Every month, I’ll be highlighting Alzheimer’s research that is going on RIGHT NOW! Harvested from different websites, journals and podcasts, I’ll translate them into understandable English and share them with you. Today: A NEW Alzheimer’s Drug…that apparently doesn’t work and costs $85,000 for a one year prescription…has been approved by the FDA?!?!?!?!
So, it’s finally here, you say!
I *sigh* and say, “I’m happy for those families, and while the advertising makes it sound the “Cure Is Here!!!!”, the science is far, far less certain.
This new “wonder drug”… well, let me back up.
The current cause of Alzheimer’s Disease, from the Alzheimer’s Association web site (rather than the drug manufacturer’s website: “Researchers believe there isn't a single cause of Alzheimer's disease. It likely develops from multiple factors, such as genetics, lifestyle and environment. Scientists have identified factors that increase the risk of Alzheimer’s. While some risk factors — age, family history and heredity — can't be changed, emerging evidence suggests there may be other factors we can influence.”
So, to paraphrase, “…there isn’t a single cause of AD…” It’s a disease with various dimensions, MOST likely, which work together to bring about the changes in the brain that cause the symptoms of Alzheimer’s. These factors are age, family history, genetics, head injury, there’s a heart-head connection involving heart disease and the ability of the heart and its accompanying vessels to carry properly oxygenated blood.
The culprit currently are a tandem problem: plaques and tangles.
Plaques form when protein pieces called beta-amyloid clump together. The pieces come from larger proteins found in the fatty membrane surrounding nerve cells that had started to break up. These pieces are chemically "sticky" and gradually build up into clumps – or plaques – between the brain cells. These clumps may block cell-to-cell signaling as well as kick off an immune response that trigger inflammation, which can lead to the body itself devouring disabled cells.
Tangles, on the other hand, come from dead and dying nerve cells. The tangles are made up of twisted strands of another protein that’s broken up. Nutrients and other essential supplies that keep the brain healthy and functioning, can no longer move through the cells, which eventually die.
There have been several drugs prescribed to Alzheimer’s patients, and while there have been small improvements in some people, as a whole, the “silver bullet” has eluded 20th and 21st Century medicine.
The newest drug doesn’t do anything notably different: “Aduhelm, which is based on the surrogate endpoint of reduction of amyloid beta plaque in the brain…”
Translated? No idea. But this is a bit more transparent: “Aduhelm works by removing beta amyloid, delay[ing]…mild cognitive impairment…or mild Alzheimer's dementia. Some people…experienced significant benefits on measures of cognition and function…such as memory, orientation and language, daily living skills…[like] conducting personal finances, performing household chores (such as cleaning, shopping and doing laundry) and independently traveling out of the home.”
Some patients may experience “temporary swelling in areas of the brain that usually resolves over time and does not cause symptoms…others may have symptoms such as headache, confusion, dizziness, vision changes, or nausea…[a] hypersensitivity reaction, including angioedema (rapid swelling of the area beneath the skin or mucosa [like in] the face and throat, as well as the limbs and genitals.” Also, urticaria (you break out in hives).
The most common side effects of Aduhelm were headache, fall danger, diarrhea, and confusion/delirium/altered mental status/disorientation. (Honest observation of my dad? This seems like things he experienced already without taking Aduhelm…)
But other drugs have removed beta-amyloid, and while I’m sure that’s great, removing beta-amyloid is only one small part of the problem. There are OTHER factors that go into Alzheimer’s…
Carlie Porterfield of Forbes Magazine reports that at least two major hospital systems – the Cleveland Clinic, and Mount Sinai in New York, remain unconvinced that the new drug is particularly effective against Alzheimer’s. First of all, “…approved by the FDA in June [Aduhelm] was the first major Alzheimer’s medication to receive the green light from the agency in nearly 20 years.” Can you say, “PRESSURE LOBBYISTS”? Also, there are concerns “over conflicting data from clinical trials about the efficacy of the drug. While a phase 3 study found a 22% reduction in cognitive decline in patients who took Aduhelm, a following clinical trial found no benefit.” And (in a totally stunning surprise) “…the cost of the treatments [would be] $56,000 annually and [a] financial burden…place[d] on Medicare.”
I think the fallout is only beginning: “…some outside advisors [are] quitting in protest of the approval, while Sen. Joe Manchin (D-W.Va.) called for FDA Acting Commissioner Janet Woodcock to be refused a permanent role as the head of the agency.”
Worst of all, families who thought that help was on the way – and we were one of those families a few years ago – have once again had their hopes dashed by…well…I’ll keep my opinion on that to myself, though you can probably figure out what I think about drug companies and profiteering just by reading this essay…
Resources: https://www.kare11.com/article/news/nation-world/fda-approves-first-new-alzheimers-drug-in-nearly-two-decades-biogen-aducanumab/507-85338078-26c9-4d3b-ba4e-89ba4e64c25e
References: https://www.alz.org/alzheimers-dementia/what-is-alzheimers/brain_tour_part_2, https://www.alz.org/media/documents/fda-approved-treatments-alzheimers-ts.pdf, https://www.forbes.com/sites/carlieporterfield/2021/07/15/heres-why-2-major-health-centers-wont-carry-controversial-new-alzheimers-drug/?sh=64b2cbb9445d
Image: https://encrypted-tbn0.gstatic.com/images?q=tbn:ANd9GcSYobM5GeFry6lVayNtb8o5ks8AftNG0URFgu_oXUYoYAK2ON3Kix5-x8KikJh6cUqX6s07sMTjm_qfOA&usqp=CAU
So, it’s finally here, you say!
