Insight: Diabetes breakthrough stalled in safety debate
GETTING IT RIGHT
Brewer’s passion is born out of the fear and frustration shared by many parents of children with type 1 diabetes, in which the immune system destroys cells in the pancreas that make insulin.
Type 1 diabetics currently must monitor their blood sugar and take insulin several times a day. Getting it right is tricky. Meals, exercise, stress, even a growth spurt, can alter blood sugar. And mistakes are costly.
Taking too little insulin can cause high blood sugar, increasing the risk of long-term complications such as eye damage, kidney failure and heart disease. Taking too much can cause blood sugar to drop, causing hypoglycemia, which can result in seizures, unconsciousness, brain damage and death.
Racial and Ethnic Differences in Diagnosed Diabetes
National estimates of diagnosed diabetes for some but not all minority groups are available from national survey data and from the IHS NPIRS, which includes data for about 1.9 million American Indians and Alaska Natives in the United States who receive health care from the IHS. Differences in diabetes prevalence by race/ethnicity are partially attributable to age differences. Adjustment for age makes results from racial/ethnic groups more comparable.
Data from the 2009 IHS NPIRS indicate that 14.2 percent of American Indians and Alaska Natives ages 20 years or older who received care from the IHS had diagnosed diabetes. After adjusting for population age differences, 16.1 percent of the total adult population served by the IHS had diagnosed diabetes, with rates varying by region from 5.5 percent among Alaska Native adults to 33.5 percent among American Indian adults in southern Arizona.
After adjusting for population age differences, 2007–2009 national survey data for people ages 20 years or older indicate that 7.1 percent of non-Hispanic whites, 8.4 percent of Asian Americans, 11.8 percent of Hispanics/ Latinos, and 12.6 percent of non-Hispanic blacks had diagnosed diabetes. Among Hispanics/Latinos, rates were 7.6 percent for both Cuban Americans and for Central and South Americans, 13.3 percent for Mexican Americans, and 13.8 percent for Puerto Ricans.
Compared with non-Hispanic white adults, the risk of diagnosed diabetes was 18 percent higher among Asian Americans, 66 percent higher among Hispanics/Latinos, and 77 percent higher among non-Hispanic blacks. Among Hispanics/Latinos compared with non-Hispanic white adults, the risk of diagnosed diabetes was about the same for Cuban Americans and for Central and South Americans, 87 percent higher for Mexican Americans, and 94 percent higher for Puerto Ricans.
That was the case with Brewer’s son Sean. About 16 months ago, the 14-year-old decided to have a late-night snack.
“He forgot he had given himself insulin and gave himself another dose,” Brewer said. “Unfortunately, he was behind a locked door, so the fire department came with an axe and broke the door down. He spent the next 36 hours in the intensive care unit.”
For about a day, Brewer’s son could not recall his name.
Sean recovered fully from this serious episode of hypoglycemia, but many families are not so lucky.
“People are hurting themselves and killing themselves all the time with insulin,” Brewer says. “The data says one out of every 20 people with this disease might actually die with hypoglycemia.”
That’s where a small cellphone-sized device like Medtronic’s Veo would help, Brewer said. The JDRF organization has been pushing hard to get the FDA to allow these devices to enter the U.S. market without a lot of additional testing. The group, along with other diabetes advocates, have been ramping up the pressure.
In October, the American Diabetes Association, the American Association of Diabetes Educators, the Endocrine Society and the American Association of Clinical Endocrinologists sent a letter to FDA Commissioner Margaret Hamburg urging the agency not to repeat the low glucose suspend decision.
In early November, they sent a petition to the FDA with 100,000 signatures from lawmakers and diabetes experts. They followed up with ads in the New York Times and the Washington Post featuring a young girl named Piper who, like other type 1 diabetics, is at risk of dying from hypoglycemia.
The ad said the new artificial pancreas guidelines are the FDA’s chance to show the world the United States “is leading in medical innovation, not standing in the way.”