# Presentation: 106818

## Should Orlistat Be Approved ForOver-The-Counter?

- Laurie Tansman, MS, RD, CDN
- Department of Clinical Nutrition
- The Mount Sinai Hospital
- and
- Department of Community & Preventive Medicine
- Mount Sinai School of Medicine

## Issues to consider for OTC approval

- Adverse Side-Effects/Safety
- Gastrointestinal disturbances
**Malabsorption of fat soluble vitamins**
- Appropriate Use
**Will lifestyle changes such as diet and exercise be disregarded?**
- Abuse by those with eating disorders
- Impact on the obesity epidemic
**Third party insurance reimbursement**

## Malabsorption of fat soluble vitamins

- 	“The company recommends patients take multivitamins when using the drug, said Steve Burton, GlaxoSmithKline's vice president of weight control. Whether that would happen remains unclear: at least 47 percent of the people involved in trials of the drug did not take multivitamins as recommended, the FDA said.”
- 	*As reported by the Associated Press on 21 January 2006.*

## Will lifestyle changes such as diet and exercise be disregarded?

- Cornerstones of weight loss treatment:
- Diet
- Exercise
- Behavior Modification

## XENICAL patient education material

**“****You must use XENICAL******** with a recommended mildly reduced-calorie diet.”**

- 	The OTC version of orlistat, to reportedly be marketed as ALLI, will also emphasize the importance of diet and fitness as part of a weight control program.

-       Robert Bonow, MD, past president of the American Heart Association and professor of cardiology at Northwestern University's Feinberg School of Medicine in Chicago, was quoted as follows:
-      "You would love to get the drug in the hands of people who need it," Bonow said. "But we may be giving the medicine to people who don't need it and who will be told they have to take it for their lifetimes. **There is another problem—human nature.**** ****People who ought to be dieting and exercising are going to feel**** ****that since they're taking a pill they can now continue habits**** ****that are unhealthy."**** **
**	***Mitka M.  Are OTC statins* *ready for prime time?*  JAMA.  *2004;292:317-318. *

## Impact on the obesity epidemic

- “Obesity in the US has reached epidemic proportions and challenges so many aspects of our health.
- 	**While a healthy diet and exercise remain core treatment approaches, they have not halted the epidemic.”**
**	**** ***July 19, 2004 press release from GlaxoSmithKline*

## VanItallie Center for Nutrition and Weight Management

- Reimbursement
- 	“Insurance reimbursement varies, depending on your health plan.  Physician visits are usually covered, but nutrition classes and exercise sessions most often are not.”

## From the XENICAL website

-    “Insurance Information and CostsHaving a weight-related illness or risk factor may increase your chances of being reimbursed, but it is possible that you will have to pay for XENICAL**** yourself.”

## Getting serious about weight loss

-      We need to have consistent insurance reimbursement for:
- 	dietary counseling as provided by Registered Dietitians (the nutrition experts) or for participation in a recognized and reliable weight control program such as Weight Watchers.
- 	exercise intervention (e.g. gym membership, exercise under the supervision of a physical therapist.)
-        prescription weight control medications.

- 	Until the insurance industry can get serious about weight loss, we cannot begin to see a statistically significant decline in the obesity epidemic.
- 	Approving orlistat for OTC rather than fighting for insurance reimbursement may have a negative impact on obtaining reimbursement for the “core treatment” approaches to weight loss.

- 	In fact, approving orlistat for OTC diminishes the seriousness of how we approach the treatment of obesity.
- 	Obesity deserves to be treated with the same seriousness as other chronic medical illnesses.

- 	If we are going to get serious about addressing the girth of this nation, then insurance reimbursement for recognized treatment modalities is a MUST!