alt Hacker NewsThe bureaucracy blocking the chance at a cure
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> 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.
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.
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
The usual line is "the regulations are written in blood", and it's a cliche because it's true.
The cure for cancer will come via a revamp of regulations. /s
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.
'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.
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.
A rich person engineering their own RNA modifications for their dog? Yeah, I don't want that and bureaucracy is how we voice that.
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.