5 ms·

FDA Approves First Medication to Treat Severe Frostbite

106 points by jyunwai 3y ago

Vecr 3y ago
Interesting, however > to reduce the risk of finger or toe amputation is not how risk works, similar to a basic conditionalization that tells you not to go to the doctor for an illness as that action would provide evidence for an increased probability of death.
- Aurornis 3y ago
  > is not how risk works, similar to a basic conditionalization that tells you not to go to the doctor for an illness as that action would provide evidence for an increased probability of death. I don't know what you're saying here, but this medication is an injection that is given to someone by doctors after they've sought emergency medical treatment. The article was trying to communicate that it increases the odds of being able to keep the appendage. Debating the wording is rather pedantic.
  - Vecr 3y ago
    Assuming you're fine with (somewhat debatable) casual language, "this drug (probably) causes probabilistic physical events leading to a lower chance of medically determined necessity to amputate, conditional on the correct medical examination being done at the right times".
    - Intermernet 3y ago
      This is analogous to how much medical research is done. Unless you want to go the literal Nazi method of inducing illness or incapacity and then testing remedies, this is sort of the best we have. Final stage medical research involves humans to test on. Preferably voluntarily, and preferably when they require the treatment through actual misfortune .
- nulbyte 3y ago
  It's exactly how risk works. The primary definition if risk is "possibility of suffering harm or loss; danger," according to The American Heritage Dictionary of English Language.
  - Vecr 3y ago
    It should be closer to casual than the simplest conditionalization you can do, right?
- deleted 3y ago
  [deleted]
yellow_lead 3y ago
> One of these groups (Group 1) received iloprost by vein (intravenously) for 6 hours daily for up to 8 days. The two other groups received other medications that are unapproved for frostbite, given with iloprost (Group 2) or without iloprost (Group 3). > On day 7, the bone scan finding predictive of needing amputation was observed in 0% (0 of 16) patients receiving iloprost alone (Group 1) compared to 19% (3 of 16) patients in Group 2 and 60% (9 of 15) patients in Group 3. The presence of the bone scan abnormality was significantly lower in the two groups receiving iloprost. Most patients had follow-up information on whether they subsequently underwent at least one finger or toe amputation. The need for amputation was consistent with the bone scan findings. It seems like an effective drug based on this result.
- fs_tab 3y ago
  Does anyone on here know if this is due to the fact that it's a general vasodilator, or if there are specific pathways (eg: from activating prostacyclin and prostaglandin receptors) which have the effect of reducing tissue/bone damage?
- sidkshatriya 3y ago
  > On day 7, the bone scan finding predictive of needing amputation was observed in 0% (0 of 16) patients receiving iloprost alone (Group 1) compared to 19% (3 of 16) patients in Group 2 and 60% (9 of 15) patients in Group 3. Ah ! It would have sucked to have Frostbite not be in Group 1 and then need to undergo amputation. Talk about bad luck ! However, I totally understand that this is the main way for the science to progress and treatments to get validated.
  - yjftsjthsd-h 3y ago
    The flip side is that it could have made things worse. Epistemology and ethics get complicated fast in this kind of thing:\
    - idontknowifican 3y ago
      this is why PrEP has no double blind study. it was considered unethical
tommiegannert 3y ago
Seems the news here is just the study and approval for frostbite; nothing special about how it works? > Iloprost is a medication used to treat pulmonary arterial hypertension (PAH), scleroderma, Raynaud's phenomenon, frostbite, and other conditionss in which the blood vessels are constricted and blood cannot flow to the tissues. This damages the tissues and causes high blood pressure. Iloprost works by opening (dilating) the blood vessels to allow the blood to flow through again. https://en.wikipedia.org/wiki/Iloprost https://en.wikipedia.org/wiki/Iloprost
nxobject 3y ago
Surprisingly enough, the original trial took 12 years: > Between 1996 and 2008, we randomly assigned 47 patients (44 men and 3 women) with severe frostbite to one of three treatment regimens in an open-label study. Severe frostbite was defined as having at least one digit (finger or toe) with frostbite stage 3 (lesion extending just past the proximal phalanx) or stage 4 (lesion extending proximal to the metacarpal or metatarsal joint).4 The study was approved by the ethics committee at the University of Grenoble. Sadly, I'm curious to see how the business case (in America!) pans out – I wouldn't be surprised if the biggest cause of frostbite in the US is winter homelessness.
- c22 3y ago
  I keep some Narcan in my car and so far I've only given it to homeless people.
  - Kerb_ 3y ago
    I think that likely has more to do with housed people not needing to be on the streets when they take their drugs and overdosing inside than it does with homeless people getting frostbite.
    - c22 3y ago
      It has nothing to do with frostbite except to demonstrate that there may still be a market for a product that is beneficial to homeless people even if the homeless themselves don't buy it. (The homeless, of course, may also be able to buy frostbite medicine, assuming it's cheaper than a house.)
      - nxobject 3y ago
        It might be that public money might end up buying it for disaster response, in the same way that Narcan's being bought by municipalities etc., rather than people. (Considering that this was shepherded through orphan drug programs, it wouldn't be the first time this was subsidized by public money.) That being said, the price of Narcan's heavily dropped since it became generic – I remember when Narcan was either distributed in vials and IM injection training was required, or nasal spray packaging was a lot more expensive.
reisse 3y ago
Wonder why it took so long for FDA. Seems it was used elsewhere (I've found reports from EU and Nepal) for treating frostbites at least a decade.
pfdietz 3y ago
I really wouldn't want to lose appendages from frostbite, so this sounds great. The first treatment addressing lack toes intolerance.
subpixel 3y ago
Anectdote: I got mild frostbite twenty years bc I was unprepared for a Fall hike in the Adirondacks. It still makes me miserable - when other people feel a nip of cold my fingers are pulsing with pain. I have to be really careful in winter not to expose my hands to frigid air skiing etc, it sucks.

