6 ms·

There is a group that is producing medication that has yet to hit the market for self use. Someone got a hold of a patent, found a chemist and a lab willing to

by avgDev 2y ago

There is a group that is producing medication that has yet to hit the market for self use. Someone got a hold of a patent, found a chemist and a lab willing to test the substance. I'm waiting for the actual medication to hit the market but if the FDA approval takes a long time, I will make the med myself. The substance in the medication has been used orally for a long time with a good safety profile and it was discovered that it can help regenerate nerves. Maybe I made all of this up to sound cool on the internet. If you know what I mean.

QuantumGood 2y ago
The FDA does not take information from other countries into account much. EDIT: Foreign approval and use history can be supportive information in an FDA review process, but are not determinative factors for U.S. approval. For example, Promethazine has been popular in the UK for a very long time (ingredient in UK Sominex), but its not approved in the U.S. as a sleep aid. InHousePharmacy.vu/search.aspx?searchterm=promethazine
- lenerdenator 2y ago
  Seems rather myopic to me. We already share critical intelligence with the Five Eyes countries; why not share medication safety/efficacy information with them too?
  - NetworkPerson 2y ago
    Because then you can’t sue someone as easily in the US when you find out the drug popular in Europe actually caused cancer 50 years later. The US has to be sure it’s completely safe. Or that it will make enough money to outweigh the lawsuits later…
    - mnau 2y ago
      > The US has to be sure it’s completely safe. That doesn't make sense to me, who does US refer to in this case? The manufacturer is the one that would be sued and they generally only want to expediate process. FDA is one that aproves/denies application. They wouldn't get sued for using data from other countries (or at least no more that they already are).
    - lenerdenator 2y ago
      The "Five Eyes" countries are the United States, Canada, the UK, New Zealand, and Australia. Of the four countries that aren't the US, I'm sure that all have regulatory safety standards that would satisfy the safety and efficacy expectations of the American public.
  - Beijinger 2y ago
    I remember a blog post of an MD or psychologist about Russian/Soviet psychotropic drugs that are not used or unknown in the west and used as an analogy that if Russia had found new elements in the periodic table, and we would not use them.
    - XorNot 2y ago
      It might be worth considering that until very recently, Russia's military was definitely supremely capable and on-par with NATO. Russia lies. About everything. And culturally Russians have been immersed in a narrative that they're the absolute best in the world at everything, that all good ideas were originally Russian ideas (see how the narrative of LK-99 started getting modified before anything was verified). So do they have processes or techniques not used in the West? Sure it's possible: but it's also far more likely that the reason we don't use them is that the actual investigation of their effectiveness can't reproduce the results. Because no one looks up the clinical studies: they just repeat the fun narrative about big mysterious super-technology from behind the Iron Curtain. Which itself was essentially an invention of interest groups looking for funding in the West (i.e. there's was never a "missile gap" the US was going to lose). Like as noted here: you remember the story, but not any actual specific drugs or processes? Why?
      - Beijinger 2y ago
