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ABSTRACT There has been considerable scientific, corporate and policy interest in the more effective use of genetics in both drug development and delivery. Pharmacogenetics — the study of
the relationship between an individual's genetic makeup and response to medicinal drugs — has attracted global interest, but will it live up to its promise? Looking beyond the hype that
has accompanied much of the commentary in the area, the future of pharmacogenetics will depend on how competing interests and options are resolved. Access through your institution Buy or
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BIOMEDICAL RESEARCH * Christiane Auray-Blais * & Johane Patenaude _BMC Medical Ethics_ Open Access 06 April 2006 ACCESS OPTIONS Access through your institution Subscribe to this journal
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REFERENCES * Smart, A. & Martin, P. The promise of personalised medicine? Assessing the prospects for disease and patient stratification. _Stud. Hist. Philos. Biol. Biomed. Sci._ (in the
press). * Department of Health. _Our Inheritance, Our Future – Realising the Potential of Genetics in the NHS_ (The Stationary Office, London, 2003). * Frantz, S. & Smith, A. New drug
approvals for 2002. _Nature Rev. Drug Discov._ 2, 95–96 (2003) Article CAS Google Scholar * Brazell, C., Freeman, A. & Mosteller, M. Maximizing the value of medicines by including
pharmacogenetic research in drug development and surveillance. _Br. J. Clin. Pharmacol._ 53, 224–231 (2002). Article CAS Google Scholar * Food and Drug Administration. _Glaxo Wellcome
Decide to Withdraw Lotronex from the Market_. <http://www.fda.gov/bbs/topics/answers/ANS01058.html> (Office of Public Affairs, Washington, 2000). * Food and Drug
Administration. _FDA Approves restricted marketing of Lotronex_. <http://www.fda.gov/bbs/topics/NEWS/2002/NEW00814.html> (Department of Health and Human Services, Washington,
2002). * Houn, F. Letter, NDA-21-107/S-005, Office of Drug Evaluation II, Centre for Drug Evaluation and Research <http://www.fda.gov/cder/foi/appletter/2002/21107s5ltr.pdf>
(Food and Drug Administration to GlaxoSmithKline, 2002). * Goldstein, D. B. Pharmacogenetics in the laboratory and the clinic. _N. Engl. J. Med._ 348, 553–556 (2003). Article Google Scholar
* Holtzman, N. A. in _Pharmacogenomics: Social, Ethical, and Clinical Dimensions_ (ed. Rothstein, M. A.) 163–186 (Wiley-Liss, Hoboken, New Jersey, 2003). Book Google Scholar * Omenn, G.
& Motulsky, A. in _Pharmacogenomics: Social, Ethical, and Clinical Dimensions_ (ed. Rothstein, M. A.) 137–162 (Wiley-Liss, Hoboken, New Jersey, 2003). Google Scholar * Nuffield Council
of Bioethics. _Pharmacogenetics: Ethical Issues_ (Nuffield Council of Bioethics, London, 2003). * Melzer, D. et al. _My Very Own Medicine: What Must I Know?_
<http://www.phpc.cam.ac.uk/epg/Report.pdf> (Department of Public Health and Primary Care, Univ. Cambridge, Cambridge, 2003). Google Scholar * Lindpaintner, K. Pharmacogenetics
and the future of medical practice. _Br. J. Clin. Pharmacol._ 54, 221–230 (2002). Article Google Scholar * Pirmohamed, M. & Park, B. K. Genetic susceptibility to adverse drug
reactions. _Trends Pharmacol. Sci._ 22, 298–305 (2001). Article CAS Google Scholar * Roses, A. Pharmacogenetics and the practice of medicine _Nature_, 405, 857–865 (2000). Article CAS
Google Scholar * Clozapine Summary Sheet SS95/09 <www.keele.ac.uk/depts/mm/MTRAC/ProductInfo/summaries/ C/CLOZAPINEs.html> (MTRAC, Department of Medicines Management, Keele
Univ, Keele, 1995) * Arranz, M. J. et al. Pharmacogenetic prediction of clozapine response. _Lancet_ 355, 1615–1616 (2000). Article CAS Google Scholar * Mancama, D., Arranz, M. J. &
Kerwin, R. W. Genetic predictors of therapeutic response to clozapine: current status of research. _CNS Drugs_ 16, 317–324 (2002). Article CAS Google Scholar * Holtzman, N. A. &
Watson, M. S. (eds) _Promoting Safe and Effective Genetic Testing in the United States_. Final Report. (Johns Hopkins Univ. Press, Baltimore, Maryland, 1998). Google Scholar * Robertson, J.
