FDA approves controversial Biogen Alzheimer's drug | DW News

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  • เผยแพร่เมื่อ 6 มิ.ย. 2021
  • US government health officials have approved the first new drug for Alzheimer's disease in nearly twenty years. Regulators say the drug, which will be known as Aduhelm, is the first treatment that targets the causes of the disease, rather than its symptoms. But the approval is controversial - with some experts saying there's not enough firm evidence of real benefits.
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    #Alzheimers #Biogen #FDA

ความคิดเห็น • 131

  • @Alexa-hh8so
    @Alexa-hh8so 3 ปีที่แล้ว +25

    My mother is beginning to have symptoms of dementia. Hope it will be ready.

    • @karmaisreal9341
      @karmaisreal9341 3 ปีที่แล้ว

      Mine too. But she will never treat it. If her husband dies first it's going to be a very bad situation.

    • @Jen-qd7sc
      @Jen-qd7sc 3 ปีที่แล้ว +3

      Hope she can afford it. It’s $56,000 a year.

    • @heavenlymonkey
      @heavenlymonkey 3 ปีที่แล้ว

      A fact is that dietary changes (low carbohydrate diet) and modest exercise is by far more efficacious than any pharmaceutical (including this newly approved one)
      Alzheimer like many other diseases of civilization are driven by hyperinsulinemia (insulin resistance), caused by decades of overconsumption of sugar and carbohydrates.

  • @infantryspecter
    @infantryspecter 3 ปีที่แล้ว +37

    I’m so happy right now I could cry

    • @Jen-qd7sc
      @Jen-qd7sc 3 ปีที่แล้ว +5

      It’s $56,000 a year to take this medication. Yes, I’m crying and so are all those that can’t afford it. Actually, the side effects are HORRIBLE!!!

    • @sandrathomas2921
      @sandrathomas2921 3 ปีที่แล้ว +2

      Omg Same here it great news.
      My mom and uncles have dementia ..its a horrible. It just robs their personality and memory. I wouldn’t wish it on anyone. Lets hope this is a beginning to the end of Alzeihmer .

    • @passionatesingle
      @passionatesingle 3 ปีที่แล้ว +1

      I cried too because I don't think it will help my mum. She is moderately severe now and doesn't live in the States 😞

  • @Lipigipi
    @Lipigipi 3 ปีที่แล้ว +23

    Good news!! Miss you mom... 😥💔💔💔

    • @elpolloguapo530
      @elpolloguapo530 3 ปีที่แล้ว +4

      May she rest in peace, I'm sorry for the pain you and your family must have endured.

  • @ayalqie4587
    @ayalqie4587 3 ปีที่แล้ว +6

    I lost my Mom six month ago and I fear that I have early symptoms

  • @IKEMENOsakaman
    @IKEMENOsakaman 3 ปีที่แล้ว +32

    If only this was developed 10 years earlier...

    • @Jen-qd7sc
      @Jen-qd7sc 3 ปีที่แล้ว

      It’s $56,000 a year to take this drug. And the side effects are HORRIBLE!!!! Look up ARIA event. Falls are a side effect due to dizziness, therefore more $$$$$ for surgeries!!!

    • @kgcotton326
      @kgcotton326 3 ปีที่แล้ว +1

      This drug was co-developed by the US and Japan! 😍😍

    • @calvinsylveste8474
      @calvinsylveste8474 3 ปีที่แล้ว +2

      The build up of the amyloid protein may not be the cause, but due to inelasticity of blood vessels in the brain. Those vessels usually expand while you sleep to help clear out the days buildup of junk.

  • @londonw9317
    @londonw9317 3 ปีที่แล้ว +10

    Step foward. Belive in medical resreach.

    • @Jen-qd7sc
      @Jen-qd7sc 3 ปีที่แล้ว +1

      I don’t trust the effectiveness of this drug. Too many side effects!! Look up ARIA event. A stands for amyloid. Stocker shock at $56,000 a year!!

  • @jakeg3126
    @jakeg3126 3 ปีที่แล้ว +5

    How can you actually accurately test that if it’s more of a preventive treatment and takes that long between doses and it has to be hard to have an accurate baseline?

