There has been a long standing debate over the contribution that has been made by medical innovation to health improvement

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1 W orking Paper 34 Andrew Webster, SATSU, University of York , UK Do not quote without authors permission : email [email protected] Evaluation, governance and moves to a socially robust assessment of health technology Introduction One of the core questions that is raised by the Workshop is ‘how do new narratives, either in the form of actual artefacts or in the form of expectations regarding new artefacts, influence the sociotechnical landscape?’ Expecta tions about new technologies are subject to the discursive and material narratives of as forms of governance evaluation that review and reshape the ways in which new technologies are taken up and deployed. There are attempts to create new narratives of eva luation that take seriously how technologies occupy specific sites in a ‘socio - technical landscape’ (Lehoux, 2006). This has been most noticeable in the field of medicine, and especially the debates surrounding ‘evidence - based medicine’. This paper explore s the debates within EBM as a form of socio - technical governance and argues for an approach to evaluation that is not simply the producer of ‘reliable knowledge’ but also, in Helga Nowotny’s (2006) sense, one that here is something of a societal value that needs to is more ‘socially robust’, that is that ‘t be integrated into the definition of good science’. How might such normative expectations influence the evaluation of medical technologies? Let me first provide some context for my argument. There has be - standing debate over the contribution that has been made by en a long medical innovation to health improvement. Reference is often made, for example, to McKeown’s (1976 per se has made to ) analysis of the limited contribution that medicine population healt h arguing that more progress has been made over the past century through general improvements in public health (especially in regard to sanitation and hygiene) than through the changes wrought by increasingly sophisticated health technologies (see Harris, 2004). Sociologists have argued in a complementary way that health improvements are also about broader changes in social structure and a more equitable distribution of income and wealth. Yet, clearly, technical development in enables clinicians to undertake quite routinely what have medicine has occurred and now been in the past highly dangerous procedures. Heart transplants or brain surgery are cases in point. Such innovations rely on ever greater technical sophistication and clinical skill, an extensiv e range of support sciences (such as immunology or pathology), a supportive regulatory environment, and perhaps most important of all, willing patients who in the early stages of a technology act as ‘moral pioneers’ (Rapp, 1999) negotiating the choices, ri sks and hazards of these new techniques on behalf of others. On the other hand, the increasing sophistication of health technology to probe, rechart, new forms of disease, as Foucault (1988) has and redefine pathology may serve to generate argued in rega rd to the role of screening in health care: this can simply produce the asymptomatically ill, as in screens for hypertension in assessing blood pressure levels. 1

2 Innovative technologies here create and define diseased bodies and do so for people who have no sense, no lived experience of being ‘ill’: they are the ‘new ill’. To this extent, health innovation is generative of new uncertainties that cannot, as risks, be easily calculated. Much of the success of biomedicine has been in coping with acute medical roblems but in doing so has relocated patients from acute illness into the category of p the chronically sick. Recent commentary from within medicine itself raises similarly strong doubts about the – or what the authors call ‘the fidelity of social utility health care’ – of contemporary medicine. Woolf and Johnson (2005), practitioners in US family medicine, argue that few innovations make the ‘break - even point’ wherein they provide real gain to health care. ent finds support with the American They note that ‘industry’s technological advancem public, which marvels over scientific discovery and technological breakthroughs. Robotic mapping are more thrilling than bland quality improvement efforts, devices and genome such as reminder systems and organizational r of whether the latter edesign, irrespective saves more lives’ (p. 550). And indeed, policy - makers themselves acknowledge the limits of medical innovation and its ultimate social utility: as the Australian Productivity Commission recently concluded, it i s virtually impossible to conclude that a particular technology will always be cost effective or, for that matter, not cost effective — this will depend on who is receiving it and the cost effectiveness of available alternative treatments.’ (2005, p. xlv). Moreover, the focus of health innovation and interventions deriving from it typically neglects some of the major health problems at a global level, especially in respect to the effect of infectious disease. One might presume that the widespread adoption of a health technology is a reasonably good indication that it must ‘work’, and is effective (in terms of relative cost/benefit analysis) and efficacious in terms of actually performing a specific function well. But linical intervention can often be difficult to define, what counts as failure or success of a c especially in managing chronic disorders such as cancer: does the chemotherapy work, and what sort of criteria should be used to determine this? Sometimes drugs that have on the body can produce side effects that can be the desired biochemical effect experienced as a worsening of the disease itself. This has been observed, for example, with respect to the effect of drugs a cocktail known as HAART (Highly Active Anti - – Retroviral Therapy) used to manag e AIDS. – The growth of medical technologies and their spread, as well as the higher expectations that patients and primary care practitioners have of them that they are safe and work - - has not meant that they have gone unregulated. On the contrary, pre cisely because medical technologies have had the capacity to develop rapidly and expensively, the state has complemented its policy for fostering innovation (such as that being implemented by the HITF [Healthcare Industries’ Task Force] in the UK) with a r egime that seeks to rein them in, as well as the researchers or clinical practitioners using or hoping to develop them. There are various ways in which this is done. One of the most commonplace relates to the governance and thereby evaluation of research p roposals or clinical trials about new technologies through review and approval mechanisms associated with ethics and research governance. The ‘material narratives’ of consent and research governance 1 forms in the UK health care system act as technologies t hat relocate a patient from the 1 Lodged with the Workshop Exhibition 2

