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The Inaugural Conference on Disease Mongering

PUBLIC LIBRARY of SCIENCE | Volume 3 | Issue 4 | APRIL 2006
PUBLIC LIBRARY of SCIENCE | | Volume 3 | Issue 4 | APRIL 2006
Published by the Public Library of Science ISSN 1549-1277
Disease mongering
Water supply and birth rate
Influenza in the subtropics
Genetics of osteoporosis
PLoS Medicine | 0001
April 2006 | Volume 3 | Issue 4 | e191
Disease mongering turns healthy
people into patients, wastes
precious resources, and causes
iatrogenic harm. Like the marketing
strategies that drive it, disease
mongering poses a global challenge
to those interested in public health,
demanding in turn a global response.
This theme issue of PLoS Medicine is
explicitly designed to help provoke and
inform that response.
What Is Disease Mongering?
The problem of disease mongering
is attracting increasing attention
[1–3], though an adequate working
defi nition remains elusive. In our view,
disease mongering is the selling of
sickness that widens the boundaries
of illness and grows the markets for
those who sell and deliver treatments.
It is exemplifi ed most explicitly by
many pharmaceutical industry–funded
disease-awareness campaigns—more
often designed to sell drugs than to
illuminate or to inform or educate
about the prevention of illness or
the maintenance of health. In this
theme issue and elsewhere, observers
have described different forms
of disease mongering: aspects of
ordinary life, such as menopause,
being medicalised; mild problems
portrayed as serious illnesses, as
has occurred in the drug-company-
sponsored promotion of irritable
bowel syndrome (see pp. 156–174 in
[2]; [4]) and risk factors, such as high
cholesterol and osteoporosis, being
framed as diseases.
Drug companies are by no means the
only players in this drama. Through
the work of investigative journalists, we
have learned how informal alliances
of pharmaceutical corporations,
public relations companies, doctors’
groups, and patient advocates
promote these ideas to the public
and policymakers—often using mass
media to push a certain view of a
particular health problem. While
these different stakeholders may
come to these alliances with different
motives, there is often a confl uence of
interests—resulting in health problems
routinely being framed as widespread,
severe, and treatable with pills, as
has happened recently with social
anxiety disorder [5]. Currently, these
alliances are working with the media
to popularize little-known conditions,
such as restless legs syndrome [6]
and female sexual dysfunction [7], in
each case lending credence to infl ated
prevalence estimates. In the case
of female sexual dysfunction, there
has been a serious, though heavily
contested, attempt to convince the
public in the United States that 43% of
women live with this condition (see pp.
175–195 in [2]). This is happening at a
time when pharmaceutical companies
perceive a need to build and maintain
markets for their big-selling products
and when pipelines for new and
genuinely innovative medicines are
perceived as being weak.
A Context for Disease Mongering
Three decades ago, Ivan Illich
argued polemically that the medical
establishment was “medicalising”
life itself [8], and in the 1990s
Lynn Payer described widening the
boundaries of illness as “disease
mongering” [3], highlighting the role
of pharmaceutical companies. Today’s
debate about this phenomenon, while
still maturing, both acknowledges the
axiomatic interest of corporations and
professionals in maximizing turnover
and appreciates that well-informed
citizens may choose to embrace the
medicalisation of health problems
previously regarded as troublesome
It can also be argued that disease
mongering is the opportunistic
exploitation of both a widespread
anxiety about frailty and a faith in
scientifi c advance and “innovation”—a
powerful economic, scientifi c,
and social norm. In many nations,
government policy priority is to secure
market-based economic development,
while more equitable social policies,
such as public health strategies, can
become subordinate or redundant.
Disease mongering can thrive in
The Fight against Disease Mongering:
Generating Knowledge for Action
Ray Moynihan, David Henry*
Funding: RM received a commissioning fee from
PLoS to write this article, and to serve as a guest
editor, but RM and DH received no other specifi c
funding for this piece.
Competing Interests: The authors declare that they
have no competing interests.
Citation: Moynihan R, Henry D (2006) The fi ght
against disease mongering: Generating knowledge
for action. PLoS Med 3(4): e191.
DOI: 10.1371/journal.pmed.0030191
Copyright: © 2006 Moynihan and Henry. This is
an open-access article distributed under the terms
of the Creative Commons Attribution License,
which permits unrestricted use, distribution, and
reproduction in any medium, provided the original
author and source are credited.
Ray Moynihan and David Henry are the guest editors
of the April 2006 theme issue of PLoS Medicine on
disease mongering. Ray Moynihan is a journalist,
documentary maker, author, and conjoint lecturer at
the University of Newcastle, Newcastle, New South
Wales, Australia, and recently co-authored Selling
Sickness: How the World’s Biggest Pharmaceutical
Companies Are Turning Us All into Patients (Nation
Books, New York, 2005). David Henry is a professor of
clinical pharmacology at the University of Newcastle,
Newcastle, New South Wales, Australia, and co-
founder of Media Doctor (http://www.mediadoctor., a Web site that monitors media coverage of
* To whom correspondence should be addressed.
The Essay section contains opinion pieces on topics
of broad interest to a general medical audience.
“The coming years will
bear greater witness to
the corporate sponsored
creation of disease.”
PLoS Medicine | 0002
such a normative environment.
The practical consequences are
that many of the so-called disease-
awareness campaigns that inform
our contemporary understanding of
illness—whether as citizens, journalists,
health professionals, industry leaders,
academics, or policymakers—are
now underwritten by the marketing
departments of large drug companies
rather than by organizations with
a primary interest in public health.
And it is no secret that those same
marketing departments contract
advertising agencies with expertise
in “condition branding,” whose skills
include “fostering the creation” of new
medical disorders and dysfunctions
[9]. As a recent Reuters Business Insight
report on so-called lifestyle drugs—
designed to be read by pharmaceutical
industry leaders—pointed out, “The
coming years will bear greater witness
to the corporate sponsored creation
of disease” [10]. We hope the coming
years will also bear witness to a much
more vigorous effort from within civil
society to understand and to challenge
that corporate process.
Problems Defi ning Disease
While the term “disease mongering” is
now commonly used as shorthand to
describe campaigns that inappropriately
widen the boundaries of treatable
illness, there is uncertainty about how
to operationally defi ne the concept.
With most disorders or conditions,
there will be a number of individuals
who suffer severe forms of the problem,
who will benefi t greatly from treatment
and may be helped enormously by the
publicity and marketing given to both
the treatment and the disorder. For
example, industry-funded awareness
raising about the treatment and
prevention of HIV/AIDS has surely
been valuable. But in other cases, the
same marketing/awareness-raising
campaign will be viewed very differently
depending on the perspective of the
observer: what an industry-linked
professional group may consider to
be legitimate public education about
an underdiagnosed disease, an activist
group free from industry sponsorship
may regard as a crude attempt to build
markets for potentially dangerous drugs.
The Eli Lilly–sponsored promotion
of premenstrual dysphoric disorder
to help sell a re-branded version
of fl uoxetine
(rebranded from
Prozac to Sarafem)
is a case in point
(see pp. 99–118 in
[2]). Considered by
some as a serious
psychiatric illness,
dysphoric disorder
is regarded
by others as a
condition that does
not exist.
These discordant
views of the same
activity reinforce
the fact that
there are often
different motives
for the different
individuals who
get caught up in
campaigns. In the
industry and in the
public relations
companies that
serve them, the
marketers often
now dominate.
But these
corporations are
not heterogeneous,
and staff working in
research or medical
departments may
express the same doubts as many
working outside industry. For their
part, the motives of health professionals
and health advocacy groups may well be
the welfare of patients, rather than any
direct self-interested fi nancial benefi t,
but we believe that too often marketers
are able to crudely manipulate those
motivations. Disentangling the
different motivations of the different
actors in disease mongering will be a
key step towards a better understanding
of this phenomenon.
Generating Better Knowledge
The views in this article are based
on observations and interpretation
informed by interviews with stakeholders
and other more journalistic research
methods, rather than a deeper
academic investigation that employs
qualitative and quantitative research
techniques. Before embarking on
research agendas to investigate disease
mongering and its impacts, a broader
conception of the phenomenon is
warranted—requiring researchers to
explore the uncertainty surrounding
the defi nition of the problem, how and
why different stakeholders understand
it differently, and the deeper social and
economic contexts. For example, the
broad shift away from government-run
programs and towards the marketplace
within social democracies worldwide,
and the consequent commercialisation
and commodifi cation of health services,
may be a useful framework for a more
profound explanation of this problem.
In a climate where governments are
encouraging corporations to vigorously
pursue for-profi t activities within the
health-care sector, it is hardly surprising
that pharmaceutical companies will
use a range of promotional activities to
widen the defi nitions of disease in order
to grow the potential markets for their
April 2006 | Volume 3 | Issue 4 | e191
DOI: 10.1371/journal.pmed.0030191.g001
Most people in Western countries take medication to treat or
prevent illness or enhance well-being
(Illustration: Anthony Flores)
PLoS Medicine | 0003
Along with deeper refl ection, we
suggest researchers start to develop
strategies for generating data on
the impact of disease mongering.
More conventional health-science
methodologies may prove to be
valuable ways of investigating the
potential infl uences of a disease-
marketing campaign on outcomes such
as public perceptions of a particular
disease, prevalence/incidence rates for
that disease, prescription patterns for
the drugs linked to that disease, and
even health status of those diagnosed
with and/or treated for that disease.
Multisite controlled studies of drug
company–funded disease-awareness
campaigns would be the ideal.
However, defi ning appropriate control
groups and devising indices to measure
outcomes such as inappropriate
medicalisation will prove extremely
challenging since almost everyone is
exposed to disease mongering in some
form. Similarly, rigorous studies of
publicly funded “counter-detailing”—
where noncommercially oriented
information about disease is promoted
to physicians and citizens—may be
warranted, though, again, it is very
diffi cult methodologically.
Apart from these more challenging
approaches, we believe there is a
range of research projects that are
both achievable and urgently needed.
First, academic investigation of the
prevalence of this problem would be
highly desirable. Researchers could,
for example, take a group of the most
common (high-burden) diseases/
conditions, and investigate how and
why the defi nitions of those diseases/
conditions have changed over time in
different nations. Such retrospective
investigations could include analysis of
the decisions and recommendations
of the panels that defi ne and re-
defi ne illness, the evidence informing
those decisions, the confl icts of
interest of panel members and their
respective professional bodies, and
the sponsorship of these processes.
Early versions of this investigation are
happening in a random, ad hoc way
[11], but a coordinated systematic
effort by a multinational group of
respected researchers or research
institutes is obviously preferable. As
part of such an examination, a series of
case studies would inevitably emerge,
warranting deeper study and research
and serving as a way to popularize
awareness of the process of disease
Another potentially rich research
method might involve a prospective
study of the launch of a new or recently
expanded disease or condition.
A global collaboration could, for
example, study the way female sexual
dysfunction is being constructed and
then promoted. “Creating the need” is
now an established and integral part of
the promotion of any new blockbuster
drug, and sometimes that involves
introducing a whole new condition
to the wider public [12]. The success
of sildenafi l depended on corporate-
funded disease-awareness campaigns
promoting erectile dysfunction [13],
and similarly the commercial success
of any pharmaceutical treatments for
female sexual dysfunction will hang
in part on similar campaigns. While
activists and scholars have begun the
process of observing these activities, it
is our view that the magnitude of public
and private resources spent on these
products, the potential harm that can
ow from inappropriate medicalisation,
and the opportunity cost in terms
of treating and preventing genuine
pathology demands more rigorous
scientifi c investigation.
Time for Action?
Around the world, there are tentative
steps to identify, understand, and
combat the threat to human health
from the corporate-sponsored selling
of sickness. These small steps are being
taken by several players within the
health fi eld, and we trust this theme
issue may support and augment these
At a consumer level, Health Action
International (http:⁄⁄www.haiweb.
org)—the activist group working for
a more rational use of medicines
globally—has for a long time been
concerned about what it has described
as the blurring of boundaries between
ordinary life and medical illness in
order to expand markets for drugs
and other technologies [14]. Unlike
many patient advocacy groups, Health
Action International does not accept
pharmaceutical company sponsorship,
and actively warns others about the
threats to independence from doing
so [15]. By way of contrast, many
consumer/advocacy groups around
the world now rely on such funding
[16], raising questions about their
credibility, particularly as they are often
used as the human face of disease-
awareness campaigns sponsored by
their funders. An open debate within
the health consumer movement about
its close engagement with industry, and
its involvement in disease mongering,
would be welcome.
Likewise, amongst journalist circles,
there are nascent debates about the
media’s propensity to exaggerate
disease prevalence and severity, and
how to deal with this problem. In
this issue of PLoS Medicine, two high-
profi le scholars with an interest in the
area of medicine and the media, Lisa
Schwartz and Steven Woloshin, present
a timely and relevant case study on the
“selling” of restless legs syndrome [6].
In Australia and Canada, a new media
watch group called Media Doctor is
also investigating the extent to which
media stories on medicine either report
appropriately on the nature and extent
of illness or tend to simply regurgitate
the promotional messages of disease-
mongering campaigns (http:⁄⁄www.
While many professional
organizations remain reliant on
industry support, some are actively
debating the problem of disease
mongering. In a submission to the
recent House of Commons inquiry into
the infl uence of the pharmaceutical
industry in Britain, the Royal College of
General Practitioners outlined serious
concerns about the process [17]. The
subsequent report recommended that
industry-funded disease-awareness
campaigns should no longer be “veiled
advertising” of branded drugs [18].
Shareholders in the world’s large
pharmaceutical companies have
the strongest fi nancial interest in
widening the boundaries of treatable
illness in order to widen markets
for their products. Yet in the debate
about research and development for
treatments for neglected diseases in the
developing world, there are strong signs
that shareholders can support policies
driven by motivations other than profi t
[19]. It may be that as key shareholders
April 2006 | Volume 3 | Issue 4 | e191
A challenge to the
excesses of disease
mongering may come
from within the industry.
PLoS Medicine | 0004
and company executives alike
understand more of the implications
of what their marketing departments
do, a challenge to the excesses of
disease mongering may come from
within industry, just as other parts of
the health sector challenge excesses of
disease mongering from within.
Genuine sustainable change, however,
will not come until policymakers
better understand the phenomenon of
disease mongering and the potential
benefi ts of responding against it. In
Australia, for example, it has been
estimated that winding back the public
subsidy for inappropriate prescriptions
of several high-profi le drugs to people
with milder health problems could
save hundreds of millions of dollars
per year [20]. Those responsible for
managing Australia’s publicly funded
national formulary, the Pharmaceutical
Benefi ts Scheme, have become
increasingly concerned about what is
described as “leakage”—the process
where subsidised drugs are prescribed
by physicians to people for whom
use of the drug has been deemed
not cost-effective because of a poor
cost–benefi t ratio. We suspect that
the estimated hundreds of millions
of dollars of public money wasted on
leakage in Australia annually is in part
a result of drug companies promoting
their products, through physicians,
to people with mild problems for
whom a powerful prescription may be
unnecessary or even do more harm
than good. In summary, combating
disease mongering may improve the
personal health of individuals, as well
as the fi nancial health of public (and
private) insurers.
As an initial step toward combating
disease mongering at a health policy
level, we would urge decision makers
to promote a renovation in the way
diseases are defi ned. Continuing
to leave these defi nitions to panels
of self-interested specialists riddled
with professional and commercial
confl icts of interest is no longer viable.
As a priority, new panels should be
assembled, free of commercial confl icts
of interest, involving a much wider, and
less self-interested, group of players,
who would ultimately generate more
credible information.
Until a rigorous research agenda is
initiated, and the social renovations
and policy reforms that research might
inform are enacted and evaluated,
our beliefs, like those who argue for
the benefi ts of corporate-sponsored
disease-awareness campaigns, will
remain based more on opinion than
evidence. We hope this theme issue can
start to change that. 
April 2006 | Volume 3 | Issue 4 | e191
1. Moynihan R, Heath I, Henry D (2002) Selling
sickness: The pharmaceutical industry and
disease-mongering. BMJ 324: 886–891.
2. Moynihan R, Cassels A (2005) Selling sickness:
How the worlds biggest pharmaceutical
companies are turning us all into patients. New
York: Nation Books. 254 p.
3. Payer L (1992) Disease-mongers: How doctors,
drug companies, and insurers are making you
feel sick. New York: Wiley and Sons. 292 p.
4. Moynihan R (2002) Alosteron: A case study
in regulatory capture or a victory for patients
rights? BMJ 325: 592–595.
5. Koerner B (2002) Disorders made to order.
Mother Jones 27: 58–63.
6. Woloshin S, Schwartz LM (2006) Giving legs
to restless legs: A case study of how the media
helps make people sick. PLoS Med 3: e170.
DOI: 10.1371/journal.pmed.0030170
7. Tiefer L (2006) Female sexual dysfunction: A
case study of disease mongering and activist
resistance. PLoS Med 3(4): e178. DOI:
8. Illich I (1976) Limits to medicine. London:
Penguin. 294 p.
9. Parry V (2003) The art of branding a
condition. Med Mark Media 38: 43–49.
