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Pharmaceuticalization of Society in Context: Theoretical, Empirical and


Health Dimensions
John Abraham
Sociology 2010 44: 603
DOI: 10.1177/0038038510369368

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Volume 44(4): 603–622
DOI: 10.1177/0038038510369368

Pharmaceuticalization of Society in Context:


Theoretical, Empirical and Health Dimensions
■ John Abraham
University of Sussex

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

Introduction: Building a Conceptual and


Methodological Frame

ociologists have studied pharmaceuticals in society for over 20 years

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.

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Pharmaceuticalization of society Abraham 605

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

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606 Sociology Volume 44 ■ Number 4 ■ August 2010

increasing in all fields of medicine. Understanding areas of contraction could


contribute further insights into the nature and extent of pharmaceuticalization.
Moreover, if pharmaceuticalization, as a sociological concept, is to be more
than merely an observation of growing pharmaceutical presence in society, then
it needs to be related to the validity (or otherwise) of the biomedicalism thesis,
which claims that growth in drug treatment is a response to advancing health
needs revealed by the progressive capacity of biomedical science to discover
pharmaceutical solutions to new or established illnesses. Indeed, if the biomed-
icalist thesis were correct, then pharmaceuticalization could be largely encap-
sulated under ‘therapeutic diffusion of pharmaceutical-medicine’. Incorporating
the biomedicalism thesis into sociological analysis throws light directly on the
implications of pharmaceuticalization for health – a curiously elusive feature of
medicalization and pharmaceuticalization theory (Conrad and Leiter, 2008: 835;
Rose, 2007).
Continual reference to pharmaceutical expansion has also influenced the
conceptualization of patients and consumers. Their role tends to be solely clas-
sified under an ideology of consumerism characterized by a craving for phar-
maceuticals, whether generated by advertising or a fusion of industry marketing
activities and cultural expectations (Applbaum, 2006; Conrad, 2005a: 138–40;
Fox and Ward, 2009; Marshall, 2009: 143; Rose, 2007; Williams et al., 2009a).
Consumer demand for, and effective marketing of, some pharmaceutical prod-
ucts is indisputable, but there are consumer-based objections to drugs and their
marketing in the politico-legal sphere, whose complexities require disaggrega-
tion of ‘consumerism’ before being integrated into the overall sociological
architecture of pharmaceuticalization. Furthermore, Conrad’s concentration on
DTCA as a central explanation for growing medicalization or pharmaceutical-
ization must be restricted to the US because in every other western country,
except for New Zealand, DTCA is illegal. Yet the expansive phenomena to
which he refers are also evident in Europe, Canada and Australia (House of
Common Health Committee [HCHC], 2005; Lexchin, 2001; Lofgren, 2004;
Moynihan and Cassels, 2005). It may be that much broader and fundamental
shifts in regulatory ideology or policy, beyond DTCA, need to be considered.
Discussion of pharmaceuticalization (and associated medicalization) in
sociological literature has referred mostly to developments regarding the
prescription drug sector in the last 15–20 years in western societies. To preserve
analytical consistency, the same temporal and spatial focus is adopted here.
In this article, I argue that pharmaceuticalization should be understood by refer-
ence to five main explanatory factors, which are mutually interactive but com-
peting. These dimensions are: biomedicalism (including industry drug research,
development and innovation); medicalization; industry drug promotion and mar-
keting; consumerism; and the ideology or policy of the regulatory state.
Methodologically, I do not assume that each of these factors must have
driven growth of pharmaceuticalization. Rather, I analyse the plausibility of
the hypotheses that each factor has contributed to such growth. This includes the
need to relate the explanatory factors to aspects of contraction or decline in

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Pharmaceuticalization of society Abraham 607

pharmaceuticalization, as well as growth. Rose (2007) and Marshall (2009)


have criticized ‘medicalization’ as a cliché of suspicion and implication in soci-
ological analysis. The methodology here avoids the same fate for the concept of
‘pharmaceuticalization’ because biomedicalism is explicitly included as a
competing explanatory factor and it is explicitly related to satisfaction of health
needs. The more plausible is the biomedicalist thesis, with or without support
from interacting explanatory factors, then the more likely the expansion of
pharmaceuticalization is to have resulted from medical drugs meeting health
needs (‘therapeutic diffusion’). Conversely, the more plausible are competing
explanatory factors, at the expense of biomedicalism’s explanatory power, then
the more likely the expansion of pharmaceuticalization is to reflect commercial
priorities, government agendas, and false expectations of doctors and patients,
which are largely divorced from health needs.

