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Pharmacogenetics and pharmacogenomics: recent developments, their clinical relevance and some ethical, social, and legal implications

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Abstract

In recent debates on novel procedures of molecular medicine pharmacogenomics is attracting more and more attention as a genotype-based approach for improving safety and efficacy of the use of therapeutic substances. Promoted by basic knowledge generated in the field of medical genomics, facilitated by novel technological tools for mapping genetic variation in individuals, and supported by results of initial clinical studies linking specific genotypes to metabolic characteristics of individuals important for assessing drug response, procedures of pharmacogenetics and pharmacogenomics now are starting to impact significantly on clinical research and development and medical practice. In this situation assessing the goals, risk, and benefits of pharmacogenetics and pharmacogenomics is essential for the medically successful, ethically justifiable, and socially acceptable implementation of genotype-based diagnosis and pharmacotherapy. We discuss the current state of the art in pharmacogenetics and pharmacogenomics and introduce a model for evidence based assessment of its goals, risk, and benefits. We differentiate here between pragmatic and normative issues in the development of pharmacogenomics in order to contrast prevailing, insufficiently interest-based modes of public technology assessment with the evidence-based mode that can be established as part of clinical study design. Finally, we provide a framework for the analysis of social accountability that can be used for technology development and technology assessment with regard to pharmacogenomics in particular and molecular medicine in general.

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Authors and Affiliations

  1. Bioethics and Science Communications, Max Delbruck Center for Molecular Medicine, Robert-Rössle-Strasse 10, 13125, Berlin, Germany

    Norbert W. Paul

  2. Institute for Medical History, Program in Genetics, Ethics, and Society, Heinrich Heine University, PF 10 10 07, 40001, Düsseldorf, Germany

    Norbert W. Paul

  3. Genetics Research, GlaxoSmithKline, Research Triangle Park, NC 27709, USA

    Allen D. Roses

Authors
  1. Norbert W. Paul
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  2. Allen D. Roses
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Correspondence to Norbert W. Paul.

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Paul, N.W., Roses, A.D. Pharmacogenetics and pharmacogenomics: recent developments, their clinical relevance and some ethical, social, and legal implications. J Mol Med 81, 135–140 (2003). https://doi.org/10.1007/s00109-002-0415-6

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  • DOI: https://doi.org/10.1007/s00109-002-0415-6

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