‘Open Insulin’ Could Change the Future of Diabetes Treatment — But Is It Safe?


#1

A group of biohackers has created an “open source” site for small-scale production of insulin.

Insulin.

Everyone needs it to survive, and for people with diabetes, receiving regular infusions of the drug is literally a matter of life or death.

Scientists and doctors have known how to produce insulin for nearly a century, yet prices remain high — often $400 or more per month for the uninsured.

In the United States alone, more than 29 million people with diabetes can’t afford the drug, according to a 2015 report from NPR.

Not being able to afford the drug means medical complications or worse.

Such was the case of Shane Patrick Boyle, a person with type 2 diabetes who died after his GoFundMe page for “a month’s worth of insulin” supply fell short of its goal.

Enter the Open Insulin Project.

This group of San Francisco Bay Area biohackers is trying to reduce the cost of insulin by developing a protocol for its production on the micro scale.

READ MORE HERE: https://www.healthline.com/health-news/is-open-insulin-providing-a-safe-product-for-people-with-diabetes


#2

So far it’s just aimed at producing a glargine “Lantus” analog, but that’s a start. Interesting stuff about the regulations too.

“The only innovation model for biohacked insulin that would not be subject to any regulation is the production of insulin for personal use. No structure exists at present for regulatory oversight of noncommercial products, and reports of self-experimentation with unregulated treatments have begun surfacing,” they wrote.

So that’s “personal use,” but it’s not clear to me whether regulatory oversight kicks in only if you charge for it. In other words, if the start-up and production price were low enough, as it seems to be, would it be feasible for small, crowd-funded groups to get their own facility going and distribute the insulin to themselves without charging for it directly, and would that get around the regulatory barrier?

Also: they’re starting out with glargine, but I’d love to know if insulin lispro or aspart (Novolog or Humalog) would also be doable this way. And if so, could a distribution model be set up to bypass the patents–e.g., if the production was crowd funded but the product distributed for free or something along those lines. IANAL, obviously. But if the thing was set up right, as a public service for people who can’t begin to afford the outrageously inflated price of the patent stuff, I can see where it could bring major PR pressure to bear, if nothing else. Any patent suits could result in blowback: “How can these independents do it for so cheap when Big Pharma wants thousands of bucks for the same thing?” The problem right now is that even though a “generic” Lantus exists, it’s also owned by Lily and only marginally cheaper because, as we say here in Boston, “Eff you, that’s why.” Any thing that exerts downward price pressure on the Big Pharma producers is a good thing.


#3

I am so glad there are much smarter people out there thinking this stuff up. We are all so tired of waiting (True closed loop pump) & of course paying for insulin. I say, keep it up and maybe the companies that supply us will learn the hard way when they lose our business!


#4

@DrBB. I might be very wrong, but I thought the patent on Humalog had recently expired. I know they have a newer one on the delivery method (kwikpen) which ostensibly locks the product down again price wise