1. Introduction
2. Background
3. Misleading Claims, The Evidence and Commentary
    A.   Benefits and Risks of Surgery
    B.   Cost-Benefit of Surgery
    C.   Misutilization of Surgery by Patients
4. Improving Quality of Care
5. Conclusion

1. INTRODUCTION

In the last few weeks, several health insurers have announced plans to eliminate coverage of bariatric surgery for the treatment of morbid obesity. These decisions are often justified by statements which are misleading, unscientific, speculative and wrong. As obesity is a major cause of death and sickness in the United States, these statements are causing many patients and physicians to be confused about the nature of surgery for the treatment of morbid obesity. It is, therefore, of great concern that many individuals whose lives can be saved and their health dramatically improved will be deterred from receiving this intervention, no matter who is paying for it.

To correct these misunderstandings, the American Obesity Association has developed this Editorial Memorandum to help inform this important public policy debate. For background information about the American Obesity Association, read About AOA. Also on this site is information on morbid obesity, surgery and insurance.

In brief:

• Morbid obesity is a fatal disease. Surgery is the treatment of choice for morbid obesity. Recent studies show that surgery extends the lives of patients, causes significant weight loss, resolution of many conditions caused by obesity, including Type 2 diabetes, the metabolic syndrome, cardiovascular risk and dramatically improves the quality of life of patients.
• Major governmental health agencies, including the National Institutes of Health, the United States Preventive Services Task Force and the Agency for Healthcare Quality and Research support bariatric surgery, based on the medical evidence.
• The decisions of the insurance companies increases the likelihood of premature, preventable death and a lifetime of suffering among patients with morbid obesity, of whom many are poor, African-American, Hispanic, female and/or are survivors of childhood abuse.
• All available evidence suggests that access to bariatric surgery should be expanded, not contracted, not only because of its demonstrated health benefits but also because of its cost-effectiveness.
• All players ­ governments, health insurers, employers, hospitals, physicians and surgeons ­ should undertake reasonable steps to improve the quality of care provided to patients with morbid obesity.

Obesity is now recognized as a major public health problem in the United States and globally. About 97 million Americans are overweight of which approximately half are considered clinically obese.

Obesity is simply defined as excess body fat. There are several measurement tools. The most common measurement in the medical community is the Body Mass Index (BMI) which is a number reflecting the ratio of weight to height. The surgical community also refers to Excess Weight Loss (EWL) to designate the percent or amount of weight above the person’s ideal or healthy weight. Obesity is usually defined as a BMI of 30 or greater. A BMI of 40 or more is considered the definition of morbid obesity. (A BMI calculator is available on this web site.) Morbid obesity is roughly 100 pounds over one’s ideal or healthy weight.

Approximately 4.7% of the United States population (about 9 million persons) is classified with morbid (sometimes called severe or class III) obesity. For comparison purposes, this is over twice the size of the country’s population with Alzheimer’s disease (4 million). Under the NIH consensus statement (see below), persons eligible for bariatric surgery include those with morbid obesity and those with a BMI of 35 or greater who also have a comorbid condition, such as heart disease or diabetes. Thus, the total number of persons considered eligible may be as high as 20 to 25 million.

Morbid obesity is understood as a complex biological process involving genetics, the environment and behavior. There is a very strong genetic component in morbid obesity. (Bouchard, Perusse, Thirbly) Approximately 15% of African-American women are morbidly obese. Overall, 6.3% of women have morbid obesity while 3.1% of men have the condition. Only 1.2% have 4 years of college or more.

Women, and especially minority women, have the highest prevalence of morbid obesity. Between 15% and 30% of all women have been sexually abused as children. Obesity is one of the adult manifestations of this abuse. (Roberts) Physical abuse and verbal abuse are strongly associated with body weight and obesity. (Williamson) Sexual abuse, in one study, was found to be significantly higher in women with obesity than in women with eating disorders (Koop)

Morbid obesity is a fatal disease, significantly raising the risk of death. A recent study in Canada comparing over 1,000 patients who had gastric bypass to over 5,000 persons with morbid obesity who did not, found that bariatric surgery reduces by 89% the relative risk of death for people who underwent the surgery and a 5.4% reduction in absolute mortality between the operated and non-operated patients. Thus, this paper demonstrated a real effect of bariatric surgery in reducing mortality in an extremely high-risk population. Regarding the comorbid conditions, only 4.7% of the people who underwent the surgery had cardiovascular disease while nearly 6 times as many, 26.7%, developed cardiovascular disease. (Christou) Many studies have established that mortality increases with higher weight levels. (Bender, Peters, Rogers, Seidell)

In one such study morbidly obese men age 25 to 34 had a 12-fold risk of mortality over their non-obese peers. The risk was 6-fold in the 35 to 44 year old group and declined steadily. Cardiovascular disease was the primary cause a death. (Drenick)

The effects of morbid obesity, known as comorbidities, are numerous, affecting virtually every organ system including cardiovascular (e.g. hypertension, coronary heart disease), respiratory (e.g. sleep apnea, asthma); metabolic (e.g. diabetes); musculoskeletal (e.g. osteoarthritis of knee and hip); gastrointestinal (e.g. cholelithiasis, cirrhosis of the liver); endocrine and reproductive (e.g. cancers of the uterus and breast and reproductive disorders); neurologic (e.g. pseudotumor cerebri); dermatological (e.g. dermatitis); and psychological, (e.g. depression).

