4 ms·

The baseline reaction I'm seeing from commenters is appalling. This drug has been shown to NOT be particularly dangerous in clinical trials, while having a bioc

The baseline reaction I'm seeing from commenters is appalling. This drug has been shown to NOT be particularly dangerous in clinical trials, while having a biochemical effect on amyloid protein buildup, which has strong correlations with degenerative brain diseases. It's another tool in the arsenal. There's no evidence that it cures one of the worst diseases around, but that shouldn't be the requirement for whether the public (only after having it prescribed by a medical doctor, mind you), has access to a drug. How can you be pro-Marijuana and then not trust doctors to have another tool in their arsenal? The FDA should exist to prevent fraud and monitor quality, and nothing else. In this case, it would be highly reasonable to restrict the claims of the drug based on the study. But to ban it? What gives you or them the right to protect people from themselves?

burnished 5y ago
Probably the appalling upfront profit motive driving it. Yeah, I think thats probably it.
- lend000 5y ago
  Yes, how dare they try to sell a bioactive compound that cost billions to produce for... money! Especially to willing buyers only after prescribed by a medical doctor! In your fantasy world, I suspect there isn't a lot of technological progress.
  - tsimionescu 5y ago
    Yes, actually, how dare they sell a substance with no known effect on any disease as 'Alzheimer's medicine', just because they might lose some money if they don't? How dare they market this to desperate people willing to try anything?
quickthrowman 5y ago
> How can you be pro-Marijuana and then not trust doctors to have another tool in their arsenal? It doesn’t cost $55,000 a year to smoke weed, and if nothing else weed will get you high. Most people have a problem with Medicare paying for this drug, not people taking the drug itself.
- lend000 5y ago
  And if someone created a strain and tried to sell it for 55k a year, you would then support the FDA banning it, instead of letting people decide for themselves? You're right about Medicare, though. A socialized healthcare system creates negative incentives (for example, banning things that might be costly, instead of letting the market direct that item to people willing to pay more). I always struggle to relate to many people's infantilism. You aren't a baby, and other adults aren't babies. If people can vote, sign up for the military, etc., then they can make a decision about their own body given accurate information.
  - quickthrowman 5y ago
    The FDA does not regulate marijuana strains. If someone wants to pay $55,000 for weed so be it, but socialized medicine shouldn’t pay for treatments with no efficacy.
    - lend000 5y ago
      After accurately describing the problem, would you now say that the real root of the problem is our socialized healthcare system, or having choice in drugs?
      - ivalm 5y ago
        You can sell/buy the drug as supplement without fda approval, it is not banned/on a schedule. So the problem is with the fda approval, not socialized healthcare.
        heavyset_go 5y ago
        Novel molecules can't be sold as supplements, only compounds found in plants or animals, or those that can be classified as vitamins, minerals, amino acids, etc. The makers of Aduhelm can't actually turn around and sell it as a supplement if they can't sell it as an approved medication in the US.
  - 5y ago
pg_bot 5y ago
The problem with this particular drug is that there is no evidence that it leads to longer or better lives for the patients who have taken it. Therefore there is no real reason to prescribe it for Alzheimer's, but it will be prescribed and it will cost American taxpayers billions.
- alasdair_ 5y ago
  The solution seems to be to ban medicare/medicaid from paying for any treatment that isn’t proven to work.
  - tsimionescu 5y ago
    It's not just a problem for Medicare/medicaid. BioGen will be allowed to push this through their marketing to desperate patients and caregivers, who will nag their doctors into prescribing it, even though they could just as well drink a glass of water.
    - jcims 5y ago
      That’s their risk to take.
    - refurb 5y ago
      The doctor is the final decision maker on prescribing. If they don’t think it’s effective then don’t prescribe it?
      - tsimionescu 5y ago
        Then the doctor gets bad reviews for refusing to prescribe FDA-approved medicine to desperate patients. The doctor themselves may not have looked deeply into this, and just know that it is an FDA approved medication, so it must be effective, right?
  - CamperBob2 5y ago
    That's the whole problem. The company can now point to its FDA approval and say, "See? It's proven to work!" It hasn't been, and probably doesn't, but now they can get billions from Medicare for it.
phnofive 5y ago
The risk/benefit model is broken here: Some risk and no benefit. I'm not going to even address the cost - the benchmark for benefit is incredibly low. All BioGen needed to show was that their drug delayed progression of cognitive impairment for a few months, and they couldn't do it. The FDA acknowledged as such in their conditional approval, weakly suggesting expanded access might allow BioGen to demonstrate this in a larger population. This would lead Medicare to pay for an extensive, unethical study fueled by nothing more than the hopes of desperate patients and their caregivers.
tsimionescu 5y ago
> while having a biochemical effect on amyloid protein buildup, which has strong correlations with degenerative brain diseases. That correlation has actually been turning out to be very weak. The very studies conducted to test this drug are some of the proof (reducing amyloid buildup doesn't affect disease progression), And there is also mounting proof from brain imaging that Amyloid buildup exists in the brains of many people with no mental problems. And in general, if we know the drug does nothing at all, why allow the company to force doctors to prescribe it (by marketing to desperate patients)? The drug can still be used in new research. But unless and until research shows that it has an effect on some disease, it should be illegal to market it as medication. At best it could be sold as a supplement, for those gullible enough to try it.
- lend000 5y ago
  > it should be illegal to market it as medication That's exactly what I stated. But banning substances outright is anti-science and anti-freedom. Just prevent fraud, and make sure it isn't poison.
  - tsimionescu 5y ago
    FDA approval is needed to seek something as medication. If they want to package it as a supplement, they can sell it today.
- ehsankia 5y ago
  Don't forget that it also has major side effects such as brain swelling and bleeding... If I recall something like 40% of patients? So it's not without risks
- The_rationalist 5y ago
  Beta amyloids plays a major role in Alzeihmer, there is a drug that delay Alzeihmer by 66% by doing just that. It's cringe that people that have no expertise in Alzeihmer just regurgitate the refuted claim that beta amyloids are debunked.
mcguire 5y ago
Ah, I was wondering where this kind of comment would be, after the last time this drug approval came up. "There's no evidence that it cures one of the worst diseases around...The FDA should exist to prevent fraud and monitor quality..." Then the FDA is doing exactly it's job. If there's no evidence that it works, then selling it would be fraud, right?
bradleyjg 5y ago
I have no problem with this drug being put in the same category as marijuana. If people want to synthesize it in their basements I wouldn’t support throwing them in prison.

