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How Drug Companies Keep Generic Insulin Off American Shelves

A new unaffordable drug is hardly better than an old unaffordable one.

by Ben Richmond
Mar 18 2015, 9:33pm

Image: ​York Vision/Flickr

​Insulin was first patented way back in 1923, but here it is 2015, and Americans can't buy a cheap generic version of it. It is a particularly cruel irony that poverty increases the risk that one could d​evelop diabetes, which could necessitate taking insulin, and that those are the people mostly to feel the sting of the $120 to $400 a month out of pocket for it under a brand name, because that's how it's always sold.

A pair of researchers from Johns Hopkins just pu​blished an article in the New England Journal of Medicine in which they investigated why this is the case. They found that steady, incremental improvements to insulin have made it more effective, but also kept drug companies from offering a cheaper generic version. That's because, the reasoning goes, why would a doctor prescribe an inferior drug when a better one just came out?

The paper traces the history of insulin back to the early '20s, when the method for extracting active insulin from an animal pancreas was, counterintuitively, patented as means of making the formula as widely distributed as possible. "When the details of the method of preparation are published anyone would be free to prepare the extract, but no one could secure a profitable monopoly," they explained in a letter.

Insulin, even back then, was seen as a huge, lifesaving discovery. Over the course of the 20th century, small changes that made insulin injections effective for longer amounts of time were made, and improvements were made to the purity of insulin collected. By the '70s, animal insulin was no longer needed, as methods were developed for making human insulin from Escherichia coli. Today biosynthetic insulin is normal.

These new versions, however, came with new patents. This re-patenting tactic is known as "evergreening," where small changes keep a drug behind the profitable patent wall. The practice kept drug companies from offering a generic insulin based on one of the older, patent-expired formulas.

It's not that patents are necessarily a bad thing; the period of exclusivity, in theory, provides a way to offset the high cost of bringing a new drug to market. And it's not that the improvements were inconsequential, either; if you're comparing the new drugs to the old ones, they are better. But a new unaffordable drug isn't better than an old unaffordable one, and it sure isn't better from either an individual or public health perspective.

"No doubt for many patients, these incremental innovations were worth the added price," the paper states. "What's surprising is that the trailing edge of old insulin products did not generate a market for generic competition but rather became a set of obsolete products that were promptly removed from US shelves."

"Insulin is an inconvenient medicine even for people who can afford it," said Kevin Riggs, one of the study's co-authors, i​n a press release. "When people can't afford it, they often stop taking it altogether."

In a passionate article over at Lo​ndon Review of Books, the physician, anthropologist, and author Paul Farmer pointed out that all over the world, disease isn't killing people, a lack of access to proper treatment is. "Who lives and who dies depends on what sort of healthcare system is available," Farmer writes.

And while many of his examples are drawn from his work in Haiti and Peru, Farmer notes that even in America, even and especially in our biggest cities, the poor and uninsured lack access to treatment and medicine. The question of "why" this remains the case has been getting more attention lately. At least part of the blame falls on America's $31-billion-prescription-drug marketplace, which has come to incentivize short-term projects, and high prices, without—in the case of insulin, at least—any incentive to offer an alternative.