What's yours is yours...right?

Does information describing the pattern of genetic markers embedded in your genome, and even the sequence of your own DNA, belong to you?  I would say yes, but evidently the California Department of Public Health (DPH) has its doubts.

As reported in the LA Times, the DPH has sent cease and desist letters to 13 companies that offer direct-to-consumer genetic testing.  I am especially confused about this because if you have an extra $1-10 million sitting around, you can FedEx your DNA to any number of sequencing companies and have them send you an electronic copy of your sequence in a few months (see my earlier post, "The Million Dollar Genome").

The LA Times, The San Jose Mercury News, and The San Francisco Chronicle all report that the letters were sent following "consumer complaints" about "the price and accuracy of the results".  According to the Chronicle, "California law requirescompanies that conduct genetic testing to have those tests ordered by a licensed physician and to use laboratories that are both licensed by the state and have federal certification."

There appears to be some tension between the interpretation of tests ordered for diagnostic purposes, which probably should require a prescription, and sequencing or genotyping services that provide information about a consumer's genetic makeup.

From the Mercury News:

A spokeswoman for 23andMe, which has financial backing from Google Inc. and Genentech Inc., described the company as an "informational service."

"What we do is offer people information about their genetic makeup, including ancestry and applicable scientific research," spokeswoman Rachel Cohen said.

If physical or pharmaceutical intervention of some sort will be based the results of the test, you probably want a doctor involved in interpreting the results, particularly since correlations between genome sequence and health are still being elucidated.  But even when such correlations are strong, practicing physicians may not know what to do with the information.  As the LA Times points out, "Public health officials have urged consumers to be skeptical, pointing out that most of the research is in its earliest stages and that doctors have little training in interpreting the results."

This gets to the heart of the matter for people interested in knowing their own sequence.  It may be true that connections between relating sequence information and physiology may be sparse, but should that prevent consumers from having access to the raw information?  A physician may take some time to integrate genetic testing into daily practice: should we all be forced to wait until doctors are up to speed?  And what if you just want to know about the pattern of mutations that gives you insight into your ancestry, or are simply curious about the sequence of your own DNA?

Over at Wired News, Thomas Goetz has a few things to say on these issues to the California DPH:

[The cease and desist letters reflect] 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 doctors 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.

For Goetz, who reported for Wired last year on direct-to-consumer genetic testing, the DPH is inserting its bureaucratic nose, and a physician, where neither are wanted or needed:

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.

So, bringing this back to the motivations for the cease and desist letters, what of the complaints about "price" and "accuracy"?

The 23andMe homepage advertises that the company provides:

A web-based service that helps you read and understand your DNA. After providing a saliva sample using an at-home kit, you can use our interactive tools to shed new light on your distant ancestors, your close family and most of all, yourself.

Nothing about diagnostics there.  But following the "Gene Journal" link leads to an "Odds Calculator" that will:

Help you put it all in perspective, allowing you to combine genetic information, age, and ethnicity to get an idea of which common health concerns are most likely to affect a person with your genetic profile. While the Odds Calculator is neither a medical diagnostic nor a substitute for medical advice, it can help you confront the bewildering array of health news reported in the mass media and help you decide where you may want to focus your attention.

(Note the specific caveat that the service is not "a medical diagnostic".)

Given the early stage of most efforts to link genomes with physiology, it would be very surprising if a small start-up could assemble the resources to "put it all in perspective".  But even if they don't have the ability to pull that off in a manner I would be satisfied with, it isn't clear that the state should be denying them the opportunity to try.

With respect to the "price" complaint, the last time I checked we are living in a society in which goods and services are priced according to what the market can bear.  Since neither private insurers nor the government is paying for these particular services, which are not intended to provide information to be used in healthcare, there does not appear to be a good argument that the state should care what the price is.

With respect to the "accuracy" complaint, it would seem that these companies are already trying to do business in a competitive environment -- if they aren't providing accurate information then presumably they will succumb to companies that provide better information to consumers.  Again, since this isn't a diagnostic service, it is not clear that the state should intrude in the transaction.

There are a great many snake oil peddlers and quacks out there who offer no caveats as to accuracy or effectiveness, and in comparison 23andMe and its competitors appear paragons of virtue.  Direct-to-consumer genetic information services are creating a new market, and there always bumps along the way in that endeavor, particularly when regulators decide they know more about technology than do innovators.  But it is a market. It is not, in priciple, directly related to health.  Caveat emptor.  Since when is this the concern of Department of Public Health?