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aaaaaa5a

(4,667 posts)
Mon Nov 25, 2013, 08:40 PM Nov 2013

FDA halts sales of 23andMe DNA test kits

Source: USA TODAY

WASHINGTON (AP) - The Food and Drug Administration has ordered Google-backed genetic test maker 23andMe to halt sales of its personalized DNA test kits, saying the company has failed to show that the technology is supported by science.

23andMe's saliva-based test kit, launched more than 5 years ago, claims to tell customers if they are at risk for more than 250 diseases and health conditions. The FDA says only medical tests that have been cleared by the government are permitted to make such claims.

For years, 23andMe resisted government regulation, arguing that it simply provides consumers with information, not a medical service. But last year the company changed course, submitting several of the disease-specific tests included in its test kit.

Consumers order the company's $99 product online. Once the kit arrives by mail they are instructed to spit into a small tube, providing a saliva sample which is sent back to the company for analysis. 23andMe says the customer's DNA is analyzed to determine their likelihood of developing various diseases and responding to various drugs. The test also claims to provide information about ancestral background, though this information is not regulated by the FDA.

Read more: http://www.usatoday.com/story/news/nation/2013/11/25/23andme/3699329/

45 replies = new reply since forum marked as read
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FDA halts sales of 23andMe DNA test kits (Original Post) aaaaaa5a Nov 2013 OP
I just saw a commerical for 23andMe!! rocktivity Nov 2013 #1
Nutty? Why? Duer 157099 Nov 2013 #2
That's not what they're doing.... paleotn Nov 2013 #3
They claim no such thing. Xithras Nov 2013 #6
That is what the human genome is all about. lostincalifornia Nov 2013 #28
empowering people with medical info is one thing... paleotn Nov 2013 #37
I believe people can put the information in context for themselves marshall Nov 2013 #38
So you believe the government should restrict INFORMATION because people might not understand it? Xithras Nov 2013 #39
Well Said! KoKo Nov 2013 #18
Because there's no reason why you shouldn't be able to get that info rocktivity Nov 2013 #44
I hear their ads all day on XM. 7962 Nov 2013 #4
The health part is only a small part of the test marshall Nov 2013 #5
The FDA is being dumb on this topic, imho. The FDA needs to stick to regulating treatments. w4rma Nov 2013 #7
It's being marketed as a diagnostic kit jberryhill Nov 2013 #30
My concern about 23andMe HeiressofBickworth Nov 2013 #8
No, they aren't, and are up front about that. nolabear Nov 2013 #11
But...WHO is holding them Account for the Options you Didn't Allow...but, that KoKo Nov 2013 #21
Good lord, I'm, a 59 y.o. professional woman and mother. I'm not John Dillinger. LOL! nolabear Nov 2013 #26
But, what if you were upset about a work situation, your kids education KoKo Nov 2013 #29
As I said elsewhere, if the inclination is there it's not hard to do. nolabear Nov 2013 #42
Agreed. It does at least raise questions. aaaaaa5a Nov 2013 #15
Well, privacy with regard to genetic testing information is a major concern... BlueEye Nov 2013 #19
Even if they claim to be private Sgent Nov 2013 #20
There is no guarantee of whose DNA it is jberryhill Nov 2013 #31
yep me too and I thought maybe I was being a bit paranoid azurnoir Nov 2013 #32
Google money made this company. That's enough for me to doubt any privacy claims they make. Gormy Cuss Nov 2013 #35
crap... shanti Nov 2013 #9
I bought it, and am awaiting results. nolabear Nov 2013 #10
you got in under the wire-lucky! shanti Nov 2013 #12
Try familytreedna.com flyingfysh Nov 2013 #13
Can they determine your full ethnic background? nt. aaaaaa5a Nov 2013 #17
No, it's sex linked. Women go through their mothers and men their fathers. nolabear Nov 2013 #24
Both men and women can do the mtdna test marshall Nov 2013 #33
They report percentages of various ethnic groups flyingfysh Nov 2013 #41
Nat geo is a reputable company shanti Nov 2013 #34
Yeah, I'm sorry I can't trace my paternal grandmother for the same reason. nolabear Nov 2013 #23
I posted this because I found it interesting. aaaaaa5a Nov 2013 #16
I bought it too...the results make sense to me radhika Nov 2013 #14
So...You trust in them is complete? Even with the Revelations of NSA Spying KoKo Nov 2013 #22
Honestly, by the time this would be commonplace and used against people in some way nolabear Nov 2013 #25
True...You and I and our Families and Friends are not Terrorists...so KoKo Nov 2013 #27
I didn't say I don't care. I just think it's easy anyway. nolabear Nov 2013 #43
!$@!$%@#$ @!$@# !$!@#$..... DeSwiss Nov 2013 #36
More and more medicine is test based. Jesus Malverde Nov 2013 #40
I've had my 23andMe results since they started business Paulie Nov 2013 #45

