Probleme und Methoden der Gesundheitsökonomie: Personalisierte Medizin als Sonderfall?

Objective For the economic evaluation of medical services, a well-established range of methods is available. The aim of this paper is to determine how and to what extent these methods are applicable to the much-discussed area of personalized medicine and which features may be encountered and how they can be addressed. Methods For this study, an exploratory literature search was conducted. Results In contrast to conventional medicine, personalized medicine might be considered either in terms of physiological differences or in terms of individual preferences of the participants. Depending on the approach, there are different implications for the methodological challenges in health economic evaluations. Improving health care provision regarding physiological differences brings up the problem of parameterization, since evidence is often very weak due to small sample sizes. Value of information analysis can reveal details about the potential benefits of further research. The concept of “expected value of individualized care” provides a very similar approach to the value of information analysis to quantify the potential value of including individual preferences in the health care provision. Welfarism and Extra Welfarism offer different solutions, such as how benefits of biomarker-based information in the sense of “empowerment” can be included in evaluations. Conclusion In general, the methods of economic evaluation are applicable to the field of personalized medicine. However, a number of specific challenges exist. Further research is necessary to solve these problems.     

„Die kommen alle her und gaffen.“ Hohes Körpergewicht als medizinische,ethische und gesellschaftliche Herausforderung

Ethik in der Medizin -     

Personalisierte Medizin und Informed Consent: Klinische und ethische Erwägungen im Rahmen der Entwicklung einer Best Practice Leitlinie für die biobankbasierte Ganzgenomforschung in der Onkologie

Definition of the problem Breakthrough discoveries in genomics allow the sequencing of the human genome within a couple of days at a reasonable price. In cancer research, whole genome sequencing helps to identify the molecular lesions that drive tumour growth and thereby provide the basis for the development of targeted therapies. However, genomic research also raises new ethical questions. The interdisciplinary EURAT project in Heidelberg (Germany) addresses these normative questions. It aims at developing an ethically and legally informed practice for biobank-based genomic research in Heidelberg. Arguments This paper gives an overview of the relevant ethical and clinical questions of biobank-based genomic sequencing with regard to the informed consent process. It also presents a code of conduct as an institutional ethics response to the following question: how research institutions can foster the responsible handling of genetic information in biobank-based research throughout the institution. Conclusion A thorough informed consent process and the code of conduct are elements of a best-practice guideline and should be a guide for responsible conduct of all employees who handle sensitive genetic data.     

Kommentar I zum Fall: „‚Die kommen alle her und gaffen.‘ Hohes Körpergewicht als medizinische,ethische und gesellschaftliche Herausforderung“

Ethik in der Medizin -     

Kommentar II zum Fall: „‚Die kommen alle her und gaffen.‘ Hohes Körpergewicht als medizinische,ethische und gesellschaftliche Herausforderung“

Ethik in der Medizin -     

Zwischen Todesverdrängung und -integration. Ambivalenzen moderner Medizin

Definition of the problem It is a very common conviction that modern societies are suppressing death. But this belief is hard to verify sociologically, and it also seems to be impossible to disprove it. (A) Modernity is certainly aware of death. Because of its functional differentiation, it works with various images of death. Its high standard of individualization, on the other hand, gives death a new meaning: death is looked upon as the irreversible loss of a unique person worth in his own right. (B) Because many of modernity’s images of death ignore individual death, it is also seen as suppressing death. Arguments A closer look at modern medicine helps to make sense of these ambiguities: (A) Because medicine addresses death primarily in an empirical way, it excludes the unique person and his own death. This is also true for pain, which is the reason why modern medicine tends to ignore both death and pain. (B) At the same time, modern medicine is more than just science since it is, of course, also interested in understanding the individual patient’s case. Conclusions These two tendencies can contradict, but they can also complement each other. Whereas the exclusive focus on natural sciences does not do justice to either the individual death or to pain, the focus on the individual case sheds light on the complexity of this phenomenon. It also allows the respective paradigm of modern medicine to be criticized. Especially palliative medicine tries to find a new balance between these two logics of medical action. It remains to be seen whether it will succeed.     

