April 16, 2014

Yay Team!

At the risk of sounding like one of the Borg collective from Star Trek Star Trek: The Next Generation, I was 6 of 17. One of a diverse group of people who spoke at the Afrezza ADCOM meeting.

It was an interesting day. It overstate things, possibly wildly, but I’ll describe the day as MannKind spoke about the wonders of their insulin and FDA showered upon it a lack of love. Pubic speakers talked of a need for options. The panel considered risk, patient needs and in what the called a difficult choice voted almost unanimously for the drug. 

I don’t know what FDA will do, approve it or not. They have to July 15.  

I do know that those who spoke with me were a fascinating group that spanned the cross section of the diabetes community.  There were a number of physicians who treat PWDs, CDEs who teach PWDs, ADA and JDRF that represent PWDs, and a mix of type 1, type 2 and type 3 (caregivers) people who live with diabetes.

I have not seen as wide a mix at any previous FDA meeting. Nor I had not seen anything like Manny Hernandez’s video presentation, bringing views into the room from a champion who could not be there physically. He spoke of reactions to the drug at tuDiabetes and estudiabetes. He spoke in Spanish, with subtitles when representing Spanish speaking American. That was an appropriate first in my experience. 

Through the diversity of speaker, the message could not have been clearer if we had sat down and scripted it out. In fact one public speaker commented about that, noting that we had not. 

There is not one best way to manage diabetes. People with diabetes need more options to consider with their health care professionals. 

Doctors and patients should consider care plans that reflect individual lifestyles, fears and aspirations. There is an emotional component to care, some folks are afraid or needles. Some shy away from the stigma of injecting in a restaurant, plane or other public place. Some fear hypoglycemia. Others reached unprecedented control with an ultra fast acting insulin.  

Following the public comments, it seemed that in addition to the critical safety issues, the panel also considered the psycho - social aspect of diabetes self care.  All too often, it seems to me, these are overlooked with words like adherence and compliant.

I hope the panel would have had those discussions without the hour of public comments. In the hand full of these meeting I have attend, that as not been the case, certainly to the extent we saw on April 1. 

I hope this was not some twist of April Fool’s Day fate. I hope that the broad community of physicians, CDEs, Big Advocacy and individual PWDs will continue speak in one voice because more options means better care. 

No doubt, the idea of options will need to be better appreciated by third party payers. We can help. Advocacy, just like good diabetes care, work best with a team, doctors, educators and advocates all working with and for patients. 


  1. I listened to Manny and all 18 advocates who presented before AD-Com.. If the message wasn't clear to the FDA on this meeting as to the need for Afrezza approval from the public side, then it will never be...Lets just pray for everyone one this passing soon.....

  2. Thanks Edwin. manny was very good as were the other. I think the message of more options was well delivered by all and I too hope that the safety evidence warrants approval.