FDA EMDAC Public Comments

I had the privilege of offering public comments at the December 12 FDA Advisory Committee meeting for BMS/AZ's dapagliflozin (aka DAPA). My comments were roughly what follows. I say roughly because I know I get lost and stray from the notes. I have tried to bring what portions of my ad-libbing I remember into what follows.

My sincerest thanks to Kelly Close and the team at diaTribe for sharing detailed background material that made it possible to offer informed comments. DAPA has had a complex and carefully scrutinized regulatory path. There were concerning possible signals of risk. Without being able to read though its history it would have been impossible to appreciate the Sponsor's (FDA hearing speak for the pharma companies behind the drug application), FDA's and committee's conversation on those risks. 

My Comments:

Good afternoon. My name is Bennet Dunlap. I have no relationship with the sponsor. My travel here today is at my own expense, including the cost to a good nights sleep of getting up at 4:am to drive down from Philly for this meeting. 

I am a diabetes advocate, a blogger, been a PCORI reviewer and I recently created the StripSafely.com campaign for meter accuracy. I am a member of Diabetes Advocates, an association of diabetes patients and writers. Last time I was here I absolutely slaughtered the name of the drug in question, so this time I’m not even going to try.

Like 26 million other Americans, I live with diabetes. This morning somebody spoke of unintended wisdom. Those of us with diabetes will take wisdom any which way we can.

I often feel that, the conventional wisdom in medical literature projects that diabetes care is easy. Many of us have felt it is not.  We have found  it doesn’t help when – despite our best efforts – we are labeled non-compliant.  Maybe the problem has to do with unrealistic expectations, or maybe the problem has to do with imperfect treatments.

What I am certain about is while all of us with diabetes can benefit from similar diet and exercise, there is no one size fits all approach to good diabetes medications. We need choices to talk about with people like Bob Ratner, (Gesture to Bob who just spoke) our doctors…  and we need innovation.

Which brings me to the purpose of today’s meeting.

Has the sponsor met the safety and efficacy requirements to market their candidate drug and does it present potential heal value to some of us living with diabetes?             

Broadly speaking, the class of SGLT medication is an exciting new opportunity for glucose regulation. The class encompasses four benefits we haven’t seen together before in one diabetes therapy:

- improved glucose, 

- weight loss, 

- less hypoglycemia, 

- and ease of use that comes with a pill. 

Expanding the class with this DAPA increases choice: although there is already one approved for SGLT-2 therapy, a second one would provide obvious benefits from competition, broader education and outreach. 

We all know third party payers love to bid the pharma. companies against each other and a second SGLT-2 would give them a chance to do so in this exciting new class.

As you consider benefits of diabetes medication outcomes, I encourage you to look to endpoints that can create success in patients’ daily lives. In addition to endpoints of lowering A1C, and avoiding cancer and CV risk profiles -  look to endpoints that we can see and feel in our daily efforts to be “compliant.” Medicines that show less weight gain or even loss and less hypoglycemia can help with the phyco-social struggle to stay compliment. 

The safety issues raised at the DAPA first hearing we're quite concerning. Nobody wants to trade blood sugar control for cancer. I appreciate the scrutiny the the agency and sponsor have given to the issues. I was particularly interested in this mornings presentation on the bladder cancer risk and look forward to detailed professional exploration of it this afternoon. 

As Dr Wilding pointed out this morning, we need better treatments. As a patient I worry that regulation creep may inhibit those innovation. That the endpoints move after trials have begun. What constitutes an effective study need to be resolved before the trials start, not after the fact in discussion at an advisory meeting. 

In closing, please remember diabetes care… is self-care. As patients, we see our doctors just a few times a year, maybe for a combined total of an hour, or two if we are really lucky. That leaves us on our own, responsible for self-care the other eight thousand, seven hundred, fifty eight hours a year. 

We could use a hand seeing success in that.  

Thank you very much.