The insulin market can compete toe-to-toe for drama with any election-year political campaign. A quick search for insulin news reveals pharmaceutical companies being sued for illegal collaboration, protests over prices, and people taking desperate measures to get the insulin they need—or even going without.
A group of “citizen scientists” in California’s Bay Area have decided that they can do better. They call themselves the Open Insulin project, and they’re working to reverse engineer a patent- and drama-free insulin platform and offer that platform to everyone who’s interested.
The self-proclaimed biohackers envision “the first freely available, open protocol for insulin production.” If successful, they could create a generic platform appropriate for small-batch, “home brewed” insulin that could be made by anyone with some know-how and ingenuity.
At first, it might sound like an outlier group of bohemian scientists who believe in peace, love, and free insulin. But while the project has a very casual tone when it comes to branding and philosophy (all are welcome at their Wednesday night meetings), they continue to get attention in the serious medical community.
Open Insulin puts the blame for the high cost of insulin on the practice of making small modifications to previous versions of insulin so that pharmaceutical companies can continue to get new patents instead of making cheaper, generic versions of current insulins. If a generic drug company, or even a small pharmacy, had access to the recipe, so to speak, for insulin, they could create a dramatically less expensive version.
But the tweak-and-renew-patent technique is only part of the problem.
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Another problem is insulin itself. It’s a biologic drug, meaning that it’s made using a living organism, or bio-manufactured, rather than chemically synthesized like aspirin. Insulin is grown by injecting human insulin genes into bacteria to make them produce insulin. This isn’t a cheap or easy process. And going through the approval process for highly-regulated biologics is a major investment—as in a $30 to $250 million-dollar investment, according to a case study in Trends in Biotechnology.
And therein lies the rub. The three pharmaceutical companies that control 96 percent of the world’s insulin supply (Novo Nordisk, Sanofi, and Eli Lilly), have already paid these costs. For them, patenting new versions of tried-and-true insulins is a much easier and cheaper process. But starting from scratch? A company looking to make a profit wouldn’t want to spend the capital if they couldn’t also get a patent that would allow them to make up for the significant startup costs.
New biologic drugs must go through an expensive regulatory process involving lengthy clinical trials. The regulatory process is designed to keep consumers safe by keeping dangerous drugs from being marketed too soon, and that’s a good thing. But now that same process is discouraging the production of affordable insulin, which presents a new set of dangers for people who ration or fast because they can’t afford it.
But Open Insulin wants to find a patent-free method of making insulin and share that with companies that could then make generic insulin. However, this doesn’t solve the regulatory cost problem (unless the project is somehow able to handle those costs, which doesn’t currently look plausible).
But what’s more likely, according to The Conversation, is that people could use the information to make insulin batches on their own, thus legally circumventing the regulatory process. People with diabetes are versed in creativity—many have already created their own insulin pumps and monitoring systems. Home-brewed insulin could be next.
But there are a lot of unanswered questions. How long could home brewed insulin go unregulated, if it became popular? And would it be safe in the first place?
Anthony Di Franco, co-founder of the Open Insulin Project, wants to see insulin produced in small clinics, pharmacies, or hospitals. He argues that this small-batch approach could actually be safer since it would be easier to identify the source of any contamination and less likely to be shipped all around the country, reducing the risk of damage or contamination during storage and transport.
Specific details of what it would take to produce this small-batch insulin are still lacking, though Di Franco estimates that the envisioned insulin platform could be purchased for “about the cost of a small car.”
Though Open Insulin cannot promise success, the DIYbio movement is refreshing in a world where just pharmaceutical companies seem unmotivated to make insulin affordable. In the face of the pharmaceutical giants, biohackers threaten, “We don’t need you anymore.” But whether that’s true, and whether a biohacking David can succeed against three resource-rich Goliaths, remains to be seen.Whizzco