6 ms·

Such studies are great but there is no regulatory pathway to extend the use of existing drugs for new indications of use without the consent of the manufacturer

by oezi 4mo ago

Such studies are great but there is no regulatory pathway to extend the use of existing drugs for new indications of use without the consent of the manufacturer (or becoming a manufacturer yourself). This means such studies can give more clarity on which off-label use is beneficial but it can't be an officially allowed usage.

boxed 4mo ago
That seems wild. Do you have a citation to back that up? And in what country/countries?
- amanaplanacanal 4mo ago
  I'm in the US, and there are a couple of wrinkles to this: insurance typically won't cover off label use, so patients end up paying the full cost of the medication, and if there is a big enough market, I believe companies can patent the new use even if the patents for the original use have run out. Doctors here are allowed to prescribe them though.
  - bonsai_spool 4mo ago
    > I believe companies can patent the new use even if the patents for the original use have run out. This is not true > insurance typically won't cover off label use Generally not true but it can be the case, especially for expensive medications
    - amanaplanacanal 4mo ago
      Yes new uses of existing drugs can be patented: https://www.drugpatentwatch.com/blog/patenting-new-uses-for-existing-drugs-a-legal-and-strategic-analysis-of-drug-repurposing/ https://www.drugpatentwatch.com/blog/patenting-new-uses-for-...
      - bonsai_spool 4mo ago
        This is clearly made by an LLM and thus not a credible resource. From: https://pmc.ncbi.nlm.nih.gov/articles/PMC9336118/ https://pmc.ncbi.nlm.nih.gov/articles/PMC9336118/ "COM claims can be difficult to gain for repurposed compounds, as the patentee must somehow differentiate their patent claims over what is in the public domain and present data that the drug is a credible candidate for the new indication [41, 42]." citing 41 https://pubmed.ncbi.nlm.nih.gov/32241561/ https://pubmed.ncbi.nlm.nih.gov/32241561/ 42 https://pubmed.ncbi.nlm.nih.gov/30310233/ https://pubmed.ncbi.nlm.nih.gov/30310233/
        amanaplanacanal 4mo ago
        Do you like this source better? https://synapse.patsnap.com/blog/what-are-the-types-of-pharmaceutical-patents https://synapse.patsnap.com/blog/what-are-the-types-of-pharm...?
        bonsai_spool 4mo ago
        It’s somebody’s random blog instead of three published, peer reviewed articles. I’m not sure what you expect to hear
        amanaplanacanal 4mo ago
        It's a matter of law, not science. Ask a patent attorney. If you like, here is a paper from the Vanderbilt law review: https://scholarship.law.vanderbilt.edu/cgi/viewcontent.cgi?article=2919&context=vlr https://scholarship.law.vanderbilt.edu/cgi/viewcontent.cgi?a...
        bonsai_spool 4mo ago
        Did you actually read that article that spends many pages explaining how there is no good way for a firm to patent a repurposed drug that is working the same way as it worked in a prior indication, but is being used for a new indication where it has the same function - exactly what you’re asserting and what I said is not possible? Thanks for the article, it is a good one.
  - Aurornis 4mo ago
    > insurance typically won't cover off label use I’m in the US. This is not true. Insurance will have prior authorization rules for certain drugs that are expensive that require the doctor to submit documentation of the condition, but in most cases the common medication is simply covered if prescribed. The insurance company does not receive documentation of every condition for every prescription to determine if the prescription is on label or off label. Insurance companies can and do also support some off label treatments that are commonly used under their prior auth requirements. I don’t know why there are so many comments in this thread making confident assertions that off label prescribing or insurance or so uncommon. This happens all day long at doctors offices and pharmacies.
    - dpark 4mo ago
      So much weirdly confident misinformation here. When LLMs do this we can it hallucination.
      - Jblx2 4mo ago
        Can't tell if this comment is agreeing with Aurornis or calling them out.
        dpark 4mo ago
        Agreeing. There is a ton of blatant misinformation being shared in this thread by people who seem utterly confident despite their apparently complete ignorance.
    - amanaplanacanal 4mo ago
      Yeah I definitely misspoke on that one. I believe they aren't required to cover off label use, so it's up to them whether they do or not.
  - jpk2f2 4mo ago
    Insurance absolutely covers off label use. And depending on the area of medicine, off label use can be incredibly common (see cardiac pediatrics).
  - tekla 4mo ago
    > insurance typically won't cover off label use That's a lie, I get off-label drugs prescribed monthly covered.
ktallett 4mo ago
This isn't completely true at least in the UK. It is simply that the manufacturer is no longer responsible legally. The GMC allow prescibing of unlicensed meds. However the change needs to be made to the pathway. So many issues in the NHS has been due to pathway problems.
vidarh 4mo ago
The article points out that it is typically after patent expiry that the universities and hospitals start looking at repurposing.
- oezi 4mo ago
  The patents aren't hindering off-label use. The hinder commercial exploitation by others.
  - vidarh 4mo ago
    Yes, but that isn't relevant to what happens after the type of trials described in the article, which tends to happen when the patents are no longer relevant. As the article points out, while the drugs are patented, the manufacturers themselves are generally very interested in repurposing because it broadens their market. The article is discussing trials that mostly happens once the patents have expired.
intrasight 4mo ago
There tens of millions of people being treated off-label.
- uberex 4mo ago
  Can confirm. LDN user here.
  - cjbgkagh 4mo ago
    Also a LDN user, that drug saved my life. I bought it from a shady dude online, the initial effect was so strong that I thought they shipped me meth instead - that wore off after a week but the lifting of the brain fog persisted.
    - jnovek 4mo ago
      It didn’t have that sort of immediate, intense effect for me (though yours isn’t the only account like this that I’ve seen) but I’m still happy with the outcome; it dropped my average 1-to-10 pain score by about two points at three months.
      - cjbgkagh 4mo ago
        It is a rare side effect, I helped a bunch of people (~50) get LDN, primarily for LongCovid, and only one other had a similar ‘too much energy’ effect and both of us have multiple TNXB SNPs and a very similar rare personality profile. I think the brain is so starved for dopamine at that point that it becomes hyper sensitive. I do miss the extra high energy but I also know that isn’t maintainable and I try to err on the side of caution. I’ve had ME/CFS my whole life but the third covid vaccine shot sent me to new lows, to the point LDN just wasn’t cutting it anymore. These days I take a combo of modafinil in the morning and amitryptiline at night. And low dose ozempic has been super helpful as well. I was researching GLP1As prior to the current craze because I was worried about hyper sensitivity so I waited for more data before trying, I started at 1/100th the normal starting dose and still got temporary gastroparesis. These days I take a more regular dose of 1mg/wk but it also seems that my body has largely normalized as the hypersensitivities have worn off. Probably a good sign that I’ve successfully addressed actual deficiencies.
dpark 4mo ago
This is all untrue so far as I understand. A research group can file for a new drug application (or abbreviated new drug application) for an existing drug. There is no mandate that an NDA sponsor be a manufacturer or the existing manufacturer. Only the entity holding an approved NDA can file a supplemental NDA but that’s not the only path. The real reason no one files for off label use is that there’s high cost and little to no practical benefit to doing so.
- oezi 4mo ago
  On paper you are right. You can file an NDA. But in reality you can't prove that the product on the market (the drug you are adding an NDA to) is sufficiently under your control to enable you to claim that it is safe and effective. Only a manufacturer can control the product. If you want to piggyback on top of an existing product in the market, you have to become a manufacturer or sign a contract with an existing one. You are absolutely right about the incentives. There are absolutely none except to help humanity which is why only hospitals and universities are doing these off label studies.

