Integrating genomics into clinical oncology: ethical and social challenges from proponents of personalized medicine.
BACKGROUND
The use of molecular tools to individualize health care, predict appropriate therapies, and prevent adverse health outcomes has gained significant traction in the field of oncology under the banner of "personalized medicine" (PM). Enthusiasm for PM in oncology has been fueled by success stories of targeted treatments for a variety of cancers based on their molecular profiles. Though these are clear indications of optimism for PM, little is known about the ethical and social implications of personalized approaches in clinical oncology.


OBJECTIVE
The objective of this study is to assess how a range of stakeholders engaged in promoting, monitoring, and providing PM understand the challenges of integrating genomic testing and targeted therapies into clinical oncology.


METHODS
The study involved the analysis of in-depth interviews with 117 stakeholders whose experiences and perspectives on PM span a wide variety of institutional and professional settings.


RESULTS
Despite their considerable enthusiasm for this shift, promoters, monitors, and providers of PM identified 4 domains that provoke heightened ethical and social concerns: (1) informed consent for cancer genomic testing, (2) privacy, confidentiality, and disclosure of genomic test results, (3) access to genomic testing and targeted therapies in oncology, and (4) the costs of scaling up pharmacogenomic testing and targeted cancer therapies.


CONCLUSIONS
These specific concerns are not unique to oncology, or even genomics. However, those most invested in the success of PM view oncologists' responses to these challenges as precedent setting because oncology is farther along the path of clinical integration of genomic technologies than other fields of medicine. This study illustrates that the rapid emergence of PM approaches in clinical oncology provides a crucial lens for identifying and managing potential frictions and pitfalls that emerge as health care paradigms shift in these directions.
Department of Bioethics, Case Western Reserve University School of Medicine, Cleveland, OH. Electronic address: michelle.mcgowan@case.edu.
Michelle L
ML
McGowan
College of Public Health and Human Sciences, Oregon State University, Corvallis, OR.
Richard A
RA
Settersten
Center for Bioethics, Department of Social Medicine, University of North Carolina, Chapel Hill, NC.
Eric T
ET
Juengst
Biomedical Ethics Unit, Department of Social Studies of Medicine, McGill University, Montreal, Quebec, Canada.
Jennifer R
JR
Fishman
D003219:Confidentiality / Q000941:ethics; D003695:Delivery of Health Care / Q000941:ethics / Q000379:methods; D030881:Disclosure / Q000941:ethics; D030661:Genetic Privacy / Q000941:ethics; D005820:Genetic Testing / Q000941:ethics* / Q000379:methods; D023281:Genomics / Q000941:ethics* / Q000379:methods; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D007407:Interviews as Topic; D008495:Medical Oncology / Q000941:ethics* / Q000379:methods; D009369:Neoplasms / Q000175:diagnosis / Q000235:genetics / Q000628:therapy; D057285:Precision Medicine / Q000941:ethics* / Q000379:methods
Cancer genomics; Ethics; Genomic testing; Personalized medicine; Social implications; Targeted therapies