Pharmaceuticalization of Medicine: Biomedicalism,


Medicalization and Marketing

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).

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608 Sociology Volume 44 ■ Number 4 ■ August 2010

Yet, during this increased pharmaceuticalization, the technical advances


declared by biomedicalism exhibited many uncertainties within scientific litera-
ture and clinical settings (Rafalovich, 2005). Brain-imaging studies for ADHD,
supposed to detect biochemical bases for the condition and drug effects, lacked
replicability and experimental rigour in sample size and matching the children’s
ages in control and test groups (DeGrandpre, 2000; Thambirajah, 1998).
Furthermore, direct measurement of dopamine levels in the brain could not be
sampled from living people, so they had to be inferred from dopamine metabo-
lites in the blood, urine or cerebro-spinal fluid. The validity of such measure-
ment was, and remains, questionable. The setting of ‘normal’ levels of dopamine
in the brain, from which people diagnosed with ADHD are supposed to devi-
ate, was, and remains, similarly problematic (Glenmullen, 2000; Yuwiler, 1994).
Proponents of biomedicalism also contend that growing pharmaceutical-
ization reflects increasingly sensitive clinical diagnostics that have facilitated
discovery of more people needing drug treatment. However, over the last
40 years, diagnostic criteria for ADHD have consistently widened making it
virtually impossible to disentangle increased identification of ADHD sufferers
from increased medicalization, and leading to concern that the threshold
between ‘normal behaviour’ and ADHD has been set too low. Official diagnos-
tic criteria for ADHD apply to almost 20 per cent of school-age children in the
US (Goldman et al., 1998). The diagnostic criteria overlap with ‘normal’ expe-
rience and other psychiatric diagnoses to the extent that, in the US, large-
scale epidemiological studies found that nearly 50 per cent of children satisfied
ADHD symptom criteria, while 70 per cent of children diagnosed with ADHD
were also diagnosed with ‘conduct disorder’ or ‘oppositional defiant disorder’
(Bird et al., 1990; Sharma, 2000).
ADHD illustrates why, in many psycho-social areas of medical intervention,
the biomedicalist thesis is unpersuasive because of technical implausibilities and
the fact that broadening diagnostic criteria could readily reflect medicalization
as much as discovery of previously undetected sick people. Similarly, growth in
prescriptions for antipsychotics in recent decades is due to those drugs being
redefined by medical experts to also treat ‘bipolar disorder’ – a condition whose
medicalization increased 50-fold since entering the Diagnostic and Statistical
Manual of Mental Disorders (DSM) in 1980 (Healy, 2006a). Meanwhile, the
UK ‘Defeat Depression Campaign’, a disease-awareness campaign during the
1990s run through the Royal Colleges of Psychiatrists and General Practitioners,
targeted doctors to prescribe SSRIs to combat the declared epidemic of depres-
sion (HCHC, 2005: 70).
In these respects medicalization seems to be a significant factor in explaining
increased pharmaceuticalization. Given that expert medical elites involved in
diagnostic boundary changes and disease-awareness campaigns are often
funded or influenced by the pharmaceutical industry, then, as Conrad (2005b)
argues, industry interests are drivers of some medicalization. I refer to this
mutually reinforcing two-way causality as the ‘medicalization-pharmaceutical-
ization complex’. The biomedicalist claim that the growth of pharmaceuticalization

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Pharmaceuticalization of society Abraham 609

