FDA Approves First Medication to Treat Severe Frostbite(fda.gov)

106 pointsby jyunwai2 tahun yang lalu22 comments

FDA Approves First Medication to Treat Severe Frostbite

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

23 comments

yellow_lead2 tahun yang lalu

> 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.

sidkshatriya2 tahun yang lalu

> 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-h2 tahun yang lalu

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

idontknowifican2 tahun yang lalu

this is why PrEP has no double blind study. it was considered unethical

A_D_E_P_T2 tahun yang lalu

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.

mlyle2 tahun yang lalu

3/32 vs 9/15 is -probably- a pretty big effect size, but I am not sure how you know that a priori without trying it on a couple dozen people first and comparing. They didn’t require huge n for approval, but it took a long time to just try it on a minimal number of patients.

fs_tab2 tahun yang lalu

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?

nxobject2 tahun yang lalu

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 tahun yang lalu

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

Kerb_2 tahun yang lalu

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.

c222 tahun yang lalu

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.)

nxobject2 tahun yang lalu

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.

tommiegannert2 tahun yang lalu

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

reisse2 tahun yang lalu

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.

subpixel2 tahun yang lalu

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.

pfdietz2 tahun yang lalu

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

The first treatment addressing lack toes intolerance.

Vecr2 tahun yang lalu

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.

Aurornis2 tahun yang lalu

> 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.

Vecr2 tahun yang lalu

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".

Intermernet2 tahun yang lalu

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 .

nulbyte2 tahun yang lalu

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.

Vecr2 tahun yang lalu

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

[deleted]2 tahun yang lalu