For those interested in the FDA’s decision to regulate 23andMe’s direct-to-consumer genetic testing service, it is worth reading a recent comment in Nature by Robert Green and Nita Farahany. The piece raises two core objections to the FDA’s decision that deserve further attention.
One objection is that the FDA’s decision runs contrary to “the historical trend of patient empowerment that brought informed-consent laws, access to medical records and now direct access to electronic personal health data.” Green and Farahany suggest that 23andMe and manufacturers of other consumer medical products (such as mobile health apps) “democratize health care by enabling individuals to make choices that maximize their own health,” and that we must not “stifle all innovations that do not fit into the traditional model of physician-driven health care.”
While I agree with Green and Farahany that we should not be locked into physician-driven health care, I am not sure that the information provided by 23andMe and medical apps is unambiguously “patient-empowering” and “democratizing” (a framing of personalized medicine that pervades both marketing materials and academic journals). Though there is certainly truth to this characterization, it also obscures important parts of the story, such as the ways in which the manufacturers of these devices will be monetizing the data that they gather, and the ways in which “empowerment” can give rise to new burdens. For instance, the availability of this new health data could give rise to obligations to make health-related decisions in conformance with social norms, or even contracts (e.g., with insurance companies). As the current NSA controversy makes clear, new information technologies facilitate various new forms of surveillance. In addition, the focus on individual choice and responsibility might lead policy makers to neglect other environmental and institutional approaches to health promotion that are more desirable on grounds of justice or fairness.
A second objection raised by Green and Farahany is to one of FDA’s stated rationales for its decision: its claim that patients may be harmed if they do not adequately understand their test results or if they are provided with incorrect test results. As examples of such harms, the FDA noted that genetic results could drive consumers to take extreme steps, such as having unnecessary surgery to prevent cancer, or abandon or alter prescribed treatments without consulting health professionals. Green and Farahany challenge this rationale on empirical grounds, providing an overview of the various consumer surveys that have found that receipt of consumer genomics information does not provoke distress or inappropriate treatment (while acknowledging that more systematic research is needed to draw a firm conclusion).
Even if further empirical studies confirm a lack of harm, however, it is not clear that this data would provide a sufficient basis for objecting to the FDA’s decision. The objection would seem to suggest that FDA should only regulate a medical device after it has performed a particularized risk assessment of that device, rather than placing the burden of proof on the manufacturer to prove safety and efficacy, as our law currently does. Of course, as a practical matter, the FDA will likely need to exercise its discretion to not regulate some things that might meet the formal definition of a medical device, and in doing so remove the burden of proof from the manufacturer. But I am not convinced that the information provided 23andMe should, as Green and Farahany suggest, be on the same side of this discretionary line as the information provided by a simple bathroom scale.