Medical Device Daily Contributing Writer
WASHINGTON — The American Society for Metabolic and Bariatric Surgery (ASMBS; Gainesville, Florida) met here last week with its new banner that added "metabolic" to its previous name, remarking on the newest understanding of the complexity of obesity.
No longer is it believed that a mechanical reduction of the size of the stomach, or bypassing part of the intestine, considered the long-term cure for obesity.
This group of surgeons is dedicated to the treatment of metabolic disease and obesity, leading the path to better understanding of the root causes — and then hopefully cures behind this worldwide epidemic that is caused by a plethora of various factors that are still baffling.
Previous thinking was that morbid obesity led to diabetes and could be cured by mechanically altering the alimentary tract, but current thinking proposes that it is a complex neuro-hormonal feedback to and from the brain and gut that allows for obesity and diabetes to occur, initiated by poor eating and exercise habits.
Long-term studies following patients who had bariatric surgery 10 to 15 years earlier have shown that weight re-gain is a common occurrence, suggesting more than just a re-routing of the intestines can cure it.
According to ASBMS, about 64 million adults in the US are considered obese, which is associated with many other diseases and conditions including Type 2 diabetes, heart disease, sleep apnea, hypertension and cancer.
While 15 million people in the U.S. have morbid obesity and are clinically eligible for surgery, only about 1% or 205,000 in 2007 are being treated through bariatric surgery.
In an industry-sponsored workshop, "Economics and its Influence on the Evolution of Bariatric and Metabolic Surgery," Eric Finkelstein, PhD, director of public health economics at RTI International (Research Triangle Park, North Carolina) and author of the book The Fattening of America, offered his opinion on how America and soon the world became obese.
"Economics drove us to obesity and economics may be our way out," he said. "It is no longer a problem of poverty. There are economic causes of obesity, such as the fact that we have made it easier and cheaper to consume bad food and more difficult and expensive to consume good food. Sodas and snacks have gone down in price and are quick and easy to eat (thanks, in part, to the microwave), while vegetables and fish have gone up in price and require some time to prepare."
He added, "It is harder to get accidental exercise, it costs more to get intentional exercise, and our leisure-time activities, which are passive, crowd out exercise. Obesity is a side affect of our own success," Finkelstein said.
Besides the economic drivers mentioned above, the consequences of obesity have been diminished due to pharmaceuticals such as statins and blood pressure meds that counteract the medical conditions caused by obesity. In addition, the costs of the cures (i.e., surgery, etc.) are borne by the entire population — both thin and not — through government or insurers, resulting in thin people contributing to the cure of the obese.
All of these reasons contribute to the finding that more rational people, and not just the uneducated, are becoming obese. "A successful obesity prevention program should make it cheaper and easier to be thin," Finkelstein said. "Currently the economics are working against this."
According to Finkelstein, for a change to occur the economics have to be reversed such that the thin are rewarded and the obese suffer financial consequences.
An economic factor preventing many of the potential patients in this 19 million-person pool is the cost of bariatric surgery, specifically the gastric bypass and Lap-Band procedures that can range from $20,000 to $30,000 and are the two most common procedures performed in the U.S.
In a nationwide survey of 409 bariatric patients conducted by Harris Interactive (Rochester, New York), affordability was cited as the No. 2 reason patients did not have the surgery, second only to not knowing enough about it (see Table 1).
One way to prod more patients into having the life-saving surgery is to make it more affordable as well as conquer their fears of surgery, which has several companies developing new products and procedures to meet these requirements.
Other than avoiding major surgery as it exists today by using a less-invasive, less-costly, yet possibly less-effective method for weight loss, another way to skirt the economics of reimbursement for bariatric surgery is to position the procedure as a cure for diabetes as opposed to weight loss.
Recent studies have shown a reversal of diabetes among bariatric surgery patients even before any weight has been lost.
Several reports delivered here showed a resolution of diabetes after patients received a gastric bypass, sleeve gastrectomy or other novel weight loss procedure. Although the mechanism of action is still unclear, the fact that many bariatric procedures reverse diabetes almost instantly is not only newsworthy, but may also be lucrative.
When it comes to paying for a surgical procedure, bariatric surgery is held to a different standard than other procedures. Insurance companies would prefer to pay for prevention of obesity rather than surgery. But if the surgery is medically necessary to treat a disease such as diabetes, then they may be more likely to pay.
Unlike bariatric surgeons, endocrinologists have aligned themselves tightly with insurance companies and along with the American Diabetes Association, are a formidable adversary to get things done and reimbursed. Because of this, diabetes resolution was featured as a prime endpoint—not just weight loss—in measuring outcomes of bariatric procedures. Reimbursement for diabetes control may be the key to expanding the bariatric surgery market.
This new line of thinking pervaded the meeting in regard to focusing on diabetes resolution, as opposed to percent excess weight loss (EWL), once considered the gold standard for measuring bariatric surgery outcome. Now diabetes resolution — often measured in days — has stolen the limelight and for several reasons, some of which are economic as opposed to medically driven.
Type 2 diabetes affects 20 million Americans, or 7% of the population, and has much co-morbidity associated with it. Type 2 was once thought to be a disease of obesity and caused by excess weight, so the resulting reversal of diabetes, along with weight loss, that was found after bariatric surgery was not surprising.
A landmark study in rats that showed an immediate reversal of diabetes without accompanying weight loss when a plastic sleeve was placed in the duodenum forced thought leaders to re-think the mechanism of diabetes and the role gut hormones and peptides may be playing in root cause of the disease.
This study caught industry by surprise and several companies benefitted, while others may have to re-group based on this finding because they were not looking for diabetes resolution, but rather, weight loss.