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    California Thinks It's Dangerous For You To Look At Your Own DNA
    By Lee Silver | June 22nd 2008 05:12 PM | 13 comments | Print | E-mail | Track Comments

    California thinks you shouldn’t be allowed to see your OWN fingerprints (of the DNA variety) without a doctor’s permission. Last week, the California Department of Public Health sent "Cease And Desist" orders to 13 private companies that were set up during the last several months to provide curious individuals with information about their own DNA.   The crux of the letter is that California regulations "prohibit the offering of a clinical laboratory test directly to the consumer without a physician order, unless specifically exempt.  Genetic tests are NOT exempt." According to Karen Nickel, the official who signed the letter, "the genetic tests have not been validated for clinical utility and accuracy, and they are scaring a lot of people to death."

    One of the companies targeted by California is 23andMe, which has a scientific advisory board that includes some of the top geneticists in the country including Harvard’s George Church.  Send them $1,000 and a tube of spit, and they’ll provide you with a data file containing the specific DNA basepairs present in your  genome at 500,000 locations previously shown to vary among people in the world. Before the crackdown occurred, I took advantage of this service and had my own DNA scanned.   Here’s a tiny part of the data file that I got back, showing my genotypes (one letter comes from my dad, the other from my mom on each line) at just 10 locations in the middle of chromosome 9.

    rs3739795 9 101822934 TT

    rs4743380 9 101847100 AG

    rs7028939 9 101848506 AA

    rs10156395 9 101852863 TT

    rs16918878 9 101886451 CT

    rs7849323 9 101894009 TT

    rs12552646 9 101908296 CT

    rs12346672 9 101908590 AG

    rs846756 9 101923997 CT

    rs2787366 9 101934539 CT

    According to the California health department, it’s dangerous for me to see this information about myself without a doctor's permission.  Does this make any sense at all?   I can tell you that anyone willing to spend $1,000 for a file containing 500,000 lines with a bunch of letters and numbers (like those shown above) knows more about the genetic meanings of those characters than 99.9% of the doctors in this country.   And if you really are scared to death by the results of such a test, no one is forcing you to do it! As far as privacy goes, 23andMe and the other companies encourage clients to use pseudonyms on sample packages, so they have no idea who you are.

    This is a boutique product  being sold to individuals who are simply curious about their heritage and their predispositions to certain behaviors and other traits.  As 23andMe makes perfectly clear, “This service is for research and educational use only.” If you are concerned about certain results and you bring the information to your doctor to consider some sort of treatment, what’s wrong with that?  And if you decide to treat yourself . .  . well that’s exactly what millions of people do every day with dietary supplements after receiving bogus diagnoses on radio and TV, and no one stops them.

    But the thing that really angers me about Karen Nickel and her colleagues in California is that she really doesn’t understand what she is trying to regulate when she questions the “accuracy” of the product. The DNA information that the company gives you is more than 99.9% accurate (I’ve assessed it myself).  Some of these DNA variants can provide probabilistic assessments of your risk to certain diseases (which you can look up on the internet).  Those assessments -- whatever they are -- are a hell of lot more “accurate” than the stuff routinely passed through the mass media. I think that the real reason Karen is so scared-to-death is that the new era of private genetic tests will almost certainly destroy a worldview (that she and others cling to) in which genes don’t matter at all.   And so like the Pope in Galileo’s time, she wants to stop the telescopes from peering into our own bodies, at our own molecules.

    Letter 

    Comments

    adaptivecomplexity
    Are you just getting DNA sequence, or is 23andME offering disease risk analysis? If it's just sequence, these California officials are nuts.

    It'll be interesting to see how this holds up in court. This is one steamroller the California Dept. of Public Health won't be able to stop.

    Mike

    Mike
    Lee Silver
    23andMe just gives you access to the same information that is already on the web.   Take a look at the SNPedia site, and you'll get an idea of what you can get out of the private DNA scans, so far.  In most cases, you're talking about 2x increases in risk relative to the normal population, although there are some examples that are much more extreme.   In a few years, the risk data will become much more sophisticated, and there will be more genotype-specific therapies.  But for the moment, what you get mostly is a chance to satisfy your curiosity.  (I discovered some fragments of Chinese DNA that almost certainly made their way into my otherwise-all-European family tree 200-300 years ago. Pretty amazing.)
    adaptivecomplexity
    Karen Nickel and her crew should not stop people from simply getting themselves genotyped, since that's a resource people can keep forever and use when health risk prediction is better. And like you said, your DNA is your DNA - you shouldn't need permission from a physician to get it sequenced.

    But there will have to be a period of adjustment between regulators and these companies - some of the claims being made, or even just implied, by these companies seem to me to be misleading. The Navigenics web site header says "Your genes offer a road map to optimal health." With our current knowledge, that's just not right - no genome-wide SNP typing right now offers a clear "road map to optimal health."

    But the industry needs early adopters right now who are willing to pay the $1000 for the service - that's a good thing, and California's official shouldn't stand in the way.

    Mike

    Mike
    Hank
    Some of the business plans I have received from these companies made me ask when this was going to happen, because of claims like they will 'commercialize discoveries from GWA studies' from these SNPs. Not structural variants, SNPs.

