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Psychiatric Times. Vol. 14 No. 11
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New Weight Loss Controversy Flares

By Michael Jonathan Grinfeld | November 1, 1997

America's pop culture can send a dizzying blur of mixed signals. On the one hand, its massive restaurant and food industries serve up an abundance of calorie laden, often unhealthy processed meals that have turned Americans into the most overweight people in the world. On the other hand, fashion designers and other purveyors of style pound home images of lean and muscular men and waiflike women, creating a national yearning for body types that rarely approach the reality of what most of us will ever look like.

Mediating between these two contradictory forces is a burgeoning weight-loss industry whose own feeding frenzy consumes billions of dollars each year. According to a report last summer in the Washington Post, Americans spent nearly $500 million on prescription and over-the-counter diet drugs in 1996. Meanwhile, they disgorged another $30 billion annually on diet programs and products, according to a National Task Force on the Prevention and Treatment of Obesity. The cost of excess isn't only economic-an estimated 300,000 people die each year from obesity-related causes.

But a combination of serendipity and science last summer threw the medicine and business of weight reduction into turmoil. As researchers scurried to determine what mechanisms in a combination of weight reduction drugs cause cardiac damage to millions of people, Eli Lilly and Co., the manufacturer of Prozac (fluoxetine), landed in the center of a controversy, though one not of its own making. Pitted against Nutri/System Weight Loss Centers, which is heavily marketing Prozac in combination with phentermine(Drug information on phentermine) (Adipex, Fastin) as a weight-loss drug, Lilly now finds itself in a public relations, legal and public health quagmire as physicians and consumers agonize over what to do next.

A mere five years ago, it seemed as if researchers had discovered a magic bullet that could decimate fat and bring relief to millions who had fought the battle of the bulge unsuccessfully. A combination of phentermine and fenfluramine (Pondimin), according to University of Rochester investigators, caused people to lose more weight and keep it off for longer periods of time than those taking placebo. Weight-loss companies, always hungry for new injections of capital and for a sharper marketing angle, jumped on the bandwagon, and the "phen-fen" diet blossomed into a fad that swept the country. Last year alone, doctors wrote 18 million prescriptions for the combination. In the 14 months since the Food and Drug Administration narrowly approved Redux (dexfenfluramine), a more refined version of fenfluramine, physicians have written approximately 4.2 million prescriptions.

Even earlier concerns about side effects, the most troubling of which was a connection to primary pulmonary hypertension (PPH), did not stem the growing tide of individuals willing to manage weight with pills. And despite warnings that phen-fen should not be used for long periods of time and only in patients who met medical criteria for obesity, the combination nevertheless became a panacea for moderate weight gain.

In July, when the Mayo Clinic first reported that fenfluramine and dexfenfluramine were linked to heart valve defects in women who had used the drugs, the bottom began to fall out of the phen-fen craze. As more and more doctors began to back off the combination, the FDA intensified its investigation into the disturbing reports, ultimately withdrawing the drugs from the market in mid-September. Weight-loss centers had to consider options.

Nutri/System turned to Prozac. Hanging its hat on claims made by two physicians, it replaced the "fen" portion of the phen-fen combination with Prozac. By the end of the summer, it was marketing its newly revised NutriRx program that featured "phen-Pro," a combination of phentermine and Prozac it claimed was a "clinically tested prescription medication that targets the source of the problem, the part of the brain that controls hunger."

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