March 17, 2000

Reference: CC:DOM:IT&A:2-COR-115281-99

Dear Ms. Crisalli:

On behalf of the American Obesity Association and other petitioners, I am pleased to submit the following information in support of our petition for a Revenue Ruling allowing the costs of treatment of obesity to be treated as a medical expense deduction. Obesity is a major public health crisis. It is the second leading cause of preventable death in the United States. The prevalence of obesity is increasing at an alarming rate among all racial, ethnic and gender categories. It is a major cause of other conditions, such as type 2 diabetes, hypertension, heart disease and several forms of cancer. Under interpretations of the Internal Revenue Service, weight loss is one of the very few medical treatments excluded from eligibility as a medical expense. Pursuant to the petition submitted September 14, 1999, petitioners seek a new Revenue Ruling to provide equitable treatment to persons with obesity.

The American Obesity Association is a non-profit advocacy organization incorporated in the State of Delaware and exempt from taxes pursuant to Section 501(c)(4) of the Internal Revenue Code. It is supported by membership dues and major support from corporations including Amgen, Knoll Pharmaceutical Inc, Hoffman-LaRoche, and Weight-Watchers Inc.

The contents of our submission are:

1. Background
2. Requested Action
3. The Medical Deduction Provision of the Internal Revenue Code
   1. The IRS Policy on Weight Loss
4. What is Obesity
5. Obesity Meets Generally accepted Scientific Definitions of Disease
   1. Medical Dictionaries, Encyclopedias and Texts
   2. Authoritative U. S. and International Authorities
   3. Medical Journals
   4. Other Indicia of Disease
6. Obesity Meets the Statutory Requirement “Affecting any Structure or function of the body”
7. Obesity is so closely related to the Onset of Specific Diseases that it is more than general maintenance of health and well-being. Weight Loss by an Obese Person Prevents the Onset of Disease

Appendix A Obesity and Addiction

Attachments

1. Petition for Revenue Ruling
2. Rev. Rul. 79-151
3. IRS Response
4. Definitions
5. NIH Guidelines
6. AOA Guidelines
7. ASBP Guidelines
8. ASBS Guidelines
9. AACE/ACE Guidelines
10. American Heart Association
11. Obesity Surgery
12. World Health Organization
13. Federal Trade Commission Partnership for Health Weight Management

Respectfully submitted,

Morgan Downey
Executive Director

I. Background

On September 14, 1999, the American Obesity Association and 10 other organizations petitioned the Commissioner of the Internal Revenue Service to issue a revenue ruling allowing individual taxpayers to include the costs for the treatment of obesity as a medical expense (Attachment 1), reversing Rev. Rul. 79-151. (Attachment 2)

The Internal Revenue Service responded on October 15, 1999. (Attachment 3). In its response, the IRS indicated that reversing Rev. Rul. 79-151 would require facts establishing either:

• obesity is itself a disease, or,
• weight loss by an obese person prevents the onset of disease.

We would like to note here two apparently arbitrary limitations of the IRS letter of October 15, 1999. First, the letter ignored the second phrase of the statutory authority for the medical care expense deduction, namely, expenses “or relating to the structure and function of the body.” (Section 213 of the Internal Revenue Code)

As demonstrated below (See Section VI), by definition, obesity is excess adipose tissue which constitutes part of the structure of the body. Therefore, costs for the treatment of obesity meet the statutory definition of expenses relating to the structure and function of the body.

Second, the IRS letter excluded consideration that obesity, or a subset of obesity, might be definable as an addiction which is the basis for covering smoking cessation products and programs. The IRS response noted that historically Rev. Rul. 79-162 was issued at the same time as Rev. Rul. 79-151 which similarly held that the cost of smoking cessation programs are not deductible as a medical expense. The Service went recently revoked that ruling because scientific and medical research established that nicotine is addictive. However, the IRS noted that “A similar rationale would not apply to a weight loss program.”

Today, the American Obesity Association responds to the IRS’s request for further information. We are submitting substantial, if not overwhelming, generally accepted scientific evidence that:

1. obesity meets scientific definitions of disease,
2. obesity is so closely related to the onset of disease or illness that weight loss is more than merely the maintenance of general health and well-being, and weight loss by an obese person prevents the onset of disease or illness, and,
3. obesity treatment is related to the structure and functioning of the body.

II. Requested Action

On the basis of the evidence offered, we respectfully request that the Internal Revenue Service revoke Revenue Ruling 79-151 with a new ruling allowing costs for the treatment and prevention of obesity, including surgery, pharmacology, behavioral counseling and programs for the specific purpose of weight maintenance and weight loss, be an allowable medical care expense deduction.

III. The Medical Deduction Provision of the Internal Revenue Code.

Section 213 of the Internal Revenue Code provides a deduction for the uncompensated expenses for the medical care of the taxpayer, the taxpayer’s spouse and dependents to the extent that those expenses exceed 7.5% of adjusted gross income. The statutory definition of “medical care” includes expenses for the “diagnosis, cure, mitigation, treatment, or prevention of disease, or for the purpose of affecting any structure or function of the body.

Treasury Regulation §1.213-1(e)(1)(ii) provides, “ Deductions for expenditures for medical care allowable under section 213 will be confined strictly to expenses incurred primarily for the prevention or alleviation of a physical or mental defect or illness…However, an expenditure which is merely beneficial to the general health of an individual, such as an expenditure for a vacation, is not an expenditure for medical care.”

These definitions apply not only to the individual tax returns. They also apply to the experimental program of medical savings accounts. IRC § 220(d)(2).

The IRS has approved a broad array of expenditures for the medical deduction services including:

• Acupuncture
• Alcoholism Rehabilitation
• Ambulance
• Artificial limbs
• Birth control pills
• Braces
• Crutches
• Dentures
• Diagnostic tests
• Drugs by prescription
• Eyeglasses
• Nursing
• Christian Science, chiropractors, osteopathic services
• Hospital
• Insulin
• Laboratory fees
• Physician services
• Organ donation
• Orthopedic shoes
• Oxygen
• Psychiatric services
• Psychologist fees
• Smoking cessation
• Special foods and beverages
• Wigs
• X-rays
• Vasectomy operations

• Tuition at special schools for handicapped children
• Lead base paint removal
• Braille books and magazines
• Capital improvements to homes
• Seeing eye dogs
• Specially equipped cars
• Notetaker for deaf person
• Legal fees for guardianship of mental patient
• Legal fees for involuntary commitment of mental patient
• Long distance phone calls for counseling
• Transportation expenses to a better climate

Under the Internal Revenue Code expenses not approved for the medical deduction include:

• Cosmetic surgery
• Tattoos
• Ear piercing
• Gravestones
• Baby-sitting for parent to visit doctor
• Divorce counseling
• Health clubs
• Toothbrushes, cosmetics and,
• Expenses for weight loss
• (See, United States Tax Reporter ¶ 2134.04, ¶2135)
  

An example of the Internal Revenue Service broad interpretation of “medical care” can be seen in Rev. Rul. 80-340. In that ruling the IRS looked at whether the cost of special equipment that display the audio portion of television programs as subtitles on the screen of a television set is an expense for medical care. The equipment could be either a unit which attaches to a conventional television set or the excess cost of a specially equipped color television. In Rev. Rul. 80-340, the Service held that such expenses qualify as expenses for medical care.

· IRS Policy on Weight Loss

In Rev. Rul. 79-151, the Service held that an individual’s “cost for participating in a program designed to help (individual) lose weight is not deductible as a medical expense under section 213 of the Code, but it is an expense the deduction of which is prohibited by section 262. Section 262 provides that no deduction shall be allowed for personal, living, or family expenses. Rev. Rul 55-261, 1955-1 C.B. 307, question 9 at page 310 holds that “ordinarily, fees paid to a health institute where the taxpayer takes exercise, rubdown, etc. are personal expenses.”

“Such fees,” continues the text of Rev. Rul. 79-151, “may be deductible as medical expense only when the treatments by the institute are prescribed by a physician and are substantiated by a statement by the physician to be necessary for the alleviation of physical or mental defect or illness of the individual receiving the treatment. Furthermore, Rev. Rul. 55-261, question 16 at page 312, holds that amounts expended for the preservation of general health or for the alleviation of a physical or mental discomfort that is unrelated to some particular disease or defect are not expenses for medical care.”

One notes immediately an internal inconsistency in Rev. Rul. 70-151. Namely, the discussion section underlined above is not carried over to the holding. Reading the text alone, one is led to look for a physician’s statement of necessity for the treatment of a specific condition to qualify an expenditure for weight loss. However, the holding is so broad that even a physician’s attestation of necessity for a specific condition is insufficient for the medical expense deduction. The holding of Rev. Rul 79-151 has been carried into IRS practice. IRS Publication 502, states: “You cannot include the cost of a weight loss program for your general health even if your doctor prescribes the program.”

