Tue, May 01, 2007 - Page 16 News List

The devil's in the details

Over-the-counter weight loss drugs continue to sell well despite the total lack of clinical evidence to support their often extravagant claims

By Jane E. Brody  /  NY TIMES NEWS SERVICE

PHOTO ILLUSTRATION: NY TIMES NEWS SERVICE

Do these promises sound too good to be true? Well, they are. They are among hundreds of advertising claims and testimonials touted by sellers of over-the-counter weight-loss remedies. They appear in leading magazines and newspapers, on television infomercials and the Web. And millions of people succumb to the pie-in-the-sky promises every day, throwing away good money and, sometimes, their good health along with it.

More than $1.3 billion a year is spent on dietary supplements for weight loss, most of which have had little or no scientifically acceptable testing for effectiveness and safety, especially when used for months. More than 20 percent of women and nearly 10 percent of men have used nonprescription weight-loss supplements, the Centers for Disease Control and Prevention says.

"Over-the-counter dietary supplements to treat obesity appeal to many patients who desire a magic bullet for weight loss," Robert Saper and colleagues at the Harvard Medical School wrote in the journal American Family Physician in 2004. Those desperately seeking to lose unwanted kilograms can choose among more than 50 individual dietary supplements and more than 125 combination products, none of which meets medically acceptable criteria for recommended use, the experts wrote.

In a telephone survey last year among 1,444 people trying to lose weight, by the Center for Survey Research and Analysis at the University of Connecticut, more than 60 percent mistakenly thought that all such supplements had been tested and proved safe and effective; 54 percent thought that the Food and Drug Administration approved the remedies. In fact, not one dietary supplement for weight loss has that kind of approval, although one licensed prescription drug, orlistat, has conditional approval for over-the-counter sale under the brand name Alli.

Before spending another cent on yet another nonprescription weight-loss remedy, ask yourself: "If there really was a miracle drug out there, wouldn't it drive out the competition? And wouldn't everyone know about it?" You shouldn't have to go online or ask a store clerk to find out.

If you wonder how we got into this mess of unsubstantiated claims, look no further than the US Congress, which in 1994 passed the Dietary Supplement Health and Education Act. That law permitted proliferation of supplements derived from natural products without first having to submit clinical evidence of their safety and effectiveness to the food and drug agency. That led to the weight-loss products derived from herbal or other botanical ingredients like aloe, ephedra, fiber and green tea; minerals like chromium and pyruvates; amino acids; enzymes; and tissues from organs or glands.

Millions of gullible people seem to believe that "if it's natural, it's got to be good." Judging from the growing supplement sales, few people learned from the fiasco with ephedra, an admittedly effective weight-loss supplement that the FDA banned in 2004 after it was linked to 10 deaths and 13 instances of permanent disability among 87 reports of serious adverse effects in less than two years.

Now products labeled ephedra-free, bitter orange among them, contain related chemicals that, like ephedra, may also raise blood pressure and disturb heart rhythms, possibly leading to heart attacks, strokes and death. The Mayo Clinic has warned that "people with existing heart disease, high blood pressure or other cardiovascular problems should avoid bitter orange." Note, however, that nine of the 23 crippling and fatal effects of ephedra occurred in people with no cardiovascular risk factors.

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