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What is This?
A B S T RACT
Sociological interest in pharmaceuticals has intensified, heightening awareness of
‘pharmaceuticalization’. It is argued that pharmaceuticalization should be under-
stood by reference to five main biosociological explanatory factors: biomedicalism,
medicalization, pharmaceutical industry promotion and marketing, consumerism,
and regulatory-state ideology or policy.The biomedicalism thesis, which claims that
expansion of drug treatment reflects advances in biomedical science to meet health
needs, is found to be a weak explanatory factor because a significant amount of
growth in pharmaceuticalization is inconsistent with scientific evidence, and because
drug innovations offering significant therapeutic advance have been declining across
the sector, including areas of major health need. Some elements of consumerism
have undermined pharmaceuticalization, even causing de-pharmaceuticalization in
some therapeutic sub-fields. However, other aspects of consumerism, together with
industry promotion, medicalization, and deregulatory state policies are found to be
drivers of increased pharmaceuticalization in ways that are largely outside, or sub-
optimal for, significant therapeutic advances in the interests of public health.
K E Y WO RD S
biomedicalism / consumerism / drug innovation / marketing / medicalization /
pharmaceutical industry / regulatory state
s (Abraham, 1995a, 2008; Braithwaite, 1984; Fraser et al., 2009; Gabe and
Bury, 1988). Recently, there has been an intensification of interest calling
603
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604 Sociology Volume 44 ■ Number 4 ■ August 2010
for greater attention to the field (Abraham, 2002a; Busfield, 2006; Conrad,
2005a: 145; Williams et al., 2009a). Scholars have noticed that pharmaceuti-
cals are apparently playing an increasing role in people’s lives, leading some to
refer to ‘pharmaceuticalization’, the ‘pharmaceutical person’, and the ‘pharmaceutical
imagination’ (Abraham, 2009; Fox and Ward, 2009; Marshall, 2009;
Martin, 2006).
Some pharmaceuticalization theorists assert that ‘we are seeing the phar-
maceuticalization of domestic life’ because ‘the bedroom and the kitchen are
now foci for pharmaceutical marketing and consumption’ (Fox and Ward,
2009: 41). Similarly, noting press coverage of non-medical uses or abuses of a
prescription drug for excessive sleepiness, Williams et al. (2009b: 37) define
pharmaceuticalization’ as ‘the transformation of human conditions, capacities
or capabilities into pharmaceutical matters of treatment or enhancement’. I
define ‘pharmaceuticalization’ as ‘the process by which social, behavioural or
bodily conditions are treated or deemed to be in need of treatment, with medical
drugs1 by doctors or patients2’ (Abraham, 2009: 100).
Sociology has long acknowledged the concept of ‘medicalization’ – ‘a process
by which non-medical problems become defined and treated as medical problems,
usually in terms of illness or disorders’ (Conrad, 1992: 209). Medicalization
theorists asserted that growth in medical conditions largely reflected the domi-
nance of the medical profession in society and the significance of the ‘sick role’
in redefining social deviance or dysfunctionality (Conrad and Schneider, 1992;
Freidson, 1970; Parsons, 1951; Zola, 1972). Such medicalization could increase
drug treatment, but medicalization theorists focused on interactions between
the medical professions, patients and healthcare organizations, paying sparse
attention to pharmaceuticals or the pharmaceutical industry. Recently, however,
medicalization theorists have argued that the medical profession should no
longer be regarded as the central driver of medicalization because the pharma-
ceutical industry has become a major player in medicalization in western soci-
eties since the ‘Prozac era’ of the late 1980s (Abraham and Lewis, 2002;
Conrad, 2005b).
This raises the question of whether ‘pharmaceuticalization’ is a necessary
concept, and if it can be subsumed under ‘medicalization’. Despite overlap,
there are significant differences between the two phenomena. While expansion
of pharmaceutical use affects pharmaceuticalization per se, medicalization
theorists’ concern is solely about how this expansion reflects an increase in
aspects of life, previously outside the jurisdiction of medicine, being construed
as medical problems. For example, Conrad (2005b) emphasizes how changes to
US Food and Drug Administration (FDA) regulations, such as direct-to-
consumer advertising of prescription drugs (DTCA), facilitated promotion of
pharmaceuticals to be prescribed by doctors beyond medical conditions
approved by regulators. Furthermore, he argues that these changes motivated
pharmaceutical companies to market diseases, such as ‘generalized anxiety dis-
order’, as a strategy for selling drugs, which also increased medicalization.
