FDA Tells Google-Backed 23andMe To Halt DNA Test Service

Hugh Pickens DOT Com writes "Bloomberg reports that 23andMe Inc., the Google-backed DNA analysis company, has been told by US regulators to halt sales of its main product, the Saliva Collection Kit and Personal Genome Service, or PGS that tells users whether they carry a disease, are at risk of a disease and would respond to a drug because the kit is being sold without FDA's marketing clearance or approval. 'FDA is concerned about the public health consequences of inaccurate results from the PGS device,' says the agency. 'The main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work.' 23andMe was founded six years ago by Anne Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin. The FDA decided in 2010 that services claiming to evaluate a customer's risk of disease must be cleared by regulators if the companies sell directly to consumers. Most FDA-cleared genetic tests are for a single disease while 23andMe's would be the first to test for multiple conditions. 23andMe submitted FDA applications in July and September of 2012 for the least stringent of two types of medical device reviews but the FDA said the company failed to address 'the issues described during previous interactions'."

Comments

Change your place of business

[Anonymous Coward]

A new Bahamian address in 3 ... 2 ... 1 ....

Re:Change your place of business

[i kan reed]

You can market all you want to the Bahama market then. Marketing related to health in the U.S. is faced with certain proscriptions.

Re:Change your place of business

[Anonymous Coward]

Won't matter, people in the US will hear about it, send for a kit, send it back - all perfectly legal without having to bribe the FDA uphishals.

Re:Change your place of business

[Anonymous Coward]

and customs will just seize them when they enter the USA

Re:Change your place of business

[n30na]

Unlikely - many things that are technically illegal to import/export but not particularly interesting get through customs easily. At worst they'll have to insure against the 1% seizure rate.

Re:Change your place of business

[TheCarp]

Do you have any idea how many things that are technically not legal to sell here that get through?

Have you ever bought "kinder joy" or any of the other similar chocolate candies that contain a plastic egg inside the chocolate? My wife enjoys them, so I get them for her when I see them. I know many shops I can buy them at, all over the area....yet, they are not legal products for sale in the US due to.... FDA regulations.

Hell, people have been buying mail order pot seeds and drugs and....you think customs is going to be a barrier to this?

So what exactly is so special here that means this time is going to be different?

Re:Change your place of business

[i kan reed]

I think the black market potential of low-cost DNA kits can't really hold out where there are other legal DNA tests available.

Re:Change your place of business

[Anonymous Coward]

Mmm, Kin(d)er Joy Bud.

Re:Change your place of business

[Anonymous Coward]

Have you ever bought "kinder joy" ?

never heard of it

Re:Change your place of business

[TheCarp]

You, my cowardly friend, are missing out. It is a cheap plastic toy, which usually must be assembled by snapping together some parts. This toy is placed inside a plastic egg. The plastic egg is then coated with a, somewhat annoyingly thin chocolate shell.

The FDA apparently has their panties in a twist about non-food items that are actually inside food. I generally would call this a sensible restriction in form, but.... it is kind of hard to see how these could suffer the same terrible flaw of some other, more unfortunate ideas in candy/toy crossovers.

Democracy?

[operagost]

The FDA decided in 2010 that services claiming to evaluate a customer's risk of disease must be cleared by regulators if the companies sell directly to consumers

So a bunch of un-elected bureaucrats decided whether same un-elected bureaucrats had the power to regulate a product or service? Mind you, I'm not questioning whether this is a good product or not-- just whether the FDA should be deciding what's in its jurisdiction. Where are the progressives clamoring for "checks and balances"?

Re:Democracy?

[Anonymous Coward]

how is it not in their jurisdiction?

its a company performing a health and medical test. of course they should have research behind their you will get cancer promises

otherwise they need to put for entertainment purposes only

Re:Democracy?

[ColdWetDog]

This is what regulatory agencies do. They 'decide' if the product or service or what not falls under their jurisdiction. They are typically (and in this case, the FDA specifically) given legal powers to compel companies to follow rules and regulations.

Of course, the companies are not without recourse. There are detailed rules on how the regulations are enforced (go ahead, read them, that should keep you occupied for some time, be sure to stock up on adequate quantities of Doritos and Diet Dr. Pepper). The last letter in the summary is quite interesting. The FDA details an entire page of attempts to work with 23&me at various times and venues. Apparently, the company's response has been pretty minimal. If you read between the diplomatic legalese, the FDA sounds pretty annoyed at the company.

Don't get all bunched up about how we 'didn't elect' the FDA / FAA and even the NSA. We elect the people that write the enabling legislation and believe me, Congress is forever trying to meddle into details they really shouldn't (cf, the 10 million exceptions to everything in Medicare / Medicaid regulations and the horrid legislative quagmire that the ACA* is trying to create). Further, the involved companies can directly petition the regulatory agencies and even sue them.

There are plenty of checks and balances. Hardly perfect and always subject to argument about where the various lines should be drawn, but it is never a regulatory free fall, despite what Limbag wants you believe.

* ACA - Affordable Care Act - aka Obamacare

Re:Democracy?

[Anonymous Coward]

Most of us Progressives understand that Congress created the FDA (Food and Drug Administration), and gave it power to regulate the safety of foods, and the effectiveness of drugs and medicines.
When a person thinks the FDA should not regulate a given item, they can sue, and that court case might expand or limit the FDA's overall authority.

For the FDA to decide that a DNA test, which claims to tell a person what risk they have for diseases, without a physician's help or expertise, needs to be checked to make sure it isn't providing bad information, seems to be right in their purview.

Note: the FDA has been successfully limited in the past; if an item is a 'Nutritional supplement' then it's not regulated as a drug, and only needs to be safe to eat. If it's a 'vitamin' or 'treatment', then the seller must prove it does help / cure what it says it cures.

This is the way it's supposed to work.

Re:Democracy?

[i kan reed]

It can come to court as soon as they actually make the decision to include it in their purview. If the courts find the law disagrees, the manufacturer would be free to continue.

In fact, if the review of powers itself were enough of a problem, it would grant standing for taking it to court before the decision had been made. The 3 step process in the US of "legislation, executive action, court review" is pretty good, except for all those hundreds of times that all 3 steps fail in their duty.

Re:Democracy?

[Anonymous Coward]

Not if the law doesn't clearly state they have the power to regulate said diagnostic. That puts the FDA in the same boat as a dictator - my powers are what I say they are.

And the statements are clearly labelled as "Indicators that you carry have been found in 73% of cases of X disease, you may want to get a full diagnostic from your doctor."

Nuff said.

Re:Democracy?

[Anonymous Coward]

If they decided that and weren't instantly shut down by a court, then it would mean that it was already within the scope of their Congress-granted authority to exercise that power, even if there was a time that they where not exercising it. Right?

As much as you may suggest it, the FDA deciding this isn't using some magic powers to override congress and the courts.

Re:Democracy?

[Anonymous Coward]

Regulating this seems reasonable to me, as does the logic in the FDA letter...

"Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment. For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect. These risks are typically mitigated by International Normalized Ratio (INR) management under a physician’s care. The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported."

Re:Democracy?

[Anonymous Coward]

The Republicans are just protecting the medical cartel. So instead of an OTC test, we now have to get the permission of a member of the cartel to get the test done.

Re:Democracy?

[alexander_686]

Is it a health or medical test? Or are they just an information provider? I mean they are not telling me if I have diabetes or heart disease – Just that my genes mark me at a greater risk to get those diseases – in combination with lifestyle and environmental factors.

Re:Democracy?

[Anonymous Coward]

the FDA already regulates every diagnostic test and device in the USA
that's why medicine is so expensive, everything has to be tested before you can sell it with claims about what the gizmo or test does

Re:Democracy?

[tgd]

The FDA decided in 2010 that services claiming to evaluate a customer's risk of disease must be cleared by regulators if the companies sell directly to consumers

So a bunch of un-elected bureaucrats decided whether same un-elected bureaucrats had the power to regulate a product or service? Mind you, I'm not questioning whether this is a good product or not-- just whether the FDA should be deciding what's in its jurisdiction. Where are the progressives clamoring for "checks and balances"?

I think you have a badly misguided understanding of how government in the US operates... and was explicitly designed.

There's a reason the "founding fathers" intended that your voice carried no weight at the national level -- or even largely at the state level. The "public" doesn't have the knowledge to have their opinions really matter on most topics. The US form of government was explicitly set up so that you'd elect local officials -- on the basis of local matters that you, presumably, have some understanding of -- up to the level of Governor of your state or commonwealth, but beyond that *those* officials voted on national matters.

And its a DAMN good thing that the dimwit "will of the masses" is not involved in the vast majority of things the government does, because the will of the masses is both ignorant and easily controlled. In fact, IMO, the majority of the problem we've got with the federal government today stems from the fact that the separation between the will of the people and the federal government has eroded over time. Instead of good people being elected, the slime balls who can most effectively sway the opinion of the ignorant masses gets elected -- and then has to spend their time playing politics to keep that position.

Re:Democracy?

[ShaunC]

I figure that a product which makes claims about its ability to predict (note that they won't say diagnose) your potential for developing certain diseases later in life should fall under the FDA's purview. I've been interested in 23andme for a long time. The first time I heard about them, the test and resulting reports ran something like $500. I added it to my "wish list" way back then and nobody bit. It's apparently down to the $99 mark now and is being marketed on television in time for the holiday season.

I'm a fairly intelligent individual and I'd be absolutely sure to take anything they reported about my genetic profile with a grain of salt. However, the FDA exists to protect your average Joe out there, who believes those TV commercials that say taking Penalis will give you a raging boner, and that lady who was on "Las Vegas" really does have an amazing non-surgical facelift procedure that will remove 20 years from your face.

A lot of these products get away with using a very blatant disclaimer that "these statements have not been evaluated by the FDA" etc. I'm not entirely sure why 23andme can't just put that disclaimer in there as well, and be all good. But the fact is, FDA has been trying to work with them for several years to get them into whatever is considered to be FDA marketing compliance, and the company apparently hasn't cooperated.

If they'd not put commercials on TV, they probably wouldn't be in any trouble. I just checked their site and can't immediately find the old list of stuff that they said they'd test your DNA for (and there was a big list). Not saying they've taken it down, but I didn't see it with a quick glance.

All of that said, the 23andme spit-and-get-results thingy is still on my wish list.

Re:Democracy?

[Okian Warrior]

So a bunch of un-elected bureaucrats decided whether same un-elected bureaucrats had the power to regulate a product or service? Mind you, I'm not questioning whether this is a good product or not-- just whether the FDA should be deciding what's in its jurisdiction. Where are the progressives clamoring for "checks and balances"?

