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...
The problem here is the drugs that are advertised as generally considered "good things". Anybody attempting to regulate the display of these ads would likely need to prove the ads are more harmful than any positive from the ads.
The ads (and it's been debated) is (imho as well) a way to 'buy out those who can keep then in check'. Media/journalists are supposed to be doing that. But when your chief editor tells you "hey, 70% of our network's revenue comes from XYZ" even if you don't want to, you self-censor.
Anyway I have commented many times on the 'legalized bribing' called 'lobbying'. The dishonest ones always week because those with $$$ know very well who can they buy and who can they threaten.
Consumers can directly buy alcohol and tobacco, they cannot buy prescription drugs directly. If there is a problem isn't the primary culprit the prescriber?
If consumers can't even buy these drugs, why do the direct marketing at all? Are you trying to suggest the consumer doesn't have much weight in the prescribing decisions of their doctors?
Clearly the pharmaceutical companies think there's a strong reason to directly market these drugs to consumers even if they can't directly purchase these drugs. The ads almost always say "ask your doctor about..." not "think about prescribing x to your patients..." If these ads didn't do much the industry wouldn't be spending billions of dollars on them.
>If these ads didn't do much the industry wouldn't be spending billions of dollars on them.
Thats speculative. Companies spend exorbitant amounts of money on things they lose money on all the time. What's not speculative is consumers cant buy the drugs themselves. They might ask doctors about it, but if the doctors are misprescribing that's on them or their training and not the consumer.
You're acting as if people shopping around for doctors to get whatever pills they want isn't a thing. That consumers will ask their first GP about a drug, get told no, and then drop it to never ask again.
What's not speculative is consumers will find a way to buy the things they want to buy, and advertising has some amount of influence on purchasing decisions of most consumers.
Either way, can you draw this back to allowing or disallowing direct to consumer prescription drug advertising? Are you honestly suggesting the billions spent on drug advertising has no impact on drug sales?
Sure it might have an impact, but again the culpability of harm isn't on the consumer or advertiser. If people able to shop around for doctors to get any prescription then isn't that the problem, not the advertisement?
It doesn't matter if the adverts have an impact on sales, if it does then doctors are to blame, tv adverts cant prescribe people medication.
If we had heroin advertisements on TV showing how great life is while doing heroin, just ask your doctor, would you still say there is no culpability of harm on the company paying for the ads (the same company supplying all the heroin to the market)? And then remember, actually that was reality, they just didn't call it heroin.
If consumers didn't have in your face advertising about how this new magical wonderdrug will solve all your life problems and you'll be happy again just like all these paid actors, you think they'd still be shopping around doctors as hard? You think they'd even know to shop around for that wonderdrug or pressure their doctor to try it?
Do you think people's decisions to shop around for doctors has zero relation to the drug advertisements they see on TV, on billboards, on the side of busses, in magazines, on the radio, on websites, etc?
Do you think people would still buy as much Coca Cola if they stopped advertising?
With your logic we might as well allow marketing of tobacco to minors again. After all, stores aren't legally allowed to sell it to the minors, so it's just a fault of the stores and the kids.
Do you think we as a society are better off or worse off having pharmeceuticals directly advertised to consumers?
TV ads for cigarettes are not legal in the US at least. And alcohol ads have a bunch of weird regulations like they can’t show people in the act of drinking (holding the booze is fine).
> 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.
The biggest war advertising ever won was manipulating us into classifying their manipulation as speech.
Convincing people to buy things they don’t want or need shouldn’t be protected speech.
Convincing people to take medication they don’t need is the pinnacle of idiocratic capitalist absurdity.
> 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.
Since when has something being illegal/unconstitutional stopped the current administration from doing anything?
So its still a choice they are making, just one that further shows that with the current administration (and ultimately SCOTUS with their shadow docket bullshittery) the rights of corporations are protected far more than the rights of individuals.
The point they're making is that $currentAdministration ran specifically on a platform countering this behavior and have failed to keep those promises, whereas others which ignored it simply did not mention it.
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.
Why are prescription drug ads bad? Its not like consumers can prescribe or buy it for themselves.
If there is a problem with overconsumption or misuse of prescription drugs isn't the blame on the medical professionals that prescribe them? Ads to the general public seems far down on the list of culprits here.
The strategy of "making it increasingly hard to resist the pressure, increasing the pressure and then blaming the group of people for failing to resist the predictable pressure" fails.
Eventually, doctors that resist the pressure loose in the market, because they end up less liked and more criticized. And that is about it.
>Eventually, doctors that resist the pressure loose in the market, because they end up less liked and more criticized. And that is about it.
Sounds like the incentives for doctors are misaligned. They shouldnt be subject to market demand for improper prescribing, for example that should be offset by fines or license revocation for misprescribing. Consumers cant be expected to know if a treatment is appropriate, so they consult doctors and if doctors are swayed by financial incentives to prescribe thats on the doctors.
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.
I think it can be both actually. The FDA through over regulation scared local manufacturing from generics which are generally low margin. Overtime you become dependent on Indian generics which have a horrible track record, this is a country that has massive lead contamination from spices and the government does nothing about it. Too late now the ship has sailed and you are now forced to utilize these. No doubt it’s a structural problem in the FDA but it can also be one where perhaps the stakes were kept too high for manufacturing in the US.
That is a problem of the government not inspecting imports and/or allowing them from places with known problems.
If the government had said the imports from India are not allowed due to insufficient quality controls, then the market price for the generics would increase in the US, maintaining the necessary profit margins for the manufacturers to provide higher quality medicine produced at higher cost.
This all seems entirely reasonable. This is a cost benefit calculation. If bad drugs kill 1 person, and drug shortage kills 100, what do you choose?
The FDA chose a practical middle ground. Ban what isn't critical, and for those that are, they put additional mitigations in place:
> Exempted drugs were sent to the United States in a “phased manner,” the company said, with third-party oversight and safety testing.
>“The odds of these drugs actually not being safe or effective is tiny because of the safeguards,” said one former FDA official involved in the exemptions who declined to be named because he still works in the industry and fears professional retribution. “Even though the facility sucks, it’s getting tested more often and it’s having independent eyes on it.”
>Internal divisions and pressure from Congress also limited the FDA's response to overseas violations,
whistles
>delays in launching a generic version of Lipitor could cost Americans up to $18 million a day, according to a 2011 letter from a group of U.S. senators to the FDA commissioner.
It can be true that not every function of the FDA works as intended, while it still does provide functions that are crucial to American society and are being removed.
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?*
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.)
This doesn't really make sense, especially to the Chesterton's Fence parable. If it doesn't have a latch and you don't know why it doesn't have a latch...
We know for a fact (like actual empirical fact) that FDA prevents vast numbers of unsafe and ineffective drugs from reaching the market. This is absolutely indisputable.
So uhhh, maybe we think in reality instead of offloading to metaphor.
The whole “let’s paint a general principle with a broad brush over this highly nuanced thing I know nothing about” is a huge problem with discourse in our society.
> We know for a fact (like actual empirical fact) that FDA prevents vast numbers of unsafe and ineffective drugs from reaching the market. This is absolutely indisputable.
we also know for a fact that the FDA lets unsafe and ineffective drugs into the market, especially from overseas, slapped with a label that its safe according to the FDA. if its a crapshoot, what's the point really?
Despite its failures (however many you want to point out), our regulatory regime converts a pipeline of almost universally ineffective and/or dangerous compounds into a marketplace of almost universally safe and/or effective compounds. This is a fact.
