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The Ills Of Diet Pills Migraine Headaches, Heart Problems And Now Possible Brain Damage. Is Losing Weight Using Fen-Phen Worth The Risk?

Fri., Sept. 5, 1997

Immobilized in the corner of her couch, a terrified Georgia Andreas prayed for the crushing pain in her chest to subside.

She knew what she had to do. When the pain finally eased, “I took the pills and flushed all of them down the toilet,” she says. The pills were fen-phen, a popular diet drug combination.

A Mayo clinic study linking the use of fen-phen to a heart valve disorder recently brought notoriety to the drugs. And a set of National Institute of Mental Health studies released last week suggests that the drug combination kills brain cells.

But fen-phen had already gained itself a large number of fans and detractors long before the research made headlines. Andreas, a 30-year-old triage nurse at the Yakima Heart Center, knew the risks and the promises surrounding fen-phen. She chose the promises.

Andreas wanted a dream body for a dream vacation. And she wanted it fast. What she got instead were debilitating migraines that lasted for days and heart palpitations that derailed her regular exercise program. Even everyday chores left her short of breath.

But it took chest pains, so severe she thought she was having a heart attack, to convince Andreas to stop taking fen-phen. Trained to recognize the symptoms of heart problems in her patients, she was startled to discover similar symptoms in herself.

To get the drugs, she made an appointment with a friend’s general practitioner. The friend assured Andreas there would be no problems.

“Are you here for the fen-phen?” asked the office manager. Andreas says she thought it was a strange question to ask a new patient, especially since it was the only question asked. “There was no preliminary paperwork at all,” says Andreas. She was given a release form to sign, then was asked for payment in full. Her blood pressure and weight were recorded by a medical assistant.

The consultation with the doctor, she says, “took less than five minutes.” He wrote out a month’s prescription and told her to call if she had any complications. He didn’t mention what the complications might be. She didn’t ask.

Less than a month later, frightened and ill, Andreas flushed what was left of the drugs down the toilet. Now, seven months later, she is just beginning to feel like herself again. She considers herself lucky. Dr. Ann Blake Tracy, a Utah-based bio-psychologist (a psychologist specializing in the study of the relationship between the physiology of the body and psychiatric problems), agrees.

“These drugs set people up for many chronic, debilitating illnesses affecting the liver, lungs, heart, pancreas and brain,” says Tracy, author of “Prozac: Panacea or Pandora?” (Cassia Publications, 1997).

The latest research, which last week lined fen-phen to brain damage, also reconfirmed widely accepted clinical evidence that the drugs impair blood circulation in the lungs, which can lead to a sometimes fatal disorder called primary pulmonary hypertension.

The problem with fen-phen, according to Tracy, is the body’s inability to metabolize the elevated levels of serotonin produced by fenfluramine, the “fen” in fen-phen. Fen-phen is a combination of two drugs, fenfluramine and phentermine. Both drugs have been around for more than 20 years and were approved separately by the FDA for weight loss control. They were never officially approved to be used together.

It’s legal for physicians to prescribe approved drugs in combination. But, according to J.P. Smith, Director of Public Relations for the American Society of Bariatric Physicians (ASBP) in Englewood, Colo., “it’s the combination that’s the unknown.”

The drugs act on different brain chemicals in different ways. Fenfluramine produces a rapid release of serotonin and inhibits serotonin reuptake, helping to create a feeling of fullness and reducing food cravings, particularly for carbohydrates. One of its most common side effects is a feeling of grogginess and lethargy.

Phentermine stimulates norepinephrine and dopamine, suppressing the appetite. Some of its most common side effects are sleeplessness and anxiety. When taken together, the positive aspects of both drugs seem to be enhanced. The negative effects seem to cancel each other out. The two drugs combined are more effective than either one used separately.

These were the findings of Dr. Michael Weintraub, whose landmark study at the University of Rochester in 1992 launched the drugs into the mainstream. After results of the study were published, the rush was on. In 1996 alone, roughly 18 million prescriptions were written for the drugs.

