On March 22, representatives of four major groups concerned with obesity met with senior officials from the FDA to discuss the concerns about barriers to innovation in the treatment of obesity. Leaders from the Obesity Society, Obesity Action Coalition, American Society for Metabolic and Bariatric Surgery, and the American Dietetic Association met with Janet Woodcock, MD, and senior members of her staff. Woodcock is director of the FDA’s Center for Drug Evaluation and Research. FDA commented that such meetings are not common.

"We’re trying to move the dialogue forward," said Louis Aronne, MD, after the meeting. Other leaders from the obesity expert community in the meeting included Donna Ryan, MD; Patrick O’Neill, PhD; Ted Kyle, RPh; Francesca Dea, CAE; Jeanne  Blankenship, MS, RD; Joseph Nadglowski, Jr; Christopher Gallagher; and Georgeann Mallory, RD. For more information on this story, see…

http://www.medpagetoday.com/PrimaryCare/Obesity/25517

A wide range of patient and consumer advocates came together to urge the secretaries of HHS, Labor, and the Treasury to protect patients against discrimination in employer wellness programs.  Health reform legislation allows employers to offer incentives in wellness programs that could range up to 50% of the cost of health care coverage.

Ted Kyle, Chair of the Obesity Society Advocacy Committee, served on an expert panel on what works and what doesn’t for employee wellness programs.  Kyle pointed out, “Setting arbitrary BMI goals doesn’t work in wellness programs relating to obesity. What’s needed is access to effective treatment and a focus on longer-term (longer than six month) outcomes.”

For more information, see…

http://www.stopobesityalliance.org/blog/caution-don%E2%80%99t-penalize-employees-with-obesity/

and…

http://www.stopobesityalliance.org/wp-content/themes/stopobesityalliance/pdfs/What_Works_for_Obesity_in_Workplace_Wellness.pdf

Richard Atkinson, MD, and Ted Kyle, RPh, served on an expert panel meeting in Alexandria, VA, helping to deploy a registry of outcome databases for obesity and other chronic diseases.

This meeting is part of the Registry of Patient Registries (RoPR) project, sponsored by the Agency for Healthcare Research and Quality (AHRQ).  The goal is to design and deploy a searchable central listing of patient registries in the United States to enable interested parties to identify registries in a particular area (to promote collaboration, reduce redundancy, and improve transparency). The final system will be designed to be integrated with ClinicalTrials.gov, the registry of federally and privately supported clinical trials conducted in the United States and around the world.

One of the goals of the RoPR project is to promote the use of standard medical staging criteria and outcome measures across registries. Standardization will include both common definitions and common syntax (e.g., “six minute walk” instead of variations such as “6-minute walk”). Current variations in definitions between registries make it difficult to compare data across registries or link data from different registries. Standardization would help identify registries capturing relevant or similar information for collaboration or linkage, reduce redundancy, and increase the value of new registries that use the standardized data elements. The RoPR would collect metadata on patient registries, including a catalog of commonly used demographics, risk factors/staging criteria, clinical and treatment information, quality and outcome measures. By providing a system to describe common data elements and measures by condition in RoPR, information will ultimately be more useful, understandable, reproducible, and interoperable across patient registries.

Despite a favorable vote by an FDA advisory panel in December, Orexigen Therapeutics announced that FDA rejected their application for a new obesity treatment called Contrave (naltrexone/buproprion).

Obesity Society President Jennifer Lovejoy, PhD, expressed disappointment. “In the face of such a devastating, widespread and expensive public health crisis as obesity, it is baffling that the FDA has consistently denied approval for anti-obesity medications," said Dr. Lovejoy. “The FDA seems to expect that any obesity medication must be free of any side effects. This is an unrealistic standard and one to which medications for other diseases are not held. The Obesity Society will be working with other professional societies in the coming weeks to meet with FDA and Congressional leaders and discuss improvements to the process of reviewing obesity medications.”

TOS President-Elect Patrick O’Neil, Advocacy Task Force Chair Ted Kyle, and Executive Director Francesca Dea joined with other leaders from obesity organizations (Obesity Action Coalition (OAC), American Dietetic Association (ADA), and American Society for Metabolic and Bariatric Surgery (ASMBS)) in meeting with Congressional staff for Republican Members of Congress who now have leadership roles on key Congressional health care committees.  The group discussed concerns with Hill staff regarding  the "Safeway Amendment" pertaining to employer wellness incentive programs and how these programs will harm workers with obesity. Staff also learned about our efforts to secure obesity treatment services under the essential benefit package for the new health exchange plans.
 
The group met with staff members in key offices: Representative David Camp (R-MI), Chair of the House Ways and Means Committee; Representative Fred Upton (R-MI), Chair of the House Energy and Commerce Committee; Representative Wally Herger (R-CA), Chair of the Ways and Means Health Subcommittee; Representative Joe Pitts (R-PA), Chair of the Energy and Commerce Health Subcommittee; and Representative Tim Murphy (R-PA), member of the Energy and Commerce Health Subcommittee.
 
Following the adage that "all politics is local," Dr. O’Neil also arranged visits with Hill staff from the South Carolina Delegation that included Senator Lindsey Graham (R-SC) and Representatives Joe Wilson (R-SC), Tim Scott (R-SC), and James Clyburn (D-SC).
 
