15 ms·

FDA head asks for investigation into Aduhelm drug approval

206 points by tima101 5y ago

peytn 5y ago
Great. Speaking from first- and second-hand experience, the FDA is way more loosey-goosey than people think as long as you’re paying the right people.
- eddynol 5y ago
  Cuz it's a hard job. Try telling someone in a position of serious power who is going to loose his kid next year to back off. Who wants that job? Put your hand up.
  - WarOnPrivacy 5y ago
    Pharma lobbyists gained enough control over FDA oversight to get a failed Alzheimer's drug approved. I'll put my hand up to perform ethically at my job and not allow regulatory capture.
    - throwawaygh 5y ago
      > Pharma lobbyists gained enough control over FDA oversight to get a failed Alzheimer's drug approved. We'll see. What's playing out now is exactly how robust institutions work. Individual components can be corrupted, but the institution has a whole holds because of checks and balances. Here, one individual component of the FDA was compromised, but other checks-and-balances are coming to bear (namely, inclusion of Scientific Advisors in the review process, public records, and political accountability at the top). When an unconstitutional law is passed, it's law. Until a court strikes it down. If an unconstitutional law is passed and then struck down by a court, that's not the system failing. That's individuals within the institution failing but the institution as a whole working exactly as intended. > I'll put my hand up to perform ethically at my job and not allow regulatory capture. But that's not what he asked you to volunteer for. He didn't ask you to perform ethically at a job. He asked you to actually go get a PhD, do a post-doc or two, and then turn down well-paying industry jobs to work at the FDA and get demonized all day. Which, speaking as someone who has turned down similar types of government jobs because I could make 5x in the private sector, is quite a bit more of a sacrifice than I think you realize. (This isn't meant to excuse unethical behavior, btw, it's just that your comment is literally not responsive to GP's and GP is exactly right -- those jobs suck and if we want fewer failures like this one maybe we, the people, as the employer, should be at least paying market rate.)
      - WarOnPrivacy 5y ago
        > But that's not what he asked you to volunteer for. He didn't ask you to perform ethically at a job. He asked you to actually go get a PhD, do a post-doc or two, and then turn down well-paying industry jobs to work at the FDA and get demonized all day. That doesn't seem to be what he asked. He asked us to Try telling someone in a position of serious power who is going to loose his kid next year to back off. It isn't clear what losing a kid has to do with qualified officials approving a failed Alzheimer drug, ostensibly in blatant and clear violation of their own protocols. Presented with that non-sequitur, I chose to restate the event in play.
        throwawaygh 5y ago
        Yes, he was giving yet another reason no one wants to do that particular job. I was given another. So, it's a shitty job because people yell at you for <=$100K (his reason) and also you could be making $500+k elsewhere (my reason). > It isn't clear what losing a kid has to do with qualified officials approving a failed Alzheimer drug Your basic complaint is that those particular government workers were either corrupt or incompetent. I don't disagree with that assessment. But if you can't understand why people take industry jobs for $500K instead of government jobs for $100K, especially when the government job additionally requires "telling someone in a position of serious power who is going to loose his kid next year to back off", then I'm not really sure what to say. And if you can't understand how "the job is shit and doesn't pay well" has downstream effects like incompetence and corruption, then, well, I'm not really sure what to say. Most problems with failed governance in the USA basically boil down to "Want competence and ethics? Pay market rates & don't fucking outsource." See also: the Obamacare website debacle.
      - forcry 5y ago
        >Here, one individual component of the FDA was compromised, but other checks-and-balances are coming to bear.. The damning thing is the point it got up to, before the "checks and balances" came into play that we have to consider this as an exception rather than the rule. IMHO The scientific advisory resigning is itself the point where the failure of the process became apparent. Because, I am pretty sure "if you disagree then you should resign", is NOT part of the approval process. I mean, it is not within the framework that you are trying to portray as being robust.
  - mperham 5y ago
    What's the alternative? Allow snakeoil? Now insurance has to cover it, incentivizing the creation of more ineffective drugs? Trust in efficacy is critical.
    - jcims 5y ago