Yet, in a private letter ruling (Priv. Ltr. Rul. 80-04-111, October 31, 1979), the Service allowed a deduction of expenses for an individual to participate in a weight reduction program primarily for the treatment and cure of hypertension, obesity and hearing problems that are directly related to the individual’s excessive weight. The weight loss program was prescribed by two physicians to treat these specific illnesses.

In other words, Rev.Rul. 79-151 is internally inconsistent and inconsistent with Priv. Ltr.Rul 80-04-111. Therefore, the Rev. Rul. 79-151 should be clarified to be clear that expenses for the treatment or prevention of obesity are eligible for the deduction.

IV. What is Obesity

The average adult male consumes nearly one million calories a year and expends about the same amount. An error of just 1% greater intake will increase body weight 2.2 a year or 22 lbs. in a decade. Likewise, an excess of just 300 calories a day will result in the accumulation of 30 pounds in just one year. For about half of the population, the regulation of body weight does not work as it should. How does this regulation of body weight occur?

The regulation of body weight is a complex physiological process. To maintain a stable body weight, the ratio of fat to carbohydrate consumed must equal the ratio of fat to carbohydrate used in the body. The body can only do two things with excess fat or carbohydrate: burn it in energy expenditure or store it as fat. The excess stored results in an increase in body weight.

Food intake is initiated by several factors including the social environment, availability of food and internal hunger drives which lead to food seeking. Signals from the ingestion of food can act to reduce future short-term food intake by one of several mechanisms, including hormones, nutrients, or neuronal signals.

Information about the status of energy in the body and food intake is integrated in the brain, where efferent signals are generated that lead to food seeking and ingestion or termination of meals. Other signals activate various systems for storage or release of nutrients from fat tissue. The pituitary and adrenal glands are involved because the development of obesity depends on the presence of adrenal steroids to a much greater extent than any other endocrine system.

Inhibition of food intake may be produced by the nutrients themselves as well as hormones released when food enters the gastrointestinal tract. Of these hormones, cholecystokinin has received the most attention but other candidates exist. Nutrients may trigger signals transmitted over the vagus or sympathetic nerves as nutrients are absorbed from the gastrointestinal track or pass through the liver. For example, as glucose is absorbed and passes through the liver, the activity of the vagus nerve slows and this signal is transmitted to the brain. Several centers in the brain are involved in the feeding process. Afferent messages from the vagus nerve enter the vagal center and are relayed to the hypothalmus. The hypothalamic coordinating centers also receive information from other parts of the brain that monitor sight, smell, and taste of food.

Internal metabolic signals such as low glucose or high insulin levels may also act directly on areas in the medial or lateral hypothalmus. Destruction of the medial hypothalamus (specifically the paraventricular and ventromedial nucleus) is associated with an increase in food intake and obesity in a wide variety of animals and birds. The central intergration of messages about feeding involves two monoamine neurotransmitters (norepinephrine and serotonin) whose effects may be modulated by a variety of small peptides released from nerve endings.

Several peptides, including the opioids, neuropeptide Y, and galanin are known to stimulate food intake when injected into appropriate brain areas. Several other peptide hormones are known to depress food intake. These inhibitory and stimulatory systems operate on the motor control of food seeking and food intake and indirectly on the metabolic processing of food. The ingestion of food can activate the sympathetic nervous system as it leaves the brain. This alteration in sympathetic activity associated with food intake may also modulate the release of insulin from the pancreas. The scientifically emerging picture of the physiology of adipose tissue regulation appears to involve the following sequence:

1. increase in size or number of adipocytes,

2. increase expresson of the ob gene in adipocytes and increased secretion of leptin by white adipose tissue into the bloodstream,

• increased levels of plasma leptin
• increased binding of leptin to receptor in the hypothalamus
• reduced synthesis of neuropeptide Y in nerves in one region of the hypothalamus and,
• decrease in eating and loss or maintenance in body weight.

There is no doubt about the seriousness of obesity as a public health issue. Obesity is responsible for approximately 300,000 deaths each year, second only to smoking as the leading cause of preventable deaths in the United States. Between 1988-1994, 23% of adults and 11% of children were obese. Rates of obesity continue to rise throughout the American society.

Obesity is a known to substantially raise the risk of illness from such diseases as hypertension, Type 2 diabetes, heart disease, stroke, gallbladder disease, arthritis, sleep apnea, and cancers such as endometrial, breast, prostate and colon. Obese individuals may also suffer social stigmatization, discrimination and lowered self-esteem. At severe levels, obesity is a major cause of disability.

There is a spectrum of treatments for obesity including surgery, pharmacology, medically supervised diets, over the counter products, behavioral counseling, support groups, educational programs, self-help groups and individual programs of self-management. For effective weight loss and maintenance, individuals must engage in highly disciplined, sustained changes in food consumption and energy expenditure. The long term rigor and discipline required for these treatments distinguish them from personal expenses, “such as vacations” (Rev.Rul. 79-151) which are not permitted to be deducted from individual taxes.

• Obesity Meets Generally Accepted Scientific Definitions of Disease

The IRS has requested substantial generally accepted scientific evidence that obesity itself is a disease. In the following section, we will establish that:

1. obesity meets generally accepted definitions of disease, and,
2. obesity is recognized as a disease by authoritative United States and international organizations.

In addition, one can ask whether obesity meet the indicia of a disease. Were obesity to be considered a disease, one would expect to find:

• discussions of the etiology, treatment and prevention in medical literature
• medical societies focusing on the disorder including conducting conferences of medical education, developing practice guidelines and publishing journals
• a range of treatment options from surgery and medicines to counseling, therapy and self-help groups
• United States and international health care institutions examining various aspects of the disease
• research and discussions about the disease in the medical and scientific literature.

There are two issues to address. First, what is the definition of a disease and second, is the definition of disease compatible with the definition of obesity.

We note that the IRS uses both “disease” and “defect” to describe covered conditions. In the medical literature, “disease”, “defect”, “illness”, “condition” and “syndrome” all have similar meanings and are often used interchangeably. The term “disorder” is defined usually as a derangement or abnormality of function, a morbid physical or mental state. (Dorland’s). The term “disorder” is virtually synomyous with “disease” and with “illness”. It is frequently seen in connection with obesity.

Some conditions have “disease” as part of their common names, such as “Alzheimer’s disease” and “Parkinson’s Disease.” Others, such as muscular dystrophy, cancer, stroke or AIDS, are used without the additional word “disease.” For example, one almost never sees the term “cancer disease” or “autism disease” or “depression disease,” but they are diseases nonetheless. So it is with obesity.

In public perceptions, obesity may not be seen as a “disease” except in exceptional cases, such as an individual with high or morbid obesity. There are several reasons for this including a belief that overweight is a matter of willpower, gluttony or sloth and can therefore be easily preventable by an individual. However, scientific and medical understanding has moved well beyond this moralistic attitude.

Body weight regulation is now understood to be similar to the body’s ability to regulate its temperature and blood pressure. It involves genetic predisposition and environmental triggers. The reason that weight loss is so often unsuccessful is that it is met with an ever vigilant biological mechanism that effectively tries to return weight to baseline. Thus in trying to lose weight, the patient is not just testing willpower but resisting an active feedback mechanism. This mechanism is effective because it has evolved over time. Losing weight has been maladaptive throughout much of the evolution of the human species where there was more activity and less food than is the norm in the developed modern world.

1. Medical Dictionaries, Encyclopedias and Textbooks

Attachment 4 includes definitions of “disease,” “disorder,” “illness,” and “obesity” from the fifteen (15) medical dictionaries:

Stedman’s Medical Dictionary 27th Edition
Mosby’s Medical, Nursing & Allied Health Dictionary, 5th Edition
Oxford Medical Companion, 1994
Dorland’s Illustrated Medical Dictionary, 28th Edition
International Dictionary of Medicine and Biology, 1986
Taber’s Cyclopedic Medical Dictionary, Ed. 18,
The Sloane-Dorland Annotated Medical-Legal Dictionary
Churchill’s Illustrated Medical Dictionary, 1989
Dictionary of Modern Medicine,
Academic Press Dictionary of Science and Technology, online 2/25/2000
Cambridge Dictionary of American English, online 2/25/2000
The Newbury House online Dictionnary, 2/25/2000
Merriam-Webster, WWWebster Dictionary online 2/25/00
Merriam-Webster Thesaurus, online 2/25/2000
Cancer Web, the On-Line Medical Dictionary, 2/25/2000

As one would expect, most definitions of “disease” are quite similar. Two are taken here as representative definitions of disease:

Disease “A condition which alters or interferes with the normal state of an organism and is usually characterized by the abnormal functioning of one or more of the host’s systems, parts, or organs. It may be due to an unknown cause or may result from an inherent metabolic or structural deficiency, including congenital and hereditary defects and degenerative processes, or from such factors as stress, noxious stimuli, toxic agents, injury, or infection. A given disease is often manifested by a characteristic set of signs and symptoms, although a host organism can be asymptomatic while having microscopic, serologic or immunologic evidence of disease.”

International Dictionary of Medicine and Biology, 1986, J. Wiley & Sons, N.Y.

