Dr Mary Jean Walker1
1Monash University, Clayton, Australia, 2ARC Centre of Excellence for Electromaterials Science, Wollongong, Australia
Progress has recently been made into developing tissue cultures grown from induced pluripotent stem cells (iPSCs) suitable for testing how particular patients will respond to treatments. These would be of use in developing treatment regimens for conditions where multiple treatment options exist, but we lack definitive ways of telling which treatment will work best for which patient (e.g., schizophrenia, epilepsy). An iPSC tissue culture system could prevent patients from having to undergo sometimes significant periods of trialling various treatments before finding one that works for them. They could also provide data for individualising dosages.
Using iPSC cultures in this way is, we have argued elsewhere, a novel method of gaining knowledge for clinical practice, as it does not rely on the two traditional sources of evidence for predicting individual treatment responses (evidence about mechanisms and population-level correlational studies). Its novelty brings with it a number of unknowns, which raise practical and ethical questions. For instance, It is not clear what level of predictive certainty should be expected before results can be taken to direct clinical practice, and what sorts of studies should be used to test this. Candidate conditions for the system may have complex and contested subtype nosologies, implying potential variations in system reliability across patients, indicating the need for care in thinking through which patients are candidates for the system. Further, such a system does not clearly fit into current regulatory schemes, and decisions about their regulatory treatment could influence researcher decisions.
In this paper, we map the issues arising from the currently unique status of this method of predicting patient responses to treatment, with a view to developing a framework of ethical considerations for researchers working in this area.
Mary Jean Walker is a Research Fellow at Monash University in Melbourne. She has research interests in bioethics, philosophy of medicine, health policy, and personal and narrative identity. In her current role she is researching ethical issues related to advanced medical devices and personalised medicine.