Personalized Medicine in Oncology: Ethical Implications for the Delivery of Healthcare

Nathalie Egalite; Iris Jaitovich Groisman; Beatrice Godard

Personalized Medicine. 2014;11(7):659-668.

Abstract and Introduction

Abstract

While personalized medicine brings benefits for the treatment of cancer, there are still key ethical issues at stake in developing personalized medicine in oncology. We propose an ethical analysis of personalized medicine in oncology that highlights the particularities of cancer care, critically assesses the scientific advances behind personalized medicine in oncology and emphasizes fairness in resource allocation in the delivery of personalized healthcare. This allows for a broader understanding of the real impacts on both recipients and the healthcare system.

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Table 1. North American professional recommendations for selected personalized tests.
Personalized test (therapy)	Positive recommendation in guidelines in the USA	Positive recommendation in guidelines in Canada
Breast cancer
HER2 (trastuzumab)	American Society of Clinical Oncology/College of American Pathologists (2007)	Canadian National Consensus Meeting on HER2/neu testing in breast cancer (2007)
Oncotype DX® (adjuvant chemotherapy)	American Society of Clinical Oncology (2007)	Ontario Health Advisory Committee (2010)
Chronic myeloid leukemia
BCR-ABL (imatinib)	None	None
Colorectal cancer
KRAS (cetuximab and panitumumab)	American Society of Clinical Oncology (2009)	Canadian Expert Group consensus recommendations: KRAS testing in colorectal cancer (2011)
Malignant melanoma
BRAF (vemurafenib)	None	None
Large-cell lymphoma and non-small-cell lung cancer
ALK (crizotinib)	College of American Pathologists et al. (2013)	None

Table 2. Key ethical issues at stake in developing personalized medicine in oncology.
Issues	Constituents	Recommendations
Process of informed consent	Content complexity Duration	Development of innovative methods of communication to explain risks and benefits and to assess patient understanding Online guides to PM Healthcare training
Sharing and management of huge amounts of data	Having access to identifiable, integrated datasets of genomic and health information Need for patient education and consent Unintended consequences and potential risks to participants Required trained professionals who are skilled at interpreting and translating data to patients	Publicly available databases Large-scale data disclosure from all players to create an open-source database Clinical laboratory certification External quality assurance programs Broad patient consent
Communicating results	Communicating the intricacies involved in NGS and the range of possible complex results to patients becomes increasingly difficult as more testing targets are added Delay to reporting of results Implications of incidental findings and variants of unknown significance Privacy and discrimination issues	In-depth education and training for patients (counseling aids) and health professionals (webinars) Certified genetic counsellors and medical geneticists included as part of the testing process Research studying patient expectations Research studying the psychobehavioral impacts of providing personalized genetic risk assessment using NGS Discussion to develop ethical frameworks and establish counseling recommendations on disclosing information from genetic testing to patients Patients' involvement in this process
Cost and equity issues	Technical cost of generating the sequence Restricted access to newer therapies and the accompanying companion diagnostics (agent pricing often exceeds the cost) Increase in imbalances in access as the identification of novel targets and treatments continues Insurance coverage restrictions Use of research as a clinical service	Health outcome and cost–effectiveness models for PM Refine policy in terms of public pricing and reimbursement authorities Stakeholder debates
Lack of guidelines regarding the implementation of NGS	ACMG (2012): listing criteria that should be satisfied when offering genomic testing to patients, but no specific guidelines provided with regards to the implementation process	Working in partnership to derive a consensus set of guidelines

ACMG: American College of Medical Genetics; NGS: Next-generation sequencing; PM: Personalized medicine.

Sidebar

Executive Summary

Personalized medicine & its benefits in cancer treatment

Cancer clinical management has evolved from a stratified approach towards a personalized one and will continue to be affected by emerging genomic technologies

Key ethical issues in developing personalized medicine in oncology

The consent process is made difficult due to time limitations, information overload, management of incidental findings, impeded patient understanding and decision-making, and potential psychosocial implications of germline and somatic genetic testing.
For patients, return of results is linked to genetic privacy and the involvement of their family members; for physicians, to the interpretation of the results.
There remains ambiguity in law and professional guidelines regarding how to manage documented privacy and discrimination concerns arising from the integration of genomic testing into cancer care.
Patients unable to afford or obtain personalized medicine may be enrolled in trials in order to benefit from otherwise inaccessible therapies, increasing vulnerability and reinforcing health disparities.

Emphasizing the particularities of cancer care

Cancer patients are especially enticed by therapies offering negligible gains in survival and
may have unrealistic expectations of treatment outcomes. Given that genetic information is inherently familial in nature, healthcare systems should promote the autonomous decisions of family members impacted by cancer.
Critically assessing the scientific advances behind personalized medicine in oncology
Integrative models of analysis combining genes, the environment (epigenetics), gene expression (RNA and proteins), drug metabolism and treatment influence in cancer progression are needed.

Emphasizing fairness in resource allocation

The implementation of genetic information in medical decision-making must address the risks of healthcare inequities and possible discrimination for patients.
Regulatory structures will prove crucial for the development of target-specific medications and cost reduction while leaders in clinical oncology can play an active role in rectifying jurisdictional inconsistencies and easing reimbursement challenges.
Healthcare should be thought of as a matter of social justice.
Setting priorities in healthcare requires that society favor the wiser and fairer choices made possible through personalized medicine.

Future perspective

Assessments of personalized medicine could be enhanced with findings on how key actors perceive ethical concerns.
Ethicists could be instrumental in guiding stakeholders in the continued implementation of personalized medicine, as well as in the review of evidence and issues of recommendations.