Biohackers Creating Open-Source Insulin
When Anthony Di Franco was diagnosed with type 1 diabetes in his early 20s, he never dreamed that a decade later he’d be teamed up with a group of biohackers working to homebrew their own insulin.
That’s what he is doing now in Berkeley, California, as a part of the Open Insulin project that aims to create a blueprint for insulin, an open-source protocol that would be universally created and shared so that others could actually make a generic version of insulin.
This project is a part of Counter Culture Labs, which sprung up from hacking community projects in the Bay Area and became a stand-alone non-profit organization. The goal: to develop an open insulin roadmap within the next decade.
Along with Anthony, the Open Insulin project team began with roughly 50 self-described “hackers and tinkerers” who proudly point out they are all “bio-curious" -- with a mix of genetic engineering, software, biochemistry and biotech experience.
Just as other tech-savvy and gadget-connected hackers and do-it-yourselfers have done with diabetes device and data, Open Insulin is embracing the #WeAreNotWaiting mantra that has taken the D-world by storm and is changing the regulatory and industry view on expanding open access to innovations.
“The spirit of #WeAreNotWaiting is really with us,” says Anthony, who closely watched the D-tech hacker movement and is wanted to bring that to the insulin production side. “But we don’t just want to 'not wait' on better ways of managing diabetes, we also don’t want to wait on big bureaucratic organizations to find the right incentives to bring us the best of what research has to offer.”
Make no mistake: The aim is not mass-produced, assembly-line made insulin where hundreds of vials can be created in a production cycle. No, this would be a very small and focused batch just for research purposes, a proof-of-concept that independent insulin production can be done.
Think of it like a highway system. Open Insulin hasn't set its sights on building expressways and roads across the country. Instead, their focus is sending a couple of explorers through uncharted territory to map out the route and show that expressways and roads could, someday, be built for people to travel on.
Generic insulin remains many years off, but this is an important step in making that happen. And it’s great to have Anthony leading the charge and inspiring the team with his own T1D story.
A Biohacker’s Diagnosis
Anthony was diagnosed in the mid-2000s when he was a senior in college. That’s when he “went down for three days” with what he believed to be the worst case of flu ever. After that, the traditional symptoms hit: sleepiness, thirst, frequent bathroom visits that woke him up every couple of hours, and about 50 pounds in weight loss over the course of two months.
“I really didn’t know what was going on, but it was my last semester of college so I tried to postpone dealing with it until after I’d graduated.”
Right after his last exam, Anthony rushed to the hospital where his blood sugar reading was “off the charts high” and the doctors diagnosed him with T1D.
Anthony started on Lantus and at first his doctor prescribed Symlin, too. Then after a few years on injections he decided to try an insulin pump. Interestingly, Anthony says his observations about cybersecurity and medical device hacking combined with the high cost of supplies persuaded him to go back on injections. That’s the regimen he remains on today.
“I work in software myself, so to imagine that something as important as an insulin pump needs to go through years of regulatory work just for a software patch to improve security was a big turnoff for me,” he says. “It just wasn’t worth it.”
Professionally, Anthony worked on mechanisms for decentralized finance at a startup called Credibles, before going into programming language research and doing contracts for Wikipedia and other open access orgs. Being connected to the tech and hacking communities in Northern California, Anthony has long been a fan of open-source everything. With his feelings on diabetes device insecurities, he originally thought about developing protocols for an open-source insulin pump. But that was already being done and going into closed-loop systems, and it didn’t solve the more pressing issue of costly insulin… and that set the stage for what he’s doing now.
“People across the world are going without insulin because it’s so expensive, and we need to do something about that,” Anthony says. “Maybe someday, what we’re doing here could lead to a do-it-yourself insulin factory.”
Counter Culture Labs and Blueprinting Insulin
Counter Culture Labs is an emerging non-profit (still waiting on the IRS to make that official) that spun off from the biotech hacker community in Oakland, CA. As Anthony tells it: “It’s a science and biology heavy group of hackers and tinkerers, and there’s a strong interest in making things more fair and addressing economic and other forms of injustice."