    • @daguido742
      @daguido742 3 ปีที่แล้ว +1

      im no expert but i assume they will compare the progress of Alzheimers of peple who take the medication and people who dont take it. if the sample size is big enough they can see if the people who take the drug actually show less symtoms over time or not. but yeah i agree that this could be kinda inaccurate. either way i hope it helps at least a few people

  • @zenkakuji3776
    @zenkakuji3776 3 ปีที่แล้ว +18

    I am truly hopeful this results in an effective treatment. I know a number of families who are affected by this condition in a family member. Also hoping the FDA uses this same approval rationale for the Ivermectin protocol as there are numerous studies published showing a positive effect with those affected by the pandemic.

  • @jron20r51
    @jron20r51 3 ปีที่แล้ว +4

    56,000dollars for it a year. If it better work

  • @silvialogan9226
    @silvialogan9226 3 ปีที่แล้ว +13

    I hope that this treatment is effective and a life saver for those Alzheimer's patients.

  • @jamesroth8997
    @jamesroth8997 3 ปีที่แล้ว +4

    Doctors opinions are highly questionable these days.

    • @jamesroth8997
      @jamesroth8997 3 ปีที่แล้ว

      @@Gopniksquat the doctor gave an opinion. And it goes without saying that doctor's are human, they do have there own interest in mind. The way I look at it, is that it is a really expensive drug. that is unproven and using desperate people as Ginnie pigs.

    • @jamesroth8997
      @jamesroth8997 3 ปีที่แล้ว

      @@Gopniksquat yes, I agree That R&D is important. I think they need more clinical trials, before the government more or less tells people it's safe. And you gotta wonder if they just need the cash.

    • @wentoneisendon6502
      @wentoneisendon6502 3 ปีที่แล้ว

      Ahh Dr TH-cam commenter. I'll listen to you and ignore the experts

  • @gusposey8218
    @gusposey8218 3 ปีที่แล้ว

    It's disappointing to see you using such a misleading headline.

  • @DanA-nl5uo
    @DanA-nl5uo 3 ปีที่แล้ว +2

    The FDA said they don't know if it will benifit the patients but that there will definitely be high profits for the drug companies. So one more victory for the caplistist to get these high profits for no proven results.

  • @user-qe1fo1pb5t
    @user-qe1fo1pb5t 3 ปีที่แล้ว

    Unfortunately this drug doesn't work. FDA is simply desperate to approve this drug.

  • @VULTUSPRIME
    @VULTUSPRIME 2 ปีที่แล้ว +1

    When I saw this I thought it is good news, until he mentioned brain swelling. That's when he lost me.

  • @kgcotton326
    @kgcotton326 3 ปีที่แล้ว +4

    This drug was co-developed by the US and Japan! 🇯🇵🤝🇺🇸💊😘😘

    • @antonioblackfox
      @antonioblackfox 3 ปีที่แล้ว

      Makes sense with Japans pop. Wouldn't be surprised if Japan started with the program first only to gain support. Good info

    • @walterkoch7328
      @walterkoch7328 3 ปีที่แล้ว

      Might be, Sir, patent payments end up in Schlieren and the University of Zurich.

  • @Kicikicimaj
    @Kicikicimaj 2 ปีที่แล้ว

    This is one of best news ever! I am so so happy, and I hope it will work wonders. Bless you all.

  • @lohphat
    @lohphat 3 ปีที่แล้ว +6

    "Monthly injections for a year."
    That translated in US English as "Will cost $5000 a shot."

    • @IpSyCo
      @IpSyCo 3 ปีที่แล้ว +3

      Not bad for a drug that completely halts dementia. I’d pay tens of thousands for a drug like that.

    • @lohphat
      @lohphat 3 ปีที่แล้ว +3

      @@IpSyCo Then it only protects the rich.

    • @IpSyCo
      @IpSyCo 3 ปีที่แล้ว +3

      @@lohphat Well you can’t expect them to release a drug that took billions worth of capital to research at a price of $25.

