I have had Type 1 diabetes for 52 years and, like so many other Canadians with this condition, learned about the heroic scientists who discovered insulin from the very first day I was diagnosed.
Over the past year, the country has been celebrating that time 100 years ago when Banting, Best, Collip and McLeod discovered insulin – with the first successful experiment on a dog in November 1921 and the first human treated in January 1922. When the group transferred the patent for insulin to the University of Toronto for $1 in 1923, Banting famously said: “Insulin does not belong to me. It belongs to the world.”
This creed guided the U of T as it developed a distribution strategy to ensure that no company would have a monopoly on the manufacture and sale of insulin. Both public and private manufacturers around the world were licensed to produce insulin on condition that they sell it at a price as close to production costs as possible.
While I celebrate the discovery of insulin, I’m dismayed by the way modern-day pharmaceutical companies have linked their opportunistic gambits in the insulin market to the achievements of insulin’s co-discoverers. Canadians deserve the real story about how Pharma drove up insulin prices, created a global oligarchy and increased the burden on those who need this life-giving medicine.
The centenary should have provided an opportunity to look at the impact on diabetics of the decision in the mid-1980s to privatize the legendary Connaught Labs, where insulin was first developed. Many Canadians may know that Connaught was one of the world’s most important vaccine producers and distributors and that its privatization has negatively affected our access to vaccines. But they are less likely to know that Canada no longer produces a single drop of insulin, neither for ourselves nor for anyone else.
Today, we are completely dependent on three companies – Eli Lilly, Novo Nordisk and Sanofi – that control 95 per cent of the global insulin market. Two of these together have withdrawn dozens of safe, effective and affordable insulin options from the Canadian market, not because they were unsafe – they weren’t – but because they didn’t generate the profits Pharma investors wanted.
And there’s no guarantee that global producers will continue to supply Canadians with insulin. In 1985, Eli Lilly was the sole producer of insulin in Argentina when the country was facing a severe economic crisis. With inflation rates above 800 per cent, the government implemented price controls on all products, including medicines. In response, the company closed its plant, creating a sudden shortage of insulin for 73,500 men, women and children.
Eli Lilly, along with Sanofi and Novo Nordisk, has also been part of a vigorous and aggressive campaign to overturn our own system of protecting Canadians against unfair prices on patented drugs. This has included threats to withhold or delay the introduction of new medicines for Canadians. Yet stronger price controls are exactly what people who use insulin need.
We have become more, not less vulnerable since Connaught was privatized. Health Canada can’t be relied on to protect access to insulin because – unbelievably – it claims not to have a mandate requiring manufacturers to supply Canadians. It was this stance that enabled the withdrawal of the entire range of lower-cost animal insulin developed by Connaught. These were replaced with biosynthetic human insulin (BHI) that manufacturers promoted as an innovation on the same scale as the original 1921 discovery.
Introduced in 1983 in both North America and Europe by Eli Lilly and Novo Nordisk, human insulin was the world’s first product of recombinant DNA technology. But, instead of offering a needed addition to the diabetes medicine chest, many believe Pharma saw insulin as an ideal vehicle to test drive genetic cloning, particularly because it came with a very large and captive market. And, given high levels of public anxiety at the time, biotechnology needed a respectable ambassador.
When BHI was submitted to regulators such as the U.S. Food and Drug Administration and Health Canada for approval, manufacturers claimed that BHI was virtually interchangeable with pork insulin. Both regulators gave the new insulin products the stamp of approval in a record five months – at a time when the average approval times were 40-60 months. The FDA’s medical review officer, Henry Miller, claimed that the “quality of the submission from Lilly was unsurpassed and evidence of safety and efficacy was unequivocal and copious.”
The well-respected Cochrane Collaboration was less impressed. In 2002, the group noted that the studies – 70 per cent of which were sponsored by manufacturers – were of “poor methodological quality” and had failed to investigate essential endpoints such as mortality, morbidity and health-related quality of life. The evidence, collected in trials lasting five to six months, showed that BHI had no therapeutic or clinical advantage over animal insulins and that only 40 per cent of the studies provided information about adverse effects. And while Miller claimed the FDA approval was an “epochal event,” Cochrane concluded that the introduction of human insulin should serve as an example of “pharmaceutical and technological innovations that are not backed up by sufficient proof of their advantages and safety.”
