The Day Our Diabetes Community Crashed the FDA Site

Months or even years from now, I wonder if the pancreatically-challenged community will be asking: "Where were you, the day the Diabetes Community crashed the FDA's webcast system?"

Yes, that appears to have happened this past Monday.

So many people tuned in for the first-ever virtual town hall discussion between the D-Community and FDA, that the agency's ability to livestream the three-hour meeting online slowed and eventually crashed. And it wasn't only our diabetes dialogue... it seems the FDA's entire network of webcast meetings shut down for a couple hours at least.

OK, that's not technically official yet; the IT gurus within the regulatory agency are still trying to determine the exact cause and moment it happened (about 90 minutes in), but so far FDA leadership believes that we were indeed the cause, since it was essentially like having a massive crowd all trying to peer through a tiny little window at the same time.

So needless to say, there was a pretty significant turnout for this unprecedented FDA-Patient Dialogue on Unmet Needs in Diabetes meeting, the first of its kind between top FDA brass and the diabetes patient community, held on Nov. 3 at the agency's home base in Silver Spring, Maryland, just north of Washington, D.C. Roughly 30 people were physically present (including some key patient D-advocates), while the FDA says that more than 1,059 people had registered and likely many more signed in as guests -- all attempting to watch the livestream while following along with the Twitter hashtag #DOCAsksFDA. Over 7,000 people had filled out the diaTribe survey that helped to shape the meeting as well -- an excellent showing from the patient community.

From what we were able to see and hear afterward, it's interesting that this session seemed more like #FDAasksDOC, rather than the other way around -- since so much focus seemed to be on patients sharing their experiences with FDA, and answering questions about what we patients most need and want. One of my most fave parts was the question: What two words describe diabetes best? In reply, one of the patient participants quipped, "It sucks."

The panel discussions sound like the most fruitful part of the meeting, and we hope to see some video of those sessions before long. It was great to see some live-tweeting of the action, hearing for example the FDA asked the DOC: What kind of information do you want to see on product labels? It was also great to hear the FDA mention how important Big Data is to them -- specifically platforms like T1DExchange that can help guide their review and decision-making process.

The initial event recap from the diaTribe team that helped organize this meeting is worth a read. This part sums it up nicely:

Along with 9 committed patient representatives ... we were thrilled to have the opportunity for an open and direct discussion about the challenges that people with diabetes face every day, the tools we'd like to see, and what FDA reviewers should keep in mind as they consider new drugs and devices. The three-hour event included a patient panel, an FDA leadership panel moderated by Kelly Close, and perspectives from The diaTribe Foundation, JDRF, ADA, and the FDA.

Overall, we were hopeful to hear so many moving patient stories, enthusiasm from the FDA on future dialogue, and a compelling conversation on the need to move past A1c (and more understanding of time in range)...

We've started seeing some initial impressions from others in the DOC, like Stephen and Elizabeth, and are happy to now have access to the list of materials presented:

The full roster of D-Advocates speaking included: T1 Adam Brown, T1 Kelly Close, T2 Brian Cohen, T2 Francisco Estrada, T1 LADA Manny Hernandez, T1 Rebecca Killion, T2 PWD Howard Lee, T1 Anna McCollister-Slipp, D-Mom Angie Platt, T2 Rubin "RJ" Scott, T1 LADA Cherise Shockley and Dr. Aaron Kowalski, who was there in his role as JDRF's VP of Artificial Pancreas and is also a longtime T1 who spoke personally about his own experiences.

Stayce Beck of the FDA:

We were frustrated and disappointed that the webinars went down. We had brought out so many great voices, and we tried to have a diverse mix of the types of diabetes along with different geographic regions. After the webcast went down, we did bring the patient panel back up to continue the discussion. Some in the room were videotaping on their phones, and we're in the process of figuring out what video is out there so we can post it to share. This was still a success, no mater how you look at it. We will also have our social media teams reviewing the hashtag #DOCAsksFDA.

One of the most interesting things was just hearing the patient voices. One that stood out was hearing one person on the panel talk about how much of a challenge and everything they have to do to manage diabetes when going out to eat, and someone else said they hadn't been out to eat in five years due to the burdens of carb-counting. And then one of the patients talking about the challenges of going through clinical trials. Those stories are so important, and they were great to hear so we can keep them in mind when making decisions.

We want to raise the level of consciousness for FDA reviewers about the patient voice. There was never a formal plan for follow up, but we'll just review this and look at how we can use all of this information within the agency by reviewers. We will be looking at how to make these experiences a part of our processes -- like with labeling products. We need to think outside the box. We shared resources, and it was surprising some to hear patients say they hadn't heard of things like MedWatch to see safety information and report adverse events. Those are important, and we want people with diabetes to tell their doctors about that so it can be more widely shared. You can influence how we do our job by using those resources.

