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Discussion » Statements » Rosie's Corner » The FDA just approved a new drug to treat Alzheimer's. The first new drug for that disease since 2003. Know anyone who has it?

The FDA just approved a new drug to treat Alzheimer's. The first new drug for that disease since 2003. Know anyone who has it?

Allegedly 6 MILLION Americans currently suffer with it/from it. I don't know how many worldwide. Good news for a change?

Posted - June 7

Responses


  • 6419

    Aduhelm

    "Instead of judging Biogen’s treatment solely on its effects on cognition, the FDA granted a conditional approval based on Aduhelm’s ability to clear the toxic proteins, called beta-amyloid. In order to continue marketing the drug, Biogen will need to complete a large clinical trial to confirm that removing the plaque has cognitive benefits, the FDA said. If that study fails, the FDA has the authority to rescind its approval.

    In approving the drug on a conditional basis, the agency departed from decades of regulatory precedent, setting a new bar for treatments with considerable potential but unproven benefits — a standard that could also be applied to other devastating disease."
    ..."Biogen believed it could succeed where the others failed; it designed Aduhelm to be more potent and therefore better able to eliminate amyloid plaques than earlier drugs. The company also focused on administering Aduhelm to people with mild cognitive impairment or the earliest signs of Alzheimer’s, before brain cells were too damaged to stem the tide of the disease."


    https://www.statnews.com/2021/06/07/fda-grants-historic-approval-to-alzheimers-drug-designed-to-slow-cognitive-decline/



    This post was edited by Honeydew at June 8, 2021 2:30 AM MDT
      June 7, 2021 10:08 AM MDT
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  • 108991
    Thank you for your reply Hd and Happy Tuesday to thee. Do you  know anyone who has it? This post was edited by RosieG at June 8, 2021 3:08 AM MDT
      June 8, 2021 2:32 AM MDT
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  • 6419
    Not currently.
      June 8, 2021 3:09 AM MDT
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  • 17840
    I heard about this on the news tonight.  Personally, I would be afraid to take this unless it was a life-or-death situation.  Even members of the FDA said it shouldn't have been approved.  There just hasn't been sufficient testing for this to be brought to market at this point.  Having said that, I'm sure that someone with Parkinson's, a devastating disease, would try most anything, if they thought it would help.
      June 7, 2021 7:07 PM MDT
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  • 108991
    It has to be used early to have any effect L. I'm not brave or adventurous but I'm pretty sure I'd GRAB anything that could possibly help slow it down. Apparently it helps prevent the formation of that scum that collect in the brain. Do you know anyone who has it? Thank you for your reply and Happy Tuesday to you m'dear! :) This post was edited by RosieG at June 8, 2021 8:57 AM MDT
      June 8, 2021 2:34 AM MDT
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  • 17840
    The side effects are brain damage, among other things.  If taken early and you have brain damage, how are you better off?  Both my parents had dementia.  Happy Tuesday. :)
      June 8, 2021 8:58 AM MDT
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  • 108991
    "Possible" side effects. No drug that I ever heard of had 100% side effects listed for everyone who ever took them. Here's the thing. You have STAGE 4 cancer and you are dying. There is a new untested med that COULD extend your life but might have certain side effects. Wouldn't you chance it since you are dying very quickly if you do nothing?  I think I told you years ago I participated in a test for a drug that was said to be a great weapon to combat osteoporosis. They never know what the side effects are until they test the drug on homo saps. I volunteered. The drug was CALCITONIN. Some of us got placebos (turns out I did but I didn't know that going in) and others got the med. It was a two-year test at the stage of FDA testing. It could have affected me adversely very badly. I chanced it because my mom had osteoporosis and at the time I was on the edge of osteopenia which had me on the road to osteoporosis. At the end of two years the doc adminisitering the program broke protocol and told me that I had to start taking something for my bones  because in those two years I became osteoporotic. I would not have known until I slipped and fell and broke some bones. So that's when I was put on FOSAMAX which I stayed on for 15 years. Turns out the maximum time we're supposed to be on it? 7 years. I've been off it for about 10 years now and I get bone density tests every two years. I'm holding my own because of our diet I'm sure. If there were another study that interested me I'd volunteer but I'm pretty sure they don't take 83 year old dames. Thank you for your reply L! :). This post was edited by RosieG at June 8, 2021 2:59 PM MDT
      June 8, 2021 12:24 PM MDT
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  • 17840
    Agreed that there's no drug without some side effects.  You are correct that this drug has to be taken in the very early stages which is exactly why I would not want to take a chance of having brain damage with so many possible years to go before I died of dementia.  Dying from dementia is not like dying from a Stage 4 cancer.  
      June 8, 2021 3:03 PM MDT
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  • 108991
    As is always true sweetie we can't KNOW FOR SURE what we'd do until we are in that situation. At least I can't. I know what I think now being on the outside looking in. But being there? That's a horse of a different color. Thank you for your reply L! :)
      June 9, 2021 1:28 AM MDT
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  • 17840
    This was posted on Axios this morning:

    "Biogen's controversial new FDA-approved drug for Alzheimer's, a disease 500,000 Americans are diagnosed with each year, will cost $56,000 annually, Axios health care editor Tina Reed writes.

    • If half of the newly eligible Americans in a year began treatment with Aduhelm, the cost would be $14 billion — roughly equivalent to Medicare Part B spending in 2019 on the next 8 products combined, per a Bernstein analysis.

    Why it matters: It's experts' nightmare drug-spending scenario — an extremely expensive product that millions of desperate patients could be eligible for. And it may not even work.

    • The numbers alone could give new ammunition to advocates who argue that drug prices are too high and should be limited."
    https://mail.yahoo.com/b/folders/4/messages/AMzTxOAou1V6YMCbmQFEOF9CW94?.src=ym&%3Breason=myc&%3BfolderType=INBOX&folderType=TRASH&showImages=true&offset=0
      June 9, 2021 7:39 AM MDT
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  • 108991
    I can see that you are very sincerely anti this L. Thank you for the info and the link! :)
      June 9, 2021 10:17 AM MDT
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  • 17840
    I am not at all in favor of this without further testing.  How many average people could pay for that kind of treatment out of pocket as it's pretty much a foregone conclusion that insurance isn't going to pay for it?  
      June 9, 2021 4:15 PM MDT
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  • 108991
    I know you are sweetie. Would you ever participate in FDA studies?  If it were not for people who do and gamble they'll be OK everyone would be at risk for everything and anything. That way the field of possibility for harm is limited. I survived stage 3 cancer and was given a 14% chance of surviving 5 years. That was in December 2007. Here I am still. What I had was a combination of two deadly cancers so they had to concoct chemo for something they had not dealt with before. I was very healthy.It was VERY STRONG stuff. What they gave me was two types...every three weeks..three days in a row for 6 months. I had a vein collapse only once. So I was very lucky. Some folks have a implant in the chest through which the chemo is administered if their veins can't take it. Day 1 I was there for 8 hours. Days two and three it was about 5 hours each day. Then there was 25 days of radiation in a row excluding weekends. If I hadn't been healthy I probably wouldn't have survived the treatment. What I'm saying is I've been there and maybe you haven't. So that's why I'm all for gambling. Thank you for your reply L and Happy Thursday to thee and thine.
      June 10, 2021 3:23 AM MDT
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  • 17840
    I'm all for gambling when there is a real possibility that the treatment will work and when the illness is so advanced that you have nothing to lose.  Since this drug has to start in the very early stages of Alzheimers, and because an Alzheimers patient can live for years with some quality of life, I don't believe I would take a chance on having my brain melted in that very early stage.  Yes, I do comment anyone who will volunteer for these test groups, but I would l have to weigh all the information vs the risks.
      June 10, 2021 7:24 AM MDT
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  • 108991
    That's the thing. NO ONE KNOWS what the risks are. That's why they do the testing. To determine that. Thank you for your reply L! :)
      June 10, 2021 8:05 AM MDT
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  • 7397
    I have known a few of then one of them was one of my grounds keeping customers he used to  play for the Saskatchewan Roughriders. I found it very sad to watch him slowly forget about his glory days. So I am glad they found a new drug to help fight it. Cheers!
      June 7, 2021 7:33 PM MDT
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  • 108991
    It has to be used early on. I think the gunk that forms in the brain is slowed down by it. I think they're going for "emergency" approval to speed up the delivery to people who have it. Anyway fingers crossed. A tiny bit of llight in a dark tunnel. We'll take it! Thank you for your reply Nanoose and Happy Tuesday to you and your family! :)
      June 8, 2021 2:30 AM MDT
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