paleotn

(17,778 posts)
3. That's not what they're doing....
Mon Nov 25, 2013, 09:18 PM
Nov 2013

...they claim their tests can predict one's chances of contracting 250+ diseases and conditions. That's bullshit. Detecting certain mutations in one's Y chromosome or mitochondrial DNA is a whole different ball of wax compared to what these charlatans are claiming. That's the reason for their delaying tactics that FDA is apparently fed up with.

Xithras

(16,191 posts)
6. They claim no such thing.
Mon Nov 25, 2013, 09:37 PM
Nov 2013

Their only claim is that they can identify whether you carry genes that have been identified as potential genetic components of various diseases. They don't identify your chances of getting them, but simply identify genetic markers that may predispose you to certain maladies.

For example, three journal published medical studies, published in Nature, the New England Journal of Medicine and the Journal of Human Genetics, have found that there are genetic markers that make childhood asthma likely (one found that each copy of the T gene at rs7216389 increases your childs odds of having childhood asthma by roughly 1.5x). Their test checks for these genetic markers and will let you know whether your child has them.

I can't find a single reason why empowering people with their own medical information is a BAD thing.

paleotn

(17,778 posts)
37. empowering people with medical info is one thing...
Tue Nov 26, 2013, 08:43 AM
Nov 2013

...taking money from people and giving them out of context info in return is not empowering. For even childhood asthma, as you mention above, there are many other factors other than just certain genetic markers. If you want to have that kind of info, more power to you but do it right, in context and with your physician.

Secondly, if they're so great why not come clean with FDA? Just tell them what you do and how you do it. It's not all that hard to simply come clean. Why all the secrecy and run around to the point that FDA slams them with cease and desist? FDA doesn't just hand those out like candy, you know. Tell me, why can't they come clean with FDA? Hmmmmm.

marshall

(6,661 posts)
38. I believe people can put the information in context for themselves
Tue Nov 26, 2013, 12:02 PM
Nov 2013

One of the FDA's grievances is that women might have unnecessary surgery or chemotherapy based on genetic results. How would that be done without the intercession of a physician? Do that really anticipate the development of black market back alley surgical centers?

People know what they eat and they know what sort of exercise they undertake. Many people know the health conditions of immediate blood relatives. People can buy simple machines to test their blood sugar level, blood pressure, etc. women can buy something to determine pregnancy. There are many ways that people today can access information about their health, and this is another tool.

I believe the real threat here is to the medical industry and the hagiographical treatment of doctors in our society.

Xithras

(16,191 posts)
39. So you believe the government should restrict INFORMATION because people might not understand it?
Tue Nov 26, 2013, 01:25 PM
Nov 2013

Remember that we're not talking about treatment here. We're not talking about DIY mastectomy kits, or empowering people to write their own asthma inhaler prescriptions. The only thing 23andMe is doing is providing INFORMATION. Nothing more.

There isn't a single medical decision that can be made from that information without the assistance of a doctor anyway. In fact, the FDA's idiotic public assertion that "women whose results indicate a risk for breast cancer, for example, could undergo unnecessary surgery or chemotherapy" makes zero sense whatsoever. Find me ONE doctor who would irradiate a patient, or remove her breasts, because an INTERNET BASED TEST told her that she might carry a cancer gene. There isn't a doctor in America who would risk the malpractice suits OR their medical license in a situation like that.

The reality here is simple. 23andMe undermines the FDA's idea that all medical information should come from a doctor, and it undermines the medical professions profit model. A DNA sequencing through your private doctor can cost you anywhere from $1000 to $5000, so having an Internet company offer the same service for $99 translates to a lot of lost profit for the medical community.

rocktivity

(44,555 posts)
44. Because there's no reason why you shouldn't be able to get that info
Tue Nov 26, 2013, 11:25 PM
Nov 2013

through a DOCTOR.

