Weight-Loss Drugs Face High Hurdles At FDA

Tammy Wade knew she had to try something else to lose weight when she stepped on the scale and saw the number: 203 pounds.

Wade, 50, of McCalla, Ala., is only 5 feet 3 inches tall. She had tried everything. Nothing worked.

“I had problems with my feet and ankles, and they were saying I was borderline diabetic,” Wade says. “I’m like, well, I gotta do something, you know. So, I needed, really did need to lose the weight.”

So Wade volunteered to help test Qnexa, an experimental drug pending before the Food and Drug Administration. She quickly noticed a big difference.

“I didn’t feel ravenous, and I didn’t want to snack all day long,” she says.

Over the next year, Qnexa helped Wade slowly drop about 40 pounds, and keep it off for another year. “It makes you feel so much better,” Wade says. “Your back don’t hurt, your feet don’t hurt.”

But the FDA rejected Qnexa in 2010 because of concerns about side effects, especially possible heart problems and birth defects.

Qnexa’s rejection came amid a flurry of failed attempts by drug companies to win approvals of new weight-loss drugs. The setbacks put a spotlight on how the FDA handles these drugs.

Even though obesity is at epidemic levels, the FDA hasn’t approved any new weight-loss medicines since 1999.

“We have two-thirds of all Americans who are overweight or obese, and the costs are nearing $150 billion a year,” says Christine Ferguson, a health policy professor at George Washington University. “The sheer magnitude of the problem really requires us to address it more aggressively and thoughtfully than we have.”

Ferguson has been helping to organize a series of meetings involving public health experts, anti-obesity advocates, government officials and others to try to figure out what the FDA should do.

“We actually have this huge gap,” says Joe Nadglowski of the Obesity Action Coalition, who has been participating in the meetings. “We go from Weight Watchers to bariatric surgery. And the fact that there isn’t … medical treatments for obesity, including pharmaceuticals, really is a challenge, considering how big the problem is in this country.”

Part of what’s going on is that the FDA has gotten a lot more cautious about approving new drugs in general after some serious drug-safety problems, such as heart problems linked to the painkiller Vioxx.

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