Unless you think no one is trying to, would try to, or would deceive themselves into accidentally releasing a dangerous or ineffective compound to 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.
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.
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.
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.
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.
I used to work for that branch. They'd joke it's the FDDA. Paid peanuts but I learned a lot and had a great boss (who showed up to my house one day unannounced to gift me the Art of Programming because I said I didn't have a copy months prior).
Also "medical device" is a broader term than most people realize. For instance: a blood draw or tissue biopsy, followed by DNA sequencing, followed by data analysis, leading to a report for personalized cancer treatment.
There are serious cyber security implications too.
A recent discovery was a heart rate monitor used in hospitals that sent all data, including full patient details, to Chinese servers, and would accept arbitrary code updates from said servers.
If you wanted to kill a diplomat, muting or spoofing heart rate data while they have a cardiac event in hospital would be a very sneaky way to do it.
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.
They also would like it if occasionally everyone reviewed legislation in light of whether it actually had a positive cost-benefit. The claim has to be something significantly more valuable than a few 100 people dying from poisons each year for the thousands to millions of deaths caused by inefficiencies in the biomedical industry. 3,000,000 people die in the US each year right now. Optimising the medical system for nimbleness and low costs is a much better path to take rather than optimising for something that is presented as a statistical rounding error.
If people don't think a drug manufacturer is safe they don't have to buy drugs from them.
> The claim has to be something significantly more valuable than a few 100 people dying from poisons each year for the thousands to millions of deaths caused by inefficiencies in the biomedical industry.
It's extremely misleading to argue with confidence that even a significant fraction of those thousands to millions of deaths would be prevented if only we had the good sense to eliminate medical regulations entirely and that doing so would only result in a few hundred deaths.
It's not just about poisoning deaths from toxic medicine -- it's also about additional deaths from people taking snake oil treatments over proven effective treatments. If the US response to COVID shows us anything, it's that this latter group can be quite significant.
A big problem that's led us to where we are is that many in the right wing fringes that brought us the current administration make their fortunes off selling snake oils in the form of supplements. And while I'm sure some will immediately point out that left wing fringes have their own bullshit cures (e.g., essential oils, healing crystals, etc.), the difference is that this group is still treated as the kooks they are.
I remember the Tylenol hysteria (in the 1980's?) when there were a few poisonings.
It may well be that the legitimate drug manufacturers benefit from tight regulation by the FDA. They can give them legitimacy when the public may otherwise overreact.
I'm not sure an anything-goes environment is going to be something they're going to enjoy. Oh well.
And if they had stuck with making sure medicine sold is exactly what it says on the bottle instead of expanding to telling me which medications I am allowed to have, I would be their biggest supporter.
I was going to say "The FDA, in general, does not tell you which medications you can or cannot take." but often when people make a comment like yours and you press them on it, it turns out they're angry because they can't find a doctor who will inject something insane into an unusual part of their body so instead I am going to ask:
What medicine, SPECIFICALLY PLEASE, does the FDA not allow you to have?
edit: because I'm pretty sure you can find doctors who will prescribe 3 liters per minute of elephant farts to treat high blood pressure, or compound up some turbofentanyl mixed with vitamin q to grow hair on your gooch if you look hard enough and there's nothing the FDA can do about it so most of the time peoples' problems are with insurance companies or pesky medical ethics and various state boards of medicine.
Good question. I have narcolepsy. There is a medication called TAK-861 which is the first drug to actually treat the root cause of the disease. It has passed phase 1 and 2 trials proving it is safe and effective. My doctor is involved in the research has said he wishes he could prescribe it to me now, but it is still in phase 3 trials and will not be approved by the FDA for another 2 years, so he can't give it to me.
I despise nothing more than these bureaucrats. If I want to take the risk on a new medication then that's my choice. If someone else doesn't then that's fine too. I'm not the one telling other people what to do, these worthless busybody bureaucrats are.
>will not be approved by the FDA for another 2 years, so he can't give it to me.
edit: I wrote a bunch of bullshit and then deleted it but the points are:
1. Narcolepsy sucks
2. The FDA can't stop your doctor from giving you TAK-861, the likely culprit is Takeda. It is 100% legal for Takeda to sell Oveporexton so long as they don't claim that it treats narcolepsy until it has been approved, and it is 100% legal for your doctor to give it to you.
3. Have you looked at >>>RIGHT TO TRY<<<? Again, with this the ball's in Takeda's court.
>Unapproved drugs exist in a gray area in U.S. law. Although it is not illegal to prescribe non-FDA approved drugs, it is also not viewed as best practice. If a doctor prescribes an unapproved drug, he or she could face civil liability for the patient’s injuries, illnesses, side effects or death upon taking the drug if the physician reasonably should have known of the potential health risks due to the lack of FDA approval.
It may not be the FDA that is directly responsible here, but if the FDA approved it tomorrow, all my problems will go away. That's because, as you mentioned, our system relies on bureaucratic stamps of approval to adjudicate responsibility rather than anything real. Doctors who prescribed oxycontin and harmed their patients get off scot free because they can just say "but I was told it wasn't addictive" because it has this stamp of approval.
I will certainly take a look at those links as they may help me, but this doesn't change my opinion on the state of things. It infuriates me that I have to jump through all these bureaucratic hoops to get what I need. There is a company with a product they want to sell, and a customer who wants to buy it. The fact that they won't just sell it to me is an indication that our system is fundamentally broken.
I put little weight on the fact that the FDA in particular isn't outright banning me access. They are just one arm of the bureaucratic squid that is strangling me. The FDA says "take this at your own risk" which is on the face of it a fair statement. But they know that the civil liability system, which is just the other arm of the squid, will deny me the ability to actually take my own risk. And they know that the arm of the squid that mandates Takeda can't sell me the medicine without the approval of a doctor means that I won't be able to get through that bureaucratic gatekeeper. So the whole system works together against me while ensuring that no part of it can be blamed because it isn't the decision of any one part that prevents me from getting it, but rather the interaction between these parts. This is why "burn it all down" is such a popular position.
I don't know. I doubt it. This points to a fundamental problem in our liability system that there is no simple "This is my choice and there is nobody to blame but me. I take all the risk and can't sue anybody" contract. Our laws are written by lawyers for lawyers.
My concern is that today this could happen and people wouldn’t care. Peoples cultlike ideologies, political tribalism, and belief systems are more important to them. There was a father whose child died of measles in Texas who continues to be anti vax.
It didn't use to be like this. I've considered a number of things in our society that I could point a finger at as the cause but often when I dig just a little below the surface the one thing that I always seem to uncover in all cases is fear.
How did we (U.S.) become such a fearful country? The pace of change? A media narrative? Starting with cable television and 24-hour news?
The US became a fearful (and hateful) country because of the media, both traditional and tech/social.
Fear, hate, and other base emotions maximize engagement. A negative story that inspires fear or hate will get often thousands of times more clicks than a neutral or positive one. Media tends to be ad supported and run on attention maximizing KPIs, therefore the media pushes fear and hate.
Social media added a layer of personalized algorithm-driven amplification that dialed this way up, which is why politics has become hyper-polarized and dominated by insane narratives. It drives engagement.
Edit: the reason for this is probably an evolutionary bias toward negativity and paranoia. As the saying goes: If your ancestor mistook a bush for a lion, they lived. If your ancestor mistook a lion for a bush, they are not your ancestor. We are all the descendants of paranoids. Negative media pushes that button.
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.
> The government was actually succeeding, albeit at “another objective altogether”—the enrichment of its own members.
Indeed. And as soon as the flow of foreign money propping the whole thing up was cut off, they vanished like melting snow across the border.
