For those of modest means there is also the "fail first" insurance process where you need to use less expensive therapies before a more appropriate therapy is approved. Each failure can be costly to a patient's health, often exacting irreversible comorbidities, not even considering lost work, family wellbeing, and pain/suffering.
For those with rare diseases, insurance also doesn't help with "N of 1" efforts. A case report to consolidate critical details would be invaluable. Yet there's no administrative path to fund this personally let alone with insurance help. Without summary case report it's harder to see the big picture, get a care team on the same page, and dial in on the underlying disease mechanism.
Pharma is also not enthusiastic about "off label" use of their medications. They are happy to lower costs when insurance denies coverage for an indicated diagnosis, to demonstrate benefit so it then becomes covered. However, "off label" use is often full cash fare, making it impossible for common folk to perform low-risk physician-guided experiments when standard therapies are ineffective.
I can see why some things landed here. Medicine is expensive. Desperate people are more susceptible to fraud. Yet things are improving: someone like me would be long dead a generation ago.
We should look at these challenges holistically and think about better fiscal/social engineering of our marketplaces. Alvin Roth's book, "Who Gets What and Why", is a good introduction to identifying market failures and thinking about how to address them.
Step therapy is required in countries with universal healthcare, too.
It can actually be harder to get access to new therapies in countries with universal healthcare because they’re more uniform and strict in what they allow.
For a relatable example: The UK just raised the age of eligibility for COVID vaccines all the way up to 75 years old: https://www.mirror.co.uk/news/health/covid-russian-roulette-... Contrast this with the US where COVID vaccine coverage is a basic expectation of health insurance for all ages. And that’s for a simple, cheap medicine without step therapy! It doesn’t matter if your doctor thinks you need it, the rules are set from the top.
We do let them do that if you are willing to pay them for it. The fact is that if you "let doctors do medicine" without any cost benefit analysis, then you really aren't going to like the cost.
As someone who has looked at things like Renewable energy deployments within the UK, this is a pattern that seems to be quite pervasive across all industries. The byzantine web of planning approvals, goose counting, public outcry that you have to deal with to deploy essentially a relatively small solar farm is monstrous.
What that results with is that the only people capable of creating & managing these processes have the legal teams & resources necessary, stifling growth. Even once you get an approval, it may be years in order to get a grid connection.
This risk averse attitude pervades into all walks of life, including medical beurocracy. This essentially locks out a ton of real innovation, as it's too expensive to square up against a mass of beurocracy attempting to stifle you at all turns.
Its a double edged sword. yes, it stifles renewable energy innovation, but those rules are usually put in place in a more general sense, and you would really want them in place if next door was suddenly announced to be a landfill, or chemical plant, or a chicken farm, or an xAI datacenter....
It depends on your point of view. For the person deciding on giving permission they will not be thanked for allowing it, but might well be blamed if something goes horribly wrong.
Yes, but this is a clasical agent-principal problem.
Theoretically, the bureaucracy works on your behalf, but only approximately so. If it makes a mistake that kills you, the decision maker does not pay any price.
Maybe one solution for this issue would be some kind of “developer’s ombudsman” that is an affordable public service to 1) help people navigate the bureaucracy and 2) produce a report recommending streamlining of rules where possible.
This avoids “cutting down all the laws to punish the devil”. Some regulations are necessary.
Genuine question — is there a common factor across the regulations you'd keep? Because if there is, you could encode that directly instead of maintaining the specific rules. And if there isn't, "some regulations are necessary" isn't really a position yet.
To play the devils advocate, in places with low bureaucracy most of the risk taken is not innovation. It's just risk that leads to the death of others. Buildings with shitty concrete with too little rebar in it. Electrical wiring that will kill you. Improper foundations and such.
At the end of the day there is no simple answer here. It's no different than the talks about AI that dominate HN these days. You can build good things with AI, but the vast majority of it is crap, so we put up filters and hoops to ensure we don't get flooded with that crap.
Have you tried the "forgiveness is easier than permission" approach? What would happen if you just installed the solar panels? I know that in some countries they'd come by with a bulldozer and tear them down again - is your country one of those?
I am not sure about a bulldozer, but in the UK you will be forced to demolish it yourself. I am not sure what the penalty is for failing to do so when ordered to, but it seems to be usually effective.
"Forgiveness is easier than permission" only makes sense when you know what you're doing and understand the consequences. (IE, paying taxes a little late in the US is okay because the fine is roughly the same as the interest of holding the money in the bank.)
In the case of solar panels, I'm going to assume the OP is talking about something like a grid-scale solar farm instead of rooftop solar production:
1: You need an agreement with "the grid" to get payment for the electricity you generate.
2: Feeding electricity into a power grid is a very dangerous thing, at a minimum the grid operator needs to make sure you aren't going to cause a fire or otherwise break their equipment.
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That being said: If you're a homeowner trying to set up a small solar installation, you can pair the panels with batteries and skip feeding into the grid.
I'd say the underlying problem is our capital-first regulatory environments. For the topic of the original article, anyone can see that it would be reasonable for a guy who loves his dog to make what appears to be a prudent medical decision in her interest, trying out an unknown vaccine without any sort of government involvement - and a government that prevents this is unjust. But with the way the system is set up, if this were legally sound it would then automatically imply that a corpo scaling up the situation to thousands of dogs that it (the corpo) doesn't care about would also be okay. The fundamental problem is that there is no recognition of scale (because small scale operators don't have the pull with the government to fix the regulations).
