By: Margaret A. Hamburg, M.D.
As FDA Commissioner I frequently learn about exciting and promising new developments in science and medicine to treat disease and improve lives. Some involve advances in science and technology and others relate to the development of improved ways of doing business that promote innovation. But the most inspirational moments relating to these developments are when I have the chance to meet with people who deal personally with the challenges of a particular disease or condition and to hear first-hand what is needed in terms of education and research and development, as well as the difference that FDA’s work can make in their lives.
Earlier this week, I had just such an opportunity, when I met with officials and representatives from the JDRF, formerly known as the Juvenile Diabetes Research Foundation, who were in town for their annual Children’s Congress.
It was a delight to meet with the group’s President and CEO, Jeffrey Brewer and several other top officials of the organization, with whom FDA has a strong working relationship. But the highlight of the meeting was when we heard from three children with diabetes and their parents who accompanied the group’s leaders. Ten year old Willa Spalter from California, nine year old James Cravero from Iowa, and thirteen year old Fallon Blackbull from New Mexico were among 150 children who were in town to meet with government officials and share their stories of life with diabetes in order to stimulate efforts to develop policies to cure, treat and prevent the disease.
These eloquent and inspiring young people offered compelling personal stories about their struggles with the disease, which, shockingly, included having it properly diagnosed. In fact, the doctors failure to diagnose their disease until the symptoms became life-threatening highlights the very real need for more education, not simply of the public or Congress, but of the medical community itself.
As I listened to these young people I was pleased to learn how FDA’s work is making a difference in their lives and the lives of others with juvenile diabetes. Perhaps most exciting are the remarkable strides being made to develop a safe and effective “artificial pancreas.” This innovative device type automatically monitors blood glucose and provides appropriate insulin doses in people with diabetes who use insulin. It can be life-changing for individuals with insulin-dependent diabetes, helping them reduce dangerously high and low blood sugar levels and lowering the risk for future diabetes-related complications.
To advance the development of this revolutionary type of system, we have worked to foster discussions between government and private researchers and have sponsored public forums to promote rapid and efficient development of artificial pancreas devices. Additionally, at the FDA we have prioritized the review of artificial pancreas research studies and have provided clear guidelines to industry on performance and safety standards for these systems — efforts that we hope will shorten overall study review time and ultimately get these devices into the hands of researchers and users more quickly. Most recently, we approved clinical studies for artificial pancreas devices to take place at diabetes camps this summer. This is a major milestone, as it will represent the first time in the U.S. that we have been able to study artificial pancreas devices in camp settings, where children participate in camp activities and wear the artificial pancreas during the day and night.
It was gratifying to hear how Willa, James and Fallon each participated in trials related to the artificial pancreas. They know better than anyone the benefits that come from pushing this agenda and making sure the best science is available to take on juvenile diabetes.
I am so pleased to have had the opportunity to meet with these three courageous and inspiring young people. Hearing their stories and watching how they bravely and competently manage their diseases will provide me and my colleagues additional motivation in our work on behalf of these and other children.
Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration