Abraham - Pharmaceuticalization of Society in Context- Theoretical, Empirical and Health Dimensions

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Health DimensionsPharmaceuticalization of Society in Context: Theoretical, Empirical and

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Pharmaceuticalization of Society in Context:Theoretical, Empirical and Health Dimensions

�� John AbrahamUniversity of Sussex

ABSTRACT

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 thatexpansion of drug treatment reflects advances in biomedical science to meet healthneeds, is found to be a weak explanatory factor because a significant amount ofgrowth in pharmaceuticalization is inconsistent with scientific evidence, and becausedrug innovations offering significant therapeutic advance have been declining acrossthe sector, including areas of major health need. Some elements of consumerismhave undermined pharmaceuticalization, even causing de-pharmaceuticalization insome therapeutic sub-fields. However, other aspects of consumerism, together withindustry promotion, medicalization, and deregulatory state policies are found to bedrivers of increased pharmaceuticalization in ways that are largely outside, or sub-optimal for, significant therapeutic advances in the interests of public health.

KEY WORDS

biomedicalism / consumerism / drug innovation / marketing / medicalization /pharmaceutical industry / regulatory state

Introduction: Building a Conceptual andMethodological Frame

sociologists have studied pharmaceuticals in society for over 20 years(Abraham, 1995a, 2008; Braithwaite, 1984; Fraser et al., 2009; Gabe andBury, 1988). Recently, there has been an intensification of interest calling

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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 torefer to ‘pharmaceuticalization’, the ‘pharmaceutical person’, and the ‘pharmaceuticalimagination’ (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 arenow foci for pharmaceutical marketing and consumption’ (Fox and Ward,2009: 41). Similarly, noting press coverage of non-medical uses or abuses of aprescription drug for excessive sleepiness, Williams et al. (2009b: 37) definepharmaceuticalization’ as ‘the transformation of human conditions, capacitiesor capabilities into pharmaceutical matters of treatment or enhancement’. Idefine ‘pharmaceuticalization’ as ‘the process by which social, behavioural orbodily conditions are treated or deemed to be in need of treatment, with medicaldrugs1 by doctors or patients2’ (Abraham, 2009: 100).

Sociology has long acknowledged the concept of ‘medicalization’ – ‘a processby which non-medical problems become defined and treated as medical problems,usually in terms of illness or disorders’ (Conrad, 1992: 209). Medicalizationtheorists 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 increasedrug treatment, but medicalization theorists focused on interactions betweenthe medical professions, patients and healthcare organizations, paying sparseattention to pharmaceuticals or the pharmaceutical industry. Recently, however,medicalization theorists have argued that the medical profession should nolonger 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 necessaryconcept, and if it can be subsumed under ‘medicalization’. Despite overlap,there are significant differences between the two phenomena. While expansionof pharmaceutical use affects pharmaceuticalization per se, medicalizationtheorists’ concern is solely about how this expansion reflects an increase inaspects of life, previously outside the jurisdiction of medicine, being construedas medical problems. For example, Conrad (2005b) emphasizes how changes toUS Food and Drug Administration (FDA) regulations, such as direct-to-consumer advertising of prescription drugs (DTCA), facilitated promotion ofpharmaceuticals to be prescribed by doctors beyond medical conditionsapproved by regulators. Furthermore, he argues that these changes motivatedpharmaceutical companies to market diseases, such as ‘generalized anxiety dis-order’, as a strategy for selling drugs, which also increased medicalization.

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Yet, the concept of medicalization does not cope well with some casesConrad uses to support his thesis. He cites the huge amplification in the lastdecade of sales of drugs, such as Ritalin, to treat children with attention-deficit-hyperactivity-disorder (ADHD) (Conrad, 2005b: 7). However, Ritalinhas been available to treat this condition since the 1960s (Conrad andSchneider, 1992: 156–8). While some growth in Ritalin prescription is due tomedicalization via increased diagnosis, a significant amount could have resultedfrom decisions to opt for drug treatment instead of psychotherapy to addresspre-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 dietcontrol or surgery (Padwal and Majumdar, 2007; Throsby, 2009). Thus, phar-maceuticalization can grow without expansion of medicalization, because somedrugs are increasingly used to treat an established medical condition involvingno transformation of a non-medical problem into a medical one.

Pharmaceuticalization may also occur without medicalization because themedical profession is by-passed in pharmaceutical choice, purchase and use: forexample, direct consumer purchase of ‘lifestyle drugs’ (including prescriptiondrugs, 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-onlydrugs as OTC products magnifies use (Abraham, 2009).3 There is, then, a needfor the concept of ‘pharmaceuticalization’ because the empirical phenomena towhich it refers cannot be adequately captured or explained by recent revisions tomedicalization theory.

Medicalization and pharmaceuticalization theorists alike tend towardsan overly teleological fixation on the expansion and increase of pharma -ceutical prescriptions and uses. Clarke et al. (2003) even claim that growthin ‘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 drugswith expanded ‘off-label’4 use and increased market size. Sociological debateabout pharmaceuticalization and medicalization revolves almost exclusivelyaround 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 inthe US, of the 14 prescription drugs most widely used off-label, six wereused off-label for bipolar (manic-depressive) disorder, one for anxiety, one fordepression and one for sleep disturbance (Scrip, 2008a, 2008b). Nonetheless, tobe fully appreciated, these phenomena need to be set in the context of trends inother parts of the pharmaceutical sector. Pharmaceuticalization may not be

605Pharmaceuticalization of society Abraham



increasing in all fields of medicine. Understanding areas of contraction couldcontribute further insights into the nature and extent of pharmaceuticalization.

Moreover, if pharmaceuticalization, as a sociological concept, is to be morethan merely an observation of growing pharmaceutical presence in society, thenit 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 healthneeds revealed by the progressive capacity of biomedical science to discoverpharmaceutical 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’. Incorporatingthe biomedicalism thesis into sociological analysis throws light directly on theimplications of pharmaceuticalization for health – a curiously elusive feature ofmedicalization and pharmaceuticalization theory (Conrad and Leiter, 2008: 835;Rose, 2007).

Continual reference to pharmaceutical expansion has also influenced theconceptualization 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 marketingactivities 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 theirmarketing in the politico-legal sphere, whose complexities require disaggrega-tion of ‘consumerism’ before being integrated into the overall sociologicalarchitecture of pharmaceuticalization. Furthermore, Conrad’s concentration onDTCA 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 towhich he refers are also evident in Europe, Canada and Australia (House ofCommon Health Committee [HCHC], 2005; Lexchin, 2001; Lofgren, 2004;Moynihan and Cassels, 2005). It may be that much broader and fundamentalshifts in regulatory ideology or policy, beyond DTCA, need to be considered.

Discussion of pharmaceuticalization (and associated medicalization) insociological literature has referred mostly to developments regarding theprescription drug sector in the last 15–20 years in western societies. To preserveanalytical 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 havedriven growth of pharmaceuticalization. Rather, I analyse the plausibility ofthe hypotheses that each factor has contributed to such growth. This includes theneed to relate the explanatory factors to aspects of contraction or decline in




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 acompeting explanatory factor and it is explicitly related to satisfaction of healthneeds. The more plausible is the biomedicalist thesis, with or without supportfrom interacting explanatory factors, then the more likely the expansion ofpharmaceuticalization is to have resulted from medical drugs meeting healthneeds (‘therapeutic diffusion’). Conversely, the more plausible are competingexplanatory factors, at the expense of biomedicalism’s explanatory power, thenthe more likely the expansion of pharmaceuticalization is to reflect commercialpriorities, 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 asa percentage of GDP in western societies. However, from the early 1980s to2002, prescription drug sales tripled to nearly US$400 billion worldwide, andalmost 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, whileglobal sales reached US$600 billion by 2007 (IMS Health, 2008; Scrip, 2008c).

