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Pharmacogenomics, drug development, and ethics: Some points to consider
Author(s) -
Lunshof Jeantine,
de Wert Guido
Publication year - 2004
Publication title -
drug development research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.582
H-Index - 60
eISSN - 1098-2299
pISSN - 0272-4391
DOI - 10.1002/ddr.10373
Subject(s) - pharmacogenomics , engineering ethics , context (archaeology) , drug development , relevance (law) , medicine , political science , pharmacology , drug , biology , engineering , law , paleontology
Pharmacogenomics will contribute in the near future to significant changes in drug delivery and drug development. In both areas, the application of pharmacogenomics gives rise to ethical, legal, and social concerns. These concerns have recently been addressed by various national and international working groups. In this article, we will give a concise overview of the ethical issues raised in particular by the application of pharmacogenomics in the context of drug development. Taking a basic approach, we will show the cumulative development of ethical issues in clinical research, medical genetics, and in pharmacogenomics with special focus on drug development. The relevance of “genetic exceptionalism” will be scrutinized with regard to its impact on questions concerning stratification in particular. To this end, we will refer to the views expressed in documents by various expert working groups and to the recent recommendations made by international organizations. We will show which points to consider arise specifically in the context of pharmacogenomics in addition to the known issues covered by the established guidelines on ethical, legal, and social aspects of clinical research and genetics. Drug Dev. Res. 62:112–116, 2004. © 2004 Wiley‐Liss, Inc.