Ethics and policy perspectives on personalized medicine in the post-genomic era.

The completion of the human genome project and the accompanying biotechnological revolution hold great promise for the creation of pharmaceutical agents to combat not only previously incurable diseases, but also those for which therapeutics exist, yet they either cause severe adverse effects or exhibit no benefit in subsets of the population. In many instances variation in therapy response can be attributed to genetic differences, more particularly single nucleotide polymorphism (SNPs). Detection of the genetic differences which affect drug response, commonly referred to as pharmacogenomics, may result in further classification of diseases, and consequently, the development of 'personalized' therapies. While of potential great benefit, the widespread use of pharmacogenomic data poses social, ethical, and economic risks that need to be addressed by regulatory agencies such as the Food and Drug Administration (FDA). This paper explores some of the common problems associated with the use of pharmacogenomic data including validation of the data, patient confidentiality, social stratification, economic risks faced by pharmaceutical and insurance companies, and offers suggestions for regulatory procedures to ensure the appropriate use of the data in drug development and clinical trials.