From: MorgDowney@aol.com
Sent: Tuesday, September 30, 2003 3:21 PM
To: FDADOCKETS@oc.fda.gov
Subject: Comments on Docket #2003N-0338

September 30, 2003

Commissioner Mark McClellan
Dockets Management Branch (FDA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

                        Re: Docket # 2003N-0338

Dear Commissioner McClellan:

The American Obesity Association (AOA) was pleased to participate in the 
Secretarys roundtable discussion of obesity on July 30, 2003. We applaud your and 
Secretary Tommy Thompsons leadership on the issue of obesity and the 
significant interest expressed by the leadership of HHS in this issue.

AOA is a non-profit tax-exempt educational and advocacy organization. We have 
some seven hundred members, both professional and lay. Our financial support 
comes principally from pharmaceutical research and development companies as 
well as other companies in the weight management field such as Weight Watchers 
Inc., Jenny Craig, Inc.and SlimFast Foods.

Obesity is the most prevalent, fatal, chronic disease of the 21st Century. 
The World Health Organization (WHO) has identified obesity as one of the ten 
leading health risks in the world today; one of the top five in the developed 
world. WHO reports that over one billion people are overweight in the world out 
of a population of 6 billion and that 300 million persons (5%) are clinically 
obese. WHO projects 3 million deaths annually worldwide from obesity rising to 
5 million by 2020.

In the United States, 65% of adult Americans are overweight and 31% are 
clinically obese. Fourteen percent of American children and adolescents are obese.  
Obesity is unique in that it is a chronic disease that is increasing at rates 
previously only seen with infectious diseases.  Obesity is a leading cause of 
mortality, morbidity, disability, and discrimination in health care, 
education, and employment. According to a recent RAND study, the health consequences 
of obesity are as significant or greater than smoking, problem alcohol 
consumption and poverty.  The consequences of obesity include
various cancers,  heart disease, stroke,  type 2 diabetes , osteoarthritis,  
sleep apnea,  and problem pregnancies and childbirth  among others.

Too often, discussions about obesity seem to focus on normal weight persons 
at risk for becoming obese or persons with just borderline obesity. It should 
be kept in mind that persons would have morbid or severe obesity, defined as a 
Body Mass Index or BMI of 40 or greater, approximately 100 pounds overweight, 
includes some 10 million Americans. For comparison purposes, the population 
with Alzheimers disease is about 4 million. This population is the one where 
the adverse health and socioeconomic effects of obesity are most pronounced and 
which suffers the greatest lack of access to health care and treatment.

 Obesity is poorly treated in the medical community even though effective 
treatments are available including bariatric surgery, FDA approved medications, 
physician counseling, dietitian services and behavioral interventions. Coverage 
for these treatments is modest to poor in both governmental and 
non-governmental health insurance programs. Inexplicably, the very insurance programs that 
do not reimburse for weight maintenance do cover the costs of treating the 
diseases caused by obesity.  The desire for effective methods of weight 
management can lead to adverse interventions by consumers including the initiation or 
continuation of tobacco smoking  and the use of ineffective or harmful consumer 
products. 

With any major public health crisis, the tools developed by the United States 
over many decades have demonstrated their effectiveness. Unfortunately, many 
of these tools are not being employed in the fight against obesity. The tools 
are research, education, prevention, treatment, anti-stigmatization efforts 
and consumer protection. We would like to examine each of these areas and 
provide some specific suggestions.

At the outset, we believe the HHS must rethink its traditional approaches to 
obesity and adopt a paradigm which is more scientifically driven than current 
approaches. This paradigm involves the following understandings:
A. Obesity is not a behavior; obesity is excess adipose tissue. 
B. Obesity is a disease because it meets any rational definition of "disease".
C. Obesity is a fatal, chronic, relapsing disease that is at least as 
complicated to treat as heart disease or cancer.
D. Obesity is a problem that will largely be solved by more research.
E. Obesity prevention and treatment includes more than just diet and 
exercise, as the effectiveness of these treatments over the long term has been poor. 
F. Obesity is a global problem arising from a combination of genetic, 
environmental and behavioral factors.
G. We do not know now how to prevent and effectively treat obesity over the 
long-term, with the exception of bariatric surgery for persons with morbid 
obesity.
H. If we do not drastically and quickly expand the research base of obesity 
and develop new treatments, the entire health care system in the United States 
is at risk.
I. Simplistic assertions that obesity is easily prevented or easily remedied 
do a disservice to persons with obesity and inhibit discovery of effective 
solutions.

