Main description:

In 2009 the University Medicine Greifswald launched the "Greifswald Approach to Individualized Medicine" (GANI_MED) to implement biomarker-based individualized diagnostic and therapeutic strategies in clinical settings. Individualized Medicine (IM) has led not only to controversies about its potentials, but also about its societal, ethical and health economic implications. This anthology focusses on these areas and includes - next to clinical examples illustrating how the integrated analysis of biomarkers leads to significant improvement of therapeutic outcomes for a subgroup of patients - chapters about the definition, history and epistemology of IM. Additionally there is a focus on conceptual philosophical questions as well as challenges for applied research ethics (informed consent process, the IT-based consent management and the handling of incidental findings). Finally it pays attention to health economic aspects. The possibilities of IM to initiate a paradigm shift in the German health care provision are investigated. Furthermore, it is asked whether the G-DRG system is ready for the implementation of such approaches into clinical routine.

Contents:

Preface
1 Introduction
Part I Definition and concept of Individualized Medicine
2 The meaning of "Individualized Medicine" - A terminological adjustment of a perplexing term
3 Individualized Medicine within the GANI_MED project
Part II Perspectives of socio-cultural and historical studies
4 Inventing traditions, raising expectations. Recent debates on "Personalized Medicine"
5 The "Epistemics" of "Personalized Medicine". Rebranding pharmacogenetics
Part III Medical perspectives
6 Use of biomarkers for the prediction of treatment response: Immunoadsorption in dilated cardiomyopathy as a clinical example
7 The role of pharmacogenomics in Individualized Medicine
Part IV Concept-based ethical questions
8 On a philosophy of Individualized Medicine - Conceptual and ethical questions
9 The concept of disease in the era of prediction
Part V Applied research ethics
10 Informed Consent in GANI_MED - A sectional design for clinical epidemiological studies within Individualized Medicine
11 Ethics Meets IT: Aspects and elements of Computer-based informed consent processing 12 Handling incidental findings from imaging within IM related research
Part VI Health economic assessment of Individualized Medicine
13 Individualized Medicine: From potential to macro innovation
14 Assessing Individualized Medicine - the example of immunoadsorption
15 How individualized is medicine today? The case of heart failure in the G-DRG system
16 Conclusions and recommendations
Index