This month, Uppsala Monitoring Centre initiated a research collaboration with the Centre for Applied Philosophy of Science at the Norwegian University of Life Sciences (NMBU CAPS). The project, called CauseHealth Pharmacovigilance, will investigate causation, evidence and complexity in medicines safety. It will be funded by UMC and hosted by NMBU in Norway.
CAPS researchers Rani Lill Anjum and Elena Rocca, who work at the interface between philosophical theories of causation and scientific methodology in medicine, will lead the project. Together with UMC’s director Marie Lindquist, former director Ralph Edwards and other UMC researchers, they will develop a new approach to patient safety based on dispositionalism, a novel philosophical theory of causation.
Unlike the classic reductionist approach to science, which tends to classify observations into pre-defined categories, dispositionalism takes into account the complex and dynamic relationships which make up the world.
As philosopher Chris Lucas wrote in ‘The Philosophy of Complexity’, it is about “studying the dynamics of interactions rather than the static makeup of parts”. When applied to causation in pharmacovigilance, this means taking the innate characteristics – or dispositions – of both the medicine and the patient into consideration.
“Each of us has a unique set of dispositions, which affect the way we react to medicines.
“Each of us has a unique set of dispositions, which affect the way we react to medicines. The challenge is not only to look at what happens at the population level, but to identify the critical factors that determine when and how a medicine can be used safely by a particular individual,” said Dr Lindquist.
Dispositionalist thinking allows a more nuanced analysis of how medicines affect individuals. In it, marginal and outlier cases are not an exception to dismiss, but exemplary starting points for causal investigation, where a rare combination of properties interact in unexpected ways.
This framework has already been applied to the clinical setting in the original CauseHealth project. The aim there was to promote person-centred treatment of medically unexplained syndromes, such as chronic pain and fatigue. In CauseHealth Pharmacovigilance, dispositionalism will work as a solid conceptual foundation to ground systematic improvements in drug safety assessment.
“Pharmacovigilance is a perfect case of causal evidencing when statistical knowledge is limited.
“Pharmacovigilance is a perfect case of causal evidencing when statistical knowledge is limited. This makes it an interesting starting point for looking into how individual dispositions contribute to tease out previously hidden dispositions of the drug,” said Dr Anjum.
The project aims to:
- develop a person-centred adverse drug effect report;
- improve qualitative analysis of case reports;
- communicate uncertainty in relation to the individual and their dispositions, rather than statistical frequencies;
- promote a transdisciplinary approach, in which pharmacovigilance represents a crucial source of evidence for all medical disciplines, including basic research;
- shift the evidence-based paradigm away from relying on population trials as the best source of evidence for clinical decision making;
- analyse expert disagreement over weighing of evidence and the philosophical biases underlying these.
Joint teaching activities and networking events will be part of the project.