burnished 5y ago

Probably the appalling upfront profit motive driving it. Yeah, I think thats probably it.

lend000 5y ago
Yes, how dare they try to sell a bioactive compound that cost billions to produce for... money! Especially to willing buyers only after prescribed by a medical doctor! In your fantasy world, I suspect there isn't a lot of technological progress.
- tsimionescu 5y ago
  Yes, actually, how dare they sell a substance with no known effect on any disease as 'Alzheimer's medicine', just because they might lose some money if they don't? How dare they market this to desperate people willing to try anything?

quickthrowman 5y ago

> How can you be pro-Marijuana and then not trust doctors to have another tool in their arsenal? It doesn’t cost $55,000 a year to smoke weed, and if nothing else weed will get you high. Most people have a problem with Medicare paying for this drug, not people taking the drug itself.

lend000 5y ago
And if someone created a strain and tried to sell it for 55k a year, you would then support the FDA banning it, instead of letting people decide for themselves? You're right about Medicare, though. A socialized healthcare system creates negative incentives (for example, banning things that might be costly, instead of letting the market direct that item to people willing to pay more). I always struggle to relate to many people's infantilism. You aren't a baby, and other adults aren't babies. If people can vote, sign up for the military, etc., then they can make a decision about their own body given accurate information.
- quickthrowman 5y ago
  The FDA does not regulate marijuana strains. If someone wants to pay $55,000 for weed so be it, but socialized medicine shouldn’t pay for treatments with no efficacy.
  - lend000 5y ago
    After accurately describing the problem, would you now say that the real root of the problem is our socialized healthcare system, or having choice in drugs?
    - ivalm 5y ago
      You can sell/buy the drug as supplement without fda approval, it is not banned/on a schedule. So the problem is with the fda approval, not socialized healthcare.
      - heavyset_go 5y ago
        Novel molecules can't be sold as supplements, only compounds found in plants or animals, or those that can be classified as vitamins, minerals, amino acids, etc. The makers of Aduhelm can't actually turn around and sell it as a supplement if they can't sell it as an approved medication in the US.
- 5y ago