There's a core team of 10 people who work together on a regular basis, and a bigger group of about 50 who are in and out with contributions. With more promotion and media attention on this project in the past months, interest has gone global and Anthony says they’re already adding to and tweaking their protocols based on new contributions.
He first thought a homebrew insulin plant would be feasible. But after studying that possibility, it became clear that the protocol-publishing path was where his team needed to focus.
This isn’t a generic insulin they’re developing, he emphasizes.
“I wouldn’t classify this as us wanting to make a generic, because when I say 'generic' I think of an off-brand drug that’s gone through regulatory processes and is sold on the market. That takes millions of dollars and many years of trials, and that’s not something we are looking to do in the near future.”
The plan, Anthony says is to "do the design and engineering work, to craft protocols that are simple and easy to reproduce."
To be clear, this differs from generic insulins under development in that those are direct copies of brand-name insulins — for instance, a recombinant insulin such as glargine. They will have the same biological form and clinical results as existing the brand-name drugs. By comparison, the much-hyped biosimilars are highly similar but have some differences because they're made from living organisms. As development of those is quite complex, the EMA (European Medicines Agency) has led the charge on issuing and updating specific guidelines for that work.
Medicines Agency (EMA) has updated its guideline on the requirements
for clinical and non-clinical development of biosimilar insulin products
- See more at:
http://www.raps.org/Regulatory-Focus/News/2015/03/12/21708/EMA-Updates-its-Biosimilar-Insulin-Guideline/#sthash.BA2w5R7K.dpuf
The Open Insulin group is taking an alternate course. The big question is: How would their insulin actually be produced?
The explanation involves a whole bunch of science and molecule lingo, much detail of which went over our heads as Anthony explained it. Bottom line: They’re injecting an insulin gene into e-coli DNA so that it would grow from there, and they have to engineer the three-pronged insulin chain while also purifying it to ensure it’s safe enough to work in a human body. They wouldn’t have to meet as stringent safety requirements as those for a drug being sold on the open market, since that isn't required at this stage in developing a protocol. But Anthony says it would be as close as possible to that standard so that getting there wouldn’t take as much time later on in the research.
For now, Anthony says the focus is on creating a setup at Counter Culture Labs for that initial molecule and insulin-chain work. Then, once they have an insulin prototype to use in research, he says “that’s where the real fun begins.”
Nope, they won’t actually be injecting insulin into anyone anytime soon. Just figuring out if they could, at some point, actually do that. Realistically, the project will take anywhere from 2 to 3 years or possibly longer.
“Whatever the path and timeline is ahead, it’s going to involve a lot of trial and error on which protocols to use and determine what insulin can actually be produced,” he says.
The Path Forward
Embracing the open-source movement behind this project, Anthony says many skilled biohackers have come out of the woodwork to help make this happen, even after only a month of promotion.
“There isn’t a lot to show right now because it’s so early, and we’re really at the chicken-and-egg stage where we raise some money to do the work and then see what’s next."
The Open Insulin project ran a fundraising campaign on the crowdfunding platform Experiment and raised 277% of their goal ($16,656 total over the initial $6,000 ask). More than 220 parties backed the project initially, according to the website.
We at the 'Mine are thrilled to hear about this open-source insulin project, even as we acknowledge the difficulty of the task at hand.
We can only imagine the insulin manufacturers chuckling, more than anything else -- because we’ve seen the insulin-making assembly lines up close and personal and know it’s not easy or cheap, the reason we haven't seen much insulin innovation through the years on a broad scale from manufacturers.
But we also believe that it can be done efficiently and less expensively by those who don’t have patents and dollar signs in their eyes. It has to, because we can't afford to keep the status quo. Insulin costs have skyrocketed in recent years and they continue rising. Many of us pay as much as $220 a vial in recent years, in large part due to high-deductible insurance!
Take note, Insulin Makers: People are frustrated beyond belief, and it’s outrageous how inaccessible insulin is to so many people globally. This DIY effort is coming out in a big way, and through consumer momentum alone will undoubtedly change the game -- just as the #WeAreNotWaiting movement has done in the device arena.
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Originally published on DiabetesMine in 2015
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