Law′s Dilemma: Validating Complementary and Alternative Medicine and the Clash of Evidential Paradigms

Abstract

This paper examines the (in)compatibility between the diagnostic and therapeutic theories of complementary and alternative medicine (CAM) and a science-based regulatory framework. Specifically, the paper investigates the nexus between statutory legitimacy and scientific validation of health systems, with an examination of its impact on the development of complementary and alternative therapies. The paper evaluates competing theories for validating CAM ranging from the RCT methodology to anthropological perspectives and contends that while the RCT method might be beneficial in the regulation of many CAM therapies, yet dogmatic adherence to this paradigm as the exclusive method for legitimizing CAM will be adverse to the independent development of many CAM therapies whose philosophies and mechanisms of action are not scientifically interpretable. Drawing on history and research evidence to support this argument, the paper sues for a regulatory model that is accommodative of different evidential paradigms in support of a pluralistic healthcare system that balances the imperative of quality assurance with the need to ensure access.

Medicina Tradicional Complementar e Integrativa: desafios para construir um modelo de avaliação do cuidado

“…It is built taking into account the technical knowledge, the living experiences, and the understanding from different medical rationalities; c) care has a modus operandi in understanding the process of illness and a unique interaction with the resources of biomedicine, as it seeks to integrate physical symptoms, emotional aspects and the context of life, without necessarily eliminating the biomedicine care strategies. TCIM is a diverse set of modes of care, and its complexity challenges the traditional models of health evaluation [6][7] . Both the process of illness and the care present different subjectivities, emotions, values and sociocultural perspectives between user and professional that interfere in the success of the process 35 .…”

“…The complexity and diversity of what is proposed under the nomenclature of Traditional Complementary and Integrative Medicine (TCIM) in the world, and Integrative and Complementary Practices in Health (ICPH), in the Unified Health System (SUS) constitute a challenge for professionals and decision makers interested in evaluating their effectiveness. The increase in their offer and use has stimulated the debate about the safe and effective use of these practices 1,2 , besides the introduction of new evaluative approaches that contribute with some criteria for its incorporation [3][4][5][6] which are methodologically useful to the practice of managers and health professionals, and that are beyond the scope of normative evaluation.…”

“…Recent studies 1,[3][4][5][6][7] show the need for evaluations which emphasize the complexity of intervention processes and the intersubjective dimensions related to TCIM, because it deals with the uniqueness of symptoms and subjectivities that need to be included in order to understand or to measure their therapeutic success. Therapeutic interaction and the health professional-user dialogue are often carried out from a set of strategies and processes with specific characteristics that influence their outcomes 6,8 ; and would need to be included in the evaluation proposals beyond the traditional models 6,7,9 .…”

Traditional medicines, law and the (dis)ordering of temporalities

“…A few examples can be used here to open up some of those questions: first, the question of training and registration of health professionals; second, the idea that medicine needs to be 'evidence based' and largely dependent on clinical trials as the central way of proving reliability and safety; third, and underlying all this, that medicine should be able to prove its own effects within particular time frames (Barry, 2006;Iyioha, 2010). When those temporal assumptions are applied to other forms of medicine, they almost inevit a b l ye f f a c et h ep a r t i c u l a r i t i e so ft h em e d i c a ls y s t e m st h e yr e g u l a t e ,r e s h a p i n g both medical practices and the nature of what becomes the new 'unregulated' spaces of medicines.…”

The relationship between the advancement of CAM knowledge and the regulation of biomedical research

“…'State law's espousal of science' (Santos 2002, Iyioha 2011) is, to many, critical to the history of exclusion of alternative knowledge systems, whether within or outside the health care domain (Iyioha 2009; see also Polich et al 2010): 'Historically, state law has been known to espouse the dictates of science, and science, bolstered by the force of law, has been deployed as a tool of exclusion of nonwestern medical norms', writes Iyioha (2011: 8; see also Cohen 2004). The emergence and current domination of evidence-based medicine (EBM) further consolidated an epistemological commonality between law and science which goes back as far as the seventeenth century: a 'concern with degrees of certainty or, in more modern terminology, probability' (Shapiro 1983: 168), manifest in 'emphasis on the grading of evidence on scales of reliability and probable truth' (168).…”