Empirical Investigation of Ethical Challenges Related to the Use of Biological Therapies

Bladt, Tara; Vorup-Jensen, Thomas; Sædder, Eva Aggerholm; Ebbesen, Mette

doi:10.1177/1073110520958883

Cited by 4 publications

(12 citation statements)

References 14 publications

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“…7/56 empirical studies, all qualitative interview studies, recruited participants internationally with no specific location stated [ 40 , 54 , 55 , 58 , 60 , 63 , 73 ]. Of the remaining studies, all but one were single-country studies: Botswana [ 75 ], Canada [ 41 , 65 ], China [ 57 ], Denmark [ 39 , 43 ], Dominican Republic [ 44 ], Germany [ 51 , 84 ], India [ 61 ], Iran [ 38 , 46 , 49 , 68 , 70 – 72 , 78 , 82 , 98 ], Italy [ 45 ], Mexico [ 87 ], the Netherlands [ 76 ], New Zealand [ 47 ], Norway [ 42 , 52 , 56 , 64 , 80 , 81 , 83 ], Saudi Arabia [ 34 – 37 ], Tanzania [ 69 , 74 ], Uganda [ 67 ], UK [ 86 ], and USA [ 50 , 53 , 59 , 62 , 66 , 77 , 79 , 85 , 85 ]. The remaining study was undertaken in both Sierra Leone and the UK [ 48 ].…”

Section: Resultsmentioning

confidence: 99%

Defining ethical challenge(s) in healthcare research: a rapid review

et al. 2021

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Background Despite its ubiquity in academic research, the phrase ‘ethical challenge(s)’ appears to lack an agreed definition. A lack of a definition risks introducing confusion or avoidable bias. Conceptual clarity is a key component of research, both theoretical and empirical. Using a rapid review methodology, we sought to review definitions of ‘ethical challenge(s)’ and closely related terms as used in current healthcare research literature. Methods Rapid review to identify peer-reviewed reports examining ‘ethical challenge(s)’ in any context, extracting data on definitions of ‘ethical challenge(s)’ in use, and synonymous use of closely related terms in the general manuscript text. Data were analysed using content analysis. Four databases (MEDLINE, Philosopher’s Index, EMBASE, CINAHL) were searched from April 2016 to April 2021. Results 393 records were screened, with 72 studies eligible and included: 53 empirical studies, 17 structured reviews and 2 review protocols. 12/72 (17%) contained an explicit definition of ‘ethical challenge(s), two of which were shared, resulting in 11 unique definitions. Within these 11 definitions, four approaches were identified: definition through concepts; reference to moral conflict, moral uncertainty or difficult choices; definition by participants; and challenges linked to emotional or moral distress. Each definition contained one or more of these approaches, but none contained all four. 68/72 (94%) included studies used terms closely related to synonymously refer to ‘ethical challenge(s)’ within their manuscript text, with 32 different terms identified and between one and eight different terms mentioned per study. Conclusions Only 12/72 studies contained an explicit definition of ‘ethical challenge(s)’, with significant variety in scope and complexity. This variation risks confusion and biasing data analysis and results, reducing confidence in research findings. Further work on establishing acceptable definitional content is needed to inform future bioethics research.

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Section: Resultsmentioning

confidence: 99%

Defining ethical challenge(s) in healthcare research: a rapid review

et al. 2021

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“…Next, we present the Danish Medicines Council (DMC) and its task of evaluating whether new medicines should be introduced as standard treatments in Danish hospitals. We then introduce the Beauchamp and Childress ( 2019 ) ethical principle of justice and present a qualitative study in which semi-structured interviews were conducted with critical stakeholders as informants experienced in antibody therapy or prioritizing resources for expensive medicines in Denmark (Bladt et al 2020 ). The validity and relevance of the study are considered, and the results are discussed in the light of Beauchamp and Childress’s theory ( 2019 ).…”

Section: Introductionmentioning

confidence: 99%

“…This assessment rests on the high overall risk-taking of making effective drugs that deal with multifactorial diseases and the high manufacturing costs of the requirements of biological systems, which essentially limit production to highly specialized facilities and raise the entry-level costs for bringing competing drugs to the market. Other factors may include physician ignorance of biosimilar availability (Troein et al 2021 ) or their general unwillingness to use these alternatives based on personal experience of differences in, for instance, side effects compared to the original product (Bladt et al 2020 ).…”

Section: Introductionmentioning

confidence: 99%

“…Biological therapies are therefore likely to remain a significant economic burden on healthcare systems, which gives rise to several questions tightly linked with ethical considerations relevant to healthcare systems. As we have discussed elsewhere (Bladt et al 2020 ), if one particular therapy comes at a high economic cost, it may exclude the possibility of offering other treatments in a healthcare system with finite budgets. Moreover, the rapid increase in available treatments, combined with the fact that the disease indications in question now include relatively common morbidities, for example, rheumatoid arthritis, means there are many more patients to treat.…”

Section: Introductionmentioning

confidence: 99%

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Principles for Just Prioritization of Expensive Biological Therapies in the Danish Healthcare System

Bladt,

Vorup-Jensen,

Ebbesen

2023

Bioethical Inquiry

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The Danish healthcare system must meet the need for easy and equal access to healthcare for every citizen. However, investigations have shown unfair prioritization of cancer patients and unfair prioritization of resources for expensive medicines over care. What is needed are principles for proper prioritization. This article investigates whether American ethicists Tom Beauchamp and James Childress’s principle of justice may be helpful as a conceptual framework for reflections on prioritization of expensive biological therapies in the Danish healthcare system. We present an empirical study exploring the principles for prioritizing new expensive biological therapies. This study includes qualitative interviews with key Danish stakeholders experienced in antibody therapy and prioritizing resources for expensive medicines. Beauchamp and Childress’s model only covers government-funded primary and acute healthcare. Based on the interviews, this study indicates that to be helpful in a Danish context this model should include equal access for citizens to government-funded primary and acute healthcare, costly medicine, and other scarce treatments. We conclude that slightly modified, Beauchamp and Childress’s principle of justice might be useful as a conceptual framework for reflections on the prioritization of expensive biological therapies in the Danish healthcare system.

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“…In their recent paper, Bladt et al 1 focus on the delicate question of whether the four principles of biomedical ethics identified by Tom L. Beauchamp and James F. Childress 2 are reflected in the process of prioritization of financial resources in the Danish heath care system. They focus on biological treatment and multiple sclerosis, conducting a study based on eight semi-structured interviews.…”

mentioning

confidence: 99%