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Underwriting Obesity andBariatric Procedures

Nicola Charlton, MD.

Medical Director at Catholic Financial Life

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Venus of Willendorf • Statuette of female form circa 24,000

BC

• This idealized portrait was thought to represent high status in a hunter-gatherer society.

• Fat and nude meant fed and warm, as opposed to starving and cold.

• It was an emblem of security and success.

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Extra weight was for yearsconsidered beautiful

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Obesity in Medical History

• Hippocrates wrote obese people died suddenly and earlier compared to lean

• Charles Dickens in the Pickwick Papers described obesity and an associated condition: sleep apnea

• President Taft’s challenges with obesity reported in Annals of Internal Medicine

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Genetics and Natural Selection

• Our biological tendencies to regulate body weight at levels above our ideal weight CANNOT be controlled

• This suggests that natural selection favored FAT

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Western Abundance

• Never before has there been such an abundance of rich, fatty foods and less physical exertion

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The Role of Food Companies• David Kessler, former FDA

Administrator, in his book “The End of Overeating” suggests that food companies cause addictions because of their additives

• Much like cigarette companies use the addictive agent nicotine, food companies manipulate salt, fat, and sugar levels in food - making them more addicting

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High Fructose Corn Syrup

• HFCS significantly cheaper than real sugar• Found in almost everything since 1976 when it

was approved by the FDA• Princeton University study shows rats fed HFCS

with the same amount of calories as rats fed natural sugars, have increased obesity and greater abdominal obesity

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“Environment is the Real Cause of Obesity”Director of Yale University, Center on Obesity Kelly Browning

Environmental Factors:

• Elevator

• Moving sidewalk

• Escalator

• Computer/Video Games

• Television

• Automobiles

• Riding Lawnmowers

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The Beginning of Suspected Problems• While obesity was desirable and

beautiful in the past, the beginnings of suspected problems are just a few decades old

• It was around WWII that there has been an increased understanding that obesity was a risk for increase mortality and the other problems such as Hypertension

• Some of the first to understand this were Life Insurance companies

WWII era poster emphasizing the Basic 7 Food Groups10

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Metrics of Obesity

• Weight/Height

• BMI

• Waist Circumference

• Body Composition - Bioelectric impedance studies, DEXA, skin fold measurement

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Case Study - the applicant

• 55 year old Caucasian female

• 5’6” 220 lbs., BMI 34, BP 135/80, Waist 100 cm

• Past Medical History: Hypertension, dyslipidemia, post-menopausal

• Social/Family- Married, works full-time, walks daily

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Case Study – Underwriting factors

• Post-menopausal

• Central obesity

• Increased CV risk

• Co-morbidities

• Elevated BMI

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Case Study – Underwriting factors

• Family History - Mother d. MI age 60, parents and siblings - obese

• Medications - Atenolol, Simvastatin, multi-vitamin

• Labs - A1C 6%, LDL 110, Cholesterol 240

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In 1943 Metropolitan Life Insurance introduced their standard height-weight tables for Men and Women Height/Weight for Women Height/Weight for Men

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Early Mortality Studies Based on Met Life Weight Tables• 1979 Norwegian study based on 4.2 million

policy holders insured by 25 U.S. and Canadian Life Insurance Companies

• Most favorable mortality was 15% below to 5% above the desirable weight identified in the Met Life height and weight table

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Actual Deaths to Actuarial Deaths

Relative Risk Mortality (RRM)

Women Men

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History of Obesity as a Disease• 1950s - Obesity was seen as a

personal responsibility issue• 1980s - Public Health issue.

