Over the last several decades, the Food and Drug Administration has allowed pharma companies to sell hundreds of drugs to patients without adequate evidence that they work and, in many cases, with clear signs that they pose a risk of serious harm.
Yeah, didn’t one of 'em dickheads recently say we all have to die somehow… this is just one other way.
It is almost as if …hmmmm…they are working for the very people they regulate? Say it isn’t so. 🤔
and yet puberty blockers should be banned despite being tested with no ill effects for thirty years
the problem with puberty blockers is that they have an explicit and verifiable use case. thats not what drugs are supposed to do! theyre supposed to do whatever you say they do!
Hmmm, now where have I heard this before?..
They even got to the FDA? Fuck that…
Always_has_been.jpg
Notably, Phenylephrine was approved in pill form for decongestion, and is all over the place… but doesn’t do a damn thing. Trying to keep pseudoephedrine limited in the market to try to fight meth.
Over the last several decades…
This is systemic.
I didn’t know that before today
In 2023, the pharmaceutical industry spent $383 million on federal lobbying, more than all other industries same in 2024.
Pharmaceutical companies have always spent more on lobbying, spending over $6.3 billion from 1998 to 2025
Since “evidence based medicine” has been a corrupt joke for many decades now, why be surprised now? As long as people continue to claim that real science - which assumes and even demands skepticism and testing and trial and even disagreement as a never-ending process that works for real results and continued improvement - is somehow “anti-science”, there is no limit to how whacked “medication” or “treatment” can be or become.
The article brings up some great points, some of which that I, an industry insider, weren’t even aware of, especially the historical context surrounding the AIDS epidemic. I’ll jump into the thread to critique an issue within the article.
One of the four pillars recommended by the FDA (control groups) are great in theory but can lead to very real problems in practice, specifically within indications that have an unmet treatment need or are exceptionally rare conditions.
If you have a disease that is 99% fatal but has 0 standard of care treatment options, is it ethical to ask a participant to enroll in a clinical trial and potentially not receive the study treatment/be on placebo? Or, what if the trial involves an incredibly invasive procedure like brain surgery - is it ethical for people to do a placebo procedure? Food for thought - and an explanation for why so few trials meet all four criteria proposed by the FDA.
Happy to answer questions about the industry if anyone has them.
Medicine has always relied on killing enough patients to determine how safe/effective or not a drug or procedure might be. We simply do not have the technology to provide definitive answers any other way as of yet. This is why one “practices” medicine and not “does” medicine. And administering a drug to a patient is called a “trial.” There is simply no way to know the outcome until the outcome arrives. Years of experience can give you a fair indication of what to expect, but expectations are not definitive answers.
As a keynote speaker ER Doctor stated at an EMS seminar I attended, “No matter how much knowledge and skills we think we know and have, modern medicine still boils down to doing things to keep the patient amused and letting nature take it’s course.” As a simple medic, that was a thought that stuck with me through my 15 years in the back of the bus. It scared the bejeezus out of me.
Unless you actually start looking into the whole of the aids epidemic its easy to miss what an absolute clusterfuck it was. The systems in place weren’t prepared at all for it and through a combination of maliciousness, ideological hardheadedness, and novel circumstances more Americans were killed by a virus than by the Viet Cong. But because it hit a group that was already fighting for our rights as well as the fact physicians in high places understood that their duty was not to the public “morality” but to public health things were able to be fought.
When it comes to therapies that are likely toxic, e.g. chemo, that’s why the sponsor has to demonstrate through pre-clinical data that there is a high enough likelihood that the benefits will outweigh the harm that it is a legitimate therapy to trial on humans. Even then there should still be thorough, audited processes for obtaining fully informed consent before recruiting patients into these trials, including making certain they are aware the trial may cause more harm than standard of care.
It’s the burden of evidence required in pre-clinical data that makes me defend animal testing despite being vegan.
The consent process for clinical trials has a ton of guidance (ICH GCP), but the onus is on the clinical monitors and hospitals to make sure it’s done correctly. Many trials now generate supporting documentation in which hospital staff are required to describe the circumstances in which consent was acquired. If the documents are generated, then it’s auditable.
Things get a bit hairy when you look at trials in Alzheimer’s and other cognitive disorders, because the patient may not be coherent enough to withdraw from the trial. In those cases, a legal guardian is responsible for the decision.
