Author: Hansson, Mats G

Source: Personalized Medicine, Volume 7, Number 1, January 2010 , pp. 75-85(11)

Publisher: Future Medicine

Abstract:

From the perspective of current and future patients, the development of the field of pharmacogenetics is of immense interest. The encouraging vision that is now being established is that we may move from trial and error therapies to evidence-based personalized medicine in clinical practice. However, research and the application of pharmacogenetics to clinical practice are believed to raise a host of controversial ethical issues. Some of these are related to the research process, for example, confidentiality and informed consent in association with human tissue sampling. Other issues arise on a societal level, for example, issues regarding justice and the use of race or ethnicity as proxies for genotyping. In this perspective, I comment on this debate and also suggest what we may learn from previous discussions regarding DNA testing and gene transfer methods. Arguably, the most important ethical perspective in medical research and drug development is related to the interests of patients wanting medical treatment that is both effective and carries low risks of adverse effects. Risk:benefit ratios must always be compared with existing alternatives, and while the risk of adverse effects may be tolerable for some individuals, owing to genetic reasons, this may not be relevant for others. This will have consequences for regulatory policies regarding drug development. In the future, personalized medicine will also need to take epigenetic and environmental factors into consideration.

Keywords: bioethics; ethics; hype; informed consent; justice; personalized medicine; pharmacogenetics; race; risk management

Document Type: Research article

DOI: http://dx.doi.org/10.2217/pme.09.47

Affiliations: 1: Centre for Research Ethics & Bioethics, Department of Public Health and Caring Sciences, Uppsala University, PO Box 564, SE 75122, Uppsala, Sweden., Email: mats.hansson@crb.uu.se

Publication date: 2010-01-01

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• Personalized Medicine translates recent genomic, genetic and proteomic advances into the clinical context. The journal provides an integrated forum for all players involved - academic and clinical researchers, pharmaceutical companies, regulatory authorities, healthcare management organizations, patient organizations and others in the healthcare community.
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