      With cancer drugs at least, efficacy trials are regularly scoped to a fairly narrow portion of the patient population along things like the presence of specific mutations, whether those mutations are germline or somatic, previous treatment types administered and staging. Efficacy found for one combination of the above generally isn’t seen as transitive to the rest. The solution now seems to be to simply not allow that medication to be used if the patient doesn’t match the parameters of the trial. Some portion of those people then die because the current ‘standard of care’ is the same toxic shit they have been pumping i to veins for the past 30 years to little or no effect.
- pfisherman 5y ago
  What experience have you had? How many INDs, 510ks, etc have you worked on? Because this does not line up with my experience at all. IME FDA is very anal about even the appearance of the conflict of interest, and loosey-goosey is the last descriptor you would ever want to use for any interaction with FDA. That being said, informal interactions where FDA talks you through regulatory options do happen for high priority / unmet need diseases, but there the “friendlies” are compartmentalized away from the those who review the applications. My guess is that the review will show that someone from FDA met with the company to facilitate the application because Alzheimer’s is a priority disease, but strict compartmentalization from the review process was maintained. If not, then someone is getting fired.
- rgrieselhuber 5y ago
  What does that mean for the Covid vaccines?
  - WarOnPrivacy 5y ago
    Nothing, I believe. Every drug approval isn't suspect. Just the ones where pharma lobbyists get to spend the power they bought thru beefy campaign contributions. Also - Covid vaccines were under intense public and medical scrutiny, during every bit of their development. Good government and transparency tend to go together.
  - seriousquestion 5y ago
    Maybe nothing, maybe a lot. Big pharma has huge influence in the government. The vaccines are authorized under emergency use, which is predicated on not having alternatives. That there is a campaign to discredit cheap off patent alternatives (Ivermectin) is at least concerning.
    - khuey 5y ago
      There's a "campaign to discredit cheap off patent alternatives" because they don't actually work and people are going out and poisoning themselves with pills made for horses.
      - seriousquestion 5y ago
        Taking a horse quantity of any drug is unwise, even one that won the 2015 Nobel Prize (Ivermectin). It still needs large scale RCTs for Covid-19 use, but there are some small trials that at least indicate it should be taken seriously and not outright discredited and smeared. "Meta-analysis of randomized trials of ivermectin to treat SARS-CoV-2 infection" - "there was a 56% reduction in mortality; p=0.004 .. with favorable clinical recovery and reduced hospitalization." https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofab358/6316214 https://academic.oup.com/ofid/advance-article/doi/10.1093/of... "Ivermectin was associated with decreased mortality in patients with COVID-19... The certainty of evidence for mortality reduction was low." https://www.sciencedirect.com/science/article/pii/S187140212100206X?via%3Dihub https://www.sciencedirect.com/science/article/pii/S187140212...
- dang 5y ago
  If you're going to make a comment like that it would be better to share some of the experiences—it would add substance, and be much more interesting.
gnicholas 5y ago
> The drug in question, Aduhelm, was approved by the agency last month and has caused an uproar in the scientific community. Three of the agency's scientific advisors resigned following the decision. Is this sort of thing common? Seems like an investigation is definitely warranted if this type of resignation is a rare as I would imagine it be.
- db48x 5y ago
  90% of all drug candidates that are brought to the FDA for approval fail one of the FDA’s required studies. It is probable that some of the 10% that pass and are approved are marginal, and someone at the FDA has to make a judgement call. Thus it is likely that occasionally a drug is approved which later turns out to be ineffective or even dangerous. But it seems to happen fairly rarely, and it’s quite rare that people resign in protest.
  - gnicholas 5y ago
    What I couldn't tell was whether the "scientific advisors" are FTEs or some other role. It would take a lot for someone to give up a government job/pension, so three resignations of that nature would be incredible. But if these are just part-time consultants, the statement would be less notable.
    - wiredearp 5y ago
      If it's a fake drug that's been priced at a level to break American health care [1], they could potentially be this kind of employee that actually care or perhaps they just considered the corruption too obvious even for the FDA and wanted to clear themselves of charges. [1] https://www.theatlantic.com/ideas/archive/2021/06/aduhelm-drug-alzheimers-cost-medicare/619169/ https://www.theatlantic.com/ideas/archive/2021/06/aduhelm-dr...
    - jdavis703 5y ago
      Government STEM positions tend to be under paid vs the private sector. A lot of these people are taking a pay cut because they want to serve the greater good or work on an interesting problem.
