FDA Approves First Medication to Treat Severe Frostbite

https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-treat-severe-frostbite

by jyunwai • 2 years ago

106 22 2 years ago

Vecr3• 2 years 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• 2 years 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.

Vecr3• 2 years 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".

nulbyte• 2 years 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.

Vecr3• 2 years ago

It should be closer to casual than the simplest conditionalization you can do, right?

yellow_lead• 2 years 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• 2 years 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• 2 years 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• 2 years ago

The flip side is that it could have made things worse. Epistemology and ethics get complicated fast in this kind of thing:\

A_D_E_P_T• 2 years ago

In the future this sort of thing will inevitably be viewed the way we view bloodletting with razors and leeches -- if not more harshly. They didn't know any better, way back when. We ought to know better.

It's as simple as this: Double-blind, placebo-controlled studies are absolutely not required in drugs that are have extremely large effect sizes. In these cases, open-label trials, compassionate use programs, and post-marketing surveillance can be employed to continue gathering data on safety and efficacy without denying any patients access to critical treatments. And, in the end, the data you gather is just as useful, if not more useful.

tommiegannert• 2 years 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

nxobject2• 2 years 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.

c222• 2 years ago

I keep some Narcan in my car and so far I've only given it to homeless people.

Kerb_• 2 years 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.

reisse• 2 years 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• 2 years ago

I really wouldn't want to lose appendages from frostbite, so this sounds great.

The first treatment addressing lack toes intolerance.

subpixel• 2 years 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.

FDA Approves First Medication to Treat Severe Frostbite

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