Since no one has done it yet, I'll ask the obvious question about the FDA: how many people die or need a liver transplant each year because the FDA is being unreasonable here?
Here's some quotes from the article:
Approximately 40% of people who ingest the deadly Amanita mushrooms die or require a liver transplant, according to Dr. Pierre Gholam, the liver specialist at University Hospitals who treated Hickman.
...
They immediately began preparing an application to the FDA for the emergency use of an investigational antidote – that if administered within 72 hours of ingestion can prevent liver damage and death in almost every patient who receives it.
The drug, called Silibinin, is derived from the milk thistle plant and given intravenously. It has been available in Europe for over 30 years, but here in the United States it has yet to be approved by the FDA, so it is not stocked in hospitals or pharmacies.
The result is that in order to obtain it for patients, an emergency use application must be submitted to the FDA for every patient who needs it, after which it is flown in by courier directly from the FDA laboratory in Philadelphia.
“This literally takes an army of people working after hours,” said Gholam. “There are tireless, really unsung heroes at the UH research office who make this happen for every patient – they have to do this over and over and over.” Forty-seven times in the last 10 years to be exact.
The biggest enemy in this process, says Gholam, is time. If the drug is administered after the 72-hour window closes, the chances of a full recovery drop dramatically.
Making licensed physicians jump through these hoops while risking their patients lives should be a criminal offense. Yes, it's great that this particular patient survived, but there needs to be a better cost benefit analysis for drug approval. Almost certainly, there are patients who have suffered permanent damage or death because of the difficulty of obtaining this drug. What benefit is there to making this drug so hard to get? How many people miss the time window because of these requirements? How safe does a drug need to be if result of not getting it is a 40% chance of death or a liver transplant?
"Gholam says that the process of FDA approval for Silibinin is slow, primarily because it only works for amatoxin poisoning, from the Amanita mushroom species. Those poisonings are rare – so gathering enough data to satisfy the safety and efficacy requirements of the FDA takes time. And there is little financial incentive by the company that owns the drug to invest in its research and development."
Incidentally, these protections exist because of several breakdowns in drug safety in the past, notably Elixir sulfanilamide and Thalidomide.
I'm not suggesting that there should be no improvements, I think there should be a conditional use waiver program that allows these drugs to be in the field. But suggesting that it should be criminal that it's not is over the top moralizing and provocation of outrage for little return.
My question is: why does the FDA need to (get domestic pharma companies to) conduct its own studies here? If the drug has been used in Europe for 30 years, presumably there are 30 years of evidence in European clinical practice that can be used as evidence. Maybe even existing meta-analyses of said evidence in European medical journals. Why isn't that sufficient?
I think Thalidomide is exactly the wrong reason to not approve drugs like Silibinin and what is wrong with the drug system. Yes, it was a huge scandal. But we are not talking about a drung for general usage, especially not for taking as a healthy person. There should be entirely different approval paths for drugs which are to be taken in a live-and-death situation. Which can be clearly diagnosed. Especially, if it also has been approved and used for a long time in the EU.
>And there is little financial incentive by the company that owns the drug to invest in its research and development.
This is the real reason it hasn't been approved. If only we had some kind of system in place where profit wasn't the main, and often only, motivator for getting life-saving medications approved by the FDA.
> Those poisonings are rare – so gathering enough data to satisfy the safety and efficacy requirements of the FDA takes time.
Since we're talking about something that cause death or liver transplant to such an enormous proportion of the patients (for efficiency, you just need a sample of 6 cases to get a result with p<0.05).
Safety certifications tend to be blanket 'this thing is safe to treat this disease' things.
Whereas they should be 'in the last 10 years, 100 people were treated with this drug and 27% survived. 71 were not treated with the drug and 1% survived. You use your professional judgement to decide if it is suitable for your patient'.
The FDA shouldn't be doing blanket approvals or bans. They should be making the information available for medical professionals to make the decision themselves.
Maybe this is the only way to reliably make available a drug that is used nationwide on average less than 5 times a year? Most hospitals wouldn’t stock a drug that they’d likely never use.
By keeping stock centralized at the FDA they can keep enough on hand and rubber stamp the exception.
Without wanting to be callous, 47 people in 10 years, then look at common cold, flu, covid etc. It should be very low on the priority list if you optimise for saving lives.
