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.