California’s Department of Public Health has issued cease and desist letters to 13 genetic testing startups - most notably 23andMe, which Michael tried out earlier this year. The C&D’s are mandating that the labs demonstrate that they have been certified by both the state and federal government, and, perhaps more importantly, that all genetic tests were ordered by a patient’s doctor, which is required by state law. 23andMe is going to have a little trouble with that one - Michael was never asked to consult his doctor before ordering his test results.
California isn’t the first state to take the genetics companies to task - earlier this year New York cracked down on the sites with similar complaints.
But what’s the big deal? Required state and federal certifications seem obvious given the sensitivity and personal nature of the data. But what about the mandated doctor’s note? It’s my DNA - shouldn’t I be able to read about it whenever I want?
Maybe not. The problem with this kind of casual DNA testing is that it almost trivializes the importance of genetic information. 23andMe considers itself as something of a novelty, providing lots of fascinating information that it says isn’t to be used to diagnose medical conditions.
Of course, the site still provides some probabilities of getting certain diseases. And while none of these sites are going to offer any life-shattering information (e.g. “You will die before you hit 30″), many health care professionals worry that any amount of genetic information could be misinterpreted. What happens when a patient finds out they have a lower-than-average risk of heart failure that leads them to neglect regular checkups? Then again, it’s my information - shouldn’t I be free to (mis)interpret it as I see fit?
The fact of the matter is that genetic testing will be commonplace within the next decade, and the outcome of these cases will be setting important precedents. New York and California may be misguided in their efforts to mandate a doctor’s approval, but we should remember that these are two unusually progressive states that don’t seem keen on hampering citizens’ rights. Regardless of the eventual outcome of these cases, there’s one important message we should take from their hesitation: tread lightly.
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California isn’t bad at all compared to Canada.
Why not judge the C&Ds on the merit’s??
Did you have a doctor’s prescription to get the test Mike?
Facebook sent me a C&D based on NO Facts what so ever. Only suspicion.
Look at what this idiot regulator says according to the New York Times:
”We think if you’re telling people you have increased risk of adverse health effects, that’s medical advice,” said Ann Willey, director of the office of laboratory policy and planning at the New York State Department of Health.”
What a complete bunch of horse shit. Are all these regulators in the pockets of the medical profession? There is not need for empirical evidence to be interpreted by an MD? You’re telling us that we can’t interpret our own over-the-counter pregnancy test. I need some fucking MD to tell me I’m pregnant and what the consequences of that is?
Anne Wiley, you’re a pathetic tool. I didn’t know there were so many mickey mouse universities handing our PhDs. What a joke this country has become. Yeah. Like we need doctors to protect us about as much as we need lawyers to protect us.
We won’t provide you healthcare for free, but we sure the fuck will tell you who you must buy it from.
I need a doctor right away to come to my house and give me a prognosis after she reads the thermometer in my ass.
“Michael was never asked to consult his doctor before ordering his test results.”
NM. at any rate, you didn’t know you were breaking the law.
Its about time the gov’t stepped in and stopped the danger that is DNA testing.
Comment system stripped out my sarcasm tag above (I hope it would be obvious anyways)
Jesus! Now the state of California wants to drive away businesses. IDIOTS!!! 23andMe should open up shop in Nevada.
dd
sent from: fav.or.it [FID173935]
I don’t get what harm would come from using services like 23andme. And, yes, I’d travel to Las Vegas to get such a test done if I wanted it.
Jason, obviously you do not know anything about genetic diseases like Huntington’s chorea. If you have family history of that disease, you will either slowly degenerate around the age of 30 or stay healthy. This is predetermined at the birth and what will actually happen may be revealed by genetic testing.
For persons like that knowing results of genetic testing may have very serious consequences. Genetics is no joke.
Big deal. Some people are born with two heads. You using your logic, it would be better not to tell them.
@Artem
Thanks for the condescending comment. I actually majored in Biology and took many courses on genetics and the ethical implications of genetic testing.
I agree that genetics are no joke, which is the message that I hope readers of this post will come away with. Honestly, it scares me a little. But 23andMe is using SNPs for their testing, and they aren’t looking at any of those mono-gene diseases like Huntington’s. The worst thing anyone is going to come away with is the knowledge they’ll have a possibly increased likelihood of developing something like heart disease or diabetes.