10. Coe J (2003) Healthcare: The lifestyle drugs
outlook to 2008, unlocking new value in well-
being. London: Reuters Business Insight. 243 p.
11. Moynihan R (2004) The intangible magic of
celebrity marketing. PLoS Med 1: e42. DOI:
12. Moynihan R (1998) Too much medicine.
Sydney: ABC Books. 308 p.
13. Lexchin J (2006) Bigger and better: How Pfi zer
redefi ned erectile dysfunction. PLoS Med 3:
e132. DOI: 10.1371/journal.pmed.0030132
14. Mintzes B (1998) Blurring the boundaries.
Amsterdam: Health Action Internatonal.
Available: http:⁄⁄
blurring.intro.html. Accessed 7 March 2006.
15. Health Action International (1999) The ties
that bind: Weighing the risks and benefi ts
of pharmaceutical industry sponsorship.
Amsterdam: Health Action International.
Available: http:⁄⁄
spon/toc.html. Accessed 7 March 2006.
16. Health and Social Campaigners News
International (2004 April) Health campaigners,
fundraising and the growth of industry
involvement. Knighton (Wales): Patient View.
57 p.
17. Royal College of General Practitioners [RCGP]
(2004 August 17) RCGP warns against unhealthy
pharmaceutical industry. London: RCGP.
Available: http:⁄⁄
aspx?page=1609. Accessed 7 March 2006.
18. House of Commons Health Committee (2005)
The infl uence of the pharmaceutical industry:
Fourth report of session 2004–2005. London:
House of Commons. Available: http:⁄⁄www.
pdf. Accessed 7 March 2006.
19. Moran M (2005) A breakthrough in R&D
for neglected diseases: A new way to get the
drugs we need. PLoS Medicine 2: e302. DOI:
20. Moynihan R, Murphy K (2002 March 18)
Doctors causing a drug costs blowout.
Australian Financial Review: 1.
PLoS Medicine | 0001
April 2006 | Volume 3 | Issue 4 | e132
In the pursuit of profi ts,
pharmaceutical companies are
continuously looking to expand the
market for their products. This article
examines how Pfi zer transformed
Viagra from an effective product
for erectile dysfunction (ED) due to
medical problems, such as diabetes and
spinal cord damage, into a drug that
“normal” men can use to enhance their
ability to achieve an erection and to
maintain it (in a “harder” state) for a
longer period of time.
The Rise of Lifestyle Drugs
An important emerging issue in health
care is the availability of medications
to treat what until recently have been
regarded as the natural results of
aging or as part of the normal range
of human emotions. Thus, we now see
treatments widely advertised for male
pattern baldness and shyness. Deviating
even further, drug therapy is moving
out of treating diseases to providing
enhancements to what had hitherto
been seen as normal functioning. This
evolution in the use of medications has
introduced dilemmas and controversies
about what are legitimate conditions
and treatments for those concerned
with prescription medications: is any
deviation from normality fair game for
treatment? What about people who
have nothing medically wrong with
them, but just want to feel better? Who
will pay for these therapies, and what
are the implications for the way we use
health-care resources?
Medications that embody these
controversies are generally referred
to as lifestyle drugs and perhaps the
best known of these is sildenafi l citrate
(Viagra) This article will examine the
strategies used by Pfi zer, the maker
of Viagra, to ensure that the drug was
seen as legitimate therapy for almost
any man. Pfi zer took steps to make sure
that Viagra was not relegated to a niche
role of just treating men who had ED
due to organic causes, such as diabetes
or prostate surgery.
There is no doubt that Viagra is
an effective and quite safe drug in
treating ED secondary to these causes,
although a systematic review of the
evidence found that the drug probably
only results in successful intercourse
50%–60% of the time [1]. Had Viagra
been confi ned to use only in cases
of ED secondary to organic causes,
the drug would probably have been a
modest success for Pfi zer. In order to
grow the market, Pfi zer had to make
Viagra the treatment of choice for a
much wider population of men. The
perceived prevalence of ED needed to
be expanded. The impression had to
be created that ED was of signifi cant
concern to many, perhaps even most,
men or at least those over 40 years
of age. The criterion of success for
The Essay section contains opinion pieces on topics
of broad interest to a general medical audience.
Bigger and Better: How Pfi zer Redefi ned
Erectile Dysfunction
Joel Lexchin
Funding: The author received no specifi c funding for
this article.
Competing Interests: The author has declared that
no competing interests exist.
Citation: Lexchin J (2006) Bigger and better: How
Pfi zer redefi ned erectile dysfunction. PLoS Med 3(4):
DOI: 10.1371/journal.pmed.0030132
Copyright: © 2006 Joel Lexchin. This is an
open-access article distributed under the terms
of the Creative Commons Attribution License,
which permits unrestricted use, distribution, and
reproduction in any medium, provided the original
author and source are credited.
Abbreviations: ED, erectile dysfunction; MMAS,
Massachusetts Male Aging Study
Joel Lexchin is at the School of Health Policy and
Management, York University, Toronto, Ontario,
Canada; the Emergency Department, University
Health Network, Toronto, Ontario, Canada; and the
Department of Family and Community Medicine,
University of Toronto, Toronto, Ontario, Canada.
DOI: 10.1371/journal.pmed.0030132.g002
(Illustration: Giovanni Maki)
PLoS Medicine | 0002
treating ED had to be redefi ned. And
nally, Viagra had to be seen as an
important treatment option for men
with any degree of ED, including rare
or transitory failures to achieve or
maintain erections.
Redefi ning the Prevalence of ED
and Its Psychological Effects
On its Web site, Pfi zer states that “in
fact, more than half of all men over 40
have diffi culties getting or maintaining
an erection” (http:⁄⁄www.viagra.
com/ed/index.asp). The Web site
does not give a reference to support
this statement. One possible source
of support for this statement is the
Massachusetts Male Aging Study
(MMAS), a community-based, random
sample observational survey of men
aged 40 to 70 years old conducted
from 1987 to 1989 in cities and towns
near Boston, Massachusetts [2]. The
authors of the study extrapolated the
results to argue that 52% of the entire
male population in the United States
between the ages of 40 and 70 suffer
from ED. The authors stated: “In
the MMAS sample the prevalence of
impotence of all degrees was estimated
at 52%. Projection of these results to
1990 population data would suggest
that impotence affects 18 million
American men 40 to 70 years old” [2].
However, the MMAS fi gures must be
viewed with a number of caveats.
First, there were actually two different
groups of men in this study. The fi rst,
and larger, group answered a series of
nine questions about sexual activity.
The second, and much smaller, group
answered the same nine questions,
plus an additional question to self-rate
themselves as not impotent, minimally
impotent, moderately impotent, or
completely impotent. The answers to
this fi nal question by the men in the
second group were then applied to
the fi rst group to derive the percent
in the various classes of potency. The
authors do not provide any information
about whether the two groups were
similar, and there are reasons to think
that differences may exist between the
groups. The fi rst group was randomly
selected from towns and cities in the
Boston Standard Metropolitan Statistical
Area [3], while the second group
was made up of men presenting to a
university center urology clinic [2].
Even if the scores from one group
can be transferred to the other, the
52% fi gure is still deceptive because
it doesn’t differentiate ED by age. In
the MMAS, 40% of 40-year-old men
had ED, including 17% who were only
minimally impotent, whereas 67% of
70 year olds were impotent. Moreover,
not all studies are in agreement with
these fi gures. Analysis of data from the
US National Health and Social Life
Survey indicates that among men 50–59
years old, 18% complained of trouble
achieving or maintaining an erection
during the past year [4]. A survey in
the Netherlands found that only 1% of
men 50–65 years of age had a complete
inability to achieve an erection, and it
was only in men aged 70–78 years that
the rate of ED was similar to that in the
MMAS [5]. Out of 13 studies on the
prevalence of ED that were published
until June 1998, the MMAS results were
among the highest [1]. Thus, Pfi zer’s
statement that “more than half of all
men over 40 have diffi culties getting
or maintaining an erection” does
not refl ect the large variation in the
prevalence of ED found in different
The MMAS found a strong
association between ED and
psychological factors, including
“depression, low levels of dominance,
and anger either expressed outward
or directed inward.” The authors
suggested that psychological symptoms
might be a cause of ED, but these
symptoms could also be an effect
of ED (they wrote that “a man who
has experienced a recent pattern of
ED may be expected to be anxious,
depressed and lacking self-esteem
and self-confi dence”) [2]. While not
to deny that there is an association
between ED and psychological
symptoms, once again the MMAS
may be an outlier. In the Dutch study
previously mentioned, only one-third of
all men and only 20% of men over the
age of 70 with signifi cant ED had major
psychological concerns. Furthermore,
in sexually active men, 17%–28% had
no normal erections, indicating that
full erectile function is not essential
for sexual functioning [5]. Only 20%
of Japanese men 40 to 79 years of age
reported more than little worry and
concern about sexual functioning,
suggesting that perceptions of elderly
male sexual function and its impact on
health-related quality of life may differ
among cultures and ethnic groups with
differing values [6].
On its Web site, Pfi zer states:
“VIAGRA can work for you. In fact,
studies show that VIAGRA works for
more than 80% of men with ED taking
VIAGRA 100 mg versus 24% of men
taking a sugar pill” (http:⁄⁄www.viagra.
The 80% success rate that Pfi zer quotes
for Viagra is important, though not
critical, to being able to promote its
use to a wide variety of men. But that
number is qualifi ed on the Pfi zer Web
site as the number who experience
improved erections (http:⁄⁄www.viagra.
asp). It is open to speculation whether
the goal of most men is improved
erections, or successful intercourse and
the achievement of an orgasm. In most
studies on Viagra, a 50%–60% rate of
successful intercourse is recorded (in
the dose titration studies reviewed in
[1] for patients taking placebo, up to
25% of attempts at intercourse were
successful compared with 50%–60% for
patients taking Viagra 25–100 mg). This
50%–60% rate is far short of the “more
than 80% of men” that Pfi zer trumpets.
Viagra for Any Degree of ED
To make Viagra into a lifestyle drug,
Pfi zer needs to convince men that it
is the fi rst choice for therapy for any
degree of ED, whatever the genesis of
the problem. However, drug therapy
may not always be the most appropriate
treatment option. The National Health
and Social Life Survey data indicate
that emotional and stress-related
problems such as a deteriorating
social and economic position generate
elevated risk of experiencing sexual
diffi culties. In these cases, Viagra may
be less important than counseling
or help in fi nding a new job. These
April 2006 | Volume 3 | Issue 4 | e132
DOI: 10.1371/journal.pmed.0030132.g001
Figure 1. Pfi zer Hired 39-Year-Old Baseball
Player Rafael Palmeiro as a Spokesman for
PLoS Medicine | 0003
possibilities are never mentioned on
the Viagra Web site. Here is a sample
of the questions and answers on the
“About ED” portion of the Web site:
Question: “I don’t have ED because
the problem doesn’t happen often.
Does this mean that VIAGRA is not for
Answer: “Even if erection problems
happen only once in a while, VIAGRA
can help. You should know that most
men with ED only experience problems
some of the time. In one study,
VIAGRA helped 87% of men with mild-
to-moderate ED have better erections
versus 36% of men taking a sugar pill”
In case the message is missed, there
is a couple on the Web page where the
man looks to be in his mid-to-late 30s.
Pfi zer reinforces its message with direct-
to-consumer magazine ads, such as one
featuring a virile looking man around
40 saying, “A lot of guys have occasional
erection problems. I chose not to
accept mine and asked about Viagra.”
The initial television ads in the US
for Viagra used an aging Bob Dole
(born 1923) as a spokesman, a 1996
Republican presidential candidate.
Since then, Pfi zer has refocused its
advertising campaign to match the
lifestyle message on its Web site. There
is now advertising of Viagra at NASCAR
races, and Pfi zer hired 39-year-old
Rafael Palmeiro, a former Texas
Ranger baseball player as a spokesman
(Figure 1) [7]. Pfi zer teamed up with
Sports Illustrated magazine to create the
Sportsman of the Year Trivia Game
asp). Between 1999 and 2001, Pfi zer
spent over US$303 million in direct-to-
consumer advertising to get its message
about Viagra to men [8–10]. Besides
the large promotion budget, Pfi zer has
also paid a number of doctors to act as
“consultants,” delivering public lectures
and appearing in the mass media to
expound on ED and Viagra [11]
Pfi zer denies that it is targeting
younger men or that it is positioning
Viagra as a lifestyle drug. Mariann
Caprino, a spokeswoman for the
company, is quoted in the New York
Times as saying, “Have we gone out and
given our advertising agency instructions
to speak to this young population?
No, we haven’t” [7]. But the message
from the pictures on the Web site,
in magazine ads, and from people
like Rafael Palmiero is that everyone,
whatever their age, at one time or
another, can use a little enhancement;
and any deviation from perfect erectile
function means a diagnosis of ED and
treatment with Viagra. Increasingly, the
age profi le of men using Viagra refl ects
the younger audience that Pfi zer denies
it is targeting. Between 1998 and 2002
the group showing the largest increase
in Viagra use was men between the ages
of 18 and 45, and only one-third of these
men had a possible etiologic reason for
needing Viagra [12].
Economic and Social Implications
of the Expanding Market for
Lifestyle Drugs
Drug companies have identifi ed
lifestyle drugs as a “growth market.”
The problems that they are designed
to treat are easily self-diagnosed—we
can all see if we are bald or fat—and as
the baby boomers age, the population
looking to these drugs will continue to
grow. Drug companies, driven by profi t,
go where the money is.
Because of the potential size of
the market for Viagra, paying for it
in unlimited quantities will be very
expensive. Viagra may only be the tip of
the iceberg. If we believe the prophets
of technology, soon there will be drugs
for memory enhancement and the
possibility of genetic manipulation to
make us taller or to keep a full head
of hair. Here we come back to the
enhancement debate. Do we accept our
limitations with grace, or is it legitimate
to seek technological solutions for
them? In one corner is the view of
health as freedom from disease, where
“the central purpose of health care is
to maintain, restore, or compensate
for the restricted opportunity and
loss of function caused by disease
and disability” [13]. In this model, a
just medical system would not cover
treatments and interventions that aim
to enhance abilities not affected by
disease and disability. Opposing this
is an expansionist defi nition, such as
the one offered by the World Health
Organization, where health is “a state
of complete physical, mental and
social well-being” (http:⁄⁄www.who.
int/about/defi nition/en/print.html).
If we accept this view, then are we not
obliged to provide for people who want
to enhance themselves so that they can
achieve mental and social well-being?
This debate is further complicated
because there is not an equal balance
in how we look at the options of
accepting limitations and seeking
enhancement. In a market-driven
world, the money is in promoting
enhancements, not in accepting
limitations. The ad featuring the
man who chooses not to accept even
occasional erection problems is one
example of how commercial pressures
bias the debate [14].
Because of the possibility that large
numbers of men would request Viagra
from their doctors, getting insurance
companies to pay for Viagra presented
Pfi zer with special problems. Early
on, Kaiser Permanente refused to
cover Viagra for its 9 million members
because of costs expected to be in
the range of US$100 million per year
[11]. According to one interpretation,
reactions from insurers such as Kaiser
Permanente were the reason that Pfi zer
put in place a US$35 million campaign
to change insurers’ decisions [11].
Another goal of Pfi zer’s campaign was
to make ED an acceptable topic for
public discourse, in order to remove
the stigma attached to it and increase
the possibility that third parties would
provide coverage.
Viagra presents a microcosm of
the debate surrounding drugs that
enhance lifestyle choices. The drug
is effective and safe for people
with medical problems warranting
treatment, but it also can be used
by a much wider population. The
company that manufactures the drug,
recognizing that the potential market
is huge, has aggressively targeted
that much larger community. Pfi zer’s
well-fi nanced campaign was aimed at
raising awareness of the problem of
ED, while at the same time narrowing
the treatment possibilities to just a
single option: medication. Having
succeeded in turning Viagra into a
consumer product, Pfi zer then turned
its attention to payers in order to reap
the benefi ts of the expanded market.
Ultimately, there must be a debate
about how limited resources for health
care should be spent and who should
April 2006 | Volume 3 | Issue 4 | e132
Drug companies have
identifi ed lifestyle drugs
as a “growth market.”
PLoS Medicine | 0004
Leonore Tiefer and Annie Potts commented
on an earlier version of this manuscript.
My special thanks to Arthur Schafer for his
gracious help with revisions.
1. Burls A, Clark W, Gold L, Simpson S (1998)
Sildenafi l—An oral drug for the treatment of
make those decisions. Are men who seek
to enhance their normal sexual function
“worthy” enough to have their treatment
paid for? If we pay for drugs and other
procedures that enhance lifestyles,
then other treatments either may
not get funded at all or may become
inadequately funded. Who will get the
lifestyle drugs? Everybody who wants
them? And do they get an unlimited
supply? As the number of enhancement
treatments grows, the scenario
surrounding Viagra will become all too
familiar with other drugs. Now is the
time to start preparing for how we will
deal with the inevitable explosion of
drugs and other interventions that can
make us “better than well” [16]. 
