The ‘Molecularly Unstratified’ Patient: a focus for moral, psycho-social and societal research

Authors: Hordern J, Maughan T, Feiler T, Morrell L, Horne R, Sullivan, R

Biomedicine Hub November 2017

What is it about?

This article concerns the culture and practices which surround personalised precision medicine (PPM). Existing research into the promise, hype and pitfalls which characterise PPM raises questions about patients who do not fit and so do not receive new targeted, genomic treatments. These become ‘molecularly unstratified patients’ who are left bobbing about untidily behind the wave of scientific ‘advance’. We argue that care of these patients should have significant influence on PPM research culture and practice. We give reasons why pressures on PPM researchers may be particularly acute. Finally, we outline how we will evaluate these claims and address these issues.

Abstract

The biomedical paradigm of personalised precision medicine – identification of specific molecular targets for treatment of an individual patient – offers great potential for treatment of many diseases including cancer. This article provides a critical analysis of the promise, the hype and the pitfalls attending this approach. In particular, we focus on ‘molecularly unstratified’ patients – those who, for various reasons, are not eligible for a targeted therapy. For these patients, hope-laden therapeutic options are closed down, leaving them left out, and left behind, bobbing untidily about in the wake of technological and scientific ‘advance’. This process creates a distinction between groups of patients on the basis of biomarkers and challenges our ability to provide equitable access to care for all patients. In broadening our consideration of these patients to include the research ecosystem that shapes their experience, we hypothesise that the combination of immense promise with significant complexity creates particular individual and organisational challenges for researchers. The novelty and complexity of their research consumes high levels of resource, possibly in parallel with undervaluing other ‘low hanging fruit’, and may be challenging current regulatory thinking. We outline future research to consider the societal, psycho-social and moral issues relating to ‘molecularly unstratified’ patients, and the impact of the drive towards personalisation on the research, funding, and regulatory ecosystem.

Authors’ information

Joshua Hordern is Associate Professor of Christian Ethics, Faculty of Theology of Religion in the University of Oxford and a Fellow of Harris Manchester College. He leads the Oxford Healthcare Values Partnership. Twitter: @oxfordhvp.

Correspondence to: Harris Manchester College, Mansfield Road, Oxford, OX1 3TD, United Kingdom, joshua.hordern@theology.ox.ac.uk, 01865 281479 (tel/fax)

Tim Maughan is the Clinical Director of the CRUK/MRC Oxford Institute for Radiation Oncology at the University of Oxford and an Honorary Consultant Clinical Oncologist at the Oxford University Hospital Foundation Trust.

Therese Feiler is the Postdoctoral Researcher with the Oxford Healthcare Values Partnership in the University of Oxford’s Faculty of Theology and Religion and a Research Fellow at Harris Manchester College.

Liz Morrell is a postdoctoral researcher at the UCL/Oxford Centre for the Advancement of Sustainable Medical Innovation (CASMI) at the University of Oxford.

Rob Horne is Professor of Behavioural Medicine, UCL School of Pharmacy and Academic Fellow at the UCL/Oxford Centre for the Advancement of Sustainable Medical Innovation (CASMI).

Richard Sullivan is Professor of Cancer and Global Health, KCL, Director, Institute of Cancer Policy and co-Director of King’s Conflict and Health Research Group.

Funding

Joshua Hordern’s and Therese Feiler’s research is supported by the University of Oxford Wellcome Trust Institutional Strategic Support Fund (grant number 105605/Z/14/Z); and the Arts and Humanities Research Council (grant number: AH/N009770/1). The authors gratefully acknowledge this funding and also that of the Sir Halley Stewart Trust. Liz Morrell is funded by the Policy Department, Cancer Research UK. Tim Maughan’s research is funded by the Medical Research Council and Cancer Research-UK. The views expressed within this article are those of the authors and not necessarily those of any of these funders.