Translation of cancer molecular biomarkers: Ethical and epistemological issues

Abstract

The phenomenon of high cancer mortality has been the key factor in driving drug approval processes and health-care policies. In this paper, we discuss the inconsistencies of the genetic model of cancer as applied in the case of colorectal cancer (CRC). The result of relying on a genetic model of CRC is the approval of cancer drugs based on the inhibition of the epidermal growth factor receptor. The poor clinical performance of these drugs has prompted the use of a molecular biomarker to find the respondent patients. Due to the complexity of the cancer cell biological pathways, even the use of a molecular biomarker has not improved the clinical response of treated patients. Within the clinical uncertainty derived from the limited predictive value of a cancer molecular biomarker, we analyse the patient-doctor relationship. Beyond the challenge of communicating the medical uncertainty, many influences coming from the health-care system make the medical decisions biased. We analyse the ethical justification in using drugs that, at best, extend the patients survival for a few weeks, then we proceed to highlight the excessive cost of these drugs that create a problem for the allocation of resources for the whole society. We hold that a sensitive evaluation before the use of costly drugs for metastatic cancers must enter into the physician-patient relationship balancing the ethical concerns of the oncologist community and the need for the development of preventive policies.