April 3, 2014

I was 6 of 17 at FDA's ADCOM on Afrezza

I was one of a large group of public voice who spoke the the Afrezza ADCOM hearing April 1. It was an privilege to be part of the amazing range of patients, doctors, science officers, CDEs, seventeen of us in all speaking up for people with diabetes. I felt it was an unusually powerful set of presentations. My personal favorite was Adam Brown. His comment about the short comings of A1C were fantastic. Adam's point was very much inline with Aaron Kowalski's, he said that being in range is often a passing state between highs and lows. Many of us spoke about hypos while other spoke to the need to lower the anxiety level associated with needles. 

Maybe all were my favorites. The power came from the diversity of presenters and uniformity of message - People with diabetes need more and better insulin options. I wish I could reproduce them all. I can't.

Here are my notes. 






Hello I am Bennet Dunlap. I have no relationship with the sponsor. I am the father of two type 1 children and I work to be successful in managing my type 2 diabetes. As an advocate I created the StripSafely campaign for accuracy in diabetes testing tools, work with other programs and recently was a PCORI infrastructure reviewer.




As a parent caregiver and person with diabetes. I appreciate the panel's individual commitments to work with FDA to help layperson like myself understand the nuanced risks medications. When considering those nuances I urge you to remember that there is significant risk in the diabetes status quo. Insulin is a very dangerous drug. It is not a cure. It is a treatment, self administered by millions of laypersons in the wild.








Just a few weeks ago JAMA published estimates of emergancy room visits and hospitalizations caused hypoglycemia. The estimate is over NINTY SEVEN THOUSAND American a year go to the Emergence Room because of insulin and 29% are admitted. The American Journal of Managed Care, a publication that is going to be super geeky about costs, estimate the “costs for hypoglycemia visits.”




The cocktail napkin arithmetic of EVENTS times COSTS works out to $645 Million for insulin overdose every year. Seniors over 80 are twice as likely to visit the ER and five times more likely to be admitted.














The JAMA article points to two real world reasons for ER visits. Less food consumption and taking the wrong insulin. An insulin, such as todays candidate, that is sufficiently fast acting that it can be taken with or after a meal, can be balanced to the food actually eaten. vs insulin taken in anticipation of what may be eaten. Bolus insulin taken in a uniquely different way from basal insulin can help address confusing types.









Insulin options can help individuals and their care teams create personalize treatments plans. As you look at risk do please not overlook the real world reasons for ER TRIPS in the wild.

Let me put that risk into a March Madness perspective. NIH estimates that stimulants including methamphetamine, are involved in 93k ED visits annually. Insulin is responsible for 97k. I don’t know who picked Duke to loose in the first round but that isn't the only bracket madness this year. : 









That insulin beats breaking bad in ER visits is a real world signal that innovative insulins are desperately needed.






Citations Citations  are appropriate so there they are.
Thank you for your diligence in bringing innovative insulins SAFELY to market.

National Estimates of Insulin-Related Hypoglycemia and Errors Leading to Emergency Department Visits and Hospitalizations
Andrew I. Geller, MD; Nadine Shehab, PharmD, MPH; Maribeth C. Lovegrove, MPH; Scott R. Kegler, PhD; Kelly N. Weidenbach, DrPH; Gina J. Ryan, PharmD, CDE; Daniel S. Budnitz, MD, MPH
AMA Intern Med. March 10, 2014. doi:10.1001/jamainternmed.2014.136

The Incidence and Costs of Hypoglycemia in Type 2 Diabetes
Brian J. Quilliam, PhD; Jason C. Simeone, PhD; A. Burak Ozbay, PhD; and Stephen J. Kogut, PhD
AJMC.com. October 10, 2011 http://www.ajmc.com/publications/issue/2011/2011-10-vol17-n10/AJMC_11oct_Quilliam_673to680#sthash.iHj0bkb9.dpuf

DrugFacts: Drug-Related Hospital Emergency Room Visits 
NIH, National Institute on Drug Abuse

National Diabetes Statistics
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 2011







6 comments:

Anonymous said...

Thanks for bringing the concepts into language I could understand

Bennet said...

Happy to, that is the goal.

$645 Million here and there and the next thing you know it adds up to real money...

Scott E said...

Awesome.

The delivery. Not the statistics.

Scott S said...

Thanks; I concur. Although I don't envision using Afrezza personally, I do believe it meets an unmet patient need, and the company has done everything FDA required to gain approval. I would like to see ongoing post-marketing analysis (and FDA needs to make sure the company provides it, something FDA is notoriously bad at collecting) on lung function, and I would caution against pediatric use except on an off-label basis, but there is no reason I can think of to deny approval for this.

Edwin Varney said...

I am so thankful for all 17 advocates at the AD-Com presentation... We can only pray that the messages from the user world was clear to those that make the decision on this life saving concept in Afrezza for the diabetic world....lets pray.

Edwin Varney said...

I watched the entire 17 advocates presentation at AD-Com... Lets pray that this message was clear to all those who decide on the approval process got the message from the diabetes world...lets pray for everyone.