Beruflich Dokumente
Kultur Dokumente
45 Extra Issue45X10-conrad
VALERIE LEITER
Simmons College
Journal of Health and Social Behavior 2004, Vol 45 (Extra Issue): 158176
This paper examines the impact of changes in the medical marketplace on medicalization in U. S. society. Using four cases (Viagra, Paxil, human growth hormone and in vitro fertilization), we focus on two aspects of the changing medical marketplace: the role of direct-to-consumer advertising of prescription
drugs and the emergence of private medical markets. We demonstrate how consumers and pharmaceutical corporations contribute to medicalization, with
physicians, insurance coverage, and changes in regulatory practices playing
facilitating roles. In some cases, insurers attempt to counteract medicalization
by restricting access. We distinguish mediated and private medical markets,
each characterized by differing relationships with corporations, insurers, consumers, and physicians. In the changing medical environment, with medical
markets as intervening factors, corporations and insurers are becoming more
significant determinants in the medicalization process.
Delivered by Ingenta to :
MrOver
Matharu
(cid three
32629),
ingenta
internal
live a2.3.1/F4
(cidof75000325),
University
of Delawareas
the past
decades
there
has been
process
medicalization
been transformed
Library (cid 2443)
marked increase in the medicalization
of Dec
soci-2005
well?
In an ambitious paper, Clarke and her
Tue, 27
00:27:44
ety (Zola 1972; Conrad and Schneider 1992; colleagues (2003) argue that the technoscienBarsky and Boros 1995; Riska 2003). tific changes in medicine have expanded medMedicalization occurs when previously non- icines boundaries even further into biomedmedical problems are defined and treated as icalization, a wide ranging process that
medical problems, usually in terms of illnesses includes complex and multi-sited transformaor disorders. While medicalization can be bi- tions in medical knowledge, technology, surdirectional, there is strong evidence for veillance, and bodies. Our task here is narrowincreases in medicalization. This growth of er and more focused. We ask, how have
medical jurisdiction is one of the most potent changes in the institution of medicine affected
transformations of the last half of the twentieth the process of medicalization? Have the shiftcentury in the West (Clarke et al. 2003:161). ing power dynamics in medicine altered medIn this same period, the institution of medicine icalization? What are current engines driving
has undergone major changes in its social increased medicalization? What factors conorganization, with the advent of managed care, strain its growth?
the declining power of the medical profession,
Most previous analyses of medicalization
and a rise in consumer advocacy and account- focused on the influence of physicians, lay
ability (Starr 1982; McKinlay and Marceau reformers, or medical and scientific discover2001). As medicine has changed, has the ies. This paper departs from that tack, focusing
instead on the creation of markets and the
impact of these markets on medicalization.
* Our thanks to Phil Brown, Emily Kolker, Stefan Although the players are similar, the emphasis
Timmermans, anonymous reviewers, and the editors
for comments on a earlier version of this paper. Send is different. Given the changing medical scene,
correspondence to: Peter Conrad, Department of important arenas of medicalization are moving
Sociology, MS-71, Brandeis University, Waltham, from professional to market domains.
In this paper we examine the impact of
MA 02454-9110. Email: conrad@brandeis.edu.
158
159
161
through one of two kinds of markets: mediated components of health care, rising at 15 percent
a year, now constituting 8 percent of health
markets and private markets.
In mediated markets, there is an indirect care spending (Angell 2000). In the same year,
relationship between consumers, on the Americans purchased 2.5 billion prescriptions,
demand side, and medical producers or averaging nine per American, for a total of
providers, on the supply side, with third party $125 billion (Cohen et al. 2001). The pharmapayers occupying an intervening role. Third ceutical industry has a long history of marketparty payers (typically private or public insur- ing prescription medication directly to doctors
ers) intervene in the exchange relationship through detailing, direct mail, ads in medical
between consumers and providers or producers journals, gifts, travel subsidies, and sponsoring
in two ways: by defining what is medically events (Wanzana 2000).
While some direct-to-consumer advertising
necessary and then paying for only those
goods and services that they have deemed existed in the United States for over two
medically necessary. The degree of control decades (Pines 1999), recently the pharmaceuexercised by third party payers varies, depend- tical industry has substantially increased its
ing upon the level of management of care investment in targeting consumers directly.
being exercised. Managed care regulations Annual spending on direct-to-consumer adverdampen consumer demand for medical goods tising for prescription drugs tripled between
and services, particularly regarding access to 1996 and 2000; it is only 15 percent of all marnew technologies (Mechanic 2002), reducing keting, but by far the fastest rising segment.
consumers ability to purchase medical solu- Much of this increase has been in television
advertising after the Federal Drug
tions to perceived health problems.
Consumers who want medical goods or ser- Administration Modernization Act of 1997
vices but cannot obtain them through mediated made it easier to advertise drugs to the general
markets may turn instead to private markets, public (Lyles 2002). This change allowed
depending upon the cost of the goods or ser- broadcast ads to name both the disorder and
DeliveredInby Ingenta
to so
: long as they also contain limited
the drug
vices and consumers financial resources.
Mr Matharu
(cidthere
32629),
internal
live 2.3.1/F4
(cid benefit
75000325),
Universitymaking
of Delaware
risk and
information,
televiprivate
markets,
is a ingenta
more direct
economLibrary
2443)
drug advertising more feasible and more
ic relationship between consumers and
med-(cidsion
Tue, 27 Dec 2005 00:27:44
ical producers or providers: If consumers can attractive to the pharmaceutical industry.
afford a treatment, they can most likely find a Spending specifically on television advertising
medical provider who will provide it for increased six-fold between 1996 and 2000, to
cash. Again, cosmetic surgery is one exam- $1.5 billion dollars (Rosenthal et al. 2002).
The pharmaceutical companies claim that
ple of private medical markets. In private medical markets, care is provided to consumers direct-to-consumer advertising has an educawho can afford to pay for it, and other potential tional function that creates better informed
consumers, encouraging consumers to consult
consumers are excluded.