Disease. 1. “An interruption, cessation, or disorder of body functions, systems, or organs. Syn. Illness, morbus, sickness. 2. A morbid entity characterized usually be at least two of these criteria: recognized etiologic agent(s), identifiable group of signs and symptoms, or consistent anatomical alterations.3. Literally, dis-ease, the opposite of ease, when something is wrong with a bodily function.

Stedman’s Medical Dictionary, 26th Ed, Williams & Wilkins.

Some definitions of disease are more specific. Mosby’s second definition states, “a specific illness or disorder characterized by a recognizable set of signs and symptoms, attributable to heredity, infection, diet or environment.”

Two representative definitions of obesity are:

Obesity “A state of excess accumulation of body fat. Obesity is defined specifically as an increase in body weight of more than 20% above the standard weight for a person’s height, adjusted for age, sex, and race, although some authorities recommend that an excess of 10% is cause for treatment. Obesity has been associated etiologically with genetic, hypothalmic, and endocrine factors, and physical and psychologic trauma. Obese individuals have increased morbidity and mortality from respiratory diseases, hypertension, and endocrine and metabolic disorders. The usual treatments consist of diet therapy and behavior modification.”

International Dictionary of Medicine and Biology, 1986, J. Wiley & Sons, N.Y.

Obesity “An abnormal increase in fat in the subcutaneous connective tissues.”
Stedman’s Medical Dictionary, 26th Ed.

Medical dictionaries include different subtypes of obesity including: adrenocortical,
alimentary,
centripetal,
endocrine,
exogenous,
obesity of hyperinsulinism,
hyperinterrenal,
hypogonadal,
hypothalamic,
hypothyroid,
morbid,
pituitary,
plethoric and
simple.

Other common subtyping involves the time of the development of fat cells. The type of obesity involving mainly an increase in cell size is called hypertrophic while that involving an increase in cell number is called hyperplastic.

The terms “overweight” and “obesity” are sometimes used interchangeably. However, they are different. Obesity properly defined is excess body fat or adipose tissue. When overweight is sufficiently great, it almost certainly implies obesity.

Stedman’s Medical Dictionary quoted above contains one of the more restrictive definitions, namely, “A morbid entity characterized usually by at least two of these criteria: recognized etiologic agent(s), identifiable group of signs and symptoms, or consistent anatomical alterations.”

Does obesity meet these criteria? We can see that “obesity” meets not just two but all three criteria.

First, does obesity have recognized etiologic agent(s)?

The answer is yes. Consistent with generally accepted scientific understanding, the National Institutes of Health has stated:

“Adipose tissue is a normal constituent of the human body that serves the important function of storing energy as fat for mobilization in response to metabolic demands. Obesity is an excess of body fat frequently resulting in a significant impairment of health. The excess fat accumulation is associated with increased fat cell size; in individuals with extreme obesity, fat cell numbers are also increased. Although the etiologic mechanisms underlying obesity require further clarification, the net effect of such mechanisms leads to an imbalance between energy intake and expenditure. Both genetic and environmental factors are likely to be involved in the pathogensis of obesity. These include excess caloric intake, decreased physical activity, and metabolic and endocrine abnormalities. Hence, a number of subtypes of obesity exist.” (Health Implications of Obesity, NIH Consensus Statement, online 1985, Feb. 11-13 5(9):1-7)

Second, does obesity have an identifiable group of signs and symptoms?

The signs and symptoms are an excess accumulation of adipose tissue or body fat. Other signs or symptoms normally found include insulin resistance, increased glucose, elevated cholesterol and triglyceride levels, decreased HDL and norepinephrine and alterations in the activity of the sympathetic and parasympathetic nervous system.

Third, does obesity have consistent anatomical alterations?

Clearly yes, the altered physical dimensions of the individual, frequently measured in waist size.

Therefore, obesity meets all the accepted definitions of “disease” on the basis of generally accepted scientific evidence.

Obesity also receives full treatment in a host of medical encyclopedias and textbooks. Copies of the chapters or references can be supplied upon request. A representative sample includes:

• “Obesity is a serious chronic disease associated with numerous complications and comorbidities that involve most systems of the body.” (at p. 1460)
• The Encyclopedia of Human Nutrition( Academic Press) has a section on obesity with chapters on the Definition, Aetiology and Assessment, Early Obesity and Prognosis, Fat Distribution, Treatment, Prevention, and Complications of Obesity. (p. 1430-1466)
• The New Encyclopedia Brittannica,Macropaedia, defines obesity.
• Pathophysiology, 5th Edition (Lippincott) treats obesity p. 1254-1258
• Pathology, 3rd Edition, (Lippincott-Raven) devotes p. 344-346 to obesity.
• Human Physiology and Mechanisms of Disease, 6th Edition, (W.B.Saunders Company) devotes a chapter to Dietary Balances, Regulation of Feeding, Obesity and Vitamins.
• Nutritional Biochemistry, 2nd Edition (Academic Press) devotes a chapter of 40 pages to obesity.
• Women and Health (Academic Press) has a chapter on obesity.
• The Textbook of Women’s Health states, “Obesity is a chronic disease requiring treatment.” (Wallis, LA, editor, Lippincott-Raven) at page 554.
• The Williams Textbook of Endocrinology, 9th Ed. (W.B. Saunders Company) has a chapter, “Eating Disorders: Obesity, Anorexia Nervosa, and Bulimia Nervosa).
• Endocrinology, 3rd Ed. (W.B. Sauders Company) has a chapter, “The Syndromes of Obesity: an Edocrine Approach)
• The Dictionary of Endocrinology and Related Biomedical Sciences (Oxford University Press) contains a definition of obesity.

2. Obesity is Recognized as a Disease by Authoritative United States and International Authorities.

Obesity is recognized as a disease by agencies and officials of the United States government, world health organizations and authoritative complications of disease, as well as by major non-governmental medical and scientific authorities. These sources include the National Academy of Sciences, The National Institutes of Health, The Food and Drug Administration, the Social Security Administration, the Surgeon General of the United States, the former Surgeon General of the United States, the World Health Organization, the American Medical Association and the American Heart Association.
• The National Academy of Sciences, established by an act of Congress in 1863, is composed of four organizations. One, the Institute of Medicine, has created the Food and Nutrition Board. In 1995, the Food and Nutrition Board published a report from its Committee to Develop Criteria for Evaluating the Outcomes of Approaches to Prevent and Treat Obesity entitled, Weighing the Options. This report states, “ These figures (regarding the prevalence of obesity) point to the fact that obesity is one of the most pervasive public health problems in this country, a complex, multifactorial disease of appetite regulation and energy metabolism involving genetics, physiology, biochemistry, and the neurosciences, as well as environmental, psychological, and cultural factors. Unfortunately, the lay public and health-care providers, as well as insurance companies, often view it simply as a problems of willful misconduct – eating too much and exercising too little. Obesity is a remarkable disease in terms of the effort required by an individual for its management and the extent of discrimination its victims suffer.” (at page 1.)
• According to the National Institutes of Health, “Obesity is a complex mutlifactorial chronic disease developing from interactive influences of numerous factors – social, behavioral, physiological, metabolic, cellular, and molecular.” (Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults,The Evidence Report, National Institutes of Health, National Heart, Lung and Blood Institute, No. 98-4083, 1998)
• An earlier statement of the National Institutes of Health stated, “Current knowledge of human obesity has progressed beyond the simple generalizations of the past. Formerly, obesity was considered fully explained by the single adverse behavior of inappropriate eating in the setting of attractive foods. The study of animal models of obesity, biochemical alterations in man and experimental animals, and the complex interactions of psychosocial and cultural factors that create susceptibility to human obesity indicate that this disease in man is complex and deeply rooted in biologic systems. Thus, it is almost certain that obesity has multiple causes and that there are different types of obesity.” (Health Implications of Obesity, NIH Consensus Statement, online 1985, Feb. 11-13 5(9):1-7) Emphasis added.
• The World Health Organization has stated, “Obesity is a chronic disease, prevalent in both developed and developing countries, and affecting children as well as adults. (WHO Press Release 46, 12 June 1997)
• The Surgeon General of the United States, David M. Satcher, M.D., speaking at an American Obesity Association conference on September 15, 1999 stated, “If we don’t get a handle on the risk factors in childhood, including being able to deal with the disease of obesity, then we have to look forward to a future in which there are going to be more and more people suffering from diabetes and hypertension and various forms of cardiovascular diseases. (AOA Newsletter, Vol. 3, No. 3, 1999, p.3)
• The Food and Drug Administration stated “obesity is a disease” under recently enacted final rules. According to the FDA, obesity is a disease and the state of overweight but less than obese is not a disease but a reference to the structure and function of the body. (Federal Register, January 6, 2000, Vol. 65, p. 1028) (Note: The Internal Revenue Code statutory language encompasses both diseases and structure or function of the body whereas the FDA regulation to implement the Dietary Supplements Health and Education Act necessitated distinguishing between disease and structure/function for different regulatory treatment.)
• The Centers for Disease Control and Prevention Director Jeffrey P. Koplan has written, “In contrast to tobacco use, energy intake derives from multiple foods rather than a single product. Furthermore, people can choose not to smoke, whereas they cannot easily choose not to eat without adverse health consequences. As in the case of tobacco users, obese individuals must not become the target of discrimination but should be seen as persons with a chronic health condition in need of support and treatment.” Koplan, JP and Dietz, WH. Caloric imbalance and public health policy. JAMA 1999;282:1579-1580.
• The Federal Trade Commission which has policed commercial weight loss practices organized the Partnership for Healthy Weight Management. Members of the Partnership agreed to Voluntary Guidelines for Providers of Weight Loss Products or Services, which state, “Obesity is a serious, chronic disease that is known to reduce life span, increase disability and lead to many serious illnesses including diabetes, heart disease, and stroke.” The guidelines were established to “promote sound guidance to the general public on strategies for achieving and maintaining a healthy weight.” (Attachment 13)

