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.
There's loads of precedent pointing to commercial speech such as marketing as having some specific carve outs on the right to free speech. After all we have limits on tobacco marketing and food labeling requirements.
The politicians are getting funded/paid (lobbying/donations) by the very same people/companies that pay the ad revenue to those media. Why on earth would politicians legislate against their actual bosses? (As a real life reminder - a dog that bites the hand that feed him is put down). Courts btw don't make up shit.. they 'judge' (verb) with the criteria of 'what does the law define'. So if politicians legislate wisely, courts will enforce any 'parliamentary' and/or executive order to ban the advertisements of medicine.
But they won't. Not until push-comes-to-shove, and the true bosses will reposition to 'the next thing' (smoking, sugary-foods, medicine) and then they will allow the politicians to finally block meds ads. In which case the 'next wave' will begin. Story as old as time...
> Merck published the first print DTC ad for a pneumonia vaccine targeting those aged 65 years and older, and Boots Pharmaceuticals aired the first DTC television commercial in 1983 for the prescription ibuprofen Rufen.
But that sentence was worded weirdly, so I checked the sources. This is one of the two for that part:
> While 2006 marks the 10-year anniversary of the Claritin ad, it was actually 24 years ago that the FDA unwittingly opened the door to DTC. Speaking at the American Advertising Federation conference and addressing the Pharmaceutical Advertising Council, then-FDA Commissioner Arthur Hull Hayes Jr. summarized the state of drug advertising, saying it "may be on the brink of the exponential-growth phase of direct-to-consumer promotion of prescription products."
> Drug companies jumped on the phrase "exponential growth" and took it to mean the FDA, however tacitly, supported DTC.
> 'Opening a closed door'
> "It was viewed by the industry as FDA opening a closed door," said Kenneth R. Feather, a former associate FDA commissioner.
> A year later, in 1983, Boots Pharmaceuticals aired the first direct-to-consumer TV ad when it promoted its prescription ibuprofen medication, Rufen. The company also ran newspaper ads at the same time. That was in May; by September, the FDA asked the industry for a voluntary moratorium on drug advertisements. (Ibuprofen actually went over the counter a year later.)
> In 1984, Upjohn sponsored a major conference on DTC advertising in Washington, D.C., where it made no bones about expressing its opposition to the practice. But less than five years later, Upjohn was touting the merits of DTC after its hair-restoration medication, Rogaine, was approved by the FDA and needed to be marketed.
It was a very strange experience once when I was in the US, at a hotel reception, suddenly hearing an advert for a sildenafil drug on TV behind the receptionist.
> We are one of only two countries in the world that allow pharmaceutical companies to advertise directly to consumers on television. Not surprisingly, Americans consume more pharmaceutical products than anyone else on the planet.
> As I told @JoePolish, on my first day in office I will issue an executive order banning pharmaceutical advertising on television
Unfortunately, this is probably illegal. See cases like United States v Caronia.
Worth reminding everyone that, on top of pharma and food, the FDA also regulates medical devices.
Insufficient regulation both on approval _and_ inspection of medical devices (thinking surgical applications and implantables for example) is as impactful on patient safety as drugs.
That's a relatively minor danger. My father, before retirement, was responsible for certifying medical devices. The number of outright scams which reached his desk was off the charts.
Half of that stuff didn't work as advertised, the other was actually dangerous, because it e.g. didn't control dosage.
The damage to U.S. government safety institutions by the current administration may be significant, from faulty pacemakers and cancer-inducing scanning machines to disabled babies and Ebola.
It’s not some temporary thing where we can just raise awareness and then people will vote them out of office next time. The changes that have been made affect the ability for those opposing to win the next election, and even if they were to, the checks and balances have gone.
At this point, unless you plan to work to undo it long-term, you could accept that our society will be quickly devolving maybe 100-150 years or more.
In the past, opportunity abounded in fake science, magical thinking, weird products, dirty industry, manual labor, inequity, and brutish behavior.
If they want to outlaw processed foods and we all start eating flavorless thick hard biscuits of grain and beans and less-than-stellar-looking fruits and vegetables, it’ll probably be better for my mental and physical health.
However, that may be offset by my teeth rotting from lack of fluoride and getting cancer and intestinal problems from lack of regulation. And the death, disease, and disablement will overshadow the fear and excitement from street fights, arcing electrical devices, dangerous bubbling chemicals, planes falling from the sky, things exploding, medicine shows, and AI whorehouses.
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.
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.
> Digging through company records and test results, they found more evidence of quality problems, including how managers hadn’t properly investigated a series of complaints about foreign material, specks, spots and stains in tablets.
> Those unknowns have done little to slow the exemptions. In 2022, FDA inspectors described a “cascade of failure” at one of the Intas plants, finding workers had destroyed testing records, in one case pouring acid on some that had been stuffed in a trash bag. At the second Intas factory, inspectors said in their report that records were “routinely manipulated” to cover up the presence of particulate matter — which could include glass, fiber or other contaminants — in the company’s drugs.
> Sun Pharma’s transgressions were so egregious that the Food and Drug Administration imposed one of the government’s harshest penalties: banning the factory from exporting drugs to the United States.
