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After FDA Objections, 23andMe Won't Offer Health Information

timothy posted about 4 months ago | from the regulators-know-best dept.

Biotech 146

sciencehabit writes "The company 23andMe will no longer provide health information to people who purchase its DNA testing kit, it announced last night.The change was 'to comply with the U.S. Food and Drug Administration's directive to discontinue new consumer access during our regulatory review process,' the statement said. While current customers will still have access to a 23andMe online database noting the health issues associated with their particular DNA, the company will not update that information, and customers who purchased its Personal Genome Service (PGS) on or after 22 November will receive only information about their ancestry and their raw genetic data without interpretation." It would be great to see a secondary market in this kind of analysis emerge.

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146 comments

nigger DNA (-1)

Anonymous Coward | about 4 months ago | (#45623719)

It's the same as poop and gorilla's. in other words, worthless as fuck and on welfare.

Canada (-1)

Anonymous Coward | about 4 months ago | (#45623729)

Great, except I'm in Canada.

Re:Canada (-1, Flamebait)

rmdingler (1955220) | about 4 months ago | (#45623785)

Well, it could've been worse. Don't be hateful, be grateful... hell, second best country in North America ain't half bad.

Re:Canada (0, Flamebait)

SJHillman (1966756) | about 4 months ago | (#45623877)

I don't know... for most people it comes down to maple syrup and hockey vs tacos, burritos, salsa and donkey shows. Mexico makes a pretty good case for second place.

Re: Oh Canada (1, Offtopic)

rmdingler (1955220) | about 4 months ago | (#45624047)

Maple syrup is a huge plus. But really and truly, nationalized health care>entrenched government corruption.... hell, I could even learn to yell at hockey games.

Re: Oh Canada (1)

PopeRatzo (965947) | about 4 months ago | (#45626753)

But really and truly, nationalized health care>entrenched government corruption.... hell, I could even learn to yell at hockey games.

Just because the US is in third place is no reason to gloat.

Re:Canada (0)

Anonymous Coward | about 4 months ago | (#45624541)

You can ger tacos, burritos, and salsa in Canada.

And Vermont also makes maple syrup.

-- hendrik

Re:Canada (1)

Anonymous Coward | about 4 months ago | (#45623931)

You can not say the USA is the best country in north america. Or you have not been paying attention for the last 30 years here. Or you are very very rich and have almost no touch with reality anymore.

Canada is number one. By pretty much any measure including common sense.

And yes. i am in the usa. but quite realistic about where we currently are. (which we currently are fucking sad on pretty much every measure)

Blind nationalism does not help anyone. But we do have alot of it. One of the reasons why we are not the number one country in north america....

We need to fix it. Not continue to pretend we are the best. When we clearly are not anymore.

Re:Canada (1)

Anonymous Coward | about 4 months ago | (#45624147)

Or you are very very rich and have almost no touch with reality anymore. ...We need to fix it.

I agree with your statements, above.

But the problem is, the people you mention above ( "the very rich who have almost no touch with reality" ) ARE the
people who are in control of the US. Can you see how that is not going to lead to any change ? They are quite
comfortable, and they have absolutely no incentive to change. Change is not going to happen unless those in control
perceive a real threat to their comfortable positions, and it's doubtful any such threat will appear from within the US.
As for any threats from outside the US, the rich can and will rely on the working classes to provide expendable young
men and women who are ready to enlist in the armed forces because it might be their only chance for a job. I could go on,
but I am enjoying my evening and no one here is going to care what I say anyway, so fuck it. //

Re:Canada (0)

Anonymous Coward | about 4 months ago | (#45624315)

the rich can and will rely on the working classes to provide expendable young men and women who are ready to enlist in the armed forces because it might be their only chance for a job

Not only that, those same young men will open fire on their own countrymen for a banker's buck, minted from thin air.

Wanna read something scary? Try Stanley Milgram's "Obedience to Authority" to see how most people will obey the headhocking of those they perceive to be in power.

If people begin to see their "leader", not as an authority, but as just a big windbag with vocal cords attached. spewing hot gas intended to motivate us to protect his interests at the cost of ours, things would change damned fast.

But for now, people will accept the coin of the realm, created from nothing, as payment for turning on their fellow man and doing to them whatever the ownership class tells them to do.

I am so brimming with disgust over how I have seen the "ownership" class ramrod their agenda over the "working" class that I am going to have to post AC. I know there are those who are keeping records over who sees through their petty scheme to keep the masses enslaved, by owing to the banks that which the banks themselves created from a charter issued from our own government to create notes ( money ) from absolutely nothing. People are expected to WORK for any money they EARN, while the banks are allowed to simply PRINT it, and even then, they do not even have to declare that which they printed as income.

This whole mess makes me sick.

Yet people accept it.

Please do not get me wrong... I am not against owning private stuff... what I am against is law enabling one class of people to print their wealth, while another class must work for it. I feel we ALL must work for it. Not print it. and ALL pay property tax, not just the working class who does not qualify for the loopholes of the people who have the funds to buy laws.

Re:Canada (0)

Anonymous Coward | about 4 months ago | (#45624373)

Oh i wouldn't bet on the armed forces going after the citizens of america if ordered to.
We have been treating our vetrans like dirt lately. And the word is starting to get around.

By the time the shit hits the fan. The armed forces will be on the other side with the rest of us.

What we do to our vets now is shameful. Tragic. Unacceptable.
But. It will put them on the side of the rest of the people being fucked over.

More likely it will be 'UN security forces'. A much worse thing. But at least we'll have plenty of soldiers on our side as well.

Future gonna be interesting.

Re:Canada (0)

Anonymous Coward | about 4 months ago | (#45624915)

Oh i wouldn't bet on the armed forces going after the citizens of america if ordered to.

Tell that to the Japanese. The armed forces imprisoned American citizens without a trial or some kind of due process.

Re:Canada (1)

sumdumass (711423) | about 4 months ago | (#45625083)

But they didn't imprison the German Americans or the Italian Americans. So maybe, just maybe, there was something about the Japanese Americans and Japanese born legal residents that the armed forces saw differently. Just maybe there was something different about the US back then. "race prejudice, war hysteria, and a failure of political leadership" comes to mind but I'm not sure how loudly it gets said when it is talking about FDR.