In some areas of medicine, pharmaceuticalization increased along withexpansion of pharmaceutical markets. Between 1993 and 2002, NHS prescrip-tions in England for antidepressant drugs, known as selective serotonin re-uptakeinhibitors (SSRIs), grew from 1,884,571 to 15,500,000, and for Ritalin, theygrew from 3500 to 161,800 (Department of Health, 1994, 2003). In the US,sales of the SSRI, fluoxetine (Prozac), more than doubled between 1994 and2000, sales of Viagra nearly doubled within four years of market release in1998, and sales of Ritalin multiplied five-fold in the 10 years after 1992 (DrugEnforcement 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 thebiomedicalist view that growing pharmaceuticalization reflects progress inmedical science, enabling people with conditions such as ADHD, depression orerectile dysfunction, who were previously undiagnosed or untreated, to receivemedication that they need (Castellanos, 2002; Harding, 2001). For example, onthis view, ADHD may be diagnosed as an organic brain dysfunction – due todopamine 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).




Yet, during this increased pharmaceuticalization, the technical advancesdeclared 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, lackedreplicability and experimental rigour in sample size and matching the children’sages in control and test groups (DeGrandpre, 2000; Thambirajah, 1998).Furthermore, direct measurement of dopamine levels in the brain could not besampled 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 dopaminein 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 facilitateddiscovery of more people needing drug treatment. However, over the last40 years, diagnostic criteria for ADHD have consistently widened making itvirtually impossible to disentangle increased identification of ADHD sufferersfrom increased medicalization, and leading to concern that the thresholdbetween ‘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 theUS (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 satisfiedADHD symptom criteria, while 70 per cent of children diagnosed with ADHDwere 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 andthe fact that broadening diagnostic criteria could readily reflect medicalizationas much as discovery of previously undetected sick people. Similarly, growth inprescriptions for antipsychotics in recent decades is due to those drugs beingredefined by medical experts to also treat ‘bipolar disorder’ – a condition whosemedicalization increased 50-fold since entering the Diagnostic and StatisticalManual of Mental Disorders (DSM) in 1980 (Healy, 2006a). Meanwhile, theUK ‘Defeat Depression Campaign’, a disease-awareness campaign during the1990s 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 explainingincreased pharmaceuticalization. Given that expert medical elites involved indiagnostic boundary changes and disease-awareness campaigns are oftenfunded or influenced by the pharmaceutical industry, then, as Conrad (2005b)argues, industry interests are drivers of some medicalization. I refer to thismutually reinforcing two-way causality as the ‘medicalization-pharmaceutical-ization complex’. The biomedicalist claim that the growth of pharmaceuticalization




in these areas is merely a reflection of health needs is not credible becauseindustry-sponsored disease-awareness campaigns have exaggerated the benefitsof drugs, such as SSRIs, tranquillizers and Viagra, resulting in them beingprescribed in ways that have no techno-scientific basis (Abraham and Sheppard,1999; HCHC, 2005: 69–70; Healy, 2004; Medawar, 1992; Medawar andHardon, 2004). For example, Kirsch et al. (2008) found that scientific clinicaltrial data for the four most widely prescribed SSRIs in the UK and US, duringthe 1990s, implied that these drugs were clinically effective only in very severecases of depression, despite being promoted and prescribed for moderate ormild depression.

