Fighting Food Without Fen-Phen

Sheryl Cooney did not always worry about her weight. That started 15 years ago, after she suffered a miscarriage during her third pregnancy. A month later, she left a job she loved to follow her husband to his new job in Walla Walla. Separated from family and isolated with two toddlers, Cooney, also a diabetic, struggled to make friends in the small town and at her new job."I cried and ate and gained 50 pounds in two years," recalls Cooney, now a research technologist for the Heart Institute of Spokane. Cooney tried all kinds of diets, with minimal success -- until fen-phen came along.Because of the risks associated with her diabetes, her doctor prescribed fen-phen. "I took it for five months and felt energetic, wonderful. I wasn't hungry at all and lost 30 pounds."Her doctor recommended a one-month respite from the medication. When Cooney resumed the drugs, she immediately suffered excruciating headaches. "It felt like someone was behind my eyeballs trying to poke them out."Cooney assumed this side-effect would pass and tolerated the pain for seven days. "I took Ibuprofen all day and a Darvocet at night. I knew it was crazy, but I would have done just about anything to lose weight." The day after she quit taking the fen-phen, the headaches stopped.Cooney never tried the fen-phen again. Fortunately she had modified her diet and lifestyle while on the medication and only regained 10 pounds.Her family is glad to have her cheerful disposition back. "I knew I was edgy on the pills, but I thought I was handling it," she says. "Later my daughter told me she was afraid I was going nuts, and my husband said he half expected my head to start spinning around."Cooney's experiences are far from unique. The National Institutes of Health report that half of all Americans are overweight and one-third are clinically obese -- weighing 20 percent above their ideal body weight. While obesity can be caused by other health conditions or heredity, overeating and lack of exercise are also contributing factors. The number of obese Americans rose 8 percent from 1980 to 1991, according to a study by the Center for Disease Control in Atlanta.Dieters are not only looking for the affirmation weight loss offers in a society apparently seduced by skinniness, but also for the health benefits of staying within an ideal weight zone. Americans spend $33 billion a year on weight loss products and services. Doctors wrote a combined 9.4 million prescriptions for fen-phen and its cousin Redux in 1996.Last month, manufacturers took fenfluramine -- the "fen" in fen-phen -- and dexfenfluramine, sold as Redux, off the market. So with the diet wonder pill off the market, where does that leave those looking to shed some weight?Obesity itself poses significant health risks. More than 300,000 people die of obesity-related disorders each year. Dr. Stephan King, a Spokane family practice physician, routinely prescribed either fen-phen or Redux to help his patients combat obesity.Like a growing number of physicians and researchers, King believes obesity should be recognized as a serious medical condition, one that is at least partially manageable by drug treatment. Doctors prescribe lifelong medication for patients with high blood pressure and should consider long-term drug therapy for obesity, he says.King currently prescribes phentermine (the "phen" of fen-phen, which is unaffected by the removal of fenfluramine from the market) alone and finds many of his patients doing well, although their weight loss has slowed. He anticipates the new drugs and drug combinations now in various stages of development.And King also sees an emotional cost to obesity. "Being obese is a very difficult thing. I think the obese are discriminated against."King says he treated only clinically obese patients and monitored their health regularly. He estimates that at least 60 percent of his patients developed better eating and exercise habits while in his program. "Fen-phen and Redux were just tools. If you do something and it has an effect, you are more likely to keep going, to change your behavior."Other professionals disagree. "The problem with drug therapy is that it seems to be a quick fix. People don't redesign their lifestyles, and they gain the weight back," says Spokane psychologist Dr. John Klopsch.Quick fixes lured many who didn't meet the standards for clinical obesity to seek fen-phen for cosmetic weight loss. King concedes doctors inappropriately prescribed the drugs for those only slightly overweight. He defends their use in conservative programs like his, however.Now doctors and diet centers are experimenting with various drug combinations to replace Pondimin and Redux. Nutri/System Weight Loss Centers, a national chain with 450 locations, has begun prescribing a combination of Prozac, an anti-depressant, and phentermine for its clients.Prozac's manufacturer does not endorse the phen-Pro combination for weight loss and has asked Nutri/System to refrain from using the trademark name in its advertising.Although the drugs appear to be safe when taken separately -- Prozac is the most frequently prescribed drug in the world -- the combination has not been subjected to clinical trials. Anecdotal reports from doctors who have prescribed it for two years show it to be effective for most people, but note transient side effects such as severe nausea, insomnia and heart palpitations.King criticizes the phen-Pro combination and won't use it. "In doses high enough to suppress the appetite, Prozac can cause Serotonin syndrome. The