American Association of Clinical Endocrinology & American College of Endocrinology Consensus Conference on Obesity

March 23-25, 2014; Washington, D.C.; Full Report – Draft

Executive Highlights

Hello from the National Press Club in Washington, DC, where we attended the AACE/ACE Consensus Conference on Obesity. This three-day meeting convened representatives from several stakeholder communities to discuss major issues in obesity and culminated in the drafting of a “Consensus Framework” revealed at a concluding press conference where the conference leaders – Drs. W. Timothy Garvey (University of Alabama at Birmingham, AB), Jeffrey Mechanick (Mt. Sinai Hospital, New York City, NY) and Daniel Einhorn (UC San Diego, CA) – presented the new framework surrounded by photographs of famous reporters, politicians, and celebrities As background, in the eyes of AACE/ACE, solving the obesity epidemic will require the support of four key stakeholder “pillars:” (i) Biomedical, (ii) Government & Regulatory, (iii) Health Industry & Economics, and (iv) Organizations, Education, & Research. Thus, the meeting attracted HCPs, researchers, payers, and representatives from the government, medical organizations, and pharmaceutical industry to the JW Marriott with the mission of building an evidence base for comprehensive action to combat obesity in the US.

The Sunday morning sessions provided background and context on the obesity epidemic and the available tools and therapies, featuring keynotes from Dr. Garvey, AMA Board of Trustee Dr. Patrice Harris, and Partnership for a Healthier America CEO Mr. Larry Soler, among others. That afternoon, each “pillar” broke off into a four-hour discussion of the meeting’s five key questions:

  • What is obesity?
  • What options are available for obesity management?
  • What is the optimal use of therapeutic modalities?
  • Can the optimal framework be cost-effective?
  • What are the knowledge gaps and how can they be filled?

On Monday morning, all attendees reconvened to discuss these five questions more broadly, with open and lively discussions dedicated to each of these topics.

On Monday night, the writing committee (composed entirely of physicians) drafted a summary of the meeting’s findings. The writing committee agreed upon three key findings, which it felt efficiently represented the Consensus Conference’s results: i) obesity is a chronic disease, and once diagnosed, it should be managed using the AACE/ACE algorithm; ii) a preventive medicine paradigm (consisting of structured lifestyle interventions, behavior changes, and alteration in the built environment) is necessary to improve outcomes in overweight/obesity, and iii) comprehensive overweight/obesity interventions producing improved outcomes require demonstration of value in a combined biomedical and public health model.

Looking to the future, the writing committee hopes to have the full paper completed by April 14, well in time for AACE’s annual meeting (May 14-18 in Las Vegas). The annual meeting will feature a symposium on the consensus framework, which Dr. Garvey indicated could take the process a “little step forward.” In roughly twelve months, AACE/ACE plans to host another conference, which will discuss concrete treatment recommendations. Subsequently, AACE/ACE will lead discussions on how the logistics of implementing these recommendations.

To guide your reading, our report is organized into five sections:

i) the top highlights from the conference’s discussions,

ii) our coverage of the Consensus Framework that emerged from the conference’s discussions and the related press conference held at the end of the conference,

iii) detailed summaries and transcriptions of the discussions that took place during the conference about the five key questions,

iv) the keynote speeches,

and v) an Appendix including details on how each of the four stakeholder pillars answered each question during its breakout session.

 

Table of Contents 

 

Top Five Highlights from Conference Discussions

  1. We were struck by the immense knowledge gaps that appear to exist in the obesity field – a sentiment also expressed by several members of the writing committee. Dr. Francesco Rubino (King’s College, London, UK) suggested that a theme for the conference has been the uncertainty that exists around how to define obesity as a disease, and the consequences of the resulting confusion. Like many attendees, Dr. Rubino sees BMI as an imperfect definer of obesity (comparing it to using a fever to define the flu) that does not spate out those who are heavy and will not develop cardiometabolic complications from those who are metabolically ill. Due to the focus on BMI, Dr. Rubino thinks that many people see weight loss as a cosmetic issue. As a result, some patients concerned about the cosmetics are potentially being treated for obesity (exposing them to health risks) unnecessarily, while some people who are ill are being undertreated. Furthermore, Dr. Rubino sees payers hesitating to cover anti-obesity treatment, because they are unconvinced the approaches will positively impact health outcomes. Another knowledge gap seems to be how exactly to escalate treatment – while discussants seemed to agree that obesity should be treated using a stepped care model in which lifestyle is the foundation and medications or surgery might be added on, there does not seem to be a good idea of how and when to escalate treatment or good data on how to predict a patient’s response to treatment.
    • Representatives from CMS, Aetna, and Cigna expressed their openness to reimbursing anti-obesity approaches, but also their desire to see real world, health outcomes (not surrogate measures). Dr. Elizabeth Koller (CMS) explained this is because obesity is associated with increased morbidity and a reduced lifespan. Thus, CMS and other payers think that an effective therapy should have a measurable impact on the development of complications (Dr. Koller highlighted CV events, degenerative joint disease, and sleep apnea). The silver lining of this high bar is that health economist Dr. Eric Finkelstein (Duke-NUS Graduate School, Singapore) and Dr. Richard Silverman (Cigna) indicated they would likely accept real world data (i.e., from claims). If true, this suggests they do not expect companies to run massive, randomized control trials to produce evidence on cost-effectiveness and outcomes.  
  2. Notably, Dr. Phil Smith from the National Institutes of Health noted that states can and do require certain types of insurance coverage if deemed in the public good regardless of cost-effectiveness on the individual level. He cited the example of car insurance, for which states can mandate what plans must cover.
  3. Attendees had mixed opinions on whether anti-obesity approaches have been proven to be cost-effective. Dr. Jonathan Leffert (Secretary, American Association of Clinical Endocrinologists) hypothesized the reason obesity prevalence has not been reduced more is due to interventions not being effective enough rather than people not having access to effective interventions due to poor reimbursement. Similarly, Dr. Jeffrey Mechanick (Mt. Sinai Hospital, New York, NY) acknowledged that while he came to the conference wanting to “vilify those who prevent access because of cost,” he had learned from the economists and payers that the scientific evidence is lacking. For example, Dr. Kenneth Snow (Aetna) remarked that the data supporting anti-obesity approaches “is not always there.” (We found this frustrating since it’s hard to figure out what the bar is; does every trial need to show cost effectiveness? Even when that wasn’t the design?) During the Health Industry & Economics Pillar, Dr. Snow cited the Look AHEAD’s negative CV findings, as an example of data that could discourage a payer from covering an anti-obesity strategy. Similarly, Dr. Koller stated that CMS is concerned about “the poor quality of data for obesity interventions and long-term data.” (Other payers explained they are not as convinced by the oft cited studies showing interventions’ impact on surrogate markers; they did, however, say that they would accept real world data demonstrating impact on clinical outcomes and cost-effectiveness.) Additionally, CMS expressed concerned about whether the data that is available can be accurately translated to its elderly and/or disabled population. As an example, she noted that most bariatric surgery data is in young, white women.
  4. In the Government and Regulatory Pillar session, Dr. Jonathan Leffert (Secretary, American Association of Clinical Endocrinologists) noted that the CDC can easily capture the public’s attention during an infectious disease outbreak and asked how the agency can similarly heighten awareness about obesity. Dr. Ann Albright (CDC) noted that obesity lacks the drama and urgency that accompanies infectious disease outbreaks and stated that in her personal opinion, the public undervalues chronic obesity (presumably because the effects of obesity are more long-term, while the direness of an infectious disease breakout is more immediate). The low public awareness of obesity’s criticality negatively impacts how the government prioritizes addressing the obesity epidemic. Indeed, Dr. Albright and Dr. Leffert noted that though Congress has given money to diabetes and prediabetes, Congress reacts to the public and the level of funding these areas have received is a reflection of that. 
  5. During the keynote presentations, American Medical Association (AMA) board member Dr. Patrice Harris (District Health Director, Fulton County, GA) discussed how the AMA plans to tackle prediabetes as part of the Improving Health Outcomes initiative (which began last year). The AMA wishes to recast prediabetes as a screenable and treatable condition. The AMA sees prediabetes as a good target because there exists relatively solid evidence supporting strategies to prevent diabetes, but those strategies are not applied on a sufficient scale.

 

Honorable Mentions

  • Dr. Finkelstein argued that it is a myth that today’s children will likely be the first generation in the US to have a shorter life expectancy than their parents due to the obesity epidemic. Dr. Finkelstein acknowledged that the obesity epidemic and its sequelae (e.g., diabetes and cardiovascular disease) are likely negatively impacting people’s lifespans. However, he thinks that the US’ rising GDP (while a driver of obesity) is leading to more access to technology, vaccines, etc. that are enhancing life expectancy. As evidence, he noted that the US life expectancy has continued to grow since the 1970s despite a worsening obesity epidemic. Dr. Finkelstein thinks the myth will only come true when the rising GDP’s negative indirect effects on health (e.g., via obesity) counter the positive direct effects it has on health – a tipping point he has not seen in the data yet.
  • Although this conference was not designed to come up with specific treatment recommendations, Dr. W. Timothy Garvey (University of Alabama at Birmingham, AB) suggested a means by which waist circumference could be used to augment BMI-based obesity diagnoses. He noted that waist circumference is not easy to measure and generally does not add value in patients with very high or very low BMIs. However, for patients with a BMI between 25 and 35 kg/m2, factoring in waist circumference could help exclude muscular patients from obesity diagnoses, and include patients from certain ethnic groups that are at risk at a lower BMI. The suggestion received mixed feedback during discussion sessions; attendees did agree that adding another metric to BMI would help improve the quality of diagnosis. A poll of attendees found that only about one-third of practitioners regularly measure waist circumference. Based on attendees’ comments this lack of use seems to be driven by the often laborious, awkward, and imprecise reality of measuring a patient’s waist circumference.

 

Detailed Discussion and Commentary

Concluding Press Conference: Presenting the “Consensus Framework”

Affirmed Concepts

Jeffrey Mechanick, MD (Mt. Sinai Hospital, New York, NY)

While a key goal of the AACE/ACE Consensus Conference on Obesity was to come up with novel insights on obesity, the two days of discussion also served to identify where firm consensus already existed. The writing committee called these points “affirmed concepts” and we have listed and discussed each below. A key goal for AACE and ACE will be to expand the consensus on these points from the medical community (where it is already fairly strong) to other groups where they may not be fully accepted or understood such as policymakers, payers, and the public.

  • “Obesity is a chronic disease.” Participants broadly agreed that obesity met the AMA’s key criteria for a disease.  The writing committee pressed that recognition of obesity as a disease is necessary to encourage a proactive approach in which multiple stakeholders confront the disease.
  • “The AACE/ACE Obesity Algorithm should be implemented in patients with obesity.” During the conference people did repeatedly call for obesity to be treated in a stepped-care, complications-centric model (where treatment is intensified by the addition of new approaches like drugs or surgery). We did not hear much detailed discussion about the AACE/ACE Obesity Algorithm itself; however, the AACE/ACE Obesity Algorithm’s guidance is in line with this stepped-care framework.
  • “Lifestyle intervention is critical to an obesity comprehensive care plan.” The consensus was that more granular recommendations for specific lifestyle interventions are needed. The AACE/ACE framework called for a more standardized approach, with increased community involvement and support. During the press conference to announce this framework, Dr. Jeffrey Mechanick (Mt. Sinai Hospital, New York, NY) expanded on this point, suggesting (as an example of the specificity that is needed) that lifestyle intervention should include not only aerobic exercise, but also resistance training to build muscle mass.
  • “The obesogenic factors in the environment need to be reduced.” Although this was definitely a point of agreement, there was also a broad understanding that this is much more easily said than done. The framework document noted that buy-in from a wide range of stakeholders, including the government, will be key in this effort.
  • “Primary and secondary prevention strategies are critically important.” The framework document did not devote much space to elaborating upon this point, and perhaps it didn’t need to – the importance of prevention was perhaps the strongest consensus point during the entire meeting (although there were some divergent views on how specifically to design effective prevention strategies).

 

Emergent Concepts

Jeffrey Mechanick, MD (Mt. Sinai Hospital, New York, NY) and Daniel Einhorn, MD (UC San Diego, CA)

Continuing the press conference, Dr. Jeffrey Mechanick presented a series of points that emerged from the conference thanks to having diverse stakeholders in the same room. The writing committee called these ideas “emergent concepts.” One emergent concept on which Dr. Mechanick placed heavy emphasis was the need for an improved definition of obesity. Dr. Daniel Einhorn (UC San Diego, CA) suggested that another key emergent concept is the notion that the value of obesity treatment needs to be better understood by patients, HCPs, payers, and employers. Each of the five emergent concepts included in the draft framework document are listed and discussed below.

  • “The definition of obesity needs to be improved.” Dr. Mechanick characterized the definition of obesity as a hub-and-spoke model, in which the various stakeholders represent the spokes. A weak obesity classification is a central limitation to addressing obesity, as it hinders efforts by almost every stakeholder “spoke” to take concerted action to prevent and treat the disease. Indeed, throughout the conference, representatives from nearly every stakeholder pillar expressed concern with solely defining obesity by BMI, as is currently done. For example, HCPs and payers noted that BMI’s flaws make it challenging for them to know who is ill and needs treatment versus who is metabolically healthy; the FDA explained that because they are uncertain how to define obesity, it is more difficult for them to design a path for obesity-drug approval; and research funders cited the weak definition as making it harder for them to determine which research proposals to fund.
    • In the Consensus Framework, the writing committee explains that while BMI may be predictive for risk, it may not reflect the impact of weight gain on a patient’s health or well being. During the conference, Dr. Francesco Rubino (King’s College, London, UK) suggested that using BMI to define obesity is analogous using body temperature to define the flu. Additionally, BMI’s predictive power varies among ethnicities and body types, and does not account for the impact that the location of excess weight can have on complications risk (for example, central obesity is associated with higher risk).
    • The writing committee suggests that a more meaningful obesity definition would include BMI, other anthropometrics (e.g., waist circumference), and the presence and severity of complications. The Framework also notes the need for a definition to consider variables such as a person’s ethnicity and age.
  • “Regulatory, governmental, and insurance organizations require different thresholds of evidence based on specific mandates and decision processes.” Throughout the conference, government agencies (i.e., FDA, CDC, NIH, CMS) and private groups underscored the differences between their mandates and decision processes that obesity advocates need to account for. For example, the CDC and NIH can operate based on the existing evidence and can seek to add to this knowledge base. In contrast, CMS requires sufficient existing evidence of improved health outcomes in its beneficiary population. While CMS is legally restricted from considering cost-effectiveness, private payers are interested in the health benefits and value-per-dollar of a therapy, particularly over a three-to-five year period. The writing committee thinks that a failure among obesity advocates to recognize this variability has impaired concerted and uniform action. By accounting for these differences, the writing committee thinks an obesity action plan can be more efficient and comprehensive.
  • “Public awareness can change private insurance carriers’ reimbursement strategies and health care coverage provided by employers.” During the conference, payer representatives such as Dr. Kenneth Snow (Aetna) and Dr. Richard Silverman (Cigna) explained that the benefits included in an insurance plan are often dictated by the large employers purchasing the plan for its employees. Dr. Snow highlighted that while Aetna does offer obesity coverage, it cannot force employers to pay for it. Similarly, he noted that some plans on the health exchanges include obesity coverage, but that individuals are free to pick plans that don't. The writing committee sees a need to increase public and employer awareness of the importance of treating obesity, which could push more employers to request obesity coverage in their plans for employees. To build the case for employer coverage, the Consensus Framework recommends that more research be conducted on the impact of weight loss therapies and prevention programs on employee health, healthcare costs, absenteeism, employee morale, and presenteeism (all of which translate to value for different stakeholders).
    • During the conference, Dr. Phil Smith (National Institutes of Health) recognized that insurers cannot dictate what benefits employers will offer to their employees, but emphasized that states can and do dictate what benefits are required in insurance plans.  As an example, he drew on the automobile insurance industry where states do legislate certain types of mandatory coverage for the protection of the public at large rather than the benefit of the individual.  Minimum coverage for liability and uninsured motorists coverage are examples. We think this would be a tremendous but challenging step, since federal laws currently in place actually prohibit Medicare from covering obesity pharmacotherapies. However, if this exclusion could be removed, and the evidence of obesity treatment preventing complications could be built we think it could one day be possible for the US Prevention Task Force to give an anti-obesity approach Grade A or B status. This would mean that Medicare, as well as new group and individual health plans would have to cover this service under the ACA.
  • “Intergenerational obesity must be prevented through intervention in children, including children 0-24 months old, in pregnancy to manage excessive maternal weight gain, and in reproductive age females.” The writing committee highlighted that obesity can be propagated by maternal weight gain, which impacts the intrauterine environment. This can, in turn, promote obesity in children, and obese children often age into obese adults.
  • “Understanding the value of obesity care is important for patients, physicians, payers, and employers.”  The writing committee differentiated between value and cost-effectiveness. It called value the effectiveness, as well as the perceived and documented health benefits, of an anti-obesity strategy. This contrasts with cost-effectiveness, which typically relates quality-of-life years based on cost. The writing committee thinks that the value of different treatment and prevention modalities should receive greater emphasis in reimbursement decisions.
    • During the conference, private and public payers provided some color on what value they are looking for, and how the cost of a drug plays into their decision making. CMS noted that it cannot really consider the cost-effectiveness of an agent; instead, it can only consider the agent’s demonstrated value in its member population. Private payers indicated that they do consider cost-effectiveness over a three-to-five year time period, but that they do not necessarily need an obesity approach to be cost saving. Based on comments made by CMS, private payers, and health economists during the conference, we think a challenge obesity advocates face is that payers want to see hard clinical outcomes, rather than surrogate markers, in order to be soundly convinced of an agent’s health value. The silver lining of this high bar is that health economist Dr. Finkelstein (Duke-NUS Graduate School, Singapore) and Dr. Richard Silverman (Cigna) indicated they would likely accept real world data (i.e., from claims). If true, this suggests they do not expect companies to run massive, randomized control trials to produce evidence on cost-effectiveness and outcomes.  