        EDIT: Someone found the link: https://slatestarcodex.com/2014/08/16/an-iron-curtain-has-descended-upon-psychopharmacology/ https://slatestarcodex.com/2014/08/16/an-iron-curtain-has-de... I did not find the blog post anymore. But the blog linked to a pharmacy website that had tons of stuff available. A few links: https://en.wikipedia.org/wiki/Phenazepam https://en.wikipedia.org/wiki/Phenazepam https://nah.sen.es/vmfiles/vol9/NAHV9N2202155_68EN.pdf https://nah.sen.es/vmfiles/vol9/NAHV9N2202155_68EN.pdf https://cosmicnootropic.com/blog/popular-nootropics/ https://cosmicnootropic.com/blog/popular-nootropics/ https://medicine.umich.edu/dept/psychiatry/news/archive/202010/phenibut-russian-cosmonaut-drug-you-can-buy-online-reduce-anxiety https://medicine.umich.edu/dept/psychiatry/news/archive/2020...
      - Beijinger 2y ago
  - e-_pusher 2y ago
    There is the famous example of Thaladomide, which was approved by the regulators in the Germany and caused a disaster in birth defects: https://en.wikipedia.org/wiki/Thalidomide_scandal https://en.wikipedia.org/wiki/Thalidomide_scandal US FDA however was skeptical of the safety of the drug and never approved it for sale in US.
    - smsm42 2y ago
      It doesn't look like FDA - or, specifically, Frances Oldham Kelsey - had any data or any evidence to suspect something was wrong with thalidomide. Partly it was because the manufacturers hid whatever suspicious data they had, but Kelsey had no way of knowing it - she basically just run out the clock until it so happened that the news about birth defects caused by it started coming in. That seems to have validated the idea that the strategy should be "delay approval as long as possible and request more and more tests for as long as possible". Which, of course, technically makes it safer for the drugs that manage to pass - but the cost is hugely inflated costs and absence of access to many drugs.
    - dekhn 2y ago
      Wrong: FDA was approved in the US and is used as an effective cancer drug. We just don't give it to people who would be at risk.
- slashdave 2y ago
  > The FDA does not take information from other countries into account. The FDA doesn't care where data comes from. Much of drug testing in the US is done overseas in CROs. > but its not approved in the U.S. as a sleep aid. Approval is not automatic just because another country did so. Someone needs to take responsibility and formally apply.
  - QuantumGood 2y ago
    The issue is that foreign approval and use history are not allowed to be determinative factors for U.S. approval in an FDA review process, but rather as supportive information only.
- spondylosaurus 2y ago
  It's still prescribed in the US for other uses though. I fucked up once and took one as an antiemetic, forgetting it was a sedative... right before I had an important meeting. Lesson learned :P
- MassPikeMike 2y ago
  But for that kind of thing it would seem to be much easier and probably cheaper just to mail order the drug from overseas, or even book an inexpensive flight and buy some. For example, bromhexine and ambroxol are cold remedies that many people find effective, are not available in the US, but are easy to mail order from any number of Japanese sellers. The difficulty of hiring a lab or setting one up yourself would seem to be worthwhile only for new or unusual medicines that could not be obtained this way.
  - pennybanks 2y ago
    gettong those drugs are legal? and do you know someone in japan willing to do this ? sounds pretty specific.
SuperShibe 2y ago
Out of actual interest for my own medical use: Which medication would this be about?
salad-tycoon 2y ago
tacrolimus and which group? Sounds like an interesting story, not sure why the lack of transparency.