In our analysis, we examine how four rela- their physicians about underdiagnosed symptively recent medical developments are distrib- toms and treatment options, and enabling
uted through mediated and private markets, patients to make better choices (Bonaccorso
and how distribution through these two types and Sturchio 2002; Lyles 2002). Critics are
of markets is related to medicalization. concerned that such advertising leads to physiSpecifically, we look at (1) the creation of cians wasting time during medical visits
demand for new medical products in mediated explaining why a treatment is not appropriate,
medical markets; and (2) the development of can lead to unnecessary use of medical
resources and excessive profits for drug comprivate medical markets.
panies, and medicalize normal conditions
(Mintzes 2002; Rosenthal et al. 2002). The
vast majority of direct-to-consumer advertisCREATING AND CAPITALIZING ON
ing focuses on a limited number of drugs; in
MEDICAL MARKETS
2000, 20 drugs accounted for 60 percent of
In 1999, the pharmaceutical industry was direct-to-consumer advertising. These include
the most profitable industry in the United a wide range of drugs, including antidepresStates, with an 18.6 percent return on revenues sants, antihistamines, antihyperliplidemics,
(Angell 2000). It is among the fastest growing and anti-inflammatory agents.
One aspect of direct-to-consumer advertising that has not been discussed is its impact on
expanding the medicalization of human problems. So-called consumer education campaigns are used to introduce products, bringing new people into a market by creating a previously unrecognized demand for the product
(Applbaum 2000). The direct-to-consumer
advertising may well shape the way the public
conceptualizes problems and it may increase
consumer demand for medical solutions. At
least two of the top 20 drugs promoted with
direct-to-consumer advertising (see Rosenthal
et al. 2002) have significant implications for
medicalization: Viagra (ranked 6) and Paxil
(ranked 4).
163
Viagra was a factor in the diagnostic expan- expansion of the concept of male sexual dyssion of sexual dysfunction and the increased function has prompted other companies to
medicalization of sexual performance (cf. enter and expand this market, including pharConrad and Potter 2000). Prior to Viagra, med- maceutical companies either developing new
ical treatment was largely limited to major dys- drugs to compete with Viagra (Tuller 2002) or
functions (e.g., as from prostate surgery). Now seeking a female Viagra (Moynihan 2003;
it included mild dysfunctions (e.g., occasional Hartley 2003). Given the aging baby boomers
erectile problems) and could be used as an and the entrepreneurial pharmaceutical indusenhancement (Conrad and Potter 2004), offer- trys increased promotion of lifestyle drugs
ing a jump start or extra strength for sexual marketed directly to consumers (Mamo and
encounters (Loe 2001).
Fishman 2001), the medicalization of sexual
Viagra is not an inexpensive medication: It dysfunction is likely to continue to expand, at
costs about $10 per pill. Within months of the least for the foreseeable future.
FDAs approval of the drug, many large insurers (e.g., Kaiser Permanente and Aetna U.S.
Healthcare) decided that they would not cover Paxil and Social Anxiety Disorders
the drug, except at an extra cost to employers
When the FDA approved Paxil (paroxetine
or individuals, while others did cover the drug
(e.g., Blue Cross/Blue Shield plans in Indiana hydrochloride) for the treatment of depression
and California, Harvard Pilgrim Health Care, in 1996, Paxil followed Prozac and several
and the Defense Departments health plan). other selective serotonin reuptake inhibitors
However, many insurers who currently cover (SSRIs) into an already saturated market for
the drug limit the number of pills per month. the treatment of depression. The manufacturer
For example, Tufts Health Plan (2002) covers of Paxil (now called GlaxoSmithKline)
four tablets every 30 days, and Blue Cross and responded to the saturated depression marBlue Shield of Texas (2003) covers eight ket by requesting FDA approval for additionDeliveredtheby Ingenta
to :
al applications
of Paxil, specializing instead in
tablets every 30 days. In Britain, however,
Mr Matharu
(cidService
32629),covers
ingenta
internal
(cid 75000325),
Universitypanic
of Delaware
the anxiety
market, including
disorder
National
Health
Viagra
onlylive
for2.3.1/F4
Library
2443)
obsessive compulsive disorder at first, and
sexual dysfunction related to conditions
such(cidand
Dec 2005
00:27:44
then
social anxiety disorder (SAD) and generas diabetes, prostate cancer, and Tue,
renal27
failure
alized
anxiety disorder (GAD). Paxils applica(Michael Bury, University of London-Royal
tion to SAD and GAD has contributed to the
Holloway, personal communication).
The health insurance industry was involved medicalization of emotions, expanding medin the debate over whether sexual dysfunc- ical jurisdiction over emotions such as worry
tion was a medical necessity and whether and shyness.
SAD and GAD were fairly obscure diagViagra should be covered by health insurance,
resulting in mixed insurance coverage for noses when they were added to the American
Viagra. In this case, the insurance industry Psychiatric Associations Diagnostic and
attempted to counteract increased medicaliza- Statistical Manual (DSM) in 1980. According
tion of male sexual dysfunction by restricting to the DSM-IV, SAD (or social phobia) is a
access to Viagra. However, individuals with a persistent and extreme fear of social and perphysicians prescription could of course pur- formance situations in which embarrassment
chase the drug on their own or through a range may occur (American Psychiatric Association
1994:411) and GAD involves chronic, excesof Internet sites.
One important social benefit from the popu- sive anxiety and worry (lasting at least six
larity and widespread use of Viagra is a reduc- months), involving multiple symptoms
tion of the stigma of sexual dysfunction. (American Psychiatric Association 1994:
Seeing ads for Viagra in so many mainstream 43536). Both conditions are defined as being
locations and making Viagra part of everyday associated with significant distress and impairdiscussions has made sexual dysfunction and ment in functioning. Horwitz (2002) notes how
its treatment appear conventional and com- small changes in wording of criteria for SAD
monplace. This has most likely also increased resulted in a tremendous growth in its estimatthe market for Viagra, since it would be less ed prevalence (and potential market).
Marketing diseases and then selling drugs to
stigmatizing to inquire about and use it.
