Brendan I Koerner on the ugly truth about doctors, PR firms and drug companies

Brendan I Koerner
Guardian

Tuesday July 30, 2002

http://www.guardian.co.uk/Archive/Article/0,4273,4471963,00.html

Word of the hidden epidemic began spreading in spring last year. Local news reports around the United States reported that as many as 10 million Americans suffered from an unrecognised disease. Viewers were urged to watch for the symptoms: restlessness, fatigue, irritability, muscle tension, nausea, diarrhoea, and sweating, among others. Many of the segments featured soundbites from Sonja Burkett, a patient who had finally received treatment after two years trapped at home by the illness, and from Dr Jack Gorman, an esteemed psychiatrist at Columbia University.

The disease was generalised anxiety disorder (GAD), a condition that, according to the reports, left sufferers paralysed with irrational fears. Mental-health advocates called it "the forgotten illness". Print periodicals were awash with 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 US food and drug administration (FDA) had approved the antidepressant Paxil, made by British pharmaceutical giant GlaxoSmithKline, for the treatment of Gad. But it was a little-known ailment; according to a 1989 study, as few as 1.2% of the US population merited the diagnosis in any given year. If GlaxoSmithKline hoped to capitalise on Paxil's newapproval, it would have to raise Gad's profile.

That meant revving up the company's public-relations machinery. The widely featured quotes from Burkett were part of a "video news release" the drug maker had distributed to TV stations around the country; the footage also included the comments of 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 which revealed that "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 PR firm.

The modus operandi of GlaxoSmithKline - marketing a disease rather than selling a drug - is typical of the post-Prozac era. "The strategy [companies] use - it's almost mechanised 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 afiction, a necessary step in obtaining FDA approval for a new use, or "indication". Prominent doctors are enlisted to publicly affirm the malady's ubiquity, then 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 stories for the media; many of the groups are heavily subsidised by drugmakers, and some operate directly out of the offices of drug companies' PR 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 previously obscure afflictions - Gad, social anxiety disorder, premenstrual dysphoric disorder, and so on. The proliferation of diagnoses has contributed to a dramatic rise in anti-depressant sales, which increased eightfold between 1990 and 2000.

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 have also been encouraging the use of medication, rather than more costly psychotherapy, to treat problems such as anxiety and depression.

But while most health experts agree that SSRIs have revolutionised 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.

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 Smith-Kline 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 inuenced by cultural norms (until 1973, homosexuality was listed as a mental disorder) and political compromise: it 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 college of medicine at the University of Wales 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 generalised 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.

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 characterised as "extremely rare".

Obtaining such a new approval 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.

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 my 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 non-profit 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 and Cohn & Wolfe handled all media inquiries on behalf of the group.

The FDA's advertising regulations also helped the Cohn & Wolfe strategy. "If you are carrying out a disease-awareness campaign, legally the company doesn't have to list the product risks, notes Barbara Mintzes, an epidemologist at the University of British Columbia's centre for health services and policy research. Because the "Imagine Being Allergic to People" posters did not name a product, they did not 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 gave journalists a press statement stating that SAD "affects up to 13.3% of the population," - one in eight 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 3-13% of people may suffer the disease at some point in their lives, but that only 2% "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. 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 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, appearing on numerous television shows, including ABC's Good Morning America.

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 Smith-Kline consultant, and the company funded many of his clinical trials on SAD.

Cohn & Wolfe's campaign 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 US publications and television news programmes, including the New York Times, Vogue, and Good Morning America. A few months later, Smith-Kline 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 anapproval 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 $3bn by 2009.

· This is an edited excerpt from an article in Mother Jones magazine.