April 2006 | Volume 3 | Issue 4 | e132
male erectile dysfunction. Report number 12.
Birmingham (United Kingdom): West Midlands
Health Technology Assessment Collaboration,
Department of Public Health and Epidemiology,
University of Birmingham. 94 p.
2. Feldman HA, Goldstein I, Hatzichristou DG,
Krane RJ, McKinlay JB (1994) Impotence
and its medical and psychological correlates:
Results of the Massachusetts Male Aging Study.
J Urol 151: 54–61.
3. Longcope C, Goldfi eld SRW, Brambilla DJ,
McKinlay J (1990) Androgens, estrogens, and
sex hormone-binding globulin in middle-aged
men. J Clin Endocrinol Metab 71: 1442–1446.
4. Laumann EO, Paik A, Rosen RC (1999) Sexual
dysfunction in the United States: Prevalence
and predictors. JAMA 281: 537–544.
5. Blanker MH, Bosch JLHR, Groeneveld FPMJ,
Bohnen AM, Prins A, et al. (2001) Erectile and
ejaculatory dysfunction in a community-based
sample of men 50 to 78 years old: Prevalence,
concern, and relation to sexual activity.
Urology 57: 763–768.
6. Masumori N, Tsukamoto T, Kumamoto Y,
Panser LA, Rhodes T, et al. (1999) Decline
of sexual function with age in Japanese men
compared with American men—Results of two
community-based studies. Urology 54: 335–345.
7. Warren J (2003 December 14) In an oversexed
age, more guys take a pill. New York Times.
Available: http:⁄⁄
Accessed 1 March 2006.
8. Findlay S (2000) Prescription drugs and mass
media advertising. Research brief. Washington:
(D. C.): National Institute for Health Care
Management. Available: http:⁄⁄www.nihcm.
org/fi nalweb/DTCbrief2001.pdf. Accessed 2
March 2006.
9. IMS Health (2001) Leading 10 products by
U.S. DTC spend, 2000. Plymouth Meeting
(Pennsylvania): Available: http:⁄⁄www.
Accessed 1 March 2006.
10. Yuan Y, Duckwitz N (2002) Doctors and
DTCA. Pharmaceutical executive. Plymouth
Meeting (Pennsylvania). Available: http:⁄⁄www.
2005112345DoctorsDTC.pdf. Accessed 1 March
11. Deer B (1998 September 6) Viagra: Sex drugs
& rock ’n’ roll. Sunday Times Magazine.
Available: http:⁄⁄ zer-viagra.
htm. Accessed 2 March 2006.
12. Delate T, Simmons VA, Motheral BR
(2004) Patterns of use of sildenafi l among
commercially insured adults in the United
States: 1998–2002. Int J Impot Res 16: 313–
13. Parens E (1998) Is better always good? The
enhancement project. Hastings Cent Rep 28:
14. Parens E (2005) Authenticity and ambivalence.
Hastings Cent Rep 35: 34–41.
15. Klein R, Sturm H (2001) Viagra: A success story
for rationing? Health Aff 21: 177–187.
16. Caplan A, Elliott C (2004) Is it ethical to use
enhancement technologies to make us better
than well? PLoS Med 1: e52. DOI: 10.1371/
PLoS Medicine | 0001
April 2006 | Volume 3 | Issue 4 | e182
Over the last twenty years,
attention defi cit hyperactivity
disorder (ADHD) has
emerged as a disorder of importance
in childhood. Prescription of
psychostimulants for ADHD escalated
in many countries through the 1990s.
Between 1990 and 1995, prescriptions
of methylphenidate for young people
increased 2.5-fold in the US [1], and
5-fold in Canada [2]. In New South
Wales, Australia, rates of treatment for
children in 2000 were nine times those
in 1990 [3].
ADHD joins dyslexia and glue
ear as disorders that are considered
signifi cant primarily because of their
effects on educational performance.
Medicalising educational performance
can help children receive specialised
medical and educational services; at the
same time it can lead to them receiving
medications or surgical therapies which
may have short-term and long-term ill
In the case of ADHD, there has
been a complex, often heated debate
in the public domain about the
verity of the illness and the personal
cost-benefi t ratio of treatment with
psychostimulant medication [4–6].
Much of the polemic for and against
psychostimulants is concerned with the
part played by doctors, the prescribers
of medication, in diagnosing or
discounting ADHD. ADHD is, however,
a disorder of educational performance,
and so teachers have a critical role
in advocating for the illness, and its
medical treatment. This essay explores
the roles of teachers as
brokers for ADHD and
its treatment, and the
strategies used by the
pharmaceutical industry to
frame educators’ responses
to ADHD.
The Teacher’s Role in
Managing ADHD
In his essay on
medicalisation processes,
Conrad argued that when
disorders previously
viewed as non-medical
are redefi ned as
sicknesses, non-medical
people often perform
the “everyday routine
work” of disseminating
understanding of the
new sickness [7]. A
temperance society worker,
for example, might have
disseminated the concept
of alcoholism as a disease
through everyday contacts
with alcoholics and their
families. With ADHD, the
teacher’s work extends
beyond simply ensuring
the disorder is understood
by parents. Instead, the
teacher participates in the diagnosis,
and may broker different forms of
treatment, or rejection of treatment.
Brokerage is not a disinterested activity:
teachers may have a vested interest in
detecting and managing disruptive
children, or they may adhere to beliefs
about learning disorders which lead
them to dissuade parents of the need
for treatment.
The role of the teacher as the
sickness and treatment broker for
ADHD has been elaborated more
clearly for ADHD than for any other
childhood disorder. The DSM-IV
diagnostic criteria accord teachers
a formal role in diagnosis through
specialised assessment instruments such
as the Conners Teacher’s Rating Scale
[8]. Teachers often agree to administer
Medicine Goes to School:
Teachers as Sickness Brokers for ADHD
Christine B. Phillips
Funding: The author received no funding to write
this article.
Competing Interests: The author declares that she
has no competing interests.
Citation: Phillips CB (2006) Medicine goes to school:
Teachers as sickness brokers for ADHD. PLoS Med
3(4): e182.
DOI: 10.1371/journal.pmed.0030182
Copyright: © 2006 Christine B. Phillips. This is an
open-access article distributed under the terms
of the Creative Commons Attribution License,
which permits unrestricted use, distribution, and
reproduction in any medium, provided the original
author and source are credited.
Abbreviations: ADHD, attention defi cit hyperactivity
disorder; CHADD, Children and Adults with Attention
Defi cit/Hyperactivity Disorder
Christine B. Phillips is a Senior Lecturer in Social
Foundations of Medicine, Australian National
University Medical School, Acton, Australia. E-mail:
The Essay section contains opinion pieces on topics
of broad interest to a general medical audience.
Prescription of psychostimulants for ADHD escalated
in many countries through the 1990s
(Photo: Sponge, published under the GNU Free
Documentation License)
PLoS Medicine | 0002
psychostimulant medication during
the school day, although there is in
Australia, the UK, and the US no legal
compulsion to do so. A subtle incentive
for teachers to administer medication
in the middle of the day may be the
assurance of a tractable child in the
An informal role also exists for
teachers as “disease-spotters.” There
appears to be considerable difference
internationally in the alacrity with which
teachers engage in disease-spotting. In a
study of 491 physicians in Washington,
D. C., almost half of the diagnoses
of ADHD in their patients had been
suggested fi rst by teachers [9]. In
the UK, on the other hand, parental
concerns that a child has ADHD may be
discounted by teachers [10].
How Drug Companies Infl uence
As teachers have some agency
in diagnosing ADHD, and may
in fact contest the diagnosis, the
pharmaceutical industry has an interest
in directing teachers toward medical
treatment. Pharmaceutical companies
have been able to exploit the Internet
to access teachers and to infl uence
their brokerage role. The approach
to teachers tends to mirror strategies
used to familiarise doctors with
The pharmaceutical company as
disinterested purveyor of education.
The drug promotion that masquerades
as professional education is such a
xture in the medical domain that
many universities train medical
students to critique promotional
material. Both Shire (manufacturer
of Adderell) [11] and Novartis
(manufacturer of Ritalin) [12] have
established educational websites
separate from their own industry
sites, each of which contains specifi c
resources for teachers. On a page
entitled “If parents ask…,” Novartis
suggests responses teachers might make
to concerned parents:
“Make it clear to them that it is
important for them—and their child—
to understand and follow the doctor’s
medical advice about medication and
other therapies for ADHD. ADHD is a
serious condition that may require the
child to be on medication and undergo
counselling for a long duration [12].”
Each site incorporates links to the
manufacturer responsible for the site
[13] or directly to the psychostimulant
produced by the manufacturer [14],
discussion of the diagnostic process,
and references to the legislation
governing the rights of access for
disabled people to treatment, such
as the Individuals with Disabilities
Education Act in the US. An activity
such as Shire’s funding of an annual
toll-free “ask the experts” ADHD
hotline, 1-888-ASK-ADHD, [15] is
another example of the provision of
advertorial information to teachers
in the guise of objective education.
Experts provided for this free hotline,
now in its seventh year, include
teachers, as well as school nurses,
doctors, and advocates; suggested
topics include the management of
ADHD within the school.
Other school personnel are also
targeted. In 1997, Novartis collaborated
with the National Association of
School Nurses in the US to run a
nationwide campaign, in which 11,000
school nurses were provided with a
resource kit containing information
on ADHD, its treatment, and various
support organisations [16]. Novartis
later collaborated with the National
Association of School Nurses and
others to produce a resource aimed
at curbing misuse of psychostimulant
medication, which again provided links
to Novartis pharmaceuticals [17].
Support of advocacy groups
which lobby teachers. In the US,
the pre-eminent advocacy group
for people with ADHD is CHADD
(Children and Adults with Attention
Defi cit/Hyperactivity Disorder).
In the 2004–2005 fi nancial year
(year ended 30 June 2005), 22% of
CHADD’s total revenue came from the
pharmaceutical industry [16]. CHADD
undertakes educational programs
for teachers [18], including acting
as the lead editorial consultant of a
special issue on ADHD in Health in
Action, a quarterly publication of the
American School Health Association
[19]. The UK’s answer to CHADD, the
National Attention Defi cit Disorder
Information and Support Service
(ADDISS), also carries a brief to
develop and publicise educational
programs for teachers. A charity-based
organisation set up by the Department
of Health, the service has also received
funding from Janssen-Cilag, UCB
Pharma, and Eli Lilley, according to
reports in the UK press [20].
Creating a presence in the school
for the pharmaceutical industry.
A more general staking of claim
to a role in schools is provided
through the range of online science
educational materials now provided
by GlaxoSmithKline [21], Pfi zer
[22], and the Association of the
British Pharmaceutical Industry [23].
Although these sites do not mention
specifi c medications, they reinforce the
place of the pharmaceutical industry
as a benevolent and authoritative
presence within the school, much as
the provision of branded educational
materials to doctors reinforces the
position of the pharmaceutical industry
within the clinic.
The organised penetration of the
pharmaceutical industry associated
with ADHD into the education domain
is a new phenomenon. While there
has been extensive discussion about
the ethics of fast-food marketing
within schools [24,25], there has been
little about the consequences of the
pharmaceutical industry’s infi ltration
of schools.
It could be argued that in
providing information to teachers,
pharmaceutical industries are simply
acting as good corporate citizens.
Such an argument would carry
more weight if these companies
also provided education programs
addressing autism and dyslexia, two
other conditions which impact upon
educational performance, but which
Box 1. Suggestions to Support
Teachers as Independent
Advocates for Children with
Teachers should be trained to decode
and question marketing strategies
used by the pharmaceutical industry,
just as medical students are.
Teachers should have a mechanism
to report their observations about
medication to an independent body,
such as Australia’s Adverse Drugs
Reaction Advisory Committee.
Teachers should contribute to
documenting educational and other
outcomes of children with ADHD,
through participating in formal
collation of data across school regions
about outcomes.
April 2006 | Volume 3 | Issue 4 | e182
PLoS Medicine | 0003
do not have accepted pharmaceutical
therapies. While there is an argument
for providing unbiased education to
teachers about a high-profi le condition,
education provided by pharmaceutical
companies is self-serving in that it often
provides education which references
their own products, and channels the
reader toward medical therapy.
There are calls for doctors to learn
about pharmaceutical marketing
strategies in their training [26,27],
to participate in the monitoring of
outcomes of medication, through post-
marketing surveillance, and to maintain
a global watch on pharmaceutical
marketing [28]. The wide acceptance
of disorders of educational
performance, and the penetration
of the pharmaceutical industry into
schools, point to similar needs for
teacher training and participation in
surveillance (see Box 1). Children
have no agency in this market. To
be effective advocates for children,
teachers need to be supported to be
objective and accurate interpreters
of information for parents and
healthworkers, rather than franchisees
in the sickness marketplace. 
April 2006 | Volume 3 | Issue 4 | e182
I am grateful for comments on this essay
from Clare McGuiness and Marjan Kljakovic.
1. Safer DJ, Zito JM, Fine EM (1996) Increased
methylphenidate usage for attention defi cit
disorder in the 1990s. Pediatrics 98: 1084–1088.
2. Miller A, Lee SK, Raina P, Klassen A, Zupanic
J, et al. (1998) A review of therapies for
attention-defi cit/hyperactivity disorder.
Ottawa: Canadian Coordinating Offi ce for
Health Technology Assessment. Available:
adhd_tech_rep.pdf. Accessed 29 January 2006.
3. Salmelainen P (2002) Trends in the
prescribing of stimulant medication for the
treatment of attention defi cit hyperactivity
disorder in children and adolescents in New
South Wales. N S W Public Health Bull 13
(Supplement S-1): 1–65.
4. Breggin PR (2002) The Ritalin fact book: What
your doctor won’t tell you about ADHD and
stimulant drugs. Cambridge (Massachusetts):
Perseus Publishing. 208 p.
5. Church of Scientology International (2006)
Protecting the rights of children. Available:
pub/human-rights/pg011.html. Accessed 29
January 2006.
6. American Academy of Pediatrics (2006)
Children’s health topics: ADHD. Available:
Accessed 29 January 2006.
7. Conrad P (1992) Medicalization and social
control. Ann Rev Sociol 18: 209–232.
8. Conners CK (1997) Manual for the Conners’
Rating Scales—Revised. North Tonawanda
(New York): Multi-Health Systems.
9. Sax L, Kautz KJ (2003) Who fi rst suggests the
diagnosis of attention-defi cit/hyperactivity
disorder? Ann Fam Med 1: 171–174.
10. Malacrida C (2004) Medicalization,
ambivalence and social control: Mothers’
descriptions of educators and ADD/ADHD.
Health 8: 61–80.
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December 2005.
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sch_if_parents_ask.jsp. Accessed 19
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14. Shire Pharmaceutical Group (2006) Adderell
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Accessed 14 September 2005.
15. Shire Pharmaceutical Group (2005) Celebrity
carpenter Ty Pennington to host ADHD
experts on call program [press release].
Available: http:⁄⁄
archives/2005-09/pn-net091405.html. Accessed
14 February 2006.
16. Kidsonline (2006) National Association of
School Nurses (NASN) supports educational
program about management of attention
defi cit hyperactivity disorder (ADHD) in
schools. Available: http:⁄⁄
Accessed 29 January 2006.
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Straight talk about responsible treatment
(START). Available: http:⁄⁄www.adhdinfo.
com/startnow/index.jsp. Accessed 29 January
18. CHADD (2005) CHADD Annual Report
2004–2005. Available: http:⁄⁄
pdfs/2005_Annual_Report.pdf. Accessed 2005.
19. CHADD (2004) Reaching educators.
Available: http:⁄⁄
Accessed 23 December 2005.
20. Foggo D (2005) ADHD advice secretly paid for
by drugs companies. Available: http:⁄⁄www.
news/2005/10/09/nadhd09.xml. Accessed
29 January 2006.
21. GlaxoSmithKline (2004) Partners with
education. Available: http:⁄⁄
education/index.htm. Accessed 23 December
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Accessed 23 December 2005.
23. Association of the British Pharmaceutical
Industry (2005) Resources for schools.
Available: http:⁄⁄
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24. Story M, French S (2004) Food Advertising
and marketing directed and children and
adolescents in the US. Int J Behav Nutr Phys
Act 10: 3.
25. Linn SE (2004) Food marketing to children in
the context of a marketing maelstrom. J Public
Health Pol 25: 367–378.
26. Rogers WA, Mansfi eld PR, Braunack-
Mayer AJ, Jureidini JN (2004) The ethics of
pharmaceutical industry relationships with
medical students. Med J Australia 180: 411–414.
27. Wilkes MS, Hoffman JR (2001) An innovative
approach to educating medical students about
pharmaceutical promotion. Acad Med 76:
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for appropriate marketing of pharmaceuticals.
Med J Australia 167: 590–592.