The success of Viagra and the subsequent treat those diseases is now common in the
post-Prozac era. Since the FDA approved the its loosely defined boundaries and the aggresuse of Paxil for SAD in 1999 and for GAD in sive marketing of it as a disease: [T]he
2001, GlaxoSmithKline has spent millions of impression often conveyed by commercials for
dollars to raise the public visibility of SAD and the drugs is clear: almost anyone could benefit
GAD, by sponsoring well-choreographed dis- from them (Goode 2002). Murray Stein, a
ease awareness campaigns. The pharmaceuti- psychiatry professor at the University of
cal companys savvy approach to marketing California at San Diego, has called the use of
SAD and GAD, which relied upon a mixture of prescription medicines such as Paxil, which
expert and patient voices, simultaneously are costly and may have significant side
gave the conditions diagnostic validity and cre- effects, cosmetic psychopharmacology
ated the perception that it could happen to any- (Vedantam 2001:1). Paxils web page
one (Koerner 2002). Soon after the FDA (www.paxil.com) stresses the elimination of
approved the use of Paxil for SAD, Cohn and symptoms (e.g., improved sleep) and improved
Wolfe (a public relations firm that was work- performance (e.g., improved ability to coning for what was then SmithKline) began centrate and make decisions) as benefits.
putting up posters at bus stops with the slogan,
Efforts to define SAD and GAD as condiImagine Being Allergic to People. Later in tions, and market Paxil as treatment for them,
1999, a series of ads featured Paxils efficacy have been extremely successful. Paxil is one of
in helping SAD sufferers brave dinner parties the three most widely recognized prescription
and public speaking (Koerner 2002:61). drugs, after Viagra and Claritin (Marino 2002),
Barry Brand, Paxils product director, said, and it is currently ranked sixth in terms of preEvery marketers dream is to find an uniden- scriptions (Nittan 2001), with U.S. sales of
tified or unknown market and develop it. approximately $2.1 billion and global sales of
Thats what we were able to do with social anx- $2.7 billion. It is of course not possible to disiety disorder (Vedantam 2001).
tinguish how much of this was for SAD or
Through media campaigns, GlaxoSmithKline
GAD and
Delivered by Ingenta
to :how much of it was prescribed for
redefined
SAD
GAD,
paradoxically,
as2.3.1/F4
other (cid
problems
including
depression,
obsesMr Matharu
(cid and
32629),
ingenta
internal live
75000325),
University
of Delaware
both common (reducing the stigma associated
sive
compulsive
disorder,
or
post
traumatic
Library (cid 2443)
with having a mental illness) and
abnormal
stress
disorder.
Tue,
27 Dec 2005
00:27:44
(subject to medical intervention, in the form of
But there has been some recent backlash
Paxil). Prevalence estimates of both SAD and against the drug. In 2002, a federal judge
GAD range widely. For example, estimates of ordered a temporary halt to Paxil ads over the
the prevalence of SAD range from 3 percent to claim that Paxil is not habit forming (White
13 percent (American Psychiatric Association 2002). Apparently, patients and health care
1994:414), with the National Institute of providers have submitted thousands of reports
Mental Health estimating that 3.7 percent of to the FDA describing withdrawal symptoms
the U.S. population has SAD (Vedantam (Peterson 2002). Multiple lawsuits have been
2001). Higher prevalence rates are associated filed, asserting that physicians and consumers
with less stringent application of the DSM- were misled by advertisements regarding the
specified criteria for these conditions.1 severity of withdrawal (Barry 2002). Like simHorwitz (2002) argues that, Because commu- ilarly marketed consumer goods, such as music
nity studies consider all symptoms, whether and clothing, it is possible that Paxils popularinternal or not, expectable or not, deviant or ity may be waning. However, along the way,
not, as signs of disorder, they inevitably over- the GalaxoSmithKline campaign for Paxil has
estimate the prevalence of mental disorder in increased the medicalization of anxiety, inferthe community (p.105). Likewise, the disease ring directly and indirectly that shyness and
awareness campaign focused on individuals worrying may be medical problems and that
feelings in social situations likely to evoke fear Paxil is the way to treat them.
in many people, especially public speaking,
and offered consumers symptom-based self
tests to assess the likelihood that they had DEVELOPMENT OF PRIVATE MEDICAL
SAD and GAD (www.paxil.com). This kind of MARKETS
clinical ambiguity is fertile ground for creating
When treatments or services are not covered
an expansive medical market.
Some question the validity of SAD, due to by health insurance, but the demand for the
165
approved by the FDA only for treating hypopituitary dwarfism (or growth hormone deficiency) and chronic renal failure. While individual cases might be disputed, the medical
profession established strict guidelines (Bercu
1996) to distinguish between growth hormone
deficiency disorder and what has been called
idiopathic short stature or ISS (children with
normal growth hormone who are short).3
As time went on, physicians, patients, and
drug companies all sought other medical uses
for human growth hormone. By 1990,
researchers and leading drug companies were
investigating the possibility of administering
human growth hormone to children with idiopathic short stature, that is normal children
who were of short stature but had no deficiency of the hormone. Short stature is defined as
the lower 3 percentiles for age and sex, which
is roughly two standard deviations below the
sex-age means. For adult males it is 64.5 inches or less; for adult females it is 59.5 inches
(NHANES 2000). It is estimated that 1.8 million children in the United States and a similar
number in Europe can be characterized with
Human Growth Hormone and Idiopathic
significant short stature. Only 20 percent of
Delivered by Ingenta
to referred
:
Short Stature
these are
to pediatric endocrinologists
Mr Matharu (cid 32629), ingenta internal live 2.3.1/F4
(cid 575000325),
Delaware
and only
percent ofUniversity
these are ofgrowth
horLibrary
2443)deficient (Hintz 1996). The vast majoriMedications are frequently prescribed
for(cidmone
27 Dec 2005
00:27:44
off-label uses, as treatments ofTue,
conditions
ty of
short children therefore can be considered
beyond those approved by the Federal Drug idiopathic short stature, defined as a heteroAdministration. While physicians, in practice,2 geneous state that encompasses individuals
have autonomy and authority to prescribe for with short stature, including those with FSS
off-label uses of a drug, manufacturers cannot (familial short stature), for which there is no
legally market for off-label uses.
recognized cause (Kelnar et al. 1999:151).