Corruption endangers security in all sorts of ways. This came up at the start of the Russian invasion of Ukraine, when it became apparent that maintenance money (and in some cases entire pieces of equipment) had been diverted, resulting in operational failure. The US Navy had a corruption scandal a while ago too ("Fat Leonard").
> to declare that the government may commit crimes in order to secure the conviction of a private criminal
Not even conviction, just straight up execution. The lesson of the BLM backlash was that, no, really the US public demanded that the police had the right to execute citizens in the street without accountability.
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.
Just to spell it out it will become necessary in the future to prove that your parents were citizens, so make sure you save your birth certificates and other documents for any children you may have. They won’t automatically be citizens just because they were born here. And they may get rounded up and deported before they can find those documents or have a trial to establish their citizenship.
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.
Sadly, I expect it has to founder on the rocks before things will turn for the better. I'm channelling Great Depression —> FDR here. Hopefully a world war is not required.
We've already come close to Trump causing a war [0]. However, there is one aspect of the man (that's on display here) that gives me hope. He is a moron who can't take advice, and who appoints other morons (to make him look good?).
If it was Stalin, or Hitler, or Erdoğan or god help us Xi, the USA would be in real trouble. All of them are very competent leaders, who could take their countries in the direction they desired for a decade(s). Trump, well you just have to look at his popularity ratings, or the economy shrinking 0.5% in his first quarter. He could have poured money on the economy and had everyone getting high and merry on debt, while he took in billions in bribes via is cryptocurrencies. But nooooo, no one has a clue why he is perusing his economic policies, probably because there aren't much in the way of clues to be had.
It could have been so much worse. As it is, it looks like most countries have his measure and are working around him. I don't know what made me cringe more: Netanyahu showing Trump his letter of recommendation for the Nobel Peace price, or Trump lapping it up. Before that is was the European leaders showering gifts on him. It was disgusting. And it worked. Such is the art of politics, I guess. If you are dealing with pigs, it must appear to the pig that you enjoy rolling in their shit just as much as they do. All leaders except Putin that is. Putin played him for such a fool that even Trump picked up on it.
Vinay Prasad, the new FDA chief medical and scientific director, is an extremely sensible guy and a co-author of a great 2013 book on evidence-based medicine targeting the lay audience (Ending Medical Reversal)
The NYT article presents his COVID vaccine policy changes as yet more crazy MAGA shit, whereas in fact he holds nuanced views, based on up-to-date review of available evidence. He has published in NEJM and elsewhere on the topic:
Huh? That NEJM bit is crazy MAGA shit. It admits that if you're in a high risk group you should get it, but then turns around and says that because it hasn't been proven in every sub-group it shouldn't be done for the rest of the population. That makes no sense, it's just p-hacking in reverse.
And it completely ignores the long covid elephant.
“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.
That was my first reaction to this article too: "Ok, gutting the FDA is bad, but the destruction of some other agencies that are not even mentioned in this article actually has worse consequences. If someone believes the quacks, takes Ivermectin or EDTA and dies, that's fine for me - I hope they at least get a Darwin Award for their effort!". But when you think about people doing this to other people (including but not only children) who can't decide for themselves, it gets much more complicated...
Yeah this is one of those situations where people freak out about their neighbor's behavior and try to change who they are with administrative policy. It's really just counter productive.
I think better would be for people to be more personally picky who they share spaces with.
> 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.
I find this quote so fascinating. Who makes ivermectin and hydroxychloroquine? Pharma companies! Who makes vitamins and supplements? Massive corporations! Is there a single doctor on the planet who doesn't tell their patients that sunshine and exercise are good for them?
> Is there a single doctor on the planet who doesn't tell their patients that sunshine and exercise are good for them?
Yes, because doctors are secretly plotting alongside with big renewables to trap sunshine with solar panels and imprison it in batteries. They don't want patients to compete with them for access to sunshine.
The raw milk thing is funny to me in a semi-morbid way i guess, i find it for sale all over the place and more expensive then just regular, even organic, whole milk. Pasteurization doesn't seem to be some evil ultra-processing of milk, it just kills bacteria that can make you sick. There's no preservative or other additives that i'm aware of. Pasteurization just doesn't seem like something anyone would get worked up about but here we are.
Well the thing is that they want the enzymes and bacteria that pasteurization kills. There is limited (but existing) published research that shows the naturally existing enzymes aid digestion and immune function.
Back about 15 years ago before it became a weird culture war issue, my sister, who had a diagnosed casein allergy (casein is the main protein in milk), found that she could consume raw milk without any adverse effects.
"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."
To tell the truth, I don't remember. I've kept a "quotes.txt" file for the last two or three decades where I paste in anything I feel is worth remembering. It's been in there as long as I can remember, but I apparently didn't bother with a proper attribution.
I want to guess Oliver Wendell Holmes for some reason, but it doesn't read like something he said. Sorry I can't be more helpful.
I don't know who said the above, but the following is from Isaac Asimov:
"Anti-intellectualism has been a constant thread winding its way through our political and cultural life, nurtured by the false notion that democracy means 'my ignorance is just as good as your knowledge'"[0]
And I'd add that as Peter Medawar correctly pointed out[0][1]:
"The USA is so enormous, and so numerous are its schools, colleges and religious seminaries, many devoted to special religious beliefs ranging from the unorthodox to the dotty, that we can hardly wonder at its yielding a more bounteous harvest of gobbledygook than the rest of the world put together."
Destruction precedes creation. Things have ossified to the point where change seems impossible. While I think the way we’ve gone about it is absurd, I can still hope that something better will replace it.
The one thing I liked about RFK is that he was going to "take on" the big food conglomerates and all the garbage that they are feeding Americans especially those unable to afford, or who do not have easy access to, healthy alternatives (whereas the garbage food is ubiquitous).
It would seem dismantling the FDA is the opposite of that; what's needed are more regulations on food, or at least policies that result in more healthy food being available and affordable to Americans, not less regulation.
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.
It’s really not, though; it’s just the proverbial relief crew in a later inning of the same ball game. The players have been shuffled around or replaced, but look at the tenures of some of the players in question and you can draw a pretty direct line all the way back.
It’s not minimizing or trivializing the harms of today by pointing out their origins in the past; rather, it’s acknowledging this has been a long-term goal of those in power for decades, and it’ll take decades of continued, organized change to improve things.
There are no easy solutions or quick wins here. It’s a long game, always has been and always will be. More people need to understand that
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
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
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.
People with opiate addiction have access to the cheapest and strongest narcotics ever available on the street. Unfortunately they are of uneven strength and cut with horrors that make their body shut down. I would much prefer they could just buy clean drugs from the pharma companies.
> People with opiate addiction have access to the cheapest and strongest narcotics ever available on the street. Unfortunately they are of uneven strength and cut with horrors that make their body shut down. I would much prefer they could just buy clean drugs from the pharma companies.
Fair point.
This is a complex societal problem having no simple solution. Unfortunately, what you proposed:
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.
Is not a viable solution either. Government agencies and regulations would be needed in order to ensure pharma's do not increase drug addictiveness or otherwise engage in nefarious activities. Agencies are also an avenue for accountability in distribution, a much cheaper and effective enforcement mechanism than civil lawsuits, and can provide options for people wanting to address their addictions.
Remember, every person who dies from an overdose cannot "sue if they get harmed" as they are dead.
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.
Not to the same extent, and the solution to that is to improve the FDA, not to demolish it and let companies poison and fool people freely.