A key question to be asked is, "Is HHS organized to address the national and 
international crisis in obesity?" The answer is no. No office is charged with 
monitoring the obesity epidemic, monitoring federal governments response and 
advising federal agencies and Congress on issues affecting obesity. We 
recommend that the Secretary establish in the Secretarys office an Office of Obesity 
Research, Prevention and Treatment and an advisory council. This office would 
be charged with coordinating HHS activities in relation to obesity and to 
work with other federal agencies and departments on issues affecting obesity. The 
Office should be charged with providing annual reports to Congress and the 
public on the progress in dealing with the obesity epidemic.

A. RESEARCH
Obesity will be solved, in the end, by the tools of modern life sciences, 
including insights on the genetic, environmental and behavioral causes of obesity 
and a multiplicity of effective interventions. Many people believe that it is 
simply a matter of personal self-control and is easily controlled if not 
eliminated by attention to modest changes in diet and physical activity. 
Scientific studies over three decades have shown that obesity is a complex 
neuroendocrine disease caused by the interactions of our genetic makeup, environmental 
exposure and personal behavior. Research has recently elucidated some of the 
mechanisms by which various peptides and hormones affect our feelings of hunger 
and satiety. We currently understand that dysregulation in these substances and 
others to be discovered greatly influences our ability to regulate eating 
behavior, energy metabolism, and a persons ability to achieve long-term weight 
loss.

Body fat is now known to be regulated by several hormones and neuropeptides, 
including leptin and ghrelin. Food products such as glucose, amino acids and 
fatty acids affect the production of the hormones insulin, growth hormone, 
insulin-like growth factor and leptin act on specific receptors in the 
hypothalamus and other areas of the brain to regulate feeding behavior and energy 
metabolism. The next stages of the human genome program hold the promise to integrate 
the molecular understanding of normal body weight regulation with abnormal 
body weight regulation. Fresh insights on the significant racial and ethnic 
disparities in obesity and its comorbid conditions are foreseen.  With such 
information, more precise and informed prevention strategies, behavioral 
interventions, pharmacology, and surgical interventions can be developed and tested. Such 
prevention and treatment strategies will give rise to questions of economic 
efficiency and legislative and regulatory approaches. The current lack of 
attention in medical training and health professional disciplines on obesity can be 
directly and immediately approached through programs to develop obesity 
researchers and health education campaigns. Research needs to also be greatly 
expanded on a global scale. Obesity is rising in virtually every country of the 
world except for sub-Sahara Africa. There are significant differences in these 
cultures and their differing rates provide a natural laboratory to understand 
the interaction of various causal factors.

Unfortunately, it must be recognized that the commitment of the National 
Institutes of Health to the obesity epidemic has been wholly inadequate. Billions 
of dollars are spent on the conditions caused by obesity; pennies on obesity 
itself. Broad areas of obesity research are undersupported. In addition, 
obesity is situated at the lowest rung of the NIH hierarchy, guaranteeing that new 
initiatives are not developed and that there is no articulate, 
scientifically-based voice on obesity. In summary, despite obesity impact on health, despite 
its increasing over the last twenty years and despite the doubling of the NIH 
budget over the last 5 years, obesity remains in the budgetary and 
organizational cellar of NIH.

Therefore, we propose at a new National Institute of Obesity be established 
at the National Institutes of Health. We see it has having seven components or 
divisions:

      1.   Basic research on adipose tissue
2. Epidemiology and Population Studies. 
3. Genetics, Metabolism and Disease Development;
4. Neuroscience and Behavioral Research;
5. Prevention, Therapeutic Development and Clinical Trials,
6. Economics and Health Policy, and,
7. Training and Education. 

These areas reflect both the needs and robustness of the obesity research 
field. Critical work in all these areas is going on but vastly more needs to be 
done. Above all, meaningful integration of the specific research areas has not 
occurred. In 1999, the Senate Appropriations Committee called on the 
Department of Health and Human Services to develop a comprehensive research plan on 
obesity.  This has never been implemented and is even more needed today.