    23andme should not be a target just because the founder is high profile but one thing Nickel has correct is that some people are making claims about this capability no differently than homeopathy companies do - and they're preying on the less educated when they do that, which makes the science look bad.

    I find it interesting that regular untrained people could become scared of seeing such a scientific paper. What needs to be done is ferret out the supposed "experts" and expose them as Scare mongers. It is idiocy, to think the Untrained could even begin to understand the genetic sequences, or DNA strand setup, not counting the understanding of how genes interact . I would think the Science community would bounce these "Frauds" into jail, or at least identify them to the public., such nonsense for the legal system to get involved, it wastes taxpayer money

    Hank
    I'm one of 5 conservatives in California but when they banned smoking without actually asking anyone in California to vote on it, my only issue with it (I am not a smoker) was that it would give governments the idea they can just do anything if they could claim it is in the interests of public health.

    We've had other 'health' laws that thankfully did not get implemented here, though car seats for 8 year old children and mandatory neutering for pets and making tanning salons for anyone under 18 illegal (*), probably haven't died yet.

    So this does not surprise me.

    I would also not be surprised if Google doesn't buy California in retaliation. The state is pretty deep in debt and Sergey Brin will have a lousy home life if he lets his wife's company get legislated out of business.

    (*)Foie gras laws - yes, we need to regulate how to eat our ducks, did get passed. I can list more.

    It's your DNA; why shouldn't you get to know something about yourself. Even if it's not perfect, it cuts down on guessing about who we are and what our options might be.

    The regulators are obsessed with DNA as a death sentence, which defines your exit strategy from life. So they want physicians to control whether you should know anything about yourself.

    But the fact is that almost all of your gens are, guess what, involved with your everyday life, not your death. Genes help define your personality, your physical body, and how you interact with your environment. The DNA blueprint is just that, a blueprint. What shapes who you are is what you do with that blueprint.

    If five brand new identical homes were built, after 20 years those identical homes would look very different. That's because how they're lived in and maintained becomes important.

    Same with your genetics.

    Researchers are finding how DNA influences everyday things like dance, how we love, how we learn from experience, food tasting, how we react to events in our life and a host of other valuable things.

    Fredric

    Lee Silver

    Yes, I agree.   I like the metaphor of DNA being a "recipe" rather than a blueprint, since different products of the same recipe are similar but not identical.

    Lee 

    Mixed bag on this one - on the one hand, the intrusion of the state to stop the mere reading of the encoded genetic data does seem ludicrous at first glance. Absolutely, there should be no obstruction by the state to prevent a person from accessing their own, most personal information. On the other, while such services scream caveat emptor loud and clear, and it is ultimately up to the consumer during the decision to use a particular sequencing provider to exercise due diligence determining the accuracy and legitimacy the outfit they're dealing with, based upon the import of the information being generated, some sort of minimal standards or licensing to deter fly-by-night, slipshod, or even downright predatory operators seems well within the scope of generally acceptable governmental public safety involvement.

    An alternative approach is for the state to set definitions and standards for the controls and procedures in place, and operations wishing to gain 'certification' or 'accreditation' that their procedures met standardized guidelines and procedures for developing the sequencing information, with a demonstrated accuracy rate could then cover the cost of independent, outside verification (by either governmental or private inspectors), which the reputable providers would proudly display.

    Keeping the public from knowing their own bodies' information? Not the Government's job. Helping ensure that the public is being well served as opposed to just being fleeced? The argument is there that government does have a role to play.

    Does the Cali Department of Public Health understand or care about the distinction? Not sure, and many would say probably not. It certainly looks doubtful given the ham-handed approach they've adopted so far.

    Lee Silver
    Keeping the public from knowing their own bodies's information? Not the Government job. Helping ensure that the public is being well served as opposed to just being fleeced? The argument is there that government does have a role to play.
    I agree with your distinction and I think voluntary certification is a good solution in situations where there is evidence that members of the public are being harmed in a substantial way.  But as far as I can tell, there is no evidence that any individual client of a Whole Genome Scanning company (23AndMe, Navigenics, or deCODEme) has filed a complaint, and no evidence that anyone feels they've been fleeced by these companies (even though they've paid ~$1,000 to get the data).  On the other hand, astrologers, palm readers, and other pyschic scam artists fleece California residents every day and (I suspect) cause some people to act in ways that really are detrimental to their health.   So here's the question:  why is California so worried about people getting genetic information (which is real), and not so worried about people getting  psuedo-science nonsense that is known to be harmful to at least some members of the public??  Either Karen and her buddies think the human genetics enterprise is fradulent, and/or she's scared to death that her anti-genetics worldview will be shown to be false when people actually gain some knowledge they can use.  If someone can provide an alternative explanation for California's behavior, I'd like to hear it.
    OK, coming to the party real late, I realize, but what does this statement mean?

    "I think that the real reason Karen is so scared-to-death is that the new era of private genetic tests will almost certainly destroy a worldview (that she and others cling to) in which genes don’t matter at all."

    What worldview is that?

    Thanks.

    James Ph. Kotsybar
    Perhaps the solution could be as simple as the astrology technique of adding in fine print that "Looking at your genetic code is for entertainment purposes only."  a Miss Cleo will emerge to champion the cause.