For whom the bell tolls: precision medicine, private virtue and the public good

On Saturday our Assistant Director Peter Mills was in Washington, DC, to present at the AAAS Annual Meeting on Global Science Engagement. The following is a transcript of his talk from the session on Precision medicine and bioethics.

I want to preface my remarks by saying something about what I see as the work of bioethics in relation to the emergence of precision medicine. Bioethics is often seen, wrongly, as impeding science and innovation: an unnecessary subterfuge that distracts from the ‘vital’ work of science and raises obstacles in the path of progress. I want to recall that what drives developments in bioscience and biomedicine – and the funding of science and scientists – is a profoundly moral impulsion to improve human health and wellbeing. Bioethics is not against but on the side of this impulse. It recognises, however, that to achieve its ends this impulse has to find expression in a more complex moral and social reality.

No man is an island

My starting point is a simple observation about precision medicine that may appear trite but that I think, nevertheless, has some non-trivial and mostly unresolved implications. The observation is this: that, in general, the precision with which we can treat any one person depends upon the quantity, quality and variety of information we can obtain from a great number of other people. The more data we have about the multitude, the better we may treat the individual.

In the early seventeenth century, recovering from a sickness that brought him close to death, the English metaphysical poet and divine, John Donne, put it well when he wrote:

No man is an island entire of itself;

every man is a piece of the continent,

a part of the main;

The proposition that the advance and the very effectiveness of precision medicine depends upon the cooperation or contribution of many people together immediately foregrounds something about the relationship between an individual and the other members of the population of which they are a part. The question I want to raise is: what normative significance might this have? What might it mean we have reason to expect of others and what might they expect of us in return?

Convergences and confusions

The grounding of medical decisions in evidence accumulated from previous experience is the foundation stone of modern medicine. Precision medicine, however, represents a step change, which is enabled by a number of developments, the most important of which I take to be:

• First, the generation and accumulation of highly detailed and varied individual-level data, including microbiological data, through technologies such as genome sequencing, as well as correlated longitudinal data about lifestyle, morbidity and mortality. In England we have large scale initiatives such as UK Biobank and the ‘Hundred Thousand Genomes’ project that aim to gather such data at scale.
• Second, the preservation, curation and manipulation of those data using information technologies, so that they can be linked together in large databases and for analysis.
• And third, the application of bioinformatics, and data science more generally, to compare, analyse and extract meaningful information from huge and diverse datasets.

The convergence of these conditions gives rise to new kinds of hybrid artefacts (electronic health records that support care as well observational research and service commissioning), hybrid protocols (research projects that are also partly care packages), and hybrid institutions (‘learning’ health systems, which meld two senses of ‘service improvement’: as increased business productivity and better health care). The convergence also requires reconfigurations of professional relationships (the superimposition of different professional cultures, for example, those of IT managers, clinical administrators and biomedical researchers) and the alignment of different practices (for example, consent practices in research and treatment). And, what is of most interest in bioethics, the new conjuncture that I am suggesting underlies precision medicine in a very general sense, requires normative reconfigurations: resolving confusions about values. I have only a few minutes so I’ll mention just three issues.

Precision medicine as ‘medicine for all’

The first issue I want to mention arises from the confusion of public and private interests in precision medicine. Now, obviously, questions of public interest are particularly pertinent if the underlying initiatives are publicly funded. And while this need not be the case, precision medicine initiatives do tend to rest on ambitious ‘big science’, requiring prodigious data collections, expensive research infrastructure, and very long-term investment. These considerations all make it particularly appropriate for public or philanthropic funding, quite apart from the need to secure the widest possible and lowest cost sharing of data.

Nevertheless, the precision medicine model foresees that the maximisation of public benefit will require harnessing the capacity and expertise of private companies. So: how can we ensure that public benefit is secured and the benefits of precision medicine are distributed fairly in society? More challengingly: should we develop precision medicine only if its benefits can be equally distributed among the population?