PLoS Medicine | 0001
April 2006 | Volume 3 | Issue 4 | e178
The creation and promotion of
“female sexual dysfunction”
(FSD) is a textbook case
of disease mongering by the
pharmaceutical industry and by other
agents of medicalization, such as health
and science journalists, healthcare
professionals, public relations and
advertising fi rms, contract research
organizations, and others in the
“medicalization industry.” Whether
one relies on Lynn Payer’s original
defi nition of disease mongering
(“trying to convince essentially well
people that they are sick, or slightly
sick people that they are very ill” [1]),
her checklist (Box 1), or the analysis
of our pill-popping society that was
recently offered by Greg Critser [2],
the sequence of events and cast of
participants involved in FSD matches
the classic disease-mongering tactics
Each physical condition or life
event that has been subject to disease-
mongering tactics has its own unique
history. Sexual life has become
vulnerable to disease mongering for
two main reasons. First, a long history
of social and political control of
sexual expression created reservoirs
of shame and ignorance that make
it diffi cult for many people to
understand sexual satisfaction or cope
with sexual problems in rational ways.
Second, popular culture has greatly
infl ated public expectations about
sexual function and the importance
of sex to personal and relationship
Thus the public is led to want and
expect high rewards from sexual
life without having tools to achieve
these rewards. People fed a myth that
sex is “natural”—that is, a matter of
automatic and unlearned biological
function—at the same time as they
expect high levels of performance and
enduring pleasure, are likely to look
for simple solutions. This sets the stage
for disease mongering, a process that
encourages the conversion of socially
created anxiety into medical diagnoses
suitable for pharmacological treatment.
In this essay, I begin by examining
sexual attitudes in the 20th century that
were crucial in setting the scene for the
creation of FSD. I then highlight key
steps in the history of FSD and of the
campaign to challenge its reductionist
approach to women’s sexual problems.
Setting the Scene: Sex and the
20th Century
In the early 20th century, sexual life and
interest were stimulated by intensive
urbanization and immigration that
disrupted old community-based patterns
of sexual regulation [3,4]. Sexual
choices and expectations, however,
were still largely governed by traditional
religion and a double standard. Public
discourse around sex was moralistic,
and sex-education materials were
limited and stigmatized. By mid-century,
surveys showed wide variation in sexual
habits, with behavior patterns related to
social class, gender, cohort, and other
background factors [5].
Dramatic liberalization occurred
after World War II as purity campaigns
failed to hold back the sex-promoting
impact of changes in longevity, leisure,
employment and childrearing, new
technology, and mass media [4].
Effective oral contraceptives and
medical treatments for venereal
diseases removed sexual inhibitions
due to fear of pregnancy and disease.
A youth culture of charged eroticism
developed. Changes in obscenity laws
permitted sexual explicitness in the
mass media. The women’s and gay-
Female Sexual Dysfunction: A Case Study
of Disease Mongering and Activist Resistance
Leonore Tiefer
Funding: The author received no specifi c funding for
this article.
Competing Interests: The author has declared that
no competing interests exist.
Citation: Tiefer L (2006) Female sexual dysfunction:
A case study of disease mongering and activist
resistance. PLoS Med 3(4): e178.
DOI: 10.1371/journal.pmed.0030178
Copyright: © 2006 Leonore Tiefer. This is an
open-access article distributed under the terms
of the Creative Commons Attribution License,
which permits unrestricted use, distribution, and
reproduction in any medium, provided the original
author and source are credited.
Abbreviations: FDA, US Food and Drug
Administration; FSD, female sexual dysfunction; P&G,
Procter & Gamble; UCLA, University of California Los
Leonore Tiefer is Clinical Associate Professor of
Psychiatry, New York University School of Medicine,
New York, New York, United States of America. E-
The Essay section contains opinion pieces on topics
of broad interest to a general medical audience.
Box 1. The Major Disease-
Mongering Tactics Identifi ed by
Lynn Payer [1]
1. “Taking a normal function and
implying that there’s something wrong
with it and it should be treated” (p. 88)
2. “Imputing suffering that isn’t
necessarily there” (p. 89)
3. “Defi ning as large a proportion of the
population as possible as suffering
from the ‘disease’” (p. 89)
4. “Defi ning a [condition] as a defi ciency
disease or disease of hormonal
imbalance” (p. 93)
5. “Getting the right spin doctors” (p. 93)
6. “Framing the issues in a particular way”
(p. 94)
7. “Selective use of statistics to
exaggerate the benefi ts of treatment”
(p. 95)
8. “Using the wrong end point” (p. 96)
9. “Promoting technology as risk-free
magic” (p. 96)
10. “Taking a common symptom that
could mean anything and making
it sound as if it is a sign of a serious
disease” (p. 98)
PLoS Medicine | 0002
and lesbian-rights movements of the
1960s and 1970s raised the importance
of sexual behavior and identity. Each
new technological development in
communications—movies, car radios,
television, videotapes, Internet—was
used to promote sex-related products
and to escalate the importance of
sexual life and the availability of
Medicalizing Sexuality
Beginning in the 1970s, along with
the increasing sexual explicitness
in popular culture, there were two
competing academic theories of
sexuality. In the social sciences and
humanities, a social-constructionist
perspective emphasized political,
economic, and social determinants
of sexual life [6]. It tended to see
learning and education as keys to
sexual satisfaction. In psychology and
medicine, by contrast, a reductionist
view of sexuality prevailed that stressed
universal, evolution-based patterns of
sexual motive, attraction, and conduct.
This view saw satisfaction as an inherent
result of normal function. In truth,
however, there wasn’t much academic
sex research of any sort, as the topic was
controversial and hence underfunded.
There were very few academic or
professional training programs, and
sexological organizations, conferences,
and journals were lively but small and
somewhat defensive, rather than parts
of an established specialty area of
sexuality studies.
In the 1980s, the nature of sex
research and expertise began to shift
as a new “sexual medicine” focused
on function was created by urologists,
insurance reimbursement programs,
diagnostic technologies, science and
medicine journalists, and, then, the
pharmaceutical industry [7].
Urologists looked to new
opportunities in genitourinary sexual
medicine as their surgical careers were
limited by the new (1984) kidney stone
lithotripsy and by effective medications
for benign prostate disease. Insurance-
based reimbursement for sex-problem
treatments (including psychotherapy)
became linked to a diagnostic
classifi cation system that recognized
only discrete sexual “dysfunctions”
such as low desire, inadequate
arousal/erection, and premature
or delayed orgasm/ejaculation.
Technologies for measuring genital
blood fl ow and nerve function were
widely used to substantiate dysfunction
diagnoses. Taking advantage of
post-1980s deregulatory policies, the
pharmaceutical industry began to
redirect its pipeline to new “lifestyle
drugs” and its marketing to consumer
advertising. Science and medicine
journalists played key roles in whetting
the public’s appetite for medical news
about sex by breathlessly covering each
new discovery and treatment.
In the 1980s and 1990s, urologists
created organizations, journals, and
“sexual health clinics” that focused on
men’s erection problems. In 1992, a US
National Institutes of Health consensus
conference on “impotence” legitimized
this work. Its outcome was a 34-page
document that mentioned factors
involved in etiology, maintenance, and
treatment such as culture, partners,
and sexual techniques, but, for the
most part, it reifi ed “erection” as the
essence of men’s sexuality, and called
for new treatments and vastly expanded
research into physiological details
and treatments [8]. The creation of
“erectile dysfunction” as a serious,
prevalent, and treatable medical
disorder was fi rmly in place by the time
Viagra was launched in 1998 with an
unprecedented global public-relations
campaign, as Joel Lexchin describes in
this issue of PLoS Medicine [9].
Creating FSD
Although journalists began calling
for a “female Viagra” only days after
the March 1998 US Food and Drug
Administration (FDA) approval of
Viagra (examples of journalists’ calling
DOI: 10.1371/journal.pmed.0030178.g001
Figure 1. Timeline for the Promotion of FSD from 1997 to Present
AUA, American Urological Association; CME, Continuing Medical Education; JAMA, Journal of the
American Medical Association
(Figure: Rusty Howson)
April 2006 | Volume 3 | Issue 4 | e178
PLoS Medicine | 0003
for a “pink Viagra” are collected on
it was far from clear what medical
condition Viagra was supposed to treat
in women. Urologists had used the
term “female sexual dysfunction” as
early as 1997, referring to aspects of
genital pathophysiology that might be
akin to erectile dysfunction. Figure 1
offers a timeline of events shaping the
creation and promotion of FSD, from
1997 to the present.
A May 1997 Cape Cod conference,
“Sexual Function Assessment in
Clinical Trials,” which was sponsored
by pharmaceutical companies, was a
watershed moment in the FSD story
[10]. These companies bypassed
existing sexology organizations and
their annual conferences to convene
an invitation-only industry–sexologist
get-together. Papers and discussion
were published in a special supplement
to the International Journal of Impotence
Research [10]. Signifi cantly, the
introduction stated:
“In the area of female sexual dysfunc-
tion, there is widespread lack of agree-
ment about the defi nition of sexual
dysfunction, its pathophysiology or
clinical manifestations, and the opti-
mal approach for research or clinical
assessment (p. S1).”
Defi nitional issues have plagued
the FSD literature ever since, despite
repeated industry-supported attempts
to draw a bright line between healthy
sexual function and medical disorder.
The quest for a valid and reliable FSD
assessment instrument has become a
small growth industry in and of itself.
For the fi rst few years, the key players
in the medicalization of women’s
sexual problems were a small group
of urologists who capitalized on their
relationships with industry and recruited
many sex researchers and therapists
as allies. Irwin Goldstein of Boston
University, an active erectile dysfunction
researcher, opened the fi rst Women’s
Sexual Health clinic in 1998 [11].
He convened the fi rst conference on
female sexual function (called “New
Perspectives in the Management of
Female Sexual Dysfunction”) in October
1999 in Boston. Goldstein is the editor
of a journal that launched in 2004—the
Journal of Sexual Medicine (http:⁄⁄jsm.—which has already published
an industry-supported supplement on
FSD [12].
Jennifer Berman, Goldstein’s urology
trainee at Boston University, together
with her sister, sex educator Laura
Berman, became the female face of
FSD, opening a clinic at University
of California Los Angeles (UCLA) in
2001, and continuing to popularize
FSD and off-label drug treatments on
their television program, Web site, and
books; in appearances on the television
show “Oprah”; and in innumerable
women’s magazines [13]. The UCLA
clinic was closed in 2005, as both
Jennifer (in Los Angeles, California)
and Laura (now in Chicago, Illinois)
opened fee-for-service women’s sexual-
health centers that offered medical
assessments and treatments plus spa
and yoga services [13]. Laura will also
have her own reality TV sex-advice show
later in 2006 (http:⁄⁄
do). One clear future angle to the
FSD story will be its intersection with
the new “holistic” and “boutique”
(specialized, retainer, or cash-paying)
medical trends as well as with drug-
friendly celebrity experts.
Pfi zer, the world’s largest
pharmaceutical company, was the main
promoter of FSD from 1997 to 2004,
when its quest to have Viagra approved
to treat “female sexual arousal
disorder” ended because of consistently
poor clinical-trial results. In its public
statement, Pfi zer said that that several
large-scale, placebo-controlled studies
including about 3,000 women with
female sexual arousal disorder showed
inconclusive results on the effi cacy of
the drug [14]. Commenting on these
trial results on Viagra, John Bancroft,
director of the Kinsey Institute, told
the BMJ: “The recent history of the
study of female sexual dysfunction is a
classic example of starting with some
preconceived, and non-evidence based
diagnostic categorisation for women’s
sexual dysfunctions, based on the male
model, and then requiring further
research to be based on that structure.
Increasingly it is becoming evident
that women’s sexual problems are not
usefully conceptualised in that way”
[14]. Nevertheless, Viagra (and the
idea that it must work for women) has
DOI: 10.1371/journal.pmed.0030178.g002
Figure 2. Timeline of Events Beginning in 1999 of Activism, Which Came to Be Called the
“Campaign for a New View of Women’s Sexual Problems”
(Figure: Rusty Howson)
April 2006 | Volume 3 | Issue 4 | e178
PLoS Medicine | 0004
been so successfully branded that it
continues to be prescribed off-label for
women [15].
Next in line with a potential drug
for FSD has been Procter & Gamble
(P&G), the multibillion-dollar soap,
shampoo, and snack company that
makes only fi ve prescription drugs [16].
P&G’s 2004 annual report states that its
drug risedronate (Actonel, approved in
1998 for Paget disease and in 2000 for
osteoporosis), “became a billion-dollar
brand faster than any other brand in
P&G history” [17]. Perhaps encouraged
by this success in selling medicine to
women, P&G had begun investing
heavily in a testosterone patch (brand
name Intrinsa) to treat “hypoactive
sexual desire disorder.” The unnoticed
shift in 2004 in FSD identity and
promotion from female sexual arousal
disorder to hypoactive sexual desire
disorder is another hallmark moment
in the FSD story, illustrating how the
effort to match up some drug with
FSD moved freely among symptoms
and labels. P&G’s trials with Intrinsa
got many gynecologists and their
organizations heavily involved in the
new sexual pharma–medicine for the
rst time. Unfortunately for the drug
company, an FDA advisory panel voted
unanimously not to approve Intrinsa,
saying that P&G had not provided
suffi cient long-term safety data and
questioning the clinical signifi cance
of the Intrinsa trials [18]. However,
testosterone researcher Jan Shifren
estimates that one-fi fth of all the
prescriptions of testosterone products
approved for men are actually written
(off-label) for women [19].
By 2006, FSD has become a medical
and media reality, despite the obvious
ongoing diffi culties in defi ning the
condition and in getting a drug
approved. Disease mongering has led
to the successful “branding” of FSD.
Activist Response
In 1999, I became concerned that
the imminent inaugural Boston
conference on FSD would represent
only the reductionist view of women’s
sexual problems and would likely
ignore the fundamental political
and interpersonal reality of women’s
sexual lives. I had been employed as
a research and clinical psychologist
in urology departments from 1983
to 1996, and I worried that the
mechanistic view of sexuality I had seen
applied to men’s sexual function would
just be transposed to women. Viagra
had just been approved, I knew about
the Cape Cod conference, and I feared
that urologists (with fi nancial backing
from Pfi zer) would use a conference on
FSD to promote Viagra for women.
Although I had no experience in
organizing, I felt I had to take steps
to make sure a space was created for
diverse (i.e., not just medical) opinions
about women’s sexual problems. I
submitted a critical essay about the new
FSD to a Boston feminist newsletter
[20], and, with Carol Tavris, I wrote
an op-ed for the Los Angeles Times [21].
Through Internet communication, I
invited feminist critics of medicalization
to meet with me in Boston and take
some action at the FSD conference.
Figure 2 offers a timeline, beginning
in 1999, of the activism that came to be
called the “Campaign for a New View of
women’s sexual problems” [22].
The campaign and its challenge
to FSD disease mongering have had
two crucial components [23]. The
rst, a theoretical critique of the
medical model of sexual problems, was
developed in the New View Manifesto,
books, articles, and lectures. The
manifesto, now available in several
languages [22], was authored by a
group of feminist academics, activists,
and clinicians calling themselves
“The Working Group on a New View
of Women’s Sexual Problems.” The
second component of the campaign is
pharma–watchdog activism, consisting
of media interviews, conferences, FDA
and professional presentations, and a
Web site (http:⁄⁄
The New View Manifesto focuses on
weaknesses of the prevailing sexual
dysfunction classifi cation and medical
model. It promotes a politically
sensitive social-constructionist
perspective and recommends
abandoning the effort to defi ne
“normal” sexual function. It offers
an alternative classifi cation system of
causes for sexual problems rooted in
society, relationships, psychology, and
disease. The activism challenges claims
made for each emerging FSD drug
in terms based on recurring biases
in clinical trials, dangers of off-label
promotion, researchers’ confl icts of
interest, and neglect of nonmedical
theory and research on sexuality.
Sexual life and its pleasures, problems,
and satisfactions are subject to
changing demands and expectations.
Recently, the pharmaceutical industry
has taken an aggressive interest in
sex, using public relations, direct-
to-consumer advertising, promotion
of off-label prescribing, and other
tactics to create a sense of widespread
sexual inadequacy and interest in drug
The public fi nds medicalization
attractive because the notion of simple
but scientifi c solutions fi ts in with
a general cultural overinvestment
in biological explanations and
interventions, and promises to bypass
sexual embarrassment, ignorance, and
anxiety. This wish will inevitably end
in stories of personal disappointment,
but media promotion, advertising
hyperbole, and an active pipeline will
create continuing hope for the next
new drug along with a neglect of other
models of sex and ways to deal with
sexual discontent.
The New View Campaign to
challenge the disease mongering of
FSD can be seen as part of a widespread
new arena of public-health advocacy
that deals with corporate practices
that affect health, such as those in
the tobacco, automobile, and food
industries [24]. Activism on behalf
of women’s sexuality leads also to
coalition with sexual-rights, sex-
education, and reproductive-rights
organizations. It has taken the work
of many public-spirited people and
organizations to shed the necessary
light on FSD disease mongering. But
the diffi culties the industry and its
experts continue to have in nailing
down FSD testify to some small success
on our part. 
