Creating an (ethical) epistemic space for the normalization of clinical and “real food” oral immunotherapy for food allergy

Abstract

Researchers and sociologists have argued the consequences of standardization vis-à-vis clinical practice guidelines are diverse and argue they should be explored empirically. Sociologists have also argued that “best evidence” for the development of clinical practice guidelines is not restricted to randomized controlled trials and that other forms of knowledge should be embedded in and inform CPGs. There is little research concerning how other types of knowledge are mobilized and taken up in CPGs. This article presents the results of an ethnographic investigation in Canada between 2015 and 2020 of the development of a clinical practice guideline for immunotherapy for food allergy. My research shows that immunotherapy has become the source of controversy regarding whether immunotherapy should be offered in the clinic or remain experimental and whether it should be offered using food or commercial products. I argue that the clinical practice guideline for oral immunotherapy reaffirms what has been previously noted by sociologists; guidelines can serve normative purposes and are not merely technical documents. This case study is unique as it demonstrates how guidelines can serve as “community-making devices” to consolidate “epistemic communities” through the explicit and formal mobilization of ethical principles alongside other forms of “traditional” evidence. The mobilization of a multi-criteria approach that included ethical principles was mobilized in part to counter the de-legitimization and peripheralization of clinical and real food oral immunotherapy.

Historical and social science perspectives on food allergy

“…Immunotherapy for food allergy can be traced to 1908, just 2 years after von Pirquet coined the term allergy, but due to the risks involved it fell out of favour 65 . In recent decades, however, it has been hailed as a ‘paradigm shift’ in allergy treatment 63‐65 . As Nairn has shown, however, variations in immunotherapy products and practices, and differing claims about what constitutes the ‘best’ ways to do immunotherapy—‘standardised’ FDA regulatory approved or in a ‘real food’ format—mean that allergic patients still have to contend with scientific and medical uncertainties 63,66 .…”

“…23,60 The ambiguities and uncertainties that Nairn has identified with immunotherapy for life-threatening food allergies also show how the perception of risk is contingent on numerous factors. 63,64 Immunotherapy for food allergy can be traced to 1908, just 2 years after von Pirquet coined the term allergy, but due to the risks involved it fell out of favour. 65 In recent decades, however, it has been hailed as a 'paradigm shift' in allergy treatment.…”

“…65 In recent decades, however, it has been hailed as a 'paradigm shift' in allergy treatment. [63][64][65] 'real food' format-mean that allergic patients still have to contend with scientific and medical uncertainties. 63,66 This is not the least because external factors, such as stress, have historically been thought…”

Anthropological and sociological perspectives on food allergy

“…A small body of work has explored the ethics of different treatments ranging from epinephrine 64 to OIT and the development of clinical guidelines. 79,80 Glabau, for example, has focused on the 'ordinary ethics' and 'moral significance' of epinephrine within the broader context of U.S. health care economics. 64,65 Drawing on prior sociological work, 123 she argues that contemporary biomedicine is not morally neutral' (p5).…”

“…Nairn has analysed how the first clinical practice guidelines for OIT in Canada were produced in 2019. 80,124 Previous studies have argued that the evidence used for clinical practice guidelines should not be limited to randomised controlled trials but should incorporate alternative types of knowledge and evidence. 125,126 Nairn explores how different stakeholders engaged with diverse types of evidence to create the guidelines.…”