And that is not to mention that Japanese Americans were in the armed forces during the same time period too.

Re:Canada (1)

BlueStrat (756137) | about 4 months ago | (#45625163)

But they didn't imprison the German Americans or the Italian Americans.

Sorry, guy. That's incorrect.

Well, the Italians were treated with a bit more discretion, but many innocent Italians were interned.

"The laws regarding "enemy aliens" did not make ideological distinctionsâ"treating as legally the same pro-Fascist Italian businessmen living for a short time in the U.S. and trapped there when war broke out, anti-Fascist refugees from Italy who arrived a few years earlier intending to become U.S. citizens but who had not completed the process of naturalization, and those who had emigrated from Italy at the turn of the 20th century and raised entire families of native-born Italian Americans but who were not naturalized themselves. They were all considered enemy aliens."

http://en.wikipedia.org/wiki/Italian-American_internment [wikipedia.org]

The Germans had it a bit rougher, but neither compared to the scale or extent of the Japanese internment.

http://en.wikipedia.org/wiki/German-American_internment [wikipedia.org]

Strat

Re:Canada (0)

Anonymous Coward | about 4 months ago | (#45625235)

Being a pissed-off American, sick of how the elite have screwed us over, may not be of any specific ethnicity, I am very sure they are going to use the general classification of "terrorist".

Re:Self-Loathing Pussy Emo Bitches Like You (0)

Anonymous Coward | about 4 months ago | (#45625257)

Lookit Junior: That opinion might get you into some drunk, fat freshman girl's panties, but it ain't worth shit in the real world.

Without the US to absorb the brunt of illegal immigration, Canada would have been annexed by Mexico, and even the smelly fucking Quebecois would be speaking Spanish just to get a job. The EU? Fuck, boy - without the US Army camped in their borders, Russia could, even post-cold-war, take the whole continent in about the same time it takes to drive from Moscow to Lisbon at highway speed.

But I don't even have to bring any of that up, because like most children trying to debate for the first time ever, your very premise is full of fail. No, not your stupid opening line, but the self-loathing, self-hating bullshit that gave birth to it.

Tell you what, boyo - if it's so damned rotten here, then maybe you can move to your belled "number one" country? Oh, that's right - you can't - because Canada, like most EU nations, have immigration requirements that are tighter than a schoolgirl's asshole. Oh, and you suddenly have to watch what you say (free speech is diminished - you can go to jail for using the wrong words out there), what how much you make (get too successful and you get taxed incredibly hard), and oh yes, almost forgot - be certain that you don't have any complicated health issues. Oh, I know what you'll say, dumbass: "but they have free healthcare, derp!" Sure - which explains why Canadians are busting ass to come to the US for treatments they are otherwise denied, cannot get locally due to technological retardation, or on a waiting list 40 kilometers long for (essentially meaning that by the time they get their turn, their conditions are too far gone to get any real benefit from it).

But, that's the problem with dumbasses like you; you don't know shit about the outside world beyond what your PolSci 1001 prof spewed out, and his total experience comes from a combination of what he read on cpusa.org and a chauffeured PeaceCorp gig he did 42 years ago.

Neither you or he knows shit about the ugly side of the planet. You've never seen a man beheaded in a Saudi marketplace for the 'crime' of selling weed on the down-low. You've never watched local mobsters beat the unholy fuck out of some poor schlub on a St. Petersberg street corner while the morning crowd and a couple of cops do their collective best to not see it happen. You've damned sure never had to deal with the levels of bribery that are usual and required to do business in China, Egypt (before it went to hell), Italy, France (yes, France), or any South American nation you care to name.

But yeah - please continue to 'enlighten' us on how the US sucks oh-so-bad. Please save everything you write, too. Why? Because when (if) you finally grow the fuck up and realize just how good you had it with Mommy and Daddy's money caring for your pimple-specked sorry ass while you pursue a major in Ethnic Art, you might just learn something.

Re:Self-Loathing Pussy Emo Bitches Like You (0)

Anonymous Coward | about 4 months ago | (#45626319)

Please remove your shoes and step into the full body microwave scanner.

I'm from Australia. We got our own problems; but America is a poverty stricken fucking shithole. (nice tourist destination though)! Affordable these days too thanks to the level of regulation you guys have on your banking sector!

Oh, and before you say: "But you rely on us to stop China Annexing you!!!" (because you are a patriotic Americentric moron) - I don't see it happening. Maybe because you exist? but it doesn't mean your country isn't a shithole.

So I guess I should say thanks, for keeping your country a shithole to fund my protection. But I won't because you're an idiot.

Re:Canada (0)

Anonymous Coward | about 4 months ago | (#45624071)

Mexico is pretty awesome it's true, but it's true, there's one country worse than both.

disinfo much? (0)

Rujiel (1632063) | about 4 months ago | (#45624253)

That answer wasn't remotely relevant, nor were the replies. Good to see some paid trolls about--this issue must be important to someone.

smart (0)

farble1670 (803356) | about 4 months ago | (#45623783)

It would be great to see a secondary market in this kind of analysis emerge.

so, after the FDA forced 23andMe to stop analyzing, you think it's a good idea for another company to come along and do the same thing? i have a nice bridge you might be interested in ...

Re:smart (3, Informative)

Albanach (527650) | about 4 months ago | (#45623857)

There is a secondary market. Most large hospitals have genetic counselors who are trained and qualified to interpret and present the results of genetic testing.

Re:smart (2)

farble1670 (803356) | about 4 months ago | (#45623889)

if it was that simple, wouldn't 23andMe have just hired some of these people? it might cost them, but probably cheaper than losing their entire business. how useful is it to the average person to gut a bunch of raw genetic data dumped on them?

Re:smart (1)

Anonymous Coward | about 4 months ago | (#45623933)

But why pay for people who are qualified to give medical advice, which would then have to be a lot more differentiated and have a lot more "maybe", "possibly" and "well okay the scientific basis for this is kinda sorta not very there" after it than it has already, when you can not do that and make more money?

Re:smart (0)

Anonymous Coward | about 4 months ago | (#45623947)

They haven't "lost their entire business." They've discontinue[d] new consumer access during [their] regulatory review process, as clearly stated in the summary. For all we know, hiring those sorts of people is exactly what they're doing to pass FDA muster.

