Two major diabetes organizations in the United States and Europe have taken issue with the efforts of Sanofi-Aventis to get regulators to approve Acomplia (rimonabant) not just as an anti-obesity drug but as a comprehensive approach to treating "metabolic syndrome."

In fact, the American Diabetes Association and the European Association for the Study of Diabetes questioned whether "metabolic syndrome," a cluster of conditions that raises the risk of heart disease and diabetes, is actually a syndrome at all.

The two organizations, in a paper published on the Web sites of both groups, said doctors should not diagnose people with metabolic syndrome or prescribe drugs for it because it may not independently affect the likelihood of developing heart disease.

The challenge could well impact how U.S. and European regulators view Acomplia during the drug approval process now underway.

Metabolic syndrome has been described as a combination of abdominal obesity together with several other risk factors including elevated triglycerides, low levels of "good" cholesterol, high blood pressure, and a prediabetic condition known as impaired glucose tolerance.

Clinical trials of Acomplia have shown that the new drug is capable of producing not just weight loss, but improvement in all of these risk factors.

Sanofi already promotes rimonabant on its Web site as "a comprehensive management approach" to metabolic syndrome. "Most current treatment strategies generally focus on individual risk factor management, rather than addressing underlying pathophysiological causes," Sanofi has said.

But Richard Kahn, chief scientific officer of the American Diabetes Association, said diagnosing various combinations of these risk factors as a syndrome "misleads the patient into believing he or she has a unique disease.

"The combination of risk factors doesn't add up to a more significant or higher cardiovascular risk than the individual components," said Kahn.

Each of the conditions that make up metabolic syndrome is potentially life threatening, the ADA contends, and the statement by the two diabetes associations said doctors should treat each risk factor individually.

"Whether or not one accepts that the metabolic syndrome is a specific disease entity or a cluster of risk factors, there is no dispute that individuals with multiple risk factors are at high risk for diabetes and cardiovascular disease, and require treatment for these risk factors," responded Sanofi spokeswoman Julissa Viana.