Why Isn't There Any Cheap, Generic Insulin?

By Serena Gordon

HealthDay Reporter

WEDNESDAY, March 18, 2015 (HealthDay News) -- New research examines why people with diabetes who depend on injections of lifesaving insulin still have no cheaper generic options to treat their disease.

"Surprisingly, this issue has not been talked about, so we're asking the question: Why is there no generic insulin?" said senior study author Dr. Kevin Riggs, a research fellow at Johns Hopkins University School of Medicine in Baltimore.

In their report, published March 19 in the New England Journal of Medicine, Riggs and his colleague Dr. Jeremy Greene describe how the unique development of insulin allowed pharmaceutical companies to continually improve the medication while extending patents for decades. Generic drugs cannot be made until a patent on a brand-name drug expires.

One expert pointed out the possible repercussions.

"This is a big issue. Some patients simply cannot afford to pay for the insulin that keeps their blood sugar down, even people who have health insurance," explained Dr. Joel Zonszein, director of the Clinical Diabetes Center at Montefiore Medical Center in New York City. He added that if insulin prices remain out of reach for some, the health care system will end up paying more in hospitalizations and treatments for complications related to undertreated or untreated diabetes.

The cost of insulin for someone who doesn't have insurance runs from $120 to $400 a month, the researchers noted.

Insulin is a naturally occurring hormone that's necessary for the body to use the sugars found in foods as fuel for the cells in the body and brain. In people with type 1 diabetes, the body's immune system mistakenly attacks the insulin-producing cells (called beta cells) in the pancreas. This destroys their ability to make enough insulin to survive. People with type 1 diabetes must inject insulin to stay alive.

In type 2 diabetes, the body's cells become increasingly resistant to insulin, which causes the pancreas to make more and more insulin. Eventually, the pancreas can't keep up with the increasing demand. This is generally when people with type 2 diabetes need to take insulin injections. Up to half of people with type 2 diabetes will need to be on insulin on a temporary or permanent basis, according to Dr. Samuel Dagogo-Jack, the president of medicine and science for the American Diabetes Association (ADA).

Without insulin, blood sugar levels rise to dangerous levels. This can cause immediate, life-threatening consequences, usually in people with type 1 diabetes. Over time, high blood sugar levels can lead to heart and kidney disease, vision problems and amputations, according to the ADA.

There are a number of different types of insulin. For example, some are long-acting and some are short-acting, according to the ADA. Short-acting insulins are typically taken at meal times. Intermediate-acting insulins are also available.

But none of these types of insulin is available as generics.

To get a better idea of why, Riggs and Greene reviewed the history of insulin.

Insulin was first discovered in 1921 by orthopedic surgeon Frederick Banting and medical student Charles Best, from the University of Toronto. The pair later sold the patent for insulin to the university for $1.

"Insulin was immediately perceived as a lifesaving drug of vast clinical and public health significance," the study authors wrote.

The university couldn't produce enough insulin for the number of people who needed it. So they teamed up pharmaceutical companies in the United States and abroad. Part of the deal was that drug makers could take U.S. patents on any manufacturing process improvements.

Over the years, improvements were made to insulin that allowed people to take fewer shots. At the time, insulins were made from beef and pork, which presented a number of problems, such as impurities in the insulin and immune reactions after injection, according to the study authors.

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