There’s a lot to be said about the seemingly overbearing nature of the majority of FDA/ISO standards that result in the mass amount of hurdles that need to be jumped before a treatment is available, but that’s mainly due to institutional trauma from past events (thalidomide, primarily) as well as the fact that treatments are not simply binary. The options are not just “does not work” and “makes patient better,” there’s also “makes the problem worse.” These additional tests and trials are to catch and prevent adverse effects just as much as they are to ensure the drug or treatment actually works.
During covid, the FDA testified to congress that they were putting the vaccines on an approval fast track that would not reduce safety or efficacy. Why is this not the standard approval track?
We're computer people, so we have a good analogy here; the COVID vaccine did speculative branch prediction. They basically operated _as if_ they would get approval at all stages where they could, parallelizing much more of the process at the cost of a _very_ expensive branch fail if something went wrong.
Everything not mRNA failed. Sometimes miserably with bad effects, and those effects have all been swept under the rug. Some of the vaccines gave people lifelong sensitivities to the adenovirus vectors. I can go on and on.
We got damned lucky that mRNA vaccines against Covid work as well as they do. Nobody new a priori (go look at Derek Lowe's writing from "In the Pipeline" during it all) and "everything would strike out" was not off the table.
And the mRNA stuff only worked because people already had been working on mRNA vaccines for other things slowly over decades. We got "lucky" that Covid appeared when we had all the pieces in places (liposome encapsulation, alternate amino acid replacement, etc.)
Before advocating for "fast track", advocate for better and more stable funding on the "slow track" pure research that takes decades but feeds into this kind of thing. The work of Katalin Karikó was instrumental in this stuff and yet she had to swim through mountains of shit to do the research and was denied tenure. With better funding, this stuff could have been done a decade earlier.
Regulatory systems need omsbuds within the government who can ask for help and explanations from all the agencies regulating a project yet are (primarily) accountable for helping projects succeed as soon as possible and (secondarily) responsible for providing transparent feedback to those agencies and the public where regulation is malfunctioning.
The LLM didn't oneshot the mRNA treatment, it merely suggested the idea. Most of the steps in the process were done with specialized tools. And no novel treatments were invented wholesale, it's more applying a documented process with existing open-source tools that's just too personalized and expensive to be offered by any vet.
> More and more promising treatments are accumulating in the pipeline, fueled by an explosion of new therapeutic modalities, ranging from mRNA to better peptides and more recently, by AI.
If the pipeline is backed up you put a bigger pipe in place, not get rid of it and hope some of the resulting flood goes where you want.
It’s less of a pipeline and more like a rocket engine. The exhaust gas (clinical data) spins the pump. We’ve put restrictors on that flow, and it’s taking a lot of fuel to get off the ground.
No, it's a cliche because it's false and/or just rephrased alarmism. Most regulations are changes made to solve no problem, simply because someone thought it was a good idea, or because they were vaguely related to a Current Thing, and then persisted because undoing any decision is organizationally extremely hard and nobody cared enough. 'Written in blood' is a great catchphrase for eliminating any discussion of cost-benefit tradeoffs, and the lives that could have been saved but for inaction by default.
I too, like everyone one else, often hate the tedious and often absurd, effort that bureaucratic procedures sometimes require, but this story doesn't make any sense to me.
We're talking about a guy who's used AI to make personalized ground-breaking medicine for his dog but says he spent three months typing a 100-pages long document for the red tape. In reality, current AI technology isn't particularly designed to help you making radical medical breakthrough on its own (at least yet), but is extremely proficient when comes to writing text that must just check boxes.
I'm sorry but how does that story not smells like complete bullshit to anyone reading this? Given that the guy telling his story is “an AI entrepreneur”, I'm almost 100% sure that the story is almost entirely made up for self-promotion.
It's not a radical medical breakthrough, it's applying a technique already documented in the literature and years into human clinical trials. The LLM is just doing literature summary and planning. The most notable AI innovations here are in protein folding and binder prediction.
Yeah. It's possible to think that there are cases where lowering the cost of first phase trials or making it relatively simple for people capable of offering informed consent to obtain access to existing safe medications currently undergoing trials for their specific ailments and thinking that a person who claims to have "designed an RNA vaccine" by asking an LLM to teach him about RNA and now wants to inject it into animals under his care might be the exact thing such laws were meant to restrict.
Plus as others have pointed out, LLMs are much better at generating something that looks like compliance documentation than they are at designing drugs (and providing generic background info on compliance processes than they are at relatively little-documented cutting edge research), so if most people aren't instantly sceptical of a yarn spun about how a layman with ChatGPT easily taught himself enough to find an RNA immunotherapy cure for his dog but then was stymied by the amount of typing involved in a 100 page document, it's a good indication of why barriers to even nominally consenting people trying experimental stuff exist.
The LLM did not design the drug. The LLM summarized some papers on how to design similar drugs, and then a dozen specialized tools were used in an established pipeline to design the drug. You people need to read the article and read the background before writing nonsense based on your assumptions.
> I'm sorry but how does that story not smells like complete bullshit to anyone reading this?