The FDA bears the brunt of all public outrage of anything even tangentially related to medicine. They are bureaucrats who want to avoid responsibility at any cost. The FDA also bears none of the costs of testing new products.

What outcome did you expect?

A different model might take the utility of public safety into account. Instead of "safety at any cost", it might be "more good than harm".

The current diagnosis model is probabilistic fitting, where a self-confessed list of symptoms is matched against a list of possible conditions. The doctor starts with "try this, see if it clears up" and moves to the next condition if it doesn't. (And heaven help you if you get a rare condition.)

I don't see how a diagnostic test, even an inaccurate one, could be worse than what we have now. A false positive would have to be confirmed by more accurate testing, and a false negative wouldn't be any different from not taking the test (ie - you'd wait for symptoms to appear). Maybe instead of the FDA requiring companies to prove perfection, it should be up to the FDA to prove that something *doesn't* work. They would eliminate all the obvious scams and swindles, and allow companies to try new things(*).

(*) With normal legal protections - companies would still be liable for damages.

Re:Democracy?

[Anonymous Coward]

It definitely isn't a food or medicine. I don't think this is a health test (phenotype versus genotype) unless you think that genes are unhealthy. (I recall some fascists once thought like that.) It is arguably a medical test -- but so is measuring weight, BP, temperature, pulse, and examining an individual for albinism, eye color, and gender. I guess all companies who state, "You have high BP and you are male; you are at higher risk of cardiovascular disease" and back it up with research should be shut down too.

Re:Democracy?

[Archangel Michael]

Well, considering that the FDA told the Walnut Marketing Association, that any marketing of "health benefits" regarding walnuts would classify them as "drugs" and thus they are not allowed to even promote Proven benefits of Walnuts, this makes perfect sense. They are, after all, protecting us from the boogie man of health.

We need a government approved, ObamaCare Certified doctor our plan approves of, in order to tell us anything medical. "We are from the Government, we are here to help."

Of course they are a bunch of un-elected bureaucrats. THAT is why we keep voting for (R) and (D)s who keep giving us more Bureaucracy, never less. And queue the Republicrat response of "Somalia is a Libertarian dream" in 3 - 2 - 1 .... (And by the same measure North Korea is a Bureaucrat dream!)

Re: Democracy?

[Bill, Shooter of Bul]

Its not a democracy, it's a republic. If, we, the people, don't like what they are doing we simply need to elect people who will change the law. The check on the fda, is congess and the courts. In this case, I think it's actually good policy.

Re:Democracy?

[Minwee]

And its a DAMN good thing that the dimwit "will of the masses" is not involved in the vast majority of things the government does, because the will of the masses is both ignorant and easily controlled. In fact, IMO, the majority of the problem we've got with the federal government today stems from the fact that the separation between the will of the people and the federal government has eroded over time. Instead of good people being elected, the slime balls who can most effectively sway the opinion of the ignorant masses gets elected -- and then has to spend their time playing politics to keep that position.

So the only problem with democracy is that the people are allowed to vote. Take that away and you can accomplish anything -- even making the trains run on time.

Re:Democracy?

[Anonymous Coward]

You brought up the founding fathers, so riddle me this.
Amendment 10 (paraphrase from memory) All powers not listed within the Constitution are to be handled by the states.
Now please point to me where the "founding fathers" put in the FDA in the Constitution, or which amendment it was added in.

If you want to argue individual states have this power, I can agree. What state is the FDA under?

Seems to me most of the issues with the Federal Government could easily be cleared up by Congress, Executive Branch, Supreme Court, being forced to READ the 10th amendment and the 14th amendments every day out loud and if what they are proposing does not fit, toss it out.

Re:Democracy?

[Anonymous Coward]

Interstate commerce. If you think 23andme selling a product over the internet, which is then mailed to consumers, typically in different states, and then mailed back, typically to a different state, and then the results are transmitted via the internet, across all sorts of state lines, isn't interstate commerce, I'm not sure what is.

Which isn't to say interstate commerce isn't abused, but 23andme is certainly engaging in it.

Re:Democracy?

[nbauman]

The FDA jurisdiction over medical tests (as opposed to therapeutic drugs) is interesting.

I once researched this. The manufacturer has to give the FDA enough information that the FDA has to certify that tests used for medical purposes are accurate.

Question: Exactly what do they accurately measure?

Take this test, for example: http://www.walgreens.com/store/c/at-home-drug-test,-marijuana/ID=prod375983-product

Is it enough to measure the presence of marijuana (with 99.9% accuracy)?*

Or is the medical question whether the person being tested has marijuana abuse, which means that marijuana use is interfering with education, recreation, social functioning, or some important life function?

Suppose a parent tests his teenager for marijuana, and beats her if she fails the test. Does the FDA have to consider those broader results of testing?

The FDA had a bit of trouble with these tests, and finally decided that their responsibility ended at certifying that it accurately indicated the presence of marijuana.

In 23andme, the FDA seems to be saying that it's not enough to report the results accurately (or within the stated accuracy), but they have to consider the consequences of finding out the results.

__________
*Slashdot readers will immediately recognize that if the false positive rate is 0.1%, it will falsely accuse a 1 out of 1,000 subjects, which is a lot.

Re:Democracy?

[hairyfeet]

Uhhh..you might want to look up the history of the FDA friend as its one of the government services that has a DAMN good reason for existing!

You see back in the 1920s, soon after the discovery of Radium and X-Rays...and you just KNOW when a sentence starts like that its gonna end badly..a bunch of companies started selling "Health restoring radium water" which of course not only had zero oversight since there wasn't an FDA but also had zero standards when it came to doses. Needless to say several people died most horribly, including on industrialist whose jaw literally rotted off and who ended up so damned radioactive that they had to bury him in a lead casket to keep him from contaminating the entire area, and THAT is the event that caused the birth of the FDA.

Now if you want to argue that this shouldn't be under their jurisdiction? Fine and dandy although I would argue that a bad test result could cause folks to die as they might ignore symptoms because "The test says I'm not at risk for X", not to mention we have ZERO proof that their labs are even monitored in any way. Don't forget that there was a gal at a state crime lab recently that got busted for just tossing samples and telling cops what they wanted to hear and who knows whether or not they have any bad apples at this place so...yeah I kinda want their to be oversight when it comes to DNA testing, especially since more and more things like insurance and jobs could very well be affected by bad results.

Re:Democracy?

[Anonymous Coward]

Fortunately for the rest of us, you're one of the dimwits without a voice.

Re:Democracy?

[operagost]

How is this a medical device? Answer: because they say so.

Re:Democracy?

[operagost]

be sure to stock up on adequate quantities of Doritos and Diet Dr. Pepper

Nope, the FDA banned them this morning.

Re:Democracy?

[Anonymous Coward]

It's neither.

It's a genetic test that tells you which markers you have, that have been linked (by healthcare professionals and researchers) to illnesses and conditions.

They aren't making a diagnosis, they aren't telling you that you have anything, they just tell you what markers you have, and what the potential links are.

This is just the FDA trying to protect their wallets.

Re:Democracy?

[Bill_the_Engineer]

How is this a medical device? Answer: because they say so.

They being 23andMe. If they market it as a diagnostic service then they are providing a medical test regulated by the FDA.

Re:Democracy?

[Anonymous Coward]

such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.

Yes of course! The first step any reasonably sane person would take after a $99 test would be to spend tens of thousands of dollars on preventative procedures... The obvious step is to spend a couple of thousand on a more detailed genetic checkup that one would likely not have gotten if it were not for the $99 test. I am a 23andMe member, my test results returned a high Warafin sensitivity. I have advised my wife and my general practitioner of the result and the source of the result. I told my wife to make sure that if I am incapacitated and warafin could be of benefit that additional tests be ran. If every product and service has to account to the lowest denominator what level of product and service does that leave us?

Can the government guarantee with 100% accuracy all the FDA approved tests and procedures? No. The government does get a pretty hefty chunk of change for sticking its finger in the pie so I definitely understand the motives for this action. This is government stifling innovation. At worst I think they should make 23andMe put a disclaimer on their side saying that the procedure is not FDA approved.

Re:Democracy?

[nbauman]

If doctors were actually using these mail-order tests to make medical decisions, that would be a concern.

I don't think it's realistic to expect that anybody would for example get a double mastectomy/ovarectomy on the basis of this test. No licensed doctor in the US would operate on a woman on that basis.

(In fact, a doctor in Australia wrote an article about that in the New England Journal of Medicine. A woman had gone to a "free screening" at a "health fair" and the "alternative medicine practitioner" told her that she had cancer, and sold her a few thousand dollars worth of "alternative medicines" to treat it. This woman went to this real doctor, an oncologist, demanding to be treated for cancer. The oncologist kept telling her, "but you don't have cancer!")

Similarly, I can't follow the FDA's argument that this test could affect a patient's use of warfarin (although I give them credit for trying to make a case).

The FDA seems to give a free hand to companies selling some dubious tests http://www.hairanalysiskit.com/glink/1a.htm?gclid=COTshpbjgLsCFQbNOgodGUMAbQ so there are some legitimate questions.

Regulators protecting us from dangerous health fraud? Or jack-booted thugs restricting our freedom? You decide.

Re:Democracy?

[ewieling]

Drug tests usually test for compounds the drug is metabolized into, not the actual drug. For example if you had not used cocaine, then snorted a couple of lines and immediately took a drug test, you would still test negative. I'd have few moral issues with drug tests if they tested for intoxication at the time of the test.

Re:Democracy?

[JWW]

This is why we can't have "Affordable" care.

This company provides a valuable service to their customers at a very inexpensive price.

Now that the FDA is involved, its likely 23 and me is done. The companies that run through their regulatory gauntlet will likely offer their services for prices that are an order of magnitude larger than 23 and me did.

It is literally the price of regulation. We're not really paying for health care. We're paying for this regulation and that regulation and this insurance rule and that restriction and the doctor's insurance and the clinic's insurance, and that administrator's porsche (because what good is an administrator that isn't payed the big bucks), and this drug company's kickbacks that lead to the regulatory hurdles and that companies kickback's to local politicians to keep new competitor clinics from opening.

No wonder health care costs a fortune. Pretty soon we'll be paying everyone EXCEPT the Doctors!!

Re:Democracy?

[Crashmarik]

Just under what legal theory before the FDA was poisoning people a legitimate business ?

And just what stops people from selling something similar as a nutritional supplement ?

If you don't recall

http://www.nemsn.org/Articles/summary_tryptophan%20Fagan.htm

Re:Democracy?

