Controversy surrounds OTC sales of diet drug
By Lisa Ryckman
Scripps Howard News Service
Tucson, Arizona | Published: 02.07.2006
advertisementA fat-blocking drug called orlistat, currently sold as the prescription drug Xenical, is poised to become the first such substance approved by the U.S. Food and Drug Administration for over-the-counter sales. It's not magic, experts say, but it might help improve the health of a country that appears to be getting fatter every day.
"I think because obesity is such a complex problem, the more effective tools you have in the shed, the more likely you are to have a solution," says Roberta Anding, a registered dietitian and spokeswoman for the American Dietetic Association. "At least with Xenical, the medication has gone through FDA approval. We know the pros and cons."
The drug works by blocking digestion of about 30 percent of the fat in your food. Over six months, people who used the OTC version, tentatively called Alli (pronounced "ally," as in your buddy), lost 4-6 pounds more than those who took a placebo.
That doesn't sound like much of a difference, but some experts say every little bit helps.
The drug is supposed to be used for only six months in conjunction with a reduced-fat diet and exercise. Combine orlistat with your usual deep-fried diet, and you'll be sorry. Very sorry.
According to orlistat's maker, Hoffmann-LaRoche, common side effects include "gas with oily discharge, an increased number of bowel movements, an urgent need to have them and an inability to control them, particularly after meals containing higher amounts of fat than are recommended."
In testimony before the FDA, Dr. Sidney Wolfe, director of the nonprofit consumer group Public Citizen's Health Research Group, said granting orlistat OTC status would be a "serious, dangerous mistake in light of its marginal benefits. . . common, bothersome GI adverse reactions, (and) significant inhibition of absorption of fat-soluble vitamins."
Wolfe noted that prescriptions for Xenical dropped by more than 50 percent from 2000 to 2004. GlaxoSmithKline, which bought U.S. rights to Xenical from Roche last year, estimated that 5 million Americans a year would use Alli at a weekly cost of $12 to $25.
Efficacy notwithstanding, orlistat has a good track record in terms of safety, says Dr. James Hill, director of the Center for Human Nutrition at the University of Colorado Health Sciences Center.
"The bottom line is, look at what's out there for weight loss. There are some really, really scary products," he says. "This one is not very scary."
Hill says he thinks orlistat is unlikely to be abused, but FDA adviser Dr. Ruth Parker, a professor at Emory University's School of Medicine, expressed concern that the drug would be misused by teenagers.
There are reasons to worry. In a University of Michigan survey, 58 percent of 737 girls ages 11 to 19 thought they should lose weight, and only 14 percent were happy with their bodies. More than 60 percent said they dieted with varying frequency, and nearly 25 percent had purchased diet pills.
Anding, who works with kids at Texas Children's Hospital in Houston, said most adolescents would be put off by orlistat's side effects. "If you don't follow the diet and reduce fat intake, you can have oil leakage," she says. "You're not a fun date."
But kids who have eating disorders might not be dissuaded. "If I'm already abusing laxatives, extra trips to the bathroom probably aren't going to concern me very much," she says. "This drug might be abused."
there is some heavy talk on the news (msncbc/cnn) that a low dose form of meridia may come out as well. and a number of politicians have been discussing reevaluation of the FDA medical scheduling, to allow a number of "low risk" medications to be sold over the counter to adults, given the advice of the selling pharmacist with no visit to a doctor or need for a prescription. it's something toward a better future in terms of prohibition, but why must that something be a giveaway to drug companies who want to essentially bypass the middleman to sell their medications to hypochondriacs?
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