  The Partnership is comprised of the following representatives from academia, government, commercial organizations and advocacy groups: American Dietetic Association, American Obesity Association, American Society for Clinical Nutrition, American Society of Bariatric Physicians, Centers for Disease Control, Comprehensive Weight Control, Council on Size and Weight Discrimination, University of Alabama at Birmingham’s Department of Nutrition Sciences, Division of Nutrition Research Coordination of the National Institutes of Health (NIH), the Federal Trade Commission’s Bureau of Consumer Protection, The George Washington University’s Obesity Management Program, Health Management Resources, Jenny Craig, Inc., Knoll Pharmaceutical Company, Lindora Medical Clinics, Maryland Department of Health and Mental Hygiene’s Division of Cardiovascular Health and Nutrition, Medical University of South Carolina’s Weight Management Center, The National Heart, Lung and Blood Institute at NIH, The National Institute of Diabetes and Digestive and Kidney Diseases at NIH, The New York Obesity Research Center, North American Association for the Study of Obesity, Novartis Nutrition Corporation, Shape Up America, Slim-Fast Foods Company, Tanita Corporation of America, St. Lukes-Roosevelt Hospital’s Nutrition and Weight Management Center, University of Colorado Center for Human Nutrition, U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition, Weight Watchers International, Inc.

• The United States Department of Health and Human Services Maternal and Child Health Bureau of the Health Resources and Services Administration convened a conference to deal with the rising tide of obesity in children and adolescents in 1997. A report of the conference states:

  “Obesity in children and adolescents represents one of the most frustrating and difficult diseases to treat. Furthermore, as recent data from the National Center for Health Statistics (NCHS) indicate, approximately one in five children in the United States is now overweight. To develop guidance for physicians, nurse practitioners, dietitians/nutritionists, and others who care for overweight children, the Maternal and Child Health Bureau, Health Resources and Services Administration, the Department of Health and Human Services convened a conference in Washington, DC, on March 18-19, 1997. The Expert Committee members were chosen for their clinical and research experience in the field of pediatric obesity. Those who attended the conference were professionals from the American Academy of Pediatrics, the American Dietetic Association, the American Heart Association, the National Association of Pediatric Nurse Associates and Practitioners, the Maternal and Child Health Bureau, the National Institutes of Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the US Department of Agriculture. The Committee reached consensus on the evaluation and treatment of childhood obesity. Subsequently, a group of nurse practitioners, pediatricians, and nutritionists reviewed these recommendations for content and usefulness and approved their appropriateness for practitioners.” Barlow, SE and Dietz, WH. Obesity Evaluation and Treatment: Expert Committee Recommendations. Pediatrics Online, Pediatrics 1998;102(3):29.

• The Social Security Administration, for the purposes of determining eligibility for disability, has determined that “obesity is a medically determinable impairment, that obesity is often associated with disturbances of these body systems, and that disturbances of these body systems can be a major cause of disability in individuals with obesity.” (Fed Register Vol. 64, No. 163, August 24,1999, p.46122, 46126)
• The authoritative International Classification of Diseases (ICD-9-CM), published by the World Health Organization lists “Obesity and other hyperalimentation as #278.0 in the section of Endocrine, Nutritional, Metabolic and Immunity Diseases. The ICD-9-CM is recommended for use in all clinical settings but is required for reporting diagnoses and diseases to all U.S. Public Health Service and Health Care Financing Administration programs.
• Obesity is listed in the Professional Guide to Diseases, 6th Edition, Springhouse Corporation, Springhouse, PA, 1998 at. P. 874.
• Obesity is also found in Current Diagnosis 9, (Conn RB, editor, W.B. Saunders Company, 1997) as “Obesity, which is defined as excess body fat, present with the complaint of overweight, as a functional impairment such as hypertension, in the context of an eating disorder, or as an observation at the time of assessment for another complaint.”
• American Medical Association has taken the position that “Our AMA will urge physicians as well as managed care organizations and other third-party payors to recognize obesity as a complex disorder involving appetite regulation and energy metabolism that is associated with a variety of co-morbid conditions…” Policy Statement H-150.953. Obesity as a Major Public Health Program.
• The American Heart Association Medical/Scientific Statement on Obesity in Heart Disease, states, “Obesity is an increasingly prevalent metabolic disorder affecting not only the US population but also that of the developing world.”

The American Heart Association Vice Chairman of the Nutrition Committee has stated, "Obesity itself has become a life-long disease, not a cosmetic issue, nor a moral judgement -- and it is becoming a dangerous epidemic." Robert H. Eckel, M.D., Online – Press Release -- 10 a.m. ET, Monday, June 1, 1999

http://www.americanheart.org/Whats_News/AHA_News_

Releases/obesity.html

• The American Association of Family Practitioners recognizes obesity as a disease. FP Report, Sept. 18, 1998.
• The American Society of Bariatric Physicians position states “Obesity used to be understood in fairly simple terms, excess body weight resulting from eating too much and exercising too little, due in large part to a lack of willpower or self-restraint. Fortunately for the millions of American adults who are overweight, obesity is now regarded as a chronic medical disease with serious health implications caused by a complex set of factors.

“Recognized since 1985 as a chronic disease, obesity is the second leading cause of preventable death, exceeded only by cigarette smoking. Obesity has been established as a major risk factor for hypertension, cardiovascular disease, diabetes mellitus and some cancers in both men and women. Obesity affects 58 million people across the nation and its prevalence is increasing. Approximately one-third of adults are estimated to be obese.”

Online - http://www.asbp.org/pubsframeset.htm

• The American Obesity Association and Shape Up America! Guidance on the Treatment of Adult Obesity (See Attachment 6) states,

Obesity is a disease afflicting millions of Americans and causing a great deal of pain and suffering. In our society, stereotyping of overweight and obese individuals is quite common. Despite evidence to the contrary, many people view obesity as a lack of willpower on the part of the individual. As a result, obese persons are frequently the object of prejudice and discrimination. They may be viewed as lazy and unlikeable by their leaner counterparts-- and very often by themselves as well. Guidance for Treatment of Adult Obesity, Revised 1998

3. Medical Journals

Numerous articles on obesity appear in the medical literature. Since the beginning of 1999 3,205 papers on obesity are listed in the index of journals by the National Library of Medicine Medline system. During this period, 24 articles on obesity were published in the New England Journal of Medicine, 11 in Lancet, 7 in Nature and 4 in Science. The Journal of the American Medical Association devoted an entire issue to obesity which included 12 articles in October, 1999. In addition, journals are present in the obesity field, including the International Journal of Obesity , Obesity Surgery , International Journal of Obesity and Related Metabolic Disorders and Obesity Research. Recently published articles included the following references to obesity as a disease:

1. “Obesity is a disease that is neglected – indeed, frequently it is not even thought of as a disease but more as a self-inflicted condition, easily prevented and cured by self-control and determination.” “One reason for these negative attitudes is that although a positive energy balance, which is the pathogenesis of obesity, should be easy to correct, in practice it is not.” Bjorntorp, P. Obesity. Lancet 1997;350:423-426.
2. “Obesity is a chronic disease that requires chronic management. We must establish models that allow primary care physicians to participate in the chronic management of obesity, while recognizing that the interest and ability of primary care physicians to participate in obesity management will vary.” Hill, JO. Dealing with Obesity as a Chronic Disease. Obesity Res 1998;6(1):34S-38S.
3. “Despite the acknowledged association between obe­sity and chronic disease, relatively little recognition has been given to the fact that obesity is itself a chronic disease. And a very common disease it is! It has increased by 30% in the last 10 years, and now afflicts 35% of American women and 31% of American men.
   
   A chronic disease is a disruption of bodily function that develops slowly, sometimes insidiously, and persists for an extended period, often for the life of the affected individual. Treatment for a chronic disease aims at alleviating symptoms rather than curing it. Obesity is now beginning to be characterized as a chronic disease and a review by Bray and Gray stands out. It compares the obese patient with one having asymptomatic hypertension. Both require chronic treatment but may be unwilling to seek medical help, follow a prescribed regimen, or continue treatment when treatment-related side effects are experienced.”
   
