By ANDREW POLLACK
“I see this as the first step in the march toward changing the standard of care,” E. Francine Stokes McElveen, the consumer representative on the committee, said during the meeting in Gaithersburg, Md.
The advisory committee to the Food and Drug Administration voted 8 to 2 that the benefits of Lap-Band surgery exceeded the risks for patients in the lower range of obesity. It voted 8 to 2 that the device was safe, and 8 to 1, with one abstention, that the device was effective. 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 of 40 and above — or 35 and above if they have diabetes, hypertension or another severe health problem associated with diabetes.
Allergan wants to lower the threshold to a B.M.I. of 35 for people without health complications, and to 30 for people with health problems, which also would no longer have to be severe.
A person who is 5 feet, 5 inches with hypertension must weigh at least 210 pounds to qualify for surgery now. Under the proposal endorsed by the committee, that person would have to weigh only 180 pounds.
An Allergan executive said at the meeting that 27 million Americans had a B.M.I. between 30 and 35 and at least one associated health condition.
The panel’s endorsement coincided with the release of a new report by F.D.A. staff members on a diet pill, Contrave, that another panel plans to consider next week. The report said the drug seemed to be effective, but might pose potential cardiovascular risks.
Other new diet pills have been rejected by the F.D.A. in recent months, leaving few options for overweight Americans.
About one-third of American adults are obese, defined as a B.M.I. of 30 or more. A study published in the New England Journal of Medicine this week showed that women with a B.M.I. of 30 to 35 had a 44 percent higher risk of death than women of normal weight, which is a B.M.I. under 25.
The Lap-Band is an inflatable silicone ring that is placed around the upper part of the stomach. It restricts how much a person can eat and makes one feel full more quickly.
Allergan submitted a study to the F.D.A. in which 149 people in the new proposed weight range received the device. Those patients lost an average of about 18 percent of their weight after a year, an amount considered enough to have positive effects on their health.
But some committee members said the study was too small and too short, especially since people might have the band inside them for decades. Some wanted more evidence that the operation resolved diabetes or other health problems. Most panel members said the study included too few men, blacks and Hispanics.
Still, most of the committee, which included several bariatric surgeons, said that Allergan could do longer, larger studies after approval and there was enough evidence, including from other studies in the literature, that the band was safe and effective.
Two participants in Allergan’s study, whose transportation to the meeting was paid for by the company, testified that the surgery had changed their lives. “I couldn’t walk up a flight of stairs or even take a shower without taking a rest,” said one of them, Brandi Jirka of Nashville, who did not specify how much weight she lost. “Now I can run and play with my children, I do yoga and can shop at regular stores in the mall. I’ve even been snorkeling while wearing a bikini.”
In her testimony, Diana Zuckerman of the National Research Center for Women and Families urged the committee to vote against approval, saying there was not enough long-term data. “We need that information before approval is expanded to include such a very large number of adults,” she said.
Some forms of weight-loss surgery, like gastric bypass, are considered medical procedures, not devices, so are not regulated by the F.D.A. But all types of bariatric surgery are covered by federal guidelines from 1991, 10 years before the Lap-Band was approved.
There are now efforts to revise those guidelines to lower the weight threshold. Some members of the committee said that the advent of minimally invasive surgery had made bariatric surgery much safer than it was in 1991. Some also said that B.M.I. was too crude a measure of how much a person needs surgery.
“The B.M.I. criterion is so seriously flawed,” said Dr. John G. Kral, professor of surgery and medicine at SUNY Downstate Medical Center in Brooklyn. “Removing this barrier of this idiotic number in itself would be an important step.”
Allergan, which is known mostly for Botox, hopes that expanding use of the Lap-Band to less obese adults — and also eventually to teenagers — will spur sales. Sales of its obesity products, mostly Lap-Band, fell 4 percent to $182.4 million in the first nine months of this year, a decline the company attributed to the weak economy. But obesity products make up only 5 percent of Allergan’s overall product sales.
Shares of Allergan rose 52 cents, to $68.80 in regular trading Friday. The shares rose 3 percent, to $70.89 in after-hours trading, following the panel’s vote.
No comments:
Post a Comment