Yes, though if the sponsor is doing it on the cheap then they might pick facilities and monitors who don’t care or don’t have the capacity to pick up on all the details, or scrutinise minutiae. The monitor can only QC what’s written down for example, and an investigator can be perfectly capable of having the bare minimum of a consent process and copy pasta as if it was done thoroughly.
I’m glad all my participants are of sound mind; the idea of navigating the world of incapacity and research gives me the heebie jeebies.
Good point, I’m assuming all monitors are as good as mine.
I wish all mine were as good as the best I’ve had.
Thank you for providing the extra context. That’s very helpful.
Opening someone’s head to pretend to have done something sounds very unnecessarily cruel and stupid.
Thats their point. How do you test placebo effect for a surgical operation?
You can do single-blind. You do prep, anesthetize, then open the card that decides if the surgery continues, or if the patient is simply awakened at the expected time.
You can also do it for surgeries that use locals, but then the surgical staff has to do a lot of miming/acting instead of actual cutting.
Medlife Crisis did a could of Placebo effect videos, and mentioned that he participated in a single-blind stent study.
I don’t know how you’d do double-blind.
That a great take.
Double blind could be a different team comes In and either does the surgery or fakes it. And this team also does or Fakes the after care.
This team is never to communicate with patient or normal staff.
Either way, that is a pretty massive digression from the article, which is about medications. Apparently more people are dying on average from recently approved drugs than are dying from all illegal drug use combined. And the examples are not for extremely rare medications
“We need an agency that’s independent from the industry it regulates and that uses high-quality science to assess the safety and efficacy of new drugs,”… “Without that, we might as well go back to the days of snake oil and patent medicines.”
We basically are already there now, it seems
Fair point, but a lot of the article talks about how many studies aren’t meeting all four pillars of clinical trial design - that’s where my issue comes in, I think reporting that X% of trials do not meet all pillars is a bad metric.
And, not all medications these days are pills or IV infusions - some medications and treatments, which are governed by the FDA, are more invasive and more complicated.
Sell drug, make money, bribe officials, repeat…Seems like it works fine, for big pharma.
Big Pharma protocol for decades now, with revolving door executives via FDA. What could go wrong?
THIS is going to Help people TRUST the Government! THANKS Trump!
Unfortunately, this was an issue before Trump and will continue to be one afterwards. Assuming there even is an afterwards…
“Terrorist State’s Drug Lobby Somehow Not Trustworthy”
American health insurance companies are famously miserly, and this seems like a great area to use penny pinching for good. Where the hell are the insurance CFOs who should be demanding efficacy proof instead of being swindled along with the masses?
They absolutely do this. A drug with a lack of efficacy data is a great way to get shortlisted to insurance denials
It’s one of the frustrating things bc people can then easily manipulate the issue. A drug that can be prescribed a doctor and filled by a pharmacy being denied by an insurance company is very easy to write about online. Then it’s a slam piece, “x insurance company denied me my meds”. Basically 0 people will have any interest in the nuance that the medication is bullshit or possibly even harmful. Too bad insurance companies made their bed by being absolutely horrible for decades, I guess.
From the article:
While drug companies profit from the sales of unproven drugs, everyone else — patients, insurers, and the government — pays a heavy price. In just four years, from 2018 through 2021, the taxpayer-funded health insurance programs Medicare and Medicaid shelled out $18 billion for drugs approved on the condition that their manufacturers produce confirmatory trials that had yet to be delivered.
I’m guessing their citation only includes Medicare and Medicaid because those have publicly-available data for the study to review, but I have to assume that private insurers pay a ton as well. I can see your point that insurance denials result in angry sick people, but there’s not really a lot of nuance in “that medication has never been shown to be safe and effective for your (or any) condition.”
I dunno. Everyone sucks here.
They’re busy researching new and exciting ways of denying coverage.
Not arguing against the substance of the article, but I can’t help but wonder if this is the best way to address this issue. Measles was eradicated from the US but is now back and has claimed lives purely due to vaccine skepticism. I just worry that yet another article criticizing the FDA for pushing drugs that aren’t safe/effective will do more harm than good at this point. Idk, I just sincerely question if now is the time to give americans more reasons not to trust medical professionals. (Again, not arguing with the substance of the article—very disappointing and disturbing that FDA is doing this—but just concerned about the time, manner, and place of this criticism.)