I *sigh* and say, “I’m happy for those families, and while the advertising makes it sound the “Cure Is Here!!!!”, the science is far, far less certain.
This new “wonder drug”… well, let me back up.
The current cause of Alzheimer’s Disease, from the Alzheimer’s Association web site (rather than the drug manufacturer’s website: “Researchers believe there isn't a single cause of Alzheimer's disease. It likely develops from multiple factors, such as genetics, lifestyle and environment. Scientists have identified factors that increase the risk of Alzheimer’s. While some risk factors — age, family history and heredity — can't be changed, emerging evidence suggests there may be other factors we can influence.”
So, to paraphrase, “…there isn’t a single cause of AD…” It’s a disease with various dimensions, MOST likely, which work together to bring about the changes in the brain that cause the symptoms of Alzheimer’s. These factors are age, family history, genetics, head injury, there’s a heart-head connection involving heart disease and the ability of the heart and its accompanying vessels to carry properly oxygenated blood.
The culprit currently are a tandem problem: plaques and tangles.
Plaques form when protein pieces called beta-amyloid clump together. The pieces come from larger proteins found in the fatty membrane surrounding nerve cells that had started to break up. These pieces are chemically "sticky" and gradually build up into clumps – or plaques – between the brain cells. These clumps may block cell-to-cell signaling as well as kick off an immune response that trigger inflammation, which can lead to the body itself devouring disabled cells.
Tangles, on the other hand, come from dead and dying nerve cells. The tangles are made up of twisted strands of another protein that’s broken up. Nutrients and other essential supplies that keep the brain healthy and functioning, can no longer move through the cells, which eventually die.
There have been several drugs prescribed to Alzheimer’s patients, and while there have been small improvements in some people, as a whole, the “silver bullet” has eluded 20th and 21st Century medicine.
The newest drug doesn’t do anything notably different: “Aduhelm, which is based on the surrogate endpoint of reduction of amyloid beta plaque in the brain…”
Translated? No idea. But this is a bit more transparent: “Aduhelm works by removing beta amyloid, delay[ing]…mild cognitive impairment…or mild Alzheimer's dementia. Some people…experienced significant benefits on measures of cognition and function…such as memory, orientation and language, daily living skills…[like] conducting personal finances, performing household chores (such as cleaning, shopping and doing laundry) and independently traveling out of the home.”
Some patients may experience “temporary swelling in areas of the brain that usually resolves over time and does not cause symptoms…others may have symptoms such as headache, confusion, dizziness, vision changes, or nausea…[a] hypersensitivity reaction, including angioedema (rapid swelling of the area beneath the skin or mucosa [like in] the face and throat, as well as the limbs and genitals.” Also, urticaria (you break out in hives).
The most common side effects of Aduhelm were headache, fall danger, diarrhea, and confusion/delirium/altered mental status/disorientation. (Honest observation of my dad? This seems like things he experienced already without taking Aduhelm…)
But other drugs have removed beta-amyloid, and while I’m sure that’s great, removing beta-amyloid is only one small part of the problem. There are OTHER factors that go into Alzheimer’s…
Carlie Porterfield of Forbes Magazine reports that at least two major hospital systems – the Cleveland Clinic, and Mount Sinai in New York, remain unconvinced that the new drug is particularly effective against Alzheimer’s. First of all, “…approved by the FDA in June [Aduhelm] was the first major Alzheimer’s medication to receive the green light from the agency in nearly 20 years.” Can you say, “PRESSURE LOBBYISTS”? Also, there are concerns “over conflicting data from clinical trials about the efficacy of the drug. While a phase 3 study found a 22% reduction in cognitive decline in patients who took Aduhelm, a following clinical trial found no benefit.” And (in a totally stunning surprise) “…the cost of the treatments [would be] $56,000 annually and [a] financial burden…place[d] on Medicare.”
I think the fallout is only beginning: “…some outside advisors [are] quitting in protest of the approval, while Sen. Joe Manchin (D-W.Va.) called for FDA Acting Commissioner Janet Woodcock to be refused a permanent role as the head of the agency.”
Worst of all, families who thought that help was on the way – and we were one of those families a few years ago – have once again had their hopes dashed by…well…I’ll keep my opinion on that to myself, though you can probably figure out what I think about drug companies and profiteering just by reading this essay…
Resources: https://www.kare11.com/article/news/nation-world/fda-approves-first-new-alzheimers-drug-in-nearly-two-decades-biogen-aducanumab/507-85338078-26c9-4d3b-ba4e-89ba4e64c25e
References: https://www.alz.org/alzheimers-dementia/what-is-alzheimers/brain_tour_part_2, https://www.alz.org/media/documents/fda-approved-treatments-alzheimers-ts.pdf, https://www.forbes.com/sites/carlieporterfield/2021/07/15/heres-why-2-major-health-centers-wont-carry-controversial-new-alzheimers-drug/?sh=64b2cbb9445d
Image: https://encrypted-tbn0.gstatic.com/images?q=tbn:ANd9GcSYobM5GeFry6lVayNtb8o5ks8AftNG0URFgu_oXUYoYAK2ON3Kix5-x8KikJh6cUqX6s07sMTjm_qfOA&usqp=CAU
No comments:
Post a Comment