106 points by jyunwai 3y ago

Vecr 3y ago

Interesting, however > to reduce the risk of finger or toe amputation is not how risk works, similar to a basic conditionalization that tells you not to go to the doctor for an illness as that action would provide evidence for an increased probability of death.

Aurornis 3y ago
> is not how risk works, similar to a basic conditionalization that tells you not to go to the doctor for an illness as that action would provide evidence for an increased probability of death. I don't know what you're saying here, but this medication is an injection that is given to someone by doctors after they've sought emergency medical treatment. The article was trying to communicate that it increases the odds of being able to keep the appendage. Debating the wording is rather pedantic.
- Vecr 3y ago
  Assuming you're fine with (somewhat debatable) casual language, "this drug (probably) causes probabilistic physical events leading to a lower chance of medically determined necessity to amputate, conditional on the correct medical examination being done at the right times".
  - Intermernet 3y ago
    This is analogous to how much medical research is done. Unless you want to go the literal Nazi method of inducing illness or incapacity and then testing remedies, this is sort of the best we have. Final stage medical research involves humans to test on. Preferably voluntarily, and preferably when they require the treatment through actual misfortune .
nulbyte 3y ago
It's exactly how risk works. The primary definition if risk is "possibility of suffering harm or loss; danger," according to The American Heritage Dictionary of English Language.
- Vecr 3y ago
  It should be closer to casual than the simplest conditionalization you can do, right?
deleted 3y ago
[deleted]

yellow_lead 3y ago

> One of these groups (Group 1) received iloprost by vein (intravenously) for 6 hours daily for up to 8 days. The two other groups received other medications that are unapproved for frostbite, given with iloprost (Group 2) or without iloprost (Group 3). > On day 7, the bone scan finding predictive of needing amputation was observed in 0% (0 of 16) patients receiving iloprost alone (Group 1) compared to 19% (3 of 16) patients in Group 2 and 60% (9 of 15) patients in Group 3. The presence of the bone scan abnormality was significantly lower in the two groups receiving iloprost. Most patients had follow-up information on whether they subsequently underwent at least one finger or toe amputation. The need for amputation was consistent with the bone scan findings. It seems like an effective drug based on this result.

