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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

#241

Post by pfdietz »

Matticus_Rex wrote: post #217
pfdietz wrote: post #66

Earlier quoted context omitted.

I know, right? What's the upside? Possibly interesting flavor. What's the downside. AGONY AND DEATH. Why is this even a question?

There's no risk of agony and death from foraging many edible species. If I'm foraging big orange pored shelf mushrooms, for example, my risk of death is zero. This is like saying "what's the upside of drugs when some of them kill you?!"

Yes, there is no risk if you know what you're doing.

But above that, the risk is that you have misestimated your level of "knowing what you're doing".

So, the sensible thing to do is make the cutoff at the point where the risk of that error is lowest. And that point is "is it a wild mushroom?"

Or you can just assume your knowledge is good enough and risk becoming a Dunning-Kruger statistic.

Re: A rash of nearly lethal mushroom poisonings in Ohio

#242

Post by junofan »

Aeolos wrote: post #180
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 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.

This is completely untrue. Foreign data may be used as the sole basis for marketing approval [1].

[1]: https://www.govinfo.gov/content/pkg/CFR-2006-title21-vol5/pd...

Re: A rash of nearly lethal mushroom poisonings in Ohio

#243

Post by junofan »

quickthrower2 wrote: post #236
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…

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.

Re: A rash of nearly lethal mushroom poisonings in Ohio

#244

Post by mhb »

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.

Fortunately, realpolitik can still prevail over wokeism in international affairs in which there are obvious life and death consequences.

Re: A rash of nearly lethal mushroom poisonings in Ohio

#245

Post by junofan »

bee_rider wrote: post #129
ratsmack wrote: post #122

Earlier quoted context omitted.

With the FDA, you need to follow the money.

Did you? Where did it lead?

It’s pretty well-known that a big reason there’s no cross-border approval pathway is that the FDA is partially funded by user fees.

Re: A rash of nearly lethal mushroom poisonings in Ohio

#246

Post by pigbearpig »

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…

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.

Re: A rash of nearly lethal mushroom poisonings in Ohio

#247

Post by pzone »

pigbearpig wrote: post #246
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…

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.

Re: A rash of nearly lethal mushroom poisonings in Ohio

#248

Post by chiefalchemist »

pigbearpig wrote: post #246
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…

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.

Not necessarily. Would a child know the risks?

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?

Re: A rash of nearly lethal mushroom poisonings in Ohio

#249

Post by s1artibartfast »

sokoloff wrote: post #234
boppo1 wrote: post #188

Earlier quoted context omitted.

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

I would imagine you could create a shared medicine treaty group and structure it with explicit membership qualifications and then a voting on membership and long enough delay to make the membership politically tenable.

It would be a very tough job to align the health and testing requirements for even the US and European countries

Re: A rash of nearly lethal mushroom poisonings in Ohio

#250

Post by BurningFrog »

refurb wrote: post #182
BurningFrog wrote: post #114

Earlier quoted context omitted.

Sure, a rational version of FDA would accept it based on EU approval data. But that's not the FDA we have.

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?

The fact that the only example you have is 60 years old makes this a terrible argument.
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