At the same time, it might not be wise to let people get comfortable with the idea of genetic testing in the first place.
Ok, thanks California for not letting me know facts about my own body. Thanks a lot! I guess I’m too stupid to look at these results myself and make my own decisions. So, now I have to go wait at some clinic and pay my doctor $200 just to order the same $1000 test.
Plus, I guess he’ll get the results and not me. Then I’ll have to pay him another $200 to “interpret” the results and give me a 5 minute lecture on why I shouldn’t eat at McDonald’s so much.
Thanks California! Now keep your freaking government bureaucracy out of my body!
We won’t provide you healthcare for free, but we sure the fuck will tell you who you must buy it from.
C&D for 23andme was inevitable. why they lasted this long is the surprise here. even though they maybe “innocent” and trying to do us no harm but many more companies using genetic testing could do a lot of harm. this is an area that needs to be regulated to protect the consumers from fraud and outrageous claims and making horrible choices based on technology and information that is not very well understood today.
“It’s my DNA - shouldn’t I be able to read about it whenever I want?”
Answer = yes
“The problem with this kind of casual DNA testing is that it almost trivializes the importance of genetic information”
Answer = yes but see previous point.
I honestly have to say that I have never seen a debate that is a more useless waste of time. If you don’t want to know don’t ask. Next thing they will start testing Fortune Tellers and if they are more than 50% correct you will have to have a doctors note. Sigh…
Yes of course the state of CA is way out of line.
Shiiiiiiiiiii . All they have to do is move their head office to Ghana or some obscure country . Its all done over the internet right …
Do the police need a doctor’s not to take your dna???
i meant doctor’s note!
I think one of the reason laws like this are being put into effect is that when you are young, Schools put you through many assemblies and talks about this disease and that disease that could kill you, but you are too young to realize that just because you have Symptom X, doesn’t mean you absolutely are going to have disease Y (And the correlation is embedded in the back ofyour brain) . And then when people get these kinds of tests, they over react if they don’t have someone to remind them that Symptom A =/= Disease B. The same effect probably takes place in a lot of events (friends, family, media, etc,etc)
Nonsense. Both progressive and conservative states hamper their residents’ rights.
Government overstepping their bounds. They should not legislate morality. I would never participate in such testing, but consenting adults want to participate, the should let them. California has some really fucked-up laws.
Next thing you know, they’ll tell me I can’t put a substance in my body.
Or, that I can’t marry someone of my own sex.
True Americans, like Thomas Jefferson, are rolling over in their graves.
I’m no fascist and will never move to CA.
@7, The test is MAILED Scoble. MAILED. So are the results. Your comment about traveling to Las Vegas was comedic to the max.
Live cam on opening the result envelope, and you cry for the audience, right?
My mystical powers of prediction are extra-ordinary!
Better just play with online data and leave life alone
What right does the state of California or New York to negate the judgment of one’s mind and tell him under what circumstances he may be allowed to have his DNA sequenced? (The fact that some may choose poorly is irrelevant–it is a government’s job to ensure that men are free to make their own choices and act on their own judgment.)
I hope that 23AndMe will simply refuse to comply with this vicious nonsense–and simply respond by withholding their services in areas where backward governments choose to make it harder (or impossible) to do business.
[quote]
# Artem
June 17th, 2008 at 7:40 pm
Jason, obviously you do not know anything about genetic diseases like Huntington’s chorea. If you have family history of that disease, you will either slowly degenerate around the age of 30 or stay healthy. This is predetermined at the birth and what will actually happen may be revealed by genetic testing.
For persons like that knowing results of genetic testing may have very serious consequences. Genetics is no joke.
[/quote]
Yes that is EXTREMELY true. Now, agreeing on that point, what part of my knowing if I have the condition or not is any of your OR the governments business?
Why is it better in your view that I DON’T know whether or not what happened to my uncle will happen to me? Unless of course I give a local doctor a fee to find out?
What?
Why don’t you try again to defend that, This time without your false sense of superiority.
genetic testing is such coarse-grained stuff compared to the subtlety of reality
and doesn’t cover a lot of what goes to make up a person’s life
sort of like early cyrstal set radio, compared to the internet
Other than the required “doctor’s note” which we all seem to think isn’t likely to hold up, we *should* be concerned that the organizations that are doing this work on our behalf are certified.
