Canadian Regulatory Evaluation of “Alternative” Medicines

A review of An Empirical Study of Scientists’ Reasoning in the Canadian Regulatory Evaluation of Traditional, Homeopathic, Herbal, and other “Natural” Medicines by Jennifer Cuffe.

Jennifer Cuffe’s dissertation is a rich description and analysis of how scientists reasoned in a Canadian government Directorate mandated to assess the safety and efficacy of natural health products (NHPs) and/or medicines. This dissertation emerges in an important time when healthcare systems are changing globally to engage with and at times integrate multiple aspects of non-biomedical healing practices and systems, forming variations of what has been termed “integrative” medicine (IM) or healthcare (IHC). The dissertation will be relevant to a wide array of health scholars, health policymakers and practitioners who are working with and/or examining how traditional, complementary and alternative medicine (TCAM) are engaging with IM and health systems around the world. Based on 13 months of extensive anthropological fieldwork among 100 scientists within Canada’s Natural Health Products Directorate (NHPD), the main “puzzle” of the dissertation is how scientists come to reason in a uniform manner while respecting the philosophical and cultural diversity of the medicines or health practices of which they were evaluating, or in Cuffe’s words:  “The dissertation’s central puzzle is how 100 very different scientists reasoned in a relatively uniform manner during their work in public health protection” (pp. xv-xvi). Cuffe is clearly influenced and inspired by the seminal work by Ludwik Fleck, Genesis and Development of a Scientific Fact (1979), which argues that “the development of a scientific fact is inseparable from the ideas circulating in scientists’ historical context, and from the inherent sociological dynamics of collective activity” (p. 19).

In order to explore the primary research “puzzle,” the dissertation draws on a variety of qualitative anthropological ethnographic research methods, including: participant-observation within the Directorate, formal interviews, strict observation, analysis of internal documents, archival and historical research, informal interviews with other key experts and a small quantitative survey of the institutions’ assessment officers (see pp. 27-29). Within the history of anthropological studies, it is fair to say that this ethnography is unique in that the anthropologist accepted overt employment within the institution under study with the awareness among informants that overt employment was facilitating anthropological fieldwork. Although Cuffe states she was “… both an employee of the Directorate and … an autonomous researcher” (p. 28) and was therefore known to the subjects under study, the so-called dual position of the researcher within the institution provided what could be viewed as a further reflective opportunity to experience the actual social processes or aspects of socialization that led to scientists’ reasoning. As Cuffe notes, the fieldwork was guided by the following central research question:  “How are medicines, used in various traditions, made commensurable by a scientific regulatory body that values cultural diversity?” (p. 29). In refreshing anthropological style, the dissertation presents detailed summaries and analyses of multiple interrelated topics and inquiries in response to the main research question. The focus of the research study is creatively interspersed with the “author’s voice,” which documents her personal understanding of the research and her movement or growth as she travels through an extremely complex and shifting research landscape.

The dissertation is divided into six main parts. In Part I, “Introduction and Thesis” (pp. 3-78), Cuffe describes: the institutional context under study and within comparable international jurisdictions, situates the study within the literature and also outlines the theoretical framework from which the dissertation draws, particularly inspired from Ludwik Fleck’s premise that scientists’ participation in what he called “thought collectives,” including group activities, “… shaped scientists’ disposition, directed the scientists’ attention to certain features, [and] interpellated the scientists into a certain style of reasoning” (p. 25), in addition to discussing the various research methods for the study (noted above). Also contained within the first part of the dissertation is a thesis and chapter overview/summary of the salient research findings related to how scientists reason in a Canadian government Directorate. As Cuffe states, “The dissertation is an empirical study of scientists’ reasoning and judgment in public health protection. It is empirical because it addresses scientists’ observable actions, statements, and emotional expressions. It is a study of reasoning because it examines the processes by which scientists came to a decision (judgment). It is a study of public health protection because the decisions made by the scientists included a recommendation regarding whether a particular medicine should be licensed for sale to the general public on the basis of evidence of safety and efficacy” (p. xv). The substantive research findings are summarized and hinted at early on in Part I, where Cuffe argues that the uniformity in scientists’ reasoning cannot be simply explained by common demographic or psychological traits among scientists prior to their work within the Directorate, nor can this uniform style of reasoning be attributed to the existence of official standards and consultations. Rather, Cuffe argues that scientists’ uniform style of reasoning was based upon such socio-cultural and/or contextual aspects of “agnostic perspective towards the validity of various textual standards; repetition of phrases such as ‘we have to be flexible’, especially in moments of uncertainty; acute and explicit sensitivity to fairness and the limits of their own authority; common affective disposition toward certain traits of files such as their easiness or messiness; directed perception of ‘issues’ in files; and explicit consideration given to the licensing backlog” (p. xvi). Cuffe argues that these social features of reasoning were also inseparable from the “tools of managerialism” such as performance standards and tenuous staffing appointments. As Cuffe indicates, “the ethnographer’s task is to articulate the way in which, in this particular institution, these particular features of scientists’ style of reasoning interrelate” (p. xvi). Thus, the majority of the dissertation from this point forward sequentially examines official standards, textual standards, numerical standards and “people standards” in the Directorate. The reader is consistently and gently reminded to “keep in mind” the theoretical premise inspired from Fleck that “humans are social creatures” and as such, “humans are never completely outside society and human reason is therefore never outside society” (p. xvii). As Cuffe discovered, “… while written rules and standards shape practice, written instructions never fully determine practice, whether in law, science, or other fields” (p. 63).

