After the FDA intervened this week, Walgreens has decided to postpone selling do-it-yourself DNA testing kits in 6,000 of its stores nationwide. The drugstore chain had arranged to sell kits made by Pathway Genomics that promised to reveal your risk of health issues ranging from obesity to breast cancer, as well as your children’s risk of serious genetic disorders.
Walgreens reversed its decision after the FDA raised concerns that the kits would encourage consumers to make rash decisions based on genetic information not fully understood even by experts, and without consulting their doctors. The FDA also raised questions about the legality of selling the tests; Alberto Gutierrez told the Associated Press, “selling a test over the counter without an FDA clearance, particularly for the type of claims they have, is not legal.” The Federal Trade Commission likewise warned that direct-to-consumer genetic tests “provide medical results that are meaningful only in the context of a full medical evaluation.”
Context—medical, ethical, and, for Christians, theological—is sorely needed as companies market personal DNA tests as vital tools for informed health decisions. While the FDA’s action keeps the tests off store shelves for now, inexpensive DNA tests are already available online and through fertility clinics. The Pathway Genomics test, available online, allows consumers to send a saliva sample for DNA analysis. The analysis costs up to several hundred dollars, depending on how much information the customer wants. Late last year, a company called Counsyl started advertising $350 tests that allow prospective parents to determine if their children risk inheriting any of 100 single-gene disorders.
Americans have become experts at gathering medical information on the Internet rather than relying on doctors as all-knowing gatekeepers. As someone with a lifelong physical disability and the parent of a child with the same disability, I’ve had lots of interactions with doctors. Because our disorder is rare and I have online access to information and to other affected families, I often know more about treatments, new developments, and daily coping strategies than our doctors do. Our most valuable doctor-patient relationships are partnerships; I offer my information and perspective, the doctors offer theirs, and together we make treatment decisions.
Access to health information can contribute to successful doctor-patient relationships and, ultimately, to better health. But direct-to-consumer DNA tests have several troubling aspects, beyond their reliance on genetic science that is complex, evolving, and far from precise.
Media reports often provide a simplistic view of how the tests will save money and enhance health. A Newsweek article on the Counsyl test, titled “A Cure for Health Costs?” argued, “It’s … a money saver at $350—nothing compared with the lifetime cost of caring for a sick kid.” A Washington Post article about Pathway’s test naively states, “The pregnancy planning test could prompt couples to decide not to get married or have children” as a result of learning their children have even a small risk of inheriting a genetic disorder.
But with reproductive technology increasingly sophisticated and accessible, would-be parents who learn that their children risk having genetic disorders are unlikely to simply call off the wedding, remain childless, or adopt children—at least not without first exploring other options. They are likely to go to a fertility clinic for help conceiving children guaranteed to be free of known genetic problems.
Pre-implantation genetic diagnosis (PGD, which is in vitro fertilization with the added step of genetic screening) may cost less than a lifetime of care for a seriously ill child, but it is still expensive ($12,000 to $15,000 per cycle) and is often performed multiple times before it succeeds, if it succeeds at all. As more knowledge of genetic risk leads to more prospective parents using technology like PGD, our overall medical costs will rise. A host of potential costs—and a host of ethical questions—lie between genetic tests costing a few hundred dollars and lifelong care for disabled children costing millions.
As believers in the Word made flesh, Christians understand that our bodies matter. We also know that human identity goes far beyond our genes’ messages or our bodies’ capabilities. Good medical care recognizes the complex interactions of physical, spiritual, and emotional factors that contribute to health. Handing consumers a genetic test and promising that it will help them make health-enhancing decisions, without offering any further context or resources, is akin to handing teenagers a book on the mechanics of sex and reproduction, and telling them that they are now free to make informed choices about how to exercise their emerging sexuality. Human flourishing requires more than a good grasp of the facts.
Despite the FDA’s action this week, personal DNA tests are likely to become more available in the coming years. We need to be skeptical of glowing predictions about how direct-to-consumer genetic tests will save us money and make us healthier. We need to insist on adequate consideration of the medical, ethical, emotional, and theological questions raised by genetic and reproductive technology. Information is a wonderful tool, but it is not the only tool we need to craft a meaningful life.
Ellen Painter Dollar is a writer who focuses on Christian reproductive ethics and disability theology. She is writing a book for Westminster John Knox Press (forthcoming in 2011) about the ethics and theology of assisted reproduction and genetic screening. She blogs at ChoicesThatMatter.blogspot.com and Five Dollars and Some Common Sense. She has written for CT about disability and genetic testing.
