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updated 8/25/2005 12:55:05 PM ET 2005-08-25T16:55:05

The world’s top two diabetes organizations have questioned the existence of a medical condition widely cited by drug firms.

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The American Diabetes Association and European Association for the Study of Diabetes said in a joint statement on Thursday that “metabolic syndrome” — which has come to be seen as a predictor of cardiovascular disease — was poorly defined, inconsistently used and in need of further research.

Doctors should not diagnose people with the “syndrome” or treat it as a separate condition until the science behind it is clear, according to a paper to be published in the September issue of Diabetes Care and Diabetologia.

“There is no combination of risk factors that boosts a person’s cardiovascular risk beyond the sum of the parts, or constitutes a separate disease,” said Dr. Ele Ferrannini, president of the European diabetes association.

Invented disorder?
“Metabolic syndrome” is often defined as applying to anyone with three or more of the following conditions — a large waist circumference, high triglyceride levels, high blood pressure, low levels of HDL “good” cholesterol and high blood glucose.

It is typically found in people who are overweight, physically inactive or have certain genetic factors, according to the American Heart Association. Often called insulin resistance syndrome, in which the body can't use insulin efficiently, it's become an increasingly common condition, affecting an estimated 25 percent of U.S. adults, the AHA reports.

The large and growing section of the population in North America and Europe reflects the increasing problem of obesity in developed countries.

Yet studies showing a connection between "metabolic syndrome" and risks of developing heart disease are inconsistent, the groups say.

Taken individually, all of the above conditions can be considered a risk factor for heart disease, the two associations said. But they should each be treated separately, and doctors should not try to prescribe treatments for the "syndrome" until new, solid evidence is obtained.

Their experts’ concerns over "metabolic syndrome" follow similar controversies surrounding other new disorders that the pharmaceutical industry stands accused of inventing.

Conditions such as "generalized anxiety disorder" and "female sexual dysfunction" have been cited in the past as examples of so-called disease-mongering by drug companies eager to carve out new markets for their products.

The drug makers say they are addressing serious, chronic medical conditions.

In particular, the statement is seen as hampering prospects for Sanofi-Aventis’s new drug Acomplia, which is positioned as a way to treat "metabolic syndrome" because it helps with risk factors such as lipid levels. Acomplia, which Sanofi hopes to launch next year once it has received regulatory approval, is viewed as a potential multibillion-dollar-a-year seller for the French company.

Sanofi had no immediate comment on the statement by the two groups.

Reuters contributed to this report


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