Prior to 1985, human growth hormone The causes of short stature may well be familextracted from cadavers was used to treat indi- ial (short parents), genetic, or nutritional, but it
viduals who had a growth hormone deficiency. can be seen as normal shortness as opposed
The growth hormone was in low supply and to more specific deficiency shortness.
thus very expensive and carried severe risks of
A national survey of 534 pediatric endocriCreutzfeldt-Jacobs disease, a potentially fatal nologists documented that 94 percent of them
brain disease. In 1985 the FDA removed it had prescribed human growth hormone within
from the market. With fortuitous timing, the previous 5 years for children who were not
Genentech introduced an FDA approved syn- hormone deficient (Cutler et al. 1996:532).
thetic human growth hormone within six Genentech and, to some extent, Eli Lilly (who
months of the removal of cadaver-extracted marketed a similar hormone) worked closely
growth hormone. The recombinant hormone, with the Human Growth Foundation, a nonmarketed as Protropin, could be produced in profit advocacy group that supported short
potentially unlimited quantities (Lantos et children (Werth 1991), a more general term
al. 1989:1020) to such an extent that physi- including both hypopituitary dwarfism and
cians credited the new technology with ending idiopathic short stature. Genentech also supthe market shortage of the hormone ported research by pediatric endocrinologists
(Glasbrenner 1986). Genentech soon claimed and began its own longitudinal research on
75 percent of the existing $200 million U.S. healthy children who were not hormone
market (Werth 1991). The hormone had been deficient. These activities further blurred the
boundaries demarcating legitimate and off- eased limitations upon manufacturers, broadlabel use of human growth hormone.4 In ening the information that they may provide to
2003, the FDA approved Eli Lillys Humatrope physicians about off-label use of their products
to treat idiopathic short stature children in the (Stapleton 1999). In terms of shortness, the
shortest 1.2 percent of the population, which potential market is considerable, with nearly
will likely accelerate its use in potentially short four million children in the United States and
children (Kaufman 2003).
Europe who could be defined as having idioThere is some evidence that shortness (and pathic short stature. This could further increase
especially extreme shortness) often is a deval- the medicalization of short stature.
ued status and can have social consequences,
especially for males. Some researchers have
found social disadvantages of shortness, In Vitro Fertilization and the Medical
including discrimination in hiring and salaries, Treatment for Infertility
assumptions regarding maturity and compeThe development of reproductive technolotence, issues around self-esteem and perceived
attractiveness, and practical problems such as gies has resulted in the medicalization of inferbuying well-fitting clothes (see Conrad and tility. In vitro fertilization (or IVF), in which
Potter 2004). Whatever the real or imagined eggs are abstracted and fertilized and then
disadvantages of shortness, some parents have implanted inside a womans uterus, is one such
anxieties about their childrens height. With the case. When it was first practiced successfully,
availability of synthetic human growth hor- resulting in the conception of the first test
mone, parents could consider interventions tube baby in 1978, in vitro fertilization held
that would influence the height of their chil- out hope of a technological fix to an estimated 7 percent of couples who experience
dren.
At least 13,000 children in the United States infertility (Centers for Disease Control 2001).
Persons
perceive that not only can the
with idiopathic short stature were treated
withby Ingenta
Delivered
to now
:
source(cid
of infertility
be University
diagnosed,of
butDelaware
it can be
Research
on2.3.1/F4
human
growth
hormone
1994.5 internal
Mr Matharu
(cid
32629),iningenta
live
75000325),
treated
(Scritchfield
1995:139),
and
assisted
growth hormone treatment with idiopathic
Library (cid 2443)
reproductive
short children has been equivocal.Tue,
It is27
debatDec 2005
00:27:44 technology has transformed
able how much treatment can increase growth infertility into a clinical need (Bates and
from predicted height (cf. Hintz 1996). One Bates 1996:301).
Yet the medical market for in vitro fertilizamajor multi-center study, sponsored by
Genentech, reported that of the 80 individuals tion has remained fairly constrained because
in the study who reached final height, the many consumers do not have insurance covermean gain from predicted height was 5.9 cen- age for in vitro fertilization (Neumann 1997).
timeters in girls and 5.0 centimeters in boys One study found that a minority of plans (14 to
(Hintz et al. 2000). The height gains are mod- 17 percent, depending upon the type of plan)
est; human growth hormone will not transform cover in vitro fertilization (Alan Guttmacher
a short person into a tall one, but only into a Institute 1993), and another study found that
less short one. Human growth hormone treat- 30 to 40 percent of in vitro fertilization serment costs about $20,000 a year and must be vices are covered partially and that insurance
continued for three to six years. Parents of reimburses for about half of the costs when in
idiopathic short stature children must pay this vitro fertilization is covered (Collins et al.
out of their own funds, since health insurance 1995). At first, health insurers justified their
will only cover treatment for hormone defi- exclusion of IVF from coverage on two
ciency. If the average height gain is two inch- grounds: efficacy and cost. Initially, success
es, and the average cost is $100,000, the cost of rates were estimated to be 1520 percent per
height enhancement is roughly $50,000 an attempt (Kolata 1983), and recent estimates of
success rates range from 32.2 percent for
inch.
The relative ease with which manufacturers women under 35 years to 9.7 percent for
may promote and physicians may prescribe women ages 4041 (Centers for Disease
human growth hormone for off-label treatment Control 2001). Insurance companies have
has increased the range of possible uses often labeled in vitro fertilization as experi(Conrad and Potter 2004). The Federal Drug mental, as a result of these relatively low sucAdministration Modernization Act of 1997 cess rates. In vitro fertilization is also a fairly
167
financial arrangements to increase the private mitted (e.g., for off-label uses), corporations
market for their services. These arrangements promote indirectly to providers or consumers
offer money-back guarantees or substantial (e.g., on the Internet). Consumers are the
refunds if patients do not get pregnant or if prime driver for demand, generally without
they miscarry early in the pregnancy insurance support, and must pay directly for
(Hamilton 1996; Wilcox and Rossi 2002; medical products or services. Physicians are
necessary facilitators for treatment but are
Wozencraft 1996).
The private market for in vitro fertilization sometimes promoters (i.e., entrepreneurs) for
appears to be here to stay. Physicians are drawn the product as well (e.g., cosmetic surgery).
