From: Dr. L. Pincus [pincus@drlpincus.com]
Sent: Friday, November 21, 2003 3:58 PM
To: fdadockets@oc.fda.gov
Subject: Docket 2003N-0338

To the obesity study group:

I am sending this comment to you via email, as the docket/comment web page
seems to be inactive at this time.  Thank you for requesting comments. I
have attached my cv and bio sheet as a form of introduction. I am a
practicing general internist in Dallas, Texas, with board certification in
internal medicine and bariatric (obesity) medicine. Having made the
treatment of the obesity epidemic my life's work and my great passion, I
would like to respond to you re: two of the six areas that were topics for
discussion at the public meeting held October 23.

Item 3: 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?
There is absolutely no question that the approach to the treatment of the
obesity epidemic must be multifactorial. Part of the attack on this disease
must come from physicians and allied health personnel.  From an educational
point of view our treatment of obesity as a disease and our teaching to
physicians, physician assistants and nurse practitioners of the simple yet
effective ways to treat obesity in the office are just awful, and need
emergent remediation.  Each year I speak to thousands of health
professionals, mostly physicians, about the successful office management of
obesity, and I have a nationally recognized minimum one year lifestyle
change program for high body mass index adult, the To Life! Lifestyle Change
and Weight Loss Program (www.drlpincus.com). What I teach, as a result of
what I have learned, is that lifestyle change, other than surgery, is the
only treatment for this disease, and that the proper use of safe, effective
prescription medication allows patients to lose more weight and participate
in structured programs longer than simply lifestyle change alone.  Over the
last 5 years I have placed close to 500 patients on sibutramine (Meridia)
and or orlistat(Xenical), with approximately 90% of this number takiing
sibutramine alone.  There is absolutely no question, as reflected in a
recent study in progress by Dr. Thomas Wadden at Penn, and by our own as yet
unreported series of the first year progress of our first 400 patients, as
well as others, that when a physician can give a patient behavioral change
coaching in combination with safe prescription medication, the resultant
weight loss is greater. The longer you have a patients participation in a
structured lifestyle change approach, the longer they have time to develop
their own new "system" for eating healthy and getting more active.  So we
must educate physicians and the public that obesity is a long term, chronic
management problem. Like the treatment of diabetes, hyperlipidemia, and
hypertension, where current therapy involves using multiple modalities to
"get to goal", we cannot expect to "get to goal" (Stop the gaining, lose 10%
of what you weigh, and be healthier because of it) without using all of the
modalities that have been proven to help, including prescription medication.
Any national set of reccomendations that comes from your efforts that does
not encourage the medical community to learn more and do more about treating
obesity as a disease will miss  a huge opportunity.  You must, however, do
more than look to education, food industry cooperation, and food label
reform. Many patients, not all certainly, can benefit from the long term use
of safe medication, and you should not shy away from this.

Item 6, 6. 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?
It is unconscionable to me that the government and therefore the health care
insurance industry still refuse to allow physicians to code for obesity,
278.00, without fear of not getting reimbursed.  Do we refuse to pay for
diabetes, hypertension, dyslipidemia, the metabolic syndrome...all of which
are overwhelmingly and scientifically linked to the common denominator of
obesity?  Private health care will not pay for obesity as a codable
diagnosis until the government says it must be done. We have an EPIDEMIC
here, and not incentivizing responsible physicians to treat this disease is
a disgrace.  If you really want an answer to item 6, the FDA and Secretary
Thompson can push hard to stand behind the message given to the public that
obesity is a disease by taking action to allow doctors to treat it.  As it
now stands most doctors will not treat obesity either because of their own
prejudice, their lack of knowledge re how to treat obesity as a disease, and
/ or the reality that if they want to get paid for their time they have to
lie on their claim form and code for something else. Isn't this stupid?  I
don't think you can hide behind the cost concerns of suddenly saying that
obesity can be treated in the doctors office,or by encouraging physicians to
learn more about the safe use of prescription medications so that they might
use them more effectively. Yes, this is going to be expensive, but so are
the 300,000 to 400,000 deaths each year from this disease.
Please call on me if you require my assistance. I would be happy to help.
Sincerely,
Lewis M. Pincus, D.O.
Medical Director
Weight Management Institute
Methodist Health Care System, Dallas, TX
w: 972.298.3972
fax: 972.709.7698
www.drlpincus.com
Medical Director
To Life! Lifestyle Change and Weight Loss Program
Dallas, TX