SHOULD THE FDA APPROVE LAP-BAND FOR LOW BMI?
The FDA Advisory Committee, which recently agreed to review the current criteria that Allergan Corporation and physicians and hospitals may use to promote the laparoscopic adjustable gastric band will soon be deciding to broaden these criteria. Until now, the LAP-BAND has been approved under FDA guidelines for people with a body mass index of 35 and greater if an obesity related health problem is present. The most common ones include diabetes, hypertension and obstructive sleep apnea, although the list is truly very long and includes nearly every organ system. The proposal from Allergan Corporation would lower these criteria to a body mass index of 30 with an obesity related disease or 35 without documented disease.
Should the FDA grant this approval?
The recommendations should be grounded in data and should not take into account fears of excess costs, social implications and politics. The recommendation should acknowledge the deadly seriousness of the obesity epidemic and the tragedy of the lives claimed by obesity.
To most of us working in the field of obesity treatment, obesity research and bariatric medicine, all too often it seems the media focus on sensational stories about unusual complications of weight loss treatments and weight loss surgery. Most stories do not focus on the deadly effects of obesity, although it now ranks as the number one cause of early disease and death in the United States.
At least five longitudinal studies have examined weight loss surgery and compared surgical patients with similarly obese non-surgical patients over a period of time. Each study demonstrated a profound disadvantage for people electing not to undergo weight loss surgery. In studies by Flum and Christou, obese individuals undergoing weight loss surgery enjoyed a dramatic reduction in disease and mortality risk over the span of just a few years. Other authors have confirmed these findings.
What these studies indicate, in my view, is less a commentary about the dramatic success of surgery, but more about the deadliness of obesity and disease.
More to the point on low BMI LAP-BAND, O’Brien and numerous other authors have examined and continued to examine the outcomes of low BMI patients who undergo LAP-BAND surgery. The complication rate of this out-patient, thirty minute procedure is markedly low and pales in comparison to the deadliness of obesity as a disease. The reductions in weight achieved with LAP-BAND surgery, and an associated weight loss program complete with counseling, weigh-ins, band adjustments and support groups are profound and significant. And because obesity is such a deadly risk factor, even modest weight loss produces major gains in health status and longevity.
So whether the FDA committee will examine the data critically and without bias remains to be seen. There are indeed major implications of a decision which would expand the recommendations to tens of millions of Americans. But time and time again, healthcare providers, leaders and regulators have continued to overlook obesity as a serious disease and have continued to turn away from treatments and policies that would favorably impact obesity related disease and deaths.
In my view and in the view of most experts in the field of obesity treatment, the data for LAP-BAND approval for BMI 30 and over has been in for a long time. Its approval is well overdue.