3 landscape of therapy to that of research. Technology performs in a different way as part of a trial or research experiment and is given a special provisional status as one of , inasmuch as its actual effect (in term becoming s of a physical one) is uncertain or open to redefinition such that what marks out its specific role in healthcare is yet to be stabilised. The redefinition of existing drugs through pharmacogenetic clinical trials is a case in point (Webster, et al 2005). In contrast, those technologies that have been widely adopted through being licensed for use are subject to different evaluative mechanisms, related more closely to governing broadly their economic and clinical efficiencies. These mechanisms can be said to fall under the umbrella of ‘evidence - based medicine’. The evaluation discourse of EBM concerns expectations about a health intervention’s efficacy (can something work) and effectiveness (does it work in specific situations – especially if alternatives are available?) (see May et al, 2003). Of course STS asks how efficacy and effectiveness are socially and politically constructed, and thereby why some medical technologies are seen to succeed and some fail, or indeed why some – such as drugs – do both. I nnovation does not speak for itself in terms of its efficacy or benefit, but has to be spoken for through, what I call in this paper, the ‘holy trinity’ of evidence - based medicine: randomised controlled trials, health technology assessment (HTA) and Qualit y of Life measures (the latter’s purpose to evaluate health interventions from the patient’s perspective). Indeed my religious analogy to the trinity has echoes in the way EBM was said, by Sir David Weatherhall, to be ‘a gift from the gods’ (2001). Continu ing the metaphor, in a sardonic commentary Traynor (2000) observes that medics have now ‘found the light’ and been ‘converted’ to EBM. In this paper I consider some criticisms made of EBM from within the social world of EBM itself, as well as those from o utside, identifying the limitations of this form of governance not least in terms of the way it frames expectations about new technologies, and suggest how we might begin to develop a different narrative of evaluation. Evidence - based medicine: its promi se and development The principal rationale for EBM is that clinical decisions should be informed by the best available evidence derived from systematic research. While the actual term, ‘evidence - based medicine’, was coined in 1992 by Canadian clinical epid emiologists based at McMaster University, its origins lie in the work of Archie Cochrane (1909 - 88) who was a strong advocate of medical intervention being based on as comprehensive a knowledge of current research and practice as possible, and of the RCT as a means to establish the merits of particular interventions. This has since created a global network the Cochrane – Collaboration – reviewing RCTs, HTA reviews, clinical evaluations and so on. Mykhalovskiy and Weir (2004) describe EBM as ‘... one of the mos t important and successful initiatives to recompose contemporary biomedical reasoning and practice’ (p.1060). This recomposition, a sort of evidential triage that filters off good from poor information and practice, depends on access to as wide a range of information sources as possible. Indeed Nettleton et al. (2004) actually locate EBM within a wider socio - technical frame, viz, that of ‘informatised’ medicine. They argue that: ‘ medical evidence is collated and disseminated not by clinically trained prac titioners, but by experts in information science. Again, we see that medical knowledge has moved 3

4 beyond the clinic and is available ‘over the wire’ – primarily on databases available on the - f the practitioner but internet. Clinical decision making is rooted not in the intellect o within health ‘intelligence’ which is again an information science.’ They go on to argue that: ‘There is an affinity between the technological form of ICTs and the nature and form of medical practice, in that vast quantities of inf ormation are systematically retrieved, communicated and disseminated in support of the aspiration that clinical interventions should be informed by rather than experience’. evidence Citing the work of Fraser and Greenhalgh (2001, 799) they note that: ‘ The modern expert, it has been argued, is no longer a person with specialist knowledge, but rather is “someone who knows how to access knowledge efficiently and judiciously and who can form conceptual links between seemingly unrelated areas”’. Not only, then, is evidence - based medicine an important narrative that frames the material positioning and institutional place of medical technologies within health care it is one that is itself increasingly mediated through and dependent upon - based medicine. (se e e Figure 1 below). Figure 1: There has been considerable effort expended over recent years to ensure that the ways in which evidence might be seen to be meeting certain standards, and so act to govern the selection o f therapies of diagnostics etc, conforms to an agreed set of evaluative rules or based Medicine at Oxford has played a key role in - protocols. The Centre for Evidence 4