in these areas is merely a reflection of health needs is not credible because


industry-sponsored disease-awareness campaigns have exaggerated the benefits
of drugs, such as SSRIs, tranquillizers and Viagra, resulting in them being
prescribed in ways that have no techno-scientific basis (Abraham and Sheppard,
1999; HCHC, 2005: 69–70; Healy, 2004; Medawar, 1992; Medawar and
Hardon, 2004). For example, Kirsch et al. (2008) found that scientific clinical
trial data for the four most widely prescribed SSRIs in the UK and US, during
the 1990s, implied that these drugs were clinically effective only in very severe
cases of depression, despite being promoted and prescribed for moderate or
mild depression.
Pharmaceuticalization is also driven by industry promotion and advertising
of individual drug products to the medical profession for established medical
conditions, whether on- or off-label. Zyprexa, a drug approved for treatment
of schizophrenia and bipolar disorder, was also promoted to doctors by the
manufacturer’s marketing staff for off-label treatment of established dementia
and Alzheimer’s condition, reaching global sales of US$4.8 billion, even though
there was no scientific evidence to support such off-label use (Scrip, 2009). This
is outside the medicalization-pharmaceuticalization complex because it involves
no medicalization. Zyprexa is one of many examples (Scrip, 2009: 7). Such
advertising or promotion is huge, and has been growing, but neglected by
sociologists blinkered by the apparent novelty of disease-marketing. During
increased pharmaceuticalization of psycho-social and lifestyle fields of medicine,
marketing grew much faster than research and development (R&D). Between
1995 and 2005, research staff numbers in the UK pharmaceutical industry fell
by 2 per cent, while marketing staff increased by 59 per cent (HCHC, 2005: 58).
In the US, industry expenditure on marketing has been about double that on
R&D – US$54 billion and US$26 billion in 2000, respectively (Angell, 2004:
40, 120). Such findings cast further doubt on the biomedicalism thesis, because
if the major drivers of pharmaceuticalization were scientific discoveries meeting
new medical needs, rather than promotion and medicalization, then one would
expect clearer evidence of growth in R&D relative to marketing activities, and
fewer cases like Zyprexa.
The integration of senior medical professionals into pharmaceutical
companies’ marketing strategies by funding them to be involved in product
development, and to speak favourably about the drug at medical symposia, also
contributes to pharmaceuticalization, but not necessarily medicalization or
marketing of diseases. This may be combined with publication in special
supplements of journals, the editors of which are company sponsored (HCHC,
2005: 56–7). Before publication, editorial changes may be made to scientists’
manuscripts, portraying the drug more positively than intended by the author,
or the manuscript may be ‘ghost-written’ by a medical writer working for the
manufacturer, rather than by the researcher under whose name the publication
will appear (Abraham, 1995a; Healy, 2006b). Pharmaceutical companies may
hire public relations firms to create favourable media and professional receptions
for articles showing their drug in a positive light, but delay or withhold publication

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610 Sociology Volume 44 ■ Number 4 ■ August 2010

of negative findings, leading to bias in medical literature read by prescribing


doctors (Abraham, 1994a, 1995b; HCHC, 2005: 55–6; Lexchin et al., 2003).
Firms’ strategies to contain criticism of their products also sustain prescribing
rates and hence pharmaceuticalization. They include withdrawal of funding
from institutions providing platforms for critics’ views; attempts to prevent
publication of critics’ data; and mobilization of experts supportive of manufac-
turers to undermine critics’ concerns (Abraham, 2002b; Abraham and Sheppard,
1999; Healy, 2004).

Consumerism: Adversity, Collaboration and


Ideological Appropriation

Alongside pharmaceuticalization has emerged consumerism characterized by


greater reflexivity, expertise and/or activism among patients and consumer
organizations (Milewa, 2009). However, consumerism is not necessarily a driver
of growing pharmaceuticalization. In western societies, at least two distinct
types of active consumerism need to be identified: injury-oriented adversity to,
and access-oriented collaboration with, the pharmaceutical-industrial complex.
The former involves citizens, who believe they (or their relatives) have been
harmed by particular drugs, embarking on campaigns or litigation against
pharmaceutical manufacturers. Such adversarial consumerism has been more
extensive and successful in the US than other countries because of the
consumer-friendly legal culture of no-win-no-fees, greater rights of freedom of
information giving lawyers more confidence to file cases, and the comparatively
well-resourced consumer movement (Abraham and Sheppard, 1998).
The scale and implications of adversary have grown. In the late 1980s,
plaintiffs claiming compensation against Eli Lilly for alleged injury from the
arthritis drug, benoxaprofen (Oraflex), were awarded tens of millions of dollars
by American courts in punitive damages against the company (Abraham,
1994b). Twenty years later, US plaintiffs received US$4.85 billion to settle
27,000 lawsuits against Merck and US$894 million against Pfizer for fatal and
severe injuries allegedly caused by their arthritis drugs, Vioxx, Bextra and
Celebrex (Scrip, 2007, 2008d).
In Europe, injury-oriented adversarial consumerism has been less common
and successful. When UK plaintiffs embarked on legal actions against Eli Lilly
regarding benoxaprofen (Opren), litigation dissipated into a low-cost, no-blame,
out-of-court settlement offered by the company. Similarly, large-scale legal action
was taken in the 1990s by patients against the manufacturers of benzodiazepines
and a BBC TV Panorama documentary attacked Upjohn for its handling of
safety problems with the benzodiazepine, Halcion, but this injury litigation
collapsed, leaving many patients without compensation, while Upjohn won a
libel action against the BBC regarding Halcion (Abraham, 1994b; Abraham
and Sheppard, 1999; HCHC, 2005: 65–6). Nevertheless, benoxaprofen and
Vioxx were withdrawn from the market worldwide with subsequent marked

