Go find a phone number

Word of the hidden epidemic began spreading in the spring of 2001. Local newscasts around the country reported that as many as 10 million Americans suffered from an unrecognized disease. Viewers were urged to watch for the symptoms: restlessness, fatigue, irritability, muscle tension, nausea, diarrhea, and sweating, among others. Many of the segments featured sound bites from Sonja Burkett, a patient who'd finally received treatment after two years trapped at home by the illness, and from Dr. Jack Gorman, an esteemed psychiatrist at Columbia University. Their testimonials were intercut with peaceful images of a woman playing with a bird, and another woman taking pills.

The disease was generalized anxiety disorder (GAD), a condition that, according to the reports, left sufferers paralyzed with irrational fears. Mental-health advocates called it "the forgotten illness." Print periodicals were awash in stories of young women plagued by worries over money and men. "Everything took 10 times more effort for me than it did for anyone else," one woman told the Chicago Tribune. "The thing about GAD is that worry can be a full-time job. So if you add that up with what I was doing, which was being a full-time achiever, I was exhausted, constantly exhausted."

The timing of the media frenzy was no accident. On April 16, 2001, the U.S. Food and Drug Administration (FDA) had approved the antidepressant Paxil, made by British pharmaceutical giant GlaxoSmithKline, for the treatment of generalized anxiety disorder. But GAD was a little-known ailment; according to a 1989 study, as few as 1.2 percent of the population merited the diagnosis in any given year. If GlaxoSmithKline hoped to capitalize on Paxil's new indication, it would have to raise GAD's profile.

That meant revving up the company's public-relations machinery. The widely featured quotes from Sonja Burkett, and the images of birds and pills, were part of a "video news release" the drugmaker had distributed to TV stations around the country; the footage also included the comments of Dr. Gorman, who has frequently served as a paid consultant to GlaxoSmithKline. On April 16--the date of Paxil's approval--a patient group called Freedom From Fear released a telephone survey according to which "people with GAD spend nearly 40 hours per week, or a `full-time job,' worrying." The survey mentioned neither GlaxoSmithKline nor Paxil, but the press contact listed was an account executive at Cohn & Wolfe, the drugmaker's P.R. firm.

GlaxoSmithKline's modus operandi-marketing a disease rather than selling a drug--is typical of the post-Prozac era. "The strategy [companies] use--it's almost mechanized by now," says Dr. Loren Mosher, a San Diego psychiatrist and former official at the National Institute of Mental Health. Typically, a corporate-sponsored "disease awareness" campaign focuses on a mild psychiatric condition with a large pool of potential sufferers. Companies fund studies that prove the drug's efficacy in treating the affliction, a necessary step in obtaining FDA approval for a new use, or "indication." Prominent doctors are enlisted to publicly affirm the malady's ubiquity. Public-relations firms launch campaigns to promote the new disease, using dramatic statistics from corporate-sponsored studies. Finally, patient groups are recruited to serve as the "public face" for the condition, supplying quotes and compelling human stories for the media; many of the groups are heavily subsidized by drugmakers, and some operate directly out of the offices of drug companies' P.R. firms.

The strategy has enabled the pharmaceutical industry to squeeze millions in additional revenue from the blockbuster drugs known as selective serotonin reuptake inhibitors (SSRIS), a family of pharmaceuticals that includes Paxil, Prozac, Zoloft, Celexa, and Luvox. Originally approved solely as antidepressants, the SSRIs are now prescribed for a wide array of heretofore obscure afflictions--GAD, social anxiety disorder, premenstrual dysphoric disorder. The proliferation of diagnoses has contributed to a dramatic rise in antidepressant sales, which increased eightfold between 1990 and 2000. Prozac alone has been used by more than 22 million Americans since it first came to market in 1988.

For pharmaceutical companies, marketing existing drugs for new uses makes perfect sense: A new indication can be obtained in less than 18 months, compared to the eight years it takes to bring a drug from the lab to the pharmacy. Managed-care companies also have been encouraging the use of medication, rather than more costly psychotherapy, to treat problems like anxiety and depression.

But while most health experts agree that SSRIS have revolutionized the treatment of mental illness, a growing number of critics are disturbed by the degree to which corporate-sponsored campaigns have come to define what qualifies as a mental disorder and who needs to be medicated. "You often hear: `There are 10 million Americans with this, 3 million Americans with that,'" says Barbara Mintzes, an epidemiologist at the University of British Columbia's Centre for Health Services and Policy Research. "If you start adding up all those millions, eventually you'll be hard put to find some Americans who don't have such diagnoses."

WHEN PAXIL hit the market in 1993, the drug's manufacturer, then known as SmithKline Beecham, lagged far behind its competitors. Eli Lilly's Prozac, the first FDA-approved SSRI, had already been around for five years, and Pfizer had beaten SmithKline to the punch with Zoloft's debut in 1992. With only a finite number of depression patients to target, Paxil's sales prospects seemed limited. But SmithKline found a way to set its drug apart from the other SSRIS: It positioned Paxil as an anti-anxiety drug--a latter-day Valium--rather than as a depression treatment.

SmithKline was especially interested in a series of minor entries in the Diagnostic and Statistical Manual of Mental Disorders (DSM), the psychiatric bible. Published by the American Psychiatric Association since the 1950s, the DSM is designed to give doctors and scientists a common set of criteria to describe mental conditions. Entries are often influenced by cultural norms (until 1973, homosexuality was listed as a mental disorder) and political compromise: The manual is written by committees of mental-health professionals who debate, sometimes heatedly, whether to include specific disorders. The entry for GAD, says David Healy, a scholar at the University of Wales College of Medicine and author of the 1998 book The Antidepressant Era, was created almost by default: "Floundering somewhat, members of the anxiety disorders subcommittee stumbled on the notion of generalized anxiety disorder," he writes, "and consigned the greater part of the rest of the anxiety disorders to this category."

Critics note that the DSM process has no formal safeguards to prevent researchers with drug-company ties from participating in decisions of interest to their sponsors. The committee that recommended the GAD entry in 1980, for example, was headed by Robert L. Spitzer of the New York State Psychiatric Institute, which has been a leading recipient of industry grants to research drug treatments for anxiety disorders. "It's not so much that the industry is there in some Machiavellian way," says Healy. "But if you spend an awful lot of time with pharmaceutical companies, if you talk on their platforms, if you run clinical trials for them, you can't help but be influenced."

SmithKline's first forays into the anxiety market involved two fairly well-known illnesses--panic disorder and obsessive-compulsive disorder. Then, in 1998, the company applied for FDA approval to market Paxil for something called social phobia or "social anxiety disorder" (SAD), a debilitating form of shyness the DSM characterized as "extremely rare."

Obtaining such a new indication is a relatively simple affair. The FDA considers a DSM notation sufficient proof that a disease actually exists and, unlike new drugs, existing pharmaceuticals don't require an exhaustive round of clinical studies. To show that a drug works in treating a new disease, the FDA often accepts in-house corporate studies, even when companies refuse to disclose their data or methodologies to other researchers, as is scientific custom.

With FDA approval for Paxil's new use virtually guaranteed, SmithKline turned to the task of promoting the disease itself. To "position social anxiety disorder as a severe condition," as the trade journal PR News put it, the company retained the New York-based public-relations firm Cohn & Wolfe. (Representatives of GlaxoSmithKline and Cohn & Wolfe did not return phone calls.)