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back to article Bad genes? US watchdog halts 23andMe's handy home DNA test kits

Vanity DNA testing company 23andMe has hit a major roadblock, having been told by the US Food and Drug Administration (FDA) that it must stop selling its personal genome testing kits. Backed by Google and run by Anne Wojcicki, the estranged wife of Google cofounder Sergey Brin, 23andMe has marketed its Saliva Testing Kit and …

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Anonymous Coward

Without a testing kit

I can already see that there is some bad blood between those two.

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Fuck off FDA! They're my genes, not yours.

There should be a loophole though. As far as I know it's still legal to do gene testing as long as you don't attempt to interpret the results. Just return the raw gene information. Then a separate outfit could tell you "for educational purposes only" what a given bunch of genes might indicate.

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Anonymous Coward

The medical lobby wants more money.

I have had this test, its very clear when they present the results that you cannot make a diagnosis based on this.

A number of countries restrict access to DNA testing, France for example.

It is based on the argument that people are too stupid and ignorant to make decisions for themselves. In many cases this is true but it doesn't mean the rest of us should not have access to interesting information.

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The word you are looking for is "cartelization".

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The main problem is really just down to marketing here. 23andme are over emphasising the reliability and importance of their tests. They need to go to much greater lengths to explain that the tests are just suggestive indicators and not guarantees of immunity or death from certain conditions. Perhaps where there are any potentially serious results advise or even provide proper medical consultation from a doctor.

This is where regulation would be a good idea, to ensure proper unbiased medical advice.

I would use their service if it were available in this country, but really more for curiosity than medical paranoia.

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Now Google has a crappy gene test...

...to match their increasingly crappy search engine. You have to put quotes everywhere, even quotes won't work, garbage returned that doesn't have ANY of your terms, cache that no longer shows coloured terms (Bing, bless their incompetent souls still has ONE thing right, however trivial), horrible youTube changes...

Did I mention the search engine is crappy? Well, what do you expect from glorified internet PR flaks? Search? wtf is that?

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Trollface

In case the administrator comes around

You better get the shill that goes Bing!

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Big Brother

The nanny state minding people's own business again?

Yep, can't have these folks draw bad conclusion by themselves or exhibit judgement. I mean, where would we be when world&dog could be relied upon to get non-government approved information or even (GASP!) a second opinion. Better let the appropriately regulated medical profession take the bad conclusion and send the patient ad patres by prescription of a fully inappropriate treatment.

Remember folks: too much information can hurt you, in particular knowing what the government is up to can result in serious reduction of life expectancy.

Now be a good boy and girl and stand in line for a dose of Obamacare, whereby WE decide what is insurance and how much you will get. What's that? No longer eligible for any insurance whatsoever? Tough luck, but remember: its for your own good.

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Re: The nanny state minding people's own business again?

It's not really about it being government approved information, it's about misleading or confusing people into thinking they are or will become seriously ill by providing an improperly explained genetic testing service without unbiased medical advice.

The service is sold as a method of finding out if you have or could be at risk from various serious medical conditions. But the results provided are likely to scare people into radical unnecessary treatment because they are presented as answers not just indicators, without proper medical advice.

I'm not a fan of governments controlling everything or restricting information, but ensuring important things like medical care and testing aren't improperly advertised/represented and come with suitably qualified advice, , that is something they definitely should be doing.

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Second opinions

Often lead people to go for "remedies" that are proscribed by naturopaths or homoeopaths. You know, remedies that have about as much chance as effectively treating the condition/illness as placebo.

But I do believe the FDA should also be targeting the aforementioned naturopaths and homoeopaths, as well as "faith healers" if they are truly worried about people getting the wrong information and/or ideas about their health.

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Re: The nanny state minding people's own business again?

> likely to scare people into radical unnecessary treatment

Right, so who is going to carry out said radical unnecessary treatment?

It's not like you are going to get the test results; nip off into the kitchen for a quick DIY mastectomy

No you would visit a honest to dog sawbones & one would hope they would set you straight before anything tragic happens.

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Re: Second opinions. My enemy's enemy is my friend

> Often lead people to go for "remedies" that are proscribed by naturopaths or homoeopaths.

if it is /proscribed/ by a homeopath, maybe it is not all bad... :-)

> You know, remedies that have about as much chance as effectively treating the condition/illness as placebo.

Ironically, placebo is the one area in which there could be said to be solid evidence for the efficacy of alternative therapies.

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Re: The nanny state minding people's own business again?

"Right, so who is going to carry out said radical unnecessary treatment?"

It is my understanding that there are a great many plastic surgeons, particularly in the good old US of A, who will do things like a double mastectomy simple because you asked and have the money to pay.

Or the person might have a GP who is an old quack and takes the fancy genetic testing results at face value and gives a prescription.

I'm not suggesting in either of the above cases that the fault does not lie with doctor rather than 23andme, but regardless the situation could still occur.

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So this is illegal while all the homeopathy and natural supplement crap is still legal? What?

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Boffin

where's the sequence...?

The FDA may have a point here. I remember going to a talk from one of the prof's involved, and left feeling a little bit like it was over simplified.