Future Steps

W. Timothy Garvey, MD (University of Alabama at Birmingham, AB), Jeffrey Mechanick, MD (Mt. Sinai Hospital, New York, NY), and Daniel Einhorn, MD (UC San Diego, CA)

Drs. W. Timothy Garvey, Jeffrey Mechanick, and Daniel Einhorn concluded the press conference by discussing plans for the next steps of the framework process. Dr. Mechanick began by sharing that the AACE/ACE Task Force will finalize and submit the full framework manuscript, then give it time to be shared and discussed. He forecast a roughly twelve-month cycle until the next conference, which will discuss concrete treatment recommendations – given that the Consensus Conference required well over a year of planning, we didn’t see that timeline as unreasonable. Dr. Garvey shared that there will be a symposium on the consensus framework at AACE’s upcoming national scientific meeting May 14-18 in Las Vegas, which could take the process a “little step forward.” Dr. Garvey singled out the lack of a single, clear, medically meaningful definition of obesity as something that may need to be dealt with sooner than the next step in the formal framework process, given that it is a major hindrance for a range of stakeholders. Dr. Einhorn affirmed that the task force will be working on a number of fronts during the year, including advocating for better coverage for obesity medications and other types of obesity management.

 

Pillar Forum: Question One – What is Obesity?

Summary of Discussion

The generally strong consensus among the four pillars was that obesity meets the AMA criteria for a disease and should be considered as such. The issue of what is a “disease” was discussed most in the Organizations, Education & Research Pillar, which noted that many obese patients (as diagnosed by BMI) do not suffer from complications – however, the pillar was not out to “rob” obesity of its disease status. The widespread consensus was that finding a single specific definition of obesity is near-impossible right now, given the lack of understanding of the factors that lead to the disease and its complications. This led Dr. George Grunberger (Grunberger Diabetes Institute, Wayne State University, Bloomfield Hills, MI) to express frustration that the scientific and medical community, as a result, must dance around the issue of finding a specific definition for obesity. We heard a wide variety of opinions on what might be effective diagnostic criteria; many participants seemed to still see BMI as a good starting point, albeit one that does not tell the full story. The Biomedical Pillar, led by Dr. W. Timothy Garvey (University of Alabama at Birmingham, AB), suggested that a metric like waist circumference could be used to further inform and improve diagnoses for patients in a 25-35 kg/m2 BMI range. However, other attendees pushed back that waist circumference is laborious and awkward to measure, and not straightforward to interpret due to it predictive thresholds being impacted by gender and potentially ethnicity. All pillars agreed that the presence and severity of complications are perhaps the most relevant factor in the definition and management of obesity, and that the disease is truly multifactorial in nature.

  • We noticed a great deal of variation in participants’ thoughts on BMI as a tool to diagnose and inform the treatment of obesity. The Biomedical Pillar was the most positive on BMI. Most in this pillar thought BMI was at least as good as other available metrics in terms of predicting complications, and saw it as the easiest measurement to make in the clinical setting. Participants in this pillar did acknowledge the limitations of BMI, namely, that it does not tell the whole story in some ethnic groups and with patients that are very muscular. Other pillars focused more on these limitations, and as a result put less stock in BMI. Both the Government & Regulatory Pillar and the Organizations, Education & Research Pillar stated that BMI does not capture the complexity of obesity – the latter pillar suggested that more mechanistic parameters (such as adipose tissue inflammation) tell a more complete story.
    • During the open discussion, Dr. Francesco Rubino (King’s College, London, UK) recommended that the writing committee think about obesity in terms of dysfunctional fat rather than excess fat. He noted that few people would consider 30% of the US adult population to be truly ill, since some people are metabolically healthy obese. On the other side, he thinks a focus on BMI misses people who should be called obese, because while they are a normal weight, they have lipodystrophy. Dr. Rubino pressed that the definition of obesity should help payers and HCPs identify those who are metabolically ill, from those who are only too heavy, so that they can effectively prioritize whom to treat.
    • The Organizations, Education & Research Pillar emphasized that there are frequently variations in BMI and other metrics between different ethnic and age groups. These variables should be explored as modifying factors in the diagnosis of obesity and its impact on risk for comorbidities.
  • The Health Industry & Economics Pillar called obesity “The most under-reimbursed major disease in the USA.” Dr. Daniel Einhorn (UC San Diego, CA), the pillar’s Co-Moderator, noted that obesity is a major financial burden that weighs down all sectors of society, and that it should be treated like other chronic diseases.
  • Additionally, the Biomedical Pillar suggested that neck circumference is useful in assessing risk for sleep apnea. Dr. Janet McGill (Washington University in St. Louis), the pillar’s Co-Moderator, also conveyed that fitness is a good indicator of overall health independent of BMI, and that pediatrics must use a percentile-based definition of obesity rather than BMI.
  • The Health Industry & Economics Pillar noted that payers pay for “obesity treatment” rather than “weight loss.” While weight loss can be desired for cosmetic or health reasons, payers are solely focused on treating the illness of obesity (i.e., its complications). This distinction drives payers to want to see anti-obesity agents improve clinical outcomes, rather than just the loss of excess body weight or improvement in surrogate markers. In this vein, the Health Industry & Economics Pillar guided for obesity complications (including diabetes, cardiovascular disease, apnea, mobility issues, and cancer) being incorporated into the definition obesity, and for the relief of these complications being included in the value of treating obesity.

 

Panel Discussion

Dr. George Bray (Pennington Biomedical Research Center, Baton Rouge, LA): We have good ways of measuring body fat but not all fat has the same health implications. There is data on the gluteal and femoral fat being protective. I am concerned that no matter how you define excess adipose tissue as a number, it distorts the effects of health.

Dr. Daniel Einhorn (University of California, San Diego, San Diego, CA): Dr. Bray, what do you think is the best way to measure fat and fat distribution?

Dr. Bray: We can measure fat quite accurately; the question is how you interpret it. From DEXA to MRI, I think we have good methods for measuring. From my perspective, adipose tissue measurements are variable between ethnicities, ages, and are distributed differently throughout the body. I find it more complex to use from a diagnostic perspective, and the value of BMI from my viewpoint is that it is a gender-neutral measure. It has the same predictive value for men and women. There is an ethnic interpretation where you need to modify minimum values for Asian Americans, but it’s a starting point that is simple. After the first measure, what I really want to know is what the cardiometabolic risk factors are, so that’s where I would go next. I don’t think body fat measurements are that helpful.

Comment: I think we really need to have a definition whether obesity is a disease or whether it is a science and symptom or syndrome. As a primary care endocrinologist, we need that push. One might think it is politicized but we definitely need to have a definition of it being a disease. Google calls obesity being grossly fat or overweight. Do we like that definition? Of course not, I would propose that it is a chronic disease, due to genetic susceptibility interacting with environmental influences resulting in cumulative positive energy balance. This results in numerous metabolic disorders and has characteristic symptoms of increased BMI, neck and waist circumference, and risk for many disorders. We need to commit ourselves to it being a chronic disease.

Dr. Garvey: I think that is consistent with AACE and AMA’s definitions. What I am seeing so far is that the weight of consensus at this conference will reconfirm what you just said.

Dr. Francesco Rubino (King’s College, London, UK): It looks like the most important problem is coming up with a definition. I think that nobody would agree that 30% of the US population is sick. It is a portion of those people who are obese by BMI who will develop complications ­– who are actually sick. The challenge is how to identify them. It is a major gap in knowledge, but we should come to an agreement on what clinical syndrome we can use to define obesity. We only define obesity by one symptom, which is misleading, and you end up capturing some who are not sick, and excluding some who are sick. Second, I would be careful about calling obesity a condition of excess fat, as excess fat isn’t necessarily a problem. There are people with lots of fat who are very healthy, and there are people with lipodystrophy who don’t have much excess fat but are very sick metabolically. Possibly, it is better to define it in terms of dysfunctional fat rather than excess fat.

Dr. Garvey: When anyone talks with an Italian accent it always sounds like they are correct [laughter].

Dr. Rubino: I’m learning the British accent so it will be even better.

Dr. Garvey: You could have an increased body weight and normal fat, but the person could still have biomechanical complications.

Dr. Rubino: Someone can have a problem from being too heavy, and all the life altering problems from being healthy, but that is one weight issue. The other is a metabolic issue. Until we differentiate between the two – the being too heavy and being metabolically ill – that is a problem. The interventions might be different for the two, and payers might want to prioritize treatment for the two differently. We have to measure the clinical metabolic syndrome. The metabolic syndrome means you already have damage from being heavy, while being heavy alone is a risk factor for other diseases. You can’t merge the risk factor and the disease.

Dr. Garvey: Perhaps the key is emphasizing that obesity is heterogeneous. It could be seen as MODY, which has a number of different types. Perhaps obesity could fall into that type of format. You could have obesity  with fat accretion that results in sleep apnea and GERD, and obesity with fat accretion that leads to prediabetes.

Dr. Rubino: That would be one way, yes. You could also consider overweight to be a condition in which there is only excess weight and fat, but is not associated with metabolic conditions. Then you could have multiple stages, and use “obesity” specifically for someone with a clinical syndrome and metabolic problems. That would lead to quite a different set of interventions.

Dr. Steven Smith (Translational Research Institute for Metabolism and Diabetes, Orlando, FL): I would like to expand on the conversation around BMI and disease risk. We live in a cardiometabolic-centered world for reasons I don't totally understand. We are very good at understanding cardiometabolic risk. Our gap here is not the understanding of cardiometabolic risk – I think we have great data on that – I think our gap is the risk of adiposity or dysfunctional tissue and other health issues. I would focus on health outcomes not cardiometabolic risk, and how adiposity links to those. We can measure body composition but our gap is connecting that to health outcomes and I would focus specifically on cancer risk because our understanding is less formed.

Q: For those of us that work in busy city clinics and that teach medical students and residents, I would like to talk about waist circumference. How many of you actually measure waist circumference in most of your patient visits? [Approximately one-third of attendees raise their hands] See, not even half. When it is in the guidelines, I feel like I need to teach residents and students to measure it, which is time-intensive. So, specifying that waist circumference is only needed in patients with a BMI in the 25-35 kg/m2 range would be very helpful.

Dr. Garvey: Patients with a BMI above 35 are highly likely to have a risk level above threshold, so waist circumference does not provide much additional information there. The same for those below 25; most will also have a waist circumference below threshold. Waist circumference only really provides extra information within a BMI range of 25-35 kg/m2, where waist circumference can confer additional risk independent of BMI.

Dr. Handelsman: If you look at a BMI of 25 to 30 kg/m2 that is still overweight and not even obesity. The discussion here is obesity not overweight. I also want to point out what George was eluding to, the fact that there might be differences between males and females with regards to waist circumference. So maybe waist circumference is not much of a help, because now you are only looking at a BMI of 30 to 35 kg/m2 and differences in men and women.

Dr. Guillermo Umpierrez (Emory University, Atlanta, GA): I understand the complexity of trying to define obesity in simple terms. Are we going to commit to a number today, be it BMI or a combination of BMI and other metrics, or are we just going to say that it is too much weight for a certain height, associated with risk factors? I am surrounded by patients, residents, and fellows; we have to be very clear with how we communicate to them. Will we work on that this afternoon?

Dr. Garvey: We are going to take the evidence base and compile that, and see if we can come up with answers. I’m not sure if we’ll get to answer those questions in this meeting, but I understand your sentiment. It’s emerging that anthropological measures are not going to get us to the promised land. We’ll need to evolve a definition that references the impact of weight accretion on the health of the individual.

Q: I was reflecting on how we can learn from the diabetes analogy. We use A1c not as an endpoint, but as a marker for the risk of complications. In the past, we’ve picked 7% or 6.5%, depending on the guideline, based on where the inflection point is in the risk for complications. Do we envision a similar approach in obesity, where we don’t look at BMI as BMI, but we look for an inflection point where complications begin to increase? Our adventures in diabetes showed us that when we aimed for lower and lower A1c targets, we learned that lower was not better. Are we going to follow the same story for BMI?

Dr. Jeffrey Mechanick (Mt. Sinai Hospital, New York, NY): I was thinking the same thing. There are a lot of parallels between obesity and diabetes, and patients with obesity and patients with diabetes, using A1c and using BMI. Do patients with diabetes only have the disease due to the A1c and markers of dysglycemia? Clearly the disease encompasses more, yet we have no intellectual problem with a diabetic state, but we are confronting some dilemmas with the obese state. I don't think there is a problem with this group drawing parallels with diabetes.

Dr. Einhorn: There are just as many limitations for A1c, in that there is something about many people with diabetes that is the cause of their complications distinct from what we can measure with A1c. I like the parallels between obesity and diabetes care, and the fact that we have a robust history with a chronic disease like diabetes that I think we can learn a lot of lessons from.

Dr. Garvey: In my talk yesterday, I presented a model for chronic disease in which there are interactions between genes and environment that determine whether someone will become obese, and another set of interactions that determine how severely the disease will impact health and lead to complications. It is true of diabetes that 30% of patients don’t know that they have it. Many patients might be hyperglycemic for years, not get any complications, and die at a ripe old age of 94. They may have had genes that predisposed them to hypoglycemia, but not the genes that predisposed them to complications.

Dr. Samuel Dagogo-Jack (University of Tennessee Health and Science Center, Memphis, TN): Even in the diabetes space, the definitions have shifted over time. The most recent iteration was predicated upon looking at data for the inflection point for the uptick of microvascular data. So in a sense even in diabetes the definitions have been complications centric. The problem with obesity is do we have a BMI cut-off for the complications that is sensitive enough for us to incorporate into a definition?

