Insulin, though is possibly one of the most nightmarishly difficult proteins to make. It's kind of astonishing to me that Insulin was both the first protein sequenced and the first pharmaceutically relevant protein synthesized. Mother necessity, I suppose.
Genentech started making separated-chain insulin in E coli, back in the day, and that is emphatically not how it is done today. You get a whole bunch of crap because you need to keep the two chains denatured, and that results in scrambled disulfide bonds. If you try to do it in protein-folding conditions, one of the chains crashes out into plaques structurally similar to alzheimer's plaques.
You could make it as a single-chain protein, and then cleave out the middle section, except that the protease that you would use to cleave it out has another site internally!! And all of the proteases which leave a "clean end" leave a "clean end" in the wrong direction to yield a good insulin molecule.
Industrially, insulin is made (in yeast, not E coli) by going ahead and cleaving at that extra site, and then performing a reverse proteolysis to install a synthetically generated peptide, restoring the molecule. That's also why most insulin variants (e.g. humalog) have mutations in the tail end, that's the part that is "reinstalled". Note how crazy this is. Proteases are usually used to break proteins apart. Although technically all chemical reactions are indeed reversible, to force the chemical reaction in the other direction, you're fighting entropy, to put humpty dumpty back together again.
Honestly OIP's best shot is probably Michael Weiss' one-chain insulin molecule, which should have gone off-patent this year (https://patents.google.com/patent/US8192957B2/en) (15 years, right? IANAL) but for some reason got extended to 2028!!
However, the big danger with insulin analogs is that you really need to test the F out of them because insulin cross-reacts with the IGF-1 pathway and cause cell hypergrowth = cancer. I would also be very careful with home-made stuff because I would need to be convinced that the forumlation whipped up doesn't change the properties in such a way to to increase IGF-1 activation.
I advised Open Insulin on a ton of stuff in the first few months, but they took literally none of my advice on anything, and last I checked their mailing list a few years ago they were still stuck on some stuff I warned them about (e.g. insulin doesn't stain in coomassie blue -- another thing which makes insulin a pain in the ass).
I think you are severely underestimating what it takes to produce a protein drug like insulin. Getting the bug to make it is just the first step. Then next step is purifying it. Which takes SO much water, and salts, and specialized equipment (resins, columns, high-pressure apparatus). A decentralized insulin production scheme is going to be VERY ecologically destructive.
Buying out a patent and properly documenting it should be doable.
We could revoke the IP and thus force these companies to compete on price... but that hasn't happened. Thus the only solution that is making any progress is circumventing the IP and developing an open process.
There is IP around the production process (specifically the genetic strain of e-coli). Because the production process is biological, generics produced with a different process are not automatically approved by the FDA and have to undergo an expensive approval process. Thus the goal here is to devolop a process with open IP and get that process approved.
You really need to buy out trade secrets of this particular brand.
This is not really decentralized and is really risky, for obvious reason. https://www.ibj.com/articles/eli-lilly-asking-employees-to-w...
There's a lot that's ridiculous about bread being so expensive that recreating the entire supply chain in your backyard is the only economically viable option for obtaining it.
The metaphor pretty clearly was not about critiquing baking as a hobby.
Insulin must make it into the bloodstream intact, typically through injection. It’s also incredibly potent, a unit of insulin dried to crystalline form weighs less than 40 micrograms, so it much be administered in a sterile carrier fluid.
Lastly the penalty for overdosing is generally called insulin shock or diabetic hypoglycemia, and ‘it is rare but possible for diabetic hypoglycemia to result in brain damage or death. Indeed, an estimated 2–4% of deaths of people with type 1 diabetes mellitus have been attributed to hypoglycemia.‘ [1]
That’s with pharmaceutical insulin, not DIY.
In addition to doing it the way you described (put out flour and water in a bowl and wait for it to bubble and smell nice), you can also buy a $100 microscope, collect wild yeast, clean the bactiera off, and grow mass cultures. Sometimes it pays to work at the last step of the industrial, scientific and agricultural revolutions.
Regardless, it was all still done with science: Observation followed by trial and error informed by those observations. Maybe not the scientific method formalized by Francis Bacon, but it's still there in the outlines.
Either way, I don't see a fundamental aspect of the scientific method missing from an observation -> trial -> results loop. I also don't see crop cultivation as unintentional, although I'm not clear what you meant by that. What wasn't intentional? Deciding to experiment with planting seeds would have been a deliberate choice. Probably based on some observation that where wild grains were gathered together and and little things fell off of them, sometimes the same type of plant would grow. Followed by the idea that putting those things in different places might produce the same effect. Etc.
I don't think you get from wild gathering in a nomadic lifestyle to settled agriculture without observing, coming up with ideas about what you observed, testing those ideas, and checking the results. That is. A scientific process.
Toesinte turning into maize would may have simply been a blind generations long domestication process, but not that spark of insight and experimentation that led to stationary agricultural societies.