As noted earlier in the author’s words, the central puzzle of the dissertation was to explore “how 100 diverse and very differently-trained public servants came to speak, reason, even notice as one, in their work activities – despite many of them professing to reason in very different ways in their non-work lives” (p. 7). As Cuffe states, the dissertation “…details many of the mundane tools used in the social and technological coordination enabling these many individuals to speak-as-one and come to adopt a relatively uniform style of reasoning” (p. 7). Cuffe is careful to note that the dissertation is an ethnographic account of the mundane workings of scientists in a regulatory organization, rather than a study of policy per se. As such, the primary theoretical or intellectual orientation for the dissertation could be viewed as an extension of the anthropology and/or sociology of scientific reasoning, drawing from Ludwik Fleck, to create a present-day ethnography of science. As Cuffe points out, the dissertation draws from sociology as well as scholarship in the social studies of science by examining the order observed in science, through an explanation for the uniformity of scientists’ reasoning in a particular government Directorate. Additionally, Cuffe notes that the dissertation draws from early anthropological ethnographies of science by documenting scientists’ particular evaluation activities and work relationships. Thus, while the dissertation is studying scientists, Cuffe is careful to note that she is not studying “scientists-in-action in laboratories” or multi-site fieldwork (p. 15).

Beginning with Fleck, the dissertation addresses scientists’ reasoning rather than scientific reasoning, also drawing on the collective works of such additional scholars such as Ian Hacking, Lorraine Daston and Allan Young, who have located “scientific” reasoning as a collective endeavor. In other words, the primary theoretical orientation of the dissertation is oriented from the perspective that scientists’ reasoning is not individual or cognitive but rather, draws from the narrative techniques and social dynamics often contained within institutions that are in turn involved with the social production of facts. Cuffe further notes that the above theoretical approach is consistent with work in social anthropology on reasoning more broadly (such as from Mary Douglas). The varied work of each of the above authors is viewed as an extension from Ludwik Fleck’s earlier work in Genesis and Development of a Scientific Fact. As Cuffe describes in detail, Fleck’s theoretical premise is that scientific reasoning occurs through “thought collectives” whereby a group of individuals exchanges ideas and where the more deeply one enters into a scientific community, the stronger one’s reasoning becomes bound to a particular collective’s “thought style” (p. 21). Drawing on the above theoretical orientation or intellectual genealogy, the dissertation investigates “… how scientists’ participation in the thought collective, including the structuring of the social group and the structuring of the group’s activities, shaped scientists’ disposition, directed the scientists’ attention to certain features, [and] interpellated the scientists into a certain style of reasoning” and further investigates “… how the individual’s inclusion in thought collectives, including the material-embedded activities and habits of those thought collectives, shapes reasoning” (pp. 25-26).

Part II of the dissertation (pp. 79-164) examines official standards such as regulations, definitions and processes related to natural health products in Canada. The socio-contextual history of the Natural Health Products Directorate is traced from its early years evaluating and regulating prepackaged traditional and ethnic herbal medicines to the establishment of a much wider scope, including such natural health products as “vitamins, deodorants, homeopathic medicines, synthetic duplicates of naturally-occurring compounds, probiotics, conventional toothpastes, smoking-cessation products, and more” (p. xvii). As Cuffe describes, natural health products then became regulated as categories of commodified medicines, viewed as inherently “risky.” This second section also provides a detailed and extensive overview of the various scientists involved with the regulatory process at the NHPD, in addition to describing important regulatory and procedural textual standards which, in effect, sets the stage for the analysis that follows.

