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Personalised Medicine: the promise, the hype and the pitfalls

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Richard Doll Building

Oxford

OX3 7LF

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Convenors

Professor Tim Maughan, Professor of Clinical Oncology, Clinical Director of the CRUK/MRC Oxford Institute for Radiation Oncology within the Department of Oncology, University of Oxford.

Professor Joshua Hordern, Associate Professor of Christian Ethics, Faculty of Theology and Religion, Harris Manchester College, University of Oxford.

Supported by Dr Kezia Gaitskell, Pathology registrar and DPhil student in Population Health, University of Oxford; Dr Therese Feiler, Wellcome Trust postdoctoral researcher, Oxford Healthcare Values Partnership, University of Oxford.

The Healthcare Values Partnership is delighted to be holding this event in association with the Centre for Personalised Medicine and CASMI-Academic.

Funding for this project has been provided by the Wellcome Trust (Wellcome Trust Institutional Strategic Support Fund for Oxford), the British Academy and the Sir Halley Stewart Trust. It is organised by the Oxford Healthcare Values Partnership (OHVP) (more information at www.healthcarevalues.ox.ac.uk/personalised-medicine).




Programme

Session 1: 9:15-10.30am The promise and the hype of ‘personalised medicine’

In recent years a significant gap has emerged between the promise of progress made by industry, researchers and politicians on the one hand and the reality of biomarker-based personalised medicine in research findings and clinical practice on the other. A variety of problems – commercial, scientific, clinical and public – may arise when the hype meets the reality of slow progress or no progress. This session will explore the dynamics and ethics of hype and promise in relation to personalised medicine.

Questions for discussion include:

  • What are the myths around personalised or ‘precision’ medicine?
  • What stories are told about its past and future?
  • How good are those involved in personalised medicine at distinguishing between optimism and over-promising (even intentional exaggeration or distortion)?
  • What are the arguments for and against hype in the context of such medicine?
  • Have population health approaches suffered unduly because of personalised medicine hype?
  • Are there good reasons for hype in privately funded research that do not apply to publicly funded research?
  • Who bears the risk of hype?
  • Where funding for personalised/precision medicine research derives from private and commercial sources, how should such research influence the agenda in public healthcare?
  • How should the phenomena of hype and promise be best understood from a historical perspective?
  • Are researchers and clinicians more susceptible to imprudent hype around genomic medicine than patients?
  • How might scientific, clinical and public expectations be best protected from the effects of unrealistic hype and unfulfilled promises while not extinguishing realistic hope and appropriate ambition?

CHAIR: Joshua Hordern (Associate Professor of Christian Ethics, Healthcare Values Partnership, University of Oxford)

SPEAKERS: Tim Maughan (Professor of Clinical Oncology, University of Oxford), John Tooke (Professor of Medicine, UCL) and Co-Chair, Centre for the Advancement of Sustainable Medical Innovation (CASMI), Steve Sturdy (Professor of the Sociology of Medical Knowledge, University of Edinburgh)



Session 2: 11am-12.30pm The human person and the communication of risk

It is important to distinguish between different possible meanings of ‘personalised medicine’ and to situate the experience of personalised medicine by patients and healthcare workers within the practice of healthcare and wider society’s expectations. A notion of biological determinism might shape a certain biomedical, genomic understanding of the person in ‘personalised medicine’. Preceding the genomic usage but now re-emphasised as an overarching category, another sense of ‘personalised medicine’ has focussed on relational aspects of care, individual beliefs and values, shared decision-making, risk communication and strategies for individualised compliance. In a related but distinct way, typically emphasised in medical humanities disciplines such as theology, patients are persons who bear both worth and vocation which are not exhausted by genetic data, may become submerged in healthcare systems but are essential to a social vision which can underpin political solidarity in suffering and healthcare. Understanding what communication of risk and value in clinical care involves requires careful navigation of each of these senses of the person.

Questions for discussion include:

  • What bridges need to be built between these different senses of ‘personalised’?
  • How ought ‘precision’ medicine to pay attention to the patient as person?
  • What risks to ‘care’ are attendant on a focus on biomedical ‘cure’?
  • Does medical professionalism need to adapt in any way to meet the challenge of genomic medicine?
  • What factors affect patient perceptions of value and risk in clinical conversations concerning personalised medicine?
  • How can clinicians best communicate with and advise their patients on the risks and benefits of precision medicine in an everyday, meaningful way?
  • Is it possible to stratify on the basis of psychological factors as well as biological ones? What outcomes are important to patients in ‘precision’ medicine?
  • How might industry, scientific, clinical and political actors maintain due regard for patients as persons whom they seek to serve in compassion?
  • How might other non-healthcare related institutions help in this regard?