5 this regard, developing a range of criteria against which evidence about new technologies can be evaluated. These go from mere ‘expert opinion’ to ‘systematic reviews with homogeneity’ of measures used to assess the value of new technologies. While these are now routinely used to govern expectations about the merits of interventions, even the xford Centre acknowledges their limitations. As they observe: O ‘...these levels and grades speak only to the validity of evidence about prevention, diagnosis, prognosis, therapy, and harm. Other strategies must be applied to the clinically useful measures of its potential clinical evidence in order to generate implications and to incorporate vital patient - values into the ultimate decisions ’ (2001). Here expert opinion is reinstated as of value as is the view of the patient, such that in pertise should, it is argued, be governed by three forms of practice, clinical ex information: information about the clinical state and condition of the patient, the patient’s preferences, and evidence based research. However, how these three are to - work together is rarely expl ained, and it is this failure that informs much of the critique made of EBM by those working within the epistemic community of health evaluation itself. The internal critique Thus, despite the recognition among EBM modellers of the role of clinical exper tise and patient values, there is little in the literature on this: as Kristiansen and Mooney (2004) say with respect to the first, ‘EBM in reality offers no methods for improving clinical skills, or takes it for granted that doctors obtain clinical exp ertise by practising medicine’ (p. 18). Moreover, in regard to patient values, the economic rationale for EBM favours a standard ‘currency’ in valuing outcomes (eg 3 deaths equivalent to 5 severe strokes’ [ Sinclair 2001] ): but this may not only bear lit tle relation to patient experience or values but also vary between countries and over time, undermining the universalist claims upon which EBM is based. The RCT is of course typically regarded as the (universal) gold standard upon which EBM’s real founda tions lie. The use of RCT’s test a specific intervention – say a new drug, device, or diagnostic test – across a target patient group. RCTs are designed to identify the safety and efficacy of interventions and are organised as a sequence of pre - clinical tests, through to a full trial on the target patient group. The ‘phases’ from objective of such trials is not only to test a new (or indeed existing) intervention but thereby to provide a more rigorous basis on which clinicians can be advised what to use, w hen and with what groups of patients. The assumption is, that these results can be generalised across equivalent populations beyond the trial group. Clearly, the warrant for this depends on the ways in which the initial sample was derived, and how represen tative this is of those for whom the intervention is ultimately aimed for. Criticisms made of RCTs (Healy, 2006) have focused on this question of representativeness, noting that drugs trials often begin with healthy, young, typically male volunteers in d etermining the toxicity of new compounds. Not surprisingly, down the line, following approval such drugs can have quite severe side effects on those prescribed them who do not conform to the norm built into the sample population. Adverse drug he side effects of taking drugs that have been approved by regulatory t reactions – 5

6 agencies – are a major source of morbidity and mortality: in the US in 2004 they accounted for 104,000 deaths (Martin et al., 2006). This in part is a result of the rugs – combined effects of d the problem of ‘polypharmacy’ especially significant among older patients being treated for multiple, rather than one, condition. Moreover, RCTs assume stable pathologies or diseases that can be addressed by standardised treatments, erefore for mental health or more behaviourally based interventions inappropriate th (Slade, 2001). Internal criticism has also noted that RCTs can be as flawed as ‘observational studies’ external gold standard through which to determine which of these two is since there is no more or less biased. Advocates of RCTs will respond to this by claiming that the use of meta - analysis of a range of published RCTs in the area acts as a validation for evidence - based claims. But critics (such as Lindbaek and Hjortdahl, 1999) have ar gued that criteria used to include some and exclude other RCTs are often unclear, that comparisons may be poor, and even that quite independent meta - analyses of the same subject may draw very different conclusions. This should not be surprising to STS, not least as the very process of conducting and completing an RCT is often a highly precarious social endeavour: as Mort (2003) has put it, ‘Clinical research practitioners undergo heroic struggles to produce Official Evidence. Most often they find that the RCTs they try to use will just not work, since nothing stays in place. The technologies are constantly changing, or being modified; the clinical colleagues just cannot patients are constantly moving about criteria; and often be relied on to refer or recrui t or enrol either themselves or their patients into the studies constructed to produce Evidence’ Overall, the internalist critique argues that EBM acts as a narrative that frames nd resource - technology and its material expression in terms that are managerially a driven, and fosters a discursive culture of standardisation that is in practice probably unreal but has the effect of marginalising the patient and his or her views of the value and utility of clinical interventions. More generally, the EBM e nterprise has also been criticised for moving beyond its initial scope and expertise – evaluating technologies and interventions to improve clinical to wider judgements about health priorities and the social agenda for - making – decision health. In addition , it has been criticised for oversimplifying the social and economic context within which health care is chosen and delivered. As one critical paper has observed, EBM ‘...involves reducing problems to the exploration of simple input output - – relationships sentially a set of answers. But they are answers to questions that es decision - makers have not asked and relate to problems they do not face’ (Birch and Gafni, 2004, p. 60). It is arguable whether EBM is addressing questions that have not been asked by policy makers, since this would make the huge government investment in - the field both surprising and inexplicable: government seeks the governance of EBM precisely to manage health technology resources. However, it is more acceptable perhaps to argue that it dea ls with ‘problems they do not face’, for such problems relate less to input - output relations and more to the political management of health expectations, a much more demanding form of governance beyond the capacity of EBM to deliver (as is ontroversies surrounding recent NICE decisions). evident in the c 6

