April 9, 1998

The American Obesity Association (AOA) is pleased to comment on the proposed regulations of the Ohio Board of Medical Examiners regarding the dispensing of anti-obesity pharmaceutical products. The AOA is a non-profit, 501(c)(4) organization incorporated in Delaware and headquartered in Washington D.C. AOA was established just three years ago to advocate on behalf of patients with obesity. Our comments are intended to provide information helpful to the Ohio Board of Medical Examiners in establishing regulations which assist individuals with obesity in Ohio to reduce weight or maintain a healthy weight.

First, we would like to provide some background on the scale and costs of the growing epidemic of obesity in the United States. In 1985, the National Institutes of Health recognized obesity as a disease. The NIH Consensus Development Conference 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 psychological 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." [1]

Poor diet and inactivity (virtual synonym for obesity) is the second leading cause of preventable death in the United States after smoking. [2] According to the latest reports from the Center for Disease Control and Prevention about 58 million American adults are overweight to the point where they are incurring health risks. The percentage  of American adults with obesity as increased 30% in 10 years, from 25% in 1980 to 33% in 1991. Conservative estimates indicate that 14% of children and 12% of adolescents are overweight. 33% of men and 36% of women are overweight. Obesity disproportionately effects minorities; the prevalence is 48.5% of non-Hispanic black women and 47.2% of Mexican American women. [3]

Former Surgeon General C. Everett Koop, M.D. and AOA support the estimate that 300,000 premature U.S. deaths a year are attributable to overweight. [4] In other words, premature deaths due to overweight equal over 4 Oklahoma City bombings a day!

Obesity is a long term chronic disease. There are at least eight other diseases that worsen as obesity increases or decreases as weight is reduced. They include heart disease, hypertension, dyslipidemia, adult-onset diabetes, stroke, sleep apnea, osteoarthritis of weight bearing joints and deep vein thrombosis.

The costs of obesity are equally staggering; estimates range up to $100 billion. Utilization of health care resources is proportionate to excess body fat. [5]   Nearly 80% of patients with adult onset or non-insulin-dependent diabetes mellitus are obese. Much of the estimated $11.3 billion spent each year to diagnose, treat and manage NIDDM stems from obesity. Nearly $2.4 billion dollars or 30% of the total amount spent on gallbladder disease and gallbladder surgery are related to obesity. Nearly 70% of the diagnosed cases of cardiovascular disease are related to obesity. Obesity accounts for $22.2 billion or 19% of the total costs of heart disease. Obesity more than doubles one’s chances of developing high blood pressure which affects approximately 26% of obese American men and women. The annual cost of obesity-related high blood pressure is close to $1.5 billion dollars. Almost half of breast cancer cases are diagnosed among obese women; an estimated 42% of colon cancer cases are diagnosed among obese individuals. Obesity-related breast cancer and colon cancer account for 2.5% of the total costs of cancer of $1 billion dollars annually. [6]

Obesity is also increasing  worldwide as more Western type diets are introduced into other countries and as people become less active. It is no wonder then that in 1997 the World Health Organization declared obesity to be “the biggest, global chronic health problem in adults. If action is not taken to stem the pandemic, millions will develop related diseases such as diabetes and heart disease.” According to data compiled by the World Health Organization International Obesity Task Force, the economic costs of obesity are 3% to 8% of the total health care expenditures in the United States and Europe - proportions at least as great as those for all cancer and AIDS. [7]

Reducing overweight and increasing physical activity has been a major goal of the federal Health People 2000 program. Unfortunately, meeting the goals established has been one of the biggest failures of that program.

In the context of this epidemic, the proposed regulations should be viewed from the perspective, “Will these regulations assist Ohio citizens in achieving weight reduction and weight maintenance goals?” The answer of AOA is that they do not.

Our specific reasons for this conclusion follow.

Section 4731-11-04

(C)(1) requires the physician to determine through review of his or her own records, records of other physicians or weight-loss programs that the patient has made a substantial good faith effort to lose weight in a treatment program utilizing a regimen of weight reduction based on caloric restriction, nutritional counseling, behavior modification  and exercise without controlled drugs and said treatment was ineffective.

There are several problems with this section. First, the terms (especially “ineffective”)  are  not defined and the time period is not mentioned. However, even if the definitional problems were solved, the section places a great burden on the patient to collect and provide records. It invades the privacy of the patients. It establishes as a matter of Ohio law that anti-obesity products are “ For Losers Only.” What about the patients who want to maintain their weight loss? What about those who did not have the funds or time to engage in a comprehensive  program? How many such programs are  available in their area? Are such comprehensive programs available in the extensive rural areas of Ohio or in its inner cities? Does health insurance in Ohio pay for such programs?  A great many health conditions are positively affected by weight loss and physical activity. Does Ohio restrict anti-cancer agents to patients who have a healthy diet and do not smoke or drink? Is the nicotine patch restricted to patients who have tried and failed at behavioral approaches to stop smoking? If such previous therapies are not required for other drugs, why are they imposed for obesity?

(C)(2)  prohibits dispensing anti-obesity agents to anyone with a BMI of at least 30.

This is higher than the generally accepted BMI of 27 as the line where risks to health begin to appear.

(C) (4) prohibits dispensing anti-obesity agents to anyone who is pregnant.

This may not be the case with all anti-obesity agents and should instead rely on FDA approved restrictions.

