By Truman Lewis
ConsumerAffairs.com
September 13, 2010
A clinical trial of Meridia finds that the controversial diet pill not only raises the risk of heart attacks and strokes but also doesn't do much to trim excess weight. European regulators have ordered the drug removed from the market but the U.S. Food and Drug Administration (FDA) continues to move more gingerly.
The FDA has asked a panel of experts to make recommendations about the drug, but isn't bound by the panel's recommendations. The consumer group Public Citizen has been pressuring the FDA to ban Meridia for years, with no success.
Last December, Public Citizen cited early results of the clinical trial, known as "SCOUT," showing that Meridia caused a "significantly increased number" of heart attacks and strokes, the second time in four years it had asked the FDA to withdraw the drug.
The latest study -- financed by Meridia manufacturer Abbott Labs and published in the New England Journal of Medicine -- found that while the drug did raise the risk of heart attacks and strokes, Meridia's label already warned against the use of the drug in patients with heart problems.
But that didn't stop the editors of the Journal from writing an unusual editorial saying that the study clearly showed Meridia should be removed from the market.
The editors didn't challenge the study's findings but said the authors didn't go far enough, noting that many overweight persons may have cardiovascular disease without realizing it and might therefore be putting themselves at risk by using the medication.
The FDA's cautious approach reflects the view that medications that may be beneficial to some individuals should not be banned because of the damage they may or may not cause to others but the agency's critics don't buy it.
If the FDA truly intends to operate as a public health agency, then it should acknowledge that the continued approval of this drug cannot be justified based on science, said Dr. Sidney Wolfe, director of Public Citizens Health Research Group said last year. The FDA should therefore tell Abbott to pull Meridia from the market immediately.
Public Citizen first petitioned the FDA to ban sibutramine, the active ingredient in Meridia, on March 19, 2002. The organization based its request on results of pre-approval clinical trials that demonstrated increases in blood pressure, pulse rate and palpitations in obese patients taking the drug.
Despite scientific evidence that these patients were three times more likely to experience clinically significant electrocardiogram changes than obese patients taking placebos - coupled with the minimal benefit of an average six-and-a-half pound weight-loss difference between the two groups - the FDA approved the drug in 1997.
By March 2003, there were reports to the FDAs adverse reaction system of 49 cardiovascular deaths among patients taking Meridia. Twenty-seven of the 49 (55 percent) were in people younger than 50 years old. The number is likely higher, as the FDA estimates that only one in 10 adverse reactions to drugs are reported to the agency.
Based on the findings from the SCOUT study and Public Citizens updated figures based on an analysis of FDA data, Public Citizen calculates that there have been 84 post-approval cardiovascular deaths of patients taking Meridia. This includes 32 patients who were 50 or younger and 11 patients 30 or younger.