This is a catalyst, an entry point for our bigger, and more specifically-focused discussions with the diabetes community moving forward.

Aaron Kowalski, JDRF's VP of Artificial Pancreas & Type 1 for 30 years

It was fantastic to have the key stakeholders there, and have the voice of diabetes really be heard. I've been fortunate to work with the FDA and this team for a number of years, through the JDRF, and we've seen some really good movement there -- from guidance to devices -- and it's very encouraging for us. We have seen approvals speed up and get more efficient (on the device side) in the past 3 or 4 years, and I like knowing they have an idea of what's important to us when judging success for these things as they go through the review process.

We're not out to discredit A1C or knock it down to the ground, but you didn't hear people there at the meeting say it's a big concern when it comes to devices and treatments. The challenges of managing diabetes was the big thing. Having the FDA hear from the community in such a loud and unified voice, that's so important. The agency does its best to determine what the adequate risk-benefit looks like, but having them hear from us is really important since we're the ones using these products. Having the videos, the patient panel, and the book (from diaTribe) with all the patient comments... to me, seeing everyone's reaction from the FDA was very powerful. it all adds up and moves the needle. This is the real world for us, and seeing all the emotions put on the table, it was interesting and powerful for me to watch them absorb all that.

I think it was very powerful for the FDA to have the DOC tuned in online, even just on Twitter and seeing all the comments and interactions in real-time. I was having a conversation with someone at the JDRF on ... how this is a critical example of how important advocacy is. We have been a research organization over time, and just in the past years have bolstered our advocacy efforts on the Artificial Pancreas and beyond that. All of this, with the FDA, is a perfect example of how the Diabetes Community, working together, can achieve great things by speaking loudly and with a unified voice.

Brian Cohen, Type 2 patient advocate

I always thought of the FDA as being a closed-off regulatory agency that just talked to industry, researchers and medical professionals, but that has changed.  The FDA is now recognizing that it's important to hear the patient voice, and that the patient has a key role in defining effectiveness, safety and the context of risk and benefit. FDA representatives are really starting to get it. I really was particularly impressed with Helene Clayton-Jeter for championing the patient voice and Courtney Lias, Stayce Beck and Naomi Lowry who came across as not only extremely competent but really eager to hear from patients. I think these FDA representatives are perhaps the new guard who will lead important changes.

I was fortunate to sit on a panel with a number of very prominent diabetes advocates where each of us was given an opportunity to share our stores and reveal a picture of what it's like to live with diabetes. We also had an opportunity to share things that are difficult in our lives because of diabetes. And through this we could share those things which should be considered during FDA deliberations but have traditionally not been. Patients talked about quality of life, issues with hazards and side effects and the need to look beyond simplistic measures of effectiveness like A1c.  The panel, which consisted of 11 people, was exactly on point, and I don't think I've ever seen nearly a dozen people take part in a 45-minute panel and be so clear.

I came away feeling like the FDA is listening to patients, something I'm not sure I would have necessarily believed before seeing it.  I think many of us as patients feel vulnerable at times. We aren't always sure who is looking out for us and who is looking to make a buck.  I came away feeling much better that the FDA has my back.

Cherise Shockley, LADA patient advocate and #DSMA founder

It was disappointing that the webcast went down, and everyone in the room felt the same way about that. The big highlights for me were hearing the agency talk to the patients, and us talking to them directly. What many didn't get to see was them actually listening to us. One of the FDA panelists said toward the end that hearing our patient experiences was the most eye-opening part of this. Especially Francisco (Estrada) who is living with type 2, and talked about his experiences going through a clinical trial. The FDA woman said that was something she'd never heard, and that they get so caught up in data and regulation that they often don't see the human side of what they're doing. One of the that I didn't know was that FDA can't just pull drugs or equipment off the market, as they can on the food side. It makes sense. I wish they moved faster, but understand they are being cautious and have to weigh risk.

Sometimes, the FDA is hurt by the fact that they can't say anything because (the law makes the review process) confidential. Going forward, what we heard was that the FDA will be trying more to help communicate what's going on where they can. We will see more dialogue between patients and the FDA. With so many registered, that made a difference and they heard our cry, I'm sure!

So what exactly is next?

As was emphasized at the meeting and during our phone calls with FDA and others, this is a starting point and not a finish. It's important to note that this isn't the first time the FDA has listened or engaged with us; one of the slides presented at the meeting shows what they've done with the patient community so far in 2014.

FDA will be holding another diabetes meeting next week -- a Nov. 13 public workshop (open to all) in which the agency will be talking about diabetes software and interoperability.

What we most want to say at this point is simply: THANK YOU to the diaTribe team for making this discussion possible, and even moreso to the FDA for listening and making this dialogue a priority. We look forward to continuing the conversation with you.