Weight-Loss Drugs Face High Hurdles At FDA

Feb 17, 2012
Originally published on February 21, 2012 5:52 pm

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.

The FDA has been especially tough on weight-loss drugs because of previous problems with those drugs, such as the diet drug cocktail fen-phen.

"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," says Janet Woodcock, a top FDA official.

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

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

What might look like a rare problem now could turn into another public health disaster, she says.

But some say the agency's aversion to accepting any risks is outdated. They say the FDA wrongly still tends to view weight-loss drugs as diet pills — something frivolous and used primarily for cosmetic purposes.

"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," Nadglowski says.

So Nadglowski and others are pushing the FDA to take into consideration whether the risks of new drugs may be outweighed by their benefits beyond weight loss, such as reducing the risk for heart disease, diabetes and other complications of obesity.

Woodcock says officials realize they may have to think about things differently.

As the FDA works through this, many are watching how the agency handles Qnexa. An FDA advisory panel is scheduled to review Qnexa again on Feb. 22.

Barbara Troupin of Vivus, the company that is developing Qnexa, says the drug appears to do a lot more than just help people lose weight.

"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 benefits," she says.

Vivus hopes the FDA will agree that 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 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.

For her part, Wade just wants to be able to start taking it again. She's gained back half of the weight she lost.

"I need to lose 20 more pounds again," she says. "And I need the help."

Copyright 2012 National Public Radio. To see more, visit http://www.npr.org/.

Transcript

RENEE MONTAGNE, HOST:

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. Transcript provided by NPR, Copyright National Public Radio.