There may be a tension between restricted
to reproductive medicine because of the cutting edge nature of the work, as well as the access to health care and the expansion of
potential for commercial profit (Brody 1987). mediated and private markets. Private markets
In vitro fertilization clinics advertise using tend to emerge when insurers define a problem
Internet websites with links to finance compa- or treatment as not medically necessary and
nies to help pay for the procedure. Consumers therefore not subject to third party reimbursewho wish to have biological children are drawn ment. Thus insurers here attempt to constrain
to technological solutions to infertility. Yet the access to medicalized solutions by refusing to
consumer demand for in vitro fertilization and cover particular treatments or services. These
other reproductive technologies is constrained markets are not fixed; given changes in proby insurers refusals to pay for such services, motion, insurance coverage, or consumer role,
except under specific medical circum- private markets could become mediated marstances. This has resulted in the creation of a kets and vice versa. In operation, such markets
private medical market for consumers who can are more on a continuum than mutually excluafford to pay for in vitro fertilization or who sive in their attributes.
A key to all markets is the existence of a
are willing to take on significant debt to do so.
medicalto product
and consumer demand. In
Delivered by Ingenta
:
Mr Matharu (cid 32629), ingenta internal live 2.3.1/F4
75000325),
University of companies
Delaware
some (cid
cases,
the pharmaceutical
Library (ciddevelop
2443) strategies to expand their markets
DISCUSSION
Tue, 27 Dec 2005
00:27:44
(e.g.,
Viagra and Paxil), while in others the
We have described four cases where the markets are more consumer-driven. Table 2
development of medical markets facilitated outlines the different modes of promotion and
medicalization, and we have identified two their relation to medicalization.
forms of medical markets: mediated and priIn two cases the development of medical
vate markets. We outline the main attributes of markets is primarily corporate driven. Viagra
these markets in Table 1. In mediated markets, and Paxil are promoted by pharmaceutical
corporate medical producers attempt to companies through direct-to-consumer adverincrease demand for their products by promot- tising, but the goals and means differ. With
ing directly to consumers and providers, with Viagra, the goal is to increase the appeal of the
the market mediated by health insurers and product to a wider population. When first
managed care organizations. Consumers introduced, Viagra was aimed at older men or
become the target for market expansion, with others with established erectile dysfunction.
physicians largely remaining as gatekeepers However, in recent years much of the advertisprescribing treatment.6 In private medical mar- ing has been aimed at a younger and broader
kets, due to limits in types of promotion per- population, with the implicit message that
TABLE 1. Comparison of Mediated and Private Markets
Relation to
Corporate
Insurers
Consumers
Physicians
Mediated Markets
Private Markets
Direct promotion to providers and consumers
Indirect promotion to providers via off-label
(direct-to-consumer advertising)
use or consumers on the Internet
Problem is generally covered by insurance with Problem is not covered
relatively flexible criteria
by insurance or only covered under strict
medical criteria
Targeted for market expansion
Promoter of market expansion
Gatekeeper, with authority to define problem
Facilitator, with authority to define problem
and prescribe treatment
and prescribe treatment
169
Promoter
Corporate Driven
Paxil
Corporate Driven
Human
Consumer and
Growth
Corporate Driven
Hormone
In Vitro
FertiliConsumer Driven
zation
Goal
Create new populations
for product
Means
Direct-to-consumer
advertising to younger
and virile types
Create new problems for Direct-to-consumer disapproved product
ease awareness campaign
Expand product to non- Secure off-label use of
FDA approved uses
product
Medicalization
Expands diagnosis of
erectile dysfunction
Further medicalizes
infertility
Promotes disorders of
SAD and GAD
Makes short stature into
a medical problem
Viagra can help them too with whatever sexual/ to achieve medical legitimacy for all kinds of
performance problems they may have. This infertility so that third parties will pay for
market expansion means offering a medical treatment. When human growth hormone for
solution to a wider range of mild or transitory idiopathic short stature and in vitro fertilizaerectile problems. The promoters of Paxil, on tion for infertility are not covered by health
the other hand, want to differentiate their drug insurers, consumers must pay for these serfrom others on the market. After getting FDA vices out-of-pocket, creating a private medical
approval for new uses, GlaxoSmithKline market. This type of market has all the characdeveloped a direct-to-consumer disease teristics of any private market: Those who can
awareness campaign to alert consumers afford to pay can acquire the services.
that they might have a diagnosable problem
Medical markets can change, based upon
(e.g., SAD) and that Paxil could be
the
right
whether
deem the product to be a
Delivered by Ingenta to insurers
:
choice
for
them.
This
encourages
people
to
medical
necessity
and
cover a service
or drug.
Mr Matharu (cid 32629), ingenta internal live 2.3.1/F4 (cid 75000325), University
of Delaware
redefine their life difficulties in medical
terms(cidThe
in vitro fertilization debate clearly turns
Library
2443)
27 Dec 2005
and creates a further demand for Tue,
the product.
on 00:27:44
whether infertility treatment is medically
In both cases the advertising aims to increase necessary; consumers say it is and should be
the consumer demand for the medical treat- covered by insurance while insurers claim havment product. Increased medicalization is a ing children is a social choice, not a medical
by-product.
one. We see medical necessity reflected in the
Human growth hormone can be seen as human growth hormone and Viagra cases as
jointly corporate and consumer driven. While well, even if the term is not typically applied.
there was no direct corporate product advertis- Consumer advocates claim that human growth
ing to consumers, Genentech had to pay a $50 hormone is a medical necessity since medical
million settlement for overpromoting human treatment could mitigate the suffering, stigma,
growth hormone to medical practitioners for and discrimination due to the biological limitatreating unapproved conditions (including tion of extreme shortness. Is the treatment of
idiopathic short stature) (Nordenberg 1999). It erectile dysfunction a medical necessity? In
is unclear how much the promotion to doctors terms of insurers, the answer is, sort of.
and hospitals stimulated the development of When insurers cover the cost of Viagra, they
the medical market for growth hormone, but is often limit it to four to eight pills a month.
safe to assume it had some effect. Genentech Does this mean sexual intercourse is a medical
and other pharmaceutical companies support necessity four to eight times a month?