Dr. John Jakicic (American College of Sports Medicine): I think the question here is whether we have anything that is more robust than BMI at this point. I was part of the obesity guideline writing panel for the NIH. We looked at the data pretty extensively, and we didn’t find anything that was more robust than BMI in terms of predicting complications. Is finding a more robust measure a knowledge and research gap, or are we going to come out of this meeting saying that BMI is going to work for us. Perhaps we need to consider a more refined approach. Mobility impairment starts at a BMI of 30, but that might be different when you are looking for effects on cholesterol or A1c. In 1988, I read an article from Dr. George Bray about BMI, and thought it was very insightful, but it was only recently that patients started getting a real grasp of BMI. If we change to a different target, we’ll have to start all over again. From a public health perspective, we can use BMI as a jumping-off point, but take into account the other factors and define that cut point as a starting point.  

Dr. Phil Smith (National Institutes of Health): I agree that we shouldn’t throw out something that works well for cardiometabolic risk. BMI is Caucasians is a good predictor of cardiometabolic risk, but it isn’t as good in Asian Americans, as becomes more difficult if the patient has an ethnic background and you’re not sure what it is. The studies that are required to generate the risk profile are large and expensive, as they were for generating BMI as a cutoff. Data is lacking for other populations other than the classic Caucasian population for which it was derived. We need to make sure that the patients we talk about aren’t of just one type. As for the point that nobody is going to consider 30% of America as sick, if you consider prediabetes, that is an even larger number of Americans, and that is a condition that puts you at risk of disease. I don’t think you can say that you can throw out diagnostic criteria just because it covers a large population.

Dr. Bray: I liked Jeff’s comment about the analogy with diabetes. I think hypertension is the other analogy. We have blood pressure cut points but not everyone above that cut point is at risk for a stroke.

Pillar Forum: Question Two – What Options are Available for Obesity Management

Summary of Discussion

There was broad consensus between groups that lifestyle intervention, pharmacotherapy, and surgery all had a place in the treatment of obesity. Additionally, we were pleased to see some of the pillars think more broadly about what qualifies as an “option” for obesity. Most pillars highlighted the role of high-level environmental changes (driven at the government level) as a part of the anti-obesity toolbox – we think this will be absolutely essential to make meaningful change. Most pillars also considered primary obesity prevention as part of obesity treatment – the Organizations, Education & Research Pillar characterized prevention as THE most important modality. Many participants called for a more thorough examination of the specifics of what comprises an effective lifestyle modification. In terms of treating existing obesity, the Biomedical Pillar called for a multi-pronged approach that would involve individual and group lifestyle programs, self-monitoring, and the overcoming of barriers to improvement. Additionally, the “intensive multicomponent” approach the pillar recommended would also involve pharmacotherapy and surgery for select patients. The Health Industry & Economics pillar stated that simply throwing “lifestyle” onto the pile is not adequate, and that “quality lifestyle Rx” must being administered by dietitians and effective physical activity interventions.

  • The Biomedical Pillar emphasized the need to address treatment gaps and improve patient access to the range of options available. This point came up frequently in this pillar, due in large part to the presence of physicians and allied health providers from a broad range of specialties (most of which are not reimbursed for obesity care).
  • The Government & Regulatory Pillar mentioned “technology” as an option available for obesity management, but did not elaborate much on this tool. In general, we did not hear too much on the use of technology for treating obesity, at least as compared to lifestyle interventions, pharmacotherapy, and bariatric surgery – this could be attributed to the still young state of this field in medicine, or the selection of representatives who were in attendance at the meeting (it would have been nice to have representatives from companies working in eHealth and telemedicine like WellDoc and DPS Health in attendance).
  • The Health Industry & Economics Pillar posed an open-ended question: is a commercial or medical model of weight loss better? No other pillars discussed this point in much depth. This pillar also noted that creating healthier cultures in schools, companies, and other environments could be an effective strategy in the campaign against obesity.
  • The Organizations, Education & Research Pillar included medical devices in its list of options – later, in the panel discussion for question four (“Can the optimal framework be cost-effective?”), Dr. Phil Smith of the NIH expressed the hope that the wave of coming devices for obesity will be able to deliver results for less cost than current surgical procedures. The Organizations, Education, & Research Pillar also highlighted nutritional supplements and over-the-counter medications in its list of treatment options, but underscored that the use of these items is not evidence-based, and that the market is full of “snake oil salesmen.”

 

Panel Discussion

Dr. Susan Kansagra (NYC Department of Health and Mental Hygiene): While there are options for managing obesity at the individual level, including medication, counseling, dietary and lifestyle changes, there are also interventions at the population level, linking policy and the environment. Think about smoking: although there are medications and counseling available, some of the most effective measures to  decrease smoking have been cigarette taxes and smoke-free air legislation. I want to challenge the audience to think not just of the medico-clinical environment, but also to think broadly at a population level. Local governments have a particular role to play here. Especially because over the last 30 years, it is not that individual genes have changed, but it’s the environment that has changed, particularly the food environment.

Dr. George Bray (Pennington Biomedical Research Center, Baton Rouge, LA): Most of the discussion here is on what options we can provide patients with. If you are a person with obesity in the community, you have many more options than the ones we talked about. You can go online to get advice, you can go into health food stores and buy all types of things, some good and some not. You have options for commercial and non-commercial weight loss programs. It might be important to frame this from two perspectives, and also consider what the person with obesity can do. We are not the only sources of help. A lot of people I have seen who have lost weight have done it themselves, with a diet book that they adhered to.

Dr. Jeffrey Mechanick (UC San Diego, CA): There are a lot of different therapeutic options, far more options than lifestyle or surgery. Patients can be free to explore those, but obesity experts should be utilized in that decision mechanism to provide advice on their use.

Ms. Karen Miller-Kovach (Weight Watchers): I think it is incredibly important for the writing committee to explicitly define lifestyle modification. Lifestyle modification currently varies so much in terms of what it means. If it is not explicitly spelled out, it can mean different things to different people. I has been convincingly shown that low or moderate-intensity behavior modification does nothing. It is only high-intensity, multicomponent lifestyle modification that is effective. It seems that so often, when a report or guidelines come out, lifestyle modification is all just clumped together. Because this consensus statement is being touted as being evidence-based, it needs to look at all the evidence on behavioral modification.

Dr. Jeffrey Mechanick (Mt. Sinai Hospital, New York, NY): One of the lifestyle elephants in the room with lifestyle intervention is the short falls in reimbursement for lifestyle interventions.

Dr. Jonathan Leffert (Secretary, American Association of Clinical Endocrinologists): One of the major issues in relationship to that is the lack definitions of what the disease is and what the outcomes are. Without more precise definitions, related to our first discussion, it is then difficult to determine how we are going to pay for those individual visits and the long-term studies that are required. It is developing that research base that can give us specific definitions so we can target the people who need care at the right time.

Dr. Mechanick: What about education?

Dr. Samuel Dagogo-Jack (University of Tennessee Health and Science Center, Memphis, TN): In the general theme of education, we identified a knowledge gap in the caregivers themselves. Most people do not understand the intricacies of referring for lifestyle. Providers need education in that regard.

Dr. W. Timothy Garvey (University of Alabama at Birmingham, Birmingham, AB): To what degree does the imprecision of the obesity diagnosis keep policy makers from being part of the solution, or payers from reimbursing these drugs, or funding agencies for paying for research?

Dr. Jonathan Leffert: Could we hear from Dr. Ann Albright on this?

Dr. Ann Albright (Centers for Disease Control and Prevention): I think that part of it depends on what government agency you are referring to. Regulatory agencies such as the CMS and VA that provide coverage need a level of evidence that they feel would warrant coverage. Working with private payers, they are primarily interested in outcomes. CDC has set up a recognition program for diabetes prevention programs as part of the National DPP, and there we look at outcomes such as weight loss. The things I’ve heard mentioned regarding policies around such things as food taxation, we need to try those out to determine if they will have an impact. They are what we  call natural experiments.  That is the policy is put in place and we use experimental and quasi-experimental methods to examine the impact of the policy. That is what we are currently doing at the CDC to examine some health care policies. The only other way to do that is by modeling. So it depends if it is a regulatory body that is paying for an intervention, or a body like the CDC or NIH that is looking to contribute to evidence and see if a program can be put in place on a small scale, which can then be scaled up to have a positive health impact. 

Dr. Sheela Magge (American Academy of Pediatrics): I would jus stress the importance of staring early. I represent the little people – I’m a pediatrician. Obese children become obese adults. We are seeing ten year olds with type 2 diabetes, and there is evidence that the disease progresses faster in children. I am a pediatric endocrinologist, and one of the things that is frustrating for me is that we have evidence that moderate to high intensity interventions do make changes in BMI. There are recommendations for lifestyle interventions, but there is not coverage for them. We are trying to tailor our care to what insurance will cover. I’m not sure how to change that. It is difficult to implement what the evidence supports if we are not getting coverage for it. There is public outcry about childhood obesity, but hospitals usually have to lose money to have an effective childhood obesity intervention program.

 

Pillar Forum – Question Three: What is the Optimal Use of Therapeutic Modalities?

Summary of Discussion

Health Industry & Economics Pillar Co-Chair Dr. Daniel Einhorn (UC San Diego, CA) proposed that a multi-disciplinary team should provide patients with lifestyle interventions, anti-obesity pharmacotherapies, and bariatric surgery in a stepwise manner, in which intensifying treatment will likely involve adding an additional approach (e.g., adding a drug to lifestyle therapy), rather than substituting the index strategy with a new one. Dr. Einhorn acknowledged that his personal bias is to give a medication (like Vivus’ Qsymia or Arena/Eisai’s Belviq) at the same time as referring a patient to an expert in lifestyle management. However, he indicated that the pillar did not reach consensus on when to escalate treatment, or add a medication. Indeed, Dr. Samuel Dagogo-Jack (University of Tennessee Health and Science Center, Memphis, TN) and other committee members identified the ability to predict who will respond to lifestyle or another approach as a key knowledge gap. Other conference participants approached the question from a broader public health perspective. The Government & Regulatory Pillar suggested that an optimal approach for selecting therapeutic modalities is to translate ideas that demonstrate success in clinical trials or intervention pilot studies (e.g., DPP) to the broader society. For example, Dr. Susan Kansagra (Health Promotion and Disease Prevention, NYC Department of Health and Mental Hygiene) suggested that the 5% drop in obesity among New York City five to seven year olds might indicate that recent policy initiatives (e.g., improved Women Infants and Children Program (WIC) food packaging and stronger childcare nutrition and physical activity standards) are effective and therefore should be implemented on a larger scale.

  • The consensus seemed to be that obesity should be treated using a stepped care model in which lifestyle is the foundation and medications or surgery might be added on. Unfortunately, attendees did not appear to settle on the best way to determine when to escalate treatment. Some attendees suggested that the decision to escalate might be based on a person’s weight trajectory or their initial response to a strategy. Others, like the Organizations, Education, & Research Pillar, offered risk stratification (around undetermined metrics) as an option for choosing when to intensify. The desire to be able to anticipate how a patient will respond to a potential anti-obesity therapy was the most common knowledge gap highlighted by members of the writing committee, demonstrating the importance of research on predicting responders.
  • Other suggested answers (and the pillar that raised them) included:
    • The importance of both patient and HCP health literacy for any treatment modality to be successful (Government & Regulatory);
    • The need to focus on early intervention, particularly in pediatrics (Government & Regulatory; the cost-effectiveness of early intervention was countered some in the Health Industry & Economics Pillar, where Dr. Eric Finkelstein [Duke-NUS Graduate Medical School, Singapore] had presented research suggesting this is not very cost-effective [details in Health Industry & Economics report below]);
    • The necessity of patient adherence for an approach to be successful (Government & Regulatory);
    • The importance of avoiding unproven therapies (Government & Regulatory);
    • The need for clinicians to be “more forceful and proactive” in offering obesity interventions (i.e., not waiting for the patient to express motivation to lose weight; Health Industry & Economics);
    • The use of delivery and monitoring tools like pedometers, apps, social media, and telemedicine (Health Industry & Economics);
    • The need for patients to have appropriate access to medications (Organizations, Education & Research; Health Industry & Economics).

Panel Discussion

Dr. W. Timothy Garvey (University of Alabama at Birmingham, AB): In diabetes, we treat aggressively with what is needed. How do you translate that to obesity?

Dr. Daniel Einhorn (UC San Diego, CA): I have a personal bias about using lifestyle and something else once you have the disease – certainly when the disease is diabetes. In diabetes we don't see the use of drugs as a failure. I don't know if we are there in the obesity space. It gets back to the question about what is obesity. As a clinician I have to decide if I feel confident enough that you have a disease to give you a medication, as I refer you to someone for lifestyle management. I think that is where we are heading – that we will do the two things [lifestyle intervention and prescribing a drug or surgery] that are needed rather than waiting to fail.

Dr. Garvey: Maybe waiting to fail is the wrong term. Lifestyle can work, but in trials we see that adding a drug can help increase the weight loss that is achieved. Did you have a recommendation for when to add a drug to lifestyle?

Dr. Einhorn: We [the Health Industry & Economics pillar] did not have consensus on that. The threshold for the addition of a weight loss medication is one of the gaps. Personally, I am very comfortable doing a medication at the same time that I am doing something else; that medication may be withdrawn at a later date if it is no longer necessary. However, in my pillar, I don't think there was consensus on initiating with lifestyle and a drug.

Dr. Samuel Dagogo-Jack (University of Tennessee Health and Science Center, Memphis, TN): We did identify a need to predict people who will be responders to lifestyle, and those who may need to be transitioned to medical therapy.

Dr. Einhorn: Similar to the diabetes model with regards to the point of where you start a new drug, if it does not work after say three months then you go to the next thing and usually it is am additive therapy not substitutive.

Comment: I would urge the writing committee to consider the important role of community partners and non-health specific folks. There is growing evidence that lay people can do very effective interventions to address obesity. Referral models are an important part of that. The national DPP needs to be represented in this discussion.

Comment: I think we need to have more robust recommendations. Some background, decades ago there was a consensus conference organized by John Conwell between the FDA and ADA. We put a lot of pressure on the industry there. There were two abstracts presented on the effects of hematocrit on the accuracy of glucose meter. Then FDA said industry had to improve the accuracy of their glucose monitoring. Here, we need to put pressure on the food industry for being responsible for the food environment that promotes the obesity. We had two snack bars offered here. One, a Nature Valley Crunchy granola bar – it has 190 calories per serving. The other, a Power Bar, has 240 calories. If you go to Japan, some of these snacks are only 80 calories per serving. They need to put a warning on the Power Bar saying that if you eat 15 of these bars, you will gain a pound. We need help. We need USDA and CDC to get involved.

Ms. Karen Miller-Kovach (co-CSO, Weight Watchers): I have to respond to some of what was just presented. You mentioned that lifestyle modification sees a big bump in efficacy when a drug is added. The comment was also made that lifestyle modification works in Look AHEAD and the DPP. The difference is that when you look at the intensity of the lifestyle modification, both studies used intense programs, while most other studies do not. Weight Watchers and other lifestyle options are not anti-drug, but they are useful tools to be considered along with drugs. This subject area is one of the biggest knowledge gaps we have.

Dr. John Morton (American Society for Metabolic & Bariatric Surgery): So many people need help. We need early intervention. We often see patients who have a BMI of over 60 kg/m2, which is difficult to eradicate from the body. Our field has a good model for step therapy: we work closely with internists and dieticians to ensure the best outcomes. We have good data in surgery for long-term outcomes; SOS is fifteen years out. Also, we have heard talks about intrauterine influences ­– there are studies showing that women who have had metabolic surgery are less likely to have overweight and obese children. We need to work collectively to get the best for our children.

Dr. Robert Silverman (Medical Director, Cigna): I can provide an overall view of how Cigna manages plans and comes up with coverage plans. The vast majority of our business comes from managing employer plans. The employers determine a summary of the benefits they want, and determine the language they want for plan. There are some plans that we do manage ourselves, and we manage the decisions for those plans. Some employers that we help will ask our input when framing the plan, but quite honestly we ought to make sure that in our emphasis on educating the public, we need to educate employers to ask for the kind of language that will allow their employees to maintain healthier lifestyles. It isn’t’ just the payers; it’s the people whose business the payers manage that we need to convince of the importance of all this. For the five percent of plans where Cigna controls the language, as part of the pharmaceutical and therapeutics committee, we respond entirely to evidence. What has been missing is tying evidence with complications, because certainly Cigna as a company would love to have the people we cover be healthier and require less costs for healthcare, to put it simply. We’re constantly changing our policies, when evidence directs us that way.

