7 ms·

From my layman's understanding, in the US, it is almost impossible to get FDA approval for drugs that "improve" or "enhance" human biology. The tl;dr is if you

From my layman's understanding, in the US, it is almost impossible to get FDA approval for drugs that "improve" or "enhance" human biology. The tl;dr is if you invented a drug tomorrow that stopped human aging, you wouldn't be able to get FDA approval to sell it. This sadly means that research into how to improve human life and potential are very limited. An alternative explanation is that it may just be super hard to make into a useful pill or convenient injectable, limiting commercial viability! Most drug companies aren't going to dumping $ into a chemical that may cure a disease but has no practical way to get it to the target site!

loeg 2y ago
Sure, but treating Alzheimer’s is a big deal.
matheusmoreira 2y ago
> almost impossible to get FDA approval for drugs that "improve" or "enhance" human biology What is the rationale for this?
- cowmoo728 2y ago
  I recently spoke with someone in biotechnology who was doing a deep dive on "exercise pills". she told me that it would only be approved if it treated a specific disease, like muscular dystrophy, because the FDA views any potential negative side effect as too risky to approve for healthy people. Long term negative side effects are tolerable in Duchenne muscular dystrophy because those people are going to die without intervention. Once people with DMD show the safety profile it can be evaluated for more conditions.
- ted_dunning 2y ago
  This wasn't necessarily an informed opinion. Note their "layman's opinion" qualification.
- com2kid 2y ago
  You can only make drugs to treat medical problems of some sort. I think the argument is that the cost/benefit is never positive for drugs that aren't attempting to just bring you back to baseline. Basically imagine you are perfectly healthy, and you take a drug that has a 99.9% chance of increasing your IQ by 20 points, or a 0.1% chance of reducing your IQ by 5 points. The FDA would basically say "no way in fucking hell, you don't need the extra IQ points to cure any problem, and there is a risk of brain damage". Now if that same drug was instead marketed towards helping people with traumatic brain injuries heal, then it could maybe get approval. There was a petition a few years back to the FDA to change this to allow research into life extending drugs, but AFAIK it didn't go anywhere.
  - delfinom 2y ago
    Death is a medical problem, terminal disease really. Stopping aging stops death.
    - moffkalast 2y ago
      We can give a lab mouse any form of cancer and cure it. We can reverse their aging symptoms... yet we've only been able to extend their lifespan by a measly third at best. It's safe to say we're very far away from getting anywhere close to solving aging in humans if we can't even make an immortal mouse despite a century of throwing every possible thing at them without holding back.
      - AlexErrant 2y ago
        I agree, but the pedant in me wants to point out that > despite a century of throwing every possible thing at them without holding back is incorrect. IACUCs exist for a reason. We do hold back.
        ClumsyPilot 2y ago
        Also, a century? What did we have a century ago? MRI was only invented in 1977, first commercial CT scanner came out in 1970’s, same for ultrasound. Before 1970’s we didn’t have antiviral drugs or DNA sequencing Medicine a hundred years ago was brutal and medieval
copperx 2y ago
Luckily, it's almost a certainty that a drug that slows down aging or improves cognition will also affect disease processes. If there's a drug that improves cognition, it will likely get approved for Alzheimer's.
- com2kid 2y ago
  Studies won't be done on long term risks in young adults taking it. Do you want to take a drug that rewires your brain but has had exactly 0 studies done on what happens to users after 20 years? Alzeimer's drugs don't need 20 year follow up studies because, with the exception of early onset, the patients are, to put it bluntly, dead. Actually right now Namenda is being used off-label for cognition enhancing properties, and suffers from the exact issue that its impacts on healthy adults is mostly unstudied. (FWIW I had negative cognitive side effects with it to the extent that I had to abandon it, but plenty of people seem to like it!) If you want to talk even higher risk profiles, there are plenty of substances that may very well increase neural growth if given to children, but there is no way in hell any ethical medical team is going to ever run those studies. For one thing, we know that plenty of awful diseases are the result of too much activity in the brain. No one wants to be the lead author on a study titled "Boosting IQ by 10 points in adolescents, with only a 20% risk of seizures."
gopher_space 2y ago
> if you invented a drug tomorrow that stopped human aging, you wouldn't be able to get FDA approval to sell it. Due to the chaos it would kick off, I'm assuming. The FDA just needs to ask themselves "What happens if we OK this?" and if the answer is "I have no idea." they withhold approval.
- ClumsyPilot 2y ago
  > What happens if we OK this?" and if the answer is "I have no idea." they withhold approval lol, withholding it would cause massive riots
  - gopher_space 2y ago
    The FDA would be wise enough to know a political hot potato when they see one. If you think the riots would be massive for a ban, imagine the riots if there wasn't worldwide access immediately. Biological immortality is very much a situation where you want to bring enough gum for everyone.
- lmpdev 2y ago
  An interesting tangent is Australia’s FDA equivalent -the TGA - make decisions by a single Doctor called The Delegate This is a single anonymous doctor chosen at random from a pool of qualified doctors usually from a TGA committee So effectively all that is required is convincing one very powerful secret doctor For instance this is why we are the first country to allow MDMA/psilocybin research to resume since Nixon sent the field underground Amazing to think how powerful organisations have odd quirks
  - thaumasiotes 2y ago
    > An interesting tangent is Australia’s FDA equivalent -the TGA - make decisions by a single Doctor called The Delegate > This is a single anonymous doctor chosen at random from a pool of qualified doctors usually from a TGA committee Is this choice made on a per-decision basis, or do they serve terms, or what?
strbean 2y ago
> From my layman's understanding, in the US, it is almost impossible to get FDA approval for drugs that "improve" or "enhance" human biology. Drugs must treat disease, and the benefits must outweigh the risks. With the exception of cosmetic surgery; for some reason Botox's "avoid face wrinkles" somehow outweighs the risk of permanent paralysis. But this is a treatment for a serious disease, so I'm sure those standards aren't the barrier here.
- jklinger410 2y ago
  > Drugs must treat disease, and the benefits must outweigh the risks. But why? lol
  - xvector 2y ago
    Because our society is rooted in puritanical, old and crude notions of what it means to be human. This makes its way into legislation. It is one of the reasons I despise the FDA, it is an incredibly narrow-minded institution. If you made a drug that immeasurably improved QoL for 99.99% of users, you still wouldn't be allowed to sell it. The administration sucks.
- bobthepanda 2y ago
  Botox was not originally developed for wrinkles or approved for wrinkles, and a lot of the ways it gets used today are off-label.
  - bboygravity 2y ago
    Botox was originally developed by a bacterium because: evolution.
thaumasiotes 2y ago
> The tl;dr is if you invented a drug tomorrow that stopped human aging, you wouldn't be able to get FDA approval to sell it. It wouldn't matter; you'd still be free to sell it as an unregulated supplement. Medical insurance wouldn't cover that, but who cares?
- gehwartzen 2y ago
  My thinking as well. I’m fine with the FDA not giving drug approval to a substance as long as they don’t ban it. There are a few drugs I take regularly that are not FDA approved in the US (I.e Moclobemide as there are no approved reversible MAOIs in the US) but I’m still legally allowed to import them and usually it’s pretty cheap.
- com2kid 2y ago
  > It wouldn't matter; you'd still be free to sell it as an unregulated supplement. Patent protections on supplements are very weak compared to the protections afforded to FDA approved drugs. That alone limits research into supplements. Also what counts as a supplement is limited, companies cannot just declare any random drug to be a supplement. Dietary supplements have to have some tenuous connection to being from a natural source. (Though obviously that line gets skirted a lot, such was with DMAA prior to 2013)
  - thaumasiotes 2y ago
    > That alone limits research into supplements. Why is that relevant? In the scenario under discussion, you've already invented the drug.

