Why the new insulin inhaler doesn't matter.

This month marks the release of Afrezza, an inhaled insulin approved by the FDA to treat both type 1 and type 2 diabetes. Developed by pharmaceutical companies Sanofi and Mannkind, Afrezza will be the only inhalable insulin available on the U.S. market. This alternative to insulin injections is expected to generate almost $200 million in sales this year.

While at first glance an insulin inhaler sounds like an exciting innovation, Afrezza will do little to improve the lives of those living with the disease and fails to address the underlying cause. Afrezza is touted as more convenient and faster acting than injections, but its poor design makes it unrealistic for use in treating type 1 diabetes. Afrezza will likely suffer the same fate as its failed predecessor Exubera, an insulin inhaler released in 2006 by Pfizer.

Most conversations around “diabetes” are truly referring to type 2 diabetes. This makes sense – 95% of diabetics in America have type 2. Unfortunately, type 1 and type 2 diabetes have surprisingly little in common. The distinction is important – each disease has its own unique causes and treatments. Type 1 diabetes is an autoimmune disorder where the patient’s own immune system destroys their insulin-producing cells. The cause is thought to be genetically and environmentally linked but remains largely a mystery. Onset often occurs during childhood and treatment always requires multiple daily insulin injections. Type 2 diabetes is caused by insulin insensitivity. It is associated with older age, being overweight, and a diet high in carbohydrates and sugars. Type 2 can sometimes be treated with diet and exercise or with a variety of oral and injectable drugs. The development of Afrezza is yet another instance of type 1 diabetes getting lumped in with type 2 diabetes under the umbrella of “diabetes” treatment.

Anyone living with a chronic illness will tell you that convenience is king. Anything that makes an individual’s daily treatment plan simpler will be embraced wholeheartedly. Afrezza’s creators are aware of this – the “convenience” of the inhaler is one of its main selling points. But while the drug is approved for treatment of both, it does little to improve the treatment regime of a type 1 diabetic. Type 1 diabetics are always insulin dependent and typically require larger dosages. Importantly, type 1 diabetics must take both short and long lasting types of insulin, so Afrezza doesn’t actually eliminate their need for daily injections.

To most, an inhaler appears to be an improvement from an injection. The Afrezza inhaler, however, is only available in 4 and 8 unit single use cartridges. The unit is the same as that used by injectable insulins to attempt to make dosage translation easy, but instead it complicates the process. With Afrezza, a diabetic hoping to take 12 units at mealtime now has to take one 8-unit cartridge inhaler as well as a 4-unit cartridge inhaler. As dosages increase, the number of cartridges needed increases as well. For type 1 diabetics taking anywhere from 25 – 60+ total units of insulin daily, that could add up to many individual cartridges.

In fact, Type 1 diabetics relying on Afrezza would need to pack 5-10 inhaler cartridges just to leave their house for a typical day. As they use their inhaler, they generate a huge amount of waste while having to refill cartridge prescriptions often and in large quantities. Sanofi might see the need for constant refill as a potential moneymaker, but for the patient (and the environment) it poses a massive inconvenience.

The specificity of insulin dosage also suffers with the Afrezza cartridge design. If a diabetic typically takes 9 units at mealtime they would have to rely on one 8 unit cartridge. If they took 14 they would have to decide between rounding to 12 or 16 units. At a small dosage, a one-unit difference is considerable.

Research and development for Afrezza is estimated to have cost more than $1.5 billion dollars. With their patent on Lantus insulin (the world’s most prescribed) expiring this year, Sanofi’s motivation to retain influence in the diabetes treatment market is no mystery. But while the drug has been approved by the FDA for both type 1 and type 2 diabetes, its design clearly favors treatment for type 2. This makes sense from a financial perspective – 27 million more Americans suffer from type 2 than type 1. By ambiguously creating this drug for “both” types, Sanofi gains 27 million more potential customers. The creation of Afrezza is innovation for the sake of profit rather than improvement. This insulin inhaler presents complicated issues for type 1 diabetics and serves as an example of the ways that type 1 diabetes continues to be overshadowed by and assimilated into “diabetes” treatment and research.

Some exciting and meaningful type 1 diabetes research is going on. Technological improvements in continuous glucose monitors and insulin pumps are allowing devices to start working together as an “artificial pancreas”. Researchers around the world are working with many different immune response and cellular regenerative pathways towards a potential cure. There is hope for better treatment and ultimately a cure for type 1 diabetes, but innovation has progressed at a disappointingly slow rate. In 1992, my parents conceived a child they knew would be genetically predisposed to type 1 diabetes. Their doctor told them not to worry, that “this is the decade of the cure” – and indeed, it might have been if more pharmaceutical research and development money went to finding that cure rather than to unnecessary treatment options like Afrezza.