A second issue which has been prominent within sociological analyses of PGx is to do with inequality and access to biomedical innovation. Healthcare inequality is of central importance in medical Sociology and has a lengthy history within the discipline. The recent expansion of genomic medicine has generated a focus on the (in)equality of access to biomedicine and the ways in which existing patterns of (in)accessibility are reproduced in genomic practices.
To being with, Barash (2001) questions whether the resources allocated to PGx drug development in the wealthy West would be better spent on national and international public health concerns, such as the provision of clean water in developing countries, which she understands as being more ‘urgent’. These sentiments are also echoed by Holm (2008) who questions how useful PGx will be for low- and middle-income countries where access to basic healthcare provisions is problematic. Global healthcare inequalities may, then, be reproduced through the apportioning of genomic research resources within wealthy Western countries. As a result, the chasm between Western ‘lifestyle’ diseases and those which are endemic in poor countries (see Trouiller et al., (2001) for an overview) may widen as genomic interventions are identified for the former but neglected for the latter.
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In contrast, Pang (2009) argues that PGx will in fact be useful for developing countries in providing genomic solutions to tropical diseases, problems associated with increased globalisation and by allowing these countries to make valid contributions to global expertise in this area. This final point is also echoed by Boulyjenkov and Schapper (2007) who argue that genomic variation research (they particularly note research in Mexico, India and Thailand) will allow developing countries to compete in the global knowledge economy as well as improving health in these countries. Although Boulyjenkov and Schapper’s (2007) and Pang’s (2009) papers provide useful counter-arguments to traditional views of PGx as out of reach of developing countries, these papers do not fully analyse the existing structures of inequality in these countries which place biomedical expertise and techniques out of reach of certain population sub-groups.
Other commentators have explored the potential for PGx to compound or transgress existing structures of ‘race’11
and race inequality in biomedicine and scientific research. Briefly, whilst some scientists argue that racial categories are a potentially scientifically valid and important way of categorising populations (see for example Ioannidis et al., 2004; Shriver et al., 2004), others argue that race is socially and politically constituted and is ‘a proxy for socio-cultural, economic, and
particular historical processes and experiences’ (Lee, 2009: 1184). Race as a means
of categorisation is a pervasive issues and was addressed in a 2004 special issue of
Nature Genetics which examined the links between race, ethnicity and genetics. In
interviews with the then editors of Nature, Smart et al. (2006) note that this special issue was produced as a way of addressing the potential measurement and communication problems raised by using race as a means of stratification. They identify two broad strategies for addressing these problems; continuing to use race and ethnicity for categorisation until these become scientifically obslete or replacing racial and ethnic categories with alternatives based on socio-cultural and geographical ancestry. This first strategy bears similiarities to Cooper (2003) who argues that genomic technologies could offer a way in which the contentious use of
11 ‘Race’ has been acknowledged as a a problematic term and is, as such, commonly presented in
inverted commas (see Ware and Back 2002, Gilroy 2000). For stylistic reasons, ‘race’ is not presented in this way throughout the thesis.
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race for characterising variations might be questioned and undermined. He notes that whilst genomics has identified variations between racial groups, it has also identified that these are minimal when compared with variations within population sub-groups and, so, race as a means of categorisation should be questioned.
However, contrary to Cooper’s (2003) reflections in interviews with genetic scientists Ellison et al. (2008) found that the minor differences between racial groups identified by genomic science provided scientists with evidence of the importance and scientific validity of racial categorisations. As such, they argue that there has been a resurgence of race in genomic research where racial groups are redefined by these scientists as ‘genetically-distinct subspecies’, despite efforts to move to a more socio-cultural definition of ‘ethnicity’ (Williams, 2011).
