Bush league pharmacologists have to be an optimistic bunch.
It's been almost a century since the first patent for insulin was filed by Canadian researchers. But for the millions of people who rely on the drug to treat diabetes, insulin is still a pricey brand-name product, costing hundreds of dollars per month.
A group of biohackers working under the banner Open Insulin want to challenge this status quo by devising a method for creating a generic, and cheaper, version of insulin. They plan on making it available to anyone willing to take up the challenge of producing it—but even the Open Insulin team admits getting their DIY insulin to a point where it can rival what's sold by big pharma won't be easy.
The main reason that a generic version of insulin isn't available today is that pharmaceutical companies keep "evergreening" the drug—making small improvements that are just enough warrant a refresher for the patent—and generics manufacturers don't want to take the risk of coming up with a way to make insulin that's as effective as what the big companies have developed over the years. At Counter Culture Labs, a maker space for biohackers in Oakland, California, a group of genetics enthusiasts are trying to do just that.
"We're just trying to get the easiest, simplest to follow, and lowest cost protocol for producing insulin together and documented"
"I've had diabetes since 2005, and I've seen basically no change in the therapies," said Anthony Di Franco, co-founder of Counter Culture Labs and leader of the Open Insulin project. "I'm very excited about citizen science groups doing this kind of research, just so that it doesn't all happen behind closed doors and depend on the political and economic incentives of these enormous institutions."
The group's chosen process is to engineer a plasmid for insulin—basically, a bit of DNA—and insert it into E. coli bacteria. The E. coli, acting as a host organism, will convert the plasmid into a protein, and begin to grow more. The resulting protein will still have to be verified to make sure that it is, in fact, insulin, and of high quality, a process that will probably take a few tries to get right.
If all goes well, the group hopes to have some life-saving insulin on their hands, and a method of creating it that generics companies can use.
So far, the group has designed the plasmid and created a prototype, but they have yet to insert it into the bacteria. To do that, they need funding; a campaign on Experiment, a platform for science fundraising, is well on its way to achieving its $12,000 goal.
Still, insulin is a deceivingly complex drug, and for even a ragtag group of amateurs, drug production is no trivial task. There are many, many steps that remain before the Open Insulin team produces some actual insulin, Di Franco said, and there's no guarantee it's going to be smooth sailing.
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There's been some skepticism around the idea of DIY insulin. Dr. Marcus Hompesch, founder of the diabetes research firm Profil Institute for Clinical Research, Inc., have expressed concern over biohacker-made insulin to NPR in July in an article about the Open Insulin team's work during the project's earliest stages.
"Manufacturing insulin or any peptide or any biologic for that matter is a very complex affair," Hompesch told NPR. "If you don't understand what it all entails, you could end up manufacturing something that is downright dangerous for patients."
These are "valid criticisms," Di Franco said, and not ones that he expects the Open Insulin project will be able to overcome easily, if at all. That's why they're focusing on producing something that existing companies can run with, rather than creating a process that anyone can follow at home.
"We're just trying to get the easiest, simplest to follow, and lowest cost protocol for producing insulin together and documented," Di Franco told me. "Once we have that, and once we've debugged that and think it's ready for other people to use, we're going to see if existing generics manufacturers can take it and go forward with the next steps."
If all goes well, Di Franco says, he expects the Open Insulin team will produce an open protocol for generic insulin in three years. It's an optimistic estimate—brazen, even—but when we've gone nearly 100 years without a cheap version of a drug that so many people depend on, what other choice do a group of bush league pharma scientists have?