Can we get the government to listen?

We’re now a week removed from another Thanksgiving, and in the spirit of the season, I realize just how much I have to be thankful for in this past month alone. The big news this month was an FDA advisory panel’s recommendation to approve Novo Nordisk’s degludec, its new ultra-long-acting basal insulin. With a number of other patients, I had the privilege of addressing the panel, and I emphasized the continued need for therapies that reduce hypoglycemia and offer more flexibility for patients. Click here to read my remarks and here to view the diaTribe slides we prepared for the panel to see. Bennet Dunlap, author of Your Diabetes May Vary and father of two teenagers with type one, also spoke passionately about the importance of looking beyond A1c as a measure of glycemic control. His remarks can be read here.

It was a tense day of discussion and deliberation, with the panel members raising concerns about degludec, particularly regarding potential cardiovascular risks – we go into more detail in this month’s new now next. Ultimately, the final vote came down 8-4 in favor of approving degludec – this was great news from our view at diaTribe, since we think the insulin not only represents an important advance in its own right, but that it also will be exciting to combine with other therapies, particularly new rapid-acting insulins and GLP-1. Novo Nordisk deserves big credit for gathering data in over 10,000 patients (the largest insulin development program in history!) and in doing important research in making a good product better. Notably, in terms of the recommendation for approval itself, I believe it was largely the impassioned advocacy of people living with diabetes who made the difference for panel members. This is very positive since the FDA faces a real challenge in balancing patient safety with the need for innovation – the Agency has perhaps leaned too much on the side of excessive safety or caution in recent years. The people who best understand the risks and benefits are the patients themselves, and I’m thankful to have had the opportunity to speak in front of the FDA. Of course, every patient has different levels of risk they are willing to take on; I believe risks associated with degludec are very low, and while every patient will decide for himself or herself with their doctor or educator, what is most important from my view is that patients have multiple alternatives.

Degludec isn’t the answer to all our problems with insulin therapy; clearly, we need much more innovation in fast-acting insulin. But, degludec does represent an improvement, especially if the hypoglycemia benefits seen in clinical trials are borne out in real world use. What’s more, Novo Nordisk is currently researching the fixed combination injection of degludec with the company’s once-daily GLP-1 Victoza (liraglutide), which would be convenient for type 2 patients. Last, degludec offers the potential for much more flexible dosing (i.e., you don’t need to take it at the same time each day), meaning that people can fit their therapies around their lives rather than the other way around. Now, these advances will likely have an opportunity to come to market sooner than they otherwise would have.

I’m also appreciative for my constant opportunities to learn, for all I learn from our team, and even more important, to share these insights with all the readers of diaTribe. This issue shines a spotlight on Europe. Much of the diaTribe team recently attended the annual meeting of the European Association for the Study of Diabetes (EASD), and our conference pearls feature offers a digest of six packed days of presentations. We also have a diaTribe dialogue with Dr. Dorothee Deiss, who takes us inside the unique challenges of diabetes care in the German healthcare system – it’s a real eye-opener to anyone whose only healthcare experience is with the American system! Finally, I remain eternally thankful for all the researchers and doctors working tirelessly to improve the lives of people with diabetes and for the incredible global diabetes community that is such a constant source of strength – as we saw during World Diabetes Day on November 14. That’s just the start of my list for what I’m thankful, but what a start it is!

very best,