B. EDUCATION

For an issue as much in the public eye as obesity, the lack of education is 
appalling.

1. Due to television coverage, many in the public assume that when we talk 
about obesity they believe that we are talking about morbid obesity. On 
television, the public often sees persons who are 100 pounds overweight described as 
obese; rarely do they see persons at the defined level of obesity, about 30 
pounds overweight. This means that many do not feel they or family 
members/co-workers are at risk. When the NIH Guidelines for the Treatment of Obesity were 
issued, there was widespread public confusion over the definition of overweight. 
To many, it seemed an arbitrary cutoff, rather than a recognition of the 
level at which weight-related health problems develop. HHS and NIH failed to 
respond to this misperception in the public and media. Because of this 
misperception, the public less likely to take health warnings seriously. HHS could 
ameliorate this by providing visual aids to television and other media outlets on 
what obesity truly looks like in a compassionate manner and by encouraging 
government and private partnerships to provide opportunities for industry to 
disseminate these messages.

2. The level of physician and other health professional knowledge of obesity 
and its treatment is tragically low. HHS should use its health education 
resources to encourage education in medical schools and other health professional 
schools about obesity and its treatment. We propose that the HHS set aside 
funds to develop faculty programs for obesity education and research in medical 
schools, similar to the programs for primary care medicine and womens health 
that have insured that specialists in these areas are in most of the medical 
schools in the country.

3. Even the most motivated person, seeking to manage their weight will be 
confused by the information on food labels, the Food Pyramid and the Dietary 
Guidelines. The Nutritional Label has become as complicated as the package insert 
on FDA approved drugs. Greater and greater levels of information may be useful 
to some but they are of little value if too complicated for consumers to 
understand. HHS through the FDA should require a large label on the front of each 
package of food giving the packages total calories. Consumers seeking to 
control their weight will have clear information and can make allocations 
according to their own usage or portions. This would stop the gaming of calorie 
information by food companies who are now allowed to report only their own calorie 
per portion information. Restaurants should also be required to post calories 
on their menus.

4. Schools have abdicated their responsibility to provide students at all 
levels with
skills to understand their body weight and caloric requirements. In addition, 
schools have drastically curtailed physical activity for their students while 
providing greater access to vending machines and bringing in fast food 
franchisees to provide food services. DHHS should initiate an aggressive program 
with the Department of Education to amend federal and state education laws to 
require the provision of age-appropriate obesity, nutritional information and 
portion size information

5. Several surveys, including one conducted by AOA, indicate that parents 
have little understanding of the importance of their childrens weight as well as 
family strategies to manage weight effectively. AOA recommends that HHS and 
the Department of Education undertake a campaign focused on parents of 
elementary school children, in particular, to allow them to assess their childs 
weight status and appropriate strategies for weight management.

C. PREVENTION

Prevention of obesity and the complications of obesity are of critical 
importance. However, there is an amazing paucity of reliable information on how to 
prevent obesity.
In addition, the important community-based programs now arising around the 
country are being carried out without independent reliable evaluations. Thus, 
after those programs have been implemented we will not know what really works 
and what does not. 

HHS needs to be realistic about prevention. The federal government encourages 
massive over-production of food. The federal government expends approximately 
$72 billion dollars a year on agricultural subsidies. This massive investment 
results in production of nearly twice the calories the U.S. population 
requires. This over production reduces the cost of foods to consumers, encourages 
portion sizes to increase without regard to the cost of the food and encourages 
massive marketing campaigns as companies strive for market share. In addition, 
the US Department of Agriculture and many states have programs to increase 
consumption of particular foods such as dairy, meat and corn produced in those 
states. The relevance of these programs to our Nations health must be 
rethought. Through the Federal Communications Commission, the government is 
encouraging children viewing of television and increased television utilization by 
forcing communities to adopt high definition television systems (HDTV). Food 
companies are able to heavily advertise to children and consumers through the 
deductibility of advertising expenses on their corporate income taxes. Our 
commercial and industrial policies encourage information technology and the service 
economy which are much less labor intensive than our earlier industrial and 
agricultural basis. Our transportation policies encourage use of the private 
automobile and discourage means of transportation which would expend more calories. 

