Open Insulin is Changing the Future
Open Insulin is Changing the Future of Diabetes Treatment
Many experts believe that insulin made from “open source” materials could very well be safe and significantly cheaper than products that are currently on the market.
It is something needed by everyone to survive, even more so for people with diabetes, receiving times infusions of the drug is very well a matter of life or death.
Researchers and doctors have known the ability to manufacture insulin for well over a century. However, prices remain incredibly high, ranging upwards of 400$ per month for uninsured people.
The United States alone has more than 29 million people who can’t afford insulin to treat their diabetes; an in-depth report by NPR discovered this.
Not being able to purchase insulin to treat diabetes means major medical issues or worse with arise.
Unfortunately, this is what happened to Shane Patrick Boyle, who had type 1 diabetes and sadly died after a GoFundMe page for “a month’s worth of insulin” supply fell short of its goal.
The Open Insulin Project.
There is a group of biohackers in the San Francisco area working to reduce the cost of insulin by developing a protocol for small scale production. Their goal is to upset the insulin monopoly that is held by a few Pharmaceutical companies.
Just like the name suggests, the development platform will be “open source,” with templates and processes available to everyone who has the funding and the willingness to attempt to make the drug themselves.
This new project shows the potential to change the very basis of how insulin is manufactured and sold.
It very well could break through the price-fixing monopoly that is held by the three major insulin producers.
But does it work? And is it safe? Is it legal? Is it ethical?
How we got here
Before we can come to conclusions on the questions above, it is vital to have an understanding of insulin. Like where it comes from, how it is produced and regulated, and how we have gotten to the point where something like insulin manufacturing on a small scale is feasible.
Insulin is a naturally occurring hormone, produced by the pancreas in healthy people, and its primary role is to regulate blood sugar levels.
Individuals with diabetes require insulin because their bodies either don’t produce enough or don’t respond to increased insulin levels in their blood.
This is why people with diabetes need regular infusions for the rest of their lives by injection or pump to maintain healthy blood sugar levels.
The first iteration of insulin was done in an exciting manner, by harvesting the hormone from pigs and cattle, then refining it for human use.
The new modern insulin is mostly grown by bacteria injected with human genes for insulin production then harvested. This method of production originated in the 1970s.
Any drug that is made using living organisms is considered a “biologic drug,” these types of drugs are notorious for being harder to produce effectively and in turn much more costly to make. Most other drugs are produced much safer and cheaper through chemical synthesis like pain killers.
Biologic drugs much like any other drug that is on the market are heavily regulated by the Food and Drug Administration (FDA), but there are only three manufacturers who produce insulin: Eli Lilly and Company, Sanofi, and Novo Nordisk.
Now insulin, unlike many other drugs, does not have a significantly cheaper generic version. The generic version of insulin is only about 10-15 percent less expensive than the competitors. This is well shy of the usual 80 percent that is seen in many other generic drugs when compared to the name brands. However, this version just so happens to be owned by Eli Lilly.
Much of this can be accounted to the issues and difficulty with creating a new drug and bringing it to market under FDA regulations. It is almost prohibitively expensive, and there are very few companies that would be willing to do that for a drug that has been around for a long time, such as insulin.
Wait, but what about the first insulin?
As these newer forms of insulin made their way to the marketplace, the older animal-based insulin just disappeared and didn’t stick around to become available as a low-cost alternative. This in no small part was due to the high cost of producing insulin in that method. This caused the companies who were controlling the production to discover it to no longer be profitable.
Now when you look at it from a business and pure profit motive, which is the likely culprit. Since the cost per unit of insulin has more than quadrupled in price since the turn of the century.
Doing it yourself
Since “Big Pharma” isn’t willing to make insulin affordable, the next logical step is for individuals to figure out how to make it themselves. They do say that necessity is the mother of invention.
In the same manner as open-source software, the Open Insulin Project is aiming to set the standard as the first openly available, and open protocol for insulin manufacture, according to the project's website.
The technology that is required to make biologic drugs is not nearly as complicated as many people think. It has become easier to get the needed machinery and supplies that would be hard to come by in the past.
The science behind engineering with biology, or bioengineering as some would call it has made terrific leaps in the modern age. Currently, we are at the point where we know how to make the organism do all of the hard work. Leaving the cleanup and refinement to people so that what comes out is pure and safe.
The specific type of insulin the project is focused on making is glargine insulin. This is very similar to products sold under the brands of Lantus by Sanofi, as well as the supposedly “generic” Basaglar by Eli Lilly.
The projects insulin can possibly be manufactured for a fraction of what the brand names insulin sells for.
Hold on, is it safe?
The goal of this project is to help people take to costs of their treatment into their own hands. The project has no hopes to produce insulin for the public themselves. Their goal is to create a platform for insulin creation to be scaled down and democratized.
The result of this would likely be a platform for insulin production that would cost around the same as a small car, which is a small price to pay when the average cost of insulin per month is similar to a loan payment on a luxury car.
The vision is to have production take place away from the big players and instead have it moved into small collectives, clinics, and hospitals.
When worrying about safety factors, it is essential to note that Open Insulin might end up being safer due to its small scale nature.
When insulin is made in smaller batches, it can be significantly easier to test and recall bad batches compared to one shipment of millions of units all over the globe.
There was a recently published report on the Open Insulin Project that set a bullish tone on the safety of the project and others like it.
The review found that insulin does have variations between batches, but this had more to do with transportation and storage of the liquid, rather than who manufactured it.
Making sure that the insulin remains cold through out its storage and transport is a much stronger determinant of the product’s viability rather than the manufacturing of the insulin.
The biggest hurdle always has and always will be the regulatory issues that this method will face.
The only way for this bio hacked method of making insulin not to be subjected to any regulation would be if the production were only for personal use. There are no structures that currently exist for regulation and oversight for non-commercial products.
The Stark Truth.
There is good news. Open Insulin isn’t alone in their quest to solve the insulin price-fixing.
Several other organizations are working to create the ability to manufacture small scale biologics.
MIT’s Amino Labs sells educational kits like a “biomanufacturing starter kit” priced around $2,000 that can be used to do precisely what Open Insulin is hoping to do but on a tiny scale.
The end goal is to make it affordable for everyone to get insulin, those who need it to survive should have access, and it should not be profit-driven. The poorest section of the market and the uninsured can’t afford it much of the time.
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