The author is a co-founder and member of the Board of Independent Voices for Safe and Effective Medicines. She is also a member of the steering committee of the Therapeutics Initiative at the University of British Columbia.
I have had type 1 diabetes for 52 years and like many other Canadians with the condition, I learned about the heroic scientists who discovered insulin the very first day after I was diagnosed.
Over the past year, the country has marked the moment when Banting, Best, Collip, and McLeod discovered insulin 100 years ago—the first successful experiment on a dog in November 1921 and the first human treatment in January. 1922. When the group awarded the insulin patent to the University of Toronto for one dollar in 1923, Banting made the famous statement: “Insulin does not belong. She belongs to the world. »
This credo helped the University of Toronto develop a distribution strategy to ensure that no single company has a monopoly on the manufacture and sale of insulin. Public and private manufacturers around the world have been allowed to produce insulin on the condition that they sell it as close to cost as possible.
While I rejoice in the discovery of insulin, I am appalled by how modern pharmaceutical companies attribute their opportunistic maneuvers in the insulin market to the achievements of its co-inventors. Canadians deserve to know the truth about how the pharmaceutical industry has skyrocketed the price of insulin, created a global oligarchy, and increased the burden on those who need this life-saving drug.
The century was to be an occasion to study the implications for diabetics of the mid-1980s decision to privatize Connaught’s legendary insulin laboratories. Many Canadians may be aware that Connaught was one of the largest vaccine manufacturers and distributors in the world and that its privatization threatened our access to vaccines. But what they don’t know is that Canada no longer produces a single drop of insulin for us or anyone else.
Today we are completely dependent on three companies – Eli Lilly, Novo Nordisk and Sanofi – which dominate 95% of the global insulin market. Two of them withdrew dozens of safe, effective, and affordable insulin options from the Canadian market, not because they were unsafe—no—but because they didn’t deliver the returns that pharmaceutical company investors had hoped for.
And there is no guarantee that global manufacturers will continue to supply Canadians with insulin. In 1985, Eli Lilly was the only insulin manufacturer in Argentina when the country was in a severe economic crisis. Faced with inflation rates above 800%, the government imposed price controls on all products, including medicines. In response, the company closed its plant, resulting in a sudden lack of insulin in 73,500 men, women and children.
Eli Lilly, like Sanofi and Novo Nordisk, has also engaged in a vigorous and aggressive campaign to overthrow our own system of protecting Canadians from unfair patent drug prices. In particular, she threatened to suspend or delay the introduction of new drugs in Canada. However, tighter price controls are exactly what people using insulin need.
We have become more, not less, vulnerable since Connaught was privatized. Health Canada cannot be relied upon to protect access to insulin because—incredibly—the ministry claims manufacturers do not have the authority to supply it to Canadians. It was this position that led to the recall of the entire line of less expensive animal-derived insulin developed by Connaught. It was replaced by biosynthetic human insulin (BHI), which manufacturers touted as an innovation on the same scale as the original 1921 discovery.
Introduced in 1983 in North America and Europe by Eli Lilly and Novo Nordisk, human insulin was the world’s first product made using recombinant DNA technology. But many believe that instead of providing a needed addition to the arsenal of diabetes drugs, the pharmaceutical industry saw insulin as the ideal vehicle for testing gene cloning, not least because it was a very large and captured market. And given the high level of public unrest at the time, biotechnology needed a respectable ambassador.
When BHI was submitted for approval by regulatory agencies such as the U.S. Food and Drug Administration and Health Canada, manufacturers claimed it was virtually interchangeable with porcine insulin. Both regulators approved new insulin products in a record 5 months compared to an average approval time of 40-60 months. FDA Medical Review Officer Henry Miller argued that “the quality of Lilly’s presentation was unparalleled, and the evidence for safety and efficacy was unequivocal and plentiful.”