[nbauman]

The FDA bears the brunt of all public outrage of anything even tangentially related to medicine. They are bureaucrats who want to avoid responsibility at any cost. The FDA also bears none of the costs of testing new products.

What outcome did you expect?

A different model might take the utility of public safety into account. Instead of "safety at any cost", it might be "more good than harm".

That's not true. I've read the FDA regulations, and I've read transcripts of FDA hearings, which are now online. They have to weigh the benefits of the new drugs against the dangers. They have long debates in the hearings over the benefits and the potential harm. And some of the people on the panel are sympathetic to the industry. It's a difficult balance http://www.reuters.com/article/2013/10/18/us-ariad-cancer-idUSBRE99H0BP20131018

There were lots of drugs, like erythropoetin, that the drug companies over-promoted and made lots of money on, even though they were killing people. Their excuse was, "We didn't get a statistical signal." Every time a pro-business administration takes over, the FDA loosens up its regulations, and the bodies start dropping, so they tighten up the regulations again.

The FDA is not allowed to take the financial cost of the new drugs into account. That's not in their legal mandate.

Re:Democracy?

[Anonymous Coward]

FDA just wants to protect the breasts.

Re:Democracy?

[sjames]

Present and accounted for! The FDA has been on a power binge for far too long, expanding their domain at every opportunity and no excuse too thin. meanwhile they have been neglecting the core of their charter. They should be focusing on proper regulation of drugs (like making sure people don't get fungus injected into their spines) and other things that actually get put in to people.

Really, their regulatory authority should end with the swab.

As for progressives with any actual political clout, good question.

Re:Democracy?

[nbauman]

I think the wording of the law is "diagnose or treat."

Informing someone of a predisposition to a disease may not fall under that authority.

I'm glad that Sergy Brinn's ex-wife has enough money to take it to court to get a fully-argued resolution.

Re:Democracy?

[Curunir_wolf]

Regulating this seems reasonable to me, as does the logic in the FDA letter...

Because the peasants are so stupid that they need to be protected from themselves, or because you enjoy having tyrannical bureaucrats dictating every aspect of people's lives?

Re:Democracy?

[interkin3tic]

Just under what legal theory before the FDA was poisoning people a legitimate business ?

Bit of a strawman argument there. Snake oil isn't "poisoning" people, it's a specialized form of fraud. You rely on whatever snake oil you are selling to be beyond the technical understanding of your average consumer. They assume it's safe because you're the "expert." People back then had zero experience with radiation. Even the experts were blissfully unaware of the dangers, see the Curies. The FDA was established to make sure people did their homework and correctly tested products before selling them to the public, not to stop murder.

In this case though, this seems to be overstepping the legitimate goals of the FDA. I mean, it's a blood test. Any fallout from the tests are going to be social, not health related. The FDA might as well ban people from going online: they might read Andrew Wakefield and conclude that vaccinations were bad. Unless 23 and me is promising things it doesn't deliver (sequencing results), this seems to be bullshit.

Re:Democracy?

[stenvar]

how is it not in their jurisdiction? its a company performing a health and medical test. of course they should have research behind their you will get cancer promises

There is research behind it. It's just not research that the FDA likes. For example, the FDA is worried that people receiving positive DNA tests are going to run out to demand additional tests from their doctors. Those tests may well make sense from an individual point of view, but the FDA doesn't like them because they don't make sense in an average cost/benefit analysis across all insured.

Re:Democracy?

[stenvar]

They being 23andMe. If they market it as a diagnostic service then they are providing a medical test regulated by the FDA.

Yes, but why should the FDA have the power to regulate these tests in the first place?

Re:Democracy?

[spmkk]

"Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these."

Show that the level of false positives/negatives is higher with genetic testing than with conventional testing, and you might have a point. Otherwise, alarmist "OMG MY BREASTS!" scare mongering.

For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist."

Correct, but -- again -- irrelevant unless the error rate is higher than in hands-on testing that's currently being used.

"The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage..."

Ahh...THERE it is. We can't have patients going around getting informed about what's in their own bodies and making decisions based on that information. That's the purview of PROFESSIONALS.

Kind of like auto mechanics telling you they're the only ones that should be allowed to read the OBD messages from your car.

Re:Democracy?

[Anonymous Coward]

Is a bathroom scale a diagnostic device?

Because that's what 23andMe is doing. They're making something that was once part of the expensive and costly medical world and bringing to the masses. They're turning genetic testing into the equivalent of a fancy bathroom scale.

I for one think their service is amazing, particularly because it costs $99. I'm also under no delusion that it's not particularly valuable regarding my health. Part of that is because I have several molecular and genetic biologists friends, but also because 23andMe tells you this.

For the few people out of a thousand who actually find they may have a serious genetic condition, they'll obviously go directly to a doctor. For the rest of us, it's like the 21st century version of a mood ring, except actually based in real science.

Also, the ancestry stuff is cool, although genes don't tell you much about your ancestry, because we think of ancestry in terms of who our Great-Great Uncle Joe was. But within three or four generations your actual genes quickly link you to almost everybody in a sizeable geographic region, while your great old Uncle Joe doesn't really stick out much. Your real, genetic ancestry is exceptionally boring. I found out a very, very white friend have a Y-chromsome from Southeastern China, which had migrated over a thousand years or so North to Siberia and then East to Finland. That's relatively recent genetically, but kinda yawn inducing in terms of what we care about.

Re:Democracy?

[Albanach]

Which is just the same as carrying a BRCA mutation that increases your likelihood of breast cancer. Yet almost every medical authority would agree you should only get BRCA testing done alongside counseling from an appropriately trained genetic counselor.

Are members of the public equipped to interpret a 55% or greater chance of their child developing Alzheimer's Disease?

It's not about withholding the test. It's about making sure the test results are accurate, that the recipient understands what the test may uncover, and that they are equipped to rationally process the result.

Re:Democracy?

[stenvar]

There's a reason the "founding fathers" intended that your voice carried no weight at the national level -- or even largely at the state level. The "public" doesn't have the knowledge to have their opinions really matter on most topics.

The Founding Fathers never imagined or desired a federal government that regulates every aspect of our lives and runs 25% of the economy. They certainly did not imagine or want anything like the FDA, DEA, or other such institutions. The federal government is supposed to defend the nation and make sure that nobody interferes with free trade between the states, that's all.

but beyond that *those* officials voted on national matters.

Yes, and health care, education, drug laws, etc. should not be national matters.

And its a DAMN good thing that the dimwit "will of the masses" is not involved in the vast majority of things the government does, because the will of the masses is both ignorant and easily controlled.

And it's high time that we kick representatives with that kind of arrogant attitude out of office.

Re:Democracy?

[sjames]

Except they HAVEN't done anything about the boner pills. While less frequent, I still see the commercials pop up from time to time, including the old Enzyte commercials.

Should Tarot cards be regulated by the FDA? What of crystal balls?

I haven't seen any commercials for 23 and me.

Re:Democracy?

[Anonymous Coward]

I wouldn't mind if the FDA forced them to put a label saying that it was not FDA approved, or that it was not "conclusive", but to just say you can't sell this period is where it gets annoying.

The potential harm is that somebody may act on the information without further testing in a way that harms only themselves.

The potential good is that somebody doesn't die because they found out they were at risk, and didn't know that before.

I kind of think that the good outweighs the bad, and that proper labeling solves the problem.
I think the "to a hammer every problem looks like a nail" approach is what they are doing here.

The bureaucracy of hoop-jumping paperwork is a big reason our government is so inefficient. Just ask the VA

Re:Democracy?

[Anonymous Coward]

Pregnancy tests are also regulated as medical devices. They cost $5.

23andMe can grow up and have their work validated clinically. Or they can find an industry where accuracy is not regulated.

Re:Democracy?

[stenvar]

You see back in the 1920s, soon after the discovery of Radium and X-Rays...and you just KNOW when a sentence starts like that its gonna end badly..a bunch of companies started selling "Health restoring radium water" which of course not only had zero oversight since there wasn't an FDA but also had zero standards when it came to doses.

If you poison people by irresponsibly selling something that harms them, you are already liable. The FDA might well give advice to companies on what labeling would protect them from legal liability, but there is no justification for making these tests unavailable.

on industrialist whose jaw literally rotted off

How many stupid, wealthy people do you think kill themselves with FDA-approved drugs every year? How many people do you think doctors kill each year with FDA-approved drugs? Nobody has ever shown that FDA oversight survives a cost/benefit analysis.

Fine and dandy although I would argue that a bad test result could cause folks to die as they might ignore symptoms because "The test says I'm not at risk for X", not to mention we have ZERO proof that their labs are even monitored in any way.

As long as they are honest about what they are selling, I don't see the problem. If they properly disclose what's known about the test and you draw the wrong conclusions, that should be your problem, not theirs.

Re:Democracy?

[Chelloveck]

I'm a fairly intelligent individual and I'd be absolutely sure to take anything they reported about my genetic profile with a grain of salt.

Me, until I see evidence to the contrary I'm going to assume that this test is every bit as accurate as calling Miss Cleo. No more, no less. At least her commercials had to have a "For entertainment purposes only" disclaimer at the bottom. IMHO, unless 23andMe are going to stick that phrase on the boxes I'm all in favor of the FDA requiring that they demonstrate accuracy. (And yes, I wish the FDA did that with herbal supplements and other snake oil. Or at least make manufacturers prove that the contents of the pill match the label on the box.)

Re:Democracy?

[bws111]

You're probably right, no doctor would perform a mastectomy on the basis of the test. On the other hand, what if the test said you did not have the gene for breast cancer, when in fact you do? Are you and your doctor going to trust that result? If you do, you are no better off than you were before you took the test (in fact, you may be worse off if you forgo other testing). If you don't trust the result, then what have you done besides waste $99? And that is exactly what the FDA is trying to prevent - people being fleeced out of their money for 'medical advice' that has no value and may actually cause harm.

Re:Democracy?

[Stan92057]

Ya fuck theses people for wanting truth and paying to get it. Fuck um were allowed to bring false hope or false death sentences funk them. Corporate profits come first Fuckum.Fuck all the stupid bastard wants truth in advertising. How dare they.

Re:Democracy?

[bws111]

Show that the level of false positives/negatives is higher with genetic testing than with conventional testing, and you might have a point.

I think you have that backwards. It is up to the company performing the tests to demonstate what the false positive/negative rates are. That is, in fact, what the FDA wants them to do.

Re:Democracy?

[heteromonomer]

Blah blah blah. You deregulation types don't tone down until you've been had by quacks a few times. Do you realize how hard it is to judge quality in these services and products? Even experts in one area find it hard to make a call about another area.

