Wednesday, December 22, 2010

More People To Become Eligible For Obesity Surgery

The FDA is considering revising the thresholds that guide who is allowed to have bariatric surgery. While there may be some concern that this is being pushed by the manufacturer of one of the lap-band products, there is some valid medical merits to having a more nuanced set of guidelines. A one-size-fits-all (pardon the pun) approach simply does not encompass the diverse needs of patients with not only obesity issues, but other comorbid conditions such as hypertension or diabetes. As the NYTimes article from December 1, 2010 notes:
Weight-loss surgery, once a last resort for extremely overweight people, may soon become an option for those who are less heavy.

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.”

Like any medical advance, it is important to consider the benefits as weighed against the risks. Specifically, one must consider a metric called the "number needed to treat" or NNT. What the NNT is define the number of people that have to receive a treatment in order for one person to have the intended outcome. For example, the NNT of lap-banding might be 3, meaning that 3 people need to have lap-banding in order for (on average) one person to achieve a BMI less than 25 (ie, a normal BMI). But, there already is a large research on banding itself showing it to be effective; the issue now is merely extending this research. The article goes on to discuss how lap banding has expanded over the years:
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.

The research also needs to consider the impact on not only BMI but other comorbid conditions like diabetes (blood glucose levels) and hypertension (blood pressure). These other major diseases are leading causes of kidney and heart disease, not to mention blindness and amputations. If banding can help stem the onset of the epidemic of diabetes in this country, then it may possibly be worth the fact that some people will not be helped by the procedure. And, even in those cases, is it the banding that failed, or that the individual did not stick with the treatment plan? If you get banding, you need to realize that this is a total life change, not a one-stop quick fix. Be the change you want to see in your life. The article describes these comorbid effects:
One factor that is moving some experts to advocate surgery for lower body mass index levels is its effectiveness in resolving diabetes, hypertension and some other ills associated with obesity.

“There are dramatic metabolic effects that in many cases go well beyond the weight loss effects,” said Dr. Lee M. Kaplan, director of the weight center at Massachusetts General Hospital.

He said that while it was once thought that surgery worked mainly by mechanically restricting how much one can eat, it is becoming clear that gastric bypass, at least, has effects on hormones.

Some experts say body mass index does not adequately measure risk of health problems. For instance, Asians tend to get diabetes at a lower B.M.I. than whites.

“The B.M.I. limitation of 35/40, set in the period when the major objective of the operations was weight control, is no longer the primary appropriate guideline for the selection of candidates for bariatric surgery,” Dr. Walter J. Pories, a surgeon, and colleagues wrote in the journal Obesity earlier this year. Dr. Pories will be a member of the F.D.A. advisory committee on Friday.

Today can be the day you make the change. Whether you live in downtown Houston or the outer reaches of Galveston, the Woodlands to Sugar Land, start the process of your personal metamorphosis today. Don't simply be that man or woman in the mirror you've come to despair about. Be the change you want to see in your life now!


Reference:
1. http://www.nytimes.com/2010/12/02/business/02obese.html?_r=1

0 comments:

Post a Comment