A., Brody, B., Buchannan, A., Kahn, J. & McPherson, E. Pharmacogenetic challenges for the health care system. _Health Aff._ 21, 155–167 (2002). Article Google Scholar * Rothstein, M.
A. & Epps, P. G. Ethical and legal implications of pharmacogenomics. _Nature Rev. Genet._ 2, 228–231 (2001). Article CAS Google Scholar * Issa, A. M. Ethical perspectives on
pharmacogenomic profiling in the drug development process. _Nature Rev. Drug Discov._ 1, 300–308 (2002). Article CAS Google Scholar * Smart, A., Parker, M. & Martin, P. Tailored
medicine: who will it fit? The ethics of patient and disease stratification. _Bioethics_ (in the press). * Pirmohamed, M & Lewis, G. in _Regulating Pharmaceuticals in Europe: Striving
For Efficiency, Equity and Quality_ (eds Mossialos, E., Mrazek, M. & Walley, T.) 279–296 (Open Univer. Press, Maidenhead, 2004). Google Scholar * Stearns, V., Davidson, N. E. &
Flockhart, D. Pharmacogenetics in the treatment of breast cancer. _Pharmacogenetics_ 4, 143–153 (2004). Article CAS Google Scholar * Marsh, S. & McLeod, H. Cancer pharmacogenetics.
_Brit. J. Cancer_ 90, 8–11 (2004). Article CAS Google Scholar * Department of Health and Human Services. Draft guidance for industry: pharmacogenomic data submissions
<http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0497-nad0001vol1.pdf> (Food and Drug Administration, 2003). * Savage, D. R. FDA guidance on pharmacogenomics data submission. _Nature
Rev. Drug Discov._ 2, 937–938 (2003). Article Google Scholar * The European Agency for the Evaluation of Medicinal Products. Concept paper on pharmacogenetics — briefing matters.
CPMP/4445/03 <http://www.emea.eu.int/pdfs/human/pharmacogenetics/444503en.pdf> (The European Agency for the Evaluation of Medicinal Products, 23 Jan 2003). * Lesko, L. J. &
Woodcock, J. Pharmacogenomic-guided drug development: regulatory perspective. _Pharmacogenomics J._ 2, 20–24 (2002). Article CAS Google Scholar * Ratner, M. L. Pharmacogenomic data and
labeling: a less-safe harbor for existing drugs? _Windhover's Update_ <http://www/windhover.com/update/05252003/2003800094> (2003). * Anonymous. FDA's Lesko says
pharmacogenomics guidance paper due mid-year. _Pharmacogenomics Reporter_ (_New York_) 6 (17 Jan 2003). * Abraham, J. & Lewis, G. _Regulating Medicines in Europe_ (Routledge, London,
2000). Google Scholar * European Commission. The _in vitro_ diagnostic medical devices directive (98/79/EC). _Official J. Eur. Communities_ L331/1 (27 Oct 1998). * Danzon, P. & Towse,
A. The economics of gene therapy and of pharmacogenetics. _Value Health_ 5, 5–13 (2002). Article Google Scholar * Audit Commission. A spoonful of medicine: medicines management in NHS
hospitals. <http://www.audit-commission.gov.uk/Products/NATIONAL-REPORT/E83C8921-6CEA-4b2c-83E7-F80954A80F85/nrspoonfulsugar.pdf> (Audit Commission, London, 2001). Download
references ACKNOWLEDGEMENTS This research on which this paper is based was supported by a Wellcome Trust grant titled 'The clinical and commercial development of Pharmacogenetics'.