> despite its several beneficial effects on the liver, silibinin and all the other compounds found in silymarin, especially silychristin seem to act as potent disruptors of the thyroid system by blocking the MCT8 transporter. The long term intake of silymarin can lead to some form of thyroid disease and if taken during pregnancy, silymarin can cause the development of the Allan–Herndon–Dudley syndrome. Although this information is not being taken into consideration by all regulatory bodies, several studies now consider silymarin and especially silychristin to be important inhibitors of the MCT8 transporter and a potential disruptor of the thyroid hormone functions. (From Wikipedia)
The funny thing is that 100 mg of Silybi mariani fructus extactum siccum is OTC in Poland used for liver problems that people might have after ingesting a heavy meal.
And it's been for decades without any safety issues.
Granted that in cases of mushroom poisoning it's given only in hospital setting probably through IV, probably in much higher doses.
But those people would die without it. Any reasonable safety profile of this drug is better than safety profile of untreated deathcap poisoning.
> This literally takes an army of people working after hours,” said Gholam. “There are tireless, really unsung heroes at the UH research office who make this happen for every patient – they have to do this over and over and over.” Forty-seven times in the last 10 years to be exact.
Ohh, the poor guys have to hand in 4.7 forms per year to get access to an unapproved medicine they need.
I would've thought it was satire, but it seems you're serious? Amazing.
Oh, no, the amazing person is definitely you here.
Here's a life-saving drug that US pharmacists (only) are not allowed to stock; a drug that saves lives but only if given in a small time windows; and to get this drug you need to fill out a form and simply hope that someone happens to be working at whatever time you start to die.
And here you are, making fun of people who think this is a ridiculous idea!
Why is something that's been approved in Europe for 30 years still waiting for FDA approval in the first place?
If they issue the medication immediately after the form is submitted, without further inquiry or scrutiny (which is actually good in the case of something this urgent), why are they even bothering keeping it under such lock and key anyway?
That's what would sound like satire to anyone without an unflinching faith in the importance of a nanny state.
FDA will consider real world data and real world evidence in regulatory decision making. If this has been in use in the EU for 30 years, then where is the data?
Robert Califf (FDA commissioner) has a funny saying, “In God we trust. All others must bring data.”
It's not criminal to be cautious about approving drugs. Remember the people affected have purposely eaten a wild mushroom -- they risked their own lives first.
It should be criminal given the immense harm that it causes. The FDA’s single minded obsession with liability holds back medical advances that could save lives.
Well, given they were injecting untested and unproven SARS-CoV-2 "vaccine" which wasn't even a vaccine till they changed the definition, they could do a traditional medicine plant despite the mild toxicity and the absence of other clinical evidence...
But why FDA is to blame? Just get it from nearby euro-drugstore and do your unlicensed fix.
"derived from the milk thistle plant" likely involves more than just "eat some powered plant"; Wikipedia seems to indicate it involves more purification steps than the supplement form of things.
I've been foraging mushrooms for 30+ years, and I triple-check every single specimen before cooking it. The idea of a novice forager using an app to identify mushrooms is... unconscionable! Like... breathtakingly stupid.
I've commented on this before, but it continues to baffle me how poorly-educated our public is about wild plants, berries, and mushrooms. And stories like this just perpetuate the fear (and stigma?) around foraging, when in fact there's a whole universe of flavors and textures to be had from wild mushrooms that are simply better, and more fun, than the grocery store.
Now I wonder if this thing only exists in Hungary, but here there are lots of mushroom checking stations, typically near markets, where an expert checks your bag of mushrooms. They have an official license from the food safety authority and there is a central register for these mushroom experts.
My dad always brought the stuff we picked there, it was close by enough and it's just a totally normal thing here.
I would imagine it would be a nightmare to do this in the US due to legal liabilities.
I can confirm that we do not have such a thing in the US. I wonder how this began in Hungary. I’m sure plenty of mycologists would be eager to have this kind of role in the US.
> The idea of a novice forager using an app to identify mushrooms is... unconscionable! Like... breathtakingly stupid.
Out of curiosity, have you used any of the apps?
They're really good at flora, and include identification of fungi because they are outdoors and attached to soil and flora. They greatly amplify the most passive and casual interest to something far beyond the tools employed professionals would have. Even the state (but thats a low bar, admittedly).
