ASMBS News and Update—April 2011

| April 15, 2011

by Robin L. Blackstone, MD, FACS, FASMBS

Robin L. Blackstone, MD, FACS, FASMBS
Dr. Blackstone is President-Elect of the American Society for Metabolic and Bariatric Surgery and Medical Director, Scottsdale Healthcare Bariatric Center, Scottsdale, Arizona.

ASMBS Statement on Gastric Plication: An Investigational Procedure
The American Society for Metabolic and Bariatric Surgery (ASMBS) is often the source that patients, colleagues, government, and others turn to when a question about a procedure arises. In 2010, the ASMBS Executive Council was contacted by a surgery center with a question: Was the plication an approved procedure of the ASMBS? In addition, they were interested in the Society’s recommendation for safe use/patient consent for this procedure if it was going to be offered. Prompted by these questions, the ASMBS Clinical Issues Committee reviewed the literature and advised the Executive Council that insufficient evidence existed in the literature to support a clinical guideline for gastric plication. The data show promise for safety and efficacy but are insufficient in depth and quality to endorse the procedure as a standard therapy for metabolic and bariatric surgery. The mechanism of action is unknown, the reversibility is not explored, and there are no randomized trials comparing it to other procedures. In light of that information, the Executive Council voted to release a statement about the status of gastric plication to be issued by the Society and posted on the ASMBS website, stating that the ASMBS regards gastric plication as an investigational procedure and advised that it be done under a medical control board or as part of a clinical trial sanctioned through an Institutional Review Board (IRB). This is advised to protect the patient and the surgeon/program by requiring more extensive informed consent and requiring that all patients be operated under a reporting requirement. For the ASMBS Centers of Excellence (COE) members reporting through Bariatric Outcomes Longitudinal Database (BOLD), the Surgical Review Corporation (SRC), working with Ethicon Endosurgery, has established a special report in BOLD where surgeons performing this procedure can record their cases. The procedure does not count toward the volume requirement of the ASMBS COE program. As ongoing new data become available, this statement will be revised. To view the statement please visit http://www.asmbs.org/Newsite07/resources/asmbs_items.htm

2nd World Congress on Interventional Therapies for Type 2 Diabetes
Diabetes and obesity are the twin epidemics that define the population exemplified by our specialty: metabolic and bariatric surgery. By understanding how the procedures we perform affect diabetes, we begin to understand their true mechanisms of action. Increasingly, this new understanding is bringing together some of the most dedicated scientists, surgeons, and diabetologists to answer questions that hold the answer to improved health for millions of people.

The finding that diabetes remission occurs after general surgery procedures was reported as early as February 1955 by Friedman Murray in an article published in Surgery, Gynecology and Obstetrics entitled, “The amelioration of diabetes mellitus following subtotal gastrectomy.” The effect was memorialized in 1995 in a large series reported in the landmark article by Dr. Walter Pories published in Annals of Surgery entitled, “Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus.”

The following are some of the highlights of this landmark conference:
1.    A much more clear picture of how genes, metabolism, and the system of hormones, which govern hunger and satiety, work in the patient with obesity are emerging.
a) The persistent question—Why has the epidemic become so prevalent since 1960?— begins to be explained by the effect of epigenetics (i.e., gainingweight changes the gene pool. These new obesity genes are passed on in the next generation.
b) An individual with obesity has critical defects in his or her neurobiology that make it difficult to alter his or her phenotype. It is clear that the neurobiological system that controls whether someone has obesity vigorously defends the obese state resulting in a high rate of recidivism from treatment.
c) Biological evidence of the mechanism of obese metabolism should begin to change the public perception that obesity has a neurobiological basis like other medical problems, and establish obesity as a disease.
2.    Major efforts have evolved in the last few years to develop animal models to study the mechanism of action of bariatric procedures. While surgeons have always described the procedures in terms of restriction and malabsorption, it is clear that the procedures work primarily through the changes in key hormones that govern metabolism, hunger and satiety and in neuromodulation. Some investigators now believe that less than 10 percent of the effect of gastric bypass has to do with restriction and malabsorption.
3. Treatment of patients who become hyperglycemic should be initiated early and with intent to preserve the beta cell.
4. On the first day of the conference, Paul Zimmet, MD, PhD, released the first position statement of the International Federation of Diabetes (IDF) about the treatment of type 2 diabetes with bariatric surgery. Important recommendations taken from the document include:
• Bariatric surgery is an appropriate treatment for people with type 2 diabetes and obesity (body mass index [BMI] greater than or equal to 35kg/m2) not achieving recommended treatment targets with medical therapies, especially where there are other obesity related comorbidities. Under some circumstances, people with a BMI between 30 and 35kg/m2 should be eligible for surgery.
• Surgery should be considered as an alternative treatment option in patients with a BMI between 30 and 35 when diabetes cannot be adequately controlled by optimal medical regimen, especially in the presence of other major cardiovascular disease risk factors.
• It is up to each health system to determine whether bariatric surgery, with its support services, is economically appropriate.
• Surgery should be considered complementary to medical therapies to reduce microvascular and cardiovascular risk.
• Patients should be assessed and managed by experienced multidisciplinary teams.