Yet, the concept of medicalization does not cope well with some cases
Conrad uses to support his thesis. He cites the huge amplification in the last
decade of sales of drugs, such as Ritalin, to treat children with attention-
deficit-hyperactivity-disorder (ADHD) (Conrad, 2005b: 7). However, Ritalin
has been available to treat this condition since the 1960s (Conrad and
Schneider, 1992: 156–8). While some growth in Ritalin prescription is due to
medicalization via increased diagnosis, a significant amount could have resulted
from decisions to opt for drug treatment instead of psychotherapy to address
pre-existing diagnoses of ADHD. The latter scenario involves pharmaceutical-
ization, but not medicalization. Another example of this is the treatment of obe-
sity with ‘weight-loss’ pharmaceuticals when previously treated solely by diet
control or surgery (Padwal and Majumdar, 2007; Throsby, 2009). Thus, phar-
maceuticalization can grow without expansion of medicalization, because some
drugs are increasingly used to treat an established medical condition involving
no transformation of a non-medical problem into a medical one.
Pharmaceuticalization may also occur without medicalization because the
medical profession is by-passed in pharmaceutical choice, purchase and use: for
example, direct consumer purchase of ‘lifestyle drugs’ (including prescription
drugs, such as Viagra) on the internet or over-the-counter (OTC) drugs in super-
markets and pharmacies (Fox and Ward, 2009; Stevenson et al., 2009). Indeed,
the same single process may enlarge pharmaceuticalization, but decrease medi-
calization, such as when governments’ re-classification of prescription-only
drugs as OTC products magnifies use (Abraham, 2009).3 There is, then, a need
for the concept of ‘pharmaceuticalization’ because the empirical phenomena to
which it refers cannot be adequately captured or explained by recent revisions to
medicalization theory.
Medicalization and pharmaceuticalization theorists alike tend towards
an overly teleological fixation on the expansion and increase of pharma-
ceutical prescriptions and uses. Clarke et al. (2003) even claim that growth
in ‘biomedicalization’ represents an epochal transformation of American medicine.
Such expansion in some pharmaceutical fields is undeniable. However, empha-
sis on growth has led theorists to concentrate on pharmaceutical fields or drugs
with expanded ‘off-label’4 use and increased market size. Sociological debate
about pharmaceuticalization and medicalization revolves almost exclusively
around psycho-social or ‘lifestyle’ areas of medicine and associated pharma-
ceuticals to treat sexual activity, sleep disorders, social anxiety, hyperactivity,
attention difficulties and depression.
These issues are important. In 2008, globally, antidepressants, mood stabi-
lizers and antipsychotics were in the top four therapy classes for sales; while in
the US, of the 14 prescription drugs most widely used off-label, six were
used off-label for bipolar (manic-depressive) disorder, one for anxiety, one for
depression and one for sleep disturbance (Scrip, 2008a, 2008b). Nonetheless, to
be fully appreciated, these phenomena need to be set in the context of trends in
other parts of the pharmaceutical sector. Pharmaceuticalization may not be
Between 1960 and the early 1980s, prescription drug sales were almost static as
a percentage of GDP in western societies. However, from the early 1980s to
2002, prescription drug sales tripled to nearly US$400 billion worldwide, and
almost US$200 billion in the US (Angell, 2004: 1–5). Between 2002 and 2006,
US prescription drugs sales grew annually by 10 per cent on average, while
global sales reached US$600 billion by 2007 (IMS Health, 2008; Scrip, 2008c).
In some areas of medicine, pharmaceuticalization increased along with
expansion of pharmaceutical markets. Between 1993 and 2002, NHS prescrip-
tions in England for antidepressant drugs, known as selective serotonin re-uptake
inhibitors (SSRIs), grew from 1,884,571 to 15,500,000, and for Ritalin, they
grew from 3500 to 161,800 (Department of Health, 1994, 2003). In the US,
sales of the SSRI, fluoxetine (Prozac), more than doubled between 1994 and
2000, sales of Viagra nearly doubled within four years of market release in
1998, and sales of Ritalin multiplied five-fold in the 10 years after 1992 (Drug
Enforcement Administration, 2001; Eli Lilly, 2000; Rafalovich, 2005; Scrip,
1995, 1999; Timmerman, 2003). There are similar trends in Canada and Australia
(Phillips, 2006: 433). The explanation for this growth is one important dimen-
sion of pharmaceuticalization.