Labs that do this in the diagnostic realm get certifications like CLIA etc. for good reasons. DNA genotyping and sequencing technology some years away from being foolproof and the consumers do need some assurance that the information they are receiving is correct.
Another issue that needs to be broached is genetic counselling - what does it all mean and what do you do with the information? You might be surprised at how few docs are ready to utilize this information.
jos
No problem, just move the company abroad. I guess Larry can offer some help….
Old-school, conservative western medicine believes that: 1.) the patient is an idiot, completely incapable of any rational thought, 2.) only the practitioners themselves have any hope of helping their patients, 3.) patients cannot and should not invest in their own health, 4.) their income is sacred and should not be threatened in any way, 5.) and finally, when they fail, they’re not responsible, after all, it’s the patient’s illness!
Its about time the gov’t stepped
As a quick aside. Your DNA picture is wrong! The DNA should have small groves and big groves, i.e. the spacing between the spirals should alternate between large and small.
Lobby, not government
@Jason
I am sorry for my comment, it’s just that the idea that your fate is predetermined at inception to some degree - scares me. And I think that people with a possibility of genetic diseases should go through professional help.
I did not know 23andme does not test for things like that, thanks for the insight!
I think someone’s shoving government regulation down our throats.
This is through the mail. If you have any friends at all, you can simply have them forward it to you, and forward it back through their address.
With all due respect Jason you seem to be missing the business point even though you majored in Biology. This is simply the Health Care Mafia of this country asserting their control to prevent openness, control, freedom, and lower pricing for the consumer. More control means more revenue less competition.
Medicine is an inexact sciences, and more knowledge consumers have will allow them to align their lifestyle, diet, and other environmental factors better. This is same as telling people what brand of bottled water , orange juice, and green tea they can drink.
The CA health department needs to stuff it, and actually there needs to be coordinated investigation of who is pulling these strings…. AMA, Insurance Companies, Big Phrama, Providers….or all cooperating to prevent competition.
It is all about control man, and not science. I think you missed that part. By the way I work in envirogenomics.
SORRY CALIFORNIA BUREAUCRATS,
But I don’t need YOUR PERMISSION to put my DNA under a microscope.
Has it occurred to anyone that this is kinda tit-for-tat with the GINA legislation to keep insurance companies from getting hold of people’s profiles?
Simple solution - single-payer health care, everyone gets screened because it lowers the cost of healthcare overall, and no one gets screwed by insurers dropping their coverage or by doctors trying to keep people from learning about themselves.
http://dirkschweitzer.net/DNATests.html
I am glad I already got my deCODEme scan done.
I spoke with a world-renowned human genetics expert a few months ago after articles about 23&Me and similar companies appeared in the national press.
Naturally, I wanted to know what he (the expert) thought about these companies, their profit potential, and their health value.
Of course, he was a bit biased in the sense that his research has led him to believe that nearly every human trait has a genetic component. But I still wanted to hear his opinion.
He suggested that companies such as 23&Me and other direct-to-consumer genetic testing firms fully expect that our susceptibility to certain types of advertising and propaganda is genetically-determined.
Which means that: the business plan for 23&me will be to offer cheap or low-cost genetic testing. When users log onto their sites to look up the results, they’ll be treated to ads for products that their genes make them want.
!!???!!
This may sound quite ridiculous. But…consider. Once your genetic profile gets into the hands of companies like 23&Me, and if you use Web tools like google that can track your behavior, then what’s to stop them from running the world’s most massive genetic association study, and use your data to find the SNPs and genes that influence your what you buy, where you travel, etc etc?
This business plan may be scientifically bogus, but I have no doubt that it is convincing enough to persuade advertisers and investors to hand over their cash, in which case it’s basically harmless. Marketing budgets get spent on all kinds of silliness. (My DoubleTwist Agent doll in his little lab coat is pretty awesome.) However, what if the business plan is not actually bogus? I can probably evaluate the risk myself, because I get to talk to world-famous genetics experts and ask them questions.
But the vast majority of people simply don’t have ability to check into these things. So I hope people will view this business with some skepticism and suspicion, and that the state will step in to protect those of us who didn’t have the time (or interest) to spend six years in graduate school and pursue a career in science.
BTW, I offer reasonably-priced consultation and interpretation service of one’s deCODEme and 23andMe results.
