The critique of evidence-based medicine and the diversification of medical evidence practices

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In the first phase of the research project, we examined how growing patient participation through digital technologies in the context of personalized medicine influences the production of medical evidence. In this second phase, we intend to investigate the criticisms that have arisen against evidence-based medicine (EBM). After its inception in 1992, EBM has become the dominant paradigm for both clinical research and decision making in clinical practice, thereby forming an evidence regime. However, destabilizing criticisms of EBM have emerged in different contexts over the last three decades and have reached a new high point in the latest years, precipitating the so-called crisis of EBM. Personalized medicine has played an important role in the formation of these criticisms. This project intends to historically reconstruct these phenomena in both the English- and the German-speaking worlds and to analyze their implications for medical ethics and the philosophy of medicine. Satisfying the standards of EBM in research and clinical practice through the adherence to EBM-based guidelines has become a hallmark of quality on which professional success and publication on peer-reviewed scientific journals depend. As a result, EBM has assumed a strong normative dimension. At the same time, evidence is increasingly experienced as a problem in medical specialties in which it is only partially possible to satisfy the EBM requirements. The project aims to examine how this issue has been discussed so far in both the medical and the medical humanities literature and to investigate the evidence practices of specialties in which the traditional evidence hierarchy is not applicable. For instance, how can patients make evidence-based decisions if the relevant evidence is poor and it is not easy to acquire better evidence, as in the case of carriers of mutations to the BRCA1/2 genes? How do surgeons manage to assert the epistemic value of their studies, which are often not randomized? In some domains, like rare diseases, the patients themselves initiate alternative modalities of evidence generation whose product is the so-called “real-world evidence”. However, these complementary forms of evidence are not widely accepted in institutionalized medicine, and look destabilizing to many practitioners. But could real-world evidence contribute to the re-stabilization of EBM? Our research hypothesis is that, with a gradual and specialty-specific modulation of evidence standards, EBM could be bolstered and counter at least some criticisms. The project will involve the context-sensitive analysis of the dynamics of destabilization and potential re-stabilization of medical evidence. This would greatly contribute to an ethical and epistemic examination of alternative evidence production modalities and satisfy an urgent research need.