Disorders Made to Order

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 Smith- Kline 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.)

By early 1999 the firm had created a slogan, "Imagine Being Allergic to People," and wallpapered bus shelters nationwide with pictures of a dejected-looking man vacantly playing with a teacup. "You blush, sweat, shake-even find it hard to breathe," read the copy. "That's what social anxiety disorder feels like." The posters made no reference to Paxil or SmithKline; instead, they bore the insignia of a group called the Social Anxiety Disorder Coalition and its three nonprofit members, the American Psychiatric Association, the Anxiety Disorders Association of America, and Freedom From Fear.

But the coalition was not a grassroots alliance of patients in search of a cure. It had been cobbled together by SmithKline Beecham, whose P.R. firm, Cohn & Wolfe, handled all media inquiries on behalf of the group. (Today, callers to the coalition's hot line are greeted by a recording that announces simply, "This program has successfully concluded.")

There were numerous good reasons for SmithKline to keep its handiwork discreet. One was the public's mistrust of pharmaceutical companies; another was the FDA's advertising regulations. "If you are carrying out a disease-awareness campaign, legally the company doesn't have to list the product risks," notes Mintzes, the University of British Columbia researcher. Because the "Imagine Being Allergic to People" posters did not name a product, they didn't have to mention Paxil's side effects, which can include nausea, decreased appetite, decreased libido, and tremors.

Cohn & Wolfe's strategy did not end with posters. The firm also created a video news release, a radio news release, and a matte release, a bylined article that smaller news-papers often run unedited. Journalists were given a press packet stating that SAD "affects up to 13.3 percent of the population," or 1 in 8 Americans, and is "the third most common psychiatric disorder in the United States, after depression and alcoholism." By contrast, the Diagnostic and Statistical Manual cites studies showing that between 3 and 13 percent of people may suffer the disease at some point in their lives, but that only 2 percent "experience enough impairment or distress to warrant a diagnosis of social phobia."

Cohn & Wolfe also supplied journalists with eloquent patients, helping to "put a face on the disorder," as account executive Holly White told PR News. P.R. firms often handpick patients to help publicize a disease, offering them media training and sending them on promotional tours. In 1994, for example, drugmakers Upjohn and Solvay funded a traveling art show by Mary Hull, a Californian who suffered from obsessive-compulsive disorder and spoke frequently with journalists about the disorder's toll-as well as her SSRI-aided recovery. Not coincidentally, the companies were awaiting FDA approval to market their SSRI, Luvox, for the treatment of obsessive-compulsive disorder. Among the patients most frequently quoted in stories about social anxiety disorder was a woman named Grace Dailey, who had also appeared in a promotional video produced by Cohn & Wolfe.

Also featured on that video was Jack Gorman, the Columbia University professor who would later make the rounds on Paxil's behalf during the GAD media campaign. Gorman appeared on numerous television shows, including ABC's Good Morning America. "It is our hope that patients will now know that they are not alone, that their disease has a name, and it is treatable," he said in a Social Anxiety Disorder Coalition press release.

Dr. Gorman was not a disinterested party in Paxil's promotion. He has served as a paid consultant to at least 13 pharmaceutical firms, including SmithKline Beecham, Eli Lilly, and Pfizer. Another frequent talking head in the SAD campaign, Dr. Murray Stein of the University of California at San Diego, has also served as a SmithKline consultant, and the company funded many of his clinical trials on SAD.

Retaining high-profile academic researchers for promotional purposes is standard practice among drug companies, says Mosher, the former National Institute of Mental Health official. "They are basically paid for going on TV and saying, 'You know, there's this big new problem, and this drug seems to be very helpful.'"

Cohn & Wolfe's full-court press on SAD paid immediate dividends. In the two years preceding Paxil's approval, fewer than 50 stories on social anxiety disorder had appeared in the popular press. In May 1999, the month when the FDA handed down its decision, hundreds of stories about the illness appeared in U.S. publications and television news programs, including the New York Times, Vogue, and Good Morning America. A few months later, SmithKline launched a series of ads touting Paxil's efficacy in helping SAD sufferers brave dinner parties and public speaking. By the end of last year, Paxil had supplanted Zoloft as the nation's number-two SSRI, and its sales were virtually on par with those of Eli Lilly's Prozac. (Neither Prozac nor Zoloft has an indication for SAD.)

The success of the Cohn & Wolfe campaign didn't escape notice in the industry: Trade journals applauded GlaxoSmithKline for creating "a strong anti-anxiety position" and assuring a bright future for Paxil. Increasing public awareness of SAD and other disorders, the consulting firm Decision Resources predicted last year, would expand the "anxiety market" to at least $3 billion by 2009. In 2000, the New York chapter of the Public Relations Society of America named the Cohn & Wolfe SAD campaign "Best P.R. Program of 1999."