Class action is what I meant with the difficulty of organizing. To make a class action happen and win, the damage done must be massive enough to get enough people to notice it and take action, and must be easily and cheaply provable. A class action is not going to fund expensive scientific studies that prove their problem was caused by the company they're suing. Your solution would only prevent the absolute worst cases. Any damage that's rare, hard to notice or prove, small, long term, etc would not get compensated and would cost society much more than properly funding 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 reason clinical trials are so expensive and complicated is because it's extremely hard to isolate signal of "what is this drug doing to people."
So on what basis would you possibly sue a company?
As another commenter said, we have an entire industry of the form you desire: supplements. Go take them to treat your next illness so you can really experience the creme de la creme that FDA is apparently keeping from you. Good luck suing for lack of effectiveness or for any harms you encounter.
What incentive does an insurance company with an expected coverage period of 4 years have to prevent a drug with long term harm from reaching its patients?
What about drugs that people do not buy via insurance? Just have a free for all there?
Why wouldn't pharma just release the drug to the public at very low cost to use the unwitting public as its test subjects instead of running trials to satisfy insurance companies? If a bunch of people die then welp, you know not to pursue "insurance approval?"
Can't see how we could go wrong by making it very difficult to sell a working, expensive drug, and make it extremely cheap to sell a mass-market ineffective/unsafe drug...
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.
Unfortunately, they don't fail often, and we've seen the government bailing companies out so they don't fail.
But in the end, it's a moot point—even when companies fail, they are replaced with companies that either are equally wasteful, or as the replacement companies grow, their wastefulness increases.
> 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.
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?
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 us government should only provide a system for contract resolution, police, and defense. I can’t think of a single other thing the government should do
> 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.
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.
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/...)
so cowboys meet Darwin and their population drops. An alternative is a "nanny state" where every personal choice must pass regulation. This is as old as the hills, but add new abilities to monitor for compliance at scale; new orders of magnitude advantages for certain high-tech; and new amounts of money in an active and massive economic system.
Without prescribing any solution here, is it that much of a stretch to think that the FDA in practice exhibited dysfunctional characteristics in markets? With the longevity of the players and the deep pockets associated with health care, is it a stretch to see large changes to the institution as constructive in the long-run?
The point of the nanny state is to stop aggressive actors causing widespread harm.
not allowing companies to poison people for profit, ensuring people are qualified to do safety critical jobs. Making sure that companies can't cut OSHA for profit, ensuring that buildings are built to withstand the weather properly, even though it costs more.
A lot of the "nanny state" shit is there because people died. Now, of course some of it is because conservatives/liberals/that class you don't like got their knickers in a twist as well. But that tends to disappear pretty quick.
But that means that big money can use that as a spring board to remove expensive regulation.
You want clean air? but thats expensive! nevermind, soot spewing engines is manly, everything else is what those people you don't like do.
You want social media to stop sending porn to tweens? freedom of speech my friend! thats what makes america better than communism. You want your child to read the great american novels? oh did we say freedom of speech? no we meant don't do our country down.
All of that is theatre, what matters is the food and drugs you eat are safe, effective and well controlled so that the most amount of good is allowed with the least amount of harm
this is moronic twaddle lacking any middle ground. If you want to prove that public forums are a doomed method of communication, this post is a great start.
It's deadly *on the street* because of it's tendency to clump, meaning that your average drug dealer is not competent to dilute it properly. That's not a problem when handled by professionals.
What is even more bad is companies running competitions to encourage family doctors prescribe opiods for long term use.
sure heroin on the streets is bad, don't get me wrong, but giving it to unsuspecting patients, getting them addicted and then effectively forcing them onto the streets is even worse.
Advertising of drugs is fucking stupid, bribing doctors is even more stupid. But as thats where a lot of money comes for politics, its not going to change.
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....
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.
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
Would you like to see a HTML standard imposed by law and that takes years and billions of dollars to amend? I don't think you would like that either. If I had to choose between the two, I'll take the wild west no standard option.
You're asking me if I, as a full-time web developer, would like to see an HTML standard that is incredibly expensive to modify? A standard that could be relied upon to be bedrock atop which you could build frameworks and polyfill to bridge any arbitrary issue you may encounter between the underlying interface and the developer's interface, for years if not decades? A concrete, unyielding standard the browser implementers could forever optimize towards, confident their optimizations won't run afoul of a change to the standard coming down the pipe, or an entirely new feature in the standard that demands novel support at the cost of breaking abstractions that supported the existing standard?
... is there, like, a change.org petition I can sign in favor of this? ;)
For some reason, that reminds me of how Microsoft abused web development with their IE6 browser. So much wasted time and effort by so many developers just so that Microsoft could extend their monopoly.
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...
They used to be paid of RJ Reynolds, etc as well.
The problem here is the drugs that are advertised as generally considered "good things". Anybody attempting to regulate the display of these ads would likely need to prove the ads are more harmful than any positive from the ads.
The ads (and it's been debated) is (imho as well) a way to 'buy out those who can keep then in check'. Media/journalists are supposed to be doing that. But when your chief editor tells you "hey, 70% of our network's revenue comes from XYZ" even if you don't want to, you self-censor.
Anyway I have commented many times on the 'legalized bribing' called 'lobbying'. The dishonest ones always week because those with $$$ know very well who can they buy and who can they threaten.
Consumers can directly buy alcohol and tobacco, they cannot buy prescription drugs directly. If there is a problem isn't the primary culprit the prescriber?
If consumers can't even buy these drugs, why do the direct marketing at all? Are you trying to suggest the consumer doesn't have much weight in the prescribing decisions of their doctors?
Clearly the pharmaceutical companies think there's a strong reason to directly market these drugs to consumers even if they can't directly purchase these drugs. The ads almost always say "ask your doctor about..." not "think about prescribing x to your patients..." If these ads didn't do much the industry wouldn't be spending billions of dollars on them.
>If these ads didn't do much the industry wouldn't be spending billions of dollars on them.
Thats speculative. Companies spend exorbitant amounts of money on things they lose money on all the time. What's not speculative is consumers cant buy the drugs themselves. They might ask doctors about it, but if the doctors are misprescribing that's on them or their training and not the consumer.
You're acting as if people shopping around for doctors to get whatever pills they want isn't a thing. That consumers will ask their first GP about a drug, get told no, and then drop it to never ask again.
What's not speculative is consumers will find a way to buy the things they want to buy, and advertising has some amount of influence on purchasing decisions of most consumers.
Either way, can you draw this back to allowing or disallowing direct to consumer prescription drug advertising? Are you honestly suggesting the billions spent on drug advertising has no impact on drug sales?
Sure it might have an impact, but again the culpability of harm isn't on the consumer or advertiser. If people able to shop around for doctors to get any prescription then isn't that the problem, not the advertisement?
It doesn't matter if the adverts have an impact on sales, if it does then doctors are to blame, tv adverts cant prescribe people medication.
If we had heroin advertisements on TV showing how great life is while doing heroin, just ask your doctor, would you still say there is no culpability of harm on the company paying for the ads (the same company supplying all the heroin to the market)? And then remember, actually that was reality, they just didn't call it heroin.
If consumers didn't have in your face advertising about how this new magical wonderdrug will solve all your life problems and you'll be happy again just like all these paid actors, you think they'd still be shopping around doctors as hard? You think they'd even know to shop around for that wonderdrug or pressure their doctor to try it?
Do you think people's decisions to shop around for doctors has zero relation to the drug advertisements they see on TV, on billboards, on the side of busses, in magazines, on the radio, on websites, etc?
Do you think people would still buy as much Coca Cola if they stopped advertising?