Re:smart (4, Informative)

JWSmythe (446288) | about 4 months ago | (#45624721)

That quote isn't quite complete. They've only discontinued new user access to health related tests. They're still providing ancestry information.

The majority of the really useful information is genetic. The health information was secondary. Really, the whole health thing was vague at best, and it didn't take a rocket scientist to figure it out.

For example, gallstones. My risk is 6.2%, where avg risk is 7.0%. Not bad, I have a lower chance.

I had to have my gallbladder removed a year ago, because I had two golf ball size stones. Yup, anything greater than a 0.0% chance means there is a chance. Lucky me.

Anyways, here's the full email they just sent out to 23andMe customers today.

Dear 23andMe Customers,

I'm writing to update you on our conversation with the U.S. Food and Drug Administration and how it impacts you.

If you are a customer whose kit was purchased before November 22, 2013, your 23andMe experience will not change. You will be able to access both ancestry and health-related information as you always have.

23andMe has complied with the FDA's directive and stopped offering new consumers access to health-related genetic results while the company moves forward with the agency's regulatory review processes. Be sure to refer to our 23andMe blog for updates.

We stand behind the data we have generated for customers. Our lab partner adheres to strict quality standards that are part of the Clinical Laboratory Improvement Amendments of 1988 - known as CLIA. These are the same standards used in the majority of other health and disease-related tests.

You are among the first people in the world to ever get access to their genomes. You are genetic pioneers. Thank you for your ongoing support and we look forward to continuing to serve you.

Anne Wojcicki
Co-founder and CEO, 23andMe

Thank you for the problematic example. (1)

Kludge (13653) | about 4 months ago | (#45626047)

For example, gallstones. My risk is 6.2%, where avg risk is 7.0%. Not bad, I have a lower chance.

If you think that "23andMe" can detect a 0.008 difference in the probability of your getting gallstones based on a genetic test, then you have been duped. The studies that 23andMe use to estimate these values are not nearly accurate enough to make these kinds of statements. That sort of statement has not been validated, and that is part of the FDA's problem with these scams.

Re:smart (2)

ColdWetDog (752185) | about 4 months ago | (#45623999)

The problem is that 23andme was trying to make it 'that simple' and beyond. Their recent literature downplayed the (difficult) part about relative risk, probabilities and how to analyze the data in a rationale way and played up the 'we can make you live longer' aspect. Taking the information to a qualified genetic counselor would be the best way to evaluate the subject for the vast majority of people. But that is time consuming, expensive and you have to really think about stuff.

Not a very good way to make money these days. The FDA put a kabosh to that.

Re:smart (2)

nitehawk214 (222219) | about 4 months ago | (#45624607)

The problem is that 23andme was trying to make it 'that simple' and beyond. Their recent literature downplayed the (difficult) part about relative risk, probabilities and how to analyze the data in a rationale way and played up the 'we can make you live longer' aspect. Taking the information to a qualified genetic counselor would be the best way to evaluate the subject for the vast majority of people. But that is time consuming, expensive and you have to really think about stuff.

Not a very good way to make money these days. The FDA put a kabosh to that.

How did they plan on making people live longer if they did not have anyone analyze the results? Or was their entire business plan to get people to pay top dollar for information they cannot understand?

Re:smart (1)

citizenr (871508) | about 4 months ago | (#45626005)

How did they plan on making people live longer if they did not have anyone analyze the results? Or was their entire business plan to get people to pay top dollar for information they cannot understand?

Doh, In a true and tested spirit of google they replaced humans with an algorithm. PGM PGM on the wall, tell me who will live the longest of them all?

Re: smart (1)

pegr (46683) | about 4 months ago | (#45626511)

Nope. This is a clear FDA overreach. They were not involved in any process designed to diagnose, treat, or prevent illness. They were involved only in protected speech. And because of the FDA, we now have prior restraint on protected speech. 23andme should have released the lawyers on the FDA.

Re:smart (2)

ceoyoyo (59147) | about 4 months ago | (#45624065)

The problem is, if a random person gets a genetic test done their report is along the lines of "such and such a variant has been associated with a 0.000000028% chance of developing such and such", etc. That's not very sexy marketing.

Re:smart (4, Informative)

pepty (1976012) | about 4 months ago | (#45623919)

Those are the results of individual FDA approved genetic tests.

A "secondary market" for running thousands of tests at once would run into the same problem that 23andMe did: if you are going to sell diagnostic services in the USA then you will need to get FDA approval. The options are to only provide raw data and let someone else generate the report for free (see Promethease, mentioned below) or move the whole company someplace where law enforcement won't bother it. I could see 23andMe spinning off an independent foundation that would generate free reports, thus allowing their core business (building up a database of peoples DNA and personal/family medical histories that they can rent out for medical research free from the normal regulatory hurdles) to proceed unhindered. They would just have to be very careful to make certain there was no linkage between the for profit and the free companies: the non-profit would have to generate reports from data of any source, not just SNPs from 23andMe, it couldn't share any board members or employees with 23andMe, Google, etc.

Next legal challenge for 23andMe: doing medical research on people (gathering their DNA and medical histories, analyzing, allowing 3rd parties to analyze, etc) without getting IRB approvals first.

DOn't need IRB always (1)

Anonymous Coward | about 4 months ago | (#45624701)

I don't think there's any law that requires you to have IRB approval for anything you do. If you receive government funds, then sure, a condition of the grant or contract will be "you need to have an IRB". You can also hire an IRB. That is, there's no objective standard for approval. You sign up to the Belmont principles, etc, but it's not like there's some certification process for IRBs.

Re:DOn't need IRB always (1)

pepty (1976012) | about 4 months ago | (#45624913)

Actually if the research involves human subjects and is intended to support a product that would require FDA approval an IRB is required even if the funding is all private. The FDA has rules about how IRBs must be formed, but I dont' think they certify them. 23andMe and the companies it sells data/research services to might be exempt though since they could claim the data wasn't collected for any particular study: the data just happened to be available after customers plonked down their $99.

Re:smart (1)

swillden (191260) | about 4 months ago | (#45625031)

if you are going to sell diagnostic services in the USA then you will need to get FDA approval

I don't think so. I don't think there's any requirement that people have FDA approval in order to issue opinions on medical issues. You have to be an MD to call yourself a doctor, but if you just want to tell people stuff and aren't claiming to be a doctor and aren't doing any sort of medical procedures on them, go nuts. Likewise, if you're producing medical devices or performing medical tests (like 23andme), then you need approval but if you're not, do what you like.