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Pharmaceuticalization of society Abraham 611

declines in the development and marketing of similar types of arthritis drugs


internationally (Abraham and Davis, 2007a; Brown, 2006).
The growth of injury-oriented adversarial consumerism has not increased
pharmaceuticalization. Rather, it has raised doubts about the safety of drug
products and hence reduced pharmaceutical prescription and use (Scrip, 2008e).
As occurred with arthritis drugs, injury-oriented adversarial consumerism can
be powerful enough to produce de-pharmaceuticalization. By contrast, access-
oriented collaborative consumerism increases pharmaceuticalization because it
involves patient groups seeking faster access to new drugs via accelerated
approval by government regulators. The focus is on expectations about drugs’
therapeutic efficacy, rather than safety. Access-oriented collaborative consumerism
has also involved public campaigns and litigation, but often in alliance with
pharmaceutical manufacturers and against regulators. Access-oriented
consumerism has enjoyed considerable success on both sides of the Atlantic.
Growth in American access-oriented consumerism has its roots in the
activism of HIV/AIDs patients in the late 1980s, who lobbied the FDA to allow
patients faster access to HIV/AIDS drugs by either accelerating their market
approval or permitting wider availability of those in development (Epstein,
1996). Several authors have mistakenly attributed this ‘AIDS activism’ to be the
sole cause of subsequent FDA provisions for accelerated approval of drugs.
(Carpenter, 2004; Daemmrich and Krucken, 2000; Edgar and Rothman, 1990).
Rather, such activism had support from drug firms, who saw it as a way
to reduce the FDA’s regulatory barriers to pharmaceutical markets, and from
the Reagan and Bush Senior Administrations, whose de-regulatory political
proclivities were already putting pressure on the FDA to reduce its regulatory
‘burden’ on industry (Scrip, 1988). The American consumerism spawned by AIDS
activism was a form of collaboration with industry and its deregulatory allies
in government.
Indeed, since the late 1980s, the FDA has cut regulatory review times for
all types of new drugs by more than half (FDA, 2004). From 1992, the FDA
established regulations permitting ‘accelerated approval’ of drugs intended to
treat serious or life-threatening illnesses based on very limited scientific evidence
of clinical benefit (Code of Federal Regulations, 1992). In these respects,
American access-oriented collaborative consumerism has been largely successful
in making pharmaceuticals available to patients sooner, so increasing pharma-
ceuticalization, though it is doubtful that such haste and ‘fast-tracking’, which
involve less regulatory checks on drug safety and efficacy, are beneficial to pub-
lic health (Gale, 2001). In 2004, it was reported that of 23 new cancer drugs
approved by the FDA under accelerated procedures, for only six had post-market
studies confirmed their clinical benefit and the average projected time for
completion of confirmatory studies was 10 years (Fleming, 2005; Roberts and
Chabner, 2004).
In the UK, access-oriented collaborative consumerism has focused on
patient access to new drugs on the NHS. It has grown significantly since the late
1990s, especially in relation to judgements by the National Institute for Health

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612 Sociology Volume 44 ■ Number 4 ■ August 2010

