My Visit to the FDA – A New Front in Diabetes Management
Last March, the diaTribe Foundation contacted me with a powerful opportunity. They were looking for advocates, or persons with diabetes, who could help stand up and speak regarding the approval of two new medications, in front of an FDA regulatory committee. This was to take place at FDA headquarters in Silver Springs, Maryland, and they would pay for all travel arrangements and accommodations. I’ve had a few travel offers before, to give input to companies of various kinds… But this was different.
They were interested in having an ‘arsenal’ of people with diabetes present, and advocates who could voice a strong support for these medications, on various fronts. These were ground breaking medications, and people with diabetes – of all types – could benefit from these.
Of course, after considering the matter of travel and work absence with my employers, I immediately said yes. There is nothing more important to me than to fight for more management tools for people with diabetes, and to spread an understanding of the challenges we face.
The medications in question are iGlarLixi and IDegLira. These are medications which are a novel combination of a GL1-agonist plus insulin, and provide a powerful new way of managing diabetes with minimal side effects. Patients can benefit from the safety track record of two FDA approved medications, in one; a single once daily injection with ease of dosage, a single co-pay, a significant reduction in A1C, no significant weight gain, no significant hypoglycemic events or cardiovascular events, and reduced nausea, etc.
After two days of exposition, debate, question and answer sessions, deliberation, and public discourse, these two medications came away with solid FDA approval. And with very good reasons. iGlarLixi and IDegLira could seriously impact patient engagement in their own self care. I have seen the struggle of persons with diabetes who are emotionally paralyzed at the prospect of needing to take multiple injections of a day – the worry of regaining weight, the risks of hypoglycemic events, and the high costs of multiple copays for sophisticated medications. These are worries which keep many people from diabetes from following through with the next steps in their management – especially if they don’t see any significant benefits to outweigh the bad.
But it isn’t just people with diabetes who struggle with the decision. Often, clinicians deny a patient access to insulin for as long as possible, with worries about its learning curve, risks of hypoglycemia, and risks of liability to their practice. The end result are patients who suffer the consequences health-wise, with the progression of their diabetes, and development of complications from being exposed to high blood glucose levels for longer than necessary.
So, as a united front, we stood up and spoke up – with experience, with statistics, with power behind our voices. And I’d like to believe we made a powerful impact. The public speaking sessions for these hearings were open to many who expressed their strong approval and feelings toward these medications: From clinicians, to ADA leaders, to patients who struggled to get their needs heard by their medical teams, to those who were a part of the trials – and to those like me, who have had loved ones pass on, from having long delayed access to much needed medications.
So I pondered deeply about my father. I pondered out loud, and powerfully, to the FDA… and I was his voice. I talked openly about how his life and how his decisions would have been affected by having these medications around. How he would have felt freed by knowing his 165 lb weight loss would not have been jeopardized; how he would not have to face his fear of the needle more than once a day. How we would not have to face many more hypoglycemic events.
But sadly, my father didn’t have these choices. Choices are denied to us, every day, either by our own fears, or by our medical teams… and by the time my father made his choices, it was too late. He died with many diabetes complications in 2003 – at the operating table, as he was about to undergo leg amputation.
And… as it had turned out, just a week prior, I was also denied a choice. I became sick with a gastrointestinal virus which sky-rocketed my glucose levels to over 300 mg/dL. I was DENIED insulin at the hospital to help bring it down, and told that ‘my blood glucose level was steady.’ No further discussion was allowed.
We all know how this is not an exception, but the rule, not just in ER’s across this nation, but in doctor’s offices as well. As I got to relay this reality, I wish you could have seen the faces in that room.
We are in a WAR against diabetes. We are in a war, and we need the most weapons we can have access to, in our arsenal. The FDA had a powerful opportunity to put CHOICE back in the patients’ hands, and greatly impact patient engagement… and they took it.
While many of the details will need to be ironed out, these two new medications present a hopeful new horizon for diabetes management to many… and I was very excited to help be a part of that.
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