Kyla Cavaliere, centre, and her parents Katerina and Marco Cavaliere at their home in Kleinburg, Ont., in March.Sammy Kogan/The Globe and Mail
For Kyla Cavaliere, the hardest part of being diagnosed with Type 1 diabetes in Grade 7 was her terrible reaction to insulin.
Intermittent pains radiated through her muscles and joints after each of her four daily injections, springing up in her legs, arms, feet and even her ears. Kyla’s doctors were baffled. Her parents, Katerina and Marco Cavaliere, were desperate.
Eventually, they persuaded an endocrinologist at the Hospital for Sick Children in Toronto to let their daughter try an old-fashioned insulin derived from the pancreases of pigs. Kyla, now 16, has been taking porcine insulin ever since, without pain and with excellent blood sugar control.
But now she and a small number of other Canadians who can’t tolerate modern insulins are at risk of losing access to the porcine version in a situation that highlights how patients who want and need old, unprofitable medications can be left behind by the pharmaceutical industry and a hidebound federal drug regulator.
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Wockhardt Ltd., an Indian drug company that is the world’s last maker of porcine insulin, is switching the distribution method for the product from vials to cartridges, the reservoirs of insulin used in injection pens.
Changing the format means Wockhardt must re-apply to Health Canada for marketing authorization, something the company is only willing to do if the federal regulator waives application fees that range from $44,269 to nearly $320,000, depending on the data a company submits.
But Health Canada has so far declined to say if it will agree to Wockhardt’s terms.
“The actual medication is the same. It’s just coming in a different format,” Mr. Cavaliere said. “It is just so frustrating to swallow.”
Kyla Cavaliere at home.Sammy Kogan/The Globe and Mail
Mr. and Ms. Cavaliere, high school teachers who live in Kleinburg, north of Toronto, have been searching for a workaround for their daughter ever since Health Canada announced in March of 2025 that Hypurin – the brand name of Wockhardt’s porcine insulin – would no longer be sold here. The discontinuation notice warned that the remaining vials would expire this spring.
Ms. Cavaliere hopes they can stretch Kyla’s supply of expired vials until November or December, after which they’re considering flying to Britain to try to buy a 90-day supply of porcine insulin. Hypurin is made at a Wockhardt factory in Wales.
“It’s not a long-term solution by any means,” Ms. Cavaliere said. “But as parents, how can we ask Kyla to inject herself with something that has knowingly caused her harm?”
For decades, people with diabetes took insulin made from the pancreases of cows or pigs. Human insulin, produced using recombinant DNA technology inside E. coli cells or baker’s yeast and then purified, came to market in Canada in the 1980s.
More recently, analogue insulins, which are genetically modified to alter their peaks and duration, have mostly supplanted earlier versions of human insulin. Animal insulin, meanwhile, fell out of favour because it is less profitable, and because the vast majority of people with diabetes do well on newer types of insulin.
Still, a small number of people with Type 1 diabetes don’t, for reasons that aren’t clear.
Katerina Cavaliere shows the pork-based insulin her daughter Kyla uses.Sammy Kogan/The Globe and Mail
When Colleen Fuller, a Vancouver health researcher, switched from animal to human insulin in the mid-1990s, she experienced pain and blood-sugar lows that hit without any of the warning signs she’d grown accustomed to since being diagnosed with Type 1 in 1969.
“It was a nightmare,” Ms. Fuller said. “I couldn’t be alone for more than two hours because people were afraid that I would black out.”
After five years of pain, unwanted weight loss and obsessive titrating of her human insulin doses to minimize hypoglycemia, Ms. Fuller switched back to porcine insulin, which was rarely prescribed at the time but still on the Canadian market. Her symptoms disappeared.
The experience turned Ms. Fuller into an advocate for access to animal insulin. As pharmaceutical companies withdrew their unprofitable animal insulins from the Canadian market, she helped convince a parliamentary committee to hold hearings on the issue in 2003.
That contributed to Health Canada working to ensure that animal insulin would continue to be available, Ms. Fuller said. Hypurin vials were accessible to the dwindling number of Canadians who needed them until the discontinuation notice was issued last year.
Ms. Fuller and other advocates, including the patient groups Diabetes Canada and Breakthrough T1D, say that somewhere between 60 and 100 Canadians still use animal insulin.
However, Bhakti Kamble, the export manager for Wockhardt UK, said in an e-mail to The Globe and Mail that that company has been informed by Health Canada that fewer than 20 patients in Canada still use animal insulin.
In a written statement sent to The Globe on March 27, Health Canada said Wockhardt had discontinued Hypurin in Canada, and that the regulator could not compel any company to apply to market a product here.
Health Canada also said Wockhardt refused to participate in the regulator’s special access program (SAP,) which allows doctors to request drugs that aren’t normally sold in Canada for individual patients with serious or life-threatening conditions.
“In this case, the company has declined to supply Hypurin through SAP. Without the manufacturer’s cooperation, SAP cannot be used to provide access,” Marie-Pier Burelle, a Health Canada spokeswoman, said by e-mail.
On the same day, March 27, Ms. Kamble of Wockhardt told The Globe by e-mail that her company would, in fact, participate in the SAP. Ms. Kamble also wrote that Wockhardt is willing to apply for market authorization for porcine insulin in cartridges if Health Canada waives the application fee.
The Globe forwarded Wockhardt’s response to Health Canada the same day and asked if the regulator would waive the fee or accommodate the remaining Hypurin users through SAP.
More than a week later, Health Canada has not responded.
Breay Paty, a Vancouver endocrinologist and president of the Canadian Society of Endocrinology and Metabolism, said there is no straightforward explanation for why a small number of people react poorly to human or analogue insulins when most thrive on those modern options.
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The professional society that Dr. Paty leads, along with the Canadian Pharmacists Association and the Canadian Society of Healthcare-Systems Pharmacy, issued a joint statement advising their members on how to help patients switch to new types of insulin when porcine insulin is no longer available in Canada.
“As endocrinologists, I think most of us prefer to have more therapeutic options rather than fewer. So we’re certainly not supporting the loss of animal-derived insulins,” Dr. Paty added. “We have no role in that decision ... we just have to do our best to support our members and, by extension, to support patients who are going through that transition.”
For Glenn Thibeault, executive director of government affairs, advocacy and policy at Diabetes Canada, the discontinuation of porcine insulin underscores how reliant Canada is on insulins of all kinds manufactured abroad.
“We take credit for discovering insulin and changing the world, but we do not make a vial of it in Canada,” he said. “And that, in my opinion, is shameful.”