Obesity is a disease onto itself, rather than just a risk factor for HTN and Type 2 Diabetes

• 1990s - Obesity is seen as an epidemic

McDonald’s starts in 1952

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Obesity is a Disease• Obesity results in a multitude of chronic health issues • The #1 Health problem in America

It was estimated that up to 400,000 people may die prematurely each year due to obesity related diseases

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Obesity is a leading cause of preventable death worldwide

Leading causes of preventable death worldwide as of 2001, according to researchers working with the Disease Control Priority Network and the World Health Organization

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Body Mass Index History

Developed in mid 19th century by Belgium Socio-physicist as a measure of human body shape based on height and weight

BMI = kg/m2

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Body Mass Index

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Met Life Tables and BMI• J. Epidemiology 1991 from Department of Medicine, USC• One of many papers that correlated the relative weight

derived from Metropolitan Life Tables to BMI to other measures of fatness

• Found them to be very accurate and “nearly identical”• Concluded that BMI is a very good estimate of fatness

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BMI and Adiposity

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Classification of Overweight and Obesity by BMI

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Uneven Progress of Obesity

• Highest prevalence of obesity is among African American women (53%)• Followed by Mexican American women 40-59 years of age (51%)• African Americans are 63% more likely to be obese than non-Hispanic whites• African Americans aged 40-59 years are 54% more likely to be obese than those in the 20-29 year age group

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BMI and Race

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Waist circumference still used

• High Risk: Men >102 cm (>40 in)

• High Risk: Women >88 cm (>35 in)

• No predictive value of waist circumference if BMI >35

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Waist ,BMI, Disease risk

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Prevalence of Obesity Today• According to

NHANES (National Health and Nutrition Examination Survey) 61% of the U.S. population is classified as overweight or obese

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Increasing BMI (1971-1999)Largest among us have become much larger, with the severely obese making up one of the fastest growing segments of the obese population; increasing by 50-75%

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Obesity Trends Among US Adults (BRFSS 2009)

BMI ≥30, or ~ 30 lbs. overweight for 5’ 4” person

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Childhood Obesity

• BMI > 95% for age & sex

• Tripled in the past 30 years

• 32% of children are overweight or obese

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Childhood Obesity

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Childhood Obesity

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Childhood Obesity

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Then and NowIn the 1950s, kids had three cups of milk for every cup of soda. Today that ratio is reversed, meaning they get all the calories and none of the nutrients

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Consequences of Childhood ObesityCommon• Growth• Psychological • Hyperlipidemia• Hepatic Steatosis• Abnormal glucose

metabolism• Persistence into

adulthood

Uncommon• Hypertension• Sleep Apnea• Pseudotumor• PCOD• Cholelithiasis• Orthopedic complications

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Genetics and Morbid Obesity

• Children– With normal weight parents– Slight chance obesity

• Adopted children – Show little correlation of body weight with

adoptive parents– Show 80% correlation with genetic parents

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Adipocyte

The hyperplasia and hypertrophy of the fat cell is the pathologic lesion of obesity

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Physiological Impact of Obesity

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Obesity Related Health Care Costs

• 9% Total Medical Costs• High Personal Costs: spend more money on

health care than smokers• Direct National Cost: Treating obesity related

illness $61 billion• Indirect Costs: i.e. missed work - $56 billion• Disability: increasing disability

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Mortality and Obesity

New England Journal of Medicine, 1999

First Major Study Associating Mortality with Increasing BMI

•1 Million adults followed for 14 years, found relationship between BMI and risk of death

•White men and women- RR of death was 2.58 and 2.0 respectively at BMI > 24.9

•Greater BMI predictive of increased death from CVD, cancer, and all cause mortality

•Lowest rate of death from all causes between 23.5-24.9 kg/m2

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Mortality and BMI

U-shaped curve for BMI

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Mortality and Obesity

Nurses Health Study• Risk of death increases progressively in women

with a BMI > 29kg/m2• Mortality was lowest for women who weighed

15% less than the US average and whose weight has been stable since early adulthood

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Mortality and Obesity

American Cancer Society Prevention Study I Large groups of men and women followed for 14 years, finding that greater BMI associated with increase rate of death from ALL causes and from cardiovascular disease in both men and women up to age 75

- Impact of increased body weight was higher among younger study participants

- BMI.40kg/m2 Risk of death 2.6 times higher for men and 2 times higher for women

