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Ethical Considerations in Pharmacogenomics

  • Anjana Munshi
  • Yog Raj Ahuja
Chapter

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.

Keywords

Genomic Information Orphan Drug Isosorbide Dinitrate Pharmacogenomic Study Pharmacogenomic Research 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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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Copyright information

© Springer India 2013

Authors and Affiliations

  1. 1.Department of Molecular Biology, Institute of Genetics and Hospital for Genetic DiseasesOsmania UniversityHyderabadIndia
  2. 2.Department of Genetics and Molecular MedicineVasavi Medical and Research CentreHyderabadIndia

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