Earlier quoted context omitted.
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?
The FDA does not accept any studies conducted overseas as clinical evidence. They request studies to contain at least 50% US citizens and be analyzed by US certified physicians. Now whether that leads to better outcomes or is just a protectionist measure for the local industry is anyone’s guess. A bit of both, I would imagine.
A rash of nearly lethal mushroom poisonings in Ohio
231–240 of 311 posts
Re: A rash of nearly lethal mushroom poisonings in Ohio
#232Earlier quoted context omitted.
"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, thes…
There's a difference between measuring safety against morning sickness in pregnant women and a drug that literally saves your life Drug safety is important but I think we can agree you can't beat the alternative in the case of poison antidote
Re: A rash of nearly lethal mushroom poisonings in Ohio
#233Re: A rash of nearly lethal mushroom poisonings in Ohio
#234Earlier quoted context omitted.
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'd trust European data more than , say chinese or pakistani data. However, that kind of exclusivity is politically untenable.
Re: A rash of nearly lethal mushroom poisonings in Ohio
#235Earlier quoted context omitted.
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?
"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…
Re: A rash of nearly lethal mushroom poisonings in Ohio
#236Since 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. ... Th…
Re: A rash of nearly lethal mushroom poisonings in Ohio
#237I'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?)…
It's maddening to me that Melzer's reagent, which is commonly used in identification for microscopic inspection of fungi, is a controlled substance.
Re: A rash of nearly lethal mushroom poisonings in Ohio
#238> When the app matched his photos of the backyard mushrooms with an edible species, [...] it almost killed him. Now there's an app that'd have to be designed very conscientiously.
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.
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...
Re: A rash of nearly lethal mushroom poisonings in Ohio
#239Since 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. ... Th…
I guess FDA only understands the urgency only if you have money and power.
Re: A rash of nearly lethal mushroom poisonings in Ohio
#240I never understood why people don't just eat store bought mushrooms. Why risk liver failure and other serious health complications not to mention countless hours of hospital time over something as trivial as eating wild mushrooms. Why not teach in school explicitly to not eat wild mushrooms and may be teach how to farm safe varieties if someone desperately needs to eat their own picked ones.
It's trivially easy to avoid toxic species, though. If you put in a tiny amount of effort into learning and limit yourself to thinks without toxic lookalikes (or put in more effort into learning), you are not risking liver failure and hospital time.