A critical history of the FDA
midwesterndoctor.com
midwesterndoctor.com
Almost a century ago, the 1929 book by the first FDA leader, https://archive.org/details/historyofacrimeagainstthefoodlaw...
The story of the fight which has been waged for the protection of the public against adulterated and unfit foodstuffs is not a pleasant one. Politics has often played a larger part than a consideration of the welfare of the public. While some adulterations have only a commercial and not a public health interest, none the less the people should be protected against them. Suppressing natural therapies
Protecting the pharma industry
Preventing hustlers from peddling false hope (at best ineffective, at worst harmful) to less educated people in dire straits
It's 'Fly by night companies are able to push bullshit onto unsuspecting consumers... again.'
A small number of capitalists did get rich selling ivermectin. We all noticed the emergent social media energy toward ivermectin and someone was going to sell it at a profit.
The FDA noticed that this had stature on algorithmic social media and made the mistake of trying to also get on social media. FDA does not prevent doctors from picking a treatment. FDA does not criminalize anything. But FDA is required to try to protect people even if they don’t believe in the FDA.
A small number of doctors sued because of that social media messaging. Not because ivermectin was better than or safer than a vaccine.
One of the most infuriating things about COVID was seeing this sort of passive-aggressive buck passing raised to an artform. In my kids' school district, no one individual could be assigned responsibility for the fact they had to wear pointless cloth masks across their faces for six hours a day -- the superintendent blamed the state health department, the state health department blamed the governor, the governor blamed the CDC, the CDC blamed state health departments, and round and round it went.
Delayed the release of vital, proven medicines to the public, leading to hundreds of thousands of people needlessly dieing.
> the most important thing to understand about this dynamic is that it typically takes an incredible amount of work to reach the functional compromise that’s eventually settled upon, so if the existing process is scrapped (e.g. because people who are polarized on the issue can only see it from their side’s perspective) what follows… is often much worse than what preceded it.
There are currently several hundred medicines sold elsewhere in the world and considered essential in most places in the world, that no US company is willing to go through FDA trials for, because there’s already an existing foreign patent on the drug, so it’s not worth it because all the US company would end up being able to produce and market is a generic. (US doctors still supply these drugs clinically from time to time; but to do so, they must get special one-time FDA exceptions to import them, and then use them “investigationally.” This usually takes months of back-and-forth and has extreme labor overheads. It also is vulnerable to foreign-market supply shocks.)
The way to cut this Gordian knot is to just not require trials for these drugs. They were already proven long ago to the satisfaction of some other drug agency; and even if the FDA doesn’t trust the standards of that agency, with at least 20 years of existing use, they can simply refer to longitudinal studies conducted in that country that recorded all-cause mortality of patients on the drug vs not.
The “what about” for me is quack vitamins and bullshit that people are actually pushing.
I've sorta followed this doctor's posts for a while. He has some good insights on the deterioration of the medical profession, and its capture by big business. I particularly appreciated his post on the deterioration of the competency of surgeons.
A lot of the comments below seem to not want to acknowledge that the dissidents against the status quo might be more correct in their philosophy for making the most of our lives.
> Because of this, many life-changing medical therapies (discussed throughout this article) were blacklisted by the FDA and faded into obscurity.
This is where I decided to stop reading, any piece of writing making a claim like this and not immediately listing at least one example is going to be a load of horseshit that is full of lies.
Honestly, just _fuck_ off with this nonsense. "I have a treasure trove of data that shows vaccines cause autism, and it can be verified. But I won't release it, but trust me."
I'm sorry the world isn't more interesting and there's no shadow government in place pulling the strings. The simple fact is people have always been autistic, and just went undiagnosed. I could even see arguments for it being less apparent when those children didn't have the comfort of the Internet to avoid developing their social skills etc.
/Rant.
All of that can be true without conspiracy. Literally anyone can lie and do it for profit all alone or with a friend. No conspiring required. Just a bit of common greed, and the knowledge that the average consumer is likely not trained in how to identify real or falsified research, and not trained in chemistry or any science for that matter, is quite enough to deceive the public.
What we need is more scientists in politics, and fewer politicians in science.
Instead it was a media effort to demonize scientists who gave their expert opinions if they were not in line with a particular narrative. Agreeable or not, right or wrong, moral or immoral that's not science.
Disagreement and free speech are necessary for science. And when you remove that, whether your reasons are dire or not, breaks the scientific approach to information. And that works, as expected, to erode trust. For better or worse, that's the cost of attempting to control the conversation.
Further, it means you can't just jump back to free-speech absolutism. Please explain how, at the time and given the circumstances, their actions were flawed to the point of deserving the criticism you're dishing out.
Now you're refusing to back that up.
Meaning, to your exact point, cite how they should have known at the time that the overall cost/benefit analysis for vaccinating children was negative.
