It wasn’t 14-year-old Caroline Jacobs’ first trip to Washington, but this time the Shapleigh resident wasn’t in the nation’s capital just to tour the monuments.
And sure, some perks came with being a delegate to the Juvenile Diabetes Research Foundation’s Children’s Congress late last month — including a meeting with actor Kevin Kline. But Jacobs was in D.C. to be a public policy advocate, not a tourist.
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She hopes that her testimony at a special Senate hearing on diabetes research — chaired by Sen. Susan Collins, R-Maine, who founded the Senate Diabetes Caucus — will help push the U.S. Food and Drug Administration to take action to speed research into, and approval of, an artificial pancreas and other devices that can improve the lives of people with type 1 diabetes.
Type 1 diabetes is a very different disease from the more common type 2 diabetes, which mainly affects people later in life. Type 1 diabetes is an auto-immune disease that makes the body attack its own pancreas.
A kid who has lived with it since age 10 knows a lot about the disease, a lot about her own body and its special vulnerabilities to problems with glucose and insulin imbalances, and a lot about medical technology.
Jacobs can discuss, with the sophistication of a medical professional, how she monitors her body’s blood sugar level. She can speak of the finger sticks and insulin checks, the pain and the uncertainty that come with current monitoring systems that people with type 1 diabetes remain, well, stuck with every day.
Kids from across the country came to the Children’s Congress, which aims to make lawmakers and federal policy makers and regulators aware of the need for more funding and research.
This year, a main focus was on the artificial pancreas, an external device that can provide continuous and accurate monitoring of glucose levels and provide tight control of high and low blood sugar levels 24 hours a day. It combines a continuous glucose monitor with an insulin pump to provide just the right amount of insulin at precisely the needed times, says the Juvenile Diabetes Research Foundation.
People with type 1 diabetes now must monitor their own levels, and it’s very difficult to keep those levels as tightly in check as most people’s bodies do naturally. That means that most people with type 1 diabetes have healthy glucose levels just 30 percent of the time, the foundation says, and that often leads to complications such as kidney failure, blindness, nerve damage and amputations.
Collins, who does not have diabetes but got interested in the issue after arriving in the Senate, notes that aside from the human toll, diabetes takes a giant financial toll nationwide — accounting for $174 billion in health care costs annually, and one of every three Medicare dollars.
Health care costs for a child with type 1 diabetes are likely to be six times as much as those for a child who doesn’t have the disease, Collins notes.
Progress is being made on the artificial pancreas, which is showing promise in trials at hospitals. But advocates like Jacobs want the FDA to move more quickly toward allowing at-home trials.
They also want the FDA to approve a more sophisticated type of insulin pump, called a low glucose suspend system, which reduces the risk of low blood sugar and is already in use in other countries. The device lacks the comprehensive nature of the artificial pancreas, but it makes life a lot safer and healthier for people with diabetes.
So Kline — whose son has type 1 diabetes — Jacobs and several other children with diabetes testified at the Senate hearing to make the case for streamlining the FDA process and why it’s so important to move more quickly.
“Living with diabetes is every day. … You are always having to be aware of yourself and how you are feeling, always keeping tabs,” Jacobs said in a phone interview, recalling her message to lawmakers and officials from the FDA and the National Institutes of Health.
“The impact the artificial pancreas would have on my life is, I would never have to test my blood sugar anymore, wouldn’t have to poke my fingers. It is a closed loop system and it would do everything for me,” she said.
Jacobs and her mother, Grace Jacobs, are frustrated with the FDA bureaucracy. They said a friend of Caroline’s did an in-hospital trial for several days and found that the artificial pancreas worked perfectly to keep her blood sugar at a constantly healthy level.
Caroline Jacobs, who will be a freshman at The New School in Kennebunk, said she believes she helped educate some senators who weren’t very knowledgeable about diabetes and the need for an artificial pancreas to be more widely available — and maybe made an impact on federal regulators.
But was the Children’s Congress and the hearing before the Senate Committee on Homeland Security and Governmental Affairs just public relations, or was it an effective way to move the regulatory train down the track?
In early May, Collins spearheaded a letter signed by 58 other senators, including Sen. Olympia Snowe, R-Maine, urging the FDA to move forward more expeditiously.
But it wasn’t until the day of the hearing that the FDA released what is known as a draft guidance document — something that gives a blueprint to companies that are trying to develop new drugs or medical devices — concerning the approval process for that new and better insulin pump.
At the hearing, an official who chairs the FDA’s artificial-pancreas initiative told senators who were critical of the agency for moving too slowly to approve new medical devices that it is working hard to streamline its process.
The FDA promised at the hearing that a guidance document setting out an approval path for comprehensive artificial pancreas devices would be released by the end of the year — a promise it had put word out about two days before the hearing.
The Children’s Congress “does make an impact,” said Cynthia Rice, vice president of government relations for the Juvenile Diabetes Research Foundation.
Of course, you would expect Rice to say that. But she offers as evidence the fact that clinicians and lawmakers have been asking the FDA for months to put out a road map for development of the artificial pancreas. The Senate hearing gave the FDA a deadline for doing so, Rice said.
“The FDA was aware this was a major focus of the Children’s Congress,” Rice said. “They didn’t want to be there (at the hearing) without a pledge of their own to move these treatments and therapies forward.”
Grace Jacobs agrees, saying, “I believe everybody sitting there (in the hearing room) put pressure on (the FDA) to do that.”
The FDA disagrees. A spokeswoman said the agency has been working diligently with everyone, from the Juvenile Diabetes Research Foundation to academicians, on the new insulin pump and the artificial pancreas, and that timing around the hearing was a coincidence.
“It’s been a high priority for the agency,” said Karen Riley of the FDA public affairs office. “It certainly was a good time to announce, but we have been working on it.”
Regardless, Caroline Jacobs says this won’t be the last time she steps forward as an advocate rather than just a patient.
“I am definitely going to keep working to help with raising money for JDRF and to help keep pressure on the FDA, as well as the senators,” she said.
MaineToday Media Washington Bureau Chief Jonathan Riskind can be contacted at 791-6280 or at:
jriskind@mainetoday.com
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