By ANDREW POLLACK, New York Times
Weight-loss surgery, once a last resort for extremely overweight people, may soon become an option for those who are less heavy.
Rashida Brown of Jamaica Plain, Mass., wanted gastric banding surgery but her body mass index was below federal guidelines.
An advisory committee to the Food and Drug Administration will consider on Friday a request by Allergan, the pharmaceutical company, to significantly lower how obese someone must be to qualify for surgery using the company’s Lap-Band device, which restricts intake to the stomach.
On Wednesday, the F.D.A. acknowledged that a new study by the company showed that people in the proposed range of obesity who had the band experienced “statistically significant decreases in all measures of weight loss.”
If the agency approves the change, the number of Americans eligible for the Lap-Band operation could easily double, ensuring more sales for Allergan and probably more insurance coverage for such operations. But the proposed change, sought at a time when the obesity epidemic in the United States seems intractable, still leaves some people uneasy, in part because of side effects and failure rates. In addition, long-term weight reduction is hard to maintain.
“You’re talking about millions and millions of people who would meet these criteria,” said Dr. George Blackburn, associate director of the division of nutrition at Harvard Medical School. “Let’s make sure by the most rigorous research that this is safe and effective.”
A new generation of diet pills has failed to gain federal approval, limiting options for overweight Americans, and Allergan and other companies are betting that surgery will become more of a frontline option rather than a last resort.
“It would be kind of ironic if people have access to surgery and not medical therapies, where they can go from Weight Watchers to surgery and have nothing in-between,” said Dr. Louis J. Aronne, an obesity expert at Weill Cornell Medical College. “But it appears it may be the way it will be in the near future.”
Doctors have already started to operate on extremely heavy teenagers, not just adults. And some experts are recasting weight-loss procedures, known as bariatric surgery, as metabolic surgery, saying that it might be justified to treat diabetes, even in people who are barely obese or not obese. Gastric banding involves placing an inflatable silicone ring around the upper part of the stomach, which limits food consumption and makes one feel full faster.
Current guidelines say weight loss surgery is appropriate for people who have failed to lose weight through diet and exercise and have a body mass index, or B.M.I., of 40 and above, or 35 and above if a person has at least one serious health problem, like diabetes or high blood pressure, that is tied to obesity. Allergan wants to lower the threshold for the Lap-Band to a B.M.I. of 35 with no associated health problems and to 30 with such problems.
For instance, a person who is 5 feet 6 inches and has diabetes would have to weigh 216 pounds to qualify now. Under the proposed lower threshold, that person could weigh 30 pounds less, or 186 pounds.
Federal statistics suggest that nearly 20 percent of the adult population has a B.M.I. between 30 and 35, more than double the population above 35. Probably half or more of the people between 30 and 35 have some associated health condition.
Bariatric surgeons and some obesity experts say that surgery has proven to be the only way many people can lose a lot of weight and keep it off, and some cite a Swedish study suggesting that it prolonged lives. And, they say, the operations have become safer since the obesity thresholds were first set in 1991 in a meeting organized by the National Institutes of Health.
“The whole risk-benefit ratio is completely different than it was back then,” said Dr. Marc Bessler, chief of the division of minimally invasive and bariatric surgery at Columbia.
Banding is a less radical operation than the main alternative, the gastric bypass. It is also reversible and costs less — from $12,000 to more than $20,000, compared with $20,000 to more than $30,000 for a bypass. But banding also leads to a weight loss of about 20 percent on average, less than that of bypass.
Bypass has been the preferred operation in the United States, though Allergan executives said on a recent call with investors that banding now has about 50 percent market share. Within the banding market, Allergan’s Lap-Band has about 70 percent market share, according to the company, with the rest belonging to the Realize Band sold by Ethicon Endo-Surgery, a division of Johnson & Johnson. Allergan’s band was approved in 2001.
To win approval of the lower threshold, Allergan sponsored a study in which 149 of these less obese people had the band implanted. About 80 percent of the participants achieved the goal of losing at least 30 percent of their excess weight, meaning the amount by which they were overweight, after one year. About 70 percent of patients experienced a side effect, like vomiting or pain. The F.D.A. indicated on Wednesday that it had questions about how meaningful the weight loss was and whether the results of the study would be applicable to people other than the white women who made up a large portion of the participants.
Some doctors are dropping the band, in part because some older studies suggest that up to a third of patients eventually have the band removed because of side effects or ineffective weight loss. While about one in 1,000 patients die within 30 days of surgery, a survey of members of the bariatric surgery society suggested that deaths occurring later are under-reported.
“Before they start putting the Lap-Band on patients who are 50 pounds overweight, the public has to be made aware of how dangerous this is,” said Stephanie Quatinetz, a New York lawyer whose daughter, Rebecca, died at age 27 in August 2009, two months after getting Lap-Band surgery.