Re:Democracy?

[bws111]

What about the potential harm because somebody does not act because the test said all was good when in fact it was not? Proper labelling does not solve anything. All proper labelling would do is let you know the test is worthless because you can not trust either positive or negative results.

Re:Democracy?

[Anonymous Coward]

The FDA had a recent argument for existing in the early half of the 20th century, notwithstanding constitutional quibbles.

But that argument is significantly diminished in the 21st century. It's _far_ easier to find reliable information these days. The FDA still nominally protects idiots, but many of us are being held back. Like, wju isn't modafinil saleable over the counter? It's almost as safe as candy--if you read the research experiments, which have proliferated since modafinil went off-patent, that's how the scientists treat it.

Also, harm is easier to prove these days because our science is better, and we also have these things called class action lawsuits. Why Republicans dislike them, I'll never understand, because class action law suits allow you to reduce government regulation. Their aversion to class actions belies their interest in only helping the rich by manipulating government.

If some drug causes a teensy bit of harm to each individual, it used to be that the only way to stop the large, net social harm was government regulation. But now society can police itself through class action lawsuits. That means bad drugs get punished, and drugs that can't be proven to cause harm can still be freely marketed.

(Yes, class lawsuits can be costly even if you did nothing wrong, but on the whole they're less costly than a huge government bureaucracy sticking their thumb in everybody's eye, and you can buy insurance up front to cover the expected costs. And unless you did something truly odious lawyers will only go after big corporations, because their expected return drugs which cause uncertain harm is less, so smaller companies have fewer risks. Also, unequivocally helpful drugs--like vaccines--are already immune from all lawsuits.)

Diminishing the FDA means turning everybody into guinea pugs, but we're already all guinea pigs, we just don't know it.

The only thing the FDA should be doing in the modern world is 1) enforcing strict transparency laws and 2) being a first-responder agency, which can quickly react with temporary measures when a product has actually exhibited a significant risk of harm. Everything else is ludicrous.

Re: Democracy?

[Tokolosh]

Yeah! Like we did with slavery!

"That principle is, that the sole end for which mankind are warranted, individually or collectively, in interfering with the liberty of action of any of their number, is self-protection. That the only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others. His own good, either physical or moral, is not sufficient warrant. He cannot rightfully be compelled to do or forbear because it will be better for him to do so, because it will make him happier, because, in the opinion of others, to do so would be wise, or even right... The only part of the conduct of anyone, for which he is amenable to society, is that which concerns others. In the part which merely concerns himself, his independence is, of right, absolute. Over himself, over his own body and mind, the individual is sovereign." - John Stuart Mill

"We fought for freedom, and all we got was democracy" - Pieter-Dirk Uys

Re:Democracy?

[steviesteveo]

"Are you kidding? I just told you like a minute ago."

Re:Democracy?

[interkin3tic]

It's a complex issue, and simplistic thinking like "get rid of it entirely" is foolish. That would create larger problems than the ones we have now.

The most obvious is counterfeit drugs. It's already a problem, removing the FDA is a good way to ensure a choice of thousands of cheap sugar pills, and absolutely no real drugs. Pharmaceuticals could move into the herbal supplement market and shut down their research entirely. They already mostly repackage old pills rather than develop new effective treatments.

Actually, you'd be lucky to get sugar pills. Those won't kill you.

Re:Democracy?

[Derec01]

Not what he said at all. Just that it was founded as a representative republic, not a democracy. You choose people you trust for a term to collectively make decisions rather than voting on every issue. In kind, of course, the national level government didn't have anywhere near the power it does today, so it wasn't as big a sacrifice.

Take California's ballot initiative system. Raising taxes will always be unpopular, and cutting services will be unpopular and both fail as individual measures. And yet, you need someone to make those decisions.

Your Nazi (Fascist?) analogy is a little overkill.

Re:Democracy?

[Jazari]

So if you can't afford to get this low cost and effective test ($99) then you should get nothing at all? Their test is more than reliable enough for most purposes. And if you're planning on getting a double mastectomy, obviously your surgeon will do a specific follow up test.

Re:Democracy?

[WillAffleckUW]

Which is just the same as carrying a BRCA mutation that increases your likelihood of breast cancer. Yet almost every medical authority would agree you should only get BRCA testing done alongside counseling from an appropriately trained genetic counselor.

Are members of the public equipped to interpret a 55% or greater chance of their child developing Alzheimer's Disease?

It's not about withholding the test. It's about making sure the test results are accurate, that the recipient understands what the test may uncover, and that they are equipped to rationally process the result.

Here's a fact. If you're female, you're at greater risk to develop AD, even accounting for age.

And, another thing, most impacts of AD are highly linked to other things - which these tests won't show you.

Yes, Apolipoprotein-E is a significant risk allele, but it's not the whole story. You'd be far better off getting enough sleep and moderate exercise and laying off the typical American diet.

Re:Democracy?

[Jazari]

Nobody is forcing you to submit your samples to 23andMe. Of course there should be standards for police DNA evidence labs. But 23andMe is basically an entertaining service that also provides some health information. Why shouldn't consenting adults be allowed to submit their DNA to it? Especially when there is no health hazard at all (unlike "radium water").

Re:Democracy?

[nbauman]

No doctor would make a decision on the basis of this test.

The main benefit of BRCA testing is that some women have breast cancer in their family. BRCA has such a high likelihood of developing into breast and ovarian cancer at a relatively young age that many women decide that they'd rather have a bilateral mastectomy and ovarectomy first and (probably) escape that risk. But if they don't have the relative's gene, then they don't have that risk of breast or ovarian cancer, so they don't have to worry about it.

The current recommendations for BRCA testing is that it's only indicated for people who already have breast cancer in the family. The person with breast cancer has to be tested (as they usually have been for treatment purposes).

If the person with breast cancer has the BRCA gene, then other people in the family can get tested.

If a relative has the gene, she's at risk and can consider a prophylactic mastectomy/ovarectomy.

If a relative doesn't have the gene, she's not at risk. The gene passed her over. A prophylactic mastectomy/ovarectomy would be pointless.

But a relative who is really at risk of breast cancer, and under treatment by a doctor, would use an FDA-approved test kit, not 23andme.

There may be a situation in which the relative can't afford an FDA-approved test kit, but can afford $99 for 23andme. You could say, 23andme is better than nothing. But if the relative can't afford the FDA-approved test kit, she couldn't afford a prophylactic mastectomy/ovarectomy either.

BTW, BRCA (or rather, BRCA1 and BRCA2) is just the most common gene. There are others. If the person with breast cancer tests negative for BRCA, she still has other genes she could test for. There are new genes being discovered regularly, so if she couldn't find the gene, she should keep testing.

I'm glad the FDA is looking out for me. I don't think they've made the case yet that DIY testing can be harmful, but I don't understand why 23andme didn't take care of the paperwork.

Re:Democracy?

[nmnilsson]

It's always strange to hear Americans talk about their government like it's an entity removed from themselves.

Most of us here in Scandinavia trust the government. We think it's on our side, against the drawbacks of capitalism.
We see that businesses are excellent at providing goods and services, but also that that's a by-product of their primary purpose: making money.
Left unchecked, businesses will do bad things to maximize profit.
Not because we, their owners, are evil capitalists, or that we, their employees, are without conscience.
It's just the way that humans - and by extension businesses, our most perfectly egoistic creations - work.

I don't mean to troll, but this is what I experience:
I hear your arguments against a strong government, and most of them don't make sense to me.
I see private citizens open their mouths, and out come the words of business representatives. It's like some darn spooky ventriloquism trick.
You identify yourselves with businesses and not with your government.
Truly, to me many Americans seem indoctrinated to mistrust and want to minimize their government (i.e. their own power, as I see it).
It's the only way I can make sense of it.

Re:Democracy?

[kbolino]

The phrase "interstate commerce" does not appear in the U.S. Constitution. The exact wording is (emphasis mine):

The Congress shall have Power ... To regulate Commerce with foreign Nations, and among the several States, and with the Indian tribes ....

The purpose of this power was to allow the Federal government to intervene whenever a state imposed a trade restriction upon commerce with other states.

Re:Democracy?

[Albanach]

Which is why you want test results on things like this handed over by an expert, not an email.

There are some areas where government regulation is appropriate. This is one of them.

Re:Democracy?

[kbolino]

Your contempt for the human race is duly noted.

Instead of good people being elected, the slime balls who can most effectively sway the opinion of the ignorant masses gets elected -- and then has to spend their time playing politics to keep that position.

As opposed to your alternate scheme, where fools elect conmen who then somehow manage to appoint supergeniuses to govern us all. How does that work, exactly?

Re:Democracy?

[kbolino]

Never let principles get in the way of your pettiness.

Re:Democracy?

[TangoMargarine]

only if you buy them in sufficiently large packaging, though

Re:Democracy?

[Hatta]

The "public" doesn't have the knowledge to have their opinions really matter on most topics.

Nor do our representatives. They get briefed on important issues by lobbyists who care for nothing but their own self interest. They exchange their time for money, so that the only policies they are even able to contemplate are those that favor the extremely wealthy. If someone did have a clue, those monied interests would not support his candidacy, because they could not control him.

its a DAMN good thing that the dimwit "will of the masses" is not involved in the vast majority of things the government does, because the will of the masses is both ignorant and easily controlled

Whereas the will of our government is malicious, greedy, and easily controlled. You know how poorly you think of your fellow citizens? Now realize that our elected representatives are the most ambitious, self serving bastards among them.

IMO, the majority of the problem we've got with the federal government today stems from the fact that the separation between the will of the people and the federal government has eroded over time

No, it's because the will of a tiny but extremely wealthy elite has come to matter much more than the will of the rest of us.

Instead of good people being elected, the slime balls who can most effectively sway the opinion of the ignorant masses gets elected

And the slime ball does that by spending money given to him by the extremely rich, to whom he is then indebted.

Re:Democracy?

[Hatta]

You choose people you trust for a term to collectively make decisions rather than voting on every issue.

It's a lot easier to sway the opinions of a small group of ambitious sociopaths than it is an entire nation. What's good for 51% of Congresspeople is only good for 0.00015% of Americans. What's good for 51% of Americans is good for 51% of Americans.

Re:Democracy?

[Anonymous Coward]

I'm a fairly intelligent individual and I'd be absolutely sure to take anything they reported about my genetic profile with a grain of salt.

Me, until I see evidence to the contrary I'm going to assume that this test is every bit as accurate as calling Miss Cleo...

