Re-focusing the ethical discourse on personalized medicine: a qualitative interview study with stakeholders in the German healthcare system

Abstract

BackgroundIn recent years, personalized medicine (PM) has become a highly regarded line of development in medicine. Yet, it is still a relatively new field. As a consequence, the discussion of its future developments, in particular of its ethical implications, in most cases can only be anticipative. Such anticipative discussions, however, pose several challenges. Nevertheless, they play a crucial role for shaping PM’s further developments. Therefore, it is vital to understand how the ethical discourse on PM is conducted, i.e. on what – empirical and normative – assumptions ethical arguments are based regarding PM’s current and future developments.MethodsTo gather this information, we conducted a qualitative interview study with stakeholders in the German health care system. Our purposive sample included 17 representatives of basic research, clinical research, health economics, regulatory authorities, reimbursement institutions, pharmaceutical industry, patient organizations, as well as clinicians and legal experts involved in PM developments or policy making. We used an interview guide with open-ended questions and analyzed transcriptions of the interviews by means of qualitative content analysis.ResultsThe respondents addressed a multitude of concerns in the context of research on as well as application of personalized preventive and therapeutic measures both on the individual and on the societal level. Interestingly, regarding future developments of PM the ethical evaluation seemed to follow the rule: the less likely its application, the more problematic a PM measure is assessed. The more likely its application, on the other hand, the less problematic it is evaluated.ConclusionsThe results of our study suggest re-focusing the ethical discourse on PM in Germany towards a constructive ethical monitoring which ensures to include only, nevertheless all of the actual and/or potential concerns that are ethically relevant in order to allow balancing them against the actual and potential ethically relevant benefits of PM measures. To render this possible, we propose a strategy for evaluating ethical concerns in the context of PM.

Patients’ and professionals’ views related to ethical issues in precision medicine: a mixed research synthesis

“…In many studies, researchers [ 42 , 47 , 53 ] were also represented. Those mentioned explicitly were clinical researchers [ 54 – 56 ], bioinformaticians [ 31 , 32 ], laboratory scientists [ 31 ], experts from genome research [ 32 , 57 ] and, in general terms, representatives from basic [ 54 , 58 ] and translational research [ 58 ].…”

Patient and interest organizations’ views on personalized medicine: a qualitative study

“…Similarly, the general attention given to cancer in the PM discourse and the fact that most targeted drugs that have been marketed are cancer drugs [ 40 ] may explain why cancer PIOs were generally more aware of PM than non-cancer PIOs. As an illustration, several representatives from non-cancer PIOs believed PM to be primarily focusing on cancer to the disservice of other disease areas; a belief previously observed among health care professionals [ 41 ] and patient representatives [ 9 ]. It is therefore important that decision-makers work to increase levels of awareness regarding PM among PIOs, and provide support to those PIOs that have limited resources and competency but are willing to contribute to the PM agenda.…”

A Network-Based Mixed Methods Approach to Analyze Current Perspectives on Personalized Oncological Medicine in Austria

“…Altogether 16 stakeholders-i.e., 14 experts and two cancer patients-were interviewed from 8 December 2018 to 21 February 2019. The sample size was in a magnitude comparable to similar studies [16,17] and large enough to guarantee data saturation. Amongst the experts, 10 were clinicians or health system experts and four were basic scientists.…”

“…In the study by Budin-Ljøsne et al [ 15 ] for example, semi-structured telephone interviews among patient and interest organizations’ representatives in Europe and North America were carried out to investigate their views on PM. Stakeholders of the German HC system—including amongst others patient organizations, clinicians, researchers, representatives of the pharmaceutical industry and regulatory authorities [ 16 ], and clinical researchers working on PM in colorectal cancer [ 17 ]—were asked to share their thoughts on the new medical concept. The former study focused in particular on ethical issues and the latter on patient-doctor interactions.…”