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Yep. And then you have to breach a very ugly topic most people don't like to discuss. When does regulation kill more people by not having the $thing versus ha

Yep. And then you have to breach a very ugly topic most people don't like to discuss. When does regulation kill more people by not having the $thing versus having the $thing? And how many people would suffer complication/dying with the $thing? It's a very delicate balance, especially when you consider capitalist forces that encourage "move fast and break ~things~ people". The FDA is the chopping block for that... But also FDA overaction also kills people.

BurningFrog 8y ago
Right. The whole FDA system is set on the premise that inaction can cause no harm. This causes a lot of harm.
hopler 8y ago
For every suction pump and super glue getting held up by regulation, there is also a witch doctor or snake oil. People love to talk about the clever hacks in some poor country, but not the high cost in QALY of superstitious or scam practices. Since no one is clamoring to wholseale trade USA healthcare for India's, there are obviously done tradeoffs.
throwaway5752 8y ago
"Though FDA can trace its origins back to the creation of the Agricultural Division in the Patent Office in 1848, its origins as a federal consumer protection agency began with the passage of the 1906 Pure Food and Drugs Act. This law was the culmination of about 100 bills over a quarter-century that aimed to rein in long-standing, serious abuses in the consumer product marketplace." I have no personal doubt that the FDA has saved millions of lives in the US and internationally, and the balance of harm/good they have caused would would make the harm side look infinitesimally small. Also... I be interested in what cases you know that the FDA caused the deaths of people by overaction. There are people out there with axes to grind who thought they were going to get rich with some drug or device, who couldn't subsequently prove the safety and/or efficacy of their product.
- silotis 8y ago
  The FDA's drug approval criteria are extremely strict. Ask anyone who works in pharma and they can probably name at least a couple of drugs which showed great promise but got axed by the FDA on dubious grounds. A classic example is Aspirin. We know from over a hundred years of experience that Aspirin is a widely useful and relatively safe drug, but if it were discovered today the FDA would never allow it to market, let alone approve it for OTC sales. Aspirin's mechanism of action is far too broad and the gastrointestinal side effects alone would be considered grounds for rejection.
  - throwaway5752 8y ago
    Perhaps if you dropped a few more specific examples would could talk about their issues instead of in generalities, instead of Aspirin? I was going to reply in my own words, but will instead yield to this retired FDA compliance officer: https://www.quora.com/Would-aspirin-be-approved-by-the-FDA-today https://www.quora.com/Would-aspirin-be-approved-by-the-FDA-t...
- Symmetry 8y ago
  So, the food regulation side of the FDA's activities have certainly saved millions of lives and probably swamp what the FDA does in terms of drug regulations. But generally new drugs tend to be rolled out gradually, doctors hear about disasters, and I'd be surprised if the FDA saved more than a thousand lives a year at most. On the other hand a bad call in disallowing new medicines can have very bad consequences. The FDA only allowed the use of beta blockers in the US about a decade after they came into use in Europe which probably cost something on the order of 100,000 excess deaths. Those early beta blockers did have serious problems and the FDA's decision also probably saved 1,000 people from liver failure after taking those drugs but I don't think that justified withholding the category until a liver-safe version was made. These days the FDA is less strict than it was in the 1960s and has certainly improved. But we can still do better to move more in the direction of European style regulation where they have a dozen competing EpiPen equivalents.
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Shorel 8y ago
This can only be known after the fact. To complain about "this obvious treatment that obviously works but regulations delayed for 10 years", is as valid as to complain about "this obviously flawed treatment that kills one person out of ten people and killed my husband, because obviously not enough testing was done". The error in both complains is to assume that the answer was in anyway obvious. It was not. It almost never is. I agree with you, totally. I just wanted to emphasize that point.

BurningFrog 8y ago

Right. The whole FDA system is set on the premise that inaction can cause no harm. This causes a lot of harm.

hopler 8y ago

For every suction pump and super glue getting held up by regulation, there is also a witch doctor or snake oil. People love to talk about the clever hacks in some poor country, but not the high cost in QALY of superstitious or scam practices. Since no one is clamoring to wholseale trade USA healthcare for India's, there are obviously done tradeoffs.

throwaway5752 8y ago

"Though FDA can trace its origins back to the creation of the Agricultural Division in the Patent Office in 1848, its origins as a federal consumer protection agency began with the passage of the 1906 Pure Food and Drugs Act. This law was the culmination of about 100 bills over a quarter-century that aimed to rein in long-standing, serious abuses in the consumer product marketplace." I have no personal doubt that the FDA has saved millions of lives in the US and internationally, and the balance of harm/good they have caused would would make the harm side look infinitesimally small. Also... I be interested in what cases you know that the FDA caused the deaths of people by overaction. There are people out there with axes to grind who thought they were going to get rich with some drug or device, who couldn't subsequently prove the safety and/or efficacy of their product.

silotis 8y ago
The FDA's drug approval criteria are extremely strict. Ask anyone who works in pharma and they can probably name at least a couple of drugs which showed great promise but got axed by the FDA on dubious grounds. A classic example is Aspirin. We know from over a hundred years of experience that Aspirin is a widely useful and relatively safe drug, but if it were discovered today the FDA would never allow it to market, let alone approve it for OTC sales. Aspirin's mechanism of action is far too broad and the gastrointestinal side effects alone would be considered grounds for rejection.
- throwaway5752 8y ago
  Perhaps if you dropped a few more specific examples would could talk about their issues instead of in generalities, instead of Aspirin? I was going to reply in my own words, but will instead yield to this retired FDA compliance officer: https://www.quora.com/Would-aspirin-be-approved-by-the-FDA-today https://www.quora.com/Would-aspirin-be-approved-by-the-FDA-t...
Symmetry 8y ago
So, the food regulation side of the FDA's activities have certainly saved millions of lives and probably swamp what the FDA does in terms of drug regulations. But generally new drugs tend to be rolled out gradually, doctors hear about disasters, and I'd be surprised if the FDA saved more than a thousand lives a year at most. On the other hand a bad call in disallowing new medicines can have very bad consequences. The FDA only allowed the use of beta blockers in the US about a decade after they came into use in Europe which probably cost something on the order of 100,000 excess deaths. Those early beta blockers did have serious problems and the FDA's decision also probably saved 1,000 people from liver failure after taking those drugs but I don't think that justified withholding the category until a liver-safe version was made. These days the FDA is less strict than it was in the 1960s and has certainly improved. But we can still do better to move more in the direction of European style regulation where they have a dozen competing EpiPen equivalents.
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Shorel 8y ago

This can only be known after the fact. To complain about "this obvious treatment that obviously works but regulations delayed for 10 years", is as valid as to complain about "this obviously flawed treatment that kills one person out of ten people and killed my husband, because obviously not enough testing was done". The error in both complains is to assume that the answer was in anyway obvious. It was not. It almost never is. I agree with you, totally. I just wanted to emphasize that point.