Caveat Emptor, Caveat Spittor
Spit is hitting the fan this week in the world of direct-to-consumer gene tests. Back in January, Biopolitical Times blogger Jesse Reynolds titled a post here, "Whither Personal Genomics?" On Tuesday came one answer from Pathway Genomics and its partner Walgreen's: Try Aisle 6, next to the cough syrup.
But the Federal Drug Administration immediately fired back with its own response to the marketing innovation: Not so fast. Upon hearing this, Walgreen's thought again, and announced it would postpone putting the test on its shelves "until we have further clarity on this matter."
The FDA's action is in line with what the public health departments of New York and California [PDF], along with many others, have been suggesting for some time: DTC gene tests are being promoted as medical procedures, and thus may constitute practicing medicine without a license. The rules of the road in this area are complex, but as FDA's Dr. Alberto Gutierrez told the Washington Post on Tuesday, "They are making medical claims. We don't know whether the test works and whether patients are taking actions that could put them in jeopardy based on the test." Gutierrez did not hold back: "We think this would be an illegally marketed device if they proceed."
The health issues connected to DTC gene tests go beyond narrow legal questions. Given the current state of scientific knowledge - and lack thereof - DTC gene tests may well constitute practicing bad medicine without a license. Doctors, bioethicists, and public-interest policy analysts (including CGS) have pointed out that the accuracy and meaning of many DTC gene test results are uncertain, and that promoting them as medically actionable is irresponsible. Far more than gene tests performed and interpreted in a medical setting, DTC tests could all too easily lead to unjustified alarm, complacency, and decisions - and to harmful outcomes.
Sharon Terry, president of the patient advocacy group Genetic Alliance, warned that DTC gene tests don't "seem like a good use of resources or something people should be spending their money on yet." Stanford University bioethicist Hank Greely called them "reckless." "Information is powerful," he said, "but misunderstood information can be powerfully bad."
As readers of Biopolitical Times are likely aware, broader societal concerns are also in play. Will gene tests feed genetic reductionism and gene mania - especially if they're sold in the local drugstore and all over the Internet? And what of the eugenic potential of DTC gene tests aimed at parents-to-be? The FDA won't take on these questions - so it's up to the rest of us.
Previously on Biopolitical Times:
- Whither Personal Genomics?
- The spitterati and trickle-down genomics
- 23andMe Lite
- Consumer genetics: Coming of age?
See also several very informative posts from May 11-13 by Dan Vorhaus at Genomics Law Report