Part III of the dissertation (pp. 165-380) comprises five detailed anthropological descriptions and analyses of what Cuffe refers to as “textual standards in practice” (p. 165) and provides leading examples of what anthropologists are best known for – the “thick” description and “unpacking” of seemingly obvious social phenomena and/or facts. Among these thick descriptions are: “… two worms’-eye descriptions of cubicle-bound scientists” (p. xix) entailing a description and analysis of scientists’ reasoning through taxonomy and comparison where scientists developed particular sensibilities, affects and dispositions, which, in turn, then became socialized norms used by scientists; a detailed summary and analysis of the author’s own evaluation of a natural health product as an employee of the Directorate and the related tensions and issues that accompanied Cuffe as a part of this process; a description and analysis of the evaluation of “traditional medicines” within the Directorate, describing scientists’ “everyday” activities in the assessment of traditional medicines and the various challenges perceived by the traditional medicine’s unit as a part of this process; and finally, a unique analysis of how scientists inside and outside the homeopathic medicine’s unit engaged with the evaluation of homeopathic medicines for quality, safety and efficacy. It is clear in this section that the talent of the anthropologist – researcher comes to the fore in this part of the dissertation with the detailed observation and analysis of stereotypically-viewed “boring” cubicle “life” and/or work activities (that proved to be essential to the overall analysis); the author’s account of her own examination of a natural health product both as an anthropologist and as an employee of the Directorate and two valuable “insider’s” look at the evaluation of two popular TCAM systems, that of traditional Chinese medicine (TCM) and homeopathy.

Part IV of the dissertation (pp. 381-480) continues on with a description and analysis of the Directorate’s particular mandate and its respective scientists’ reasoning. This fourth section provides another revealing glimpse for the reader in terms of how NHPD scientists either incorporated or did not incorporate various values central to the mandate of the institution, such as respecting cultural and philosophical diversity and the logical extension of multiculturalism. This section also provides a snapshot into how scientists “reason” in the evaluation of natural health products, again drawing on “social constructs” alongside more formal evidence.

In Part V (pp. 457-582), Cuffe presents four significant chapters summarizing and discussing how “numbers of science,” “numbers of management,” the “backlog” of applications and “science culture” versus “MBA culture” significantly influenced the regulatory and evaluatory process for natural health products. For instance, Cuffe documents how, similar to other ethnographic studies of science, the overt use of numbers by science in effect “disappeared,” where statistical analysis and reasoning became inseparable from other sociological attributes. In this case, “numbers of management” such as productivity quota on the number of natural health product assessment reports that were required weekly for each NHPD officer had a significant impact on assessment officers’ everyday work, such as threatening the job security of many temporary staff and privileging application files that could be completed quickly, while potentially “glossing over” safety concerns. Cuffe also discusses the paradoxical occurrence of a backlog in completed product license applications within a government institution and further, the various tensions between managerialism (“MBA culture”) and the scientific evaluation of natural health products where the “MBA culture” ultimately determined the conditions within which regulatory scientists’ activities occurred. The final Part VI (pp. 583-678) closes the analysis by discussing and analyzing what are called “people standards,” whereby the effect of quotas on Directorate staff were also complicated by the extent of precarious or tenuous employment contracts for regulatory scientists and the occurrence of so-called Canadian values of “fairness” in staff and evaluating, all of which had a significant impact on the evaluation of natural health products.

As with any scholarly review, dissertation or otherwise, there is potential for particular areas to be commented upon or summarized in less detail than others, or interpretations of the material that the original author may disagree with either partially or wholly. It is also the inevitable case that despite many reviewers’ intent to review material in entirety, the reviewer ultimately summarizes, comments upon or “takes away” what is meaningful to the reviewer as an extension of his or her own socio-contextual and/or cultural background from which he/she draws. Drawing from this reviewer’s particular “thought collective” (to use a theoretical term inspired from this dissertation), this reviewer suggests that drawing from the anthropological stance of the dissertation, each respective reader will come away with something, or many things, meaningful to that reader. Rather than viewed as an inherent drawback of the review noted here or the nature of the dissertation, both can be viewed as a strength in that this particular dissertation has encouraged this reviewer to become reflective of his own socio-cultural background and thought collective, and further, the dissertation is rich and detailed enough to offer valuable insights to even those readers who may only have a passing interest in TCAM.