Dr. Susan Kansagra (Health Promotion and Disease Prevention, NYC Department of Health and Mental Hygiene): One of the things for the writing committee to consider is looking at where we have started to see declines in obesity rates. One of the few places we are seeing this is with five to six year olds in NYC where obesity has gone down 5% in this age group. One of the things that may be responsible for this decline is changing the WIC food packaging for NY state residents. There were also changes to day care standards, including those around sugary drinks and physical activity. We need to be thinking about what kinds of environmental and system changes would influence families’ and children’s lifestyles.

Dr. Adelaide Robb (American Psychiatric Association): One thing we haven’t talked about is how psychological disorders frequently require treatment that is associated with weight gain, and themselves are primarily responsible for weight gain. There are things like binge eating, which is now in the DSM and can be reimbursed, as well as major depression and bipolar disorder. If we don’t screen for those conditions in our obesity patients, we will miss factors that are impediments for our patients.

Dr. Elizabeth Koller (Center for Medicaid & Medicare Services): I would like to explain some of the issues that drive what Medicare does in terms of its coverage. Medicare is not the same as a regular insurance agency, because it has other kinds of constraints. Medicare is primarily a fee-for-service program. When it serves that way [fee for service], the item or service cannot be covered unless there is a benefit category and those are not decided by Medicare itself. In addition, things like screening and preventive services are controlled by a different rubric. CMS is allowed to include prevention and screening services if they meet certain levels of data – Grade A or B according to the US Preventive Services Task Force. They also must meet the criteria of  being reasonable and necessary, and appropriate to our patient population. What Medicare does provide is prevention and screening during the wellness visit and that may allow other kinds of things to happen downstream. It does have intensive counseling, and if someone is making progress they can have additional visits. We do have criteria for bariatric surgery. These are under Parts A and B – fee for service. Drugs are under a different rubric – Part D. Other things might occur that are somewhat similar to what happens with Cigna – like Medicare Advantage plans. Different services can be provided under that kind of setting. There are some limitations on Medicare and they are constraints that have to do with the law and what was set up to be the original intent of the program.

Medicare has a basis for looking at coverage – it looks at all of the data. It tries to look at the data repeatedly and make decisions based on that. It recognizes that sometimes a decision can be made broadly – a national coverage decision that impacts all Medicare beneficiaries. Sometimes if there is less certainty about the decision, it will be left to the local contractor. Medicare was designed to not be centrally controlled, and local contractors do have some discretion. If there is a national coverage decision, it applies throughout the country and the local contractors cannot change that. If Medicare sees some promising therapeutic intervention that is coming along, it can potentially cover it under something called coverage of evidence development. I won’t get into more details than that.

Medicare recognizes that science may be evolving and is always willing to entertain new data, but like Cigna we have to operationalize things so that we can implement a program. CMS is aware of the concerns of using BMI to define obesity, but we also need something that we can use so that you can operationalize it. That is why in our bariatric surgery coverage determination, BMI is one of the criteria. CMS is concerned about the poor quality of data for obesity interventions and lack of long-term data. CMS is concerned about whether the data can be translated to our beneficiary population; we have the elderly patients without and with disabilities and we have people who are younger and disabled. We are aware that the bariatric surgery data is largely driven by young, white women, which might not translate to our patient population. We are concerned about hard clinical endpoints – we want to know more about CV events rates, sleep apnea, and degenerative joint disease. Because there is lifespan discrepancies that logically should be driven by clinical events, CMS is less persuaded by glycemic endpoints and other surrogate endpoints. Instead, we would like hard clinical outcomes. CMS is interested in the durability of an intervention, and who will and will not respond. CMS would also like to know what are the characteristics for someone who will relapse. CMS is concerned about the patient as a whole, and the adverse events that may accompany an intervention. CMS is interested in looking at the entire patient and what we might do to benefit our patient population. We continuously reevaluate the data, and there are limitations what we can and cannot do by statute of law.

Comment: I am an obesity medicine specialist from Duke University, representing the American Society of Bariatric Physicians, the largest group of obesity specialists in the world. Our physicians learn to use a combination of tools. Most of our doctors want better reimbursement, and many are in their own practices. Their practices need to work or they have no job. I would encourage the committee to include referral to obesity medicine specialists. Our obesity treatment algorithm is available online.

Dr. Domenica Rubino (Washington Center for Weight Management and Research, Arlington, VA): In talking about stepwise versus combination approach, I would push for the combination approach. One thing we don’t always understand is that patients that struggle with obesity are always trying to change their lifestyle. Using medication allows the patient to make lifestyle changes, and they will feel better, exercise, and fight the physiological response that drives hunger and craving. The best modality will be multidimensional and provide the interventions that the patient needs. But you need to do it all at once with a patient, and you will see the most success that way, because otherwise the patient starts feeling hopeless.

 

Pillar Forum: Question Four – Can the Optimal Framework Be Cost-Effective?

Summary of Discussion

This question lead to a lively discussion around i) what cost-effectiveness in obesity looks like, ii) if it matters that an obesity agent is cost-effective, iii) how private payers and CMS make coverage decisions, and thereby iv) how private payers and CMS can be convinced to reimburse obesity therapies. Notably, attendees seemed to have mixed opinions on whether anti-obesity efforts are cost-effective – for example, the Government and Regular Pillar’s consensus was that they are generally unproven, while the Organizations, Education & Research Pillar concluded that many therapies are in fact cost-effective. Though some clinicians in attendance expressed frustration with the importance of economic metrics (Dr. Samuel Dagogo-Jack [University of Tennessee Health and Science Center, Memphis, TN] characterized them as “arcane”), the sentiment seemed to be that they are inescapable given mounting cost pressures. CMS represents a notable exception; Dr. Elizabeth Koller (Center for Medicaid & Medicare Services) emphasized that CMS is legally not allowed to consider either comparative effectiveness (i.e., on one drug’s efficacy versus another’s) or cost-effectiveness data. Both representatives from CMS and private payers like Aetna and Cigna indicated that they are looking for hard clinical outcomes – not surrogate markers like A1c, weight loss, blood pressure reductions, etc. – when determining if an anti-obesity drug should be reimbursed. The silver lining of this high bar is that the payers are willing to accept real world data (i.e., from claims), suggesting they do not expect companies to run massive, randomized control trials to produce this evidence.

  • Dr. Jeffrey Mechanick (Mt. Sinai Hospital, New York, NY) acknowledged that while that he came to the conference wanting to “vilify those who prevent access because of cost,” he had learned that economists and payers are limited by a lack of evidence. Similarly, Dr. Jonathan Leffert (Secretary, American Association of Clinical Endocrinologists) hypothesized that the reason that current obesity therapies have not been more successful is due to interventions’ lack of efficacy rather than excessive cost reducing access. On the payer side, Dr. Kenneth Snow (Aetna) expressed openness to reimbursing anti-obesity approaches (indeed, Aetna has publicly called obesity a disease requiring medical treatment), but stated that the “data is not always there.” During the Health Industry & Economics Pillar, Dr. Snow cited the Look AHEAD’s negative CV findings as an example of data that could discourage a payer from covering an anti-obesity agent. Similarly, Dr. Elizabeth Koller (Center for Medicaid & Medicare Services) stated that CMS is concerned about “the poor quality of data for obesity interventions and long-term data.” Additionally, CMS is concerned about whether the data that is available can be accurately translated to its elderly and/or disabled population. As an example, she noted that most bariatric surgery data is in young, white women.
    • Dr. Koller raised other concerns regarding the current knowledge base on anti-obesity therapies, including a lack of clarity on i) how CMS should define obesity (e.g., CMS recognizes that there are concerns with using BMI to define obesity, but needs some measure to determine who should undergo bariatric surgery, etc. and without clear recommendations from groups like AACE resorts to using BMI), ii) the durability of an intervention, iii) who will and who will not respond to an intervention, iv) who will relapse, and v) what an intervention’s adverse effects are.
    • Dr. Koller reminded attendees that obesity therapies are excluded from Medicare D by statutory law. The federal government would have to change this exclusion. We note that while Congressmen and women have brought bills to the Senate and House that would do this, it is our understanding these bills have not made it out of committee.
  • Aetna’s Dr. Kenneth Snow effectively reframed payers as working to honor a social contract with their members, rather than the more common story of them thwarting access to needed treatments in the interest of their bottom lines. Dr. Snow explained that insurance companies do not spend their own money on constituents’ care, but rather spend the money (gathered largely through premiums) of their healthier members. Dr. Snow sees payers and their members as entering a social contract in which people agree to give the payer some of their money so long as the payer ensures that money goes to people who are ill and can benefit from its use on therapies. Thus, when asked to cover a new anti-obesity therapy, Dr. Snow thinks payers must be able to answer to questions: i) Will the person’s obesity likely negatively impact their health through the development of complications? And ii) will the agent in question likely (but not necessarily) prevent that complication from developing? Dr. Snow indicated that without outcomes data or a robust definition for who is obese and ill (rather than “just” heavy), it is hard for payers to know if they are honoring their “social contract” in reimbursing obesity agents.
  • Dr. Koller emphasized that unlike private payers in the US, CMS legally cannot consider comparative effectiveness data and is limited in its ability to consider cost effectiveness. Additionally, unlike private payers who can encourage or mandate the use of cheaper alternatives (drugs that are equivalent but cheaper to an agent a patient is taking), CMS’s local contractors cannot. As a result, CMS has only two strategies for trying to make healthcare cost-effective: i) it can implement competitive bidding (she cited CMS’s cuts to test strip reimbursement as an example), or ii) make bundled payments (where a provider is paid a lump sum to treat a person with certain condition, rather than for each service it performs on the patient).
    • For context, Dr. Koller made controversial and inflammatory remarks concerning BGM and diabetes care at the Diabetes Technology Society’s meeting on post-approval BGM accuracy. For example, she surprised attendees with statements about the low need to target hyperglycemia in the Medicare population; the acceptability of less accurate, lower quality meters in older patients with type 2 diabetes; and the actuarial considerations that “cannot be underestimated.”
  • Public and private payers indicated that when evaluating clinical effectiveness, they want to see hard outcomes rather than surrogate markers (e.g., A1c, blood pressure, etc.). Dr. Koller explained that this is because obesity is associated with morbidity and a reduced lifespan, suggesting that an effective therapy should be able to restore this at least in part.
  • Dr. Snow and Dr. Robert Silverman (Cigna) pushed back on the idea that payers are fully to blame for low coverage rates of anti-obesity approaches. Dr. Snow highlighted that Aetna does offer coverage for anti-obesity programs and therapies, but that it cannot force employers or individuals to pay for the benefit (large employers can opt to not include it and people on the exchanges can select plans that don't offer it). Similarly, Dr. Silverman explained that 95% of Cigna’s plans are largely designed by employers, and that Cigna must work within the language the employer gives them. Thus, Dr. Snow and Dr. Silverman suggested that obesity advocates need to convince employers and individuals that anti-obesity benefits have value.
  • Dr. Einhorn hypothesized that if anti-obesity approaches were reimbursed, HCPs would prescribe them – a notion that Dr. Snow rebutted. To make his case, Dr. Snow explained that while Medicare cannot reimburse anti-obesity agents, Medicare Advantage plans can. However, Dr. Snow has not heard a Medicare Advantage plan that does cover anti-obesity agents state that it is spending more on obesity. Thus, Dr. Snow concluded that the “coverage is not leading to more use; it is not a coverage issue – it is an education issue among physicians.” While we agree that HCP education is critical, based on Dr. Snow’s description of the case study, we think it is possible that Medicare Advantage plans have not been strained by increased spending on obesity due to restrictive rules on their coverage.
  • On the cost-effectiveness side, obesity economist Dr. Eric Finkelstein (Duke-NUS Graduate Medical School, Singapore) explained that he and payers do not like financial models, because “you [can] get pretty much any result you want by tweaking the assumptions.” Additionally, private payers indicated that they are most interested in outcomes and cost-effectiveness over a three-to-five year timespan. The silver lining accompanying this high bar is that the payers indicated they would accept real world data (i.e., from claims), suggesting they do not expect companies to run massive, randomized control trials to produce this evidence. For example, Dr. Finkelstein recommended that when obesity advocates and pharmaceutical companies work with progressive payers (he referenced Kaiser Permanente and Humana) on a pilot of an anti-obesity agent, they should measure the clinical and cost outcomes their partner is interested in, as well as those that might be important for other stakeholders (e.g., absenteeism). This way, a company could hopefully use that data to convince other payers and large employers to adopt its approach.
  • During the subsequent discussions section, Dr. Phil Smith (National Institutes of Health) raised the possibility that state governments could legislate the inclusion of obesity coverage in health plans if they believed that this would have a public health impact. He drew a parallel with car insurance, for which states specify the benefits that plans must include. There are some limitations here – for example, current legislation actually prevents Medicare from covering obesity pharmacotherapies, and draft legislation to change this paradigm has not been popular. Although forcing payers’ hand is certainly not sufficient in and of itself, we think there is certainly room for the medical community and the public to proactively request and encourage payers to cover obesity therapy. Education, especially for employers, will be key in this regard.

 

Panel Discussion

Dr. Jeffrey Mechanick (Mt. Sinai Hospital, New York, NY): How much relative emphasis was there on cost effectiveness versus effectiveness in the biomedical pillar’s discussion?

Dr. Jonathan Leffert (Secretary, American Association of Clinical Endocrinologists): I think we were more focused on the effectiveness than the cost effectiveness as this point. I think part of that was that we are still so early into looking at effectiveness that cost-effectiveness is hard to define.

Dr. Mechanick: I’m trying to drill down why we have not succeeded sufficiently in terms of prevalence rates; do you think that is because of a cost factor or because of a lack of evidence?

Dr. Leffert: More the lack of effectiveness of the interventions.

Dr. Mechanick: We come into this with a bias thinking it is about cost and vilify those who prevent access because of cost, but what has emerged is those bodies saying, “No, it is a lack of scientific evidence.”

Dr. Mechanick: Dr. Einhorn, if cost effectives is derived from studies, how are you defining value or value added? Particularly in a landscape where there are limited dollars being spent?

Dr. Einhorn: Value is a synonym for effectiveness. The question is, Can we find that person or population in whom it is clear that intervening produces health outcomes that are beneficial? I wish we had better metrics for that. I think that question is at the heart of what insurance companies need to know and what CMS has asked of us.

Dr. Mechanick: Is value a perception?

Dr. Einhorn: It is not quantifiable at this point in time.

Dr. Samuel Dagogo-Jack (University of Tennessee Health and Science Center, Memphis, TN): The question posed was whether the optimal framework can be cost-effective. We deliberated the framework. As to cost-effectiveness we discussed effectiveness per se. We know that lifestyle, medications, and surgery have proven efficacy and can be effective if properly translated. Cost should not be too narrowly focused upon; there are hidden costs of not treating obesity. The societal benefits, the QALYSs, and more arcane metrics used by economists have a role. But for our pillar we thought we should not focus excessively on dollar costs. We should focus on treating obesity as a way of preventing downstream obesity comorbidities. Then we thought that there ought to be value for that even if it has not been economically demonstrated at this time.

Dr. George Grunberger (Grunberger Diabetes Institute, Wayne State University, Bloomfield Hills, MI): We struggled with question of what the optimal framework was for evaluating cost-effectiveness. We had trouble understanding the basic question, but we felt the answer was yes. From the population perspective, what is the cost of not doing anything? We can’t afford not to do something. Saying that we must wait until we have a perfect randomized control trial is a perfect excuse for those who don’t want to pay for new things, but we will need to act soon. 

Dr. Yehuda Handelsman (Metabolic Institute of America, Tarzana, CA): We can look at prediabetes, which is more a part of obesity than a part of diabetes in many instances. Analyses have shown that the cost of prediabetes is far, far less than the cost of diabetes. Already, that is data showing that we need to intervene.