Obesity and, particularly morbid obesity, pose social, marital and sexual problems. Obese people are frequently ridiculed, shunned, and considered inferior to persons of normal weight. Discrimination against this group is socially permissible, the last socially acceptable discrimination. This discrimination is manifest in employment discrimination, restriction of educational opportunities and the refusal or exorbitant expense of health, life or disability insurance. Maternal morbid obesity carries a higher risk of preeclampsia, antepartum stillbirth, cesarean delivery, instrumental delivery, difficult delivery, fetal distress, early neonatal death and large-for-age births than normal weight mothers. (Cedergren, Rosenberg) Severely obese children and adolescents have lower health-related quality of life than children who are healthy and have a similar quality of life as those diagnosed with cancer. (Maher) Obesity has negative impact on treatment of infertility. (Al-Azemi)

For these reasons, obesity has become recognized as a major, perhaps the major, pubic health problem of the 21st Century. The federal government has repeatedly pointed to the enormous human suffering, health effects, and effect on health care costs and utilization from obesity. Examples are Healthy People 2010, Dietary Guidelines for Americans and the Surgeon General’s Call to Action 2001. These profound concerns have led Secretary of Health and Human Services (HHS), Tommy Thompson, to require the major components in HHS develop plans to combat obesity. The major agencies involved are the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Centers for Disease Control and Prevention (CDC).

3. MISLEADING CLAIMS, THE EVIDENCE AND COMMENTARY

In recent weeks, spokespersons for health insurers have been widely quoted in the press making statements about bariatric surgery. To a distressingly high degree, these statements (a) are not based on scientific evidence and/or (b) are contradicted by the scientific evidence and (c) fail to provide a balanced and accurate picture of the benefits and risks of surgery for the treatment of obesity.

These statements fall into three categories. Category A includes statements as to the state of the scientific evidence on the benefits and risks of bariatric surgery in general or of laparoscopic surgery in particular. Category B includes statements as to the cost-benefit of bariatric surgery. Category C includes statements as to the misutilization of bariatric surgery. Below are examples of these statements, the state of the evidence and a brief commentary.

Category A: Benefits and Risks of Bariatric Surgery

A.1. Examples of Misleading Claims

"We’ve had an explosion in obesity and an explosion in the demand for quick fixes, if you will, to the problem of obesity, said Helen Darling, president of the National Business Group of Health, which represents major corporations on health issues. (Stein)

"Some researchers also question the reliability of the data on the safety and effectiveness of the procedures. "We don’t have quality longer-term studies that give us good data on long-term safety and effectiveness," said Frank LeFevre, an associate professor of medicine at Northwestern University who evaluated the procedures for the Blue Cross and Blue Shield Associations." (Stein)

"Some experts liken the situation to what happened with bone marrow transplants for breast cancer in the 1990s when terminally ill breast cancer patients clamored for the procedure until carefully designed studies finally showed it did not save lives. "Whenever a new technique seems to be providing a benefit, it tends to proliferate," said Jonathan Moreno, a University of Virginia bioethicist who studies surgical procedures. "Oftentimes, these things gradually become the standard of care without going through any studies." (Stein)

"Even if they (the patients) have no serious complications, patients often experience unpleasant side effects, including a phenomenon known as "dumping" ­ nausea, vomiting and diarrhea ­ when they overeat. As a result, patients have to undergo intensive counseling and monitoring to make sure they eat appropriately and do not suffer nutritional deficiencies." (Stein)

"Some of our concerns are not just about whether or not the severely obese ­ who are already very sick and would meet criteria where either an employer, insurance company or the government would pay for it ­ should have the surgery, but about what seems to be much too easy acceptance that the operation is the only effective way for millions of people to lose weight," quoting Helen Darling. (Stein)

"Bob Forster, the company’s (Blue Cross Blue Shield of Florida) vice-president and chief medical officer, said the treatments lack the effectiveness and cost benefit to justify coverage. "This self-induced lifestyle problem needs to be addressed at the root...not [through] an easy-fix procedure in which we think there are safety and efficacy risks, Forester said regarding weight-reduction surgery. Forster said with a wide number of surgeries available now, there are a lack of controlled studies to prove they are effective and safe. And, he said, other excluded therapies, such as nutritional and group therapies, don’t work long-term." (Skidmore)

There is a subgroup in Category A which relate to statements about the laparoscopic versus open operation. ("Open" refers to the creation of a large incision in the abdomen for the operation. "Laparoscopic" refers to the creation of smaller incisions through which the surgeon performs the operation.) The most cited is the BlueCross BlueShield Tech Assessment which states: "The evidence is not sufficient to form conclusions about the relative efficacy and morbidity of less-invasive (than open) approaches to bariatric surgery, specifically laparoscopic gastric bypass and laparoscopic gastric banding." (Blue)

A.2. The Evidence on Safety and Effectiveness of Bariatric Surgery

In obesity research, no intervention has as long term, positive safety and effectiveness data as bariatric surgery. For this reason, bariatric surgery has been widely endorsed as the intervention of choice for the treatment of morbid obesity by independent governmental and non-governmental authorities who have reviewed the large number of studies on this topic. This has led one leading researcher in the field to state, "There is a growing consensus that bariatric surgery is the treatment of choice for extremely obese individuals who have failed to reduce their weight satisfactorily using behavioral or pharmacologic interventions. The gastric bypass in particular is associated with excellent long-term weight loss." (Wadden) Another observer has written, "Morbid obesity is an extremely common and severe health problem in the United States. Presently, there is no nonoperative solution for severely obese patients who are unable to control their weight through diet and exercise. Bariatric surgeons are well aware that gastric bypass offers a reliable means to help these often-desperate patients. There is often a dramatic improvement in quality of life and substantial amelioration of obesity-related comorbidities. It is well known that bariatric patients present special operative and rehabilitation challenges, but in careful hands the surgical risks with open gastric bypass are surprisingly low, and the patient satisfaction gratifyingly high." (See)

The claim that bariatric surgery does not have long term, positive safety and effectiveness, is simply wrong. The wealth of these studies has convinced independent, governmental bodies to support bariatric surgery for the treatment of persons with morbid obesity who cannot achieve significant weight loss through less invasive means.