   Another noteworthy discussion of obesity as a chronic disease is the 1993 review by Yanovski. She argues that, although it fits the model of a chronic disease, obesity is rarely considered to be a disease at all. When it is acknowledged to be a disease, obesity tends to be considered more like a subacute illness that will respond to a time-limited course of treatment and eventually be cured. The fallacy of this approach is indicated by the fact that most well-motivated patients treated with current techniques regain most of their weight within 5 years. Yanovski asserts that regarding obesity as a chronic disease of multifactorial origin has several benefits: it decreases the stigma associated with obesity; recognizes it as a heteroge­neous disorder that, like hypertension, should be treated on an individualized basis; and encourages physicians and their patients to develop realistic treat­ment goals. Stunkard, AJ. Current views on obesity. Am J Fam Med 1996;100:230-236.
4. “Obesity is a chronic disease that is a long-term or lifelong condition for most persons. In many persons it is characterized by slow progression throughout adult life, while in others it is characterized by periods of weight stability or short-term weight loss followed by relapse.”
   
   “The etiology of obesity is multifactorial. Genetic, environmental, metabolic, and behavioral issues may all contribute to the development and progression of obesity. Furthermore, obesity is associated with common causes of morbidity and mortality, such as coronary heart disease (CHD)) , type 2 diabetes, hypertension, and dyslipidemia. Each of these associations follows a dose-response relationship wherein risk increases as the degree of obesity increases. Considering obesity to be a chronic disease carries important implications for the treatment model employed. Just as in other chronic diseases, obesity is most effectively managed with lifestyle interventions combined, when necessary, with pharmaceutical therapy and, in selected patients, surgery.” Rippe, JM; Crossley S; and Ringer R. Obesity as a Chronic Disease: Modern Medical and lifestyle Management. J Am Diet Assoc 1998;98(suppl 2):S9-S15.
5. “Although the etiology of obesity is still unclear, genetic, metabolic, and social factors are all believed to play a role in its development, progression, and therapy. Little attention has been paid to the fact that obesity is a chronic condition or disease and, as such, requires a continuing care model of therapy for adequate management, similar to cardiovascular disease or diabetes mellitus. Dietetics professionals are in an excellent position to work with physicians and other health care professionals to provide the follow-up care and support necessary for successful therapy of such chronic conditions.” Coulston, AM. Obesity as an Epidemic: Facing the Challenge. J Am Diet Assoc 1998;98(suppl 2):S6-S8.
6. “Morbid obesity is defined by a body mass index greater than 40 kg/m2 and constitutes a real disease, which shortens the patient's life expectancy, especially as a result of multiple metabolic, endocrine or respiratory complications.” Fourtanier G, Cadiere GB. Surgery for pathological obesity Ann Chir Plast Esthet 1999 Aug;44(4):431-9 - Chirurgie Digestive, CHU Toulouse-Rangueil, France.
7. “The evaluation of an obese subject aims at better understanding the disease, its causes and consequences, in order to optimize its management. Schematically, this task can be done in three successive steps. First, it is necessary to analyse data from the past, by asking about family and personal history. Then, the present data should be carefully analysed, especially the severity of overweight, its type of distribution and the importance of associated complications. Finally, it is mandatory to project these data into the future, in order to assess the final prognosis of the obese patient allowing a better definition of the goals and the therapeutical strategies.” Scheen AJ, Luyckx FH. How I evaluate a overweight or obese patient. Rev Med Liege 1999 Jun;54(6):553-6. Service de Diabetologie, Nutrition et Maladies metaboliques, Universite de Liege.
8. Obesity poses a serious health hazard and its treatment is often disappointing. Major advances have been made during recent years in the understanding of body weight regulation, with the discovery of leptin, a protein produced by adipocytes and acting on the central nervous system to reduce food intake, and that of beta-3 adrenergic receptors and uncoupling proteins which contribute to stimulate energy expenditure. Numerous metabolic complications are associated with abdominal obesity and most of them, such as diabetes mellitus, dyslipidaemias and arterial hypertension, appear to be linked to insulin resistance and may be part of the so called metabolic syndrome or syndrome X. While very-low-calorie diets are usually effective in the short-term, they cannot, in the long-term and for most patients, solve the problem of severe obesity. Pharmacological antiobesity treatment may include drugs that reduce food intake, drugs that increase energy expenditure and drugs that affect nutrient partitioning or metabolism. All of these pharmacological approaches have potential efficacy, but unfortunately serious limitations. This is also the case of mechanical means, such as intragastric balloons. Consequently, bariatric surgery may be considered as a valuable alternative therapy in well-selected patients with morbid obesity refractory to classical treatments. In conclusion, obesity is a chronic disease and should be treated as such with reasonable expectations. Scheen AJ, Luyckx FH. Medical aspects of obesity. Acta Chir Belg 1999 May-Jun;99(3):135-9. Department of Medicine, CHU Sart Tilman, Liege, Belgium.

4. Other Indicia of Disease

A. Professional Societies One indicia of a disease is the formation and development of scientific and clinical societies focused on prevention and treatment of the disease. Such societies exist in the field of obesity. They include:

• The American Society of Bariatric Physicians, (ASBP) a nonprofit national association of physicians (M.D.s and D.O.’s) who offer specialized programs in the medical treatment of obesity and associated conditions. Through research, continuing education and peer exchange of information, the ASBP seeks to encourage excellence in the practice of bariatric medicine. The ASBP conducts conferences for Continuing Medical Education credit.
• The American Society for Bariatric Surgery (ASBS), a nonprofit association of bariatric surgeons throughout the world formed in 1983. It publishes Obesity Surgery. It conducts conferences and provides Continuing Medical Education opportunities.
• The North American Association for the Study of Obesity (NAASO) is composed of researchers and clinicians involved in the study of obesity. NAASO publishes Obesity Research and conducts programs of Continuing Medical Education on obesity.
• The American Association of Clinical Endocrinologists (AACE) is a professional medical organization devoted to the field of clinical endocrinology. The AACE represents the interest of patients and endocrinologists in socioeconomic and related matters with government agencies, the insurance industry, organized medicine, health related organizations and others. Members of the AACE are fully licensed physicians with special education, training and interest in the practice of clinical endocrinology. Many of the members are affiliated with medical schools and universities, contribute on a regular and continuing basis to the scientific literature on endocrine diseases and conduct medical education programs on this subject.
• The American College of Endocrinology (ACE) is the educational and scientific component of the American Association of Clinical Endocrinologists. The ACE's mission is to provide and promote education, research, and communication in the art and science of clinical endocrinology and to provide appropriate recognition of advances and achievements relating to clinical endocrinology.

B. Clinical Guidelines. Another indicia of disease is the development of guidelines for physicians, health care practitioners and others on the preferred methods of treating the disease or condition. Authoritative bodies have developed several guidelines for the treatment of obesity. Since these guidelines contain detailed information about obesity and its treatment, we have attached full copies of these guidelines to assist the Service in writing a new Revenue Ruling. They include Guidelines from:

1. The National Institutes of Health
2. American Obesity Association and Shape Up America!
3. American Society of Bariatric Physicians
4. American Society for Bariatric Surgery
5. American Association of Clinical Endocrinologists.

1. National Institute on Aging
2. National Institute on Child Health and Human Development
3. National Cancer Institute
4. National Heart, Lung and Blood Institute

Most of the obesity research and related activity is carried on at the National Institute for Diabetes, Digestive and Kidney Diseases (NIDDK). According the statute authorizing NIDDK, Public Law 103-43, the Director of NIDDK and the Director of NIH are authorized to establish a program of conducting and supporting research, training, health information dissemination, and other activities with respect to “nutritional disorders, including obesity.”

Further, the Act authorizes establishment of centers “for research and training regarding “nutritional disorder, including obesity….Each center shall (B) conduct basic and clinical research into the cause, diagnosis, early detection, prevention, control and treatment of nutritional disorders, including obesity and the impact of nutrition and diet on child development.”

(Emphasis added.)

NIDDK supports the study of obesity in its own laboratories and clinics and at universities, hospitals and research centers across the United States helping increase understanding about the role of genes and metabolism in obesity and the relationship between obesity and various medical conditions. Ongoing research efforts also look at better ways to define and treat the various types of obesity and understanding how the body stores and uses fat. NIDDK also manages the National Task Force on Prevention and Treatment of Obesity which develops papers, brochures and pamphlets available from the NIDDK’s Weight Information Network (WIN) . WIN assembles and disseminates information to health professionals and the general public on weight control, obesity and nutritional disorders.

The National Heart Lung and Blood Institute (NHLBI) is also involved in obesity research and education. It has established an Obesity Education Initiative. NHLBI and NIDDK were responsible for the development and dissemination of the Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults, a publication of the National Institutes of Health.

