Re-focusing the ethical discourse on personalized medicine: a qualitative interview study with stakeholders in the German healthcare system
Open accessAbstract
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.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Professionals and patients fear discrimination based on the results of genetic testing, particularly by insurance companies or employers.
“In addition to possible disparities in access to PM, professionals and patients fear discrimination based on the results of genetic testing [27, 79, 92, 97], particularly by insurance companies or employers [46, 51, 54, 63, 86, 94–96, 98, 115].”
From Patients’ and professionals’ views related to ethical issues in precision medicine: a mixed research synthesis (2021) · cites this paper as [54]
The Results (Ethical implications of PM; page unavailable) report that most respondents raised concerns about sensitive genetic data, discrimination, health insurance, and job-market opportunities. The Methods (Sample; page unavailable) identify respondents as healthcare stakeholders, including representatives of patient organizations, but do not establish that patients themselves expressed these fears. (LLM, conf=0.83)
Experimental — accuracy not yet measuredIn several studies, professionals and patients express concern about the high cost of PM.
“In several studies, professionals and patients express concern about the high cost of PM.”
From Patients’ and professionals’ views related to ethical issues in precision medicine: a mixed research synthesis (2021) · cites this paper as [54]
The Results (Ethical implications of PM; Future perspectives of PM) report stakeholder concerns about escalating or extremely high costs of personalized medicine. But this is one interview study of experts, including a patient-organization representative—not evidence from several studies of professionals and patients expressing that concern. (LLM, conf=0.87)
Experimental — accuracy not yet measuredSome professionals doubt that all patients will benefit significantly from precision medicine.
“Apart from these positive assessments, studies also demonstrate that some professionals are uncertain about the value of genetic testing [51, 90] and doubt that all patients will benefit significantly from PM [30, 31, 42, 49, 54, 57].”
From Patients’ and professionals’ views related to ethical issues in precision medicine: a mixed research synthesis (2021) · cites this paper as [54]
Some health care professionals question the cost-benefit ratio of PM.
“Although professionals expect a reduction of the overall health care costs in the long term [47], some health care professionals question the cost–benefit ratio of PM [30, 54, 84, 105].”
From Patients’ and professionals’ views related to ethical issues in precision medicine: a mixed research synthesis (2021) · cites this paper as [54]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Slamon, D. J., Clark, G. M., Wong, S. G., Levin, W. J., Ullrich, A., & McGuire, W. L. (1987) · Science · doi:10.1126/science.3798106 · Cited by 11,760 · see citing works
Slamon, D. J., Leyland-Jones, B., Shak, S., Fuchs, H., Paton, V., Bajamonde, A., Fleming, T., Eiermann, W., Wolter, J., Pegram, M., et al. (2001) · New England Journal of Medicine · doi:10.1056/nejm200103153441101 · Cited by 11,500 · see citing works
The SAGE Encyclopedia of Qualitative Research Methods
Given, L. (2008) · doi:10.4135/9781412963909 · Cited by 6,134 · see citing works
Trastuzumab plus Adjuvant Chemotherapy for Operable HER2-Positive Breast Cancer
Romond, E. H., Perez, E. A., Bryant, J., Suman, V. J., Geyer, C. E., Davidson, N. E., Tan-Chiu, E., Martino, S., Paik, S., Kaufman, P. A., et al. (2005) · New England Journal of Medicine · doi:10.1056/nejmoa052122 · Cited by 5,355 · see citing works
Trastuzumab after Adjuvant Chemotherapy in HER2-Positive Breast Cancer
Piccart-Gebhart, M. J., Procter, M., Leyland-Jones, B., Goldhirsch, A., Untch, M., Smith, I., Gianni, L., Baselga, J., Bell, R., Jackisch, C., et al. (2005) · New England Journal of Medicine · doi:10.1056/nejmoa052306 · Cited by 5,084 · see citing works
Trastuzumab-Induced Hepatotoxicity: A Case Report
Vucicevic, D., Carey, E. J., & Karlin, N. J. (2013) · Breast Care · doi:10.1159/000346844 · Cited by 4,432 · see citing works
Adjuvant Docetaxel or Vinorelbine with or without Trastuzumab for Breast Cancer
