The Food and Drug Administration's (FDA) Endocrime and Metabolic Advisory panel is meeting today to review a new obesity drug application, and obesity prevention advocates say they hope it gets a fair hearing.
The drug Contrave is under review today, after two other newly developed obesity treatments - Qnexa and Lorguess - were rejected in October, when the FDA cited safety issues. Also in October, the FDA asked for the removal of the previously approved weight-loss drug Meridia (sibutramine) from the market due to safety concerns.
In the case of Qnexa, an FDA advisory panel recommended against its approval , citing potential side effects, such as increased heart rate, birth defects, and psychiatric problems. Those voting in favor of the drug said obesity itself was a greater health risk. The two obesity groups tend to reside in that camp.
"We are deeply concerned about the effect that the FDA's recent decisions will have for on-going and future research into desperately needed new obesity treatments,â€ said Jennifer Lovejoy, president of The Obesity Society. "As the FDA's advisors consider the application before them, we hope that the agency will assure a balanced process, taking into account the urgent medical need."
Lovejoy says a study published in the most recent New England Journal of Medicine provides a stark reminder that the obesity epidemic is a deadly disease. In a study of mortality in 1.46 million people sponsored by the NIH, investigators reported that weight classifications "overweight" and "obesity" are associated with significant excess mortality.
"The time for action is now," said Joe Nadglowski, Obesity Action Coalition president and CEO. "The number of those affected by obesity is growing at an incredibly rapid rate and the millions of Americans already affected by the disease are lacking the necessary medically approved treatment and long-term options so desperately needed."
The two groups said the FDA and its advisors can play a proactive and constructive role to improve what they called "this extremely serious situation.â€
An appeal to the FDA
"It is imperative that the FDA review any obesity treatment presented to them with the understanding that more than 93 million Americans are depending on them for help with this disease," said Lovejoy.
Drug companies have placed new emphasis on developing medications to promote weight control, as obesity has become a greater public health concern. The track record is not inspiring.
The last major weight control drug disaster was fen-phen, which was withdrawn from the market in 1997 after it was shown to cause heart valve damage. Onexa may have been rejected, in part, because it contains part of the fen-phen cocktail.Contrave, meanwhile, is a combination of two approved drugs, bupropion and naltrexone. Individually, both drugs have shown some results in weight loss, according to researchers.