7 The external critique made by STS Beyond internal debate in the field, there are a number of challenges that can be made to EBM from STS (see Timmermans and Berg, 2003) . These relate to the relationship be tween knowledge and outcomes, the meaning attributed to the value of things, and how the latter relates to the importance of context. In regard to knowledge and outcomes, the role of expertise increasingly contends with its own reflexive embrace with unc ertainty. Indeed, Beck (2000, p 217) sees this as an inescapable condition of contemporary expertise: ‘The inability to know is becoming ever more important in modernity...[within] highly developed expert rationality’. this inability is expressed, but one of the more There are a number of ways in which obvious is in terms of the production of unanticipated effects and risks. Expertise does not addre ss unknown unknowns (Wynne, 2005 ) that are inevitably involved in the implementation of socio - technologies in health care. For example, while in theory ICTs associated with telehealthcare may be cost - saving per unit basis they may generate unanticipated costs as they help unwittingly to redefine risk thresholds associated with health disorders and create new pati ent/carer demand for intervention and monitoring Such uncertainty explains the common preoccupation with risk (Royal Society, 2006). management through the scrutiny, audit, and surveillance cultures that prevail in modernity (Bauman, 2000). In terms of t he value of technologies, Callon (2005) speaks of the metrological work that is required to create an agreed value attributable to a product or service, such as a new medical intervention. As he says, ‘The characteristics of a good are not properties whi ch already exist and on which information simply has to be produced so that everyone can be aware of them. Their definition or in other words their objectification implies specific metrological work and heavy investment in measuring equipment. The conseque nce is that agreement on the characteristics is sometimes in fact often difficult to achieve’ (Callon et al. 2005) EBM may indeed reflect ‘heavy investment in measuring equipment’ but agreeing a technology’s value, its objectification, is especially diffi cult where the contingencies of context play an important role. As Berg has shown in his own analysis of telehealthcare and its value, Asking the question whether Electronic Medication Systems can prevent medication errors without integrally taking its p ractices of use into account is like evaluating the efficacy of a drug without taking note of how and when and with what other substances the drug is taken. (Berg, 2005) To a large degree it is the need to go beyond trialing and to review technologi es in their ‘practices of use’ after their more general adoption that led to the establishing of HTA as a way of monitoring technologies . The state’s desire to manage the potential economic and legal risks associated with innovation has seen priority being given to ‘early warning’ about the likely impact of a new development. HTA is now a major enterprise commissioned from public and private sector providers: the University of York’s Centre 7

8 for Health Economics employs over 100 staff to undertake such work for the UK and overseas governments. Critique of HTA from within STS has been limited (see Faulkner, 1997 ). But some of the questions that ha ve been raised about HTA (see Le houx and Blume, 2000; Webster, 2004; Berg et al., 2004) relate to its tendency to review technologies as discrete innovations rather than, as is often the case, part of wider integrated systems; its presumption that it can deploy a similar methodology in measuring ‘success’ across diverse medical fields; its failure to engage with more qualitative measures of evaluation, and more generally, a failure to recognise that evaluation is a contested terrain involving different sorts of evidence related to different sorts of context (such as the experimental derived from clinical trials, eviden tial, derived from existing clinical practice, and experiential, based on patients’ experience of an intervention). There has been some attempt within the HTA discipline to respond to these criticisms (Giacomini, 2005) and ologies that provide for more complex evaluation develop more sophisticated method atte ntive to context (Sculpher, et al 2006 ; Ades, et al, 2006; Gabbay and Walley, 2006). But as Blume (2005) has argued, the HTA field developed within a specific political context (that promoting evidence - b ased medicine [EBM] and the claim to be able to generalise results from one study) and this has this limited what it can do. In many ways, the sort of data deemed key to the HTA world reflects the interests of more powerful actors within government and hea lth delivery: certain ‘variables’ used for assessment are deemed relevant others not so, and much of the latter relates to context of use, and how, ultimately, the patient benefits. Blume has argued strongly that HTA neglects the political, social and ethi cal dimensions of new technologies, and has argued for a more socially and politically informed HTA. However, we should not thereby assume that this attempt is always successful or indeed t, as Blume (1997) has based on a proper understanding of the target patient group. In fac shown with respect to his study of the cochlear implant used to treat deafness in children, the deaf community were highly critical of the implant technology not only because of its costs and side effects, but also because designers presumed no value should be accorded to the use of sign language and the distinctive deaf culture that the community holds in high regard. Furthermore, where the design of a technology inscribes (i.e. presumes) specific contexts of use, but that technolo gy is deployed in a different setting, we can expect that users will struggle to give value to it in the way envisaged by the innovator. A good illustration of this is the study by Heaton et al. (2006 ) of the use of life - sustaining technologies for serious ly and chronically sick children, devices originally developed for use in a hospital setting. The meaning, combination, use, effectiveness and efficacy of the devices and systems (such as assisted ventilation and intravenous feeding) are quite different in the home, where complex care regimens have to be managed by the children’s families (including siblings) in conjunction with statutory and voluntary services. Many such technologies work only through constant monitoring and intervention which in the 24/7 nursing shifts of a hospital is more easily achieved. Parents were also responsible for preparing the equipment and providing supplies: the responsibilities and demands on parental time were extensive. As Heaton (in Seymour 2006) observes, ‘ While families were, to varying degrees, able to incorporate aspects of the care regimes into their everyday routines, at the same time, they experienced a range of difficulties as a result of the time demands of the care regimes being incompatible with other domestic, nstitutional and social schedules.’ (p. xxx). i 8

