My latest Mind and Matter column in the Wall
Street Journal is on the regulation of genetic testing
I just took a detailed genetic test by sending some spit to a
firm in California and looking up the results on the Net. It seems
I'm probably descended from a peculiarly fecund fourth-century
Irish king called Niall of the Nine Hostages and a slightly more
unusual Mesopotamian Neolithic matriarch. Oh, and I have mostly
average risk of most diseases: The medical part of the test gave me
a bit of risk here, a bit of reassurance there, nothing very
drastic.
I had been hanging back from doing this partly because the
results of such tests seem to be generally unexciting. But a few
weeks ago I decided to get on with it. Why? Because 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
[see Daniel MacArthur, for example.]. 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.
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.