The conference confirmed that bariatric procedures that produce an incretin effect (particularly an increase in glucagon-like-peptide 1 [GLP1]), including gastric bypass, sleeve gastrectomy, and biliopancreatic diversion with duodenal switch (BPD/DS), are the procedures that should be offered to patients with type 2 diabetes. The adjustable gastric band has shown efficacy against diabetes in patients on one medication and with less than two years of diagnosis who lose a substantial amount of weight, but the mechanism of action, outside of weight loss is unknown.

On the last day of the conference, experts in the field spoke to the audience about the following topics: 1) mechanisms of action of the ghrelin-growth hormone signaling pathways, 2) the paradigms of the pathophysiology of obesity, 3) the role of the gut in energy and glucose homeostasis, 4) the role of microbiota in the gut on the processing of food, and 5) impaired gastrointestinal (GI) physiology in individuals with diabetes/obesity. Finally, the congress was challenged by Congress Director, Francesco Rubino, MD, with the introduction of a new paradigm of type 2 diabetes with the gut as the central figure in the control of the system.

The congress has established a strong and essential collaborative effort to enhance our understanding and treatment of type 2 diabetes. A DVD featuring full session recordings and slides from all presentations, including discussions from the three break-out sessions, will be available in early summer and can be ordered for $165 at www.wcidt.org.

The Obesity Society, ASMBS, Obesity Action Coalition, and American Dietetic Association Meet with the FDA about Approval of Drugs for the Treatment of Obesity
Over the last year, three medications proposed for the treatment of obesity have been turned down by the United States Food and Drug Administration (FDA), despite a unanimous recommendation by the evaluating FDA panel that one of the medications be approved, and one medication has been pulled off the market. The reasons cited the incidence of side effects, including birth defects, depression, and suicide. This leaves few options for the patient with obesity between medical/behavioral therapy and surgery.

On March 22, representatives from the Obesity Society (TOS), Donna Ryan, MD; Louis Arrone, MD; Pat O’Neil, PhD; Ted Kyle, TOS Executive Director, Francesca Dea; the Obesity Action Coalition (OAC) Executive Director Joe Nadglowski; the ASMBS, Executive Director Georgeann Mallory; and the American Dietetic Association (ADA) representative Jeanie Blankenship, along with Chris Gallagher from Potomac Currents met with Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER), and members of her staff, Robert Temple, MD, Deputy Center Director for Clinical Sciences; John Jenkins, MD, Director of New Drugs; Curt Rosenbraugh, MD, Director, Office of Drug Evaluation Obesity; and Mary Parks, MD, Director, Division of Metabolism and Endocrinology, to discuss ways to provide safe and effective medical therapy for the disease of obesity and our concerns about the recent lack of approval for weight-loss drugs.

The meeting sought to establish the importance of treating Class 1 obesity as a serious medical problem and shift the risk/benefit ratio in favor of including the benefit on comorbid disease in addition to that of weight loss in the pharmaceutical treatment of obesity. Specific issues addressed included the following:
•    Concerns regarding the review panel makeup and lack of obesity experts
•    Concern over misinterpretation of the Guidance for Obesity Drug Review and Approach
•    Stifling effect of drug discovery process for this disease.
The meeting was collegial. The development of a white paper regarding pharmaceutical development in the area of obesity pharmaceuticals, led by The Department of Health Policy at the George Washington University School of Public Health and Health Services, is planned.