I work in bioinformatics. I recently had the opportunity to compare 23andMe data with exome sequencing data. Long story short, I didn't find any major discrepencies - i.e. there was overwhelming agreement in the variant calls. I'm sure there will eventually be shady genetic testing companies that are pumping out garbage data. But that's not the case with 23andMe.

And, data quality is not what this particular battle is about. In the past, medicine has mostly opporated in a hand-crafted model: like having a business suit custom made by an individual tailor - or eating at a gourment restaurant with a single set menu decided by the chef. But now technology is making it possible to do the medical equivalent of shopping for clothes at Walmart or eating your lunch at McDonalds. And that raises some interesting questions about the future roll of medicial doctors in medical care - and not all of them like it.

Re:Democracy?

[div_2n]

The world today is so far removed from anything the Founding Fathers knew that it is absurdly silly to try to weight their intentions on current situations and necessities. Moreover, the moment the Constitution was inked, arguments about what it meant began and have never ceased. Even when they were still alive debates persisted.

But most importantly -- the fact that they created a framework of amendments means that they NEVER intended the Constitution to be a static document. So whether you agree with current interpretations of the Constitution as it is written or not, you should probably avoid saying "The Founding Fathers never would have ...". Totally irrelevant. They built the document knowing full well (or should have known) that one day it could be changed and morphed into something they would NEVER have wanted.

Re:Democracy?

[mysidia]

There's a reason the "founding fathers" intended that your voice carried no weight at the national level -- or even largely at the state level.

They also intended that the national government's voice carried no weight in your day to day life.

They specifically created a national government of enumerated powers; with very limited authority, that would have no power to intrude on people's daily life, or regulate the affairs of individual citizens ---- for example, regulating what kind of medical devices could be sold would be well outside their power, except congress could pass some laws regulating the commerce, or trading in interestate commerce (trades across state lines, exclusively).

Re:Democracy?

[pspahn]

Pregnancy tests were approved for OTC sale in the late 70's. These tests were quite different than what you would find on the shelf today and were composed of test tubes, solutions, and other components that were not something a typical user might be comfortable with. Often the tests would be sent off to a laboratory or other facility to determine results.

The $5 pregnancy test you refer to is entirely self-contained and is a result of decades of research to reduce the complexity of the test so that it could be taken easily at home. I get your point, regulated products aren't *always* expensive; however, consider the sheer amount of products the FDA regulates. Here's a nice tidbit from the FDA themselves:

FDA regulates over 1 trillion dollars worth of products, which account for 25 cents of every dollar spent annually by American consumers.

Re:Democracy?

[EvilSS]

They didn't invent the wheel here, they are using a bead chip from Illumina. I imagine accuracy information is already readily available.

Re:Democracy?

[Lando]

Likely to prevent quacks from diagnosing patients with problems and then charging an arm and a leg to fix the problem. Why they would do with with "sciency" stuff and not with the homeopathic and herbal supplement market confuses me, but government regulation is sometimes fairly illogical.

Re:Democracy?

[ShaunC]

Except they HAVEN't done anything about the boner pills.

I really do have confidence that the commercials for boner pills have been scrutinized and approved by FDA. I haven't seen an ad for Vi[boner]ra in ages, but Ci[boner]is with that low bluesy guitar riff in the background is all over TV in the US. The pills work as advertised and are prescription-based (hahahah yeah I know). Plenty of "if you encounter symptoms such as difficulty breathing, or if you have trouble with your eyesight or hearing, stop taking [boner pills] and seek medical attention right away." And the seemingly requisite "Ask your doctor about [boner pills]."

23andme isn't offering to cure anything, they aren't offering to diagnose anything, and they aren't offering to treat anything. They're advertising a service where you spit in a cup, send it off, and get back some "okay, this shit might be going on in your family lineage" results. They're not telling you that you have sickle cell, or that you're going to die if you eat asparagus, or anything of the sort. But they are making medical-type claims regarding your DNA, such that perhaps your brain isn't receptive to flubber-baz antagonists, which might make you argue with your physician or stop taking such medication altogether, to your own detriment.

Works for me, but if your average Duck Dynasty fan picks one of these up, they might flip the fuck out at what they get back. "YOU SAYIN I GOTS NIGGER IN MAH BLOOD? ANN MAH DICK NEVER GONN' GET GOIN' AFTER AH DRINK BEERS? AHHH'MA CALL UP MY REPRASENTIVE! GET THIS SHIT BANT!"

FDA's issue is very narrow. 23andme is making marketing claims of a medical nature which have not been approved by the FDA. The advertisements do not adequately disclaim that 23andme cannot prove whatever their DNA tests might come up with. If they rebrand themselves as a novelty, or work with FDA to achieve de novo compliance (which is basically FDA saying "hey! let's start it all over and get you compliant! woo! yeah let's do it!"), they should be just fine. I hope. Because I do still want to get that shit done for my spit.

Re:Democracy?

[Rockoon]

False positive and negative rates of what?

They arent performing a diagnosis. You don't seem to understand that, yet your argument relies on the very thing that you don't understand.

Re:Democracy?

[Anonymous Coward]

Which is why you want test results on things like this handed over by an expert, not an email.

OK, so in one universe your doctor tells you that you've got the risk allele but it's not the whole story, in a second universe you get an email telling you the same thing, and in a third universe all you get is the raw variant call which you look up in wikipedia to eventually find out the same thing. Why is one better than the other?

It's not as if a mere five minutes in the god-like presence of a medical doctor will somehow suffuse a person with all possible knowledge relating to their condition - that would otherwise take decades of study to fully understand. But perhaps you take a paternalistic view - that most people are too stupid to ever understand what's good for them - so they should have the major decisions in their lives made for them by carefully chosen experts (i.e. medical doctors).

Re:Democracy?

[Anonymous Coward]

It is literally the price of regulation. We're not really paying for health care. We're paying for this regulation and that regulation

I just compressed a batch of the tablets you/your mom use to stay healthy. I did it in my basement to save money. I put in nearly 99% of the active ingredient on the label. I can cut costs, and you probably won't even notice the slight difference.

Re:Democracy?

[Albanach]

I think you misread or ignored my comment. It's not about denying people the test, it's about making sure they understand it.

I think you'll find most doctors if needing something like a BRCA test for themselves would still consult a genetic counselor first. Why?

Because there are numerous different tests that might be appropriate - do you just need tested for one possible hereditary cancer, or are there others you should be tested for too based upon your family history.

There may be a better person to test than yourself.

The result of the test may be misleading to a non-specialist, even someone who is trained and has a medical degree. For example a negative result might mean another condition is more likely rather than being an all-clear.

Wikipedia is great, but it's not an adequate substitute for proper healthcare.

And it's not like 23andme couldn't provide appropriate counseling before testing and have results handed out by a specialist with a genetic counseling degree.

Re:Democracy?

[Anonymous Coward]

And it's not like 23andme couldn't provide appropriate counseling before testing and have results handed out by a specialist with a genetic counseling degree.

Sure, let them eat cake.

So 23andMe is going to fly all it's customers from around the world into San Francisco for a nice long in-person chat with a genetic counselor before the testing - and then fly them in again when they receive their results - plus compensate the lost wages from time the customers took off work - all for the low price of $99?

And somehow whatever it is that the genetic counselor might tell them in person would be absolutely impossible to tell them in an email? And there's no possibility to send an email recommending a visit to a genetic counselor under certain circumstances (family history of breast cancer, positive SNP result, etc)?

Re:Democracy?

[Albanach]

I understand there is this thing called the telephone. They could use that.

There's also this thing called the internet. Perhaps you've heard of these Google Hangout things. I'm pretty sure they've got enough talented people to set up a securely encrypted hangout for use in a counseling session.

Re:Democracy?

[Microlith]

The Founding Fathers never imagined or desired a federal government that regulates every aspect of our lives and runs 25% of the economy.

They were men of the late-18th century, there is a great deal they could never have imagined. That said, the current state of things has been 200+ years in the making- and it began almost immediately after the country was founded.

They certainly did not imagine or want anything like the FDA, DEA, or other such institutions.

To put the FDA in the same ranks as the DEA is ridiculous. The FDA came into existence because corporations and quacks were pushing shit out that was tainted, dangerous, and exploited people's ignorance and penchant for magical thinking. The DEA exists because prudish people beset by an "us vs. them" atmosphere are easily manipulated.

With luck, times will change and the DEA will go away. The FDA needs maintenance, but will remain because it serves a useful purpose.

The federal government is supposed to defend the nation and make sure that nobody interferes with free trade between the states, that's all.

Maybe in a naive, simplistic view of government. Frankly I rather like not having to deal with corporations on the basis of caveat emptor.

Re:Democracy?

[Microlith]

Consenting adults will absolutely be allowed to, once 23andMe complies with the regulations we have empowered the FDA to impose upon corporations acting in a medial scope.

This isn't an impingement on your rights to control you, it's a regulatory burden imposed upon a corporation to defend the validity of its product.

Re:Democracy?

[CTachyon]

Just under what legal theory before the FDA was poisoning people a legitimate business ?

THE RADIUM WATER IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

Back in the U.S. robber-baron era (1870-1905) it used to be the case that it was your own fault if you put it in your mouth. It didn't matter if the seller marketed it as edible despite knowing or suspecting that the product was poisonous (such as radium water or formaldehyde-preserved milk). As the buyer you were supposed to know better, as summarized by the legal doctrine caveat emptor ("let the buyer beware"). It was only later that caveat emptor was _partially_ overturned by the invention of the "implied warranty", as federally formalized in the Uniform Commercial Code of 1952 (though the concept was kicking around decades earlier than that on a state-by-state basis). In the absence of a warranty (explicit or otherwise), the seller had made no promise to the buyer about the product sold, and with no promise to break there was therefore no fraud on the seller's part. No fraud, therefore no wrong and no restitution: no wrongful death damages, no medical bill expenses, not even a "satisfaction or your money back" refund guarantee.

To this day, there's still quite a bit of caveat emptor in the law. For example, cigarette smoke is poisonous at the intended dosage, full stop. Habitual smoking of cigarettes is known to inactivate hemoglobin by way of carbon monoxide, to reduce lung capacity by accumulation of scar tissue, to damage the cardiovascular system by hardening the arterial walls, and to dramatically increase the risk of lung and other cancers. But despite their documented toxicity, to this day tobacco companies are not held liable for selling them. They have been sued several times, but generally for their advertising, and many of the advertising suits have been for ads that played up false benefits or downplayed real drawbacks -- i.e. they made a promise (implied warranty of fitness) that was then broken (fraud). But so long as the buyer is duly warned (no false advertising, the Surgeon General's Warning is present), the situation reverts to caveat emptor and it's again the buyer's own fault if they put poison in their mouth.