consumer groups that promote hormone interIt is also possible to see some uses of human
ventions for idiopathic short stature, but con- growth hormone, Viagra, Paxil and in vitro fersumer groups are the primary advocates for tilization as biomedical enhancements rather
human growth hormone treatment (Conrad and than treatments. While there are certainly medPotter 2004). For in vitro fertilization, con- ically legitimated uses for each of these drugs
sumers are the main proponents pressuring for and procedures, some uses may constitute
insurance coverage. Through organizations, lit- enhancement
rather
than
treatment.
igation, and legislation, consumers are striving Biomedical enhancements are medical inter-
ventions used to improve physical or mental Physicians in the past have provided prescripcharacteristics or performance in those with no tions in response to patients direct requests,
identifiable pathology. Adding a few inches of even when the scientific knowledge suggested
height to ones child, insuring strong erections, that it was not appropriate, because they worincreasing ones social abilities, or having a ried about economics and their professional
biological child might all be improvements image and because they wanted to respond to
that could be sought by many individuals. One patients requests for help (Schwartz,
need not have a disorder to benefit from these Soumerai and Avorn 1989). But direct-to-conmedical interventions. Peter Kramer (1993) sumer advertising has increased consumers
claimed that Prozac can make people better role in the prescribing equation. While physithan well. There has been some debate in the cians remain the gatekeeper to these drugs,
bioethics literature about a distinction between reflected in most direct-to-consumer ads endtherapy and enhancement, but medicalizing ing with a statement like, ask your doctor if
human problems creates a slippery slope Paxil [or Viagra] is right for you, there is
between enhancement and legitimated medical increased pressure to respond to consumers
treatment (Conrad and Potter 2004).
independent requests for medications. In the
While erectile dysfunction, anxiety, short context of current debates regarding chalstature, and infertility surely can impact peo- lenges to physicians professional knowledge
ples lives to varying degrees, they are not life- (Timmermans and Kolker 2004), it appears
threatening conditions nor even major health that pharmaceutical manufacturers are circumrisks. Anti-hypertensive or cholesterol reduc- venting physicians control over knowledge
ing drugs associated with cardiovascular dis- regarding available drugs.
ease are also widely promoted, but for a well
Insurers as payers exert a strong influence
established medical problem. While prevention on medical markets. In the context of the
of disease is a major market for drugs and
examples presented here, insurers including
interventions, the relatively common
problemsby Ingenta to :
Delivered
HMOs set the limits on some medical markets,
of
on the
margins
medicine,
holdlive
the2.3.1/F4 (cid 75000325), University of Delaware
Mrlife,
Matharu
(cid
32629),ofingenta
internal
thus acting as a constraint on access to medgreatest potential for market expansion
and (cid 2443)
Library
icalized solutions to human problems. This is
medicalization.
Tue, 27 Dec 2005 00:27:44
particularly clear with in vitro fertilization,
The role of physicians as providers is
where insurers definition of the treatment as
changing in the current medical marketplace,
with some areas shifting more than others. experimental and their refusal to cover it
With off-label uses of drugs like human except in very specific diagnostic situations
growth hormone for idiopathic short stature, has limited in vitro fertilization to those who
physicians play a facilitating role in the mar- could afford to pay for it. Insurers will only pay
ket. It is a physicians prerogative to prescribe for human growth hormone for children with a
medications for uses beyond those approved by diagnosed growth hormone deficiency; idiothe FDA. Doctors commonly prescribe drugs pathic short stature children only receive treatfor unapproved uses if, in their judgment, the ment if their families can pay for it. Few can
drug would be an effective treatment for a afford the tariff. Even with Viagra, some insurpatients problem. Similarly, technical inter- ance plans dont cover this treatment for erecventions such as in vitro fertilization would be tile dysfunction, while others limit the use. It
totally unavailable without physician involve- has long been an axiom in medicalization studment. Thus physicians still have an important ies that the only way to get human services
central role in facilitating medical markets, paid for is to turn life difficulties into medical
problems. Yet under managed care insurers are
especially in private markets.
But the physicians role is challenged on responding to this medicalization by restricting
other fronts, particularly with direct-to-con- payment for these services. Insurance consumer advertising undermining physicians straints do not necessarily affect the conceptuauthority regarding which drugs to prescribe. al level of medicalization but they constrain
Physicians have always been the major conduit access to medicalized solutions at the patient
between the pharmaceutical industry and level (Conrad and Schneider 1980)7. By
patients (which is why the pharmaceutical restricting access to medical solutions in the
industry spends billions of dollars advertising name of medical necessity, insurers attempt
and promoting their wares to physicians). to limit individuals claims that they are suffer-
171
ing from illnesses rather than everyday life Manufacturers will likely promote off-label
(Sabin and Daniels 1994).
applications to the extent legally permitted,
Consumers have a dual role related to med- perhaps expanding diagnoses (Conrad and
ical markets. In some instances the market for Potter 2000) and further medicalization.8
a problem exists long before any medical proMedicalization narrows the definition of
motion. Individuals have been seeking nos- health and widens the definition of sickness.
trums to improve sexual performance or votive The direct-to-consumer advertising focuses on
objects to insure fertility for centuries, while help seeking advertisements (Lyles 2002),
short people have often tried to appear taller which try to create an awareness of symp(think elevator shoes and high heels). In a toms or conditions among consumers.
sense, there is a ready-made market demand Consumer education campaigns are used to
for a product. Consumers and medical interests introduce new products or extended applicaare already allied, and consumers may become tions, essentially bringing new people into a
the dynamic force for market creation. In other market by creating a previously unrecognized
cases, the public constitutes potential con- demand for a product (Applbaum 2000). The
sumers who must be shaped into a market. This marketing of Viagra expands the bounds of
involves persuading consumers of the necessi- erectile dysfunction, implying that it is not
ty or utility of a product offered or creating healthy or normal to have variation in
consumer demand. Direct-to-consumer adver- penile erections. Paxil ads emphasize that it
tising for Paxil exemplifies this, although it is may be pathological to be anxious or shy in
partly true for Viagra as well. Such promotion social situations and that this can be changed
can induce people to self-label their problems by using the drug. Employing human growth
as medical entities and seek more medical ser- hormone to treat short stature indicates a narvices. This medical commodification shifts rowing of the range of normal height as well as
both definition and solution into the medical reinforcing the notion that shortness is deviant
sphere.
and undesirable, and that it should be altered.