(C)(5)(a)  requires the patient to lose weight in fourteen days or be discontinued from treatment.

This is an unfair burden on a patient who is sincerely trying to lose weight. Actual weight loss may be slow or not appear for some time. In any event, actual weight loss is out of the patient’s control even when on programs of calorie restriction or exercise. Weight loss is simply too variable to be employed to disqualify patients seeking care.

(C)(5)(b)  requires discontinuation of prescriptions to patients who are not compliant with the physician’s recommendations.

This is truly inappropriate. The psychological burden of both obesity itself as well as efforts to lose weight is well known. Also well know to patients with obesity that too frequently family members or friends or co-workers actually act to sabotage the best intentioned weight loss programs. External stress such as a divorce, loss of employment or death in the family may deter the most determined patient from continuing on a program for a period of time. To penalize such patients is unconscionable. The Board should keep in mind that the vast majority of consumers will spend their own funds on such medications. If a patient is willing to pay out of pocket for an appropriately prescribed medication and then discontinue use, they lose their payments as well as any benefit of weight loss from the medication. This is incentive enough to continue on the physician’s recommendations.

(C)(6) has left in the otherwise struck phrase “controlled substances.”

Whether this is intentional or not is unclear. Unfortunately, it indicates a casual approach to the difficult issues raised in these regulations in which an assumption is made that restrictions on controlled substances are equally applicable to anti-obesity agents no matter what their particular safety profile.

This section penalizes patients who have made any false or misleading statement to the physician regarding the use of drugs or alcohol.

This section too creates a serious question of patient privacy and is ultimately self-defeating. Many patients with obesity may well be in denial of the use of drugs , alcohol or food as coping mechanisms to deal with stress in their life. If one has said to a doctor in an initial interview that they consume little alcohol and later come to admit that they consume larger amounts, should they be kicked out of therapy because of their honesty? Is this not a classic Catch-22 designed to encourage patients to mistrust or lie to their doctors about their actual situation? Would patients confront such problems if they knew the price was removal from a physician directed weight loss program?

(C)(7)  removes patients from access to anti-obesity agents if treatment is interrupted for more than seven days unless the interruption has resulted from an illness or injury to the patient, unavailability or the physician or unavailability of the patient but only “if the patient has notified the physician of the cause and anticipated length of the patient’s unavailability before the interruption of treatment begins”.

With all respect to the drafters of this change, this provision is outrageous. It penalizes any patient with obesity who is in good faith following a program of weight reduction or health weight management, who, through no fault of their own have to discontinue treatment. Suppose one of the parents of the schoolchildren recently murdered in Arkansas were covered by such a regulation. For not notifying the physician in advance that their child was going to be killed, they cannot return to a weight reduction program? Can such a outcome be seriously suggested by the State of Ohio?

(C)(8),(9),(10) and (D) create a limit on total duration of anti-obesity agents approved for weight-loss for “a few weeks” to 12 weeks within 18 months (see (D)) unless the patient has made a false or misleading statement under (C)(6).

Unfortunately this section seems almost designed to encourage weight regain. If a patient is on a medication for three months and then goes off it, he or she must wait another year and a half before being allowed to retake the medication. Assuming they have tried and failed at earlier programs of “caloric restriction, nutritional counseling, behavior modification and exercise” (see (C)(1)) and assuming they have successfully lost weight on the anti-obesity agent (C)(5), the State of Ohio is now saying that they must wait a year and a half before they may continue on the only effective program they have experienced?  With all respect, this provision does not make sense. For all other chronic diseases, the effect ceases when treatment ceases. This is also true for obesity.

For many patients, obesity treatment is a long term treatment. Controlling obesity requires constant management and discipline. Artificial barriers to accomplishing even small losses of weight should not be imposed. We know that even small losses result in improved health. As stated in Weighing the Options, a 1995 publication of the National Academy of Sciences, Committee to Develop Criteria for Evaluating the Outcomes of Approaches to Prevent and Treat Obesity of the Food and Nutrition Board, “Small weight losses, of as little as 10 to 15 percent of initial body weight, can generally help reduce obesity-related comorbidities (e.g. hypertension, abnormal glucose tolerance, and abnormal lipid concentrations), decrease the risk of depression, and increase self-esteem. In many cases, the obese person finds that weight loss helps to resolve the symptoms of co-morbidity or slow its progression.” (at p.55)

In summary, the proposed regulations appear well designed to promote and encourage obesity among the population of Ohio. They are likely to encourage some patients to revert to obtaining treatment underground or outside of the state. Unfortunately, all citizens of Ohio, not just persons with obesity will suffer. Through its medical assistance program and insurance premiums, Ohioans will have to pay for ever higher rates of the costly co-morbid diseases of obesity such as diabetes, hypertension and stroke.

Rather than take such a course which is inimical to public health, common sense and national goals of the United States, the AOA respectfully urges the Ohio Board of Medical Examiners to reconsider ways in which it may positively support the aggressive treatment of obesity, to encourage more patients to take control of this disease and to seek  and obtain effective treatment. The burdens this regulation place on individuals seeking in good faith to manage this disease are, we suspect, imposed on no other disease in the state and imposed by no other state in the nation. They are unfair and we strongly urge their withdrawal and reconsideration.

Respectfully Submitted,

Morgan Downey, J.D.
Executive Director/CEO
American Obesity Association
April 7, 1998

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