And yes, it was obviously a mistake at the time to issue an "emergency use authorization" for use of the vaccines in people for whom COVID was not even remotely an emergency.
But in the end it comes down to: thousands of children died of covid-19. How many died from the vaccine? Do you understand why, statistically, it might be difficult to demonstrate a clear clinical benefit, while still confident that such a result would occur?
Or put simply: are you substituting your judgement for that of medical researchers based on a full and clear understanding of the facts, which you simply interpret differently? Or are you speculating based on an armchair understanding of the situation?
Then you would demonstrate that your sense of morality is quite warped indeed. I would argue that no one is obligated to undergo a potentially hazardous medical procedure in order to mitigate potential threat to others, but this is especially the case with COVID, where we are talking about a disease that was primarily a threat to elderly people who had lived a long life already. Also, I'm not sure why you would bring up effects on transmission when it was clear by the time of the pediatric EUAs that the vaccines had almost none. I'm also not sure why you bring up "long-term unknown effects of COVID" when the vaccines did not prevent infection, so there was no benefit to be had there.
> But in the end it comes down to: thousands of children died of covid-19. How many died from the vaccine? Do you understand why, statistically, it might be difficult to demonstrate a clear clinical benefit, while still confident that such a result would occur?
This is a deeply unscientific process you are describing, fraught with exactly the sorts of biases and guesswork that objective and repeatable processes are meant to eliminate. With regard to the question "how many children were killed by the vaccine?" I would say it's completely impossible to know because the plain institutional imperatives of the FDA and medical community were to assiduously avoid acknowledging any such events. I would reference VAERS, but every time I do I'm told that's not a reliable system, and there's no other operational pharmacovigilance system I'm aware of, so we seem to just not have one at all. But the anecdotes from numerous people who experience severe AEs in close proximity to COVID vaccination, and experienced tremendous difficulty getting doctors to consider the link, and saw no follow-up from the FDA to their reports, does not give me confidence we have any real handle on such numbers at all.
The problem is not with the vaccine itself for most of us. It is about forcing it on us.
"He says, if you give me the data, all I want is the data and I'll take on the data and show that it's not safe. And then if you pull the product liability, the companies will yank these vaccines right off of the market. So that's his point.” - Howard Lutnick, Trump transition team co-chair, CNN interview, October 30
Safe does not mean 100% safe, nor does effective mean 100% effective. Take the flu vaccine fro example. While the risk is small, there are cases of GBS associated with it. And even with the flu vaccine, you can still get the flu even of the same strain.
So it always comes down to an individual assuming what risks they want to take.
You other quiote was tied to RFK Jr saying this:
https://www.newsnationnow.com/politics/2024-election/rfk-jr-...
“I’m not going to take away anybody’s vaccines,” Kennedy told NBC News when asked whether there were specific vaccines that Kennedy would want to remove from the market.
“If vaccines are working for somebody, I’m not going to take them away. People ought to have [a] choice, and that choice ought to be informed by the best information,” he said.
“So I’m going to make sure scientific safety studies and efficacy are out there, and people can make individual assessments about whether that product is going to be good for them,” Kennedy added.
I will come back to this in 4 years to show you how wrong you were.
I do not need a hundred sources, I need only one, from the person himself, right?
https://www.politico.com/news/2024/11/06/rfk-jr-vaccines-tru...
“We’re not going to take vaccines away from anybody,” he told NPR in an interview this morning after Trump’s overnight victory. He repeated the message a few hours later in an interview with MSNBC.
Instead, Kennedy said he wants to improve the science of vaccine safety, which he said “has huge deficits in it,” so Americans can have all the right information to choose whether to get vaccinated.
“I’m going to make sure scientific safety studies and efficacy are out there, and people can make individual assessments about whether that product is going to be good for them,” he told MSNBC.
So it's optional to get it or not get it.
> It is about forcing it on us.
Oh. So you were forced to get it. We should fight against the law that forced you to get a vaccine. Can you help me track down the legislation so I can help you spread the word?
https://www.kff.org/coronavirus-covid-19/press-release/1-in-...
Federal workers were forced to get the vaccination as well.
https://www.whitehouse.gov/briefing-room/statements-releases...
A list of mandates here: https://en.wikipedia.org/wiki/COVID-19_vaccination_mandates_...
Do you have some sort of mind blindness to what happened during COVID?
There were vaccine related injuries that were not expected from the trials, as is usual in new vaccines.
Even if they weren't weird and different, previous vaccine rollouts like Pandemrix show that caution is warranted in the early days of rollout for any vaccine. COVID vax fundamentalists couldn't accept that many people might reach a legitimately different assessment of the risks and benefits because in their absolutely hysterical worldview, SARS-CoV-2 was tantamount to a death sentence or lifelong disability.
Vaccine 2) Instruction to make Spike protein injected into body which makes a random amount of spike protein that they never quantified.
https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1002/prp...