But the identification isn't for eating things. But knowing that people do that, and for mushrooms I would say there is a case for a warning label in the apps, after positive identification of some things.
So to be clear the app didnt say it was edible or makes any recommendations about eating them, it only said it potentially looks like its from a family of mushrooms which the author found out included edible mushrooms.
Technically the person themselves made the leap to calling it edible.
Although it wouldn’t hurt for the flora identification app to have warnings about not eating things unless you’re very certain and have expertise on the subject. Or make it clear it’s a well informed guess not a perfect identification.
I've used the apps for both flora and mushrooms, and they're much worse at mushroom identification. I always tell beginners to, at most, use an app to figure out where in an ID book to start looking.
Curiosity: do you find that you (at 30+ years) are so good at identification in the wild that you don’t find any “bad” specimens once you get them home, or do you still catch some outliers where you needed to look at them more closely? Or does the process involve taking them home for closer examination?
To be honest I don't recall the last time I've ever accidentally picked up a poisonous specimen along with the good ones I was intending to pick. At this point it's such second-nature that telling apart an edible vs. poisonous mushroom is like telling a bottle of milk from a bottle of Drano.
And yet I still examine each one at home before putting it in the pot.
The other thing is that the truly deadly varieties, such as the subject of this article - Amanita phalloides, are really not that hard to avoid. When you're a novice forager, there are plenty of varieties that don't look remotely like Amanita, and are much easier to differentiate.
There are some hardcore foragers who even consume certain varieties of Amanita (some of which are edible!), but to me this would be too much of a hassle, since it would involve spore prints and maybe even microscopy of the spores to be absolutely sure.
"Old school" foragers typically stick to a few mushrooms to be safe. Meaning, they have quite an expertise on 3 or 4 kinds of mushrooms (or, even more likely, just a couple of them) and are staying away from anything else, especially, if there is a similar, poisonous mushroom. (At least, this is what all I happen to know are doing.) Also, if you aren't 100% confident, stay away from it. (And there is the real problem with apps, since lack of confidence is the entire raison d'être of these apps.)
I've only eaten wild mushrooms once. They were picked by a friend I trusted who had been picking them for 20+ years, and he ate them at the same time I did.
He damn sure was not using an app on his phone to identify them.
I do hunt mushrooms occasionally, and an app is useful if you understand the limitations. If the app gives you a name, the next thing to do is consult a mushroom book to learn if there is a risk of mixups with poisenous species.
In Western Europe, for instance, there is are edible wild champignons that are very similar “groene knol ameniet”, which is deadly.
I recently read that fatalities are on the rise because east europeans that migrate here look for wild champignons but do not know about the poisenous lookalike: it does not grow in the forests they grew up in.
Every region has some mushrooms species that you can learn to easily recognize and that don’t have “evil twins”. You should be aware that this varies by area.
So apps can be a useful tool but a good book that covers the region where you pluck is essential.
Actually gathering mushrooms is not about the taste. It’s about the process. Like hunt, but without killing any animal, or like fishing but without killing any fish. There is a nice book about this aspect of mushroom gathering, The Third Hunt by Vladimir Soloukhin:
I agree with the thread-starter that some actions look incredibly stupid, like an attempt to eat something similar to Amanita (indeed, no taste is worth the risk) or the belief that there any no deadly mushrooms in any given place on the planet. Exclusion first - as kids we were allowed to touch Boletuses only, and then some distinct non-boletuses that have no poisonous lookalikes.
But the described actions are not actually stupidity if you think about it. It’s an attempt to do something that can be done safely only if you are immersed in a culture that preserve and cherish knowledge on this subject and promotes safe indulgement in related pleasures.
We can respect all cultures, probably. But to gather and eat mushrooms safely you should follow (not necessarily) a culture you have grown up in but culture of people or groups who know how to do it safely.
Depends. Certain varieties like penny bun can taste superb, and in most areas you're extremely unlikely to confuse them with anything poisonous or even inedible.
There's no risk to eating many carefully foraged mushrooms. Many of them have no toxic lookalikes, or are so easily distinguished that the risk is essentially zero.
It's cultural knowledge passed down through generations. Mushroom foraging is super popular in Russia and other Slavic countries, and my grandmother taught me most of the fundamentals before we immigrated to the US, and I continued to study field guide books on my own.
