After a century, insulin is still expensive – could DIYers change that?

September 14, 2018 by Jenna E. Gallegos And Jean Peccoud, The Conversation
Miniature biomanufacturing kits like this prototype could revolutionize the pharmaceutical industry. Credit: Amino Labs, CC BY-ND

Soon after Federick Banting discovered that insulin could be used to treat diabetes in 1921, he sold the patent to the University of Toronto for about a dollar. Banting received the Nobel prize because his discovery meant a life-saving drug could become widely available. Nearly a century later, an American with diabetes can pay as much as US$400 per month for insulin, driving some uninsured patients to desperate and dangerous measures. Clearly, something went wrong.

Our lab studies biosecurity, so when we heard that a group of do-it-yourself biologists was working to solve the affordability problem by figuring out how to manufacture insulin patent-free, we got to know them. After digging into the insulin affordability issue, we argue that what's keeping insulin expensive is not patents – it's regulations. By operating in a regulatory blind spot, DIYers could upset the status quo for drug production.

Patents don't make insulin expensive

Discovering and developing drugs is expensive. Patents help drug companies recoup the costs from their investments by granting them a monopoly for a limited time. Once the patent expires, competing companies can begin producing generics: off-brand versions of a patented drug. This healthy competition drives prices down.

So why, with the original patent long-expired, is there still no affordable generic insulin?

The insulin for purchase today is not the same insulin used to treat nearly 100 years ago. That insulin came primarily from animals. Today, insulin is brewed up by microbes that have been genetically engineered with the gene for human insulin.

And insulin is seldom injected with an old-fashioned syringe and needle anymore. Now there are insulin pens, pumps, test strips and other devices that improve the quality of life for diabetic patients. Pharmaceutical companies have also modified the chemical formula to produce faster-acting or longer-lasting insulins.

With each of these inventions came a new patent.

Could big pharma eventually be cut out of the process by home brewers cooking up their own medications? Credit: Sanofi Pasteur, CC BY-NC-ND

But the benefits of these "improved" insulins are debatable, and there's nothing preventing competing companies from selling older, long off-patent versions of insulin. So what's the holdup?

Regulations keep insulin expensive

Insulin is a biologic drug, which means it's produced by a living organism, not a chemical reaction. This process, called biomanufacturing, is more inconsistent than chemical synthesis of non- like aspirin.

Making reliable biologic drugs is a little like winemaking. Even though the winemaker carefully follows a well-established process, minute differences will affect the final product. It's always wine, but some vintages are better than others and tasting the wine is the only way to evaluate the final product.

So if a new company wants to make insulin, that insulin has to be tested on patients in expensive clinical trials. Bringing a biologic drug to market can cost as much as $250 million. No company can afford that lump if it can't file for a patent to recoup the investments.

That's why there's only one "generic" insulin available so far. It's made by a company that was already a major player in the insulin market, and it's only 15 percent cheaper than the patented version. By comparison, most non-biologic generic drugs cost 80 percent less than the original.

Obviously, regulations are important for keeping insulin safe, but at what cost? Ten percent of people living with diabetes in the U.S. are uninsured, and there are nearly 10,000 crowdfunding campaigns related to insulin on the site GoFundMe alone. Stories about diabetic patients ending up hospitalized or worse because they tried to ration their insulin are all-too common.

Industrial-scale production – whether of hamburger or drugs – makes it harder to zero in on the source of problems when they occur. Credit: David Tadevosian/
Democratizing insulin production

Some people are taking matters into their own hands, tinkering to meet their medical needs. In 2015, patients and hobby scientists launched an initiative known as the Open Insulin Project.

As in winemaking, the specific know-how required for insulin production is a guarded secret. The goal of the Open Insulin Project is to figure out a patent-free method and release the information, so that competing companies can manufacture "generic" insulin.

Given the cost of regulatory approval, it is more likely that the project could enable patients to "home brew" their own diabetic treatments. There is currently no structure for regulating drugs that are not produced commercially. One report estimates that as many as 2,000 patients have already reverse engineered their own and electronic monitoring systems. The insulin itself could be next.

Is it possible to make biologic drugs like insulin more affordable without compromising safety? One suggestion that has been gaining steam is to scale down biomanufacturing. Right now, biologic medicines like insulin are cooked up in giant batches. Ensuring that those batches are consistent and free of contamination is a major challenge.

