4 ms·
"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.
by roywiggins 4y ago
"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?
- BurningFrog 4y agoSure, a rational version of FDA would accept it based on EU approval data. But that's not the FDA we have.
- ratsmack 4y agoWith the FDA, you need to follow the money.
- bee_rider 4y agoDid you? Where did it lead?
- junofan 4y agoIt’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.
- BurningFrog 4y agoInteresting! Haven't heard that before, but it does make sense.
- ratsmack 4y agoThere are many paths: https://mises.org/wire/legacy-corruption-fda-and-big-pharma https://mises.org/wire/legacy-corruption-fda-and-big-pharma
- refurb 4y agoYou 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?
- BurningFrog 4y agoThe fact that the only example you have is 60 years old makes this a terrible argument.
- refurb 4y ago10 years ago better? It was on the market between 1976 and 2009, and is thought to have caused between 500 and 2,000 deaths. https://en.m.wikipedia.org/wiki/Benfluorex https://en.m.wikipedia.org/wiki/Benfluorex
- BurningFrog 4y agoSure, that's more serious. It's true that the "European FDA" sometimes approves things they have to recall later. But the American FDA also does that. Only rejecting by all medications can you avoid that. My thought is that medical science works the same way in Europe as in the US, so if it was a scientific matter, approvals would be "portable". I think a model that explains things better is that the approvals are political/regulatory. And I wish the were scientific.