person gets agitated, jumpy." The dosage of Prozac in phen-Pro is almost double that commonly prescribed to fight depression.King also cautions against natural concoctions currently available. Area grocery stores recently began carrying herbal fen-phen. Over-the-counter and mail order products also deserve consumer scrutiny: slick brochures and lofty promises can blind consumers to potential risks, both to their health and pocketbook.Space-age science may someday discover a "magic diet pill," but that day hasn't yet come. The only sure and safe way to lose weight, many experts insist, is the slow, old-fashioned way -- diet and exercise."Delay of gratification, historically a societal character trait, has fallen into disrepute in the last 30 years," says psychologist Klopsch. "The advertising media has seized upon, maybe even helped create, this need for instant gratification."The idea that losing weight takes as long as gaining it did is a bitter pill for many to swallow. But Judy Keiser, a registered dietitian, says losing weight is a simple matter of math: burn more calories than you consume."Don't just count calories, though. You could eat three candy bars and stay under some diets' calorie restrictions. Instead, eat healthy foods, guided by recommendations on the food pyramid."Keiser recommends eating small amounts several times during the day rather than three large meals. Five or more servings of fruits and vegetables and six to 10 servings of grain-based foods per day will stave off hunger. Adding two servings each from the milk and meat groups meets nutritional needs. She also suggests a stress reliever or boredom buster such as a brisk walk or a good book as alternatives to eating.Most people don't get enough fluids, Keiser adds. Soda pop, coffee and tea don't count -- they contain chemicals that need to be flushed from the body. Six to eight cups of water, juice or similar fluids allow the body to cleanse itself of wastes, including dietary fat and fat released by fat cells.In addition to eating sensibly, a healthy weight loss regimen includes some form of exercise. Walking regularly is one place to start. If you have been sedentary, begin slowly with a 10 to 20 minute walk and work up to a pace you can enjoy, three to five times per week.Exercise offers benefits besides weight loss, including increased energy, insomnia relief and enhanced self-esteem.Debra Thoen, a registered nurse and personal trainer, calls the strength training she offers a fountain of youth. "There's lots of talk about what to do now that fen-phen is off the market."Thoen never encouraged the drugs' use, nor does she endorse any other drug therapy. "It seems like replacing one evil with another. There could be so many detrimental consequences."She favors strength training because lean tissue burns fat. "The more muscle tissue you have, the faster your metabolism is."Thoen's plan demands 20 to 30 minutes of steady, intense work, twice a week. It enhances cardiovascular health while building muscle mass."Most [women can] lower the percentage of fat in their body by 1 to 3.5 percent. But it's not really about weight. It's more about how you feel. Does your back ache? Are you tired? How's your golf game?"National health experts agree. They recommend achieving the best possible weight in the context of overall health. Even small weight losses can lower blood pressure, improve cholesterol levels and boost mental health. But healthy bodies come in all shapes and sizes.Dr. Mary Dietzen, a psychologist who specializes in eating disorders, wishes she could convince teenage girls of that truth. She teaches people to change the way they think, to value themselves for their own unique qualities rather than build self-images on others' expectations."I get so angry at the lengths people go to measure up to someone else's idea of beauty." The "waif-look" found in fashion magazines showcases gaunt models who look anything but healthy, she says.Dietzen says young girls are vulnerable to media influences, especially if family dynamics leave them without emotional support. "Kids are exposed to messages from peers, the media, even parental figures, that thinness is the ideal, that they are not valuable if they don't fit."And adults don't always outgrow those influences. "People need to learn to say, 'I like myself, and I'm valuable regardless of how I look,' " Dietzen says. Sheryl Cooney shares that sentiment. She resisted scheduling an echocardiogram, but finally had one last month. The test revealed a very minor heart valve abnormality."If they hadn't been looking for it, they never would have seen it," she says. Cooney will never know if fen-phen caused the abnormality. Doctors suggest it could be a preexisting condition."I will be much more cautious as a consumer," Cooney says. "We need to be more skeptical, ask more questions and read the material that comes with medications. It's like everything else. If something sounds too good to be true, it probably is."Sidebar OneOn September 15, the Food and Drug Administration requested that manufacturers withdraw fenfluramine, sold as Pondimin, and dexfenfluramine, called Redux, from the nation's pharmacy shelves.Tests conducted by the Mayo Clinic and reported in the New England Journal of Medicine had suggested a possible link between the drugs and heart valve abnormalities in one-third of tested fen-phen and Redux users. The tests did not prove the connection, but the recall was ordered as a precaution.The FDA approved fenfluramine as a diet aid in 1973. Phentermine had