BackgroundPrecision medicine development is driven by the possibilities of next generation sequencing, information technology and artificial intelligence and thus, raises a number of ethical questions. Empirical studies have investigated such issues from the perspectives of health care professionals, researchers and patients. We synthesize the results from these studies in this review.MethodsWe used a systematic strategy to search, screen and assess the literature for eligibility related to our research question. The initial search for empirical studies in five data bases provided 665 (...) different records and we selected 92 of these publications for inclusion in this review. Data were extracted in a spreadsheet and categorized into different topics representing the views on ethical issues in precision medicine.ResultsMany patients and professionals expect high benefits from precision medicine and have a positive attitude towards it. However, patients and professionals also perceive some risks. Commonly perceived risks include: lack of evidence for accuracy of tests and efficacy of treatments; limited knowledge of patients, which makes informed consent more difficult; possible unavailability of access to precision medicine for underprivileged people and ethnic minorities; misuse of data by insurance companies and employers, potential of racial stigmatization due to genetic information; unwanted communication of incidental findings; changes in doctor-patient-relationship through focusing on data; and the problem that patients could feel under pressure to optimize their health.ConclusionsNational legislation and guidelines already minimize many risks associated with precision medicine. However, from our perspective some problems require more attention. Should hopes for precision medicine’s benefits be fulfilled, then the ethical principle of justice would require an unlimited access to precision medicine for all people. The potential for autonomous patients’ decisions must be greatly enhanced by improvements in patient education. Harm from test results must be avoided in any case by the highest possible data security level and communication guidelines. Changes in the doctor-patient relationship and the impact of precision medicine on the quality of life should be further investigated. Additionally, the cost-effectiveness of precision medicine should be further examined, in order to avoid malinvestment. (shrink)

Personalized medicine plays an important role in the development of current medicine. Among the numerous statements regarding the future of personalized medicine, some can be found that accord medicine a new scientific status. Medicine will be transformed from an art to a science due to personalized medicine. This prognosis is supported by references to models of historical developments. The article examines what is meant by this prognosis, what consequences it entails, and how feasible it is. It refers to the long (...) tradition of epistemological thinking in medicine and the use of historical models for the development of medicine. The possible answers to the question “art or science” are systematized with respect to the core question about the relationship between knowledge and action. The prediction for medicine to develop from an ‘empirical healing art’ to a ‘rational, molecular science’ is nonsensical from an epistemological point of view. The historical models employed to substantiate the development of personalized medicine are questionable. (shrink)

Personalised medicine has been discussed as a medical paradigm shift that will improve health while reducing inefficiency and waste. At the same time, it raises new practical, regulatory, and ethical challenges. In this paper, we examine PM strategies epistemologically in order to develop capacities to address these challenges, focusing on a recently proposed strategy for developing patient-specific models from induced pluripotent stem cells so as to make individualised treatment predictions. We compare this strategy to two main PM strategies—stratified medicine and (...) computational models. Drawing on epistemological work in the philosophy of medicine, we explain why these two methods, while powerful, are neither truly personalised nor, epistemologically speaking, novel strategies. Both are forms of correlational black box. We then argue that the iPSC models would count as a new kind of black box. They would not rely entirely on mechanistic knowledge, and they would utilise correlational evidence in a different way from other strategies—a way that would enable personalised predictions. In arguing that the iPSC models would present a novel method of gaining evidence for clinical practice, we provide an epistemic analysis that can help to inform the practical, regulatory, and ethical challenges of developing an iPSC system. (shrink)