loeg 2y ago

Sure, but treating Alzheimer’s is a big deal.

matheusmoreira 2y ago

> almost impossible to get FDA approval for drugs that "improve" or "enhance" human biology What is the rationale for this?

cowmoo728 2y ago
I recently spoke with someone in biotechnology who was doing a deep dive on "exercise pills". she told me that it would only be approved if it treated a specific disease, like muscular dystrophy, because the FDA views any potential negative side effect as too risky to approve for healthy people. Long term negative side effects are tolerable in Duchenne muscular dystrophy because those people are going to die without intervention. Once people with DMD show the safety profile it can be evaluated for more conditions.
ted_dunning 2y ago
This wasn't necessarily an informed opinion. Note their "layman's opinion" qualification.
com2kid 2y ago
You can only make drugs to treat medical problems of some sort. I think the argument is that the cost/benefit is never positive for drugs that aren't attempting to just bring you back to baseline. Basically imagine you are perfectly healthy, and you take a drug that has a 99.9% chance of increasing your IQ by 20 points, or a 0.1% chance of reducing your IQ by 5 points. The FDA would basically say "no way in fucking hell, you don't need the extra IQ points to cure any problem, and there is a risk of brain damage". Now if that same drug was instead marketed towards helping people with traumatic brain injuries heal, then it could maybe get approval. There was a petition a few years back to the FDA to change this to allow research into life extending drugs, but AFAIK it didn't go anywhere.
- delfinom 2y ago
  Death is a medical problem, terminal disease really. Stopping aging stops death.
  - moffkalast 2y ago
    We can give a lab mouse any form of cancer and cure it. We can reverse their aging symptoms... yet we've only been able to extend their lifespan by a measly third at best. It's safe to say we're very far away from getting anywhere close to solving aging in humans if we can't even make an immortal mouse despite a century of throwing every possible thing at them without holding back.
    - AlexErrant 2y ago
      I agree, but the pedant in me wants to point out that > despite a century of throwing every possible thing at them without holding back is incorrect. IACUCs exist for a reason. We do hold back.
      - ClumsyPilot 2y ago
        Also, a century? What did we have a century ago? MRI was only invented in 1977, first commercial CT scanner came out in 1970’s, same for ultrasound. Before 1970’s we didn’t have antiviral drugs or DNA sequencing Medicine a hundred years ago was brutal and medieval

copperx 2y ago

Luckily, it's almost a certainty that a drug that slows down aging or improves cognition will also affect disease processes. If there's a drug that improves cognition, it will likely get approved for Alzheimer's.