When you get to know the specific bits of anatomy of the mushroom body, the trees with which they're symbiotic, the seasons in which they occur, etc., then identifying different varieties becomes as clear as identifying a baseball vs. a tennis ball.
books with photos, very in-depth descriptions, pictures and descriptions sent to friends who also forage, and when all else fails, spore samples.
I've only had to make it to spore samples 6-7 times because I couldn't identify with the first three methods. I will note that I never ate any of the ones I took spore samples of - because I was then able to correctly identify them as poisonous (or close enough that I wasn't willing to take the chance).
Just go after a specific kind of mushroom and one that doesn’t have any close lookalikes and it’s very easy to safely pick mushrooms. Next level up from picking a single one is to pick a few known kinds which all have distinct features that can’t be confused with others.
I pick only boletus, chanterellus (which has a bad lookalike in North America but it’s not really that close and where I am in Europe there is no really poisonous lookalike at all). Even easier late in autumn when you can pick various cratherellus and there are almost no other mushrooms at all.
Yes, but not one I worry about. It’s both not known to be very poisonous (it’s surely eaten quite a lot) and it’s very easily distinguished from the real thing.
I'm from Ohio, and even before the apps, it was common to hear stories about people being poisoned by mushrooms. It's also relatively well known (though not well enough, obviously) that there are several species of toxic mushrooms that look nearly identical to edible ones. Perhaps people think an app is going to be infallible. I really think app stores ought to pull any mushroom-identifying app that doesn't come with a prominent warning. I live in Hungary now. Here we have mushroom identification centers at the local markets where we can bring mushrooms collected in the wild to be identified by professional mycologists. Maybe Ohio needs this as well.
I'm no fan of the FDA, but it's worth noting Europeans said the same about thalidomide and thankfully America didn't listen.
In 1960, Kelsey was hired by the FDA in Washington, D.C. At that time, she "was one of only seven full-time and four young part-time physicians reviewing drugs"[4] for the FDA. One of her first assignments at the FDA was to review an application by Richardson-Merrell for the drug thalidomide (under the tradename Kevadon) as a tranquilizer and painkiller with specific indications to prescribe the drug to pregnant women for morning sickness. Although it had been previously approved in Canada and more than 20 European and African countries,[8] she withheld approval for the drug and requested further studies.[3] Despite pressure from thalidomide's manufacturer Grünenthal, Kelsey persisted in requesting additional information to explain an English study that documented peripheral neuritis,[9] a nervous system side effect.[4] She also requested data showing the drug was not harmful to the fetus.[9]
Kelsey's insistence that the drug should be fully tested prior to approval was vindicated when the births of deformed infants in Europe were linked to thalidomide ingestion by their mothers during pregnancy.[10][11] Researchers discovered that the thalidomide crossed the placental barrier and caused serious birth defects.[7]
This is why America does independent review of results obtained from Europe.
Silibinin is the active ingredient in milk thistle, a supplement available at almost any health food store. Do doctors not know this or are they just letting people die rather than prescribe an OTC nutraceutical? Or is there some reason it absolutely must be delivered intravenously? That seems unlikely since it is orally bioavailable.
Edit: I found this, which suggests that it should work in theory, but intense vomiting from the poisoning probably makes it not possible to take a large dose orally: http://bayareamushrooms.org/poisonings/silymarin.html
OTC supplements in the U.S. are also notoriously under-regulated. Impurities and false labeling abound. I don't see a medical professional using them for a critically ill patient if there is a viable alternative. In fact supplements already cause 20% of liver failures nationwide: https://www.consumerreports.org/health/liver-damage-from-sup...
Some time ago, I somehow ran into a YouTuber who talks about foraging in the UK talking about how effective these apps are[1]. Each one of them misidentified at least one plant, and two of three gave incorrect (or misleading) results for the deadly plant he tested.
However he made the very interesting point that having an app tell you if something is edible is a completely incorrect starting point for foraging because the main thing you get from using a reference book is that you are forced to notice that there are many plants that may look similar but are different (meaning you are more aware that your task is more about differentiation than identification, since botany is a bit fuzzy around the edges) and might seriously differ in their toxicity. None of these apps have a feature to say "it looks like this edible plant but if the angle you took the photo from was slightly off, it's definitely poisonous because the group of plants that look like this only only one or two edible members and everything else will definitely kill you". Some list confidence percentages but there were examples where the percentages were far too pessimistic or optimistic for a certain match, making them not particularly useful.
