NAASO Statement Responding to Public Citizen's Petition to the U.S. Food and Drug Administration for

NAASO Statement Responding to Public Citizen's Petition to the U.S. Food and Drug Administration for

Michael Jensen, MD, President (507) 284-5005
Samuel Klein, MD, President-elect (314) 362-8699
Louis Aronne, MD, Chairman, Public Affairs Committee (212) 583-1000

Silver Spring, MD – March 19, 2002 The North American Association for the Study of Obesity (NAASO), in response to the Public Citizen petition to the U.S. Food and Drug Administration requesting the withdrawal of the anti-obesity drug Meridia® from the market, believes this is an opportunity to highlight the fact that obesity itself is a disease that places individuals at higher risk of death. NAASO calls upon the FDA to ensure that safe and proven weight loss treatments continue to be available to combat this epidemic.

"We need to remember that obesity is a national epidemic that currently results in more than 300,000 lost lives, and costs more than $100 billion per year. Unfortunately, because obesity can be a deadly disease, it is necessary to put events that occur in the course of treatment into perspective. How many adverse events would have occurred in the absence of treatment? Did more events (good or bad) occur with treatment than without?" said Michael Jensen, MD, NAASO President. "The FDA should examine whether there is scientific evidence that causal relationships exist between adverse events and treatment, keeping in mind that such events will also occur in the absence of treatment in a significant portion of the obese population," he added.

The prevalence of obesity has doubled in both children and adults in the last 20 years. The marked increase in obesity is now being followed by an increase in obesity-related diseases, such as type 2 diabetes, hypertension, liver disease and coronary heart disease. Even a modest weight loss of as little 5% of body weight can have considerable medical benefits by preventing the occurrence of new obesity-related diseases and ameliorating or eliminating concurrent obesity-related medical complications. For that reason, effective obesity therapy could have a considerable effect on health and health care costs.

"Obese persons are at increased risk for many serious medical problems, including premature death. Physicians need more treatment options if they are to help those afflicted with this life-threatening condition," said Samuel Klein, MD, NAASO President-elect. "While we need a tough standard to ensure the safety of all medications, obesity medications should not be held to a higher standard than those used to treat other diseases," he added.

"Given the extremely serious nature of the obesity epidemic we need to have treatment options available," said Louis Aronne, MD, Chairman of the NAASO Public Affairs Committee. "As a physician who treats obese individuals, I know the dangers of obesity as well as the benefits of medically supervised treatments," he added.

The North American Society for the Study of Obesity (NAASO) is the leading member-based scientific society dedicated to the study of obesity. Its membership is comprised of 1,500 of the leading scientists in the field. NAASO is committed to encouraging research on the causes, treatment and prevention of obesity as well as to keeping the scientific community and public informed of new advances in the field.