April 2006 | Volume 3 | Issue 4 | e178
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The pharmaceutical
industry has taken an
aggressive interest in
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PLoS Medicine | 0001
April 2006 | Volume 3 | Issue 4 | e185
One of the most famous direct-
to-consumer television adverts
for a drug begins with a
vibrant woman dancing late into the
night. A background voice says, “Your
doctor probably never sees you when
you feel like this.” The advert cuts to
a shrunken and glum fi gure, and the
voiceover now says, “This is who your
doctor usually sees.” Cutting again to
the woman, in active shopping mode,
clutching bags with the latest brand
names, we hear: “That’s why so many
people with bipolar disorder are being
treated for depression and not getting
any better—because depression is only
half the story.” We see the woman again
depressed, looking at bills that have
arrived in the post before switching to
seeing her again energetically painting
her apartment. “That fast- talking,
energetic, quick tempered, overdoing
it, up-all-night you,” says the voiceover,
“probably never shows up at the
doctor’s offi ce, right?”
No drugs are mentioned. But
viewers are encouraged to log onto, which
takes them to a Web site called
“Bipolar Help Center,” sponsored
by Lilly Pharmaceuticals, the makers
of olanzapine (Zyprexa). The Web
site contains a “mood disorder
questionnaire” (http:⁄⁄www.
mdq.jsp). In the television advert, we
see our heroine logging onto www. and fi nding this
questionnaire. The voice encourages
the viewer to follow her example: “Take
the test you can take to your doctor, it
can change your life….getting a correct
diagnosis is the fi rst step in treating
bipolar disorder. Help your doctor to
help you.”
This advert markets bipolar disorder.
The advert can be read as a genuine
attempt to alert people who may
be suffering from one of the most
debilitating and serious psychiatric
diseases—manic-depressive illness.
Alternatively, the advert can be read as
an example of what has been termed
disease mongering [1]. Whichever it
is, it will reach beyond those suffering
from a mood disorder to others who will
as a consequence be more likely to see
aspects of their personal experiences
in a new way that will lead to medical
consultations and in a way that will shape
the outcome of those consultations.
Adverts that encourage “mood
watching” risk transforming variations
from an emotional even keel into
potential indicators of latent or actual
bipolar disorder. This advert appeared
in 2002 shortly after Lilly’s antipsychotic
olanzapine had received a license for
treating mania. The company was also
running trials aimed at establishing
olanzapine as a “mood stabilizer,” one of
which was recently published [2].
Mood Stabilization
From the 1950s on, the depressions
of manic-depressive illness have been
treated with antidepressants and the
manias with antipsychotics or lithium.
Lithium was the only agent thought
to be prophylactic against further
episodes of manic-depressive illness
[3]. But lithium was not originally
referred to as a mood stabilizer. The
term “mood stabilizer” had barely
been heard of before 1995 when
Abbott Laboratories got a license
DOI: 10.1371/journal.pmed.0030185.g001
Figure 1. Articles Elicited by Medline Using the Mesh Term “Mood Stabilizer”
The Essay section contains opinion pieces on topics
of broad interest to a general medical audience.
The Latest Mania: Selling Bipolar Disorder
David Healy
Funding: The author received no specifi c funding to
write this article.
Competing Interests: DH has been a speaker,
consultant, or clinical trialist for Lilly, Janssen,
SmithKline Beecham, Pfi zer, Astra-Zeneca, Lorex-
Synthelabo, Lundbeck, Organon, Pierre-Fabre, Roche,
and Sanofi . He has also been an expert witness in
ten legal cases involving antidepressants and suicide
or homicide and one case involving the patent on
olanzapine (Zyprexa). None of these interests played
any part in the submission or preparation of this
Citation: Healy D (2006) The latest mania: Selling
bipolar disorder. PLoS Med 3(4): e185.
DOI: 10.1371/journal.pmed.0030185
Copyright: © 2006 David Healy. This is an
open-access article distributed under the terms
of the Creative Commons Attribution License,
which permits unrestricted use, distribution, and
reproduction in any medium, provided the original
author and source are credited.
David Healy is at the North Wales Department of
Psychological Medicine, Cardiff University, Cardiff,
Wales, United Kingdom. E-mail: healy_hergest@
PLoS Medicine | 0002
for using the anticonvulsant sodium
valproate (Depakote) for treating
acute mania [4].
After 1995, there was a dramatic
growth in the frequency with which
the term “mood stabilizer” appeared
in the title of scientifi c articles (see
Figure 1). By 2001, more than a
hundred article titles a year featured
this term. Repeated reviews make it
clear that the academic psychiatric
community still has not come to a
consensus on what the term “mood
stabilizer” means [5–7]. But this lack
of consensus did not get in the way of
the message that patients with bipolar
disorders needed to be detected
and once detected needed mood
stabilizers, and perhaps should only be
given these drugs and not any other
psychotropic drugs [8,9].
The fi rst group of drugs to colonize
this new mood stabilizer niche was
anticonvulsants. Anticonvulsants are
benefi cial in epilepsy and were until
recently widely thought to be benefi cial
by quenching the increased risk of
succeeding epileptic fi ts brought
about by fi ts that have gone before.
Robert Post in the 1980s suggested
that anticonvulsants might stabilize
moods by a comparable quenching
of the kindling effect of an episode of
mood disorders on the risk of further
episodes [10]. It was this idea that
provided a pharmacological rationale
for treatment of bipolar disorders that
was so attractive to pharmaceutical
companies, and, in their hands,
the growth of awareness of mood
stabilization and of bipolar disorders
was sensational.
Bipolar disorders entered the DSM
(Diagnostic and Statistical Manual of
Mental Disorders) in 1980. At the time,
the criteria for bipolar I disorder
(classic manic-depressive illness)
involved an episode of hospitalization
for mania. Since then, the community-
based disorders bipolar II disorder,
bipolar disorders NOS (not otherwise
specifi ed), and cyclothymia have
emerged. With their emergence,
estimates for the prevalence of bipolar
disorders have risen from 0.1% of
the population having bipolar I
disorder (involving an episode of
hospitalization for mania) [11] to 5%
or more when the defi nition of bipolar
disorders includes the aforementioned
community disorders [12]. A range of
academic institutions has also grown
more interested in the condition.
There has always been a rationale
to using antipsychotics in bipolar
disorders, as they are effective in
acute manic states [13,14]. However,
no companies making antipsychotics
had previously sought a license
for prophylaxis against bipolar
disorders. Against a background of
epidemiological studies indicating that
the prevalence of bipolar disorders
might be greater than previously
thought [15,16], and growing academic
interest in the condition, Lilly, Janssen,
and Astra-Zeneca, the makers of the
antipsychotics olanzapine, risperidone,
and quetiapine (Seroquel),
respectively, marched in on the new
territory to market these drugs for
prophylaxis of bipolar disorder. This, in
turn, greatly expanded the number of
companies with an interest in making
the “bipolar market.” There was,
however, no consensus on a theoretical
rationale that would lead the average
clinician to think these three drugs
might “quench” the propensity to
further affective episodes, as opposed
to simply assist in the management of
acute manic states.
But the increased prevalence
estimates were based on community
surveys that had no clear disability
criterion, while acute treatment
trials of antipsychotics for mania,
and prophylactic trials of lithium for
manic-depressive illness, have for the
most part been conducted on bipolar
I disorder. This necessarily raises the
prospect that increased efforts to detect
and to treat people risks crossing the
line where the benefi ts of treatment
outweigh its risks.
Along with this expansion in
prevalence estimates came new
journals, Bipolar Disorders (http:⁄⁄www.
asp?ref=1398-5647) and the Journal
of Bipolar Disorders (published by
Lippincott, Williams, and Wilkins), a
slew of bipolar societies, and annual
conferences, many heavily funded by
pharmaceutical companies. There
is a growing amount of patient Web
site and patient support materials
that in the case of Zyprexa state that
“bipolar disorder is often a lifelong
illness needing lifelong treatment;
symptoms come and go, but the illness
stays; people feel better because the
medication is working; almost everyone
who stops taking the medication will
get ill again and the more episodes
you have, the more diffi cult they are to
treat” [17]. Information available from
Janssen (the makers of Risperdal) states
“medicines are crucially important in
the treatment of bipolar disorders.
Studies over the past twenty years
have shown beyond the shadow of
doubt that people who receive the
appropriate drugs are better off in the
long term than those who receive no
medicine” [18].
What Lies Beneath
There is, however, much less evidence
than many might think to support
these claims for the prophylactic drug
treatment of manic-depressive illness
(bipolar I). And there is almost no
evidence to support such claims in the
case of whatever community disorders
(bipolar II, bipolar NOS, cyclothymia)
are now being pulled into the manic-
depressive net by the lure of bipolar
With the possible exception of
lithium for bipolar I disorder, there
are no randomized controlled trials
to show that patients with bipolar
disorders in general who receive
psychotropic drugs are better in the
long term than those who receive no
medicine [19]. This may stem in part
from diffi culties in conducting trials
on psychotropic drugs that last more
than a few weeks in conditions as
complex as manic-depressive illness.
One short-term, randomized, placebo-
controlled trial (in which patients were
only followed for up to 48 weeks) that
some see as a basis for claiming that
olanzapine may be prophylactic in
bipolar disorder [2] has been regarded
by others as indicating that this drug
produces a withdrawal-induced
decompensation when stopped [20].
Even in the case of lithium, there
is some dispute over what has been
demonstrated [19], with the best
evidence stemming from large open
studies in dedicated lithium services
rather than from randomized trials
This evidence of benefi t for
one agent (lithium) and possible
April 2006 | Volume 3 | Issue 4 | e185
The growth of awareness
of mood stabilization
was sensational.
PLoS Medicine | 0003
benefi t for one more (olanzapine)
must be weighed against two harms
associated with use of antipsychotics:
(1) a consistent body of evidence
indicates that regular treatment with
antipsychotics in the longer run
increases mortality [22–26]; and (2)
there is evidence that in placebo-
controlled trials of antipsychotics
submitted in application for
schizophrenia licenses there is a
statistically signifi cant excess of
completed suicides on active treatment
[27]. A range of problems associated
with antipsychotics, from increased
mortality to tardive dyskinesia, never
show up in the short-term trials aimed
at demonstrating treatment effects in
But aside from these hazards, there
are also grounds to question whether
the treatment effects that some think
have been demonstrated in bipolar
disorder trials translate into therapeutic
effi cacy. If use of these agents based
on demonstrated effects leads on
to effi cacy, admissions for bipolar
disorder might be expected to fall,
but the evidence for this is diffi cult
to fi nd. In North Wales before the
advent of modern pharmacotherapy,
patients with bipolar I disorder had
on average four admissions every ten
years. In contrast, against a background
of a constant incidence of bipolar I
disorder, and dramatic improvements
in service provision, bipolar I patients
show a 4-fold increase in the prevalence
of admissions despite being treated
with the very latest psychotropic
medications [11]. This is not ordinarily
what happens when treatments “work,”
but quite often is what happens when
treatments have effects.
The selling of bipolar disorder
stresses that the disorder takes
a fearsome toll of suicides. And
indeed the controversy surrounding
the provocation of suicide by
antidepressants has been recast by
some as a consequence of mistaken
diagnosis. If the treating physician
had only realized the patient was
bipolar, they would not have mistakenly
prescribed an antidepressant. Because
of the suicide risk traditionally linked
to patients with bipolar disorders
who needed hospitalisation, most
psychiatrists would fi nd it diffi cult
to leave any person with a case of
bipolar disorder unmedicated. Yet,
the best available evidence shows that
unmedicated patients with bipolar
disorder do not have a higher risk of
Storosum and colleagues analyzed
all placebo-controlled, double-blind,
randomized trials of mood stabilizers
for the prevention of manic/depressive
episode that were part of a registration
dossier submitted to the regulatory
authority of the Netherlands, the
Medicines Evaluation Board, between
1997 and 2003 [28]. They found four
such prophylaxis trials. They compared
suicide risk in patients on placebo
compared with patients on active
medication. Two suicides (493/100,000
person- years of exposure) and eight
suicide attempts (1,969/100,000
person-years of exposure) occurred
in the group given an active drug
(943 patients), but no suicides and
two suicide attempts (1,467/100,000
person-years of exposure) occurred
in the placebo group (418 patients).
Based on these absolute numbers from
these four trials, I have calculated (see
Figure S1 showing calculation, and
see Figure 2) that active agents are
most likely to be associated with a 2.22
times greater risk of suicidal acts than
placebo (95% CI 0.5, 10.00).
The Bipolar Future
Until recently the general clinical
wisdom was that it was very rare for
manic-depressive illness to have an
onset in the preteen years. But there
is now a surge of diagnoses of bipolar
disorder in American children [29,30],
even though these children do not
meet the traditional criteria for bipolar
I disorder (from the Diagnostic and
Statistical Manual of Mental Disorders)
[31]. The mania for pediatric bipolar
disorder hit the front cover of the
American edition of Time in August
2002, which featured nine-year-old
Ian Palmer and a cover title Young and
Bipolar, with a strapline, why are so many
kids being diagnosed with the disorder, once
known as manic-depression?
A recent book, The Bipolar Child
[32], brings out the extent of the
current mania. Published in 2000,
this book sold 70,000 hardback
copies in six months in the US. As the
Star Telegram reported in July 2000
[33], The Bipolar Child made all the
difference to Heather Norris, whose
mother, after reading it, challenged
her physician to correct Heather’s
diagnosis from ADHD, treatment of
which had made her daughter worse,
to the correct diagnosis of bipolar
disorder. As a result, Heather, at the
age of two, became the youngest child
in Tarrant County, Texas, to have a
diagnosis of bipolar disorder. The Star
Telegram article noted that “along with
the insurance woes, lack of treatment
options and weak support systems that
plague most families with mentally ill
children, parents of the very young
face additional challenges. Finding
the proper diagnosis for treatment is
a nightmare because of scant research
into childhood mental illness and the
drugs that combat them.”
If we consider adults alone for a
moment, there is already the potential
for creating an “epidemic” of bipolar
disorder, because people are being
diagnosed with the condition based on
operational criteria that depend upon
subjective judgements (rather than an
objective criterion of disability, such as
hospitalization or being off work for a
month). The potential is compounded
in the pediatric domain by the fact
that the diagnosis is based on caregiver
reports with little scope in most clinical
practice for critical scrutiny of the
social forces that may lead to these
reports. Experts that appear willing
to go so far as to accept the possibility
that the fi rst signs of bipolar disorder
may be patterns of overactivity in
utero [32] can only further compound
these problems. If the resulting
diagnoses were provisional, aimed
at researching the natural history of
childhood irritability, rather than
reaching diagnoses that lead on to
pharmacotherapy, there might be
little problem. However, drugs such as
Zyprexa and Risperdal are now being
used for preschoolers in America with
little questioning of this development
Far from research bringing a
skeptical note to bear on clinical
DOI: 10.1371/journal.pmed.0030185.g002
Figure 2. Author’s Graph of p-Value
Function Based on Data in [30]
(Illustration: Sapna Khandwala)
April 2006 | Volume 3 | Issue 4 | e185
PLoS Medicine | 0004
enthusiasm, it appears to be adding
fuel to the fi re. What might once have
been thought of as sober institutions,
such as Massachusetts General
Hospital, have run trials of Risperdal
and Zyprexa on children with a
mean age of four years old [34,35].
Massachusetts General Hospital in fact
recruited trial participants by running
its own television adverts featuring
clinicians and parents alerting parents
to the fact that diffi cult and aggressive
behavior in children aged four and
up might stem from bipolar disorder.
This does more than recruit patients
with a clear disorder; it suggests that
everyday behavioral diffi culties may
be better seen in terms of a disorder.
Given that bipolar disorder in children
is all but unrecognised outside the
US, it seems likely that a signifi cant
proportion of these children will not
meet conventional DSM criteria for
bipolar I disorder. And given that it is
all but impossible for a short-term trial
of sedative agents in pediatric states
characterized by overactivity not to show
some rating scale changes that can be
regarded as benefi cial, the outcomes
of this research are likely to appear to
validate the diagnosis and increase the
pressure for treatment.
Several years after Heather Norris
was diagnosed with bipolar disorder,
the rationale for mood stabilization
was greatly weakened by the results
of the largest-ever randomized
trial of immediate versus deferred
anticonvulsant therapy for people
who had experienced a single seizure
[36]. The trial found that although
immediate antiepileptic drug
treatment reduces the occurrence
of seizures in the next 1–2 years,
such treatment does not affect long-
term remission in individuals with
single or infrequent seizures. The
use of psychotropic medication for
bipolar disorders was based on an
analogy with epilepsy, rather than
on demonstrations of proven clinical
benefi ts over the long term or on
the basis of a correction of a known
pathophysiology. The absence of a
solid theoretical or empirical basis
for using psychotropic medication as
“mood stabilizers” raises questions as
to what lies in store for the Heather
Norris’s and others of this world
exposed to these complex psychotropic
agents from such a young age. 
Supporting Information
Figure S1. Episheet Showing Author’s
Relative Risk Calculation, Based on Data in
Found at DOI: 10.1371/journal.
