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A nurse checking the amount of insulin in a syringe in 1938. (Photo: Corbis)
Dr. Jeremy Greene wondered why so many of his diabetic patients had blood sugar levels that were off the charts.
The more he asked, the more he realized that it was often because the cost of insulin in the United States was just too high for the uninsured, anywhere from around $120 to $400 — a finding Greene confirmed in a new paper for The New England Journal of Medicine.
“There are many reasons diabetes can be hard to control — sometimes it has to do with difficulties in keeping a schedule, sometimes it has to do with changes in diet or lifestyle, sometimes it has to do with the different biology of the disease in different people,” Greene tells Yahoo Health. “But we have found a surprising number of patients without insurance say that their insulin vials were often just too expensive to afford on a regular basis.”
Doctors give an insulin injection in 1956. (Photo: Corbis)
Greene, a practicing internist and professor of medicine and the history of medicine at Johns Hopkins University, called some pharmacies to try to figure out some generic options for insulin. Whereas with other essential medications, you can usually get a generic prescription at about $4 a pop, no such option existed for insulin, despite the fact that the drug has been around for nearly a century.
Why? That’s the question that spawned Greene’s research, which he conducted with co-author and fellow practicing internist Kevin Riggs, MD, MPH.
And the answer lies deep in the history of the drug.
Back in the 1800s, scientists first uncovered the link between diabetes and damaged pancreas cells in the liver that produce insulin. In the early 1920s, researchers administered injections of insulin extracted from cattle to diabetic patients in a human trial — and most of them recovered remarkably well.
Problem was, early insulin medicines came with their own set of issues; people usually had to administer the drug multiple times a day, and were also prone to allergic reaction. But since it was so highly effective in treating diabetes, scientists continued to make better versions of insulin over the next several decades or so, with longer-lasting formulas and fewer adverse effects.
Insulin and syringes. (Photo: Corbis)
However, the 1970s brought about another game-changing innovation. Biotechnology investors set their sights on insulin, and the newest incarnation (dubbed “recombinant DNA technology”) involved inserting cloned human insulin genes into bacteria. From there, scientists began improving upon this new genetic code-derived form of the drug.
Although the other versions of the drug were still effective, they fell out of favor and off the market. Greene says that, on the surface, it appears insulin isn’t available in mass quantities because it is a biotech drug. “But if you take a broader historical perspective, that answer is insufficient,” he says.
Older versions of insulin medicines made from pork and beef sources have been off-patent for decades, yet are now gone from the market. “Why are none of these insulin products generically available in the United States today?” Greene says. “According to the FDA, manufacturers simply stopped making these older products as the market shifted to newer biotech insulins.”
Basically, the biotech insulins were more or less the cool, new thing.
By 1998, all forms of beef insulin manufactured for use in the United States had been discontinued. By 2006, this was also true for all versions of pork insulin. “For nearly 10 years, the only forms of insulin available on the U.S. market have been patent-protected — as a result of market forces, not regulatory action,” says Greene.
If you have good health insurance, you may not notice a high price for insulin, as your insurance company determines your out-of-pocket co-pay. (Greene says even most of his colleagues were unaware of this price.) “But to the patient without health insurance, paying the full price of the drug out of pocket, it can mean that insulin is often unattainable — and that it is all that much harder to control their diabetes,” he says.
Greene hopes his research on an old, but hugely important, drug like insulin can uncover a hidden problem: there’s a need for affordable, generic insulin in the United States.
Until then, those without insurance who suffer from diabetes have a couple of cost-effective options.
Pork and beef insulin is still available overseas — and the FDA has issued a guidance for this to advise consumers— but Greene says this option is “obviously only abatable to those with money and time to travel.”
As a better alternative for most consumers in need, Walmart has recently started offering an exclusive brand of low-cost insulin called ReliOn Novolin, which costs $25 a vial. “ReliOn appears to be a cheaper version of the same recombinant insulin that product Novo Nordisk sells at much higher prices to other pharmacies,” Greene says. (The higher-price version is simply called Novolin.)
The economics behind ReliOn aren’t totally obvious yet, according to Greene. “It is unclear to us, for example, how much of the low price comes from Walmart’s vaunted purchasing power versus its ability to accept losses on generic drug prices to bring consumers in the door for other purchases,” he says. “For the time being, it is a viable option for many Americans — but as it exists as a marketing effort by a single corporation, it is a thin and fragile thread for those whose lives depend on diabetes.”
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Which is why there’s still a real need for widely-available generic forms of this essential drug.
Riggs adds that the takeaway here is not that the system of generic drugs is broken, but rather that generic drugs are a massive success story. “The balance of incentives for innovation for new medicines combined with the increased accessibility and lower prices of generics has generally been a boon to the US healthcare system, Riggs tells Yahoo Health. “However, the case of insulin is an example of when the system didn’t work the way we think it should.”
Looking back at insulin’s journey, Riggs suggests that physicians, researchers, and policy-makers can invest in something called “comparative effectiveness research” which may help more and more people gain access to the medicines they need.
“When a new version of insulin or any other medicine gets approved, it isn’t approved because it is better than what is already on the market, and oftentimes physicians aren’t sure how that new medicine should fit into treatment strategies,” Riggs says. “Doing research on new medicines, after they get approved, to compare them with what doctors are already doing, is a much more rational approach than just adopting them because they are newer and assuming that they really are better.”