Pharmaceuticalization is also driven by industry promotion and advertisingof individual drug products to the medical profession for established medicalconditions, whether on- or off-label. Zyprexa, a drug approved for treatmentof schizophrenia and bipolar disorder, was also promoted to doctors by themanufacturer’s marketing staff for off-label treatment of established dementiaand Alzheimer’s condition, reaching global sales of US$4.8 billion, even thoughthere was no scientific evidence to support such off-label use (Scrip, 2009). Thisis outside the medicalization-pharmaceuticalization complex because it involvesno medicalization. Zyprexa is one of many examples (Scrip, 2009: 7). Suchadvertising or promotion is huge, and has been growing, but neglected bysociologists blinkered by the apparent novelty of disease-marketing. Duringincreased pharmaceuticalization of psycho-social and lifestyle fields of medicine,marketing grew much faster than research and development (R&D). Between1995 and 2005, research staff numbers in the UK pharmaceutical industry fellby 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 onR&D – US$54 billion and US$26 billion in 2000, respectively (Angell, 2004:40, 120). Such findings cast further doubt on the biomedicalism thesis, becauseif the major drivers of pharmaceuticalization were scientific discoveries meetingnew medical needs, rather than promotion and medicalization, then one wouldexpect clearer evidence of growth in R&D relative to marketing activities, andfewer cases like Zyprexa.

The integration of senior medical professionals into pharmaceuticalcompanies’ marketing strategies by funding them to be involved in productdevelopment, and to speak favourably about the drug at medical symposia, alsocontributes to pharmaceuticalization, but not necessarily medicalization ormarketing of diseases. This may be combined with publication in specialsupplements 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 themanufacturer, rather than by the researcher under whose name the publicationwill appear (Abraham, 1995a; Healy, 2006b). Pharmaceutical companies mayhire public relations firms to create favourable media and professional receptionsfor articles showing their drug in a positive light, but delay or withhold publication




of negative findings, leading to bias in medical literature read by prescribingdoctors (Abraham, 1994a, 1995b; HCHC, 2005: 55–6; Lexchin et al., 2003).Firms’ strategies to contain criticism of their products also sustain prescribingrates and hence pharmaceuticalization. They include withdrawal of fundingfrom institutions providing platforms for critics’ views; attempts to preventpublication 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 andIdeological Appropriation

Alongside pharmaceuticalization has emerged consumerism characterized bygreater reflexivity, expertise and/or activism among patients and consumerorganizations (Milewa, 2009). However, consumerism is not necessarily a driverof growing pharmaceuticalization. In western societies, at least two distincttypes 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 beenharmed by particular drugs, embarking on campaigns or litigation againstpharmaceutical manufacturers. Such adversarial consumerism has been moreextensive and successful in the US than other countries because of theconsumer-friendly legal culture of no-win-no-fees, greater rights of freedom ofinformation giving lawyers more confidence to file cases, and the comparativelywell-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 thearthritis drug, benoxaprofen (Oraflex), were awarded tens of millions of dollarsby American courts in punitive damages against the company (Abraham,1994b). Twenty years later, US plaintiffs received US$4.85 billion to settle27,000 lawsuits against Merck and US$894 million against Pfizer for fatal andsevere injuries allegedly caused by their arthritis drugs, Vioxx, Bextra andCelebrex (Scrip, 2007, 2008d).

In Europe, injury-oriented adversarial consumerism has been less commonand successful. When UK plaintiffs embarked on legal actions against Eli Lillyregarding benoxaprofen (Opren), litigation dissipated into a low-cost, no-blame,out-of-court settlement offered by the company. Similarly, large-scale legal actionwas taken in the 1990s by patients against the manufacturers of benzodiazepinesand a BBC TV Panorama documentary attacked Upjohn for its handling ofsafety problems with the benzodiazepine, Halcion, but this injury litigationcollapsed, leaving many patients without compensation, while Upjohn won alibel action against the BBC regarding Halcion (Abraham, 1994b; Abrahamand Sheppard, 1999; HCHC, 2005: 65–6). Nevertheless, benoxaprofen andVioxx were withdrawn from the market worldwide with subsequent marked




declines in the development and marketing of similar types of arthritis drugsinternationally (Abraham and Davis, 2007a; Brown, 2006).