> A secretive group inside the FDA gave the global manufacturer a special pass to continue shipping more than a dozen drugs to the United States even though they were made at the same substandard factory that the agency had officially sanctioned. [...] And the agency kept the exemptions largely hidden from the public and from Congress. Even others inside the FDA were unaware of the details.
FDA inspectors found actual, live contamination in drugs produced by a manufacturer, and the agency secretly (otherwise, it would have caused "some kind of frenzy" in the public") gave it an exemption anyway, to make sure supply wasn't impacted. This isn't a "funding" issue, and it's not a "regulations are too strict" issue. This is an issue with the people running the agency behaving completely inappropriately.
It feels to me like the tyranny of small differences. The fact that the various watchdogs amplified such specific issues greatly overshadowed their support of the mission. From what I've read, the FDA is a backwater from a funding perspective, and yet a punching bag from a regulatory point-of-view.
*He and his colleagues had also been engaged in a decades-long debate with a sprawling community of watchdogs — mostly doctors, lawyers and scientists from outside the agency — who were often broadly supportive of the agency’s mission but who fought with officials like Califf, sometimes bitterly, over the specifics: How should the F.D.A. be financed? What kind of evidence should new drugs and medical devices require? How should regulators weigh the concerns of industry against the needs of doctors, patients and consumers?*
The 2018 valsartan recall is a perfect example of this - an overseas manufacturer's nitrosamine contamination went undetected for years despite theoretical oversight, affecting millions of patients.
If Chesterton's fence is intangible and invisible, then it's appropriate to remove it entirely. If it doesn't have a working latch, it doesn't serve as a hard barrier, but it may still serve as a soft barrier, and that may be good enough.
Or, conversely, important things may have been relying on access via the latch-free fence gate: fixing the latch without providing a more appropriate solution to those issues could cause more harm than the benefit you get from "now the fence actually functions as a barrier". (Sure, the latch keeps the wolves out, and stops them picking off the sheep – but it also keeps the sheep away from their only freshwater source, without which most of the sheep are going to die.)
Chiron: 2004, the UK government shut down their flu vax plant (it was in the UK). It later came out that the FDA knew what was up and basically let it slide. It was one of the early ani-vax movements torches... Crunchy moms pissed about shots for kids and parents on Oxycodone were not happy with Pharma (or corporations in general: Enron etc..)
> politically unpopular drug shortages ...
Ask your ADHD friends about how they get their meds.
One side wants to keep it, the other side wants to get rid of it. No one wants to fix the problem.
It really feels like the US is a failed state at this point, but it just hasn’t had full impact yet. Not really sure how all this destruction (in only half a year!) can be reversed in any meaningful timeframe in the future.
As Sarah Chayes said about the "failed state" of Afghanistan:
> Afghanistan is often described as a “failed state,” but, in light of the outright thievery on display, Chayes began to reassess the problem. This wasn’t a situation in which the Afghan government was earnestly trying, but failing, to serve its people. The government was actually succeeding, albeit at “another objective altogether”—the enrichment of its own members.
Was it here or in the reviewed book about corruption where it's mentioned, how corruption endangers security, because guess what the civilians who are mad about the blatant corruption will do when they see an insurgent plant a roadside bomb targeting the corrupt government?
As Supreme Court Justice Louis Brandeis said (and Timothy McVeigh quoted):
> In a government of laws, existence of the government will be imperiled if it fails to observe the law scrupulously. Our government is the potent, the omnipresent teacher. For good or for ill, it teaches the whole people by its example. Crime is contagious. If the government becomes a lawbreaker, it breeds contempt for law; it invites every man to become a law unto himself; it invites anarchy. To declare that in the administration of the criminal law the end justifies the means -- to declare that the government may commit crimes in order to secure the conviction of a private criminal -- would bring terrible retribution.
I’m not trying to challenge how you feel, but I’ll note that in my social groups people don’t feel this way, life is good, and they also feel confident that they’re well informed.
So I’m open to the possibility that lot of these types of feeling, in both directions depending on the political era, is more dictated by environment and media consumption choices and their versions of doom and gloom than reality
Feeling well informed is not the same thing as being informed. Just because it's possible to live in the USA and follow some news without knowing how badly the democratic order is being eroded doesn't mean that all is actually well.
Do your friends know about the absolute immunity the Supreme Court invented for the president? Do they know about the illegal deportations that are accelerating? Do they know about the presidential order that aims to deport legal citizens of the USA (the end of birthright citizenship)? Do they know about the gutting of virtually all social programs?
If they don't, then they're ill informed, regardless of their feelings on the matter. If they do and still think all is well, then they are just as much a part of the problem as the ones doing this all.
Plenty of people feel that way when they're in Dubai or Qatar. Lovely place, just don't look at the army of migrant workers with no rights who keep it all running.
The FDA's creation was directly triggered by multiple mass poisoning incidents in the early 1900s.In 1937 over 100 people died from diethylene glycol-contaminated medicine, leading to the 1938 Food, Drug, and Cosmetic Act that significantly expanded FDA authority.
