A leading researcher has called for FDA approval for gastric banding for children
DAVID LUDWIG, director of the obesity programme at Children’s Hospital Boston, was against weight-loss surgery for children, he says, because it ignored the real problem, a “toxic environment” jammed with junk food. He has since, however, changed his mind.
The rate of obesity in children in the US has tripled since 1980, according to the Centers for Disease Control and Prevention, boosting rates of sleep apnoea, diabetes and heart disease. That’s why Ludwig, a leading childhood obesity researcher, says regulators should approve a procedure in which surgeons wrap a silicone band around children’s stomachs to help limit food intake.
A gastric band made by Allergan this year may become the first cleared by federal regulators to be sold to children as young as 14. For Allergan, the approval may open an avenue to as many as two million new customers, according to Christine Ren-Fielding, a surgeon at New York University’s Langone Weight Management Program.
Both Ren-Fielding and Ludwig say use of gastric bands should be allowed for children, with limits.
“Ultimately, we want to create a public health approach that makes surgery unnecessary – less junk food, better school lunch, physical education in school and after-school recreation activities,” says Ludwig, who is also a professor at Harvard Medical School in Boston. “But until we reach that time, surgery may be the necessary fallback for some of the most extreme cases.”
Ludwig says he has no financial ties to Allergan. The bands are already implanted in some children, doctors say, and the latest data suggest adolescents lose 11 times more weight with the devices than with diet and exercise alone.
Food and Drug Administration (FDA) approval would limit Allergan’s legal liability, says Ken Cacciatore, an analyst for Cowen Co in New York. It may also push insurers to help pay for the procedures, which can cost as much as $25,000, according to Allergan’s website. “It’s an untapped market,” Cacciatore says. “But it is fraught with liability. The risk to the company is minimised when you have an FDA-approved device.”
Price is an issue for many obese teenagers, Harvard’s Ludwig says. “Low-income, minority populations tend to have greater chronic disease burden, and less ability to pay for the needed medical care,” he says. “Reimbursement is key.”
In 2009, 220,000 people in the US underwent weight-loss surgery, according to the American Society for Metabolic and Bariatric Surgery. That’s an increase from 28,800 in 1999, the group reported. Surgery, though, should only be considered as a last resort for children, according to New York University’s Ren-Fielding, who says that she’s already implanted gastric-band devices in some adolescents.
Edward Livingston, a surgeon at the University of Texas Southwestern Medical Center in Dallas, agrees. It’s important to be cautious because there’s no data available showing lap-bands are safe and effective longer term in either adults or children, according to Livingston, who says he has performed bariatric surgeries for 17 years in adults.
Many of Livingston’s patients regain weight five to 10 years after surgery, he says. Livingston suggested the FDA approve the devices for children with strict warnings about lifestyle changes, including dieting rules, are needed to help the devices work.
“The problem with bariatric surgery is that you’re treating a psychological disease with a knife,” Livingston says. Along with the surgery, “you need warnings to counsel parents and patients about lifestyle changes. And you need to be compliant about lifestyle changes to get any benefit”.
According to Ludwig: “We need a comprehensive national strategy to make this country healthier. But for children who can’t manage their weight, especially when they develop a complication like type 2 diabetes, then bariatric surgery may be the last resort that needs to be considered.”
- Washington Post– Bloomberg
WHAT IS GASTRIC BANDING?
Gastric banding is usually performed through two to five small cuts in the abdomen. The band is placed around the upper part of the stomach, and its width can be adjusted after it is implanted. Most patients lose 40-60 per cent of their excess weight in two years, according to the website of Columbia University in New York.