The growth of injury-oriented adversarial consumerism has not increasedpharmaceuticalization. Rather, it has raised doubts about the safety of drugproducts and hence reduced pharmaceutical prescription and use (Scrip, 2008e).As occurred with arthritis drugs, injury-oriented adversarial consumerism canbe powerful enough to produce de-pharmaceuticalization. By contrast, access-oriented collaborative consumerism increases pharmaceuticalization because itinvolves patient groups seeking faster access to new drugs via acceleratedapproval by government regulators. The focus is on expectations about drugs’therapeutic efficacy, rather than safety. Access-oriented collaborative consumerismhas also involved public campaigns and litigation, but often in alliance withpharmaceutical manufacturers and against regulators. Access-orientedconsumerism has enjoyed considerable success on both sides of the Atlantic.

Growth in American access-oriented consumerism has its roots in theactivism of HIV/AIDs patients in the late 1980s, who lobbied the FDA to allowpatients faster access to HIV/AIDS drugs by either accelerating their marketapproval or permitting wider availability of those in development (Epstein,1996). Several authors have mistakenly attributed this ‘AIDS activism’ to be thesole 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 wayto reduce the FDA’s regulatory barriers to pharmaceutical markets, and fromthe Reagan and Bush Senior Administrations, whose de-regulatory politicalproclivities were already putting pressure on the FDA to reduce its regulatory‘burden’ on industry (Scrip, 1988). The American consumerism spawned by AIDSactivism was a form of collaboration with industry and its deregulatory alliesin government.

Indeed, since the late 1980s, the FDA has cut regulatory review times forall types of new drugs by more than half (FDA, 2004). From 1992, the FDAestablished regulations permitting ‘accelerated approval’ of drugs intended totreat serious or life-threatening illnesses based on very limited scientific evidenceof clinical benefit (Code of Federal Regulations, 1992). In these respects,American access-oriented collaborative consumerism has been largely successfulin making pharmaceuticals available to patients sooner, so increasing pharma-ceuticalization, though it is doubtful that such haste and ‘fast-tracking’, whichinvolve 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 drugsapproved by the FDA under accelerated procedures, for only six had post-marketstudies confirmed their clinical benefit and the average projected time forcompletion of confirmatory studies was 10 years (Fleming, 2005; Roberts andChabner, 2004).

In the UK, access-oriented collaborative consumerism has focused onpatient access to new drugs on the NHS. It has grown significantly since the late1990s, especially in relation to judgements by the National Institute for Health




and Clinical Excellence (NICE), which assesses the cost-effectiveness of drugsfor use in the NHS. For example, in March 2005, NICE recommended that fourdrugs to treat Alzheimer’s disease were not cost-effective for the NHS. However,following a high profile media campaign and formal appeal to NICE involvingpatient groups such as the Alzheimer’s Society, NICE revised its guidance toallow NHS funding of the drugs for people with moderate, but not early, stagesof the disease. The Alzheimer’s Society then took NICE to court, which insistedthat NICE should make the drugs available to all those with the disease (BBCNews 24, 2007). Notably, the manufacturers of Alzheimer’s drugs were the leadclaimants in the court case and centrally involved in the appeal (BBC News 24,2007). Similar collaborative activism occurred with the Multiple SclerosisSociety’s successful campaign for access to beta-interferon on the NHS, whileRoche, manufacturers of the breast cancer drug, Herceptin, which was rushedto market, are reported to have hired public relations firms to encourage somewomen with breast cancer to help to get the drug funded on the NHS beforeNICE approval (BBC News 24, 2006a, 2006b; Crinson, 2004).

I suggest that the power of active consumerism to achieve its objectives inpharmaceutical controversies depends significantly on whether it is supportingor contravening the interests of the pharmaceutical industry. Success is morelikely 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 natureof pharmaceuticalization in society. Moreover, collaborative consumerismmay become a permanent feature of the pharmaceutical landscape becausemany patient organizations have not only formed alliances with drug manufac-turers when tactically advantageous, they have become increasingly funded bypharmaceutical companies (HCHC, 2005: 74–6; Herxheimer, 2003; Jones,2008; O’Donovan, 2007; Phillips, 2006: 434).

