Bio-hacking is maturing and may soon run up against the FDA.
14 Sep, 2018FORTUNE.COM
People are dying from rationing their insulin as prices have more than doubled since 2012. For the last few years, California bio-hackers have been working on a crowd-funded, open-source insulin to introduce competition into the almost century-old market. But they face massive regulatory hurdles, according to a perspective published yesterday by Colorado State researchers in Trends in Biotechnology (free summary here).
The original patent holders, researchers at the University of Toronto, sold the patent to the university for $1, writing, “When the details of the method of preparation are published anyone would be free to prepare the extract, but no one could secure a profitable monopoly.”
It’s not quite a monopoly, but insulin is profitable for the three big insulin producers in the U.S.--Eli Lilly lly , Sanofi snynf , and Novo Nordisk nvo --which are now facing a lawsuit over price-fixing. Two of the firms in the lawsuit began producing insulins for human use in 1923, and for the last few years have been ramping up spending on lobbying. Earlier this year, Sanofi said it would lower insulin prices for some customers.
Insulin’s original inventors failed to anticipate how difficult producing and distributing insulin would be, according to a 2015 New England Journal of Medicine review.
Insulin is an extract made by animals, not a pure molecular product, so it requires biological laboratory expertise that is more difficult than just mixing and stirring ingredients. Think fermenting your own sourdough bread instead of preparing cake from a mix. The first pharmaceutical companies licensed to produce insulin, Eli Lilly and Nordisk Insulinlaboratorium (now Novo Nordisk), have been adding innovations to purify and improve delivery as improved lab techniques emerged. Insulin is faster-acting and longer-lasting thanks to them, but also far more expensive.
“On the whole, insulin today is demonstrably safer and more convenient to use than products available in 1923. But whether each incremental innovation is worth the price we pay, in a world where insulin remains unaffordable to many patients with diabetes, is less certain,” write the NEJM authors.
So it is unlikely that the Open Insulin team will directly replace or improve on big pharma’s state-of-the-art insulin, write the Colorado State researchers in The Conversation: “Given the cost of regulatory approval, it is more likely that the project could enable patients to "home brew" their own diabetic treatments.”
Indeed, patients have already built their own glucose monitoring devices and insulin pumps for off-the-books use. Artisanal, small-batch insulin itself could be next.