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A rash of nearly lethal mushroom poisonings in Ohio

cleveland.com

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Re: A rash of nearly lethal mushroom poisonings in Ohio

#261

Post by rosnd »

boppo1 wrote: post #188
derefr wrote: post #135

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?

I'd trust European data more than , say chinese or pakistani data. However, that kind of exclusivity is politically untenable.

How would that be politically untenable? There are tons of similar situations.

Similar rules are applied to passports and driving licenses too, some countries are trusted more than others.

Re: A rash of nearly lethal mushroom poisonings in Ohio

#262

Post by s1artibartfast »

Aloha wrote: post #130
nkurz wrote: post #44

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. ... Th…

"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…

>I think there should be a conditional use waiver program that allows these drugs to be in the field.

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?

Re: A rash of nearly lethal mushroom poisonings in Ohio

#263

Post by oldgradstudent »

raverbashing wrote: post #228
Aloha wrote: post #130

Earlier 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

> There's a difference between measuring safety against morning sickness in pregnant women and a drug that literally saves your life

That's why the FDA approves chemotherapies for cancer. Safety is always relative to the condition being treated.

> Drug safety is important but I think we can agree you can't beat the alternative in the case of poison antidote

Only 40% die or require a liver transplant. You need a treatment that would not make things even worse.

Re: A rash of nearly lethal mushroom poisonings in Ohio

#264

Post by s1artibartfast »

naasking wrote: post #258
s1artibartfast wrote: post #257

Earlier quoted context omitted.

Which is why the FDA allows it for patients who will have consumed the mushrooms. The paperwork is to show the patient is going to die anyways, and doesnt just have a trivial problem.

I think you're dramatically underselling how complicated and slow this "paperwork" really is. People on their death bed don't have the luxury of bureaucratic approval processes.

I understand full well how complicated it is. Speed is the challenge, not the lack of a process for this type of situation. Unfortunately, it is a hard one.

Re: A rash of nearly lethal mushroom poisonings in Ohio

#265

Post by naasking »

oldgradstudent wrote: post #260
naasking wrote: post #256

Earlier quoted context omitted.

> Incidentally, these protections exist because of several breakdowns in drug safety in the past, notably Elixir sulfanilamide and Thalidomide. Those protections are immaterial when the patient is going to die anyway.

> Those protections are immaterial when the patient is going to die anyway. Only 40% are going to die or require a liver transplant. There is no a-priori reason to assume it won't make things even worse. We have the recent experience of the early months of Covid. In retrospect, it is quite evident that over treatment, especially aggressive intubation and experimental drugs, caused more harm than good. The question is…

> The question is always whether the proposed treatment is safe and effective. Safety, of course, should be relative to the condition being treated.

Right, which is why the doctors actually treating the patient should be free to make judgment calls without a bureaucrat looking over their shoulder.

Re: A rash of nearly lethal mushroom poisonings in Ohio

#266

Post by s1artibartfast »

sacrosancty wrote: post #186
inkblotuniverse wrote: post #108

Earlier quoted context omitted.

Keeping emergency stocks of rarely-used drugs is fine, but you don't have to make it illegal for anyone else to stock that drug to accomplish that.

Isn't the whole idea of requiring FDA approval to protect patients from harmful or ineffective drugs? If having and administering whatever drugs you wanted was legal, then how can anyone be protected? No doubt, they're still getting around to approving it but are just too slow and have this exception process precisely to save people's lives until they get it done properly.

Manufacturers, ask the FDA for approval. The FDA doesn't just go around approving drugs. surprisingly, I guess this is a common misunderstanding.

Re: A rash of nearly lethal mushroom poisonings in Ohio

#267

Post by ohbleek »

yonaguska wrote: post #251
derefr wrote: post #135

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 cynic in me says that the FDA wants the company that makes the drug to put up the money for the studies, they won't do it for free and without any possibilities of kickbacks.

Well the FDA doesn’t conduct clinical trials. So they also can’t get kickbacks for doing them.

Re: A rash of nearly lethal mushroom poisonings in Ohio

#268

Post by hinkley »

ehecatl42 wrote: post #197
hinkley wrote: post #101

Earlier quoted context omitted.

Or like the cancer drug from yews takes something like a handful of trees per patient. You’re not just gonna chew on few cubic feet of bark.

That will kill you. Taxus baccata is highly toxic... “slips of yew, silvered in the moon's eclipse” and all that.

I should have said “took” as I learned recently that they now synthesize the chemical directly.

You often have to leach something out of a plant to get to the good stuff without damaging your liver of kidneys with the bad stuff.

Re: A rash of nearly lethal mushroom poisonings in Ohio

#269

Post by ohbleek »

bonoboTP wrote: post #227
dmitrybrant wrote: post #69

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?)…

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…

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.

Re: A rash of nearly lethal mushroom poisonings in Ohio

#270

Post by s1artibartfast »

junofan wrote: post #243
quickthrower2 wrote: post #236

Earlier quoted context omitted.

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.

The FDA’s mandate is to evaluate marketing claims, not optimize for saving lives.

This is correct, The FDA does not seek out and approve drugs. It reviews applications for approval.
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