Dr. Garvey: We are all identifying a need for additional economic data. We have to find a way to fund this research. Did the economics pillar discuss where funding sources may exist? There may be a hold there. I’m not sure the NIH is prone to funding this kind of research. There are NIH-funded nutrition and obesity research centers, but I’m not sure any of them focus in this area. Perhaps AHRQ or an investigator-initiated pharmaceutical-funded project might work?

Dr. Elizabeth Koller (Center for Medicaid & Medicare Services): At the risk of sounding like a bureaucrat I think there are some things that need to be addressed so that people here understand the constraints payers have. The constraints on each payer will be different. So, I will start first by saying that with respect to cost issues, CMS is constrained by the fact that it cannot consider comparative effectiveness data. Second, it is also limited in its ability to consider cost effectiveness. Third, it is not able to implement least costly alternatives. If something is less costly and equivalent, local contractors are not able to make that selection. Four, there are issues of who you are going to select as a provider. The people here who bill Medicare know that they have to provide a pin number – people have to be qualified providers. This is in part because CMS is a government agency and there are issues of fraud and abuse.

There are limitations with respect to cost that are different for a public agency. I work on the coverage and analysis group. We make decisions based on effectiveness under the construct of what is reasonable and necessary for the Medicare population. Our unit does not determine how that is to be paid for - that is siloed in a different group. If you want to get utilization data, that is siloed in a different group. That is done because it is a public agency. It may be different in commercial firms where a group is providing the service, and doing research for the service, and being involved in payment. It is not that CMS is unmindful of cost, but there are constraints. We try to address cost some through competitive bidding; we had implemented this in the setting of glucose strips. It was a pilot program that has become more wide spread. CMS also tries to address cost through bundled payments – an amount of money is given for the treatment of a certain condition in a patient with a certain risk [rather than for each service performed], and the outcome is measured by yet another group. I know you have raised questions of cost effectiveness but it is important to understand that different groups have different constraints.

Dr. Eric Finkelstein (Duke-NUS Graduate School, Singapore): I live in a different world, as I am an obesity health economist and I spend a lot of time working on this. The terms cost-saving and cost-effectiveness are very clearly defined. I think that it is important for a group like this to understand those specific definitions. I also think that this group needs to think hard about where cost-effectiveness is useful, if at all, in the US context. We heard from CMS that it isn’t very useful. Effectiveness equates to value, and understanding the value of different interventions is critically important. Once you have demonstrated value, if you are trying to convince the payer for reimbursement, I don’t think that cost-effectiveness is the direction to pursue. The payer will approach the issue as a question of value, and the employer wants to know things like the therapy’s impact on absenteeism and presenteeism. Large private insurance companies want to know the impact on the use of other services, the financial implications. You’re never going to be able to do randomized trials with cost-effectiveness or cost-saving as an economic endpoint, because those trials would have to be very large. I would recommend that as you make inroads into getting this out into the community, to do a good job of tracking the economic endpoints in these natural experiments you do, and to use that information to attract potential stakeholders. It is a better use of time and resources. The reality is that you don’t really get much information that is relevant to payers from clinical trials anyways, because in the real world you don’t get the efficacy you get in clinical trials. Trying to extrapolate trial data into the real world is problematic. I would recommend taking real-world data, showing that you are seeing efficacy in endpoints, and that it is the most efficient use of resources.

Dr. Mechanick: Would improving our models of obesity, so that they give rise to better information with respect to value and cost-effectiveness, be in line with what you are suggesting?

Dr. Finkelstein: No, I am not a big fan of models. The reason is models are laden with assumptions that may or may not hold. With the models I see with obesity, you could get pretty much any result you want by tweaking the assumptions. Payers care about data in the three-to-five years timeframe. The long-term models are not relevant, because payers don't think that long. You can get the three-to-five year data from real-world experiments. I would say, partner up with the Kaisers and Humanas that are making changes with obesity treatment and prevention, and use the data they collect to inform other decision makers.

Dr. Mechanick: So you are saying provide them with the evidence that they need to have decisions for reimbursement that will enhance our care?

Dr. Finkelstein: If you have a large payer that agree to reimburse Weight Watchers or Vivus’s, Qsymia try to build in measures of what is important to others – absenteeism etc. Also, there is this confusion of what is value per money – what is cost-effective, which is usually valued at about $50,000 per QALY – and what is cost savings. Cost savings is a pretty high bar that I would not push for and that is not sought for other diseases. I think that payers recognize the obesity epidemic and that their constituents need help, and that if you can make a strong case of value they will be responsive even if it does not save money, which I think is unlikely in the short-window they are interested in.

Comment: I am from the FDA, and I wanted to clarify that the FDA does not take cost into consideration in its analyses. It is easier for us if sponsors develop programs in which we all agree in the expected outcomes, if we’re trying to make a benefit/risk assessment for a product. We’ve made some changes, especially in the device realm. Last year we put out a paper that we would look at the benefit/risk paradigm and accept less benefit if the risks are also lower. If we’re having trouble defining obesity, how are we going to understand what our goals are, and what weight will yield a benefit?

Dr. Robert Silverman (Cigna): I would like to make a clarification or a distinction between what Medicare covers and what private payers might cover. As part of Cigna, I am on the Medical Technology Assessment Committee, which meets monthly to decide what we will and wont cover in medical technology. One of the things we consider is what other payers cover and what Medicare covers. I want to emphasize that just because Medicare does not cover something does not mean Cigna would not cover it. I also want to second what Eric says; that when we do look at the evidence, modeling is not a strong point that swings our opinion to decide to cover something when the modeling shows a beneficial outcome. We are much more invested in real world outcomes. I agree totally with the attention that we would pay to five-year outcomes, versus longer-term results. We are not very interested though in one-year outcomes by the way.

Dr. Phil Smith (National Institutes of Health): I wanted to clarify what the NIH does and does not support. We are not a regulatory agency and are not permitted to advocate for policy change, so we walk a fine line when people want us to do research on the impact of a policy. We can study natural experiments, and we have grant mechanisms in place to do that. We were prepared to study the impact of a NYC beverage taxing policy, but cannot at this time since that policy has been challenged in court. We can assume that there is value to patients in obesity management, because people pay $100 billion in nutritional supplements, diets and other weight loss programs.  We can and do support research projects to examine both efficacy and effectiveness of weight loss interventions.  We feel that studies like the DPP have demonstrated the efficacy of lifestyle interventions in reducing morbidity, and we are very interested in novel strategies to achieve long-term weight loss. Right now, we are suffering from a lack of novel ideas in this area and encourage the development of new approaches based on concepts emerging from basic behavioral research.  In terms of pharmacological approaches we are faced with a dearth of new therapeutics to test and the bar is very high for FDA approval of weight loss drugs. For bariatric surgery, it is difficult to demonstrate efficacy in terms of long-term outcomes. The costs of large, long-term bariatric surgery trials are prohibitive, if the costs of surgery must be borne within the trial. We are pursuing avenues to lower cost of such studies.  There are less costly approaches on the horizon in terms of devices, and we will entertain those moving forward.

Dr. Kenneth Snow (Aetna): To the writing group, I would like to put out one way to think about the position of insurers. We do not have our money to spend on people’s healthcare. In fact, we don't. We take somebody else’s money and spend it on someone else’s healthcare. There is a social contract there. We ask people to give us money, and tell them that we don't know who we are going to spend it on and that they probably don't know that person. We say we will spend their money on people who are ill, and who can benefit from their money. We do not spend the money on every medical condition. We do not cover cosmetic procedures or everything Dr. Oz supports. I am not saying that those things are not medical; I am saying that there is not enough scientific data to say that we should spend someone’s money so that a different person can have access to those things. The question of data is often an issue we have with obesity; the data is not always there. The question is if people will suffer a medical problem because of their obesity, and if so, is the therapy you are talking about likely – not guaranteed to but likely – to ­cause an improvement? That is the argument we can make with anti-hypertensives. It is not that everyone with hypertension will have a stroke, but it is likely that they will, and it is likely that antihypertensives will help prevent a stroke. With obesity, we need to know – that while not everybody who is obese will have a significant complication – that we can identify those who are likely to get a complication and who will likely not get that complication from drugs. Modeling is not the issue; it is can you make an argument that within that social contract that this is a population where money needs to be spent.

Dr. George Bray (Pennington Biomedical Research Center, Baton Rouge, LA): You can make the argument that obesity is a healthcare issue as much as you want, but I don’t think that most people we see for weight problems are there for health issues. The bulk of them want weight loss for other reasons. I think there is a quality of life issue that is separable from the health benefit, and is a major driver for many to lose weight. That has not come up in this meeting yet. You can make the case that obesity is a risk factor, but most aren’t seeking to lose weight to avoid the health consequences.

 

Pillar Forum: Question Five – What are the Knowledge Gaps and How Can They be Filled?

Summary of Discussion

When Dr. Janet McGill (Washington University in St. Louis) was asked to open discussion on the knowledge gaps that exist, she sighed and asked how much speaking time she had, alluding to the very long list of outstanding questions that exist. Despite the many gaps that were identified, the writing committee and attendees identified two overarching questions that need to be answered: i) what is obesity? and ii) what anti-obesity approach should a HCP prescribe to the patient in their office? Dr. Francesco Rubino (King's College, London, UK) sees the vagueness surrounding obesity’s definition (he compared using BMI to define obesity to using a fever to define the flu) as a factor leading more people to seek weight loss treatment for cosmetic reasons. As a result, Dr. Rubino believes payers think of anti-obesity treatment as being for cosmetic purposes. Other attendees pushed that it is also important for them to be able to effectively predict who will respond to a given treatment. Dr. George Grunburger (Grunberger Diabetes Institute, Wayne State University, Bloomfield Hills, MI) noted that this is a double-standard for obesity, since endocrinologists cannot predict who will respond to a given anti-diabetic agent; however, he concluded that obesity does need some parameters for guiding HCPs. As we understand it, obesity may be more heterogeneous than type 2 diabetes in terms of pathogenesis and responsiveness to treatment, which means predicting treatment response in obesity may be more important for maintaining benefit/risk than in type 2 diabetes.

  • Other knowledge gaps identified (and which pillar raised them) included:
    • The effectiveness of modalities on various age groups (Government & Regulatory Pillar);
    • The prevalence and nuances of health disparities and how to address them (Government & Regulatory Pillar);
    • The need for better health literacy and dietary guidelines (Government & Regulatory Pillar);
    • Clinical trials to measure environmental impact (Government & Regulatory Pillar);
    • How to address the generally negative provider attitude toward obesity and HCP’s limited knowledge on treating obesity (Government & Regulatory Pillar; Organization, Education & Research Pillar);
    • Guidance for drug development and approval (Government & Regulatory Pillar);
    • The outcomes of different policy interventions (Government & Regulatory Pillar);
    • Whether weight trajectory should be used as a metric (Health Industry & Economic Pillar);
    • Whether weight plateau is an acceptable endpoint (Health Industry & Economic Pillar);
    • Neurohormonal control of appetite and adiposity (Biomedical Pillar);
    • How to improve therapeutic interventions (Biomedical Pillar);
    • The role of genetics (Biomedical Pillar);
    • The need for more medical school and residency training on obesity (Biomedical Pillar);
    • How to maintain weight loss (Biomedical Pillar);
    • The impact of psychological disorders, endocrine disruptors, and obesogenic drugs,  (Biomedical Pillar);
    • How to create effective social messaging and increased public awareness (Biomedical Pillar);
    • The relationship between sleep disorders and weight gain (Biomedical Pillar);
    • The optimal age/life periods for intervention (Biomedical Pillar; Organizations, Education & Research Pillar);
    • The impact of obesity on inpatient costs (Biomedical Pillar);
    • The best diet (Organizations, Education & Research).

 

Panel Discussion

Dr. Jeffrey Mechanick (Mt. Sinai Hospital, New York, NY): Dr. Einhorn, one of the gaps is we don't know the optimum approach. Are you saying it might be good for us to have studies looking at one algorithm versus another algorithm? Would that help?

Dr. Daniel Einhorn (UC San Diego, CA): The knowledge gap is being able to identify a population or individuals who merit intervention and who would hopefully be reimbursed for the intervention.

Dr. Mechanick: Let me ask each member of the panel what they believe the most important gap is out of all the gaps that we listed.

Dr. Janet McGill (Washington University of St Louis, St Louis, MO): So, those of us who are clinicians would like to know what works. When you have a patient in front of you, you want to know this program, this medication, or this surgery’s risks and the benefits, and how to tailor that therapy to an individual patient. I have listened to Dr. Bray say how these things by in large work, but we would like to know how they work with a given person and how to maximize the effect.

Dr. Jonathan Leffert (Secretary, American Association of Clinical Endocrinologists): A major gap is figuring out what works on a population basis. Where is the evidence about which intervention, which medication, and where we can find out what we need to do now. The analogy would be smoking. We did things that worked, such as banning smoking in buildings, then moving from there down the road to the place we are today. I think our pillar was frustrated about not having enough evidence on what we can do to affect the future. Without that, reimbursement and sources of funding will not be available.

Dr. Einhorn: Building on what Janet and Jonathan just said, I think the reimbursement climate determines how people deliver medical care. We have a circular problem here because we aren’t certain who to diagnose and what to do. But it is clear that if the reimbursement climate had been different for the last decade, we would have better answers. So I think until the reimbursement environment is willing to pay for certain therapies for certain people, it will be hard to move forward. I think one of our missions here is to inform the reimbursement group, and make obesity a disease model. Once we have that access, clinicians become creative, and you are crowd sourcing ideas on a grand scale that no one investigator can do. That is what happens when you open a tool up to a nation of clinicians.

Dr. Samuel Dagogo-Jack (University of Tennessee Health and Science Center, Memphis, TN): Our pillar [Health Industry & Economics] focused on the concept of a weight trajectory. Nobody is born with a BMI of 30 kg/m2. It stands to reason that people progress to a BMI of 30 kg/m2, and throughout the meeting, we have largely overlooked the weight category, which we could call “pre-obese.” The transition needs to be explored further. How do people get to a BMI of 30 kg/m2? Data shows that patients tend to defend weight in a durable fashion. There are patients at 28 kg/m2 that stay there forever, and they are different than those that are on an upward incline. Maybe we could detect and deal with those patients early. Antipsychotic literature indicates that for patients placed on second-generation agents for schizophrenia, those that gained two to four pounds in the first month would gain up to forty in the first year, but those that didn’t show the initial gain would remain more level.

Dr. George Grunberger (Grunberger Diabetes Institute, Wayne State University, Bloomfield Hills, MI): I think it is the frustration of not knowing how to translate population wide benefits to the patient in front of me. We do not have the predictors of success or of failures. I don't know if a particular modality is going to work for a given patient. To be fair, we should not have a higher hurdle for obesity treatment. I can’t say that a given anti-glycemic agent will have a certain effect for a certain person. Still, how do we at least outline the predictors of success in obesity?

Dr. Yehuda Handelsman (Metabolic Institute of America, Tarzana, CA): It is hard to identify just one gap. Most people would tell you that not having data on outcomes is what prevents us from developing a good management plan. This is a relatively new disease; it’s been around forever, but as Dr. Bray said, people looked at it as a cosmetic issue for many years, and were not concerned about the medical consequences. There was no money in the field, so while the NIH was working on the basic pathophysiology there were no outcomes studies. Now there is still no money to do those studies, and I’m afraid that this knowledge gap will be a gap for a very long time. I want to know how to manage my patients, and how to utilize the modalities available in a more concrete fashion, and to combine medications and modalities, and I don’t have that ability. It’s not just a population issue; it comes down to the level of the single patient.

Dr. Paulos Berhanu (Takeda): If I were to identify one overarching gap that has been discussed, it is would be a hybrid between question four [Can the optimal framework be cost-effective?] and question five [What are the knowledge gaps and how can they be filled?]. We all agree that inaction is unacceptable. But if we are to do something there must be access, and that requires reimbursement. We have heard from payers that surrogate markers are not enough, and they want clinical hard endpoints. Those are going to be huge studies. So there is a disconnect between what is idealistic and what is realistic. I don't know what we need to do to get access.

