After a century, insulin remains extremely expensive at $ 400 per month

Operating in a regulatory blind spot, DIYers could alter the status quo for drug production. It's risky, but researchers say it's the only way to help Americans struggling to survive

Shortly 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 that a drug that saved lives could be widely available.

Almost a century later, an American with diabetes can pay up to $ 400 per month for insulin, taking some patients without insurance to desperate and dangerous measures. Clearly, something went wrong.

Our laboratory studies biosecurity, so when we learned that a group of DIY biologists was working to solve the problem of insulin affordability by discovering how to make insulin without patents, we got to know them.

After delving into the issue of insulin affordability, we argue that what keeps insulin expensive is not patents, but regulations. By operating in a regulatory blind spot, DIYers could alter the status quo of drug production.




Patents do not make insulin expensive

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

So, why, with the original patent expired a long time ago, is there still no generic insulin available?

The insulin that is purchased today is not the same insulin that is used to treat diabetic patients almost 100 years ago. That insulin came mainly from animals. Today, insulin is made by microbes that have been genetically modified with the human insulin gene.

And insulin is rarely injected with an outdated syringe and needle.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

With each of these inventions a new patent arose.

But the benefits of these "improved" insulins are debatable, and there is nothing to prevent competing companies from selling older versions of insulin that do not require a patent. So, what is the robbery?

Regulations keep insulin expensive

Insulin is a biological drug, which means that it is produced by a living organism, not a chemical reaction. This process, called biofabrication, is more inconsistent than the chemical synthesis of non-biological drugs such as aspirin.

Making reliable biological medicines is a bit like making wine. Even though the winemaker carefully follows a well-established process, minute differences will affect the final product. It is always wine, but some vintages are better than others and tasting wine is the only way to evaluate the final product.

So, if a new company wants to produce insulin, it must be tested on patients in costly clinical trials. Bringing a biological medicine to the market can cost as much as $ 250 million. No company can afford that mass if it can not apply for a patent to recover the investments.

That's why there's only one insulin & # 39; generic & # 39; available so far. It is made by a company that was already a major player in the insulin market, and is only 15 percent cheaper than the patented version. By comparison, most non-biological generic drugs cost 80 percent less than the original.

Obviously, regulations are important to keep insulin safe, but at what cost? Ten percent of people living with diabetes in the US UU They do not have insurance, and there are almost 10,000 crowdfunding campaigns related to insulin on the GoFundMe site alone.

Stories about diabetic patients who end up hospitalized or worse because they tried to ration their insulin are too common.

Democratizing insulin production

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

As in wine making, the specific knowledge required for the production of insulin is a guarded secret. The goal of the Open Insulin Project is to discover a patent-free method and publish information, so that competing companies can manufacture "generic" insulin.

Given the cost of regulatory approval, the project is more likely to allow patients to develop their own diabetic treatments. Currently there is no structure to regulate drugs that are not produced commercially. One report estimates that up to 2,000 patients have already designed their own insulin pumps and electronic monitoring systems. The insulin itself could be the next.

Is it possible to make biological medicines such as insulin more affordable without compromising safety? One suggestion that has been gaining strength is to reduce biofabrication. At this time, biological drugs such as insulin are cooked in giant batches. Ensuring that these lots are consistent and free from contamination is a big challenge.

Think about the meat department in your supermarket. Many large stores store hamburgers that were milled in a central processing plant and then distributed. If an outbreak of E. coli occurs in the plant, it will spread to all downstream stores, potentially infecting hundreds or thousands of people.

Meat is also exposed to more potential contamination events through storage and transportation. And, if contaminated meat is identified in a store, it will not be immediately clear if everyone else is safe or not.

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

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

If insulin were manufactured in smaller batches, manufacturers could forgo 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 be applied to other expensive biologics, such as those that treat cancer, HIV and rheumatoid arthritis.

The technology necessary for the production of insulin in small batches already exists. Future research could help automate and optimize the production of medicines from small batches in order to minimize safety risks.

The future of medicine

The pharmaceutical industry is ready for the interruption. In the coming decades, drugs could be produced in very different environments.

Hospitals have already started plans to manufacture their own medicines.

DIY biologists can provide patients with the knowledge they need to produce on their own the medicines on which their lives depend.

As industry and regulatory agencies gain more experience with biologics, it is also possible for regulations to decrease, reducing the cost of approval.

This would allow the emergence of small-scale drug manufacturers that could provide non-marketed drugs at a lower cost.

One thing is certain: the future of medicine will not be "business as usual".

The biofabrication technologies will continue to evolve.

These changes could allow the decentralized production of life-saving drugs. It has not yet been determined how the regulatory system and the pharmaceutical industry will adjust to that future.