Your Genes in an Envelope? More, Please
The Food and Drug Administration is in the process of demanding the power to regulate genetic tests marketed directly to consumers as if they were medical devices. This proposal has produced contrasting reactions. Physicians predictably are all in favor. They see the opportunity for a closed-shop power-grab of the kind professionals love: a gatekeeping role. The American Medical Association wants the law changed so that people can get their genes tested only on prescription from a doctor.
Many genetic commentators, on the other hand, are dead against. They see this as an unnecessary intrusion of cost and hassle between the customer and his or her own genes. Besides, physicians often complain that they know too little of genetics—even as they demand to be put in charge. In its letter to the FDA asking for a gatekeeping role, the AMA bizarrely confessed: “The number of genetic tests available directly to consumers has proliferated rapidly, and several studies have reported that physicians find it difficult to keep up with the pace of genetic technology.”
Bioethicists tend to side with physicians. They fret about the unexpected worry or psychological damage that can come from finding out that you have a genetic risk. For example, one argues that a genetic test for cytochrome P450, used to help determine what antidepressants are most appropriate, might cause a customer to change his dose by himself, with disastrous results including, perhaps, suicide.
The trouble is, evidence for hypochondria or psychological harm from genetic testing is not just rare; it is absent. In one study, “testing did not result in any measurable short-term changes in psychological health, diet or exercise behavior, or use of screening tests.” The champions of regulation respond that some firms in the direct-to-consumer genetic-testing industry are sometimes much exaggerating the health benefits of genotyping. As I said above, most results are anodyne and close to useless in terms of telling you how to live your life, but that is not how it sounds on the websites. However, this is not an argument for FDA medical-device regulation or requiring doctors’ prescriptions before testing. It is an argument for plain, old-fashioned truth-in-advertising regulation of the kind effected by the Federal Trade Commission.
CASE IN POINT: TECHNOLOGY ALWAYS EXCEEDS THE LAW
But then, ask yourself, what doesn’t?
No more than rabbits can stop themselves from breeding can regulators keep from expanding their empires whenever opportunity strikes, or doctors and high priests help jealously guarding their privileged monopolies on sacred knowledge. If software engineers had only managed to turn themselves into a guild, they would now demand that we use the Internet through them alone.
If freedom does not appeal, the clinching argument for allowing consumers unfiltered access to their own genes is a scientific one. The only way slight genetic influences on health are going to emerge is if thousands of people submit their genomes for testing, and the only way that is going to happen is voluntarily. Academic research projects cannot promise to create the huge databases that an enthusiastic populace applying to an entrepreneurial testing industry can spawn. Genetic knowledge, whether the high priests like it or not, is going to be a crowd-sourced phenomenon.