“Snake-oil,” “quack medicine,” and “industrially cultured organisms:” biovalue and the commercialization of human microbiome research

Abstract

BackgroundContinued advances in human microbiome research and technologies raise a number of ethical, legal, and social challenges. These challenges are associated not only with the conduct of the research, but also with broader implications, such as the production and distribution of commercial products promising maintenance or restoration of good physical health and disease prevention. In this article, we document several ethical, legal, and social challenges associated with the commercialization of human microbiome research, focusing particularly on how this research is mobilized within economic markets for new public health uses.MethodsWe conducted in-depth, semi-structured interviews (2009–2010) with 63 scientists, researchers, and National Institutes of Health project leaders (“investigators”) involved with human microbiome research. Interviews explored a range of ethical, legal, and social dimensions of human microbiome research, including investigators’ perspectives on commercialization. Using thematic content analysis, we identified and analyzed emergent themes and patterns.ResultsInvestigators discussed the commercialization of human microbiome research in terms of (1) commercialization, probiotics, and issues of safety, (2) public awareness of the benefits and risks of dietary supplements, and (3) regulation.ConclusionThe prevailing theme of ethical, legal, social concern focused on the need to find a balance between the marketplace, scientific research, and the public’s health. The themes we identified are intended to serve as points for discussions about the relationship between scientific research and the manufacture and distribution of over-the-counter dietary supplements in the United States.

Navigating social and ethical challenges of biobanking for human microbiome research

“…There has been limited study into broader ELSI with regard to the public impact of human microbiome research. For example, Slashinski et al examined investigator perspectives on the commercialization of human microbiome research [22]. Their study raised concerns over how the scientific value of research into the human microbiome and health is mobilized by the marketplace to promote the consumption of probiotics and dietary supplements, despite a lack of regulation and knowledge about the safety and effectiveness of these products.…”

Alzheimer's disease and the microbiome

“…For example, there is preliminary research on the influence of probiotics and nutritional factors on the prognosis of multiple sclerosis (von Geldern and Mowry, 2012), cognition (Camfield et al, 2011), neurogastroenterology in general (Saulnier et al, 2013), and stress-related psychiatric conditions including anxiety, autism, depression and schizophrenia (Bravo et al, 2012; Prasad et al, 2012; Douglas-Escobar et al, 2013). Advances in probiotic technologies in CNS disease research are already raising a number of ethical, legal, and socioeconomic concerns (Slashinski et al, 2012). …”

Investigators' Perspectives on Translating Human Microbiome Research into Clinical Practice

“…informed consent, return of research results, and data sharing); potential clinical applications; ELSI unique to human microbiome research; and other topics as they arose (e.g. commercialization of human microbiome research [12]). To achieve a diverse sample of research, applied, and clinical expertise, we used purposive and snowball sampling strategies [13].…”