I have written a first draft of a letter to Dr. Oz, as suggested above. I don't know any other way to let you folks read it than to just copy it here in it's entirety. As a rather new Afrezza patient, I am asking help from those who might know the story and the drug better than I. I welcome suggestions.
I am writing to suggest that your show might be interested in producing a segment on the new inhaled insulin drug Afrezza and some of the controversy surrounding it. It is a story that encompasses not only a revolutionary new treatment for Type 1 and Type 2 diabetics but also the tribulations in getting a drug to market and ensuring its success despite its proven efficacy for many, many patients.
Afrezza is an inhaled insulin powder developed by a company named MannKind and its founder, Al Mann. As far as I know, it is the second inhaled insulin powder to make it to the market in the US. The first, Exubera, was introduced about 10 years ago and was a quick failure, not least of which because the inhaling apparatus was about the size of a can of tennis balls. Afrezza's delivery system is totally different -- a discreet, whistle-like device in which small cartridges of medication are inserted. It's about the size of a man's thumb.
The unique thing about Afrezza is the way it works. The insulin enters the patient’s bloodstream much quicker than traditional, injected insulins, so it acts faster to reduce blood-glucose levels. It also leaves the body quicker, so that if a diabetic finds that he needs a subsequent dose of insulin to offset a high-carbohydrate meal, he can take that dose without having to worry so much about the insulin that is already working in his body and risk the possibility of a dangerous low-blood-glucose episode.
Another advantage of Afrezza is that, when taken along with meals, it somehow tends to prevent blood sugar from rising in the first place, apparently by blocking the release of insulin by the liver. What many patients find is that this combination of effects means that they do not have to be nearly as exacting with their meal-related dosages (called boluses) when using Afrezza, and their blood-glucose levels remain very stable without having to exactly count carbohydrate, protein and fat levels of each meal in order to calculate exactly how much of a bolus they need for a particular meal. As one might imagine, this is a tremendously freeing advantage. These patients also report that they are achieving some of the best blood-glucose levels of their lives with fewer highs and lows along the way when using Afrezza.
Though only about a year on the market, Afrezza has gained some very vocal fans among its users. They are not only achieving their healthiest A1C levels ever, they are doing so without having to give nearly as much thought to what they are eating and how to dose themselves. For some, it has been truly revolutionary.
Now, for the bad news. MannKind has been in a partnership with a major drug company, Sanofi, to promote and supply Afrezza to physicians. The launch of this medication has not gone well, and Sanofi announced recently, they will pull out of this partnership within six months. Afrezza, quite simply, has had difficulty gaining acceptance, despite some distinct advantages over traditional insulins.
For one thing, Afrezza is primarily for mealtime boluses. A different type of insulin is still needed by patients to provide blood-glucose control between meals, called “basal” insulin. In addition, Afrezza works so differently from traditional insulins that medical providers must be educated and familiarize themselves with the product in order to prescribe it properly and train patients in its use. Afrezza is also not for everyone. There are very clear restrictions to its use with patients who suffer from certain lung disorders.
For the right patients with proper training, however, Afrezza has been truly revolutionary in its ability to control blood sugars with minimal hassle to the patient. Many describe their experience as being almost like they no longer had diabetes at all – not a cure, but almost as good in terms of making the disease easier to deal with.
I believe the Afrezza story would be one of great interest, not only in terms of how it works differently – and better in many ways – than traditional insulin, but also as a case study on the many barriers of bringing a promising new medication to market. Should you decide to pursue it, I could assist in finding a number of users who would be more than willing to tell of their successes with it and their fears that future availability is uncertain at best. I, and many Afrezza users, hope that you will find merit in pursuing this multi-faceted story.