelerated approvals, and yet Lecanemab just recently got accelerated approval by the same agency that was just found to have aided in the accelerated approval, and with all of the questions raised with these immunotherapies and the plaques they target as well.
TL;DR: Both Aducanumab and Lecanemab appear to have the same mechanisms of action, but the controversies surrounding Aducanumab should have raised similar criticisms against Lecanemab. As evidence questioning the field of Alzheimer's came about, and with the recent congressional committee report noting possible ties between FDA members and Biogen (through contact, not necessarily through FDA members being part of Biogen), this all should have brought a halt to the approval process, and yet Lecanemab still managed to gain accelerated approval.
Jan 8, 2023·edited Jan 8, 2023Liked by Modern Discontent
Wow. The FDA is a gordian knot of fake data, greed and subterfuge. Didn’t see any mention of good intentions anywhere in there. As you rightly pointed out, if it’s cellular dysfunction, that should be the main focus of studies, not the after affects. But that’s sort of emblematic for all medical treatment right now- no one is looking for the root causes, they just medicate the symptoms afterwards.
Completely as a side note- hasn’t it been mentioned that covid can cause amyloid plaques- could this be another reason to push it more urgently to the forefront ? Not trying to be a conspiracy theorist- rather trying to see through the lens of big pharma making the biggest financial gain...
It's not known if the cellular dysfunction is the causative agent, but just like you stated if you are unsure you can't be certain that we should invest everything into targeting these plaques without knowing the underlying issues.
The Free Press actually released this article that's worth looking at. They note how the field as parochially targeted these amyloid plaques and that those who strayed from the consensus would have difficulties in publishing:
As to the amyloid protein in general it's been argued that amyloid formation occurs with both the vaccines and COVID itself. My knowledge on this matter is very poor, so I would need to look for information in order to make a coherent comment.
To that, Brian Mowrey wrote an article in June relaying information from an Alzheimer's researcher suggesting that amyloid formation may be an antimicrobial response:
Given that the amyloid formation appears in other viruses, it may indicate that this may be a typical cellular function, and for Alzheimer's maybe something went awry to not keep that mechanism in check? Again, very uninformed on the topic as of now.
A true human tragedy; our "drug" pipe line of legally prescribed drugs is as dangerous and tragic and completely morally bankrupt as the trade in illegal drugs and the human trafficking trade. It's really difficult to believe what has happened from the time such miracle drugs as penicillin, smallpox vaccine, and polio vaccine were discovered, to a USA manufacturing cartel pumping out drugs for "diseases" they invented (more are actually conditions, not "diseases"), to such practices as mass "treatment" for "blood pressure issues", blood sugar issues, any routine dental procedure, etc. etc. and then onward to moving the manufacturing outside the country to produce even cheaper products and increase the volume. Now, it has even seeped into our medical schools, where "treatment" protocols are based on a list of drugs to be prescribed. One day society will look back on this horror show, along with the Covid "vaccinations", incredulously !
The accelerated approval of the vaccines, as well as the Right to Try Act I would argue, both paved the way to pushing through any medication possible, especially if it is done with approval by the public.
This is why we should be cautious in wanting a solution as fast as possible, because that gives the FDA and other agencies the incentive to not have to do their due diligence and actually make sure these drugs pass guidelines before coming to market.
Yes, I agree. I do think the "Right to Try Act" does also have some deep roots in the foundation of a democratic REPUBLIC, the right of every individual to make their own choices, but yes, I also see a significant down side in that it gives impetus, gives a "blessing", to full speed ahead for all the new "diseases" and "conditions" that "pop" up daily on TV, along with the new medications for them !
I would argue that "Right to Try" has some well-intentioned ideas, but this is also one of those cases where we can see how it can go bad as you have mentioned. It provided a gateway for these fast approvals, and now we have to figure out how to pull them back from making such rash decisions.
Yes, it's one of those dichotomies for sure, but again, if there was a GENUINE desire to give people free choice if they want to take a chance on a new drug with no historical data, it still would not, maybe better said SHOULD NOT, effect the pace/time frame of the trials, sample sizes, control groups, etc. etc. those are things that could be radically improved, were it not for the profit motive, and yet, a "right to try" law could still be in place for those who are willing to take the risk, or, who have no alternatives. The "pandemic" was simply a vehicle for rushing unknowns to an even greater degree, a much different situation than a situation where a person has exhausted every avenue, for instance cancer treatment, and is allowed to make a choice to try an experimental drug.