Re:smart (1)

aurizon (122550) | about 4 months ago | (#45625477)

Someone in another country can easily setup a multivariate look-up grid of the kind 23andMe uses to show how various genetic patterns correlate to various aspects of your health or intelligence.. In fact 23andMe can open source their method and many people will provide this service, some for free, some for fee.

Re:smart (2)

Belial6 (794905) | about 4 months ago | (#45624275)

I don't know if I would go that far. U.C. Davis does genetic testing for pregnant women, and I got the joy of talking to one when my wife was pregnant. The 'Genetic Counselor' had no idea what the data meant. Every question I asked was met with a blank stare and the repeating of the line from the script she was given. It was awfully similar to calling an Indian tech support line.

Re:smart (1)

ColdWetDog (752185) | about 4 months ago | (#45624323)

You should ask for a refund.... Good genetic counselors are hard to find. It's not a very sexy field and it's hard work explaining complicated subjects - including the most dreaded subject of all - statistics - to lay people of varying degrees of sophistication.

The Accreditation Council for Genetic Counseling [gceducation.org] (ACGC) is the specialized program accreditation board for educational training programs granting master’s degrees or higher in genetic counseling. I wonder if your counselor had gone through an approved program.

Re:smart (0)

Anonymous Coward | about 4 months ago | (#45624485)

It's not a very sexy field and it's hard work explaining complicated subjects - including the most dreaded subject of all - statistics - to lay people of varying degrees of sophistication.

If you're trying to quote statistics to get laid, it won't matter what level of sophistication the other person has. You will fail.

Re:smart (-1)

Anonymous Coward | about 4 months ago | (#45623881)

It's Timothy... did you expect something insightful? That bitch can hardly read.

Re:smart (-1, Flamebait)

couchslug (175151) | about 4 months ago | (#45623887)

That company could be located outside the US, which is no longer a bastion of freedom.

The world should rightly see the US as an obstacle to be routed around. The American public will also benefit from foreigners renouncing being controlled by the US globalist elites. As the Snowden revelations confirm, the United States government is toxic, anti-democratic, and no longer merits any respect or admiration whatever.

End the global reach of US law and you strike a blow against the masters. War is now too expensive for building empires, so treaties are used instead.

Re:smart (0)

Anonymous Coward | about 4 months ago | (#45624057)

If they were over here, they would have been shut down a lot faster than the USA did. Don't run medical test without regulatory approval is law in most first world countries.

Re:smart (0)

Anonymous Coward | about 4 months ago | (#45625657)

Don't run medical test without regulatory approval is law in most first world countries.

Who says it has to be first world? :)

There's already plenty of medical tourism - people willing to travel halfway around the world to developing (i.e. poor) countries for major medical procedures. But what if you didn't have to travel? What if all you had to do was upload your 23andMe data to some website in a developing country?

And suppose you wanted to chat with someone about the results. How about a nice long (webcam) chat with a friendly nurse in some poor country in Southeast Asia - for only $20/hour? As with most internet technology, adult content got there first. But why not medical genetics content, eventually?

I'm all for having laws against letting random (untrained) people perform brain surgery on each other. But holding forth with opinions on another person's genetic data, even for money, really just isn't in the same category.

And one of the key things about analyzing genetics data is that, at the moment, it is extremely time consuming - perfect for a country with lower labor costs. I really have no idea where the regulation will go. But the basic economics are firmly on the side of low cost genetics websites located in developing countries.

Re:smart (1)

russotto (537200) | about 4 months ago | (#45624059)

If they simply take the raw 23&me test results and provide the analysis, there's no "device" for the FCC to use to assert jurisdiction.

23andMe is just plain bogus (2)

quixote9 (999874) | about 4 months ago | (#45624391)

They can't do analysis, a secondary market can't do it, nobody can. The science just isn't there yet to draw useful conclusions for an individual on the basis of DNA in isolation.

Note that: in isolation. That's what 23and Me was peddling. Hospitals and genetic counselors and doctors are doing something else. They have the whole medical history. They have, or should have, enough training to understand population genetics, statistics, and where somebody's DNA data fits in to all that. (Although a comment lower down this thread talks about a blank-brained counselor. They happen. Run, do not walk, out of their offices.)

So, no, it would not be "great to see a secondary market in this kind of analysis emerge." It would be just as bogus as 23andMe, given our current state of knowledge.

Re:23andMe is just plain bogus (3, Insightful)

Anonymous Coward | about 4 months ago | (#45624591)

What's your definition of "useful conclusion"? Because I'm pretty sure it's different than what 23andMe was peddling and what all of us satisfied customers expected. Most 23andMe reports are equivocal on their face, in a good way. Some, like markers for Parkinson's or Alzheimer's, are also pretty clear. They tell you in plain English that the lack of a marker does not mean you're free from risk. If a marker is present, they give you a risk factor. But in no way did they diagnose you with Parkinson's.

Everybody thinks that they're smarter than most other people, and people like you just assume that most other people can't comprehend this stuff. Well, 1) we can and 2) it doesn't matter because 23andMe reports are of a different type entirely than what a professional genetic counselor would possess.

Show me one person who was duped by 23andMe? Even my own mother, who is quite naive about science-related topics, consumed her reports with a grain of salt, and without needing any warnings from me. Everybody understood that 23andMe is to professional genetic counseling as Walgreens is to The Mayo Clinic. In other words, professional and trustworthy in so far as a commercial vendor can be, but not in the same league as a real healthcare provider.

In an age where people obsess over stuff like HFCS and juice fasts, 23andMe cut through all the crap with hard data and reports which, despite all the inherent limitations, were damn interesting, if not in the rare case positively life changing. People understood the limitations, even the science-deficient anti-HFCS and organics crowd.

What the FDA did was pounce on some lofty marketing language. Big whip. The FDA just wants to shutdown the commoditization of genetic counseling, period. And it's ultimately going to cost all of us a ton of money.

