title: Re-focusing the ethical discourse on personalized medicine: a qualitative interview study with stakeholders in the German healthcare system.
abstract: BACKGROUND
  In 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.
  
  
  METHODS
  To 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.
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  The 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.
authors.affiliation: Institute of Ethics, History and Theory of Medicine, Ludwig-Maximilians-University Munich, Lessingstrasse 2, Munich 80336, Germany. sebastian.schleidgen@med.lmu.de
authors.forename: Sebastian
authors.initials: S
authors.lastname: Schleidgen
authors.forename: Georg
authors.initials: G
authors.lastname: Marckmann
mesh_terms: D000970:Antineoplastic Agents / Q000191:economics / Q000494:pharmacology; D035843:Biomedical Research; D002986:Clinical Trials as Topic / Q000941:ethics / Q000592:standards; D003695:Delivery of Health Care / Q000191:economics / Q000941:ethics* / Q000379:methods / Q000639:trends; D004345:Drug Industry / Q000191:economics* / Q000941:ethics*; D005858:Germany; D006801:Humans; D007343:Insurance Carriers; D007348:Insurance, Health; D058990:Molecular Targeted Therapy / Q000191:economics / Q000941:ethics; D033262:Narration; D057285:Precision Medicine / Q000191:economics / Q000941:ethics* / Q000379:methods / Q000639:trends; D011322:Primary Prevention / Q000379:methods; D036301:Qualitative Research; D012108:Research Personnel
chemical_list: D000970:Antineoplastic Agents