Deep-seated within industry, techno-science and popular discourse is the
biomedicalist view that growing pharmaceuticalization reflects progress in
medical science, enabling people with conditions such as ADHD, depression or
erectile dysfunction, who were previously undiagnosed or untreated, to receive
medication that they need (Castellanos, 2002; Harding, 2001). For example, on
this view, ADHD may be diagnosed as an organic brain dysfunction – due to
dopamine deficiency and treatable with biochemical intervention (Barkley,
1996, 1997; Couvoisie and Hooper, 2003; Diller, 1998; Krause et al., 2003;
Rafalovich, 2005; Zametkin et al., 1990).
I have indicated that medicalization and industry promotion and marketing are
more convincing drivers of increased pharmaceuticalization in some psycho-
social or lifestyle areas of medicine than biomedicalism because techno-scientific
evidence to support extensive growth in use and prescription of many drugs in
those areas is weak. I have also suggested that some aspects of consumerism
have pushed pharmaceuticalization beyond boundaries that could be defended
by biomedicalism, such as the acceleration of drugs on to the market with insuf-
ficient scientific evidence of clinical benefit or the encouragement of off-label
use in ways that are inconsistent with regulatory assessments. However, if a
new drug (perhaps Herceptin) was discovered to be clearly effective in treating
an established medical condition (e.g. breast cancer), then the ensuing phar-
maceuticalization could be largely attributed to biomedicalism rationally
demanded by patients, rather than to (illegitimate) medicalization or industry
promotion or marketing claims beyond scientific knowledge. Thus, to further
understand the extent to which pharmaceuticalization may be explained by
biomedicalism, relative to other factors, it is necessary to examine pharmaceu-
tical innovations.
A pharmaceutical product innovation is a new molecular entity (NME)
brought to market. An NME is a patent-able technical novelty with unique
molecular structure (Vos, 1991). Before approval on to the market, government
regulatory agencies require new drugs to demonstrate therapeutic efficacy com-
pared with placebos, but NMEs are not required to deliver therapeutic advance
beyond drugs already on the market (Abraham and Davis, 2009). While all
innovations are commercially important for manufacturers, it is those which
offer significant therapeutic advance that are most valuable to patients’ health.
Figure 1 Number of NMEs first launched onto the world market (1994–2003)
Source: Centre for Medicines Research (2005); final column shows provisional figures for 2003
45
40
35
Number of applications
30
25
20
15
10
0
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
Financial Year
Pharmaceutical product innovation declined during the same period that phar-
maceuticalization in many psycho-social and lifestyle areas has increased
(Figures 1 and 2). More importantly, the number of NMEs offering significant
therapeutic advance (those given ‘priority’ review by FDA) has also declined
(Figure 2).6 Each year more than half the NMEs submitted to the FDA offered
little or no therapeutic advantage over drugs already on the market (receiving
‘standard’ reviews). Furthermore, French medical/pharmaceutical professionals
in La Revue Prescrire (2005), reviewed 3100 new drugs or new indications for
existing drugs, mostly on the French, EU or US markets, from 1981 to 2004, and
concluded that only 10 per cent offered moderate to significant therapeutic
advance. Thus, aggregating the sector as a whole, pharmaceuticalization in the
form of new drugs offering significant therapeutic advance has been shrinking in
the last 15 years. Expansion in pharmaceuticalization cannot be explained by
growth in techno-scientific discoveries of therapeutically significant innovations
that meet health needs because no such growth has been forthcoming.
Notably, from 1990, the FDA drastically cut its time to review and approve
both priority and standard NMEs, largely in response to complaints by the
pharmaceutical industry and anti-regulation ‘think-tanks’ that ‘over-regulation’
was inhibiting innovation (FDA, 2009; Kaitin and DiMasi, 2000; Kessler et al.,
1996). Similar measures were taken by drug regulatory agencies in Europe
(Abraham and Davis, 2007b; Abraham and Lewis, 2000). Yet this deregulatory
culture of the late 1980s and 1990s has been followed by declines in innovation
because of less demanding regulatory standards placed upon the industry to
incentivise the development of therapeutically significant drugs (Abraham and
Reed, 2002; Schweitzer et al., 1996). Evidently, deregulatory ideology (and
associated policies) have been drivers of growing pharmaceuticalization, not
primarily by releasing many more innovations needed by patients and medical
professionals, as the biomedicalism thesis would have it, but rather mainly by
allowing the industry to expand its markets for drugs that offer little or no ther-
apeutic advance in a sea of declining innovation.
Nowhere is this more evident than in the case of antibiotics. By the late
1980s and early 1990s, it was known to biomedical scientists that bacterial
resistance to existing antibiotics was becoming a significant health problem
(Blumberg et al., 1991; O’Neill and McIntosh 1987; Van Klingeren et al.,
1989). This problem has grown steadily since. The World Health Organization
(2004) ranked infections caused by drug-resistant bacteria as the area of medical
need where there was the largest ‘pharmaceutical gap’. This was also a period
of deregulatory policies and growing pharmaceuticalization in some other fields.