Because it strokes the anti-establishment anti-intellectual and anti-bureaucracy zones all at once, and a lot of nerds (with love) are contrarians. Us software guys like nothing better than a story about how a smart ass with a computer undid a problem seemingly created by institutions out of whole cloth.
This resonates. Used AI heavily during development of a recent open source project and the speed gains are real but so is the review burden. The risk isn't the generated code itself, it's the generated code you didn't read carefully enough. Cursor is fast at producing plausible looking solutions that pass a quick glance but fail edge cases. The discipline has to shift from writing to reading, which is a different skill entirely.
Am I going crazy here? A completely random person tells AI to generate a novel vaccine/compound, and people are actually upset that there were 3 months of regulatory hurdle he had to jump through before he was able to start injecting this new compound into an live animal's bloodstream? Really?
It is there to ensure an animal is not experimented on unnecessarily or with excessive pain. Discussing a process like this might require you to slightly look further than one mostly clear cut case.
Part of his filings will be actually stating the "terminally ill" part and having this approved by an ethics committee. Making a moral judgment here is the committee's actual role as not all cases are so "simple".
The animal is terminally ill and the vaccine's slated purpose is to cure that illness. If you're rich & terminally ill these kinds of regulatory mazes are less of a burden, but if you're poor you'll likely die before you can get approval.
This ridiculous arrogance pisses me off so much. In the name of safety and proper procedure, with the argument that it could do someone harm, we just let people die. No, we’re not going to give you permission to try a new drug that could potentially cure you, or much more likely give researchers valuable data about the drug. No, this is against protocol. No, it’s against your own safety, so please be so kind as to fuck off and die.
That is basically what we are telling patients who would gladly reduce the suffering of themselves and others. Because someone claims it is an irresponsible hazard to other people’s health. That it is supposedly immoral.
In the name of correct procedure and bureaucracy, someone lets other people suffer. This is what really is bizarrely immoral.
'Bureaucracy' is commonly used as a trigger word. When I see it, I'm alerted to manipulation and, in some contexts, a certain partisan dogma. After all, who likes bureaucracy? By the same token, who like stop lights or authentication or other structures in life? But every large organization functions using bureaucracy - every highly successful one, every median one, every poor one.
> A system originally conceived to safeguard patients has gradually produced a strange and troubling outcome: the mere chance of survival is effectively reserved for the very few who possess the means to assemble an army of experts capable of navigating its labyrinthine procedures.
The survival of who? The three people who are trying to experiment on themselves (with questionable results, especially when their experiment has N=1)? That's a crisis? What about the 99.9..% of sick people?
> I will focus on the former: small, exploratory trials, which will be called early-stage small n trials for the purpose of this essay.
'early-stage' - it's just like a startup! Except the human experimentation part.
> In recent years, China has been advancing rapidly in biotechnology, in part because it is easier to run early-stage clinical studies there.
> “The US can’t afford to lose the biotech race with China.”
With the 'bureaucracy', it's right out of central casting, including the scare tactic: The same arguments have been used for labor standards, property rights, democracy itself.
You're defending a government using force to prevent terminally ill people from voluntarily experimenting on themselves to find a cure and further our understanding of disease. It should not be easier for a layman to design and build a targeted mRNA vaccine then it is to navigate a regulatory maze.
> prevent terminally ill people from voluntarily experimenting on themselves to find a cure and further our understanding of disease
Those seem like a good starting point for standards: Is it voluntary? Are they of sound mind? Are they giving informed consent (to themselves)? Is the experiment likely to yield useful results?
There are many things you can't voluntarily do, such as experimenting with cures that involve opiods. Should we allow vulnerable, uninformed people to take dangerous drugs because they saw a YouTube video saying they would help? Try random gene editing?
The truth is, you probably could do those things and few would care unless you hurt someone else.
Because they were fighting for half the population, and they demonstrably lost. We now have pre-1975 law, including horrific laws like Texas creating task forces hunting out women with miscarriages and abortions in other states.
They could have made the 'umbrella' of what they were fighting for cover 100% of the population. They didn't. We're all worse for it.
You can see this pattern repeated often by conservatives (not invented by them, but currently popular with them): No matter what happens, attack your political enemies. Every problem, every event, is an opportunity to smear them.
That article is exactly on point. There is a process in place for the express reason of slowing and blocking anything that will bring about positive, meaningful solutions and potential cures to the human condition.
Because the old state of affairs had desperate people being experimented on by opportunists, charlatans and fraudsters for money. There's work to be done balancing the equities of people with terminal diagnoses but lets not pretend there's no point to the roadblocks to human experimentation on the dying.
That sounds about right. Lots of abuses have been perpetrated by opportunists, charlatans, fraudsters all for money, as you put it. I just want to make sure we correctly distinguish what is meant by "opportunists, charlatans, fraudsters."