In the spirit of a “reflexive review,” I offer the following: as a scholar actively engaged with the field of TCAM and IM for the past 15 years (drawing from the fields of medical anthropology, medical sociology and critical social health theory), I found this dissertation both intriguing and compelling on many fronts, most notably because there were significant detailed examples documenting and analyzing how regulatory scientists are significantly impacted by social constructs. Drawing on my earlier background in medical anthropology and clinical and research experience with traditional systems of medicine such as traditional Chinese medicine (TCM), I was particularly fascinated by chapters eight in part three of the dissertation. I learned here that, not only did NHPD regulatory styles severely restrict the number of traditional medicines that could be deemed fit for evaluation and potential regulation to a minimum of three (TCM, Western herbalism and Ayurvedic medicine) but that adherence by the NHPD to the traditional nomenclature and theory of even these few traditional medical systems was done so with such religious conviction that did not allow for flexibility or change that the actual system of medicine under scrutiny was currently in the process of undertaking. Although I was pleased to learn that, at the NHPD, deference to Western notions of science and evaluation did not “trump traditional knowledge” (p. 280) in that traditional medicines were viewed as “self-contained and internally, logically consistent paradigms” (p. 283), I was disappointed to learn that, as Cuffe pointed out, there was not a global awareness (as noted by historians of Chinese medicine) that the TCM that we know in the West is in fact “science-based Chinese medicine” (p. 316), a historical product of Chinese leader Mao Zedong that is only 50 years old. Thus, the brilliance of the author’s analysis in this part of the dissertation is clearly evident when she concludes that, after much further analysis, “NHPD scientists evaluate traditional Chinese medicines on the basis of it being a ‘traditional paradigm’; but traditional Chinese medicine, as included in the pharmacopeia of the People’s Republic of China, is already part of a state project to use science as the primary, and originally only, valid basis of knowledge” (p. 328). As a result of this dissertation’s analysis, a reader familiar with the way traditional medicine operates globally comes to the realization that, Canada’s evaluation and potential regulation of traditional medicines, is clearly not at a level that is equitable to the use and practice of traditional medicine, a finding that has been noted as being consistent with the general approach of Western biomedicine and Western-based healthcare systems toward the incorporation or inclusion of traditional healing practices (see Daniel Hollenberg and Linda Muzzin, “Epistemological Challenges to Integrative Medicine: An Anticolonial Perspective on the Combination of Complementary/Alternative Medicine with Biomedicine.” Health Sociology Review 19 (2010), pp. 34-56; Daniel Hollenberg, David Zakus, Tim Cook, Xu Wei Xu, “Re-positioning the Role of Traditional, Complementary and Alternative Medicine as Essential Health Knowledge in Global Health: Do They Still Have a Role to Play?” World Health and Population 10 (2008/2009), pp. 62-75).

There were many additional aspects of the dissertation that I found refreshing, both from a personal and professional standpoint. The author’s particular style of personal and first-person narrative, while a common aspect of reflexive dissertations (anthropological or otherwise), was very poignant at times and gave the reader a real sense of both the author’s personality and her theoretical journey through her research and analysis — a journey that invariably changes from beginning to end of a dissertation. I also particularly enjoyed the anthropological “thick” description of various informants as they performed their seemingly menial job tasks and duties, of which Cuffe describes and annotates with such keen attention to detail that the reader is impressed, not only with the author’s anthropological skills of observation and analysis but additionally, I felt as if I were “really there” standing at the edge of a cubicle. In conclusion, I would highly recommend this dissertation to any TCAM or non-TCAM expert or interested party, and to engage with their own thought collective as they explore with the above-noted and additional tributaries of the dissertation not fully captured here.

Daniel Hollenberg PhD
Research Associate
Office of Health Policy
Royal College of Physicians & Surgeons of Canada
dhollenberg@royalcollege.ca

Primary Sources

This dissertation involves an ethnographic account that pays particular attention to how scientists used standards in their evaluations of safety and efficacy and to manifestations of multiculturalism and managerialism in the federal public service — specifically 13 months of fieldwork among the hundred-or-so scientific staff at the Natural Health Products Directorate (NHPD), Health Canada, Ottawa (p. 26). Methods used included: participant-observation as a scientific regulator, formal interviews with staff members, periods of strict observation, a survey of the Directorate’s assessment officers, and the analysis of informal documents (pp. 26-27).
Archival research at Library and Archives Canada, Ottawa, and Archives of Ontario, Toronto
Attendance of conferences and other events in Canada on the science-based evaluation of herbal and traditional medicine
Interviews with participants in the Canadian natural health product research communities

Dissertation Information

McGill University. 2010. 753 pp. Primary Advisor: Allan Young.

 

(c) Image: Catherine Bodmer, de la série Paysage approximatif, 2008. Used with permission.
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