Although serious side effects from the drugs have been consistently reported, the Mayo study raised concern to a new level. The concern seems particularly valid given that only 26 people completed the entire three years of the Weintraub study. Just last week, the same Mayo Clinic doctors reported another 61 cases of people with damaged heart valves after taking the drug combination, 16 of which were directly confirmed by the medical center.

Dr. Gerald Lundahl, a bariatrician (a doctor specializing in the medical treatment of obesity), and author of “The Final Word on Phen/Fen” (Physicians Select, 1997), has treated over 30,000 obese patients in his 30 years of practice in California. He says vigilance is essential with these medications.

The risks, in Lundahl’s experience, seem to be dose related. The higher the dose of fen-phen, the greater the risk of complications. The Mayo study, says Smith, appears to bear this out.

According to Smith, some of the women in the study were taking doses far in excess of the prescribed amount. Others, in addition to fen-phen, were taking Prozac and Zoloft, two popular antidepressants. Like fenfluramine, both boost serotonin levels in the brain.

Although Mayo researchers don’t know yet how fen-phen might injure heart valves, they do know that fen-phen alters the way serotonin is metabolized.

Tracy, a bio-psychologist and expert witness on psychoactive drugs, notes that “medical studies have demonstrated for decades that any increase in serotonin produces a decrease in its metabolism,” which in turn is associated with depresssion, alcohol abuse, bulimia, multiple suicide attempts and hostility.

Leigh, 45, a longtime Spokane resident who didn’t want her last name used, got her fen-phen prescription from her gynecologist. Leigh took the drugs for six months and lost 50 pounds. Along the way, she nearly lost her mind, too.

“I was overwhelmed by everyday activities,” she says. “I was logging in lots of overtime at work because I couldn’t hold a thought long enough to complete one task before my mind would reel to the next. I would dissolve into tears for no reason and not be able to stop crying.”

Leigh quit her job and spiraled further into depression. While she acknowledges that she has “always been a bit prone to the blues,” she normally coped well with stress and had never before had thoughts of suicide. Now, those thoughts filled her mind morning and night.

She decided to go off fen-phen. Three weeks later, she was in a psychiatric hospital. According to Tracy, hundreds of these severe reactions of depression, exhaustion and extreme behavioral changes have been reported by patients withdrawing from the drugs.

But, as Leigh witnessed, dramatic swings in emotions and moods also occur while taking fen-phen. The drugs and the mood swings associated with them have become so common in the workplace that inexplicable emotional outbursts are often labeled as “going fen-phen.”

Phentermine, the “phen” in fen-phen, may be the source of some of the behavioral changes. Phentermine is chemically related to amphetamines, stimulants which have been abused as both prescription and street drugs for years.

Many people who have experimented with recreational drugs, including speed, crystal meth, cocaine and some hallucinogenics, report a startling similarity to the effects of those drugs and fen-phen, among them unlimited and sometimes frantic amounts of energy, complete cessation of appetite, body “rushes” or euphoric waves of tingling throughout the body, and a personal sense of invincibility.

Often the people taking fen-phen are the last to recognize the emotional changes in themselves.

“I didn’t think it was the fen-phen,” Leigh says. “I thought that it was me.” When her internist insisted that there was a connection, she ignored him. Plus, finally thin, she says, she didn’t want to accuse - or lose - the drugs that made it all possible.

Because of the enormous personal and cultural pressure to be thin, people are reluctant to give up anything that offers hope. Some people, acting on the notion that “if a little is good, a lot is better,” will take a month’s supply of fen-phen in two weeks or less. Others fail to give complete medical histories or to report side effects, fearing the pills will be reduced or taken away.

Kim Preston, Lundahl’s co-author and patient, began to lose her hair while taking fen-phen. But she also lost weight. A simple adjustment in her nutrition program restored her hair. But she considered the hair loss a minor inconvenience. “I’d rather be bald than fat,” says Preston, marketing director for Lundahl’s California-based nutrition company, Physicians Select.

While admitting her own “emotional dependence” on the drugs, Preston advises others to tell the truth. “Don’t lie about your reactions or your drug use,” she says. “An observant doctor will find out anyway. And you don’t even want to know a doctor who isn’t.”

