American and European Drug Authorities Square off over Meridia

Washington, DCThe release of preliminary data from a six-year study on Meridia sibutramine hydrochloride has not only sparked debate over the diet drug and its effectiveness, but has also showcased the divergent actions of drug authorities on opposite sides of the Atlantic.

The US Food and Drug Administration (FDA) decided to stick Meridia with a warning label regarding the potential for heart attacks, strokes and other cardiovascular problems in patients with certain health conditions. However, the European Medicines Agency (EMA) was harsher: it halted all sales of European equivalents of Meridia immediately.

The Washington-based Public Citizen, a consumer advocacy group that has railed against Meridia and lobbied the FDA for an outright ban, feels that the EMA got it right. ''The European Medicines Agency has acted appropriately,'' said Dr. Sidney Wolfe, director of the health research group at Public Citizen, which claims that in the 12 years Meridia has been on the market, the drug has been linked to more than 80 deaths, including 30 individuals under the age of 50.

''The FDA has acted recklessly,'' said Dr. Wolfe.

Meridia is an obesity drug manufactured by Abbott Laboratories. The key ingredient in Meridia, sibutramine, increases neurotransmitter activity in the brain, which makes people feel full sooner after a meal, thereby reducing their food intake.

Although sales in the US have been steadily declining, global sales hovered around $300 million last year.

The EMA became concerned with Meridia side effects in 2002 and requested a study effectively challenging the presumption that weight-loss drugs reduce the risk of heart attacks.

The six-year study, dubbed the Scout trial, involved about 10,000 overweight and obese people who had a history of heart disease, diabetes or both. About 11.4 percent of those who took the drug had a heart attack, stroke or died from cardiovascular causes, compared to 10 percent of those who took the placebo, according to preliminary data from the study released by the FDA.

For its part, the FDA has taken a wait-and-see approach. Beyond mandating a label change, the agency will await the March deadline for complete study data before drawing further conclusions, a decision supported by Dr. Louis Aronne, director of the comprehensive weight control program at NewYork-Presbyterian/Weill Cornell Medical Center.

''Running up the hill might increase your risk of having a heart attack if you have coronary disease,'' he told the New York Times on January 23. ''But if you are 23 years old and have no coronary disease, then running up the hill can prevent you from getting heart disease.''

The EMA maintains that preliminary data supports its position that the risks associated with sibutramine outweigh the benefits. The suspension of sales in Europe will remain in place unless the manufacturer provides rigorous data identifying a population of people for whom the drug's benefits outweigh its risks.