Delivered
to :
Recent changes in FDA regulations
allowby Ingenta
The marketing
of Paxil, Viagra and, to a lesser
Mr aMatharu
32629),
ingenta
internal
live 2.3.1/F4
(cidhuman
75000325),
Delaware
for
different(cid
kind
of drug
marketing
by loosdegree,
growthUniversity
hormone oftargets
rela2443)healthy people. Drug companies search
ening off-label provisions and enablingLibrary
televi-(cidtively
Tue, 27faciliDec 2005 00:27:44
sion advertising of prescription drugs,
for markets creates broader disease definitions
tating the emergence of new medical markets. for their products, indirectly reducing what is
Broadcast ads can now name the disorder and normal.
the drug, so long as they include limited risk
and benefit information (Lyles 2002). As
noted, corporate pharmaceutical spending on CONCLUSION
television advertising increased six-fold from
We highlight the increasing importance of
1996 to 2000, and ads for products such as
pharmaceutical companies, insurers, and conPaxil and Viagra have become common.
Off-label uses of FDA approved drugs is one sumers for medicalization as they are involved
of the easiest routes to the expansion of med- in the creation of medical markets. The medical markets. Once a drug has been approved ical profession has a diminished but still key
for one use or population, it can be prescribed role in medicalization. Given the changes in
for broader purposes. Ritalin is approved for medicine and its organization, important arechildhood ADHD, but for the past decade it has nas of medicalization are moving from profesbeen used widely with adults (Conrad and sional to market domains.
It is not new knowledge or technology that
Potter 2000). Provigil (modafinil) is approved
for sleep disorders, such as narcolepsy and engenders medicalization but how they are
hypersomia, but in its direct-to-consumer used. Corporate and medical promotion of
advertising, Cepahlon, the manufacturer, has products, treatments, and drugs underlies the
touted that the drug can drastically reduce the emergence of new medical markets. With our
amount of sleep required without affecting corporatized medical-industrial complex, the
performance (Wolpe 2002). While drug com- creation or expansion of medical markets
panies have been limited in their advertising becomes an important conduit to medicalizafor off-label uses, FDA regulations allow for tion. Consumer demand is not simply unfetconsiderably more latitude in promotion. tered desire for medical solutions, but it is
terion that has produced the most controversy (Lantos et al 1989; Bercu 1996). For
example, peak growth hormone levels
between 7 and 10 are considered a gray
zone, and different methods of assessing
growth hormone levels produce varying
results (Lantos et al. 1989).
4. In 1994, several federal agencies began a
series of investigations targeting Eli Lilly
and Genentech for overpromoting their
growth hormone products, that is, marketing them for non-approved uses (for details,
see Conrad and Potter 2002). The FDA
alleged and documented that, by the end of
1985, Genentech had begun marketing
Protropin for use in the treatment of medical conditions for which it did not have
FDA approval (Nordenberg 1999:33).
From 1985 to 1994, Genentech marketed
Protropin to a variety of medical practitionNOTES
ers (doctors, hospitals, and others) for treating unapproved conditions, including idio1. According to the DSM, the diagnostic critepathic short stature (Nordenberg 1999).
ria for SAD include: a marked and persisGenentech paid $50 million in settlement,
tent fear of social or performance situations
including a $20 million penalty to reimin which embarrassment may Delivered
occur, anby Ingenta
burse
and
CHAMPUS
to : Medicaid
anxiety
response,
recognition
(Nordenberg
1999).University of Delaware
Mrimmediate
Matharu (cid
32629),
ingentaainternal
live 2.3.1/F4
(cid 75000325),
that the fear is excessive or unreasonable,
This is an extrapolation. In 1994, about
Library (cid5.2443)
avoidance of the situation orTue,
endurance
children were believed to suffer from
27 Dec 2005 7,000
00:27:44
with dread, interference with daily routine
short stature due to human growth hormone
or marked distress about the phobia, and the
deficiency but 20,000 children were treated
fear not being due to substance effects or
with human growth hormone (Biotechology
other conditions (American Psychiatric
News, 1994). Therefore at least 13,000 chilAssociation, 1994:411).
dren were treated for idiopathic short
2. Professional medicine has long approved of
stature that year.
off-label uses of drugs. In 1999, the 6. There is increasing advertising on the
American Medical Association approved a
Internet for Viagra, human growth horposition statement (Resolution #528), intromone, and other prescription medications.
duced by the Society of Cardiovascular and
While it is assumed that a doctor must evalInterventional Radiology, on off-label use
uate the short forms consumers need to
of devices and medications. In summary,
complete before ordering medications, the
the AMA permits physicians to decide what
wide availability of medications through the
to prescribe for their patients and for what
Internet sources compromises the physimedical conditions, because physicians are
cians gatekeeper role.
best able to base these decisions on current 7. Some have suggested that direct-to-conclinical standards and not just FDAsumer advertising is in part a reaction to
approved indications.
managed care. Lyles (2002) notes that,
3. Criteria include (1) height of less than three
managed care controls that limit the physistandard deviations below the mean for a
cians prescription authority also reduce the
childs age and sex, (2) abnormal growth
potential of promotional activities targeting
velocity (less than 25th percentile for bone
physicians; consequently pharmaceutical
age), and (3) growth hormone provocative
companies have responded by seeking altertesting results with peak growth hormone of
native ways to influence physician prescribless than10 (g/L in a polyclonal radioiming (p. 27).
munoassay (Bercu 1996). It is this latter cri- 8. A recent case illustrates this. Parke-Davis, a
173
1992. Deviance and Medicalization: From Kaufman, M. 2003. FDA Approves Wider Use of
Badness to Sickness. Expanded ed. Philadelphia,
Hormones. Washington Post, July 26, p.A12.
PA: Temple University Press.