" It was hoped that resident and circulating immune cells attracted to the injection site make copies of the spike protein while the injected mRNA degrades within a few days. It was also originally estimated that recombinant spike proteins generated by mRNA vaccines would persist in the body for a few weeks. In reality, clinical studies now report that modified SARS-CoV-2 mRNA routinely persist up to a month from injection and can be detected in cardiac and skeletal muscle at sites of inflammation and fibrosis, while the recombinant spike protein may persist a little over half a year in blood. "
Quite frankly, if someone has problems with how the FDA operates they would be better served by talking about its weak points and how to address them from a more neutral perspective. Even if their decision making process and the decisions they arrive at can be problematic at times, I have no doubt that the organization has made considerable contributions to safety.
https://kirschsubstack.com/cp/151892950
This is one of the main other sites linked whenever something is underlined to prove that there are "sources" for claims.
> DMSO was a naturally occurring supplement
Mentions of "natural" like this usually mean objectivity is not in the room.
I also find it funny that he perfectly exemplifies why the need for blind studies:
> It had a worse effect in the food when they knew it was in the food, because it became repugnant to them.
Then proceeds to bash against "RCT fundamentalists". Obviously, we should decide on natural medicines by their taste.
That is a heuristic I like to use, but in this case the author appears to be using it in the sense of "shareholders aren't getting a cut" so in this particular article it isn't a problem. The benefit that the article is alluding to isn't that the substance is natural in the abstract but that it is easily available because it is naturally occurring and thus partially bypasses the US system of siphoning cash towards healthcare companies. In context being natural is a specific and fairly plausible benefit.
That would be exactly the same. "Healthcare companies" always get a cut, no matter how "natural" the substance is, for all definitions of natural that you can think of, because healthcare companies get a cut of everything that is even minimally active, FDA or not. In fact, there are big pharma companies that literally profit from selling water (Boiron, but plenty of others). Even if you define "natural" exactly as "something pharma companies don't currently profit from" (a very misleading definition), that definition is going to be uselessly ephemeral as pharma is sure to profit from it as soon as it becomes minimally popular.
Therefore, it is again a useless, diffuse definition that is often used simply to indicate whatever the author fancies today.
https://pmc.ncbi.nlm.nih.gov/articles/PMC9801450/
http://bmrat.com/index.php/BMRAT/article/view/614
As well as an overall immunomodulary agent:
https://www.sciencedirect.com/science/article/pii/S017129851...
I am not, of course, suggesting that everyone take DMSO, but the fact is that this very cheap molecule is not studied for one reason; it cannot be patented. And since it is possible that the pharmaceutical companies might know this, banning it would give them time for drug discovery and a patent on a molecule that acts similarly to DMSO.
It is a fact that the FDA gets nearly half of its funding from corporations it regulates.
https://today.uconn.edu/2021/05/why-is-the-fda-funded-in-par...
You at least should have a skeptical eye when it come to the FDA banning a molecule like DMSO. I can understand regulating it, but banning it was an over reaction by the FDA.
https://www.mcgill.ca/oss/article/medical-critical-thinking-...
"These companies wanted to put DMSO through its paces and eventually market it as a drug."
If anyone can think of a better title (i.e. more accurate and neutral, preferably using representative language from the article), we can change it again.
Is inflammatory content now allowed on HN?
Relativity was created after experiments had already poked holes in the ether theory. It definitely broke new ground, but from what I found far more scientists viewed it as intriguing rather than inflammatory.
I wanted to talk about DMSO. Shoot.
DMSO is a great molecule, but it has side-effects. It will give you gastric reflux (to my understanding this is pretty systematic), which will trash your oesophagus if you take it long term (my mother just got operated for this reason). My mother found out she was allergic to NSAIDs (it triggers her manic bipolarity), she take DMSO since like 2012 for everything, and just stopped taking it recently. She say she didn't noticed it before, but it was a bit like being under weed, albeit less strong: small memory gaps, weird concentration pattern (plus gastric reflux).
I have no doubt DMSO is better than the opioids it seems half of USians are prescribed (it's really rare to be given something stronger than NSAIDs here, even corticoids are rare, so it really seems like an exaggeration).
Please don't use it with children, I'm not anti-weed but I think we should avoid giving drugs that affect neurons until most of the brain is formed. If they're too young to drink, they're to young for DMSO.
I'm saying that because it's one of the only effective drug from the non-mainstream pharmacy, and when compared to the usual placebo, works really well, so it has a tendency to be idolised in groups with this minority habitus. Avoid giving it to children.
Feels like a self-taught person, perhaps a non-native speaker themselves.
I’d suggest reading a less biased account which goes into some of the more interesting details. Academic Scientists and the Pharmaceutical Industry: Cooperative Research in Twentieth-Century America is one such take but there’s others.
That said, there has definitely been a lot of political influence applied to the FDA. The current loophole around supplements and effectively fraudulent alternative medicines being one such example.