Besides, with Google involved, they'll probably end up selling your info to the Koch brothers anyway.


rocktivity

marshall

(6,661 posts)
5. The health part is only a small part of the test
Mon Nov 25, 2013, 09:34 PM
Nov 2013

I had the test and it correctly found two genetic traits in my dna that have manifested in my family, hemochromatosis and cystic fibrosis.

 

w4rma

(31,700 posts)
7. The FDA is being dumb on this topic, imho. The FDA needs to stick to regulating treatments.
Mon Nov 25, 2013, 09:45 PM
Nov 2013

Not, information.

 

jberryhill

(62,444 posts)
30. It's being marketed as a diagnostic kit
Tue Nov 26, 2013, 12:22 AM
Nov 2013

A "drug" within the remit of the FDA includes diagnostic devices.

HeiressofBickworth

(2,682 posts)
8. My concern about 23andMe
Mon Nov 25, 2013, 10:13 PM
Nov 2013

is a question of privacy. Is this an anonymous test, such as the HIV tests are (were?). Such personal information in the wrong hands can mean anything from loss of a job to identity theft and bank account and other financial theft. Their TV ads certainly do nothing to assure security, privacy and anonymity.

nolabear

(41,915 posts)
11. No, they aren't, and are up front about that.
Mon Nov 25, 2013, 10:25 PM
Nov 2013

They don't give information out but there are levels of permissions you can give for statistics and use if you don't mind being part of something. There's also the option of matching genomes and finding relatives. I didn't choose to participate in any of that, but I'm not overwhelmingly afraid of anything awful happening in the off chance my anonymity was breached.

KoKo

(84,711 posts)
21. But...WHO is holding them Account for the Options you Didn't Allow...but, that
Mon Nov 25, 2013, 11:29 PM
Nov 2013

they USED for their own means?

It's like NSA. Did we ever give them rights to do what they did? We thought we used Anti-Virus and Firewalls and Such to keep our Info Safe. BUT...we learned they were collecting the info through a Secret Back Door, anyway. And, now we find that they gave our information to anyone and everyone who could pay or worked for FBI, CIA, Homeland Security and Corporations and the rest to use at their will.

Our Privacy meant nothing. Who would be checking out to see that YOUR DNA hasn't been sent everywhere and is waiting in some police dept. if you ever get picked up for any thing in your life that comes under the Government, or your local Police Department's view.

nolabear

(41,915 posts)
26. Good lord, I'm, a 59 y.o. professional woman and mother. I'm not John Dillinger. LOL!
Tue Nov 26, 2013, 12:03 AM
Nov 2013

It's not that I can't imagine getting arrested but I'm hardly Arlo Guthrie, iykwim.

KoKo

(84,711 posts)
29. But, what if you were upset about a work situation, your kids education
Tue Nov 26, 2013, 12:14 AM
Nov 2013

or a Town Council Decision that took away your rights in some situation. Say you felt strongly enough about an issue that you joined with a group of women to protect kids/grandkids issues in some situatin and made a sign and protested to your Town or Cities Mayor or Council?

Maybe you felt so strong about an issue that you gave an interview to a local News Station and maybe some FBI agent got an "Iris Scan" of your eye from a photo...or used the new Photo Recognition on you and maybe one of your relatives or kids or grandkids got in some trouble and you and your family had to get involved legally...and got into a court case.

Remember...when NOTHING IS PRIVATE ....EVERYTHING CAN BE USED.

Think about it. Data Gathering is used for PROFIT THESE DAYS. Do YOU think the PROFIT IF for YOU? When they get it for free and can use it for anything ...once it's sold off? How would you know if and when it's sold off and for what purposes.

nolabear

(41,915 posts)
42. As I said elsewhere, if the inclination is there it's not hard to do.
Tue Nov 26, 2013, 02:56 PM
Nov 2013

DNA acquisition is easy for anyone who'd have enough interest and means. They don't need 23&ME.