com2kid 2y ago
Studies won't be done on long term risks in young adults taking it. Do you want to take a drug that rewires your brain but has had exactly 0 studies done on what happens to users after 20 years? Alzeimer's drugs don't need 20 year follow up studies because, with the exception of early onset, the patients are, to put it bluntly, dead. Actually right now Namenda is being used off-label for cognition enhancing properties, and suffers from the exact issue that its impacts on healthy adults is mostly unstudied. (FWIW I had negative cognitive side effects with it to the extent that I had to abandon it, but plenty of people seem to like it!) If you want to talk even higher risk profiles, there are plenty of substances that may very well increase neural growth if given to children, but there is no way in hell any ethical medical team is going to ever run those studies. For one thing, we know that plenty of awful diseases are the result of too much activity in the brain. No one wants to be the lead author on a study titled "Boosting IQ by 10 points in adolescents, with only a 20% risk of seizures."

gopher_space 2y ago

> if you invented a drug tomorrow that stopped human aging, you wouldn't be able to get FDA approval to sell it. Due to the chaos it would kick off, I'm assuming. The FDA just needs to ask themselves "What happens if we OK this?" and if the answer is "I have no idea." they withhold approval.

ClumsyPilot 2y ago
> What happens if we OK this?" and if the answer is "I have no idea." they withhold approval lol, withholding it would cause massive riots
- gopher_space 2y ago
  The FDA would be wise enough to know a political hot potato when they see one. If you think the riots would be massive for a ban, imagine the riots if there wasn't worldwide access immediately. Biological immortality is very much a situation where you want to bring enough gum for everyone.
lmpdev 2y ago
An interesting tangent is Australia’s FDA equivalent -the TGA - make decisions by a single Doctor called The Delegate This is a single anonymous doctor chosen at random from a pool of qualified doctors usually from a TGA committee So effectively all that is required is convincing one very powerful secret doctor For instance this is why we are the first country to allow MDMA/psilocybin research to resume since Nixon sent the field underground Amazing to think how powerful organisations have odd quirks
- thaumasiotes 2y ago
  > An interesting tangent is Australia’s FDA equivalent -the TGA - make decisions by a single Doctor called The Delegate > This is a single anonymous doctor chosen at random from a pool of qualified doctors usually from a TGA committee Is this choice made on a per-decision basis, or do they serve terms, or what?

strbean 2y ago

> From my layman's understanding, in the US, it is almost impossible to get FDA approval for drugs that "improve" or "enhance" human biology. Drugs must treat disease, and the benefits must outweigh the risks. With the exception of cosmetic surgery; for some reason Botox's "avoid face wrinkles" somehow outweighs the risk of permanent paralysis. But this is a treatment for a serious disease, so I'm sure those standards aren't the barrier here.

jklinger410 2y ago
> Drugs must treat disease, and the benefits must outweigh the risks. But why? lol
- xvector 2y ago
  Because our society is rooted in puritanical, old and crude notions of what it means to be human. This makes its way into legislation. It is one of the reasons I despise the FDA, it is an incredibly narrow-minded institution. If you made a drug that immeasurably improved QoL for 99.99% of users, you still wouldn't be allowed to sell it. The administration sucks.
bobthepanda 2y ago
Botox was not originally developed for wrinkles or approved for wrinkles, and a lot of the ways it gets used today are off-label.
- bboygravity 2y ago
  Botox was originally developed by a bacterium because: evolution.

thaumasiotes 2y ago

> The tl;dr is if you invented a drug tomorrow that stopped human aging, you wouldn't be able to get FDA approval to sell it. It wouldn't matter; you'd still be free to sell it as an unregulated supplement. Medical insurance wouldn't cover that, but who cares?

gehwartzen 2y ago
My thinking as well. I’m fine with the FDA not giving drug approval to a substance as long as they don’t ban it. There are a few drugs I take regularly that are not FDA approved in the US (I.e Moclobemide as there are no approved reversible MAOIs in the US) but I’m still legally allowed to import them and usually it’s pretty cheap.
com2kid 2y ago
> It wouldn't matter; you'd still be free to sell it as an unregulated supplement. Patent protections on supplements are very weak compared to the protections afforded to FDA approved drugs. That alone limits research into supplements. Also what counts as a supplement is limited, companies cannot just declare any random drug to be a supplement. Dietary supplements have to have some tenuous connection to being from a natural source. (Though obviously that line gets skirted a lot, such was with DMAA prior to 2013)
- thaumasiotes 2y ago
  > That alone limits research into supplements. Why is that relevant? In the scenario under discussion, you've already invented the drug.