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Pharmacogenetics Ethical Issues Published by Nuffield Council on Bioethics 28 Bedford Square London WC1B 3JS Pharmacogenetics ethical issues Published by Nuffield Council on Bioethics 28 Bedford Square London WC1B 3JS Telephone: 020 7681 9619 Fax: 020 7637 1712 Email: [email protected] Website: http://www.nuffieldbioethics.org ISBN 1 904384 06 4 September 2003 Price £10 per copy to all European countries (EU and non EU) including postage £15 per copy to countries outside Europe including postage There is no charge for orders from developing countries Please send cheque in sterling with order payable to Nuffield Foundation © Nuffield Council on Bioethics 2003 All rights reserved. Apart from fair dealing for the purpose of private study, research, criticism or review, no part of the publication may be produced, stored in a retrieval system or transmitted in any form, or by any means, without prior permission of the copyright owners. Designed by dsprint/redesign 7 Jute Lane Brimsdown Enfield EN3 7JL Printed by Henry Ling Limited The Dorset Press Dorchester DT1 1HD Pharmacogenetics ethical issues Nuffield Council on Bioethics Professor Bob Hepple QC, FBA (Chairman) Professor Catherine Peckham CBE (Deputy Chairman) Professor Tom Baldwin Professor Sir Kenneth Calman KCB FRSE The Rt Reverend Richard Harries DD FKC FRSL Professor Peter Lipton * Baroness Perry of Southwark ** Professor Martin Raff FRS Mr Nick Ross Professor Herbert Sewell Professor Peter Smith CBE Professor Dame Marilyn Strathern DBE FBA Professor Albert Weale FBA Dr Alan Williamson FRSE Professor Andrew Wilkie * (co-opted member of the Council for the period of chairing the Working Party Pharmacogenetics: ethical issues) ** (co-opted member of the Council for the period of chairing the Working Party on the ethics of research involving animals) Secretariat Dr Sandy Thomas (Director) Ms Tor Lezemore Mr Harald Schmidt Mrs Julia Fox Ms Natalie Bartle Ms Nicola Perrin Ms Elaine Talaat-Abdalla Ms Maria Gonzalez-Nogal The terms of reference are as follows: 1 to identify and define ethical questions raised by recent advances in biological and medical research in order to respond to, and to anticipate, public concern; 2 to make arrangements for examining and reporting on such questions with a view to promoting public understanding and discussion; this may lead, where needed, to the formulation of new guidelines by the appropriate regulatory or other body; 3 in the light of the outcome of its work, to publish reports; and to make representations, as the Council may judge appropriate. The Nuffield Council on Bioethics is funded jointly by the Medical Research Council, the Nuffield Foundation and the Wellcome Trust iii Preface It is a familiar fact of medical life that a medicine effective for one patient may not work for another, even though both suffer the same condition. So when we are told that there is a pharmacogenetic technology around the corner that will provide simple genetic tests to determine in advance which drugs will work for a given individual and which will not, our first reaction may well be to wonder where the ethical issues lie, since we seem here to have a medical development whose impact can only be positive. Pharmacogenetics may indeed yield a substantial medical benefit, but like any technology it will have diverse consequences that need to be taken into account if the benefits are to be maximised and the negative effects minimised. The course of development and application of pharmacogenetics will depend on scientific research, but it will also depend on decisions of policy and administration which need to provide a combination of incentives and constraints to give the most productive and just direction to pharmacogenetics. The main purpose of this report is to encourage constructive thought and discussion about some of the ethical and policy issues that pharmacogenetics raises. Many of these fall into four broad categories. The first is information. Pharmacogenetic tests yield genetic information about individuals, and this raises complicated and delicate questions about consent and confidentiality. The second is resource. Certain aspects of the projected use of pharmacogenetics may lower the cost of developing and delivering medicines, but others may drive it up, and the net effect is difficult to calculate. The third is equity. Pharmacogenetics may significantly improve medical treatment for some people, but it may also result in more people falling into categories for which effective drugs are not developed, because of inadequate financial incentives to bring to market a drug that may be very effective but only for a small population or for a large but poor population. The fourth general category is control. Who should decide whether a patient takes a pharmacogenetic test? Should the tests be made available directly over the counter or the web? Should patients be entitled to a drug even if they do not wish to take an associated test? These are some of the hard questions and problems that this report addresses. We make a number of recommendations; but what is at least as important is that this report encourage people from diverse backgrounds to think through the issues for themselves, from an informed position of what we know about this new technology and also of how much we do not know. It is early days for the application of pharmacogenetics, but certainly not too early to think about the issues of ethics and policy that pharmacogenetics raises. This Report has been a group effort and there are many people to thank. It has been a privilege for me to work with such a high-powered interdisciplinary Working Party, with members so eager to make the issues clear and the arguments cogent. We received signal support from the members of the Council under the chairmanship of Professor Bob Hepple, from the specialists whose brains we picked during fact-finding meetings, and from the thoughtful, constructive and influential comments we received from respondents to our consultation document and from the referees of our draft Report. At the Council, we are particularly grateful to Dr Sandy Thomas for her oversight and support, and to Harald Schmidt, Natalie Bartle, Julia Fox and Nicola Perrin. And we wish to pay special tribute to Tor Lezemore, who has done an extraordinary job across the board, as researcher, writer, editor and conceptual analyst. Peter Lipton v Acknowledgements The Working Party wishes to thank the many organisations and individuals who have assisted its work, particularly those who attended fact-finding meetings or submitted responses to the public consultation. The Working Party is very grateful to Ruth Boardman, Professor Baruch Brody, Professor Normal Daniels, Professor Roger Higgs, Professor Alistair McGuire, Dr Duncan McHale and Professor Tony Monaco, who all reviewed an earlier draft of the Report. Their comments contained constructive criticisms and suggestions for further discussion, which were extremely helpful. The Working Party is also grateful to individuals who responded to requests for advice on specific parts of the Report, including Ian Dodds-Smith, Andrew Freeman, Dr Ian Hudson, Mike Stott, Professor Allen Roses and Dr Philip Wright. Finally, the Working Party is grateful to Jai Shah, who conducted background research for this paper during an internship at the Nuffield Council on Bioethics in 2002. vi Table of contents Council membership and terms of reference.................................................................................. iii Preface................................................................................................................................................. v Acknowledgments............................................................................................................................. vi Members of Working Party ............................................................................................................ ix Terms of reference ............................................................................................................................ xi Summary and recommendations .................................................................................................. xiii Chapter 1: Introduction .............................................................................................................1 Ethical issues in genetics ................................................................................................................... 5 Is genetic information qualitatively different from other medical information? ......................... 6 Public perceptions of pharmacogenetics..........................................................................................7 The aims and structure of the Report............................................................................................... 7 Chapter 2: Scientific background............................................................................9 Introduction.......................................................................................................................................11 The scientific basis of pharmacogenetics ........................................................................................13 Differentiating people ...........................................................................................................14 Differentiating diseases..........................................................................................................15 The application of pharmacogenetics .............................................................................................16
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