9 This localisation of evidence based care regimes echoes a more general observation - relating to the globalising aspirations of HTA itself. As Orvain (2004) has argued, HTA faces the problem of translating a glo bal appraisal and set of recommendations to the between the abstract, global and the concrete, local levels local level. He points to the tensions and the multiplicity of social groups who shape the evaluation process; it is their very diversity that creat es a multidimensional object, a range of competing material narratives of what it actually is and does: ‘...it is clear that viewing any object (e.g. a medical device) from more than one angle (confrontation of expert opinions) often best reveals the multid imensional structure of the object (the crux of the matter)’. Prior to the arrival of HTA analysis of new technologies, patient experience was a matter that had been taken up by clinicians, who recognised that though the biomedical outcome had been ach ieved (say a lowering of blood pressure), the sense of wellness for the patient had not changed. This led in the 1970s to the development of ‘Quality of life’ (QoL) measures, which as Armstrong (2006) has argued, recognised the need for more sensitive ther apeutic markers of the patients well - being than simply those of lives saved or lives extended. That is, they were designed to try to capture the patient’s subjective experience of health and the value of health interventions, with respect, for example, to their being able to live as ‘normal’ a life as possible. However, as Armstrong also shows, QoL measures (of which there are now over 800) are a contested area, since they act as d are likely ‘social evaluations of the “good life” and these will both change over time an to differ for different people and gro ). Again, the social ups in the population’ (2006 construction of what ‘works’ or has beneficial effect is evident. From a reliable to a socially robust evaluation From the discussion above, derived from b oth the internal and external critique of EBM, it would be reasonable to argue that three forms of evidence need to be brought together to produce a more socially robust evidence base for clinical practice. These three are the experimental (for we should n ot abandon the search for safety and efficacy, and indeed effectiveness), the evidential (that which pertains to expert judgement for the inability to know does not thereby imply the inability to advise and act), and the experiential (the patients’ own nar ratives of the utility of existing and new medical technologies in the highly indexical and contingent circumstances of their own lives). I can illustrate briefly how these three construct quite different material narratives of a specific technology, acc ounts that are both descriptive and evaluative and carry expectations about the effect the technology will have on illness. The technology in question is the ACE inhibitor used to manage cardiovascular disorder. The material narrative of the experimenter runs as follows: An RCT in asymptomatic people after myocardial infarction with documented left ventricular systolic dysfunction found that an ACE inhibitor (captopril) reduced the risk of all ischaemic events, all myocardial infarctions, and fatal myocar dial infarctions compared with placebo (all ischaemic events: 29% with captopril v 33% with placebo). ) 1/4/2006 Source: Clinical Evidence (BMJ 9

