2 ms·

> Thus any approvals would require having a particular condition to get a prescription (or an unethical doctor), and this aren't immediately useful. That's not

by ska 7y ago

> Thus any approvals would require having a particular condition to get a prescription (or an unethical doctor), and this aren't immediately useful. That's not how any of this works (US specific to follow). FDA approval to market is a constraint on how the vendor markets a drug or device, not how a physician uses it. This is known as indications for use. So if I sell a drug approved for blood pressure, I can never say it may improve longevity. If there are papers out there claiming good effects on longevity I as a vendor have to be very careful to never make a public claim about that. However, if you as a physician have read the papers you can prescribe the drug for other uses based on your personal expertise. This is known as off-label (i.e. for a use not covered by the indications for use), and is very common. There are limits of course, but at the end of the day the limits are based on professional conduct/ malpractice - not the FDA. The FDA explicitly does not regulate the practice of medicine. Note that this doesn't just apply to somewhat speculative uses. For example a significant amount of pediatric care is done off-label, because setting up the clinical trials for pediatric indications is a pain. This may only be a dose change, for example, but is very common.

dannykwells 7y ago
Aware of what off label is, thank you, but I think you grossly misunderstand modern medicine if you think a doctor is going to prescribe a drug originally approved to treat cancer because you _hypothesize_ it might have some anti-aging properties. That's the whole issue with this list: none of these trials are testing the anti-aging hypothesis - it's just mentioning particular pathways -like Wnt (a core development program and implicated in many, many aspects of human health) and saying that the drug would be anti-aging. As for "unethical" - well, yes, the person would be unethical since they would likely being prescribing a drug for no reason, with no basis, based solely on misguided patient belief. This is more likely to endanger the patient than it is to help. Thus, unethical.
- ska 7y ago
  > if you think a doctor is going to prescribe a drug originally approved to treat cancer because you _hypothesize_ it might have some anti-aging properties. Of course not, but I didn't suggest that at all. In clinical practice they do this quite routinely if there is scientific evidence of efficacy; i.e. there are a number of papers and talks discussing why and how it works. There is a spectrum of course, from "huh, that's an interesting idea" to "came up in training as part of maintaining my board certification". I'm guessing most non-research clinicial staff will be well towards the later category before starting to use something off label. Many probably wait until they know other clinicians are using it - they also talk to each other a lot (hence KOL impact can be huge, here). How do these papers come to exist? Not through FDA trials. The scientists involved aren't going to jump into a human trial based on nothing but a hunch, but if there is a reasonable hypothesis about it someone will try preclinical work etc. And if all of that looks good eventually someone will report results in humans used off label. The point is this is a completely different pathway than an FDA clinical trial. I agree with you completely that premature clinical use of a drug would be unethical [1]. However, it is just wrong to suggest that the typical or only ethical path for this goes through an FDA PMA. You seem to be objecting to something that is a very common part of the development of modern medicine, as if it is obviously wrong. It certainly has interesting questions around it, but seems to be a reasonable compromise between stifling innovation/development and enhanced risk to public/patients. I'll note I don't have an opinion on whether or not any of this has been done for longevity applications to the point that a clinician could reasonably use it off label; I don't know enough about it. But it is certainly plausible that they could reach that standard at some point, without any of the vendors having it as an indication (at least initially, if it worked they would almost certainly pursue the indication in this particular case, unlike some). [1] this use tends to be very much scaled to impact and prognosis anyway - so the longevity stuff specifically, would have a pretty high bar to meet.

by ska 7y ago

dannykwells 7y ago

Aware of what off label is, thank you, but I think you grossly misunderstand modern medicine if you think a doctor is going to prescribe a drug originally approved to treat cancer because you _hypothesize_ it might have some anti-aging properties. That's the whole issue with this list: none of these trials are testing the anti-aging hypothesis - it's just mentioning particular pathways -like Wnt (a core development program and implicated in many, many aspects of human health) and saying that the drug would be anti-aging. As for "unethical" - well, yes, the person would be unethical since they would likely being prescribing a drug for no reason, with no basis, based solely on misguided patient belief. This is more likely to endanger the patient than it is to help. Thus, unethical.

ska 7y ago
> if you think a doctor is going to prescribe a drug originally approved to treat cancer because you _hypothesize_ it might have some anti-aging properties. Of course not, but I didn't suggest that at all. In clinical practice they do this quite routinely if there is scientific evidence of efficacy; i.e. there are a number of papers and talks discussing why and how it works. There is a spectrum of course, from "huh, that's an interesting idea" to "came up in training as part of maintaining my board certification". I'm guessing most non-research clinicial staff will be well towards the later category before starting to use something off label. Many probably wait until they know other clinicians are using it - they also talk to each other a lot (hence KOL impact can be huge, here). How do these papers come to exist? Not through FDA trials. The scientists involved aren't going to jump into a human trial based on nothing but a hunch, but if there is a reasonable hypothesis about it someone will try preclinical work etc. And if all of that looks good eventually someone will report results in humans used off label. The point is this is a completely different pathway than an FDA clinical trial. I agree with you completely that premature clinical use of a drug would be unethical [1]. However, it is just wrong to suggest that the typical or only ethical path for this goes through an FDA PMA. You seem to be objecting to something that is a very common part of the development of modern medicine, as if it is obviously wrong. It certainly has interesting questions around it, but seems to be a reasonable compromise between stifling innovation/development and enhanced risk to public/patients. I'll note I don't have an opinion on whether or not any of this has been done for longevity applications to the point that a clinician could reasonably use it off label; I don't know enough about it. But it is certainly plausible that they could reach that standard at some point, without any of the vendors having it as an indication (at least initially, if it worked they would almost certainly pursue the indication in this particular case, unlike some). [1] this use tends to be very much scaled to impact and prognosis anyway - so the longevity stuff specifically, would have a pretty high bar to meet.