Now The FDA Knows What It Feels Like to CrashBy Jenny McCue -
There were more than a few memorable and important achievements for patients during the FDA virtual meeting with the diabetes community this week. More than 1,000 people registered to watch and listen. More than 7,000 people filled out an online survey to tell the FDA how diabetes impacts their daily lives and what they want to see in new drugs and devices. And a panel of people from around the country representing the diversity of diabetes flew in to be part of a conversation webcasted from FDA.
Senior FDA staff were in the room and participating. The patients in the room were prepared and delivered their list of concerns. All were in the throes of a productive dialogue. And then, about 90 minutes into the meeting, the webcast malfunctioned. The FDA email alert sent to participants stated:
“experienced a crash, and are working to be running again soon.”
How ironic. While the system crash should not take away from the important things that happened in that room in the 90 minutes before the crash, it is profoundly meaningful that the FDA was able to experience — in a very real way — what it is like to live with diabetes. As patients, we can do everything right, follow every rule, take our shots and our drugs, and still have days when we crash and must work hard to get back up and running.
FDA took many of the right steps. They opened their doors ‘virtually’ and invited people with diabetes in for a dialogue. They assembled leadership from both the device and drug divisions. They listened. They responded during the meeting to the issues patients put on the table. They blocked the time. They showed up. But, the system crashed anyway.
If this event wasn’t targeted to a community who is used to doing everything right and still having our bodies sometimes fail, the meaning may have been different. If the participants weren’t required to still show up in life after a crash, we may have been less understanding. But we as a community understand what it feels like to crash.
Perhaps, like diabetes patients, the webcast system was overwhelmed by the response. That’s fitting. For all of us living with diabetes, “overwhelmed” is a word we learned long ago.
That is what makes this meeting and its “crash” so important.
The FDA received a vivid example of how the demands of living with diabetes are not met simply by checking boxes and doing what we are told. They heard personal accounts of the complexity of diabetes management, even with the best drugs and devices. They heard that endpoints beyond A1C are needed to assess the effectiveness of management tools. They heard that managing diabetes places tremendous stress on the person with diabetes, their caregiver and their entire family.
From the survey responses and the panel participants, FDA heard directly from patients asking the Agency to recognize that there are gaps in management and unmet needs that need to be addressed with a sense of urgency. For example:
“I look like I am fine. But I am not. Please move with urgency.”
Patients shared what it’s like to live with fear brought on by this disease:
“I am terrified that when I lay down to go to sleep, I may not wake up.”
very powerful experiences sent a clear message about the FDA’s risk/benefit question applied in approving new treatments:
“We live with risk every day.”
The diabetes community effectively made its case, despite the system crash. The FDA committed to future discussions. Now that key issues are on the table, we need to focus on solutions to address those issues. Patients, clinicians and the FDA together.
That may seem like vague fluff-speak, but it isn’t. Because even if the video broadcast crashed, the event and the response from the diabetes community are on record. FDA Leadership in the room heard it.
If you live with diabetes, know someone who does, or even if you’ve seen a movie with someone who has diabetes in it, then you know the disease sneaks up on you. It hits you when you want it the least. Outside of the amazing response our community showed, having the FDA system crash and have to keep going is one of the most persuasive testaments we could have delivered.
It was a job well done. But let’s not stop.