There already is a secondary market already (4, Informative)

PapayaSF (721268) | about 4 months ago | (#45623795)

From snpedia.com [snpedia.com]:

The easiest way to make a report is to visit promethease.com. This takes about 10 minutes and costs $5. [...] Promethease is a tool to build a personal DNA report based on SNPedia and a person's genotype (DNA) data. Customers of DNA testing services (23andMe, FamilyTreeDNA, Ancestry.com, Complete Genomics, ...) can use it to learn more about themselves completely independently of whichever company produced their data.

Re:There already is a secondary market already (1)

jd (1658) | about 4 months ago | (#45623985)

23&Me are very slow on updating ancestry information and weren't lightning fast on health data. Nonetheless, their data was clearly presented and had clearly stated confidence levels.

Promethease are less well-known to me. I've used their service but I know nothing about the quality of their results, frequency of updates, reaction times when new studies are published, etc. If anyone could fill me in on that, that would be great.

In fact, if 23&Me just moved their health system to an external website with import facility, you'd have the same configuration as with 23&Me + Promethease but with a data set that could evolve through self-reporting. Result - no change from b before, but legal because the DNA company just provides data.

good riddance (4, Interesting)

ljw1004 (764174) | about 4 months ago | (#45623801)

Good.

My family all had our genomes sequenced by 23andMe. The only area we have expertise in is Alzheimers, and (1) their Alzheimers explanations were misleading, (2) they made it REALLY hard to learn the raw data about what they found in our genomes, i.e. which SNPs they tested and what they found: instead they only boiled it down into a useless "you have 20% chance of getting Alzheimers" which was scientifically incorrect, lacked confidence levels, lacked context.

I would love to get the raw data from their results, and I'd love to have someone better than them provide the tools to analyze & understand it.

Re:good riddance (0)

Anonymous Coward | about 4 months ago | (#45623823)

They have offered the raw data for quite awhile. I downloaded mine about three years ago after I signed up.

Re:good riddance (1)

Paleolibertarian (930578) | about 4 months ago | (#45623849)

Perhaps this is why the FDA put the kabosh on it. I am for the free market but providing misleading or wrong interpretation is not a good thing. Since they'll be providing the raw data perhaps a market for a better analysis will spring up. Hopefully in another country beyond the gentle protections of the FDA.

Re:good riddance (-1)

Anonymous Coward | about 4 months ago | (#45623921)

It's almost as if regulation agencies exist to protect consumers from unsafe business practices.

Wait no, can't be, this is a clear example of BIG GOVERNMENT impeding PROGRESS by attempting to shut down a DISRUPTIVE company because they are EVIL.

Re:good riddance (5, Insightful)

PCM2 (4486) | about 4 months ago | (#45623987)

Perhaps this is why the FDA put the kabosh on it

The FDA was very clear about why they stopped it. It wasn't necessarily that the information was misleading, but that it would lead patients to make decisions about their own care without necessarily consulting a doctor, which the FDA thinks is not a good idea -- and I totally see their point, frankly.

For example, one of the things that 23andMe can tell you is how well you might respond to one drug versus another, because of your specific genetic makeup. If you take that advice and change the dosage of your medication or switch to a different medication without discussing the issue with your doctor, you could cause yourself serious harm.

On the far end of the scale, "false positives" for some diseases could be catastrophic -- say, if a woman was erroneously told she had a high chance of contracting a certain type of breast cancer and decided to have a double mastectomy, like Angelina Jolie had done.

23andMe claimed that all it was doing was giving people information. But really, the way the information was structured and presented to the customer made it clear that it was designed to be diagnostically relevant and that they should use it to make decisions about how to proceed with health care. Any service that performs that function clearly falls under the jurisdiction of the FDA, IMHO.

Re:good riddance (2)

E++99 (880734) | about 4 months ago | (#45624067)

The FDA was very clear about why they stopped it. It wasn't necessarily that the information was misleading, but that it would lead patients to make decisions about their own care without necessarily consulting a doctor, which the FDA thinks is not a good idea -- and I totally see their point, frankly.

For example, one of the things that 23andMe can tell you is how well you might respond to one drug versus another, because of your specific genetic makeup. If you take that advice and change the dosage of your medication or switch to a different medication without discussing the issue with your doctor, you could cause yourself serious harm.

How could that possibly be within any legitimate government's domain? Using the same rational they could shut down wikipedia or rxlist. Clearly, people DO make medical decisions for themselves based on wikipedia and rxlist without talking to a doctor. The idea that some people believe it is the responsibility of the government to stop that sort of thing is terrifying to me. I should have autonomy over my own body, and the government should not stand in the way of me obtaining information for making my own rational decisions about how to exercise that autonomy.

Re:good riddance (3, Insightful)

PCM2 (4486) | about 4 months ago | (#45624097)

How could that possibly be within any legitimate government's domain? Using the same rational they could shut down wikipedia or rxlist.

They sure would shut down Wikipedia or RXList if those services allowed you to make an appointment to consult them for medical advice. Even campus health nurses have to be licensed.

What Wikipedia offers now is pretty much the same thing as reading information out of a book. You can't stop people from doing that, and there's no law against it.

What 23andMe does is market a product that you use to extract unique information about your own body, which is then presented to you in the form of suggestions about what health measures you should take -- in other words, medical advice. Very different.

Re:good riddance (4, Informative)

E++99 (880734) | about 4 months ago | (#45624473)

What 23andMe does is market a product that you use to extract unique information about your own body, which is then presented to you in the form of suggestions about what health measures you should take -- in other words, medical advice. Very different.

Whoa, what? They have never been in the business of medical advice! What they did is to say, "you have genetic marker X which according to studies A and B are indicative of a 20% increased susceptibility to disease Y or and 50% increased likelihood to have an adverse reaction to drug Z." That is not medical advice! That is mere information, filtered by your genetic markers.

Re:good riddance (0)

Anonymous Coward | about 4 months ago | (#45625331)

Yes, and that is hugely misleading. What many people will read is "you have a 20% chance of contracting disease Y", which is not the same thing at all.

Re:good riddance (0)

Anonymous Coward | about 4 months ago | (#45625899)

What many people will read is...

If we are going to declare war on deception, let's prioritize our targets. Which is more likely to cause people to make drastic changes to their lifestyles, correct-but-misinterpretable information about a genetic marker, or false promises about an eternal reward in heaven for submitting entirely to specific authorities? Shall we make religion illegal now, and set up a government agency to interpret all truth and tell the people what they should believe? Modern times are bringing out a lot of truths that are difficult for traditional people to integrate with, and more is coming. If you don't let people take things the wrong way now, they will never learn to discern right from wrong in the future.