fs_tab 3y ago
Does anyone on here know if this is due to the fact that it's a general vasodilator, or if there are specific pathways (eg: from activating prostacyclin and prostaglandin receptors) which have the effect of reducing tissue/bone damage?
sidkshatriya 3y ago
> On day 7, the bone scan finding predictive of needing amputation was observed in 0% (0 of 16) patients receiving iloprost alone (Group 1) compared to 19% (3 of 16) patients in Group 2 and 60% (9 of 15) patients in Group 3. Ah ! It would have sucked to have Frostbite not be in Group 1 and then need to undergo amputation. Talk about bad luck ! However, I totally understand that this is the main way for the science to progress and treatments to get validated.
- yjftsjthsd-h 3y ago
  The flip side is that it could have made things worse. Epistemology and ethics get complicated fast in this kind of thing:\
  - idontknowifican 3y ago
    this is why PrEP has no double blind study. it was considered unethical

tommiegannert 3y ago

Seems the news here is just the study and approval for frostbite; nothing special about how it works? > Iloprost is a medication used to treat pulmonary arterial hypertension (PAH), scleroderma, Raynaud's phenomenon, frostbite, and other conditionss in which the blood vessels are constricted and blood cannot flow to the tissues. This damages the tissues and causes high blood pressure. Iloprost works by opening (dilating) the blood vessels to allow the blood to flow through again. https://en.wikipedia.org/wiki/Iloprost https://en.wikipedia.org/wiki/Iloprost

nxobject 3y ago

Surprisingly enough, the original trial took 12 years: > Between 1996 and 2008, we randomly assigned 47 patients (44 men and 3 women) with severe frostbite to one of three treatment regimens in an open-label study. Severe frostbite was defined as having at least one digit (finger or toe) with frostbite stage 3 (lesion extending just past the proximal phalanx) or stage 4 (lesion extending proximal to the metacarpal or metatarsal joint).4 The study was approved by the ethics committee at the University of Grenoble. Sadly, I'm curious to see how the business case (in America!) pans out – I wouldn't be surprised if the biggest cause of frostbite in the US is winter homelessness.

c22 3y ago
I keep some Narcan in my car and so far I've only given it to homeless people.
- Kerb_ 3y ago
  I think that likely has more to do with housed people not needing to be on the streets when they take their drugs and overdosing inside than it does with homeless people getting frostbite.
  - c22 3y ago
    It has nothing to do with frostbite except to demonstrate that there may still be a market for a product that is beneficial to homeless people even if the homeless themselves don't buy it. (The homeless, of course, may also be able to buy frostbite medicine, assuming it's cheaper than a house.)
    - nxobject 3y ago
      It might be that public money might end up buying it for disaster response, in the same way that Narcan's being bought by municipalities etc., rather than people. (Considering that this was shepherded through orphan drug programs, it wouldn't be the first time this was subsidized by public money.) That being said, the price of Narcan's heavily dropped since it became generic – I remember when Narcan was either distributed in vials and IM injection training was required, or nasal spray packaging was a lot more expensive.

reisse 3y ago

Wonder why it took so long for FDA. Seems it was used elsewhere (I've found reports from EU and Nepal) for treating frostbites at least a decade.

pfdietz 3y ago

I really wouldn't want to lose appendages from frostbite, so this sounds great. The first treatment addressing lack toes intolerance.

subpixel 3y ago

Anectdote: I got mild frostbite twenty years bc I was unprepared for a Fall hike in the Adirondacks. It still makes me miserable - when other people feel a nip of cold my fingers are pulsing with pain. I have to be really careful in winter not to expose my hands to frigid air skiing etc, it sucks.