Individualized medicine, methodologically rooted in pharmacogenetics and pharmacogenomics, is now venturing into clinical application. Prescribing the right drug in the right dose to the right patient according to specific health needs and individual characteristics is a core mission of individualized medicine. The intrinsic values of this mission are so self-evident that – at first glance – the ethical and social issues raised by individualized medicine seem to be negligible. However, the translation of pharmacogenetics and pharmacogenomics into clinical routine not only requires the collection and evaluation of large amounts of individual genetic data, but also heralds the need for further clinical studies on the applicability of genotype-related pharmacotherapy. Both requirements raise a set of specific normative issues. We argue that ethical and social questions of the desirability and applicability of individualized medicine should be integrated in a reconstructive approach to biomedical ethics, which is guided by criteria of social accountability. As a first step, we analyse the ethical and social issues of individualized medicine in the transition to clinical practice, using social accountability heuristically and as an evolutionary approach. Since the pharmacogenetics and pharmacogenomics of neuropsychiatric disorders are among the most advanced fields of individualized medicine, as a second step we use depressive disorders to elucidate the specific, crucial ethical and social questions involved in assessing patients situations, disease entities and phenotypes to relate them to genetic variations for the purpose of individualized drug regimens.
Keywords: Ethics, Pharmacogenetics, Pharmacogenomics, Depression, Clinical Trials, Individualized Medicine
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