With your logic we might as well allow marketing of tobacco to minors again. After all, stores aren't legally allowed to sell it to the minors, so it's just a fault of the stores and the kids.
Do you think we as a society are better off or worse off having pharmeceuticals directly advertised to consumers?
It’s baffling that TV ads for alcohol and cigarettes are illegal, but pharmaceuticals? That’s free speech!
TV ads for cigarettes are not legal in the US at least. And alcohol ads have a bunch of weird regulations like they can’t show people in the act of drinking (holding the booze is fine).
that's what illegal means.
I think you mean regulated. At best you could say ads showing people drinking alcohol are banned, but alcohol ads in general are regulated.
Pretty sure the cigarette companies are stoked they can’t / don’t have to spend any money on TV ads
Transport yourself back to the 60s when America was great and Fred Flintstone was hawking Winston's.
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.
I wonder if it would be possible to ban visuals on these ads. To allow only text.
It's not and that's bullshit from RFK.
The biggest war advertising ever won was manipulating us into classifying their manipulation as speech.
Convincing people to buy things they don’t want or need shouldn’t be protected speech. Convincing people to take medication they don’t need is the pinnacle of idiocratic capitalist absurdity.
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.
> Unfortunately, this is probably illegal.
Since when has something being illegal/unconstitutional stopped the current administration from doing anything?
So its still a choice they are making, just one that further shows that with the current administration (and ultimately SCOTUS with their shadow docket bullshittery) the rights of corporations are protected far more than the rights of individuals.
Every dollar needs equal representation.
P.S. I don't subscribe to the above but I believe it's where the owned government officials are at.
> current administration
Or previous ones.
We get it, all lives matter.
The point they're making is that $currentAdministration ran specifically on a platform countering this behavior and have failed to keep those promises, whereas others which ignored it simply did not mention it.
> We get it, all lives matter.
I don't understand what you're getting at here
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
Why are prescription drug ads bad? Its not like consumers can prescribe or buy it for themselves.
If there is a problem with overconsumption or misuse of prescription drugs isn't the blame on the medical professionals that prescribe them? Ads to the general public seems far down on the list of culprits here.
The strategy of "making it increasingly hard to resist the pressure, increasing the pressure and then blaming the group of people for failing to resist the predictable pressure" fails.
Eventually, doctors that resist the pressure loose in the market, because they end up less liked and more criticized. And that is about it.
>Eventually, doctors that resist the pressure loose in the market, because they end up less liked and more criticized. And that is about it.
Sounds like the incentives for doctors are misaligned. They shouldnt be subject to market demand for improper prescribing, for example that should be offset by fines or license revocation for misprescribing. Consumers cant be expected to know if a treatment is appropriate, so they consult doctors and if doctors are swayed by financial incentives to prescribe thats on the doctors.
forget that - suppose ozempic, blood pressure, cholesterol meds were made OTC
I would wager cardiac and arterial disease would plummet.
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.
I think it can be both actually. The FDA through over regulation scared local manufacturing from generics which are generally low margin. Overtime you become dependent on Indian generics which have a horrible track record, this is a country that has massive lead contamination from spices and the government does nothing about it. Too late now the ship has sailed and you are now forced to utilize these. No doubt it’s a structural problem in the FDA but it can also be one where perhaps the stakes were kept too high for manufacturing in the US.
That is a problem of the government not inspecting imports and/or allowing them from places with known problems.
If the government had said the imports from India are not allowed due to insufficient quality controls, then the market price for the generics would increase in the US, maintaining the necessary profit margins for the manufacturers to provide higher quality medicine produced at higher cost.
This all seems entirely reasonable. This is a cost benefit calculation. If bad drugs kill 1 person, and drug shortage kills 100, what do you choose?
The FDA chose a practical middle ground. Ban what isn't critical, and for those that are, they put additional mitigations in place:
> Exempted drugs were sent to the United States in a “phased manner,” the company said, with third-party oversight and safety testing.
>“The odds of these drugs actually not being safe or effective is tiny because of the safeguards,” said one former FDA official involved in the exemptions who declined to be named because he still works in the industry and fears professional retribution. “Even though the facility sucks, it’s getting tested more often and it’s having independent eyes on it.”
Then they should have been transparent about it.
I probably agree with transparency, there is very little information on the ways in which the FDA was not transparent.
the article states "And the agency kept the exemptions largely hidden from the public and from Congress."
How so, are the examples?
The FDA maintains a public red list of companies with import bans, and a green list companies operating under exemptions.
What transparency are we talking about?
Older article from 2019:
https://www.npr.org/sections/health-shots/2019/05/12/7222165...
>Internal divisions and pressure from Congress also limited the FDA's response to overseas violations,
whistles
>delays in launching a generic version of Lipitor could cost Americans up to $18 million a day, according to a 2011 letter from a group of U.S. senators to the FDA commissioner.
It can be true that not every function of the FDA works as intended, while it still does provide functions that are crucial to American society and are being removed.
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.
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.)
This doesn't really make sense, especially to the Chesterton's Fence parable. If it doesn't have a latch and you don't know why it doesn't have a latch...
We know for a fact (like actual empirical fact) that FDA prevents vast numbers of unsafe and ineffective drugs from reaching the market. This is absolutely indisputable.
So uhhh, maybe we think in reality instead of offloading to metaphor.
The whole “let’s paint a general principle with a broad brush over this highly nuanced thing I know nothing about” is a huge problem with discourse in our society.
> We know for a fact (like actual empirical fact) that FDA prevents vast numbers of unsafe and ineffective drugs from reaching the market. This is absolutely indisputable.
we also know for a fact that the FDA lets unsafe and ineffective drugs into the market, especially from overseas, slapped with a label that its safe according to the FDA. if its a crapshoot, what's the point really?
The point is that it's nowhere close to a crapshoot.
99.99999% of drugs ever created are unsafe or ineffective.
99%+ of the drugs you will ever encounter in your life are both safe and effective.
That is not a crapshoot. Obviously.
if you are in doubt, propublica has done a huge expose in the major, deliberate lapses of FDA regulation for foreign manufactured drugs
https://www.propublica.org/article/fda-drug-loophole-sun-pha...
How is that relevant to my point?
Despite its failures (however many you want to point out), our regulatory regime converts a pipeline of almost universally ineffective and/or dangerous compounds into a marketplace of almost universally safe and/or effective compounds. This is a fact.
Unless you think no one is trying to, would try to, or would deceive themselves into accidentally releasing a dangerous or ineffective compound to consumers?
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.
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.
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.
That just means the FDA was restricted. The FDA is fine. The people funding the FDA are not.
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.
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.
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.
I used to work for that branch. They'd joke it's the FDDA. Paid peanuts but I learned a lot and had a great boss (who showed up to my house one day unannounced to gift me the Art of Programming because I said I didn't have a copy months prior).
Also "medical device" is a broader term than most people realize. For instance: a blood draw or tissue biopsy, followed by DNA sequencing, followed by data analysis, leading to a report for personalized cancer treatment.
There are serious cyber security implications too.
A recent discovery was a heart rate monitor used in hospitals that sent all data, including full patient details, to Chinese servers, and would accept arbitrary code updates from said servers.
If you wanted to kill a diplomat, muting or spoofing heart rate data while they have a cardiac event in hospital would be a very sneaky way to do it.
But the FDA didn't stop that...
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.
