Professionalism, Insulin: The Deadly Price

Background: Diabetes and Insulin

The 'big 3' symptoms of diabetes and at home blood glucose testing method. (Image: https://www.myupchar.com/en, CC BY-SA 4.0)

A functioning human body derives essential energy from glucose, a sugar which comes from food. For glucose to enter the cells and be metabolized, the body produces a hormone called insulin, which enables the glucose to be processed by the cells. For most individuals, the body is able to regulate insulin and blood sugar (glucose) levels automatically. For individuals with diabetes, this process in impaired. Diabetes is a chronic disease which can lead to serious health problems such as heart failure and kidney disease and is fatal when left untreated.[1]

Diabetes is commonly categorized into two types. Type 1 diabetes is an autoimmune condition, in which the pancreas is unable to make insulin. It has no cure, and treatment is directed toward managing sugar levels in the blood using externally supplied insulin, as well as changes in diet and lifestyle. Type 2 diabetes, often caused by lifestyle, such as obesity or lack of physical activity, typically involves either insufficient insulin production in the body or insulin resistance where the body cannot use the insulin effectively.[1]

For individuals with type 1 diabetes and often type 2 diabetes as well, treatment depends on access to externally administered insulin. Insulin was first discovered in 1921 by Frederick Banting and Charles Best, where it was isolated from the pancreas. After initial successes in animals, insulin was administered to 14 year old Leonard Thompson, whose blood sugar rapidly returned to normal levels. Prior to this discovery, all children with diabetes died within one to two years of diagnosis, with no effective treatments beyond harsh diets.

Early production of insulin consisted of extracting insulin from the pancreas of cows and pigs that were slaughtered for food. Over time, this method was replaced by industrial production using recombinant DNA technology. In this process, a human insulin gene, built by scientists, is inserted into a loop of bacterial DNA known as a plasmid. The recombinant bacteria are then cultured in large fermentation tanks where they produce human insulin, which is then harvested and purified for clinical use.[2]

Timeline of Insulin

Frederick Banting and Charles Best with the dog who was the first test subject for insulin injections. (Image: Thomas Fisher Rare Book Library, CC BY 2.0)

Over the last 30 years, the price of insulin has skyrocketed. In 1996, insulin was considered affordable, at $24 per vial[2]. In 2023, the cost of insulin ranges from $65 to over $300, depending on the type of insulin. A timeline of the discoveries and associated prices paints the picture of the dramatic increase in cost over the last century.

1889[3]: Oskar Minkowski and Joseph von Mering, German researchers, conducted experiments on dogs. They removed the pancreas from the dogs, causing the dogs to develop symptoms of diabetes. The dogs quickly died after the pancreatic removal. Minkowski and von Mering concluded that the pancreas was where "pancreatic substances" were produced.

1910: Sir Edward Albert Sharpey-Shafer coined the term "islets of Langerhans," which were responsible for producing insulin.

1921: Frederick Banting and Charles Best were able to extract insulin from a dog's pancreas. Banting and Best sold the patent to the University of Toronto for only $1. They believed it was unethical for a doctor to profit from a discovery that could save lives.

1922: Mass production of insulin extracted from pigs and cows used to produce vials for diabetic patients. Eli Lilly became the largest producer of insulin. The cost of insulin was approximately $9 per vial for insulin.

1982: Recombinant DNA technology was introduced to E. coli to produce human insulin. Price increased to $14 per vial.

1996: Insulin analogs introduced. Analogs are designed to mimic the body's natural pattern of insulin release, such as fast acting (to be taken with food) or slow release. The analogs are completely synthetic[4]. Humalog insulin, produced by Eli Lilly, price listed at $24 per vial[2].

2019: Humalog insulin cost $332[5]. Price of production ranges from $2-4.

Based on the timeline, insulin price increases correlated with new discoveries related to insulin. Currently, the average price of insulin is $275 per vial. 13 vials of insulin are required per year per diabetic to survive. Solely looking at covering the cost of production, it would cost $71 for a year supply of insulin. However, the current price of insulin comes out to $3575 for a year supply of insulin. The profit margin is 98% on insulin.

Frederick Banting

Frederick Banting played a central role in the discovery of insulin. Working in the laboratory of John MacLeod with his assistant Charles Best, Banting first successfully demonstrated insulin’s life-changing potential in his experiments from November 1921. With the later contribution of James Collip, insulin was purified for clinical use and by 1922 patients with diabetes were experiencing noticeable and almost immediate improvements following insulin injections.[6]

In 1923, Banting along with Best and Collip were awarded patents for their extraction and purification of insulin.[7] Rather than selling the patent for their own financial gain, they famously sold the patent to the University of Toronto for only $1 each. According to Banting, “Insulin does not belong to me, it belongs to the world.” Insulin production was a life saving discovery for millions, and he wanted treatment to be easily accessible to all. He made this decision in the spirit of the medical code of ethics describing the role of medical professionals to promote access to medical care for everyone by his choice to prioritize the public good rather than his own financial profit.[8]