My impression is that these apps are developed using the same "move fast and break things" model as most other things these days, which definitely seems like the best model to use when making an app that may or may not lead to people's deaths (not your fault of course, because you waived all liability in your ToS). /s
Wow. Who would take the liability of an app such as this? Regardless of how many disclaimers you'd have to agree to I could easily see a jury holding the creator of the app liable for a horrible death like that.
I dunno, watching the video linked by this use [0], I think the apps (aside from Google Lens) do a fairly okay job of being clear that they aren't as sure on their identification and that they're about casualness, not "safe to eat or not safe to eat."
While the article cites some persons who ate poisonous mushrooms because an app said they weren't poisonous, ultimately it will come down to "Did the app sell itself as telling you what's safe to eat and what's not?"
From the video, I'm particularly harsh towards Google on this as it doesn't seem to include the confidence level or analysis process and instead focused on showing a result and even trying to sell you something based on the result. This does seem like it's the wrong approach that will get people killed, with thoughts like "well Google thinks it's this, and it's even trying to sell me some, so must be okay."
For the others, you can see warnings in the apps about eating identified stuff, you can see how confident it is in the analysis, and they at least appear to be considering things like the region you're in when making an analysis.
I think it would be fairly defensible based on the warnings and preparation that a reasonable person would not be expected to take the identification as a go-ahead to eat something. That unreasonable persons take unreasonable actions as a result of these apps wouldn't really change the legal interpretation, but of course maybe it can be persuasive in other directions.
At first I shared the same opinion as you that these are dangerous apps, but watching what the apps do in the linked video, the non-google ones are actually pretty acceptable in my opinion. I would prefer they include a few more warnings though when there is low confidence matching or when there is conflicting matching just to remind the person using the app "hey, btw, a lot of plants can kill you. Don't eat this, I'm just an app."
It's literally part of the iphone camera, if you weren't aware. Not disagreeing with you, but acknowledging that it's pretty hard to prevent these apps with how accessible machine learning is today, despite accuracy still being difficult for many things.
Most plant ID apps have a disclaimer saying that you should never eat anything that you use the app to identify. Seek reminds you every time you open the camera.
They're mostly intended as entertainment, but some of them use the data to analyze where species are growing in realtime.
Even if that does waive their legal liability (which I'm not sure it does), there is a moral obligation to try to not endanger the many people that the app developers know are going to disregard that warning. It would be intellectually dishonest for the developers of such apps to pretend that everyone who uses their app actually obeys that warning (there are plenty of YouTube videos instructing people to forage for things using these apps).
The plant app I use [0] gives a percentage confidence rather than saying "this is definitely X or Y". I've found it pretty accurate on the various plants and trees I've used it to ID. But I limit my foraging to nuts and berries I already know and generally only use the app to increase my recognition factor of what else grows around me.
I do like mushrooms but I think it's just a step too far into 'Russian Roulette' territory to risk trying to forage for those. Eating something which might make you sick for a day or two is one thing. But risking eating something which might kill you or require a liver transplant, if you get it wrong, is a bit too scary for me. The only mushroom I'm confident in my ability to ID is psilocybin.
Honestly though there should be limits to the amount that a disclaimer should be able to protect you when your product advises people to do dangerous things you know (or have every responsibility to know) could be lethal.
There’s a lot of room between a one in a billion mistake that hurts somebody and a fifty fifty chance a mushroom is poisonous. There are plenty of edible vs deadly mushrooms that only have incredibly subtle differences that you should trust nobody but a human expert to identify.
Effectively what I’m saying is a disclaimer shouldn’t be able to get you out of murder charges for a game of Russian roulette.
And this is why we can't have nice things. This opinion is wild to me. You do not trust a consumer app with life and death decisions, especially over something where the potential upside is getting to eat a mushroom you found and the potential downside is death. Making more criminals is not the answer.
Yeah that seems like a huge oversight. Every mushroom field guide book ive seen very specifically called out any potential look-a-likes for edible mushrooms and gave extra warning on mushrooms that are particularly difficult to positively identify.
Instead of a general mushroom identification app, it could be a poisonous mushroom identification app. The dataset would only include poisonous mushrooms, and it will be made clear that it is not exhaustive. This could be useful to rule out some mushrooms.