The lessons of "Imagine Being Allergic to People" were also not lost on Zoloft's manufacturer, Pfizer. In 1999, Pfizer gained FDA approval to market Zoloft as a treatment for post-traumatic stress disorder (PTSD). Until then, the condition had been associated almost exclusively with combat veterans and victims of violent crime; now, Pfizer set out to convince Americans that PTSD could, in fact, afflict almost anyone.

The company funded the creation of the PTSD Alliance, a group that is staffed by employees of Pfizer's New York public-relations firm, the Chandler Chicco Agency, and operates out of the firm's offices. The Alliance connects journalists with PTSD experts such as Jerilyn Ross, president and ceo of the Anxiety Disorders Association of America, a group that is heavily subsidized by Pfizer as well as GlaxoSmithKline, Eli Lilly, and other drug-industry titans.

In the months following the launch of Pfizer's campaign, media mentions of PTSD skyrocketed. Just weeks after the Alliance's founding in 2000, for example, the New York Times ran a story citing Pfizer-supplied statistics on childhood PTSD, according to which 1 in 6 minors who experience the "sudden death of a close friend or relative" will develop the disorder. Other stories highlighted studies promoted by the alliance according to which 1 in 13 Americans will suffer from PTSD at some point in their lives.

Eye-catching figures are integral to disease marketing campaigns, though the quality of the data is sometimes dubious. A report published last February in the Archives of General Psychiatry warned that high estimates on the number of people suffering mental-health conditions often include people whose symptoms are so mild as to not require treatment. "When people look at numbers that say close to 30 percent of the American public has a mental disorder and therefore needs treatment, most would say that is implausibly too high," the study's lead author, William E. Narrow, told the Associated Press.

Many of the statistics used to promote new disorders are taken from studies published in second-tier journals, which frequently depend on direct corporate support. One publication that has drawn fire is the Journal of Clinical Psychiatry, whose major funders include GlaxoSmithKline and Eli Lilly. In 1993, the journal published a study claiming that anxiety disorders cost the United States $46.6 billion per year, primarily due to lost productivity. That figure was repeated in countless press releases and made its way into articles in the Washington Post and USA Today.

The study was produced by the Institute for Behavior and Health, a research firm headed by Dr. Robert DuPont, who served as President Ford's drug czar. The institute's tax returns indicate that its programs are funded almost exclusively by industry research grants; in 1999, for example, it conducted clinical trials on behalf of Merck, Pfizer, and Solvay. DuPont was paid more than $50,000 that year for 10 hours of work per week, in addition to a $56,000 fee that the institute paid to his for-profit consulting firm. The 1993 anxiety study was paid for in part by Upjohn, maker of the SSRI Luvox.

Studies published in medical journals are also useful in reaching a key audience for disease-awareness campaigns-doctors. Physicians, especially general practitioners, are under growing pressure to make quick diagnoses and to treat mental-health conditions with drugs rather than refer patients to psychotherapy. Primary-care physicians now write upwards of 60 percent of antidepressant prescriptions, according to the Amer-ican Psychiatric Association. "There is a pressure to have treatments that are perceived as faster or more efficient," says Dr. Robert Michels, chief of psychiatry at Cornell Medical College.

Drug companies are understandably eager to help physicians identify conditions that can be treated with their products. One widely distributed diagnostic checklist, a 15-minute test that promises to screen for 17 different disorders using special software, was developed by GlaxoSmithKline. Pfizer has funded a test designed to help obstetricians and gynecologists identify women with mental-health problems. According to a 2000 study, sponsored by Pfizer and published in the American Journal of Obstetrics, a full 20 percent of all ob-gyn patients may need psychiatric treatment for anything from depression and anxiety to eating disorders.

Most of all, though, pharmaceutical makers seek to build word of mouth about a condition in the general public-the kind of water-cooler buzz that prompts people to ask their doctor about a disease, and the drug that might treat it. To that end, corporations have increasingly embraced patient organizations that work to publicize mental illness. One such group is the National Mental Health Awareness Campaign, created two years ago to eliminate "the fear and shame that is still strongly associated with mental disorders." The organization is particularly concerned with teenagers, and has run several ads on mtv that encourage unhappy youths to call a toll-free number or visit its Web site. A couple of weeks after the September 11 terrorist attacks, it released the results of a survey, which found that 30 percent of adults questioned felt their mental health had worsened since the tragedy. The group's press release urged "parents and children traumatized by the recent terrorist attacks to avail themselves of the opportunity to speak to mental health professionals."

