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FDA encouraged to approve first anti-obesity drug in a decade

Published: Saturday, Feb. 25, 2012 5:30 a.m. CDT

WASHINGTON – The battle of the bulge has been a big, fat failure for U.S. drugmakers, but that hasn’t stopped them from trying.

For nearly a century, scientists have struggled to make a diet pill that helps people lose weight without side effects that range from embarrassing digestive issues to dangerous heart problems.

Earlier this week, a government panel recommended the Food and Drug Administration approve the diet drug Qnexa. The recommendation raises hope the U.S. could approve the first anti-obesity drug in more than a decade. It also highlights how challenging it is to create a pill that fights fat in a variety of people without negative side effects. Even Qnexa was previously rejected over concerns it can cause heart palpitations and birth defects if taken by pregnant women.

“Having a drug for obesity would be like telling me you had a drug for the fever,” said Dr. Mitchell Roslin, chief of bariatric surgery at Northern Westchester Hospital in New York. “There can be millions of different reasons why someone is obese; it’s really a symptom of various underlying mechanisms.”

An effective and safe diet pill would be an easy sale in the U.S. With more than 75 million obese adults, the nation’s obesity rate is nearing 35 percent. But the biggest problem for weight-loss drugs is there appears to be no safe way to turn off one of the human body’s fundamental functions.

For millions of years, humans have been programmed to consume calories and store them as energy, or fat. It’s this biological mechanism that makes it almost impossible to quickly lose weight by not eating. Cutting down on food instead sends stronger signals to the body to store more calories.

“Throughout most of human history calories were scarce and hard to get, so we have numerous natural defenses against starvation,” said Dr. David Katz of Yale University’s Prevention Research Center. “We have no defenses against overeating because we never needed them before.”

So, the drug industry has been on a nearly 100-year search for a drug that can help the body shed pounds.

On Wednesday, a panel of FDA doctors and other advisers voted 20-2 in favor of approving Vivus’ Qnexa pill, which the drugmaker has resubmitted to the FDA for a second review.

The group touted the drug’s benefits, which include weight loss of nearly 10 percent for most patients taking the drug for more than a year – the highest reduction reported with any recent diet pill.  But panelists stressed the drugmaker must be required to conduct a large, follow-up study of the pill’s effects on the heart. The FDA is expected to issue its decision on Qnexa by mid-April.

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