In one sense, this question may seem nonsensical, since the whole point of precision medicine is that it offers tailored interventions rather than generic blockbusters. Some conditions, in some people, will inevitably be more tractable than others. But how might we guard against the focus of precision medicine being on what Tom Lehrer memorably described as the ‘diseases of the rich’? There are both narrow and broad questions that we might attend to here:

• First, the focus of research: since some selection is inevitable, will there be neglected phenotypes or conditions that are not investigated because they are less tractable than others?
• More broadly, how should funding be allocated to precision medicine research relative to other health or care interventions? There are questions of both social and intergenerational justice here, for example, the grounds on which we might curtail the care available now in order to lay down the basis for better health for our children or for future generations. How can we know, as we are told, that ‘the time is right’?

The ‘confused’ patient

The second issue concerns the limits and consequences of exercising individual freedoms. In 2011, the British Prime Minster’s announcement that he wanted every patient in the National Health Service – Britain’s universal health care system – to be a ‘research patient’ raised hackles among those who were concerned that the wider use of health data would infringe privacy norms.

Five years of subsequent discussion and dispute have focused largely on designing an appropriate consent model for patients and on the security of data – which is potentially very detailed and highly sensitive. The consent question has been particularly troublesome. If someone does not consent to certain uses of data and, for that reason, is denied access to the best available treatment for their condition, is that morally acceptable? Conversely, if someone who does not allow data from their care to be used to improve the common health service but nevertheless enjoys all the advantages that others receive – a ‘free rider’ – is that morally acceptable? Different scope (narrow and broad consent) and different defaults (‘opt in’ or ‘opt out’) have all been debated. But the point that almost all of the argument over consent has missed, however, is this: often, it’s not having the choice that matters but having the options.

I suggest that the interdependency of participation and benefit, in respect of a public good like health care, mean that our primary concern should not be with how people exercise their freedom to choose but with whether they are being offered a morally reasonable choice.

The ambiguity of ‘personalisation’

The third issue I want to mention concerns the evolution of the relationship between an individual and the management of their health care. Our 2010 Nuffield Council report on medical profiling and online medicine identified four different senses in which medical profiling was leading to more ‘personalised’ forms of medicine.This development can be double edged – on the one hand, individuals may have more apparent autonomy; on the other, they are obliged to take more of the responsibility for their choice of lifestyle, health care and its outcomes. This is compounded by a further sense of personalisation, in which management or treatment is personalised in the sense that it aims to provide healthcare as a good or commodity in ways not dissimilar to other traded products or services that are offered in response to consumer demand.The report identified a potential for the so-called ‘responsibilisation’ and ‘consumerisation’ paradigms to efface the distinction between the ‘ill’ and the ‘well’ and replace it with the distinction between those who are engaged with their own healthcare – or who can afford to be – and those who are not. Precision medicine deepens this by increasing the number of factors for which one can take responsibility or be expected to mitigate.

For whom the bell tolls

Different norms underwrite the relationships between the individual moral agent and others, and their society more generally, depending on whether we are thinking about universal healthcare, biomedical research, commercial insurance, etc. These generate moral entitlements and responsibilities, for example, entitlements to care and expectations of privacy (with regard to data). Precision medicine potentially confuses these frames and the norms associated with them. At the very least these need to be clarified, but in some cases they must be substantially remade.

In a continuation of the passage of John Donne that I quoted earlier, the poet writes:

And therefore the bell that rings to a sermon

calls not upon the preacher only

but upon the congregation to come,

so this bell calls us all;...

In our 2015 Nuffield Council biodata report, we recommended a deliberative governance approach to biomedical ‘data initiatives’ that aims, in each case, to define a ‘set of morally reasonable expectations about the use of data’, in preference to simply presenting participants with pre-determined set of options. In other words, we suggest that the interplay of social norms, individual freedoms and professional responsibilities is something that should be worked out in a public and inclusive ethical discourse. This, we think, offers a way of addressing the moral paradox of precision medicine, namely, if precision medicine means that we should all be treated differently, how can we satisfy principles of justice and fairness, that require that people are treated the same?