Comment: The whole question is a lack of reimbursement, and the lack of funding in research. Why don’t we take the money from people who are responsible for this problem; the food industry is being irresponsible.

Comment: I can appreciate the comments that I have continually heard about reimbursement. I want to get us to think more broadly about that. If we are going to talk about reimbursement, it is unlikely that physicians themselves are going to solve this problem – they don't have the time or the team. There are other people who can deliver the lifestyle things in a very effective way at a relatively reasonable cost. We need to broaden the discussion of reimbursement to the folks who will get this done. There are a variety of people who pay out of their own pocket a fee to the YMCA that they hope will lead to them losing weight. I hope that we can tell allied health people what they can do to help patients, and when they should be referred back to their physician when medial treatment is needed.

Dr. Adelaide Robb (American Psychiatric Association): One of the things we didn’t discuss much was the switch to low-fat or fat-free foods, which are not always low in calories. We need to make sure that the message to patients is clear. We should also encourage children to eat fruit instead of drinking fruit juice.

Dr. Kenneth Snow (Aetna): Regarding coverage, I can tell you that Aetna has a policy for weight loss agents being covered and it is very reasonable. We don't pay for these policies though, people buy these. If employers who are paying for health insurance say they do not want to purchase that benefit or people go onto the exchanges and say this is not something that they are willing to pay for, then they do not have coverage for it. We cannot force people to take the coverage and pay money for it. I cannot speak for all my competitors, but I am sure it is true across the board. There are multiple drug benefit programs out there, and until you can convince people that this is benefit is of value, it is not a payer issue, it is a perception issue. It is a different issue with Medicare. As a case study though, I will direct you to Medicare Advantage, where there is no difference in payment whether the plan does or doesn’t treat obesity, and as far as I am aware no Medicare Advantage group has said that they are spending more on obesity – the coverage is not leading to more use. It is not a coverage issue, it is an education issue among physicians.

Dr. Mechanick: We need to learn more about reimbursement mechanisms and constraints. We cannot change the system but by learning about it then we are better able to model our recommendations. It is in our charge to gather an information base so that our conclusions have a better chance for success.

Dr. George Bray (Pennington Biomedical Research Center, Baton Rouge, LA): The first key gap I see is, Why are therapeutic modalities ending up with a plateau and regardless of their mechanism producing about 7% weight loss and not more? What is it that prevents us from having dose response reductions in weight like we see with blood pressure? I don't understand it, and I don't know of anyone else does either. The other gap is the maintenance issue. The biggest inefficiency with Look AHEAD is that while we had pretty good initial weight loss of 8%, it came back up. DPP has been at 2% below baseline for the last seven years.

Comment: We have talked about what tools might work, but we should also be systematically reviewing what doesn’t work, because there are people and companies out there making claims about products that may allegedly help people lose weight. I also second the fact that the environment is the big elephant in the room. We need to develop strategies to bring the food and beverage industries to the table.

Dr. Phil Smith (National Institutes of Health): You’ve seen the bumper sticker that says “think global, act local.” The higher up in government you go, the harder it is to effect change. The further down the chain you go, the more likely you are to make an impact. It might not be an impact on a large scale, but if a small-scale strategy shows effectiveness it can serve as a model for broader change. Also, if you look at the auto industry, states can mandate what must be in an insurance policy. We have the ability to mandate what insurance must cover. Healthy people don’t spend the money that they pay into insurance; in my mind, there is a paradigm for saying that if the cost of obesity and its complications is great enough, we can mandate that insurance has to help cover it.

Dr. Francesco Rubino (King's College, London, UK): If I can wrap up, it has come across in the entire conference that the picture of obesity is too blurry. It is critical to address what obesity is. As a surgeon we define obesity by excess weight. We are using a symptom to define a disease – like saying a fever defines a disease. In doing so there is a problem: weight is perceived by certain people more than others. We see more women in surgery than is true in the general population. This shows obesity is seen as a cosmetic problem. Unless we start redefining the clinical syndrome, we will end up with the same problem: some people who see it as a cosmetic issue will seek treatment, other patients who do not care about the cosmetics as much will not seek care, and payers will think, “Why should we spend tax payer money on a cosmetic issue?” That is the gap in knowledge we have to fill.

Dr. Mechanick: So it seems the definition of obesity is in the enter and it is effecting all of the other agencies and it will be hard to determine how to progress unless we have a definition.

Dr. Rubino: Right, we have to frame the question.

 

Pillar Forum

Concluding Remarks

W. Timothy Garvey, MD (University of Alabama at Birmingham, AB)

Dr. W. Timothy Garvey briefly took the podium to close the meeting, echoing points he had included in his introduction the previous day. The “old way” of thinking about obesity – not recognizing it as a disease, and not acting urgently to solve the problem – has completely failed us, but some stakeholders (including employers, payers, and even some providers) need to be shaken out of this old way of thinking. Building an evidence base, as was done during this meeting, is the first step on a path towards the development of specific recommendations.

 

Keynote Sessions

Conference Overview & AACE Perspective: “Obesity as a Disease”

W. Timothy Garvey, MD (University of Alabama at Birmingham, AB)

Dr. W. Timothy Garvey provided context and background on the diabetes epidemic along with AACE’s actions and viewpoints on obesity. The past decade, Dr. Garvey opened, has seen paradoxical increases in obesity prevalence at the same time as a number of tools to treat obesity have been developed and refined. Clearly, Dr. Garvey stated, something is not right with that picture. In discussing AACE’s perspective on the obesity epidemic, Dr. Garvey emphasized that obesity fits the criteria of a disease and should be considered as such. Examining historical trends, Dr. Garvey showed that the positive inflection in obesity prevalence (~1980) was followed 10 years later by a positive inflection in diabetes prevalence. Therefore, even if obesity rates are plateauing (which, he noted, is far from certain), we may still see ten years of steep growth in diabetes prevalence. Regarding solutions, Dr. Garvey discussed lifestyle, diet, and pharmacotherapy interventions. Lifestyle, he said, should be seen as an intensification process, starting with a few words with the patient (“let’s talk about your weight”) and ending with highly structured and individualized therapies. A number of diet programs for weight loss exist, but adherence seems to be more of a predictor of success than the choice between the different diets. Turning to pharmacotherapy, he indicated that the area has advanced tremendously in recent years, but must be seen as a partner to behavioral interventions.

 

Obesity: Where Do We Go From Here?

Patrice Harris, MD (AMA Board of Trustee/District Health Director, Fulton County, GA)

Dr. Patrice Harris divided her speaking time into two segments: one on the AMA perspective on obesity, and the other discussing local solutions she has implemented as District Health Director in Fulton County, GA. Dr. Harris shared that the AMA is working to change public perception of diabetes prevention, recasting prediabetes as a screenable and treatable condition in order to improve health outcomes. The AMA sees prediabetes as ripe area for action, because relatively solid evidence supports strategies to progression to diabetes, but those strategies are not applied on a sufficient scale. She expressed optimism about the YMCA’s DPP program (supported by AMA pilot programs in three states), which she sees as a great example of the community involvement needed to combat diabetes on a large scale. She emphasized that developing a physician referral process and improving coverage for the YMCA DPP program will be critical for broadly achieved success. In her role in Fulton County, GA, Dr. Harris has helped implement a number of large-scale programs (such as Georgia SHAPE for childhood obesity), some of which could potentially serve as models for other localities.

 

Making the Healthy Choice the Easy Choice: Working with Industry to Reduce Childhood Obesity

Lawrence Soler (President and CEO, Partnership for a Healthier America)

Mr. Larry Soler updated attendees on how Partnership for a Healthier America (PHA) is working with the private sector and First Lady Michelle Obama to end childhood obesity in the US. Mr. Soler explained that while the private sector is frequently targeted as being a major part of the obesity problem, PHA is trying to make industry part of the solution. To those in the audience concerned about the sincerity of the commitments companies make with PHA, Mr. Soler emphasized that PHA is not allowing companies to just score the short-term win of a celebratory press conference with Mrs. Obama. PHA requires companies to make meaningful, monitored changes that involve a significant business risk (which fortunately have appeared to pay off so far for both companies and society). Additionally, Mr. Soler called for HCPs to broaden their perspective on providers’ role in fighting obesity. For example, Mr. Soler highlighted a health system he visited in Kansas City, MO that is building a grocery store alongside its new hospital.    

  • Nearly 46 million Americans (including 5.3 million children) are impacted by commitments. PHA has made more than 60 private sector partners. More than one million children in childcare are expected to be reached when PHA commitments (specifying nutrition and physical activity standards) with partners are fulfilled in 2015. The Robert Wood Johnson Foundation has estimated that the Healthy Weight Commitment Foundation (a coalition of 16 major food producers) has removed 6.4 trillion calories from the items in the marketplace. Additionally, 6,500 schools have identified with the Let’s Move Active School’s campaign and partners have dedicated more than $330 million to support healthy eating and physical activity. Furthermore, 372 new or renovated grocery stores have opened in or around food deserts impacts 3.6 million people.
  • Three partnerships and campaigns Mr. Soler paid special attention to were i) Subway’s Pile on the Veggies campaign, ii) Birds Eye’s marketing of vegetables to kids, and iii) the Drink Up campaign.
    • Both the Subway and the Birds Eye commitments are encouraging because they work to make healthy foods more appealing to children. For example, here is Subway’s commercial in which the Muppets encourage kids to “pile on the veggies,” and here is Nickelodeon’s iCarly iCook with Birds Eye promotion encouraging kids to creatively cook with vegetables. Mr. Soler was particularly excited about Birds Eye’s commercial success from its commitment. Following the campaign (the first time kids marketed vegetables to kids), the Birds Eye brand was responsible for more than one-third of the growth in frozen vegetables in the US. Within Birds Eye, the campaign is believed to have contributed to a 20% increase in brand unit sales year over year.
    • The Drink Up message ­– “you are what you drink; and when you drink water, you drink up” – has received over one billion media impressions. To initiate the Drink Up campaign, PHA brought together many different stakeholders in the water industry including bottle manufacturers, tap manufacturers, municipalities, etc. Mr. Soler noted that through the process he learned that people have “strong feelings about water within the water industry.” However, PHA was able to rally these groups for the greater good and to sell more of their products.
  • Mr. Soler characterized PHA’s annual Summit has having “far exceeded our expectations.” He explained that the Summit is a place where obesity advocates and stakeholders can gather to discuss solutions to the childhood obesity epidemic rather than name call or detail the problem. See our coverage of the 2014 Summit, held last week in Washington, DC here.
  • Mr. Soler highlighted recent reports that the US obesity rate among tw0- to five-year old children dropped 43% over the past decade. Mr. Soler acknowledged that PHA and anti-obesity advocates are “just barely getting started” in ending the obesity epidemic; however, he expressed optimism that real change is happening, especially among young children.

 

Building a Consensus: Evidence-Based Long-Term Weight Management

John Foreyt, PhD (Baylor College of Medicine, Houston, TX)

In a fast-paced presentation (covering ~95 slides in about 45 minutes), Dr. John Foreyt discussed what he believes to be the best strategies for improving weight loss and maintenance. Though Dr. Foreyt noted that he thinks lifestyle interventions, pharmacotherapies, and bariatric surgery have a role to play in obesity treatment, nearly all of his presentation was dedicated to detailing lifestyle interventions. Only two slides were focused on pharmacotherapies (one on pharmacotherapies in general and one on Orlistat) and none were centered on bariatric surgery. On lifestyle modifications, Dr. Foreyt indicated that programs must last more than six months and include weekly, bi-weekly, or monthly sessions. The research suggests that in person sessions might tend to be most effective; however, Dr. Foreyt thought that it was reasonable to maintain contact with a patient using the telephone or internet, since those approaches are probably more cost effective. Interventions should include multiple components (e.g., relapse prevention training, skills training, etc.) and a multidisciplinary team of interventionists.

 

Appendix

Pillar Breakout Sessions

Health Industry & Economics

Co-Moderators: Alan Garber, MD, PhD (Baylor College of Medicine, Houston, TX); Daniel Einhorn, MD (University of California, San Diego, CA); and Samuel Dagogo-Jack, MD (University of Tennessee Health and Science Center, Memphis, TN)

Given the pillar’s title (“Health Industry & Economics”), much of the discussion focused on the questions of whether the optimal framework for treating obesity can be cost effective and (as a foundation for that question) how to optimally use different therapeutic modalities. On the latter question, the pillar seemed to agree that the approach for obesity treatment should use diabetes care as a model – it should be done in an individualized, step-wise manner, by a multidisciplinary team. On the question of value per dollar, pillar participants appeared to conclude that current obesity treatments are likely not cost-saving, but that when the right person is identified for an approach, they are probably cost-effective. As background, cost-savings would be an agent costing less than the direct and indirect costs it saves. Cost-effectiveness is when the value of a therapy is viewed to be worth its expense. The UK’s NICE defines cost-effectiveness as one quality-adjusted life year (QALY) costing between £25,000 and £50,000 (~$40,000-$80,000). The WHO’s definition of cost-effect is one disability-adjusted life year (DALY) costing between one and three times a nation’s GDP per capita (~$50,000-150,000 in the US); it defines highly cost-effective as one DALY costing less than a country’s GDP per capita (<$50,000).

