Ethical Implications in Pharmacogenetics and Pharmacogenomics

Global Bioethics Enquiry Journal, 2018

Progress in medicine has led to the appearance of a new branch-pharmacogenomics. The use of genetic material in the patients' genotype has allowed for the development of new pharmaceutical products. Although pharmacogenomics leads to the production of effective and safe drugs, its applications raise important ethical, legal, social and regulatory issues. This technology will thus have an impact on the research and development of medicines and clinical practices in future. It will have an implication on the use and storage of genetic information as well. The ethical implications refer to the informed consent for genetic testing, personal autonomy regarding decision for DNA testing, confidentiality, the principle of equity. Discriminatory attitudes can be avoided, primarily through the management of the patients' genetic data under conditions of confidentiality.

This article, which is partly based on an article by Delden et al [1], discusses ethical issues which play a role in pharmacogenetics. Developments in pharmacogenetics have a big impact on many different areas, such as clinical trials, the practice of medicine and society at large. In clinical trials, questions arise regarding the exclusion of genetic subgroups that may be non- or poor-responders to the experimental drug. Also, there is the question of how pharmaceutical companies should deal with their growing knowledge about the relationship between genetic variation and adverse effects. Moreover, pharmacogenetics could provide disease-specific predictive information which could have a significant impact on the relationship between physicians, patients and their relatives in the practice of medicine. Here, issues also arise regarding responsibility of patients and physicians for health and disease. In society at large, the high cost of new pharmacogenetic possibilities leads to qu...

2004

Pharmacogenetics offers the prospect of an era of safer and more effective drugs, as well as more individualized use of drug therapies. The effect of human genetic variance on responses to therapy will influence drug-development clinical trials and the use of products in clinical practice. It also promises to raise new ethical challenges, in particular in the fields of research and therapy. Last but not least, pharmacogenetics is likely to fulfil the old dream of an individualised medicine, but in a totally unexpected way.

Romanian Journal of …, 2010

Pharmacogenetics aims to elucidate the interindividual variability in clinical response to a particular therapeutic regime based on patient's genetic profile, thus improving clinical-decision making process and facilitating the personalized medicine. Pharmacogenetics opens the era of more effective and safer drugs administered as individualized therapies, but, at the same time, it also raises new ethical challenges regarding confidentiality and privacy, the informed consent, the availability of drugs to the patients identified as non-responders, the anti-discriminatory legislation, as well as laws for intellectual properties and exploitation of pharmacogenetics data.

Ian P. Hall

Research in Social and Administrative Pharmacy, 2020

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American Journal of Pharmacogenomics, 2003

The Pharmacogenomics Journal, 2006

Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences, 2006

Concern about the ethics of clinical drug trials research on patients and healthy volunteers has been the subject of significant ethical analysis and policy development-protocols are reviewed by Research Ethics Committees and subjects are protected by informed consent procedures. More recently attention has begun to be focused on DNA banking for clinical and pharmacogenetics research. It is, however, surprising how little attention has been paid to the commercial nature of such research, or the unique issues that present when subjects are asked to consent to the storage of biological samples. Our contention is that in the context of pharmacogenetic add-on studies to clinical drug trials, the doctrine of informed consent fails to cover the broader range of social and ethical issues. Applying a sociological perspective, we foreground issues of patient/subject participation or 'work', the ambiguity of research subject altruism, and the divided loyalties facing many physicians conducting clinical research. By demonstrating the complexity of patient and physician involvement in clinical drug trials, we argue for more comprehensive ethical review and oversight that moves beyond reliance on informed consent to incorporate understandings of the social, political and cultural elements that underpin the diversity of ethical issues arising in the research context.

Bioethics, 2004

Numerous benefits for patients have been predicted if prescribing decisions were routinely accompanied by pharmacogenetic testing. So far, little attention has been paid to the possibility that the routine application of this new technology could result in considerable harm to patients. This article emphasises that pharmacogenetic testing shares both the opportunities and the pitfalls with 'conventional' disease-genetic testing. It demonstrates that performing pharmacogenetic tests as well as interpreting the results are extraordinarily complex issues requiring a high level of expertise. It further argues that pharmacogenetic testing can have a huge impact on clinical decisions and may influence the therapeutic strategy as well as the clinical monitoring of a patient. This view challenges the predominant paradigm that pharmacogenetic testing will predict patients' responses to medicines, but that it will not provide any other significant disease-specific predictive information about the patient or family members. The article also questions published proposals to reduce the consent procedure for pharmacogenetic testing to a simple statement that the physician wishes to test a sample of the patient's DNA to see if a drug will be safe or whether it will work, and presents an alternative model that is better suited to protect patient's interests and to obtain meaningful informed consent. The paper concludes by outlining conditions for the application of pharmacogenetic testing in clinical practice in a way that can make full use of its potential benefits while minimising possible harm to patients and their families.