Re:Democracy?

[sjames]

The viagra commercials are all over TV where I am and even go so far as to use VERY blue lighting (just like the cvisual distortion they cause in many users). Then there's a zillion ads for definitely not FDA approved boner pills of all sorts.

of course, the uissue of the day seems to be 'low T'.

I wouldn't mind so much if the FDA approval was inexpensive and/or actually meant something other than 'kissed all the right asses'.

Then there';s cases like colchicine. It's been used since before Washington was president. It's efficacy is well known. It has well understood side effects. Na being th*WS* a generic. Then, one company spent $3mil on a completely worthless study and otherwise kissed the FDAs ass and now has an exclusive on it. As soon as they got it, the cost went up several dozen *times* overnight.

Everyone but the FDA and the holder of the exclusivity was far better off before the FDA 'helped'.

I am not one of those "all regulation is evil" nuts by a longshot. I certainly agree that medicine needs regulation. However, it does NOT need the sort of expensive yet shoddy regulation that the FDA provides and we certainly don't need an agency actively straining to increase their domain.

Re:Democracy?

[stenvar]

Likely to prevent quacks from diagnosing patients with problems and then charging an arm and a leg to fix the problem.

But that's exactly what many medical doctors are frequently doing. You used to be able at least not to pay the worst of these quacks, but with ACA, everybody is forced to pay them.

Re:Democracy?

[rastos1]

A few years back I had a serious lung problem. I visited my doctor, he recognized something is wrong (though he was not sure what it was) and send me to a specialist. The specialist did an X-ray, took blood samples eventually sent me to MRI, etc. etc. He determined that the condition is serious and sent me to a specialized sanatorium/institute that specializes in lung diseases and surgeries - along with the documentation collected so far. And they did their own X-ray, blood samples, and all the other tests. (At the end I ended getting a surgery) That was the standard procedure, and IMHO the right thing to do.

Recently I've seen a lecture explaining the basics of Bayes' theorem. That was first time I've encountered it. What I took away from that is: if you test positive, you don't jump to conclusion. You get the test repeated, you get more tests, you get independent opinion, ...

Why would someone demand or reject a treatment based on a single test not preformed by an expert is beyond me. But if high percentage of population is stupid enough to jump to conclusion based on single test not performed by an expert, then yes, you probably need FDA to regulate 23andMe.

It's one of those many, many problems that could be resolved by people being more educated.

Re:Democracy?

[stenvar]

I was responding to "tgd"'s statement about the Founding Fathers and representative government, so don't blame me for bringing this up. And fact is: representative government was intended by the Constitution for districts that were much smaller than what they are today. The fact that representatives today represent districts of nearly a million people makes representative government at the federal level a farce, and means that we should return more power to state and local government, instead of letting more and more decisions be made at the federal level.

You're right that the Constitution should not be a static document, so let's talk about how things have changed. Given the vast increase in the population, complexity, and diversity of the US, it is time that we move power away from the federal government back to the states, many of which are larger and more powerful than the entire US used to be. Creating an unaccountable, uncontrollable super-state that's in the thrall of corporations, like you want, is the wrong direction.

Re:Democracy?

[stenvar]

They were men of the late-18th century, there is a great deal they could never have imagined. That said, the current state of things has been 200+ years in the making- and it began almost immediately after the country was founded.

The vast expansion of federal power happened in the 20th century, much of it after WWII. It is neither inevitable nor necessary. And given that many states are now bigger than the US used to be, it makes sense to give more power to the states and counties, instead of creating some unaccountable and uncontrollable mega-government to rule over all of it. The correct response to a bigger and more complex society is not to create ever bigger central institutions, it is to distribute decision making so that historical processes and scales continue to operate.

Maybe in a naive, simplistic view of government.

What's "naive and simplistic" is your belief that the best way of dealing with problems is to create a gigantic, all-powerful central government and elite.

Frankly I rather like not having to deal with corporations on the basis of caveat emptor.

Generally, I would. But if there is to be regulation, it can be at the state level.

Re:Democracy?

[XcepticZP]

Don't even try arguing with intellectual statists, they're too smart to admit they're wrong.

Re:Democracy?

[Anonymous Coward]

Why do you find it reasonable to use force to prevent me from purchasing someone I want when my purchase of it can do no harm to you or anyone else?

Re:Democracy?

[Anonymous Coward]

This is the same argument that kept the VA from releasing information on HIV in blood test results. Some idiots were too afraid that letting a person get the results directly, rather than from a doctor would cause them to freak out. Others argued that by not getting the information the patient would be too upset to ask the relevant questions of the doctor. Both situations could transpire. What is wrong with letting people freely choose based upon their own preferences? What is the justification for letting the government interfere with my freedom of choice?

Re:Democracy?

[umafuckit]

Yes, they should be working at higher standards. You only have to look at their "research" pages: https://www.23andme.com/about/factoids/ and click any of the links. Some are worse than others but all are shit. Click the Parkinson's & cholesterol, for instance. Vague statements and an irrelevant graph. That's the trend throughout those links. It's basically no better than astrology. The markers they test for (which is what the FDA is worried about) is a separate issue, and are more likely to be meaningful, but the fact that their "research" page is the way it is puts me off having their test. They need to explain their false positive and negative rates and say what it is for each test (e.g. penicillin sensitivity). They also need to be clearer on what a positive for particular marker means. e.g. WTF does "Slightly higher odds of developing basal cell carcinoma" actually mean? If you re-read the page more carefully you notice that it's 1.3 times greater odds. But 1.3 times greater than what? One of the basic rules of data analysis is that if you don't know what a proportional change means in absolute terms then you know nothing. i.e. it's bollocks. Yes, I could click on the original publication, but most people don't have the scientific background to understand it. Furthermore, if there are few studies linking gene X with condition Y then you're not even sure how true or how widely applicable the results are. e.g. if the studies were done on white people from Europe then are the results true for a black person from Africa? We don't know and 23andMe don't tell use this is a caveat (which it is).

Re:Democracy?

[lxs]

They are a lot like libertarians in that respect.

Re:Democracy?

[XcepticZP]

Maybe quite true, actually. The difference is we don't try to impose our "wrong" or "right" values on anyone else; nor do we kidnap and imprison them if they disagree with our values/beliefs.

"Because to take away a man's freedom of choice, even his freedom to make the wrong choice, is to manipulate him as though he were a puppet and not a person." - Madeleine L'Engle

Re:Democracy?

[JWW]

Yeah, because our choices are obviously between

No Regulation or Massive Regulation

There's absolutely positively no way to exist between these extremes. Of course the person saying they want less regulation is really speaking in code because what they really really want it no regulation.

That their is too much regulation in health care is a fact, that there should be no regulation in health care is not.

Re:Democracy?

[spectrumlogic]

Is it at least possible that we are confusing our understanding of the intent of the founding father's organizational skills with simply an impossible stretch of the "Health and Welfare" interpretation? When we invoke the intent of the founding fathers we must be careful to constrain context. I am uncertain this "least common denominator" approach (which frankly seems to have utterly failed) was really a part of the vocabulary of the day. It is quite a modern concept to regulate the many based on risks borne by the few. Correct me if I'm wrong here, but in those days the gov't wasn't really in the business of 3rd order eventualities or perceptions of responsibility...citizens generally understood they bore the risk/consequence of the beliefs/information to which they chose to adhere. It's also a very personal decision when it is appropriate to defend against the reach of governmental, religious, scientific (institutional) authority...as these groups are so wont to reach. For the last few decades, anything short of complete surrender of responsibility for personal health is unerringly frowned upon and regulated...for the benefit of the uninformed? ... or the benefit of the industry? ... or the furtherance of authority? Federal assumption of such responsibilities smacks of intrusion into personal domains (like scope creep). You might say that becoming a "child of the state" has drawbacks. The transaction cost of outsourcing every decision is possibly unsustainable. AND...as in this case...a new level of control takes a little getting used to...before everyone can get back to sleep.

Re:Democracy?

[Lando]

Under ACA you are forced to pay some insurance company. Most insurance companies allow a choice of doctors, so people aren't forced to pay quack doctors. They chose to.

Re:Democracy?

[stenvar]

Everybody pays for the quack doctors because the costs are socialized and their quack services are part of the ACA coverage requirements.

Re: Democracy?

[Bill, Shooter of Bul]

I don't get the reference, with respect to slavery. We elected a president and some other legislature that the minority didn't approve of because they thought it would end slavery or something along those lines. So a war erupted as some states tried to succeed. The condition of surrender was accepting the constitutional amendments that outlawed slavery. The southern slave owners may have been better off not succeeding from the union and followed the modern republican methods of obstructionism.

With respect to your quote by John Stuart Mill, Who cares what he thinks? I don't. Should I quote a Pope and expect you to suddenly believe it due to his resume, or be swayed by the beauty of language used?

I believe in working for the common good. That isn't code for communism, but a reasonable balance between the rights of the individual versus the good of the whole of society.

Re: Democracy?

[Anonymous Coward]

Ah, but what is a "reasonable balance"? Is it determined democratically, by the majority? If so, what if the majority decide slavery is reasonable? Or that you have to sit in the back of the bus because of your skin color?

We think slavery and Jim Crow are stupid now, and that not seceding would have been a better choice. But at the time people thought it the best policy.

What you think the obvious best choice on behalf of others today, might seem equally ridiculous in the future. The way to avoid these blind alleys, is to let people decide for themselves. Making the rights of individuals subservient to the nebulous "good of the whole society" eventually leads to good for only those who have the power to manipulate the law - large corporations and their lobbyists and politicians.

Re:Democracy?

[stdarg]

Are you talking about the false positive rate of the *actual test* as in, the test shows you have some xyz-gene but x% of the time that is incorrect? Or are you talking about false positive rate as in assuming you definitely have xyz-gene which is a marker for such and such disease, x% of the time that does not actually lead to such and such disease?

If the former, yeah sure. I'd be surprised if they didn't have that information available, at least for the FDA.

If the latter, then obviously that's an impossible standard to meet and you're actually calling for the ban of affordable genetic testing, while hiding behind nice sounding statements like "They also need to be clearer" and "They need to explain." Oh yeah, just be clearer and explain a bit! And with one company independently doing it all, it will only take a hundred years and resources equivalent to the entire US medical R&D industry, which is where these hypotheses about genetic markers for disease come from and are a current and hotly researched area.

Re: Democracy?