In terms of PGx specifically, it has been argued that race is a poor proxy for PGx knowledge (Holm, 2008) and that race-based PGx risks ‘medicalising’ (Hansson, 2010), ‘geneticising’ (Ellison et al., 2008) and ‘molecularising’ (Fullwiley, 2007) race. Fullwiley (2007: 21) argues that the structure of PGx science in the US compounds and reproduces racial distinctions through the recruitment, organisation, storage and comparison of DNA mandated by the National Institutes of Health (NIH). As such, racial distinctions are practised in everyday laboratory work without discussion or critique and scientists cultivate a ‘racialised gaze’ whereby DNA is labelled in racial terms before it is even extracted from the participants’ body. Central to much of these sociological debates about race and PGx is the congestive heart disease drug BiDil, which was licensed by the FDA in 2005 for use in African-American patients only. As such, Duster (2007: 702) understands BiDil as the world’s ‘first racial drug’ and argues that characterising drugs and drug responses along racial lines attributes health purely to biological factors and so risks overlooking the environmental inequalities, such as education, housing and nutrition, which can have significant effects on health (also see Kahn, 2005). Elsewhere, Duster (2005) argues that such racialised categorisation can lead to the simplistic construction of ‘black’ and ‘white’ diseases where large private companies are more likely to make profits on the latter owing to the, generally, greater wealth of white populations. This echoes Trouiller et al.’s (2001) work where they argue that
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diseases found in developing countries are neglected by pharmaceutical companies who are likely to see larger profits from treatments of white, Western diseases.
Elsewhere, taking BiDil as their point of departure, Tutton et al. (2008) interviewed PGx scientists and found that high throughput DNA technologies in both research and clinical settings may overcome racial categories as patients become defined by their allelic variations rather than their race-based genetic traits (also see Foster et al., 2001). As such, Tutton et al.’s findings suggest that Cooper’s (2003) vision of genomic techniques undermining racial categorisation may be a possibility.
Also central to the concerns around inequality and access to genomic medicine are concerns around the creation of a ‘genetic underclass’. Writing some years ago, Nelkin and Tancredi (1994) argued that the widespread availability of genetic testing could mean the evolution of a class of people who are socially and politically marginalised and economically disadvantaged as a result of genetically- based discrimination (also see Emmott, 2011; Wilkinson, 2010). Most of the work examining this potential ‘genetic underclass’ has focused on the insurance and employment problems potentially faced by those identified as being at an increased risk of developing a disease (Evans, 2007; Lee, 1993, Mehlman and Botkin, 1998; O'Hara, 1992), although Jasny and Zahn (2011: 872) argue that such fears were ‘much overblown’ in the early days of genomic science.
As, primarily, a means to identify drug response variations, PGx testing does not have the same potential as regular genetic testing to contribute to the production of a supposed ‘genetic underclass’. However, there is the potential for the creation of a ‘pharmacogenetic underclass’ (Brown et al., 2001: 52 (emphasis added)) whose drug reactions fall outside of those which are most common (Hansson, 2010). Elsewhere, Webster et al. (2004: 666) conceptualise this as creating ‘orphan patients’ (as opposed to orphan drugs) who are denied access to mainstream drugs because of their rare metabolism and reaction patterns (also see Robertson et al., 2002). Wertz (2003: 194) notes than in countries without nationalised healthcare systems, legislation may be necessary to ensure the insurance coverage for those who are ‘pharmacogenetically different’.
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What this section highlights is that the ethical and social concerns and commentaries around PGx fit into a wider social science focus on the impacts of genomic medicine whilst also presenting a number of distinct ethical and social concerns related to PGx specifically. Within this, the ethical and social impacts for patients (or consumers) are, necessarily, central. What is not extensively analysed within these frameworks are the potential impacts of PGx, or genomics more generally, on the professional identity, status and everyday work practices of the healthcare professionals using them as part of their routine practice. Where social scientists have been concerned with the positioning of practitioners, they have tended to be concerned with genetic counsellors (for example Pilnick, 2002, Lehtinen and Kääriäinen, 2005) and, as such, the role of more generalist practitioners such as pharmacists, has been neglected.
Outside of the social science literature, there has been some speculative work examining the potential impacts of PGx on pharmacy practice but little of this has utilised empirical data or analysed the issue in sociological terms. Nonetheless, this work provides a useful entry point into understanding the potential impacts of PGx on pharmacy practice.