Exmoor 5y ago
Full headline (presumably cut for HN length restrictions) is: > The head of the FDA is calling for an investigation into her agency's controversial decision to approve a new Alzheimer's drug
- WarOnPrivacy 5y ago
  That decision was so overtly concerning, I already knew what the headline was about. I'm suspect that a lot of lesser, bad behavior had to go unchallenged, for us to wind up with a decision that was this blatantly corrupt.
- dang 5y ago
  The HTML doc title fits the 80 char limit so we've switched to that.
deleted 5y ago
[deleted]
quickthrowman 5y ago
> Recent advances in amyloid imaging have made it possible to observe Aβ amyloid accumulation in the patient's brain. As a result, it has been found that there are many normal patients with amyloid deposits, and also AD patients with very few amyloid deposits (Edison et al., 2007; Li et al., 2008). [0] How long is it going to take for the scientists who have built their career on the amyloid hypothesis to die out so new ideas can be investigated? [0] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797629/#s3title https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797629/#s3titl...
- anonuser123456 5y ago
  One has to only look at the dumpster fire that is the USDA nutritional guidelines to know "never".
  - AnimalMuppet 5y ago
    "Die out". Everybody dies eventually. It's just a long process waiting for science to progress by funerals.
    - quickthrowman 5y ago
      Indeed, plate tectonics (sort of, Wegener had the idea but no evidence/proof) and hand washing for doctors/surgeons both faced widespread opposition, just off the top of my head.
      - ficklepickle 5y ago
        mRNA is another example
    - heavyset_go 5y ago
      Not to worry, there are plenty of opportunists who will line up to carry the torch once the older ones die.
  - tpush 5y ago
fnord77 5y ago
> we have investigated ourselves and have found no wrong-doing!
lend000 5y ago
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.
loa_in_ 5y ago
Unfortunately the link is unavailable in Poland: https://imgur.com/a/48MFia6 https://imgur.com/a/48MFia6
- thatjoeoverthr 5y ago
  Odd; it works for me.
vmception 5y ago
Is the aduhelm company publicly traded? Seems like a lot of fun volatility upcoming on binary outcomes If I was a gambling man, which I am, I would add this to my paid newsletter and call it investing (with contradictory and nullifying disclaimers of course)
- renewiltord 5y ago
  NASDAQ:BIIB
renewiltord 5y ago
The problem is obviously a type error (not different from the use of a Social Security Number as a National Identification Number). The government will pay for medication “that works”. It determines that medication is one “that works” by seeing if the FDA approves it. The FDA doesn’t want to always be too slow to approve medication so sometimes it wants to approve medication as “doesn’t hurt”. Ultimately, the problem is that American policy relies on categories rather than spectra. My personal belief is that this is because the bureaucrats and policy makers are taking advantage of common American knowledge of categories vs spectra. So it needs some categorization mechanism and since one exists, they use that one. Presumably, out there is a bureaucrat with the same impulse as the engineer reading your PR who says “We already have a function to calculate radians to degrees. Why don’t we use that?” In comparison, the NHS will measure how much to spend on a treatment based on an adjusted QALY measure (that boosts the value of the last few months). X QALYs are worth Y pounds. Almost all American policy, by comparison, is category-based. Other examples: - immigration: America does categories (so either family or employment or refugee) while other nations use scores (if you both have family and employment you get some boost from both rather than the US max(categories)) system - social security: Thresholds on disability and poverty are cliffs resulting in marginal income improvement resulting in marginal post-support income decrease. These should scale down, not drop off based on in-category/out-category
- refurb 5y ago
  No, the govt will not look to the FDA to see if it works, it can do it’s own assessment. The FDA determines if the benefits outweigh the risks. Benefits can be marginal and not worth paying for. That’s not the FDA’s job. And odd you’d call the US out when QALYs can be very subjective and the QALY thresholds in the UK create hard limits to price that don’t always make sense (as QALY doesn’t capture all benefits).
aabaker99 5y ago
Link to pdf with prescribing information highlights which includes a small bit of detail about Aduhelm's mechanism of action and other details: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761178s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/76...
grouphugs 5y ago
our bodies are as dominated chemically as they are ideologically
The_rationalist 5y ago
Yay let's decincentivise research for cures to neurodegeneration! Please people, see the bigger picture..