10 The material narrative of the practitioner modifies this and gives the materiality a more differentiated form: ACE Is are highly effective anti - hypertensive drugs that lower blood pressure and - help reverse left ventricular hypertrophy. They are particularly useful in young have a special role when patients because of the low incidence of impotence and hypertens ion is associated - morbidity such as heart failure, diabetes or with co coronary artery disease. Patients of African origin appear relatively less responsive to treatment and high doses may be necessary. The efficacy of ACE - Is is enhanced by their co - p rescription with diuretics. Source: BHF Fact file 2002 In contrast to both, a patient’s material narrative characterises ACE - Is in terms of their more immediate impact on the body and its symptoms: ‘...When you first start to take it you feel absolutely s tinking actually, and apparently it’s not uncommon...Just like the flu, flu symptoms, continual flu symptoms. And then as soon as you got rid of the symptoms on two and a half (milligrams), they’d give you five!...(but) it prevents strokes and one thing an d another, so at this moment in time it’s the best one there is.’ Source: Cowie, 2006. These narratives move from the abstract, through the typical, to the personal and though linked to a common material base – the ACE - Inhibitor – they configure the technology in quite different ways. The question is whether we can bring these together, or at least make them work together in a more holistic, rather than ‘holy’ trinity of evaluation? I doubt that this can be done as a methodological exercise, that is as one through which - inspired algorithm through which evaluation decisions we construct some sort of STS about existing/new technologies can be made. As Nowotny has argued, social robustness is not about an absolute concept of reliability but about social relationships through which reliability can be secured. In light of this, it seems that our starting point must be more about the sort of evaluative approach we adopt that can attend to these distinct narratives in such a way as to build ster both a clinical and social reliability. There are at least three features relations that fo to this approach we can nominate in light of the discussion above: First, consider the contrasting material narratives of three forms of evidence and how these might be brought together: eg a move from an emphasis on outcomes to one on process and context of use , recognising that the aggregative knowledge of EBM needs to be complemented by the qualitative knowledge of prospective users of IHTs (Coulter, ting this is to ask whether and how far different forms of 2004). Another way of put evidence attend to social relationships: in terms of the ACE - I, the RCT evidence blanks on social relationships assuming a context - free applicability of the compound (though this comes adrift in th e PIL accompanying the blister pack of pills when the contra indications are specified); in contrast, the experiential evidence points to coping relations and a personal risk biography that help to make sense of the drug and why it should ken. What we should move towards is evaluative techniques that give continue to be ta 10

11 primacy to the impact of socio technologies on relating and relationships (Bauman, 2000) - and how they can help enhance rather than disembed or disrupt both; Second ask how material narra tives of health technologies encompass social relationships that are more broadly implicated in a technology that is simply part of a wider set of - technical relationships: patients, carers, and health and social care agencies are to socio of granularity involved in the management of chronic heart disease; differing degrees Finally, recognise that dominant material narratives tend to hide the dual effects of health technologies: as Lehoux (2006) observes, ‘health technology generates advantages and disadva ntages simultaneously, disclosing the dualistic effects of health technology becomes a key avenue [of investigation]’ (p.199). This might be in terms of the immediate physical, say - I or other) technologies, or more complex effects tha t reflect the side, effects of (ACE ‘novel’ relationships that they create (Webster, 2007)? As Lehoux (2006, p. 167) has noted, ‘Medical innovations...create novel interdependencies’. What are the continuities and discontinuities of technologies and how are these experienced wit hin time and space (often not at the same time or place)? Patients, carers, clinicians, and regulators confront both of these continuities and discontinuities though not necessarily at the same time. As Franklin and Roberts (2005) have shown in their exa mination of PiGD, the frozen embryo which is selected for pre implantation in the IVF clinic evokes a sense of reproductive continuity when - it is seen the first step towards paternity, and in spatial and temporal terms encompassed, embraced, by the rhythm and narrative of ‘having a child’. Yet, the same prospective parents and clinicians frame a second embryo very differently when donated for embryo research, outside of the reproductive domain. This second embryo occupies a very different spatial and tempo ral universe that is populated by different social actors and so creative of new arrangements not least through its performing a role in conjunction with, in Barry’s (2001) phrase, ‘other objects and activities’, such as research labs, biocapital, and the ‘tissue economy’. The evaluation of IVF should, I am suggesting, encompass both continuity and discontinuity for in doing so it is sensitised in a direct way to the importance of social relationships that create the very basis on which continuity and chang e work. It is unlikely, of course, that the epistemic culture that is EBM will adopt these perspectives on evaluation, or indeed, even be able to embrace them as such. Indeed, evaluation practices are, as I have noted, more about closing down options (an d resources) than opening up and problematising the meaning and use of technologies. Moreover, despite the significance of EBM as a form of evidential triage, there are many technologies that have not been subject to any of its (HTA or other) metrics: thei r certainty (in terms of efficacy and effectiveness) might on the face of it be as uncertain as their uncertainty! However, there are some working within the field of HTA who are now beginning to treat uncertainty and contingency seriously, building on B ayesian approaches to assessment that presume rather than deny uncertainty. This may well offer STS an opportunity to enter the health policy community and begin to construct a critical constructive assessment that draws on some of the models already built through the technology assessment work undertaken in the Netherlands (Rip et al. 2000). 11