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Mortality and Obesity

American Cancer Society Prevention Study II- Even larger study of men and women over 14 years, showing the association of BMI and mortality was affected by smoking status and history of other diseases

- Black men and women had lower risks than white men and women

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BMI and Mortality Risk

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Obesity and Cardiovascular DiseaseCHD - Leading cause of mortality and morbidity in the US

770,000 Americans experience acute myocardial infarction

430,000 Americans experience recurrent cardiac adverse events

BMI>35kg/m2 = 3 fold increase in all cause mortality and cardiovascular mortality, but increase in death from CVD related to confounding variable such as hypertension, hypercholesterolemia, and diabetes

Obesity associated with increase of developing heart failure and atrial fibrillation

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Obesity and Cardiovascular DiseaseFinnish Heart StudyAssociation between obesity and CVD

Study found that for each 1kg increase in body weight, the risk of coronary mortality increased by 1%.

A large number were medicated through high blood pressure

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Obesity and Cardiovascular DiseaseSwedish Obesity StudyFollowed 2 year incidence rates of new cases for overweight individuals

Morbidities associated with increasing BMI

Increase HTN 15%

Increase Diabetes 7.8%

Increase Hyperinsulinemia 5.8%

Increase Hypertriglycerides 27.8%

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Obesity and Cardiovascular Disease

Obesity mediated through inflammatory process, such as C-Reactive Protein (C-RP)

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Relative Risk for Diastolic Blood Pressure, Hypercholesterolemia and BMI

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Obesity and Type II Diabetes Mellitus- By 2025 worldwide prevalence of Type 2 Diabetes

estimated to be 300 million

- 90% who have Type 2 Diabetes are overweight

- Recent study reported a reduction of 8 years in life expectancy in an individual who is diagnosed with Diabetes by age 40

- 65% of patients who have Type 2 Diabetes die from a cardiovascular event

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Age Adjusted Relative Risk of DM

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Obesity and Hypertension

Framingham Heart Study79% of Hypertensive men and 65% hypertensive women

are overweight or obese

- Hypertension increases CHD risks and exacerbates vascular complications including CAD, chronic kidney disease, stroke, and peripheral vascular disease

NHANES IIILinear relationship between BMI and systolic and diastolic blood pressure

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Obesity and Cancer

Overwhelming evidence that obesity increases risk for certain cancers

– Breast cancer– Colon cancer– Uterine/Ovarian

Caused from increase levels of hormones

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Obesity and Metabolic SyndromeNational Cholesterol Education Program Adult Treatment Panel

III guidelines for diagnosing the metabolic syndrome- Abdominal obesity defined as a waist circumference of 102 cm (40 in)

in men and 88 cm (35 in) in women- TG levels of 150 mg/dL or more (1.7mmol/L)- HDL-C levels of less than 40 mg/dL (1mmol/L) in men and less than

50mg/dL (1.30mmol/L) in women- Blood Pressure levels of 130/85 mm Hg or higher- Fasting glucose levels of 100 mg/dL or greater (5.5mmol/L)

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The Pathology of Excess Fat

Risks from Metabolic Changes

- DM

- Gallbladder Disease

- HTN

- CVD

- Some Cancers

Risks from increase weight

- Osteoarthritis

- Sleep Apnea

- Stigma of Obesity

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Effects of Overweight, Body Fat, and Weight Gain on Mortality

Annual deaths attributable to obesity

280,000 – 325,000

with 80% of these deaths at BMI > 30kg/m2

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Cost of Co-morbidities attributable to Obesity in the US

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Options for Treating Obesity

Non-surgical Limited long-term success

- low calorie diets

- behavioral therapy

- exercise programs

- pharmacotherapy

Surgical- Currently the best and most successful method for sustained weight-loss - Has shown to substantially improve or resolve any co-morbidities: HTN, sleep apnea, and Type 2 Diabetes

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Surgical Approaches to Obesity• Weight loss surgery is the only effective treatment for

severe, medically complicated and refractory obesity.• It does reverse, eliminate or significantly ameliorate

numerous life-threatening medical co-morbidities that occur as part of pathophysiology of obesity