In the spirit of full transparency, I've listed some of the most well-known cases. Others, due to the Iron Curtain and similar curtains are hard to document, due to lack of visual inspection. Just the same I've listed them for transparency's sake:
Western Bloc:
Tuskegee Syphilis Study (US, 1932–1972)
Project MKUltra (US/CIA, 1953–1973)
Human radiation experiments (US, 1940s–1970s)
Porton Down nerve/chemical tests (UK, 1950s–1960s)
Punitive psychiatry experiments on dissidents (USSR, 1950s–1980s)
Pre-1940s Germany:
Nazi eugenics forced sterilizations (1933 Hereditary Health Law; ~400,000 citizens)
Pre-1940s Japan:
Unit 731 biological/chemical experiments (est. 1936; pathogen injections, early vivisections on prisoners)
Axis Powers:
Nazi Germany: concentration camp medical experiments (Dachau/Auschwitz hypothermia, twins, sterilization; mainly 1941–1945)
Imperial Japan: Unit 731 & affiliates (vivisections, plague/anthrax tests; ~3,000+ direct deaths, 200k+ from field use)
Fascist Italy: No major documented equivalent programs
Asia:
Japanese-occupied territories (China, Manchuria, Korea, etc.): Unit 731 satellites (biological warfare tests on local citizens/POWs)
By the way, all the above instances are part of history.
Greed is greed, whether "Capitalist, Socialist or Communist-oriented." In my view there is no distinction between modern day and historic "opportunists, charlatans, and fraudsters." Greed is Greed!
The healthcare industry, especially in the US, isn't interested in finding cures for disease. It's interested in maximizing profits, which is a goal that the bureaucracy serves.
Regardless of their motives they're all subject to the same regulatory system so they can only stray so far for so long from the net effect of the incentives and remain not bankrupt and being auctioned to pay back creditors.
It seems to me that the leading vaccine manufacturers, who spend billions of dollars yearly in order to lobby US lawmakers that establish the bureaucracy the article is complaining about, are interested in just that (maximizing profits).
It doesn't really matter much if there are individuals or other organizations interested in curing disease, when we have a system that allows for legal bribery of lawmakers, and other individuals / organizations with more money that value profits over anything else.
Have you ever considered that "finding cures for disease" is really fucking hard to do?
Things that were easy to cure were already cured some time in the past century. What remains is the hard to crack nuts that resist simple scalable methods.
There's money to be had in curing HIV - but good luck pulling that off. Maybe someone will, this century.
Have you ever considered that once a disease is cured, the industry can no longer profit off of it being a disease? Treating disease rather than curing it, is a much more profitable venture.
How is there money to be had in curing HIV? It seems to me like it's much more profitable to continue selling expensive HIV treatments rather than curing the disease. Once a patient is cured, they no longer need to pay for expensive treatments.
Healthy people are more productive, which mean they are better paid, which mean they have more money for healthcare, which means profits for the healthcare industry.
Finding cures is a good way of maximizing profits, the best way actually, and if the healthcare industry is not doing that, it means that something else is stopping them. It can be bureaucracy, it can be just because it is really hard, it can be some systemic problem linked to health insurance and government funding, but I don't see how the healthcare industry wouldn't want to cure people.
It is an industry where demand is guaranteed, diseases in general are not disappearing anytime soon, let alone aging.
yes and no. Finding treatments that require long term commitments is more profitable than finding cures. Look at the history of ulcer drugs. Pharmaceutical companies spent huge amounts to develop drugs that ameliorated symptoms, a two person team found a cure for most ulcers.
The Pharmachy cartel will never let things like this happen.
Search for Barbara O'Nell, if I remember her surname right, she is Australian and was banned from practicing anything medicine related because she was using natural resources to help threat people that would otherwise, spend thousands of Australian dollars buying medicine. Her videos are awesome btw.
Barbara O’Neill promotes baking soda injections as a cancer cure and encourages people not to use antibiotics because she thinks they cause cancer. She’s a dimwit.
For those of modest means there is also the "fail first" insurance process where you need to use less expensive therapies before a more appropriate therapy is approved. Each failure can be costly to a patient's health, often exacting irreversible comorbidities, not even considering lost work, family wellbeing, and pain/suffering.
For those with rare diseases, insurance also doesn't help with "N of 1" efforts. A case report to consolidate critical details would be invaluable. Yet there's no administrative path to fund this personally let alone with insurance help. Without summary case report it's harder to see the big picture, get a care team on the same page, and dial in on the underlying disease mechanism.
Pharma is also not enthusiastic about "off label" use of their medications. They are happy to lower costs when insurance denies coverage for an indicated diagnosis, to demonstrate benefit so it then becomes covered. However, "off label" use is often full cash fare, making it impossible for common folk to perform low-risk physician-guided experiments when standard therapies are ineffective.
We can and should do so much better.
Imagine if we let doctors do medicine instead of letting profiteering beancounters optimize for number go up.
I can see why some things landed here. Medicine is expensive. Desperate people are more susceptible to fraud. Yet things are improving: someone like me would be long dead a generation ago.
We should look at these challenges holistically and think about better fiscal/social engineering of our marketplaces. Alvin Roth's book, "Who Gets What and Why", is a good introduction to identifying market failures and thinking about how to address them.
Step therapy is required in countries with universal healthcare, too.
It can actually be harder to get access to new therapies in countries with universal healthcare because they’re more uniform and strict in what they allow.
For a relatable example: The UK just raised the age of eligibility for COVID vaccines all the way up to 75 years old: https://www.mirror.co.uk/news/health/covid-russian-roulette-... Contrast this with the US where COVID vaccine coverage is a basic expectation of health insurance for all ages. And that’s for a simple, cheap medicine without step therapy! It doesn’t matter if your doctor thinks you need it, the rules are set from the top.
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We do let them do that if you are willing to pay them for it. The fact is that if you "let doctors do medicine" without any cost benefit analysis, then you really aren't going to like the cost.
