Reality Council Welcomes The U.S. Food And Drug Administration (FDA) Approval Of Alli(TM) (Orlistat 60 Mg Capsules) For Over-the-Counter Use

The Reality Council, a group of
experts on obesity, nutrition, diabetes and healthcare policy welcomes the
FDA approval of alli(TM), a drug marketed by GlaxoSmithKline Consumer
Healthcare with a proven safety and efficacy profile that can potentially
help some of the 130 million overweight and obese Americans achieve their
weight loss goals.


By making this drug available over-the-counter, the FDA is
acknowledging the need for a diet aid that has clinical data supporting it.
This is the first clinically-proven alternative to the unsubstantiated diet
products that distract millions from making the lifestyle changes and diet
adjustments necessary to lose weight. Consumers spend billions of dollars
each year on unproven and potentially unsafe "miracle" pills and other
weight-loss supplements.



"This drug approval is consistent with the Reality Council's call for
safe and effective weight loss options that don't promise unrealistic
results," said Reality Council co-chair Louis J. Aronne, MD, FACP, of New
York- Presbyterian Hospital/Weill Cornell Medical Center. "It is important
for consumers to realize that modest changes in body weight can provide a
health benefit for those either overweight or obese."



"Diet and exercise form the foundation of healthy weight management,"
said George L. Blackburn, MD, PhD, of Harvard Medical School and co-chair
of the Reality Council. "Unfortunately, there are still people who need
some extra help to get to a healthy weight. As experts, we welcome diet
drugs that are supported by science. These drugs offer an important
alternative to diet pills that offer false hope and exaggerated claims."



For more information or comment on this issue, please contact:



-- Dr. George L. Blackburn, Harvard Medical School



-- Dr. Louis J. Aronne, New York-Presbyterian Hospital/Weill Cornell
Medical Center, Phone: 212-583-1000



About the Reality Council



At any given time, one-third of men and one-half of women in the U.S.
are trying to lose weight, and they're collectively spending billions of
dollars each year to do so. But unfortunately, Americans are gaining
weight, not losing it. To address this growing health problem, a group of
esteemed experts on obesity, nutrition, diabetes and healthcare policy
formed the Reality Council with a goal toward advancing an agenda for
realistic approaches to weight loss to achieve improved public health.



The Council launched the Reality Initiative in 2006, supported by an
educational grant from GlaxoSmithKline Consumer Healthcare. Committed to
changing the national weight loss dialogue and broadening its sponsorship
base, the Council will expand its efforts in 2007 and invites private,
public, professional and non profit support to join them in their efforts.
This past year, the Council developed a white paper entitled Help not Hype:
Getting Real About Weight Loss (published in Obesity Management, January
2007), which it introduced together with the Federal Trade Commission at
NAASO, The Obesity Society in October 2006.
















Members include co-chairs Dr. Louis J. Aronne and Dr. George L.
Blackburn; MRC Greenwood, PhD, of University of California, Davis; Arthur
Frank, MD, Obesity Specialist; Gary Foster, PhD, Behavioral Psychologist;
Barbara Moore, PhD, Nutritionist; Judith Stern, ScD, Nutritionist;
Nathaniel Clark, MD, MS, RD, Diabetes Specialist; Anne Wolf, MS, RD,
Dietitian; Madelyn Fernstrom, PhD, CNS, Nutritionist; Susan Cummings, RD,
Dietitian; Jeremy Nobel, MD, MPH, Public Health Expert; Valentine
Burroughs, MD, MBA, Diabetes Expert; Morgan Downey, JD, Obesity Specialist.



About Overweight and Obesity



Seven years ago, Healthy People 2010 (the report of a top-level Federal
task force of health agencies) called for a one-third reduction in the
proportion of adults who are obese from 15 percent to 23 percent. Instead,
since 2000, the number of obese Americans has tripled.



Currently, approximately 65 percent of U.S. adults are overweight or
obese, according to the National Institutes of Health. Americans spend
approximately $46 billion per year on weight loss products and services
(i,ii,iii,iv). Overweight and obesity are associated with an increased risk
of developing health problems such as hypertension, type 2 diabetes and
heart disease.(v) Factors that can contribute to overweight include an
abundance of high-calorie foods, low levels of physical activity, eating
behavior, environment, and genetics.(vi) Multiple studies have shown that a
modest reduction in weight improves health outcomes significantly in
overweight or obese patients. Multiple studies have shown that a modest
reduction in weight that is sustained improves health outcomes
significantly in overweight or obese patients.



References


(i) Serdula MK, Mokdad AH, Williamson DF et al. Prevalence of attempting
weight loss and strategies for controlling weight. JAMA.


1991;282:1353-8.

(ii) Bish CL, Blanck HM, Serdula MK et al. Diet and physical activity
behaviors among Americans trying to lose weight: 2000 Behavioral Risk
Factor Surveillance System. Obes Res. 2005:13:596:607.



(iii)Wiess EC, Galuska DA, Khan LK et al. Weight-control practices among
U.S. adults, 2001-2002. Am J Prev Med. 2006;31:18-24.



(iv) U.S. weight loss market reaches $46 billion: sales of meal
replacements & OTC diet pills plunge, as bariatric surgeries and low-
carb product sales soar [press release]. Tampa, FL: Marketdata
Enterprises; March 1, 2005. Available at: mkt-data-ent/pressreleases/DietMarch2005.doc. Accessed September 17,
2006.



(v) Centers for Disease Control and Prevention: "Overweight and
Obesity. cdc/nccdphp/dnpa/obesity/ Accessed 12/22/05.



(vi) Centers for Disease Control and Prevention. "Overweight and Obesity:
Contributing Factors."
cdc/nccdphp/dnpa/obesity/contributing_factors.htm.
Accessed 12/22/05


The Reality Council