• Rapid changes in Surgical technique, technology, and demand for weight-loss surgery has made it a dynamic area of medicine

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Candidates for Bariatric Surgery- BMI > 40kg/m2 - or - BMI > 35kg.m2 with significant obesity-related co-morbidities

- Acceptable operative risk

- Documented failure of nonsurgical weight-loss programs

- Psychologically stable with realistic expectations

- Well-informed and motivated patient

- Supportive family/social environment

- Absence of uncontrolled psychotic depressive disorder

- No active alcohol or substance abuse

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Bariatric Surgical ProceduresMalabsorptive

- Biliopancreatic diversion

Restrictive- Vertical banded gastroplasty

- Adjustable gastric band

- Sleeve Gastrectomy

- Gastric balloon

Mixed Procedures- Gastric Bypass or Roux -en- Y

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Malabsorptive Procedures

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Malabsorptive Procedures• Weight loss from interference with normal physiologic absorption of nutrients by structural

changes of the GI tract• Very complex procedure• Rarely performed now because of severe problems with malnutrition• Improvement on this procedure was Duodenal Switch

– Minor part of the stomach was resected– Part of the small intestine is connected to the new stomach pouch

• Weight loss from interference with normal physiologic absorption of nutrients by structural changes of the GI tract

• Very complex procedure• Rarely performed now because of severe problems with malnutrition• Improvement on this procedure was Duodenal Switch

– Minor part of the stomach was resected– Part of the small intestine is connected to the new stomach pouch

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Advantages of Malabsorptive Procedures• Very high weight loss

• Very low risk of regain

• 98% type 2 diabetes mellitus resolved

• 99% hyperlipidemia resolved

• 83%hypertension resolved

• No dumping syndrome/can be reversible

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Disadvantages of Malabsorptive Procedures• Life-long follow-up with blood tests

• High incidence of diarrhea

• Only select centers preform operations because very complex and technical

• So many complications essentially abandoned

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Vertical Banded Gastroplasty or “Stomach Stapling”• A band and staples are used to create a small pouch with

a small whole for food to flow to rest of the stomach• Not used much anymore• 80% of patients had some weight loss, but after 10 years,

only 10% had lost 50% of their excess weight

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Vertical Banded Gastroplasty

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Advantages ofVertical Banded Gastroplasty• No dumping syndrome

• No nutritional deficiencies or malabsorption

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Disadvantages ofVertical Banded Gastroplasty• Not reversible

• Strict compliance with diet or stomach stretching and high caloric foods will decrease weight loss

• Patient complaints of gastric reflux, nausea and vomiting are common

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Adjustable Gastric Banding

• No malabsorption

• No maldigestion

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Advantages of Adjustable Gastric Banding• Less invasive than bariatric surgery• Lack of stomach stapling, cutting on intestinal re-routing• Absence of permanent changes to GI track• Reversible• Short operation and time in hospital stay• Fewer readmissions• Low Rate of early complications• Rarity of life-threatening complications• Low risk of nutritional deficiencies or malabsorptions

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Disadvantages of Adjustable Gastric Banding• Some changes in eating and disciplinary behavior• Slower initial weight loss• Regular follow-up for band adjustments is critical to

produce optimal results

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Complications of Adjustable Gastric Banding• GI perforation• Pouch dictation from over-inflation of band or

excessive food intake• Band slippage (gastric prolapse, herniation) due

to improper monitoring post-banding• Band Erosion• Port leakage or migration

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Successes ofAdjustable Gastric Banding

Weight loss- 3 large international trials have accumulated post-surgical data showed average of 56% Excess Weight Loss (%EWL) which is comparable to Roux-en-Y gastric bypass of 59%

Usually US studies show mean %EWL of:

- 53% at 36 months

- 52% at 48 months

- 54% at 60 months

- 57% at 72 months

Although AGB is good generally, Roxux-en-Y gastric bypass affords greater weight loss