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As someone who has looked at things like Renewable energy deployments within the UK, this is a pattern that seems to be quite pervasive across all industries. The byzantine web of planning approvals, goose counting, public outcry that you have to deal with to deploy essentially a relatively small solar farm is monstrous.
What that results with is that the only people capable of creating & managing these processes have the legal teams & resources necessary, stifling growth. Even once you get an approval, it may be years in order to get a grid connection.
This risk averse attitude pervades into all walks of life, including medical beurocracy. This essentially locks out a ton of real innovation, as it's too expensive to square up against a mass of beurocracy attempting to stifle you at all turns.
Its a double edged sword. yes, it stifles renewable energy innovation, but those rules are usually put in place in a more general sense, and you would really want them in place if next door was suddenly announced to be a landfill, or chemical plant, or a chicken farm, or an xAI datacenter....
The UK is begging for people to build datacenters: https://www.theguardian.com/technology/2026/mar/09/revealed-...
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That's what a lot of people seemingly struggle to understand.
Inaction is not a safe action. Inaction has a price. And sometimes a death toll too.
It depends on your point of view. For the person deciding on giving permission they will not be thanked for allowing it, but might well be blamed if something goes horribly wrong.
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Yes, but this is a clasical agent-principal problem.
Theoretically, the bureaucracy works on your behalf, but only approximately so. If it makes a mistake that kills you, the decision maker does not pay any price.
Maybe one solution for this issue would be some kind of “developer’s ombudsman” that is an affordable public service to 1) help people navigate the bureaucracy and 2) produce a report recommending streamlining of rules where possible.
This avoids “cutting down all the laws to punish the devil”. Some regulations are necessary.
> Some regulations are necessary.
Genuine question — is there a common factor across the regulations you'd keep? Because if there is, you could encode that directly instead of maintaining the specific rules. And if there isn't, "some regulations are necessary" isn't really a position yet.
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Another bureaucracy to help people navigate the existing bureaucracy? Are you missing a "/s"?
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To play the devils advocate, in places with low bureaucracy most of the risk taken is not innovation. It's just risk that leads to the death of others. Buildings with shitty concrete with too little rebar in it. Electrical wiring that will kill you. Improper foundations and such.
At the end of the day there is no simple answer here. It's no different than the talks about AI that dominate HN these days. You can build good things with AI, but the vast majority of it is crap, so we put up filters and hoops to ensure we don't get flooded with that crap.
The devil doesn't need any more advocates.
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Have you tried the "forgiveness is easier than permission" approach? What would happen if you just installed the solar panels? I know that in some countries they'd come by with a bulldozer and tear them down again - is your country one of those?
I am not sure about a bulldozer, but in the UK you will be forced to demolish it yourself. I am not sure what the penalty is for failing to do so when ordered to, but it seems to be usually effective.
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"Forgiveness is easier than permission" only makes sense when you know what you're doing and understand the consequences. (IE, paying taxes a little late in the US is okay because the fine is roughly the same as the interest of holding the money in the bank.)
In the case of solar panels, I'm going to assume the OP is talking about something like a grid-scale solar farm instead of rooftop solar production:
1: You need an agreement with "the grid" to get payment for the electricity you generate.
2: Feeding electricity into a power grid is a very dangerous thing, at a minimum the grid operator needs to make sure you aren't going to cause a fire or otherwise break their equipment.
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That being said: If you're a homeowner trying to set up a small solar installation, you can pair the panels with batteries and skip feeding into the grid.
This might work in parts of the US, but the UK will put you in jail for tweets, I would not risk this.
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I'd say the underlying problem is our capital-first regulatory environments. For the topic of the original article, anyone can see that it would be reasonable for a guy who loves his dog to make what appears to be a prudent medical decision in her interest, trying out an unknown vaccine without any sort of government involvement - and a government that prevents this is unjust. But with the way the system is set up, if this were legally sound it would then automatically imply that a corpo scaling up the situation to thousands of dogs that it (the corpo) doesn't care about would also be okay. The fundamental problem is that there is no recognition of scale (because small scale operators don't have the pull with the government to fix the regulations).
The same government that writes these regulations also has a department that rounds up and kills stray dogs so this regulation is stupid at any scale.
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There’s a lot to be said about the seemingly overbearing nature of the majority of FDA/ISO standards that result in the mass amount of hurdles that need to be jumped before a treatment is available, but that’s mainly due to institutional trauma from past events (thalidomide, primarily) as well as the fact that treatments are not simply binary. The options are not just “does not work” and “makes patient better,” there’s also “makes the problem worse.” These additional tests and trials are to catch and prevent adverse effects just as much as they are to ensure the drug or treatment actually works.
During covid, the FDA testified to congress that they were putting the vaccines on an approval fast track that would not reduce safety or efficacy. Why is this not the standard approval track?
Because it's inordinately more expensive.
We're computer people, so we have a good analogy here; the COVID vaccine did speculative branch prediction. They basically operated _as if_ they would get approval at all stages where they could, parallelizing much more of the process at the cost of a _very_ expensive branch fail if something went wrong.
For example, running very large trials in a short time is very high effort.
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a) Risk vs. reward -- not that I'm saying we're making the right balance decisions, but the correct speed depends on that balance in general.
b) The current administration is extremely unlikely to make vaccine approvals faster. If anything their instincts are the other way around.
