Blog

Attn, California & NY: DNA is Data

About the news that California health regulators have sent cease-and-desist letters to a baker's dozen genetic testing firms, forbidding them from selling tests without a doctor's order: I have two observations. First, I know that the direct-to-consumer personal genomics twosome, 23andMe and Navigenics, have been diligent in working with the FDA to make sure that their tests line up with current testing regulations and efficacy rules. So on some level, this may be a turf battle between state health departments (NY state has sent a previous notice) and the Feds.

Second, this to me reflects as much a cultural disagreement as a legal or regulatory one. That is, there is the assumption in the states' letters that, because genetic information has medical implications, the dissemination of this information must fall under their jurisdiction. But there are, in fact, all sorts of areas in life that have medical implications that we don't consider the province of government - a pregnancy test, most obviously. We neither want nor assume that doctor's should have a gatekeeper role in establishing whether we are or are not pregnant, nor do we look to the state to protect us from that information. Pregnancy is a part of life, and it has all sorts of implications and ramifications. So too with DNA.

To my mind, genetic information is a new sort of personal information that the state and even the physician community are terribly slow and old-fashioned in reckoning with. Even those with knowledge in genetics, such as the Gene Sherpa blogger, assume a paternalistic tone: "I am just shocked and awed that some in the public think that they can do this on their own without professional help. Do you build your own home? What about fight your own court cases? Some do their own taxes...but only when it isn't complicated. Trust me, this IS COMPLICATED!"

Now, I agree with Steve Murphy about a lot of things, but I totally diverge from him on this. Having been tested by both 23andMe and Navigenics, I can say that, yes, it's complicated. But frankly I don't need a doctor, and I don't want a doctor, to facilitate my understanding of what my DNA means. Yes, there are some medical implications, but these are hardly live-or-die moments. What's more, when I have shared my results with physicians, they're largely greeted with a shrug. I don't want to "trust" a doctor, no matter how skilled or well trained, I want the access to my genetic data just as I want to know, without government approval or physician filtering, all sorts of information about myself. The assumption that there must be a layer of "professional help" is exactly what the new age of medicine bodes - the automation of expertise, the liberation of knowledge, and the democraticization of the tools to interpret and put to use fundamental information about who we are as people. Not as patients, but as individuals. This is not a dark art, province of the select few, as many physicians would have it. This is data. This is who I am. Frankly, it's insulting and a curtailment of my rights to put a gatekeeper between me and my DNA.

This is *my* data, not a doctor's. Please, send in your regulators when a doctor needs to cut me open, or even draw my blood. Regulation should protect me from bodily harm and injury, not from information that's mine to begin with.

Thomas Goetz5 Comments