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June 30, 1999 |
Orlistat, sold under the brand name Xenical, has only been FDA approved
for -- and tested in -- those who are officially obese. One of these,
Cindy Smith, could be the Xenical poster child. The new fat-blocking drug
helped her take off hated pounds she had been unable to lose any other way. At 5 feet 4 inches tall, she weighed 220 pounds when she entered clinical trials of the drug
two years ago. Now the 34-year-old bank worker in Houston is a
satisfied 150. To qualify for the trials, you had to be, like Smith, officially fat. At 6 feet tall, for example, participants had to weigh at least 220 pounds, or no less than 200 if they had fat-related health problems. After two years of testing, it appeared that overweight people who took the drug lost an average of seven to 10 pounds more than those who didn't. Xenical also lowered levels of problem cholesterol beyond what could be explained by the weight loss. For the desperate to reduce, such benefits may justify the fact that Xenical is chemically addressing what is essentially a social problem. In a rational world, one might suggest not eating whatever you don't want
to digest. But in our culture, at once obsessed with both food and
thinness, the blue capsules are being embraced as a way of tempering the
consequences of excess. And not just by the truly overweight. More than 210,000 Xenical prescriptions have been sold in the drug's first seven weeks on the U.S. market. Apparently the appeal of the fat-be-gone pill trumps any memory of the recent recall of fenfluramine, another diet drug that was shown to cause heart damage after being pounced on by eager dieters. It also overshadows Xenical's own hazards, which are many and troubling. In fact, the FDA panel considering Xenical was at first split on whether to
approve it, with nay-voters stuck on distressing medical points, such as
the fact that the drug leaches vitamins from the body and disrupts the
normal digestion process. Perhaps most alarming, one study the panel
reviewed found that drug takers had a higher rate of breast cancer than
those not on it. New data that the breast cancer cases didn't
appear to be linked to the drug eased panel members' concerns enough for
them to approve Xenical in May. But even after approval, Jules Hirsch, an
internist and nutrition expert who served on the panel, says "there is a
residual worry" over the breast cancer question. And, since Xenical has been only tested for two years, its long-term effects add up to a big question mark. "We don't know what this drug does over long periods of time to gastrointestinal function," says Hirsch. "It's coating the intestine with a thin layer of fat. We just don't know
what this will do to intestinal function over years." | ||
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