Now if the company want to sequence my DNA and send me a URL to download the results, and THEN if I want them to analyse them, sure. I can get 30 different analysis quotes...

But far too much of the FUD about DNA testing is the simple fact that we have only sequenced a vanishingly small percent of humans ALIVE, COMPLETELY (both alleles).

The distinction for non-biologists is confirmation bias, since you can only have alive patients , deleterious mutations are hard to predict.... Some of the relatively homogenous populations of the world (say Iceland's) can lead us to think DNA is simple so leading to these "cheap" tests. I believe they just test SNPs, not exomes or whole genomes. These techniques can be VERY powerful but you need a lot of other information to be sure.

What is needed is for proper legal protection for what is found in every human's genes, worldwide. It is the most basic form of discrimination that you cannot choose your parents, and so there should be blanket protection. In this way sequncing DNA and therapeutics can be developed for the benefit of all, not just companies looking to lower medical costs, insurance companies looking not to pay out, and governments finding ways to denying human rights to citizens, or the inevitable scam markets. If you wish to have a proxy handle your data (e.g. your doctor) fine, but don't tell ME what I can do with MY data.

I'll end on a computing analogy for El reg. If you were called to fix my computer and I gave you the hardware details, the bios, the OS version, all the software installed, but did not tell you what work I did on it, you would be hard pressed to categorise any failings without observing the computer directly.

Think of that the next time you see your doctor, and think what you have done with your DNA that you cannot hope to explain... (this is epigenetics..)

P.

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Re: where's the sequence...?

Yes. The FDA does have a point. As generally useless as that agency is, they do occasionally have valid points.

You can have all the disclaimers and common sense explanations as you want, but the second you start talking about people's health any sort of rational thinking goes out the window. It's a very emotional thing.

That being said, the FDA is notoriously biased toward big pharma. They selectively apply regulation and push their mandate so close to the edge it's ridiculous. So while a biomed startup catches hell for providing people with information about their genetic makeup, a big pharma company can run intense multimedia marketing campaigns that attempt to scare people into going to the Dr and requesting a certain drug for symptoms they didn't know were symptoms until they read the magazine ads, TV commercials and radio spots.

I guess my problem with all this is that while the FDA is right in being concerned about problems from massive misinterpretation of the data they're OK with pharma companies deliberately forcing consumers into misinterpreting common side effects of being a Human into signs of a serious disease or condition. I just don't like unfair practices from any government.

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well-established international measurement standards

"... warfarin dosages should be assigned based on well-established international measurement standards under a doctor's care ..."

Is that a standard like the total bullshit Body Mass Index (BMI)?

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It seems like some of the posters here have never even done or seen any DNA test, so are making claimes that are just rubbish.

I've had this test done, and noted no misrepresentation on what I may or may not have. Not even close actually.

Ajacent to each DNA marker, is a reliability index based on the number and type of studies that have been done on that marker. All it states, is that of all the people tested with that marker, x percent have a particular disease, and the following studies have been done to show this. No more, no less. It doesn't mean you have that disease, it doesn't mean you'll never get it, if you already have it, it doesn't mean the DNA marker is responsible for it. Or not.

It is merely a statistical indication. No medical practitioner is going to base a cure or treatment on DNA statistics - believe it or not, they base it on YOUR OWN chance, based on your CURRENT actions. Shocking. They might recommend that you lay off your daily diet of pork chops - but shockingly, they're going to do that even if you're not statistically susceptable to heart disease.

As far as I can tell, the FDA is trying to enforce a "caution, coffee is hot and may burn your lap if you spill it" disclaimer - mainly because people are idiots.

The same idiots who go to herbmongers who "prescribe" a diet of specific herbs and spices and state that will cure their cancer. Yes, they're still around. Yes, both the herbologysts and more so, the idiots.

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Unhappy

I wonder how many people understand the difference between "may" and "will"

Because that's at the core of this.

I think a lot of people are walking around with assorted dodgy genes.

Nothing will happen to them and provided their spouses don't have them nothing will happen to their children. It does mean they should watch certain behaviors and avoid exposure to certain things.

But apparently this is all a bit complicated for a lot of people.

Explaining this seems to be a large part of what "genetic counseling" about.

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Does the FDA consider a hair cut a medical procedure?

In my opinion a medical procedure is something done to living tissue of the body NOT something done to an extract/secretion. If the dna kit is acting on a swab sample there is nothing 'medical' about it. likewise testing a stool sample is not 'medical' but instead a biochemistry procedure. However an allergy test that you apply to your skin is medical, as is any cream ointment or tincture that is likewise applied to tissue (that includes water sold as treatment homoeopathy).

Of course this is only my opinion, and not that of the FDA.

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BJS
Stop

In the USA, ONLY the FDA is allowed to give you false positives and false negatives

They have a long history of doing so. And they have the revolving-door money to back it up. They don't want any disruptive competition.

After all, gravy trains should be assigned based on well-established international standards of "public-private cooperation" under a lobbyist's care, and if consumers dare to modify their sources of health information based on the results of 23andMe tests (or anything outside of the medical-pharmaceutical-insurance complex), they could put executives of said complex at risk of serious financial losses, lawsuits, or even imprisonment.

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