By Rob Stein
December 3, 2010
A federal advisory panel panel Friday endorsed a company’s request that a device used for weight-loss surgery be approved for people who are slightly less obese, a crucial step towards making the already increasingly popular procedures available to many more patients.
The 10-member Food and Drug Administration advisory committee voted overwhelmingly to recommend the agency grant the request fromAllergan Inc. of Irvine, Calif., to market its Lap-Band device to people with a body mass index (BMI) of between 30 and 35.
Currently, the device, which is implanted around the stomach to restrict how much food a person consumes, is only approved for people who have not been able to lose weight through diet and exercise and have either a BMI of 40 or above or a combination of BMI of 35 or above and at least one serious weight-related health problem. Allergan’s request was to change that to a BMI of 35 with no health problems or 30 with health problems.
In a series of votes, the committee said there was sufficient evidence that the device was safe and effective for patients with lower BMIs and any risks were outweighed by the benefits.
A 5-foot-9 inch person would have to weigh 203 instead of 271 to be eligible for the device under the new criteria.
The agency is not bound to follow the advice of the advisory committee, but usually does. If granted, the decision would signficantly increase the number of Americans eligible for the surgery. The proportion of U.S. men with a BMI between 30 and 35 is over 20 percent, which is about double the proportion of U.S. men with a BMI above 35, according to the National Center for Health Statistics. The proportion of U.S. women with a BMI between 30 and 35 is almost 18 percent, which is about the same as the proportion above 35, the agency said.
The decision would only apply to this device, and not to another banding device sold by a division of Johnson & Johnson or to “bypass surgery” for weight loss, which is more commonly used and involves surgically reducing the size of the stomach. Currently, surgery is still only recommended for those with a BMI of 40 or above or 35 or above and a serious weight-related health problem. But those guidelines too could change.
The recommendation to expand the population of people who could get the Lap-Band device was praised by some experts as a crucial development in the nation’s battle against the obesity epidemic.
“This is an important first step to extend the benefit of weight-loss surgery to a greater number of people and extend the opportunity to lose weight before they become more seriously ill,” said Bruce M. Wolfe, president of the American Society of Metabolic and Bariatric Surgery.
Surgery has been shown to be the only way some people can lose weight and keep the weight off, proponents say. The move is especially welcome given the disappointing progress that has been made to develop more effective weight-loss drugs. The FDA has recently rejected several requests to approve new drugs because of safety concerns. Another advisory committee will consider another drug next week.
“I agree with the advisory board action, given the epidemic of the disease of obesity and that lack of treatment in this body weight category is associated with many health problems, such as cardiovascular disease, diabetes, and cancer,” said George L. Blackburn, an obesity expert at Harvard Medical School.
But others questioned whether there was sufficient evidence to allow the surgery on so many more people, given possible risks and failure rates and questions about whether the procedure leads to long-term weight loss. The operations cost between about $11,500 and $14,500 on average, according to the American Society for Metabolic and Bariatric Surgery.
“We do patients no favors when we sell them implanted medical products that have been tested on just a few patients for only one year,” said Diana Zuckerman, president of the National Research Center for Women & Families , a consumer advocacy group based in Washington. “Some lap band patients have died even in the first few years and many required additional surgery. I hope the FDA will hold companies to higher standards than this panel asked for.”
In the hopes of winning approval, Allergan presented the results of a study that involved 149 people who received the device. About 80 percent of the study subjects safely lost at least 30 percent of their excess weight after one year, the company reported.
Surgery for weight loss has skyrocketed with the nation’s obesity epidemic. At least 220,000 Americans underwent the procedure in 2009. Early safety concerns have abated somewhat, but some experts remained concerned about the widening use of the procedures. Operations are increasingly being done on teenagers in addition to adults. Some are advocating the procedures for people who are not even obese as a way to reverse diabetes.