Fortunately for 47 million obese Americans, the Wurtmans may have hit pay dirt. A French manufacturer worked with the couple in the 1980s to produce dexfenfluramine, which helps people eat less by promoting feelings of satiety. It’s been sold widely in France and 65 other countries. Last week the Food and Drug Administration approved it for sale in the United States, the first anti-obesity drug cleared in 23 years. Redux, marketed by Wyeth-Ayerst, will be available by prescription in June.
Diet drugs had fallen into disrepute since the 1960s, when amphetamines were prescribed for weight loss and widely abused. Doctors fell back on the standard advice to exercise and eat less, but that isn’t easy, as the burgeoning number of overweight Americans proves. In recent years, the Wurtmans and other researchers have convinced the medical establishment that obesity isn’t a failure of will, but a chronic medical condition with complex biochemical roots. “I remember thinking, ‘Medication? Never!’,” says Dr. Louis Aronne, director of the respected weight-loss center at New York Hospital–Cornell Medical Center. Now, he says, “this is one more tool in treating significant obesity. My hope is we’ll see a lot more soon.”
Some credit for the change in attitude belongs to “fen-phen,” a combination of two old prescription drugs that has attracted a cult following in recent years. Fenfluramine suppresses appetite but can leave patients drowsy. Phentermine also speeds up metabolism but can cause rapid heartbeat and insomnia. In 1992, University of Rochester pharmacologist Dr. Michael Weintraub demonstrated that when the drugs are used together, they are extremely effective in helping patients shed pounds. As news of his study spread in the press and on the Internet, commercial weight-loss clinics and physicians like Aronne began prescribing fen-phen, too. Many patients who struggled for years to lose weight stuck to diet-and-exercise plans more easily with the pills.
Mark Donaway is a classic case. The chef and owner of a popular Italian restaurant in Chicago, he’d ballooned to 317 pounds by last January when he tried fen-phen under a doctor’s care. Surrounded by homemade ravioli, calzones and grilled pizza, he found it no small feat to restrict his intake. But fen-phen helped him feel less hungry. He’s lost 59 pounds in just four months. Exercise helped, too. “It meant changing my whole lifestyle–you really have to work hard,” he says. “But I’ve never looked so good.”
Experts think Redux could take the place of fen-phen, largely because its side effects are milder. Health-care consultant Eileen Marshall, whose weight has fluctuated by as much as 125 pounds, found that fen-phen gave her unbearable diarrhea. She bought dexfenfluramine in Europe. Her diarrhea disappeared, and she’s kept pounds off for over a year. “I no longer have that can’t-wait-to-get-to-the-table ravenous feeling,” she says happily. “I don’t crave chocolate the way I used to.”
Some physicians have reservations, particularly because Redux has been studied in humans for only one year. In rare cases, it’s been associated with primary pulmonary hypertension. Dexfenfluramine has also been linked to brain changes in animals, and some neurologists fear it could occur in humans as well. Given such concerns, the watchdog group Public Citizen criticized the FDA’s approval as “irresponsible.” But proponents like the Wurtmans (who stand to make millions from licensing the drug) note that more than 10 million Europeans have used dexfenfluramine without significant health problems so far.
Still, experts caution that Redux should be used only by truly obese people, for whom the risks of carrying extra weight outweigh the possible hazards. But millions of other Americans hoping to swap their Relaxed Fit jeans for Slim Fits may be anxious to try it, too. “Diligent patients will have no trouble getting it–most physicians don’t know how to say no,” worries Dr. David Rothman, a professor of social medicine at Columbia University. With three quarters of American women unhappy with their bodies, he says, “the prospect of misuse is scary.”
The prospect of profits, meanwhile, is dizzying. A one-day supply of Redux will cost about $2; multiply that by 47 million potential customers, taking it for a year or more. “These are big numbers,” muses Dr. Joseph DiBartolomeo of Nutri/System, which introduced fen-phen in some centers last year and plans to add Redux soon. Not surprisingly, other pharmaceutical firms are racing to develop fat-fighting drugs (chart, page 76). Some help the body burn fat faster or block the absorption of fat in food. The genetic-engineering firm Amgen is working on a hormone that may someday signal the brain that the body has enough stored fat, thank you, and doesn’t need any more. Such drugs are years away, and even with them, experts say, overweight Americans will still need to exercise and eat sensibly. But the new drugs may make that easier, and that’s welcome news in the ongoing battle of the bulge.
(Pondimin), B_Phentermine_b: Used in combination, “fen-phen” suppresses appetite and speeds burning of calories; approved individually for decades, popular together since 1992.
(Redux): Boosts serotonin in the brain to reduce food cravings, promotes a full feeling; approved by the FDA last week, available by summer.
(Meridia): Enhances metabolism and increases feeling of fullness by blocking the “re-uptake” of serotonin and norepinephrine in the brain: awaiting FDA review.
(Xenical): Works in the intestine to block digestion and absorption of one third of all ingested fat. Clinical trials complete.
A naturally-occuring hormone that my signal the brain to stop eating. Human trials may begin late this year.
Stimulates burning of stored fat by enhancing activity of fat receptors. Going into final phase of clinical trials.