As the adage goes, "regulations are written in blood". The problem is the blood was spent before many people can remember (or bother to remember). They just know the "limitations" imposed by those regulations and therefore want to get them removed.
“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.
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.
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.
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)?
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.
EDTA removes all metals. It's simply a compound that forms water-soluble complexes with metal ions, removing them from the body.
The way idiots kill their children with it is that among other metals, it removes calcium ions, and those are necessary for life, with low enough concentration in blood eventually resulting in cardiac arrest.
So said idiots have an autistic child, read junk online that tells them that "toxins" caused this, find the compound that is legitimately used to remove toxins, and administer enough to end the autism. By stopping their child's heart.
I don't particularly like the FDA, but restricting the availability of EDTA is not something I'd criticize.
If you have such parents, you basically lost the game of life without having a chance to participate much. The only real solution would be to forcibly and permanently take children away from such people, not something I see flying in US if we don't include ie physical abuse or pedophilia.
I feel like a basic human life value has decreased recently. Be it ongoing brutal wars, news pushing doom and gloom 24/7, covid certainly didnt help or something similar. A bit like reversal to medieval times when cruel public executions were a spectacle for whole town and families and life of individual was truly worthless.
If thats the case, let the dumb die including offsprings, just don't let their bills to be picked up by society. Extremely cruel, but it seems we are heading that way, and we have this little thing called overpopulation. Extreme freedom with extreme consequences.
> Even in applications other than toxicity, no widely agreed criterion-based definition of a heavy metal exists. Reviews have recommended that it not be used. Different meanings may be attached to the term, depending on the context.
"Heavy metal" in general is a bad term, but especially when used as a proxy for toxin. There is no universal definition of heavy metal and there is no inherent connection to toxicity in any specific organism.
Then again, pretty much every metal is toxic at some relatively low body-mass concentration, even iron (which actually can and does kill people, especially when children eat adult iron supplements).
Even lovely unreactive gold does have compounds that are toxic.
"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."
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.
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.
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.
Like I said, I don’t agree with his tactics. Burning the bridges isn’t smart.
I do think a lot of DC fat is coping mechanisms. The bureaucracy is so slow to respond to change, change that this community loves, and needs a redo. Reorg. Whatever.
I get why my opinion is so downvoted but the reality is the reality.
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.
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.
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.
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
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?
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
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.
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?
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.
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!
> So you advocate a costly post-harm remediation instead of a preemptive solution provided by governmental regulations
Absolutely. Such solutions tend to be much cheaper and more effective. It's how we deal with the vast majority of problems for a good reason.
If we sold oxycontin over the counter we would have much less of an overdose problem than we do. Would also take a lot of stress off our emergency medical care system which spends an inordinate amount of time just dealing with addicts looking for drugs.
It's a funny example to use to justify the current regulatory framework because oxycontin got approved by the very same.
>> So you advocate a costly post-harm remediation instead of a preemptive solution provided by governmental regulations
> Absolutely. Such solutions tend to be much cheaper and more effective.
This is not supported by any credible analysis I am aware of, as the cost of rectifying a problem post hoc has historically been far greater than preventing it in the first place.
> If we sold oxycontin over the counter we would have much less of an overdose problem than we do.
This assertion is demonstrably wrong and could easily be categorized as insulting to people struggling with OxyContin addiction.
Insanity. Do you honestly believe the average person (probably a sick one at that) has the resources and time to fight a large pharmaceutical company in court? And do you really believe that during the time between releasing the drug and losing in court the faulty drug wouldn't make the company much more money than they'd have to pay as compensation? The amount of organization it would require to beat a large company with its resources would guarantee that most abuses would go unpunished and suffering would certainly increase compared to an environment with well functioning FDA.
> Should allow pharma to sell drugs to the market. Allow people to sue if they are harmed.
This is a comical extreme vision of libertarian politics. Everything gets worse, lots of people die, but it's okay because we have a small principle of freedom. Yeah. Great.
If you're trying to persuade people you're doing a very shit job.
The actual budget of the FDA is $4 billion. The overly restrictive regulations it puts on drug development and manufacture of generic medication costs 10-100x that.
> 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.
> 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.
> 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.
BBB is the most recent example of this. We cut spending across the board, shit on American, and in exchange we... raised the deficit by Trillions of dollars? What? How?
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.
You know so little about how the world actually works that it's funny you even try to speak about it.
Society would literally cease to function if the government stopped providing the services that your "friction" funds. Roads, the court system, police, waste and water, defense - these barely scratch the surface of what the US government provides, and yet remove any one of them and it would be enough to bring down the entire economy.
> 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.
In republican governments, yes this is real.
In democrat governments, the vast majority of taxes goes into productive issues such as education, transportation, and healthcare. Even the type of bills passed by democrats are friendly towards building a society.
Now, YOU may not want to pay for other's education, transportation, and healthcare. But a lot of people appreciate that access to high quality is not merely limited to the wealthy. This is why you'll see amazing companies in blue states vs red, you'll see amazing companies starting during blue federal governments vs red.
