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November 21, 2003

Food and Drug Administration

Dockets Management Branch (HFA-305)

5630 Fishers Lane, rm.1061

Rockville, MD 20852

RE: FDA Obesity Working Group;

Federal Register: October 8, 2003 (Volume 68, Number 195)

On behalf of The Endocrine Society, I am submitting the following
comments regarding the October 8, 2003 Federal Register request for
comments to obtain stakeholders views on reducing obesity and achieving
better nutrition practices \[Docket No. 2003N-0338\]. The Endocrine
Society represents over 11,000 researchers and clinicians in the field
of endocrinology and is committed to the dissemination of new knowledge
leading to the research, prevention, treatment, and cure of disease.
Many of our members treat and research obesity-related disorders such as
metabolic syndrome, diabetes, heart disease and infertility. We have
taken interest in your six topics of discussion and in particular your
request for input on public education campaigns and relevant areas of
obesity/nutrition research.

[Public Education Campaigns]{.underline}

*What is the available evidence on the effectiveness of various
education campaigns to reduce obesity?*

*What is the available evidence that FDA can look to in order to guide
rational, effective public efforts to prevent and treat obesity by
behavioral or medical interventions, or combinations of both?*

The Endocrine Society shares the public health concerns of the FDA
regarding obesity which is why we have chosen the topic of obesity as
the focus of The Endocrine Society's annual meeting in June 2004. The
Society has assembled the nation's leading scientific experts on obesity
to develop a meeting agenda that will focus on dissemination of
scientific obesity-related findings and treatments to members of the
scientific community. Perhaps most important, our annual meeting focus
on obesity will raise awareness with the public about this growing
epidemic. The Society will also dedicate public relations resources in
2004 to highlight the health concerns surrounding obesity. Our public
relations efforts will identify key research regarding obesity as well
as addressing health complications of obesity.

Clinical endocrinologists often see obese patients for the first time
only after they have already developed obesity-related disorders.
Treatment at this point is often frustrating considering that most
obesity-related disorders are treatable or even preventable prior to
onset of symptoms and signs of those disorders. We would encourage any
public awareness campaign to focus on educating the overweight and obese
public to recognize an unhealthy body weight prior to the symptoms and
signs of obesity related co morbidities not only in adults but also in
children. Unhealthy weight and obesity can be measured using weight and
height to calculate a body mass index (BMI). Prevention is the key to
halting this epidemic. Education campaigns should focus on prevention so
that patients can try to avoid more drastic treatments such as weigh
control medication, bariatric surgical procedures (e.g., gastroplasty or
gastric bypass surgery) or insulin treatment for diabetes.

Public education campaigns must also focus on those with predisposing
medical conditions which lead to obesity, such as certain genetic
disorders. An estimated 80% of obesity cases include genetic traits that
affect appetite, energy expenditures and hormones and other organ
systems in the body. Currently the hormone leptin, a protein produced by
the *ob* (obese) gene, is being studied by endocrinologists and others
who see this hormone as a promising target in the fight against obesity.
Many other genes and gene products which appear to play a role in
obesity also are being studied by researchers.

There are also infrequent hormonal imbalances that contribute to being
overweight. These conditions include damage to the brain/brain
dysfunction, polycystic ovarian syndrome, and Cushing\'s disease (which
causes high levels of steroid hormones). Awareness of these conditions
must be raised in order to encourage the public to seek treatment rather
than suffering with what they believe to be a social or environmental
infliction.

[Obesity & Nutrition Research]{.underline}

*What are the top priorities for nutrition research to reduce obesity in
children?*

*What opportunities exist for the development of healthier foods/diets
and what research might best support the development of healthier
foods?*

*Based on the scientific evidence available today, what are the most
important things that FDA could do that would make a significant
difference in efforts to address the problem of overweight and obesity?*

Endocrinologists are leading the charge in researching obesity and
related disorders and offer the following comments regarding our
findings to date. Research by endocrinologists has shown that one of the
most debilitating and costly complications of obesity is the metabolic
syndrome. Metabolic syndrome (also known as syndrome X, or the insulin
resistance syndrome) refers to a set of disorders that can accompany
obesity and that lead to increased risk of heart attack and stroke.
According to the World Health Organization (WHO), a patient is
considered to have this syndrome if he or she has elevated fasting
glucose ([\>]{.underline}110 mg/dL) and/or elevated insulin as well as
at least two of the following:

-   Obesity with the excess fat predominantly in the abdominal area
    rather than the hips/thighs. (This distribution of excess weight is
    associated with increased chance of developing diabetes,
    hypertension, and unhealthy cholesterol levels).

