Diet pills, with their get-thin-quick appeal, were the rage in the 1950s and ’60s, an easy answer for the mother of the bride wanting to drop 10 pounds before the wedding or the former jock looking to lose his gut before the high school reunion.
But by the early ’70s, these appetite-suppressing amphetamines were shown to be dangerous and addictive drugs that could cause insomnia, volatile mood swings and a number of physiological problems. What started as an easy answer for losing a few pounds ended in medical disgrace. Amphetamines are now classified as a controlled substance and prescribed only in highly unusual circumstances.
The American pursuit of the lose-weight-quick fix has since evolved into an overstuffed menu of diet and exercise plans laced with liquid meals, weight-loss support groups, infomercial exercise gadgets and enough diet books to fill a suburban library.
But that may be about to change.
Diet pills are making a comeback.
Many mainstream doctors, who just a year or two ago wouldn’t have dreamed of writing a prescription to accompany the standard recommendation of better diet and more exercise, are embracing new drug treatments for obese patients (defined as weighing 20 percent more than healthy body weight). Tests show the new chemicals are not addictive like the old ones, and don’t produce the serious physical problems, although they still have side effects.
The diet pill movement is expected to get a big push in the next few months when the Food and Drug Administration is likely to approve the first mass market obesity pill in more than 20 years.
But while some doctors believe that chemical treatments are a blessing for severely overweight people, the allure of a “magic pill” to shed pounds might be irresistible to anyone with a few nagging extra pounds.
A good diet and regular exercise are the best and most natural weight-control strategy, experts believe. But it can be a lot of work, and Americans like instant results.
One who has tried the new drugs is Mark Donaway, a chef who lost 47 pounds in a month without really trying.
“I have been on every diet; you name it, I’ve tried it,” said Donaway, 37, who works at Cucina Bella restaurant in Lincoln Park. Donaway started the year at 317 pounds and currently is carrying less than 270 pounds on his 6-foot-6 frame.
“This plan works for me, and everybody is asking about it. I know seven or eight other people who are doing it.”
Patients like Donaway are taking a regimen of two non-habit-forming drugs, fenfluramine and phentermine, obesity medications that were approved by the FDA for medical use in the early 1970s but didn’t show much promise for significant weight loss until a researcher discovered in 1991 that combining the two greatly improved their effectiveness.
Research is confirming the positive results of the drug regimen, known informally as “fen-phen,” though the actual pounds lost vary greatly by individual. And it does have side effects that can include dry mouth, constipation or diarrhea, jitters and increased urinary frequency and urgency.
Fen-phen is just the start. In a move expected to greatly legitimize and renew widespread interest in weight-loss drugs, the FDA is soon expected to approve Redux, the first government-sanctioned obesity drug since 1973. It is already available in 65 countries and considered to cause fewer side effects than fen-phen due to smaller dosages. Four more weight-loss drugs, all being developed by large pharmaceutical companies racing for what could grow to be billions of dollars in sales but relatively low cost to patients, should follow a similar route in the next few years.
The ratification is overdue, according to researchers who have been eying America’s obesity statistics.
“It’s disgraceful we have waited more than 20 years for the FDA to approve new drugs,” said Judith Stern, a professor of nutrition at the University of California at Davis and a leading proponent of treating obesity as a disease. “We are in the midst of an epidemic in this country. Obesity is causing preventable deaths and driving up national and personal health care costs. We’ve got to get past the stigma associated with using drugs to treat people who are overweight.”
The statistics are undeniable. The federal Centers for Disease Control and Prevention estimate 33 percent of American adults are obese, compared to 25 percent in 1980. A recent Harris Poll reported 74 percent of Americans 25 and older are overweight, up from 71 percent a year ago and 59 percent in 1985. About $70 billion is spent each year in health care costs related to obesity.
The pending FDA approval of Redux, which prompts its user to feel full or satiated after only a few bites of food, is acknowledgment that being fat may not simply be due to a lack of willpower. This seminal change in perspective is increasingly evident within the medical community.
“Obesity should be categorized as a disease like diabetes or hypertension,” said Dr. Robert Kushner, director of the Nutrition and Weight Control Clinic at the University of Chicago who has integrated fen-phen into the program during the last two years. “We don’t understand all the reasons why someone is obese. There are other causes and drives than whether people just can’t say no at the dinner table.”
