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Experts Question New OTC Weight-Loss Drug

Posted on: Friday, 23 February 2007, 18:00 CST

By ANTHONY ROTUNNO

Nearly one-third of Americans said they would consider taking a U.S. Food and Drug Administration-approved over-the-counter weight-loss drug in a recent poll, but some experts believe no pharmaceutical alternative will ever replace the tried-and-true benefits of diet and exercise.

Twenty-nine percent of Americans said they would likely try an over-the-counter weight-loss pill, according to results of the Zogby/UPI poll. The interactive poll compiled data from 10,258 U.S. participants regarding health issues Feb. 9 to 12. The poll has a margin of error of plus or minus 1 percentage point.

In February the FDA approved alli, an over-the-counter medication that contains the fat-absorbing, weight-loss drug Orlistat, formerly available only by prescription.

The FDA, for reasons I don't understand, feels it is important to provide people with a replacement for the last two over-the-counter weight-loss drugs on the market, said Dr. Sidney Wolfe, director of the Public Citizen's Health Research Group, an advocacy organization that named Orlistat as one of 211 do not use drugs on its Web site, Worstpills.org.

If you can lose weight through diet and exercise, you can lose weight without the drug. (Diet and exercise aren't) a huge change from (people's) current lifestyles, but they aren't promoted because nobody makes any money off of them, he said.

Orlistat was first approved by the FDA in 1999 for use in the prescription drug Xenical, which is still prescribed for obesity at a higher dosage than the over-the-counter version. Now that the drug has been permitted for over-the-counter use, alli will provide an FDA-approved alternative to other weight-loss drugs on the market, according to Morgan Downey, executive vice president of the North American Association for the Study of Obesity.

There are risks to taking weight-loss drugs. The FDA said the most common side effect of Orlistat is a change in bowel habits. In a statement, the agency advised taking a multivitamin while on the drug in order to maintain healthy nutrient levels.

The bowel changes caused by Orlistat are not harmful and usually stabilize after a few weeks of taking the drug, according to a statement from GlaxoSmithKline, the pharmaceutical company that produces alli. Orlistat has been used in 145 countries outside of the United States to safely and effectively promote weight loss and is the most extensively studied weight-loss drug on the market, the statement said.

Yet studies have shown Orlistat is associated with pre-cancerous lesions in the colons of rats. The FDA should be more cautious before approving an over-the-counter drug that may increase a rat's chances of developing cancer, Wolfe said.

Because there are a large number of individuals who look for over-the-counter products to help with weight loss, Downey said, such a product on the market is desirable. NAASO, a research organization that studies obesity, is funded in part by GlaxoSmithKline.

Most of the products that are sold for weight loss over-the-counter have not been tested and don't have to meet FDA requirements, Downey said. Consumers can't be sure other over-the-counter drugs are safe and effective at all.

Although the FDA instructs those who use alli to take it in conjunction with a healthy diet and regular exercise routine, some experts fear consumers will rely on the drug as a cure-all and ignore other instructions, said Michael Jacobson, executive director of the Center for Science in the Public Interest.

People don't follow instructions, he said. The vast majority of people who buy these pills ... ignore the advice to eat a healthier diet and exercise more.

Studies have shown a consistent program of healthy diets and frequent exercise can benefit health in many ways. For instance, exercise lowers hypertension, keeps weight down and improves mental health. Some research suggests diet and exercise can also prevent the leading causes of death, such as heart disease and cancer.

A good diet and frequent exercise are as effective as pharmaceuticals, but they take daily effort and many people are not willing to make that effort, Jacobson said. They'd rather visit doctors and suffer the side effects of these drugs.

Busy lifestyles place pressures on people that work against maintaining balanced diets and regular physical activity, Downey said, and an over-the-counter drug like alli offers people trying to shed pounds another option.

We've had diet and exercise options for a long time, but diet and exercise just can't get us all where we want to be, Downey said. (Drugs like alli) are trying to meet people where they are.

Source: United Press International

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