The governmental agencies supporting bariatric surgery are the US Preventive Services Task Force (USPSTF), the Agency for Healthcare Quality and Research (AHQR) and the National Institutes of Health (NIH). This is what they have to say about bariatric surgery:

United States Preventive Service Task Force (USPSTF)
"There is fair to good evidence to suggest that surgical interventions such as gastric bypass, vertical banded gastroplasty, and adjustable gastric banding can produce substantial weight loss (28kg to > 40kg) in patients with class III obesity. Clinical guidelines developed by the National Heart, Lung, and Blood Institute Expert Panel on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults recommended that these procedures be reserved for patients with class III obesity and for patients with class II obesity who have at least 1 other obesity-related illness. The postoperative mortality rate for these procedures is 0.2%. Other complications include wound infection, re-operation, vitamin deficiency, diarrhea, and hemorrhage. Re-operation may be necessary in up to 25% of patients. Patients should receive a psychological evaluation prior to undergoing these procedures. The long-term health effects of surgery for obesity are not well characterized." (USPSTF)


Agency for Healthcare Quality and Research, Department of Health and Human Services, Diagnosis and Treatment of Obesity in the Elderly, January 15, 2004.
"In the younger population (under age 65), surgery can promote large degrees of weight loss among those with extreme obesity. Its complications are infrequent, but can be severe, including death (p.vi)....Surgical intervention, among the very obese, can produce substantial weight loss and marked improvement in blood pressure, lipid profile, glycemic control (including reversal of diabetes), and quality of life measures. Surgical data, though, are of lesser quality than counseling studies, and adverse events, while uncommon, can be serious, including death.' (p.14)


NIH Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. The Evidence Report. 1999
RECOMMENDATION: SURGICAL INTERVENTION IS AN OPTION FOR CAREFULLY SELECTED PATIENTS WITH CLINICALLY SEVERE OBESITY (A BMI >40 OR >35 WITH COMORBID CONDITIONS) WHEN LESS INVASIVE METHODS OF WEIGHT LOSS HAVE FAILED AND THE PATIENT IS AT A HIGH RISK FOR OBESITY-ASSOCIATED MORBIDITY AND MORTALITY.

"Weight Loss Surgery: Weight loss surgery is one option for weight reduction in a limited number of patients with clinically severe obesity, i.e. BMIs > 40 or >35 with comorbid conditions. Weight loss surgery should be reserved for patients in whom efforts at medical therapy have failed and who are suffering from the complications of extreme obesity. Gastrointestinal surgery (gastric restriction, vertical gastric banding or gastric bypass [Roux-en-Y]) is an intervention weight loss option for motivated subjects with acceptable operative risks. An integrated program must be in place to provide guidance on diet, physical activity, and behavioral and social support both prior to and after surgery." (p.xx-xxi)


NIH Consensus Development Conference March 25-27, 1991, Gastrointestinal Surgery for Severe Obesity Summary:
The National Institutes of Health Consensus Development Conference on Gastrointestinal Surgery for Severe Obesity brought together surgeons, gastroenterologists, endocrinologists, psychiatrists, nutritionists, and other health care professionals as well as the public to address: the nonsurgical treatment options for severe obesity, the surgical treatments for severe obesity and the criteria for selection, the efficacy and risks of surgical treatments for severe obesity, and the need for future research on and epidemiological evaluation of these therapies. Following 2 days of presentations by experts and discussion by the audience, a consensus panel weighed the evidence and prepared their consensus statement. Among their findings, the panel recommended that (1) patients seeking therapy for severe obesity for the first time should be considered for treatment in a nonsurgical program with integrated components of a dietary regimen, appropriate exercise, and behavioral modification and support, (2) gastric restrictive or bypass procedures could be considered for well-informed and motivated patients with acceptable operative risks, (3) patients who are candidates for surgical procedures should be selected carefully after evaluation by a multidisciplinary team with medical, surgical, psychiatric, and nutritional expertise, (4) the operation be performed by a surgeon substantially experienced with the appropriate procedures and working in a clinical setting with adequate support for all aspects of management and assessment, and (5) lifelong medical surveillance after surgical therapy is a necessity."


The American Medical Association "Roadmaps" on The Treatment of Obesity. The AMA publication on surgery for obesity states:


"What are the expected benefits and risks from surgery?
Mean weight loss following VBG (vertical banded gastroplasty) and RYGB (Roux-en-Y gastric bypass) is approximately 30% to 35% of the preoperative weight, respectively, and is reached between 12 and 18 months post operatively. The RYBG is currently the preferred method because weight loss is superior to that typically achieved after other gastric restrictive operations. Weight loss following malabsorptive procedures is reported to be greater than with gastric restrictive procedures but with a greater incidence of metabolic complications. Multiple studies have demonstrated complete resolutions or improvement of obesity-related comorbid conditions following surgery-most notably, Type 2-diabetes, obstructive sleep apnea, obesity hypoventilation, gastroesophageal reflux disease (GERD), and peripheral edema. Often, medications for diabetes and cardiovascular disease may be reduced or eliminated entirely. Although there is an immediate reduction in the incidence of hypertension, these benefits may diminish over time. Risks from the operation are related to both the complications of any gastrointestinal procedures in a high-risk population and the complications specific to the bariatric procedure. Data from the International Bariatric Surgery Registry - a registry of more than 20,000 patients ­ reveals a 30-day mortality rate of 0.3%. The most common complications tend to be related to the underlying obesity and include respiratory complications, venous thromboembolic events, and wound infections. The most serious complication following bariatric surgery is peritonitis from an anastomotic or staple-line leak.

Post-operative complications
Following hospital discharge, the most common surgical complications include stomal stenosis or marginal ulcers (occurring in 5% to 15% of patients) that present with prolonged nausea and vomiting after eating or inability to advance the diet to solid foods. These complications are typically treated with endoscopic balloon dilatation and acid suppression therapy, respectively. Abdominal and incisional hernias (occurring in approximately 15% to 20% of patients with the open incision) necessitate an operative repair, the timing of which is determined by symptoms and stabilization of body weight.