Yet, between 1983 and 2004, the development of antibiotics declined
steadily: FDA approved 16 between 1983 and 1987; 14 between 1988 and
1992; 10 between 1993 and 1997; seven between 1998 and 2002; and just three
in 2003 and 2004 (Infectious Diseases Society of America [IDSA], 2004: 15).
Regarding antibiotics that might be approved after 2004, Spellberg et al. (2004)
found that of 506 molecules at 22 major pharmaceutical companies, only six
were antibiotics. According to Bradley et al. (2007: 68) from IDSA, ‘two years
later, very little had changed’ because ‘anti-infective drug products are less prof-
itable than other medicines, particularly those for chronic conditions [so] many
pharmaceutical companies focus their R&D efforts elsewhere’.
There is strong evidence that pharmaceuticalization has been growing within the
medicalization-pharmaceuticalization complex where medicalization is a more
convincing explanation for the scale of increased pharmaceuticalization than
biomedicalism. As Conrad has pointed out, the pharmaceutical industry has been
a major driver of such medicalization. However, industry promotion or market-
ing also operates outside the medicalization-pharmaceuticalization complex as a
driver of pharmaceuticalization without medicalization. A significant amount of
this promotion-driven pharmaceuticalization either lacks support from, or is
directly inconsistent with, the prevailing biomedical scientific evidence, so it can-
not be explained by biomedicalism. Promotion-driven pharmaceuticalization is,
however, augmented by the ideological appropriation of patients’ needs as consumer
demands, partly by-passing doctors as gatekeepers, whether in the form of DTCA
in the US or as the discourse of the ‘expert patient’ in Europe. The pharmaceuti-
cal industry, deregulatory elements of western governments, and some patient
groups have cooperated in this ideological appropriation.
In the area where one would expect to find the strongest case for a biomed-
icalist explanation of growing pharmaceutical markets, namely drug innova-
tions offering therapeutic advance, pharmaceuticalization has been declining.
While biomedicalism may be a large part of the explanation for the pharma-
ceuticalization expressed by significant therapeutic advances which have come
to market, such as Herceptin, it cannot be an explanation for the growth in
overall pharmaceutical markets or expanded pharmaceuticalization in some
therapeutic areas, because no such growth or expansion of drug innovation
offering significant therapeutic advance has occurred in the last 15–20 years.
On the contrary, the commercial priorities of the industry have so dominated
biomedical aspirations that marketing efforts have consistently outstripped
R&D, and pharmaceuticalization of therapeutic areas with low profitability,
but major health needs, has stalled or shrunk.
Deregulatory ideologies or policies of the state to lower the techno-evidential
barriers to market entry for NMEs and increased industry-consumer collabora-
tion for access to new drugs for serious and life-threatening illnesses have been
drivers of pharmaceuticalization. Yet both these drivers combined have been
unable to deliver growth in the number of drug innovations offering therapeutic
advance. This is testimony to the weakness of biomedicalism as an explanation
for growing pharmaceuticalization. Furthermore, rising consumerism in the form
of campaigns and litigation against particular drug products and pharmaceutical
firms has counteracted growth in pharmaceuticalization and, in some therapeu-
tic sub-fields, caused de-pharmaceuticalization with consequent decline of drug
development and pharmaceutical market share in those sub-fields.
The weakness of biomedicalism as an explanation for growing pharmaceu-
ticalization and the magnification in scale of drug injury cases are not only of
academic interest. They reveal that increased pharmaceuticalization is not
fuelled primarily by growth in pharmaceutical provision to meet, and advance,
Acknowledgements
Thanks to ESRC and MRC for funding some of the research on which this article
is based (Grant Ref No. L218252001).
Notes
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John Abraham
Is Professor of Sociology, Director of the Centre for Research in Health and Medicine
(CRHaM) at the University of Sussex, and Expert Adviser to the UK House of
Commons Parliamentary Health Select Committee for its eight-month ‘Inquiry into the
Influence of the Pharmaceutical Industry’ (2005). He is currently preparing a book with
Dr Courtney Davis on Challenging Pharmaceutical Regulation: Innovation and Health in
Europe and the US (Palgrave, forthcoming).
Address: Department of Sociology, School of Law, Politics & Sociology, University of
Sussex, Falmer, Brighton BN1 9SN, UK.
E-mail: j.w.abraham@sussex.ac.uk