-   Low HDL level and/or high triglyceride level. (Cholesterol and
    triglycerides are the two major types of lipids or fats in the
    bloodstream. Cholesterol has a "good" form that is HDL and a "bad"
    form that is LDL. Either low HDL or high LDL increases the risk of
    heart disease. High triglycerides can also increase the risk of
    heart disease).

-   High blood pressure.

The Center for Disease Control estimates that approximately one in five
U.S. adults have the metabolic syndrome.[^1] It is important to stress
that children can also have metabolic syndrome and are much more likely
to be afflicted if they are overweight. The Third Report of the National
Cholesterol Education Program (NCEP) Expert Panel on Detection,
Evaluation and Treatment of High Blood Cholesterol in Adults (ATPIII)
concluded that "Because the root causes of the metabolic syndrome for
the overwhelming majority of patients are improper nutrition and
inadequate physical activity, the high prevalence of this syndrome
underscores the urgent need to develop comprehensive efforts directed at
controlling the obesity epidemic and improving the physical activity
levels in the United States. [^2]\" The problem of improper nutrition is
related to the "Western Diet", characterized by higher consumption of
red meat, processed meat, French fries, high-fat dairy products, refined
grains, and sweets and desserts; a far healthier choice, is
characterized by higher consumption of vegetables, fruit, fish, poultry
and whole grains. The contributions of unhealthy eating habits,
including frequent snacking on unhealthy foods, and the role of poor
physical activity patterns must be part of educational campaigns.

Besides the American adult population, the metabolic syndrome also
affects American children. A recent estimate revealed that 1 in 4 obese
children may show signs of pre-diabetes (NEJM ref). Our health care
system is not prepared for the evolving epidemic of diabetes and
metabolic complications of obesity in our younger generations of
Americans. As supported by the research noted above it has become
apparent that additional research regarding metabolic syndrome is needed
to further examine the causes, impact, and potential cures in order to
reduce obesity in children.

To address the medical complications and health care costs of the
obesity epidemic we will need a new arsenal of tools and new therapies
to supplement the nutritional and exercise approaches. The internal
signals that control body weight and metabolism are very complex and
need much more study. Research to determine the mechanisms responsible
for obesity and the metabolic syndrome as well as for the prevention of
and the treatment for obesity and related clinical conditions, such as
diabetes and cardiovascular disease, is essential. Research also should
include funding for a significant genomics component to expedite the
identification of genes with mutations or polymorphisms linked to
obesity and the metabolic syndrome to expedite the development of more
effective therapies.

In the long term, to address this epidemic, we will also need to develop
creative new strategies to ensure funding for the clinical care of
obesity, including expanding multidisciplinary clinical obesity centers,
and assuring access to medical care for the prevention and treatment of
obesity prevention and the metabolic syndrome. Taking
regulatory/legislative action to define obesity as a disease, as was
done for other health problems, such as alcoholism, would help assure
the obese population of access to the care and treatment to which they
do not currently have access. Legislative measures are sorely needed to
increase access to programs for the prevention and treatment of
overweight and obesity.

Thank you for considering our comments and thank you for addressing what
is quickly becoming the largest health care crisis is America. Our
membership feels it is important that research continue and expand on
metabolic syndrome, leptin and other hormone imbalances if we are to
fight obesity head on. We also feel that public educational campaigns
continue to stress prevention and identification of disorders within the
public at large. Please feel free to contact Susan Koppi (301) 941-0252
at The Endocrine Society if you have any questions regarding our
comments.

Sincerely,

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E. Chester Ridgway, MD

President, The Endocrine Society

[^1]: Ford ES, Giles WH, Dietz, WH. JAMA 2002; 287: 356-9.

[^2]: Western Diet - The "Western Diet" is characterized by higher
    consumption of red meat, processed meat, French fries, high-fat
    dairy products, refined grains, and sweets and desserts; the
    "Prudent Diet\" is characterized by higher consumption of
    vegetables, fruit, fish, poultry and whole grains.