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

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.

As the name suggests, the platform will be “open source,” with processes and a template available to anyone with the know-how and funding to try to make the drug themselves.

It has the potential to change the way insulin is sold and used.

It also could break the stranglehold the three major insulin manufacturers currently enjoy on pricing.

But will it work? And is it legal? Is it safe?

How we got here
To answer those questions and understand how we got to the point where something like Open Insulin is feasible, it’s important to understand what insulin is and how it’s produced and regulated.

Insulin is a hormone, produced naturally in healthy people, that regulates blood sugar.

People with diabetes have bodies that either produce insufficient insulin or don’t respond correctly to the levels of insulin in their blood.

They therefore need regular infusions of the drug via injection, pen, or pump to remain healthy.

The first wave of insulin production was harvested from pigs and cattle and then refined.

Modern insulin, starting in the 1970s, is grown by bacteria injected with human insulin genes to produce the hormone.

Drugs made with living organisms this way are known as “biologic drugs,” which are historically harder and costlier to produce — and produce safely — than those produced through chemical synthesis (think ibuprofen).

Biologic drugs are regulated by the Food and Drug Administration (FDA) like any other drug, but only three major manufacturers make insulin: Eli Lilly and Company, Sanofi, and Novo Nordisk.

And unlike many other drugs, the “generic” version of insulin is only around 15 percent cheaper than its competitors, rather than the usual 80 percent. This version is also owned by Eli Lilly.

This is partly because bringing a new drug to market under FDA regulations is expensive and few companies would be willing to do that for an older drug such as insulin.

But what happened to the original insulin?

As new forms of insulin have come to market, the older animal-based insulin simply disappeared rather than remaining available as a low-cost alternative, Dr. Jeremy Greene, a professor of medicine and history of medicine at Johns Hopkins University in Maryland, told NPR.

The reason, he speculates, is that the companies controlling this production no longer deemed it profitable.

From a pure profit motive, that likely makes sense. The cost per unit insulin in the United States has more than quadrupled since the turn of the century.

Doing it yourself
If the big companies won’t make affordable insulin, the reasoning goes, it’s time for people to figure out how to do it themselves.

Following the tenets of open source software, the Open Insulin Project wants to be the “first freely available, open protocol for insulin production,” according to a statement on the company’s website.

“We hope our research will be the basis for generic production of this life-saving drug,” it reads.

The technology to make biologic drugs isn’t as complicated or as hard as it used to be, Anthony Di Franco, co-founder of the Open Insulin Project, told Healthline.

Di Franco, who was diagnosed with type 1 diabetes unexpectedly in his early 20s, was inspired to start the project because of his own experiences trying to obtain insulin and proper care for managing the disorder.

“Engineering with biology has advanced to the point that we know how to make the organism do most of the work,” he explained. “That means the work we’re left with is cleaning up after it and purifying what comes out.”

The insulin the project is making is a glargine insulin, similar to that sold under the brand name Lantus by Sanofi, as well as the slightly cheaper “generic” Basaglar by Eli Lilly.

But the project’s insulin could be manufactured for a fraction of the price.

Is it safe?
Open Insulin’s goal, Di Franco said, isn’t to produce insulin for the public themselves, but rather to create a platform for the creation of insulin and other biologic drugs that can be democratized and scaled down.

The result would be an insulin platform that might be priced around “the cost of a small car.”

He envisioned production that moved away from the big players and is instead “centered around the small collective or pharmacies, clinics, and hospitals.”

As for safety, Di Franco contended that Open Insulin might actually be safer because of its small-scale nature.

If insulin is being made in smaller batches, it would be easier to track down a bad batch rather than one shipping in millions of units all over the world from one of the big three manufacturers.

A recent report on the Open Insulin Project in the journal Trends in Biotechnology had a bullish view of the safety of the project and others like it.

Their review found that while insulins did feature variations between batches, this had far more to do with how they were transported and stored than who manufactured them.

“Cold chain management (including transport and storage) and sampling of biologics may be stronger determinants of variability than initial manufacturing,” the researchers wrote.

The bigger hurdle, researchers said, would be regulatory.

“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.

Others getting involved
But Open Insulin isn’t alone in forging ahead.

At least two other organizations are part of the effort to produce small-scale biologics.

MIT’s Amino Labs is selling educational kits including a “biomanufacturing starter kit” priced around $2,000 that could be used to “engineer bacteria and organisms with a new DNA program.”

Meanwhile, students at Colorado State University recently held a crowd-funding campaign to support students trying to develop small-scale insulin production.

At the end of the day, Di Franco said, these efforts are about bringing insulin to those who need it, outside of profit-motive.

“The poorest sector of the market can’t afford it and can’t get it,” he said.