The data is very clear on what produces great outcomes for society. You might not want others to get a decent life but you need to admit your selfishness.
i know this is a very political thing now but i've had friends (smart phd people who work industry) very annoyed at the fda for many years, and maybe this collapse is good!
the fda started with a noble mission but they've been getting heavy handed. or better cliched - slow handed with getting things certified.
you can solve this one or two ways: drop regulation or increase staffing.
so many institutions have unnecessary fluff, tremendous red tape (why do i need environmental review to stick a shed in my backyard??), our modern lives have too much regulation.
let's hope for the best.
the old system is holding back drugs.. there should have been more ozempics, more breakthroughs had the fda not been so slow. companies have a strong incentive not release bad drugs now.. lawyers are not cheap and law firms know money can be made.. it's not the 1930s anymore.. (okay it's still the 1930s in certain places of the world, that's a criticism)
typing this out hoping to convince any regulation reduction is good reduction, i thought of a third fda option: the fda let's everyone go hog wild initially but looks at the top consumed products and checks them for safety and efficacy each year.
> why do i need environmental review to stick a shed in my backyard??
Because cowboys make cowboy decisions, which leads to loss of lives.
"We're going to build on a flood plane, don't worry we've put in protection" turns out they didnt and the things they did made the flooding worse.
> companies have a strong incentive not release bad drugs now
Given that fentanyl exists and managed to get through, and was widely prescribed by doctors, and the whole industry setup to encourage prescription, I think thats not really true. Its not even like its that effective as a pain relief (https://www.bjanaesthesia.org/article/S0007-0912(17)37428-7/...)
If you would give a balanced PoV you would not only count the good drugs that could have been, but also list all the bad ones that were fortunately prevented from being released on the public. If you only list one side, your argument is missing something essential. Loosening regulations has an effect not only on drugs that turn out to be very net positive, we will also see more bad ones. Now I'm just waiting for someone to point out that all we need is perfect regulation that exactly lets through all the good ones and filters all the bad ones....
some drug are moneymakers. lots of people can take them. viagra was that or now ozempic etc. but there's lots of novel drugs that never get past testing because they cost too much or the market too small to recover profit.
these studies struggle to find candidates, the testers rarely have serious side effects, so i think on the net this will not cause the harm you worry.
however! i would be worried taking new broad market drugs post any fda collapse.. but there's fewer of those on average. and pharma companies compete on efficacy and side effects and love to show investors results. so mixed bag.
we play it too safe. ozempic will save many many lives. if it had been approved years earlier it would have saved many many more. waiting for perfect is what the current system feels like, and seems like something you also know is foolish.
18 studies. only 6 novel. not a healthy ecosystem imo
I will go further. In the snake oil market, trying to produce actually good novel drugs is a loosing strategy. You wont be selling more, because you will have exactly the same footing as those who just lie and exaggerate over their results. Except they will have more funds to spread those lies and to convince people, because they did not wasted money on research.
https://archive.ph/0dddh
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.
I’ve heard RFK say that it’s hard to ban TV ads for drugs. They are “speech” according to the 1st amendment, or something like that.
Too bad. News broadcasts are full of those ads, and hence TV journalists are loath to investigate the people that pay their salaries.
There's loads of precedent pointing to commercial speech such as marketing as having some specific carve outs on the right to free speech. After all we have limits on tobacco marketing and food labeling requirements.
The politicians are getting funded/paid (lobbying/donations) by the very same people/companies that pay the ad revenue to those media. Why on earth would politicians legislate against their actual bosses? (As a real life reminder - a dog that bites the hand that feed him is put down). Courts btw don't make up shit.. they 'judge' (verb) with the criteria of 'what does the law define'. So if politicians legislate wisely, courts will enforce any 'parliamentary' and/or executive order to ban the advertisements of medicine.
But they won't. Not until push-comes-to-shove, and the true bosses will reposition to 'the next thing' (smoking, sugary-foods, medicine) and then they will allow the politicians to finally block meds ads. In which case the 'next wave' will begin. Story as old as time...
I wonder if it would be possible to ban visuals on these ads. To allow only text.
They were illegal up until quasi recently… mid 90s IIRC. I believe it was right around the time of Viagra - probably not a coincidence.
Close, 1982 for print, 1983 for TV. You’re thinking of Rogaine, I think.
https://en.wikipedia.org/wiki/Direct-to-consumer_advertising
> Merck published the first print DTC ad for a pneumonia vaccine targeting those aged 65 years and older, and Boots Pharmaceuticals aired the first DTC television commercial in 1983 for the prescription ibuprofen Rufen.
But that sentence was worded weirdly, so I checked the sources. This is one of the two for that part:
https://web.archive.org/web/20250114005757/https://adage.com...
> While 2006 marks the 10-year anniversary of the Claritin ad, it was actually 24 years ago that the FDA unwittingly opened the door to DTC. Speaking at the American Advertising Federation conference and addressing the Pharmaceutical Advertising Council, then-FDA Commissioner Arthur Hull Hayes Jr. summarized the state of drug advertising, saying it "may be on the brink of the exponential-growth phase of direct-to-consumer promotion of prescription products."
> Drug companies jumped on the phrase "exponential growth" and took it to mean the FDA, however tacitly, supported DTC.
> 'Opening a closed door'
> "It was viewed by the industry as FDA opening a closed door," said Kenneth R. Feather, a former associate FDA commissioner.
