A precision approach to medical care is the allocation of patients to smaller groups for targeted therapy, with stratification being the primary unifying feature for all precision approaches.
In his letter from the editor in the latest issue of the AMA Journal of Ethics, Jason N. Batten, MA, a medical student at the Stanford University School of Medicine, notes that there is a continual debate regarding which approaches should be used to base stratification of patients to precision therapy: single biomarkers or complex analytic processes. Additionally, ethical considerations must be taken into account, particularly with regard to demographic disparities. Researchers should, according to Mr Batten, partner with underrepresented groups of patients to enhance diversity in genomic databases, particularly as a means of providing “equitable access to therapies resulting from CRISPR/Cas9 gene editing technology.”
Additional ethical considerations regarding stratification involve disturbing the social fabric, especially if the stratification results in assigning a patient to a particular outcome prediction or therapy with undeserved negative connotations. For instance, stratifying a patient with psychosis to a group with a predicted poor prognosis may be linked with social ramifications, creating an ethical challenge for physicians. This creates tension among clinicians and brings into question whether these types of stratifications should be disclosed to patients or their families directly.
As new, novel stratification and precision medicine methods become available, the ethical issues surrounding these approaches become more uncertain. “Stratification has only rarely been explored as a concept with ethical fallout and is often downplayed in favor of the label ‘precision,’” Mr Batten wrote. “We can gain increased traction on these issues [of personalized medicine strategies] by remembering how they are united: through the concept of stratification, the basis of all precision health efforts.”
Batten JN. How stratification unites ethical issues in precision health. AMA J Ethics. 2018;20(9):E798-E803.