It is a corporate conspiracy, say government-funded academics. It is constantly being improved because so many people rely on it, which leads to a new patent, say companies.
Researchers in a new article say people who need insulin can't afford it, though it is hard to believe that is still possible in the age of the Affordable Care Act and the Medicare that existed even before that. Poor people have access to medication and always did, but the article argues that some end up hospitalized with life-threatening complications, such as kidney failure and diabetic coma, though those must be people who have co-pays. Not many people now are paying the $120 to $400 per month it costs without health insurance because they never did.
In their New England Journal of Medicine editorial, authors Jeremy Greene, M.D., Ph.D., and Kevin Riggs, M.D., M.P.H., describe the history of insulin as an example of "evergreening," in which pharmaceutical companies make a series of improvements to important medications that extend their patents for many decades. It keeps it off the generic market, the authors say, because generic manufacturers have less incentive to make a version of insulin that doctors perceived as obsolete, though no one s a fan of authors subscribing motivation to entire industries.
"We see generic drugs as a rare success story, providing better quality at a cheaper price," says Greene, an associate professor of the history of medicine at the Johns Hopkins University School of Medicine and a practicing internist. "And we see the progression from patented drug to generic drug as almost automatic. But the history of insulin highlights the limits of generic competition as a framework for protecting the public health."
Except none of that is really true. Generics only exist because real scientists did a lot of creative work to create something original and what generic companies do when products aren't making enough money is the same as the pharmaceutical companies we have been taught to dislike: They drop them. So lots of drugs are in short supply.
More than 20 million Americans have developed diabetes, in which the body fails to properly use sugar from food due to insufficient insulin, a hormone produced in the pancreas. Diabetes can often be managed without drugs or with oral medications, but some patients need daily insulin injections.
"Insulin is an inconvenient medicine even for people who can afford it," says Riggs, a research fellow in general internal medicine and the Berman Institute of Bioethics at Johns Hopkins. "When people can't afford it, they often stop taking it altogether." Patients with diabetes who are not taking their 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.
Insulin has been constantly improved, it is true. In the 1930s and 1940s, pharmaceutical companies developed long-acting forms that allowed most patients to take a single daily injection. In the 1970s and 1980s, manufacturers improved the purity of cow- and pig-extracted insulin. Since then, several companies have developed synthetic analogs. Biotech insulin is now the standard in the U.S. and the first synthetic insulin expired in 2014.
So why isn't it generic? Because it takes actual work and knowledge to copy it and genetic companies have to go through a lengthy Food and Drug Administration approval process that will cost more to make. They may cost just 20 to 40 percent less than the patented versions.
That's not the fault of the industry, no one is keeping companies from making a generic version. Science remains hard and not everyone can get everything for free, including generic companies, yet they seem to get a cultural free pass even though they have the same profit-oriented policies as every other drug company.
Citation: Jeremy A. Greene, M.D., Ph.D., Kevin R. Riggs, M.D., M.P.H., 'Why Is There No Generic Insulin? Historical Origins of a Modern Problem', N Engl J Med 2015; 372:1171-1175 March 19, 2015 DOI: 10.1056/NEJMms1411398
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