AUTHOR INFORMATION AUTHORS AND AFFILIATIONS * Science and Technology Studies Unit, University of York, York, YO10 5DD, United Kingdom Andrew Webster & Graham Lewis * Institute for Study
of Genetics, Biorisks and Society, University of Nottingham, Nottingham, NG7 2RD, United Kingdom Paul Martin * Oxford Genetics Knowledge Park, University of Oxford, Oxford, OX3 7LF, United
Kingdom Andrew Smart Authors * Andrew Webster View author publications You can also search for this author inPubMed Google Scholar * Paul Martin View author publications You can also search
for this author inPubMed Google Scholar * Graham Lewis View author publications You can also search for this author inPubMed Google Scholar * Andrew Smart View author publications You can
also search for this author inPubMed Google Scholar ETHICS DECLARATIONS COMPETING INTERESTS The authors declare no competing financial interests. RELATED LINKS RELATED LINKS FURTHER
INFORMATION ENCYCLOPEDIA OF LIFE SCIENCES pharmacogenetics Institute for the Study of Genetics, Biorisks and Society Lewis' homepage Oxford Genetics Knowledge Park Pharmacogenetics
research at SATSU University of York Science and Technology Studies Unit Webster's homepage GLOSSARY * ABACAVIR An antiviral drug, used, in conjunction with other medicines, for the
treatment of HIV. * AGRANULOCYTOSIS A condition in which there is an insufficient number of white blood cells called neutrophils or granulocytes. This can be caused by a failure of the bone
marrow to make sufficient neutrophils or when white blood cells are destroyed faster than they can be produced. Affected people are susceptible to infections. * BIOBANKS Public or private
tissue collections (derived from blood, DNA or other sources) comprising samples taken from specific disease groups or healthy populations. Their long-term purpose is to build biological
banks that will provide new sources of (genetic) information about disease that have clinical value. * CLOZAPINE An antipsychotic drug that works by decreasing abnormal excitement in the
brain, used primarily to treat patients with schizophrenia who either fail to respond to or are unable to take other antipsychotic treatments. * DISPOSITION Refers to all processes involved
in the absorption, distribution metabolism and excretion of drugs in a living organism. * INVESTIGATIONAL NEW DRUG APPLICATION (IND). An application that a drug sponsor must submit to FDA
before beginning tests of a new drug on humans. The IND contains the plan for the study and is supposed to give a complete picture of the drug, including its structural formula, animal test
results, and manufacturing information. * ISONIAZID An antibacterial drug used to treat tuberculosis. * NEW DRUG APPLICATION An application requesting FDA approval to market a new drug for
human use in interstate commerce. The application must contain, among other things, data from specific technical viewpoints for FDA review — including chemistry, pharmacology, medical,
biopharmaceutics, statistics and, for anti-infectives, microbiology. * PHARMACODYNAMIC CHARACTERISTICS The characteristics of a drug that determine its biochemical and physiological effects
and its mechanisms of action. * PHARMACOVIGILANCE The process of monitoring medicines to identify previously unrecognised adverse effects; assessing the risks and benefits of medicines in
order to determine what action, information and subsequent monitoring, if any, is necessary to improve their safe use. * THERAPEUTIC INDEX The therapeutic index of a drug is the ratio of the
toxic dose to the therapeutic (that is, effective) dose, often used as a measure of the relative safety of the drug for a particular treatment. PGx is more likely to be clinically useful
where the therapeutic index is narrow (i.e. when there is a smaller amount of difference between toxic and efficacious doses). * 'RESTRICTED MARKETING' TERMS A drug may have such
serious adverse effects that regulatory approval is given for use in a specific patient group only, for whom it can be used safely. * THIOPURINES A family of chemotherapeutics used to treat
leukaemia, as well as arthritis and inflammatory bowel disease. * WARFARIN Used to prevent blood clots from forming or growing larger (anticoagulant). Typically used for patients with atrial
fibrillation and those with a venous thromboembolism. RIGHTS AND PERMISSIONS Reprints and permissions ABOUT THIS ARTICLE CITE THIS ARTICLE Webster, A., Martin, P., Lewis, G. _et al._
Integrating pharmacogenetics into society: in search of a model. _Nat Rev Genet_ 5, 663–669 (2004). https://doi.org/10.1038/nrg1430 Download citation * Issue Date: 01 September 2004 * DOI:
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