3 ms·

What some people think the FDA is doing: Suppressing natural therapies Protecting the pharma industry What the FDA is actually doing: Preventing hus

by ethbr1 2y ago

What some people think the FDA is doing: Suppressing natural therapies Protecting the pharma industry What the FDA is actually doing: Preventing hustlers from peddling false hope (at best ineffective, at worst harmful) to less educated people in dire straits The hypothetical alternate regulatory reality isn't 'Some good stuff that the FDA blocked is made available.' It's 'Fly by night companies are able to push bullshit onto unsuspecting consumers... again.'

pitaj 2y ago
What the FDA has undeniably done: Delayed the release of vital, proven medicines to the public, leading to hundreds of thousands of people needlessly dieing.
- ttyprintk 2y ago
  You might like the article > the most important thing to understand about this dynamic is that it typically takes an incredible amount of work to reach the functional compromise that’s eventually settled upon, so if the existing process is scrapped (e.g. because people who are polarized on the issue can only see it from their side’s perspective) what follows… is often much worse than what preceded it.
- Spooky23 2y ago
  Unless you talk about COVID, where in that case emergency use authorization was Bill Gates nanobots.
ttyprintk 2y ago
The linked blog post talks about historical FDA prestige (the title is The Forgotten Side of Medicine) but should be leading up to ivermectin: A small number of capitalists did get rich selling ivermectin. We all noticed the emergent social media energy toward ivermectin and someone was going to sell it at a profit. The FDA noticed that this had stature on algorithmic social media and made the mistake of trying to also get on social media. FDA does not prevent doctors from picking a treatment. FDA does not criminalize anything. But FDA is required to try to protect people even if they don’t believe in the FDA. A small number of doctors sued because of that social media messaging. Not because ivermectin was better than or safer than a vaccine.
- cempaka 2y ago
  Sending out not-so-subtle "hints" to pharmacies not to fill prescriptions for off-label uses of a particular drug, and encouraging medical boards to discipline doctors who write such prescriptions, is exactly the same thing as "preventing doctors from picking a treatment." One of the most infuriating things about COVID was seeing this sort of passive-aggressive buck passing raised to an artform. In my kids' school district, no one individual could be assigned responsibility for the fact they had to wear pointless cloth masks across their faces for six hours a day -- the superintendent blamed the state health department, the state health department blamed the governor, the governor blamed the CDC, the CDC blamed state health departments, and round and round it went.
derefr 2y ago
What about the hypothetical regulatory reality where companies can cite “20 years of clinical practice / OTC marketed sales in another country X” as justification enough for considering a medicine to be GRAS until proven otherwise (similar to how most medicines that preceded the creation of the FDA got grandfathered in as GRAS until proven otherwise)? There are currently several hundred medicines sold elsewhere in the world and considered essential in most places in the world, that no US company is willing to go through FDA trials for, because there’s already an existing foreign patent on the drug, so it’s not worth it because all the US company would end up being able to produce and market is a generic. (US doctors still supply these drugs clinically from time to time; but to do so, they must get special one-time FDA exceptions to import them, and then use them “investigationally.” This usually takes months of back-and-forth and has extreme labor overheads. It also is vulnerable to foreign-market supply shocks.) The way to cut this Gordian knot is to just not require trials for these drugs. They were already proven long ago to the satisfaction of some other drug agency; and even if the FDA doesn’t trust the standards of that agency, with at least 20 years of existing use, they can simply refer to longitudinal studies conducted in that country that recorded all-cause mortality of patients on the drug vs not.
- Spooky23 2y ago
  Congress could write a law that would allow the FDA consider those foreign processes, or cross-approve or similar. Yet nobody ever advocates for that. The “what about” for me is quack vitamins and bullshit that people are actually pushing.
Eddy_Viscosity2 2y ago
The FDA is a big organization that's been around for a long time. I would be confident in assuming, at one time or another, individuals working there have done both really bad and really good things. Citing examples of the bad things could be countered with citing examples of the good things. Best we can do is try and find out about the bad things and punish those involved to try and keep the balance leaning toward more good than bad.

by ethbr1 2y ago

pitaj 2y ago

What the FDA has undeniably done: Delayed the release of vital, proven medicines to the public, leading to hundreds of thousands of people needlessly dieing.

ttyprintk 2y ago
You might like the article > the most important thing to understand about this dynamic is that it typically takes an incredible amount of work to reach the functional compromise that’s eventually settled upon, so if the existing process is scrapped (e.g. because people who are polarized on the issue can only see it from their side’s perspective) what follows… is often much worse than what preceded it.
Spooky23 2y ago
Unless you talk about COVID, where in that case emergency use authorization was Bill Gates nanobots.

ttyprintk 2y ago

The linked blog post talks about historical FDA prestige (the title is The Forgotten Side of Medicine) but should be leading up to ivermectin: A small number of capitalists did get rich selling ivermectin. We all noticed the emergent social media energy toward ivermectin and someone was going to sell it at a profit. The FDA noticed that this had stature on algorithmic social media and made the mistake of trying to also get on social media. FDA does not prevent doctors from picking a treatment. FDA does not criminalize anything. But FDA is required to try to protect people even if they don’t believe in the FDA. A small number of doctors sued because of that social media messaging. Not because ivermectin was better than or safer than a vaccine.

cempaka 2y ago
Sending out not-so-subtle "hints" to pharmacies not to fill prescriptions for off-label uses of a particular drug, and encouraging medical boards to discipline doctors who write such prescriptions, is exactly the same thing as "preventing doctors from picking a treatment." One of the most infuriating things about COVID was seeing this sort of passive-aggressive buck passing raised to an artform. In my kids' school district, no one individual could be assigned responsibility for the fact they had to wear pointless cloth masks across their faces for six hours a day -- the superintendent blamed the state health department, the state health department blamed the governor, the governor blamed the CDC, the CDC blamed state health departments, and round and round it went.

derefr 2y ago

What about the hypothetical regulatory reality where companies can cite “20 years of clinical practice / OTC marketed sales in another country X” as justification enough for considering a medicine to be GRAS until proven otherwise (similar to how most medicines that preceded the creation of the FDA got grandfathered in as GRAS until proven otherwise)? There are currently several hundred medicines sold elsewhere in the world and considered essential in most places in the world, that no US company is willing to go through FDA trials for, because there’s already an existing foreign patent on the drug, so it’s not worth it because all the US company would end up being able to produce and market is a generic. (US doctors still supply these drugs clinically from time to time; but to do so, they must get special one-time FDA exceptions to import them, and then use them “investigationally.” This usually takes months of back-and-forth and has extreme labor overheads. It also is vulnerable to foreign-market supply shocks.) The way to cut this Gordian knot is to just not require trials for these drugs. They were already proven long ago to the satisfaction of some other drug agency; and even if the FDA doesn’t trust the standards of that agency, with at least 20 years of existing use, they can simply refer to longitudinal studies conducted in that country that recorded all-cause mortality of patients on the drug vs not.

Spooky23 2y ago
Congress could write a law that would allow the FDA consider those foreign processes, or cross-approve or similar. Yet nobody ever advocates for that. The “what about” for me is quack vitamins and bullshit that people are actually pushing.

Eddy_Viscosity2 2y ago

The FDA is a big organization that's been around for a long time. I would be confident in assuming, at one time or another, individuals working there have done both really bad and really good things. Citing examples of the bad things could be countered with citing examples of the good things. Best we can do is try and find out about the bad things and punish those involved to try and keep the balance leaning toward more good than bad.