Are Drugs the Answer to Childhood Obesity?
In an approach to childhood obesity long considered taboo, the nation’s two prescription weight-loss drugs, Xenical and Meridia, are now being tested in children and teenagers.
This first large-scale effort to examine the usefulness of diet drugs in the young reflects a growing need, says Dr. Ken Fujioka, director of the Nutrition and Metabolic Research Center at the Scripps Clinic in La Jolla. Health experts say 10% to 15% of the nation’s children are overweight and that the number is climbing.
“I don’t think we ever dreamed of doing this 10 years ago, or even five years ago,” says Fujioka, who is investigating Xenical’s effectiveness among children ages 12 to 16. “But this is a scary problem because it’s increasing [so rapidly]. So now we’re looking at more aggressive measures.”
Treating obese children with medication still elicits strong objections from many health professionals, however. They say a focus on medication ignores the fundamental problems--too much food, too much fat and too little exercise--that has precipitated the childhood obesity epidemic.
“I think a pharmacologic approach for childhood obesity is not the best approach,” says Dr. Francine Kaufman, chief of endocrinology and metabolism at Childrens Hospital Los Angeles. “The best approach is a public health solution. We need to learn a lot more about child obesity and why this is occurring now.”
But parents of obese children are increasingly desperate to help their children, experts say. Many overweight children have at least one overweight parent who fully understands how hard it is to lose weight.
Cathy Dangel kept thinking her daughter, Eryn, would shed weight naturally as she grew during adolescence. But last summer, Dangel, who lives in San Diego, decided it was time to act. Her daughter was about to enter high school and she was 40 pounds overweight.
“I thought she would outgrow it, but that never happened,” Dangel says. “And I felt if I said something about the problem, that might be more detrimental to her self-esteem.”
Dangel, who also struggles with a weight problem, heard about Fujioka’s study at Scripps while attending a class there. Eryn agreed to enter the study, although Dangel had some reservations--mostly because the drug can trigger sudden diarrhea.
“I thought if she had an accident at school that would be even worse than being overweight,” Dangel says. “But Eryn felt she could handle the side effects.”
Eryn has lost 12 pounds since September and hasn’t had problems with sudden diarrhea. The entire Dangel family has also changed their eating habits.
“We’ve learned to study food labels and cook food differently,” Dangel says. “One of the nurses at Scripps even said that Eryn probably doesn’t need Xenical any more because she is keeping her fat and calories down. So we don’t know if [the medication] is helping or if it’s the other things. But the medication really gave us the impetus to get going on the problem.”
To be sure, Xenical, approved in 1999, and Meridia, approved in 1997, are a far cry from previous generations of diet drugs. Those were typically amphetamines that suppressed appetite and caused a range of serious side effects, such as insomnia, mood changes, cardiac arrhythmias and addiction. Both of the new studies are sponsored by the manufacturer.
Xenical, made by Roche Laboratories, works by reducing the absorption of about one-third of dietary fat. The drug also limits intake of some vitamins--a potentially serious side effect in children, who are still growing, says Fujioka. In particular, Xenical can block the absorption of fat-soluble vitamin D, which helps metabolize calcium.
Exposure to sunlight generates enough vitamin D in most people. But children taking Xenical in northern climates may not get enough of the vitamin during winter months without taking a vitamin supplement, Fujioka says.
Xenical can also cause excessive gas and increased bowel movements, both of which may be urgent and difficult to control--particularly after meals that contain more fat than is recommended.
“This is tough for kids,” Fujioka says. “If they have diarrhea at school, that will be so difficult because they don’t want to do anything else to draw attention to themselves. But that may also be why Xenical might work: It forces kids to police themselves, and they begin to learn what is fat.”
The Xenical study, which involves about 450 kids and some 30 research centers, will explore the effects of vitamin loss as well as safety and effectiveness. Investigators will compare a group of kids who receive Xenical along with counseling on nutrition and exercise to a group that receives counseling only.
Studies show that about two-thirds of adults treated with Xenical and a diet plan lost at least 5% of their body weight after two years compared with 50% of the people treated with diet alone.
Meridia, made by Knoll Pharmaceutical Co., works by affecting chemicals in the brain involved in regulating appetite.
Side effects include dry mouth, headache, insomnia and constipation. Meridia can increase blood pressure in some people. In studies, about two-thirds of adults who took Meridia experienced a weight loss of 5% to 10% in one-year clinical trials.
The children’s study underway by Knoll involves about 400 kids ages 12 to 16 at more than 30 research centers. Half of the study participants will receive Meridia and counseling, while the other group will receive only counseling.
Researchers will examine effectiveness as well as potential side effects, such as an increase in blood pressure.
“Taking medication always involves a risk-benefit analysis,” says Dr. Robert Berkowitz, an associate professor of psychiatry and pediatrics at the University of Pennsylvania Medical Center who is investigating Meridia in 60 teenagers ages 13 to 17 as part of a separate, government-funded study. “For children mildly overweight, medication is not in order. Trying to focus on healthy habits is a much better approach.”
However, he says, for acutely overweight kids, such as the teens in his study, medication represents a pull-out-all-the-stops approach that’s justified. The teens and their parents also receive counseling on lifestyle changes.
“The mean weight of the kids in our study is about 240 pounds; these kids need to lose at least 50 pounds,” Berkowitz says. “Our concern is if we don’t treat these kids, they tend to be extremely overweight adults.”
Studies support the need to take obesity in children--especially those nearing puberty--seriously. Children who are obese at adolescence are highly likely to be overweight in adulthood and run the risk of developing weight-related illnesses including heart disease, hypertension, diabetes and some types of cancer. Some overweight teens have already developed adult-onset diabetes or have high blood pressure.
And, behind the 10% to 15% of U.S. children who are already obese, an additional 10% are heavier than recommended and are at risk of becoming obese.
“If we don’t do something about this now, it will consume the U.S. health-care budget in the future,” says Kaufman.
But no one should think the solution will be easy, she adds.
“Even if medication works, it’s not a magic pill. This alone is not enough.”
