I handed the pharmacist my American prescription for Humalog insulin. “Szia,” I said in my best Google Hungarian, “töltse ki ezt a receptet?” She looked at the paper, and said in English, “Sure, but we have to order it. Is tomorrow okay?”
I asked how much it would cost. “Let’s see,” she said, tapping the keyboard. Then, almost apologetically, “Ten milliliters is . . . 6,543 Hungarian forins. About 20 euros.”
My phone’s calculator made the conversion to dollars: $22 and change for a two-inch vial of Eli Lilly and Company’s fast-acting Humalog insulin lispro, purchased in a random pharmacy near my hotel in Budapest. Back home in the United States, the list price for the same small vial — the exact same insulin, also made by Lilly, except that the labeling is in English instead of Hungarian — is $325.
I’m very fortunate to have health insurance, so I don’t actually pay the “cash” price of $325 per vial (the price paid at the pharmacy by someone who does not have health insurance). With Medicare, my copay in the United States is “only” $90 per vial.
It takes three vials a month to keep me alive.
Nearly a quarter-century ago, when Lilly first received approval from the U.S. Food and Drug Administration to sell it, the list price of a vial of Humalog was $21. Since then, Lilly has raised the list price more than 1,400 percent. Not surprisingly, the two other leading pharma companies that make a similar insulin (Novo Nordisk of Denmark and Sanofi of France) have jacked up their American prices in lockstep.
The formula hasn’t changed. It’s the same insulin today as it was back in the 1990s. It’s the same insulin that Lilly can sell at a profit for $22 to someone paying full price in Budapest. And it’s not just Hungary: Lilly sells Humalog insulin in Canada, Mexico, and other countries for a small fraction of the price it charges in the United States.
That’s why my endocrinologist in Philadelphia now advises her insulin-dependent patients to watch for cheap air fares to Amsterdam. That’s why people with Type 1 diabetes in the United States are increasingly caravaning across the borders to Canada and Mexico to buy insulin and other essential medications. For many of them, affordable insulin isn’t just bargain-shopping; it’s a matter of life or death.
For thousands of people with Type 1 diabetes, the Canadian and Mexican borders are too far away, transportation costs are too expensive, or they’re too ill to travel. For all too many more, even $22 is beyond reach for what is literally a life-saving drug.
The price of a vial of Humalog insulin was $122 in 2012 when Alex Azar II, a former drug industry lobbyist, took over as president of Lilly USA. Five years later it had soared to $274. That’s when President Donald J. Trump nominated Azar to be United States Secretary of Health and Human Services, saying Azar would be “a star for better healthcare and lower drug prices.”
Lilly’s media relations department has not responded to repeated requests for comment.
Type 1 diabetes used to be called juvenile diabetes because, cruelly, it most often strikes infants, children, and adolescents. It is currently incurable. No one knows what causes it, and it is not preventable, unlike the far more common Type 2 diabetes, which is closely linked to obesity and sedentary lifestyle.
Type 2 diabetes is the fastest-growing health crisis in the world, according to the World Health Organization (W.H.O.). An estimated 500 million people worldwide have Type 2 diabetes or have “pre-diabetes.” Type 2s still produce their own insulin, but their bodies either can’t make enough of it or can’t use it efficiently. In America an estimated 30 million people have Type 2 diabetes, roughly 1 of every 11 people, a number that has doubled in the 21st century. Some Type 2s require insulin injections, but most can be treated with diet, exercise, and pills.
Type 1 diabetes is a more exclusive club, but one that no one wants to join. An estimated 1.25 million people have Type 1 diabetes in the United States, all of whom need regular injections of insulin in order to stay alive, because some unknown trigger causes their immune systems to go haywire and attack and destroy the specialized cells in the pancreas that produce insulin. Without multiple daily injections of insulin we sicken and die.
Although the causes and treatments differ significantly, Type 1s and Type 2s share the sickening and dying part. Diabetes kills some 250,000 Americans each year, either directly or indirectly through “diabetic complications” that include heart disease, kidney failure, limb amputations, blindness, nerve damage, and stroke.
Here, greatly simplified, is how it kills and debilitates:
Enzymes in the digestive system convert much of the food we eat into glucose, a simple sugar. In a “normal” body, the pancreas — an organ about the size of your open hand, located behind your stomach — secretes just enough insulin to enable the cells to metabolize glucose, which the cells, in turn, convert into energy.
Without insulin, or with insufficient amounts of it, our cells can’t absorb the fuel they need, any more than an automobile engine can absorb gasoline poured over the car. The cells begin to starve and toxic levels of glucose build up in the bloodstream, damaging blood vessels and organs and nerves and hindering the body’s ability to fight infections.
In its desperation to flush the higher concentrations of sugar from the blood, the body demands fluids, leading to relentless thirst, frequent urination, and, paradoxically, dehydration. At the same time, the starving brain sends signals to begin breaking down fat, then muscle, then organs.
For Type 1s, it happens quickly. In less than three months I went from 185 pounds to 140, attributing the loss to playing a 40-game baseball schedule in the broiling Texas summer sun while wearing catcher’s gear. I drank gallons of Gatorade and still fantasized about diving, mouth open, into a swimming pool. I had to pee between innings. My vision blurred. The baseball got fuzzy, which was not good as a batter nor as a catcher. My throws to second base started bouncing just past the pitcher’s mound.
Off the field, my concerned family tried to fatten me up by feeding me milkshakes and pizzas and extra desserts. I nodded off in meetings and woke up exhausted. The weight continued to melt away. Finally, certain that I had developed a rare form of narcoleptic, hydrophiliac cancer, I called the doctor.