D. Identification as Public Health Problem Another indicia of a disease, especially one of the magnitude of obesity, is the involvement of the Surgeon General of the United States. This is the case with obesity. The Surgeon General recently issued the Nation’s first set of “Leading Health Indicators,” a selection of ten conditions with major impact on health. “Overweight and Obesity” is listed as one of the ten Leading Health Indicators.

In addition, the Surgeon General’s office released Healthy People 2010. This important document describes the nation’s leading public health problems and sets goals for the health care community over the upcoming decade. One such goal, in the chapter, “Nutrition and Overweight” sets two national goals:

• “Reduce the proportion of adults who are obese” and
• “Reduce the proportion of children and adolescents who are overweight or obese.”

E. Range of Treatments As with many chronic diseases like diabetes, heart disease and hypertension, there is a broad range of treatment strategies for obesity. These include surgery, pharmacology, medically supervised diets, over the counter products, behavioral counseling, support groups, educational programs, self-help groups and individual programs of self-management especially of diet and exercise. According to AOA estimates, approximately 120 hospitals in the United States have programs for the treatment of obesity.

C. Obesity meets the Statutory Requirement “affecting any structure or function of the body.”

We note that the IRS response omits reference to key statutory language. Congress, in creating the deduction for medical expenses, limited such expenses to medical care for “diagnosis, cure, mitigation, treatment, or prevention of disease, or for the purpose of affecting any structure or function of the body.”

Section 213 of the Internal Revenue Code. (Emphasis added)

The Service did not ask for scientific evidence regarding structure or function of the body. Clearly, obesity meets the structure or function of the body criteria. Obesity by definition is excess body fat.

“Fat” is interchangeable with “adipose tissue”. Adipose tissue or fat consists of a mass of adipocytes or fat cells that are loosely held together by collagen fibers. Adipose tissue occurs in two forms –white fat and brown fat. White adipose tissue is colored white or yellow and has relatively few nerves and blood vessels. Each fat cell contains a single large droplet of triglycerides that is coated with a protein called perilipin. White fat is used as a site for storing energy for physical activity. Brown fat contains relatively more nerves and blood vessels. Each brown fat cell contains several small droplets of triglycercide, rather than one large droplet. Brown fat is used only for hat production. Brown fat occurs in newborn humans but not in adults. Fat deposits may be classified as subcutaneous and visceral. Subcutaneous fat occurs as a more or less continuous layer throughout the body.

Therefore, expenses for the treatment of obesity qualify for the medical expenses deduction both on the basis that obesity is a disease and on the basis of affecting any structure or function.

VII. Obesity is so closely related to the Onset of Specific Diseases

that it is more than general maintenance of health and well-being. Weight Loss by an Obese Person Prevents the Onset of Disease

The overwhelming weight of generally accepted scientific evidence presented so far demonstrates that the expenses for the treatment of obesity qualify for the medical care expense deduction on two independent bases: (1) obesity itself is a disease and (2) obesity affects the structure and function of the body. An alternative to evidence that obesity is itself a disease is evidence that obesity is so closely related to the onset of specific diseases that it is more than general maintenance of health and wellbeing. Evidence on this basis must also demonstrate that weight loss prevents the onset of disease.

Although we believe that we have well established that obesity is itself a disease, we wish to address the alternative basis suggested by the IRS.

1. Untied States and International Scientific Consensus

The most current and comprehensive consensus on obesity and overweight is that of the National Institutes of Health (Attachment 5). In 1995, the National Heart, Lung and Blood Institute’s Obesity Education Initiative in cooperation with the National Institute of Diabetes and Digestive and Kidney Diseases convened the Expert Panel on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. The panel of 24 included experts in primary care medicine, epidemiology, clinical nutrition, exercise physiology, psychology, physiology, and pulmonary disease. Five meetings were held. The guidelines developed were based on a systematic review of the published scientific literature found in MEDLINE from January 1980 to September 1997 of topics identified by the panel as key to extrapolating the data related to the obesity evidence model. 769 published papers are cited in their report.

The guidelines were the first to be endorsed by both the National Cholesterol Education Program and the National High Blood Pressure Education Program, comprising 52 professional societies, government agencies and consumer organizations as well as by the NIDDK National Task Force on the Prevention and Treatment of Obesity and the North American Association for the Study of Obesity. (Attachment 5, p. ix)

The National Institutes of Health Guidelines (Attachment 5) summarizes the scientific evidence:

All overweight and obese adults (age 18 years or older) with

a BMI of = 25 are considered at risk for developing associated comorbidities or diseases such as hypertension, high blood cholesterol, type 2 diabetes, coronary heart disease, and other diseases. Individuals with a BMI of 25 to 29.9 are considered overweight, while individuals with a BMI >30 are considered obese. ..

Obesity is clearly associated with increased morbidity and mortality. There is strong evidence that weight loss in overweight and obese individuals reduces risk factors for diabetes and cardiovascular disease (CVD). Strong evidence exists that weight loss reduces blood pressure in both overweight hypertensive and nonhypertensive individuals; reduces serum triglycerides and increases high-density lipoprotein (HDL)-cholesterol; and generally produces some reduction in total serum cholesterol and low-density lipoprotein (LDL)-cholesterol. Weight loss reduces blood glucose levels in overweight and obese persons without diabetes; and weight loss also reduces blood glucose levels and HbA1c in some patients with type 2 diabetes. Although there have been no prospective trials to show changes in mortality with weight loss in obese patients, reduction in risk factors would suggest that development of type 2 diabetes and CVD would be reduced with weight loss. (p. xii)

2. The former Surgeon General of the United States, C. Everett Koop, has stated that seven diseases including hypertension, cardiovascular disease, dyslipidemia (a disturbance of fat metabolism), type 2 diabetes, sleep apnea, osteoarthritis and infertility, “either worsen significantly as the degree of obesity increases or improve as the obesity is treated.”

The Washington Times, Jan. 30, 2000

3. The World Health Organization has published Obesity: Preventing and Managing the Global Epidemic. Report of a WHO Consultation on Obesity. Chapter 5 deals with the benefits of weight reduction. Its major conclusions are included in Appendix 12 along with it citations to over 40 published studies. This document details the specific effects of weight loss on several health conditions.

3. Federal Trade Commission led Partnership for Health Weight Management (Attachment 13) states in its Voluntary Guidelines for Providers of Weight Loss Products or Services, “ Remember, people who are overweight or obese are at increased risk of developing heart disease, diabetes, some forms of cancer, gall bladder disease, osteoarthritis and sleep apnea. Losing even small amounts of weight (five to ten percent of body weight), may reduce these risks.”

4. The Director of the Centers for Disease Control and Prevention, Jeffrey Koplan, M.D. recently wrote, “Obesity is not simply a cosmetic disorder. Approximately,60% of overweight 5- to 10- year old children already have 1 associated biochemical or clinical cardiovascular risk factor, such as hyperlipidemia, elevated blood pressure, or increased insulin levels, and 25% have 2 or more.” “Almost 80% of obese adults have diabetes, high blood cholesterol levels, high blood pressure, coronary artery disease, gallbladder disease or osteoarthritis, and almost 40% have 2 or more of these co-morbidities…Modest weight losses of 5% to 10% of body weight improve glucose tolerance, hyperlipidemia, and blood pressure in obese adults.” Koplan, JP and Dietz, WH. Caloric Imbalance and Public Health Policy. JAMA 1999;282:1579-1580.

4. In 1999 the American Obesity Association commissioned a study of the health care costs associated with obesity by the Lewin Group.

Their study included an examination of the increases in the relative risks for various conditions according to increases in body fat as measured by the Body Mass Index. The following graph developed by the Lewin Group demonstrates the very close relationship between the increases in body weight and other conditions. The data are based on a national survey NHANES III and are scaled from a BMI of >25 which is regarded as healthy weight to >30 which is the accepted cutoff for obesity to >35 which is more severe obesity.

5. In October 1999 study, published in the Journal of the American Medical Association also examined the relationship of weight to the onset of disease. The study found a substantial prevalence of chronic health conditions in association with elevated BMI for age groups and racial and ethnic groups as well as particularly strong cross-sectional associations for overweight and obesity with type 2 DM (diabetes mellitus) and hypertension. (Must A, The Disease Burden Associated with Overweight and Obesity, JAMA, Oct. 27, 1999, Vol. 282;16:1523-1529) The following chart from the article demonstrates the increasing incidence of a comorbid condition with increasing body weight and the increase in 2 or more comorbid conditions with increasing weight.

Appendix A: Obesity and addiction

In response to our petition for a new Revenue Ruling, the IRS, noting its recent change in its Revenue Ruling on smoking, stated that the Revenue Ruling on smoking was changed because scientific and medical research established that nicotine is addictive and that allowing a medical expense deduction for the cost of a program to overcome an addiction is well established. However, the IRS noted that “A similar rationale would not apply to a weight loss program.”

The request for a new Revenue Ruling does not rely on an assertion that obesity or overeating is an addiction. There does not appear to exist at this time generally accepted scientific evidence to support such a conclusion. However, we submit that there is not support for the IRS to conclude that at least one subtype – obese binge eaters – does not meet the criteria used by the IRS in the context of smoking or alcoholism treatment expenses.