Re:good riddance (1)

ceoyoyo (59147) | about 4 months ago | (#45624103)

23andMe's marketing material explicitly claimed that they were giving medical advice that could help people make decisions and live longer. The FDA's letter specifically said they'd suggested some labelling changes that could bring them into compliance.

Re:good riddance (4, Insightful)

tlambert (566799) | about 4 months ago | (#45624645)

The FDA was very clear about why they stopped it. It wasn't necessarily that the information was misleading, but that it would lead patients to make decisions about their own care without necessarily consulting a doctor, which the FDA thinks is not a good idea -- and I totally see their point, frankly.

The FDA made them stop because doctors dislike being cut out of the loop, and insurance companies like being cut out of the loop even less than the doctors, and they would prefer to have you get the data through a disclosure mechanism which gives your insurance company better actuarial information. "Having a Dr. explain the information to the patients one on one" is just a place to hang that hat.

For example, one of the things that 23andMe can tell you is how well you might respond to one drug versus another, because of your specific genetic makeup. If you take that advice and change the dosage of your medication or switch to a different medication without discussing the issue with your doctor, you could cause yourself serious harm.

Yeah, in case you wondered, people can not self prescribe non-over the counter medications. So that excuse doesn't fly, either, since your doctor will be involved in writing the script for the new medication, and your insurance company will be paying for it, and like mine did, probably try to give you a cheaper generic version of a similar drug in place of the one your doctor actually wrote the script for, and then called it "equivalent". I've had that pulled on me, and been given "generic allergy medication" containing a cornstarch binder in place of the other one - when corn products were why I taking the damn stuff in the first place.

Re:good riddance (1)

SchroedingersCat (583063) | about 4 months ago | (#45625087)

FDA is fighting a fight it already lost. Just another outdated business model fighting something it struggles to embrace. Just like music industry was fighting Napster. Just like US government was fighting for encryption export controls. The information is out there. opensnp, promethease, even google. Anyone can connect the dots and they technically don't need 23andMe to do that. 23andMe makes it easier to consume that information but it is just a messenger.

You say that "false positives" are catastrophic. I doubt that a woman would perform a double mastectomy on itself. She would get second or third opinion from doctors and surgeons. Consider the alternative for a second - what if a women never learned about this risk and died of cancer a few years later.

Consumers will get the information they need one way or another. There is nothing FDA can do to stop it. Tests can be done offshore if needed. The beauty about genetic tests is that you only need to do it once in your lifetime.

Re:good riddance (0)

paulpach (798828) | about 4 months ago | (#45626529)

The FDA was very clear about why they stopped it. It wasn't necessarily that the information was misleading, but that it would lead patients to make decisions about their own care without necessarily consulting a doctor, which the FDA thinks is not a good idea -- and I totally see their point, frankly.

I agree, it is not like your body belongs to you. A sheep does not make decisions about what medicine they are given. Your masters should make that decision. We are clearly too stupid to be trusted not to hurt ourselves. I need an overlord in Washington telling me what medicine to take, what to eat, what to dress, what job to do, to make sure I am safe from myself. It is best that I know absolutely nothing about my body so my overlord can take care of it without interference.

Re:good riddance (1)

sumdumass (711423) | about 4 months ago | (#45625447)

The FDA endorses false and misleading information all the time. For instance, look at their line on smoking in which they claim or support others making claims about the number of people with lung cancer who smoked showing you have a high risk of getting it if you do. They almost say it is a certainty that if you smoke or even be around people who smoke, you will get cancer and die. But the facts are that fewer then 10% of life long smokers will get lung cancer and to that, cancer deaths from smoking only make up 30% of all deaths from cancer (which is why it probably isn't outright banned). But when you look solely at lung cancer deaths, 87% smoked which gets turned into the you will get cancer and die claim.

Re:good riddance (1)

Anonymous Coward | about 4 months ago | (#45623853)

Uhh ... you are (and always have been) able to download the raw data from your 23andme account. Just click through to your profile, "browse raw data" and click the "DOWNLOAD" link in the upper right corner. And if you want to know the specifics about your DNA (which SNPs were tested and your results) click the "technical report" link on the Alzheimer's page: https://www.23andme.com/you/journal/alzheimers/overview/. Seems pretty clear to me.

Re:good riddance (1)

jd (1658) | about 4 months ago | (#45624023)

If you looked, they would show that for each indicator, one or two SNPs were involved. These would be identified, along with the standard values and your values.

To determine actual probability, you must multiply (not add) the probability for each indicator, remembering that not all indicators are known.

In the case of Alzheimer's, where external chemicals (aluminium being one) are involved, the indicators mean nothing until you exceed toxic levels of the chemicals. There is nothing to trigger. 100% probability with no neurotoxin is the same as 0% with no neurotoxin. Don't blame me for poor schooling given to people.

23&Me could have done a lot better, I don't consider it faultless, but when PEBKAC, there's nothing they can do.

Re:good riddance (2)

biohazard123 (1539865) | about 4 months ago | (#45624623)

I would love to get the raw data from their results, and I'd love to have someone better than them provide the tools to analyze & understand it.

Go to the dropdown link where your name is at top of left of the page. Click browse raw data, then click download...............

Re:good riddance (4, Insightful)

Mashdar (876825) | about 4 months ago | (#45624775)

Does anyone else find it upsetting that the local CVS is packed with whole aisles of homeopathic "remedies" with no proven efficacy (or worse, disproven), but some company can't tell you what your genes might mean? Apparently the FDA is about protecting what goes in your eyes than what goes in you mouth?

Re:good riddance (1)

Frosty Piss (770223) | about 4 months ago | (#45624899)

Apparently the FDA is about protecting what goes in your eyes than what goes in you mouth?

No, the FDA is about protecting the "rights" of doctors and insurance companies to make obscene amounts of money.

Re:good riddance (1)

RightSaidFred99 (874576) | about 4 months ago | (#45625103)

So let me get this straight. 23andme provided you with DNA sequencing and even provided a nice set of data (along with links to the original studies), and you're...mad that they didn't spoon feed it to you and tell you exactly what to do with it?

