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New drugs for Alzheimer's Disease

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Lani
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New drugs for Alzheimer's Disease

#1

Post by Lani »

Every time there's a new miracle drug (no, there is no miracle drug), the hype fades as the drugs cause more problems. So far, it seems that research is focused on destroying the amyloid plaques & tangles. Then it turns out that the plaques offer some sort of protection or do less damage, and the meds are doing more harm than help.

On to the next one.

From my John Hopkins newsletter:

FDA Greenlights Controversial Alzheimer's Drug
Bloomberg School epidemiologist Caleb Alexander recently warned that the FDA was poised to make an unfortunate decision: approving the controversial Alzheimer’s drug known as Aduhelm.

Yesterday, the FDA did just that, approving the drug despite strong warnings from independent advisers, including Alexander, who overwhelmingly concluded that there was insufficient evidence that the treatment had significant benefits for patients.

Aduhelm is the first new drug for Alzheimer’s disease in nearly 20 years—and the only drug that U.S. regulators believe can likely treat the underlying disease rather than manage symptoms like anxiety and insomnia. It is also expected to make billions for its maker, Biogen.

But it hasn’t been shown to help slow the disease, and experts are concerned that it’s been allowed to skirt regulatory standards.

“I’m quite surprised. The most compelling argument for approval was the unmet need but that cannot, or should not, trump regulatory standards,” Alexander told STAT. “It’s hard to find any scientist who thinks the data are persuasive.”

He explained his position in detail in a co-authored op-ed for the New York Times.
From Australia: New Alzheimer’s drug ‘available to anyone who can pay for it’, but benefits are limited
https://thenewdaily.com.au/life/wellbei ... 2020210620
Patient lobby groups pushed hard for this drug – and fair enough. The fruitless search for an effective treatment has been dispiriting for families and researchers alike.

But the celebration was tainted when three members of the FDA’s independent panel of experts resigned in protest. They said the evidence the drug slowed dementia was weak and that it shouldn’t go to market.

They also cited serious side-effects: brain swelling and brain bleeding.

Dr Aaron Kesselheim, a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, sat on the committee for six years. He walked away, telling The New York Times: “This might be the worst approval decision that the FDA has made that I can remember.”
The FDA ruling allows for anyone with an Alzheimer’s diagnosis – even one from a GP based on patient’s self-reporting – to have access to the drug. There is no requirement that the person must have proof of amyloid. The annual cost is US $56,000. Biogen's stock is soaring.
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Slim Cognito
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Re: New drugs for Alzheimer's Disease

#2

Post by Slim Cognito »

This is heartbreaking, giving people (possibly) false hope. Being adopted, I was always worried about Alzheimer's, but then my older brother, also adopted, no blood relation, found his birth mother and, guess what, she had early Alzheimer's. So now he's more stressed than I am about it. And Hubs' mother had it, both of her parents had it, and now every time Hubs forgets something I told him*, I wonder if it's starting.

*I keep threatening him that if he doesn't pay better attention to what I say, I'm taking him in for a geriatric assessment. He's doing better. Hopefully it's just a selective hearing problem, for now.
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Re: New drugs for Alzheimer's Disease

#3

Post by zekeb »

When you start seeing it advertised on TV you'll know it's priced at $1000+ per month. A drug that so few seniors will be able to afford.
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Lani
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Re: New drugs for Alzheimer's Disease

#4

Post by Lani »

Slim Cognito wrote: Sun Jun 20, 2021 9:04 am This is heartbreaking, giving people (possibly) false hope. Being adopted, I was always worried about Alzheimer's, but then my older brother, also adopted, no blood relation, found his birth mother and, guess what, she had early Alzheimer's. So now he's more stressed than I am about it. And Hubs' mother had it, both of her parents had it, and now every time Hubs forgets something I told him*, I wonder if it's starting.

*I keep threatening him that if he doesn't pay better attention to what I say, I'm taking him in for a geriatric assessment. He's doing better. Hopefully it's just a selective hearing problem, for now.
I spent my 50's worrying about early onset.

Alzheimer's Association is doing a presentation on the new drug (and some other things) on the 29th. Not really interested. My interest is in getting more support for family caregivers.
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Lani
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Re: New drugs for Alzheimer's Disease

#5

Post by Lani »

More from John Hopkins on the new drug.
The evidence has always been murky regarding whether or not the product is safe and effective, and during the course of drug development, the manufacturer conducted two large, similarly designed trials that yielded conflicting results.

Even in the one study that was partly successful, aducanumab’s effect on slowing disease progression was very modest, one of many concerns of an FDA advisory committee that nearly unanimously concluded that the evidence for the product was not persuasive.

Ultimately, rather than approving the product on the basis of this conflicting evidence, the FDA approved it using its “accelerated pathway,” which allows for product approval based on a surrogate outcome, in this case, beta-amyloid reduction.

However, it is far from clear that reducing beta-amyloid will correspond with clinical improvements in the things that people care about: memory, language, cognition. Many other failed products have been demonstrated to reduce beta-amyloid levels in the brain without any improvement in these symptoms of Alzheimer’s disease. And even the data from aducanumab’s failed trial call into question this association. Adding to many people’s surprise, the FDA did not restrict its approval to individuals with mild disease and confirmation of elevated beta-amyloid levels, even though the trials that aducanumab’s developer, Biogen, conducted exclusively enrolled these individuals
And it's $56K/year in the US.

https://www.jhsph.edu/news/stories/2021 ... numab.html
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