Long-term post-surgical complications
A surgically induced effect of the RYGB procedure is the dumping syndrome. This syndrome represents a constellation of vasomotor and neuroendocrine events that collectively serve as negative re-enforcers to the consumption of simple sugars. The syndrome, which is initiated by rapid emptying of food into the jejunum, results in a variety of unpleasant and distressing symptoms, including nausea, abdominal cramping, diarrhea, lightheadeness, tachycardia, flushing, and syncope. Although the symptom-induced intolerance to sugar-containing foods is a powerful incentive to dietary changes after surgery, the dumping syndrome often disappears within 12 to 18 months in many patients." (AMA)


The BlueCross BlueShield Association Tech Analysis:
"Gastric bypass with Roux-en-Y anastomosis has been considered the bariatric surgery of choice in the United States, and this is supported by a substantial body of literature. Roux-en-Y gastric bypass achieves greater weight loss and can be performed with low rates of morbidity and mortality.

There is sufficient evidence to conclude that surgery improves health outcomes for patients with morbid obesity as compared to non-surgical treatment. The best evidence is from the Swedish Obese Subjects (SOS) intervention trial, which has reported to date of several hundred patients in each group with up to 8 years of follow-up. This trial shows that surgery results in large amounts of weight loss compared with usual care (16% decrease in total body weight at 6 years, versus an increase of 0.8% for usual care.)"

The SOS intervention trial also shows that some comorbid conditions and quality of life are improved following surgery. The most compelling evidence for an improvement in comorbid conditions exists for diabetes. The SOS trial reported a large reduction in diabetes over a 5.5 year mean follow-up for the surgery group (3.6% vs. 18.5%, p=0.0001). Decrease in proportion of patients with hypertension was observed 2 years after surgery, but was not sustained with longer follow-up. The SOS trial also found 56% and 48% decreases in the number of patients meeting the criteria for depression and anxiety for surgery. The results of 1 randomized controlled trial (n=60) and 11 single-arm studies corroborate the findings of the SOS study." (Blue)

Numerous other studies, as well as policy positions of professional societies support surgery for the treatment of morbid obesity.

• The Position Statement on the Prevention, Diagnosis and Treatment of Obesity of the American Association of Clinical Endocrinology/American College of Endocrinology concludes, "In summary, in patients with severe obesity, surgical treatment is the only well-studied option and may be appropriate when done by surgeons who regularly perform such procedures in properly selected patients." (AACE/ACE)
• Gastric bypass in patients weighing >500 lb (>227kg) can be performed safely. A longer LOS (length of stay), need for ICU (intensive care unity) stay and mechanical ventilation should be anticipated. Complications in this group were no greater than age-matched controls who weighed >500 lb or when compared with all patients who underwent RYGBP over 3 years. Super-obese patients are candidates for surgery. (Shuhaiber)
• "Currently, surgical therapy is the most effective modality in terms of extent and duration of weight reduction in selected patients with acceptable operative risks. The most widely performed surgical procedure, Roux-en-Y gastric bypass, achieves permanent (followed up for more than 14 years) and significant weight loss (more than 50% of excess body weight) in more than 90% of patients." (Mun)
• Overall quality of life was significantly better in operated versus non-operated patients. (Arcilia)

Perhaps the most dramatic improvements in bariatric surgery come from its powerful effect to cure or significantly reduce diabetes. As indicated above, the Swedish Obese Subject Study trial has important findings on the value of bariatric surgery, especially regarding diabetes. According to another analysis the "results of the Swedish Obese Subjects Intervention Study at 10 years indicate that weight loss resulting from gastric bypass is maintained 10 years after surgery, and that 40% and 17% of patients with preoperative diabetes and hypertension, respectively, no longer have these conditions a decade after gastric bypass or other types of bariatric surgery. Surgery patients also experience significant improvements in their physiologic condition and health-related quality of life. There were five deaths among the 2,010 surgery patients, for a perioperative mortality rate of 0.2%. Three of the deaths were caused by deep abdominal infections, one by a technical mistake and the fifth by a late myocardial infarction. Postoperative complications were reported in 13% of the patients, and 2.2% had early reoperations. At two and 10 years after surgery, 70% and 40% of the surgery patients, respectively, had recovered from diabetes, while 33% and 17% respectively, had resolution of their hypertension. These rates of recovery were significantly higher than those for nonsurgical controls. The surgery patients also showed greater improvement in total cholesterol, triglyceride and high-density lipoprotein (HDL) cholesterol levels compared with nonsurgery patients, although the differences in total cholesterol and HDL cholesterol levels were not statistically significant at 10 years. Overall, surgery patients also had significant reductions in musculoskeletal pain and biliary disease." (Frei) (See also, Sjostrom)

Other studies have made similar findings:

• A study of 232 patients with morbid obesity and type 2 diabetes who received the Roux-en-Y procedure was compared to 78 controls who did not receive the surgery (in part because of lack of insurance coverage). The surgical group was followed for 9 years; the non-surgical group for 6.2 years. The percentage of the control group under medical management rose from 56.4% to 87.5% whereas the percentage of surgical patients under medical management fell to 8.6%. The mortality rate in the non-surgical group was 28% compared with 9% in the surgical group. For every year of follow-up, patients in the control group had a 4.5% chance of dying versus 1.0% chance for those in the surgical group. The improvement in the mortality rate in the surgical group was primarily due to a decrease in the number of cardiovascular deaths. (MacDonald)
• A study of 608 patients with morbid obesity followed for 14 years who underwent Roux-en-Y procedure found that the perioperative mortality rate was 1.5% and the complication rate was .5%. The surgery produced long term durable weight control and produced long-term control of type 2 diabetes. In addition to controlling weight and type 2 diabetes (both notoriously resistant to medical control), the procedure also eliminated or alleviated hypertension, sleep apnea, cardiopulmonary failure, arthritis and infertility. (Pories) Additional studies found almost identical rates of resolution of diabetes and hypertension at 84% and 65%, respectively. (Sugerman 2003, Schaeur 2003)
• If an individual is not responsive to diet, exercise and behavioral therapy, or has comorbidities that are currently compromising his or her health, pharmacology and/or surgery may be advised. (Bedno)
• Roux-en-Y gastric bypass resulted in significant improvements in disordered eating, weight-related quality of life and physical activity, in addition to weight loss. (Boan)
• Surgically induced weight loss promotes leisure time physical activity by a marked relief in shortness of breath and chest pain. (Karason)