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April 2006 | Volume 3 | Issue 4 | e189
It is often said that leading drug
companies now spend more
on marketing than on research
and development [1]. While such
contemporary pharmaceutical
marketing practices are sometimes
believed to be a modern phenomenon,
they are in fact a direct continuation
of 19th-century patent medicine
advertising. “Nostrum-mongers,” as the
novelist Henry James dubbed them,
are noted in the history of advertising
as having been the leading spenders
on, and foremost originators of,
advertising technique [2,3]. Nostrum
sellers pioneered print advertising,
use of trademarks and distinctive
packaging, “pull” or demand-
stimulation strategies, and even the
design and commissioning of medical
almanacs that functioned as vehicles for
promotion of disease awareness. Henry
James’s psychologist brother, William
James, was so exasperated by “the
medical advertisement abomination”
that in 1894 he declared that “the
authors of these advertisements should
be treated as public enemies and have
no mercy shown” (see page 235 in [4]).
There is no doubt that drug
company discoveries have profoundly
improved upon our capacity to treat
illness. But pharmaceutical marketing
is more closely aligned with consumer
marketing in other industries
than with medicine, for which the
consequences are not trivial. Once we
view pharmaceutical industry activities
in this light, we can disentangle
industry’s infl uence on contemporary
medicine. Because we believe that
we owe corporations our wealth and
well-being, we tend not to question
corporations’ fundamental practices,
and they become invisible to us. What
follows is an attempt to demystify some
of the assumptions at work in the
“culture of marketing,” toward the goal
of explaining contemporary disease
Beliefs about the Free Market
There are three beliefs commonly
associated with the “free market.” The
rst is that human beings are creatures
of limitless but insatiable needs, wants,
and discomforts. The second is that
the free market is a place where these
needs might be satisfi ed through the
exercise of free choice. The last of
these beliefs is that the surest avenue
to innovation in all industries is
unfettered competition in the market.
Insatiable needs. The anthropologist
Marshall Sahlins theorizes that the
belief in unlimited wants is unique in
the West, and stems from the Christian
notion of “fallen man” as sufferer.
This results, says Sahlins, in a peculiar
idea of the person “as an imperfect
creature of need and desire, whose
whole earthly existence can be reduced
to the pursuit of bodily pleasure and
the avoidance of pain” [5]. A historical
and philosophical examination of
professional marketing shows that an
assumption of boundless needs and
wants is also at the heart of marketing
theory. In this sense, marketing can
be regarded as the institutionalization
of this view of human nature. The
marketer’s challenge is to translate
those limitless needs into profi ts.
Sahlins also points out that “in
the world’s richest societies, the
subjective experience of lack increases
in proportion to the objective output
of wealth” [6]. In other words, the
richer we get, the more we want.
One explanation of this paradox lies
in the way marketing activities are
instrumental in getting us to think
more about what we lack. Marketers
and advertisers project and refl ect back
to us our discontent with the status
quo. Americans are said to spend,
on average, three years of their lives
watching television advertisements, and
the effect is that they are conditioned
to want more and more. According
to the advertisements, the viewer’s
personal anxieties and dissatisfactions
are best addressed by consumption.
This same message lies at the heart of
much pharmaceutical advertising.
Lifestyle choices. In a consumer
society, when individuals make choices
toward the satisfaction of their needs
and wants, they experience this as
constructing their own individuality
Pharmaceutical Marketing and the Invention
of the Medical Consumer
Kalman Applbaum
Funding: The author received no specifi c funding for
this article.
Competing Interests: The author has declared that
no competing interests exist.
Citation: Applbaum K (2006) Pharmaceutical
marketing and the invention of the medical
consumer. PLoS Med 3(4): e189.
DOI: 10.1371/journal.pmed.0030189
Copyright: © 2006 Kalman Applbaum. This is an
open-access article distributed under the terms
of the Creative Commons Attribution License,
which permits unrestricted use, distribution, and
reproduction in any medium, provided the original
author and source are credited.
Kalman Applbaum teaches medical anthropology at
the University of Wisconsin Milwaukee, Milwaukee,
Wisconsin, United States of America. KA is the author
of The Marketing Era: From Professional Practice
to Global Provisioning (Routledge 2004). E-mail:
The Essay section contains opinion pieces on topics
of broad interest to a general medical audience.
DOI: 10.1371/journal.pmed.0030189.g001
Pills are often marketed as a solution to
human anxieties and dissatisfactions
PLoS Medicine | 0002
and identity. This special consumer
identity is what people refer to when
they use the word lifestyle, though
they may not realize the consumerist
implications of the word. Marketing
claims to provide a solution to the
problem of unlimited needs and wants,
while simultaneously enhancing free
choice and the construction of lifestyle.
In pharmaceuticals specifi cally,
“lifestyle drug” marketing techniques
were honed in the 1980s and 1990s for
cosmetic and sexual enhancements
[7,8]. These techniques have been
broadened to include other areas
of medicine. The campaigns used
to market cosmetic and sexual
enhancements were focused on
expanding perceived need for these
products, and in this respect were
a simple extension of customary
marketing conduct that had existed
for over half a century. The crossover
to curative medicine occurred with
psychotropic drugs, which have a very
wide range of active properties, thus
granting the marketer latitude in
reinterpreting their value back to the
consumer. For example, one class of
antidepressants, the specifi c serotonin
reuptake inhibitors, is marketed for
eight distinct psychiatric conditions,
ranging from social anxiety disorder
to obsessive-compulsive disorder to
premenstrual dysphoric disorder.
And “lifestyle marketing” has now
extended to the promotion of many
of the blockbuster “maintenance
drugs” intended for daily, lifelong
consumption, such as drugs for
allergies, insomnia, and acid refl ux.
As a result of this sequence of
events, industry opened the treatment
of the inside of the body—the fi nal
frontier—to the same logic that
governs all other marketing. Whether,
in the antidepressant market, the
“distribution channel captain,” as
marketers refer to the predominant
competitor, ends up sailing the
serotonin reuptake channel (the
serotonin reuptake inhibitors) or the
norepinephrine reuptake channel (the
challenger, serotonin–norepinephrine
reuptake inhibitors) may yet be
determined by marketing rather than
by medical jockeying.
Competition among drug companies
yields innovation. It is an article of
faith among free market devotees
that breakthroughs spring not from
paternalistic expert systems such
as medicine but from industrial
competition. As long as fi rms are
committed to producing medications
to treat diseases—as they are
classifi ed by medical science—this
argument has some authority. But
once a fi rm becomes principally
driven by marketing—the case for
most companies in most industries
since the 1980s—then innovation
comes to mean an elaboration of
meaningless differences among
a fi eld of comparable “me too”
products. “If marketing is seminally
about anything,” said Theodore
Levitt, one of the towering fi gures
of marketing and former editor of
the Harvard Business Review, “ it is
about achieving customer-getting
distinction by differentiating what you
do and how you operate” [9]. More
harmfully, expanding and altering
the consumer’s perception of disease
is just as effective, and evidently a lot
easier, than fi nding new cures.
From Patients to Medical
Since, in a consumer society, we
see ourselves as individuals and
as free agents when we exercise
consumer choice, it is not diffi cult for
pharmaceutical companies and other
privatized health-care deliverers to
convince us that it is empowering to
think of ourselves not as patients but
as consumers. This conversion from
patient to consumer also paves the way
for the erosion of the doctor’s role as
expert. A startling report of this was
described in a recent New York Times
article: “For a sizable group of people
in their 20’s and 30’s, deciding on their
own what drugs to take—in particular,
stimulants, antidepressants and other
psychiatric medications—is becoming
the norm. Confi dent of their abilities
and often skeptical of psychiatrist’s
expertise, they choose to rely on
their own research and each other’s
experience in treating problems like
depression….A medical degree, in
their view, is useful but not essential”
[10]. This phenomenon, the article
suggested, is “driven by familiarity”
with the drugs. The emergence of
this potentially dangerous situation
demonstrates an unchecked expansion
of the drug industry into an already
accepted mode of thought—that “every
minor mood fl uctuation,” as the article
reported, can and should be remedied.
Promoting consumer familiarity
with drugs is one example of the very
broad infl uence of the pharmaceutical
industry. This infl uence extends to
clinical trial administration, research
publication, regulatory lobbying,
physician and patient education, drug
pricing, advertising and point-of-use
promotion, pharmacy distribution,
drug compliance, and the legal and
ethical norms by which company
practices themselves are to be
evaluated. Actors traditionally found
outside the “distribution channel” of
the market are now incorporated into
it as active proponents of exchange.
Physicians, academic opinion
leaders, patient advocacy groups
and other grass roots movements,
nongovernmental organizations,
public health bodies, and even
ethics overseers, through one means
or another, have one by one been
enlisted as vehicles in the distribution
chain. The inclusion of patients in
the distribution chain fundamentally
changes their role from recipients
of medical care to active consumers
of the latest pharmaceuticals, a role
which surely helps to support industry
profi ts.
Ethical Justifi cation for Marketing
Because illness is one of the most
tangible forms of suffering, the
pharmaceutical industry, more than
other industries, can link its marketing
activities to ethical objectives. The
result is a marriage of the profi t-
seeking scheme in which disease is
regarded as “an opportunity” to the
ethical view that mankind’s health
hangs in the balance. Marketers and
consumers in the West to some extent
share a common vision of needs and
the terms of their satisfaction. This
apparent complicity helps even the
most aggressive marketers trust that
they are performing a public service.
Pharmaceutical company managers
that I speak to signal this when they
characterize their engagement with
the public as “doing good while doing
An assumption of
boundless needs and
wants is at the heart of
marketing theory.
April 2006 | Volume 3 | Issue 4 | e189
PLoS Medicine | 0003
These managers also see nothing
wrong with integrating doctors,
patients, and other players into
the drug distribution channel. On
the contrary, they say, this is state-
of-the-art management, making it
professionally principled and tactically
astute. Marketers also regard the
incorporation of consumers into
the channel as ethical because then
people’s needs can best be determined
and satisfi ed, conferring upon them the
power of self-determination through
But this choice is an illusion. For in
our pursuit of a near-utopian promise
of perfect health, we have, without
realizing it, given corporate marketers
free reign to take control of the true
instruments of our freedom: objectivity
in science, ethics and fairness in health
care, and the privilege to endow
medicine with the autonomy to fulfi ll
its oath to work for the benefi t of the
sick. 
1. Angell M (2004) Over and above: Excess in the
pharmaceutical industry CMAJ 171: 1451.
2. Young JH (1961) The toadstool millionaires: A
social history of patent medicines in America
before federal regulation. Princeton (New
Jersey): Princeton University Press. 282 p.
3. Lears J (1994) Fables of abundance: A cultural
history of advertising in America. New York:
Basic Books. 512 p.
4. Laird PW (1998) Advertising progress:
American business and the rise of consumer
marketing. Baltimore (Maryland): Johns
Hopkins University Press. 480 p.
5. Sahlins M (1994) Cosmologies of capitalism:
The trans-pacifi c sector of “The World System.”
In: Eley G, Dirks NB, Ortner SB, eds. Culture/
power/history: Reader in contemporary social
theory. Princeton (New Jersey): Princeton
University Press. pp. 412–456.
6. Sahlins M (1996) The sadness of sweetness:
The native anthropology of Western
cosmology. Curr Anthropol 37: 395–428.
7. Lexchin J (2006) Bigger and better: How Pfi zer
redefi ned erectile dysfunction. PLoS Med 3:
e132. DOI: 10.1371/journal.pmed.0030132
8. Tiefer L (2006) Female sexual dysfunction: A
case study of disease mongering and activist
resistance. PLoS Med 3: e178. DOI: 10.1371/
9. Levitt T (1986) The marketing imagination.
New York: Free Press. 238 p.
10. Harmon A (2005 November 16) Young,
assured and playing pharmacist to friends. New
York Times. Available: http:⁄⁄www.nytimes.
5088&partner=rssnyt&emc=rss. Accessed 6
March 2006.
April 2006 | Volume 3 | Issue 4 | e189
PLoS Medicine | 0001
April 2006 | Volume 3 | Issue 4 | e146
The challenge of combating the
current epidemic of disease
mongering is daunting, and
anyone looking for ready solutions
should read no further. Those seeking
a way forward fi nd themselves ranged
against powerful economic, political,
and professional interests. There is
an apparently limitless amount of
money to be made from marketing
pharmaceutical remedies for diseases
and even more from remedies to
reduce risk factors for disease. An
emphasis on the treatment of disease
minimises political responsibility for
those fundamental causes of disease
that are located within the structure of
society, and substantial and lucrative
professional careers have been built on
the endless pursuit of new diseases or
risk factors for disease.
More fundamentally, disease
mongering exploits the deepest
atavistic fears of suffering and death.
Throughout history, humanity has
kept such fears at bay by accepting
burdens and sacrifi ces in the present
in the hope of future salvation.
In earlier times, the mediator was
religion and the salvation was to come
after death. Now, for those without
religious belief, death has become
more fi nal, and salvation must be
sought before death in an ever-
expanding longevity. An adequate
response to the false hopes raised
by disease mongering will demand,
from those in positions of power and
infl uence, an ability to acknowledge,
accommodate, and move beyond these
profound existential fears [1]. Such
ability is rare.
The way forward will rely on a
capacity to rediscover courage and
stoicism as both private and civic
virtues, alongside seeking a radical
realignment of the relationship
between economic, political, and
professional interests. Doctors and
biomedical scientists, in particular,
have a responsibility not only to put
their own house in order but to provide
much better advice to politicians and
to the public, both as patients and as
The Challenge to Professionals
The fi rst step has to be a genuine
disentanglement of the medical
profession from the pharmaceutical
industry—there really is no such thing
as a free lunch [2]. The pharmaceutical
industry spends millions of dollars
supporting the “education” of doctors
because it is in its economic interest
to do so (Figure 1). If prescribing
activities and industry profi ts were
not affected by this support, it would
not be offered. Doctors can only
provide appropriately independent
and authentic advice to patients and,
indeed, to politicians if they are seen
to be completely independent of other
powerful interests. Politicians genuinely
interested in the welfare of patients and
the health of citizens should actively
promote such independence [4].
Beyond this, there is a need for
better science that has the integrity to
demand more explicit acknowledgment
of the limits of medical knowledge,
less extrapolation beyond research
ndings, and much more responsible
use of statistics, so that the true extent
of the benefi ts and harms of proposed
treatments can be properly understood.
The rhetoric surrounding disease
mongering suggests that it will promote
health, but the effect is in fact the
opposite. Much disease mongering
relies on the pathologising of normal
biological or social variation and on
the portrayal of the presence of risk
factors for disease as a disease state in
itself. When pharmaceuticals are used
to treat risk factors, the vicious circle is
completed because “anyone who takes
medicines is by defi nition a patient” [5].
Most variables are distributed
across a continuum, but despite this,
the medical tradition has been to
dichotomise the continuum into normal
and abnormal [6]. Within a continuum,
there can never be a clear boundary,
so the defi nition of disease is inevitably
both arbitrary and fl uid. It is in the
interests of pharmaceutical companies
to extend the range of the abnormal
so that the market for treatments is
proportionately enlarged. We have seen
this process operating, for example, in
the continual lowering of thresholds
for treatment of blood pressure and
lipids—the most recent guidelines from
the European Society of Cardiology
can be used to identify 76% of the total
adult population of a county of Norway
as being at “increased risk” [7].
We need to reverse this situation so
that instead of defi ning an arbitrary
threshold of abnormality, governments
Combating Disease Mongering:
Daunting but Nonetheless Essential
Iona Heath
Funding: The author received no specifi c funding for
this article.
Competing Interests: The author has declared that
no competing interests exist.
Citation: Heath I (2006) Combating disease
mongering: Daunting but nonetheless essential. PLoS
Med 3(4): e146.
DOI: 10.1371/journal.pmed.0030146
Copyright: © 2006 Iona Heath. This is an open-access
article distributed under the terms of the Creative
Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in
any medium, provided the original author and source
are credited.
Iona Heath is a general practitioner at the Caversham
Practice, London, United Kingdom. E-mail: iona.
The Essay section contains opinion pieces on topics
of broad interest to a general medical audience.
Disease mongering
exploits the deepest
atavistic fears of
suffering and death.
PLoS Medicine | 0002
would make a judgement about the
appropriate level of investment in
preventive technologies for currently
healthy populations, and set the
thresholds for intervention accordingly.
For example, a government might
decide to treat the 10% of the
population most at risk of ischaemic
heart disease, and could then calculate
the thresholds of blood pressure and
cholesterol, which would identify this
most vulnerable 10% of the population.
Clearly, these thresholds would be
much higher than those recommended
Preventing Disease through
Population-Based Measures
The seeds of the current situation
were already present 21 years ago,
when Geoffrey Rose wrote his seminal
paper entitled “Sick individuals and
sick populations” [4]. In this paper,
he showed that risk factors for health
are almost always distributed across a
bell curve and argued that more could
be achieved by attempting to shift
the whole of the bell curve than by
targeting those at highest risk (Figure
2). His rationale was that the large
number of people at low risk may give
rise to more cases of disease than the
small number who are at high risk.
There has been general acceptance of
this argument, but Rose’s own warnings
seem to have been lost.
