Mail-away genetic testing promises to revolutionize the way that people learn about and manage their health. Already half a million Americans have sent their saliva to find out their risk of genetic disease--no doctors needed.
Splashed across TV sets nationwide this past summer was 23andMe's invitation to discover "hundreds of things about your health," including that you "might have an increased risk of heart disease, arthritis, [or] gallstones."
Since the company's inception in 2007, the government had allowed it to market and sell its at-home genetic tests free of regulation. For $99 and the click of a mouse, 23andMe promised a "first step in prevention" to "mitigate[e] serious diseases."
But this winter, the Food and Drug Administration issued a letter forbidding sales of the test to diagnose health conditions unless there is evidence that it works for that purpose. Shortly after 23andMe announced that it had "suspended" all sales of its "health-related genetic tests to comply" with the FDA directive, consumers brought a class action lawsuit against the company, alleging that it "falsely and misleadingly advertises" the genetic test "as providing 'health reports on 240+ conditions'" in the absence of "analytical or clinical validation."
The 23andMe controversy illustrates a stalemate over the role of direct-to-consumer genetic testing in American health care.
On one side are those like geneticist Robert Green and law professor Nita Farahany, who recently argued in the science journal Nature that people should be trusted to make responsible use of their own genetic information. Green and Farahany believe that the FDA's insistence that 23andMe prove its tests effective is unduly paternalistic. Marshaling evidence of consumer reactions to genetic testing results, they worry that the FDA's "overcautious" approach "may pose a greater threat to consumer health than the harms that it seeks to prevent."
Then there are those like bioethicist George Annas and physician Sherman Elias who argued in the New England Journal of Medicine that the FDA ban did no more than "requir[e] that companies that want to sell their health-related medical devices to the public demonstrate...that the tests do what the company claims they do." Annas and Elias fear that misreported or misunderstood genetic risk appraisals could lead consumers to make dangerous medical decisions: for example, to self-adjust prescribed treatments, forego potentially life-saving screenings, or even pressure physicians to operate on them unnecessarily.
Each position--nonintervention and prohibition--has much to commend it. Yet neither captures the diverse outcomes of genetic testing. Access to such information can generate education or ignorance, persuasion or coercion, health or illness. Green and Farahany are surely right that "[m]ore systematic research is needed to assess the outcomes of consumer genomics testing." But it is far from clear whether the need "to continue gathering data" justifies the consequences of unregulated testing.
Behavioral economics offers a range of mechanisms to break this impasse. Economist Richard Thaler and legal scholar Cass Sunstein famously argued in their best-selling book Nudge that institutions can design decisionmaking contexts in ways that help people make better choices without losing their freedom to choose. Consider a range of "nudges" to monitor the genetic information that is provided by and to consumer patients:
This innovative approach to the management of genetic health information better balances the goals of patient health and consumer freedom. Genetic testing is the next frontier of personalized medicine. But it needs a nudge.
Dov Fox is a law professor at the University of San Diego, where he and his colleagues will this spring convene leaders in law, ethics, industry, medicine, and government to examine the implications of genetic testing for American health care.
Splashed across TV sets nationwide this past summer was 23andMe's invitation to discover "hundreds of things about your health," including that you "might have an increased risk of heart disease, arthritis, [or] gallstones."
Since the company's inception in 2007, the government had allowed it to market and sell its at-home genetic tests free of regulation. For $99 and the click of a mouse, 23andMe promised a "first step in prevention" to "mitigate[e] serious diseases."
But this winter, the Food and Drug Administration issued a letter forbidding sales of the test to diagnose health conditions unless there is evidence that it works for that purpose. Shortly after 23andMe announced that it had "suspended" all sales of its "health-related genetic tests to comply" with the FDA directive, consumers brought a class action lawsuit against the company, alleging that it "falsely and misleadingly advertises" the genetic test "as providing 'health reports on 240+ conditions'" in the absence of "analytical or clinical validation."
The 23andMe controversy illustrates a stalemate over the role of direct-to-consumer genetic testing in American health care.
On one side are those like geneticist Robert Green and law professor Nita Farahany, who recently argued in the science journal Nature that people should be trusted to make responsible use of their own genetic information. Green and Farahany believe that the FDA's insistence that 23andMe prove its tests effective is unduly paternalistic. Marshaling evidence of consumer reactions to genetic testing results, they worry that the FDA's "overcautious" approach "may pose a greater threat to consumer health than the harms that it seeks to prevent."
Then there are those like bioethicist George Annas and physician Sherman Elias who argued in the New England Journal of Medicine that the FDA ban did no more than "requir[e] that companies that want to sell their health-related medical devices to the public demonstrate...that the tests do what the company claims they do." Annas and Elias fear that misreported or misunderstood genetic risk appraisals could lead consumers to make dangerous medical decisions: for example, to self-adjust prescribed treatments, forego potentially life-saving screenings, or even pressure physicians to operate on them unnecessarily.
Each position--nonintervention and prohibition--has much to commend it. Yet neither captures the diverse outcomes of genetic testing. Access to such information can generate education or ignorance, persuasion or coercion, health or illness. Green and Farahany are surely right that "[m]ore systematic research is needed to assess the outcomes of consumer genomics testing." But it is far from clear whether the need "to continue gathering data" justifies the consequences of unregulated testing.
Behavioral economics offers a range of mechanisms to break this impasse. Economist Richard Thaler and legal scholar Cass Sunstein famously argued in their best-selling book Nudge that institutions can design decisionmaking contexts in ways that help people make better choices without losing their freedom to choose. Consider a range of "nudges" to monitor the genetic information that is provided by and to consumer patients:
- DNA test discount for satisfactory completion of an online genetics quiz;
- health insurance voucher upon submitting proof of follow-up with a counselor;
- advisory notice with every order that "most people who acquire genetic testing seek expert guidance to help understand its implications for their health";
- repackaged results in terms of raw genetic data rather than future susceptibility to ill health;
- routine offer to reveal only those risks of disease that can now or might in the near future be responded to through treatment or prevention measures.
This innovative approach to the management of genetic health information better balances the goals of patient health and consumer freedom. Genetic testing is the next frontier of personalized medicine. But it needs a nudge.
Dov Fox is a law professor at the University of San Diego, where he and his colleagues will this spring convene leaders in law, ethics, industry, medicine, and government to examine the implications of genetic testing for American health care.