SATSU has an active social science research programme directed at understanding the influences shaping the commercial and clinical development of pharmacogenetics - the relationship between individual genetic variation and drug response - with particular emphasis on the social, ethical, and regulatory dimensions affecting the introduction of such technologies into health care systems.
The Unit has completed one project for the Wellcome Trust and has a number of other on-going studies on pharmacogenetics. The first of these examined the clinical and commercial development of PGx. The second is looking at clinical uptake. The third is a major prospective study of the genetic component involved in patient response to warfarin. In the latter, SATSU researchers are providing qualitative analysis of patient and clinical staff experiences of the introduction of genetic profiling into clinical practice. A fourth project, on behalf of the European Commission, is examining the 'state-of-the-art and potential socio-economic impact of pharmacogenetics. These projects are complemented by research on issues around biobanking, with an emphasis on corporate engagement in such activity.
Our interest in genetics and therapeutic regimes is set within a wider sociological context of:
1. Pharmacogenomics, diagnostic tests and clinician acceptance
Funded by the UK Economic and Social Research Council (ESRC), March 2004 - October 2006, as part of the ESRC's Science in Society programme
New therapeutic interventions based on pharmacogenetics/pharmacogenomics have important implications for patient care and health delivery systems, as indicated in the 2003 UK Goverment's Department of Health White Paper. The principal aim of this study is to advance our knowledge and theoretical understanding of the factors influencing the uptake and incorporation into clinical practice of new technologies based on pharmacogenetic and pharmacogenomic concepts of therapeutic intervention.
2. Variability in response to warfarin: a prospective analysis of pharmacogenetic and environmental factors
Funded by the UK Department of Health
Whilst much of the science of pharmacogenetics is understood there is a pressing need for evidence of the clinical benefits of introduction into medical practice. This £842,000 project, announced by the UK Health Minister, Lord Warner in June 2004, is funded by the Department of Health under the pharmacogenetics research programme in the 2003 White Paper: 'Our inheritance, our future - realising the potential of genetics in the NHS'.
The research consists of a 2000-patient study to investigate the genetic and environmental factors involved in patient response to warfarin - a widely used anti-coagulant drug. This will be validated by a study of 400 patients treated with warfarin by general practitioners.
The outcome will be an algorithm to help doctors determine the safe dosage of warfarin. Included in this will be an analysis of patients' views and experiences of genetic testing in a clinical situation. Graham Lewis and Andrew Webster at SATSU are responsible for this part of the 36 month multi-disciplinary project. The project's net effect will be an improvement in warfarin safety with reduced hospitalisations due to difficulty in controlling anticoagulation and bleeding, and through this, an improvement in patient quality of life. The study will also improve our understanding of other potential benefits of pharmacogenetics, such as cost effectiveness and factors likely to influence the introduction of pharmacogenetics in other therapeutic areas.
The principal investigator is Prof Munir Pirmohamed (University of Liverpool). Other members of the team are: Dr Graham Lewis & Prof Andrew Webster (SATSU, University of York), Prof. Kevin Park (University of Liverpool), Dr David Bentley (Wellcome Trust Sanger Institute, Cambridge), Dr Ann Daly (University of Newcastle upon Tyne), Dr Panos Deloukas (Sanger Institute), Prof. David Fitzmaurice, (University of Birmingham), Dr Dyfrig Hughes (University of Liverpool), Dr Farhad Kamali (University of Newcastle-upon-Tyne), Dr Vanessa Martlew (Royal Liverpool and Broadgreen University Hospital Trust), Dr Jane Rodgers (Sanger Institute), Cheng Hok Toh (University of Liverpool), Prof Tom Walley (University of Liverpool), and Dr Paula Williamson (University of Liverpool).
Project team resources ~ access restricted to project team
3. Pharmacogenetics and pharmacogenomics: State-of-the-art and potential socio-economic impact
Commissioned on behalf of the European Commission, September 2004 - June 2005. (Report published by Institute for Prospective Technological Studies (IPTS), Sevilla, April 2006).
Dr Graham Lewis was part of a team drawn from four member states examining the ‘state-of-the-art’ and potential socio-economic impact of pharmacogenetics (PGx) on behalf of the European Commission. The research was commissioned by the Insitute for Prospective Technological Studies (IPTS), one of the eight Research Institutes of the European Commission.
Graham was responsible for data collection and report writing with regard to regulation in the UK, USA, and Japan, plus European Medicines Agency (EMEA) activities. The 6-month project is scheduled for completion in June 2005. Other partners are SPRU (Sussex), TNO Centre for Technology and Policy Studies, Delft, Netherlands and CIRCA Group Europe, Dublin, Ireland.
Outputs are available from Publications
4. Policy Issues in Pharmacogenetics: a Policy Briefing from the UK Pharmacogenetics Study Group, July 2006
ISBN 0 9553542 0 X (978 0 9553542 0 5)
The UK Pharmacogenetics Study Group are a group of social scientists from several UK universities, including Graham Lewis at SATSU actively engaged in examining issues around the development and clinical introduction of pharmacogenetics—the relationship between individuals’ genetic profile and drug response—into health care systems. The policy briefing is the result of several years cumulative research by the authors on the social, ethical and economic aspects of pharmacogenetics funded by The Wellcome Trust, whose support is gratefully acknowledged. Additional support for individual authors from the Economic and Social Research Council, the Medical Research Council, the Department of Health, and the European Commission is also acknowledged.
Pharmacogenetics promises to improve health care in a number of ways. However, as this policy briefing highlights, many questions remain to be answered before the promised benefits are realised in routine clinical practice. The most basic of these include the scale and applicability of the technology and the timeframe for adoption, and the need for robust evidence of cost-effectiveness and clinical utility. At the same time, it is increasingly recognised that research from a social science perspective offers important insights into the development and, equally as significant, introduction of new health technologies.
Research on pharmacogenetics has been particularly well supported in the UK by bodies such as the Wellcome Trust, with results from a number of empirical studies now published in the academic literature. However, dissemination to the wider health care policy community, including politicians, regulators, senior managers and other decision makers, has been less visible and widespread.
Our aim in publishing Policy Issues in Pharmacogenetics is to help rectify this state of affairs by providing a succinct analysis of the main issues that need to be resolved before the potential benefits of this important technology can be realised, based upon this research.
To download a copy, go to Publications
An overview of the project findings is available as Integrating pharmacogenetics into society: in search of a model by Andrew Webster, Paul Martin, Graham Lewis and Andrew Smart, published in the September 2004 issue of Nature Reviews Genetics.
There will also be a Wellcome Trust report on the research, published in late 2006. Further details from Graham Lewis
For more details of PGx research at SATSU, contact:
Dr Graham Lewis
SATSU, Department of Sociology
University of York YO10 5DD
Tel: +44 (0)1904 433055
For information on other SATSU research, visit SATSU
(C) SATSU, University of York 2004 - 2006 | Site maintained by Graham Lewis | Last updated 26 July 2006