You'll fit right in with the nanny state, congratulations. Fuck the FDA in this particular instance, their job is not to restrict me from information about myself.

Re:good riddance (0)

Anonymous Coward | about 4 months ago | (#45625943)

I will bet they're doing a regression between markers and outcomes for people with those markers. The variables would all be 0/1 "dummy variables" which indicate yes or no you have the marker and yes or no you have the disease.

Doing this type of regression sort of works, but it breaks some of the assumptions required for regression to give the strongest results (e.g. reliable confidence confidence intervals).

Outsmart The System (1)

retroworks (652802) | about 4 months ago | (#45623915)

I submitted someone else's DNA. Small price to pay for invisibility. It's flawed because I could be tagged with my pal's traits. But in the near future, we'll be buying/selling "prime DNA" for our test submittals, on street corners, like clean pee at La Tour de France.

(OOps, I meant to submit anonymous coward, instead of this hacked 'retroworks' account).

Re: Outsmart The System (1)

Rujiel (1632063) | about 4 months ago | (#45624267)

Hacked account. Xfd. Why would someone joke about that? So much shitposting in this thread. I wonder who's paying?

Too bad it's taken down... (3, Interesting)

Sean Dunn (2861499) | about 4 months ago | (#45623969)

As long as people understand that the results are only based on research/papers, 23andme is really awesome. It's best to discuss things with your doctor, and get things double checked, rather than to treat 23andme as some alternate to proper healthcare and checkups.

I mean, really, who the hell would spit into a tube, pay $100 bucks and start a potentially harmful treatment regimen without seeing a doctor?

Speaking from experience, 23andme did identify that one of her genes leaves her susceptible to having bad side effects of one of the medications she was taking (and she was suffering from this side effect). Taking the 23andme health report to her doctor let her move onto an alternate treatment, which is working *much* better.

I hope that a revisited health report/traits thing comes back soon. Or maybe put it behind a test wall, and make sure people to understand exactly what they are getting.

Re:Too bad it's taken down... (1)

ceoyoyo (59147) | about 4 months ago | (#45624269)

All the people who spend hundreds of billions on "supplements" every year? There are a LOT of people who self medicate. There are even more who go to doctors and tell them what they're going to prescribe.

just do an endrun around the system... (1)

jinchoung (629691) | about 4 months ago | (#45623971)

"for entertainment purposes only" seems to be the necessary language. right?

is it cheaper? (0)

Anonymous Coward | about 4 months ago | (#45623983)

it would seem to me that if you're not getting the whole service, the cost should be lower....

Consider petitioning the White House (0)

Anonymous Coward | about 4 months ago | (#45624009)

http://wh.gov/lKu2R

Re:Consider petitioning the White House (0)

Anonymous Coward | about 4 months ago | (#45624041)

Yeah, that's going to make as much difference as a change.org petition or maybe even a "let's get some likes for 23 and Me on Facebook!" campaign.

Hope and change.

The FDA's mission to save idiots from themselves (1)

jwbales (92374) | about 4 months ago | (#45624099)

Although 99.9% of us have the common sense to get a professional opinion if some test bought on the internet delivers bad news, the FDA denies us access to such tests on the off chance that some idiot will take rash action without consulting a physician. Were that to happen, which I seriously doubt, the worst result would be a slight improvement in the gene pool.

Re:The FDA's mission to save idiots from themselve (0)

Anonymous Coward | about 4 months ago | (#45624163)

Bzz, dumbfuck.

The FDA is not denying access to these tests or the raw results.

The FDA is denying 23andme the ability to provide misleading medical information along with the raw results. The web is full of examples of the company's systems either misrepresenting the results of a study or demonstrating a fundamental misunderstanding by whoever implemented their web site's code - e.g. put in simple terms, drawing conclusions from a particular characteristic which appears in two different areas on each chromosome, when the conclusion would only apply if they were on the same part... and then telling the customer that they had a high likelihood of having inherited a serious degenerative disease.

Not even the rah rah libertarians should be supporting the "right" to talk bullshit - whether you're doing it with your own mouth or via the output of an overly simplistic computer program.

Mind you, my ex submitted her spit and her daughter's, and the two were identified as "identical twins". When she called them on it, they admitted that they must have re-used her sample, and that they'd lost her daughter's. So, their procedures seem definitely to put them in the For Entertainment Purposes category. Medicine is, despite the opinion of self-appointed rockstar geeks, hard. It's not just the intelligence you have to apply, but the care you have to take. $99 won't get you either, but if you're selling shit, you have to advertise it as shit.

Re:The FDA's mission to save idiots from themselve (2)

Lawrence_Bird (67278) | about 4 months ago | (#45626531)

Let me go rah rah for you. If 23andme is so shitty at providing accurate medical information to aid the lay person in evaluating their results then the MARKET will put them out of business as consumers will a) stop using them and b) competitors who provide better service will emerge.

There is no need for government intervention here. Please go control your own person and family and leave the rest of us the fuck alone.

The science is open.. (3, Insightful)

xtal (49134) | about 4 months ago | (#45624105)

Just need to link the science (published) and the genotype. It's all open.

Next up is banning people from sequencing their own genomes without a MD.

The real story here is who's the loser - it's not you; your DNA is your DNA, and the sequences are there or they aren't. The insurance industry are the ones who are actually worried about these tests - all of a sudden you have data they don't, and they can't apply their actuarial models anymore. Hilarity ensures.

May we all live in interesting times.