Dr. O’Neil also led a group to meet with staff of the Southern Governors Association (SGA). Founded in 1934, the SGA supports the work of Southern Governors by providing a bipartisan, regional forum to help shape and implement national policy and solve regional problems. The goal of these meetings was to establish connections with health policy leaders in the southern states where the obesity epidemic is most prevalent.

The FDA Endocrine and Metabolic Advisory committee voted 13-7 today in favor of approving a new combination product, Contrave, for the treatment of obesity by prescription. Contrave is a combination of two drugs available for other indications, buproprion and naltrexone.

This decision contrasts sharply with the outcome of three prior meetings this year of the same committee considering treatments for obesity. In those meetings, two other new products, Qnexa  (phentermine/topiramate) and Lorqess (lorcaserin) were voted down. Meridia (sibutramine), a prescription product first approved by FDA in 1998, was voted off the market by the same committee in September.

Advocacy groups testified in the public hearing that the FDA is setting the bar too high for new obesity treatment. "This panel has voted against every obesity treatment that has come before it this year," said Ted Kyle. "I ask you to take the disease seriously and take the benefits of treatment seriously." For more on this story, see http://prescriptions.blogs.nytimes.com/2010/12/07/f-d-a-panel-backs-new-diet-pill/

Ted Kyle presented Top 10 Obesity Social and Political Milestones to an audience comprised of employers and experts in workplace wellness.. 

Ted’s Top 10 List:
1. Michelle Obama Tackles Obesity
2. Health Reform Passes with Attention to Obesity
3. Government Draws Food Industry, Restaurants in Obesity Fight
4. Sugary Drinks: The Next Tobacco?
5. Harsh FDA Reviews of Obesity Drugs
6. Jamie Oliver Food Revolution
7. Cost of Obesity for Individual
8. Weight Bias Gains Increasing Media Attention
9. Women Suffer Most with Obesity
10. Weight Loss Surgery

Webinar sponsored by Free & Clear.  Free & Clear specializes in web-based learning and phone-based cognitive behavioral coaching to help employers, health plans, and state governments improve the overall health and productivity of their covered populations. Free & Clear’s evidence-based programs address the four key modifiable health risks that contribute to chronic disease: tobacco use, poor nutrition, physical inactivity, and stress.

http://www.freeclear.com/

San Diego, CA - Obesity 2010, 28th Annual Scientific Meeting of The Obesity Society.  Obesity 2010 - dedicated to increasing knowledge, stimulating research, and promoting prevention and better treatment for those affected by obesity – brought together obesity professionals, from world renowned researchers to educators, advocates, and practitioners. Among the many scientific and education sessions, oral and poster presentations, Ted Kyle, RPh, chaired a pre-conference program, “Health Reform: Getting Serious About Obesity.”   Here, attendees had the opportunity to hear policy experts talk about the implications of health reform for obesity research and treatment and the role The Obesity Society (TOS) can play in obesity policy development.

Program speakers included Amanda Cash, DrPH, Office of Planning, Analysis, and Evaluation Health Resources and Services Administration, US Department of Heath and Human Services; Christine Ferguson, JD, The George Washington University’s School of Public Health, STOP Obesity Alliance; Kelly Brownell, PHD, Yale University and the Rudd Center for Food Policy and Obesity; Barbara Thompson, MLS, Obesity Action Coalition; Geraldine Henchy, MPH, RD, Food Research Action Center; George Bray, MD, Pinnington Biomedical Research Center.

http://www.obesity.org/obesity2010/pdf/OBESITY2010_Final_Program.pdf

Adelphi, MD - FDA Advisory Committee on Endocrinologic and Metabolic Drugs advisory committee meeting to review the use of sibutramine in the treatment of obesity.  Theodore Kyle, RPh and chair of the The Obesity Society (TOS) Advocacy Task Force, presented a statement on behalf of TOS urging the panel to balance the need for effective treatments with the need to protect patients who are poor candidates for treatment with sibutramine.

Please visit http://www.obesity.org/about/advocacy.asp for more information.

Pace University, New York, NY. The “Weighty Matters” roundtable was a first ever collaboration between the National Eating Disorders Association and STOP Obesity Alliance. The program panel, which consisted of experts and leaders from the media, communications, eating disorder and obesity fields, addressed current perception, dialogue and images in media and entertainment which may be resulting in an increase in body image issues, eating disordered behaviors and obesity. Recognizing that the organizations have complementary missions, the event was jointly developed by STOP, NEDA, The Obesity Society, and the Obesity Action Coalition. Representing TOS, Ted Kyle served on the organizing committee.

Special guest experts included Diana Williams, WABC-TV, Moderator; Emme, Model and Activist, NEDA Ambassador; Dr. Max Gomez, Medical Reporter, WCBS-TV; Kate Dailey, Health and Lifestyles Editor, Newsweek.com; Wendy Naugle, Deputy Editor, Glamour Magazine; Dr. Donna Ryan, President, The Obesity Society; Jen Drexler, Partner, Just Ask a Woman; Joe Nadglowski, Jr., President & CEO, Obesity Action Coalition; and, Dr. Ovidio Bermudez, Past President, NEDA, also representing AED, IAEDP, and BEDA.

http://www.stopobesityalliance.org/events/past-events/eating-disorders-obesity-and-communications-experts-tackle-weighty-matters/