Joensuu, H., Kellokumpu‐Lehtinen, P., Bono, P., Alanko, T., Kataja, V. V., Asola, R., Utriainen, T., Kokko, R., Hemminki, A., Tarkkanen, M., et al. (2006) · New England Journal of Medicine · doi:10.1056/nejmoa053028 · Cited by 1,393 · see citing works
Mayring, P., & Fenzl, T. (2014) · Handbuch Methoden der empirischen Sozialforschung · doi:10.1007/978-3-531-18939-0_38 · Cited by 1,262 · see citing works
Lamon, D. E. J. S., Eyland, B. R. L., Hak, S. T. S., Uchs, H. A. F., Aton, V. I. P., Ajamonde, A. L. B., LeMing, T., Iermann, W. O. E., Olter, J. A. W., Egram, M. A. P., et al. (2009) · Cited by 1,199 · see citing works
Maughan, T. S., Adams, R. A., Smith, C. G., Meade, A. M., Seymour, M. T., Wilson, R. H., Idziaszczyk, S., Harris, R., Fisher, D., Kenny, S. L., et al. (2011) · The Lancet · doi:10.1016/s0140-6736(11)60613-2 · Cited by 960 · see citing works
Hochhaus, A., O'Brien, S. G., Guilhot, F., Druker, B. J., Branford, S., Foroni, L., Goldman, J. M., Müller, M. C., Radich, J. P., Rudoltz, M. S., et al. (2009) · Leukemia · doi:10.1038/leu.2009.38 · Cited by 855 · see citing works
From patients to partners: participant-centric initiatives in biomedical research
Kaye, J., Curren, L., Anderson, N., Edwards, K., Fullerton, S. M., Kanellopoulou, N., Lund, D., MacArthur, D. G., Mascalzoni, D., Shepherd, J., et al. (2012) · Nature Reviews Genetics · doi:10.1038/nrg3218 · Cited by 293 · see citing works
Tailored Medicine: Whom Will it Fit? The Ethics of Patient and Disease Stratification
Smart, A., Martin, P. A., & Parker, M. J. (2004) · Bioethics · doi:10.1111/j.1467-8519.2004.00400.x · Cited by 97 · see citing works
The Precautionary Principle and Medical Decision Making
Resnik, D. B. (2004) · The Journal of Medicine and Philosophy A Forum for Bioethics and Philosophy of Medicine · doi:10.1080/03605310490500509 · Cited by 93 · see citing works
Ethical considerations in clinical pharmacogenomics research
Issa, A. M. (2000) · Trends in Pharmacological Sciences · doi:10.1016/s0165-6147(00)01493-0 · Cited by 81 · see citing works
Sutrop, M. (2004) · Bioethics · doi:10.1111/j.1467-8519.2004.00398.x · Cited by 63 · see citing works
Fierz, W. (2004) · PubMed · Cited by 60 · see citing works
Pharmacogenetics, ethical issues: review of the Nuffield Council on Bioethics Report
Corrigan, O. (2005) · Journal of Medical Ethics · doi:10.1136/jme.2004.007229 · Cited by 55 · see citing works
Pharmacogenetics – legal, ethical and regulatory considerations
March, R. E., Cheeseman, K., & Doherty, M. (2001) · Pharmacogenomics · doi:10.1517/14622416.2.4.317 · Cited by 50 · see citing works
Pharmacogenomics: out of the lab and into the community
Nebert, D. W. (2001) · Trends in biotechnology · doi:10.1016/s0167-7799(01)01805-4 · Cited by 32 · see citing works
Foundations, promises and uncertainties of personalized medicine
Böttinger, E. P. (2007) · Mount Sinai Journal of Medicine A Journal of Translational and Personalized Medicine · doi:10.1002/msj.20005 · Cited by 30 · see citing works
Pharmacogenetics: Ethical Issues
(2004) · Bioethics · doi:10.1111/j.1467-8519.2004.00403_1.x · Cited by 19 · see citing works
Heßling, A., & Schicktanz, S. (2012) · Clinical Ethics · doi:10.1258/ce.2012.12-001 · Cited by 15 · see citing works
Francis, L. P. (2010) · Mount Sinai Journal of Medicine A Journal of Translational and Personalized Medicine · doi:10.1002/msj.20170 · Cited by 13 · see citing works
DElivering on The Promise of Personalized Healthcare
March, R. E. (2010) · Personalized Medicine · doi:10.2217/pme.10.17 · Cited by 13 · see citing works
Hochhaus, A., O'Brien, S. G., Guilhot, F., Druker, B. J., Branford, S., Foroni, L., Goldman, J. M., Müller, M. C., Radich, J. P., Rudoltz, M. S., et al. (2010) · Leukemia · doi:10.1038/leu.2010.71 · Cited by 12 · see citing works
Rogausch, A., Brockmöller, J., & Himmel, W. (2005) · Das Gesundheitswesen · doi:10.1055/s-2004-813918 · Cited by 10 · see citing works
Regulatory and Ethical Challenges of Personalized Medicine
Torr-Brown, S. (2010) · Personalized Medicine · doi:10.2217/pme.10.49 · Cited by 2 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Erdmann, A., Rehmann-Sutter, C., & Bozzaro, C. (2021) · BMC Medical Ethics · doi:10.1186/s12910-021-00682-8 · Cited by 86 · see citing works
Personalized medicine in Europe: not yet personal enough?