Laparscopic Studies
As indicated above, the Tech Analysis by BlueCross BlueShield Association found insufficient evidence for newer, less invasive surgical procedures, particularly laparoscopic gastric bypass and laparoscopic gastric banding. However, this does not mean that there are no studies showing effectiveness and safety nor does it mean that published studies portend a serious problem with laparoscopic procedures. In addition, the Tech Analysis did not address the very important considerations driving the increase in laparoscopic procedures: a reduction in hospital stay, recovery time and pain as compared to the open procedure. Patients are aware that laparoscopic procedures return their lives to normal more rapidly than the open procedures. Therefore, the Tech Analysis should not be used as any kind of justification for not covering laparoscopic procedures. Among the findings in the published literature are the following:

• A randomized prospective trial, that laparoscopic gastric bypass is superior to open gastric bypass. The study involved 104 patients diagnosed with morbid obesity, randomized to either open (OGBP) or laparoscopic procedures (LGBP). Operating time was less in the LGBP group. There were no significant differences between groups in postoperative complications. The authors concluded that "LGBP is a good surgical technique for the management of morbid obesity and has clear advantages over OGBP such as reduction in abdominal wall complications and a shorter hospital stay." (Lujan)
• "Laparoscopic GBP accomplishes the same objectives as open GBP but eliminates the large abdominal access incision. It is a safe and cost-effective treatment for morbidly obese patients that offers distinct advantages over the conventional open approach. Laparoscopic GBP was associated with fewer intensive care unit stays, shorter hospital stays, faster recoveries, and an earlier return to work compared with open GBP. This study also shows no increased risk of anastomotic leak with the laparoscopic technique. Additional benefits of laparoscopic GBP include decreased rates of postoperative wound infections and incisional hernias. Laparoscopic GBP, however, required a longer operative time and resulted in a higher anastomotic stricture rate than open GBP. Assessment of QOL (quality of life) domains showed that laparoscopic and open GBP resulted in a dramatic improvement in the health-related QOL. However, the improvement in QOL was significantly faster after laparoscopic GBP, particularly in the areas of physical functioning, social functioning, bodily pain, and general health. Weight loss outcomes were comparable between the two groups at the 1-year follow-up, but laparoscopic GBP patients had significantly greater weight loss at 3 and 6 months. We attributed this difference in weight loss to the faster recovery of physical functioning and better general health after laparoscopic GBP. Overall costs were similar for both groups. Our study shows that laparoscopic GBP is a cost-effective treatment for morbid obesity. Laparoscopic GBP was associated with favorable operative outcomes at comparable costs compared with open GBP. Therefore, in experienced hands, laparoscopic GBP should be considered a viable option for treatment of patients with morbid obesity. (Nguyen 2001)
• "All obesity surgical procedures have been performed laparoscopically. The laparoscopic approach is becoming more available because the number of centers performing the procedures is increasing rapidly. The laparoscopic gastric bypass is technically challenging with a steep learning curve. The time needed to perform the procedure and the incidence of complications decrease with increased experience. The results from initial large series and a randomized controlled trial demonstrate that weight loss after the laparoscopic procedure is the same as that after the open procedure. The laparoscopic approach is associated with decreased wound complications (infection and incisional hernia), decreased postoperative pain, less blood loss, improved cosmesis (appearance), shorter hospital stay, and an earlier return to a functional life. Perioperative mortality rate after open surgical procedures reported in studies containing large numbers of patients is usually <1.5%. Approximately 75% of the deaths are caused by anastomotic leaks and peritonitis and 25% by pulmonary embolism." (Klein)
• "Central obesity is associated with a higher degree of hyperglycemia, hyperlipidemia and leukocytosis in morbidly obese patients who undergo bariatric surgery. Although there is increased technical difficulty in patients with severe central obesity, laparoscopic bariatric surgery is safe and effective in producing weight loss." (Lee)
• "Since the introduction of minimally invasive general surgery just 10 years ago, a revolution in surgical techniques has occurred, as most surgical procedures have been adapted to limited access techniques. The demonstrated benefits of laparoscopic surgery include shorter hospital stays, earlier return to normal activity, superior cosmesis, and less pain. Incidence of incisional hernia is markedly diminished." (Wittgrove)
• After surgery excess weight loss at one year was 40%, at 2 years 46%, after 3 years 47%, and after 4 years, 54%. After 4 years the rate of cure/improvement of the comorbidities were: hypertension 58%/42%, diabetes 75%/8%, dyspenea 85%/12%, arthalagia 52%/24%, reflux 79%/11%, reduced self esteem 45%/39%, reduced general physical performance 58%/33%. Improvement was also found in stress incontinence, sleep apnea, peripheral edema and regulation of menstruation. Hypertension, diabetes, reflux, and edema improved independent of the amount of weight loss. Reoperated patients undergoing either rebanding or biliopancreatic diversion with duodenal switch had similar weight loss and reduction in comorbidities as did patients treated with LABG only. (Frigg)
• After surgery, anxiety, depression scores, scores for physical functioning, bodily pain, vitality and mental health on the SF-36 were similar to scores for Norwegian female population used for comparison. The scores from the patient sample were much better than scores published for morbidly obese patients and implies that weight loss induced by the operation has been of great benefit on mental health and health-related quality of life. (Vage)
• Laparoscopic procedures are safe and effective. (Higa)
• "More than 500 LapRYGBP (laparoscopic Roux-en-Y Gastric Bypass Procedures) have been performed, with acceptable morbidity and no mortality. Operating times approach those of the open operation. Weight loss averages 77% of excess body weight at 1 year, and is maintained through 60 months of post-operative follow-up. Concurrently, 96% of serious pre-operative co-morbidities were eliminated with 1 year of surgery. Diabetes mellitus is clinically reversed in 98% of afflicted patients. Laparoscopic Gastric Bypass is a safe and effective treatment for the serious health effects of clinically severe obesity." (Wittgrove)
• A study of outcomes after laparoscopic Roux-en-Y Gastric Bypass for Morbid Obesity involved 275 patients found, "The incidence of early major and minor complications was 3.3% and 27% respectively. One death occurred related to a pulmonary embolus (0.4%). The hernia rate was .7% and wound infections requiring outpatient drainage was only 5%. Excess weight loss at 24 and 30 months was 83% and 77%, respectively. In patients with more than 1 year of follow-up, most of the comorbidities were improved or resolved and 95% reported significant improvement in quality of life. "A laparoscopic approach to RYGP may offer benefits that have been shown to occur with other recently introduced laparoscopic procedures, including a reduction in postoperative pain and complications, a shorter hospital stay, and faster recovery. High-risk morbidly obese patients with multiple comorbidities may in particular benefit from a less invasive approach because they are more vulnerable to cardiopulmonary and wound-related complications." (Schauer 2000)
• Laparoscopic RYGBP resulted in significant weight loss (60% of excess body weight loss) and resolution (83%) of type 2 diabetes. Patients with the shortest duration and mildest form of type 2 diabetes had a higher rate of type 2 diabetes resolution after surgery, suggesting that early surgical intervention is warranted to increase likelihood of rendering patients eulycemic. (Shauer, 2003)