"Gholam says that the process of FDA approval for Silibinin is slow, primarily because it only works for amatoxin poisoning, from the Amanita mushroom species. Those poisonings are rare – so gathering enough data to satisfy the safety and efficacy requirements of the FDA takes time."
Okay, but there must be data, since the EU approved it based on something, right?
You mean like when Europe approved thalidomide but the US said “just because they approved it isn’t good enough” and saved tens of thousands of babies from birth defects?
If there's one thing I've learned in my life about mushrooms, it's that there are way, way more varieties than you think, and for any 1 there are 20 that look the same.
I used to hang out on r/mycology, and even experts would ask tons of questions before even making a guess.
There's no way in hell an app can do this reliably, and while I hate to say it, I hope people sue them into oblivion. This isn't something benign like hotdog or not, or bird ID. This has fatal consequences...
Readit News
Here's some quotes from the article:
Approximately 40% of people who ingest the deadly Amanita mushrooms die or require a liver transplant, according to Dr. Pierre Gholam, the liver specialist at University Hospitals who treated Hickman.
...
They immediately began preparing an application to the FDA for the emergency use of an investigational antidote – that if administered within 72 hours of ingestion can prevent liver damage and death in almost every patient who receives it.
The drug, called Silibinin, is derived from the milk thistle plant and given intravenously. It has been available in Europe for over 30 years, but here in the United States it has yet to be approved by the FDA, so it is not stocked in hospitals or pharmacies.
The result is that in order to obtain it for patients, an emergency use application must be submitted to the FDA for every patient who needs it, after which it is flown in by courier directly from the FDA laboratory in Philadelphia.
“This literally takes an army of people working after hours,” said Gholam. “There are tireless, really unsung heroes at the UH research office who make this happen for every patient – they have to do this over and over and over.” Forty-seven times in the last 10 years to be exact.
The biggest enemy in this process, says Gholam, is time. If the drug is administered after the 72-hour window closes, the chances of a full recovery drop dramatically.
Making licensed physicians jump through these hoops while risking their patients lives should be a criminal offense. Yes, it's great that this particular patient survived, but there needs to be a better cost benefit analysis for drug approval. Almost certainly, there are patients who have suffered permanent damage or death because of the difficulty of obtaining this drug. What benefit is there to making this drug so hard to get? How many people miss the time window because of these requirements? How safe does a drug need to be if result of not getting it is a 40% chance of death or a liver transplant?
Incidentally, these protections exist because of several breakdowns in drug safety in the past, notably Elixir sulfanilamide and Thalidomide.
I'm not suggesting that there should be no improvements, I think there should be a conditional use waiver program that allows these drugs to be in the field. But suggesting that it should be criminal that it's not is over the top moralizing and provocation of outrage for little return.
Also, there are good reasons why this drug is restricted access too - https://en.wikipedia.org/wiki/Silibinin
Drug safety is important but I think we can agree you can't beat the alternative in the case of poison antidote
This is the real reason it hasn't been approved. If only we had some kind of system in place where profit wasn't the main, and often only, motivator for getting life-saving medications approved by the FDA.
Since we're talking about something that cause death or liver transplant to such an enormous proportion of the patients (for efficiency, you just need a sample of 6 cases to get a result with p<0.05).
There absolutely is. It is called an investigational drug application (AKA clinical trial).
There was a clinical trial running for Silibinin until the manufacturer stopped it in 2020
https://clinicaltrials.gov/ct2/show/NCT00915681
Perhaps this is an opportunity for doctors to conduct an investigator initiated trial?
Those protections are immaterial when the patient is going to die anyway.
Whereas they should be 'in the last 10 years, 100 people were treated with this drug and 27% survived. 71 were not treated with the drug and 1% survived. You use your professional judgement to decide if it is suitable for your patient'.
The FDA shouldn't be doing blanket approvals or bans. They should be making the information available for medical professionals to make the decision themselves.
By keeping stock centralized at the FDA they can keep enough on hand and rubber stamp the exception.
I guess emergency use would still be okay?
And it's been for decades without any safety issues.
Granted that in cases of mushroom poisoning it's given only in hospital setting probably through IV, probably in much higher doses.
But those people would die without it. Any reasonable safety profile of this drug is better than safety profile of untreated deathcap poisoning.
Deleted Comment
https://emj.bmj.com/content/33/1/76.2
Ohh, the poor guys have to hand in 4.7 forms per year to get access to an unapproved medicine they need.
