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Ethical Considerations in Pharmacogenomics

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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 confidentiality, which are of major concern for conducting genomics-based clinical studies. Stratification 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 stratification can also result in scientific 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 firms 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.

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Abbreviations

ADRs:

Adverse Drug Reactions

DNA:

Deoxyribonucleic acid

FDA:

Food and Drug Administration

A-HeFT:

African-American Heart Failure Trial

BiDil:

Isosorbide dinitrate and hydralazine

CYP2D6:

Cytochrome P450, family 2, subfamily D, polypeptide 6

G6PD:

Glucose 6-phosphate dehydroge-nase

NADPH:

Nicotine-adenine dinucleotide phosphate

NAT-2:

N-acetyl transferase-2

HLA:

Human leukocyte antigen

ALOX-5:

Arachidonate-5 lipoxygenase enzyme

UNESCO:

United Nations Educational Scientific and Cultural Organization

HUGO:

Human Genome Organization

PharmaGKB:

Pharmacogenomics knowledge base

UK:

United Kingdom

US:

United States

VGDS:

Voluntary Genomic Data Submission

EMEA:

European Medicines Agency

COMT:

Catechol-O methyltransferase

CYP2C9:

Cytochrome P450, family 2, subfamily C, polypeptide 9

HER-2:

Human Epidermal Growth Factor Receptor 2, also known as Neu

TPMT:

Thiopurine methyltransferase

PON-1:

Paraoxonase gene-1

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Authors and Affiliations

  1. Department of Molecular Biology, Institute of Genetics and Hospital for Genetic Diseases, Osmania University, Begumpet, Hyderabad, 500016, Andhra Pradesh, India

    Anjana Munshi

  2. Department of Genetics and Molecular Medicine, Vasavi Medical and Research Centre, Khairatabad, Hyderabad, 500004, Andhra Pradesh, India

    Yog Raj Ahuja

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  1. Anjana Munshi
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Correspondence to Anjana Munshi .

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Editors and Affiliations

  1. Centre for Genomics & Applied Gene Technology, Institute of Integrative Omics and Applied Biotechnology (IIOAB), Purba Medinipur, West Bengal, India

    Debmalya Barh

  2. Institute of Life Sciences, B.V. Patel Pharmaceutical Education and Research Development Centre, Ahmedabad University, Ahmedabad, Gujarat, India

    Dipali Dhawan

  3. Policy Centre for Biomedical Research, Translational Health Science and Technology Institute (Department of Biotechnology Institute, Government of India), Office @ National Institute of Immunology, New Delhi, India

    Nirmal Kumar Ganguly

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Munshi, A., Ahuja, Y.R. (2013). Ethical Considerations in Pharmacogenomics. In: Barh, D., Dhawan, D., Ganguly, N. (eds) Omics for Personalized Medicine. Springer, New Delhi. https://doi.org/10.1007/978-81-322-1184-6_8

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