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- McKelvey, Maureen, 1965, et al.
(författare)
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Governance of medical research and innovation - Lessons from a recent crisis in regenerative medicine
- 2017
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Ingår i: Third Nordic STS (Science, Technology, Society) Conference, Gothenburg, Sweden, 31 May - 2 June 2017.
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Within the field of regenerative medicine radical steps are taken, by combining knowledge advances in engineering and medicine, in an attempt to relieve human suffering and save lives. However, such an approach is not without risks and crisis that lead to questions about its legitimacy are common, especially in prestigious and fast-moving fields (The Lancet 2014, van Hoorden 2011). A recent Swedish television documentary tells the story of the thorax surgeon Paolo Macchiarini at the Karolinska Institute and his attempts to develop a new procedure for replacing parts of the trachea by growing stem cells on both biological and synthetic scaffolds. Originally presented as a groundbreaking achievement documented in prestigious medical journals and hailed by the press, it is now seen by many as a reckless and unethical experimentation supported by research fraud. Four members of the Nobel Prize committee in Physiology or Medicine have resigned. The Vice-Chancellor of the Karolinska Institute has resigned. Police investigation is in process A former minister and head of Swedish police is investigating whether unethical research practice can be verified. At the same time The Lancet (Horton 2016) has published a comment on why they have not retracted his article. While the Maccchiarini crisis is not unique it raises many interesting questions about the governance of medical research and innovation in general, and regenerative medicine in particular. The purpose of this paper is to identify and conceptualize the governance challenges related to major advances in medical research and innovation. Based on a previous conceptual model to explain technological collaboration (McKelvey et al 2015), this paper uses the case of regenerative medicine and of the crisis surrounding Macchiarini and the Karolinska Institute to identify three challenges facing policy makers and researchers. This paper is framed through theories of the specific site of medicine as an area for innovation. Recent research on medical innovation has focused on explaining how and why medical innovation emerges through heterogeneous and dispersed actors, such as hospitals, firms and universities, interacting through sequences of problem-finding, and problem-solving, processes (Metcalfe et al 2005). In this research special attention has been given to the role of clinical practice and its mutual interaction with biomedical science, but at the same time noting the role of the physician in mobilizing and guiding industrial innovation (Blume 1992, Hopkins 2006). In this particular setting, we then apply and develop theories of governance and co-evolution of knowledge in medicine to describe the system challenges (McKelvey et al 2015). Our conceptual model of the governance of technological collaboration recognizes that different types of organizations are involved in the production and use of knowledge, where each has a different set of incentives and networks. However, the governance requires the development of common norms and institutions for the collective action. In other words, the collective action is mediated by interacting, where common norms and institutions are developed that regulate behavior and help create a common good. The challenges that we identify and will describe in this case are: Firstly, role of research funding, especially the concentration of funding into strategic areas. The hiring of an internationally acclaimed researcher, Macchiarini, coincides with a strategic investment in regenerative medicine by the Karolinska Institute supported by large government grants for research excellence in selected fields. High concentration of research funds, strong pressures for success, and global competition for talent put strains on existing systems of governance of research and innovation for which it was not designed. Secondly, the specific nature of interface between medical research and practice. The close connection between research and practice is commonly believed to be one of the strength of medical innovation. In many cases university departments and university hospitals employ the same people, which means they are involved both in research and practice. However, there are different rules within medical research and clinical practice in terms of experimentation. How should procedures, and knowledge, by transferred from research to practice and how should the results transferred back to research? Furthermore, these issues play out in a larger context, which involves development of stem cell technology and intellectual property rights to commercialize the technology. Thirdly, the emergence of medical innovations also leads to systemic problems due to the rapid development of knowledge. Due to their evolutionary nature medical knowledge and innovations may give rise to irreducible systems based on how bottlenecks direct the focus of attention in order to solve critical problems. Furthermore, as the search for new medical knowledge has a strong ethical dimension, is sought for the common good, and to a large degree funded by public funds, oversight is required for what bottlenecks should be attended to and how. This oversight is proved by a governance regime, which includes both formal and informal elements. Given the nature of the current discussion about the Macchiarini crisis the most likely response is to strengthen the oversight and regulation, including monitoring, related to the interface between medical research and practice. The focus will be on universities and hospitals without consideration of other actors involved in the production and use of medical knowledge. We argue, based on our conceptual model, that this may have the adverse effects of introducing bottlenecks in the system. The main challenge for policy makers and researchers is to understand what actors are involved in the system, at regional, national and international levels, and how best to interact in order to create mechanisms of self-regulation that benefit each type of actor and the system as a whole.
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