HHS needs to be a voice to Congress and other federal agencies on the 
implication of these policies. None of these policies were created with the intention 
of creating obesity. However, we can no longer afford to ignore the putative 
impact of these policies on creating the energy consumption and expenditure 
experience of our people. 

In addition, we recommend consideration of a novel proposal we would like to 
offer.
According to USDA, advertising of food is a $7 billion dollar annual 
investment. Again, according to the USDA, most of this advertising investment is 
expended on foods at the top of the Food Pyramid, i.e. the most calorically dense 
foods of low nutritional value.
We propose that HHS and the Department of the Treasury examine a change in 
the corporate tax laws. Currently all such advertising expenditures are 
deductible. Our proposal would require food companies to segment these expenditures 
into three categories: Category A would include foods of high nutritional value. 
Category B would comprise foods of modest or neutral nutritional value and 
Category C would include foods of low or minimal nutritional value. Criteria for 
each category would be established using USDA established protocols. Each 
food company would then allocate their advertising expenditures by category. 
Category C advertising expenditures would not be eligible for the deduction from 
corporate income. Category B advertising expenditures would be eligible for a 
one-to-one deduction. Category A advertising expenditures would, however, be 
eligible for a two- or three-to-one deduction. The Treasury Department would 
establish a modifier such that this formulation would be revenue-neutral, in 
other words, the federal government would not receive greater or lesser tax 
revenues as a result.

We believe the results of this proposal are four. First, companies could 
develop and fully market and advertise any product they wish. Second, taxpayers 
would only subsidize healthy foods not high calorie foods with little other 
nutritional value. Third, consumers would not be restricted in their choices in 
the least. Fourth, this proposal creates an incentive to shift the considerable 
marketing skill of food companies to healthier foods.

Prevention is primarily a research problem. We need the more prevention 
studies in diverse populations to provide the public and policy makers with sound 
and achievable strategies to prevent obesity. We need policy analysis support 
to develop and refine workable, efficient models of prevention. 

Too often, HHS only speaks about prevention and avoids any reference to 
treatment. This is unique in public health programs. We cannot imagine that HHS 
would only talk about preventing HIV/AIDs for example, and not address treatment. 
The messages from
DHHS need to be more balanced and not simply rely on nostrums about diet and 
exercise, as important as they are, to the detriment of other weight 
loss/management strategies as indicated by NIH in their Guidelines for the Treatment of 
Obesity. 

Prevention may also be accomplished by encouraging communities to think about 
and plan the physical environments to be more conducive to physical activity. 
The federal government makes a great investment in roads, highways, airports, 
mass transportation and urban planning. We propose that the Department of HHS 
work with the Department of Transportation and other federal agencies on a 
Physical Activity Impact Statement, modeled after the Environmental Impact 
Statement. For each federally supported program, analysis would be made whether the 
proposed project (like a highway without sidewalks) is likely to increase or 
decrease the net physical activity of the community it serves. If it were 
foreseen that the project is likely to result in a decrease in physical activity, 
remedial steps would be necessary to take the project to at least a neutral 
intervention in the human environment.

D. TREATMENT

1. New treatments including drugs and devices

AOA was very pleased to see the Food and Drug Administration announce earlier 
this year a commitment to revise its guidances for review and approval of new 
drugs for the treatment of obesity. For persons desiring to treat their 
overweight or obesity, pharmaceuticals, in conjunction with diet and exercise, 
offer the greatest likelihood for significant new developments. Effective 
treatment of obesity, as with other chronic diseases, will require probably more than 
one drug for treatment.

In April 2003, AOA convened a meeting of some dozen pharmaceutical and 
biotech companies to discuss problems with the current FDA guidances. The consensus 
of the meeting was that not only are the current guidances out of date 
scientifically, they are inconsistent with guidances in other areas, such as type 2 
diabetes, hypertension and hypercholestolemia, Also, there was consensus that 
in the past he attitude of the FDA has been to impose significant roadblocks to 
R&D companies invested in finding new therapies for obesity. This must 
change. Achieving a better scientific understanding of obesity, of the regulation of 
hunger, satiety and energy metabolism, holds great promise that physicians 
and patients will have, at some point in the future, a number of safe and 
effective agents for treating obesity. A new National Institute of Obesity can 
accelerate this process and assist in developing new treatments and improve 
existing treatments.