Insulin Monopoly

The insulin price increase can be initially understood by analyzing the industry of insulin production. Currently, there are 3 pharmaceutical companies that own 95% of the insulin market: Eli Lilly, Sanofi, and Novo Nordisk. Through this market control, the companies can charge very high prices for insulin. While some of the largest pharmaceuticals have a profit margin between 15% and 20%, insulin prices are “2 to 9 times higher” than the cost of production[9]. These pharmaceutical companies use 3 main arguments to justify the high prices of insulin, but are illogical: high cost of development, free market economy pricing, and high costs are essential for continued innovation. First, the high cost of development is not relevant to insulin because the drug is over 100 years old. Second, there is no free market economy for a product (insulin) where the customer (diabetic) is not in a position to negotiate price, because they need the product to survive. Third, the high costs are not essential for innovation. Inherently there is limited innovation with insulin, and the need for affordability is more pressing[10].

The main method through which these three companies have maintained their domination of the insulin market is patent abuse. Patents are granted to pharma companies to protect their market share for drugs they develop, incenting them to invest in research. Patents are held for 20 years, but companies use various practices to extend this much longer, disallowing competition. These practices include “patent thickets,” applying for many different patents on the same drug, “evergreening,” making slight modifications to old drugs to obtain new patents, “pay-for-delay,” compensating generic drug manufacturers to delay market entry after the patent expiration, and “product hopping,” discontinuing a drug facing patent expiry and encouraging healthcare professionals to prescribe their new, minorly tweaked products. These methods are very common in the pharma industry; for the 100 best selling drugs, 70% have had patents extended, with 50% being extended more than once[11].

Legislative efforts to reform the insulin market have been met with resistance from lobbyists. The pharmaceutical lobby is the largest in the US, spending vast amounts of money to protect their markets. For example, government negotiation of drug pricing, common in other countries, has been lacking in the US due to “fierce opposition” from pharmaceutical lobbying[11]. In 2022, as the government focused on price caps, Eli Lilly and Novo Nordisk increased their lobbying expenditures by 29% and 24% respectively[12].

The insulin monopoly has been the status quo and is the contributor to insulin’s high cost. Governments have historically been hesitant to impose price caps because insulin companies have halted production of insulin and shut down entire factories in protest to government sanctions. In the 1980s, Argentina was going through an inflation crisis of up to 800%. To combat this, the government placed price controls on all products, including insulin. Argentina’s only insulin-producing company at the time was Eli Lilly, who closed their insulin-producing plants, creating a sudden insulin shortage for 73,500 men, women, and children[13]. The company eventually returned to Argentina in the 1990s, due in large part to a new convertibility exchange policy, which pegged the Argentine peso to the US dollar[14].

To control the insulin industry, a few individuals have worked to advocate for the patients and drive government regulation. S. Vincent Rajkumar, MD, a Mayo Clinic professor of medicine, submitted a commentary to the Mayo Clinic Proceedings to explain the high cost of insulin and suggest potential solutions. He called for policy-level solutions such as price caps, patent reform, and an easier path for insulin biosimilars to enter the market. He also asked his fellow healthcare professionals to discuss affordability with patients and implement guidelines that consider cost[15]. Senator Elizabeth Warren released a report in 2023 investigating the state of the insulin market and the recent price cuts enacted by companies. She found that many patients sill faced “significant problems” obtaining the cheaper versions of insulin due to problems such as limited stocking at pharmacies and misleading information on the availability of Lispro, the cheaper generic drug[16].

Insulin is still out of reach for many Americans, but there are possible solutions at the state and federal policy level[10]:

• Protection against monopoly.
• Reforms to the regulatory and legal processes that prevent generics and biosimilars from entering the market.
• Reforms to the patent system to prevent abuse.
• Creation of an agency to oversee pricing.
• Nonprofit generic manufacturing.
• Creation of laws that provide access to affordable insulin in cases of emergency.
• Greater advocacy from professional and patient organizations.

Insulin Price Capping

There are several strides being made to cap the price of insulin, both by companies and the government, in response to sustained price increases for a life-sustaining medicine. Several members of Congress have made proposals to address insulin pricing - such as creating a generic insulin manufacturing plant owned by the federal government, or by proposing legislation to create an insulin pricing model. In January 2019, Congress held hearings on insulin prices with insulin company executives and launched a bipartisan probe in the next month. State governments have also been contributing to the fight against insulin prices. In 2019, Colorado became the first state to legislate a price cap on insulin, with several other states following suit. In 2017, Nevada passed legislation to mandate insulin pricing transparency[17]. In 2022, the passing of the Inflation Reduction Act capped the price of insulin at $35 per month for diabetics covered by Medicare. A proposal to do the same for diabetics with private insurance was killed in the senate, with certain members of Congress claiming that capping insulin will hurt competition in business and innovation in research. In President Biden’s 2023 State of the Union Address, he called for this cap to be extended to those with private insurance[18].