  • Other participants listed for the pillar included industry, payers, large employers, and health economists. Dr. Paulos Berhanu, MD (Executive Medical Director, Takeda), Dr. Jason Brett, MD (Senior Medical Director, Novo Nordisk), Dr. Elaine Ciquette, BPharm, PharmD (GI Dynamics), Mr. Brian Eckley (Director, Corporate Affairs, Eisai), Dr. Eric Finkelstein, PhD, MA (Duke-NUS Graduate Medical School, Singapore), Dr. Todd Hobbs, MD (Diabetes CMO, North America, Novo Nordisk), Mr. Matthew Maryniak, MBA (Principal, IMS Health), Ms. Mansi Mehta, RD, LDN (Brand Marketing Manager, Takeda), Ms. Karen Miller-Kovach, MBA, MS, RD (Co-CSO, Weight Watchers), Dr. Andrew Renda, MD, MPH (Program Manager, Chronic Care Strategies, Humana), Dr. Robert Silverman, MD (Medical Director, Cigna), Dr. Kenneth Snow, MD (Medical Director, Aetna), Mr. Jean-Claude Tetreault (Director, Post Marketing Research, GI Dynamics), and Dr. Barbara Troupin, MD, MBA (VP, Scientific Communications and Risk Management, Vivus).
  • What is obesity? The group came into the conference agreeing that obesity is a complex, multifactorial, chronic disease characterized by excess body fat. They indicated that it is associated with an obesogenic environment, as well as health risks, comorbidities, adverse impacts on quality of life, substantial healthcare costs, and indirect economic costs.
  • What options are available for obesity management? The group agreed with other pillars that current treatment options include lifestyle modification, pharmacological therapy, and bariatric surgery. There was consensus that people need to be diagnosed with obesity earlier on and that HCPs need to be more willing (and better trained) to speak with their patients about their weight.
    • Ms. Miller-Kovach, MBA, MS, RD (Weight Watchers) repeatedly underscored that not all lifestyle interventions are equal. She called for the consensus statement to specify the use of high intensity program (e.g., Weight Watchers). More specifically, Ms. Miller-Kovach believed that the consensus statement should adopt the USPSTF’s definition of high intensity behavioral counseling: at least 12 sessions that include self-monitoring, setting weight-loss goals, addressing barriers to change, and strategizing about the maintenance of long-term changes in lifestyle. Ms. Miller-Kovach critiqued pharmaceutical companies for not consistently using such lifestyle programs in their clinical trials of anti-obesity agents.
  • What is the optimal use of therapeutic modalities? The pillar, led by Dr. Einhorn, (UC San Diego) seemed to agree that obesity should be treated in a manner similar to the diabetes model: in an individualized, step-wise manner, by a multidisciplinary team. Dr. Barbara Troupin (Vivus) suggested that rather than the treatment algorithm being thought of as a series of discrete steps patients jump between, it should be conceptualized as a chain of Venn diagrams that they flow through, an image that emphasizes the overlap between treatment modalities (e.g., lifestyle intervention being used in conjunction with a pharmacotherapy etc). Dr. Andrew Renda (Humana) suggested that the definition of a medical team should be expanded to include payers, since payers can use their EMR and claims data to identify people requiring intervention and to follow-up to see if the treatment had an effect. Attendees also appeared to agree that most PCPs and even most diabetes care teams are probably not adequately trained at this time to treat obesity. They therefore envisioned the PCP making the obesity diagnosis, having an initial conversation with the patient about obesity, and then referring the patient to someone better trained to administer a lifestyle intervention. The hope of the pillar seemed to be that the original referring HCP would still stay involved in coordinating the patients’ care, so that the burden did not fall on the patient. While we like this model, we are concerned about whether enough providers in the US are specially trained to treat obesity, and continue to see better obesity-education of HCPs as vital.
    • Another unresolved question was how to determine which patients should be offered which specific therapies (a complications-based model appeared to be favored; however, no thresholds were set). Additionally, the details on how and when a person should be escalated remain uncertain. Dr. Jason Brett (Novo Nordisk) noted that one can usually tell if a person is going to respond to Novo Nordisk’s liraglutide 3.0 mg after a several weeks based on their initial weight loss. As an alternative, Dr. Berhanu (Takeda) commented that a treatment decision should depend on whether a patient is motivated and ready to lose weight. In response, Dr. Troupin suggested that such an approach is not used for other diseases (e.g., people are not diagnosed with type 2 diabetes and asked if they are ready to begin treating their type 2 diabetes, they are usually placed on some anti-diabetic right away) and that if obesity advocates are going to call obesity a disease, they must treat it like one.
  • Can the optimal framework be cost-effective? Pillar participants’ appeared to conclude that current obesity treatments are likely not cost saving, but that when the right person is identified for an approach, they are probably cost-effective. The thought leader in the session on obesity treatments not being cost saving seemed to be Dr. Finkelstein (Duke-NUS Graduate Medical School). Dr. Finkelstein has estimated that when one discounts for the future, converting a ten-year old boy from obesity to normal weight probably only saves $10,000 to $13,000 worth of medical costs over his lifetime if that weight is maintained. Since reversal to- and long-term maintenance of normal weight is infrequently seen even with bariatric surgery (which costs ~$25,000), the session agreed that weight loss interventions in children are likely not highly cost-effective. Dr. Finkelstein highlighted that greater cost effectiveness is seen among older adults and people with diabetes, but emphasized that cost savings is still unlikely in such patients. While some attendees seemed to feel uncomfortable with the notion, by the session’s conclusion, many had acquiesced that based on current data anti-obesity treatment is not cost saving. As an example, Dr. Todd Hobbs (Novo Nordisk) agreed to this point, while maintaining that a more complete understanding of obesity’s direct and indirect costs might demonstrate greater cost reductions. Another key outstanding question appeared to be how to identify people who will respond to a therapy.
    • An early turning point on this question in the session appeared to be Dr. Finkelstein’s comment: “Contrary to some earlier comments, with the possible exception of bariatric surgery, there is zero valid evidence of cost savings with obesity treatment.” As context, before Dr. Finkelstein took the podium Dr. Berhanu (Takeda) and Dr. Brett  (Novo Nordisk) had highlighted studies suggesting the cost-effectiveness of weight loss using models. Dr. Finkelstein explained that while the models might make logical sense, real world data have not corroborated the cost effectiveness. Still, Dr. Finkelstein supported the use of anti-obesity treatments. His argument was that cost-effectiveness not cost-savings should be demanded of anti-obesity agents, because it isn’t in other disease areas. He also suggested that it does industry a disservice to push the idea of return on investment for weight loss. Instead, he believes that companies should highlight the value their agents provide per dollar. Among currently available non-surgical approaches, he thinks the two most cost-effective are Weight Watchers (which is estimated to cost an average of $150 per kg lost) and Vivus’ Qsymia (costs ~$200/kg lost).

 

Cost

Weight loss

Average cost effectiveness ratio

Weight Watchers

$377

2.4 kg (5.3 lb)

$150

Vtrim

$682

3.2 kg (7.1 lb)

$210

Vivus’ Qsymia recommended dose

$1,366

6.7 kg (14.8 lb)

$200

Orlistat

$1,518

2.8 kg (6.2 lb)

$550

Arena/Eisai’s Belviq

$1,743

3.2 kg (7.1 lb)

$540

Jenny Craig (high income)*

$2,512

7.4 kg (16.3 lb)

$340

Jenny Craig (average income)*

$3,152

7.4 kg (16.3 lb)

$420

*Dr. Finkelstein broke out high and average income participants for Jenny Craig because the program’s realized cost varies based on how much one spent on food before entering it – the more one spent on food, the less expensive the required meal replacements will seem (and people who are high income likely spent more on food).

  • Dr. Finkelstein also argued that it is a myth that today’s children will likely be the first generation in the US to have a shorter life expectancy than their parents due to the obesity epidemic. Dr. Finkelstein acknowledged that the obesity epidemic and its sequelae (e.g., diabetes and cardiovascular disease) are likely negatively impacting people’s lifespans. However, he thinks that the technological innovations driving the obesity epidemic are also increasing GDP, and thereby lifespan. As evidence, he noted that life expectancy is climbing in developing countries along with obesity rates, and that life expectancy in the US has continued to grow since the 1970s despite a worsening obesity epidemic. Dr. Finkelstein thinks the myth will only come true when a rising GDP’s negative indirect effects on health (e.g., via obesity) counter the positive direct effects it has on health – a tipping point he has not seen in the data yet.
  • Dr. Snow (Aetna) provided a matter-of-fact payer perspective on how a payer thinks about obesity. He opened his comments by reminding attendees that the reason payers and HCPs care about obesity is because of its health effects, and that the data is not straightforward on whether current treatment options effectively ameliorate these effects. As evidence of this uncertainty, Dr. Snow highlighted the early termination of Look AHEAD and remarked, “I’m still trying to get my head around if Look AHEAD was a success. If we care about weight loss because it will prevent adverse events, then that was not seen in Look AHEAD. I admit that there may be other benefits, but in the absence of data it is dangerous to jump to the idea that because people lost weight in Look AHEAD it was good. We spent a lot of money to get just 4% weight loss and it might not have had a significant effect on health.”
    • Fortunately, Dr. Samuel Dagogo-Jack (University of Tennessee Health Science Center, Memphis, TN) highlighted that Look AHEAD did in fact show positive effects on other areas of health ranging from mobility to sleep apnea. In the past four weeks, we have heard Look AHEAD PIs Dr. George Bray (Pennington Biomedical Research Center, Baton Rouge, LA) and Dr. Anne Peters (USC, Los Angeles, CA) argue that CV events should not have been selected as the primary endpoint, and that many health benefits (microvascular) and quality of life improvements (mobility) were proven by the Look AHEAD study. Even further, Dr. Peters indicated that Look AHEAD was likely effective at reducing CV risk in people who did not have established CVD.
  • Mr. Matthew Maryniak (IMS Health) presented an analysis of IMS’ retrospective EMR data suggesting that ≥10% BMI loss over 2.4 years is not enough time to realize the benefit of anti-obesity interventions. When compared to obese patients with a stable BMI (± 2.5%) and non-obese patients, obese patients without type 2 diabetes who reduced their BMI by ≥10% did not have an improvement in the incidence of myocardial infarction or angina, and had a potential worsening of the incidence of stroke and heart failure, despite an improvement in blood pressure. They also did not appear to have a lower risk of developing type 2 diabetes. Mr. Maryniak noted that its study had several limitations including that it could not determine when the diagnosis was made (only that it was not made at the baseline BMI entry and was made by the last BMI entry), how many patients were borderline for type 2 diabetes at baseline, or how many patients were managing their type 2 diabetes with diet and exercise. Additionally, IMS did not compare event rates based on the intervention used. Thus, Ms. Mansi Mehta, RD, LDN (Takeda) argued they were “not comparing apples with apples.” These methodological issues seemed to lead people to not cite these results in later discussions.
  • What are the knowledge gaps that need to be filled? Key knowledge gaps identified by the pillar included HCPs not realizing that they can now code and prescribe for obesity, and payers/employers having a poor understanding of how to design plan benefits around the treatment of obesity. Dr. Einhorn (UC San Diego) expressed optimism that once physicians realize that they should be coding for obesity (i.e., that they will probably get paid for it under capitated or free-for-quality healthcare systems) and that they have more treatment options, they will begin to prescribe anti-obesity therapies. He explained that the last two generations of physicians were actively trained to ignore coding for obesity, since it was not reimbursed. Our remaining concern is whether HCPs will be adequately reimbursed for treating obesity – though it is our understanding that ACOs and other capitated systems usually will pay more for the care of an obese patient (since they generally have higher medical costs), this is still a system that is growing in prevalence and it remains to be seen if it will be permanently implemented. Additionally, we think that physicians have also been trained to be view obesity not as a medical disease and to be skeptical of anti-obesity medications due to their history of safety issues.
    • Dr. Troupin (Vivus) called for physicians to be educated on: i) the complex, biological basis for obesity and its pathophysiological link to comorbidities, ii) assessing for obesity and weight-related comorbidities, iii) impact of weight loss on overall health, quality of life, and costs of treatment, iv) available treatment options, and v) how to select interventions in targeted patients to assure greater benefit/risk profile and cost effectiveness. 
    • Dr. Troupin suggested that the knowledge gaps surrounding payers and employers could be addressed through pilot programs and studies of real world use of interventions in which the cost-effectiveness of an approach is mapped. She also sees a need for tools that help establish best practices for addressing weight effectively and cost effectively: i) a roadmap to assist in incorporation of pharmacotherapy for obesity treatment into benefit design so that an agent is made available to the right employees at the right time, and ii) an economic modeler demonstrating cost of treatment and cost savings associated with pharmacotherapy.

 

Government & Regulatory

Co-Moderators: Jeffrey Mechanick, MD (President, AACE/Mt. Sinai Hospital, New York, NY) and Jonathan Leffert, MD (Secretary, AACE)

The Government & Regulatory breakout session drew 25 attendees, including seven panelists representing a range of agencies: CDC, FDA, USDA, CMS, AACE, and the NYC Department of Health and Mental Hygiene. The discussion focused on the five questions posed by the conference organizers. While these topics encompassed controversial issues (e.g., the adequacy of BMI as a primary measurement for obesity and the role of surgery in obesity management), the discussion lacked the debate and critical discourse that we had expected. In general, the panelists relayed the mission and activities of their respective agencies and did not offer contrasting opinions. Each agency’s perspective did help us better understand its position on obesity; unfortunately, however, this was not a forum that drove the brainstorming of new or disruptive ideas. Indeed, Dr. Gregory Peterson (AACE) gave a friendly call for the agencies to “give up your desks” and “get into the real world and the trenches.”

  • Other participants in this panel included Dr. Ann Albright, PhD, RD (Centers for Disease Control and Prevention), Dr. Patricia Beaston, MD, PhD (US Food and Drug Administration, Office of Device Evaluation), Dr. Helene Clayton-Jeter, OD (US Food and Drug Administration, Office of Constituent Affairs), Ms. Jackie Havens, MS, RD (US Department of Agriculture, Center for Nutrition Policy and Promotion), Dr. Susan Kansagra, MD, MBA (Health Promotion and Disease Prevention, NYC Department of Health and Mental Hygiene), Dr. Elizabeth Koller, MD (Centers for Medicaid & Medicare Services), and Dr. Gregory Peterson, DO (American Association of Clinical Endocrinologists).
  • What is obesity? Most panelists acknowledged the limitations of using BMI to define obesity and the speakers agreed that obesity encompasses issues other than weight. However, the panelists noted that their agencies follow BMI-based definitions of obesity. Interestingly, Dr. Helene Clayton-Jeter (FDA) stated that it is not within the FDA’s purview to define obesity, though the agency has been involved in the discussion for decades. Dr. Peterson (AACE) gave the most specific answer to the question, stating that obesity is an endocrine disease. Taking a different approach, audience member Dr. Daniel Hurley (incoming AACE secretary) pointed out that the public’s definition of obesity is important and may differ from the definition used by the regulatory and/or medical community. The discussion concluded with Dr. Jeffrey Mechanick asking Dr. Elizabeth Koller how CMS would define obesity to optimize care, to which Dr. Koller responded that CMS lacks the required scientific data to answer the question.
  • What options are available for obesity management? The panelists reviewed the approaches of their respective agencies, which focused on prevention, health literacy, and lifestyle management. Interestingly, the discourse included little mention of pharmacology or bariatric surgery, two options that were listed as topics of “non-consensus” at the beginning of the session (based on opinions panelists had sent in ahead of time). However, by the end of the session, all panelists indicated that they saw these two approaches as being available for obesity management.
    • Dr. Jonathan Leffert (AACE) noted that the CDC can easily capture the public’s attention during an infectious disease outbreak and asked how the agency can similarly heighten awareness about obesity. Dr. Ann Albright (CDC) noted that obesity lacks the drama and urgency that accompanies infectious disease outbreaks and stated that in her personal opinion, chronic obesity is undervalued. She also remarked that diseases such as HIV have evolved from being issues of personal responsibility to issues of society, and hopes that the discussion surrounding obesity can take a similar course.
  • What is the optimal use of therapeutic modalities? The speakers underscored that lifestyle intervention represents the foundation of obesity management, and that other therapeutic modalities should be used in addition to lifestyle. Importantly, Dr. Mechanick highlighted that structured lifestyle interventions are rarely reimbursed. In responding, Dr. Koller emphasized that CMS has constraints regarding the services it can provide, and stated that individual carriers have to make their own decisions about covering lifestyle interventions. She called for more data on such interventions and underscored the importance of avoiding fraud and abuse. An audience member also remarked that Congress is currently considering a bill (the Treat and Reduce Obesity Ac) regarding obesity management and that the bill’s passage could remove the Medicare D exclusion of anti-obesity pharmacotherapies. 
  • Can the optimal framework be cost-effective? All the speakers replied “yes.” Dr. Albright (CDC) noted the importance of economic models and asserted that agencies can implement broad programs at low cost. She cited the National Diabetes Prevention Program as an example, noting that the CDC has evidence that lay people can deliver the intervention and that the program is cost effective. Dr. Albright also commented that because the positive returns of lifestyle interventions may take several years to emerge, and because people often switch insurance plans, all payers should have to cover such interventions. This way plans would be reassured that when they pay for members to receive a lifestyle intervention and the members move to another plan before the cost-effectiveness is realized, the negative ROI will be offset by people entering the plan whose earlier lifestyle interventions were paid for by other plans. Dr. Leffert also raised an important question when he asked, “what is the cost of not acting?” – a key consideration that should be a factor in the cost-effectiveness calculation.  
  • What are the knowledge gaps that need to be filled? In the liveliest discussion of the session, panelists considered how much evidence is required by an agency before the agency can carry out a program or pursue legislation. Dr. Albright explained that the CDC has enough evidence to support the initiation of certain programs – e.g., the National DPP and community transformation grants; however other areas have pretty limited data and require more before implementing on a wide scale. Dr. Kansagra (NYC Department of Health and Mental Hygiene) noted that while the literature contains strong evidence linking sugary drinks to obesity, it contains little data on the best way to reduce the consumption of such beverages. However, she noted that previous programs such as highway safety regulations were instigated without strong scientific backing and proved to be useful. Other representatives from the USDA, FDA, and CMS remarked that their guidelines and programs are evidence-based.
    • Dr. Albright (CDC) made several key observations, noting that while data from randomized controlled trials is important, agencies must also consider other types of data. She also posited which agencies were best suited to collect such data: while the NIH conducts the vast majority of research, it focuses mainly on biomedical research. More specifically, the CDC is looking for further data on several fronts: 1) the effectiveness of different interventions and their dosages in different populations; 2) population-wide environmental and policy interventions; 3) the need for culturally adapted education; and 4) better methods for engaging patients.
    • Dr. Koller explained that CMS is most interested in hard endpoints of clinical relevance to its patient population, including data on cardiovascular events, degenerative joint disease, and sleep apnea. Of note, CMS is less persuaded by glycemic control data and other surrogate endpoints. Dr. Koller believes that the VA can play an important role in collecting data, because its closed system allows it to build and maintain a patient database. As a result, it can conduct various types of research that address its patient population.
    • Dr. Albright (CDC) raised an important point in stating that agencies “need to make some decisions with what we know now – we can’t wait for everything to be well-known because we’re already in a bit of a mess [regarding obesity].” Dr. Peterson (AACE) agreed, and remarked that the recent and significant reduction in smoking can be attributed to public awareness programs – efforts that were not based on scientific evidence.