CHAIR: Rob Horne (Professor of Behavioural Medicine, UCL School of Pharmacy; CASMI-Academic)

SPEAKERS: Sian Rees (Director, Oxford Health Experiences Institute, Nuffield Department of Primary Care Health Sciences), Joshua Hordern (Associate Professor of Christian Ethics, Healthcare Values Partnership, University of Oxford), Alastair Kent (Genetic Alliance UK)



Session 3: 1.30-2.45pm Data sharing and participation

Participation and data sharing presents a distinct set of problems in relation to personalised medicine. On an important policy level, there are national and international databases which are not interacting sufficiently with each other to make the progress needed. An underlying dimension of this policy matter concerns the motivation for collaboration and participation. The combination of self-interest and compassion for present neighbours and future generations which inspires data sharing is liable to be undermined by fears of data loss and trust violation. This in turn may lead to the worry that well-motivated patient consent to share pearls of data may be trampled underfoot in the pursuit of profit.

Questions for discussion include:

  • What can be done to ensure that participation in data sharing, clinical trials and research is meaningful with respect to the values of participants?
  • What are public perceptions of and levels of trust in the recipients of big data and the technological advances those recipients pursue?
  • Do those perceptions vary across generations?
  • What public and clinical educational goals need to be considered?
  • How might greater public participation in data sharing and engagement in its use be inspired, in order to enhance the way in which precision medicine can proceed?
  • How might relevant institutions be sharing information better?
  • What can law achieve in regard to any of these concerns?

CHAIR: Ingrid Slade (Specialist Registrar in Public Health, NHS)

SPEAKERS: Mark Lawler (Prof of Genetics, Queens University Belfast), Anna Middleton (Principal Social Scientist, Wellcome Trust Sanger Institute), Jonathan Montgomery (Professor of Health Care Law, UCL; Chair of Nuffield Council on Bioethics)



Session 4: 3.15-4.30pm Equity and commissioning

There is a pressing practical need to address concepts and mechanisms of justice as pathways to personalised medicine are commissioned in the UK. While there is an intuitive attractiveness to the idea that ‘4P’ medicine will be more cost-effective, there remains questions about affordability, cost-effectiveness, ensuring equality of access, the participatory role of patients and the (re-)alignment of the existing commissioning strategy. There is also a duty of justice towards neighbours, particularly in low- and middle-income countries. A risk attendant on the development of personalised medicine is that of social stratification based on ability to pay which in certain circumstances may lead to corruption. What will the pursuit of value mean when both national and global questions of equity are under consideration?

Questions for discussion include:

  • How might precision medicine develop so as to avoid the emergence of greater inequalities?
  • What are the relevant inequalities, bearing in mind that the uneven availability of treatment will typically be due to the success of research in specific strata?
  • Are threats to a socio-political ethos of risk-pooling inherent to the stratification processes of personalised medicine? If so, can they be adequately addressed?
  • What are the policy implications of developments in personalised medicine for commissioners?
  • How should the existing emphasis on standardised equitable care for all be connected with the driver towards personalised medicine?
  • How might agreement be reached on appropriate levels of funding and outcome measures?
  • How can commissioning processes ensure that the precision medicine agenda does not distract from but rather enriches the person-centred-care agenda?
  • Who sets the goals (central planners, professionals, pharmaceutical companies, diagnostics companies, patients)?
  • Who bears the risks?
  • Can personalised medicine really deliver better value?
  • Is it a ‘Trojan horse’ for a neoliberal research agenda?
  • Will precision medicine only be available for the rich in many other countries?
  • What responsibility, if any, do medical researchers bear for unequal outcomes?

CHAIR: Mark Sheehan (Ethox)

SPEAKERS Muir Gray (Better Value Healthcare, Honorary Professor, Nuffield Department of Primary Care Health Sciences), Richard Sullivan (Chair in Cancer Policy and Global Health, KCL)



4.30pm Closing remarks

Simon Leedham (Director, Centre for Personalised Medicine, University of Oxford), Tim Maughan, Joshua Hordern





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