Microbiome research poses ethical issues
"Do-it-yourself" raises ethical concerns
Just as companies are offering whole genome sequencing to individuals, companies are offering to sequence their microbiomes and determine how they compare to others.
There has been a lot of controversy recently about direct-to-consumer genetic testing, notes Amy L. McGuire, JD, PhD, Leon Jaworski Professor of Biomedical Ethics and director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine in Houston.
"The FDA [Food and Drug Administration] recently sent a stern warning letter to 23andMe, one of the most well-known direct-to-consumer genetic testing companies," she says. The letter reiterated that the test kit is a medical device under the jurisdiction of the FDA to regulate, expressed concerns with the clinical validity and safety of the test, and reminded the company that it must comply with FDA requirements for regulatory oversight. (To view the letter, go to http://1.usa.gov/1crGLGd.)
In addition, a class action lawsuit filed against 23andMe alleges that the company has made false and misleading claims about the clinical validity of the test.
The direct-to-consumer sale of human microbiome analyses faces the same risk of being classified as a medical device subject to FDA regulation, especially as evidence of its health implications grows, says McGuire.
"There is a 'do-it-yourself' community that's developed around this. People with certain diseases see a lot of potential for benefit from the science, and are understandably desperate for treatment," says Jean E. McEwen, JD, PhD, program director of the Ethical, Legal and Social Implications Research Program at the National Institutes of Health (NIH)'s National Human Genome Research Institute.
Explain limitations of science
A related development is an attempt to "crowdfund" microbiome research projects over the Internet. "In some ways, it's an interesting new model, but it also raises all sort of potential ethical issues," says McEwen.
A key concern involves uncertainty about what the science means, and the likelihood that some people will misinterpret information about their microbiomes.
"It is very, very early. One of the risks is that people will attach more certainty to the science than is warranted," says McEwen. "Bioethicists can play a role in explaining the limitations of the science."
There are also ethical issues related to probiotic treatments making claims based on microbiome research, says McGuire, especially the regulation of probiotics like yogurts being marketed as providing benefits for digestive health.
It is important that the public is educated about the current state of microbiome research; what it can and cannot tell us about the role of bacteria on health and disease at this point; and the risks and benefits of different pharmaceuticals, probiotic foods, and supplements, she says.
"This area of research is relatively new. Although there have been some exciting advances, we still have a lot to learn," says McGuire.
Unique ethical issues
The NIH program has received funding specifically to look at ethical issues of microbiome research. "Some of these are pretty similar to the issues we've all been hearing about for a long time with genetics more generally, but some are unique to microbiome research," says McEwen.
Privacy is a major ethical concern with microbiome research, in terms of how to ensure the information generated in the research can't be tied to a particular person. "It's hard to get a sample that doesn't also include some human DNA," says McEwen. In addition, some preliminary research suggests that individuals may actually have unique microbiome signatures.
"This raises a whole new set of possible ways that somebody could be tied back to a particular sample," says McEwen. There are potentially some forensic applications, such as law enforcement using microbiomes to track someone's whereabouts. "Some of that, at this point, may seem a little bit farfetched — but maybe not," says McEwen.
There is also a concern that people might be stigmatized somehow based on their microbiomes, either at the individual or group level. For example, research may suggest that particular patterns are found more frequently in some racial or ethnic groups than others.
"We don't know where the research is heading, but some researchers are already suggesting that there may be certain differences among populations," says McEwen.
People may make negative associations about certain individuals or groups, whether they are warranted or not. "Given the historical association between microbes and contamination, there is the potential of negative reactions in people's minds that don't exist as much with other types of research," says McEwen.
Concerns about informed consent are mainly due to safety risks being largely unknown at this point. "It's hard to consent people in a way that is informed when we don't even know what the potential risks are, because the science is so new," says McEwen.