Will the FDA Learn from Meridia Sibutramine?

Washington, DCWhen is a cure not a cure? When the so-called "'cure"' turns out to be worse than the disease, and the risks outweigh the benefits. Such is the case with Meridia sibutramine, a weight-loss drug introduced with much promise in 1997, only to be pulled from the market this year.

Dr. Jonathan Kerr, writing in the December 4 edition of the Belleville Intelligencer, noted that the Meridia story is in stark contrast to the development of insulin, the miracle cure developed in 1922 to treat hyperglycemia and thus give individuals stricken with Type 1 diabetes a chance to survive.

Meridia was promoted as the pathway to a trim waistline for thousands of obese Americans, together with those in more than 70 countries across the globe. However, as Dr. Kerr pointed out, the onset of Meridia side effects had a devastating effect on many patients.

Doctors were noticing that while Meridia patients were, indeed, losing weight, they were also having heart attacks and strokes. Further researched demonstrated that patients with cardiovascular disease or diabetes exhibited a 16 percent increased risk of serious cardiovascular events while taking Meridia.

"Sure, patients lost some weight," Dr. Kerr writes, "but they were having heart attacks and strokes instead. As a result, Meridia was taken off the Canadian market in April of 2010."

It was also removed from the US market after Americans were shown to be at a greater risk for Meridia heart attack.

Critics of diet drugs, such as Meridia sibutramine, cite the reasons for obesity and the need to curb root causes, such as high-fat, fast food diets and sedentary lifestyles. Losing weight, they say, is hard work and involves lifestyle changes to be effective.

However, pharmaceutical companies continue to pursue the elusive, safe miracle drug that takes pounds off with the simple ingestion of a pill. To that end, an expert panel under the auspices of the US Food and Drug Administration (FDA) voted December 7 to approve Contrave, a new weight-loss drug that did not quite meet FDA criteria, but apparently came close enough. The panel of experts voted 13 to 7 for Contrave's approval and 11 to 8, with an abstention, that additional studies be conducted on heart risks. Experts had voiced safety concerns on the drug, but determined the benefits outweigh the risks.

The FDA is not beholden to the panel's recommendations, but often follows their lead—much like the agency did in 1997 for the approval of Meridia. Little did the FDA know that within ten years concern for Meridia stroke and other adverse reactions would lead to expulsion of Meridia from the market.

Dr. Sidney Wolfe, of the infamous consumer advocacy group Public Citizen, issued a statement ahead of Tuesday's vote recommending that the FDA reject Contrave. Wolfe cited his concern for heart-related side effects. Part of Contrave's formula, bupropion, is already known to increase blood pressure.

"The diet pill Contrave is the latest in a long line of dangerous and, ultimately, failed weight loss drugs," Wolfe said in the statement, citing drugs that have been pulled from the market, including Meridia sibutramine.