As previously stated, there are a number of ethical, legal and social issues associated with human microbiome research. In this article, we focused primarily on those issues concerning the commercialization of human microbiome research. In our examination we have considered how human microbiome research has biovalue, illustrating the power of the dietary supplements industry, and the need to find a balance between the marketplace, scientific research, and the public’s health. Investigators’ responses are less about the authority or expertise of biomedicine, and more about how biomedical research is co-opted by commercial entities that place profit over health. Investigators focused on the power of the industry, namely it is not about the products themselves, but what the public is required to know about the products. For example, a product that claims “all natural ingredients” should be natural, not engineered in a lab. 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.
Spielmans and Parry
 note that prior to understanding the utility of scientific data “science has largely been taken captive in the name of increasing profits” (p. 13). Investigators’ responses suggest the commercialization of human microbiome research, for example the production and distribution of over-the-counter dietary supplements, is predicated on mass consumption, not health or wellbeing, in pursuit of potential profits. They suggest human microbiome research opens the door for what we will refer to as a commercialized intervention, or the proliferation of commercial products that claim maintenance or restoration of good health, and prevention of disease or sickness, with the use of good bacteria. Under the current paradigm of health that encourages individual responsibility, we need to consider why individuals begin or continue to use dietary supplements even when faced with evidence questioning safety or effectiveness, as well as the ethical implications of therapeutic misconception. Previous research suggests many patients use probiotics because they consider them to be natural or part of complementary and alternative medicine
. Additionally, marketing strategies allude to the empowering affects of dietary supplements, such as “be proactive” or “nutrition possible,” and these affects create hope of good health. This political economy of hope depends on simple and quick actions or behaviors to take responsibility for our health, and we feel empowered when we spend the money on dietary supplements that promise good health
Investigators’ primary legal concerns centered on regulation and policy change. Unsubstantiated claims about the effectiveness of these products have the potential to cause harm
. Substantive changes at the policy level constitute the most effective way to regulate the current dietary supplements industry, as well as protect the public’s health. Regulations previously advanced under DSHEA
, including preventing the dietary supplements industry from deceit or manipulation, being truthful about the actual health benefits of their products, requiring manufacturers to list ingredients on each product, and how the product’s dosage is or is not useful (i.e. does the product contain an adequate amount of probiotic to affect positive health?), might be insufficient in the context of the current commercial market. Manufacturers are responsible for ensuring the safety of their products and consumers are responsible for reporting adverse events; the FDA, however, is responsible only for investigating consumer claims that a product is unsafe. Given the increasing availability of over-the-counter dietary supplements, and the profit incentive to produce these supplements, future research should examine the utility of current regulations, specifically whether or not these regulations are in place to protect the public or the market.
There are broader ethical, legal and social implications associated with commercialization and human microbiome research, which should be considered in future research. Sharp and colleagues
, for example, introduced the environmental impact of probiotics. They raised concerns about negative changes to the microbial ecosystem of the human host, focusing on the different ways in which people process these supplements and the potential for developing immunity to probiotic bacteria. They also discussed concerns about external environmental contamination, focusing on the release of genetically altered or engineered bacteria into the external environment. Future research should consider the long-term impact of internal and external environmental contamination, exploring the ways in which the commercial market has the potential to mitigate or exacerbate these concerns. Additionally, recent research highlights issues of ownership implicated in this type of research. Hawkins and O’Doherty
 explore the symbiotic relationship between microorganisms and the human body, particularly in the context of private or government biobanks. While their analysis does not focus on issues of commercialization, future research should consider how this issue might play out in a commercial market. The commercialization of human microbiome research, for example, has the potential to give a marketable exchange value to an individual’s microbiome or bacteria. Because the commercial market is focused on profit, there is potential for buying samples to access bacterial sequences for commercial research (e.g. pharmaceutical research).
The purpose of this article was to fill a gap in the literature concerning the commercialization of human microbiome research. Our findings, while not generalizable, suggest that investigators involved in human microbiome research were sensitive to these issues, and were interested in locating effective strategies to inform and protect the public. Future research should explore the ways in which these issues are similarly situated within and across populations currently incorporating dietary supplements. The issues we identified in this study are unlikely to be confined to this particular group of investigators, however through comparative research we can further examine the extent to which these issues exist elsewhere.