I wish someone would convince RFK that prescription drug ads are bad for his brand of quack medicine. We could at least get rid of that societal cancer while the rest is torn down.
dmm · 1h ago
Reading "Bottle of Lies" by Katherine Eban, I'd argue that the collapse of the FDA was well underway before the current administration. The FDA was completely unable to regulate overseas drug manufacturers, resulting in many, many problems. Sincere attempts to inspect overseas drug makers with random inspections universally results in shutdowns, which cause politically unpopular drug shortages, making enforcement politically difficult.
sorcerer-mar · 56m ago
Sooo that sounds like there's a whole lot of ways for it to get way, way, way worse.
The existence of problems does not imply there cannot be more plentiful, more diverse, and more severe problems in the near future.
cosmicgadget · 1h ago
That seems more like an "underfunded and underjurisdictioned" problem for a portion of what they do, rather than collapse of the agency.
Skates1616 · 7m ago
I’m very familiar with this space, specifically parenteral manufacturing.
The real challenge lies in the expectations the FDA has set for manufacturing. Over time, the regulatory space has been heavily influenced by academic-driven theoretical scenarios for microbiological contamination. While well-intentioned, these theoretical risks often drive overly stringent requirements that don’t always reflect real-world manufacturing risks.
As a result, it’s becoming prohibitively expensive to manufacture drugs for the U.S., especially sterile injectables.
“FDA’s war on public health is about to end,” Kennedy wrote. “This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma."
Anyone know what chelating compounds he is talking about?
He mentions clean foods, but the Trump EPA is protecting corporations from regulations more than its protecting citizens from pollution.
hinterlands · 1h ago
It's about EDTA. It can be legitimately used to treat heavy metal poisoning, plus some other things. Some people (who are probably misguided) want to self-medicate. The FDA won't let you. Hence, drama.
Metacelsus · 1h ago
yeah, because unless you legitimately have heavy metal poisoning, the side effects DEFINITELY aren't worth it
hinterlands · 56m ago
Probably, but the process doesn't work that way. The default is that you can't sell medication to people, period. Some pharmaceutical company applied to have a specific form of EDTA approved as a prescription drug, and that was that.
Separately from this, substances that meet the criteria of being "natural" can be sold as supplements as long as you don't claim they cure anything. EDTA is naturally-occurring and you can buy it as a supplement in the US, although the FDA has some beef with this, which I think is what the original remark might be alluding to.
EDTA is also a common food additive and a laboratory reagent, so people who want to use it can buy it easily, which makes the whole debate basically performance art.
sorcerer-mar · 54m ago
So in summary, the FDA prevents you from marketing something as a medicine unless you have gone through the approval process and developed all the regulatory apparatus around a medicine (e.g. packaging, suppliers, prescription guidelines, etc)?
hinterlands · 50m ago
Yes. Look, I'm not arguing this is bad, I'm just trying to respond to the original question and capture the essence of the debate.
There are three pertinent points: (1) it's EDTA; (2) it's not that EDTA is safe or not safe, it's that no one applied to have it approved as an OTC medication; (3) you can still (probably) sell EDTA as a supplement in the US, but the FDA grumbled about it, which angered various chelation cranks.
Aloisius · 1h ago
Iron, copper, zinc, cobalt, manganese and selenium are "heavy metals."
stevenAthompson · 32m ago
"We do our peers, countrymen, students, and children a grave disservice by admonishing them to think for themselves without also giving them the critical thinking tools to do so, for in so doing we foster a culture where "independent thought" is equated with "contrarian thought". This gives rise to an anti-intellectual, anti-science paradigm that supports an idea not because it meets a basic standard of evidence, but rather simply because it opposes established thought. This is worse than the intellectual calcification that stagnant "herd thinking" would give rise to, because it doesn't simply halt progress — it puts it in full retreat."
weq · 59m ago
The FDA waged a war on fly-by-night chalatens claiming false benifits from products. It was the the Conservative govnernmets who created the DEA to wage war on immigrants, psychadelics. Those same actors, created the conditions that incentivised corperate monolopies, creating laws that meant the bar could only be reached by those with enough influence. The govenernment is now waging war on the truth, and pointing in one direction while shaking down the corperate monolopies in order funnel more money into politicans pockets without them having to sit on a board of directors after office.
mcphage · 2h ago
250 years to build up, 6 months to tear down.
chung8123 · 1h ago
Unfortunately I feel like we are just seeing the snap of these government agencies. They have been bending for a while. It will feel like 6 months but we have been on the path for a while and not one administration has decided to bite the bullet and turn course.
reactordev · 1h ago
I was just saying this today. I’m originally from the DC bubble. It’s been bad for a LONG time. Entire companies designed to fight and win government contracts so that they can milk the government until retirement. SAIC comes to mind.