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Co-Morbidities Improved after Adjustable Gastric BandingBand system reduces or eliminates several major co-morbidities: • HTN• Diabetes• Sleep Apnea• Hypercholesterolemia

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Sleeve Gastrectomy

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Sleeve Gastrectomy• Functions by reducing stomach size

• Stomach becomes like a tube

• 80-85% of stomach removed

• Decreases production of Ghrelin (“Hunger hormone”)

• Limited malabsorption

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Advantages of Sleeve Gastrectomy

• Nerves to stomach and pylorus remain intact

• Stomach function preserved

• Eliminates dumping

• Eliminates reactive hypoglycemia

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Disadvantages of Sleeve Gastrectomy• Sleeve leaking

• Aversion to some foods with nausea

• Possible gastroparesis

• Esophogeal spasm and heartburn

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Gastric Bypass Roux-en-Y

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Roux-en-Y Gastric Bypass• Gold Standard bariatric surgical procedure in US

• Most common by choice in American Bariatric surgeries

• Combination of gastric resection and variable reposition of limb; either long limb resection or very very long limb resection of roux limb to enhance weight loss

• Long-term EWL of 50-60% in 80% of patients

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Advantages of Roux-en-Y

• Commonly preformed- over 90% of WLS

• Improves obesity-related co-morbidities and produces significant long-term weight loss

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Disadvantages of Roux-en-Y

• Surgical complications, anastomotic leaks, intestinal obstructions and hernias.

• Strictures

• Dumping syndrome

• Nutritional deficiencies

• Lifelong patient follow-up important

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Comparison of Surgical Procedures

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Risks of Bariatric Procedures

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Complications after Bariatric SurgeryStudy of insurance claims of 2,522 who had bariatric procedures• 22% had complications during initial hospital stay• 40% risk of complications in subsequent 6 months

Medical review of 16,1555 patients (Flum et al)• 30 day all cause mortality- 2.0%• 90 day all cause mortality- 2.8%

Age > 65 years, male sex, low surgery volume i.e. <25-30/year• 30 day all cause mortality- 4.8%• 90 day all cause mortality- 6.9%

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Malabsorptive Problems after Bariatric ProceduresProtein deficiency (protein taken in goes to glucogenesis)

Need to replace EFA (fat soluble vitamins and EFA not absorbed)

Micro nutrients• Iron: 32% in one survey had iron deficiency after one year • B-12: 30% had defciciency even with supplementation• Folate, B6, Zinc, Vit A, Vit E, Vit K, Magnesium, Thiamine• Calcium and Vit D: all have some sort of metabolic bone disease. All develop osteoporosis. Recent Mayo Clinic study showed fracture rate of post bariatric patients significantly increased in the hips, spine and wrist. Many have chronic skeletal pain and bone tenderness

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Benefits

Of Bariatric

Surgery

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Life Expectancy “What Life Underwriters care about”

• Morbid obesity: an obese young adult with co-morbidities and BMI over 45 has a 13 year shorter life-span

• Various articles all show improvement in many co-morbidities, including recent discussion in NEJM articles of Type 2 Diabetes as essentially resolved after bariatric procedure

• Some studies show increased survival after 10 years in some areas…

• But does bariatric surgical procedures improve mortality?

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Long-Term Mortality after Gastric Bypass NEJM: Retrospective cohort study of approximately 8,000 surgical patients with bariatric bypass and 8,000 controls• After 7 years, long term mortality decreased by 40% • 37 deaths per 10,000 vs. 57 deaths per 10,000• Cause specific death decreased

CAD (2.6 vs. 5.9/10,000) – 56%DM (.4 vs. 3.4/ 10,000) – 92%CA (3.5 vs. 13.3/10,000) – 60%

• Deaths from accidents & suicide were higher in surgery group than in control group (11.1 vs. 6.4/10,000- 58%) 96

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Challenges of Bariatric Outcomes• No long term mortality studies• No standardization of success or failure

