Ethical issues in autologous stem cell transplantation (ASCT) in advanced breast cancer: A systematic literature review

Abstract

BackgroundAn effectiveness assessment on ASCT in locally advanced and metastatic breast cancer identified serious ethical issues associated with this intervention. Our objective was to systematically review these aspects by means of a literature analysis.MethodsWe chose the reflexive Socratic approach as the review method using Hofmann's question list, conducted a comprehensive literature search in biomedical, psychological and ethics bibliographic databases and screened the resulting hits in a 2-step selection process. Relevant arguments were assembled from the included articles, and were assessed and assigned to the question list. Hofmann's questions were addressed by synthesizing these arguments.ResultsOf the identified 879 documents 102 included arguments related to one or more questions from Hofmann's question list. The most important ethical issues were the implementation of ASCT in clinical practice on the basis of phase-II trials in the 1990s and the publication of falsified data in the first randomized controlled trials (Bezwoda fraud), which caused significant negative effects on recruiting patients for further clinical trials and the doctor-patient relationship. Recent meta-analyses report a marginal effect in prolonging disease-free survival, accompanied by severe harms, including death. ASCT in breast cancer remains a stigmatized technology. Reported health-related-quality-of-life data are often at high risk of bias in favor of the survivors. Furthermore little attention has been paid to those patients who were dying.ConclusionsThe questions were addressed in different degrees of completeness. All arguments were assignable to the questions. The central ethical dimensions of ASCT could be discussed by reviewing the published literature.

Ethical analysis in HTA of complex health interventions

“…The Socratic approach has been applied in a range of assessments, e.g. of Bariatric surgery [ 48 ], Autologous stem cell transplantation [ 49 ] and Welfare technology [ 50 ]. These interventions carry some of the complexity characteristics and indicate that the approach is feasible for the assessment of complex health interventions.…”

“…related to prestige and stigmatisation. A systematic review of autologous stem cell transplantation (ASCT) in advanced breast cancer, using the Socratic approach, illustrates how this intervention became loaded with the symbolic value of “dissemination of phase II trial results, coverage without evidence, falsified data, high costs to the public and considerable, unnecessary harm to patients” [ 49 ]. In this case, the negative impact on recruiting patients and the doctor-patient relationship was reported.…”

“…The aim of the approach is to highlight (underlying) values, viewpoints and arguments regarding an intervention that are important for decision-making. This is achieved by comprehensiveness in the normative issues addressed [ 49 ] (also including socio-cultural and legal issues) and moral pluralism (incorporation of Deontology, Utilitarianism, Principlism, Casuistry, Virtue ethics) [ 7 ]. Altogether this should make a solid basis for the additional step that may be required in cases of complex interventions: to elucidate possible contradictions and clarify their nature and solvability.…”

Q-SEA – a tool for quality assessment of ethics analyses conducted as part of health technology assessments

“…This systematic review of ethics issues was conducted as a result of identification of ethics issues surrounding ASTC during a systematic review of the effectiveness of ASTC by the German Institute for Quality and Efficiency in Health Care (IQWiG) [23]. …”

Stakeholders’ Views on Responsible Assessments of Assistive Technologies through an Ethical HTA Matrix

“…were primarily selected to address a wide range of concerns that an RRI assessment should include for assistive technologies [17], and in addition they have been widely used to analyze ethical and social impacts of novel technologies [10,14,19,21,22,24,26,[34][35][36][37][38][39][40][41][42][43][44][45][46][47][48][49][50]. The reason for combining these two is that the Ethical Matrix can best be characterized as a general-purpose tool for practicing applied ethics, whereas the Socratic approach is highly specified towards the health field.…”