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home / magazine / July/August 2002 / Disorders Made to Order

 

Disorders Made to Order Pharmaceutical companies have come up with a

new strategy to market their drugs: First go out and find a new

mental illness, then push the pills to cure it.

by Brendan I. Koerner July/August 2002

 

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.

[Guest guest]

Is there a link or source to this article? Thanks!

[Guest guest]

Sorry Pam,

 

Here is the link:

http://www.motherjones.com/magazine/JA02/disorders.html

 

Frank

 

 

Gettingwell, " Pam B " <PamB@w...> wrote:

> Is there a link or source to this article? Thanks!