Weight-Loss Drugs Face High Hurdles At FDA : Shots - Health News The Food and Drug Administration will take a second look at a weight-loss drug it rejected in 2010. The decision to review Qnexa comes as the agency is rethinking how it judges weight-loss drugs. Though obesity is at epidemic levels, the FDA hasn't approved any new weight-loss medicines since 1999.
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Weight-Loss Drugs Face High Hurdles At FDA

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Weight-Loss Drugs Face High Hurdles At FDA

Weight-Loss Drugs Face High Hurdles At FDA

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The Food and Drug Administration is taking another look at a drug that could help people lose weight. The FDA rejected it in 2010 because of safety concerns. As NPR's Rob Stein reports, the meeting next week by an FDA panel to reconsider that drug comes as the agency is rethinking how it evaluates weight-loss drugs.

ROB STEIN, BYLINE: Tammy Wade is a bus driver who lives in McCalla, Alabama. She's 50 and knew she had to try something else when she stepped on the scale and saw the number...

TAMMY WADE: Two hundred and three pounds.

STEIN: She's five-foot-three. She tried everything. Nothing worked.

WADE: And I had problems with my feet and ankles, and they were saying that I was borderline diabetic and, you know, just stuff like that. And I'm like, well, I got to do something, you know. So, I needed to, you know, really did need to lose the weight.

STEIN: So Wade volunteered to help test a new weight-loss drug. It's called Qnexa. Wade quickly noticed a change in her appetite.

WADE: I didn't feel ravenous, and I didn't want to snack all day long.

STEIN: Over the next year, Qnexa helped Wade slowly drop about 40 pounds, and keep it off for another year.

WADE: It makes you feel so much better. Yes, your back don't hurt. Your feet don't hurt.

STEIN: But the FDA ultimately rejected Qnexa. It was worried about the drug's side effects, especially possible heart problems and birth defects. Even though obesity is at epidemic levels, the FDA hasn't approved any new weight-loss drugs since 1999. Christine Ferguson of George Washington University says that's a major problem.

CHRISTINE FERGUSON: We have two-thirds of all Americans who are overweight or obese, and the costs are nearing $150 billion a year. The sheer magnitude of the problem really requires us to address it more aggressively and thoughtfully than we have.

STEIN: Ferguson's been gathering together anti-obesity advocates, public health experts, government officials and others to try to figure out what the FDA should do. Joe Nadglowski of the Obesity Action Coalition is one of them.

JOE NADGLOWSKI: We actually have this huge gap. We go from Weight Watchers to bariatric surgery. And the fact that there isn't, you know, medical treatments for obesity, including pharmaceuticals, really is a challenge, considering how big the problem is in this country.

STEIN: Part of what's going on is that the FDA's gotten a lot more cautious about approving new drugs in general. There's been some serious missteps. One of the most notorious: the arthritis drug Vioxx. And the FDA's especially on guard about weight-loss drugs. For Janet Woodcock, a top FDA official, one disaster stands out: fen-phen.

JANET WOODCOCK: There's been a long history with obesity drugs that we've had to take off the market. You recall the fen-phen episode, where a significant number of people got heart-valve defects.

STEIN: Woodcock argues that the FDA has to be extra-careful about weight-loss drugs, because chances are it won't just be obese people taking them.

WOODCOCK: When you're talking about a drug where it could go into literally tens of millions of Americans, you know, there has to be attention to safety.

STEIN: So, what might look like a rare problem now could turn into another public health debacle. But some say the FDA's aversion to accepting any risks is outdated. Joe Nadglowski says the FDA wrongly still sees weight-loss drugs as diet pills - something frivolous, something girls swallow to look pretty.

NADGLOWSKI: We are not talking about medications to help someone lose five pounds to fit into their prom dress or wedding dress. We're talking about medications to help those who are struggling with the health impact of obesity.

STEIN: So Nadglowski and others are pushing the FDA to ask new questions: Do the drugs help people fight off diabetes, heart disease, breathing problems like sleep apnea? Woodcock of the FDA says officials realize they may have to think about things in a new way.

WOODCOCK: We're trying to work through, like, with people who are obese do have high risk, and therefore it would be worthwhile for them to take a drug, even if it had a certain amount of risk.

STEIN: As the FDA works through this, many are watching how officials handle that new drug: Qnexa. Barbara Troupin works at Vivus, the company that makes Qnexa. She says it does a lot more than just help people lose weight.

BARBARA TROUPIN: We see decreases in blood pressure. We see decreased rates of progression to diabetes. We see improvements in sleep apnea. We see improvements in quality of life. Pretty much all of our data shows significant benefit.

STEIN: Vivus hopes the FDA will agree those benefits will outweigh some of the risks, including the concerns about birth defects. The company is submitting new data it says show that the risk is lower than it had been feared. Vivus also has a plan to minimize the chances that pregnant women will take it. Some see Qnexa as a test of the FDA trying to recalibrate how it weighs risks and benefits for weight-loss drugs. Tammy Wade just wants to be able to start taking it again. She's gained back about half of the weight she lost.

WADE: I need to lose 20 more pounds again, and I need the help, because I've been trying really hard to get this 20 pounds back off.

STEIN: The dilemma for the FDA is figuring out the right balance of risks and benefits for powerful weight loss drugs like Qnexa. Whatever it decides, the agency has already scheduled a two-day hearing next month to help figure out the best way to judge obesity drugs. Rob Stein, NPR News.

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