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The bureaucracy blocking the chance at a cure

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by endymion-light

9 subcomments

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.

by clcaev

2 subcomments

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.

by just13ducks

2 subcomments

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.

by pxeger1

0 subcomment

The bureaucracy isn't trying to be utilitarian, it's trying to be democratic, and the people don't want utilitarianism. No politician wants to be the one who removed the red tape that would've stopped the reckless professor from poisoning all those children with his botched clinical trial.

by GregDavidson

1 subcomments

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.

by panzagl

1 subcomments

> 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.

by khelavastr

0 subcomment

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

by mmooss

1 subcomments

'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.

by joenot443

2 subcomments

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

by KaiserPro

0 subcomment

I beg people to step outside and look at recent history.
"Why is there byzantine regulation for this particular industry?"
because someone took the piss and killed loads of people. A good example is https://en.wikipedia.org/wiki/Carlill_v_Carbolic_Smoke_Ball_...
Where a conman made claims to lure the desperate and gullible.
The Vet case is instructive here. This is to stop suffering in animals.
The same with the people experimenting on themselves. THis is to avoid stuff like Tuskegee Syphilis Study, where unacceptable risks were taken to gain data.
tldr: these regulations are there to stop bad actors killing people for either profit, data or fun. Claiming ignorance as to _why_ these regulations exist is bad research and I would suggest is either incompetence or dishonesty.

by BigTTYGothGF

2 subcomments

The usual line is "the regulations are written in blood", and it's a cliche because it's true.

by littlestymaar

4 subcomments

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.

by thegrim33

2 subcomments

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?

by hsuduebc2

0 subcomment

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.

by msie

0 subcomment

The cure for cancer will come via a revamp of regulations. /s

by anesxvito

1 subcomments

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by mystraline

2 subcomments

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by x3n0ph3n3

4 subcomments

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by jmount

0 subcomment

A rich person engineering their own RNA modifications for their dog? Yeah, I don't want that and bureaucracy is how we voice that.

by SilentM68

1 subcomments

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.

by tinfoilhatter

4 subcomments

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.

by h4kunamata

1 subcomments

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.