by avgDev 2y ago

QuantumGood 2y ago

The FDA does not take information from other countries into account much. EDIT: Foreign approval and use history can be supportive information in an FDA review process, but are not determinative factors for U.S. approval. For example, Promethazine has been popular in the UK for a very long time (ingredient in UK Sominex), but its not approved in the U.S. as a sleep aid. InHousePharmacy.vu/search.aspx?searchterm=promethazine

lenerdenator 2y ago
Seems rather myopic to me. We already share critical intelligence with the Five Eyes countries; why not share medication safety/efficacy information with them too?
- NetworkPerson 2y ago
  Because then you can’t sue someone as easily in the US when you find out the drug popular in Europe actually caused cancer 50 years later. The US has to be sure it’s completely safe. Or that it will make enough money to outweigh the lawsuits later…
  - mnau 2y ago
    > The US has to be sure it’s completely safe. That doesn't make sense to me, who does US refer to in this case? The manufacturer is the one that would be sued and they generally only want to expediate process. FDA is one that aproves/denies application. They wouldn't get sued for using data from other countries (or at least no more that they already are).
  - lenerdenator 2y ago
    The "Five Eyes" countries are the United States, Canada, the UK, New Zealand, and Australia. Of the four countries that aren't the US, I'm sure that all have regulatory safety standards that would satisfy the safety and efficacy expectations of the American public.
- Beijinger 2y ago
  I remember a blog post of an MD or psychologist about Russian/Soviet psychotropic drugs that are not used or unknown in the west and used as an analogy that if Russia had found new elements in the periodic table, and we would not use them.
  - XorNot 2y ago
    It might be worth considering that until very recently, Russia's military was definitely supremely capable and on-par with NATO. Russia lies. About everything. And culturally Russians have been immersed in a narrative that they're the absolute best in the world at everything, that all good ideas were originally Russian ideas (see how the narrative of LK-99 started getting modified before anything was verified). So do they have processes or techniques not used in the West? Sure it's possible: but it's also far more likely that the reason we don't use them is that the actual investigation of their effectiveness can't reproduce the results. Because no one looks up the clinical studies: they just repeat the fun narrative about big mysterious super-technology from behind the Iron Curtain. Which itself was essentially an invention of interest groups looking for funding in the West (i.e. there's was never a "missile gap" the US was going to lose). Like as noted here: you remember the story, but not any actual specific drugs or processes? Why?
    - Beijinger 2y ago
      EDIT: Someone found the link: https://slatestarcodex.com/2014/08/16/an-iron-curtain-has-descended-upon-psychopharmacology/ https://slatestarcodex.com/2014/08/16/an-iron-curtain-has-de... I did not find the blog post anymore. But the blog linked to a pharmacy website that had tons of stuff available. A few links: https://en.wikipedia.org/wiki/Phenazepam https://en.wikipedia.org/wiki/Phenazepam https://nah.sen.es/vmfiles/vol9/NAHV9N2202155_68EN.pdf https://nah.sen.es/vmfiles/vol9/NAHV9N2202155_68EN.pdf https://cosmicnootropic.com/blog/popular-nootropics/ https://cosmicnootropic.com/blog/popular-nootropics/ https://medicine.umich.edu/dept/psychiatry/news/archive/202010/phenibut-russian-cosmonaut-drug-you-can-buy-online-reduce-anxiety https://medicine.umich.edu/dept/psychiatry/news/archive/2020...
    - Beijinger 2y ago
- e-_pusher 2y ago
  There is the famous example of Thaladomide, which was approved by the regulators in the Germany and caused a disaster in birth defects: https://en.wikipedia.org/wiki/Thalidomide_scandal https://en.wikipedia.org/wiki/Thalidomide_scandal US FDA however was skeptical of the safety of the drug and never approved it for sale in US.
  - smsm42 2y ago
    It doesn't look like FDA - or, specifically, Frances Oldham Kelsey - had any data or any evidence to suspect something was wrong with thalidomide. Partly it was because the manufacturers hid whatever suspicious data they had, but Kelsey had no way of knowing it - she basically just run out the clock until it so happened that the news about birth defects caused by it started coming in. That seems to have validated the idea that the strategy should be "delay approval as long as possible and request more and more tests for as long as possible". Which, of course, technically makes it safer for the drugs that manage to pass - but the cost is hugely inflated costs and absence of access to many drugs.
  - dekhn 2y ago
    Wrong: FDA was approved in the US and is used as an effective cancer drug. We just don't give it to people who would be at risk.
slashdave 2y ago
> The FDA does not take information from other countries into account. The FDA doesn't care where data comes from. Much of drug testing in the US is done overseas in CROs. > but its not approved in the U.S. as a sleep aid. Approval is not automatic just because another country did so. Someone needs to take responsibility and formally apply.
- QuantumGood 2y ago
  The issue is that foreign approval and use history are not allowed to be determinative factors for U.S. approval in an FDA review process, but rather as supportive information only.
spondylosaurus 2y ago
It's still prescribed in the US for other uses though. I fucked up once and took one as an antiemetic, forgetting it was a sedative... right before I had an important meeting. Lesson learned :P
MassPikeMike 2y ago
But for that kind of thing it would seem to be much easier and probably cheaper just to mail order the drug from overseas, or even book an inexpensive flight and buy some. For example, bromhexine and ambroxol are cold remedies that many people find effective, are not available in the US, but are easy to mail order from any number of Japanese sellers. The difficulty of hiring a lab or setting one up yourself would seem to be worthwhile only for new or unusual medicines that could not be obtained this way.
- pennybanks 2y ago
  gettong those drugs are legal? and do you know someone in japan willing to do this ? sounds pretty specific.

SuperShibe 2y ago

Out of actual interest for my own medical use: Which medication would this be about?

salad-tycoon 2y ago

tacrolimus and which group? Sounds like an interesting story, not sure why the lack of transparency.