It’s tricky. Part of the problem, I think, is if you do have corruption and carelessness in something like the FDA, there’s no amount of careful reporting that can fix it - it becomes propaganda.
It’s necessary to address the problems, though I still agree with being careful about what information is broadcast and how - but it’s necessary to keep information open and challenge things otherwise you end up worse down the line. A measles epidemic is bad. But imagine if you suppressed thalidomide results and other failures, allowing things to get worse and worse in the name of not damaging people’s trust, then eventually (after years of covered-up harm) it all comes out and people abandon scientific medicine altogether!
You don’t have to imagine… I’m sure a large component of both vaccine skepticism and Trump’s presidency have come because of suppressed and partially-suppressed wrongdoing by all the people we think the country should trust. Eventually people break and look for something else.
So, I agree with you, but in my opinion we do need to work more, not less, at transparency and truth even when it’s problematic.
Both can be true.
It can be true that the FDA was corrupted/captured to some extent and needs more ‘skeptial’ and less-industry-friendly leadership. At the same time, skepticism in science is not the answer.
This is my dillema with MAGA. Many of the issues they tackle are spot on, even if people don’t like to hear that. They’re often right, even when the proposed solutions are wrong and damaging. I think this a lot when I hear RFK speak, nodding my head at the first assertion then grinding my teeth as he goes on.
What are the issues they are “right” about?
That election companies cannot be trusted, but the deniers were careful to not approach this scientifically or convincingly. Offering instead pseudo science and illogical schemes done by madmen. Because of this they set back the paper vote movements by decades in some states.
Another thing that draws them followers is that tens of thousands of small towns have died economically, in the last three decades, but no programs to help them, and no sympathy in the large cities
How are they right about election fraud? Specifically voting.
Gerrymandering is a disgusting in the US, but that’s not election companies, that’s politicians not the election companies.
Dominion has been cleared of the fraudulent claims so that doesn’t hold up as evidence
So many states have problems with exit polls being correct , that all the major broadcasters and news agencies, in the USA, stopped using them a few years ago to predict many races.
Exit polls are used elsewhere reliably to detect large scale manipulation of ballots, and have been used by the United Nations. They used to work in the USA
Mail in ballot counting is reliable. This leaves electronic ballots as the only means to change that many votes. Indeed, if you look at states that use more traditional methods of counting their exit polls generally are accurate.
In addition many states fail other statistical tests that are also used to detect cheating in the primaries for both parties and general races.
Based on statistical tests that have been accepted worldwide for generations there is cheating happening. This is ignored by both parties and the vast majority of people .
In my opinion nothing was proved that these counting companies have accurate results. This is because most of what they do is hidden by trade secrets. And the USA has a lack of recounts that do not use these very systems.
So then the problem is exit polls, not voting gotcha.
If there is something wrong with exit polls thats not the same thing as votes.
That difference is essential to understand isnt it? Votes didn’t have to change for exit polls to be manipulated.
And the entire hanging Chad bull shit from gore/bush should never have happened either. Paper solves nothing in this instance.
Corruption of media and political groups sure, that’s a problem… Everywhere though.
Exit polls are voluntary, and are internally prone to people lying.
You jumping to “votes got changed” needs to be verified. And the voting systems themselves were not found to have been manipulated. That leaves polling stations/systems needing to be checked… Not just the reporting on those exit polls.
Regardless, I’m not trying to change your opinion on whether you think votes were changed, the point your claim that MAGA got this right has no evidence, just opinion.
They also got vaccines wrong, abortion wrong, masking wrong.
I’m truly sorry you feel they got these things right.
I’m a paper ballot and small town guy, I’m not a mega and my life was saved by vaccines. Also I indirectly help people get abortions ( I live in Texas). In all actuality I’m closer to being a communist than anything else.
So, if people can agree that exit polls are off, the next question is why?
If you look at the history of exit polling they are only off, in a historical sense, when there is mass ballot stuffing.
So that leaves either there is cheating or somehow Americans are so exceptional they overturn precedent.
And don’t forget the other stats tests. One of them which sorts the precincts by size and compares the percentage of votes each candidate received. It should be a kind of line. In California it is, in many other states it is not.
So not only do Americans have to be unique, in one way. They have to be exceptional in other ways to explain the other tests, used over the works fur generations.
