Policy makers should take citizens’ priorities seriously, argue Elisa Pieri and Brian Wynne
 
Pharmacogenetics, also known as personalised medicine, is the study of how genetic variations affect an individual’s response to medicine. It requires the use of genetic testing to prescribe and develop drugs.

In its 2003 White Paper, the UK Department of Health announced that ‘genetics holds out the promise of more personalised healthcare with prevention and treatment tailored according to a person's individual genetic profile.’1 It also claimed that ‘pharmacogenetics will lead to prescribing which is more effectively tailored to the needs of the individual.’ These promises have prompted a large investment in clinical trials, with a view to validating pharmacogenetics and evaluating its cost-effectiveness within the NHS in areas as diverse as treatment of HIV, epilepsy, liver disease, and oncology.

The discourse around pharmacogenetics emphasises the individual. It has connotations of opportunities, quality and effectiveness of care, as well as notions of choice and preferences. However, few of these promises have yet materialised. Yet the promises are given material power through huge R&D and trial investments, whose opportunity costs are ambiguously public and private.

Serious concerns

Against this backdrop, we ran a study to explore public views and priorities on personalised medicine.2 At a time when public engagement initiatives proliferate, our work was envisaged as a way of facilitating reflection by scientific institutions on their own arrangements, commitments and practices, including their governance and accountability.

Through a series of 14 focus groups, we elicited the views of traditionally ‘hard-to-reach’ sections of the public – senior citizens, young people and parents of young children – and also of citizens of various ethnic heritage in the north west of England.

The project found that members of the public had strong concerns about the increased (and often burdensome) levels of responsibility, and potential stigma, pharmacogenetics might bring. For example, genetic testing might reveal genetic susceptibilities to conditions which might only develop later in life – if at all – putting citizens under pressure to think of themselves as patients and to act now despite the uncertainties.

Public, not private, issues

Participants found problems with acting on genetic, probabilistic information, as other (often socio-economic) factors would play a role in determining specific risks, and in whether certain changes to lifestyle and treatment could be taken up by individuals.

Moreover, pharmacogenetics is touted as personalised medicine, yet members of the public thought these negative impacts would affect wider groups: their families and relatives, and other groups that they identified with. They were also concerned about insurers, mortgage advisors, providers of private medical care, and even employers having access to this information, and about how this might affect their access to key services in the future.

Finally, participants highlighted issues of equal access, treatment of data, social justice, trust and healthcare priorities that personalised medicine would entail. They resisted strongly suggestions that these political issues, and their social impacts, would require individual solutions. They saw this as 'the government' avoiding responsibility for making sure that certain conditions are established if pharmacogenetics is to enter UK public health.

Policy makers: no attempt to understand

Participants did not exclude that pharmacogenetics might bring some benefits, but they were conscious that in promoting these technologies the case for them is often overstated, the benefits – if these do accrue – are likely to be unevenly distributed and more modest than anticipated.

More importantly, our participants had significant concerns. These could be met in the way the technology is designed and implemented. They are not ‘anti-science’, but conditional statements. However, they are likely to be ignored, or – maybe the same thing – translated by policy makers into solely private, individual responsibilities (in the way that public ethical concerns about institutional hubris over GM foods were purportedly addressed by labelling, reducing them to mere individual consumer choices). 

So far, policy makers have not tried to understand public concerns as reasonable conditions (arguable as these will invariably be) rather than as intransigent opposition or private fear

Scientific and commercial developers, and policy experts, are anxious to proselytise innovations like pharmacogenetics as if they have unqualified public support, and no alternative. So far, policy makers have not tried to understand public concerns as reasonable conditions (arguable as these will invariably be) rather than as intransigent opposition or private fear.

In some cases these conditions may be impossible to fulfil, in which case the innovation, and perhaps its related science, will rightly be in jeopardy. However, if policy makers were to take them seriously, and meet them in regulatory systems which deal with more than simply post-innovation questions of risk, but also with technology's social constitutions and alternatives, we may usher in a more intelligent and mature democratic approach to such science-intensive innovation.

References
 
1. ‘Our inheritance, our future’ (2003):5, at http://tinyurl.com/ytldtm

2. The project was conducted at the ESRC Centre for Economic and Social Aspects of Genomics (CESAGen) and funded by the North West Genetics Knowledge Park (Nowgen)

Elisa Pieri and Professor Brian Wynne are at the ESRC Centre, CESAGen, Lancaster University