2. Health Care Insurance Coverage

HHS has set a very poor model for managed care and the insurance industry in 
the treatment of obesity. The Medicare Coverage Issue Manual declares that 
obesity is not an illness and that no program payment can be made. The Medicare 
drug benefit legislation now before Congress excludes drugs for the treatment 
of obesity. The Medicare medical nutrition counseling benefit does not cover 
services for persons with obesity, with or without comorbid conditions. The 
Medicaid program also largely excludes drugs and surgery for the treatment of 
obesity, as well as behavioral counseling, nutrition education and physician 
supervised weight loss programs. The Indian Health Service excludes surgery for the 
treatment of obesity

HHS policies have created and supported discrimination against persons with 
obesity by these policies. AOA calls on HHS to 
a.    incorporate the NIH Guidelines for the Treatment of Obesity in
       its own programs such as Medicare, Medicaid and the Indian Health 
Service;
b. change the Medicare programs policy to recognize obesity as a disease; 
c. encourage health maintenance organizations and traditional insurers to 
cover obesity treatments recommended by the NIH;
d. advocate that Congress include drugs to treat obesity in the pending 
Medicare drug benefit legislation and
e. advocate that Congress repeal the provision discouraging states to include 
drugs to treat obesity in the Medicaid program.

Both Medicare and Medicaid programs should commence demonstration projects to 
evaluate the effectiveness of various interventions in the elderly and 
Medicaid populations. These would include evaluations of surgery, drugs, lifestyle 
modification programs, and, nutrition counseling in individual and group 
settings.

The Centers for Medicare and Medicaid Services (CMS) needs to appreciate that 
the elderly obese Medicare population is increasing dramatically. In fact, 
the elderly-obese Medicare population is the fastest growing segment of the 
obese population. Obesity related comorbidities account for fully five of the top 
ten reported health conditions of Medicare beneficiaries. The impact of 
obesity on the Medicare population will increase in the foreseeable future as both 
baby-boomers reach Medicare eligibility and the population of disabled persons 
with obesity increases. CMS should be encouraged to work with National 
Institutes of Health to address this growing problem.

CMS and FDA have critical roles to play in the development of new 
technologies in health care. However, most of these technologies (a) have not evaluated 
in persons with obesity and/or (b) are not physically accessible by persons 
with obesity, especially severe or morbid obesity. We strongly recommend that CMS 
and FDA require such technology to be tested on persons with obesity and to 
be accessible by persons with obesity.

HHS should also launch a collaboration with the Department of Veterans 
Affairs to promote treatment of this Nations veterans with obesity, with the 
Office of Personnel Management concerning federal employees and with the Department 
of Defense concerning the problem of obesity in the military and among 
military families.

3. Increasing Health Insurance Premiums on Obese Persons

AOA was concerned with statements following the July 30, 2003 meeting to the 
effect that the Department was looking for ways to assist health insurance 
companies raise the premiums paid by persons with obesity. We object very 
strongly to the view that lean persons are subsidizing persons with obesity. This is 
a terrible approach for several reasons.
First, it constitutes a tax on the state of being obese. It assumes that 
obesity is a choice and is easily fixed. Neither assumption is true.
Second, not every obese person will require additional health care 
expenditures. 
Third, this approach taxes some people for their health status but does not 
tax others. Should we tax women because they have higher health insurance 
costs? Should we tax African-Americans because they have poorer health than whites? 
Third, why should we protect genetic information from insurance companies but 
allow them to impose greater costs merely because the health status is more 
apparent? 
Fourth, persons with obesity actually subsidize lean persons because 
insurance covers their health needs but almost universally exclude coverage of 
treatments for obesity. Why should obese persons pay insurance premiums to treat your 
skin disease when your premium prohibits coverage of my obesity?
Fifth, no health problem was ever solved by penalizing the patient. This one 
wont be either.
Sixth, this idea merely imposes greater stigmatization and discrimination on 
a significant component of the American public. 
Seventh, it merely provides additional money for insurance companies while 
providing no countervailing benefit.
Eighth, this approach would fall disproportionally on women, 
African-Americans and Hispanic Americans.
Ninth, this proposal would likely increase still rising number of uninsured 
Americans as employers dismissed them from their employment.
Tenth, dependents of obese-insureds who could not afford the extra costs 
would lose their health insurance coverage.

