Even if it was first discovered more than 90 years ago, insulin is still out of reach for a shocking 29 million diabetes patients in the United States. Yes, this is the 21st century, but even so a staggering number of human beings are forced to live in life threatening conditions. But why is insulin so prohibitively expensive? According to Jeremy Greene, M.D., Ph.D., and Kevin Riggs, M.D., M.P.H., it’s all because of a series of perverse updates to insulin treatments. While insulin made today is more effective in some instances, previous versions weren’t that bad. In fact, they saved lives. Yet, these were replaced with very expensive versions, while the older, much cheaper versions are nowhere to be found on the market anymore. The two authors explore all that’s wrong with today’s insulin big pharma.
A brief history of insulin
In their study published in the New England Journal of Medicine, the two authors outline the history of insulin manufacturing until present day to build up the context which describes the present state of affairs in the big pharma business. Diabetes is diagnosed when a person has too much glucose (sugar) in the blood. This happens because the pancreas cannot make enough insulin. Insulin is produced in the pancreas and has two jobs in the body – the first is to transport glucose from the blood supply into fat and muscle cells, where it can be used for energy. The second is to switch off the liver once the level of glucose in the blood is high enough.
In 1910, Sharpey-Shafer of Edinburgh suggested a single chemical was missing from the pancreas in diabetic people. He proposed calling this chemical “insulin”, and the name stuck and was later taken up by Frederick Banting and Charles Best, two Canadian researchers credited with the discovery of the hormone in 1921. They showed that removing the pancreas in dogs made them diabetic. Then, they isolated a fluid (the insulin in question) from the Islets of Langerhans-clusters of specialized cells within the pancreas and injected it in diabetes dogs. This restored the dogs to normalcy – for as long as they had the extract. For their work, the two were awarded the Nobel Prize in Medicine the very next year, in 1923. It might be worth mentioning that many credit R. C. Paulescu, a Romanian biologist, as the first to discover insulin.
Anyway, the University of Toronto was good enough to immediately give pharmaceutical companies license to produce insulin free of royalties. Soon enough, it became widely available throughout the world saving millions of lives. In 1955, insulin became the first protein to be fully sequenced. This was very important since once a protein’s sequence is known, it is possible, in theory, to recreate it synthetically. In fact, insulin was the first protein to be chemically synthesized in a laboratory, in 1963, but at the time it wasn’t successful since scientists were unable to make much of it.
For 60 years since Banting’s group first isolated insulin, diabetics relied on hormone purified from animals, primarily cattle and pigs. In the meantime, the drug was made purer so fewer adverse reactions occurred. It was also made to last longer in the bloodstream, so fewer injections were required. The breakthrough came in 1978 when insulin became the first human protein to be manufactured through biotechnology. A team of researchers from the City of Hope National Medical Center and the fledgling biotechnology company Genentech managed to synthesize human insulin in the laboratory using a process that could produce large amounts. Basically, they inserted human DNA in bacteria and used these as miniature factories. The result was human insulin, without the problems animal insulin sometimes causes. Humulin, as the commercial product was called, revolutionized diabetes treatment when it became widely available in the early 1980s.
Our drugs, our rules
Today, almost all diabetic people use recombinant human insulin instead of animal insulin. Then, a funny thing happened, Greene says: “The older [animal] insulin, rather than remaining around on the market as a cheaper, older alternative, disappeared from the market.”
According to Dr. Kevin Riggs, a professor of medicine at Johns Hopkins and co-author of the new insulin study, Humulin launched a highly aggressive marketing campaign targeted to doctors to take up the new product. Left without demand, the animal variety would wither away. Dr. Adriane Fugh-Berman, a professor of medicine and pharmacology at Georgetown University, says this is allowed because the FDA doesn’t require new drugs on the market to be proven better than older drugs – it only requires the drugs not be worse. ”In government-funded studies that have compared older drugs to newer drugs, often older drugs come out looking better or equal to newer drugs,” Fugh-Berman says.
For instance, he quotes studies which found animal-derived forms of insulin work better for some patients. He also notes that while animal-derived insulin isn’t available in the US anymore, it is elsewhere. “In Canada, there actually is still an animal-derived insulin on the market, and that was really due to the efforts of consumer advocates,” Fugh-Berman says.
A treatment with the newest version of Humulin can cost up to $400 a month, and many of the millions of diabetes patients in the US can’t afford it. Left without an alternative, they stop taking treatment altogether. According to a 2010 Health Action International report, the price of insulin can vary wildly according to where you live: insulin prices for 10 ml may cost from $1.55 a vial in Iran to $76.69 in Austria.
“When people can’t afford it, they often stop taking it altogether.”
Patients with diabetes who are not taking prescribed insulin come to Riggs’ and Greene’s Baltimore-area clinics complaining of blurred vision, weight loss and intolerable thirst — symptoms of uncontrolled diabetes, which can lead to blindness, kidney failure, gangrene and loss of limbs.
Biotech insulin is now the standard in the U.S., the authors say. This perverse status quo was maintained by companies like Sanofi or Novo Nordisk thanks to incremental improvements that extend their patents for many decades. Riggs and Greene note that patents on the first synthetic insulin expired in 2014.