Inhalable Insulin: Is it safe for Kids with Type 1 Diabetes
The news was big over the weekend: Pfizer won FDA approval for its new inhaled form of rapid-acting insulin, called Exubera. The press was characterizing it as the first new way of delivering insulin since the hormone was discovered in the 1920s.
As the parent of a ten-year old with Type I diabetes, I think this is great news. We’re always looking for breakthroughs that will lessen her chances of complications, improve her quality of life, and bring us closer to a cure in her lifetime. So even though this particular advance has not been approved for Annie or other children under 18 to use, we still think it’s a terrific development.
Inhaled insulin is being heralded as a huge advance for adults with Type II diabetes, because it will allow better blood-sugar control by adults who are afraid of needles and have neglected to take their insulin as a result. That’s true, but I think it will allow a better quality of life for parents whose screaming three-year olds with Type I are afraid of needles and need insulin to stay alive.
According to the Washington Post, patients who have used inhalers told researchers at Pfizer they prefer them to needles by a wide margin. "I'm just flabbergasted at the number of people who really do seem to want this, and want it substantially," said Jay Skyler, a University of Miami doctor and one of the nation's leading diabetes experts. I was surprised to find similar quotes by researchers and doctors, expressing shock at the popularity of the idea. Of course you’d have to ask someone like my daughter Annie, who has had to have thousands of shots since she was diagnosed, to see why people with Type I – especially children and their parents – like the idea.
In fact, the big insulin manufacturers were not interested in the invention at first, according to the founder of the company that developed the technology, called Nektar Therapeutics. Apparently they didn’t think there would be a big market for it, he said, but Pfizer was not in the insulin business, saw an opportunity, and bought the rights from Nektar. With the news that Pfizer is now projecting a billion dollars a year in sales, Eli Lilly and Novo Nordisk are racing to produce their own inhalable insulins.
I’m confident that because of the competition, the inhaler will become smaller and lighter in weight very quickly (it’s big and bulky right now) just as glucometers and the insulin pump did. And I’m confident that it will approved for children as well, as more and more companies conduct research studies into the safety for all patients with diabetes. There are just too many children with diabetes – both Type I and II – for the drug companies not to be interested in marketing this to them. The more we can incentivize manufacturers to produce better technology – and eventually a cure – the better for us. We’re all concerned about sky-rocketing health care costs, but the fact is the richer they’ll get, the faster we’ll get a cure.
Advances like this always involve trade-offs, like so many things in life. For example, the inhaler means no more worries about scar tissue developing at injection sites – a friend of ours ended up in the ICU because scar tissue was blocking her infusion site for her pump, and nobody knew it – and the younger they are at diagnosis, the longer they’ll be getting those shots. Because she was only five years old when she was diagnosed, for example, Annie will be considered at risk for “long term complications” by the time she leaves for college. Scar tissue is just one of our concerns.
But of course we’re also worried about the long-term effects of inhaling insulin, as is everyone else. The FDA is concerned about what the powdered insulin particles will do to lung capacity over a lifetime of use, but approved the inhaler anyway. "The issue comes down to: How do we all deal with uncertainty?" said Robert A. Rizza, a diabetes specialist at the Mayo Clinic and president of the American Diabetes Association. "We just don't know what the long-run safety record will be. Each person will now need to think very carefully about the potential benefits and the risks for them."
That’s always hard as a parent, and this time it’s no different.
Published On: January 30, 2006