Studies on laparoscopic gastric banding show similar findings although there are fewer studies overall.

• Lap-band patients were found to return to normal activity levels earlier than gastric bypass patientıs irrespective of approach. Lap-Band patients also reported recovering from surgery significantly sooner than RYGBP patients. (Fisher)
• "A report analyzing international data on laparoscopic adjustable gastric bands identified 3 deaths in 5,827 patients, approximately 1 in 2,000). In our previous series of 1,120 patients, there have been no deaths and no life-threatening perioperative complications. Significant early complications occurred in 17 (1.5%) of our patients; late problems have been more common, particularly during our early experience. Prolapse of the stomach through the band occurred in 125 (25%) of our first 500 patients but has occurred in only 28 (4.7%) of our last 600 patients. Erosion of the band into the stomach occurred in 34 patients (3%); all occurred in the first 500 patients. No erosions have occurred in the last 600 patients. Both problems are treated laparoscopically by removal and replacement. Combined international data show that weight loss after Lap-Band placement is characterized by steady progressive weight loss over a 2-to 3-year period, followed by stable weight out to 6 years. This pattern reflects the benefit of adjustability. For the international series, the percent excess weight loss (%EWL) at 2 years has been between 52% and 65%. In our series, %EWL at 5 years and 6 yeas was 54% and 57% respectively. The LAP-BAND is proving to be extremely safe, able to facilitate good weight loss, and able to maintain weight loss over time." (O’Brien)
• Investigation into the reduction in comorbidities after laparoscopic adjustable gastric banding. The pre-operative frequencies of comorbidities were: hypertension, 52%, diabetes 20%, dyspnea 85%, peripheral edema 63%, sleep apnea 36%, arthralagia 89%, reflux 57%, reduced self esteem, 95%, reduced general physical performance 96%, hyperlipidemia 39%, hyperuricemia 36%, menstrual problems 22%.

A.3 COMMENTARY ON CATEGORY A CLAIMS AND THE EVIDENCE

The statements that there are no long term studies on obesity surgery are clearly wrong. There is a wealth of such studies. They are the longest term, most successful studies in the obesity literature.

The comment that surgery is some kind of "quick fix" is both inaccurate and pejorative. It is inaccurate because patients must undergo 6 to 12 months of preoperative screening and weight loss efforts through diet and exercise and extensive counseling. The operation itself entails a hospital stay of three to five days. The postoperative care can exceed 12 months of close medical, nutritional and exercise follow-up along with a long term support group. The surgery requires a lifetime of adaptation to a much smaller stomach than before the operation. The pre- and post- operative expenses are almost never reimbursed by insurance coverage. It is pejorative because, by overlooking the enormous commitment of time and money by the patients who are morbidly obese, it attempts to play on widespread stigma of obese persons as lazy and slothful.

The "dumping" phenomenon is described as an adverse event. In fact, it is an intended consequence of the surgery so to cause an aversion to excess food intake, particularly sweets. This assists the patient in making essential dietary changes throughout life by creating a natural behavioral modification effect whereby the intake of carbohydrate rich foods elicits unpleasant sensations.

Helen Darling’s criticism that the problem is the "too easy acceptance that the operation is the only effective way for millions of people to lose weight" is simply without logic. There is nothing about the surgery that is easy for patients or physicians. Unlike the bone-marrow transplant metaphor, bariatric surgery has been around since the 1950s and has been extensively studied.

Nor is there any kind of rush to the surgery. Although the total numbers of operations performed has increased, only approximately 100,000 out of 20 million potential candidates will receive the procedure in 2004 or .04%. Insurers and employers are hardly seen as rushing to reimburse for the surgery. Surgery for obesity has had a hard time gaining acceptance. However, its acceptance today is clear from both the extensive studies of safety and effectiveness and the resulting endorsement of several government agencies. In addition, the surgery is covered by Medicare, several state Medicaid programs and most Blue Cross Blue Shield plans, among other payors. Laparoscopic procedures show similar weight loss results to open procedures while lowering hospital stays and other indicators.