by oezi 4mo ago

boxed 4mo ago

That seems wild. Do you have a citation to back that up? And in what country/countries?

amanaplanacanal 4mo ago
I'm in the US, and there are a couple of wrinkles to this: insurance typically won't cover off label use, so patients end up paying the full cost of the medication, and if there is a big enough market, I believe companies can patent the new use even if the patents for the original use have run out. Doctors here are allowed to prescribe them though.
- bonsai_spool 4mo ago
  > I believe companies can patent the new use even if the patents for the original use have run out. This is not true > insurance typically won't cover off label use Generally not true but it can be the case, especially for expensive medications
  - amanaplanacanal 4mo ago
    Yes new uses of existing drugs can be patented: https://www.drugpatentwatch.com/blog/patenting-new-uses-for-existing-drugs-a-legal-and-strategic-analysis-of-drug-repurposing/ https://www.drugpatentwatch.com/blog/patenting-new-uses-for-...
    - bonsai_spool 4mo ago
      This is clearly made by an LLM and thus not a credible resource. From: https://pmc.ncbi.nlm.nih.gov/articles/PMC9336118/ https://pmc.ncbi.nlm.nih.gov/articles/PMC9336118/ "COM claims can be difficult to gain for repurposed compounds, as the patentee must somehow differentiate their patent claims over what is in the public domain and present data that the drug is a credible candidate for the new indication [41, 42]." citing 41 https://pubmed.ncbi.nlm.nih.gov/32241561/ https://pubmed.ncbi.nlm.nih.gov/32241561/ 42 https://pubmed.ncbi.nlm.nih.gov/30310233/ https://pubmed.ncbi.nlm.nih.gov/30310233/
      - amanaplanacanal 4mo ago
        Do you like this source better? https://synapse.patsnap.com/blog/what-are-the-types-of-pharmaceutical-patents https://synapse.patsnap.com/blog/what-are-the-types-of-pharm...?
        bonsai_spool 4mo ago
        It’s somebody’s random blog instead of three published, peer reviewed articles. I’m not sure what you expect to hear
        amanaplanacanal 4mo ago
        It's a matter of law, not science. Ask a patent attorney. If you like, here is a paper from the Vanderbilt law review: https://scholarship.law.vanderbilt.edu/cgi/viewcontent.cgi?article=2919&context=vlr https://scholarship.law.vanderbilt.edu/cgi/viewcontent.cgi?a...
        bonsai_spool 4mo ago
        Did you actually read that article that spends many pages explaining how there is no good way for a firm to patent a repurposed drug that is working the same way as it worked in a prior indication, but is being used for a new indication where it has the same function - exactly what you’re asserting and what I said is not possible? Thanks for the article, it is a good one.
- Aurornis 4mo ago
  > insurance typically won't cover off label use I’m in the US. This is not true. Insurance will have prior authorization rules for certain drugs that are expensive that require the doctor to submit documentation of the condition, but in most cases the common medication is simply covered if prescribed. The insurance company does not receive documentation of every condition for every prescription to determine if the prescription is on label or off label. Insurance companies can and do also support some off label treatments that are commonly used under their prior auth requirements. I don’t know why there are so many comments in this thread making confident assertions that off label prescribing or insurance or so uncommon. This happens all day long at doctors offices and pharmacies.
  - dpark 4mo ago
    So much weirdly confident misinformation here. When LLMs do this we can it hallucination.
    - Jblx2 4mo ago
      Can't tell if this comment is agreeing with Aurornis or calling them out.
      - dpark 4mo ago
        Agreeing. There is a ton of blatant misinformation being shared in this thread by people who seem utterly confident despite their apparently complete ignorance.
  - amanaplanacanal 4mo ago
    Yeah I definitely misspoke on that one. I believe they aren't required to cover off label use, so it's up to them whether they do or not.
- jpk2f2 4mo ago
  Insurance absolutely covers off label use. And depending on the area of medicine, off label use can be incredibly common (see cardiac pediatrics).
- tekla 4mo ago
  > insurance typically won't cover off label use That's a lie, I get off-label drugs prescribed monthly covered.