    • @lohphat
      @lohphat 3 ปีที่แล้ว +5

      @@IpSyCo Do you realize that most drugs start as basic research by publicly-funded universities only then for the rights to be purchased for pennies on the dollar to be patented by a private drug company and marked up to line the pockets of the shareholders, leaving the taxpayer in the dust?
      The US drug industry is a cartel racket.
      Other developed countries like Canada, France, The UK, Germany, Japan, etc. don't shake down their citizens to receive life-saving treatment.
      Perhaps you should look up "Stockholm Syndrome".

    • @IpSyCo
      @IpSyCo 3 ปีที่แล้ว +5

      @@lohphat Key phrase to your argument "most drugs." Unless you can provide a decent source showing that this drug was funded through public universities this input is completely useless to me.
      Other countries like Canada, France, UK, Germany have all outsourced their medical research to the US. I once saved this explanation I found but I cant find the link to the original post. However I think this summarizes the US drug industry perfectly.
      "We are the LAST wealthy country with a more-or-less market-based system. 75% of the world’s medical R&D is done in or for the U.S. healthcare system, and that is why. To put it another way, our system pays for *three times* the medical advancement as the *rest of the world put together*. Canada once had a thriving medical R&D industry; when they socialized their system that industry largely shut down and moved one country south. But now, there is nowhere else left for that all to move to. If we shut it off here, it’s gone.
      A very large part of the reason our healthcare system is so expensive compared to others that seem to have equal or better outcomes is exactly this problem - that we bear the burden of paying for the world’s medical advancement, and that other systems take advantage of that without paying their fair share of it. But that leaves us with only three options - (a) keep paying for it, in which case our system will continue to be more expensive than anyone else’s, (b) socialize our system and stop paying for it, which will result in *no one* paying for it, and thus then it not getting done, or (c) make the other systems pony up and pay their fair share, which would be the best answer.
      The majority of the money for the world’s medical advancement is recovered from the American market. Most drugs cost more to develop than to make. If you have a drug that costs $5 a dose to make, but cost $100 a dose to get to market (in the U.S., amortized under our current shortened patent timer), then it will be $105 a dose. If some other country then decides that they will pay $25 a dose for it, then the company can sell it there, make back $20 a dose on the extra doses, and then the price here can go down to $85 a dose. So generally, the companies do go ahead and do that. But that still leaves us paying more than three times as much, and funding most of that development cost. Whereas if that other country had to pay a fair market price, the cost could be evenly divided, and it would be $55 a dose in both places. That other country would still have the option to have a socialized system, and to then provide that medicine to its own citizens for any price it chooses, or for free, but wouldn’t be able to do so at our expense by dumping most of the development cost burden on us in the process.
      Solving this would be tough, but most of the other wealthy countries with price controlled socialized systems are members of the WTO. Maybe a suit through the WTO for restraint-of-trade could be filed that would prevent the governments of those countries from dictating artificially low prices. Again, those other countries would still have the option to have socialized systems, and to then provide that medicine to their own citizens for any price they choose, or for free, but wouldn’t be able to do so at our expense by dumping most of the development cost burden on us in the process.
      =====
      A more detailed explanation of drug pricing:
      I’m going to create a “test case”, using some actually pretty realistic numbers. The main concept is that it very often costs FAR more to develop a drug than it does to make it once it has been developed.
      Let’s suppose, to make the math easy, that we have a drug developed that cures a condition with one dose. Once on the market, this drug costs about $25 a dose to make. Getting this drug approved in the U.S. costs $100,000,000 and consumes 12 of the 17 years of the patent duration (typical amounts). Getting the drug approved in Europe, which has similar (but not entirely compatible) standards would be about the same; $100,000,000 and 12 years. Getting the drug approved in both U.S. and Europe would save some money through avoiding duplication, and could be done in the same amount of time, for a total of $125,000,000. The investors that put up the money for this development expect to double their money (not unreasonable for a 12-17 year investment). The drug will sell in the U.S. market for what they need to sell it for. The E.U. declares they will pay $125 a dose. There are 100,000 patients a year in the U.S. with this condition, and 150,000 a year in the E.U.
      For the sake of simplicity, I’m going to ignore advertising costs and such for this example.
      So here are the options for the company:
      Seek approval only in Europe. 150,000 patients a year times five years of patent = 750,000 patients. $125 a dose, minus $25 a dose to produce, = $100 a dose return; times 750,000 patients = $75,000,000. Not economically viable. To return the costs, $200,000,000 (development + investor profit) divided by 750,000 patients = $267 a dose, plus production costs = $292 a dose.
      Seek approval only in U.S. 100,000 patients a year times five years of patent = 500,000 patients. $200,000,000 (development + investor profit) divided by 500,000 patients = $400 a dose, plus production costs = $425 a dose. Economically viable if the condition is serious enough that this price is worth it.
      Seek approval in both markets. $250,000,000 (development + investor profit), minus the $75,000,000 return from the price controlled E.U. market, leaves $175,000,000 to recover in the U.S. $175,000,000 (development + investor profit) divided by 500,000 patients = $350 a dose, plus production costs = $375 a dose. So this helps the price in the U.S. some, and is worth doing, even though it still costs three times in the U.S. what Europe has decreed it will pay. This is the scenario that is most common.
      If both markets were free, then the price would be: 250,000 patients a year times five years of patent = 1,250,000 patients. $250,000,000 (development + investor profit) divided by 1,250,000 patients = $200 a dose, plus production costs = $225 a dose. Quite a bit less for us; not much more for them if they pick up their fair share for the five years left on the patent.
      After that, a generic gets sold to everyone for $50 a dose, and everyone benefits (but only if it was economically viable to develop it in the first place).
      If we talk about patent duration reform, that transforms all these numbers a lot, and is a whole new set of scenarios. But I hope this helps you understand how the U.S. market winds up subsidizing the socialized medicine systems of other countries, and thus why medicines cost more here."