> A year later, in 1983, Boots Pharmaceuticals aired the first direct-to-consumer TV ad when it promoted its prescription ibuprofen medication, Rufen. The company also ran newspaper ads at the same time. That was in May; by September, the FDA asked the industry for a voluntary moratorium on drug advertisements. (Ibuprofen actually went over the counter a year later.)
> In 1984, Upjohn sponsored a major conference on DTC advertising in Washington, D.C., where it made no bones about expressing its opposition to the practice. But less than five years later, Upjohn was touting the merits of DTC after its hair-restoration medication, Rogaine, was approved by the FDA and needed to be marketed.
It was a very strange experience once when I was in the US, at a hotel reception, suddenly hearing an advert for a sildenafil drug on TV behind the receptionist.
"Didn't you have ads in the 20th century?"
https://www.youtube.com/watch?v=XPGgTy5YJ-g
I don't think any convincing is needed.
https://x.com/RobertKennedyJr/status/1793144103800361050
> We are one of only two countries in the world that allow pharmaceutical companies to advertise directly to consumers on television. Not surprisingly, Americans consume more pharmaceutical products than anyone else on the planet.
> As I told @JoePolish, on my first day in office I will issue an executive order banning pharmaceutical advertising on television
Unfortunately, this is probably illegal. See cases like United States v Caronia.
Worth reminding everyone that, on top of pharma and food, the FDA also regulates medical devices.
Insufficient regulation both on approval _and_ inspection of medical devices (thinking surgical applications and implantables for example) is as impactful on patient safety as drugs.
NeuralLink is suddenly going to get a miraculous green light for broad human trials hey
That's a relatively minor danger. My father, before retirement, was responsible for certifying medical devices. The number of outright scams which reached his desk was off the charts.
Half of that stuff didn't work as advertised, the other was actually dangerous, because it e.g. didn't control dosage.
The damage to U.S. government safety institutions by the current administration may be significant, from faulty pacemakers and cancer-inducing scanning machines to disabled babies and Ebola.
It’s not some temporary thing where we can just raise awareness and then people will vote them out of office next time. The changes that have been made affect the ability for those opposing to win the next election, and even if they were to, the checks and balances have gone.
At this point, unless you plan to work to undo it long-term, you could accept that our society will be quickly devolving maybe 100-150 years or more.
In the past, opportunity abounded in fake science, magical thinking, weird products, dirty industry, manual labor, inequity, and brutish behavior.
If they want to outlaw processed foods and we all start eating flavorless thick hard biscuits of grain and beans and less-than-stellar-looking fruits and vegetables, it’ll probably be better for my mental and physical health.
However, that may be offset by my teeth rotting from lack of fluoride and getting cancer and intestinal problems from lack of regulation. And the death, disease, and disablement will overshadow the fear and excitement from street fights, arcing electrical devices, dangerous bubbling chemicals, planes falling from the sky, things exploding, medicine shows, and AI whorehouses.
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.
That seems more like an "underfunded and underjurisdictioned" problem for a portion of what they do, rather than collapse of the agency.
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.
And truly it gets worse every year…
https://www.propublica.org/article/fda-drug-loophole-sun-pha...
> Digging through company records and test results, they found more evidence of quality problems, including how managers hadn’t properly investigated a series of complaints about foreign material, specks, spots and stains in tablets.
> Those unknowns have done little to slow the exemptions. In 2022, FDA inspectors described a “cascade of failure” at one of the Intas plants, finding workers had destroyed testing records, in one case pouring acid on some that had been stuffed in a trash bag. At the second Intas factory, inspectors said in their report that records were “routinely manipulated” to cover up the presence of particulate matter — which could include glass, fiber or other contaminants — in the company’s drugs.
> Sun Pharma’s transgressions were so egregious that the Food and Drug Administration imposed one of the government’s harshest penalties: banning the factory from exporting drugs to the United States.
> A secretive group inside the FDA gave the global manufacturer a special pass to continue shipping more than a dozen drugs to the United States even though they were made at the same substandard factory that the agency had officially sanctioned. [...] And the agency kept the exemptions largely hidden from the public and from Congress. Even others inside the FDA were unaware of the details.
FDA inspectors found actual, live contamination in drugs produced by a manufacturer, and the agency secretly (otherwise, it would have caused "some kind of frenzy" in the public") gave it an exemption anyway, to make sure supply wasn't impacted. This isn't a "funding" issue, and it's not a "regulations are too strict" issue. This is an issue with the people running the agency behaving completely inappropriately.
But bacteria are all natural!
It feels to me like the tyranny of small differences. The fact that the various watchdogs amplified such specific issues greatly overshadowed their support of the mission. From what I've read, the FDA is a backwater from a funding perspective, and yet a punching bag from a regulatory point-of-view.
The 2018 valsartan recall is a perfect example of this - an overseas manufacturer's nitrosamine contamination went undetected for years despite theoretical oversight, affecting millions of patients.
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.
If Chesterton's fence doesn't have a working latch, then it's appropriate to remove it entirely.