What??! And stop this new frontier in medicine? What about the dozens of heart medications or weight loss pills that can now come about with only weeks worth of studies!!
Don't dampen scientific progress!
You shall take your immunotherapy cocktails and you will like them! Just don't report any brain swelling or bleeding that you experience...
Who heard today's news (1/9/23) ? Merck's announcement ? Especially interesting was the comment of their belief that they are nearly to the point of making cancer a life long condition (as opposed to a death sentence). While this is, on the one hand, positive news, the emphasis is always on finding drugs that are permanent and daily. what if we put our full resources behind the root of the ever growing spectrum of chronic diseases that need daily medications. It's a vicious cycle. A small fortune has been made just from the simple idea of "cases" to accommodate each individual's daily pill regimen ! Along with a host of home pill sorters, cutters, etc. etc. ! We have created an entire economy around chronic illness. A miracle we have discovered so many drugs and medications to save and preserve life, but... the question is, are we carrying it "too far", to such extremes that it is to our detriment rather than our collective good ? We SUPPRESSED physical fitness, outdoor activity, healthy eating, everything possible, even to CLOSING gyms and access to OUTDOOR exercise equipment on fitness trails... all in favor of taking injections of "something" and staying indoors and out of the sun and outdoor (dangerous ?) air !
I would need to see the context (I haven't seen it), but like you stated I do wonder if this was intended to manage cancer in patients who may not have a viable treatment. It would be interesting to see what exactly they would be offering in that regard, or unless that's the direction they are telling investors to go down.
But your last comment is definitely true, we've moved typical things that help with overall help for quick fixes with unknown long-term effects. It should be that we do all we can to help ourselves before turning to medicine to help with things we can't.
This takes a lot of effort and a sharp eye to keep track of these and present it to us. Thank you for your work.
Thanks! I think I remember this series the most because it was one of my first posts so it sort of retained within my mind a bit.
I’m a bit confused- wasn’t the first drug found to not be effective because the root cause of Alzheimer’s is still unknown (eg its not the plaque build up?) And hence, the first drug was dangerous and ineffective and this second drug makes the same assumption that Alzheimer’s is from plaque build up, when it isn’t? Isn’t this a parallel to antidepressants where they had to admit that low serotonin levels are not the root cause of depression and they don’t know exactly what antidepressants do? Disclaimer- not sure I even understood those concepts correctly either...
So this requires a bit of an assessment of the timeline to answer. There will be a tl;dr if you want the short answer at the bottom.
First, both Aducanumab and Lecanemab are immunotherapies intended to target the amyloid beta plaques that form during Alzheimer's, so they both have similar mechanisms of action.
Prior to Aducanumab the field of Alzheimer's was struggling with figuring out what role the amyloid plaques played. One school of thought assumed that the amyloid plaques are the causative agent for the neurodegeneration, and therefore by targeting them you can reduce the neurodegeneration. Aducanumab's retrospective assessment added on another assumption, in that removal of the amyloid plaques would also improve cognition, which was unheard of based on the inconsistent evidence in the plaque's actual role.
The other school of thought, and one my amateur brain heads towards, is that the plaque formation is actually a consequence of cellular dysregulation, in that they are a symptom of a cell's inability to control several processes such as protein formation, among other factors. And so if this thought were to be true, then the targeting of the amyloid plaques wouldn't do much good because the neurodegeneration would be due to the cellular dysfunction with the plaques just being an indication that cellular dysfunction is occurring.
Then that leads us to Aducanumab in the summer of 2021. Prior to the accelerated approval the FDA halted Biogen's studies due to lack of futility (i.e. both studies didn't meet their primary endpoints), as the reduction in cognitive decline was seen to be either minimal or modest at best. However, Biogen looked back to one clinical trial and noted that in a select few patients neurocognition improved. Of course, this raises red flags given what was listed in the prior paragraphs.