and Clinical Excellence (NICE), which assesses the cost-effectiveness of drugs


for use in the NHS. For example, in March 2005, NICE recommended that four
drugs to treat Alzheimer’s disease were not cost-effective for the NHS. However,
following a high profile media campaign and formal appeal to NICE involving
patient groups such as the Alzheimer’s Society, NICE revised its guidance to
allow NHS funding of the drugs for people with moderate, but not early, stages
of the disease. The Alzheimer’s Society then took NICE to court, which insisted
that NICE should make the drugs available to all those with the disease (BBC
News 24, 2007). Notably, the manufacturers of Alzheimer’s drugs were the lead
claimants in the court case and centrally involved in the appeal (BBC News 24,
2007). Similar collaborative activism occurred with the Multiple Sclerosis
Society’s successful campaign for access to beta-interferon on the NHS, while
Roche, manufacturers of the breast cancer drug, Herceptin, which was rushed
to market, are reported to have hired public relations firms to encourage some
women with breast cancer to help to get the drug funded on the NHS before
NICE approval (BBC News 24, 2006a, 2006b; Crinson, 2004).
I suggest that the power of active consumerism to achieve its objectives in
pharmaceutical controversies depends significantly on whether it is supporting
or contravening the interests of the pharmaceutical industry. Success is more
likely with industry support, especially outside the US. Consequently, overall,
pro-pharmaceuticalization consequences of access-oriented collaborative con-
sumerism tend to outweigh the de-pharmaceuticalization effects of injury-
oriented adversarial consumerism, though both play a role in shaping the nature
of pharmaceuticalization in society. Moreover, collaborative consumerism
may become a permanent feature of the pharmaceutical landscape because
many patient organizations have not only formed alliances with drug manufac-
turers when tactically advantageous, they have become increasingly funded by
pharmaceutical companies (HCHC, 2005: 74–6; Herxheimer, 2003; Jones,
2008; O’Donovan, 2007; Phillips, 2006: 434).
In addition to organizational activism, consumerism has an ideological
dimension, namely the discursive appropriation of the health needs of patients
as the demands of consumers in a market. This is evident from the portrayal of
patients in industry and government policy discourse about DTCA during the
last decade. As Milewa (2009) argues, such discourse is distinct from patients’
actions and needs, and may not even be derived from them.
In Europe, the pharmaceutical industry, with support from the European
Commission’s ‘DG Enterprise’, has campaigned vigorously for legalization of
DTCA in the EU – so far unsuccessfully.5 The campaign utilized a discourse of
the ‘informed patient’ and the ‘expert patient’, subsequently adopted uncriti-
cally by the UK Department of Health (2001) to promote a consumerist
ideology of patient self-care and self-medication, arguing that patients are
sufficiently knowledgeable to evaluate advertising claims about prescription
drugs, so reducing doctors from initiators of therapy to gatekeepers at most
(Medawar and Hardon, 2004: 121). While doctors’ failure to adequately inform

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Pharmaceuticalization of society Abraham 613

patients about prescription medicines can be a problem, the ‘expert patient’


discourse needs to be put in the context of the interests of those planning to
provide the ‘information’ intended to construct ‘patient expertise’, namely a
profit-seeking industry with a record of promoting its products with misleading
information to doctors (Britten, 2008; Scrip, 2006, 2009). The US experience
suggests that it is a considerable leap of faith to assume that pharmaceutical
companies will meet patients’ health needs by filling the gap left by doctors.
American broadcast DTCA more than tripled following the FDA’s relaxation of
its regulation in 1997, with pharmaceutical industry expenditure on DTCA
reaching US$4.2 billion in 2005 (Conrad and Leiter, 2008). This encouraged
consumers to self-diagnose and make requests to doctors for advertised phar-
maceutical products, which increased prescribing (Mintzes et al., 2003). Half of
those prescriptions might be for drugs without evidence to support therapeutic
efficacy in treating the condition (Conrad and Leiter, 2008: 21).

Biomedicalism, Pharmaceutical Innovation and


Regulatory-State Ideology

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.

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614 Sociology Volume 44 ■ Number 4 ■ August 2010

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

Total Standard Priority

Figure 2 Original NME applications 1998–2007


Source: FDA PDUFA performance reports for financial years 2002 and 2007, URL (consulted June 2009):
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/PD
UFA/default.htm

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

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Pharmaceuticalization of society Abraham 615

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’.

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616 Sociology Volume 44 ■ Number 4 ■ August 2010

Discussion and Conclusion

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,

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Pharmaceuticalization of society Abraham 617

health needs. Rather, the sociological factors of consumerism, deregulatory state


policies, industry’s commercial priorities and product promotion, and medical-
ization have been expanding pharmaceuticalization in ways that are largely out-
side such provision. It may be that marketing does not necessarily create false
needs, as Rose (2007) suggests, but it may create false claims and expecta-
tions about the capacity of pharmaceuticals to meet those needs. Moreover, the
ideological appropriation of patients’ needs as consumer preferences in a market
means that public health requirements, which are poorly expressed in marketing
processes such as antibiotic development and protection from drug injury, are
inappropriately neglected by an industry supposed to advance health.

Acknowledgements

Thanks to ESRC and MRC for funding some of the research on which this article
is based (Grant Ref No. L218252001).

Notes

1 ‘Medical drugs’ are those intended to treat or prevent illness.


2 This includes after consultation with a pharmacist or health professional.
3 Space constraints prevent further discussion of internet consumption or OTC drugs.
4 ‘Off-label’ use is drug prescription for a condition not stipulated on the product
label approved by regulators.
5 The European Parliament is considering whether to permit industry provision
of some prescription ‘product information’ directly to consumers.
6 Other western drug regulatory authorities do not publish the proportion of
NMEs that offer significant therapeutic advance, but American trends reflect
international patterns because all major western pharmaceutical firms seek
FDA approval of their NMEs in the huge US market.

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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

Date submitted September 2009


Date accepted November 2009

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