New York State Regulators Want Consumers to Stay Ignorant of Their Genetics

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As a happy purchaser of direct-to-consumer genetic testing, I am very glad that I don't have New York State health bureaucrats telling me what I can and, more importantly, what I cannot find out about my genes.

genome

As GenomeWeb News reports:

Despite claims by direct-to-consumer genomics companies that they should not be regulated as clinical laboratories because they provide educational information about genetic risk, the New York State Department of Health is regulating such facilities as laboratories, according to a state health official. …

Currently, New York State law requires that all laboratories testing human specimens must first obtain a permit in order to operate in the state. The law also states that labs can only order tests at the request of a state-licensed physician, who is not employed or financially compensated by the company that will perform the test….

This has implications for 23andMe's highly publicized "spit party" last year, in which the company collected saliva samples from celebrities in order to raise awareness of its genetic-screening service.

"We have told 23andMe repeatedly that without a NY license, any samples collected in the state have to be destroyed. We've been assured that this has been done," Willey said. "Of course, we've not confirmed that the samples have been incinerated."

This is just the latest manifestation of medical paternalism. The idea is that people just can't handle the truth (whatever that is). But history shows that people learn to use new technologies and new information through a process of trial-and-error. Slowing that process down just makes it more socially painful. The good news is that genomic testing will be available offshore if it's outlawed here.

Reason has been opposing this kind of medical paternalism over genetic testing for a long time. 

Disclosure: I am a customer of 23andMe's genomic testing. The type of information that New York State bureaucrats would deny me is that I have genetic variants that decrease my risk of rheumatoid arthritis and increase my risk of celiac disease. I personally found the information very educational. In a future article I plan to reveal all of my known genetic flaws. 

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  1. I don’t understand the reason labs would have to get a physician’s orders to run any tests. Is it an insurance thing?

    I mean, I am sure I could ask my PCP and he would be happy to give me an order if I wanted these tests, but why should he have to?

    Anyway, let’s hope this doesn’t spread.

  2. Shilling for Big Genome!

  3. I don’t understand the reason labs would have to get a physician’s orders to run any tests.

    Is this where the Libertarians are grown?

  4. In a future article I plan to reveal all of my known genetic flaws.

    That’s fine. But please don’t post pictures of your colon. Thanking you in advance.

  5. ed: You can go here and scroll down to see a nifty picture of my heart from a 64 slice CT scan. 🙂

  6. Ron: As a fellow 23 and me customer, let me just say that I have two working copies of the ACTN3 gene. If you do not also, I can crush you at my whim.

  7. “ed: You can go here and scroll down to see a nifty picture of my heart from a 64 slice CT scan. :-)”

    Wanna see inside of me?

  8. Cool, Ron. Hearts I can handle. But I’m going into my colonoscopy with a blindfold on.

  9. In a future article I plan to reveal all of my known genetic flaws.

    Ron, we already know what you look like, so you’ve revealed a bunch of them already.

    ZING

  10. ed: You can go here and scroll down to see a nifty picture of my heart from a 64 slice CT scan. 🙂

    Ron, that heart can’t be yours. Your previous post applauds depriving the poor of water. You are clearly heartless.

  11. trail-and-error?

    Pube shaving gone wrong. Very sad.

  12. New Jersey’s motto: Spit free or die! I can see Hoboken making millions off genomic-info-starved New Yorkers.

  13. Nick: Damn! Fixed.

  14. Many of the rules on clinical labs came out of the Medicare Fraud wars. Doctors would send samples to bogus labs who would charge exorbitant prices while outsourcing the actual lab work to cheaper, legitimate labs. Other unscrupulous labs would run blood samples just to jack up the bills on public aid. State licensure was also installed to assure minimum standards of reliability and proper waste disposal. All well-intentioned, but not really relevant in this case.

  15. That’s true of many of the rules, but NY’s rule requiring a prescription for diagnostic tests (does not apply to self-tests like DIY pregnancy testing) on specimens is not on that basis. It was just thought that consumers don’t know enough to order only necessary tests, and that labs might otherwise oversell diagnostics. Requiring that the specimen be tested, or even taken, only by persons or labs registered to do such business in NY (not necessarily physically in NY) is supposed to be a quality control measure. Several other states have similar laws.

    Courts in NY have ruled that just about any physical “sizing up” of a person or animal is diagnostic, even if not directly related to diseases. There is an implicit exemption for religious purposes such as Scientology and fortune telling when no specimen is taken out. NJ has a broader exemption for faith healing.

  16. What? Huh? I thought only Republicans were against science?

  17. Another “out of the Dark Ages” example. (psst…..there really are little invisible things called germs that cause disease!) Catch up to the 19th century!

  18. I have been working with direct-to-consumer DNA testing companies since 1997; providing DNA testing to assist consumers with questions regarding their ancestry, unborn child’s gender, paternity (who’s the father), and other biological relationship tests, such as siblingship, grand-parantage, and etc. Maneuvering around the New York State laws had always been a part of the industry. Turning away business from NY State residents also proved to be difficult at times. Questions such as, “Why do I need a doctors prescription to get a paternity test or an ancestry test when I can buy a kit from a Rite-Aid store in New Jersey off the shelf?” Residents of New York would sometimes get very angry at our client support because they were not allowed to order a non-medical ancestry test for their own personal research purposes. Many found workarounds – requesting the kits to be sent to other states, or having a friend order them for them. But for most, the question, “Doesn’t my doctor have more important things to do then write a prescription for a DNA paternity test?” comes to mine, especially after requesting the prescription from the doctor only to have the doctor decline writing it because he/she has never heard of such a thing. This was a too common encounter. Possibly NY State should consider re-evaluating their regulations governing DNA testing.

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