206 points by tima101 5y ago

Great. Speaking from first- and second-hand experience, the FDA is way more loosey-goosey than people think as long as you’re paying the right people.

eddynol 5y ago
Cuz it's a hard job. Try telling someone in a position of serious power who is going to loose his kid next year to back off. Who wants that job? Put your hand up.
- WarOnPrivacy 5y ago
  Pharma lobbyists gained enough control over FDA oversight to get a failed Alzheimer's drug approved. I'll put my hand up to perform ethically at my job and not allow regulatory capture.
  - throwawaygh 5y ago
    > Pharma lobbyists gained enough control over FDA oversight to get a failed Alzheimer's drug approved. We'll see. What's playing out now is exactly how robust institutions work. Individual components can be corrupted, but the institution has a whole holds because of checks and balances. Here, one individual component of the FDA was compromised, but other checks-and-balances are coming to bear (namely, inclusion of Scientific Advisors in the review process, public records, and political accountability at the top). When an unconstitutional law is passed, it's law. Until a court strikes it down. If an unconstitutional law is passed and then struck down by a court, that's not the system failing. That's individuals within the institution failing but the institution as a whole working exactly as intended. > I'll put my hand up to perform ethically at my job and not allow regulatory capture. But that's not what he asked you to volunteer for. He didn't ask you to perform ethically at a job. He asked you to actually go get a PhD, do a post-doc or two, and then turn down well-paying industry jobs to work at the FDA and get demonized all day. Which, speaking as someone who has turned down similar types of government jobs because I could make 5x in the private sector, is quite a bit more of a sacrifice than I think you realize. (This isn't meant to excuse unethical behavior, btw, it's just that your comment is literally not responsive to GP's and GP is exactly right -- those jobs suck and if we want fewer failures like this one maybe we, the people, as the employer, should be at least paying market rate.)
    - WarOnPrivacy 5y ago
      > But that's not what he asked you to volunteer for. He didn't ask you to perform ethically at a job. He asked you to actually go get a PhD, do a post-doc or two, and then turn down well-paying industry jobs to work at the FDA and get demonized all day. That doesn't seem to be what he asked. He asked us to Try telling someone in a position of serious power who is going to loose his kid next year to back off. It isn't clear what losing a kid has to do with qualified officials approving a failed Alzheimer drug, ostensibly in blatant and clear violation of their own protocols. Presented with that non-sequitur, I chose to restate the event in play.
      - throwawaygh 5y ago
        Yes, he was giving yet another reason no one wants to do that particular job. I was given another. So, it's a shitty job because people yell at you for <=$100K (his reason) and also you could be making $500+k elsewhere (my reason). > It isn't clear what losing a kid has to do with qualified officials approving a failed Alzheimer drug Your basic complaint is that those particular government workers were either corrupt or incompetent. I don't disagree with that assessment. But if you can't understand why people take industry jobs for $500K instead of government jobs for $100K, especially when the government job additionally requires "telling someone in a position of serious power who is going to loose his kid next year to back off", then I'm not really sure what to say. And if you can't understand how "the job is shit and doesn't pay well" has downstream effects like incompetence and corruption, then, well, I'm not really sure what to say. Most problems with failed governance in the USA basically boil down to "Want competence and ethics? Pay market rates & don't fucking outsource." See also: the Obamacare website debacle.
    - forcry 5y ago
      >Here, one individual component of the FDA was compromised, but other checks-and-balances are coming to bear.. The damning thing is the point it got up to, before the "checks and balances" came into play that we have to consider this as an exception rather than the rule. IMHO The scientific advisory resigning is itself the point where the failure of the process became apparent. Because, I am pretty sure "if you disagree then you should resign", is NOT part of the approval process. I mean, it is not within the framework that you are trying to portray as being robust.
- mperham 5y ago
  What's the alternative? Allow snakeoil? Now insurance has to cover it, incentivizing the creation of more ineffective drugs? Trust in efficacy is critical.
  - jcims 5y ago
    With cancer drugs at least, efficacy trials are regularly scoped to a fairly narrow portion of the patient population along things like the presence of specific mutations, whether those mutations are germline or somatic, previous treatment types administered and staging. Efficacy found for one combination of the above generally isn’t seen as transitive to the rest. The solution now seems to be to simply not allow that medication to be used if the patient doesn’t match the parameters of the trial. Some portion of those people then die because the current ‘standard of care’ is the same toxic shit they have been pumping i to veins for the past 30 years to little or no effect.
pfisherman 5y ago
What experience have you had? How many INDs, 510ks, etc have you worked on? Because this does not line up with my experience at all. IME FDA is very anal about even the appearance of the conflict of interest, and loosey-goosey is the last descriptor you would ever want to use for any interaction with FDA. That being said, informal interactions where FDA talks you through regulatory options do happen for high priority / unmet need diseases, but there the “friendlies” are compartmentalized away from the those who review the applications. My guess is that the review will show that someone from FDA met with the company to facilitate the application because Alzheimer’s is a priority disease, but strict compartmentalization from the review process was maintained. If not, then someone is getting fired.
rgrieselhuber 5y ago
What does that mean for the Covid vaccines?
- WarOnPrivacy 5y ago
  Nothing, I believe. Every drug approval isn't suspect. Just the ones where pharma lobbyists get to spend the power they bought thru beefy campaign contributions. Also - Covid vaccines were under intense public and medical scrutiny, during every bit of their development. Good government and transparency tend to go together.
- seriousquestion 5y ago
  Maybe nothing, maybe a lot. Big pharma has huge influence in the government. The vaccines are authorized under emergency use, which is predicated on not having alternatives. That there is a campaign to discredit cheap off patent alternatives (Ivermectin) is at least concerning.
  - khuey 5y ago
    There's a "campaign to discredit cheap off patent alternatives" because they don't actually work and people are going out and poisoning themselves with pills made for horses.
    - seriousquestion 5y ago
      Taking a horse quantity of any drug is unwise, even one that won the 2015 Nobel Prize (Ivermectin). It still needs large scale RCTs for Covid-19 use, but there are some small trials that at least indicate it should be taken seriously and not outright discredited and smeared. "Meta-analysis of randomized trials of ivermectin to treat SARS-CoV-2 infection" - "there was a 56% reduction in mortality; p=0.004 .. with favorable clinical recovery and reduced hospitalization." https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofab358/6316214 https://academic.oup.com/ofid/advance-article/doi/10.1093/of... "Ivermectin was associated with decreased mortality in patients with COVID-19... The certainty of evidence for mortality reduction was low." https://www.sciencedirect.com/science/article/pii/S187140212100206X?via%3Dihub https://www.sciencedirect.com/science/article/pii/S187140212...
dang 5y ago
If you're going to make a comment like that it would be better to share some of the experiences—it would add substance, and be much more interesting.

