The Implications of Obesity as a Disease

Transcription

1 AGA Technology Workshop The Implications of Obesity as a Disease Lee M. Kaplan, MD, PhD Obesity, Metabolism & Nutrition Institute Massachusetts General Hospital Harvard Medical School LMKaplan@partners.org March 20, 2014

2 Obesity Recognition as a Disease 2004 Medicare abandons policy that obesity is NOT a disease 2007 IRS determines that obesity qualifies for medical deduction 2008 The Obesity Society provides support for considering obesity as a medical disorder 2013 AMA agrees that obesity is a disease

3 but Limitations Remain 1970s Blue Cross Blue Shield excludes anorexiant agents from coverage 2004 Medicare Part D excludes weight loss drugs 2012 Medicare covers nutritional counseling for obesity, but only for services provided within primary care environment 2013 AMA Council on Science and Public Health recommends against designating obesity as a disease 2013 AMA House of Delegates resolution has no legal authority

4 What is Obesity? Excessive fat accumulation that presents a risk to health The presence and severity of obesity can be estimated by a variety of biomarkers Body mass index (BMI) Body composition Body fat distribution Risk scores Comorbidities But these markers should not define obesity

5 Why Obesity is NOT a Disease? It is a lifestyle choice No specific symptoms associated with it It is a risk factor for disease, not a disease itself* Calling it a disease would define one-third of Americans as being ill and could lead to more reliance on costly drugs and surgery rather than lifestyle changes Some people might be overtreated because their BMI was above a line designating them as having a disease, even though they were healthy * What about high cholesterol or hypertension?

6 Why Obesity IS a Disease? It is associated with impaired body function Like other diseases, it results from physiological dysfunction (precipitated by numerous forces in modern society) It causes, exacerbates or accelerates more than 70 significant comorbid diseases It is associated with a substantial burden of morbidity and premature death

7 Complications of Obesity Metabolic Structural Inflammatory Degenerative Neoplastic Psychological Kaplan LM. J Gastrointest Surg 2003; 7(4):

8 Obesity Complications Targets of Therapy Diabetes Hypertension Hyperlipidemia Fatty liver disease Sleep apnea GERD Arthritis Inflammatory and autoimmune diseases Cancer (12 types) Cognitive dysfunction

9 The Economics of Obesity Cut Both Ways The health effects of obesity have severe adverse economic effects The sheer size of the epidemic provides an economic barrier to intervention Societal attitudes justify favoring one economic consideration over the other

10 Why is all this so important? The current standard of care for obesity is: 0 Multiple comparable therapies do not yet exist Thus, relative clinical value is less useful in considering For the near term, considerations of value based on absolute benefit and risk are required Such considerations are based on patient, societal and provider values

11 Barriers to Adoption of Novel Obesity Therapies Treatment Efficacy The Role of Attitude Provider Utilization Payors FDA Therapy Development Efficacy and Risk Evaluation Effectiveness And Utility Evaluation Community Persuasion SUCCESS!! Pathway to Implementation

12 Long-term Control of Obesity 2014 An Enormous Unmet Need 2.5% 1% 0.05% Lifestyle Surgery Medications Unmet Needs 1% = 800,000 U.S. adults 96%

13 Overall Treatment Strategy Typical Algorithm (progress through algorithm as clinically required) Self-directed Lifestyle Change Professionally-directed Lifestyle Change Add Medications Mid-Level Therapies Weight Loss Surgery Post-surgical Combination Therapies

14 Feedback Regulation of Energy Metabolism Sensory Organs GI Tract Environmental sensing Muscle Liver Bone Irisin Energy stores Metabolic activity and needs Leptin Food intake Nutrient handling Energy expenditure Adipose tissue

15 GI Regulation of Metabolic Function Central Mechanisms Appetite, Food Reward Energy Expenditure Metabolic Function Gut hormones Efferent neurons Immune Cells Energy Balance Metabolic Function GI Tract Liver Pancreas Nutrients

16 Overall Treatment Strategy Typical Algorithm (progress through algorithm as clinically required) Self-directed Lifestyle Change Professionally-directed Lifestyle Change Add Medications Mid-Level Therapies GI-targeted Devices Weight Loss Surgery Post-surgical Combination Therapies

17 Is Obesity Really A Disease?

18 The Heterogeneity of Obesity There is broad variability in the weight loss response to ALL therapies for obesity

19 What Differs Among Different Obesity Subtypes Timing of obesity onset Fat location and distribution Metabolic consequences Phenotypic differences Hunger Satiety Reward-based eating Energy expenditure Response to environmental causes Eating Exercise Stress Sleep deprivation Circadian disruption Response to therapies

20 Pathways of Metabolic Regulation

21 Pathways of Metabolic Regulation Better Response to Gastric Bypass

22 Pathways of Metabolic Regulation Better Response to Qsymia

23 Pathways of Metabolic Regulation Better Response to Intragastric Balloon

24 Weight Loss Variability after Gastric Bypass Bessler et al., 2008

25 Weight Loss Variability after Gastric Banding Bessler et al., 2008

26 Weight Loss Varies Widely Among Patients No. of Patients Sibutramine-induced Weight Loss < Weight Loss (kg) Responder Tail Adapted from Hansen DL et al., IJO 2001; 25:496

27 Weight Loss Outcomes From EndoBarrier

28 Heterogeneity of Response Number of Subjects Highly responsive subgroup 0 Weight Loss

29 Conclusions Obesity IS a disease, regardless of designation There are implications (to all of us) of thinking about it this way Physiologically based therapies Heterogeneity of cause Variable treatment response Opportunity to benefit selected subpopulations value of predictive markers Disease designation has important economic and policy implications GI-targeted devices provide some of the best opportunities to address the large unmet therapeutic need Attitudes about obesity underlie the major barriers to successful device development Education of all stakeholders is the key to ultimate success