An Act to Require Health Benefit Plans to Provide Coverage for the Treatment of Morbid Obesity
State legislatures are in session in most of the country, and a handful of states are looking at bariatric surgery coverage. With budget challenges all across the country, ASMBS, OAC, and our partners thought we would likely spend most of our time during this legislative session defending coverage, but in three states, Arkansas, Missouri, and Oklahoma, legislators are specifically looking at expanding coverage to state employees. Arkansas has been the first to act. On April 1, 2011, the great state of Arkansas passed a new bill to allow coverage of patients with obesity seeking access to the treatment. These actions are possible thanks to the state chapters and individual surgeons in these states and their help, and guidance of our industry partners.
In other good news, the state of Utah is about to unveil its new bariatric benefit plan for state employees in July 2011. Special thanks to the Utah surgeons, our industry partners, and Jeff Haaga, Board Member of the OAC, for their efforts in making this new benefit a reality.

Arizona, on the other hand, has left in a clause of the budget bill that would eliminate the Medicaid benefit for obesity treatment despite being turned down for a waiver from Centers for Medicare and Medicaid Services (CMS). In addition, in an ill-conceived and poorly thought-out move to punish a group of people without the political clout to protect themselves, they are going to levy a $50 additional copay on any patient who does not achieve weight loss according to a plan developed with their doctor. This is intended to apply to children as well as adults. The ASMBS, OAC, TOS, and ADA all oppose this action and are calling on the governor and legislature to rescind this motion and reinstate the coverage of obesity treatment.

ASMBS Annual Meeting—Audience Participation Planned
This year at the annual meeting, members will receive ongoing announcements and be able to participate in some of the session through the use of the ASMBS Twitter and Facebook pages. Twitter will be used to record audience responses in the course, “The Great Debate in Bariatric Surgery” on Tuesday, June 14th, and the “Low BMI Symposium” on Thursday, June 16th.
All meeting announcements, room changes, and reminders will be posted on the ASMBS Twitter and Facebook pages throughout the meeting.

In order to participate, you will need to be part of the Facebook community and be signed up for Twitter. The following are the instructions to go digital:
Facebook—www.facebook.com
1.    Establish your own Facebook account.
2.    Login to your Facebook account and enter ASMBS in the search box at the top of the page.
3.    The ASMBS page should be the first choice. Open the page and click “like.”
4.    Visit the following link for direct viewing: http://www.facebook.com
/pages/ASMBS-The-American-Society-for-Metabolic-and-Bariatric-Surgery/314886613909
Twitter—http://twitter.com/asmbs
1.    Login to your Twitter account or sign up for your own Twitter account.
2.    Once you set up your account or log in to your account, click the “Follow” button on the ASMBS page.
3.    You may also directly access the ASMBS Twitter page for viewing at http://twitter.com/asmbs.

Three Special Symposiums Scheduled for ASMBS Annual Meeting
The Program Committee of ASMBS, led by Marc Bessler, MD, has put together three very special symposiums for the annual meeting of the ASMBS taking place in Orlando, Florida, June 12–17, 2011. The special symposia topics include the following:

Longitudinal Assessment of Bariatric Surgery (LABS) Outcomes
Thursday, June 16, 2011, 3:45–5:30pm, Moderator Bruce Wolfe, MD, President, ASMBS

LABS, a National Institutes of Health (NIH)-funded, prospective multicenter trial of bariatric surgery, represents some of the strongest data in the bariatric surgery literature. This symposium is a chance to hear the investigators discuss specific outcomes using these data, to understand the foundation of data driving the national conversation about quality, and improve your practice by using high-quality data.

BMI 30–35 Symposium: The Rational for Surgical Treatment of Patients with Class I Obesity (BMI 30–35)
Thursday, June 16, 201, 2:00–3:15pm, Moderator: Robin Blackstone, MD President-Elect, ASMBS

The FDA, the first government agency to acknowledge that the morbidity and mortality of obesity begins at a BMI of 30kg/m2 and should be treated, by voting to extend the indication for the adjustable gastric band (Lap-Band, Allergan, Inc., Irvine, California). What is the evidence basis for surgical procedures in this group of patients? What is the position of ASMBS on the surgical treatment of obesity in this group of patients? A comprehensive review and panel discussion will enlighten surgeons who are extending their practice to this group of people.

Adolescent Bariatric Surgery
Thursday, June 16 3:45–5:20pm
Moderators: Marc Michalsky, MD, Co-Chair, ASMBS Pediatric Committee, and Jeffrey Zitsman, MD—A Program of the ASMBS Pediatric Committee
In light of the growing obesity epidemic among children and adolescents, as well as the controversy surrounding bariatric surgery for teenagers, this symposium has been developed to specifically assist those who work with this patient population. It will cover cutting-edge topics, such as patient eligibility, the best procedures and their outcomes, as well as content related to building an adolescent program in your facility.

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Category: ASMBS News and Update, Past Articles

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