The campaign's brochures say it has received financial support from the Surgeon General's office. The organization is less forthright about its ties to FoxKiser, a pharmaceutical lobbying firm whose clients include Bristol-Myers Squibb and AstraZeneca. Michael Waitzkin, a partner at FoxKiser, is on the campaign's board of directors, and until recently the campaign was headquartered in FoxKiser's Washington office. (It now operates from the office of the P.R. firm Health Strategies Consultancy.)

The National Mental Health Awareness Campaign wasn't the only group to step up its profile in the wake of the attacks. On September 26 the PTSD Alliance-the group headquartered in the offices of Pfizer's P.R. agency, Chandler Chicco-issued a statement warning that post-traumatic stress can affect anyone who has "witnessed a violent act" or experienced "natural disasters or other unexpected, catastrophic, or psychologically distressing events such as the September 11 terrorist attacks." During the following month, according to the trade jour-nal Psychiatric News, Pfizer spent $5.6 million advertising the benefits of Zoloft in treating PTSD-25 percent more than it had spent, on average, from January to June.

But the biggest presence in TV drug advertising after September 11 was GlaxoSmithKline, which in October 2001 spent $16 million promoting Paxil-more than it had spent in the first six months of the year combined. In December, the company rolled out a series of new commercials, often broadcast during prime-time news programs and built around lines such as "I'm always thinking something terrible is going to happen" and "It's like a tape in my mind. It just goes over and over and over."

In their search for new uses, SSRI makers are no longer limiting themselves to disorders with chiefly psychological symptoms. In the March 15 issue of the Journal of Clinical Oncology, Mayo Clinic researchers funded by Eli Lilly reported that Prozac "is a realistic alternative to estrogen replacement for reducing hot flashes" in menopausal women. A recent study at the University of Pennsylvania, funded by the pharmaceutical companies Aventis and Novartis, indicated that SSRIs can decrease the risk of heart attack in smokers.

But by far the most controversial addition to the list of maladies treatable with SSRIs is a condition whose very existence is in dispute: premenstrual dysphoric disorder (PMDD), a female ailment whose symptoms include sharp monthly mood swings and physical pain. PMDD has been listed since 1987 in the Diagnostic and Statistical Manual appendix, which catalogs potential disorders "proposed for further study."

According to Paula J. Caplan, a psychologist and visiting scholar at Brown University who was a member of a DSM committee that evaluated research on PMDD, proponents of including the condition "claimed they were so careful in defining it that it wasn't just going to be someone with cramps during their period. But they were talking about 3 to 5 percent of [menstruating] women. If you do the math as conservatively as possible, 3 to 5 percent gives you one and a half million women [in the United States]." Caplan resigned from the committee before it voted to list PMDD in the appendix.

Though the condition remains controversial in the medical profession-one 1992 study found that men and women suffered from PMDD's symptoms at almost the same rate-its inclusion in the DSM proved a god-send for Eli Lilly, the manufacturer of Prozac. In 2000, the company gained FDA approval to market Prozac as a treatment for the condition; Eli Lilly promptly re-packaged Prozac as a pink-coated pill called Sarafem and launched a P.R. campaign warning that "millions of menstruating women" suffer from PMDD. "Does juggling work, family and personal commitments leave you feeling frazzled and stressed out?" the Sarafem Web site asks. "We have some tools to help."

The idea of characterizing uncomfortable menstrual symptoms as a mental disorder troubles Caplan, who wonders where the medical community will draw the line. "I could say to you, 'Well, your propensity to call people and ask them probing questions is a disorder,'" she says. "'We'll call it intrusive exploratory disorder.'"

No such malady is yet listed in the DSM. But the quest for new uses for the SSRIs is continuing. At last year's annual convention of the American Psychiatric Association, researchers presented a major study on a new "hidden epidemic"-compulsive shop- ping. Jack Gorman, the Columbia psychiatrist who had earlier helped publicize anxiety disorders, made another appearance on Good Morning America to discuss the new condition, which host Charles Gibson told viewers could affect as many as 20 million Americans, 90 percent of them women. In the wake of the new study, Gorman said, scientists would "almost certainly" look into treating the disease with SSRIs.

The study in question was funded by Forest Laboratories, for which Gorman has served as a consultant. A laggard in the SSRI business, the company hopes to carve out the compulsive-shopping niche for its pill, Celexa. Expect the publicity machine for something akin to "persistent purchasing disorder" to rev up soon.