gnicholas 5y ago

> The drug in question, Aduhelm, was approved by the agency last month and has caused an uproar in the scientific community. Three of the agency's scientific advisors resigned following the decision. Is this sort of thing common? Seems like an investigation is definitely warranted if this type of resignation is a rare as I would imagine it be.

db48x 5y ago
90% of all drug candidates that are brought to the FDA for approval fail one of the FDA’s required studies. It is probable that some of the 10% that pass and are approved are marginal, and someone at the FDA has to make a judgement call. Thus it is likely that occasionally a drug is approved which later turns out to be ineffective or even dangerous. But it seems to happen fairly rarely, and it’s quite rare that people resign in protest.
- gnicholas 5y ago
  What I couldn't tell was whether the "scientific advisors" are FTEs or some other role. It would take a lot for someone to give up a government job/pension, so three resignations of that nature would be incredible. But if these are just part-time consultants, the statement would be less notable.
  - wiredearp 5y ago
    If it's a fake drug that's been priced at a level to break American health care [1], they could potentially be this kind of employee that actually care or perhaps they just considered the corruption too obvious even for the FDA and wanted to clear themselves of charges. [1] https://www.theatlantic.com/ideas/archive/2021/06/aduhelm-drug-alzheimers-cost-medicare/619169/ https://www.theatlantic.com/ideas/archive/2021/06/aduhelm-dr...
  - jdavis703 5y ago
    Government STEM positions tend to be under paid vs the private sector. A lot of these people are taking a pay cut because they want to serve the greater good or work on an interesting problem.