[Bill, Shooter of Bul]

I think the UN universal declaration of Human Rights (http://www.un.org/en/documents/udhr/) is a great starting point. A document that was created with the input of many nations with different religions, philosophies and economic systems. Letting people decide for themselves, without referencing any kind of rights of the individual can also lead to slavery and other non desirable outcomes.

Re:Democracy?

[umafuckit]

I don't think what I'm asking for is unreasonable. I'm not calling for a ban on genetic testing.

I think they should have disclaimers that enumerate the false positive rates of the tests (i.e. probability of a positive given that you don't have the mutation) and explain to a scientifically illiterate person what those numbers mean. I haven't seen that on the site as yet, but I haven't looked extensively. If it's there, it should be clearer.

Regarding the second issue, what a positive result means, I think they should be providing more information, more references (not just one), and explaining the caveats in the literature. They can't do anything about those caveats, but they need to be more clear about what a positive result means. They providing lay people with complicated and potentially scary information. They need to be more responsible about that.

To reiterate the example I listed above, if they state that one's chance of getting cancer X is 1.3 times greater than the rest of the population then they need to explain what that number means. i.e. what is is the absolute chance? The relative chance isn't what matters. They list how many people in the US have the disease, but that's not enough. They need to run the numbers for their customers in an easy to digest manner. Use graphs.

They also need to put these risks into context. For instance, people may not be so worried about having mutation X if they know that their absolute risk of getting the disease it's linked to is lower than their chance of being killed by falling down the stairs.

Good!

[Anonymous Coward]

Where's that damn "Good!" cat when you need him?

cue Eric Cartmen:

[Anonymous Coward]

_Respect_ _Ma_ _A-Tor-A-Tay_!!!

Sorry, you bribed the wrong people...

[Anonymous Coward]

Grease my palms and we'll let you proceed.

Sorry 'bout that.

Obama Super-Liar

[Anonymous Coward]

How many of you believe this crap? Real question, are you fooled or not? If so why>

http://news.yahoo.com/obama-im-not-particularly-ideological-person-050844120.html

"I'm not a particularly ideological person," he said, saying pragmatism was necessary to advance the values that were important to him."

This guy is the most openly partisan far left plitical person the country has seen ever, and certaily the most radical statist ever to have achieved the executive office. And he just keeps piling on the bullshit knowing that the media will cover for him at every level, by claiming to be a moderate "regular guy" who isn't pushing an agenda.

Socialized medicine has been the dream of the statist class in this country for generations, this legislation (Obamacare) will effectively place all economic power in the hands of the federal government, resulting in total control over the individual by the government, and has been what Obama and the radical Democrats have put their everything into accomplishing, and it's undeniable that this program is big government socialism from top to bottom.

And yet this genius, who can barely put words to together to form a coherent sentence without a teleprompter, tries to pull yet another lie on the people, that he is a moderate.

And I am betting a whole lot of you are going to believe it.

Am I wrong? If so I am curious, how do you justify this? How can you possibly support this assertion that Obama is not a radical - and highly partisan statist?

Re:Obama Super-Liar

[Anonymous Coward]

Once again, what the hell does this have to do with Obama? Man, these anti-Obama people are fucking dillusional.

Re:Obama Super-Liar

[Anonymous Coward]

It's a very simple question, why is answering a simple question so hard for you people?

Re:Obama Super-Liar

[TangoMargarine]

Obama and the radical Democrats

Would make me laugh if it wasn't so irritating. He's been compromising on practically everything with the Republicans screaming about his being a Muslim communist and trying to vote it down, and he finally manages to get a single watered-down thing passed that he wanted ("Obamacare"). And after 46+ pointless votes, they're still trying to kill the damn thing. But apparently the Democrats are the radicals. Thanks for explaining that one to me.

this genius, who can barely put words to together to form a coherent sentence

You're really going to use that line after Bush Jr.? Really?!

Oh, and speaking of coherent sentences, you've got an extra preposition there, or stutter or something :)

You insens17ive clod?!

[Anonymous Coward]

abysmal sales and The failure ofW 0perating systems,

Re: You insens17ive clod?!

[Anonymous Coward]

I am intrigued by your ideas and wish to subscribe to your news mailings, kind Sir!

Yeah Right,

[dale.furno]

I read that as "The FDA wants money from these people before letting them sell their product"

Entirely Reasonable

[PvtVoid]

Suppose I started marketing an HIV test, or a Hepatitis C test, or a tuberculosis test without demonstrating the test was effective? The FDA would be on me like shit on stink, and rightly so. Same here: suppose they incorrectly tell someone they have Huntington's Disease, or carry BRCA?

Now cue all the Slashbertarians ranting about how restricting unproven medical testing is an assault on freedom...

Re:Entirely Reasonable

[0123456]

Suppose I started marketing an HIV test, or a Hepatitis C test, or a tuberculosis test without demonstrating the test was effective?

Is anyone claiming these tests aren't effective? I don't see it in TFS, only claims that they don't have the right paperwork from the government.

Re:Entirely Reasonable

[TheSync]

Now cue all the Slashbertarians ranting about how restricting unproven medical testing is an assault on freedom...

I own my DNA!

Re:Entirely Reasonable

[Anonymous Coward]

My brother is working for a company that is in the prototype stage for something similar, but for use in non-developed countries.

Their test you first create a cartridge that has the dna sample doped with a radioactive substance you want to match against. You insert the patients test sample, it gets treated by different chemicals in the cartridge, and if the dna is a match the radioactive substance is released and a faint glow occurs which the machine reads giving you a nearly instant result to let you know if that dna sequence shows up in the patients sample.

It is not ready for use at this time, but you can be damned sure they will cross every single t and dot every i when they are ready to get approval for their system.

Re:Entirely Reasonable

[Anonymous Coward]

I believe that's exactly what the problem is. 23&Me is selling the test but never submitted evidence to the FDA that it works. Why should they just assume it's good because they said so?

I think likely the test is fine, but they haven't shown it to be so, so why should the FDA approve?

Re:Entirely Reasonable

[BradMajors]

Is anyone claiming these tests aren't effective?

Yes. I am claiming these tests aren't effective.

Re:Entirely Reasonable

[NoNonAlphaCharsHere]

This New Year's Eve noisemaker I have in my hand scares away elephants - there aren't any elephants in MILES of my location.

Re:Entirely Reasonable

[Anonymous Coward]

if you RTFA, they tested the tests and found a lot of problems with them. they aren't that accurate and issues in the lab

Re:Entirely Reasonable

[Anonymous Coward]

I doubt it's a radioactive substance, it's probably just chemicals like those used in glowsticks.

Re:Entirely Reasonable

[mindwhip]

There is a distinct difference between a test for a specific disease and a test that tells you if you have DNA that may make you susceptible to possibly, maybe getting a disease compared to someone else's.

Also it isn't Food or a Drug or Medicine that involves ingesting/injecting/inhaling and can't cause physical harm if misused. It is a non diagnostic test that as at no point will it say 'you have disease x' or 'you don't have disease y'.

Its only a super advanced version of taking blood pressure and pulse... If someone chooses not to consult a doctor because they think their own pulse is normal should the FDA ban everyone from putting a finger on an artery and counting the beats in 30 seconds?

If it doesn't show a genetic tendency for say breast cancer someone who finds a lump will still likely go to their doctor and is unlikely to check less often than before.
If it does show a tendency then that same person may check more often or even go sooner to get a suspect lump checked.
If someone that shows a genetic tendency overreacts and decides they need their breasts removed now to prevent any possibility of cancer in the future they have to go to their doctor who should at the very least do more tests, arrange counselling and only proceed if in his professional opinion it is warranted.

Re:Entirely Reasonable

[Anonymous Coward]

No, it is a radioactive substance. You couldn't attach part of the chemical used in glow sticks to a single sample of dna in such a manner.

Re:Entirely Reasonable

[timeOday]

And if 23&Me does work, then it is in their own best interest for the FDA to enforce these requirements. Otherwise they will be driven out of the market by somebody who makes similar claims at a lower cost, by providing a shoddy and unreliable product. This isn't an area where consumers are able to judge quality for themselves.

Re:Entirely Reasonable

[Anonymous Coward]

The FDA is claiming that they have a mandate to determine if these tests are effective. Which is similar, but not quite the same.

Re:Entirely Reasonable

[Anonymous Coward]

Isn't it stink on shit? Unless shit is somehow attracted to your armpits if you forget to put on deodorant.

Re:Entirely Reasonable

[Anonymous Coward]

Now cue all the Slashbertarians ranting about how restricting unproven medical testing is an assault on freedom...

Look, if this whole "being alive and well" thing is important to YOU, then YOU should take a little responsibility and EARN a doctorate in all practices of medicine and keep track of every health-related product released on the FREE MARKET (hallowed be its name, which should never ever ever ever never ever be subject to any regulation unless it suddenly affects me) to make sure they won't kill YOU. I'M not about to do it for you. In unrelated news, wanna help me move apartments this weekend? What?!? What sort of self-centered asshole ARE you?

Re:Entirely Reasonable

[operagost]

Suppose I started marketing an HIV test, or a Hepatitis C test, or a tuberculosis test without demonstrating the test was effective? The FDA would be on me like shit on stink, and rightly so

Please cite me the part of the federal food, drug, and cosmetic act which says they have the authority. They have jurisdiction over the following: food, drugs, medical devices, food additives, and dietary supplements.
Naturally, the kneejerk progressives already modded down my post... so thanks for responding, instead.

Re:Entirely Reasonable

[Charliemopps]

It's pretty simple. This is a screening test. It's supposed to be inaccurate as silly as that sounds. The point of it is, if there are ANY markers for the disease it's supposed to easily test positive. Then the user is supposed to go to a DOCTOR and verify the results. Even the initial tests they do in hospitals can sometimes give false positives as high as 80 to 90% of the time. So even if you do test positive, you still only have a 10% chance of actually having the disease.

Government regulation should be used to inform the public of the choices they are making to help prevent deception in the marketplace. It should not be used to prevent products the government dislikes from being made available to the public. In this case, the FDA should ask them to place clear and obvious statistics on the results of test. i.e. "You have flagged positive for suchandasuch disease. This is not a definitive diagnoses, and on average only 40% of people that get flagged on this test actually end up having the disease. Please seek a medical professional for a more definitive test and treatment if necessary"

Requiring disclosure is usually easy to comply with, welcome by nearly everyone and a non-controversial topic. If the company does not want to provide those statistics or even worse doesn't even have them yet, then I think the FDA would be in the right in telling them to stop production.

Re:Entirely Reasonable

[Anonymous Coward]

Maybe they modded you down because you are turning this into a political discussion with your radical tea party agenda views.

