Bethesda, Maryland

May 14, 1998

Mr, Chairman and  members of the panel, my name is Morgan Downey. I am a person with obesity and I am Executive Director of the American Obesity Association (AOA). AOA was founded in 1995 by  Richard L. Atkinson M.D. and Judith Stern, Sc.D. as an advocacy organization for the interests of the millions of persons in this country with obesity.

The American Obesity Association is proud to have received support from major pharmaceutical companies including Hoffman LaRoche, Knoll Pharmaceutical, Medeva Pharmaceuticals, American Home Products, Amgen and Interneuron. In addition, AOA is supported by over 500 dues paying individuals. It has not received any financial contribution from Ergo Science Corp. or Ortho- McNeil Pharmaceutical Corporation.

I appear before you today on behalf of the millions of obese persons with diabetes or at risk of developing diabetes.

According to the Centers for Disease Control and Prevention, 10.3 million Americans have been diagnosed with diabetes and another 5.4 million are thought to have the disease without knowing it. Approximately 90 to 95% of diabetes cases are of Type 2 which tends to develop after age 40. Obesity is a major risk factor for Type 2 diabetes.

The relation between average weight of a population and the prevalence of diabetes was established many years ago. The increased risk for diabetes has been reported to be about twofold in mildly obese persons, fivefold in moderately obese persons and 10-fold in severely obese persons. The duration of obesity is a more important determinant of the risk for developing diabetes - a sobering fact when one considers the increase in childhood obesity. Obesity enhances insulin resistance. It has been shown repeatedly that weight reduction improves blood glucose control in diabetic subjects and that weight loss improves morbidity in diabetic persons.

Type 2 diabetes can sometimes  be controlled by weight loss, exercise and improved nutrition. According to the American Diabetes Association, 10% to 20% of Type 2 patients are treated with diet and exercise, 30% to 40% with oral drugs and 30% to 40% with insulin or insulin and oral medications.

Survey findings report that one in three people with Type 2 diabetes feel discouraged about their ability to manage their disease. Not surprisingly, these feelings increase as the disease progresses and patients move through the continuum of care. Patients on insulin as compared to patients using diet and exercise are less likely to feel that they are winning the fight against diabetes and more likely to believe that their diabetes has interfered with their livelihood and confidence.

Obesity and diabetes present a deadly and costly combination. Direct medical and indirect expenditures attributable to diabetes were estimated at $98 billion for 1997. Approximately  57% of the costs of non-insulin dependent diabetes are attributable to obesity.

The American Obesity Association trusts that this Advisory Committee will fully consider the safety and efficacy data on Ergoset™.  We are encouraged by the report of studies indicating Erogset™ has a clinically  significant effect on both diabetic metabolism and cardiovascular risk. Should this product be found to have an acceptable risk/benefit profile, we would hope that it would be promptly approved. Patients with obesity and diabetes need the hope and encouragement that comes from new products to treat their condition.

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