Rose was careful to list the
disadvantages of attempting to shift the
whole bell curve, which included (1) a
“worrisome” benefi t–risk ratio (there
is only a small possibility of benefi t
for any one individual, but everyone
is exposed to the intervention and
thereby to any adverse effects, such as
medicalisation, anxiety, and side effects
of treatments) and (2) poor motivation
on the part of individual patients, each
of whom had a very small chance of
benefi t. These predicted disadvantages
have become more and more apparent,
so there has been a systematic attempt
to improve motivation through the
explicit use of fear, which in itself
erodes and undermines health. “If
you don’t take more exercise, improve
your diet or take this medication,
you actively put yourself at risk of an
untimely death.”
Rose was also very careful to
distinguish between two approaches to
shifting the bell curve. The fi rst restores
biological normality by preventing
exposure to hazards such as tobacco
smoke or industrial air pollution.
The second approach is to interpose
some new, supposedly protective
intervention, but this is much less
robust because it leaves the underlying
causes intact. The current use of
pharmaceuticals for public health
policy falls into this category. As more
and more risk factors are identifi ed,
closely followed by a pharmaceutical
treatment for each, the ambition to
shift the whole bell curve legitimises
the wholesale drug treatment of
healthy populations at vast expense
and with huge pharmaceutical profi ts.
There is a clear need to reiterate Rose’s
distinction and prioritise the reduction
of exposure to biological hazards above
the application of pharmaceutical
Current trends raise the prospect of
exponential spending on preventive
pharmaceuticals, justifi ed by potential
long-term benefi ts to an unidentifi able,
but statistically signifi cant, number
of people in the population. When
doctors treat patients with diseases,
progress can be assessed and the
outcome is measurable. This means
that if the patient responds to
treatment, it can be continued; if
not, the treatment can be stopped.
When doctors treat people who are
merely at risk of disease, the outcome
is probabilistic, so whether disease
is prevented or was never going to
develop, the treatment continues
indefi nitely [9].
Shifting the bell curve through
population-based interventions aimed
at protecting health is part of a long
and magnifi cent tradition which began
when John Snow capped the Broad
Street pump; shifting the bell curve
through the mass pharmaceutical
treatment of individuals turns out to
be something quite different. Further,
where individualised solutions become
prevalent, societal, population-based
interventions tend to fall away, and the
result is worsening health inequalities.
The medical profession needs to
do much more to defi ne sensible
limits to medical intervention. There
is a clear and urgent need for more
research into the psychological impact
and the wider health consequences of
being labelled “at risk” [10]. Doctors,
and society as a whole, need to stop
confusing health with happiness [11].
This confusion is at the root of much
of the medicalisation of normal human
variation that we are witnessing. Male
pattern baldness and shyness, to take
just two examples, are not diseases
but normal parts of the range of
human experience. We are witnessing
diagnostic drift in a whole range of
conditions, from depression [12] to
hypertension [13], with pressure for
more and more people to be included
within the range of abnormal and
offered treatment. The justifi cation
for these treatments is often based
on short-term studies, which are
then extrapolated over much longer
time periods. There is insuffi cient
recognition of the fact that the less
the need for treatment, the higher
the number needed to treat for given
outcomes and the higher the risk
to patients, since the rate of adverse
effects remains constant.
The Challenge to Politicians
Politicians are charged with overseeing
the organisation of society for the
benefi t of all. A major political
achievement of Western societies,
with the very notable exception
of the United States, has been the
provision of universal health-care
systems available and accessible to
all. There is now a pressing need
for politicians to recognise the
threat to these systems, and to the
social solidarity that they embody,
posed by exponential increases in
pharmaceutical expenditure. No
universal health-care system funded by
taxation can pay for the pharmaceutical
treatment of all risks to health. There
are very diffi cult decisions to be made,
but politicians must balance the wish
to support a vibrant and innovative
DOI: 10.1371/journal.pmed.0030146.g001
Figure 1. Percentage of Doctors That Use
Information Provided by Drug Company
Representatives in Their Clinical Practice
Data derived from [3].
(Image: Adapted from a slide presentation
created by No Free Lunch, http://www.
April 2006 | Volume 3 | Issue 4 | e146
PLoS Medicine | 0003
pharmaceutical industry—and the
undoubted economic, employment,
and therapeutic benefi ts that drug
companies bring—against the
increasing capacity of this industry to
bankrupt universal health-care systems.
Part of the rationale for expenditure
on the treatment of health risks is
that it will reduce health costs in the
long run, but such arguments do not
stand up to close scrutiny. The costs of
health care are highest during the year
before death, regardless of the age at
which death occurs. Everyone must die
and be cared for while dying, and no
amount of preventive pharmaceuticals
can reduce the cost of providing this
crucial end-of-life care [14]. The aim
of preventive health care should be
the reduction of untimely deaths in
relatively young people, but the fear
of accusations of ageism in health care
means that doctors are encouraged
to go on prescribing preventive
pharmaceuticals to people well into
their late eighties and nineties [15].
In any system of health care
predicated on social solidarity, the
rights of individuals to treatment have
to be balanced against the duties of
citizens to provide the appropriate
level of funding. Citizens agree to pay
tax for the care of those who are sick,
with the understanding that they, too,
will be cared for should they, in turn,
become sick. It remains unclear how far
this pact of social solidarity extends to
paying for the treatment of risk factors
and marginal “diseases”, where the
benefi ts in terms of reducing suffering
are much less clear. Publicly funded
preventive treatment of risk factors
for those who have already exceeded
the average life expectancy seems
particularly hard to justify.
Socioeconomic deprivation has
been described as a “fundamental
cause” of disease, which works
through a multiplicity of risk factors
and pathophysiological pathways
to produce multiple disease states
[16]. Even if one of these pathways
is interrupted by the application of a
preventive technology, an association
between a fundamental cause and
disease will reappear in a different
form. The closer to the individual the
intervention is situated, the less likely
the improvement in health status is to
be maintained.
In mental health problems, we see
this process operating when people
are helped to cope with poor housing
and lack of rewarding employment
through the provision of counselling,
rather than better social conditions.
Population-based interventions favour
the poor because such interventions
are applied universally and the poor
are the most at-risk; individually
based interventions favour the rich
because they are more likely to make
use of what is offered. For this reason,
population approaches to tackling the
fundamental causes of socioeconomic
deprivation must remain the most
effective way of tackling health
inequalities [17]. However, there is also
a continuing role for individually based
treatment of those at the highest risk
of particular diseases, but this must be
effectively targeted if inequalities are
not to be exacerbated.
Age is another fundamental cause of
disease, less remediable than poverty
but again generating multiple risk
factors and multiple disease outcomes.
All clinicians are familiar with the
processes by which treating one disease
in a frail, older person will often mean
that symptoms reappear through
another pathway. Authentic health care
for the old and frail has much more
to do with helping to preserve their
dignity, treating them with affection,
and supporting their continued
involvement in social activities, rather
than the pursuit of ever-more elusive
cures. Politicians have a responsibility,
alongside doctors and many others, to
make such care available, and this in
itself will be an important part of the
way forward.
The huge amount of money
that can be made from preventive
technologies has diminished the
economic importance of treatment
technologies, particularly for those
illnesses that primarily affect poorer
people in poorer countries [18]. This
has meant a shift of attention from
the sick to the well and from the poor
to the rich [19]. This effect of global
markets requires a response in the
form of an assertion of global human
solidarity. Health inequalities matter
globally as well as locally. A way forward
might be through taxation or other
means, to make the sale of preventive
technologies in countries with above-
average expectation of life conditional
on the availability of treatment for
those diseases that cause the most
catastrophic shortening of life in poor
Human societies are riven by the effects
of greed and fear. The rise of preventive
health technologies has opened up
a new arena of human greed, which
responds to an enduring fear. The
greed is for ever-greater longevity; the
fear is that of dying. The irony and the
tragedy is that the greed infl ates the
fear and poisons the present in the
name of a better, or at least a longer,
future. Ultimately, the only way of
combating disease mongering is to
value the manner of our living above
the timing of our dying. 
DOI: 10.1371/journal.pmed.0030146.g002
Figure 2. Risk Factors for Health Are Almost
Always Distributed across a Bell Curve
Geoffrey Rose argued that more could be
achieved by attempting to shift the whole of
the bell curve (the “population approach” to
prevention) than by targeting those at highest
risk (the “high-risk” approach).
(Image: Adapted from a fi gure by John
Emberson from [8])
April 2006 | Volume 3 | Issue 4 | e146
1. Barnard D (1988) Love and death: Existential
dimensions of physicians’ diffi culties with
moral problems. J Med Philos 13: 393–409.
2. Abbasi K, Smith R (2003) No more free
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3. Caudill TS, Johnson MS; Rich EC, McKinney
WP (1996) Physicians, pharmaceutical sales
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Arch Fam Med 5: 201–206.
4. Moynihan R (2003) Who pays for the pizza?
Redefi ning the relationship between doctors
PLoS Medicine | 0004 April 2006 | Volume 3 | Issue 4 | e146
and drug companies. 2: Disentanglement. BMJ
326: 1193–1196.
5. Rose G (1985) Sick individuals and sick
populations. Int J Epidemiol 14: 32–38.
6. McKinlay JB, Marceau LD (1999) A tale of 3
tails. Am J Public Health 89: 295–298.
7. Getz L, Kirkengen AL, Hetlevik I, Romundstad
S, Sigurdsson JA (2004) Ethical dilemmas
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guidelines on cardiovascular disease prevention
in clinical practice. Scand J Prim Health Care
22: 202–208.
8. Makover ME, Ebrahim S (2005) What is the
best strategy for reducing deaths from heart
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9. O’Donnell JL, Smyth D, Frampton C (2005)
Prioritizing health-care funding. Intern Med J
35: 409–412.
10. Getz L, Sigurdsson JA, Hetlevik I (2003)
Is opportunistic disease prevention in the
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11. Saracci R (1997) The World Health
Organisation needs to reconsider its defi nition
of health. BMJ 314: 1409–1410.
12. Dowrick C (2005) Beyond depression. Oxford:
Oxford University Press. 240 p.
13. Woodman R (1999) Open letter disputes WHO
hypertension guidelines. BMJ 318: 893.
14. Higginson IJ (1999) Evidence-based palliative
care. BMJ 319: 462–463.
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(2006) Quality and outcomes framework
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PLoS Medicine | 0001
Policy Forum
April 2006 | Volume 3 | Issue 4 | e170
“[Restless legs syndrome] is quite a serious sleep
disorder that affects a lot of people....Their sleep is
disturbed and, unless they are really awake, they
will not be aware of it” [1].
Life can be hard. Sometimes you
feel sad or distracted or anxious.
Or maybe you feel a compelling
urge to move your legs. But does that
mean you are sick? Does it mean you
need medication?
Maybe, maybe not. For some people,
symptoms are severe enough to be
disabling. But for many others with
milder problems, these “symptoms”
are just the transient experiences of
everyday life. Helping sick people get
treatment is a good thing. Convincing
healthy people that they are sick is
not. Sick people stand to benefi t from
treatment, but healthy people may only
get hurt: they get labeled “sick,” may
become anxious about their condition,
and, if they are treated, may experience
side effects that overwhelm any
potential benefi t.
“Disease mongering” is the effort
by pharmaceutical companies (or
others with similar fi nancial interests)
to enlarge the market for a treatment
by convincing people that they are
sick and need medical intervention
[2]. Typically, the disease is vague,
with nonspecifi c symptoms spanning
a broad spectrum of severity—from
everyday experiences many people
would not even call “symptoms,” to
profound suffering. The market for
treatment gets enlarged in two ways:
by narrowing the defi nition of health
so normal experiences get labeled
as pathologic, and by expanding the
defi nition of disease to include earlier,
milder, and presymptomatic forms
(e.g., regarding a risk factor such as
high cholesterol as a disease in itself).
Discussions about disease
mongering usually focus on the role of
pharmaceutical companies—how they
promote disease and their products
through “disease awareness” campaigns
and direct-to-consumer drug
advertising, and by funding disease
advocacy groups. But diseases also get
promoted in another way: through
the news media. News reports are a
major source of health information
for people [3]. Unless journalists
approach stories about new diseases
skeptically and look out for disease
mongering by the pharmaceutical
industry, pharmaceutical consultants,
and advocacy groups, journalists, too,
may end up selling sickness.
The Case of Restless Legs
To get a sense of how the media works
in the context of a major disease
promotion effort, we examined news
coverage of “restless legs” (see sidebar).
In 2003, GlaxoSmithKline launched a
campaign to promote awareness about
restless legs syndrome, beginning with
press releases about presentations at
the American Academy of Neurology
meeting describing the early trial
results of using ropinirole (a drug
previously approved for Parkinson
disease) for the treatment of restless
legs [6,7]. Two months later,
GlaxoSmithKline issued a new press
release entitled “New survey reveals
common yet under recognized
disorder—restless legs syndrome—is
keeping Americans awake at night”
The Policy Forum allows health policy makers around
the world to discuss challenges and opportunities for
improving health care in their societies.
Giving Legs to Restless Legs: A Case Study
of How the Media Helps Make People Sick
Steven Woloshin*, Lisa M. Schwartz
Funding: SW and LMS were supported by Robert
Wood Johnson Generalist Faculty Scholar Awards.
This study was supported by a grant from the
National Cancer Institute (R01CA104721) and
from a Research Enhancement Award from the
Department of Veterans Affairs. The views expressed
herein do not necessarily represent the views of the
Department of Veterans Affairs or the United States
Competing Interests: The funders played no role
in the submission or preparation of this paper. The
authors have declared that no competing interests
Citation: Woloshin S, Schwartz LM (2006) Giving legs
to restless legs: A case study of how the media helps
make people sick. PLoS Med 3(4): e170.
DOI: 10.1371/journal.pmed.0030170
This is an open-access article distributed under the
terms of the Creative Commons Public Domain
declaration which stipulates that, once placed in the
public domain, this work may be freely reproduced,
distributed, transmitted, modifi ed, built upon, or
otherwise used by anyone for any lawful purpose.
Abbreviation: FDA, Food and Drug Administration
Steven Woloshin and Lisa M. Schwartz are at the
Veterans Affairs Outcomes Group, White River
Junction, Vermont, United States of America, and the
Center for the Evaluative Clinical Sciences, Dartmouth
Medical School, Hanover, New Hampshire, United
States of America.
* To whom correspondence should be addressed.
☯ These authors contributed equally to this work.
What Is Restless Legs
The diagnosis of restless legs
syndrome requires the presence of the
following four criteria [4]:
An urge to move the legs due to an
unpleasant feeling in the legs.
Onset or worsening of symptoms
when at rest or not moving around
Partial or complete relief by movement
(e.g., walking) for as long as the
movement continues.
Symptoms that occur primarily at night
and that can interfere with sleep or
The severity of disease is judged by
the frequency of these symptoms, which
can range from less than once a month
to many times a day. Recommended
treatments include stretching exercises
and less caffeine for intermittent
disease and various prescription drugs
(e.g., benzodiazepines and dopamine
agonists) for daily symptoms [5].
PLoS Medicine | 0002
about an internally funded and, at the
time, unpublished study [8]. In 2005,
the US Food and Drug Administration
(FDA) approved ropinirole for the
treatment of restless legs syndrome
(the fi rst drug approved specifi cally
for this indication). Since then, the
restless legs campaign has developed
into a multimillion dollar international
effort to “push restless legs syndrome
into the consciousness of doctors and
consumers alike” [9].
Newspaper Coverage of the
Restless Legs Syndrome
To identify media coverage related
to this campaign over two years
(November 2003–November 2005),
we did full-text searches of “major
newspapers” in Lexis-Nexis and
ProQuest databases and found 187
unique articles with the phrase “restless
legs.” We excluded articles not about
the syndrome (e.g., “Elvis’s restless
legs”), nonnews stories (e.g., health
advice columns, notices of restless legs
health screenings/support groups),
and articles with only passing mention
of restless legs (most of these were
about sleep disorders, another “new
yet largely unrecognized problem”).
We analyzed the remaining 33 articles
(all focused on restless legs syndrome)
using an explicit coding scheme
organized around the key elements of
disease mongering, as outlined in the
rst column of Table 1: exaggerating
the prevalence of the disease (e.g.,
uncritically accepting a broad
prevalence estimate), encouraging
more diagnosis (e.g., doctors fail to
recognize it), and suggesting that
all disease should be treated (e.g.,
overstating the benefi ts or minimizing
the harms of treatment).
Exaggerating Disease Prevalence
Figure 1 shows that the news articles
often included elements exaggerating
disease prevalence. Only one article
questioned the disease defi nition at all
(and portrayed the act of questioning
the defi nition as insensitive: “[the
patient] knows it can sound trivial.
That’s one of the problems with restless
legs. Radio show host Rush Limbaugh,
for example, has mocked it as a
pseudoillness” [10]).
Almost two-thirds of articles provided
an estimate of disease prevalence (most
commonly, statements such as “at least
12 million Americans suffer from the
syndrome” [11] or “[it] affects 1 in 10
Table 1. Key Elements of Disease Mongering and How the Media Could Do Better
Key Elements of Disease Mongering When the Media Can Get Co-opted Suggestions for Doing Better
Exaggerate the prevalence of disease
Create a broad disease defi nition based on
vague and prevalent symptoms.