Exmoor 5y ago

Full headline (presumably cut for HN length restrictions) is: > The head of the FDA is calling for an investigation into her agency's controversial decision to approve a new Alzheimer's drug

WarOnPrivacy 5y ago
That decision was so overtly concerning, I already knew what the headline was about. I'm suspect that a lot of lesser, bad behavior had to go unchallenged, for us to wind up with a decision that was this blatantly corrupt.
dang 5y ago
The HTML doc title fits the 80 char limit so we've switched to that.

deleted 5y ago

[deleted]

quickthrowman 5y ago

> Recent advances in amyloid imaging have made it possible to observe Aβ amyloid accumulation in the patient's brain. As a result, it has been found that there are many normal patients with amyloid deposits, and also AD patients with very few amyloid deposits (Edison et al., 2007; Li et al., 2008). [0] How long is it going to take for the scientists who have built their career on the amyloid hypothesis to die out so new ideas can be investigated? [0] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797629/#s3title https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797629/#s3titl...

anonuser123456 5y ago
One has to only look at the dumpster fire that is the USDA nutritional guidelines to know "never".
- AnimalMuppet 5y ago
  "Die out". Everybody dies eventually. It's just a long process waiting for science to progress by funerals.
  - quickthrowman 5y ago
    Indeed, plate tectonics (sort of, Wegener had the idea but no evidence/proof) and hand washing for doctors/surgeons both faced widespread opposition, just off the top of my head.
    - ficklepickle 5y ago
      mRNA is another example
  - heavyset_go 5y ago
    Not to worry, there are plenty of opportunists who will line up to carry the torch once the older ones die.
- tpush 5y ago

fnord77 5y ago

> we have investigated ourselves and have found no wrong-doing!

lend000 5y ago

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.

loa_in_ 5y ago

Unfortunately the link is unavailable in Poland: https://imgur.com/a/48MFia6 https://imgur.com/a/48MFia6

thatjoeoverthr 5y ago
Odd; it works for me.

vmception 5y ago

Is the aduhelm company publicly traded? Seems like a lot of fun volatility upcoming on binary outcomes If I was a gambling man, which I am, I would add this to my paid newsletter and call it investing (with contradictory and nullifying disclaimers of course)

renewiltord 5y ago
NASDAQ:BIIB

renewiltord 5y ago

The problem is obviously a type error (not different from the use of a Social Security Number as a National Identification Number). The government will pay for medication “that works”. It determines that medication is one “that works” by seeing if the FDA approves it. The FDA doesn’t want to always be too slow to approve medication so sometimes it wants to approve medication as “doesn’t hurt”. Ultimately, the problem is that American policy relies on categories rather than spectra. My personal belief is that this is because the bureaucrats and policy makers are taking advantage of common American knowledge of categories vs spectra. So it needs some categorization mechanism and since one exists, they use that one. Presumably, out there is a bureaucrat with the same impulse as the engineer reading your PR who says “We already have a function to calculate radians to degrees. Why don’t we use that?” In comparison, the NHS will measure how much to spend on a treatment based on an adjusted QALY measure (that boosts the value of the last few months). X QALYs are worth Y pounds. Almost all American policy, by comparison, is category-based. Other examples: - immigration: America does categories (so either family or employment or refugee) while other nations use scores (if you both have family and employment you get some boost from both rather than the US max(categories)) system - social security: Thresholds on disability and poverty are cliffs resulting in marginal income improvement resulting in marginal post-support income decrease. These should scale down, not drop off based on in-category/out-category

refurb 5y ago
No, the govt will not look to the FDA to see if it works, it can do it’s own assessment. The FDA determines if the benefits outweigh the risks. Benefits can be marginal and not worth paying for. That’s not the FDA’s job. And odd you’d call the US out when QALYs can be very subjective and the QALY thresholds in the UK create hard limits to price that don’t always make sense (as QALY doesn’t capture all benefits).

aabaker99 5y ago

Link to pdf with prescribing information highlights which includes a small bit of detail about Aduhelm's mechanism of action and other details: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761178s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/76...

grouphugs 5y ago

our bodies are as dominated chemically as they are ideologically

The_rationalist 5y ago

Yay let's decincentivise research for cures to neurodegeneration! Please people, see the bigger picture..