Comment by mmooss
17 hours ago
'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!