Medizin als gesellschaftliche Praxis, sozialwissenschaftliche Empirie und ethische Reflexion: ein Vorschlag für eine soziologisch aufgeklärte Medizinethik

Definition of the problem The central focus of Empirical Ethics is the study of the social and cultural aspects inherent in medical practice. Arguments This approach distinguishes between the scientific-cognitive aspects and the cultural-normative aspects of medicine, which would conventionally be investigated separately by the social sciences. When however medicine is conceived of as social practice, the sharp distinction between scientific medicine, culturally normative aspects and ethical reflection becomes less distinct. Conclusion We suggest combining ethical reflection and empirical research in multiple stages. In this case, social scientific analyses would provide an initial framework for understanding medical practices and a foundation for further ethical investigations, which would then allow for a sociological critique.     

Ethische und rechtliche Aspekte im Umgang mit genetischen Zufallsbefunden – Herausforderungen und Lösungsansätze

Definition of the problem With an increasing number of genetic results obtained in whole genome analyses, the problem of incidental findings arises, i.e., findings that are discovered beyond the aims of the original investigation but have potential health or reproductive importance for patients or research participants. Since national or international guidelines have not been established, the authors discuss for Germany the current opinions about the management of incidental findings in clinical care and research. Arguments Following the German genetic diagnosis act (?Gendiagnostikgesetz“, GenDG), it is mandatory to inform about the possibility of incidental findings. It is part of the informed consent which findings are communicated to the patient, taking the right not to know and the protection of minors into account. In the research context, the GenDG is not valid; however, the disclosure of possible incidental findings should be also included in the consent documents. There is agreement that results of high clinical utility should be returned to participants, even if there is no obligation to do so. The following aspects have to be considered when dealing with incidental findings: (1) information given in the consent documents, (2) interpretation of genetic results according to high, moderate, possible, questionable or unknown clinical meaning, (3) processing of returning results at the present and in the future, and (4) decision about resources to evaluate the clinical utility, to communicate results and to transfer them into clinical practice. Conclusion There is urgent need for empirical research and policy development in the context of incidental genetic results. In addition, it is important to study how patients and participants understand and utilize incidental findings and to develop educative and communicative strategies.     

Medizinische Prädiktion, Prävention und Gerechtigkeit: Anmerkungen zu ethischen Dimensionen eines biomedizinischen Ideals

Definition of the problem The ideal of a truly predictive medicine vested with effective causal strategies of prevention down to the molecular level is far from being reality. However, we have to appreciate the fact that the concepts of health negotiated at the intersection of medicine and society are becoming increasingly directed towards a prediction of future health and the notion of prevention. This paper investigates whether novel concepts of a predictive–preventive medicine—especially public health genetics or public health genomics—are likely to promote the social achievability of health. Arguments The analysis presented is based on an assessment of the role of fundamental social values for the function of medicine in society, on the one hand, and on the role of the key concepts of medicine—health and disease—at the interface of medicine and society, on the other. Conclusion We observe a transition of medicine toward increasingly more predictive concepts of disease. With this shift, the normative characteristics of the key concepts of health and disease shared between medicine, individuals, and society are also subject to profound changes. This is a challenge to social values in their function as pillars of health care systems, particularly the social value of justice and its societal perceptions in the realm of health.     

?konomisierung von Krankenhaust?tigkeit �C Chancen, Grenzen und Risiken einer marktorientierten Medizin

Definition of the problem In the discussion of economizing health care, a crucial distinction of terms is often neglected. Arguments To determine where it is appropriate to refer to economization or economism in the negative sense, one has to distinguish between economy as a social sector and the econonomic dimension within all social sectors such as health care. It has to be clarified in which case economic goals should be pursued and in which case other objectives are to be pursued with the aid of economic means. Concerning the question regarding a market supervision of health care, one has to distinguish between the commodity health and health commodities as well as between public, private, and merit goods. In addition, the question regarding a market supervision of health care has to be distinguished from the question regarding the adoption of free-market instruments to enable the regulation of the handling of certain health commodities by the government. Conclusion These distinctions enable an appropriate evaluation of the complex business of ethical questions beyond anti-business or economistic, anti-market or radically free-market ideologies.