Di Paolo, A., Sarkozy, F., Ryll, B., & Siebert, U. (2017) · BMC Health Services Research · doi:10.1186/s12913-017-2205-4 · Cited by 54 · see citing works
Practicality of 3D Printed Personalized Medicines in Therapeutics
Amekyeh, H., Tarlochan, F., & Billa, N. (2021) · Frontiers in Pharmacology · doi:10.3389/fphar.2021.646836 · Cited by 47 · see citing works
3D Printed Pharmaceutical Systems for Personalized Treatment in Metabolic Syndrome
Alqahtani, A. A., Ahmed, M. M., Mohammed, A. A., & Ahmad, J. (2023) · Pharmaceutics · doi:10.3390/pharmaceutics15041152 · Cited by 34 · see citing works
Baird, A., Westphalen, C. B., Blum, S. M., Nafría, B., Knott, T., Sargeant, I., Harnik, H., Brooke, N., Wicki, N., & Wong‐Rieger, D. (2023) · Health Science Reports · doi:10.1002/hsr2.1349 · Cited by 33 · see citing works
Patient and interest organizations’ views on personalized medicine: a qualitative study
Budin-Ljøsne, I., & Harris, J. R. (2016) · BMC Medical Ethics · doi:10.1186/s12910-016-0111-7 · Cited by 32 · see citing works
“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].”
BackgroundThe ethical aspects of human organ-on-chip models: A mapping review
Weidema, J., de Vries, M., Mummery, C. L., & de Graeff, N. (2025) · Stem Cell Reports · doi:10.1016/j.stemcr.2025.102686 · Cited by 13 · see citing works
Integration of Industry 4.0 With Personalized Medicine
Waaje, A., Karim, R., Roshid, M. M., Yeamin, M. B., & Meem, T. N. (2025) · Advances in computational intelligence and robotics book series · doi:10.4018/979-8-3693-7858-8.ch002 · Cited by 12 · see citing works
Alter Wein in neuen Schläuchen? Ethische Implikationen der Individualisierten Medizin
Schleidgen, S., & Marckmann, G. (2013) · Ethik in der Medizin · doi:10.1007/s00481-013-0267-3 · Cited by 11 · see citing works
Self-citationPersonalized Medicine in Oncology: Ethical Implications for The Delivery of Healthcare
Égalité, N., Groisman, I. J., & Godard, B. (2014) · Personalized Medicine · doi:10.2217/pme.14.53 · Cited by 8 · see citing works
Stelzer, I. V., Sierawska, A. K., Buyx, A., & Simon, J. (2020) · Journal of Personalized Medicine · doi:10.3390/jpm10040276 · Cited by 7 · see citing works
Nordström, K., & Goossens, J. (2015) · Journal of Agricultural and Environmental Ethics · doi:10.1007/s10806-015-9589-0 · Cited by 7 · see citing works
Digitale Spiegelbilder – Ethische Aspekte großer Datensammlungen
Witt, E. (2015) · Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz · doi:10.1007/s00103-015-2187-5 · Cited by 6 · see citing works
Concept and Scientific Background of Personalized Medicine
Bieber, T. R. M. (2015) · Springer eBooks · doi:10.1007/978-3-662-45840-2_1 · Cited by 4 · see citing works
Kişiselleştirilmiş Tıp Envanterinin Geliştirilmesi: Geçerlik ve Güvenirlik Çalışması
Bulut, A. (2023) · Social Sciences Studies Journal · doi:10.29228/sssj.72046 · Cited by 1 · see citing works
Lehoux, P., Cheriet, I., & Grimard, D. (2017) · Ethics Medicine and Public Health · doi:10.1016/j.jemep.2017.05.006
- Authors
- Schleidgen, S., & Marckmann, G.
- Affiliations
- Institut für Ethik, Geschichte und Theorie der Medizin (DE)
- Corresponding author
- Schleidgen, Sebastian
- Venue
- BMC Medical Ethics
- Published
- 2013-05-24
- Volume
- 14
- Issue
- 1
- Pages
- 20-20
- ISSN
- 1472-6939 (ISSN-L)
- PMC
- PMC3681604
- OpenAlex
- W1988331537
- Cited by
- 15
- References
- 28
- Citations by year
- 2025: 2 · 2023: 2 · 2021: 2 · 2020: 1 · 2017: 2 · 2016: 1 · 2015: 3 · 2014: 1 · 2013: 1
- FWCI
- 2.05
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Medical Ethics (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Open access LMU (Ludwid Maxmilian's Universitat Munchen) (submittedVersion)
- Funders
- Bundesministerium für Bildung und Forschung
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Keywords
- personalized medicine, ethical discourse, anticipatory ethics, stakeholder perspectives, German health care system
- MeSH terms
- Antineoplastic Agents, Clinical Trials as Topic, Delivery of Health Care, Drug Industry, Germany, Humans, Insurance Carriers, Insurance, Health, Primary Prevention, Research Personnel, Narration, Biomedical Research, Qualitative Research, Precision Medicine, Molecular Targeted Therapy
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
