Context, ethics and pharmacogenetics
Introduction
Since the rise of modern bioethics, the usual approach to an assessment of the ethical issues relating to any new technology involves debates over the meanings of particular terms (for example, the differences, if any, between therapeutic and reproductive cloning), speculation as to the possible harms that may arise, and the application of various ethical theories to help decide how to use the technology in question. While this article is not the place to rehearse the problems with this kind of approach (Fox and Swazey, 1984, Hoffmaster, 1992, Hoffmaster, 1994), I want to show how an alternative, empirically-based, take on the ethics of a particular technology—pharmacogenetics—strengthens the case made by those who claim that the social sciences have an important role to play in exploring the ethical issues surrounding new technologies (Haimes, 2002, DeVries and Conrad, 1998, Zussman, 2000).
The core theme of this kind of research is that the ethical problems associated with a particular technology can only be seen in the context in which that technology is actually used. Since most bioethical reasoning ‘strips away’ the supposedly extraneous background and context to any particular case, the kinds of ethical issues raised bear little relation to the actual problems faced by clinicians. Instead, having presented the ethical problems linked to pharmacogenetics as seen by scientific commentators and bioethicists, this article then presents interview data with clinicians and researchers from Alzheimer’s disease and breast cancer, to show how they view the ethics of pharmacogenetics.
The broad theoretical structure for the research project supporting this article is a constructivist approach to the sociology of technology, summed up as the ‘social shaping of technology’ (Bijker et al., 1987, Bijker and Law, 1992). But in the case of this particular article, the ideas underpinning my approach are derived from the work of James Lindemann Nelson and Robert Zussman, who raise important issues for how we assess the ethical impact of particular technologies. In essence, this article is written in reaction to the ‘linear model’ of bioethics decision-making, where social scientists provide accurate and interesting descriptions of the lived clinical world, which philosophers then ‘programme’ into their ethical theories, to produce the finished ‘right’ answer (Nelson, 2000). In such a model, the social scientist becomes ‘a junior partner to the philosopher, someone who responds to ideas generated elsewhere but who generates few if any of his or her own’ (Zussman, 2000, p. 10).
An alternative is a contextual approach, which assumes that ethical decisions are not made in some sort of vacuum, but arise in particular social, technical, and cultural situations. From this point of view, the place to start any enquiry into healthcare ethics is at the clinical ‘coalface’, where ethical decisions, in this case about the use of genetic tests to govern the prescription of pharmaceutical products, are made. By rooting analysis in the decisions that clinicians actually make, we can avoid the feeling that sometimes occurs with more philosophical bioethics, that clinicians exist in some sort of amoral desert until the bioethicist turns up to tell them what they should be doing. The danger of the kind of approach used in this article is that one might lose the critical ‘teeth’ that bioethics brings when it comes from outside a particular situation. If our ethical assessment is rooted in a particular context, then we run the risk of conservatively and simply supporting current clinical practice, regardless of its ethical impact (Zussman, 2000, p. 10). The trick is, as in so many cases, a question of balance.
Section snippets
Commentators
One interesting aspect of the debate around pharmacogenetics and pharmacogenomics is the large number of review articles, or commentaries, written by academic and industry scientists themselves. These articles do not present new research results, but rather act as a forum to discuss the direction this new technology is going in and the challenges that have to be faced if pharmacogenetics is to make its way into the clinic (Hedgecoe, 2003).
One important element of these commentaries is a
Two cases: Alzheimer’s disease and breast cancer
The two case studies I explore in the rest of this article involve Alzheimer’s disease and breast cancer. More specifically, they revolve around a family of drugs called acetyl cholinesterase inhibitors and the APOE gene, in Alzheimer’s, and the drug Herceptin and the HER2 gene in the case of breast cancer. These two cases cover a number of features that scientific commentators suggest occur in pharmacogenetics. In the case of Alzheimer’s, pharmacogenetics involves the retrospective application
What do you tell people?
Respecting patients’ autonomy in making decisions over treatment, and getting their ‘informed consent’, is at the core of modern medical ethics. Both in terms of the rules laid down for ethical clinical practice (Levine, 1988, Smith, 1999) and in philosophically based medical ethics (e.g. Beauchamp & Childress, 2001), the need to get informed consent from patients is crucial. Yet a considerable amount of empirical research suggests just how hard it is to decide exactly what counts as ‘informed’
Conclusions
What this small selection of data from my interviews suggests is that introducing pharmacogenetics into the clinic may be a far more complicated procedure than most commentators seem to admit. There is always a context to a pharmacogenetic test when it enters a clinical situation. In the case of Alzheimer’s disease, this context includes a decade’s-worth of debate and restriction on the clinical use of APOE testing, as well as broader medical debates over rationing and evidence based medicine.
References (67)
- et al.
Personalized medicine: Revolutionizing drug discovery and patient care
Trends in Biotechnology
(2001) Can ethnography save the life of medical ethics?
Social Science and Medicine
(1992)The forms and limits of medical ethics
Social Science and Medicine
(1994)Ethical considerations in clinical pharmacogenomics research
Trends in Pharmacological Science
(2000)Exploiting human genetic variation in drug discovery and development
Drug Discovery Today
(2001)Resisting revolution: Generalism and the new genetics
Lancet
(1999)- et al.
Apolipoprpotein E genotype and Alzheimer’s disease
Lancet
(1993) - et al.
A SNPshot: Pharmacogenetics and the future of drug therapy
Trends in Biotechnology
(2000) - et al.
Genetic susceptibility factors for Alzheimer’s disease
European Journal of Pharmacology
(2001) - et al.
Pharmacogenomics: A clinician’s primer on emerging technologies for improved patient care
Mayo Clinic Proceedings
(2001)
Pharmacogenomics: Are pharmacists ready for genotyped prescribing?
The Pharmaceutical Journal
Current and future applications of pharmacogenomics
New Horizons
Editorial: Pharmacogenomics at work
Nature Biotechnology
Her-2: The making of Herceptin
Principles of biomedical ethics
Family values and resistance to genetic testing
Consensus statement on predictive testing for Alzheimer disease
Alzheimer Disease and Associated Disorders
The challenges of pharmacogenomics for pharmacy education, practice, and regulation
Report on ethical considerations
International Journal of Pharmaceutical Medicine
Why bioethics needs sociology
The challenges of integrating genetic medicine into primary care
British Medical Journal
Pharmacogenetics: The therapeutic drug monitoring of the future?
Clinical Pharmacokinetics
Pharmacogenomics: The inherited basis for interindividual differences in drug response
Annual Review of Genomics and Human Genetics
A controlled trial of Tacrine in Alzheimer’s disease
Journal of the American Medical Association
Statement on use of Apolipoprotein-E testing for Alzheimer disease
Journal of the American Medical Association
Medical morality is not bioethics: Medical ethics in China and the United States
Perspectives in Biology and Medicine
What can the social sciences contribute to the study of ethics? Theoretical, empirical and substantive considerations
Bioethics
Letter: Not quite pharmacogenomics
Nature Biotechnology
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