There is a subcategory of persons with obesity who are also considered “binge eaters.” Binge eating is a mental disorder; obesity is not considered a mental disorder. However, there appears to be a significant subgroups of obese persons who are binge eaters (Kalarchian MA Binge Eating in Bariatric Surgery Patients, In. J. Eat Disorders 1998 Jan;23(1):89-92. Another study estimated that a substantial portion (18%-46%) of obese persons in weight control programs are binge eaters. (de Zwaan M, Binge eating disorder:clinical features and treatment of a new diagnosis, Harv Rev. Psychiatry 1994, Mar0Apr; 1(6):310-25)

Binge eating does share many similarities with alcohol and drug abuse, including cravings, a sense of loss of control, use of the substance to regulate emotional states and cope with stress. Persons with binge eating disorder, alcoholism and drug abuse also report preoccupation with the substance and repeated attempts to stop and may deny the gravity of their problem and suffer negative psychological and social consequences. While such similarities are strong they may be superficial and may obscure fundamental differences.

The definitions of addiction, the definition of alcoholism or of nicotine craving relied on by IRS do not provide clear evidence to exclude obesity. A standard definition is “Habituation to some practice considered harmful for the subject.” (Stedman’s Medical Dictionary). The application of the term “addiction” has changed over time. Areas like drug addiction were well established but application to areas such as alcohol consumption, nicotine, caffenine, inhalants, work, sex, television or Internet surfing are evolving. On the one hand, addiction or substance abuse is sometimes defined according to the substance e.g. cocaine, heroin, nicotine. According to these schema, food or overeating is not a listed as a substance of abuse. On the other hand, there are descriptions of alcoholism or nicotine dependency which bear a striking similarity to standard definitions of obesity. In fact, were one to substitute “overeating” or “binge eating” for “alcoholism” or “nicotine dependency”, the definitions would be quite consistent.

For example, excessive alcohol consumption was for many decades seen as a personal moral failure. Gradually, the definition of alcoholism evolved into, “Alcoholism is a primary, chronic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. The disease is often progressive and fatal. It is characterized by impaired control over drinking, preoccupation with the drug alcohol, use of alcohol despite adverse consequences, and distortions in thinking, most notable denial. Each of these symptoms may be continuous or periodic. ( Morse, RM The Definition of Alcoholism, JAMA, Aug. 26, 1992, 268;8: 1012-1014)

Regarding nicotine, David Kessler, the former Commissioner of the Food and Drug Administration, writing to justify the FDA’s proposed regulations of nicotine stated, “ First, this evidence showed that nicotine in cigarettes and smokeless tobacco causes and sustains addiction. As the US Surgeon General has reported, nicotine exerts psychoactive (or mood-altering) effects on the brain that motivate repeated, compulsive use of the substance. These pharmacological effects create dependence in the user. The pharmacological processes that cause this addiction to nicotine are similar to those that cause addiction to heroin and cocaine. Second, scientific studies showed that nicotine in cigarettes and smokeless tobacco produces other important pharmacological effects on the central nervous system. Under some circumstances and doses, for instance, the nicotine has a sedating or tranquilizing effect on mood and brain activity. Under other circumstances and doses, the nicotine has a stimulant or arousal-inducing effect on mood and brain activity. Third, as the US Surgeon General also documents, nicotine in cigarettes and smokeless tobacco affects body weight. (Kessler, DA, The Legal and Scientific Basis for FDA’s Assertion of Jurisdiction Over Cigarettes and Smokeless Tobacco. JAMA, Feb. 5, 1997, Vol.277;8:405-409) Emphasis added.

Some sources do define obesity as an addiction. The Dictionary of Modern Medicine (Attachment 4) defines obesity as “A condition that is regarded as a premorbid addiction disorder, defined as 10% (or 20%) above an individual’s standard weight. One type of obesity which might be considered an addiction is binge eating. One author states, “Binges are often orgiastic in nature, and although they end in groggy feeling of relief in which uncomfortable thoughts are (temporarily) obliterated, they are followed by guilt, self-disgust, and misery. The pattern may be self-reinforcing in that a cycle of negative thoughts leads to eating, to numbness and then to guilt, and ten to eating again. A pattern is set up which is similar to those seen in other states of psychological dependence or addiction.” (Weiner S, The Addiction of Overeating: Self-Help Groups as Treatment Models, J Clin Psychol 54:163-167, 1998.)

Another author has noted that the twelve step programs of Alcoholics Anonymous and Overeaters Anonymous are similar. (Riley, EA, Eating Disorders as Addictive Behavior, Nur Clin NA, Sept. 1991, Vol.26; 3:715-721.)

As stated earlier, the petition does not claim or assert that weight loss is a treatment for an addiction. However, the generally accepted scientific understanding a subtype of persons with obesity who have binge eating disorder is not at a stage that exclusion by the Internal Revenue Service of this subtype is justified either at this time.

Attachments

1.Petition requesting Revenue Ruling

2. IRS Rev. Rul. 79-151

3. IRS Response to Petition

4. Definitions of Disease and Obesity

disease Medicine. 1. any abnormal condition of body functions or structure that is considered to be harmful to the affected individual; an illness or disorder; any abnormal condition of body functions or structure that is considered to be harmful to the affected individual; an illness or disorder. 2. a specific illness or disorder that is identified by a characteristic set of signs and symptoms, caused by such factors as infection, toxicity, genetic or developmental defects, dietary deficiency or imbalance, or environmental effects; a specific illness or disorder that is identified by a characteristic set of signs and symptoms, caused by such factors as infection, toxicity, genetic or developmental defects, dietary deficiency or imbalance, or environmental effects.

Academic Press Dictionary of Science and Technology – online, 2/25/2000

disease noun [C/U] a condition of a person, animal, or plant in which its body or structure is harmed because an organ or part is unable to work as it usually does; an illness.

Cambridge Dictionary of American English – online, 2/25/2000

dis·ease n. [C;U] 1 a sickness or serious disorder that is inherited or caused by infection or bad living conditions: Disease destroys many lives in poor parts of the world. 2 fig. an abnormal social condition: The love of money can spread like a disease.

The Newbury House Online Dictionary, 2/25/2000

Main Entry: dis·ease

Pronunciation: di-'zEz.Function: noun. Etymology: Middle English disese, from Middle French desaise, from des- dis- + aise ease. Date: 14th century

2 : a condition of the living animal or plant body or of one of its parts that impairs normal functioning : SICKNESS, MALADY 3 : a harmful development (as in a social institution)

Merriam-Webster, WWWebster Dictionary – online, 2/25/2000

Entry Word: disease

Function: noun

Text: 1 a kind or instance of impairment of a living being that interferes with normal bodily function Synonyms affection, ailment, complaint, condition, disorder, ill, infirmity, malady, sickness, syndrome; INFIRMITY 1, SICKNESS 1

Merriam-Webster, WWWebster Thesaurus – online, 2/25/2000

disease

2. An alteration in the state of the body or of some of its organs, interrupting or disturbing the performance of the vital functions, and causing or threatening pain and weakness; malady; affection; illness; sickness; disorder; applied figuratively to the mind, to the moral character and habits, to institutions, the state, etc. "Diseases desperate grown, By desperate appliances are relieved." (Shak) "The instability, injustice, and confusion introduced into the public counsels have, in truth, been the mortal diseases under which popular governments have every where perished." (Madison)

Synonym: Distemper, ailing, ailment, malady, disorder, sickness, illness, complaint, indisposition, affection. Disease, Disorder, Distemper, Malady, Affection.

Disease is the leading medical term. Disorder mean much the same, with perhaps some slight reference to an irregularity of the system. Distemper is now used by physicians only of the diseases of animals. Malady is not a medical term, and is less used than formerly in literature. Affection has special reference to the part, organ, or function disturbed, as, his disease is an affection of the lungs. A disease is usually deep-seated and permanent, or at least prolonged, a disorder is often slight, partial, and temporary, malady has less of a technical sense than the other terms, and refers more especially to the suffering endured. In a figurative sense we speak of a disease mind, of disordered faculties, and of mental maladies.

Source: Websters Dictionary

(01 Mar 1998)

Cancer Web, The On-line Medical Dictionary, 2/25/2000.
http://www.graylab.ac.uk/cgi-bin/omd?query=disease&action=Search+OMD

http://www.intelihealth.com/cgi-bin/dictionary.cgi?book=Medical&adv=0&cgi=1&t=

Disease is considered to be a harmful deviation from the normal structural or functional state of an organism. A diseased organism commonly exhibits signs or symptoms indicative of its abnormal state. Thus, the normal condition of an organism must be understood in order to recognize the hallmarks of disease. Nevertheless, a sharp demarcation between disease and health is not always apparent. -- [Encyclopedia Britannica 1996], from History of Diseases, Karolinska Institutet - online, http://www.mic.ki.se/HistDis.html

dis·ease (d-zz) n.

