As many of you know, I recently spoke with Rebecca Killion, one of a small group of people who works with the FDA as a Patient Representative, about the diabetes community's current petition to the FDA. Rebecca has Type 1 diabetes herself, is a mother of two, and runs a professional development program at a law firm in Washington, DC.
I was fascinated by the fact that Rebecca has the "inside view" of workings at the FDA. How did she get there? What has the experience been like? And how is that she stands so squarely behind our urgent call for the creation of a more grounded Diabetes Advisory Council? Some insights from Rebecca, in her own words:
On patient representation in the FDA:
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There's a very small group of patient representatives from different disease states — maybe about 50 or 60 from the whole country. We generally don't know each other and we don't interact.
I was recommended by a physician friend in 2000 to sit on the FDA's Endocrinology Advisory Committee, which is made up completely of physicians and researchers — mostly who have nothing to do directly with patients. They're all these experts, but they're pretty removed from the world of diabetes patient care.
We only exist as a panel for "the meeting" — they put together a panel comprised of different experts and members depending on what the issue is that's being deliberated. They rotate the patient reps.
On being part of the Avandia evaluation panel and Dr. Steven Nissen:
Dr. Nissen (who pushed the cardiac-testing agenda) saw a concern, wrote an article, got attention, and capitalized on a movement. I think he wants to do the right thing, but I think his approach is flawed.
I've had a lot of contact with Dr. Nissen since that first encounter at the Avandia meeting. The man is incredibly passionate about helping patients. He says we need better drugs. Absolutely. I just don't happen to agree with his approach. For example, he says the problem with diabetics and diabetologists is that we're too "glucose centric." He actually indicated that maybe diabetes should be considered a cardiovascular disease and not a microvascular disease. That just makes no sense. Cardiologists should not be treating diabetes, because they'd be treating only the cardio components. High glucose levels are the root of many other problems as well.
We need MORE AND better drugs for diabetes. In this whole climate of fear that's been created, it's going to be like molasses getting new things out there.
The Pfizer people didn't even bring the actual device with them. They only showed a video. When I asked them why not, they said they didn't want to "distract" us with the physical device. That's so unfortunate!
Also, Exubera calculated insulin doses in some totally new unit measurement. So patients had to do these complicated conversions. My comment was: Are you trying to make this completely unusable?
Honestly, you've got to walk a mile in somebody's shoes to understand what it's like to live on some of these medications...
On what she'd like to see change in the FDA's approach to diabetes care:
As a patient, I see a lot of dedicated medical professionals who truly lack a patient's perspective. They're physicians and professionals in healthcare, but they don't understand the concerns from the perspective of people living with the illness.
Right now, we have 10 classes of diabetes drugs. That's not a lot. It's not like everybody can take the whole spectrum.
You might have tried this or that drug but couldn't tolerate it, or it didn't work for you. Certainly there are specific drugs that we know we shouldn't give to high-risk patients, people with certain markers. But diabetes and its progression are very individual — the care parameters are individual and we need to take that into consideration.
For example, my mother: she's had 2 open heart sturgeries, 9 angioplasties, 2 strokes, and had her first heart attack at 52. And her doctor had her on Avandia! If there's one person who should not be on Avandia, it's her. The problem is that a lot of people are not receiving specialized diabetes care. That's a larger problem we need to solve, but in the meantime, the FDA can change some of the guidelines to be less onerous, so we all have more choices, and access to better treatments that may be more suited to us individually.
On how all of this impacts her life:
Other than raising my children, I feel that this is best chance I've ever had to make a contribution to the world.
Having a place at table is privileged. I'm grateful for that, but I'm not beholden to anyone for it ... I support patients.
Thank you for your candor, Rebecca! I for one am proud to be represented by you.
Update on the HealtheFDA campaign:
* We currently have over 1,200 signatures and counting!
* If you want to help promote the initiative, you can get banners to post on your own blog or website HERE — including this cool banner that displays the latest and greatest:
[Special thanks to Manny Hernandez of TuDiabetes for the petition site and graphics.]