They also would like it if occasionally everyone reviewed legislation in light of whether it actually had a positive cost-benefit. The claim has to be something significantly more valuable than a few 100 people dying from poisons each year for the thousands to millions of deaths caused by inefficiencies in the biomedical industry. 3,000,000 people die in the US each year right now. Optimising the medical system for nimbleness and low costs is a much better path to take rather than optimising for something that is presented as a statistical rounding error.
If people don't think a drug manufacturer is safe they don't have to buy drugs from them.
> The claim has to be something significantly more valuable than a few 100 people dying from poisons each year for the thousands to millions of deaths caused by inefficiencies in the biomedical industry.
It's extremely misleading to argue with confidence that even a significant fraction of those thousands to millions of deaths would be prevented if only we had the good sense to eliminate medical regulations entirely and that doing so would only result in a few hundred deaths.
It's not just about poisoning deaths from toxic medicine -- it's also about additional deaths from people taking snake oil treatments over proven effective treatments. If the US response to COVID shows us anything, it's that this latter group can be quite significant.
A big problem that's led us to where we are is that many in the right wing fringes that brought us the current administration make their fortunes off selling snake oils in the form of supplements. And while I'm sure some will immediately point out that left wing fringes have their own bullshit cures (e.g., essential oils, healing crystals, etc.), the difference is that this group is still treated as the kooks they are.
I remember the Tylenol hysteria (in the 1980's?) when there were a few poisonings.
It may well be that the legitimate drug manufacturers benefit from tight regulation by the FDA. They can give them legitimacy when the public may otherwise overreact.
I'm not sure an anything-goes environment is going to be something they're going to enjoy. Oh well.
[dead]
Maybe it's like Jefferson's admonition that each generation must purchase their liberty in blood.
Not happy about that possibility, but it is a possibility. "What's so bad about measles, anyway?"
Like before his confirmation, when RFK wanted to Make Polio Great Again.
And Mitch McConnell, who suffered from polio when he was 2 years old back in 1944, had strong words, but confirmed the anti-vaccine halfwit anyway.
Good job Mitch!
And if they had stuck with making sure medicine sold is exactly what it says on the bottle instead of expanding to telling me which medications I am allowed to have, I would be their biggest supporter.
I was going to say "The FDA, in general, does not tell you which medications you can or cannot take." but often when people make a comment like yours and you press them on it, it turns out they're angry because they can't find a doctor who will inject something insane into an unusual part of their body so instead I am going to ask:
What medicine, SPECIFICALLY PLEASE, does the FDA not allow you to have?
edit: because I'm pretty sure you can find doctors who will prescribe 3 liters per minute of elephant farts to treat high blood pressure, or compound up some turbofentanyl mixed with vitamin q to grow hair on your gooch if you look hard enough and there's nothing the FDA can do about it so most of the time peoples' problems are with insurance companies or pesky medical ethics and various state boards of medicine.
Good question. I have narcolepsy. There is a medication called TAK-861 which is the first drug to actually treat the root cause of the disease. It has passed phase 1 and 2 trials proving it is safe and effective. My doctor is involved in the research has said he wishes he could prescribe it to me now, but it is still in phase 3 trials and will not be approved by the FDA for another 2 years, so he can't give it to me.
I despise nothing more than these bureaucrats. If I want to take the risk on a new medication then that's my choice. If someone else doesn't then that's fine too. I'm not the one telling other people what to do, these worthless busybody bureaucrats are.
>will not be approved by the FDA for another 2 years, so he can't give it to me.
edit: I wrote a bunch of bullshit and then deleted it but the points are:
1. Narcolepsy sucks
2. The FDA can't stop your doctor from giving you TAK-861, the likely culprit is Takeda. It is 100% legal for Takeda to sell Oveporexton so long as they don't claim that it treats narcolepsy until it has been approved, and it is 100% legal for your doctor to give it to you.
3. Have you looked at >>>RIGHT TO TRY<<<? Again, with this the ball's in Takeda's court.
https://www.fda.gov/patients/learn-about-expanded-access-and...
I know nobody believes me.
Here's an ambulance chaser's blog:
>Unapproved drugs exist in a gray area in U.S. law. Although it is not illegal to prescribe non-FDA approved drugs, it is also not viewed as best practice. If a doctor prescribes an unapproved drug, he or she could face civil liability for the patient’s injuries, illnesses, side effects or death upon taking the drug if the physician reasonably should have known of the potential health risks due to the lack of FDA approval.
https://www.liljegrenlaw.com/can-my-doctor-prescribe-non-fda...
It may not be the FDA that is directly responsible here, but if the FDA approved it tomorrow, all my problems will go away. That's because, as you mentioned, our system relies on bureaucratic stamps of approval to adjudicate responsibility rather than anything real. Doctors who prescribed oxycontin and harmed their patients get off scot free because they can just say "but I was told it wasn't addictive" because it has this stamp of approval.
I will certainly take a look at those links as they may help me, but this doesn't change my opinion on the state of things. It infuriates me that I have to jump through all these bureaucratic hoops to get what I need. There is a company with a product they want to sell, and a customer who wants to buy it. The fact that they won't just sell it to me is an indication that our system is fundamentally broken.
I put little weight on the fact that the FDA in particular isn't outright banning me access. They are just one arm of the bureaucratic squid that is strangling me. The FDA says "take this at your own risk" which is on the face of it a fair statement. But they know that the civil liability system, which is just the other arm of the squid, will deny me the ability to actually take my own risk. And they know that the arm of the squid that mandates Takeda can't sell me the medicine without the approval of a doctor means that I won't be able to get through that bureaucratic gatekeeper. So the whole system works together against me while ensuring that no part of it can be blamed because it isn't the decision of any one part that prevents me from getting it, but rather the interaction between these parts. This is why "burn it all down" is such a popular position.
>I despise nothing more than these bureaucrats. If I want to take the risk on a new medication then that's my choice.
Are there laws that would indemnify the healthcare provider for unexpected adverse outcomes for voluntary recipients of experimental drugs?
I don't know. I doubt it. This points to a fundamental problem in our liability system that there is no simple "This is my choice and there is nobody to blame but me. I take all the risk and can't sue anybody" contract. Our laws are written by lawyers for lawyers.
So it's Chesterton's Fence then.
My concern is that today this could happen and people wouldn’t care. Peoples cultlike ideologies, political tribalism, and belief systems are more important to them. There was a father whose child died of measles in Texas who continues to be anti vax.
> cultlike ideologies, political tribalism
It didn't use to be like this. I've considered a number of things in our society that I could point a finger at as the cause but often when I dig just a little below the surface the one thing that I always seem to uncover in all cases is fear.
How did we (U.S.) become such a fearful country? The pace of change? A media narrative? Starting with cable television and 24-hour news?
The US became a fearful (and hateful) country because of the media, both traditional and tech/social.
Fear, hate, and other base emotions maximize engagement. A negative story that inspires fear or hate will get often thousands of times more clicks than a neutral or positive one. Media tends to be ad supported and run on attention maximizing KPIs, therefore the media pushes fear and hate.
Social media added a layer of personalized algorithm-driven amplification that dialed this way up, which is why politics has become hyper-polarized and dominated by insane narratives. It drives engagement.
Edit: the reason for this is probably an evolutionary bias toward negativity and paranoia. As the saying goes: If your ancestor mistook a bush for a lion, they lived. If your ancestor mistook a lion for a bush, they are not your ancestor. We are all the descendants of paranoids. Negative media pushes that button.
Fox News has been brainwashing people for a very long time now.
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.
> The government was actually succeeding, albeit at “another objective altogether”—the enrichment of its own members.
Indeed. And as soon as the flow of foreign money propping the whole thing up was cut off, they vanished like melting snow across the border.