If Chesterton's fence is intangible and invisible, then it's appropriate to remove it entirely. If it doesn't have a working latch, it doesn't serve as a hard barrier, but it may still serve as a soft barrier, and that may be good enough.
Or, conversely, important things may have been relying on access via the latch-free fence gate: fixing the latch without providing a more appropriate solution to those issues could cause more harm than the benefit you get from "now the fence actually functions as a barrier". (Sure, the latch keeps the wolves out, and stops them picking off the sheep – but it also keeps the sheep away from their only freshwater source, without which most of the sheep are going to die.)
Or fix the latch? Or was this a sarcastic comment?
https://fs.blog/chestertons-fence/
I know what Chesterton's fence is, my question was specifically about why one would throw it away if the latch doesn't work.
That just means the FDA was restricted. The FDA is fine. The people funding the FDA are not.
Chiron: 2004, the UK government shut down their flu vax plant (it was in the UK). It later came out that the FDA knew what was up and basically let it slide. It was one of the early ani-vax movements torches... Crunchy moms pissed about shots for kids and parents on Oxycodone were not happy with Pharma (or corporations in general: Enron etc..)
> politically unpopular drug shortages ...
Ask your ADHD friends about how they get their meds.
One side wants to keep it, the other side wants to get rid of it. No one wants to fix the problem.
> No one wants to fix the problem.
That’s not what wedge issues are for. They’re not meant to be solved, because then they’re used up, and there’s airtime to fill in the meantime.
Reject modernity. Return to the old ways
Pity the old ways are
> You’ve died of dysentery
It really feels like the US is a failed state at this point, but it just hasn’t had full impact yet. Not really sure how all this destruction (in only half a year!) can be reversed in any meaningful timeframe in the future.
As Sarah Chayes said about the "failed state" of Afghanistan:
> Afghanistan is often described as a “failed state,” but, in light of the outright thievery on display, Chayes began to reassess the problem. This wasn’t a situation in which the Afghan government was earnestly trying, but failing, to serve its people. The government was actually succeeding, albeit at “another objective altogether”—the enrichment of its own members.
From https://archive.is/CBQFY .
Was it here or in the reviewed book about corruption where it's mentioned, how corruption endangers security, because guess what the civilians who are mad about the blatant corruption will do when they see an insurgent plant a roadside bomb targeting the corrupt government?
As Supreme Court Justice Louis Brandeis said (and Timothy McVeigh quoted):
> In a government of laws, existence of the government will be imperiled if it fails to observe the law scrupulously. Our government is the potent, the omnipresent teacher. For good or for ill, it teaches the whole people by its example. Crime is contagious. If the government becomes a lawbreaker, it breeds contempt for law; it invites every man to become a law unto himself; it invites anarchy. To declare that in the administration of the criminal law the end justifies the means -- to declare that the government may commit crimes in order to secure the conviction of a private criminal -- would bring terrible retribution.
I’m not trying to challenge how you feel, but I’ll note that in my social groups people don’t feel this way, life is good, and they also feel confident that they’re well informed.
So I’m open to the possibility that lot of these types of feeling, in both directions depending on the political era, is more dictated by environment and media consumption choices and their versions of doom and gloom than reality
Feeling well informed is not the same thing as being informed. Just because it's possible to live in the USA and follow some news without knowing how badly the democratic order is being eroded doesn't mean that all is actually well.
Do your friends know about the absolute immunity the Supreme Court invented for the president? Do they know about the illegal deportations that are accelerating? Do they know about the presidential order that aims to deport legal citizens of the USA (the end of birthright citizenship)? Do they know about the gutting of virtually all social programs?
If they don't, then they're ill informed, regardless of their feelings on the matter. If they do and still think all is well, then they are just as much a part of the problem as the ones doing this all.
Plenty of people feel that way when they're in Dubai or Qatar. Lovely place, just don't look at the army of migrant workers with no rights who keep it all running.
Well. There is measles epidemic right now...
The FDA's creation was directly triggered by multiple mass poisoning incidents in the early 1900s.In 1937 over 100 people died from diethylene glycol-contaminated medicine, leading to the 1938 Food, Drug, and Cosmetic Act that significantly expanded FDA authority.
As the adage goes, "regulations are written in blood". The problem is the blood was spent before many people can remember (or bother to remember). They just know the "limitations" imposed by those regulations and therefore want to get them removed.
“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.
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.
yeah, because unless you legitimately have heavy metal poisoning, the side effects DEFINITELY aren't worth it
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.
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)?
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.
Iron, copper, zinc, cobalt, manganese and selenium are "heavy metals."
EDTA removes all metals. It's simply a compound that forms water-soluble complexes with metal ions, removing them from the body.
The way idiots kill their children with it is that among other metals, it removes calcium ions, and those are necessary for life, with low enough concentration in blood eventually resulting in cardiac arrest.
So said idiots have an autistic child, read junk online that tells them that "toxins" caused this, find the compound that is legitimately used to remove toxins, and administer enough to end the autism. By stopping their child's heart.
I don't particularly like the FDA, but restricting the availability of EDTA is not something I'd criticize.
If you have such parents, you basically lost the game of life without having a chance to participate much. The only real solution would be to forcibly and permanently take children away from such people, not something I see flying in US if we don't include ie physical abuse or pedophilia.