12 While the sociological important of context of use is therefore key to understanding how technologies are experienced, evaluated and seen to ‘work’, we should not los e sight of the way that priorities served by medical innovation systems function more generally. Here we need to attend to the of health care delivery rather than simply to structuring specific issues about context per se. That is we can ask what broader social utility is 1998 produced by a biomedical model of health innovation that, as Bury ( ) notes produces a system devoted on the one hand to high tech biomedical care and on the other management of chronic disease – from a regime of ‘treatment and cure’ t o ‘management and care’ (p.267). Despite the criticisms levelled at EBM and its component elements, they are used more and more heavily by health agencies in affluent states to assess the merits of health innovation. Its three different forms of evaluati on (RCT, HTA and QoL) act not only to evaluate existing health technologies, but also shape how new technologies are being developed. Health innovators are aware that these evaluations will be used to determine the relative merits of their product or proce dure. An important STS question then arises that impinges upon the material positioning of technologies in the healthcare system: how far do designers endeavour to construct them in such a way as to anticipate and meet the evaluative criteria against which they will be judged? In other words, how might such criteria be ‘inscribed’ (Akrich, 1992) within the very innovation itself? As Akrich argues, “Designers thus define actors with specific tastes, competences, motives, aspirations, political prejudices, and the rest, and they assume that morality, technology, science, and economy will evolve in particular ways. A large part of the work of innovators is that of ‘inscribing’ this vision of (or prediction about) the world in the technical content of the object ... an attempt to predetermine the settings that users are asked to imagine” new (1992, p. 208) If there is this feedback at work, it is an empirical question to answer how far does such s a material narrative to inscription vary by technology field, if at all, how does it act a shape that field, and how far does that then shape the evidential and experiential narratives that engage with it? This is a key area for future research in STS in seeing how evaluation as a form of governance is instantiated acro ss different domains associated with the production and use of health technology. Conclusion This paper has argued that evaluation regimes in contemporary health technology act as a form of governance that as such produce material narratives that shape a nd steer the existing and prospective use of technologies in health care systems. I have argued that the principal metrics of EBM (RCTs, HTA and QoL) serve to rationalise the provision of new technologies but do so without any real integration of the forms of evidence on which they depend. However, I have also suggested that such an integration would be highly problematic on both methodological and normative grounds since what is central to a more socially robust form of evaluation that attends to the multi dimensionality of technologies is one that attends not to absolute measures or gold standards but to everyday social relationships and the interdependencies that in the end make technologies work and have utility. Social efficacy and effectiveness and the material narratives that based medicine give them expression should become central concerns for an evidence - that would thereby be based on a socially robust form of governance. 12

13 References , A . E . , Sculpher M . J . , Sutton , A . , Abrams , A . , Cooper , N . , Wel ton , N, et al. (2006) Ades - effectiveness analysis. Pharmacoeconomics Bayesian methods for evidence synthesis in cost 24:2 - 29. Akrich, M. (1992) - scription of technical objects, in W. Bijker & J. Law (eds.), The de in Sociotechnical Change Shaping Technology / Building Society: Studies , - 224 Cambridge, MA: MIT Press, pp. 205 Evaluation as an Innovative Health Technology, in Webster, A. Armstrong, D. (2006) (ed.) New Technologies in Health Care: Challenge, Change and Innovation , Palgrave: Basingstoke, pp 232 - 42. Impacts of Advances in Medical technology in Australian Productivity Commission (2005) Australia , Canberra. Barry, A. (2001) Political Machines : Governing a Technological Society. London: The Athlone Press/Continuum Books. Bauman, Z. (2000) , Polity, Cambridge. Liquid Modern ity Beck, U. (2000) Risk Society Revisited: Theory, Politics and Research Programmes, in The Risk Society and Beyond: Critical Issues for Social Theory, Adam, B. et al. (2000) Sage: London. , priority setting and appropriate care in Berg, M. et al. (2004) Technology assessment International Journal of Technology Assessment in Healthcare , 20:35 - 43. Dutch health care, Berg, M. (2005) Clinical Quality Development and the Emergence of the EHCR, EPJ - Observatoriets Arskonference, October 26. Birch, S., and Gafni, A., (2003) Economics and the evaluation of health care programs: generalizability of methods and the implications for generalizability of results, Health Policy , 64:207 - 219 . Blume, S. (1997) - The Rhetoric and Counter Rhetoric of a “Bionic Technology.” Science Technology and Human Values 22:31 56. – Blume, S. (2005) HTA: a critical re appraisal, Innovative Health Technologies - International Conference, Rome, June Bury, M. (1998) Postmodernity And Health in G. Scambler and P. Higgs (e ds) Modernity, Medicine and Health: Medical Sociology Towards 2000 (Routledge) Callon, M. (2005) Laws of the Markets , Blackwells, Oxford. Coulter, A. (2004) Perspectives on health technology assessment, International Journal of 144. Technology Assessment in H ealth Care , 14: 135 - 13

