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  • EELS (Ethical Economic Legal and Social) Article
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EELS (Ethical, Economic, Legal & Social) Article

Ethical, social and legal issues in pharmacogenomics

The Pharmacogenomics Journal volume 3, pages 194–196 (2003)Cite this article

Within 3–5 years, new discoveries in genetics may make it possible to tailor-make drugs for individual genotypes. Population-wide genetic testing for potential adverse reactions to widely used drugs may come into use. The overriding ethical issue associated with these developments is equity of access to possibly expensive treatments, especially for those whose genetic responses to common drugs fall outside the usual range. The cost of drug development raises questions of government, industry, and insurance company responsibilities to individuals whose pharmacogenetic responses are in a minority. Other ethical issues include genetic testing of children for potential future drug reactions, duties to warn about genetically based reactions when advertising pharmaceuticals directly to the public, returning benefits to persons or communities whose genotypes made drug development possible, and treatment of transgenic animals used for ‘pharming’ new drugs. The following addresses each of these issues.

The concept of tailor-making drugs for individual genotypes contravenes the conventional model of mass-producing drugs suitable and safe for the widest possible range of people at competitive prices. Designing drugs for individuals is analogous to going back from machine-made, mass-produced goods to a crafts tradition of handmade products, which today are almost always more expensive in industrialized societies and appeal to the affluent. In view of the costs of drug development and the limited market, it is questionable whether major pharmaceutical companies are interested in tailor-making drugs. A spokesperson for Bristol-Myers-Squibb recently stated that ‘individualized treatment doesn't play to our core interests’.1 If industry is not interested, should governments underwrite development of individualized drugs, along the lines of supports currently offered for ‘orphan drugs’? Will countries with national public health insurance be willing to cover the added costs of providing these drugs? In terms of ethics, the answers should be ‘yes,’ but in most health budgets limits of some kind are necessary. Everybody cannot have everything. Health policy-makers may have to draw some lines, while making sure that people whose genetic constitutions require more expensive drugs receive them.

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Authors and Affiliations

  1. Shriver Division, University of Massachusetts Medical School, Waltham, MA, USA

    D C Wertz

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  1. D C Wertz
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DUALITY OF INTEREST

None declared.

Dr. Wertz tragically died on 29 April, 2003 in Cancun, Mexico. She is deeply missed by fellow members of the HUGO Ethics Committee, and her friends and colleagues around the world. This article is dedicated to her memory. Her academic address was: DC Wertz, Shriver Division, University of Massachusetts Medical School, 200 Trapelo Road, Waltham, MA 02452, USA.

Correspondence should be sent to

D Macer, Institute of Biological Sciences, University of Tsukuba, Tsukuba Science City 305-8572, Japan. Tel: +81 29 853 4662; Fax: +81 29 853 6614; E-mail: macer@biol.tsukuba.ac.jp

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Wertz, D. Ethical, social and legal issues in pharmacogenomics. Pharmacogenomics J 3, 194–196 (2003). https://doi.org/10.1038/sj.tpj.6500188

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