Biomedical

Co-Moderators: Timothy Garvey, MD (University of Alabama at Birmingham, AB) and Janet McGill, MD (Washington University in St. Louis, MO)

The Biomedical Pillar featured a fair number of endocrinologists and bariatric surgeons, but was largely composed of providers representing a wide variety of medical professions, from dietitians to clinical psychologists to sports medicine professionals. Regarding the definition of obesity, a large proportion of participants endorsed a BMI-based cutoff, at least for the purposes of diagnosis and to target prevention efforts. However, the widespread agreement was that the presence and intensity of obesity complications are key in stratifying patient risk to inform treatment decisions. Opinions were mixed on the utility of waist circumference: some saw it as a way to augment BMI-based diagnoses (especially within the borderline 28-35 kg/m2 range), while others argued that it is hard to measure consistently. Participants approached the question of treatment options broadly, suggesting mobile health, public policy strategies, and psychological interventions in addition to medications, surgery, and lifestyle. The range of non-physician providers present stated that their professions have an important role to play in the effort to fight obesity, but that reimbursement poses a major obstacle to them joining en-masse. Perhaps the strongest consensus emerged behind the fact that there is a huge amount that the field does not know, which must be discovered through further research.

  • Biomedical pillar participants included: Dr. Harold Bays, MD (National Lipid Association), Dr. George Bray, MD (Pennington Biomedical Research Center, Baton Rouge, LA), Dr. Alice Fuisz, MD (American College of Physicians), Dr. Angela Golden (American Association of Nurse Practitioners), Mr. Lawrence Herman (American Academy of Physician Scientists), Dr. John Jakicic, PhD (American College of Sports Medicine), Dr. Suzanne Johnson, PhD (American Psychological Association), Dr. Sheela Magge, MD, MSCE (American Academy of Pediatrics), Dr. David Marrero, PhD (Diabetes Translational Research Center, Indiana University School of Medicine), Dr. John Morton, MD, MPH (American Society for Metabolic & Bariatric Surgery), Dr. Hollie Raynor, PhD, RD, LDN (Academy of Nutrition and Dietetics), Dr. Francesco Rubino, MD (King’s College, London, UK), Dr. Adelaide Robb, MD (American Psychiatric Association), and Dr. Jennifer Seger, MD (American Society of Bariatric Physicians). The affiliations listed reflect the association each participant was representing.
  • What is obesity? Although participants acknowledged that a number of factors contribute to the development, diagnosis, and complications of obesity, much of the room endorsed the use of BMI as a primary metric for the disease, especially with regards to prevention and the targeting of prevention efforts. Dr. Alice Fuisz (American College of Physicians) stated that the ACP guidelines label obesity as a BMI of 30 kg/m2 or higher. A number of other participants, including Dr. John Morton (American Society for Metabolic & Bariatric Surgery), Mr. Lawrence Herman (American Academy of Physician Assistants), Dr. John Jakicic (American College of Sports Medicine), and Dr. George Bray (Pennington Biomedical Research Center, Baton Rouge, LA) endorsed this approach (at least in part). These and other participants characterized BMI as easy to obtain, and no worse than other metrics (waist circumference, percent body fat) at predicting long-term outcomes.
    • Certainly, there was broad recognition that obesity can be defined in large part by its complications. These additional indicators of obesity include the results of adiposopathy (adipose tissue pathophysiology) and biomechanical disorders, according to Dr. Harold Bays (National Lipid Association) and Dr. Jennifer Seger (American Society of Bariatric Physicians). Diabetologist Dr. David Marrero (Indiana University School of Medicine) agreed, expressing support for the CDC’s more open-ended definition.
    • Endocrinologist Dr. Karl Nadolsky (Leaner Living, Virginia Beach, VA) brought up waist circumference (WC) as a useful metric for obesity. He suggested that it is a better metric than BMI, because an individual with a BMI of 25 kg/m2 and significant visceral adiposity is still at high risk for metabolic disorders. Dr. Domenica Rubino (Washington Center for Weight Management and Research) agreed, noting that patients can easily monitor WC by simply seeing if their jeans are getting looser or tighter. However, a number of participants (including Dr. Raymond Bourey [University of Toledo, OH]) cited the inconsistency in how WC is measured as a detracting factor from its clinical utility. Co-moderator Dr. W. Timothy Garvey (University of Alabama at Birmingham) suggested that WC could be useful in a truncated analysis for patients between a BMI of 28 and 35 kg/m2; in these patients, WC could be used to exclude high-BMI patients who are muscular, and include those that may weight less but have excess visceral adiposity.
    • A few participants discussed “healthy obese” individuals as a factor that clouds the clear diagnosis of diabetes. Participants noted that such patients generally meet a BMI cutoff but do not suffer major metabolic problems. Clinical psychologist Dr. Suzanne Johnson (American Psychological Association) suggested that “healthy obesity” may not be measurable by any single metric.
    • Dr. Seger (American Society of Bariatric Physicians) warned against painting the medical profession into a corner by making a diagnosis solely by a BMI or a WC cutoff. She pointed out that overly narrow criteria could exclude patients from coverage for treatment. Dr. Angela Golden (American Association of Nurse Practitioners) discussed the other side of the coin: a threshold that is too easy to meet and includes those who are metabolically healthy might cause society to face higher insurance premiums, because of overtreatment.
    • In addition to considering how to diagnose obesity, some speakers discussed the importance of labeling it in a sensitive manner. Dr. Johnson (American Psychological Association) noted that children in particular (and parents of those children) do not respond well to the term “obesity” and dislike the term “fat” even more. Dr. Ted Kyle (Obesity Action Coalition) agreed, arguing that obesity is not an identity.
  • What options are available for obesity management? Participants mentioned pharmacotherapy and bariatric surgery for obesity treatment, but did not dwell on those subjects. Instead, speakers broadened their definition of “options” to go beyond what a HCP can prescribe. Dr. Golden (American Association of Nurse Practitioners) noted that public policy must be a part of the solution to the vastly multidimensional obesity epidemic. Mr. Lawrence Herman (American Academy of Physician Assistants) suggested that mobile health holds enormous potential, especially in patients under 35  years who have not yet acquired severe complications. Co-moderator Dr. Janet McGill (Washington University in St. Louis) made the astute observation that obesity management is not only about weight loss medications; it also requires that HCPs try to avoid specific drugs for other conditions that cause weight gain. An example raised was diabetes – why use a SFU (weight gain) when a DPP-4 inhibitor (weight neutral) or GLP-1 agonist (weight loss) is available? Dr. Seger (American Society of Bariatric Physicians) wondered why older agents for weight loss, such as phentermine, are no longer included on many guidelines, given that they are approved by the FDA.
    • As we would expect (and hope), multiple participants urged the group not to forget about lifestyle therapy. Sports medicine representatives noted that increased physical activity is particularly important in the maintenance of weight loss. Dr. Bray (Pennington Biomedical Research Center), quoting Dr. John Buse (University of North Carolina School of Medicine, Chapel Hill, NC), noted that if you compared the clinical outcomes of the Look AHEAD trial to those seen with diabetes drugs, the behavioral intervention would be the best by far in terms of glycemic control, lipid parameters, and other factors.
    • Other tools and interventions mentioned included meal replacements, improved sleep, prevention of weight gain during pregnancy, and psychological care.
  • What is the optimal use of therapeutic modalities? Participants agreed on a few broad themes in this session. Multiple speakers, including Dr. Morton (American Society for Metabolic & Bariatric Surgery) and Dr. Johnson (American Psychological Association), noted that major treatment gaps in anti-obesity interventions are education and access. Mr. Lawrence Herman (American Academy of Physician Assistants) highlighted that physician assistants and other HCPs generally do not have enough time to address obesity when a patient presents with more urgent conditions. Many agreed that a multidisciplinary team-based approach could improve outcomes, and that many professions (including educators, dietitians, and other non-physician providers) have a part to play in the fight against obesity. However, challenges remain in getting these team-based approaches reimbursed (see below).
    • Dr. Fuisz (American College of Physicians) argued that internists, along with other PCPs, should be screening patients for obesity. They also, she pressed, should make use of all the options available in terms of referrals, including options such as the YMCA DPP program.
    • Dr. Golden (American Association of Nurse Practitioners) urged participants to consider telehealth – we were glad to see technology-based solutions get a shout out. She highlighted telehealth’s potential in rural areas, where it would not be feasible to assemble a full multidisciplinary team.
  • Can the optimal framework be cost-effective? Dr. Johnson (American Psychological Association) expressed disbelief that treating obesity could not be cost-effective, given that we face a future where one-third of the population may have type 2 diabetes. Dr. Marrero (Indiana University School of Medicine) cited a study he co-authored showing that if Medicare picked up the cost of a YMCA DPP-type program, it would be cost-saving after only three years. Dr. Golden (American Association of Nurse Practitioners) called for realism, noting that interventions will require significant up-front investment, regardless of their long-term cost effectiveness. In this spirit, multiple speakers raised that many current obesity guidelines do not factor in cost-effectiveness analyses.
    • Poor reimbursement for non-physician providers was a major theme of the session. Representatives of physician assistants, nurse practitioners, sports medicine professionals, dietitians, and clinical psychologists all enthusiastically stated that their respective professions have a key role to play in the fight against obesity. They pressed that they can help reduce the burden on endocrinologists and PCPs in a cost-effective manner, but currently do not receive sufficient reimbursement ­– indeed, endocrinologists and PCPs generally are not adequately reimbursed. These allied health representatives urged the writing committee to include a call for broader coverage in the final document.
    • The pillar was hesitantly optimistic that accountable care models (such as those driven by the Affordable Care Act) may help providers pursue (and be reimbursed for) cost-effective strategies.
  • What are the knowledge gaps that need to be filled? As we expected, the pillar threw everything but the kitchen sink at this question. The participants felt that a wide range of topics deserve more study, including eating disorders, the pathogenic mechanisms of adipose tissue and leptin resistance, the safety of medications and surgery, the durability of different treatments, the environment’s impact, how to design behavioral interventions, sleep’s impact, best practices for managing obese patients in the hospital setting, and the gut microbiome.

Organizations, Education & Research

Co-Moderators: George Grunberger, MD (Grunberger Diabetes Institute, Wayne State University, Bloomfield Hills, MI) and Yehuda Handelsman, MD (Metabolic Institute of America, Tarzana, CA)

This pillar was one of the most diverse in its members at the Consensus Conference, although in terms of the number of participants in attendance, it was also the smallest. The ADA’s Dr. Robert Ratner was present in this pillar, as were a number of obesity care activists and academic researchers. During discussion, the pillar threw a wrench in the classification of obesity as a disease, noting that many people are obese as diagnosed by BMI but do not suffer many adverse effect. However, on the whole, the pillar did agree that obesity is a disease. Pillar participants thought broadly about the list of available treatment options, and emphatically stated that primary prevention of obesity is the most important tool in the anti-obesity toolbox. In discussing gaps in knowledge, we were glad to see a discussion on the need for better obesity care training for healthcare professionals, although not all pillar participants agreed on whether this education should occur in medical school or as part of a fellowship.

  • Pillar participants hailed from a range of backgrounds, including academic universities, advocacy groups, and medical specialty organizations. Specific participants included the much-renowned Dr. Robert Ratner, MD (Chief Scientific & Medical Officer, American Diabetes Association), Dr. Chiadi Ndumele, MD, MHS (American College of Cardiology), Dr. Solveig Cunningham, PhD (Emory University Rollins School of Public Health, Atlanta, GA), Dr. Mary Lieh-Lai, MD (Accreditation Council for Graduate Medical Education), Dr. Scott Kahan, MD, MH (STOP Obesity Alliance), and Mr. Joe Nadglowski (Obesity Action Coalition).
  • What is obesity? Pillar participants came to the general consensus that obesity is complex, multifactorial, and often involves excess adipose tissue. Increased risk for a number of complications was a substantial factor in this definition. Interestingly, the pillar did not seem to wholeheartedly support the definition of obesity as a disease, or at the very least some participants tried to play devil’s advocate on the issue, pointing out that many patients that have excess weight do not develop complications. However, ultimately, the group did seem to find the classification of obesity as a disease (at least based on the AMA’s criteria) appropriate enough.
    • Regarding the definition of obesity, the pillar felt that BMI (the most commonly used criteria) does not tell the complete story. The pillar saw a need for more research on mechanisms and processes (such as adiposopathy) that more are more closely linked to the adverse effect of obesity. The pillar also noted that more research is needed to elucidate how obesity varies between genders, age groups, and ethnic and racial groups.
  • What options are available for obesity management? Thinking outside of the box, the pillar labeled prevention as the single most important option in obesity treatment toolbox. Furthermore, it identified prevention as being the best tool for broadly turning the tide of the obesity epidemic. In this vein, the pillar included environmental change in this category, encouraging governments to act at either a local or national level. This pillar was the only one to explicitly mention obesity devices (e.g., GI Dynamic’s EndoBarrier) in its list of therapy choices, indicating that these tools hold the promise of bariatric surgery-like efficacy with less risk and cost. Nutritional supplements and over-the counter medications were also included in the pillar’s list of possible treatment options, although the pillar also underscored that the market is full of distracting options that are not evidence-based.
  • What is the optimal use of therapeutic modalities? The consensus here was that a healthy lifestyle is the foundation for all of the other modalities. Participants felt that risk assessments should drive the intensification of treatment, but were frustrated with the lack of data on the combined use of different modalities (i.e., the impact of adding medication or surgery to lifestyle on outcomes). Coverage emerged as a major issue here, as participants noted that patients need access to any therapy for it to be successful. The pillar therefore raised the concern that payers (including Medicare) do not cover obesity management therapy to a sufficient extent.
    • The pillar identified a number of gaps in knowledge related to this question, namely the lack of data or biomarkers to predict patient response to therapy, as well as data on the long-term outcomes of many therapies and combinations of obesity therapies.
  • Can the optimal framework be cost-effective? The discussion on this question was relatively brief, and culminated in a simple “yes,” given that the DPP and Look AHEAD have shown lifestyle intervention to generally be cost-effective. The data on surgery, according to participants, is less robust, although some studies show cost-effectiveness in as little as two years. A potential issue, according to the pillar, is that interventions that cause individuals to live longer can improve quality of life but also raise healthcare costs.
    • The pillar’s conclusion on the cost-effectiveness of the DPP and Look AHEAD was separately countered in the Health Industry & Economics Pillar session by Dr. Eric Finkelstein (Duke-NUS Graduate School, Singapore). Dr. Finkelstein noted that models were used to demonstrate cost-effectiveness, and that these are not generally accepted by payers since their results are highly sensitive to the assumptions made. Additionally, Dr. Finkelstein commented that DPP participants (after having done the trial) reported that they would not be willing to pay to participate in the DPP if it cost the same amount per person as the actual trial did. 
  • What are the knowledge gaps that need to be filled? There were a number of consensus points in this phase of the discussion. Participants agreed that the lack of agreement on a definition of obesity is a major issue, and that more information is needed to provide a better diagnostic and evaluative criteria than BMI alone. We were very glad that this pillar mentioned the need for health care professionals to receive more training in obesity care, although the timing of that education (medical school versus a fellowship) was open to debate. Finding the critical period for interventions, selecting the best diets, understanding the roles of different adipose tissue depots, and matching the right therapy with the right patient also featured prominently on the list.

 

--by Manu Venkat, Hannah Deming, Nina Ran, Jessica Dong, and Kelly Close