I would've thought it was satire, but it seems you're serious? Amazing.
Here's a life-saving drug that US pharmacists (only) are not allowed to stock; a drug that saves lives but only if given in a small time windows; and to get this drug you need to fill out a form and simply hope that someone happens to be working at whatever time you start to die.
And here you are, making fun of people who think this is a ridiculous idea!
Who wrote this? Death?
If they issue the medication immediately after the form is submitted, without further inquiry or scrutiny (which is actually good in the case of something this urgent), why are they even bothering keeping it under such lock and key anyway?
That's what would sound like satire to anyone without an unflinching faith in the importance of a nanny state.
Robert Califf (FDA commissioner) has a funny saying, “In God we trust. All others must bring data.”
That would depend on whether it is effective. Is it?
Making a one-off decision that ends up with a bad outcome is no reason to punish someone further.
"Oh sorry. It was you that ran the red light. The other car that hit you is not at fault. We can't treat you. It was your decision."
Really?
But why FDA is to blame? Just get it from nearby euro-drugstore and do your unlicensed fix.
Dead Comment
I guess FDA only understands the urgency only if you have money and power.
I've commented on this before, but it continues to baffle me how poorly-educated our public is about wild plants, berries, and mushrooms. And stories like this just perpetuate the fear (and stigma?) around foraging, when in fact there's a whole universe of flavors and textures to be had from wild mushrooms that are simply better, and more fun, than the grocery store.
My dad always brought the stuff we picked there, it was close by enough and it's just a totally normal thing here.
I would imagine it would be a nightmare to do this in the US due to legal liabilities.
But if your grandma checks them, no need. :)
Out of curiosity, have you used any of the apps?
They're really good at flora, and include identification of fungi because they are outdoors and attached to soil and flora. They greatly amplify the most passive and casual interest to something far beyond the tools employed professionals would have. Even the state (but thats a low bar, admittedly).
But the identification isn't for eating things. But knowing that people do that, and for mushrooms I would say there is a case for a warning label in the apps, after positive identification of some things.
Technically the person themselves made the leap to calling it edible.
Although it wouldn’t hurt for the flora identification app to have warnings about not eating things unless you’re very certain and have expertise on the subject. Or make it clear it’s a well informed guess not a perfect identification.
The other thing is that the truly deadly varieties, such as the subject of this article - Amanita phalloides, are really not that hard to avoid. When you're a novice forager, there are plenty of varieties that don't look remotely like Amanita, and are much easier to differentiate.
There are some hardcore foragers who even consume certain varieties of Amanita (some of which are edible!), but to me this would be too much of a hassle, since it would involve spore prints and maybe even microscopy of the spores to be absolutely sure.
He damn sure was not using an app on his phone to identify them.
In Western Europe, for instance, there is are edible wild champignons that are very similar “groene knol ameniet”, which is deadly.
I recently read that fatalities are on the rise because east europeans that migrate here look for wild champignons but do not know about the poisenous lookalike: it does not grow in the forests they grew up in.
Every region has some mushrooms species that you can learn to easily recognize and that don’t have “evil twins”. You should be aware that this varies by area.
So apps can be a useful tool but a good book that covers the region where you pluck is essential.
It's not like they're chocolate.
https://www.nhbs.com/the-third-hunt-book
I agree with the thread-starter that some actions look incredibly stupid, like an attempt to eat something similar to Amanita (indeed, no taste is worth the risk) or the belief that there any no deadly mushrooms in any given place on the planet. Exclusion first - as kids we were allowed to touch Boletuses only, and then some distinct non-boletuses that have no poisonous lookalikes.
But the described actions are not actually stupidity if you think about it. It’s an attempt to do something that can be done safely only if you are immersed in a culture that preserve and cherish knowledge on this subject and promotes safe indulgement in related pleasures.
We can respect all cultures, probably. But to gather and eat mushrooms safely you should follow (not necessarily) a culture you have grown up in but culture of people or groups who know how to do it safely.
When you get to know the specific bits of anatomy of the mushroom body, the trees with which they're symbiotic, the seasons in which they occur, etc., then identifying different varieties becomes as clear as identifying a baseball vs. a tennis ball.
books with photos, very in-depth descriptions, pictures and descriptions sent to friends who also forage, and when all else fails, spore samples.