E. Social and medical Support for persons with morbid or severe obesity.

Persons with severe or morbid obesity and have life-threatening problems in 
accessing routine health care not to mention treatment for their obesity. There 
are no social services or care coordinators who assist them with finding 
appropriate care, such as
ambulances, social work services, or accessible technology. HHS should 
develop programs to train case workers, hospital discharge planners and other social 
support programs in assisting persons with obesity, especially morbid obesity.

F. Discrimination
In the United States, it is generally considered acceptable to discriminate 
against persons with obesity in education, employment and in health care. This 
discrimination, like all discrimination, causes enormous personal pain and the 
loss of valuable resources to the rest of society. Given that the morbidly 
obese population is at least 10 million, the prevalence of discrimination may 
equal that experienced by women, minorities and religious adherents. We urge HHS 
to undertake a systematic investigation of discrimination experienced by 
persons with obesity and subsequently to recommend to Congress remedial 
legislation to offset such discrimination.

G. Consumer Protection

There are numerous products marketed for weight loss with little or scant 
credible scientific evidence. Many products may be dangerous to consumers. We 
encourage the FDA and the Federal Trade Commission to strengthen its protection 
for consumers from dangerous weight loss products.

Regarding the specific questions put forth from the Department.

1. What is the available evidence on the effectiveness of various educational 
campaigns to reduce obesity?

We are aware of studies which have shown a beneficial impact on body weight 
of reduced television viewing but others which have tried to improve diet or 
physical activity have either been very small or have not shown positive 
long-term body weight reduction.

2. What are top priorities for nutrition research to reduce obesity in 
children?

This question assumes that obesity in children is a nutritional question. It 
does not address questions such as the weight and height of parents, 
breast-feeding practices and television viewing which have been studied for their 
effect on childhood obesity. Reducing obesity in children, as in their parents, may 
involve multiple factors in addition to nutrition research.

3. What is the available evidence supporting whether public efforts should 
prioritize behavioral interventions to prevent obesity versus medical 
interventions to treat obesity?

We think that the formulation of the question is part of the problem. The 
question itself is divisive and not scientific. Why are behavioral interventions 
competing against medical interventions rather than behavioral and medical 
interventions combined? Current FDA protocols for drugs and surgery include both 
medical and behavioral interventions. Current scientific thinking envisions 
treating obesity through a variety of interventions over a lifetime. These 
approaches are highly likely to be used in multiple, combined forms, not in single 
"either-or" modalities. AOA Research Foundation recently completed a 
comprehensive review of the literature on combination therapies and found very little 
research in this area. The HHS should recognize that the future fight against 
obesity will entail a multiplicity of therapies. HHS would not ask whether to 
prioritize behavioral or medical interventions for other public health 
problems, such as HIV/AIDs. Both interventions have important and complimentary roles 
in addressing obesity.

4. What changes to food labeling could result in the development of 
healthier, lower calorie food and the selection of healthier, lower calorie foods by 
consumers? What opportunities exist for the development of healthier foods/diets 
and what research might best support the development of healthier foods?

We have addressed this issue above but we note that packaged food and 
restaurant menus should contain total calories. The serving sized specified now are 
confusing and misleading. an all too familiar confusion. That is the assumption 
that unhealthy foods are higher in calories and that eating "healthy foods" 
results in a reduction of obesity. Neither assumptions are supported in the 
scientific literature.

5. Based on the scientific foundation available today, what is the one thing 
HHS could do that would make a significant difference in the efforts to 
address the problem of obesity? 

The one thing HHS could do is not ask what is the one thing it could do. 
Changing the ever-increasing rates of obesity will take a massive and costly 
effort. Rather than looking for the least that HHS can do, the Department would be 
well advised to look at the most comprehensive program it can take to the 
crisis. If it came down to "one thing" it might be that every HHS program develop 
the same sense of urgency which Dr. Julie Gerberding, the director of CDC, 
expressed when she said, "The biggest problem we face in America is not 
terrorism. The biggest health problem were facing is obesity."

Respectfully submitted,

Morgan Downey
Executive Director
American Obesity Association
Suite 300
1250 24th St. N.W.
Washington, D.C. 20037
Phone 202-776-7711
Fax: 202-776-7712
email: MorgDowney@aol.com
Internet: www.obesity.org