Ethical Challenges in Biomarker‐Driven Drug Development
The principle of beneficence requires that all experiments with human subjects have a favorable risk/benefit balance. This principle is fundamental to the precision medicine movement, which aims to redefine disease in terms of particular biomarker signatures. By studying how to tailor treatments to biomarker‐defined patient populations, precision medicine can improve the overall risk/benefit profile of research—study participants will be more likely to benefit, the results of research will be more applicable to the relevant clinical populations, and the biomarker‐negative patients can be spared the burdens of ineffective treatments. Yet some commentators have argued that the research investment required to realize these benefits from precision medicine could do far more good—i.e., better express beneficence—if it were put toward research and translation of public health interventions.4
The principle of justice requires that the burdens and benefits of research should be distributed equally across society, and that those who participate in research—and thereby contribute to the advancement of knowledge—should have access to the fruits of this labor. Some commentators have argued that as biomarkers are used to “salami slice” patient populations into smaller and smaller groups, the costs of therapies targeted to these groups is likely to rise considerably.5 If this is correct, and the predictable result of biomarker research is higher drug costs, which will restrict future patients' access to the benefits of the research, then this research activity itself may be unjust.