Corruption endangers security in all sorts of ways. This came up at the start of the Russian invasion of Ukraine, when it became apparent that maintenance money (and in some cases entire pieces of equipment) had been diverted, resulting in operational failure. The US Navy had a corruption scandal a while ago too ("Fat Leonard").
> to declare that the government may commit crimes in order to secure the conviction of a private criminal
Not even conviction, just straight up execution. The lesson of the BLM backlash was that, no, really the US public demanded that the police had the right to execute citizens in the street without accountability.
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.
Just to spell it out it will become necessary in the future to prove that your parents were citizens, so make sure you save your birth certificates and other documents for any children you may have. They won’t automatically be citizens just because they were born here. And they may get rounded up and deported before they can find those documents or have a trial to establish their citizenship.
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.
It's also possible we're living in the Roaring Twenties. (Checks calendar. Actually kind of appropriate.)
Sadly, I expect it has to founder on the rocks before things will turn for the better. I'm channelling Great Depression —> FDR here. Hopefully a world war is not required.
> Hopefully a world war is not required.
We've already come close to Trump causing a war [0]. However, there is one aspect of the man (that's on display here) that gives me hope. He is a moron who can't take advice, and who appoints other morons (to make him look good?).
If it was Stalin, or Hitler, or Erdoğan or god help us Xi, the USA would be in real trouble. All of them are very competent leaders, who could take their countries in the direction they desired for a decade(s). Trump, well you just have to look at his popularity ratings, or the economy shrinking 0.5% in his first quarter. He could have poured money on the economy and had everyone getting high and merry on debt, while he took in billions in bribes via is cryptocurrencies. But nooooo, no one has a clue why he is perusing his economic policies, probably because there aren't much in the way of clues to be had.
It could have been so much worse. As it is, it looks like most countries have his measure and are working around him. I don't know what made me cringe more: Netanyahu showing Trump his letter of recommendation for the Nobel Peace price, or Trump lapping it up. Before that is was the European leaders showering gifts on him. It was disgusting. And it worked. Such is the art of politics, I guess. If you are dealing with pigs, it must appear to the pig that you enjoy rolling in their shit just as much as they do. All leaders except Putin that is. Putin played him for such a fool that even Trump picked up on it.
[0] https://theconversation.com/trumps-first-term-lies-at-the-he...
Well. There is measles epidemic right now...
Vinay Prasad, the new FDA chief medical and scientific director, is an extremely sensible guy and a co-author of a great 2013 book on evidence-based medicine targeting the lay audience (Ending Medical Reversal)
Here's an EconTalk podcast with the other co-author, Adam Cifu, talking about the book. https://www.econtalk.org/adam-cifu-on-ending-medical-reversa...
The NYT article presents his COVID vaccine policy changes as yet more crazy MAGA shit, whereas in fact he holds nuanced views, based on up-to-date review of available evidence. He has published in NEJM and elsewhere on the topic:
https://www.nejm.org/doi/full/10.1056/NEJMsb2506929
A short take on the above from Adam Cifu, whom I respect greatly: https://www.sensible-med.com/p/prasad-makary-and-an-evidence...
With all of that, I suspect that the rumours of FDA's death are greatly exaggerated.
Huh? That NEJM bit is crazy MAGA shit. It admits that if you're in a high risk group you should get it, but then turns around and says that because it hasn't been proven in every sub-group it shouldn't be done for the rest of the population. That makes no sense, it's just p-hacking in reverse.
And it completely ignores the long covid elephant.
“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.
That was my first reaction to this article too: "Ok, gutting the FDA is bad, but the destruction of some other agencies that are not even mentioned in this article actually has worse consequences. If someone believes the quacks, takes Ivermectin or EDTA and dies, that's fine for me - I hope they at least get a Darwin Award for their effort!". But when you think about people doing this to other people (including but not only children) who can't decide for themselves, it gets much more complicated...
Yeah this is one of those situations where people freak out about their neighbor's behavior and try to change who they are with administrative policy. It's really just counter productive.
I think better would be for people to be more personally picky who they share spaces with.
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.
Not allowing self medication was probably a mistake.
I find this quote so fascinating. Who makes ivermectin and hydroxychloroquine? Pharma companies! Who makes vitamins and supplements? Massive corporations! Is there a single doctor on the planet who doesn't tell their patients that sunshine and exercise are good for them?
> Is there a single doctor on the planet who doesn't tell their patients that sunshine and exercise are good for them?
Yes, because doctors are secretly plotting alongside with big renewables to trap sunshine with solar panels and imprison it in batteries. They don't want patients to compete with them for access to sunshine.
The raw milk thing is funny to me in a semi-morbid way i guess, i find it for sale all over the place and more expensive then just regular, even organic, whole milk. Pasteurization doesn't seem to be some evil ultra-processing of milk, it just kills bacteria that can make you sick. There's no preservative or other additives that i'm aware of. Pasteurization just doesn't seem like something anyone would get worked up about but here we are.
Well the thing is that they want the enzymes and bacteria that pasteurization kills. There is limited (but existing) published research that shows the naturally existing enzymes aid digestion and immune function.
Back about 15 years ago before it became a weird culture war issue, my sister, who had a diagnosed casein allergy (casein is the main protein in milk), found that she could consume raw milk without any adverse effects.
"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?
To tell the truth, I don't remember. I've kept a "quotes.txt" file for the last two or three decades where I paste in anything I feel is worth remembering. It's been in there as long as I can remember, but I apparently didn't bother with a proper attribution.
I want to guess Oliver Wendell Holmes for some reason, but it doesn't read like something he said. Sorry I can't be more helpful.
I don't know who said the above, but the following is from Isaac Asimov:
"Anti-intellectualism has been a constant thread winding its way through our political and cultural life, nurtured by the false notion that democracy means 'my ignorance is just as good as your knowledge'"[0]
[0] https://www.goodreads.com/quotes/84250-anti-intellectualism-...
And I'd add that as Peter Medawar correctly pointed out[0][1]:
"The USA is so enormous, and so numerous are its schools, colleges and religious seminaries, many devoted to special religious beliefs ranging from the unorthodox to the dotty, that we can hardly wonder at its yielding a more bounteous harvest of gobbledygook than the rest of the world put together."
[0] https://www.azquotes.com/quote/1064507
[1] As a middle-aged American who's lived their whole life in the US, this quote is spot on.
Important quote! Citation?
stevenAthompson from HN.
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Destruction precedes creation. Things have ossified to the point where change seems impossible. While I think the way we’ve gone about it is absurd, I can still hope that something better will replace it.
The one thing I liked about RFK is that he was going to "take on" the big food conglomerates and all the garbage that they are feeding Americans especially those unable to afford, or who do not have easy access to, healthy alternatives (whereas the garbage food is ubiquitous).
It would seem dismantling the FDA is the opposite of that; what's needed are more regulations on food, or at least policies that result in more healthy food being available and affordable to Americans, not less regulation.
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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’s really not, though; it’s just the proverbial relief crew in a later inning of the same ball game. The players have been shuffled around or replaced, but look at the tenures of some of the players in question and you can draw a pretty direct line all the way back.
It’s not minimizing or trivializing the harms of today by pointing out their origins in the past; rather, it’s acknowledging this has been a long-term goal of those in power for decades, and it’ll take decades of continued, organized change to improve things.
There are no easy solutions or quick wins here. It’s a long game, always has been and always will be. More people need to understand that
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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.
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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
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.