I've only had to make it to spore samples 6-7 times because I couldn't identify with the first three methods. I will note that I never ate any of the ones I took spore samples of - because I was then able to correctly identify them as poisonous (or close enough that I wasn't willing to take the chance).
I pick only boletus, chanterellus (which has a bad lookalike in North America but it’s not really that close and where I am in Europe there is no really poisonous lookalike at all). Even easier late in autumn when you can pick various cratherellus and there are almost no other mushrooms at all.
https://en.m.wikipedia.org/wiki/Hygrophoropsis_aurantiaca
It seems reckless and stupid to not immediately approve it given the impact.
Edit: I found this, which suggests that it should work in theory, but intense vomiting from the poisoning probably makes it not possible to take a large dose orally: http://bayareamushrooms.org/poisonings/silymarin.html
Now there's an app that'd have to be designed very conscientiously.
However he made the very interesting point that having an app tell you if something is edible is a completely incorrect starting point for foraging because the main thing you get from using a reference book is that you are forced to notice that there are many plants that may look similar but are different (meaning you are more aware that your task is more about differentiation than identification, since botany is a bit fuzzy around the edges) and might seriously differ in their toxicity. None of these apps have a feature to say "it looks like this edible plant but if the angle you took the photo from was slightly off, it's definitely poisonous because the group of plants that look like this only only one or two edible members and everything else will definitely kill you". Some list confidence percentages but there were examples where the percentages were far too pessimistic or optimistic for a certain match, making them not particularly useful.
My impression is that these apps are developed using the same "move fast and break things" model as most other things these days, which definitely seems like the best model to use when making an app that may or may not lead to people's deaths (not your fault of course, because you waived all liability in your ToS). /s
[1]: https://youtu.be/sjS0PgC9KSc
While the article cites some persons who ate poisonous mushrooms because an app said they weren't poisonous, ultimately it will come down to "Did the app sell itself as telling you what's safe to eat and what's not?"
From the video, I'm particularly harsh towards Google on this as it doesn't seem to include the confidence level or analysis process and instead focused on showing a result and even trying to sell you something based on the result. This does seem like it's the wrong approach that will get people killed, with thoughts like "well Google thinks it's this, and it's even trying to sell me some, so must be okay."
For the others, you can see warnings in the apps about eating identified stuff, you can see how confident it is in the analysis, and they at least appear to be considering things like the region you're in when making an analysis.
I think it would be fairly defensible based on the warnings and preparation that a reasonable person would not be expected to take the identification as a go-ahead to eat something. That unreasonable persons take unreasonable actions as a result of these apps wouldn't really change the legal interpretation, but of course maybe it can be persuasive in other directions.
At first I shared the same opinion as you that these are dangerous apps, but watching what the apps do in the linked video, the non-google ones are actually pretty acceptable in my opinion. I would prefer they include a few more warnings though when there is low confidence matching or when there is conflicting matching just to remind the person using the app "hey, btw, a lot of plants can kill you. Don't eat this, I'm just an app."
[0] - https://news.ycombinator.com/item?id=33220688
They're mostly intended as entertainment, but some of them use the data to analyze where species are growing in realtime.
I do like mushrooms but I think it's just a step too far into 'Russian Roulette' territory to risk trying to forage for those. Eating something which might make you sick for a day or two is one thing. But risking eating something which might kill you or require a liver transplant, if you get it wrong, is a bit too scary for me. The only mushroom I'm confident in my ability to ID is psilocybin.
[0] https://play.google.com/store/apps/details?id=com.floraincog...
There’s a lot of room between a one in a billion mistake that hurts somebody and a fifty fifty chance a mushroom is poisonous. There are plenty of edible vs deadly mushrooms that only have incredibly subtle differences that you should trust nobody but a human expert to identify.
Effectively what I’m saying is a disclaimer shouldn’t be able to get you out of murder charges for a game of Russian roulette.
I'll just stick to distinguishing a '67 from a '68 Mustang.
Okay, but there must be data, since the EU approved it based on something, right?
But that's not the FDA we have.
I used to hang out on r/mycology, and even experts would ask tons of questions before even making a guess.
There's no way in hell an app can do this reliably, and while I hate to say it, I hope people sue them into oblivion. This isn't something benign like hotdog or not, or bird ID. This has fatal consequences...