· A pathological condition of a part, an organ, or a system of an organism resulting from various causes, such as infection, genetic defect, or environmental stress, and characterized by an identifiable group of signs or symptoms. 2. A condition or tendency, as of society, regarded as abnormal and harmful.

Dictionary.com – online, 2/25/2000. . Source: The American Heritage® Dictionary of the English Language, Third Edition

Copyright © 1996, 1992 by Houghton Mifflin Company. Published by Houghton Mifflin Company. All rights reserved.

disease n : an impairment of health or a condition of abnormal functioning

Dictionary.com – online, 2/25/2000. . Source: WordNet ® 1.6, © 1997 Princeton University

Main Entry: dis·ease
Pronunciation: diz-'Ez
Function: noun
: an impairment of the normal state of the living animal or plant body or one of its parts that interrupts or modifies the performance of the vital functions and is a response to environmental factors (as malnutrition, industrial hazards, or climate), to specific infective agents (as worms, bacteria, or viruses), to inherent defects of the organism (as genetic anomalies), or to combinations of these factors. Merriam Webster Medical Dictionary – online, 2/25/2000.

Attachment 5 NIH Guidelines
Attachment 6 AOA Guidelines
Attachment 7 ASBP Guidelines
Attachment 8 ASBS Guidelines
Attachment 9 AACE/ACE Guidelines
Attachment 10 American Heart Assn. Statements
Attachment 11 Obesity Surgery

Attachment 12 World Health Organization

• World Health Organization

5.3 Weight loss and general health

5.3.1 Modest weight loss

Data from a number of studies have shown that modest weight loss (as defined by a weight loss of up to 10%) improves glycaemic control, reduces blood pressure and reduces cholesterol levels (1). Modest weight loss also improves lung function and breathlessness, reduces the frequency of sleep apnea, improves sleep quality, and reduces daytime somnolence. However, the degree of improvement often depends on the length of time that the condition has been present. Modest weight loss will also alleviate osteoarthritis, depending on the degree of structural damage, as well as back and joint pain.

5.3.2 Extensive weight loss

Following surgically banded gastroplasty, severely obese patients who lose 20-30 kg in weight, at a rate of 4.5 kg per month for the first 6 months, gain substantial health benefits. They show a marked fall in blood lipids within the first two years of follow-up, and the conditions of 43% of hypertensive patients and 69% of NIDDM patients are improved. Furthermore, at a population level, the incidences of hypertension, hyperlipidemia and NIDDM are reduced to about a sixth of those seen in obese patients who maintain their excess weight (2, 3).

5.4 Weight loss and mortality

Unfortunately, most studies investigating weight loss and mortality have not controlled for unintentional weight loss nor for cigarette smoking. In one large study of overweight white women in the USA where these variables were evaluated, intentional weight loss consistently reduced mortality in women with obesity-related co-morbidities such as NIDDM or CVD. However, the effects in women without co-morbidities were inconsistent with the association between intentional weight loss and reduction in mortality. Thus the benefit of intentional weight loss was best seen in those with a poorer health status (4).

In a randomized controlled dietary intervention trial of post-infarct patients in India, the effect of the dietary intervention on cardiac mortality was greatest among those patients who had also lost around 10% of their body weight (5). Thus, more longer-term, well-controlled studies are clearly needed to define accurately the benefits of weight loss on mortality.

5.5 The impact of weight loss on chronic disease, and on endocrine and metabolic disturbances

5.5.1 Cardiovascular disease and hypertension

A number of cardiovascular risk factors related to blood clotting (haemostatic, rheological and fibrinolytic) have been associated with overweight (fi 8). In particular, coagulation factors VII and X, which are directly associated with BMI, are involved with thrombosis (9) and increased risk of myocardial infarction (10). Weight loss in overweight subjects has been shown to reduce red blood cell aggregation and to improve fibrinolytic capacity.

Weight loss induces a fall in blood pressure. Short trials lasting a few weeks show that each 1% reduction in body weight leads, on average, to a fall of I mmHg systolic and 2 mmHg diastolic pressure (11 14). Marked falls in blood pressure can occur with very low energy diets, although modest dietary restrictions are also beneficial. Anti-hypertensive drug therapy, reducing a high alcohol intake, lowering salt intake (15,16), and altering the fatty acid content of the diet in favour of one with less saturated fat (17,18) all further reduce blood pressure independent of weight loss. It is estimated that a 10 kg weight loss can produce a fall of 10 mmHg systolic and a fall of 20 mmHg diastolic blood pressure (19). Longer trials, with a 10-year follow-up of patients identified originally as mildly hypertensive, show that positive dietary change together with smoking cessation and an increase in isotonic exercise (e.g. running) reduce both body weight and blood pressure. These levels can be sustained for 10 years and significantly limit the need for drug therapy (12).

5.5.2 Diabetes mellitus and insulin resistance

Studies of weight loss in NIDDM patients have consistently shown that weight reduction of 10% to 20% in obese individuals with NIDDM results in marked improvements in glycaemic control and insulin sensitivity. These improvements can last from 1 to 3 years even if the weight is subsequently regained. Of the 75% of newly diagnosed NIDDM patients who are overweight, 15% to 20% weight loss in the first year after diagnosis seems to reverse the elevated mortality risk of NIDDM (20). However, not all Type II diabetic patients respond to weight loss with metabolic improvements; the loss of abdominal adipose tissue may be more important for improvements in diabetic control than loss of weight per se.

Hyperglycaemia frequently decreases as soon as a low energy diet is initiated, suggesting that dietary energy restriction has a beneficial effect independent of weight loss. Exercise training also improves glucose tolerance and insulin sensitivity independent of weight loss. The American Diabetes Association (21) recommends that aerobic exercise be performed at moderate intensity for 20 to 45 minutes, three days per week. However, although epidemiological studies have emphasized the value of vigorous activity, mainly because it is easy to assess, the total level of energy expenditure may be the important factor in limiting NIDDM rather than the periods of intense physical activity (22).

5.5.3 Dyslipidaemia

The adverse changes in blood lipids associated with obesity, namely high triacylglycerides, high cholesterol and low HDL cholesterol can also be expected to return towards normal after modest weight loss. LDL cholesterol has been estimated to reduce by 1% for every I kg lost (23).

A 10 kg weight loss can produce a fall of 10% in total cholesterol levels, 15% decrease in LDL levels, 30% decrease in triacylglycerides and an increase of 8% in HDL cholesterol (19). Also, it has been found that serum triglyceride and HDL cholesterol levels show the most favorable changes after weight loss in those with a high waist-hip ratio (24).

5.5.4 Ovarian function

Overweight and obese women with hirsutism and polycystic ovaries show improved insulin sensitivity and ovarian function when more than 5% weight loss occurs. In addition, some women with amenorrhoea may be restored to normal menstrual function after weight loss.

5.6 Weight loss and psychosocial functioning

Most studies on the quality of life of obese patients before and after weight loss have been conducted on patients following surgery for obesity. These studies all indicate dramatic improvements in the overall quality of life. The SOS study in Sweden (25), for example, showed significant improvements in social interaction, anxiety, depression and mental well-being which were sustained two years after weight loss surgery. Although it is unclear whether these improvements will be seen with modest weight loss following non-surgical intervention, Klem et al. (26) recently reported that reduced-obese subjects indicated substantial improvements in quality of life following weight loss. While this is based on self-reports of individuals who were maintaining weight losses for periods of over one year, it provides additional evidence of the benefits of weight loss.

Dieting is often perceived to have untoward psychological effects including depression, nervousness and irritability. However, studies have shown that weight loss is associated with a decrease in depression score, particularly when weight loss is achieved by behavior modification (2 7, 28).

A dramatic example of how severely overweight persons perceive their disorder has been provided by Rand and MacGregor (29,30) who studied a group of severely obese patients before and after losing weight as a result of gastric surgery. Prior to surgery, all patients felt unattractive and a great majority felt that people talked about them behind their backs at work. They also felt that they had been discriminated against when applying for jobs and treated disrespectfully by the medical profession. Having achieved a weight loss of 50 kg, all the patients said they would prefer to be deaf, dyslexic, diabetic, or to suffer very bad heart disease or acne than to return to their previous weight. Given a hypothetical choice, all preferred to be of normal weight than to have "a couple of million dollars", a choice that they made within less than one second!

5.9 The effects of weight loss in obese children and adolescents

Weight loss of just 3% significantly decreased blood pressure in obese adolescents, and blood pressure was further improved if exercise was added to the weight-loss programme (38). A weight loss of nearly 16% in obese children resulted in a parallel decrease in serum triacylglycerides and plasma insulin in the first year, and HDL cholesterol increased. These changes remained stable in the second year of the study; after 5 years, weight loss was still 13% below the initial weight, peripheral hyperinsulinaemia was reduced, and HDL cholesterol remained higher (39).

The symptoms of hepatic steatosis in obese children eventually disappear when excess weight is lost (40).

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