The Myth Of Psychiatry And Pharmaceutical Drugs

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The Myth Of Psychiatry And Pharmaceutical Drugs

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.

 

Mother Jones, July-August, 2002, by Brendan I. Koerner

 

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.)

 

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 newspapers 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 posttraumatic 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 American 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.)

 

he 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 journal 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 repackaged 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 shopping. 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.

 

" I became curious about the pharmaceutical industry's ability to turn disorders

into cocktail-party talk when Paxil was approved for treating social anxiety

disorder, " says Brendan I. Koerner ( " Disorders, Made to Order, " page 58). His

last Mother Jones feature, " Losing Signal " (September/October 2001), examined

the FCC.

COPYRIGHT 2002 Foundation for National Progress

COPYRIGHT 2002 Gale Group

 

 

 

 

 

 

 

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