The esteemed Cochrane Collaboration was less impressed. In 2002, the group noted that the studies, 70% of which were sponsored by manufacturers, were of “poor methodological quality” and did not take into account key health-related parameters such as mortality, morbidity, and quality of life. Evidence gathered in trials lasting five to six months showed that BHI had no therapeutic or clinical benefit over animal insulins and that only 40% of the studies provided information on side effects. While Miller called the FDA approval “historic,” Cochrane concluded that the administration of human insulin should exemplify “non-evidence-based pharmaceutical and technological innovation” sufficient for its benefits and safety.
By telling regulators that BHI is as safe and effective as animal-derived insulin, the manufacturers were telling the public that human insulin is identical to the insulin produced by non-diabetics—almost like a cure. Eli Lilly’s rep, when asked by a reporter about the superior benefits of human insulin, rhetorically replied, “Would you like to inject something human or something from a pig?” »
For the pharmaceutical industry, BHI has been a gold mine with profits that have exceeded all expectations. Today, the average cost to manufacture insulin is around $5 for a 10 ml vial, but most people in Canada pay between $35 and $80 (up to $380 in the US). The situation is even worse in the countries of the South. It is now estimated that half of the people who need insulin cannot afford it, which is a death sentence for people who have to go without it. Children like Leonard Thompson, Banting’s first patient, are still dying from lack of insulin in low- and middle-income countries. For these kids, it’s still 1921.
The pharmaceutical industry claims that this is the price of innovation and that the higher prices are because insulin is safer or better than it was 30 or 40 years ago, when it cost less than a third of what it is now. However, insulin is currently the second most reported drug for serious but non-fatal side effects. One such side effect, hypoglycemia, is the leading cause of emergency room visits for diabetic patients.
Hypoglycemia is the term used to describe low blood sugar, the most common side effect of insulin therapy, regardless of the type or type of insulin. When a person’s blood sugar levels are too low, the body releases hormones that send warning signals to the brain. The absence or weakness of these signals are major risk factors for severe and even fatal hypoglycemia.
Shortly after the introduction of BHI, diabetics began to report a decrease or disappearance of the warning signs of hypoglycemia. A 1991 report in the UK documented the unexpected overnight deaths of young otherwise healthy diabetics who were switched to BHI, a tragedy described as “death in bed syndrome”. Insulin manufacturers have changed their product labels to emphasize that switching from animal insulin to human insulin may result in weaker hypoglycemic signals in some. During his 2003 speech to the Canadian Health Standing Committee, Eli Lilly acknowledged that several patients with long-term diabetes suffered from a condition called “unconscious hypoglycemia” when they were switched to biosynthetic human insulin.
To date, studies show that up to 50% of people using biosynthetic human insulin fail to safely detect hypoglycemia, and no more than 40% of such episodes are detected in young children. A 2018 study found that diabetics whose condition required calling an ambulance were twice as likely to have hypoglycemic impairments of consciousness, which is a frightening reality, especially for children and parents.
Lack of awareness of hypoglycemia and other issues associated with biosynthetic human insulin was the subject of three attempted class actions in the UK, US and Canada between 1992 and 2004. reaction to insulin Humulin manufactured by Eli Lilly. In an obscure 1988 report, one of the company’s scientists described “a syndrome consisting of arthralgia, arthritis, myalgia, elevated erythrocyte sedimentation rate, and mild normochromic or hypochromic anemia without alteration in serum complement or hematuria … human insulin.”
How has the industry responded to these issues? Instead of giving diabetics access to a wide range of insulin options, manufacturers have moved away from animal-based insulin, the only safe option for the roughly 10% of people who need this treatment. They partnered with device manufacturers to create an industry that produced technology solutions, each with its own risks and costs—insulin pumps, blood glucose meters, pens, and other expensive high-tech instruments, most of which are needed to reduce the risks associated with insulin therapy.
People who need insulin deserve more. Health Canada, in response to requests from people with diabetes who use insulin, has worked to ensure that animal insulin products are always available in Canada.
The best way to do this is to return the production of insulin, both animal and biosynthetic, to the public domain and expand the range of safe and effective options by removing financial barriers to entry. This was the plan of 1921 and is worth celebrating and fighting for today.