“Classic Type 1,” the doctor said after examining me and doing some blood tests. He gave me a bottle of insulin and a pack of syringes and sent me to a Type 1 diabetes class, where we learned to check our blood glucose with fingersticks several times a day, and to calculate how much insulin we needed to stab into our bellies.
Insulin, it turns out, is an exceptionally powerful drug. Too little leads to hyperglycemia and diabetic complications, but too much leads to dreaded “hypoglycemic reactions,” where blood sugar gets dangerously low. The body slams out adrenalin, the brain becomes disoriented, muscles tremble, sweat pours uncontrollably, and language slurs. Unchecked, hypoglycemia can lead to coma, seizures, and all too often death.
Some of my classmates in “Welcome to Type 1 Diabetes” class were in elementary school. Some were frightened parents holding their newly diagnosed Type 1 toddlers. “If you’re going to get an incurable disease,” the nurse told us, “at least diabetes is a manageable incurable disease.”
As we would soon learn, the health care system apparently finds that managing diabetes is far more profitable than curing it.
Until less than a century ago, a diagnosis of Type 1 diabetes was a cruel death sentence. Healthy children and adolescents, but also some adults, were quickly reduced to emaciated, suffering husks. Perversely, the only known way to keep blood glucose from rising fatally was to radically reduce eating; already skeletal young patients were put on near-starvation diets. Life expectancy after diagnosis typically was less than a year.
Then, in the summer of 1921, two young researchers in Canada — Dr. Frederick Banting, a surgeon not yet 30 years old, and his assistant Charles Best, a chemistry student at the University of Toronto — discovered a way to isolate and extract small amounts of insulin from the pancreases of dogs and other animals. That winter they injected the animal insulin into a boy, Leonard Thompson, who was dying at Toronto General Hospital. The boy recovered enough to be sent home.
The “discovery” of insulin 98 years ago by Banting and Best is now regarded as one of the most important advances in the history of medicine.
News of their success spread quickly through medical journals and word of mouth, and by the summer of 1922 it was impossible for Banting and his colleagues to extract and refine enough life-saving insulin to meet the desperate pleas from physicians and patients across the continent.
The news also attracted investors eager to capitalize on the new discovery. An American businessman raced to Toronto to offer Banting one million dollars in cash if he would hand over the patent to a group on Wall Street. The group would in turn secure a patent on insulin in every country of the world, and would pay Banting a five percent royalty on all insulin sold. Banting would be fabulously wealthy, the investor told him, and would no longer have to see patients “except for a few very wealthy ones by appointment.”
“I only asked him one question,” Banting recalled years later in his memoir. “What would you do for the poor diabetic who could not pay?” Unsatisfied with the man’s answer, Banting told him, “The indigent diabetic is our greatest problem. Every effort must be made to reduce the cost of insulin . . . ”
As a physician, Banting argued, he was bound by his profession’s code to make such a life-saving advance in health care freely available to mankind. It was immoral, in his view, to profit from the misfortunes of those who were desperately ill. At the same time, Banting recognized that patenting the discovery would be a safeguard against unscrupulous or incompetent companies that would make and market inferior, perhaps dangerous, insulin.
An ethical compromise was reached: Charles Best and another researcher, neither of them physicians, would patent the process (Banting was eventually persuaded to add his name), and then, in return for the sum of one Canadian dollar each, they would assign the patent to the University of Toronto. The University would in turn freely publish details of the insulin preparation process, thereby preventing any one company from ever establishing a monopoly.
Patent issues aside, the more immediate challenge was to produce more insulin. The researchers were able to harvest only a few cubic centimeters of insulin solution in one production run, barely enough to treat one patient, and their repeated efforts to scale production to commercial levels failed. Even though the number of patients who were given the experimental treatment was kept deliberately small, an “insulin famine” ensued. The researchers resorted to rationing what meager supplies they had, with predictable results.
In February 1922 an emaciated young girl, a friend of Charles Best, was admitted to Toronto General. She showed improvement soon after receiving insulin injections, but then the insulin supply ran out and she slipped into a coma. Doctors scrounged what they could of partially prepared insulin from the lab, and the girl awakened, the first time any diabetic patient in Toronto had recovered from coma. But once again the supply was exhausted. The girl died in April, becoming perhaps the first person to die from inability to obtain insulin since the miracle treatment was discovered. She would not be the last.
The best hope of rapidly producing large quantities of high-quality insulin, the University of Toronto’s Insulin Committee decided, was to partner with Eli Lilly and Company of Indianapolis, Indiana, the leading “ethical” pharmaceutical company in the United States, at a time when quack medicines and snake-oil charlatans were common. Already in business for nearly 50 years, Lilly had earned a deserved reputation for medical rigor and manufacturing expertise.
Lilly was eager to help, on the condition that it receive an exclusive, one-year license to sell insulin in the Americas outside of Canada. In return, Lilly promised to supply Banting and the university with all the insulin they needed for their patients; any surplus insulin, Lilly promised, would be sold at cost. Afterward, Lilly would also pay royalties to the University of Toronto to support its medical research program.
The deal was struck. By the summer of 1923 Lilly was churning out enough therapeutic-grade insulin to save the lives of some 20,000 Type 1 diabetics.
Later that year Frederick Banting was awarded a share of the 1923 Nobel Prize in Medicine, which he insisted on sharing with his assistant, Charles Best.
The patent they had willingly relinquished for one dollar each would soon generate millions of dollars in royalties for the University of Toronto, and millions more in profits for Lilly, which had parlayed its exclusive license into a dominant market position.
Also, without informing the Canadians, Eli Lilly and Company had also secretly applied for the American patent covering the process that the Canadians had invented. It was necessary, Lilly executives argued when confronted by the Canadians, to protect the investments Lilly made to scale up and refine the manufacturing process.
End of Part I.