Ethical considerations in pharmacogenomics

Abstract

The science of pharmacogenomics holds the promise to change the way in which clinical drug trials are conducted as well as the prescription of drugs on a routine basis. However, there are a number of ethical and regulatory challenges such as subject recruitment, privacy, sample collection and storage, and confi dentiality, which are of major concern for conducting genomics-based clinical studies. Stratifi cation of clinical study subjects into subgroups on the basis of genotype is another problem in designing clinical studies which might lead to the subject selection biases. This could also lead to spurious interpretations of statistical analysis. Subtype stratifi cation can also result in scientifi c challenges and data analysis because of penetrance. The variable degree of clinically relevant phenotypic expression of genetic variation can lead to false positives. Moreover, the discrimination by job providers and insurance fi rms are other issues of legal considerations and need to be answered. The pharmacogenomics can also lead to the development of orphan phenotype. If a new drug molecule is being developed only for a subpopulation of patients, then issues such as distributive justice and fairness to accept the new drug also need to be considered. No doubt pharmacogenomics is emerging as a boon for medical fraternity; however, the translation of pharmacogenomics into clinical practice requires to frame and address the legal and ethical issues along with incentives to overcome these roadblocks.