Obesity Association Calls Petition on Obesity Drugs Unfounded and Harmful

WASHINGTON, April 1, 2002 — The American Obesity Association (AOA) requested that Tommy Thompson, the Secretary of the Department of Health and Human Services, reject a petition to withdraw sibutramine (Meridia), a drug used to treat obesity. The petition, submitted on March 19, 2002 by the consumer advocacy group Public Citizen, would set unobtainable standards for new drugs to treat obesity.

Morgan Downey, AOA Executive Director, called the Public Citizen petition a document "based on faulty reasoning, poor science and disregard for the lives and well being of 65 million Americans with obesity."

In a nine-page letter to Secretary Thompson, the AOA, which receives funding from leading companies in the treatment of obesity including Abbott Laboratories, maker of sibutramine, criticized Public Citizen‘s erroneous assessment of sibutramine as "unacceptably dangerous."

The AOA indicated that current statistical evidence shows sibutramine‘s fatality rate to be lower than the rate for persons with obesity overall. A number of experts have reviewed patient data referred to by Public Citizen and found no causality between the drug and deaths.

The Public Citizen petition called the weight loss effects of sibutramine "meager" and the drug "ineffective." The AOA questions:

1. what is Public Citizen's expertise in reaching this conclusion?
2. what is Public Citizen's acceptable level of weight loss?
3. why are standards established by the Food and Drug Administration, the Surgeon General and National Institutes of Health contrary to the public interest?
4. why did Public Citizen overlook a published clinical trial which made the opposite finding?

The AOA challenged Public Citizen's conclusion that weight loss with sibutramine is "meager," when such a claim is inconsistent with the range of weight loss considered acceptable by medical experts, namely 5% to 10% of body weight. As recently as December 2001, the Surgeon General of the United States noted that weight loss of between 5% and 10% of excess body weight "reduces the risk factors for at least some diseases, particularly cardiovascular disease, in the short term." The AOA letter indicates to Secretary Thompson that, "By Public Citizen's own statement, sibutramine falls within the Surgeon General's acceptable range of weight loss."

The AOA castigated Public Citizen for calling sibutramine and others "diet drugs." Such labeling trivializes a life or death disease and implies a superficial effort to lose weight driven by vanity. The AOA also criticized Public Citizen for presuming that physicians and patients with obesity are unable to weigh the risks of drug usage and initiate an appropriate approach to therapy as is common with most long-term chronic diseases.

The AOA's strongest critique was for Public Citizen‘s petition to require evidence that each and every drug to treat obesity prove the benefit of weight loss compared to total mortality and health. The AOA argues that such a standard for drug approval is unheard of for other diseases, and the costs of such trials would halt the development of new products based on decades of research in genetics, molecular biology, and neuroscience.

The American Obesity Association is a non-profit tax-exempt advocacy and education association. The AOA is supported by grants from corporations such as Amgen, Abbott Laboratories, Health Management Resources, Roche Laboratories, Slim-Fast Food Co, and Weight Watchers Intl. Inc. as well as by professional and lay members.