Everything not mRNA failed. Sometimes miserably with bad effects, and those effects have all been swept under the rug. Some of the vaccines gave people lifelong sensitivities to the adenovirus vectors. I can go on and on.
We got damned lucky that mRNA vaccines against Covid work as well as they do. Nobody new a priori (go look at Derek Lowe's writing from "In the Pipeline" during it all) and "everything would strike out" was not off the table.
And the mRNA stuff only worked because people already had been working on mRNA vaccines for other things slowly over decades. We got "lucky" that Covid appeared when we had all the pieces in places (liposome encapsulation, alternate amino acid replacement, etc.)
Before advocating for "fast track", advocate for better and more stable funding on the "slow track" pure research that takes decades but feeds into this kind of thing. The work of Katalin Karikó was instrumental in this stuff and yet she had to swim through mountains of shit to do the research and was denied tenure. With better funding, this stuff could have been done a decade earlier.
The FDA didn't approve thalidomide, though! That was Europe!
Regulatory systems need omsbuds within the government who can ask for help and explanations from all the agencies regulating a project yet are (primarily) accountable for helping projects succeed as soon as possible and (secondarily) responsible for providing transparent feedback to those agencies and the public where regulation is malfunctioning.
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This writer could be more inflammatory. Refusal to provide adequate or fair services to disabled is systemic or worse bigotry.
It's fine to encourage society to hold each family drawing income from medical corruption accountable
I'm glad this is getting more attention!
I posted the original reporting from The Australian yesterday - it's a good primer.
https://news.ycombinator.com/item?id=47379740 https://archive.is/pvRaG
99% sure it's BS though.
How can anyone believe that a guy could use a text-generating AI to design a novel cancer treatment, but not write some compliance document?
Come on!
The LLM didn't oneshot the mRNA treatment, it merely suggested the idea. Most of the steps in the process were done with specialized tools. And no novel treatments were invented wholesale, it's more applying a documented process with existing open-source tools that's just too personalized and expensive to be offered by any vet.
I find this story perfectly plausible.
> More and more promising treatments are accumulating in the pipeline, fueled by an explosion of new therapeutic modalities, ranging from mRNA to better peptides and more recently, by AI.
If the pipeline is backed up you put a bigger pipe in place, not get rid of it and hope some of the resulting flood goes where you want.
It’s less of a pipeline and more like a rocket engine. The exhaust gas (clinical data) spins the pump. We’ve put restrictors on that flow, and it’s taking a lot of fuel to get off the ground.
> The exhaust gas (clinical data) spins the pump
Not really. Real-world data is used very heavily already and is far less helpful than we'd hope for in drug development.
It's much more like a pipeline.
Rockets with unrestricted flow are called bombs.
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The usual line is "the regulations are written in blood", and it's a cliche because it's true.
No, it's a cliche because it's false and/or just rephrased alarmism. Most regulations are changes made to solve no problem, simply because someone thought it was a good idea, or because they were vaguely related to a Current Thing, and then persisted because undoing any decision is organizationally extremely hard and nobody cared enough. 'Written in blood' is a great catchphrase for eliminating any discussion of cost-benefit tradeoffs, and the lives that could have been saved but for inaction by default.
Please show me the blood that zoning regulations are written in
The context is medical regulations.
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I too, like everyone one else, often hate the tedious and often absurd, effort that bureaucratic procedures sometimes require, but this story doesn't make any sense to me.
We're talking about a guy who's used AI to make personalized ground-breaking medicine for his dog but says he spent three months typing a 100-pages long document for the red tape. In reality, current AI technology isn't particularly designed to help you making radical medical breakthrough on its own (at least yet), but is extremely proficient when comes to writing text that must just check boxes.
I'm sorry but how does that story not smells like complete bullshit to anyone reading this? Given that the guy telling his story is “an AI entrepreneur”, I'm almost 100% sure that the story is almost entirely made up for self-promotion.
It's not a radical medical breakthrough, it's applying a technique already documented in the literature and years into human clinical trials. The LLM is just doing literature summary and planning. The most notable AI innovations here are in protein folding and binder prediction.
There's pictures of the dogs tumor progression and scientists from government labs validating his story.
Yeah. It's possible to think that there are cases where lowering the cost of first phase trials or making it relatively simple for people capable of offering informed consent to obtain access to existing safe medications currently undergoing trials for their specific ailments and thinking that a person who claims to have "designed an RNA vaccine" by asking an LLM to teach him about RNA and now wants to inject it into animals under his care might be the exact thing such laws were meant to restrict.
Plus as others have pointed out, LLMs are much better at generating something that looks like compliance documentation than they are at designing drugs (and providing generic background info on compliance processes than they are at relatively little-documented cutting edge research), so if most people aren't instantly sceptical of a yarn spun about how a layman with ChatGPT easily taught himself enough to find an RNA immunotherapy cure for his dog but then was stymied by the amount of typing involved in a 100 page document, it's a good indication of why barriers to even nominally consenting people trying experimental stuff exist.
The LLM did not design the drug. The LLM summarized some papers on how to design similar drugs, and then a dozen specialized tools were used in an established pipeline to design the drug. You people need to read the article and read the background before writing nonsense based on your assumptions.
