The Promise of Generic Insulin

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The headline you’ve probably read more than once, including here on A Sweet Life, is one of outrage surrounding rumors of price-fixing along with (surprise!) the escalating costs of insulin. People who take insulin rarely switch brands, which means that whatever Big Pharma wants, Big Pharma gets. Insulin is my medical version of water. I don’t go a day without it. So, when I learned about the Open Insulin Project, an evolving group of scientists working to democratize the life-sustaining hormone, I let out a small cheer. Today, the team at Counter Culture Labs in Oakland, California has made tremendous progress on how to “easily” make insulin and their network is growing to include biohacker groups Reagent in Ghent, Belgium and Biofoundry in Sydney, Australia, as well as Fair Access Medicines, a non-profit in the U.S.

Biomedical research takes a village.

Anthony Di Franco informally heads up the Oakland-based group. In between working towards a PhD in computer science at U.C. Davis, Di Franco is working to understand enough about producing insulin in a simpler and cheaper way to establish a protocol for enabling almost any business entity to produce insulin. Without the enormous R & D costs that Big Pharma likes to point to when they speak to costs, the Open Insulin Project hopes to open the market to cheaper insulin and happier people with diabetes.

In a study published in the New England Journal of Medicine about why no generic versions of insulin exist, Dr. Jeremy A. Greene writes that economists estimate the average cost to bring a new drug to market at “$1 billion and rising.” Scientists at the University of Toronto first discovered insulin in 1921. That’s almost a century of small changes to one medicine that allow drug companies to continue their patent stranglehold, locking out generics, and passing along the ever rising costs to you and me.

The scientists at the University of Toronto didn’t patent their discovery at first, but when they licensed it to companies that could better manufacture the life-saving drug––Eli Lilly and what is now Novo Nordisk––the patents followed. Much has been done to improve insulin’s physiological effects since that first dose extracted from animal pancreas, but it’s still a surprise to everyone that we don’t yet have generics. This is where the Open Insulin Project steps in.

The project officially launched in late 2015 with almost seventeen thousand dollars from a crowd funding campaign on Experiment.com. “One of our priorities is to make a protocol that is as simple as possible without large-scale systems or complex infrastructure,” says Di Franco. What he means is: no fancy lab equipment. While the unpaid group is always evolving, there are usually about a dozen people working to create insulin from scratch. It only took a few months for the group to grow bacteria cultures they could use to grow proinsulin, the protein in our body that is converted into mature insulin, which is what directs glucose to enter our body’s cells as molecular fuel.

Anthony Di Franco
Anthony Di Franco

After this, the team made a second version with green fluorescent protein fused to the proinsulin so they could easier spot the protein expression. “By the end of 2016, we were pretty successful in growing large quantities,” says Di Franco. The team started by working with E. coli, a simple bacterium, with plans to expand efforts to work with yeast, another lab workhorse that will allow the proinsulin protein to be produced alongside the enzymes needed to convert it to mature insulin. Di Franco tells me that yeast can secrete the insulin outside of the cells, which will make purification easier. “Then we will have a simple and low cost way to make insulin,” he says.

The Open Insulin Project is very close to isolating proinsulin in a definitive way, which is the biochemical equivalent of hitting a bulls eye.

There are pros and cons to using an unpaid team like the Open Insulin Project. Scientists with amazing skills work for free when they are in between jobs or academic appointments, but then they tend to come and go. Di Franco, one of the original members, isn’t going anywhere. He has type-one diabetes. The 34-year old was diagnosed in his last semester of college. Di Franco knew something was unusual, but his schoolwork came first. “I lost 40-60 pounds. All my friends thought I was dying of cancer,” says Di Franco. “I was probably eating 12-13,000 calories a day,” he recounts. “My tray would be full of three plates and four drinks because I was so thirsty.” (Sound familiar?) Di Franco turned in his last assignment and then checked himself in to Yale New Haven hospital only to learn he wasn’t dying of cancer. Pros and cons.

The Promise of Cheap Insulin 2With this strong personal connection, it’s no surprise that the Open Insulin Project is making such great headway and perhaps in the next decade we will see a generic insulin reach the market. Think of all the money we could save. “Today, more than 80% of prescriptions are filled with generics, which saves the health care system billions of dollars each year,” writes Greene in his study on generic insulin. This is also Di Franco’s fervent hope. “Part of the problem is that insulin is so lucrative that no one has a financial incentive to get people off of it,” he says. “If we could introduce competition to insulin maybe we could dry up the market and get them to do something different.”

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3 Comments on "The Promise of Generic Insulin"

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Cindyrendy

Great project. If this was put into the market, I do believe quite a lot money could be saved. By the way, I’m quite interested in how you use green fluorescent protein fused to the proinsulin so to easier spot the protein expression?

Noel Carrascal

Hi everyone, I am one of the volunteers helping Anthony with his work on a generic insulin. I am running the San Francisco marathon to raise funds for the open insulin project. If you would like to donate, please click on the link below https://www.crowdrise.com/open-insulin-project-at-counter-culture-labs
The money will be given directly by the San Francisco marathon to the Open Insulin project. Thanks!

rick phillips

It certainly makes sense that Insulin would become generic. However, the difference between making small batch insulin and large scale insulin production may well be the factor that determines the price. Biosimilar manufacturers seem to be a better bet for the long-term reduction of price. Now having said that I applaud the effort. All effort to lower cost is good effort. I hope the effort works out.

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