pg_bot 5y ago

The problem with this particular drug is that there is no evidence that it leads to longer or better lives for the patients who have taken it. Therefore there is no real reason to prescribe it for Alzheimer's, but it will be prescribed and it will cost American taxpayers billions.

alasdair_ 5y ago
The solution seems to be to ban medicare/medicaid from paying for any treatment that isn’t proven to work.
- tsimionescu 5y ago
  It's not just a problem for Medicare/medicaid. BioGen will be allowed to push this through their marketing to desperate patients and caregivers, who will nag their doctors into prescribing it, even though they could just as well drink a glass of water.
  - jcims 5y ago
    That’s their risk to take.
  - refurb 5y ago
    The doctor is the final decision maker on prescribing. If they don’t think it’s effective then don’t prescribe it?
    - tsimionescu 5y ago
      Then the doctor gets bad reviews for refusing to prescribe FDA-approved medicine to desperate patients. The doctor themselves may not have looked deeply into this, and just know that it is an FDA approved medication, so it must be effective, right?
- CamperBob2 5y ago
  That's the whole problem. The company can now point to its FDA approval and say, "See? It's proven to work!" It hasn't been, and probably doesn't, but now they can get billions from Medicare for it.

phnofive 5y ago

The risk/benefit model is broken here: Some risk and no benefit. I'm not going to even address the cost - the benchmark for benefit is incredibly low. All BioGen needed to show was that their drug delayed progression of cognitive impairment for a few months, and they couldn't do it. The FDA acknowledged as such in their conditional approval, weakly suggesting expanded access might allow BioGen to demonstrate this in a larger population. This would lead Medicare to pay for an extensive, unethical study fueled by nothing more than the hopes of desperate patients and their caregivers.

tsimionescu 5y ago

> while having a biochemical effect on amyloid protein buildup, which has strong correlations with degenerative brain diseases. That correlation has actually been turning out to be very weak. The very studies conducted to test this drug are some of the proof (reducing amyloid buildup doesn't affect disease progression), And there is also mounting proof from brain imaging that Amyloid buildup exists in the brains of many people with no mental problems. And in general, if we know the drug does nothing at all, why allow the company to force doctors to prescribe it (by marketing to desperate patients)? The drug can still be used in new research. But unless and until research shows that it has an effect on some disease, it should be illegal to market it as medication. At best it could be sold as a supplement, for those gullible enough to try it.

lend000 5y ago
> it should be illegal to market it as medication That's exactly what I stated. But banning substances outright is anti-science and anti-freedom. Just prevent fraud, and make sure it isn't poison.
- tsimionescu 5y ago
  FDA approval is needed to seek something as medication. If they want to package it as a supplement, they can sell it today.
ehsankia 5y ago
Don't forget that it also has major side effects such as brain swelling and bleeding... If I recall something like 40% of patients? So it's not without risks
The_rationalist 5y ago
Beta amyloids plays a major role in Alzeihmer, there is a drug that delay Alzeihmer by 66% by doing just that. It's cringe that people that have no expertise in Alzeihmer just regurgitate the refuted claim that beta amyloids are debunked.

mcguire 5y ago

Ah, I was wondering where this kind of comment would be, after the last time this drug approval came up. "There's no evidence that it cures one of the worst diseases around...The FDA should exist to prevent fraud and monitor quality..." Then the FDA is doing exactly it's job. If there's no evidence that it works, then selling it would be fraud, right?

bradleyjg 5y ago

I have no problem with this drug being put in the same category as marijuana. If people want to synthesize it in their basements I wouldn’t support throwing them in prison.