|10-14-2006, 07:17 AM||#1|
Lost In Space
Join Date: Apr 2004
Ok this is a joke - FAT KIDS article
Allergan seeks FDA OK for gastric band in youths By Debra Sherman
Fri Oct 13, 12:35 PM ET
As childhood obesity rates soar in tandem with the rest of the U.S. population, Allergan Inc. AGN.N is eyeing use of its implantable gastric band to cut food intake in adolescents.
Bart Bandy, a senior vice president at Allergan, said the company, which also makes skin and eye care products, Botox and breast implants, is talking with the U.S. Food and Drug Administration about getting approval for use in children as young as 14.
"I think there's some frustration among surgeons that they can do (gastric) bypass on (children), but you can't use a Lap-Band," said Bandy, who attended the Cleveland Clinic's three-day meeting on obesity which ends Saturday.
That's because the FDA has to approve the device, but does not have to approve a surgical procedure.
The percentage of young people who are overweight has more than tripled since 1980, according the U.S. Centers for Disease Control and Prevention.
Bariatric surgery is sometimes considered as a treatment option for adolescents with a body mass index -- a ratio that considers both height and weight -- of at least 40 who also have serious weight-related health issues.
Allergan acquired Lap-Band, approved by the FDA in 2001, with its purchase of Inamed earlier this year.
The device has been growing in popularity, partly because, unlike gastric bypass -- which involves rerouting of the intestinal tract -- the band can be adjusted or removed.
The Lap-Band system is surgically implanted and placed around the upper part of the stomach, creating a small pouch above the rest of the stomach. It limits the amount of food that can be consumed, reducing appetite and slowing digestion.
Illinois Masonic Hospital in Chicago and New York University Medical Center and Children's Hospital of New York-Presbyterian have obtained FDA approval to use the device in teens under an Investigational Device Exemption.
Bandy expects more hospitals to seek such approval as the company keeps talking with the FDA. He declined to characterize those discussions or estimate when they might conclude.
DATA SUGGESTS DEVICE IS SAFE
Dr. Jeffrey Zitsman, director of the Center of Adolescent Bariatric Surgery at Children's Hospital of New York-Presbyterian, said there is a lot of data from Australia and Europe that demonstrate the device is safe and effective in adolescents.
Zitsman's program, which was launched in early 2006, has a full schedule of patients through the end of the year.
"They don't just come here and sign up for surgery," Zitsman said. "The program mandates that potential candidates try to lose weight under supervision, getting patient-specific diet and exercise programs for six months."
If patients are able to lose 20 percent of their excess weight, it's considered a success. "We're not interested in operating on people who can lose weight," he said.
But most cannot.
Potential surgical candidates are also put through a battery of psychological tests.
"All of these kids are depressed. Some have mutilating behavior. One was actively suicidal. Being depressed is not a contraindication for surgery, but we need to evaluate them and know where they are," Zitsman said.
Dr. Philip Schauer, head of the Cleveland Clinic's bariatric surgery program, said he would not hesitate to intervene with surgery -- bypass or Lap-Band -- if there was other disease, like type 2 diabetes, caused by the obesity.
"Kids need to be at a center that is designed for kids," he said, adding that the number of such surgeries is growing more slowly partly because it's controversial and partly because insurers often deny coverage.
Insurers usually reverse their decision on appeal, said Schauer.
Dr. Lee Kaplan, a surgeon at Massachusetts General Hospital, said it is far too early to say whether gastric banding or bypass is preferable for a teenager.
"They are completely different operations and we don't know which is safer, or better. We need more research. You could argue either way...We just don't have the data."
(Additional reporting by Kim Dixon)
How about this instead, parent stop feeding your kids juke food, and get them involved in sports and turn off the play station.