ktallett 4mo ago

This isn't completely true at least in the UK. It is simply that the manufacturer is no longer responsible legally. The GMC allow prescibing of unlicensed meds. However the change needs to be made to the pathway. So many issues in the NHS has been due to pathway problems.

vidarh 4mo ago

The article points out that it is typically after patent expiry that the universities and hospitals start looking at repurposing.

oezi 4mo ago
The patents aren't hindering off-label use. The hinder commercial exploitation by others.
- vidarh 4mo ago
  Yes, but that isn't relevant to what happens after the type of trials described in the article, which tends to happen when the patents are no longer relevant. As the article points out, while the drugs are patented, the manufacturers themselves are generally very interested in repurposing because it broadens their market. The article is discussing trials that mostly happens once the patents have expired.

intrasight 4mo ago

There tens of millions of people being treated off-label.

uberex 4mo ago
Can confirm. LDN user here.
- cjbgkagh 4mo ago
  Also a LDN user, that drug saved my life. I bought it from a shady dude online, the initial effect was so strong that I thought they shipped me meth instead - that wore off after a week but the lifting of the brain fog persisted.
  - jnovek 4mo ago
    It didn’t have that sort of immediate, intense effect for me (though yours isn’t the only account like this that I’ve seen) but I’m still happy with the outcome; it dropped my average 1-to-10 pain score by about two points at three months.
    - cjbgkagh 4mo ago
      It is a rare side effect, I helped a bunch of people (~50) get LDN, primarily for LongCovid, and only one other had a similar ‘too much energy’ effect and both of us have multiple TNXB SNPs and a very similar rare personality profile. I think the brain is so starved for dopamine at that point that it becomes hyper sensitive. I do miss the extra high energy but I also know that isn’t maintainable and I try to err on the side of caution. I’ve had ME/CFS my whole life but the third covid vaccine shot sent me to new lows, to the point LDN just wasn’t cutting it anymore. These days I take a combo of modafinil in the morning and amitryptiline at night. And low dose ozempic has been super helpful as well. I was researching GLP1As prior to the current craze because I was worried about hyper sensitivity so I waited for more data before trying, I started at 1/100th the normal starting dose and still got temporary gastroparesis. These days I take a more regular dose of 1mg/wk but it also seems that my body has largely normalized as the hypersensitivities have worn off. Probably a good sign that I’ve successfully addressed actual deficiencies.

dpark 4mo ago

This is all untrue so far as I understand. A research group can file for a new drug application (or abbreviated new drug application) for an existing drug. There is no mandate that an NDA sponsor be a manufacturer or the existing manufacturer. Only the entity holding an approved NDA can file a supplemental NDA but that’s not the only path. The real reason no one files for off label use is that there’s high cost and little to no practical benefit to doing so.

oezi 4mo ago
On paper you are right. You can file an NDA. But in reality you can't prove that the product on the market (the drug you are adding an NDA to) is sufficiently under your control to enable you to claim that it is safe and effective. Only a manufacturer can control the product. If you want to piggyback on top of an existing product in the market, you have to become a manufacturer or sign a contract with an existing one. You are absolutely right about the incentives. There are absolutely none except to help humanity which is why only hospitals and universities are doing these off label studies.