Allergan drops bid for FDA approval to promote Lap-Band for teens
The maker of the Lap-Band weight-loss device, Allergan Inc., has dropped its controversial bid for federal approval to market the product for overweight teens.
The Irvine company had sought permission from the U.S. Food and Drug Administration to promote Lap-Band surgeries for adolescents as young as 14 and it has been conducting clinical trials on teenage patients. A spokesman for Allergan said it pulled that government application earlier this year as part of a routine evaluation of its business priorities.
“As part of this ongoing process, we made the decision at the beginning of the year to not pursue an adolescent indication for the Lap-Band system in the U.S. and worldwide,” said spokeswoman Naziah Lasi-Tejani.
A spokesman for the FDA said the agency doesn’t comment on company applications.
The Lap-Band is a silicone tube that is surgically implanted around the stomach to discourage overeating. Doctors already can perform Lap-Band surgery on minors with parental consent. The FDA approval would have allowed Allergan to market the product specifically for younger people and it could have encouraged more insurers to pay for those procedures in children.
Overall, government officials, healthcare companies and employers are grappling with how to respond to the nation’s obesity epidemic. About a third of U.S. children are overweight or obese, according to the U.S. Centers for Disease Control and Prevention.
Allergan’s bid to extend the weight-loss surgery to teenagers had raised concerns among some health experts and patient safety advocates. They say there’s not enough data about the Lap-Band’s long-term safety and effectiveness, particularly when dealing with children.
Diana Zuckerman, president of the National Research Center for Women and Families, a nonprofit in Washington that tracks medical device safety, said she welcomed Allergan’s move, but called on the company to publish the results of its clinical trials on teens.
“Allergan has made a lot of money off the American public and they owe it to the public to make this information from the clinical trials available,” she said.
Lasi-Tejani said the company would complete the clinical trials already underway, but she couldn’t be reached for comment on the call to release the results. “The Lap-Band system has a 19-year safety and effectiveness record with more than 650,000 procedures performed to date,” she said.
In the Los Angeles area, five adult patients have died after Lap-Band procedures at medical clinics from 2009 to 2011, according to lawsuits, autopsy reports and other public records. Allergan said it had stopped selling the Lap-Band device to those facilities allegedly involved and adverse events have been reported in less than 2% of patients overall.
Sales of the Lap-Band have slumped in recent years. In the first half of 2012, sales of Allergan’s obesity intervention products, including Lap-Band, were down 20% from a year earlier.
Health experts say more effort should be put into pushing diet and exercise rather than making it easier for children to get weight-loss surgery.
Dr. Namir Katkhouda, director of bariatric surgery at Keck Medical Center of USC, said Lap-Band and other weight-loss surgeries should remain a last resort for obese teenagers after other measures have been exhausted. “You have to be even more cautious in teenagers,” he said.
