It is not an image that many pediatricians relish: Overweight teenagers popping prescription diet pills.
But it soon might be reality.
With the number of overweight and obese youngsters having doubled in the past 20 years, the manufacturers of two popular prescription weight-loss pills believe they may have found a vast potential market.
Hoffman-LaRoche Inc., which makes the weight-loss drug Xenical, and Abbott Laboratories, maker of Meridia, are testing the pills in overweight and obese teenagers at medical centers across the country.
Both drugs are approved for use in people over 16. The manufacturers hope the studies will win U.S. Food and Drug Administration approval to market them for children as young as 12.
Some experts say the epidemic of obesity among American youth _ as many as one in five are overweight _ has reached the point where it's clear diet and exercise alone won't work. New tools should be welcomed, they say.
"Some of those kids are carrying so much weight so early, you start to wonder _ why force them into the sort of struggle of managing this all on their own, when there's a potential that a drug could be a useful tool for them?" argues Dr. Margo Heath-Chiozzi, an internist and senior medical director of global marketed product development for Abbott. "Some of these kids, they're a good 25 to 50 percent overweight already. That's a lot of weight to ask a kid to get off unassisted."
But others, while admitting drugs may be valuable for some severely obese children, object to making drugs part of the routine regimen for overweight children. To some, resorting to medication suggests the child's parents and doctor have abandoned any hope of controlling weight through diet and exercise, which should be especially attainable for children.
"The problem with kids, you're talking about putting them on drugs for 30 or 40 years or more. That's sort of uncomfortable," said Dr. Frank B. Diamond, a pediatric endocrinologist at All Children's Hospital in St. Petersburg.
Meridia, which was initially developed as an anti-depressant, helps the stomach feel full, suppressing appetite. Xenical, by Roche, works entirely differently. It blocks the absorption of some fat, so the body doesn't process as many calories. Both drugs have helped some people obtain modest reductions in weight, and both have minor side effects.
The argument over whether children should use these drugs is not likely to be simply in their approval, but in how they're marketed and how widely they are used.
Diamond expects them to be received like Ritalin and other medications designed to control hyperactivity in children: Although those drugs are controversial, and many experts say they're overused, they also are popular.
"You can see that there will be a lot of pressure to treat even mildly affected kids if these medications are approved for use in the pediatric age range," Diamond said. "I wouldn't be comfortable with that until I saw some more long-term studies."
Diamond, who usually sees children with serious obesity-related complications like type II diabetes, believes there is value in some cases.
He recalled a 350-pound 12-year-old boy who dislocated a hip because the joint couldn't handle his weight. He needed surgery, but his fat made anesthesia unsafe. That meant he was stuck in a wheelchair, making weight loss doubly difficult.
Diamond used a special high-protein, low-calorie diet to knock off about 30 pounds and make him fit for surgery.
But the drugs wouldn't be appropriate for simply chubby children. "Those kids need to watch less TV, spend more time outside, get more exercise, drink less juice and sodas and eat smaller portions."
U.S. Surgeon General David Satcher, who plans to issue a "call to action" on America's weight problem by early fall, said he is uncomfortable with giving such medication to children, but he would not rule it out.
"It's hard for me to get excited about the drugs, because I believe there is so much to be done with diet and exercise," he said. "But I wouldn't sit here and make blanket statements."
Abbott is testing Meridia in 300 youths ages 12 to 18, who also are getting counseling to help them improve diet and exercise. An additional 100 are just getting the counseling, and Abbott will compare the results.
Roche's Xenical trial involves 450 children at 30 medical centers in the United States and Canada. Smaller trials of both drugs in teens are under way as well.
One skeptic is Dr. William H. Dietz, director of the U.S. Centers for Disease Control and Prevention's division of nutrition and physical activity, and one of the nation's top experts on childhood obesity.
Recently, he figured out the cost of putting all obese Americans on Xenical or Meridia: $30-billion.
"It's too expensive to treat with drugs, and too expensive not to treat," Dietz said. "My view is that first, that's an argument for prevention, and secondly, the first steps toward treatment should be behavioral, rather than (drugs)."