Uncritically accepts disease defi nition. Learn exact defi nition of disease and question whether it is appropriately
specifi c.
Publicize a large prevalence estimate. Uncritically repeats a broad prevalence estimate. Determine whether the prevalence estimate is credible: Are the “gold
standard” diagnostic criteria being used as designed? Does the sample
truly represent the general population?
Blur the distinction between mild and severe
Highlights the important physical, social, and
emotional consequences of severe disease; only
telling anecdotes of people with very severe
Be clear about the spectrum of disease. When describing important
consequences or personal anecdotes, provide the appropriate
prevalence estimate by stating proportion with disease this severe.
Encourage more diagnosis
Highlight that doctors fail to recognize
Quotes an “expert” about how doctors miss the
diagnosis; provides anecdotes of people whose
diagnoses were missed.
Acknowledge the problems of overdiagnosis (e.g., downside of labeling
people with disease or medicalizing healthy people).
Encourage people to see themselves as sick. Presents anecdotes or descriptions of people who
are unaware that they are sick; encourages self-
diagnosis (e.g., symptom checklist).
Same as above.
Promote disease awareness (e.g., disease
awareness week, screening clinics, support
groups, disease foundations).
Publicizes disease awareness activities without
noting industry involvement (e.g., “nonprofi t”
Learn and state whether disease awareness activities are industry
Suggest that all disease should be treated
Exaggerate the benefi ts of the drug for
everyone with disease.
Overstates the benefi t by providing only
qualitative descriptions (e.g., only stating
“signifi cant improvement” or telling stories of
dramatic benefi t).
Objectively report benefi t by quantifying how well the drug works (e.g.,
present the proportion with clinically important symptom improvements
in the drug and comparison group). Be clear about the populations
studied (i.e., acknowledge that the benefi t is much smaller for people
with mild disease).
Overstates the benefi t by using miracle language
to describe the benefi t.
Avoid miracle language.
Overstates the benefi t by quoting a strong claim
of benefi t from researchers with strong industry
Learn and state industry ties of researchers who make strong claims
about a drug’s benefi t.
Imply that there is no downside to
Minimizes the harms by not mentioning the
possibility of them or by only telling stories of
people who did not experience any harms.
Quantify side effects (e.g., present the proportion with side effects in the
drug and comparison group).
Imply that long- term treatment is safe and
Ignores concerns about duration of clinical trials
(e.g., not mentioning length of follow-up).
Caution readers that although treatment is generally long term, the
longest study was x weeks. So, the long-term benefi ts and harms are
DOI: 10.1371/journal.pmed.0030170.t001
April 2006 | Volume 3 | Issue 4 | e170
PLoS Medicine | 0003
adults in the United States” [12]). No
article questioned the validity of the
prevalence estimates. In fact, there
are reasons to believe the estimates
overstate the prevalence of clinically
meaningful disease. For example, the
frequently cited 10% estimate came
from a study that used a single question
to identify restless legs syndrome rather
than the four standard criteria [13].
The less stringent defi nition infl ates
the estimate because people with
other causes of leg symptoms (e.g.,
leg cramps or diabetic neuropathy)
are counted incorrectly as having the
In a recent large study, only 7%
of respondents reported all four
diagnostic criteria, and only 2.7%
reported moderately or severely
distressing symptoms two or more
times per week (i.e., the group for
whom medical treatment might be
appropriate) [14]. Even the 2.7%
estimate is probably too high, because
of bias inherent in the study sample.
The authors claimed an implausible
98% response rate to their random-
digit dial survey (typical response rates
are 50%–70% [15]). Most likely, the
authors meant that 98% of individuals
who agreed to participate completed
the survey. But respondents agreeing
to participate in a restless legs study
are more likely to have leg-related
symptoms than nonrespondents.
Nearly three-quarters of newspaper
articles highlighted the potentially
serious physical, social, and emotional
consequences of restless legs: “…the
condition sounds like a joke, but its
consequences can be devastating.
Driven to despair by years of sleepless
nights, patients have become suicidal”
[16]). While over 40% of the articles
provided anecdotes about people with
severe disease, no article provided
anecdotes about people who did
not fi nd their symptoms especially
Encourage More Diagnosis
The articles also reinforced the
need for more diagnosis. About
half reported that the syndrome
is underdiagnosed by physicians
(“…relatively few doctors know about
restless legs. This is the most common
disorder your doctor has never heard
of” [17]) and underrecognized by
patients (“…many people can suffer in
silence for years before it is recognized”
[18]). One-quarter of articles
encouraged patient self-diagnosis and
suggested people ask their doctor
whether restless legs might explain
various problems (including insomnia,
daytime fatigue, attention defi cit
disorder in children, and depression).
One-fi fth of articles referred readers
to the “nonprofi t” Restless Legs
Foundation for further information;
none reported that the foundation is
heavily subsidized by GlaxoSmithKline.
No article acknowledged the possibility
of overdiagnosis (the idea that some
people will be diagnosed unnecessarily
and take medication they do not really
Suggest That All Disease Should
Be Treated
About half the news stories mentioned
the drug ropinirole by name. Only one
story quantifi ed the drug’s benefi t.
By contrast, about half the stories
mentioning ropinirole included
anecdotes about patients who took
the drug (and in most cases noted
substantial improvement). One-third
of articles used “miracle language”
to describe patient response to
medication (e.g., “it has been a
miracle drug for me” [19]). The actual
benefi t of the drug is modest. The
drug label reports that in a 12-week
US clinical trial, restless legs symptom
scores (measured on a 40-point scale)
improved by 13.5 points for patients
taking ropinirole compared with 9.8
points for those taking placebo [20].
In more clinical terms, 73% taking
ropinirole responded to the drug (i.e.,
restless legs scores improved by six
points) compared with 57% taking
The drug label [20] also notes that
ropinirole has a number of side effects,
including nausea (40% in ropinirole
group versus 8% in placebo group) and
dizziness (11% versus 5%, respectively).
Somnolence and fatigue (ostensibly,
the real target of the drug) were also
higher in the ropinirole versus the
placebo group (12% versus 6%; 8%
versus 4%, respectively). Nonetheless,
April 2006 | Volume 3 | Issue 4 | e170
DOI: 10.1371/journal.pmed.0030170.g001
Figure 1. Frequency of Key Elements of Disease Mongering in Newspaper Articles
Top bar graph analyzes all articles about restless legs syndrome. Bottom bar graph analyzes the
subset that mentions ropinirole.
PLoS Medicine | 0004
only fi ve of the 15 articles mentioning
ropinirole noted that it could have
side effects and just one quantifi ed the
chance of any side effect (“nausea was
the most common side effect, reported
in 38% of patients” [18]). Finally,
only one news story noted that the
ropinirole trials were “relatively short”
in duration (the longest was 36 weeks),
despite the fact that many people
would use the drug for years or even a
Suggestions for How the Media
Could Do Better
Unfortunately, there is no obvious
way to distinguish information from
infomercial. In Table 1, we highlight
clues that should alert journalists to
the presence of disease mongering,
and suggest some things they can do to
expose these efforts.
First, journalists should be very
wary when confronted with a new
or expanded disease affecting large
numbers of people. If a disease is
common and very bothersome, it is
hard to believe that no one would have
noticed it before. Prevalence estimates
are easy to exaggerate by broadening
the defi nition of disease. Journalists
need to ask exactly how the disease is
being defi ned, whether the diagnostic
criteria were used appropriately,
and whether the study sample truly
represents the general population
(e.g., patients at an insomnia clinic
cannot be taken to represent the
general public).
Journalists should also refl exively
question whether more diagnosis is
always a good thing. Simply labeling
people with disease has negative
consequences [21]. Similarly,
journalists should question the
assumption that treatment always
makes sense. Medical treatments
always involve trade-offs; people with
mild symptoms have little to gain, and
treatment may end up causing more
harm than good.
Finally, instead of extreme,
unrepresentative anecdotes about
miracle cures, journalists should
help readers understand how well
the treatment works (e.g., what is the
chance that I will feel better if I take
the medicine versus if I do not?) and
what problems it might cause (e.g.,
whether I might be trading less restless
legs for daytime nausea, dizziness, and
The news coverage of restless legs
syndrome is disturbing. It exaggerated
the prevalence of disease and the need
for treatment, and failed to consider
the problems of overdiagnosis. In
essence, the media seemed to have
been co-opted into the disease-
mongering process. Although our
review was limited to the coverage of a
single disease promotion campaign, we
think it is likely that our fi ndings would
apply to others. It is easy to understand
why the media would be attracted to
disease promotion stories and why
they would be covered uncritically.
The stories are full of drama: a huge
but unrecognized public health crisis,
compelling personal anecdotes,
uncaring or ignorant doctors, and
miracle cures.
The problem lies in presenting
just one side of the story. There
may be no public health crisis, the
compelling stories may not represent
the typical experience of people with
the condition, the doctors may be
wise not to invoke a new diagnosis for
vague symptoms that may have a more
plausible explanation, the cures are far
from miraculous, and healthy people
may be getting hurt.
We think the media could report
medical news without reinforcing
disease promotion efforts by
approaching stories like “restless legs”
with a greater degree of skepticism.
After all, their job is to inform readers,
not to make them sick. 
April 2006 | Volume 3 | Issue 4 | e170
We would like to thank Elliott Fisher and
Brenda Sirovich for helpful comments on
earlier drafts.
1. Revill J (2004 September 19) Restless legs
keep 6m awake. The Observer. Available:
0,,1307797,00.html. Accessed 2 March 2006.
2. Moynihan R, Cassels A (2005) Selling sickness.
How the world’s biggest pharmaceutical
companies are turning us all into patients. New
York: Nation Books. 254 p.
3. Kaiser Family Foundation (2005) Kaiser
health poll report: Public opinion snapshot on
health information sources—July 2005. Menlo
Park (California): Kaiser Family Foundation.
Available: http:⁄⁄
pomr071805oth.cfm. Accessed 2 March 2006.
4. Reuters (2005 May 6) Glaxo drug for restless
legs syndrome is approved. The New York
Times; Sect C: 3.
5. Silber M, Ehrenberg B, Allen R, Buchfuhrer
M, Earley C, et al. (2004) An algorithm for the
management of restless legs syndrome. Mayo
Clin Proc 79: 916–922.
6. GlaxoSmithKline (2003 April 1) Restless
legs syndrome can signifi cantly impair
quality of life. Research Triangle Park
(North Carolina): GlaxoSmithKline.
Available: http:⁄⁄
402&newsid=175. Accessed 7 March 2006.
7. GlaxoSmithKline (2003 March 31) Study shows
Requip® (ropinirole HCl) improves symptoms
of Restless legs syndrome. Research Triangle
Park (North Carolina): GlaxoSmithKline.
Available: http:⁄⁄
402&newsid=71. Accessed 7 March 2006.
8. GlaxoSmithKline (2003 June 10) New survey
reveals common yet under recognized
disorder—Restless legs syndrome—is keeping
America awake at night. Research Triangle
Park (North Carolina): GlaxoSmithKline.
Available: http:⁄⁄
press_06102003.htm. Accessed 7 March 2006.
9. Rundle RL (2005) Motion sickness: Restless
legs syndrome has long been misdiagnosed and
misunderstood; that’s about to change. The
Wall Street Journal; Sect R: 5.
10. Lerner M (2005) Respect, relief for restless
legs; pill helps relieve pain and exhaustion for
those who suffer from syndrome. Star Tribune,
Metro ed; Sect B: 1.
11. O’Connor A (2004 May 25) Restless legs;
uncomfortable and overlooked. The New
York Times. Available: http:⁄⁄www.nytimes.
Accessed 2 March 2006.
12. Rackl L (2005 May 23) Drug to calm sleep-
robbing leg syndrome okayed by FDA;
uncontrollable urge to move limbs affects
1 in 10, runs in families. Chicago Sun-Times.
Available: http:⁄⁄
ai_n14648506. Accessed 2 March 2006.
13. Phillips B, Young T, Finn L, Asher K, Hening
WA, et al. (2000) Epidemiology of restless legs
symptoms in adults. Arch Intern Med 160:
14. Allen R, Walters A, Montplaisir J, Hening W,
Myers A, et al. (2005) Restless legs syndrome
prevalence and impact: REST general
population study. Arch Intern Med 165: 1286–
15. Groves R, Fowler F, Couper M, Lepkowski J,
Singer E, et al. (2004) Survey methodology.
Hoboken (New Jersey): John Wiley and Sons.
448 p.
16. Lantin B (2004 December 1) No sleep for
those with restless legs. The Daily Telegraph.
Available: http:⁄⁄
17. O’Neill P (2004) Restless legs treatments under
study in Oregon. The Oregonian; Sect B: 1.
18. Cresswell A (2005) Relief at hand for restless
legs. The Weekend Australian; Sect C: 29.
19. Fiely D (2005) Restless legs syndrome; ads for
drug raise awareness of annoying condition.
The Columbus Dispatch. Home Final Edition
ed; Sect G: 1.
20. GlaxoSmithKline (2005) Requip® (ropinirole
hydrochloride)—Prescribing information.
Research Triangle Park (North Carolina):
GlaxoSmithKline. Available: http:⁄⁄www.fda.
Accessed 2 March 2006.
21. Haynes R, Sackett D, Taylor D, Gibson E,
Johnson A (1978) Increased absenteeism from
work after detection and labeling of hypertensive
patients. N Engl J Med 299: 741–744.
PLoS Medicine | 0001
Randomized controlled trials
(RCTs) are generally considered
to be a robust form of evidence,
free from bias, and the trial results are
often used as a powerful tool to promote
new drugs [1,2]. However, because
the inclusion criteria for many RCTs
are often very restrictive (for example,
trials generally exclude patients with
serious concomitant illnesses) and
because patients in trials tend to receive
better care than those in standard-care
settings, clinicians should be careful
about generalizing RCT results to their
own patients. Unfortunately, many
drug treatments are widely used in
clinical practice, sometimes beyond
the approved indications, even when
doubts remain about whether the
results of RCTs of these drugs should be
generalized. In this article, we discuss
the use of cholinesterase inhibitors
in patients with a variety of types of
dementia and cognitive impairment,
looking critically at the clinical trial
evidence on these drugs.
If the results of these trials are
not carefully evaluated, together
with evaluating the methodological
quality of the studies, this could
lead to inappropriate prescribing
of cholinesterase inhibitors. Drug
companies have invested heavily in
developing treatments for Alzheimer
disease, and then were actively
involved in expanding the market to
other forms of dementia. In the last
decade, donepezil, galantamine, and
rivastigmine have been tested not only
in patients with Alzheimer disease but
also in patients with vascular dementia,
dementia with Lewy bodies, dementia
associated with Parkinson disease, and
mild cognitive impairment (MCI). Even
when the evidence on the effi cacy of
these drugs is lacking, or inconclusive,
the results are often presented in such
a way as to create a false perception
of effi cacy. For example, about 23
different scales or instruments (on
average six per trial) were used, in the
trials considered here, as primary or
secondary outcome measures. Most of
them were not validated for the disease
for which the drugs were tested and are
not currently used in clinical practice,
undermining the translation of these
research fi ndings into clinical practice.
Moreover, the treatment effect in the
trials is usually expressed through the
average change from baseline in test
scores, without discussing the clinical
importance of the usually small effect
size observed.
Alzheimer Disease: Waiting
for New Treatments
The cholinesterase inhibitor donepezil
was licensed in the US in December
1996, before the full results of clinical
trials were available in medical journals
[3]. The drug was launched with claims
that it had produced “highly signifi cant
improvements in cognitive and clinical
global assessments” in randomized
trials lasting 30 weeks and had
increased the proportion of “treatment
successes” by 245% in patients with
mild to moderate Alzheimer disease
[3]. Donepezil, galantamine, and
rivastigmine went on to be approved
in many countries for the treatment
of Alzheimer disease, even though it
was clear that the effi cacy, in the short
term, was modest, symptomatic, and
evident only in a subgroup of patients
In a meta-analysis of randomized,
double-blind placebo-controlled trials
of cholinesterase inhibitors, Lanctôt
and colleagues found that the pooled
mean proportion of responders to
drug treatment in excess of that for
placebo treatment was only 10% (95%
confi dence interval, 4%–17%) [9].
In this study, response to therapy was
defi ned (according to a defi nition fi rst
proposed by the US Food and Drug
Administration) as an improvement of
four or more points on the Alzheimer
Disease Assessment Scale–cognitive
portion (ADAS-cog) [10].
Policy Forum
April 2006 | Volume 3 | Issue 4 | e140
Cholinesterase Inhibitors: Drugs Looking
for a Disease?
Marina Maggini*, Nicola Vanacore, Roberto Raschetti
Funding: The authors received no specifi c funding
for this article.
Competing Interests: The authors’ research is often
funded by the Italian National Health Service and by
the Italian Medicines Agency, which is the authority
responsible for drug reimbursement procedures
(including costs connected to the prescribing
of acetylcholinesterase inhibitors). The authors
themselves have no role in decisions concerning such