The Food and Drug Administration on Monday approved the first new treatment for Alzheimer’s disease in nearly two decades, a landmark decision that has been eagerly awaited by millions of Americans diagnosed with the condition but that will be hotly contested by some in the scientific community who doubt the drug’s effectiveness.
While other drugs treat symptoms of Alzheimer’s, the new medicine, called Aduhelm, is the first to attack what some believe is an underlying cause of the disease and slow cognitive decline, albeit marginally. It does so by eliminating clumps of a toxic protein believed to destroy neurons and cause dementia. Aduhelm is not a cure for Alzheimer’s, and it doesn’t reverse the disease’s progression.
The drug — which just two years ago was declared a stunning failure — is now expected to generate billions of dollars in revenue for its maker, Biogen.
These beta amyloid, are also present in other forms of dementia, not just alzheimers. I have just finished caring for both my parents who had both alzheimers and for my father, vascular dementia, they decided not to do brain scans on my mother to discover the other side of her dementia. I understand the families needing hope. My sister has just been diagnosed with the beta amyloid on her brain. So this was good news hearing of this medication. However I do not believe it will get passed in the U K.
So now it is a waiting game.
Is approving this product an appropriate response? The targets of this pharma product are incredibly vulnerable to emotional manipulation. With the efficacy being as thin as reviews seem to indicate, are the costs compared to the anxious-last-ditch-grasp-for-hope decision drivers of love-ones appropriately balanced? I’d love it if my mother’s quality of life could be maintained or perhaps improved over her last few years, but this treatment could bring my family to the brink of economic ruin if we let hope alone trump our decision process. Can we be trusted to make the right decision? Can we appropriately evaluate the pros and cons of this approach when our hopes and fears of loss fog our ability to grapple with the nuances involved? I think not. And given the thrust of the “marketing” promise already in the wind, I feel that the thin margins of benefit offered are unethical.
Check out “Awakening from Alzheimer’s”. The issue of the plaques is a SYMPTOM. The question is, what is causing the body’s immune system to generate the plaques?
Much hope is offered through research on teleomeres.
I would love to get my mom in the clinical trial. She has early onset Alzheimer’s disease. She would be perfect for the trials
Would this medicine also be an alternative for patients with phase one vascular dementia
business and bribes always trump science
Where to find the pills 💊
40% Chance of cerebral edema for a debatable minuscule chance of only a tiny benefit and the honor of paying $10,000 for the privilege. Wow, I think the regulators must also have approved LCD and were on it when they granted FDA approval on this one. Come on people, desperation for treatment is not a legitimate reason to approve a potentially dangerous drug with little efficacy, no matter how emotionally beautiful the commercials will sound. This will play on desperation and money unless better consistent data on efficacy can be found. Look how many hundreds of millions that snake oil Prevagen had made.
There are now multiple trials showing that plasma exchange with albumin replacement actually slows cognitive and functional decline in Alzheimer’s. Here is one: https://pubmed.ncbi.nlm.nih.gov/32715623/
Here is another: https://www.prnewswire.com/news-releases/grifols-demonstrates-a-significant-reduction-61-in-the-progression-of-moderate-alzheimers-disease-using-its-ambar-treatment-protocol-300738956.html There are many more.
Insurer are willing to cover a cheaper drug that probably doesn’t work. I wonder if the same insurer would also cover the plasma exchange treatment that has been shown to slow cognitive decline in clinical trials. Probably not.
In the (unlikely) case you missed it, the “study” was conducted and sponsored by Grifols, a company that makes/sells plasma products. Not exactly different from Biogen’s fantasy therapy claims