From the FDA to Vienna and Back: Giving Thanks for Another Year

As it gets closer to 2015, I’ve been reflecting on all that I am thankful for this past year. Of course, I am most thankful for the health and happiness of my loving family, who I am lucky to say are my personal cheering squad. But I am also thankful to be part of something larger through the work of The diaTribe Foundation, a nonprofit we founded that just received its 501c3 nearly a year ago today! Our mission is basic, and, we hope, very clear - to improve the lives of people with diabetes, prediabetes, and obesity, and to advocate for action.

Toward that end, our team spoke four times in 2014 at the FDA to advocate for better alternatives for patients – specifically, we spoke in favor of MannKind’s inhaled insulin Afrezza (now approved), Novo Nordisk’s Saxenda (liraglutide) for obesity (the Advisory Committee had a positive 14-1 YES vote to recommend approval – we’re still waiting to hear on final approval though the deadline passed weeks ago), and cardiovascular outcome trials. Our work culminated in a November 3 public meeting with the FDA, an unprecedented patient dialogue on the unmet needs in diabetes. Not only did we recruit nine compelling patient panelists from across the country, with dQ&A and many patient advocacy groups, we also enlisted nearly 10,000 patients to take a survey and tune in virtually for this event. Collectively, we discussed the challenges that people with diabetes face every day, the FDA guidance we’d like to see, some of the products we’d like to see approved, and the issues that FDA reviewers should keep in mind as they consider new drugs and devices. Whew – a promising result in our ongoing conversation with the FDA! You can read more about the meeting here.

I am also incredibly thankful to share innovations in the field with readers through diaTribe. From novel flash-glucose monitoring technology with the launch of Abbott’s Freestyle Libre system (I just got this myself, due to having family in England – wow! This is transformation personified); to major drug approvals like Xultophy (also called IDegLira – this is also incredibly innovative and very highly regarded) in Europe, Trulicity (once weekly GLP-1, known as dulaglutide), and Jardiance (SGLT-2 empagliflozin), to name a few!; to remote monitoring made possible by Dexcom Share and Nightscout (not FDA approved but out in the wild); to remarkable research updates in the artificial pancreas and stem cell fields; and more, progress has been seen on many fronts this year. I am proud that we can help bring all the news and insights to patients, and that this year we’ve been able to improve diaTribe with more frequently updated content - now every two weeks instead of once a month, plus lots of real-time updates right at our homepage, diaTribe.org. 

We have also worked to bring the smartest medical minds together to address the biggest problems in diabetes. At ADA, we teamed up with the inspiring leaders at TCOYD to convene a forum on the state of the disease. A few months later, The diaTribe Foundation held our first ever international event at EASD in Vienna, Austria, on Solvable Problems in Diabetes – we convened an illustrious duo to discuss today’s most pressing and solvable problems in the field, Professor Philip Home and Professor Jens Sandahl Christiansen. We learn enormously at these events and hope to do more, bringing the voices of patients, health care providers, industry leaders, policy makers, and others together, to clarify issues, set priorities, and develop an action plan.

Last, I am so thankful for the members of the diaTribe patient and caregiver community who chose to get involved. The stories you shared with us inspire our team every day, and this year you came together in a huge way to make your voices heard. The surveys you’ve taken, videos you’ve made, posts you’ve shared – they’ve all been vital to making our work at The diaTribe Foundation possible. It is clear that the patient perspective is playing a larger role than ever, but there is still a lot of work to be done.

In the coming year, we plan to continue providing cutting-edge diabetes insights, advocating for patients, and convening the best minds in the field. If you like what we’re doing, please let us know! And as a non-profit organization without any advertising, we’d also be so thankful for your support. Click here for more details on investing in our work to help more people with diabetes and prediabetes. By working together to tackle the huge burden of diabetes, we hope to make the world a happier and healthier place.

yours,

Kelly