Here's a previous comment of mine talking about personalized mRNA vaccines with useful citations: https://news.ycombinator.com/item?id=47210284
> I'm sorry but how does that story not smells like complete bullshit to anyone reading this?
Because it strokes the anti-establishment anti-intellectual and anti-bureaucracy zones all at once, and a lot of nerds (with love) are contrarians. Us software guys like nothing better than a story about how a smart ass with a computer undid a problem seemingly created by institutions out of whole cloth.
I'm calling absolute 100% bullshit.
This resonates. Used AI heavily during development of a recent open source project and the speed gains are real but so is the review burden. The risk isn't the generated code itself, it's the generated code you didn't read carefully enough. Cursor is fast at producing plausible looking solutions that pass a quick glance but fail edge cases. The discipline has to shift from writing to reading, which is a different skill entirely.
LLM account
Wrong assumption bro
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Am I going crazy here? A completely random person tells AI to generate a novel vaccine/compound, and people are actually upset that there were 3 months of regulatory hurdle he had to jump through before he was able to start injecting this new compound into an live animal's bloodstream? Really?
It's an animal, and a terminally ill one at that. What's your worst case scenario?
Is it that the dog dies faster than it would have?
That's not actually an issue. We already have vets who just put terminally ill pets down.
So, who does the bureaucracy help? Who's protected by it? Why is it there at all?
It is there to ensure an animal is not experimented on unnecessarily or with excessive pain. Discussing a process like this might require you to slightly look further than one mostly clear cut case.
Part of his filings will be actually stating the "terminally ill" part and having this approved by an ethics committee. Making a moral judgment here is the committee's actual role as not all cases are so "simple".
The animal is terminally ill and the vaccine's slated purpose is to cure that illness. If you're rich & terminally ill these kinds of regulatory mazes are less of a burden, but if you're poor you'll likely die before you can get approval.
This ridiculous arrogance pisses me off so much. In the name of safety and proper procedure, with the argument that it could do someone harm, we just let people die. No, we’re not going to give you permission to try a new drug that could potentially cure you, or much more likely give researchers valuable data about the drug. No, this is against protocol. No, it’s against your own safety, so please be so kind as to fuck off and die.
That is basically what we are telling patients who would gladly reduce the suffering of themselves and others. Because someone claims it is an irresponsible hazard to other people’s health. That it is supposedly immoral.
In the name of correct procedure and bureaucracy, someone lets other people suffer. This is what really is bizarrely immoral.
'Bureaucracy' is commonly used as a trigger word. When I see it, I'm alerted to manipulation and, in some contexts, a certain partisan dogma. After all, who likes bureaucracy? By the same token, who like stop lights or authentication or other structures in life? But every large organization functions using bureaucracy - every highly successful one, every median one, every poor one.
> A system originally conceived to safeguard patients has gradually produced a strange and troubling outcome: the mere chance of survival is effectively reserved for the very few who possess the means to assemble an army of experts capable of navigating its labyrinthine procedures.
The survival of who? The three people who are trying to experiment on themselves (with questionable results, especially when their experiment has N=1)? That's a crisis? What about the 99.9..% of sick people?
> I will focus on the former: small, exploratory trials, which will be called early-stage small n trials for the purpose of this essay.
'early-stage' - it's just like a startup! Except the human experimentation part.
> In recent years, China has been advancing rapidly in biotechnology, in part because it is easier to run early-stage clinical studies there.
> “The US can’t afford to lose the biotech race with China.”
With the 'bureaucracy', it's right out of central casting, including the scare tactic: The same arguments have been used for labor standards, property rights, democracy itself.
You're defending a government using force to prevent terminally ill people from voluntarily experimenting on themselves to find a cure and further our understanding of disease. It should not be easier for a layman to design and build a targeted mRNA vaccine then it is to navigate a regulatory maze.
> prevent terminally ill people from voluntarily experimenting on themselves to find a cure and further our understanding of disease
Those seem like a good starting point for standards: Is it voluntary? Are they of sound mind? Are they giving informed consent (to themselves)? Is the experiment likely to yield useful results?
There are many things you can't voluntarily do, such as experimenting with cures that involve opiods. Should we allow vulnerable, uninformed people to take dangerous drugs because they saw a YouTube video saying they would help? Try random gene editing?
The truth is, you probably could do those things and few would care unless you hurt someone else.
> using force
Yes, guns ablazing!
The cure for cancer will come via a revamp of regulations. /s
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I don't see how you can blame this on feminists when other people should also have been pushing for those same rights?
Why are you putting more of the blame on feminists and women than any other section of society here? It just reads as unhinged misogyny.
"It's women's fault" is a long-standing thing in the culture.
Because they were fighting for half the population, and they demonstrably lost. We now have pre-1975 law, including horrific laws like Texas creating task forces hunting out women with miscarriages and abortions in other states.
They could have made the 'umbrella' of what they were fighting for cover 100% of the population. They didn't. We're all worse for it.
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You can see this pattern repeated often by conservatives (not invented by them, but currently popular with them): No matter what happens, attack your political enemies. Every problem, every event, is an opportunity to smear them.
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As long as we do my parents last, and yours first.
Didn't Covid take care of that?
Did you even read the article? What does this have to do with anything?
/s?
I clicked on the wrong link on mobile and responded to the wrong article. Was absolutely written in the spirit of Swift, though.
