FDA approves drug for Alzheimer’s

[jayem]

The drug is aducanumab (brand name, Aduhelm.) Alzheimer’s is theorized to be caused by clusters of amyloid proteins forming plaques in the brain. Which disrupt neuronal function, leading to dementia. Amyloids are naturally occurring products of potein breakdown. They’re normally neutralized by enzymes and don’t cause major problems. But in some people, this doesn’t happen. Excessive amyloid builds up in various organs, in addition to the brain. Which results in a number of diseases. Aducanumab is a monoclonal antibody thought to bind to amyloid in the brain and allow it to be removed by the circulation. But that’s in theory. As the article notes, one Phase 3 clinical trial showed only about 20% of subjects had improvement. In another trial, there was no benefit. But the FDA approved it because there are no other drugs which might reverse the actual pathology of Alzheimer’s Disease. And it’s an excellent question if a drug of very modest effectiveness is worth the estimated $50,000+ yearly price tag.

F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works

 

[Strathos]

I'm not sure if it's true, but I heard that chess players don't get Alzheimer's.

 

[jayem]

I'm not sure if it's true, but I heard that chess players don't get Alzheimer's.

I’ve read the same is true for bridge players. Solving word puzzles, too. I think any kind of mental exercise where you have to evaluate variables, and find a solution to a problem, strengthens your cognitive abilities.

 

[HiltiesGwerf]

I’ve read the same is true for bridge players. Solving word puzzles, too. I think any kind of mental exercise where you have to evaluate variables, and find a solution to a problem, strengthens your cognitive abilities.

...or anything that will keep your mind off the $50,000 annual price tag?

 

[jayem]

...or anything that will keep your mind off the $50,000 annual price tag?

The vast majority of Alzheimer’s patients are in the Medicare age group. Traditional Medicare pharmacy benefits (Part D) are funded partly by premiums paid by enrollees and partly by the Supplemental Medicare Trust Fund. To which Congress appropriates money. Meaning we, the taxpayers will likely be paying for part of it. But I doubt this one drug will affect it very much.

Edited to add: I forgot to mention that there’s no guarantee that Medicare will cover this drug. What benefits are provided can be based more on politics and public relations than medical science. And if it is covered, I’m pretty sure Biogen (the manufacturer) will give Medicare a deal just to get the product in use. Medicare won’t be paying the sticker price.

 

[essentialsaltes]

As the article notes, one Phase 3 clinical trial showed only about 20% of subjects had improvement. In another trial, there was no benefit

This has gotta be a really tough call for the FDA. In addition to the potentially imaginary benefits, I seem to recall that brain bleeds was a common enough side effect that people were dropped from the study. And in addition to the cost of the drugs, patients would need to get regular head MRIs to check for bleeding.

On the other hand, we really could use a treatment.

Once it's approved, we'll probably get better data on safety, but without a proper study it'll be hard to judge efficacy. I'm sure many people will think there's a benefit even if there isn't. And if the next study shows no benefit, and FDA wants to pull the approval, it will be a messy event.

 

[pgp_protector]

On the Alzheimer's groups I'm in, most are saying the same thing.

Given the cost, risk, and that it doesn't stop, or reverse the progressing of this bleeping condition, it's not worth it.

 

[HiltiesGwerf]

I would love to see us eradicate Alzheimers as it's a brutal, brutal disease - but I'd also hate to see yet another in a long list of drugs hastily brought to market (and let's be honest, that's the primary goal here) that will only find itself several years later the target of a class-action lawsuit for the unanticipated side-effects of the drug - notwithstanding all the currently KNOWN side effects.

 

[Strathos]

I’ve read the same is true for bridge players. Solving word puzzles, too. I think any kind of mental exercise where you have to evaluate variables, and find a solution to a problem, strengthens your cognitive abilities.

Then let's just make chess mandatory in schools, that will cure Alzheimer's.

 

[FrumiousBandersnatch]

Then let's just make chess mandatory in schools, that will cure Alzheimer's.

Checkmate! Simples...

 

[essentialsaltes]

A member of a US Food and Drug Administration advisory committee said Wednesday he had resigned over the agency's approval of a new Alzheimer's drug.