In addition to organizational activism, consumerism has an ideologicaldimension, namely the discursive appropriation of the health needs of patientsas the demands of consumers in a market. This is evident from the portrayal ofpatients in industry and government policy discourse about DTCA during thelast 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 EuropeanCommission’s ‘DG Enterprise’, has campaigned vigorously for legalization ofDTCA in the EU – so far unsuccessfully.5 The campaign utilized a discourse ofthe ‘informed patient’ and the ‘expert patient’, subsequently adopted uncriti-cally by the UK Department of Health (2001) to promote a consumeristideology of patient self-care and self-medication, arguing that patients aresufficiently knowledgeable to evaluate advertising claims about prescriptiondrugs, so reducing doctors from initiators of therapy to gatekeepers at most(Medawar and Hardon, 2004: 121). While doctors’ failure to adequately inform




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 toprovide the ‘information’ intended to construct ‘patient expertise’, namely aprofit-seeking industry with a record of promoting its products with misleadinginformation to doctors (Britten, 2008; Scrip, 2006, 2009). The US experiencesuggests that it is a considerable leap of faith to assume that pharmaceuticalcompanies will meet patients’ health needs by filling the gap left by doctors.American broadcast DTCA more than tripled following the FDA’s relaxation ofits regulation in 1997, with pharmaceutical industry expenditure on DTCAreaching US$4.2 billion in 2005 (Conrad and Leiter, 2008). This encouragedconsumers to self-diagnose and make requests to doctors for advertised phar-maceutical products, which increased prescribing (Mintzes et al., 2003). Half ofthose prescriptions might be for drugs without evidence to support therapeuticefficacy in treating the condition (Conrad and Leiter, 2008: 21).

Biomedicalism, Pharmaceutical Innovation andRegulatory-State Ideology

I have indicated that medicalization and industry promotion and marketing aremore convincing drivers of increased pharmaceuticalization in some psycho-social or lifestyle areas of medicine than biomedicalism because techno-scientificevidence to support extensive growth in use and prescription of many drugs inthose areas is weak. I have also suggested that some aspects of consumerismhave pushed pharmaceuticalization beyond boundaries that could be defendedby biomedicalism, such as the acceleration of drugs on to the market with insuf-ficient scientific evidence of clinical benefit or the encouragement of off-labeluse in ways that are inconsistent with regulatory assessments. However, if anew drug (perhaps Herceptin) was discovered to be clearly effective in treatingan established medical condition (e.g. breast cancer), then the ensuing phar-maceuticalization could be largely attributed to biomedicalism rationallydemanded by patients, rather than to (illegitimate) medicalization or industrypromotion or marketing claims beyond scientific knowledge. Thus, to furtherunderstand the extent to which pharmaceuticalization may be explained bybiomedicalism, 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 uniquemolecular structure (Vos, 1991). Before approval on to the market, governmentregulatory agencies require new drugs to demonstrate therapeutic efficacy com-pared with placebos, but NMEs are not required to deliver therapeutic advancebeyond drugs already on the market (Abraham and Davis, 2009). While allinnovations are commercially important for manufacturers, it is those whichoffer significant therapeutic advance that are most valuable to patients’ health.




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


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

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Figure 2 Original NME applications 1998–2007Source: FDA PDUFA performance reports for financial years 2002 and 2007, URL (consulted June 2009):http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/PDUFA/default.htm



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 offeredlittle or no therapeutic advantage over drugs already on the market (receiving‘standard’ reviews). Furthermore, French medical/pharmaceutical professionalsin La Revue Prescrire (2005), reviewed 3100 new drugs or new indications forexisting drugs, mostly on the French, EU or US markets, from 1981 to 2004, andconcluded that only 10 per cent offered moderate to significant therapeuticadvance. Thus, aggregating the sector as a whole, pharmaceuticalization in theform of new drugs offering significant therapeutic advance has been shrinking inthe last 15 years. Expansion in pharmaceuticalization cannot be explained bygrowth in techno-scientific discoveries of therapeutically significant innovationsthat meet health needs because no such growth has been forthcoming.