  • @capsulaemil2452
    @capsulaemil2452 3 ปีที่แล้ว +1

    How much per dose?

    • @BBtheKing86
      @BBtheKing86 3 ปีที่แล้ว

      ££££!

    • @Jen-qd7sc
      @Jen-qd7sc 3 ปีที่แล้ว

      $4,666 a dose.
      Math: take $56,000 \ 12 months.

  • @edwardkim1652
    @edwardkim1652 3 ปีที่แล้ว

    Gemvax finished phase 2 for medium/serious stage Alzheimer patients and the test showed efficacy without any serious side effects. Biogen had test for mild case patients.

  • @John-gm5mf
    @John-gm5mf 3 ปีที่แล้ว +8

    Nice, that guy they interviewed has an Order of Canada(white badge on his lapel), no small feat.

    • @bobd5119
      @bobd5119 3 ปีที่แล้ว +3

      Thanks for noticing that. Yay, Canada!

  • @lovinglife8097
    @lovinglife8097 3 ปีที่แล้ว +2

    I hope this drugs will help our elders with Alzheimer's desease.! 🙏

  • @wentoneisendon6502
    @wentoneisendon6502 3 ปีที่แล้ว

    I'm not sure why this was approved, it was voted 0 yes's and 10 no's among the board?

  • @brianeduardo1234
    @brianeduardo1234 3 ปีที่แล้ว

    Does not seem to help those with vascular dementia... is that so?

  • @GeorgeKafantaris
    @GeorgeKafantaris 2 ปีที่แล้ว

    "How can you say definitively that [Aduhelm] doesn't work any more than the FDA could say definitively that it does?"
    Exactly.
    Here’s something that does work: Use it severely - or lose it - body and mind. Not complicated, and also not easy. But easy is for the grave.

  • @dengslacson1
    @dengslacson1 3 ปีที่แล้ว +10

    Wow, it's a hope for the future 👍☀️🌻

  • @Greenpoloboy3
    @Greenpoloboy3 3 ปีที่แล้ว +6

    some good news

    • @Jen-qd7sc
      @Jen-qd7sc 3 ปีที่แล้ว +1

      Not really. Not effective. Costs $56,000

  • @sugarmonster9311
    @sugarmonster9311 3 ปีที่แล้ว +4

    I'd rather take MCT oil + switch fuel and use ketones.