These agencies haven’t been able to do their actual jobs in ages. Trump is doing what he said he was going to do (unpopular as that is) and we’ll have to figure out how to build back better (or whatever that term was).
I don’t agree with anything he’s doing but I do see opportunities in it. If we can survive without these departments until then.
js8 · 52m ago
While seeing opportunity in a crisis is a good coping mechanism, that doesn't mean it's a good idea to destroy first and rebuild from scratch. (It is however one of the core unjustified beliefs of free market fundamentalists.)
It actually seems to be true more generally, good coping mechanisms are not particularly efficient in the absence of crisis. Another example: People who lived through a dictatorship, which destroyed social trust and capital, learned to cope by distrusting state authorities. That's a coping mechanism that doesn't work well in the absence of dictate, a system that is open to democratic self-governance. You need people who are willing to apply more bold strategies to effectively run a democratic state.
sneilan1 · 35m ago
Sorry, this SAIC? https://www.saic.com/ Just curious which SAIC you are referring to.
stego-tech · 1h ago
Don’t give the buffoon too much credit, as a lot of these weaknesses were engineered starting around Reagan (with Carter and Nixon also shouldering some, but far less overall, blame). Neoliberalism and its “invisible hand of the free market” alliance with Laissez-Faire Capitalism all but ensured the demise of institutions and social safety nets in the name of maximum profit for the moneyed classes. We built a Golden Age atop the New Deal, and Capital threw it all away to return to the 20s, violent strikebreaking and all.
King-Aaron · 1h ago
I see this argument of "oh it's been happening for a long time" getting thrown around a lot, and it feels like a really non-good-faith point of view that seems to ignore the administration directly targeting these institutions for destruction.
Yes, poor management is a big problem that could be seen as an intentional structural issue, but this is a totally different ball game that's being played right now.
No comments yet
umeshunni · 2h ago
That's how most oppressive regimes end. Sometimes faster.
sorcerer-mar · 53m ago
What's oppressive about FDA? Be specific.
andrewflnr · 19m ago
They obviously weren't referring "specifically" to the FDA at that point.
nine_zeros · 2h ago
It is easy to complain and destroy. It is hard to build.
For a narcissistic hateful administration that wants easy votes, the destructive path is rational.
randcraw · 42m ago
Before the wreckage this administration has created consumes us, that is. Like when our next round of influenza is especially bad but we've destroyed so much public health infrastructure that the US is the last to respond to the crisis, and the state authorities have to turn elsewhere for help -- to WHO or even to China -- to bail us out.
monero-xmr · 46m ago
It’s easy to hand out money when you are not the one paying, and have no consequences for success or failure. Feeling justified and righteous is the icing on the cake
mcphage · 14m ago
> you are not the one paying
We are, though.
> have no consequences for success or failure
Oh, the consequences for the failures of this administration will be felt by everyone, for decades.
sorcerer-mar · 43m ago
These types of oblique, semantically empty comments are so tiring. Bonhoeffer's theory of stupidity rings true: "one virtually feels that one is dealing not at all with a person, but with slogans, catchwords and the like, that have taken possession of him."
What the actual fuck are you talking about "handing out money" as it pertains to this topic?
monero-xmr · 37m ago
Government agencies that spend massive amounts of tax dollars while accomplishing nothing and being net-negative for society. Anyone who has worked for or dealt with the government for extended periods of time will clearly know how fucked it is
sorcerer-mar · 33m ago
Anyone who has worked in drug development knows how vital FDA is.
The FDA costs taxpayers less than $4 billion per year.
If FDA is a net negative, next time you need a medication you're aware you can go participate in a Phase I study, and get paid to take a cutting edge drug for it? Why bother looking at the stuff on the medicine shelf that costs you money?
Can you give us all an idea of your experience working with government, and especially FDA?
monero-xmr · 26m ago
Should allow pharma to sell drugs to the market. Allow people to sue if they are harmed. Do not care about a government agency preventing access to new drugs. They can gatekeep government funds at best, limiting Medicaid / Medicare to those that want to pass their hoops
My experience is in selling tech to government. Disgusting and corrupt.
jcranmer · 10m ago
The more-or-less unregulated drug industry that you envision is something that already exists: it's called "health supplements." And it's a disasters; there's been quite a few studies that show that many of the companies selling health supplements can't even be bothered to put in their claimed active ingredients.