Category B: Cost-Benefits of Bariatric Surgery

B.1. Examples of Misleading Statements

"It’s beginning to dawn on insurance companies and employers that even after the surgery, there are a lot of big expenses and a lifetime of care. Many employers and insurance companies feel this is just not affordable today." Helen Darling, president of the National Business Group of Health, which represents major corporations on health issues. (Stein)

"Since it is estimated that 20-25 million Americans already meet the criteria for the surgery, and we are still in the very early years of the full cost impact of obesity, capitulating to surgery as the answer for millions will have a devastating impact on the costs of health care. Those who have had the surgery will have a lifetime of expensive care needs. All who need this care will expect others to pay for it. For many, either their employer will be stuck with the bill or the taxpayers. Either way it is all of us. Helen Darling memo to members of the National Business Group on Health, April 13, 2004.

B.2. The Evidence on Cost-Benefits of Bariatric Surgery

Most of the misleading statements in this category fail to address the significant, documented improvements in costs resulting from surgery. Likewise, they fail to capture the heavy burden of treating the comorbidities caused by morbid obesity that frequently resolve following weight loss. Below are a few of the studies indicating improvements.

• "The average monthly medication expenditure was reduced from $317 preoperatively to $135 postoperatively. This was regarded as a statistically significant amount. These medication savings offset the costs of the initial procedure and represent permanent financial savings for the patient and society." (Monks)
• "Operative treatment of clinically severe obesity reduces obesity-related expenditures and utilization of healthcare resources. The cost of undertaking RYGBP at the VA (Veterans Administration) is offset by reduction of health-care costs within the first year after surgery. These data support allocation of resources to support existing bariatric surgery programs throughout the VA system." (Gallagher)
• A study of General Motors employees showed lower health expenditures as BMI and comorbid conditions were reduced. "Medical costs and the prevalence of diabetes were lower when the number of additional health risks were lower, regardless of the BMI category. The current results suggest that a strategy focused on reducing health risks within any weight category could provide an alternative strategy to achieve medical cost savings and a lower prevalence of diabetes. (Musich)

B.3. COMMENT ON CATEGORY B CLAIMS AND THE EVIDENCE

The obesity literature is overwhelming clear that, as body weight (or fat) increases, there is a higher risk and incidence of the comorbid conditions. As the number and severity of the comorbid conditions increase, so do the costs of medical care and indirect costs, such as lost productivity. Conversely, as weight is lost, the number and severity of comorbid conditions decline. Although the literature could be more robust, most studies find that costs follow this decline. Certainly, in the studies cited in this paper, there is a significant reduction in costs following obesity surgery.

Helen Darling’s comment that "even after surgery, there a lot of big expenses and a lifetime of care" is of dubious validity. There are post-surgical expenses to be sure in some cases. Even when there is insurance coverage of the operation, most patients pay extensively out of pocket for the follow-up care. However, the dramatic remission of many comorbid conditions indicates that costs will be reduced and the per-person expenditure become closer to the average per patient expenditure. To overlook these dramatic improvements in health care costs is to only look at half the coin. The statement of Ms. Darling’s that "All who need this care will expect others to pay for it," is unfortunately another ill-informed and pejorative statement. It is ill-informed because, as far as we can determine, there is no evidence that "all" persons with morbid obesity expect others to pay for it. It is pejorative by depicting the morbidly obese (mainly poor, African-American and Hispanic women) as selfish and greedy in addition to being lazy and slothful. 'How arrogant of the obese, that they expect their health insurance to pay for their major health problem! The nerve!!' she appears to state.

The National Business Group on Health and BlueCross BlueShield of Florida do not appear outraged that people who are genetically susceptible to skin cancer, who had high environmental exposure to the sun and failed to take personal protective steps should ask their health insurer to cover treatments for melanoma. Or that smokers would have their cancer treatments paid for, or that mountain bikers should ask insurance companies to pay for their injuries. Why is this population singled out for this kind of treatment?

Two other points should be made concerning costs. First, we do not ask that surgery for breast cancer show a rate of return. We do not ask it of heart surgery, even for patients with multiple heart attacks, or of stroke surgery, head injuries caused by reckless driving or extreme sports. We do not deny insurance coverage to persons with skin cancer because they should have used sun block creams. Only in obesity, do we impose a unique standard and then find either the obese or their care-givers inadequate.

Secondly, the real cost debate has to do with the market condition of the insurance company. It takes two to three years for the significant cost reductions in obesity conditions to become achieved. Health plans which have high retention rate of customers, therefore, support the surgery because they will see the financial benefit down the road. Plans which have high turnover rates, however, worry that they will bear the expense of surgery today but not have the patient as a participant in the near future. Therefore, the cost issue is not about the surgery; it is about the companyıs bottom line and its ability to retain members.

Category C: Misutilization of Bariatric Surgery

C.1 Examples of Misleading Statements

"At the same time, the operations which force people to eat less by reducing the size of their stomachs, are being performed too commonly on people who might be able to lose weight through diet and exercise, particularly younger adults and teenagers, they say. (Stein)

Barry Schwartz Blue Cross Blue Shield of Florida, "Many patients who are not morbidly obese are trying to get the procedure. It’s viewed as the answer to obesity, and more and more say, "I can get surgery done as an answer to my problem. We have seen a couple of patients who decided with their doctor that they would eat more so they could quality. It’s perverse." (Stein)

C. 2 COMMENT ON CATEGORY C CLAIMS ON THE UTILIZATION OF SURGICAL TREATMENT

Unlike the discussion of Category A and B claims, there is little evidence here to discuss. Proponents of statements such as the operations "are being performed too commonly on people who might be able to lose weight through diet and exercise" cite no data, no published literature or other sources. Yet, these are the same people who belittle a rich body of evidence-based medicine in support of surgery.