While telling regulators that BHI was on par with the safety and effectiveness of animal insulin, manufacturers were telling the public that human insulin was identical to the insulin produced by nondiabetics – practically a cure. One Eli Lilly rep, when questioned by a reporter about the superior benefits of human insulin, answered rhetorically, “Which would you like to inject, something that’s human, or something from a pig?”
Canadians deserve the real story about how Pharma drove up insulin prices, created a global oligarchy and increased the burden on those who need this life-giving medicine.
For Pharma, BHI was a gold mine, boosting profits beyond what could have been imagined. Today, the average cost of producing insulin is about $5 per 10ml vial, but most people in Canada are paying between $35 and $80 (in the U.S., it’s up to $380). It’s even worse in the global south. It’s now estimated that half of the world’s people who need insulin can’t afford it, a death sentence for those who must do without. Children like Leonard Thompson, Banting’s first patient, are still dying for lack of insulin in low- and middle-income countries. For these children, it’s still 1921.
Pharma argues that this is the cost of innovation and that higher prices can be explained by insulin that is safer or better than it was 30 or 40 years ago when it cost less than a third what it costs now. Yet today insulin ranks second among reported drugs for serious, nonfatal adverse side effects. One of those adverse events – hypoglycemia – is among the leading causes of hospital emergency department visits by diabetics.
Hypoglycemia is the term used to describe low blood sugar, the most common side effect of insulin therapy, regardless of type or species. When a person’s blood sugar dips too low, the body releases hormones that send warning signals to the brain. Absent or weak signals are key risk factors for severe and sometimes fatal hypoglycemia.
Not long after BHI was introduced, diabetics began reporting that their early warning signs of low blood sugar had weakened or disappeared. A 1991 report from the U.K. pointed to unexpected deaths during the night among otherwise healthy young diabetics who had switched to BHI, a tragedy described as “dead-in-bed syndrome.” Insulin manufacturers amended product labels to warn that switching from animal to human insulin could result in weaker hypoglycemia signals for some. Appearing before Canada’s Standing Committee on Health in 2003, Eli Lilly acknowledged that a few patients who had had diabetes for a long time reported a condition known as “hypoglycemia unawareness” when they switched to the biosynthetic human variety.
Today, studies indicate that up to 50 per cent of people who use biosynthetic human insulin are unable to safely detect low blood sugar and that young children fail to detect more than 40 per cent of such episodes. One 2018 study found that diabetics who needed an ambulance were more than twice as likely to experience impaired awareness of hypoglycemia, a frightening reality especially for children and parents.
Hypoglycemia unawareness and other problems associated with biosynthetic human insulin were the subjects of three attempted class action lawsuits in the U.K., the U.S. and Canada between 1992 and 2004. One of these was initiated by a woman who claimed she experienced excruciating pain in response to Humulin insulin made by Eli Lilly. In an obscure 1988 report, one of the company’s scientists described a “syndrome consisting of arthralgia, arthritis, myalgia, elevation in the erythrocyte sedimentation rate and a mild normochromic or hypochromic anemia without changes in serum complement or hematuria … All cases responded to cessation of treatment with human insulin.”
How did the industry respond to these problems? Instead of ensuring diabetics had access to a broad range of insulin options, manufacturers withdrew animal insulin, the only safe alternative for an estimated 10 per cent of people requiring this therapy. They partnered with device makers, spawning an industry producing technological fixes, each with its own risks and costs – insulin pumps, glucose monitors, pens and other expensive high tech interventions, most of which are needed to mitigate the risks associated with insulin therapy.
People who need insulin deserve better than this. Health Canada, in response to demands by diabetics who use insulin, has worked to ensure the ongoing availability of animal insulin products in Canada.
The best way to achieve this is to bring insulin production, both animal and biosynthetic, back into a public setting, and to increase the range of safe and effective options while removing financial barriers to access. That was the plan in 1921 and it’s one worth celebrating and fighting for today.