People with opiate addiction have access to the cheapest and strongest narcotics ever available on the street. Unfortunately they are of uneven strength and cut with horrors that make their body shut down. I would much prefer they could just buy clean drugs from the pharma companies.
> People with opiate addiction have access to the cheapest and strongest narcotics ever available on the street. Unfortunately they are of uneven strength and cut with horrors that make their body shut down. I would much prefer they could just buy clean drugs from the pharma companies.
Fair point.
This is a complex societal problem having no simple solution. Unfortunately, what you proposed:
Is not a viable solution either. Government agencies and regulations would be needed in order to ensure pharma's do not increase drug addictiveness or otherwise engage in nefarious activities. Agencies are also an avenue for accountability in distribution, a much cheaper and effective enforcement mechanism than civil lawsuits, and can provide options for people wanting to address their addictions.Remember, every person who dies from an overdose cannot "sue if they get harmed" as they are dead.
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.
All of that still happens even with the FDA approving drugs. Luckily we have class action process
Not to the same extent, and the solution to that is to improve the FDA, not to demolish it and let companies poison and fool people freely.
Class action is what I meant with the difficulty of organizing. To make a class action happen and win, the damage done must be massive enough to get enough people to notice it and take action, and must be easily and cheaply provable. A class action is not going to fund expensive scientific studies that prove their problem was caused by the company they're suing. Your solution would only prevent the absolute worst cases. Any damage that's rare, hard to notice or prove, small, long term, etc would not get compensated and would cost society much more than properly funding 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.
Tell me: how do you prove that a drug hurt you?
Spoiler alert: you cannot.
The reason clinical trials are so expensive and complicated is because it's extremely hard to isolate signal of "what is this drug doing to people."
So on what basis would you possibly sue a company?
As another commenter said, we have an entire industry of the form you desire: supplements. Go take them to treat your next illness so you can really experience the creme de la creme that FDA is apparently keeping from you. Good luck suing for lack of effectiveness or for any harms you encounter.
Insurance companies will not cover ineffective drugs. Pharma will have to prove efficacy. Allow free people to spend their own money how they want
What incentive does an insurance company with an expected coverage period of 4 years have to prevent a drug with long term harm from reaching its patients?
What about drugs that people do not buy via insurance? Just have a free for all there?
Why wouldn't pharma just release the drug to the public at very low cost to use the unwitting public as its test subjects instead of running trials to satisfy insurance companies? If a bunch of people die then welp, you know not to pursue "insurance approval?"
Can't see how we could go wrong by making it very difficult to sell a working, expensive drug, and make it extremely cheap to sell a mass-market ineffective/unsafe drug...
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.
The private company can fail. The government will only reform very very rarely, and do so kicking and screaming and shrieking like we see now
> The private company can fail.
Unfortunately, they don't fail often, and we've seen the government bailing companies out so they don't fail.
But in the end, it's a moot point—even when companies fail, they are replaced with companies that either are equally wasteful, or as the replacement companies grow, their wastefulness increases.
> 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.
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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.
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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 us government should only provide a system for contract resolution, police, and defense. I can’t think of a single other thing the government should do
> I can’t think of a single other thing the government should do
Have you ever flushed a toilet before?
> 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.
> Letting people keep more of the money they earned through productive work is how we increase wealth.
This isn’t even remotely true.
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.
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.
It seems to me they were referring to FDA as a member among other "oppressive regimes" that fail in this way.
The FDA didn't take 250 years to build up.
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Can you speak directly to what you're referencing, please?
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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?
Challenge: Answer basic question with anything other than slogans
Difficulty level: Impossible
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/...)
so cowboys meet Darwin and their population drops. An alternative is a "nanny state" where every personal choice must pass regulation. This is as old as the hills, but add new abilities to monitor for compliance at scale; new orders of magnitude advantages for certain high-tech; and new amounts of money in an active and massive economic system.
Without prescribing any solution here, is it that much of a stretch to think that the FDA in practice exhibited dysfunctional characteristics in markets? With the longevity of the players and the deep pockets associated with health care, is it a stretch to see large changes to the institution as constructive in the long-run?
>so cowboys meet Darwin and their population drops.
I'm not sure why you think "let people poison others for profit, their customers will die" is a good argument.
no - I said nothing like that
What's the difference? You called them cowboys? Pretended like companies wouldn't actually sell poison?
The point of the nanny state is to stop aggressive actors causing widespread harm.
not allowing companies to poison people for profit, ensuring people are qualified to do safety critical jobs. Making sure that companies can't cut OSHA for profit, ensuring that buildings are built to withstand the weather properly, even though it costs more.
A lot of the "nanny state" shit is there because people died. Now, of course some of it is because conservatives/liberals/that class you don't like got their knickers in a twist as well. But that tends to disappear pretty quick.
But that means that big money can use that as a spring board to remove expensive regulation.
You want clean air? but thats expensive! nevermind, soot spewing engines is manly, everything else is what those people you don't like do.
You want social media to stop sending porn to tweens? freedom of speech my friend! thats what makes america better than communism. You want your child to read the great american novels? oh did we say freedom of speech? no we meant don't do our country down.
All of that is theatre, what matters is the food and drugs you eat are safe, effective and well controlled so that the most amount of good is allowed with the least amount of harm
this is moronic twaddle lacking any middle ground. If you want to prove that public forums are a doomed method of communication, this post is a great start.
I mentioned none of those things
Fentanyl is not a bad drug.
It's deadly *on the street* because of it's tendency to clump, meaning that your average drug dealer is not competent to dilute it properly. That's not a problem when handled by professionals.
my friend, opiods out of acute settings are super bad.
Being prescribed opiods to take home, is a sure fire way to get someone addicted https://www.gov.uk/drug-safety-update/opioids-risk-of-depend...
What is even more bad is companies running competitions to encourage family doctors prescribe opiods for long term use.
sure heroin on the streets is bad, don't get me wrong, but giving it to unsuspecting patients, getting them addicted and then effectively forcing them onto the streets is even worse.
Advertising of drugs is fucking stupid, bribing doctors is even more stupid. But as thats where a lot of money comes for politics, its not going to change.
Surefire? That doesn't say that. And I see a problem:
Typical signs of addiction are: ... Expression of a need for more, or reporting additional use of other pain-relief medicines
In other words, if the doctor doesn't prescribe a high enough dose for the situation the patient has an addiction problem.
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....
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.
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
More of your "lots", "rarely", "fewer"... but zero actual data at all. Two large posts of your opinion, and no information to back it up.
People tend to be annoyed by things they interact with frequently.
I get annoyed by web development, but I wouldn't want to see the solution be a federally mandated burning to the ground of the HTML standard.
Would you like to see a HTML standard imposed by law and that takes years and billions of dollars to amend? I don't think you would like that either. If I had to choose between the two, I'll take the wild west no standard option.
You're asking me if I, as a full-time web developer, would like to see an HTML standard that is incredibly expensive to modify? A standard that could be relied upon to be bedrock atop which you could build frameworks and polyfill to bridge any arbitrary issue you may encounter between the underlying interface and the developer's interface, for years if not decades? A concrete, unyielding standard the browser implementers could forever optimize towards, confident their optimizations won't run afoul of a change to the standard coming down the pipe, or an entirely new feature in the standard that demands novel support at the cost of breaking abstractions that supported the existing standard?
... is there, like, a change.org petition I can sign in favor of this? ;)
For some reason, that reminds me of how Microsoft abused web development with their IE6 browser. So much wasted time and effort by so many developers just so that Microsoft could extend their monopoly.
This perspective is addressed in the article... TLDR; that doesn't seem to be where this is going.