Contested legitimacy of regenerative vs. established biomedicine in Brazil: On the circulation and co-regulation of immunostimulant therapies for autoimmunity

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How does the development of a new therapeutic model, whose potential emergence threatens the hegemony of an already established biomedical model, affect, and how is it affected by law, science and society? To anchor this question in a particular context, I conduct an anthropological study into how scientific innovation, established biomedicine and informal health care co-exist and interface in contemporary Brazil, and how their relations are mediated by legal institutions and other actors. For it, I delineate and explore ‘life assemblages’ related and interconnected through the use of ‘immunostimulant drugs’ for the treatment of autoimmune diseases, which are conventionally treated with ‘immunosuppressant drugs’ worldwide.My central case study is the ‘anti-brucellic vaccine’ (vacina anti-brucélica or VAB) – a drug produced in Brazil and largely used by patients against several autoimmune diseases. After more than 10 years seeking to become authorized by medico-legal authorities, the VAB remained an object of controversies and was recently taken as basis for the development of a further biotechnological innovation called Complex of Essential Amino Acids (CAE) that is currently commercialized as a ‘manipulated drug’ while rnew andomized controlled trials are being prepared. Inspired by Actor-Network-Theory, I follow the VAB/CAE in order to re-trace associations and map the main relations that have constituted it as a biotechnological innovative agent and, simultaneously, as an object of judicial dispute and regulation. Related to that I compare the VAB/CAE case to other cases of circulation and regulation of immunostimulant drugs as contested innovations in Brazil, such as the synthetic phosphoethanolamine. By doing this, I weave an ethnography of the VAB/CAE out of a multi-sited ethnographic fieldwork through participant observation (including autoethnography) and, complementarily, digital methods and documentary research.I argue that, from an international perspective, the VAB/CAE case reveals how research into the production, circulation and regulation of immunostimulant therapies for autoimmune diseases in Brazil can provide critical insights into the emergence of regenerative medicine as a transnational process. Moreover, whilst shedding light on legal conflicts between established regulatory science and challenging innovative biotechnologies, the VAB/CAE case highlights how the renewal of established biomedicine for autoimmunity partially unfolds by means of informal pharmaceutical economies, other cultures of legality and respective moralities.