4 ms·

A cure for aging only needs to get through human clinical trials for treating one aging-associated condition like osteoporosis. Once it has FDA approval for tre

A cure for aging only needs to get through human clinical trials for treating one aging-associated condition like osteoporosis. Once it has FDA approval for treating that one condition it can be prescribed off-label by a willing physician. If the osteoporosis treatment has unusual side effects of also making skin appear more youthful, improving short term memory, and increasing libido, then there will probably be a lot of off-label prescriptions written a few years later. So if you have a great way to cure aging but are worried that the FDA does not recognize aging as a condition, that's how you get the treatment to market.

JumpCrisscross 5y ago
> if you have a great way to cure aging but are worried that the FDA does not recognize aging as a condition, that's how you get the treatment to market If you have a cure for aging, I'm decently sure you can earn your ROI without respect to the FDA.
- cwkoss 5y ago
  Yeah if you cure aging, fuck the FDA, sell it to billionaires for $1B/year until they are broke, then buy congress so you control the FDA
  - cwkoss 5y ago
    On second thought, you could certainly buy our mostly-geriatric congress with the cure directly, and probably sidestep a bunch of messy FEC regulations
ska 5y ago
If anyone actually comes up with an empirically verified treatment for aging (let alone a "cure"), market access or payment is not a problem they will face.
- nostromo 5y ago
  David Sinclair is an expert on this and has said otherwise. Clinical trials are expensive. To fund them you need billions of dollars. Pharmas won’t fund research in anti-aging directly because it’s not considered a disease, can’t get FDA approval, and thus couldn’t be sold. So, yes, you need to find another route to approval, similar to metformin and rapamycin.
  - ska 5y ago
    Pharma companies won't fund research because they don't consider the risk-reward tradeoff worthwhile compared to other options for their resources. Off label use in endemic, and it does give a path to play with some things clinically; however if you formed a company around this idea and could have been demonstrated to do it, you'll be pulled off the market so fast it will make your head spin. What you are really talking about is about funding the research that wont work, in the hopes that eventually you hit on something that does. If you do hit on that and can rigorously demonstrate it, market access will not be a problem.
  - ALittleLight 5y ago
    One thing I've never understood, given that trials are so insanely expensive, is why healthcare companies with billions of dollars don't open up "offshore" research facilities to do trials in more lax jurisdictions. I've done none of the research, just imagining, but if you were to open up a compound in Somalia or somewhere, make the appropriate political contributions, would you really be bogged down with lots of red tape? Could you just experiment and iterate fast enough to develop convincing therapies cheaply and then bring them to mature markets?
    - beardyw 5y ago
      So, experiment on poor black people? I think you are on the wrong forum.
      - ALittleLight 5y ago
        The necessary part is only that the prospective subjects aren't protected by strict regulatory regimes like in the United States. Somalia, as, essentially, a failed state, I assume, has lax medical regulations and is a possible candidate for experimentation. I think it's a bit racist for you to generalize my description of a poor and under regulated state, like Somalia, as being equal to "black people". Not all countries in Africa are like Somalia, you know. I suggest reading a bit more about Africa. I personally enjoy watching YouTube videos made by creators in different countries, African countries have a wide range. As Mark Twain said, "Travel is fatal to prejudice". Today, we can virtually "travel" with the click of a button. Not all black people are poor Somalis!
bserge 5y ago
> off-label by a willing physician Just great.

JumpCrisscross 5y ago

> if you have a great way to cure aging but are worried that the FDA does not recognize aging as a condition, that's how you get the treatment to market If you have a cure for aging, I'm decently sure you can earn your ROI without respect to the FDA.

cwkoss 5y ago
Yeah if you cure aging, fuck the FDA, sell it to billionaires for $1B/year until they are broke, then buy congress so you control the FDA
- cwkoss 5y ago
  On second thought, you could certainly buy our mostly-geriatric congress with the cure directly, and probably sidestep a bunch of messy FEC regulations

ska 5y ago

If anyone actually comes up with an empirically verified treatment for aging (let alone a "cure"), market access or payment is not a problem they will face.

nostromo 5y ago
David Sinclair is an expert on this and has said otherwise. Clinical trials are expensive. To fund them you need billions of dollars. Pharmas won’t fund research in anti-aging directly because it’s not considered a disease, can’t get FDA approval, and thus couldn’t be sold. So, yes, you need to find another route to approval, similar to metformin and rapamycin.
- ska 5y ago
  Pharma companies won't fund research because they don't consider the risk-reward tradeoff worthwhile compared to other options for their resources. Off label use in endemic, and it does give a path to play with some things clinically; however if you formed a company around this idea and could have been demonstrated to do it, you'll be pulled off the market so fast it will make your head spin. What you are really talking about is about funding the research that wont work, in the hopes that eventually you hit on something that does. If you do hit on that and can rigorously demonstrate it, market access will not be a problem.
- ALittleLight 5y ago
  One thing I've never understood, given that trials are so insanely expensive, is why healthcare companies with billions of dollars don't open up "offshore" research facilities to do trials in more lax jurisdictions. I've done none of the research, just imagining, but if you were to open up a compound in Somalia or somewhere, make the appropriate political contributions, would you really be bogged down with lots of red tape? Could you just experiment and iterate fast enough to develop convincing therapies cheaply and then bring them to mature markets?
  - beardyw 5y ago
    So, experiment on poor black people? I think you are on the wrong forum.
    - ALittleLight 5y ago
      The necessary part is only that the prospective subjects aren't protected by strict regulatory regimes like in the United States. Somalia, as, essentially, a failed state, I assume, has lax medical regulations and is a possible candidate for experimentation. I think it's a bit racist for you to generalize my description of a poor and under regulated state, like Somalia, as being equal to "black people". Not all countries in Africa are like Somalia, you know. I suggest reading a bit more about Africa. I personally enjoy watching YouTube videos made by creators in different countries, African countries have a wide range. As Mark Twain said, "Travel is fatal to prejudice". Today, we can virtually "travel" with the click of a button. Not all black people are poor Somalis!

bserge 5y ago

> off-label by a willing physician Just great.