Critics see two new FDA-approved drugs as a gamble.
At first glance, Dr. Angela Fitch admits, the numbers don't seem too impressive. One pill was only 4 percent better than a placebo; the other, 7 to 9 percent better.
But in the battle against obesity, Fitch says, even that is no small achievement.
In the past few weeks, the Food and Drug Administration has given its blessing to both pills, Belviq and Qsymia, the first new weight-loss drugs to win approval since 1999. To Fitch, an obesity specialist at Park Nicollet Clinic, that's reason to celebrate. "Most of us are very excited," she said.
Critics, though, see the drugs as a risky gamble -- the latest in a string of diet pills that have been plagued by safety questions since the 1990s, when the drug fen-phen was pulled from the market after the Mayo Clinic linked it to heart-valve damage.
One consumer watchdog, the Health Research Group, called the latest FDA approvals "reckless." Consumer Reports has urged consumers to stay away. "Bottom Line: We recommend avoiding all weight-loss drugs and supplements," the magazine said in an online post July 18, the day after Qsymia was approved.
The two new diet pills, which are expected to hit the market later this year or early next year, have traveled a rocky path to approval. Both were initially rejected by the FDA in 2010 because of safety concerns. Both will include warnings of potentially risky side effects, including warnings against use by pregnant women. In both cases, the drug makers are under strict rules to monitor the risk of heart disease or stroke among their customers.
At the same time, doctors say the pills can make a significant difference in patients who are dangerously obese.
"It's not for the everyday 45-year-old woman who wants to lose 30 pounds," said Dr. Claudia Fox, a specialist in childhood obesity at the University of Minnesota. "We're talking about the really morbidly obese person who can't walk well, who might have to use a walker, who has sleep apnea."
Until now, the medical bag for treating those patients has been pretty small. Only two FDA-approved weight-loss drugs are still on the market: Xenical, which is sold over the counter as Alli; and phentermine, an appetite suppressant that's been around since the 1950s (it was the "safe" half of the fen-phen combination drug withdrawn in 1997).
"It's wonderful to have a couple of other options," said Dr. Roxana Merz, an obesity specialist at Fairview Southdale Hospital in Edina. "A pill can't make people make lifestyle changes, but a pill can help people get off to a good start."
Fitch, who treats patients at Park Nicollet's Melrose Institute for eating disorders in St. Louis Park, says the drugs are just one piece of a large puzzle.
"There's no wonder drug," she said, and pills are not a substitute for eating well and exercising. But they can help people by decreasing their appetite or increasing their metabolism as part of a comprehensive weight-management program.
"Everything's a tool," she said. "The idea is to take these drugs while you're making these changes, until these lifestyle changes become your lifestyle."
Small but important
One of the new drugs, Qsymia (kyu-sim-ee-ah), is a combination of two drugs already on the market: an anti-seizure drug known as topiramate, and phentermine, the appetite suppressor. Fitch notes that she and many other doctors have been prescribing that combination to patients for years, in what's called an "off-label" use, and that she's seen a significant effect.
One of her patients, a 37-year-old woman, said her "craving for the carbs" subsided when she started taking topiramate several months ago, and she's now losing close to a pound a week. She hasn't told her family she's on the medication, so she didn't want her name used, but hopes to lose about 70 pounds in all. "I'm not looking for a quick fix,'' she said, "but I'm open to accepting help along the way."
Even with the pills, most patients won't lose all the weight they'd like, said Fitch. But medically, even a 5 to 10 percent drop in weight can significantly reduce the risk of heart disease and diabetes.
"I get people in my office all the time, they're 250 pounds and they want to weigh 150," she said. "What we are trying to reach is the middle ground, which is to retrain people to think that 5-10 percent is a good thing, and really has a lot of benefits."
The easy way out?
Brenda Navin, a registered dietician, is skeptical of the new drugs. "I don't think a drug is going to solve our weight issue," said Navin, who oversees a weight-loss and wellness program at Woodwinds Health Campus in Woodbury. "People get desperate and they're looking for anything that's new."
Pills may sound appealing, she said, because "people are looking for the easy way." But given the risks, she recommends a more holistic approach. "Ultimately, when it comes down to it, there is no substitute for just moving your body, eating healthy and proper self-care," she said. "There's no pill that's going to take [the need for] that away."
Yet obesity specialists like Fox say the new pills -- with more in the pipeline -- are arriving just as science sheds new light on obesity.
"[People] think OK, obesity is really a choice and you should just pull yourselves up by your bootstraps and say no to the second hamburger," said Fox, who directs the pediatric weight management program at the university's Amplatz Children's Hospital. But some people lack the biological signals to know when to stop eating, she said, and "are chronically hungry; they never feel full." One, she said, is a teenage patient who weighs more than 400 pounds. "For me to say, 'Oh, just go home and eat less food and exercise more,' that's not going to cut it," she said.
The new drugs, she said, may provide "a critical piece that has been missing for years."
Maura Lerner • 612-673-7384