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.

Published by: tgoetz on June 17th, 2008 | Filed under Law, Policy, Genetics, Health Care Industry

5 Responses to “Attn, California & NY: DNA is Data”

  1. Steven Murphy MD Says:

    The porblme I see, is that a pregnancy test is binary. Genomes are not. At least not for the next 20 years. That is why there are the regulations. Not to deprive you. The PATIENT ALWAYS OWNS THERE MEDICAL RECORD. UNFORTUNATELY YOUR DNA is owned by 23andME

    p.s. I hope your readers understand that!

  2. Stephen Peroutka, M.D., Ph.D. Says:

    An individual does indeed have the right to learn about their medical condition(s). However, the naivete in comparing a pregnancy test to genome wide SNP analysis in 2008 illustrates the true crux of the current problem with SNP analysis.

    A pregnancy test provides an individual with data that are unequivocally relevant to their health. A positive test predicts a sequence of physiological events that will occur with 100% certainty and indicates that a specific set of medical issues should be addressed by the individual.

    By contrast, a SNP analysis in 2008 provides statistical assessment of “known” medical risks that may not be replicated, may not be relevant within a certain group of individuals and/or may be contradicted or superceded by future research. An objective assessment of SNP analysis in 2008 would probably assign a predictive medical value to it that slightly exceeds the predictive value of an individual’s daily horoscope.

    The difference between the two tests is not subtle and should be clearly understood by all, physician and non-physician. An individual does have the right to know their DNA sequence just as they have a right to read their daily horoscope and to take a pregnancy test. They also have the right to know the truth about the predictive abilities of each product.

  3. tgoetz Says:

    @ Stephen Peroutka: I think your statement that a SNP analysis provides, de facto, a “statistical assessment of ‘known’ medical risks” says a lot about many doctors’ perspective. In fact, a SNP analysis does *not* provide such an assessment. Rather, a SNP analysis provides a rundown of your SNPs, which can then be extrapolated and compared to medical literature. That’s a subtle but significant distinction, and it’s the crux of my argument: Yes, genomic information has medical implications, but it is not in and of itself medical information; it is simply information. What we do with that is a cultural choice, and a personal choice, not a matter for state regulation.

  4. Steven Murphy MD Says:

    What about other biologic information. LDL? Blood Pressure? Your urine’s odor?

  5. Steven Murphy MD Says:

    And It Is Not Just the SNP companies at threat here. In fact THEY are in the minority. You Should cover this Thomas. Read the GAO reports.

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