FDA Approves 'Controversial' New Alzheimer's Drug 1

FDA Approves ‘Controversial’ New Alzheimer’s Drug

 

Former FDA Commissioner Dr. Peggy Hamburg and NBC's Dr. John Torres join Andrea Mitchell with their analysis of the FDA's approving a new Alzheimer's drug for the first time since 2003, and why that approval comes with controversy.
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25 comments

  1. My mom and my aunt, her sister, both passed away due to Alzheimer’s. It was a slow and agonizing way of passing. The hardest part was when my mom didn’t recognize me, her only daughter! The pain of seeing my once vibrant, learned, energetic mom gradually fade away still affects me today, 10 years later. My mom and aunt passed away within one month of each other. If this medication can prolong just one life, then I’m all for it! Never stop the research!

  2. So, it’s just to make money for the company since it doesn’t cure or help the disease? Couldn’t I take aspirin for that?

  3. Alzheimer is something serious, is not only the affected patient, it’s also the families that have to go trough the process, so i hope this new drug or treatment will lift some of the weight on those families and doctors shoulders

    1. Yes but u cannot deny many medications
      helps people i don’t like them approving medicines like this tho
      U know what sucks its when
      after the all clinical trials and medical research etc is finished
      Alot of people still hate medicines like desoxyn a controversial stimulant even if  it has a paradoxical effect on adhd combined type= hyperactivity, inattention, impulsiveness,
      Emotional liability, psychomotor agitation, etc

  4. I’m truly sorry for those who have had experience with the illness in a loved one and fully recognize that it could happen to anyone without anyone’s fault or shortcoming. However, I’m sorry, but this is the Food and Drug Administration and its decisions regarding approval of drugs (the highest level of support they can give to a certain drug or treatment and higher than clearance or emergency use authorization) has to be based on very strong evidence (as close to a proof as we can get) not creating “hope” for the families of those affected or the expectation that the drug company itself will conduct further research into its efficacy. This is not a good day for FDA’s credibility, if they ever had any.

    1. I’m sure that all safety criteria were met. The question is regarding effectiveness. My wife works in food safety in a public sector outside the United States. Her organization generally does not simply go with what the FDA or EU approved. It’s not so much out of mistrust, per se. Rather, all such organizations have a stack of applications from manufacturers/producers to go through. The applicants submit what they believe to be evidence of safety, and that evidence is subject to interpretation by the organization regarding its methodological soundness, its applicability to humans, and in the case of food, factors like normal/average daily intake. But as time goes on, evidence from other sources may come in, leading to a different interpretation. What agency X approved 6 months ago may not be approved or approved only under certain limited contexts by agency Y. It happens.

  5. The Stable Genius was willing to be the guinea pig for hydroxychloroquine. I’m sure he’d be fine with this new Alzheimer’s drug too. Would help him remember that the zipper goes on the front, not the back of his pants.

  6. I wonder though, if it has any benefits for early onset of Alzheimer’s disease? Like, start breaking down the plaques before the disease worsens.

  7. When I started working in the area of nootropics during my graduate studies, nearly 40 years ago, many different substances were being tried out, all with the eventual hope of somehow “curing”, reversing, or at least slowing Alzheimer’s Disease. What I learned as time went on, was that the researchers understood the neuropharmacology extremely well, but had precious little understanding of how normal human cognition works.

    Human information processing is not a symmetrical machine. Yes, you can block a transmitter system, or a person can have low levels of some critical transmitter, and show clear cognitive deficits. But that does not automatically mean you can raise levels of a transmitter or increase the efficiency of transmission and see *improvements* in processing, memory, etc. above what such persons show on a regular basis. “Better” processing and memory is always a function of what the person *does* voluntarily (and often automatically and unconsciously, but still deliberately). This is why, in study after study over the last 40 years, the pattern we see with the vast majority of these “miracle drugs” is that *some* recipients show some benefit, *some* show deleterious effects, and most show no effect. This is because the effects of the drug depend on what the person *does* and no drug replaces or creates a deliberate strategy.

    Muddying up a windshield will interfere with *anyone’s* driving. But cleaning the windshield does not instantly turn them into Dale Earnhart or Bobby Unser unless they *know* how to drive well. And the trouble is that by the time someone has been diagnosed with probable dementia, they have already lapsed into poor cognitive habits for a great many things. So simply giving them a drug, no matter how strong the neuropharmacological rationale might be, and no matter what apparent benefit the drug provides to mice learning a passive avoidance task, is not going to suddenly reinstate good automatic cognitive habits.

    We know from the study of memory in older adults that many of the memory strategies younger adults employ are largely abandoned by older individuals. Those same individuals, however, CAN be encouraged and taught to use those strategies once again, and they show clear benefit. But this is not something that can be consistently resumed after someone smacks their forehead and says “What was I thinking?! Of COURSE I should do more of X!”. Reflexive use requires more than mere momentary encouragement.

    I should note that, traditionally, the progress of the disease was faster the younger one was at age of diagnosis. So, someone in their late 30 might succumb in 18 months, post-diagnosis, while someone in their early 70s might take another 7 years to go from diagnosis to institutionalization and death. At one point, this led some researchers to think Alzheimer’s might be an auto-immune disease, because immune function declines with age. But the differential decline rates might also be because younger persons compensate with effective cognitive strategies until such time as the disease overwhelms them, while older adults start to show deficits – hence get diagnosed – much earlier in the disease progression, because they are engaging in effective cognitive strategies much less frequently. I should add that younger adults also tend to excuse their everyday memory slips more, while older adults tend to treat them as more diagnostic, so there is an element of “Why should I consult with a doctor? There’s nothing wrong.” that may play a role in life-expectancy from time of diagnosis.

    Substances like Aducanumab most likely *could* assist someone swimming against a strong neural current to hang in there longer, until the disease completely overwhelms them, but simply can not do the job on its own. It MUST be accompanied by extensive and immersive cognitive training. And we’re not talking some silly little phone-app game, or a weekend workshop. That’s simply not how automatic processing strategies get entrenched. If anything, spending more time NOT in training than time in training simply means more time to entrench bad cognitive habits.

    So, even if there are no known side-effects of the drug, earning it a sort of “chicken soup” approval (I.e., it can’t hurt, so why not try it) from the FDA, I think people should have very low expectations for it as a treatment.

  8. Or you could just stop the evil component of the 1% from spraying the atmosphere with nanoparticle aluminum.

  9. They’ve been watching Biden and decided they’d better try SOMETHING. 4 years of this guy destroying everything he touches is unacceptable

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