American Medical Association: You Can't Look At Your Genome Without Our Supervision

The American Medical Association has written a letter to the US Food and Drug Administration as part of the lead-up to the FDA's meeting on direct-to-consumer (DTC) genetic testing next month. The tone is predictable: the medical establishment is outraged by the idea of people having access to their own genetic information without the supervision of its members, and they want the FDA to stop it:

We urge the Panel to offer clear findings and recommendations that genetic testing, except under the most limited circumstances, should be carried out under the personal supervision of a qualified health care professional, and provide individuals interested in obtaining genetic testing access to qualified health care professionals for further information.

In other words, the AMA is seeking to maintain its members' traditional monopoly over the interpretation of genetic information - and they expect regulators to act as their enforcers, beating down the upstart DTC genomics companies who have wandered onto their sacred turf.

This is, of course, an absurd, desperate demand. If doctors think that people should consult them about their genomes, they shouldn't run crying to the regulators to provide the necessary force; instead, they need to convince the public that a medical consultation adds genuine value to their genomic information. Unfortunately for the AMA, right now it's far from clear that this is true: in many cases, DTC genomics customers are far better equipped to interpret their results than their doctors are.

The AMA implicitly acknowledges this in the final paragraph of the letter, and thus effectively undermines its entire argument:

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.

Brilliant. So, to paraphrase:

We don't actually know how to interpret genetic information, but we should be the only people allowed to do it.

So when the AMA pleads to the FDA to please, just think of the patients:

Without the guidance of a physician, genetic counselor, or other genetics specialist, test results could be misinterpreted, risks miscalculated, and incorrect health and lifestyle changes pursued.

...the appropriate response is: dude, the test results are going to be misinterpreted, risks miscalculated, and incorrect health and lifestyle changes suggested if they come and ask their friendly local physician, given that he thinks "SNP" is a slang term for vasectomy. Show me a primary physician who can explain a multi-variant risk prediction for Crohn's disease as well as, say, 23andMe does, and then we'll talk.

So what is the appropriate way to protect consumers? As Dan Vorhaus and I argued last year, the answer is not to take genetic testing out of the public's hands, but simply to ensure that consumers are provided with the objective data required to make an informed decision about whether to take a test and how to interpret its results.

Should DTC genetic testing customers be encouraged to consult a clinician before making major lifestyle changes based on a test result? Sure. But they shouldn't be obliged to. And this is a fight that's far bigger than genomics: as Western populations age, we simply will not be able to sustain viable health systems without encouraging individuals to take greater responsibility for managing their own healthcare.

That means the "doctor as universal gatekeeper of health information" model has to die, no matter how desperately the AMA and its proxies try to keep this obsolete, paternalistic vision alive.