Ethics of pharmacogenetic and pharmacogenomic research - Problems and perspectives

Pharmacogenetics is referred to as the study of variability in drug response due to genetic factors in individuals or populations. It uses genomically derived information in identifying specific subpopulations and may be useful in order to target pharmaceutical agents. Pharmacogenomics applies the information on genome (DNA) or its products (RNA, proteins) to drug design, discovery, and clinical development, reflecting the state or responses at cellular, tissue, individual or population level. Both disciplines are expected to influence considerably the future of human drug therapies, but also diagnostic procedures, prognosing of the clinical course and outcome in a patient, and ultimately the overall practice of medicine in our century and beyond. The paper examines, from the ethical point of view, some of the present problems and future perspectives of development in the field, especially its influence upon the conduct of clinical research, including the clinical trials of new drugs. Besides various methodological considerations, the pharmacogenetic and pharmacogenomic components of the clinical research require an appropriate ethical analysis, which should include also the evaluation of risks and benefits for at least the main acting parties involved - researchers (the 'science'), sponsors (the pharmaceutical industry, grant agencies; and also the particular community, society - 'the taxpayers'), and research participants (the 'research subjects'; together with their relatives and families).