BlueEye

(449 posts)
19. Well, privacy with regard to genetic testing information is a major concern...
Mon Nov 25, 2013, 11:28 PM
Nov 2013

Addressed in the 2008 Genetic Information Nondiscrimination Act (GINA). The law was supported by the Human Genome Project and NIH, and was co-sponsored by Sen. Ted Kennedy. It passed with broad bipartisan support.

http://en.wikipedia.org/wiki/Genetic_Information_Nondiscrimination_Act

In order for 23andMe to be legal, they had to disclose their business plan to the government and prove that the "genetic information" they produce for customers is totally confidential and would not be distributed to future insurers or employers. The key to the 2008 GINA law was preventing insurance companies from getting information about prospect customers and their potential for preexisting conditions which could then be used in a discriminatory manner. Even today, post PPACA, this privacy is a major concern and 23andMe is GINA compliant, according to their Terms of Service.

That is to say nothing of the accuracy of their results, of course.

Sgent

(5,857 posts)
20. Even if they claim to be private
Mon Nov 25, 2013, 11:28 PM
Nov 2013

they (and the individual) is a a world of hurt if someone sends the a supena -- in either civil or criminal proceedings (DNA matching).

They, nor the patient, have any right to privacy on that information and must release it. Compare that to test done through a physician for medical purposes -- which is privileged.

 

jberryhill

(62,444 posts)
31. There is no guarantee of whose DNA it is
Tue Nov 26, 2013, 12:26 AM
Nov 2013

Unlike a test administered in a clinical environment, there is no reliable indication that the person who paid for the test is the person whose DNA is in the sample.

This fact opens up some other interesting scenarios.

Gormy Cuss

(30,884 posts)
35. Google money made this company. That's enough for me to doubt any privacy claims they make.
Tue Nov 26, 2013, 01:06 AM
Nov 2013

Google is dismissive of the need for individual privacy with its own products. I wouldn't expect them to behave differently here.

nolabear

(41,915 posts)
10. I bought it, and am awaiting results.
Mon Nov 25, 2013, 10:21 PM
Nov 2013

If you purchase and register you can access the community on the website, where lots of discussion is going on. I'm not so much interested in genetic markers for health as ancestral background.

As far as I can tell customers want the FDA to back off, and are pretty well informed as to what they are getting. I was concerned that they wouldn't be able to process what they've got, including mine (should be done in another week or two) but that doesn't seem to be the case.

Several companies do this, and only if they're making false promises can I see shutting them down. Will people do things like prophylactic mastectomies based on something they see in the results? Probably. But people do all kinds of things for reasons that aren't easy to fathom. If they're being deceptive and the results are fake, then hell yeah, but that doesn't seem to be the case and I didn't think they misrepresented a thing.

I'm just hoping I find something really interesting to torture my sisters with back there.

shanti

(21,670 posts)
12. you got in under the wire-lucky!
Mon Nov 25, 2013, 10:30 PM
Nov 2013

i'd heard about 23 and me for awhile, but had been putting it off the test. when they lowered the cost, it made it more enticing. most of the other dna tests around are quite expensive for someone on a fixed income.

my brother would be the designee, as he is the last surviving male in our particular line. i'm trying to follow an ancestral line which ties us to a mohawk indian woman. she would be the only indian (that i know of) in our line, so if it shows up on a dna test, bingo! the health issue section is definitely of interest too, although i'm pretty sure what would show up.

flyingfysh

(1,990 posts)
13. Try familytreedna.com
Mon Nov 25, 2013, 10:40 PM
Nov 2013

They trace ancestry only, and already found a lady whose great-grandmother was a sister of my grandfather. I hadn't known his name or anything about him.

They also showed that my grandmother has North African ancestors; nobody in the family expected that, we thought her ancestry was probably Indian.

FamilyTreeDNA also does the genetic testing for the Genographic project, run by National Geographic magazine.

nolabear

(41,915 posts)
24. No, it's sex linked. Women go through their mothers and men their fathers.
Mon Nov 25, 2013, 11:51 PM
Nov 2013

It's father's father's father, etc. and the same for mother's mother's etc. So I guess you can do more if you have a sibling of the opposite sex by having him or her do it too.

marshall

(6,661 posts)
33. Both men and women can do the mtdna test
Tue Nov 26, 2013, 01:02 AM
Nov 2013

Mitochondrial dna is passed from women to all children, but it isn't passed by men. I had both myself and my parents tested. I am the same Y chromosome haplogroup as my father dna the same mitochondrial dna haplogroup as my mother, but my father has a different mtdna.