Think about the meat department in your grocery store. Many big-box stores stock hamburger that was ground in a central processing plant and then distributed. If an E. coli outbreak occurs in the plant, it's going to spread to all of the stores downstream, potentially infecting hundreds or thousands of people.

The meat is also exposed to more potential contamination events through storage and transport. And, if contaminated meat is identified in one store, it won't be immediately clear whether or not all the others are safe.

Now, consider a small local butcher who grinds meat in-house. Any safety risk is going to be isolated to the customers of that one store and the source will be obvious.

The authors describe how biohacking insulin and other biologic drugs have important implications for the future of pharmaceutical drug regulation.

Similarly, producing medications in smaller batches reduces the potential impact of any one safety event. Pharmacy compounding provides an example. In compounding, drugs are specially mixed or produced for a very small number of patients. Compounded medications are not subject to clinical trials.

If insulin were made in smaller batches, manufacturers might be able to forego clinical trials and use simpler and less expensive tests to confirm that each batch of insulin produced is safe and comparable to previously approved insulins. It would be like using chemical tests to identify important flavor compounds in two vintages of wine instead of organizing taste tests. This model could also apply to other expensive biologic drugs such as those that treat cancer, HIV and rheumatoid arthritis.

The technology necessary for small-batch already exists. Future research could help automate and streamline small batch medicine production in order to minimize safety risks.

The future of medicine

The pharmaceutical industry is ripe for disruption. In the coming decades, drugs might be produced in very different settings. Hospitals have already begun plans to make their own medicines. DIY biologists could provide patients with the knowledge needed to produce for themselves the drugs their lives depend on.

As the industry and regulatory agencies gain more experience with biologic drugs, it is also possible regulations will ease up, lowering the cost of approval. This would enable the emergence of small-scale drug manufacturers that could provide off-brand drugs at a lower cost.

One thing is certain, the future of medicine will not be "business as usual." Biomanufacturing technologies will continue to evolve. These changes could enable decentralized production of life-saving drugs. How the regulatory system and pharmaceutical industry will adjust to that future is yet to be determined.

Explore further: Increasing cost of insulin has serious health consequences

Related Stories

Increasing cost of insulin has serious health consequences

August 4, 2018
(HealthDay)—The increasing cost of insulin is potentially exposing those with diabetes to serious health consequences, according to an American Diabetes Association statement published in the June issue of Diabetes Care.

Human insulin as safe and effective to treat type 2 diabetes as costlier insulin analogs

June 27, 2018
Patients with Type 2 diabetes who were treated with the newer generation of insulin analog drugs did not have substantially better outcomes than those treated with less costly human insulin, according to a study by Yale School ...

AMA: Federal government must tackle rising insulin prices

June 15, 2018
(HealthDay)—U.S. officials need to take action to control spiking insulin prices, the American Medical Association (AMA) says.

Patients, health care workers call for affordable insulin

May 12, 2018
Activists are rallying in Massachusetts, demanding more affordable insulin.

Why people with diabetes can't buy generic insulin

March 18, 2015
A generic version of insulin, the lifesaving diabetes drug used by 6 million people in the United States, has never been available in this country because drug companies have made incremental improvements that kept insulin ...

Recommended for you

Can't exercise? A hot bath may help improve inflammation, metabolism, study suggests

November 14, 2018
Hot water treatment may help improve inflammation and blood sugar (glucose) levels in people who are unable to exercise, according to a new study. The findings are published ahead of print in the Journal of Applied Physiology.

Diabetic foot ulcers heal quickly with nitric oxide technology

November 12, 2018
Diabetic foot ulcers can take up to 150 days to heal. A biomedical engineering team wants to reduce it to 21 days.

Diabetes drug might also ease heart failure risks

November 12, 2018
(HealthDay)—The diabetes drug Farxiga might do double-duty for patients, helping to ward off another killer, heart failure, new research shows.

Marijuana use tied to serious diabetes complication

November 8, 2018
(HealthDay)—People with type 1 diabetes who use marijuana may double their risk of developing a life-threatening complication, a new study suggests.

Researchers report connection between intestinal bacteria and development of diabetes

November 7, 2018
Researchers at Örebro University have, together with a well-known research team in Denmark, developed a method for studying how metabolism in gut bacteria influences health. Their method will now be published in its entirety ...

Genetic factors tied to obesity may protect against diabetes

November 2, 2018
Some genetic variations linked with obesity actually protect against Type 2 diabetes, heart attack and stroke, new findings suggest.


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.