What’s to stop me from sending the DNA of my best buddy or my worst enemy and having it tested. It seems like that’s the big risk with 23andMe and the others.
What makes the government think the doctors have a clue understanding the genetic results. Went to the doctor with my report and received and blank stare and a Ohhh..
Perhaps Californians should consider a ballot initiative to guarantee their rights to see their own genetic make-up on their own initiative, with professional counseling available as an option.
It’s fine to have lab testing be done in certified labs, and to clamp down on false advertising. But that’s not the real issue. The key issue is choice - is the choice over how to find out about and interpret your own DNA yours or someone else’s?
You have the option of whether and when to use a travel agent or a real estate agent or a OB/GYN, whether or not you also book travel online, negotiate a real estate transfer, or take a home pregnancy test kit. Buying and interpreting a DNA test is logically equivalent.
Time for a ballot initiative?
I was wondering when this was going to happen. We work with many disease research foundations and help them with genetic testing in a CLIA certified environment that is certified and we provide genetic counselors so patients do not mis-interpret the results. Genetic testing isn’t a toy ….
There is too much room for covert DNA profiling without some regulations. I am not keen on living in a Gattaca-like society.
It is not surprizing that California begin to regulate activities of 23andme. Note that this company is far from beeing alone on this field: deCODEme, Navigenics, Genebase. Even in Europe, such companies are appearing (GeneTonix, Belgium).
I just started a blog about personal genomics, because in fact I think lots of people need to be more aware of several important questions about genetic testing… and also because there is some fun about it. For example: could the whole information included in my genome be recorded on my iPod? If you’d like to know the answer:
http://www.personomics.wordpress.com
However, on a legal point of view, as usual, countries are far behind the Internet. But some countries are more strict than other ones. Take that example:
In some european countries, it is legal to perform analysis on your own genome. BUT, it is *illegal* to go with your data to negotiate with your bank or your insurance company a lower mortgage for example.
I don’t think the debate should be “is it wrong or is it wright to perform DNA analysis?” but rather “In what conditions is it a benefit to get that information?”. The aim should be helping healthcare, not Gatacaing.
California has their head up their ass on this one. Physicians are no more qualified to interpret these large genome scans than the lay person who orders the kit. It takes a trained genetic counselor, geneticist, and/or bioinformatist to properly interpret these results. Companies such as 23andme translate the ‘genetic speak’ into ‘lay person speak’ much better than your doctor ever could.
Navigenics, 23andMe, and others also have in-house genetic counselors for further interpretation. Regulation is needed, but not the kind described with this C&D letter. Medical doctors are not the proper channel for this information.
As for advertising conspiracies to target your desires based on your genetics, I can assure you that scientists in this field are extremely diligent to prevent such occurrences. Myself being one of them. Even in the face of investors/share holders.
Anon., Ph.D.
this move by California is definitely NOT on the progressive side, to assume everything ca and ny does is progressive is nonsense, direct to consumer is a step in the right direction, ballot initiative would only be cool if the general public understands the issue
Absurd. This is our body and information about our body. We should control that, not the government, period. If our government wasn’t full of lobbiest pandering, immoral knuckle-heads I might take their advice (which is all it should be, advice).
woops…typo…make that ‘lobbyist’
@Arden - “What’s to stop me from sending the DNA of my best buddy or my worst enemy and having it tested.”
Well as someone that’s done the 23andMe thing I think getting your best buddy or worst enemy to spit up for five minutes into a small test tube might actually tip them off that something’s not quite right. We’re not talking about plucking a hair from their comb here.
As for the CA ruling, it sounds like the US is heading towards the nanny state that we have to put up with here in the UK. I hate to think what laws I’ve broken by not being a US resident and using a service like 23andMe if those of you over there can’t even query your own DNA without a Doctor’s note. I have no idea whether that same law applies in the UK.
For what its worth, 23andMe go to very great lengths to make you understand that the information they provide is not for diagnosis and is for personal use only. They outline very clearly both the reliability of research on their site (group size, replicated elsewhere, etc) and I think do a good job of pointing out that genetics is only part of the picture and the environment, and other things play a part too.
If after all of this you’re still going to self diagnose based on the results then you’re probably talking about the crowd that already self-medicate and think a minor patch of eczema is necrotizing fasciitis! Creating laws to stop you analysing your own DNA is not going to help manage that.
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