Why Do You Need A Doctor's Note To Get A Genetic Test?

from the makes-no-sense dept

There have been a bunch of personal genetic testing services popping up over the past couple of years. One of the most well known is 23andMe, who got a PR lift for being founded by Sergey Brin's wife -- and also getting an investment from Google. Typically, the program lets people send in a cheek swab and receive back personal genetic info. These services are still in their early stages, but the few folks I know who have used 23andMe have found it to be an interesting learning process. However, now it's coming out that 23andMe and other personal genetic testing services may actually be breaking California law. California has sent a bunch of these firms cease-and-desist letters demanding they close up shop until certain conditions are met.

Apparently any labs doing the tests need to get both state and federal certification and can only do tests based on a physician's recommendation. The state claims it sent the letters after receiving "multiple consumer complaints about the accuracy and costs of genetic testing advertised on the Internet." This seems quite questionable for a variety of reasons. First, if people have "complaints" about the costs... then the proper response is to simply not buy the test. I have complaints about the price of Ferraris, but I'm not going to complain to the state of California -- and I doubt that the state would send cease and desist letters to Ferrari dealers.

Secondly, it seems quite ridiculous to say that these sorts of tests can only be taken with permission from a physician. There seems no reason not to let those who are willing to pay the associated fees to get a personal genetic test without involving a physician at all. As we move more and more towards more personalized medicine, this problem is only going to come up more and more. Not all medical tests and treatments need to be done under a doctor's care -- and requiring it in all cases seems more like a way to protect physicians' fees rather than citizens' health.
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Filed Under: california, cease-and-desist, genetic tests
Companies: 23andme

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  1. identicon
    Doctor, 17 Jun 2008 @ 12:37pm

    Re: Interpretation

    I believe the article has really gotten some bad press.

    For some reason everyone seems outraged that the government wants to try and protect them.

    Aside from all the misdirected comments about the norm of getting orders for largely medical procedures.

    Has anyone ever considered that this is a good thing? That by mandating government & medical oversight we are stopping companies from mandating genetic screening as part of the hiring process, or insurance companies from requiring it as part of the application process?

    Can you imagine if genetic screening entered the free market? This is totally unlike drug testing or pregancy testing. Both of which are temporary personal choice conditions. Did some drugs in high school? Thats ok, just stay clean for a while and they won't show up on your record.

    With genetic testing, your make-up never changes, one test and someone could potentially see your risk for all types of cancers or defects. Would you or even your kids or grandkids want to be discriminated against based on your genetic makeup? Because thats what you're asking for if you side with this entering the free market.

    If you regulate it then companies can't touch it, and if they try then there are a lot of necks to wring if something bad does happen to the public.

    To the comment on FDA approval.

    I used to work for a pharmaceutical company. Trust me, "cures" and "experimental procedures" are thought up by marketing departments. R&D is literally mixing stuff together and testing it on rats to see what it does. If your uncle was dying of a disease and they didn't want to let him try an unapproved research medication it was in his best interest. Subjects dying of disease are a research protected population since they are so willing to try anything.

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