been on the market for more than a dozen years at that time. Neither drug was particularly effective in bringing about lasting weight loss. But in 1979, Dr. Michael Weintraub, then professor of clinical pharmacology at the University of Rochester, tried the drugs in combination.Weintraub engaged 121 obese patients in a four-year study and demonstrated an average weight loss of 30 pounds. Patients on placebos suffered hunger and gained weight while those on the combined fenfluramine and phentermine felt satiated and lost weight. Because the drugs had been on the market for years, Weintraub assumed they were safe. Although he did look for side-effects, he found none. He never checked for damage to heart valves. Animal studies never revealed heart valve abnormalities. And no drug, except high doses of a migraine headache preparation, had ever been known to cause such damage. Weintraub's study was not published until July, 1992. Once the word spread, patients began calling doctors and demanding fen-phen.The FDA had not approved the drugs in combination or for long-term use. However, in a common practice known as "off-label use," doctors may prescribe an approved drug in combination with any other approved drug.Success created demand, and doctors wrote millions of prescriptions for fen-phen between 1994 and 1996. In April, 1996, the FDA approved dexfenfluramine -- aka Redux -- a purified fenfluramine with fewer side-effects. Redux, more expensive than its older cousin, was prescribed 2.4 million times in '96.On July 8 of this year, the Mayo Clinic reported its findings of valvular heart disease in 24 fen-phen users. The FDA asked doctors around the country to report similar cases and soon had 100 on file. The FDA directed five clinics to perform echocardiograms (ultrasound images of the heart in motion) on 291 fenfluramine users who had no symptoms associated with heart disease. Ninety-two of those subjects had abnormalities in their valves. Coincidentally, 24 of the 291 subjects had echocardiograms prior to taking fen-phen. Eight of those developed the abnormality after taking the drug.The Mayo Clinic will soon begin a study of 1,200 obese subjects to prove the connection between the drugs and the heart valve abnormalities. The study will compare 400 subjects who never took Pondimin or Redux with 400 who took each. Both American Home Products (whose subsidiary Wyeth-Ayerst Laboratories makes fenfluramine and distributes Redux) and Interneuron Pharmaceuticals, which manufactures Redux, will be hard hit by the recall. American Home Products estimates it will lose nearly $300 million. Redux is the only product Interneuron had on the market. Sales of Redux had exceeded $14 million so far this year.Sidebar TwoHuman nature being what it is, we tend to look for the easiest way to achieve our desires. With the 21st century just around the corner, expecting science to invent a safe, effective weight-loss pill seems perfectly reasonable.And with a multi-billion dollar market out there, drug companies are scrambling to do just that. Pharmaceutical solutions, however, tend to have side-effects -- some known and others yet to be discovered (as is apparently the case with fen-phen), and many experts say hoping for a miracle pill puts off the wieght loss that can be accomplished through natural means.One of the first new diet drugs to reach the market will be sibutramine. Sibutramine, to be sold as Meridia, increases the levels of serotonin and norepinepherine in the brain. Both chemicals suppress appetite by signaling satiety in the brain. No serious side-effects have shown up in tests to date, and the drug is in the final stages of FDA approval.A second drug, which seemed to be on the fast track to FDA approval, was removed from FDA consideration in August, while its maker investigates a possible link between the drug and increased incidence of breast cancer among test subjects. Orlistat, to be marketed as Xenical, blocks intestinal absorption of dietary fat. Tests showed weight losses up to 10 percent over two years.Leptin, cloned from a hormone produced by the gene that regulates the storage of body fat, aims to suppress the appetite and speed the metabolism. Leptin is also in the final study stages.Already available but controversial and untested in combination, is phentermine and the anti-depressant Prozac, or phen-Pro. Phen-pro has succeeded fen-phen as the diet cocktail of choice. Prozac suppresses hunger by enhancing levels of serotonin in the brain, which causes a person to feel satisfied.Herbal fen-phen combines phenylalanine (an essential amino acid), fennel seed, St. John's wort (a natural anti-depressant that works like Prozac to increase serotonin levels in the brain), ma huang (a natural form of ephedrine that increases the metabolic rate) and vitamin B-6. Because these substances come from natural, rather than pharmaceutical sources, no agency regulates their use. But don't assume natural means safe. The FDA has received reports of 17 deaths associated with ma huang. More than 800 cases of adverse side effects have also been documented.A form of the amino acid tryptophan, called 5 hydroxy tryptophan, which at least one practitioner has combined with phentermine for weight loss, has some doctors worried. L-tryptophan, a different form of the substance, killed 21 people and seriously injured 1,500 others a few years ago. L-tryptophan is no longer available and the deaths and injuries may have been attributable to impurities in the pills.

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