While the FDA plans to issue “guidances” on using the drugs only for technically obese individuals, it does not have the legal authority to prohibit their use by any patient deemed appropriate by a physician.
And that worries some doctors, including Kushner.
“An obesity drug is not for someone trying to drop five pounds,” he said. “I am deeply concerned (fen-phen, Redux and other new drug regimens) will be prescribed without discrimination. It’s the same thing as Prozac. You worry how many doctors are giving it to someone who is feeling blue rather than saving it for patients who are diagnosed with clinical depression.
“If someone is five, 10 or even 15 pounds overweight, chances are the extra pounds are due to a lack of physical activity. Taking a drug won’t deal with the problem at hand. You may have a better reading on the bathroom scale but you won’t build the muscle mass or achieve cardiovascular fitness associated with exercise.”
That’s not enough to stop some people. One Chicago woman who recently moved here from suburban Washington, D.C., explained how a Virginia physician provided her with copied pages from a booklet showing doctors around the country who are willing to prescribe fen-phen to any patient desiring easy access to the drugs. She visited one Chicago doctor listed and received a prescription despite her self-described status as “young, healthy and active.”
“I overheard the woman who went in before me,” said the new Chicagoan, who quit the fen-phen combination after two days because her body temperature was noticeably warmer. “She wanted to lose six pounds and begged the doctor for a prescription. The doctor said no at first, then caved in.”
Not surprisingly, the Redux approval process has been controversial. It passed by only a 6-5 vote when recommended by a special FDA advisory committee in November. There was concern among dissenters that one side effect, primary pulmonary hypertension, though rare, could be fatal by shutting down blood circulation in the lungs and causing heart failure. Also, research showed most subjects using Redux were losing only five to 10 percent of body weight when shedding 20 percent or more of body weight was recommended. One pharmacologist speaking before the FDA panel also called for more tests to confirm the drug would not have any long-term toxic effects on the brain.
Still, the drug has its healthy share of supporters and the FDA rarely rejects the recommendations of an advisory committee.
“What impressed me were the pro-Redux arguments being made by eminent people who specialize in obesity,” said Dr. Robert Marcus, director of geriatric research at the Veterans Administration Medical Center in Palo Alto, Calif., and FDA committee member who voted yes on the Redux approval. “These are scholars, not quacks or pill pushers.”
Redux, chemically known as dexfenfluramine, acts to selectively increase levels of the neurochemical serotonin, which makes you feel more full. You will still get hungry, but you will tend to eat less. Its side effects are in most cases minimal and less severe than those from fen-phen, according to research presented to the FDA panel: Sleep disruption, possible moodiness and short-term memory lapses.
Dexfenfluramine, though a cousin of antidepressant drugs like Prozac (which works on certain serotonin receptors in the brain related to depression), does not significantly alter mood or emotional state. Researchers say it acts only on serotonin receptors affecting feelings of satiation. In contrast, fenfluramine, a key part of the fen-phen plan, has not been thoroughly evaluated for possible antidepressant tendencies.
Donaway said fen-phen hasn’t altered his emotions and he has never considered himself to be suffering from depression. He does acknowledge feeling more energetic. Most impressively, the drug has allowed him to analyze his daily eating habits, especially in the restaurant kitchen.
“I was tasting everything without knowing it, especially the cream sauces and the chocolate we used for our chocolate-covered fruit desserts,” he explained. “But then when I felt full (from the fen-phen treatment), I noticed it. I must have been eating an extra 2,000 calories a day.”
The hope is a patient can eventually go off obesity drugs and maintain a healthy weight by eating right and keeping active.
The pills won’t do it alone, said Dr. Gerald Berkowitz, an internist on staff at Weiss Memorial Hospital on the North Side who has advised Donaway, several other local chefs and even Hollywood stars.
“I talk to my patients about a proper diet, basically high protein and eating four smaller meals a day, and regular exercise,” said Berkowitz. “Some patients come in here and simply want a pill that will keep them from getting any fatter. I’m not a prescriber of pills.”