However, this retrospective analysis led the FDA to accelerate its approval under the guise that Biogen had to produce information showing futility, and because there was no real effective treatment for Alzheimer's so far.
But nearly everyone on the approval committee voted against it's approval, and so the FDA's ruling was seen as so egregious that 3 members of the committee left.
Then that brings us to Summer 2022, where Science releases an investigative report. The report was spurred on by a scientist who was hired by an attorney for two scientists with investments in a biotech company. The scientists were concerned that the company may have been manipulating data, leading the hired scientist to dig into available information on said company.
The researcher found some concerning evidence of data tampering, however as he dug deeper and reexamined old studies he noticed that one of the most widely cited studies on these amyloid plaques may have tampered with their blots, essentially copying and pasting over bands from different blots to manipulate their data. In short, this raised questions as to whether the specific plaques from this heavily-cited study were related to Alzheimer's, or if they even existed.
But the findings were so monumental that other Alzheimer's researchers used it to find treatments that targeted these plaques, even though several labs reported they couldn't find these specific plaques themselves.
So given the fact that one of the most widely cited studies in Alzheimer's may be fraudulent, it puts these immunotherapies in a new light because now you have to deal with the fact that you are attempting to target either a red herring or something that may not exist.
So then that leads us to Lecanemab and the findings from the press release in September 2022. With everything that came before the results of Lecanemab (the controversies with Aducanumab and the recent Science report) this press release should have been met with skepticism, especially given the fact that Lecanemab's initial results were comparable to Aducanumab (in my opinion). So my criticisms of Lecanemab were based on the mounting evidence criticizing these immunotherapies given everything that has been coming out.
Then, right at the end of 2022 a joint congressional committee releases a report noting that Biogen may have been in talks with people at the FDA in order to get accelerated approval.
Essentially, the regulatory agency that should have shown impartiality actually showed a pharmaceutical company how to maneuver the accelerated approval process to get their immunotherapy to market.
So with this report that should tell us that both Biogen and the FDA should not be trusted with these accelerated approvals, and yet Lecanemab just recently got accelerated approval by the same agency that was just found to have aided in the accelerated approval, and with all of the questions raised with these immunotherapies and the plaques they target as well.
TL;DR: Both Aducanumab and Lecanemab appear to have the same mechanisms of action, but the controversies surrounding Aducanumab should have raised similar criticisms against Lecanemab. As evidence questioning the field of Alzheimer's came about, and with the recent congressional committee report noting possible ties between FDA members and Biogen (through contact, not necessarily through FDA members being part of Biogen), this all should have brought a halt to the approval process, and yet Lecanemab still managed to gain accelerated approval.
Wow. The FDA is a gordian knot of fake data, greed and subterfuge. Didn’t see any mention of good intentions anywhere in there. As you rightly pointed out, if it’s cellular dysfunction, that should be the main focus of studies, not the after affects. But that’s sort of emblematic for all medical treatment right now- no one is looking for the root causes, they just medicate the symptoms afterwards.
Completely as a side note- hasn’t it been mentioned that covid can cause amyloid plaques- could this be another reason to push it more urgently to the forefront ? Not trying to be a conspiracy theorist- rather trying to see through the lens of big pharma making the biggest financial gain...
It's not known if the cellular dysfunction is the causative agent, but just like you stated if you are unsure you can't be certain that we should invest everything into targeting these plaques without knowing the underlying issues.
The Free Press actually released this article that's worth looking at. They note how the field as parochially targeted these amyloid plaques and that those who strayed from the consensus would have difficulties in publishing:
https://www.thefp.com/p/where-is-the-cure-for-alzheimers
As to the amyloid protein in general it's been argued that amyloid formation occurs with both the vaccines and COVID itself. My knowledge on this matter is very poor, so I would need to look for information in order to make a coherent comment.
To that, Brian Mowrey wrote an article in June relaying information from an Alzheimer's researcher suggesting that amyloid formation may be an antimicrobial response:
https://unglossed.substack.com/p/its-probably-not-an-alzheimers-virus
Given that the amyloid formation appears in other viruses, it may indicate that this may be a typical cellular function, and for Alzheimer's maybe something went awry to not keep that mechanism in check? Again, very uninformed on the topic as of now.