All of this while the hidden counting of ballots is going on, without enough recounts .
Occam’s razor and all that.
Tens of thousands?
As of 2018, there are 19,495 incorporated cities, towns and villages in the United States. 14,768 of these have populations below 5,000. Only ten have populations above 1 million and none are above 10 million. 310 cities are considered at least medium cities with populations of 100,000 or more.
Unincorporated towns in Texas is 4k, I would guess the number of very unincorporated is a ratio of 2:1 nation wide I am not sure.
But using some rough math , and being incredibly stubborn to prove my point, that brings the total number up to 60k, of which 1/3 ( maybe) have seen economic hardship
You are guessing at numbers and figures now.
Can you find any statistics to look at? California as an example has about a million people living in unincorporated area. But that includes forests and other natural sites in it.
Where can i find that 4k unicorporated texas towns information?
I know the Texas count is accurate, I looked it up. I was too lazy and uninspired to look at other states. However I would be surprised if it were not at least half the corporate areas, nationally in total?
Yeah that’s absolutely how they lure people in. Sensible issues to be concerned about, starts out normal, then about two links of thought in, the tinfoil hats come out and the solution is fucking nuts.
This is such an important thing to note. The MAGA set aren’t completely oblivious. It’s the same issue with how they don’t trust “mainstream media,” the problem doesn’t lie in accepting that media must be viewed with skepticism and critical thinking, the problem lies with the critical thinking ending at “I can’t trust the mainstream media.”
What the MAGAs are actually practicing is cynicism not skepticism. They have thrown the baby out with the bathwater. Because they have realized some sources aren’t always entirely trustworthy, they stop trusting them entirely and instead listen to random jackholes on the internet. It’s actually an abdication of critical thinking. Just flat out rejection instead of reading with a critical eye and skeptical mind.
They also don’t apply the same attitude to those random sources they use instead. That is really the biggest problem with their approach. Literally going “you can’t trust anyone any more” would be better than what they do.
Phenylephrine is back on the menu, boys!
That’s the best case.
I’m thinking thalidomide.
Maybe we can get LSD pregnancy medicine to market this time
can we only test in on men too?
I was thinking whatever those horse tranqs were back during COVID days.
Elon took all the horse tranqs (ketamine).
The horse paste majic covid cure (trust me bro, my brainworm never lies), was Ivermectin.
Is that what killed the brainworm? Fuck
… somewhat ironically, it is at least barely, slightly plausible that ivermectin could have taken out the brain worm…
it is an actual anti-parasitic, but uh… its only been tested and approved as an anti-parasitic for humans via oral ingestion…
… but it is intravenously administered to cows and pigs as an anti-parasitic.
So… IV ivermectin in a human could potentially work, but … good luck figuring out the right dosage, and hopefully human bio chemistry and blood brain barrier just function identically as within pigs and cows.
I am not a medical expert, but I suspect that latter part just maybe might not be a great assumption.
Generally if it’s effective orally, it’ll be effective intravenously, so I would expect it to work…the issue with dosage is more likely to be in the opposite direction, with significant side effects due to overdosing.
One concern is neurotoxicity after large overdoses, which in most mammalian species may manifest as central nervous system depression,[58] ataxia, coma, and death
I suppose if you overdose hard enough, it would cure COVID in addition to the brain worm
the issue with dosage is more likely to be in the opposite direction, with significant side effects due to overdosing.
Yes, I wasn’t clear enough about it, but that is what I would be worried about, lol.
Its… probably not just as simple as a direct proportion between cow weight:cow cow dose to human weight:human dose… as … humans are not cows.
I suppose if you overdose hard enough, it would cure COVID in addition to the brain worm
I remember reading hermancainaward posts about idiots who did actually take waaay too much oral (or in some cases, suppository…) ivermectin…
So now they’re on a ventilator from the covid, and also uncontrollably shitting themselves and massively dehydrated.
Can’t say I remember a case of ivermectin OD leading to CNS shutdown… but yeah.
Covid skeptic/deniers were and still are astoundingly, lethally, suicidally stupid.
EDIT: Also, … ataxia.
Could ataxia lead to muscular control difficulty with say… your diaphagm, your throat?
Boy would that be counter productive as a covid ‘cure’ fucking christ…
Ivermectin (anti-parasitic) aka horse dewormer.
…and human dewormer.