- Most studies consider 50% of excess weight-loss “success”• Few agreed-upon measures of outcomes• No agreement on what is a major or a minor surgical complication• No consistent agreement of what constitutes an early surgical

complication or a late complication (some studies do not even

consider re-operation a complication)• Studies are difficult due to lack of consistent follow-up by patients,

patients switching health providers, health insurance changes, and

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What’s Ahead - Medications

Medical treatment of obesity

•Lorcaserin– Trade name: Belviq

•Phenteramine/Topiramine– Trade name: Qsymia

•Both approved BMI > 27 with comorbidities

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Lorcaserin

• Selective Serotonin Receptor Agonist - 5HT receptor

• Appetite and weight reducing effect of serotonin are thought mediated by 5HT receptor in brain

• Side Effects/warnings: Valvular heart disease

• Cognitive impairment

• Depression and suicidal thoughts

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Phenteramine/Topiramate • 2 old drugs packaged together

• Teratogenicity- only prescribed through central pharmacy

• Lots of Side Effects/warnings

• Mood changes, cognitive disorders, suicidal ideation, increased Creatinine, metabolic acidosis

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Orlistat

• FDA Approved in 1999

• Interferes with the absorption of fats in the intestines

• Numerous clinical trials show efficacy and safety

• Often used in Metabolic Syndrome and Major Type 2 Diabetes Mellitus

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Obesity Drugs in the near futureand on the distant horizonRimonabant – Cannabinoid receptor block

- 1 receptor antagonist

- Marijuana stimulates Cannabinoid receptors and causes increase in

high-fat, high-sweet foods. This drug blocks Cannabinoid receptors.

- Several major studies will be out soon (approved in Europe)

Leptin – Leptin hormone-modulator

- Lack of Leptin (derived from fat cells) causes massive obesity, replacement of Leptin reduces weight

- Studies focus on a general treatment of obesity

Axokine – Neurotransmitter, histamine

- 3 antagonists: brain energy and sensing modulations -product of fat cells

- Originally used for ALS, found to cause loss of appetite 102

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Obesity Drugs in the near futureand on the distant horizonGhrelin

- Hunger regulating hormone produced in stomach and pancreas

- Receptors in many tissues also found associated with dopamine levels and thus stress, depression, sleep issues

- Levels decrease significantly after gastric bypass , possible vaccine or medication targeted at receptors

- Medication binds to targeted receptors. Prevents Ghrelin from binding with receptors and reaching the CNS, which prevents weight gain

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Pharmaceutical companies looking for antagonists to inhibit food intake

- Numerous peptides in stomach and small intestine that are released to restrain consumption and minimize postprandial glucose

- Gastrointestinal signals seem to respond to macronutrients consumed

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Exercise and Diet• Backbone of Obesity Treatment (before

and after surgery) is still Exercise and Diet

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Now back to our Applicant

• Weight history• Over weight child or as a young adult?

• Co-morbidities and duration of them?

• Additional problems:• tobacco • exercise• psychological history• alcohol history

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Pregnancy after Bariatric surgery• Weight loss does help fertility• Reduced rate of gestational diabetes, HTN, pre-eclampsia

and macrosomia• Complications increase – risk of intestinal obstruction or

other surgical emergencies. One study had 3 maternal deaths and 5 neonatal deaths from these surgical emergencies.

• Increase risk of growth retardation of neonate or low birth weight

• Treat all pregnant women after bariatric surgery as a high-risk pregnancy

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Checklist for Underwriters

• BMI

• Waist circumference

• Co-morbidities and duration of them?

• Any secondary causes or medications?

• Bariatric procedure• Type of procedure and location?

• Follow-up and regular blood work?

• Co-morbidities resolved or improved?

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Underwriting is an Art and Science

• Applicant, and others like her, have many variations on similar themes, but many decisions involve an interplay of factors and subtle differences that only an experienced Underwriter can ascertain.

• Mortality increasingly found linked to many social determinants and not medical ones.

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Determinants of Health

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The EndThe End

I’m not over-weight, I’m under-tall.111