BB&T Contributing Editor

SAN FRANCISCO – More than 30 million Americans meet the minimum guidelines to receive surgery as treatment for their obesity and related illnesses, making it a multi-hundred-billion-dollar industry. The American Society of Bariatric Surgeons (ASBS; Gainesville, Florida) held its 23rd annual scientific meeting here to interchange ideas and share information and experiences pertaining to bariatric surgery in order to better address the worldwide obesity epidemic. The ASBS, the largest society in the world dedicated solely to obesity surgery, boasts a membership of 2,600, with close to 2,000 of them in attendance at this year’s meeting. As with any market this size and growing, new device manufacturers, investment bankers and venture capitalists were additional attendees at this meeting, seeking to explore this huge financial opportunity.

Morbid obesity is defined as a life-threatening disease with many associated medical problems (co-morbidities) such as diabetes, cardiovascular disease, hypertension, sleep apnea, respiratory and orthopedic problems. Obesity levels can be broken down into categories defined by Body Mass Index (BMI), a standardized rating of obesity calculated using measurements of height and weight (Table 6).

There is no end in sight to this ugly epidemic and at this time, the best solution for long term weight loss and resolution of the accompanying co-morbidities is surgery. In a key study presented at this conference, “Risk of Dying From Morbid Obesity Higher Than From Bariatric Surgery,” by Randolph Reinhold, MD, chairman of the department of surgery at Hospital of St. Raphael (New Haven, Connecticut), it was shown that the risk of dying from morbid obesity was 50% to 85% higher than the risk of having the surgery that treats the disease. The study evaluated 1,185 patients with morbid obesity, 908 of whom had surgery to treat their obesity. Over the seven years that the patients were followed, the mortality rate for the patients who had surgery was 2.9% compared with 14.3% for those who deferred surgery. At five years follow-up, 97% of the bariatric surgery patients survived, while only 78% survived from the non-surgery group. At this juncture, surgery is clearly the standard of care for treatment of morbid obesity.

Not only are there too many obese Americans who are candidates for this complex and expensive surgery, it appears as though the epidemic is just beginning. In a poster presentation titled “Obesity Begets Obesity,” by Picard Marceau, MD, PhD, department of surgery, Laval University (Laval, Quebec), and John Kral, MD, SUNY Downstate Medical Center (Brooklyn, New York), 1,200 obese mothers who had Biliopancreatic Diversion (BPD) surgeries were studied. This is the first study to compare children born after their mothers had bariatric surgery to their siblings and to those in the general population. They concluded that the lower birth weights found after the mother’s BPD surgery proved that the intrauterine condition is important in transmitting obesity and plays a major role.

Marceau and Kral found that if the mother was morbidly obese during the pregnancy, those babies were “prewired” to become obese themselves-that something in the uterine environment affected the fetus to become obese. Those children born from the same mothers after bariatric surgery when the mother was of normal weight never became obese and showed no tendency for them to ever become obese. Conversely, the siblings born from the same mother prior to her bariatric surgery became obese at an early age and the obesity persisted throughout adolescence. On average, the offspring of obese mothers were 50% heavier than those born from a normal-weight mother. This study demonstrates the power of transgenerational transmission of obesity and points out that the epidemic may just be beginning since “obesity begets obesity.”

Realizing the prominence of the problem and recognizing that these patients will proceed to develop more and more medical problems related to their weight, Stacie Perlman, MD, of the Hospital of St. Raphael, asked the question “How Do Family Practitioners Perceive Surgery for the Morbidly Obese?” in a poster presentation. She said that there were misconceptions about bariatric surgery among family practitioners despite the increasing numbers of patients presenting with obesity. From the responses in her survey, she concluded, “educational programs need to be designed and implemented for the family practitioner regarding obesity” (Table 7).

Studies from previous years have proven that almost all co-morbidities, such as diabetes, hypertension, sleep apnea, etc completely resolve or at least improve significantly after surgery. After diet and exercise fail, surgery is the gold standard for treating morbid obesity. The mortality rate for bariatric surgery is 1% or less at centers of excellence.

In 2005, the ASBS reported an estimated 170,000 people in the U.S. received bariatric surgery, and it is estimated that number will approach or exceed 200,000 procedures in 2006.

Overeating which leads to obesity may be influenced by many different factors, including genetics, behavior, psychology, hormones, or environment, making it difficult to address all the contributing factors with one solution. Several of the surgeons polled felt that for many patients a combination therapy would be the best solution for their long-term success. The difficulty is in knowing which combination of therapies will work for which patient group. To date, this has been the most frustrating factor clinically: predicting which patients will respond to which therapies. As clinical trials using different therapies progress, the answers to these enigmas may become apparent – at least that is the hope.

In the interim, single-focused therapeutic ap-proaches can be segmented into several categories: intake restrictive, capacity reduction, delayed emptying, malabsorption, or electrical modulation.

Because bariatric surgery is technically challenging – with a suggested 125-procedure learning curve – and costly, many new approaches are being developed to effect weight loss using a less-invasive procedure in order to reduce surgical risk and lower costs (see Table 8 below).

It could be argued that obesity is a lifetime disease and cannot be treated temporarily; however, some companies are addressing the temporary weight loss market segment. Main reasons cited for providing a temporary weight loss procedure are lower cost, less invasiveness and less patient risk. Initially, the temporary procedure would be used for patients in preparation for standard bariatric surgery because super-obese patients have a higher surgical risk, with up to 30% complications and mortality rates of 5% to 12%, which are considered to be unpalatable by many when even a moderate weight loss would bring the morbidity and mortality rates to a more reasonable level.

In a paper presented at the plenary session, Jose Alfonso Sallet, MD, of Instituto Sallet (Sao Paulo, Brazil), studied the use of an intragastric balloon to reduce weight in 51 super-obese patients prior to their bariatric surgery. He found that by using the balloon for four months, more than 80% of them showed significant improvement in hypertension, sleep apnea and diabetes, thereby reducing their surgical risk. There were no mortalities in this group at surgery.

Temporary weight loss procedures are also good for patients who need to undergo other unrelated surgeries such as cardiovascular or orthopedic. By losing weight prior to surgery, patients reduce their surgical risk and improve surgical outcomes. It is not impossible to conceive that sometime in the future these temporary weight loss procedures may even enter into the cosmetic surgery arena for patients who need a little help losing those excess 20 pounds. Most of the temporary products are inserted and removed through the esophagus non-invasively and in a clinic setting. In fact, several of the new products – temporary as well as permanent – are inserted this way, allowing for the end-user to be a surgeon, gastroenterologist or interventional gastroenterologist.

This large emerging device market addressing obesity appears to be almost endless in both opportunities and numbers of patients, with plenty of room for many successes – for patients, surgeons, gastroenterologists and investors.