Indeed, proponents of this view reveal that they do not understand obesity. The view that obese persons can simply ameliorate their condition by eating less and exercising more is at odds with overwhelming scientific facts. The hereditability of obesity is equivalent to that of height, which most people readily accept as genetically driven. It is greater than for almost every other condition, including breast cancer, schizophrenia and heart disease. (Allison) The average human consumes hundreds of thousands calories per year. Yet, for most people, weight changes very little. Energy balance is regulated to a level of exactness of about 99.5%, far exceeding the level at which calorie intake can be effectively monitored. (Friedman) Current scientific insights into obesity are focusing on pivotal hormonal mechanisms which regulate appetite control. For example, grehlin which is secreted in the stomach and intestine increases hunger signaling time for a meal. Researchers have recently established that grehlin levels are higher in patients with morbid obesity and rise even under diet conditions, thereby significantly stimulating appetite. Grehlin levels after gastric bypass surgery are very low, conrrelating with the reduced appetite these patients experience. (Cummings)

Over the past twenty years, a dialogue has gone back and forth between the obesity field and the insurance industry. The insurance industry has said that, for coverage, there needed to be strong data supporting coverage and that anecdotal reports were inadequate. So the field, particularly, bariatric surgery undertook to produce such studies, even though there was scant support from the primary research institution in the United States, the National Institutes of Health. Now that these studies are at hand, the insurance industry is saying, 'Never mind, anecdotes and assumptions are good enough for us to deny life-saying therapy no matter what your studies say.' At the very least, the insurance industry should be held to the same standard of proof in its own statements which it demands from others.

The issue of operations in children and adolescents is more complex. The increase in childhood obesity is well understood. Here, some comment on definitions is useful. The Centers for Disease Control and Prevention (CDC) tracks the population changes in obesity. It has a policy that children are measured against norms for their age. Height and weight criteria were set in the 1970s. CDC calls all children who exceed these norms "overweight." It does not describe children or adolescents as "obese" or "morbidly obese." Nevertheless, clinicians are daily exposed to parents with children who would meet the adult criteria for morbid obesity. There are few, in any, validated protocols for any treatment for these children. While parents often look to surgery in desperation, generally surgeons have been reluctant to operate on these patients for several reasons. The first is the lack of clinical trials establishing the validity of the surgery. The second is concern that children are still growing and puberty is a time a great hormonal change which is also affected by the surgery. Finally, there is a practical concern about malpractice exposure if the operation is not considered a success.

4. IMPROVING QUALITY OF CARE

It is clear that obesity surgery has been increasing and that there is ample room for improvement in quality. One putative reason for this is the entrance of surgeons into the field who do not have sufficient training and experience or whose practice does not have the important pre- and post- operative support, e.g. trained nurses, support groups, etc. Another cause may be too low a volume of surgeries at some hospitals. In a paper presented April 15, 2004 at the American Surgical Association meeting, researchers compared high volume, medium volume and low volume hospitals performing bariatric surgery. They studied over 90 hospitals with over 24,000 surgeries. They found that compared to patients at low volume hospitals, patients who had gastric bypass at high volume hospitals had a shorter hospital stay, lower complications and lower costs. The mortality rate was the same (0.6%). (Nguyen, 2004)

Improving quality is a daily task throughout medicine and surgery and efforts are underway to improve quality. They include the recent attention of the National Institutes of Health to increase research on bariatric surgery. In addition, the American Society for Bariatric Surgery (ASBS) has several initiatives underway. They include:

1. Increased hospital credentialing standards for surgeons performing obesity surgery. See the ASBS’s Guidelines for Granting Privileges in Bariatric Surgery.
2. A consensus conference of experts in obesity in May, 2004 to evaluate the most recent scientific findings on different forms and techniques of bariatric surgery and patient selection criteria.
3. Development of an independent credentialing process to identify Centers of Excellence in bariatric surgery which have demonstrated clinical success with low rates of morbidity and mortality.
4. Participation in the Coalition to Prevent DVT (Deep Vein Thrombosis), an often fatal condition for persons with obesity.

Such steps are how medicine improves care for patients. For these efforts, employers and insurers should be partners not opponents. It is simply unreasonable and unethical to eliminate coverage for bariatric surgery on the thinnest of evidence when proven, available steps are available to improve services. Indeed, the challenge to public health is not how to further limit bariatric surgery, it is how to expand its availability, consistent with high quality to the millions of persons, (many women, minority and poor) who can most benefit from it.

5. CONCLUSION

A highly regarded columnist for the New York Times, Jane Brody, has succinctly summarized the picture of bariatric surgery:

"Despite a false start with an intestinal bypass operation that initially gave weight-loss surgery a bad name, modern versions of so-call bariatric surgery are safer and more effective, and they are increasingly popular. The most common operation, Roux-en-Y gastric bypass surgery, has a long-term success rate of nearly 90 percent when combined with intensive counseling, support and nutrition education. Success is defined as maintaining a weight loss of 50 percent or more of one’s excess weight for up to 10 years. The operation, even though sometimes done through a laparoscope, is hardly a minor procedure. Like all operations, it has risks and complications, including blood clots, wound problems and death. About 15% of patients experience complications and 0.5 percent to 1 percent die because of the surgery. But the benefits are profound. In addition to durable weight loss, bariatric surgery can rapidly reverse Type 2 diabetes, improve cardiac function and blood lipid levels, correct breathing problems like sleep apnea, reduce blood pressure, improve the quality of life and lower health care costs, disability and risks of premature death. Many patients whose weight had kept them form working or taking part in physical and other activities are able to go back to their jobs, exercise regularly and maintain active social lives. Sexual interest is often restored and women who were infertile because of hormonal problems are able to conceive. In addition, there are the emotional benefits of extreme weight loss: an improvement in self-image and self-esteem and lifting of depression." (Brody)

For decades, employers and the health insurance industry have avoided the ample literature attesting to the fact that obesity is a primary cause of disease and death. Instead of addressing this crisis through prevention programs, education campaigns and support for the aggressive treatment of obesity, insurers opted to cover the conditions caused by obesity but not treatments for obesity. That approach has failed to either improve the public health or save employers money. Health insurers have been AWOL from the most critical threat to health in the 21st Century- obesity. Rather than evade the epidemic of obesity, employers and insurers need to look to validated, successful methods of achieving long term weight control and incorporate such strategies into their plans and programs.

May 3, 2004

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