This isn't some hypothetical "well, we haven't tried to see what it would look like without regulation;" this is something that is already in existence and whose effects can be measured today!
op00to · 2m ago
Weird. I worked for and dealt with the government for extensive periods of time, namely cancer and basic biomedical research. We did fucking awesome things. Go hide in a lot cabin in the wilderness or something and leave the rest of us to our civilization. Don’t take us all down with you.
mcphage · 11m ago
> Government agencies that spend massive amounts of tax dollars while accomplishing nothing and being net-negative for society.
I’ve spent my entire career working for wasteful companies who accomplish nothing and are net-negative for society. The government at least picks up my garbage every week.
nine_zeros · 26m ago
> Government agencies that spend massive amounts of tax dollars while accomplishing nothing and being net-negative for society. Anyone who has worked for or dealt with the government for extended periods of time will clearly know how fucked it is
This is only true of republican governments. Republican-led governments are truly appalling in their spending, and wasteful tax cuts. Democrat governments are far far more efficient, effective, and work for the people.
An example of this is one beautiful bill which literally increased deficits while giving nothing of value to people but the biden-led inflation reduction act literally created new energy infrastructure without increasing deficit.
monero-xmr · 19m ago
Letting people keep more of the money they earned through productive work is how we increase wealth. Taxes are literally a friction on the economy - we remove funds from productive entities every time they transact, retarding economic activity. The funds then are redirected to a sclerotic and uncaring state, and then the productive people are shamed when they ask for less of it to be taken.
The existence of problems does not imply there cannot be more plentiful, more diverse, and more severe problems in the near future.
The real challenge lies in the expectations the FDA has set for manufacturing. Over time, the regulatory space has been heavily influenced by academic-driven theoretical scenarios for microbiological contamination. While well-intentioned, these theoretical risks often drive overly stringent requirements that don’t always reflect real-world manufacturing risks.
As a result, it’s becoming prohibitively expensive to manufacture drugs for the U.S., especially sterile injectables.
And truly it gets worse every year…
Anyone know what chelating compounds he is talking about?
He mentions clean foods, but the Trump EPA is protecting corporations from regulations more than its protecting citizens from pollution.
Separately from this, substances that meet the criteria of being "natural" can be sold as supplements as long as you don't claim they cure anything. EDTA is naturally-occurring and you can buy it as a supplement in the US, although the FDA has some beef with this, which I think is what the original remark might be alluding to.
EDTA is also a common food additive and a laboratory reagent, so people who want to use it can buy it easily, which makes the whole debate basically performance art.
There are three pertinent points: (1) it's EDTA; (2) it's not that EDTA is safe or not safe, it's that no one applied to have it approved as an OTC medication; (3) you can still (probably) sell EDTA as a supplement in the US, but the FDA grumbled about it, which angered various chelation cranks.
These agencies haven’t been able to do their actual jobs in ages. Trump is doing what he said he was going to do (unpopular as that is) and we’ll have to figure out how to build back better (or whatever that term was).
I don’t agree with anything he’s doing but I do see opportunities in it. If we can survive without these departments until then.
It actually seems to be true more generally, good coping mechanisms are not particularly efficient in the absence of crisis. Another example: People who lived through a dictatorship, which destroyed social trust and capital, learned to cope by distrusting state authorities. That's a coping mechanism that doesn't work well in the absence of dictate, a system that is open to democratic self-governance. You need people who are willing to apply more bold strategies to effectively run a democratic state.
Yes, poor management is a big problem that could be seen as an intentional structural issue, but this is a totally different ball game that's being played right now.
No comments yet
For a narcissistic hateful administration that wants easy votes, the destructive path is rational.
We are, though.
> have no consequences for success or failure
Oh, the consequences for the failures of this administration will be felt by everyone, for decades.
What the actual fuck are you talking about "handing out money" as it pertains to this topic?
The FDA costs taxpayers less than $4 billion per year.
If FDA is a net negative, next time you need a medication you're aware you can go participate in a Phase I study, and get paid to take a cutting edge drug for it? Why bother looking at the stuff on the medicine shelf that costs you money?
Can you give us all an idea of your experience working with government, and especially FDA?
My experience is in selling tech to government. Disgusting and corrupt.
This isn't some hypothetical "well, we haven't tried to see what it would look like without regulation;" this is something that is already in existence and whose effects can be measured today!
I’ve spent my entire career working for wasteful companies who accomplish nothing and are net-negative for society. The government at least picks up my garbage every week.
This is only true of republican governments. Republican-led governments are truly appalling in their spending, and wasteful tax cuts. Democrat governments are far far more efficient, effective, and work for the people.
An example of this is one beautiful bill which literally increased deficits while giving nothing of value to people but the biden-led inflation reduction act literally created new energy infrastructure without increasing deficit.