A woman would have to get a brother or father tested to get that information.

flyingfysh

(1,990 posts)
41. They report percentages of various ethnic groups
Tue Nov 26, 2013, 01:54 PM
Nov 2013

It also finds cousins from parents back 5 or 6 (I forget which) generations. And the report shows you exactly which parts of your chromosome match those of someone else you are looking at.

In the special case of mitochondrial (maternal line) dna and Y-chromosome (paternal line) dna, those tests allow you to establish relationships much farther back. But it also finds relatives who are not on either of those lines (most cousins are not)

You probably want to take the Family Finder test, it's only $99. In my case, it found hundreds of people in its database, inclulding fifth cousins. But anyone has lots of fifth cousins they don't know about. Most people are not in their database, but it will probably find a lot of your cousins who are.

nolabear

(41,915 posts)
23. Yeah, I'm sorry I can't trace my paternal grandmother for the same reason.
Mon Nov 25, 2013, 11:47 PM
Nov 2013

Though my Choctaw g-g-grandmother was well known so it's not really a mystery. Still, as far as I know we're largely Irish and English on both sides and I'd love to know what precedes that.

Also, my mother died when I was a kid and it's kind of a trip to have her lineage and reclaim her, in a way.

I'm a little old to worry too much about health issues, and in spite of the fact that everybody who died a natural death died of cancer of some sort there doesn't seem to be any rhyme or reason to it. I suspect I might be more disposed to that than heart disease (none in the family that I know of) but there are not any of the supposedly hereditary types. We'll see. I'm actually kind of pleased that I'm doing it.

aaaaaa5a

(4,667 posts)
16. I posted this because I found it interesting.
Mon Nov 25, 2013, 11:20 PM
Nov 2013

I am interested in doing this. I wonder if it will be available in the future?


radhika

(1,008 posts)
14. I bought it too...the results make sense to me
Mon Nov 25, 2013, 10:59 PM
Nov 2013

based on observed health issues in the family, and what we know of our origins.

KoKo

(84,711 posts)
22. So...You trust in them is complete? Even with the Revelations of NSA Spying
Mon Nov 25, 2013, 11:34 PM
Nov 2013

on ALL OF US? You believe that these Companies are doing this for the goodness of YOU? and that PROFIT isn't going to be in their future?

How do you have control over who they sell this info to? You don't see how this info could come back to bite your family and you somewhere down the road?

nolabear

(41,915 posts)
25. Honestly, by the time this would be commonplace and used against people in some way
Mon Nov 25, 2013, 11:58 PM
Nov 2013

it'll be a piece of cake to collect. Nobody gives a rip about my genetic markers and the technology is moving really fast. It'll be a quarter of my kids' DNA and I doubt they're any more outstanding genetically speaking than anyone else on the planet.

KoKo

(84,711 posts)
27. True...You and I and our Families and Friends are not Terrorists...so
Tue Nov 26, 2013, 12:05 AM
Nov 2013

why the hell should we care that the NSA is spying on us without our permission. After all there's nothing that we would say that would matter to anyone, anywhere and particularly our Government because we don't have anything that would "mark us" in an idle comment or whatever that would matter.

Correct?

nolabear

(41,915 posts)
43. I didn't say I don't care. I just think it's easy anyway.
Tue Nov 26, 2013, 03:01 PM
Nov 2013

My DNA could be collected by anyone interested and with resources. Worrying about that is a trap that I won't get into lest I end up in a cave somewhere.

Jesus Malverde

(10,274 posts)
40. More and more medicine is test based.
Tue Nov 26, 2013, 01:36 PM
Nov 2013

They have to make sure the tests are administered by doctors or we'll be getting our care from robots or online for much cheaper.

Some day your medical care might come out of something like a vending machine and be more competent than your average doctor for routine tasks.

Paulie

(8,462 posts)
45. I've had my 23andMe results since they started business
Tue Nov 26, 2013, 11:35 PM
Nov 2013

One item was a predisposition for Macular Degeneration for the markers I carried. So I took the results to my ophthalmologist last year and decided to do an early baseline study so it's in my file and start some vitamins.

Of the other items I was most happy learning I'm a fast caffeine metabolizer which explains why I can drink coffee before bedtime no problem.

I think the FDA is being silly.

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