Kelnar, C.J.H., K. Albertsson-Wikland, R.L. Hintz,
Cuttler, Leona, J. B. Silvers, Jagdip Singh, Ursula
M.B. Ranke, and R.G. Rosenfeld. 1999. Should
Marrero, Beth Finkelstein, Grace Tannin, and
We Treat Children with Idiopathic Short
Duncan Neuhauser. 1996. Short Stature and
Stature?Hormone Research 52:15057.
Growth Hormone Therapy: A National Study of Koerner, Brendan I. 2002. Disorders, Made to
Physician Recommendation Patterns. Journal
Order. Mother Jones 27:July-August, pp.5863.
of American Medical Association 276:53137.
Kolata, G. In Vitro Fertilization goes Commercial.
Dyer, Allen R. 1997. Ethics, Advertising, and
Science 221:116061.
Assisted Reproduction: The Goals and Methods Kowalczyk, Liz. 2002. Drug Firm Seen Skirting
of Advertising. Womens Health Issues
FDA OK. The Boston Globe. November 2, p. 1.
7:14348.
Kramer, Peter. 1993. Listening to Prozac. New York:
Fabbri, A., A. Aversa, and A. Isidori. 1997. Erectile
Penguin Books.
Dysfunction:
An
Overview.
Human Kroll-Smith, Steve and H. Hugh Floyd. 1997.
Reproduction Update 3:45566.
Bodies in Protest: Environmental Illness and the
Freidson, Eliot. 1970. Profession of Medicine. New
Struggle over Medical Knowledge. New York:
York: Dodd, Mead.
New York University Press.
Gilbert, Bonny. 1996. Infertility and the ADA: Kurz, Demi. 1987. Emergency Department
Health Insurance Coverage for Infertility
Responses to Battered Women: Resistance to
Treatment. Defense Counsel Journal 63:4257.
Medicalization. Social Problems 34:6981.
Glasbrenner, K. 1986. Technology Spurt Resolves Lang, Anne Adams. 1998. For Infertility
Growth Hormone Problem, Ends Shortage.
Treatments, Now Youre Covered, Now Youre
Journal of the American Medical Association
Not. The New York Times, January 15, sec. 15,
255:581584, 587.
p. 12.
Halpern, Sydney. 1990. Medicalization as a Lantos, John, Mark Siegler, and Leona Cutler. 1989.
Professional Process: Post War Trends in
Ethical Issues in Growth Hormone Therapy.
Pediatrics. Journal of Health and Social
Journal of the American Medical Association
Behavior 31:2842.
261:102024.
Delivered by Ingenta
to :
Hamilton,
Joan.
1996.
A Pregnant
Fertility
Laumann,
O., Anthony
Paik, of
andDelaware
Raymond
Mr Matharu
(cid
32629),
ingentaClause:
internal
live 2.3.1/F4
(cidEdward
75000325),
University
Clinics are Offering Controversial Guarantees.
C. Rosen. 1999. Sexual Dysfunction in the
Library (cid 2443)
Business Week, March 25, p. 46. Tue, 27 Dec 2005 United
States. Journal of the American Medical
00:27:44
Hardey, Michael. 2001. E-Health: The Internet
Association 281:53744.
and the Transformation of Patients into Levine, Martin P. and Richard R. Troiden. 1988.
Consumers and Producers of Health
The Myth of Sexual Compulsivity. Journal of
Knowledge. Health, Communication and
Sex Research 25:34763.
Society 4:388405.
Light, Donald W. 1993. Countervailing Power: The
Hartley, Heather. 2003. Big Pharma in our
Changing Character of the Medical Profession in
Bedrooms: An Analysis of the Medicalization of
the United States. Pp. 6980 in The Changing
Womens Sexual Problems. Advances in Gender
Medical
Profession: An
International
Research 7:89129.
Perspective, edited by F.W. Hafferty and J.B.
Hintz, Raymond L. 1996. Growth Hormone
McKinlay. New York: Oxford University Press.
Treatment of Idiopathic Short Stature. Light, Donald W. 2000a. The Medical Profession
Hormone Research 46:20814.
and Organizational Change: From Professional
Hintz, Raymond L., Kenneth M. Attie, Joyce
Dominance to Countervailing Power. Pp.
Baptista, and Alex Roche. 2000. Effect of
20116 in The Handbook of Medical Sociology,
Growth Hormone Treatment on Adult Height of
5th ed., edited by Chloe Bird, Peter Conrad and
Children with Idiopathic Short Stature. New
Alan Fremont. Upper Saddle River, NJ: Prentice
England Journal of Medicine 30: 50207.
Hall.
Horwitz, Allan V. 2002. Creating Mental Illness. Light, Donald W. 2000b. The Sociological
Chicago: University of Chicago Press.
Character of Health Care Markets. In
Hughes, Edward H. and Mita Giacomini. 2001.
Handbook of Social Studies in Health and
Funding In Vitro Fertilization Treatment for
Medicine, edited by Gary L. Albrecht, Ray
Persistent Subfertility: The Pain and the
Fitzpatrick, and Susan C. Scrimshaw. San
Politics. Fertility and Sterility 76:43142.
Francisco: Sage Publications.
Imershein, Allen W. and Carroll L. Estes. 1996. Loe, Monika. 2001. Fixing Broken Masculinity:
From Health Services to Medical Markets: The
Viagra Technology for the Production of Gender
Commodity Transformation of Medical
and Sexuality. Sexuality and Culture 5:97125.
Production and the Nonprofit Sector. Lown, Bernard. 2000. Market Health Care: The
International Journal of Health Services
Commodification of Health Care. Philosophy
26:22138.
and Social Action 26:5771.
175
Peter Conrad is Harry Coplan Professor of Social Sciences at Brandeis University, where he is also Chair
of the Health: Science, Society and Policy program. He has published numerous books and articles and is
currently completing a book on the medicalization of society.
Valerie Leiter is Assistant Professor of Sociology and Director of the Society and Health Program at
Simmons College. Her work focuses on the social construction of childhood disability and the provision of
health and therapeutic care to children with disabilities.
Delivered by Ingenta to :
Mr Matharu (cid 32629), ingenta internal live 2.3.1/F4 (cid 75000325), University of Delaware
Library (cid 2443)
Tue, 27 Dec 2005 00:27:44