I feel like a basic human life value has decreased recently. Be it ongoing brutal wars, news pushing doom and gloom 24/7, covid certainly didnt help or something similar. A bit like reversal to medieval times when cruel public executions were a spectacle for whole town and families and life of individual was truly worthless.
If thats the case, let the dumb die including offsprings, just don't let their bills to be picked up by society. Extremely cruel, but it seems we are heading that way, and we have this little thing called overpopulation. Extreme freedom with extreme consequences.
Wow, that's an interesting rabbit hole: https://en.wikipedia.org/wiki/Heavy_metals.
> Even in applications other than toxicity, no widely agreed criterion-based definition of a heavy metal exists. Reviews have recommended that it not be used. Different meanings may be attached to the term, depending on the context.
"Heavy metal" in general is a bad term, but especially when used as a proxy for toxin. There is no universal definition of heavy metal and there is no inherent connection to toxicity in any specific organism.
Then again, pretty much every metal is toxic at some relatively low body-mass concentration, even iron (which actually can and does kill people, especially when children eat adult iron supplements).
Even lovely unreactive gold does have compounds that are toxic.
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"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."
Excellent statement, but who is the "great man" who once said this?
Important quote! Citation?
stevenAthompson from HN.
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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.
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.
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.
Like I said, I don’t agree with his tactics. Burning the bridges isn’t smart.
I do think a lot of DC fat is coping mechanisms. The bureaucracy is so slow to respond to change, change that this community loves, and needs a redo. Reorg. Whatever.
I get why my opinion is so downvoted but the reality is the reality.
Sorry, this SAIC? https://www.saic.com/ Just curious which SAIC you are referring to.
Would you prefer Leidos?
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.
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.
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.
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.
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
> 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.
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?
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
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.
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?
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.
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!
> Should allow pharma to sell drugs to the market.
This was the case pre-FDA. IIRC, that is how heroin was sold in drug stores. See also OxyContin[0].
> Allow people to sue if they are harmed.
So you advocate a costly post-harm remediation instead of a preemptive solution provided by governmental regulations?
> Do not care about a government agency preventing access to new drugs.
See previous reference to heroin once being an over-the-counter product.
0 - https://apnews.com/article/purdue-pharma-sackler-settlement-...
> So you advocate a costly post-harm remediation instead of a preemptive solution provided by governmental regulations
Absolutely. Such solutions tend to be much cheaper and more effective. It's how we deal with the vast majority of problems for a good reason.
If we sold oxycontin over the counter we would have much less of an overdose problem than we do. Would also take a lot of stress off our emergency medical care system which spends an inordinate amount of time just dealing with addicts looking for drugs.
It's a funny example to use to justify the current regulatory framework because oxycontin got approved by the very same.
>> So you advocate a costly post-harm remediation instead of a preemptive solution provided by governmental regulations
> Absolutely. Such solutions tend to be much cheaper and more effective.
This is not supported by any credible analysis I am aware of, as the cost of rectifying a problem post hoc has historically been far greater than preventing it in the first place.
> If we sold oxycontin over the counter we would have much less of an overdose problem than we do.
This assertion is demonstrably wrong and could easily be categorized as insulting to people struggling with OxyContin addiction.
Insanity. Do you honestly believe the average person (probably a sick one at that) has the resources and time to fight a large pharmaceutical company in court? And do you really believe that during the time between releasing the drug and losing in court the faulty drug wouldn't make the company much more money than they'd have to pay as compensation? The amount of organization it would require to beat a large company with its resources would guarantee that most abuses would go unpunished and suffering would certainly increase compared to an environment with well functioning FDA.
> Should allow pharma to sell drugs to the market. Allow people to sue if they are harmed.
This is a comical extreme vision of libertarian politics. Everything gets worse, lots of people die, but it's okay because we have a small principle of freedom. Yeah. Great.
If you're trying to persuade people you're doing a very shit job.
The actual budget of the FDA is $4 billion. The overly restrictive regulations it puts on drug development and manufacture of generic medication costs 10-100x that.
"If you think safety is expensive, try an accident!"
> 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.
> 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.
> 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.
A true believer, neat.
BBB is the most recent example of this. We cut spending across the board, shit on American, and in exchange we... raised the deficit by Trillions of dollars? What? How?
Republican fiscal policy.
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.
You know so little about how the world actually works that it's funny you even try to speak about it.
Society would literally cease to function if the government stopped providing the services that your "friction" funds. Roads, the court system, police, waste and water, defense - these barely scratch the surface of what the US government provides, and yet remove any one of them and it would be enough to bring down the entire economy.
> 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.
In republican governments, yes this is real.
In democrat governments, the vast majority of taxes goes into productive issues such as education, transportation, and healthcare. Even the type of bills passed by democrats are friendly towards building a society.
Now, YOU may not want to pay for other's education, transportation, and healthcare. But a lot of people appreciate that access to high quality is not merely limited to the wealthy. This is why you'll see amazing companies in blue states vs red, you'll see amazing companies starting during blue federal governments vs red.