“These drugs are marketed to any licensed physician,” says Smith. “Look at the ad campaigns for drugs, then look at the fine print. The only education some doctors are getting is what is provided in the drug information itself.”

Dr. Cheryle Hart, Director of the Women’s Workshop in Spokane, requires all patients participating in her programs to make regular office visits. Medications are monitored closely. Proper nutrition is a key component.

“These drugs work so well as appetite suppressants,” says Hart, “that you can literally be starving yourself on them.” Hart says many of the serious side effects of fen-phen can be directly attributed to improper or inadequate nutrition.

Hart, a member of the American Society of Bariatric Physicians has treated over 800 women for obesity. The majority have been treated with fen-phen. None, according to Hart, has suffered any serious side effects.

Hart’s typical patient has “tried every diet, every group, every method, multiple times, with no lasting results,” she says. Many of them face life-threatening diseases as a direct result of their obesity.

For them, the benefit of the medications often outweigh the risks. “But the pills are only a tool,” says Hart. “The key to lasting weight loss resides in modifying lifestyle and eating behaviors.”

Given the risks, do the drugs at least work? The answer seems to be yes, but only for as long as you take them. And sometimes, not even then.

All of the participants in Weintraub’s three-year study regained their weight after discontinuing the medication. This, and the chronic nature of obesity, led experts to conclude that the medications might be indicated for lifetime use in some patients.

“You don’t cure obesity,” says Lundahl. “You contain it. There are cultural, emotional and hereditary aspects to this disease.” The understanding of obesity as a disease, rather than a character flaw, has gained wide acceptance. But some patients are getting mixed messages.

Chris Walker, 37, a software engineer based in Spokane, and his wife, Dena, 36, used fen-phen to jump-start a diet and exercise program. Neither had any serious side effects from the drugs. They were encouraged to view fen-phen as a temporary tool. Both lost weight initially but began to plateau at three months.

“At this point we were told that the drugs were probably for life, the theory being that the brain chemistry in overweight people is fouled up,” he says.

While the engineer in Walker is fascinated by the way things work, including brain chemistry, he says understanding of it is limited. Both he and his wife have discontinued the drugs and are working on lifestyle changes.

Ines Wynn, 45, an international project manager based in Spokane, did not lose a single pound while taking fen-phen. She got the pills from a weight loss clinic that insisted she cut her calories to 800 per day.

“I wasn’t willing to go below 1000 calories,” she says. “I have Type 2 diabetes and good nutrition is important in managing it.” The restrictive diet that the clinic urged did not make sense to her. “Why am I taking drugs,” she wondered, “if I’m starving myself anyway?” Frustrated by the expense and the lack of results, she discontinued the medication.

A promising focus of study is the relationship between insulin resistance and obesity management. Hart, who has watched patients lose weight only to plateau and regain, thinks insulin resistance may be the key to understanding chronic obesity.

“Fen-phen is the Model T of weight loss management,” says Hart. “It represents the first serious attempt to treat obesity medically.” And it’s only the beginning.

New diet drugs are currently in development that may work more safely and effectively. And new diets are born every minute. In Hart’s experience, most diets work, it’s the maintenance that fails. “Diets represent deprivation. It’s human nature not to tolerate deprivation of food or love without snapping,” she says.

Food or love. Of the many reasons people eat, hunger is only one of them. Understanding the emotional reasons behind overeating is critical to changing destructive patterns. For some, it’s a lifelong process.

Andreas’ experience with fen-phen brought her to the realization that “I’d rather be alive than thin for two weeks.” Frightened by the side effects she experienced, she says she will never use the drugs again.

Leigh says that fen-phen played a key part in her mental illness but would take the drugs again if her weight got out of control. “Body image is so important,” she says. When asked if being thin is more important than being healthy, she replies, “Right now, my self-esteem is so low that I’d have to say yes, being thin is more important.” She admits that she suffers from “flawed logic” and speculates that someday her thinking might change.

But beyond, or maybe before change comes acceptance. “We all have different bodies and different chemistries,” says Walker. “We all have the expectation that we can be perfect. We can’t. It’s important to be able to look in the mirror and say, ‘Yes, I’m not as thin as the guy or girl next door. But my family is healthy and so am I.”’

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