Insulin companies initially took smaller strides to insulin price capping, but have started to take bigger leaps following public pressure and increased regulatory scrutiny. In a 2019 response to mounting public pressure, Eli Lilly announced it would provide a generic version of its insulin analog Humalog. This generic version is identical to Humalog, but would cost half the price. Since then, Novo Nordisk announced it would also sell a generic version of their insulin analog Novolog at half price, and Sanofi announced it would cap insulin at $99 a month for those without insurance[17]. Following the passing of the Inflation Reduction Act and industry competition, Eli Lilly announced that they would cap insulin prices at $35 a month. The cap went into effect immediately, and has already encouraged other companies to do the same[19].

The movement to cap insulin prices highlights the ethical limits of relying on market mechanisms to govern access to life-sustaining technologies. Insulin for many patients it is required for survival. When pricing decisions contribute to insulin rationing and harm, ethical responsibility extends beyond responding to market mechanisms to include patient welfare and access.

This case shows how ethical responsibility can become diffused within large healthcare systems. Alex Azar, President of Eli Lilly USA from 2012 to 2017 and later U.S. Secretary of Health and Human Services, is an example of this dynamic. During Azar’s tenure at Eli Lilly USA, the company substantially increased insulin prices and was later named in class-action lawsuits alleging coordinated pricing practices among major insulin manufacturers. [20] Azar publicly acknowledged at the same time that insulin prices were too high, often attributing them to intermediaries and broader systemic incentives rather than to individual corporate decision-makers. [21]

Insulin price capping suggests that markets alone may fail to protect vulnerable populations when products are essential for survival. In these cases, regulations can fserve to enforce ethical responsibility to prevent harm even when responsibility is diffuse within large institutions.

References

• ↑ a b "What is Diabetes?". www.nationwidechildrens.org. Retrieved 2025-12-15.
• ↑ a b c Hirsch, Irl (Aug 29, 2016). "Insulin in America: A Right or a Privilege?".{{cite web}}: CS1 maint: url-status (link)
• ↑ "The History of a Wonderful Thing We Call Insulin | ADA". diabetes.org. Retrieved 2023-05-07.
• ↑ "Insulin Analogs :: Diabetes Education Online". Retrieved 2023-05-07.
• ↑ "100 Years: From Gift to Greed - T1International". www.t1international.com. Retrieved 2023-05-07.
• ↑ "Frederick Banting, Charles Best, James Collip, and John Macleod". Science History Institute. Retrieved 2025-12-15.
• ↑ "Nobel Prize in Physiology or Medicine 1923". NobelPrize.org. Retrieved 2025-12-15.
• ↑ "100 years of insulin". Diabetes UK. Retrieved 2025-12-15.
• ↑ Panzirer, David (2023-10-24). "Insulin is increasingly affordable in the U.S. What about the rest of the world?". STAT. Retrieved 2025-12-15.
• ↑ a b "Why insulin is overpriced". PNHP. Retrieved 2023-05-07.
• ↑ a b Nagel, Kathryn E.; Ramachandran, Reshma; Lipska, Kasia J. (2024-03-27). "Lessons From Insulin: Policy Prescriptions for Affordable Diabetes and Obesity Medications". Diabetes Care. 47 (8): 1246–1256. doi:10.2337/dci23-0042. ISSN 0149-5992.
• ↑ Zhang, Rachel Cohrs (2022-01-25). "Insulin giants Eli Lilly and Novo Nordisk boosted their lobbying spending as Democrats eyed pricing reform". STAT. Retrieved 2025-12-15.
• ↑ "History matters – a century after insulin's discovery, we're going backwards". Healthy Debate. 2022-02-14. Retrieved 2023-05-07.
• ↑ Foley, Joseph (2021-07-18). "Elly Lilly calls it quits in Argentina". PharmaBiz.NET (in Spanish). Retrieved 2023-05-07.
• ↑ "There's plenty of blame to go around for high insulin prices". American Pharmacists Association. Retrieved 2025-12-15.
• ↑ "New Report From Warren, Warnock, Blumenthal: Uninsured Patients Face Significant Problems Getting Affordable Insulin | U.S. Senator Elizabeth Warren of Massachusetts". www.warren.senate.gov. Retrieved 2025-12-15.
• ↑ a b academic.oup.com https://academic.oup.com/jlb/article/7/1/lsaa061/5918811. Retrieved 2023-05-07. {{cite web}}: Missing or empty |title= (help)
• ↑ Kimball, Spencer. "Biden proposal to cap all insulin prices at $35 a month has little chance of passing Congress". CNBC. Retrieved 2023-05-07.
• ↑ "Lilly Cuts Insulin Prices by 70% and Caps Patient Insulin Out-of-Pocket Costs at $35 Per Month". March 1, 2023.
• ↑ "Sign-On Letter Opposing Nomination of Alex Azar as Secretary of Health and Human Services." The Leadership Conference on Civil and Human Rights. https://civilrights.org/resource/sign-letter-opposing-nomination-alex-azar/. Retrieved 2025-12-15.
• ↑ "Alex Azar." EBSCO Research Starters: Health & Medicine. https://www.ebsco.com/research-starters/health-and-medicine/alex-azar. Retrieved 2025-12-15.

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