That article is exactly on point. There is a process in place for the express reason of slowing and blocking anything that will bring about positive, meaningful solutions and potential cures to the human condition.
Because the old state of affairs had desperate people being experimented on by opportunists, charlatans and fraudsters for money. There's work to be done balancing the equities of people with terminal diagnoses but lets not pretend there's no point to the roadblocks to human experimentation on the dying.
That sounds about right. Lots of abuses have been perpetrated by opportunists, charlatans, fraudsters all for money, as you put it. I just want to make sure we correctly distinguish what is meant by "opportunists, charlatans, fraudsters."
In the spirit of full transparency, I've listed some of the most well-known cases. Others, due to the Iron Curtain and similar curtains are hard to document, due to lack of visual inspection. Just the same I've listed them for transparency's sake:
Western Bloc:
Tuskegee Syphilis Study (US, 1932–1972)
Project MKUltra (US/CIA, 1953–1973) Human radiation experiments (US, 1940s–1970s)
Porton Down nerve/chemical tests (UK, 1950s–1960s)
Ewen Cameron brainwashing/LSD experiments (Canada, 1950s–1960s)
Eastern Bloc:
Soviet Gulag prisoner chemical/medical experiments (USSR, 1930s–1950s)
Punitive psychiatry experiments on dissidents (USSR, 1950s–1980s)
Pre-1940s Germany:
Nazi eugenics forced sterilizations (1933 Hereditary Health Law; ~400,000 citizens)
Pre-1940s Japan:
Unit 731 biological/chemical experiments (est. 1936; pathogen injections, early vivisections on prisoners)
Axis Powers:
Nazi Germany: concentration camp medical experiments (Dachau/Auschwitz hypothermia, twins, sterilization; mainly 1941–1945)
Imperial Japan: Unit 731 & affiliates (vivisections, plague/anthrax tests; ~3,000+ direct deaths, 200k+ from field use)
Fascist Italy: No major documented equivalent programs
Asia:
Japanese-occupied territories (China, Manchuria, Korea, etc.): Unit 731 satellites (biological warfare tests on local citizens/POWs)
By the way, all the above instances are part of history.
Greed is greed, whether "Capitalist, Socialist or Communist-oriented." In my view there is no distinction between modern day and historic "opportunists, charlatans, and fraudsters." Greed is Greed!
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The healthcare industry, especially in the US, isn't interested in finding cures for disease. It's interested in maximizing profits, which is a goal that the bureaucracy serves.
The healthcare industry in the US in made up a huge range of individual and organizations, they don’t all have the same motives.
Suggesting otherwise is projecting your own fears not representative of reality.
>they don’t all have the same motives
Regardless of their motives they're all subject to the same regulatory system so they can only stray so far for so long from the net effect of the incentives and remain not bankrupt and being auctioned to pay back creditors.
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Then feel free to point out the outliers that aren't interested in maximizing profits.
https://www.somo.nl/big-pharma-raked-in-usd-90-billion-in-pr...
It seems to me that the leading vaccine manufacturers, who spend billions of dollars yearly in order to lobby US lawmakers that establish the bureaucracy the article is complaining about, are interested in just that (maximizing profits).
It doesn't really matter much if there are individuals or other organizations interested in curing disease, when we have a system that allows for legal bribery of lawmakers, and other individuals / organizations with more money that value profits over anything else.
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Doesn't matter. Not all have the same level of influence. The ones with the most clearly follow GP's characterization.
Have you ever considered that "finding cures for disease" is really fucking hard to do?
Things that were easy to cure were already cured some time in the past century. What remains is the hard to crack nuts that resist simple scalable methods.
There's money to be had in curing HIV - but good luck pulling that off. Maybe someone will, this century.
Have you ever considered that once a disease is cured, the industry can no longer profit off of it being a disease? Treating disease rather than curing it, is a much more profitable venture.
How is there money to be had in curing HIV? It seems to me like it's much more profitable to continue selling expensive HIV treatments rather than curing the disease. Once a patient is cured, they no longer need to pay for expensive treatments.
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Healthy people are more productive, which mean they are better paid, which mean they have more money for healthcare, which means profits for the healthcare industry.
Finding cures is a good way of maximizing profits, the best way actually, and if the healthcare industry is not doing that, it means that something else is stopping them. It can be bureaucracy, it can be just because it is really hard, it can be some systemic problem linked to health insurance and government funding, but I don't see how the healthcare industry wouldn't want to cure people.
It is an industry where demand is guaranteed, diseases in general are not disappearing anytime soon, let alone aging.
yes and no. Finding treatments that require long term commitments is more profitable than finding cures. Look at the history of ulcer drugs. Pharmaceutical companies spent huge amounts to develop drugs that ameliorated symptoms, a two person team found a cure for most ulcers.
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"lax lab controls are a feature, not a bug" -Wuhan Institute of Virology
A rich person engineering their own RNA modifications for their dog? Yeah, I don't want that and bureaucracy is how we voice that.
The Pharmachy cartel will never let things like this happen.
Search for Barbara O'Nell, if I remember her surname right, she is Australian and was banned from practicing anything medicine related because she was using natural resources to help threat people that would otherwise, spend thousands of Australian dollars buying medicine. Her videos are awesome btw.
Barbara O’Neill promotes baking soda injections as a cancer cure and encourages people not to use antibiotics because she thinks they cause cancer. She’s a dimwit.
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