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
    Oliver Wendell Jones, 17 Jun 2008 @ 7:38am


    I used to work in a hospital laboratory, back before HIV became the issue it is today - back when it was "safe" to work around blood and bodily fluids...

    When I transitioned through the Serology department, the first thing they taught me was "when a patient calls and asks about the results of the test(s) - you tell them to call their doctor - you never, ever, ever give results directly to a patient".

    I asked why and the answer (which now seems obvious) is that you don't know the context in which the test was performed - you don't know if the patient wants a positive or negative result and you're not trained to tell a patient that (s)he is positive for a life-threatening disease, or that the couple who have been trying for 30 months to conceive don't want to hear that their pregnancy test result is negative. You can't always assume that what you think is good news is what the patient wants to hear.

    If you take a cheek swab from your infant and send it on for DNA profiling, do you want a form letter printed from a computer that says "Your sample show a high probability of a crippling genetic condition and you will be lucky to live long enough for a second birthday"? Or would you rather have a doctor explain it to you and be there to answer the questions that you are no doubt going to have?

    I don't necessarily agree that it needs to be a law that doctors have to be involved, but there are good reasons for wanting a doctor to be between you and the lab.

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