Elena Rocca

Oslo Metropolitan University · Faculty of Health Sciences

Traditionally, understanding biological mechanisms has had a central role in clinical reasoning. With the raise of the evidence-based paradigm, however, such role has been under debate. On the one hand, evidence of pathophysiological mechanisms has been de-emphasised in clinical guidelines. This is often motivated by the unreliability of our unders...

IntroductionThe safety profile of remdesivir, conditionally approved for COVID-19, was limited at its 2020 introduction. Adverse drug reactions (ADRs) for medicines are collected in VigiBase, the WHO Global Database of Individual Case Safety Reports (ICSRs).Objective This study aimed to provide a descriptive analysis of COVID-19 ICSR data focusing...

Safety assessment of technologies and interventions is often underdetermined by evidence. For example, scientists have collected evidence concerning genetically modified plants for decades. This evidence was used to ground opposing safety protocols for “stacked genetically modified” plants, in which two or more genetically modified plants are combi...

In this chapter we discuss the idea of complexity. While this concept is widely used, its meaning and interpretation usually remain implicit. We show that a mereological view, in which complexity is seen as composition of multiple unchanged parts, motivates an investigation that starts from the separation of causal factors, and their investigation...

This book is intended as an intellectual resource for clinicians and healthcare professionals who are interested in digging deeper into the philosophical foundations of their daily practice. It is a tool for understanding some of the philosophical motivations and rationality behind the way medicine and healthcare are studied, evaluated and practice...

From the philosophical perspective presented in the first part of this book, together with the clinical application of this framework in the second part, it follows that we must change the way we approach causal evidence of health and illness conceptually, methodologically and practically. This has some practical consequences for the clinical encou...

This chapter offers a philosophical diagnosis of the challenges that medicine is facing, regarding medically unexplained symptoms and complex illnesses. We propose that a crucial problem comes from applying a Humean regularity theory of causality, in which a cause is understood as something that always provokes the same effect under ideal condition...

This chapter outlines three different interpretations of the concept of probability and explains why CauseHealth supports an understanding of probability as propensities, and how such understanding influences clinical decision making and medical investigations in general. For an illustration of the difference between the three perspectives presente...

This ‘Erice Call for Change’ is a report from a group of experts, patients and patient representatives who met in Erice in September 2019 following previous similar meetings after the original Erice Declaration (1996). The aim of the meeting was to discuss the challenge of causal complexity and individual variation in modern healthcare. The group’s...

Since the introduction of evidence-based medicine, there have been discussions about the epistemic primacy of randomised controlled trials (RCTs) for establishing causality in medicine and public health. A growing movement within philosophy of science calls instead for evidential pluralism: that we need more than one single method to investigate he...

In order to make predictions about potential harms and benefits of treatments for the single patient, pharmacology needs to gain deep causal knowledge. That is, one needs to understand the causal mechanism underlying a certain outcome. Here, we base our argument on a particular philosophical framework, causal dispositionalism, which urges that caus...

This open access book is a unique resource for health professionals who are interested in understanding the philosophical foundations of their daily practice. It provides tools for untangling the motivations and rationality behind the way medicine and healthcare is studied, evaluated and practiced. In particular, it illustrates the impact that thin...

Measurements of environmental toxicity from long-term exposure to oil contamination have delivered inaccurate and contradictory results regarding the potential harms for humans and ecosystems. This has led to a methodological discourse, in which orthodox approaches to risk assessment of oil toxicity are questioned. We argue that methodological stan...

Pharmacovigilance currently faces several unsolved challenges. Of particular importance are issues concerning how to ascertain, collect, confirm, and communicate the best evidence to assist the clinical choice for individual patients. Here, we propose that these practical challenges partially stem from deeper fundamental issues concerning the epist...

Scientists seek to eliminate all forms of bias from their research. However, all scientists also make assumptions of a non-empirical nature about topics such as causality, determinism and reductionism when conducting research. Here, we argue that since these 'philosophical biases' cannot be avoided, they need to be debated critically by scientists...

A question has been raised in recent years as to whether the risk field, including analysis, assessment, and management, ought to be considered a discipline on its own. As suggested by Terje Aven, unification of the risk field would require a common understanding of basic concepts, such as risk and probability; hence, more discussion is needed of w...

In “The evidence that evidence‐based medicine omits”, Brendan Clarke and colleagues argue that when establishing causal facts in medicine, evidence of mechanisms ought to be included alongside evidence of correlations. One of the reasons they provide is that correlations can be spurious and generated by unknown confounding variables. A causal mecha...

Objectives The ‘reproducibility crisis’ revealed the need for a deep reflection on current approaches to evidence evaluation and their reliability (Begley and Ellis,2012; Ioannidis, 2005, Prinz et al(2011). Hidden moderators (Hanin, 2017), publication bias and low power have been identified as possible sources for such results (Etz and Vandekerckho...

Scientific risk evaluations are constructed by specific evidence, value judgements and biological background assumptions. The latter are the framework-setting suppositions we apply in order to understand some new phenomenon. That background assumptions co-determine choice of methodology, data interpretation, and choice of relevant evidence is an un...

The cultural divide between scientists and clinicians has been described as undermining the advance of medical science, by hindering the production of practice-relevant research and of research-informed clinical decisions. Here, I consider the field of post-marketing risk assessment of drugs as an example of strict interdependence between basic bio...

Genetically modified (GM) crops may bring new proteins with immunogenic and allergenic properties into the food and feed chains. The most commonly grown GM maize, MON810, expresses a modified version of the insecticidal Cry1Ab protein originating in the soil bacterium Bacillus thuringiensis (Bt). Immune reactions following inhalation of pollen and...

The olfactory bulb (OB) receives odor information from the olfactory epithelium and relays this to the olfactory cortex. Using a mouse model, we found that development and maturation of OB interneurons depends on the zinc finger homeodomain factor teashirt zinc finger family member 1 (TSHZ1). In mice lacking TSHZ1, neuroblasts exhibited a normal ta...

The genetically modified (GM) maize event MON810 has been inserted with a processed version of the transgene, cry1Ab, derived from the soil bacterium Bacillus thuringiensis (Bt) to express proteins with insecticidal properties. Such proteins may introduce new allergens and also act as adjuvants that promote allergic responses. While focus has been...