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The IFTF Blog
Ethical issues raised by direct-to-consumer (DTC) genetic testing
Congratulations! You are the lucky winner of a Stanford Hospital/Medical Center trifecta. You'll notice that my co-blogger-in-crime, Bradley Kreit, wrote the other day about the hospital's experimental drive-thu ER program, and I recently blogged about its new in-patient menu. Although Stanford is in our backyard, I promise you that has nothing to do with our sudden focus on news from there. Nonetheless, here is our third item in a row.
Brad and I spend a lot of time talking about the ethics of direct-to-consumer personal genomics offerings. Turns out some Stanford bioethicists have questions about this trend, too, specifically in terms of how consumers are turning to social networking sites to share information. As you know, opportunities for patients to connect online with others who have similar health concerns is one of the most important developments in the Health 2.0 revolution. So why is Sandra Soo-Jin Lee, a senior research fellow at Stanford's Center for Biomedical Ethics, making a big deal about ethical questions, at least in the context of genetic information?
Lee and her colleagues published an article earlier this summer in the American Journal of Bioethics entitled, "Research 2.0: Social Networking and Direct-To-Consumer (DTC) Genomics." Lee is quoted in a Stanford press release about her research and her concerns that complicated issues of privacy and consent arise because genetic information applies to others than the consumer who has taken the test:
Genetic information is unique in that it’s not only relevant for the individuals who receive the information, but also for their family members, their children and even their children’s children. For example, if you receive information on your breast cancer risk and share it with others, you might also be sharing information about your daughter’s risk for breast cancer—even though she never consented to have that information shared.
Lee et al. are continuing to study who people share their genetic information with. Using an approach called "social network analysis," which is a methodology with deep roots in anthropology, Lee plans to map "how people forge connections based on their genetic information."
Lee is also interested in understanding how consumers interpret and act upon personal genetic information. So am I!! One of the issues these DTC tests raise for me is how generally unprepared consumers and health care providers are to interpret the data they receive. I recently took the Navigenics Health Compass test, and I am left with many questions about the results (blog post about this to follow, eventually). I am also curious to see whether 23andMe's test would yield similar information about my health risks. As Lee notes, "Results depend on the number and type of markers that are used, as well as how robust their databases are." Lee calls for "greater oversight of this information to ensure that consumers understand what their results actually mean."
In a podcast of an interview she gave last month (available here), she suggests that current laws and regulations are inadequate and that the resulting lack of oversight of genetics is akin to the wild, wild West. A policy paper Lee and her colleagues published early this summer, this time in Science, focuses on genetic ancestry testing and the insufficiencies of existing regulations governing these tests, which offer consumers insight into their genetic origins. They argue that recent guidelines issued by the American Society of Human Genetics, along with the federal Office of Human Research Protections, do not protect consumers from having their DNA used for research purposes to which they did not consent. Lee's co-author, Kimberly TallBear, assistant professor of science, technology and environmental policy at UC-Berkeley, is quoted in the Stanford press release about the paper: “We encourage regulatory agencies such as the Federal Trade Commission, the Food and Drug Administration, and the Centers for Disease Control to help set industry standards for responsible and accountable practices in genetic ancestry testing.” Good luck with that, I say.