FDA approves much-debated Alzheimer's drug panned by experts

[Omaha Steve]

Source: AP

By MATTHEW PERRONE

WASHINGTON (AP) — Government health officials on Monday approved the first new drug for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease.

The Food and Drug Administration said it granted approval to the drug from Biogen based on results that seemed “reasonably likely” to benefit Alzheimer’s patients.

It’s the only drug that U.S. regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia.

The decision, which could impact millions of older Americans and their families, is certain to spark disagreements among physicians, medical researchers and patient groups. It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits.



This image provided by Biogen on Monday, June 7, 2021 shows a vial and packaging for the drug Aduhelm. On Monday, June 7, 2021, the Food and Drug Administration approved Aduhelm, the first new medication for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease. (Biogen via AP)


Read more: https://apnews.com/article/science-government-and-politics-business-health-2147d824af9cfde629041d83d9ca7a8d

[Midnight Writer]

1. Just watched a financial analyst explain that it doesn't matter if it works or not, profit-wise.

There are no other treatments, and people are desperate.

She said doctors will prescribe this even if they don't believe it will work, because they don't want to look patients and family members in the eye and dash their hopes.

Biogen up about 40% on the day.

[slightlv]

2. There really aren't any treatments for other kinds of dementia, either.

Families are desperate, I agree. Watching a loved one devolve into a child, and sometimes an intransigent, belligerent child is so hard on everyone... including the patient. We've had mom on aricept for years to no avail. But you hate to give up the only treatment, even if it's not showing any improvement. Mom doesn't have Alzheimer's. She has "normal" age-related dementia, but she can get downright mean and abusive at times. Not to mention she's four times my size. I'd hoped with the right medicine I'd be able to keep her here with us in an environment that was familiar and with family who love her. The hardest thing I ever had to do was to admit the medicine wasn't helping, and neither could I. The best thing I could do was to hunt for a memory care home where there were people trained in this phase of life. But gods, even still I can beat myself up for it; wondering if there was more I could have done.

The group that comes up with a drug or treatment regimen that actually works to slow dementia will make a mint. I don't care. This disease is just too heart wrenching.

[Liberty Belle]

3. Try medical cannabis chocolates or other chewables. It helped my Mom be less belligerent and happier

and also helped with pain and sleeping somewhat.

It's safer than the other drugs the doctors load patients up on. Mom did great on this until she had a fall and fractured her back; now she's in care facility and doctors won't allow the cannabis so they've tried various other drugs that don't really work but have side effects such as making her groggy.

[JudyM]

7. There's research that suggests cannabis does more for dementia than just help with behavior.

There haven’t been enough rigorous controlled studies, of course, largely due to the schedule 1 mischaracterization in the US, and also to the politicization and lack of pharmaceutical co. support.

[JudyM]

8. There's research that suggests cannabis does more for dementia than just help with behavior.

There haven’t been enough rigorous controlled studies, of course, largely due to the schedule 1 mischaracterization in the US, and also to the politicization and lack of pharmaceutical co. support.

[Omaha Steve]

5. I have FTD

Trazodone has shown good results in trials. I'm on it. A safe drug that has been around a long time.

https://www.researchgate.net/publication/8527842_Frontotemporal_Dementia_A_Randomised_Controlled_Trial_with_Trazodone

Results of this first placebo-controlled trial suggest that trazodone is an effective treatment for the behavioural symptoms of FTD.

Back to my ball game, NU vs Arkansas.

[targetpractice]

6. I've been taking trazodone for 20+ years for sleep...

... That's very interesting... Thank you Omaha Steve!

It's super helpful for sleep, and I have lovely dreams.... And wake up in a good mood everyday.

[Maxheader]

10. Good luck with that Omaha.

Lost a parent to dementia. Fortunately she had really great care

at a local retirement home. A big salute to the aids at these

homes for retirement. ..

[moonscape]

9. How can you tell the difference between age-related

memory loss and Alzheimer’s?

[bucolic_frolic]

4. What's going on in a fatty brain

originates in the quantity and type of fats in the liver, in my opinion. My personal plan is high quality oils - fish, EV olive oil, lecithin as an emulsifier - but decades in advance and in small to moderate amounts.