A true human tragedy; our "drug" pipe line of legally prescribed drugs is as dangerous and tragic and completely morally bankrupt as the trade in illegal drugs and the human trafficking trade. It's really difficult to believe what has happened from the time such miracle drugs as penicillin, smallpox vaccine, and polio vaccine were discovered, to a USA manufacturing cartel pumping out drugs for "diseases" they invented (more are actually conditions, not "diseases"), to such practices as mass "treatment" for "blood pressure issues", blood sugar issues, any routine dental procedure, etc. etc. and then onward to moving the manufacturing outside the country to produce even cheaper products and increase the volume. Now, it has even seeped into our medical schools, where "treatment" protocols are based on a list of drugs to be prescribed. One day society will look back on this horror show, along with the Covid "vaccinations", incredulously !
The accelerated approval of the vaccines, as well as the Right to Try Act I would argue, both paved the way to pushing through any medication possible, especially if it is done with approval by the public.
This is why we should be cautious in wanting a solution as fast as possible, because that gives the FDA and other agencies the incentive to not have to do their due diligence and actually make sure these drugs pass guidelines before coming to market.
Yes, I agree. I do think the "Right to Try Act" does also have some deep roots in the foundation of a democratic REPUBLIC, the right of every individual to make their own choices, but yes, I also see a significant down side in that it gives impetus, gives a "blessing", to full speed ahead for all the new "diseases" and "conditions" that "pop" up daily on TV, along with the new medications for them !
I would argue that "Right to Try" has some well-intentioned ideas, but this is also one of those cases where we can see how it can go bad as you have mentioned. It provided a gateway for these fast approvals, and now we have to figure out how to pull them back from making such rash decisions.
Yes, it's one of those dichotomies for sure, but again, if there was a GENUINE desire to give people free choice if they want to take a chance on a new drug with no historical data, it still would not, maybe better said SHOULD NOT, effect the pace/time frame of the trials, sample sizes, control groups, etc. etc. those are things that could be radically improved, were it not for the profit motive, and yet, a "right to try" law could still be in place for those who are willing to take the risk, or, who have no alternatives. The "pandemic" was simply a vehicle for rushing unknowns to an even greater degree, a much different situation than a situation where a person has exhausted every avenue, for instance cancer treatment, and is allowed to make a choice to try an experimental drug.
I am so glad you brought it up -- a completely outrageous story.
Perhaps a moratorium on accelerated approvals would be in the public’s best interest.
What??! And stop this new frontier in medicine? What about the dozens of heart medications or weight loss pills that can now come about with only weeks worth of studies!!
Don't dampen scientific progress!
You shall take your immunotherapy cocktails and you will like them! Just don't report any brain swelling or bleeding that you experience...
Who heard today's news (1/9/23) ? Merck's announcement ? Especially interesting was the comment of their belief that they are nearly to the point of making cancer a life long condition (as opposed to a death sentence). While this is, on the one hand, positive news, the emphasis is always on finding drugs that are permanent and daily. what if we put our full resources behind the root of the ever growing spectrum of chronic diseases that need daily medications. It's a vicious cycle. A small fortune has been made just from the simple idea of "cases" to accommodate each individual's daily pill regimen ! Along with a host of home pill sorters, cutters, etc. etc. ! We have created an entire economy around chronic illness. A miracle we have discovered so many drugs and medications to save and preserve life, but... the question is, are we carrying it "too far", to such extremes that it is to our detriment rather than our collective good ? We SUPPRESSED physical fitness, outdoor activity, healthy eating, everything possible, even to CLOSING gyms and access to OUTDOOR exercise equipment on fitness trails... all in favor of taking injections of "something" and staying indoors and out of the sun and outdoor (dangerous ?) air !
I would need to see the context (I haven't seen it), but like you stated I do wonder if this was intended to manage cancer in patients who may not have a viable treatment. It would be interesting to see what exactly they would be offering in that regard, or unless that's the direction they are telling investors to go down.
But your last comment is definitely true, we've moved typical things that help with overall help for quick fixes with unknown long-term effects. It should be that we do all we can to help ourselves before turning to medicine to help with things we can't.
OMG that is SO PAST DUE !