The data is very clear on what produces great outcomes for society. You might not want others to get a decent life but you need to admit your selfishness.
That's how most oppressive regimes end. Sometimes faster.
What's oppressive about FDA? Be specific.
They obviously weren't referring "specifically" to the FDA at that point.
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Can you speak directly to what you're referencing, please?
I am referencing the grotesque overregulation, and hence ridiculous costs and greatly reduced supply, of medical innovations such as new drugs.
The FDA approved an average of 47 new drugs annually from 2015 to 2024.
A few notables.
Ekterly (sebetralstat) – Treats hereditary angioedema (approved July 3, 2025)
Zegfrovy (sunvozertinib) – For NSCLC with EGFR exon-20 insertion mutations (July 2, 2025)
Widaplik (amlodipine + indapamide + telmisartan) – Single-pill hypertension therapy (June 5, 2025)
Tryptyr (acoltremon ophthalmic) – First in class dry-eye treatment (May 28, 2025)
mNEXSPIKE – Next-gen Moderna mRNA COVID-19 vaccine (May 30, 2025)
Emrelis (telisotuzumab vedotin) – Lung cancer (NSCLC) targeted therapy (May 14, 2025)
Yutrepia (treprostinil inhalation) – For pulmonary arterial hypertension (May 23, 2025)
Brekiya (dihydroergotamine autoinjector) – Acute migraine and cluster headache therapy (May 14, 2025)
Gomekli, Journavx, Grafapex, Datroway – Novel agents in oncology and pain management (early 2025)
Opzelura (ruxolitinib cream) – For vitiligo and atopic dermatitis (2022–2023)
Cobenfy (KarXT) – New schizophrenia medication targeting cholinergic receptors (Sept 2024)
Tarlatamab (Imdelltra) – First in class BiTE immunotherapy for small-cell lung cancer (May 2024)
Pegcetacoplan (Empaveli/Syfovre) – First complement C3 inhibitor for PNH & geographic atrophy (May 2021)
Leniolisib (Joenja) – First treatment for APDS immune deficiency (March 2023)
Nedosiran (Rivfloza) – siRNA therapy for primary hyperoxaluria (Sept 2023)
Retifanlimab (Zynyz) – PD-1 antibody for Merkel cell carcinoma (March 2023)
Are you aware of any of these?
i know this is a very political thing now but i've had friends (smart phd people who work industry) very annoyed at the fda for many years, and maybe this collapse is good!
the fda started with a noble mission but they've been getting heavy handed. or better cliched - slow handed with getting things certified.
you can solve this one or two ways: drop regulation or increase staffing.
so many institutions have unnecessary fluff, tremendous red tape (why do i need environmental review to stick a shed in my backyard??), our modern lives have too much regulation.
let's hope for the best.
the old system is holding back drugs.. there should have been more ozempics, more breakthroughs had the fda not been so slow. companies have a strong incentive not release bad drugs now.. lawyers are not cheap and law firms know money can be made.. it's not the 1930s anymore.. (okay it's still the 1930s in certain places of the world, that's a criticism)
typing this out hoping to convince any regulation reduction is good reduction, i thought of a third fda option: the fda let's everyone go hog wild initially but looks at the top consumed products and checks them for safety and efficacy each year.
> why do i need environmental review to stick a shed in my backyard??
Because cowboys make cowboy decisions, which leads to loss of lives.
"We're going to build on a flood plane, don't worry we've put in protection" turns out they didnt and the things they did made the flooding worse.
> companies have a strong incentive not release bad drugs now
Given that fentanyl exists and managed to get through, and was widely prescribed by doctors, and the whole industry setup to encourage prescription, I think thats not really true. Its not even like its that effective as a pain relief (https://www.bjanaesthesia.org/article/S0007-0912(17)37428-7/...)
If you would give a balanced PoV you would not only count the good drugs that could have been, but also list all the bad ones that were fortunately prevented from being released on the public. If you only list one side, your argument is missing something essential. Loosening regulations has an effect not only on drugs that turn out to be very net positive, we will also see more bad ones. Now I'm just waiting for someone to point out that all we need is perfect regulation that exactly lets through all the good ones and filters all the bad ones....
some drug are moneymakers. lots of people can take them. viagra was that or now ozempic etc. but there's lots of novel drugs that never get past testing because they cost too much or the market too small to recover profit.
these studies struggle to find candidates, the testers rarely have serious side effects, so i think on the net this will not cause the harm you worry.
however! i would be worried taking new broad market drugs post any fda collapse.. but there's fewer of those on average. and pharma companies compete on efficacy and side effects and love to show investors results. so mixed bag.
we play it too safe. ozempic will save many many lives. if it had been approved years earlier it would have saved many many more. waiting for perfect is what the current system feels like, and seems like something you also know is foolish.
18 studies. only 6 novel. not a healthy ecosystem imo
I will go further. In the snake oil market, trying to produce actually good novel drugs is a loosing strategy. You wont be selling more, because you will have exactly the same footing as those who just lie and exaggerate over their results. Except they will have more funds to spread those lies and to convince people, because they did not wasted money on research.
This perspective is addressed in the article... TLDR; that doesn't seem to be where this is going.