Notably, from 1990, the FDA drastically cut its time to review and approveboth priority and standard NMEs, largely in response to complaints by thepharmaceutical 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 deregulatoryculture of the late 1980s and 1990s has been followed by declines in innovationbecause of less demanding regulatory standards placed upon the industry toincentivise the development of therapeutically significant drugs (Abraham andReed, 2002; Schweitzer et al., 1996). Evidently, deregulatory ideology (andassociated policies) have been drivers of growing pharmaceuticalization, notprimarily by releasing many more innovations needed by patients and medicalprofessionals, as the biomedicalism thesis would have it, but rather mainly byallowing 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 late1980s and early 1990s, it was known to biomedical scientists that bacterialresistance 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 medicalneed where there was the largest ‘pharmaceutical gap’. This was also a periodof deregulatory policies and growing pharmaceuticalization in some other fields.

Yet, between 1983 and 2004, the development of antibiotics declinedsteadily: FDA approved 16 between 1983 and 1987; 14 between 1988 and1992; 10 between 1993 and 1997; seven between 1998 and 2002; and just threein 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 sixwere antibiotics. According to Bradley et al. (2007: 68) from IDSA, ‘two yearslater, very little had changed’ because ‘anti-infective drug products are less prof-itable than other medicines, particularly those for chronic conditions [so] manypharmaceutical companies focus their R&D efforts elsewhere’.




Discussion and Conclusion

There is strong evidence that pharmaceuticalization has been growing within themedicalization-pharmaceuticalization complex where medicalization is a moreconvincing explanation for the scale of increased pharmaceuticalization thanbiomedicalism. As Conrad has pointed out, the pharmaceutical industry has beena major driver of such medicalization. However, industry promotion or market-ing also operates outside the medicalization-pharmaceuticalization complex as adriver of pharmaceuticalization without medicalization. A significant amount ofthis promotion-driven pharmaceuticalization either lacks support from, or isdirectly 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 consumerdemands, partly by-passing doctors as gatekeepers, whether in the form of DTCAin the US or as the discourse of the ‘expert patient’ in Europe. The pharmaceuti-cal industry, deregulatory elements of western governments, and some patientgroups 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 cometo market, such as Herceptin, it cannot be an explanation for the growth inoverall pharmaceutical markets or expanded pharmaceuticalization in sometherapeutic areas, because no such growth or expansion of drug innovationoffering significant therapeutic advance has occurred in the last 15–20 years.On the contrary, the commercial priorities of the industry have so dominatedbiomedical aspirations that marketing efforts have consistently outstrippedR&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-evidentialbarriers to market entry for NMEs and increased industry-consumer collabora-tion for access to new drugs for serious and life-threatening illnesses have beendrivers of pharmaceuticalization. Yet both these drivers combined have beenunable to deliver growth in the number of drug innovations offering therapeuticadvance. This is testimony to the weakness of biomedicalism as an explanationfor growing pharmaceuticalization. Furthermore, rising consumerism in the formof campaigns and litigation against particular drug products and pharmaceuticalfirms has counteracted growth in pharmaceuticalization and, in some therapeu-tic sub-fields, caused de-pharmaceuticalization with consequent decline of drugdevelopment 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 ofacademic interest. They reveal that increased pharmaceuticalization is notfuelled primarily by growth in pharmaceutical provision to meet, and advance,




health needs. Rather, the sociological factors of consumerism, deregulatory statepolicies, 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 falseneeds, as Rose (2007) suggests, but it may create false claims and expecta-tions about the capacity of pharmaceuticals to meet those needs. Moreover, theideological appropriation of patients’ needs as consumer preferences in a marketmeans that public health requirements, which are poorly expressed in marketingprocesses such as antibiotic development and protection from drug injury, areinappropriately neglected by an industry supposed to advance health.

Acknowledgements

Thanks to ESRC and MRC for funding some of the research on which this articleis 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 reflectinternational patterns because all major western pharmaceutical firms seekFDA 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: [email protected]

Date submitted September 2009Date accepted November 2009


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