|
|
The U.K. Guardian examines covert psychotropic drugs
marketing strategies.
Instead of producing drugs for recognized diseases, drug manufacturers are
creating diseases in order to sell their drugs.
The Guardian reports how this is accomplished: “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.
FDA’s advertising regulations help drug marketing strategies that hide the
facts from doctors and the public: FDA does not require companies to list
the risks and adverse side-effects "if a company claims to be carrying out a
disease-awareness campaign."
An example was the advertising campaign that launched "generalised anxiety
disorder" (GAD), a condition that, according to marketing promotions, left
sufferers paralysed with irrational fears.”
The mental-health advocacy industry called it “the forgotten illness”.
The Guardian reports that Dr Jack Gorman, an “esteemed psychiatrist at
Columbia University has frequently served as a paid consultant to
GlaxoSmithKline” and helped promote the condition SAD in a video made by
Cohn & Wolfe, the drugmaker’s PR firm.
Dr Loren Mosher, a San Diego psychiatrist and former official at the
national institute of mental health, and a member of the board of The
Alliance for Human Research Protection, told the Guardian that “The strategy
[companies] use - it’s almost mechanised by now.”
According to another report in The Guardian, the UK Committee on Safety in
Medicines (equivalent to FDA MedWatch) has received more complaints of
adverse drug side effects —particularly drug withdrawal problems —with
Seroxat (Paxil) than the rest of the top 20 drugs put together. Paxil is the
drug being promoted for anxiety disorder (GAD): 1, 281 complaints have been
filed for Paxil.
Complains from those trying to stop taking the drug include: “sensations
that feel like electric shocks in the head, dizziness, mood swings, upset
stomachs and unpleasantly vivid dreams, all of which are only alleviated by
going back on the drug.”
[See, Antidepressant Seroxat tops table of drug withdrawal symptoms, Sarah
Boseley, health editor, The Guardian. Saturday July 27, 2002.
http://www.guardian.co.uk/Archive/Article/0,4273,4469899,00.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 new approval, 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 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, 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 influenced 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 an approval 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. |