Mayo Clinic neurologist Dr. David Knopman told CNN Wednesday he had resigned from the committee in protest.

The Washington Post first reported Knopman's resignation. A second member of the committee, Dr. Joel Perlmutter, did not immediately respond to CNN's queries about a report in STAT News he had also resigned.

While the FDA is not bound by the advice of its committees, it usually follows them, so the decision to approve the drug was unusual and controversial.

 

[FrumiousBandersnatch]

A member of a US Food and Drug Administration advisory committee said Wednesday he had resigned over the agency's approval of a new Alzheimer's drug.

Mayo Clinic neurologist Dr. David Knopman told CNN Wednesday he had resigned from the committee in protest.

The Washington Post first reported Knopman's resignation. A second member of the committee, Dr. Joel Perlmutter, did not immediately respond to CNN's queries about a report in STAT News he had also resigned.

While the FDA is not bound by the advice of its committees, it usually follows them, so the decision to approve the drug was unusual and controversial.

Interesting that Biogen said that higher doses of the drug didn't show improvements but slowed the decline, yet several news items I saw on the BBC uncritically presented a surgeon, who'd been diagnosed 10 years ago and was taking the drug again after the earlier trial, saying that he felt significant improvement in memory and reduced confusion...

 

[essentialsaltes]

A member of a US Food and Drug Administration advisory committee said Wednesday he had resigned over the agency's approval of a new Alzheimer's drug.

While the FDA is not bound by the advice of its committees, it usually follows them, so the decision to approve the drug was unusual and controversial.

House investigation faults FDA, Biogen for Alzheimer’s drug approval​

The biotechnology company Biogen and its regulator, the Food and Drug Administration, worked in concert, ignoring internal concerns from the company and skirting the agency’s own written guidance, to allow the Alzheimer’s treatment Aduhelm to receive accelerated approval and hit the market at a cost to patients of $56,000 a year, according to a scathing report released Thursday by two House committees.

The “unusual” collaboration, which resurrected Aduhelm three months after Biogen had canceled clinical trials, unfolded through at least 115 meetings, calls and email exchanges between the company and the FDA in a year, said the report by the Committees on Oversight and Reform, and Energy and Commerce.

The joint effort climaxed with staff from the agency helping Biogen draft a document used to brief the FDA’s advisory committee before it met to discuss Aduhelm on Nov. 6, 2020. Although the FDA often follows an advisory committee’s recommendation, it did not this time. After no member of the advisory committee recommended Aduhelm, the FDA changed course, allowing Biogen to move its drug to an accelerated approval process.

 

[pgp_protector]

Sorry the wife still won't be taking it.

 

[FrumiousBandersnatch]

House investigation faults FDA, Biogen for Alzheimer’s drug approval​

The biotechnology company Biogen and its regulator, the Food and Drug Administration, worked in concert, ignoring internal concerns from the company and skirting the agency’s own written guidance, to allow the Alzheimer’s treatment Aduhelm to receive accelerated approval and hit the market at a cost to patients of $56,000 a year, according to a scathing report released Thursday by two House committees.

The “unusual” collaboration, which resurrected Aduhelm three months after Biogen had canceled clinical trials, unfolded through at least 115 meetings, calls and email exchanges between the company and the FDA in a year, said the report by the Committees on Oversight and Reform, and Energy and Commerce.

The joint effort climaxed with staff from the agency helping Biogen draft a document used to brief the FDA’s advisory committee before it met to discuss Aduhelm on Nov. 6, 2020. Although the FDA often follows an advisory committee’s recommendation, it did not this time. After no member of the advisory committee recommended Aduhelm, the FDA changed course, allowing Biogen to move its drug to an accelerated approval process.

That's a very strange & suspicious approval process...

The new drug lecanemab (from Eisai and Biogen) looks like a better option, shown to slow the progression of Alzheimer's by 27% by clearing amyloid plaque - albeit with important caveats: though statistically significant, the measurable effect is tiny; there are risks of brain swelling and bleeds; the long-term benefits are yet to be assessed.

It looks like they're making progress towards an efficacious drug, but I don't think they're there yet...