14 Cowie, L. (2006) The Value of Medicines , Doctoral Thesis, Department of Sociology, University of York. ) Strange bedfellows’ in the laboratory of the NHS? An analysis of the Faulkner, A. (1997 new science of health technology asse ssment in the United Kingdom. In: Elston MA (ed) . Sociology of Health and Illness Monograph The sociology of medical science and technology. Politics, Philosophy, and Culture: Interviews and Other Writings, Foucault, M. (1988) - , edited by M. Morr is and P. Patton, New York: Routledge . 1984 1977 Born and Made: An Ethnography of Franklin, S. and C. Roberts (2005) , Princeton University Press, Princeton. Preimplantation Genetic Diagnosis Gabbay, J. and Walley (2006) Introducing new health interventions, Briti sh Medical Journal , 332:64 65 . - Giacomini, M. (2005) Health technology as policy. IHT/HTAi International Conference, Rome ( see http://www.york.ac.uk/res/iht/events/HTAiRome2005.htm ) Harris, B. (2004) Public Health, Nutrition, and the Decline of Mortality: The McKeown Thesis Revisited, Social History of Medicine : 17: 379 - 407. Healy, D. (2006 ) Manufacturing Consensus , leep Disruption in Heaton J, Noyes J, Sloper P and Shah R. (2006) The Experiences of S Children & Society Families of Technology - dep endent Children Living at Home, – 196 20: 208 Evidence Based Medicine: In its Place, Kristiansen, I.S. and Mooney, G. (eds.) (2004) - Routledge, London. Lehoux, P. (2006) The Problem of Health T echnology: Policy Implications for Modern Health Care Systems , London: Routledge houx, P. and S. Blume (2000) Technology assessment and the socio - politics of Le health technologies, Journal of Health Politics, Policy and Law , 25:1083 - 1120. an Lindbaek , M How do two meta d Hjortdahl, P. ( 1999 ) - analyses of similar data reach opposite conclusions? 1999 March 27; 318(7187): 873. BMJ. May, C.R., Harrison, R., Finch, T., MacFarlane, A., Mair, F.S., and Wallace, P. (2003) Understanding the normalization of telem edicine services through qualitative evaluation. Journal of the American Medical Informatics Association 10: 596 - 604 Martin, P. et al., (2006) False Positive ? The Clinical and Commercail Development of Pharmacogenetics , IGBis/SATSU publication. Dream, Mirage or Nemesis, McKeown, T. (19 76 ) The Role of Medicine – London 14

15 Mort, M. (2003) Evidence in Action. The Craft of Medicine: A Dialogue Between Practitioners and Researchers, Workshop, Lancaster University. m of evidence - based medicine: Mykhalovskiy, M. and Weir L. (2004) The proble directions for social science, - 1069 Social Science & Medicine , 59: 1059 ows, R. and O’Malley, L. (2004) Health E - types: an analysis of the Nettleton, S., Burr Information, Communication and Society (special issue use of the internet for health everyday - Health), vol. 7, no. 4. on E Interdisciplines Nowotny H. (2006) The Problem of Transdisciplinarity, , http://www.interdisciplines.org/interdisciplinari ty/papers/5 ). Orvain, J . et al. (2004) Overview of health technology assessment in France , International o 25 20, n journal of technology assessment in health care 1 : - 34 . , Rapp, R. (1999 ) Testing Women, Testing the Fetus , London: Routledge ( 1995 ) Rip, A. et al. Managing Technology in Society: Approach of the CTA , Pinter, London. Royal Society (2006) The impact of information and communication technologies on health and healthcare , Royal Society Publications, London (forthcoming). (2006) Whither trial Sculpher , M . J . , Claxton , K . , Drummond , M . , and McCabe , C. based - economic evaluation for health care decision mak ing, Health Economi cs, 15:677 - 687 . The Slade, M. 2001. Are randomised controlled trials the only gold that glitters?, (2001) 179: 286 - 287. British Journal of Psychiatry Timmermans, S., and Berg, M. (2003). The gold standard: The challenge of evidence - based medicine and standardization in health care , Philadelphia: Temple University Press. d movements . Health , 4, Traynor, M. (2000) Purity, conversion and the evidence base 139 – 158 Webster, A. (2007) Health, Technology and Society: A Sociological Critique , Palgrave, Basingstoke (forthcoming). Webster, A. et al. (2005) Integrating pharmacogenetics into society: in search of a model, Nature Reviews: Ge netics, vol 5: 7 - 14 . Webster, A. (2004) Health Technology Assessment: a Sociological Commentary on International Journal of Technology Assessment in Health Care , 20, No 1: Reflexive Innovation, 1 6 . - Woolf , S. H. and Johnson , R.E. (2005) The Break - Even Po int: When Medical Advances Are Less Important Than Improving the Fidelity With Which They Are Delivered Am J Public Health , 95: 1306 - 1307 Wynne, B. (2005 ) Reflexing Complexity Post - genomic Knowledge and Reductionist 94 Returns in Public Science, Theory, Cult ure & Society, 22(5): 67 – 15

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