From a 2010 Cell paper (5, Informative)

sat1308 (784251) | about 4 months ago | (#45624223)

One company, for example, offers 166 tests in one of its testing packages where approximately 60% of the tests (99) are categorized as âpreliminary researchâ(TM) because the genetic-association data have not yet been replicated (www.23andme.com/health/all/). These tests are given 1, 2, or 3 stars based on the size of the study that supports the genetic association for which they test. Information for each of these tests cites references for the original ïnding of the genetic association, including the journal where it was published and the study size. It also provides the number of attempted replications and the number of contrary studies that have been published. Although transparent, examination of the scientiïc evidence provided for many of the genetic associations in this category raises the question of whether these tests should even be included in a genetic-testing package. Two of the ïve genetic tests with 1-star status (those for âavoidance of errorâ(TM) and âobsessive compulsive disorderâ(TM)) are based on single studies with fewer than 100 participants (https://www.23andme.com/you/health/). In both cases the variants map to the D2 dopamine receptor, a gene that has repeatedly been associated with human behavioral traits and attracted newspaper headlines, only to have the associations refuted in later studies [8]. Eight of the 37 (22%) available 2-star-rated genetic associations (originating from a single study with less than 750 participants) have a âcontrary studyâ(TM) indicated. Two different 3-star tests, one for Lou Gehrigâ(TM)s Disease (ALS) and another for obesity, utilize variants that have been positively associated with disease in one or two studies, respectively. However, both these variants have failed replication in four additional studies (https://www.23andme.com/you/health/). Although, the company boasts of its 'systematic vetting processâ(TM) used to determine which research ïndings to include in its genetic-testing package, a number of highly questionable tests continue to be offered to consumers.

http://www.ncbi.nlm.nih.gov/pubmed/20828856 [nih.gov]

offensive arrogance (1)

stenvar (2789879) | about 4 months ago | (#45625199)

Whether you have a variant dopamine receptor is certainly a reasonable thing to include in a genetic testing package like 23andMe: even if current studies don't have clear results about what that means, there is a good chance that there will be meaningful associations in the future. If 23andMe only included those tests for which absolutely clearcut associations had been worked out, people would have to get retested constantly.

The company did what it should have done: it picked a large number of important markers and disclosed things correctly and properly.

Fortunately, this kind of FDA stupidity is not going to work long term: people are simply going to get their entire genomes sequenced, and there will be a huge number of free tools and web sites for searching for disease associations, ancestry, and relatives.

Typical Government Interference in the Free Market (-1)

Anonymous Coward | about 4 months ago | (#45624259)

They (the Government) can't get their sh*t together in Obama-Crap so they have to go after a company that provides wonderful service for a minor fee. Typical....

Absolutely! (1)

no-body (127863) | about 4 months ago | (#45624289)

"It would be great to see a secondary market in this kind of analysis emerge"

Health/Life insurance Co's need to increase profit margins, employers figure out whom to fire first, police departments preventative arrests, - Minority Report-Style, paradise for extortionists getting their hand on those data worth a fortune.

Meanwhile, in America (1)

Rujiel (1632063) | about 4 months ago | (#45624301)

The FDA can't guarantee it'll get dangerous foods off the shelves within even a few years. It couldn't halt BP from ditching millions of gallons of neurotoxic, carcinogenic dispersants into the gulf after Deepwater Horizon. But it's sure as sin make sure your life isn't ruined by an unclear genetics report--as if there were any way people could imperil theirselves with the information.

Re: Meanwhile, in America (0)

Anonymous Coward | about 4 months ago | (#45624551)

Do you want that guarantee? They will have to do a lot more testing, but it could be done.

I doubt you will pay the pricer.

Re:Meanwhile, in America (1)

fluffy99 (870997) | about 4 months ago | (#45624741)

The FDA can't guarantee it'll get dangerous foods off the shelves within even a few years. It couldn't halt BP from ditching millions of gallons of neurotoxic, carcinogenic dispersants into the gulf after Deepwater Horizon./quote>

Um, you seem to have EPA and FDA confused. But I agree that there are bigger issues out there with the food supply chain that should be a higher priority.

Thord party analysis (4, Informative)

n6kuy (172098) | about 4 months ago | (#45624449)

> It would be great to see a secondary market
> in this kind of analysis emerge.

There are already companies (livewello.com, for instance) that will take your 23andme raw data and analyze it for certain traits and risk factors.

open source analysis (1)

stenvar (2789879) | about 4 months ago | (#45625181)

There are plenty of tools and sources that help you analyze the data. Long term, the FDA decision will simply mean that people who are skilled and/or rich enough to go abroad will get the benefit of this analysis, while everybody else will be screwed. Congratulations, FDA, for doing your part in increasing health disparities.

Re:open source analysis (0)

Anonymous Coward | about 4 months ago | (#45625875)

...rich enough to go abroad...

That will depend on the regulations. In the longer term, everyone will have their genome sequenced anyway. So you'll only need to upload your data to a call center in India or the Philippines, so to speak. And, in the short term, even full genome sequencing can be done with a saliva sample - that can be FedEx'd overnight to anywhere in the world.

And a full genome analysis is actually quite time consuming - you could easily spend a month if you wanted to be thorough. Imagine hiring a board certified American medical doctor, with specialized genetics training, to spend a month looking at your genome. I mean, even 10 minutes with a medical doctor can run you $100 easy. Plus, there's a huge amount of specialized knowledge for each genetic disorder. Can a single American medical doctor really do any better then a call center in the Philippines, or perhaps China, with a thousand experts each specializing in a particular disorder?

Now, whether Americans will be allowed by law/regulation to connect to webcam chats in the Philippines to get advice on their genetics is another matter entirely. It may turn out the Americans have to travel down to special internet cafes in Mexico to be allowed to connect to webcam chats in the Philippines. But I suspect that a lot of Americans would be opposed to that level of regulation. Interesting times.

FDA (0)

Anonymous Coward | about 4 months ago | (#45625395)

i KNEW that the FDA was gonna shut this company down after i saw another post here on slashdot about the same company. I thought to myself "The FDA would never allow a company to do shit like this" low and behold they went after them.

all medical advice should be taken with a grain of (0)

Anonymous Coward | about 4 months ago | (#45625997)

...salt.

The FDA is wrong for trying to ban information based on it's source when that source has no reason to deliberately lie or mislead.

It is one thing when a drug company says that its miracle drug makes hair regrow or fixes acne or prevents breast cancer without having proved these claims in some other way since the company benefits by selling the drug; it is another thing when a company offers an inexpensive test for blood sugar leveles but does not sell anything beyond the test and the results itself.

In this case, 23andme was selling a test and its results for a low price. With the results, the consumer could make a decision to take out more insurance, see a doctor, get medical tests, tell their relatives that they could be at risk for things, etc but 23andme does not benefit for most of this (they may sell more tests, but $99 is not going to make or break anyone).

This is shocking news (1)

Lawrence_Bird (67278) | about 4 months ago | (#45626537)

I really figured that all these dna testing outfits were either fronts for DHS or at least in cahoots. Shocking the FDA did not get the memo. Has Rudi Guilliani been on Fox yet to lament the loss of info for the DNA databse?

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