ZusammenfassungDie sogenannte individualisierte Medizin (IM) ist in den letzten Jahren zu einem Schlagwort in Wissenschaft, Politik und Öffentlichkeit geworden. Wie jede technologische Neuentwicklung hat sie jedoch (potentielle) ethische Implikationen, die es zu berücksichtigen gilt, um eine angemessene Entwicklung und Anwendung individualisierter Präventions- und Therapiemaßnahmen zu ermöglichen. Allerdings steht eine ethische Bewertung der IM vor verschiedenen methodischen Herausforderungen, die sich insbesondere aus der Heterogenität des Problembereichs, begrifflicher Unklarheit sowie dem Frühstadium ihrer Entwicklung ergeben. Der vorliegende Beitrag spezifiziert zunächst den Begriff der (...) IM, um den Kontext der weiteren Überlegungen einzugrenzen. Anschließend wird eine heuristisch zu verstehende Typologie (möglicher) individual- und sozialethischer Implikationen der IM entwickelt. Sie verdeutlicht, dass die IM vorwiegend ethische Probleme aufwirft, die aus anderen biomedizinischen Bereichen bekannt sind. Welche dieser Probleme tatsächlich relevant sind, ist allerdings abhängig von der jeweils spezifischen IM-Maßnahme. Eine adäquate ethische Bewertung kann daher nur durch die Evaluation jedes einzelnen individualisierten Ansatzes erfolgen. (shrink)

Die sogenannte individualisierte Medizin (IM) ist in den letzten Jahren zu einem Schlagwort in Wissenschaft, Politik und Öffentlichkeit geworden. Wie jede technologische Neuentwicklung hat sie jedoch (potentielle) ethische Implikationen, die es zu berücksichtigen gilt, um eine angemessene Entwicklung und Anwendung individualisierter Präventions- und Therapiemaßnahmen zu ermöglichen. Allerdings steht eine ethische Bewertung der IM vor verschiedenen methodischen Herausforderungen, die sich insbesondere aus der Heterogenität des Problembereichs, begrifflicher Unklarheit sowie dem Frühstadium ihrer Entwicklung ergeben. Der vorliegende Beitrag spezifiziert zunächst den Begriff der (...) IM, um den Kontext der weiteren Überlegungen einzugrenzen. Anschließend wird eine heuristisch zu verstehende Typologie (möglicher) individual- und sozialethischer Implikationen der IM entwickelt. Sie verdeutlicht, dass die IM vorwiegend ethische Probleme aufwirft, die aus anderen biomedizinischen Bereichen bekannt sind. Welche dieser Probleme tatsächlich relevant sind, ist allerdings abhängig von der jeweils spezifischen IM-Maßnahme. Eine adäquate ethische Bewertung kann daher nur durch die Evaluation jedes einzelnen individualisierten Ansatzes erfolgen. (shrink)

The idea of personalized nutrition is to give tailored dietary advice based on personal health-related data, i.e. phenotoype, genotype, or lifestyle. PN may be seen as part of a general trend towards personalised health care and currently various types of business models are already offering such services in the market. This paper explores ethical issues of PN by examining how PN services within the contextual environment of four future scenarios about health and nutrition in Europe might affect aspects of social (...) justice according to Martha Nussbaum’s capability approach. The scenarios have been created by a mixed group of stakeholders and experts in three consecutive workshops. This resulted in the definition of four future scenarios within a scenario space consisting of two variables: the ‘logic of health care systems’ and ‘conception of health’. Within each scenario, PN is likely to play a more or less important role in improving health by influencing food consumption patterns in society. Nussbaum’s capability approach implies a concept of social justice as a function of a minimum standard of human dignity. This denotes an account for equality in terms of a minimum of entitlements. However, also the ability of achieving individual objectives is essential for social justice. Personalisation advice in health and food consumption patterns, as aimed for by PN, is therefore acceptable provided a minimum of entitlements is guaranteed to all members of a society, and at the same time freedom concerning personal preferences is respected. Potential variation of how different people might benefit from PN should therefore be consistent with the minimum required as defined by the list of capabilities. (shrink)

In light of the successful occupation of the term ‘person’ for Personalised Medicine, it is necessary to ask what different notions of personhood practically imply. This article examines two. The first is the reductionist molecular individual, embraced by PM enthusiasts. Here the person is a contradictory dividuum, oscillating between increased autonomy and a new, infantilising tech-paternalism. The second relies on a Christ-analogical distinction of two modes. The dramatic amplitude of personal absence-presence then unfolds throughout time. This provides the logic or (...) spirit of the medical act. Drawing on the ethics of war, it will be recast as an arduous task of mending. (shrink)