Criteria influencing the clinical uptake of pharmacogenomic strategies

doi:10.1136/bmj.328.7454.1482

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Jai Shah, former graduate student (jai.shah-alumni@lse.ac.uk)

Department of Social Policy, London School of Economics and Political Science, London WC2A 2AE

Pharmacogenomics and related genomic technologies may hold the potential to improve efficacy and safety in prescription, but complex factors affect their clinical success

Introduction

After bold claims and much anticipation, the impact of new genomic information and technologies is emerging and evolving in a complex fashion. This is certainly true of pharmacogenetics and pharmacogenomics, the study of the effect of genetic or genomic variation on drug response, which is purported to improve the safety and efficacy of prescription. The first products and services have reached the market in recent years, but their highly touted potential has not yet resulted in widespread clinical uptake, for a variety of reasons. This review explores some of the complex factors affecting the clinical success of pharmacogenetic and pharmacogenomic drugs and drug related tests. A series of criteria to inform clinicians, policy makers, and the public has already been established for predictive genetic tests1 2; given the importance of genetic testing for pharmacogenomics, the clinical uptake of pharmacogenomic drugs and strategies reflects similar factors.

Methods

The observations made in this paper draw on a broad literature review conducted during a research internship with the Nuffield Council on Bioethics' Working Party on Pharmacogenetics (my conclusions do not necessarily reflect the views of the council or its working party). I mined the Council's library, citations from key papers, and meetings of the working party. More recently, I searched Medline-PubMed and articles from the Wellcome Trust and the UK Human Genetics Commission, using the terms “pharmacogenetics or pharmacogenomics,” and variations of “economics,” “regulation,” “licensing,” and “ethics.”

Factors affecting the clinical uptake of pharmacogenomic products

Uncertainties in how genomic technologies will affect and be affected by the discovery, development, licensing, and postmarketing factors of drugs mean that the success of “candidates” is far from certain.3^–6 Assessments of economic, regulatory, ethical, legal, and social considerations …