  • @hasanmaalik5438
    @hasanmaalik5438 3 ปีที่แล้ว

    May Allah cure all patients..aameen

  • @doozowings4672
    @doozowings4672 2 ปีที่แล้ว

    56,000 a year for something that is not a cure ?

    • @totallynotalex8299
      @totallynotalex8299 2 ปีที่แล้ว

      Either this or you wait for slow inevitable death
      Wish we had a cure

  • @HatiKeseorangan
    @HatiKeseorangan 3 ปีที่แล้ว +1

    If human not war and continue working each other... many progression will done

  • @jennifercuddy5663
    @jennifercuddy5663 3 ปีที่แล้ว +2

    I think it’s awesome if it is possible.

  • @monowarachowdhury4754
    @monowarachowdhury4754 3 ปีที่แล้ว +1

    MAY GOD HELP US ALL!!!

  • @vladimirseven777
    @vladimirseven777 3 ปีที่แล้ว

    Yet another "anecdotal evidence".

  • @Immortal-Daiki
    @Immortal-Daiki 3 ปีที่แล้ว +2

    If the treatment is highly successful, the developers need to have the Nobel Prize in Medicine. They deserve. That’s after the new randomised study ofc

  • @theoscarman
    @theoscarman 2 ปีที่แล้ว

    Oh my God just in time. Please ship a three-and-a-half-year supply to the White House ASAP!!!!

  • @danielwadford3699
    @danielwadford3699 8 หลายเดือนก่อน

    I wonder what kind of animals they tested this drug on. Hopefully they weren't sharks or apes.

  • @AnilSingh-rn3kx
    @AnilSingh-rn3kx 2 ปีที่แล้ว

    I need this for my mom she has alzheimer's please

  • @mercury7
    @mercury7 3 ปีที่แล้ว

    Right to try

  • @ninjaninnin6786
    @ninjaninnin6786 3 ปีที่แล้ว

    good news !! god bless for all country !!😀😀😀🗺️😀😀😀

  • @vintageb8
    @vintageb8 3 ปีที่แล้ว +1

    FASTING will delay alzhemier

  • @elonmusk9588
    @elonmusk9588 3 ปีที่แล้ว

    Tráduscanlo a español porque no entiendo nada 😗

  • @BubblewrapHighway
    @BubblewrapHighway 3 ปีที่แล้ว

    Just eat lion's mane and psilocybin mushrooms. 😂🍄🍄🍄

  • @DecinergyAt
    @DecinergyAt 3 ปีที่แล้ว

    NO, because tests / 2 studies were .......... 😉✌🏻🇪🇺

  • @stevenmadrid9350
    @stevenmadrid9350 2 ปีที่แล้ว

    Biden is on the list to take this, hopefully.

  • @Kruse1
    @Kruse1 3 ปีที่แล้ว

    Works on Biden.

  • @nukar.ghulamdin2457
    @nukar.ghulamdin2457 3 ปีที่แล้ว

    Hi braitain boris jonsan take things tell you in punjabi.
    1 goya
    2 dahi
    3 bowl
    Mix well 2 things put on earth cover with bowl you see with in days
    Auntes like creation come in being do this experiment its not monkey begains in start

  • @tmm83093
    @tmm83093 3 ปีที่แล้ว +1

    Finally some hope for President Biden!

  • @jeanrichardvarre6062
    @jeanrichardvarre6062 3 ปีที่แล้ว +1

    This will help Biden find the Bathroom !

    • @jron20r51
      @jron20r51 3 ปีที่แล้ว

      Trump blew it out, all kinds of dead smart phones from his years 3am Twitter attacks

  • @yournameshere
    @yournameshere 3 ปีที่แล้ว +2

    The perfect drug for Joe Biden

    • @Jen-qd7sc
      @Jen-qd7sc 3 ปีที่แล้ว

      He’s the only one that can afford it. It’s $56,000 a year!!