Re:Entirely Reasonable

[ColdWetDog]

Here is a nice slide show which shows you the regulatory framework. You can, if you really have nothing more entertaining to do, look up the enabling legislation in the CFR (Code of Federal Regulations).

I do really hope you have something more enlightening to do....

Re:Entirely Reasonable

[nbauman]

"don't have the right paperwork" is a big deal. That's like not having a reliable source in a Wikipedia article.

You wouldn't want to go to a doctor who didn't have the right paperwork.

Re:Entirely Reasonable

[jd]

They ARE NOT telling you you have X, Y or Z. They are telling you that gene G is ASSOCIATED WITH an N% increased risk.

For chrissakes (or, as my kindle spellchecker insists, cheesecakes), at least bother to do basic research. Oh, that's right, the serious COMPETENT Slashdotters abandoned the site because of the overwhelming sheer stupidity out here.

I don't know why I bother. Anyone with an ounce of brain capacity can figure out that raised odds of 0.23% do not equal an absolute certainty of instant death. But, clearly, you and the FDA lack even that.

Re:Entirely Reasonable

[jd]

Then you're an idiot, because that is the only way to make any claim regarding effectiveness (positive or negative) at the individual gene level when we don't know all the genes, all the interactions of genes or the impact of "Junk DNA" (which we now know isn't junk but metadata).

23&Me do not diagnose. They identify SNPs that have a given (often very low) correlation with a condition. They state the current best guess at that correlation. That is it. There are no "tests" except for the SNPs themselves. And those will be accurate.

Re:Entirely Reasonable

[stenvar]

Suppose I started marketing an HIV test, or a Hepatitis C test, or a tuberculosis test without demonstrating the test was effective?

Why should you have to demonstrate that to the FDA, instead of to your customers? As long as you are truthful in your disclosures, I think you should be able to sell your test.

Re:Entirely Reasonable

[Anonymous Coward]

I only take issue with the FDA thinking this falls under their purview. It almost seems more like a CPSC issue.

Re:Entirely Reasonable

[Anonymous Coward]

That slideshow just goes to show how far a government regulatory agency can move outside its original mandate.

Although even with the massive expansion of powers, it is unclear how if the testing should be under FDA regulation.

Re:Entirely Reasonable

[gregor-e]

The FDA should be required to perform some sort of cost/benefit analysis of shutting 23andMe down. I was made aware of a potentially life-threatening response I am likely to have to an antibiotic that is used outside the US. If the FDA had prevented me from discovering this, I could end up dead if I travel and am given that antibiotic. How many people will the FDA kill through this action?

Re:Entirely Reasonable

[DarkOx]

Suppose they do, what would be the real harm?

The first thing most people would do is probably go see a doctor. Which is might be a good idea any way for many people who don't see them often. That doctor is then going to either take 23&Me's results for what they are and attempt to confirm them with other kinds of tests, might be mammography for BRCA or some kind of reflex test for Huntingtons; or he will simply order more genetic testing from a traditional lab.

Worst case someone is out a few insurance co-pays.. The only way its harmful is if a person takes the results and does something rash like; oh I am dying of huntingtons better quit my job, sell all my possessions and travel the world spending everything I've got because hell there are only a few years left. The truth is though the sort of person who would do that without gathering some additional facts is probably quite vulnerable to me walking up to them on the street telling them "the spirts speak to me and they tell me you've got six months to make your peace."

The government inst protecting anyone from anything here, simply infantalizing the public as always.

Re:Entirely Reasonable

[Anonymous Coward]

The FDA would be on me like shit on stink, and rightly so.

That reversal is pretty mind boggling...

Re:Entirely Reasonable

[jd]

I would agree with that. I would even agree to 23&Me putting more emphasis on the fact that it measures probabilities, not certainties. I certainly think they should quantify their confidence in a marker better than they do.

I also absolutely agree with you that information on life-threatening reactions to medications should be unhindered. If it is wrong, then the doctors either used an equally effective alternative (so, no loss) or gave you unnecessarily extensive monitoring (no harm done and everyone likes being fussed over occasionally). If it is right, it saved your life. There is no obvious downside.

Besides, doctors aren't going to go by your printouts for personalized medicine. They will use your raw data files, but any hospital with that level of expertise (and there won't be many) will have their own databases built from the existing literature and the hospital's experience. They will have actual geneticists on-hand or readily available via strong links with the local university. That is how these things work - and, yes, I am very aware of how regular (non-teaching) hospitals work with universities for mutual benefit. I've seen it, even been a part of the process.

So, who is 23&Me potentially misinforming? If not the patients or the practitioners, who is left?

Re:Entirely Reasonable

[Rockoon]

Why should you have to demonstrate that to the FDA, instead of to your customers? As long as you are truthful in your disclosures, I think you should be able to sell your test.

Exactly. Once upon a time the FDA's only job was to make sure that medications were safe. It wasn't their job to verify efficacy.

Now the FDA acts as gatekeeper, making sure that its extremely expensive to do business.. and that whole safety thing has been sacrificed in the process (when the list of side effects is long, and all of them worse than the condition the medication is supposed to be treating...)

Re:Entirely Reasonable

[Anonymous Coward]

And this is likely exactly where the problem is. 23&me probably don't want to go through the necessary work to certify their product in a proper medical context. its too much work to do right.. They want to sell a boutique toy. There is a LOT of effort that goes into proper genetic testing, say by sequencing technology. Verification of results from one test (like miSEQ) by using another test on a tangential technology (eg Sanger). Quality checks that are entirely exposed and written into a detailed SOP (things like depth of read, read verification in both directions etc). Oh but wait! they don't do that do they? in fact they use illumina snp chips. so, aside from some technical problems in quantifying these chips that can happen unless you're careful (are they?) now we are getting just a snapshot of known variants in genes like for example BRCA1. But BRCA1 has lots of SNPs, some are known (eg ones in founder populations) but others aren't; some of which are obviously deleterious, like large scale variations, early stop codons and so forth. All of this information, when its done right, is used by a genetic counsel and physician to make an assessment and give the proper picture to the patient.

And then there's the problem of false positive and false negative. I see a lot of comments on here by people saying that 23&me gives them enough warning on the validity of the results etc, which is basically them covering their liability in case of a problem. The issue is that with mass marketing its just not that easy of an argument to say the warnings are enough.And they clearly are selling this as a health diagnostic. People WILL ignore those warnings. If they have a false positive they will not bother doing the intelligent thing and getting another opinion or a proper test. They will change their lifestyle and make decisions and some of these decisions may cause them harm. False negatives are more scary. They will act thinking they have a superpower (i'll never have heart disease!!) and then this may cause them harm.

My advice (i'm in this field), go to a physician and get a test if you think you really need one. like for example if you're a first and second degree relative of multiple family members with a certain pathology. do a pedigree analysis with them to see if you're in an at risk group and actually need genetic testing. It will be done as best as possible and you'll get proper advice from a genetic counsellor. If you have a disease, look into options WITH your physician that may help. Some things are definitely groundbreaking, like certain types of point mutations in EGFR that predict drug response in lung cancer, or mutations near IL28B for treating people with Hepatitis C. Others are dubious. Don't fall into the trap of thinking you know more than experts in this field. Its an excessively complex subject, and even experts can disagree on some findings and they have to tested over and over to make sure they work the way we think.

Re:Entirely Reasonable

[Anonymous Coward]

And if 23&Me does work, then it is in their own best interest for the FDA to enforce these requirements

You're correct that superficially this doesn't make sense. As others have pointed out, 23andMe is using standard equipment from other companies - with known error rates, etc. If the FDA really thinks that 23andMe somehow isn't operating these machines correctly then it would have been trivial to submit some known samples to 23andMe and then show that the results were full of errors.

I work in bioinformatics and I recently had the opportunity to compare 23andMe data with exome sequencing data from an Illumina CSPro certified facility (for the same individuals). And the 23andMe data is good - there's overwhelming agreement with the exome data. I've also been to genetics conferences and the word on the street is all the same: when people go back and double check the 23andMe results, the results are correct.

So, if it's not about accuracy of the data then what is this about, really?

Think about the difference between buying your clothes at Walmart versus having them custom made by hand by an individual tailor. In the past, medicine followed the handmade individual tailor model - because that's all that was possible with the available technology. But recent advances are making the Walmart/McDonalds mass-production model of medicine more and more feasible - and, for those who can't afford gourment meals and handmade business suits, much more accessible.

But does the FDA require medical doctors to prove that they are making accurate diagnoses? Does a medical doctor have to see a certain number of "test" patients every year and verify that they can provide the correct diagnosis? No, in fact, there's an implicit assumption that a medical doctor is the final authority - that they are correct by definition. Of course, anyone who has ever gone to a variety of different specialist and received a variety of conflicting diagnoses will tell you that that's nonsense - medical doctors make mistakes all the time.

Imagine a world where Walmart had to prove that their clothes were just as good as what is produced by hand by an individual tailor - but where the standard of "good" was whatever the individual tailor happened to produce. It would be impossible without someone involving an individual tailor in the process - because then the clothes would be good by definition.

And that's almost certainly what this is really about - not data quality - but whether medical tests can be provided directly to consumers without involving a medical doctor.

Re:Entirely Reasonable

[russotto]

And if 23&Me does work, then it is in their own best interest for the FDA to enforce these requirements. Otherwise they will be driven out of the market by somebody who makes similar claims at a lower cost, by providing a shoddy and unreliable product. This isn't an area where consumers are able to judge quality for themselves.

Except that there's no way in hell that the FDA is going to approve 23&Me as a Class III medical device. And even if they could, it would end up costing $999 instead of $99 and you'd have to get a doctor's prescription to be able to use it.

Re:Entirely Reasonable

[Anonymous Coward]

Is anyone claiming these tests aren't effective? I don't see it in TFS, only claims that they don't have the right paperwork from the government.

Team Foundation Server isn't where you should be looking. Sure, it's great for managing a source code repository, but it's not designed to vet genetic testing routines.

Re:Entirely Reasonable

[Anonymous Coward]

do you have any proof that their tests do this or are you just taking their word for it?

Re:Entirely Reasonable

[Anonymous Coward]

Suppose I started marketing an HIV test, or a Hepatitis C test, or a tuberculosis test without demonstrating the test was effective? The FDA would be on me like shit on stink, and rightly so. Same here: suppose they incorrectly tell someone they have Huntington's Disease, or carry BRCA?
Now cue all the Slashbertarians ranting about how restricting unproven medical testing is an assault on freedom...

It actually has more to do with marketing. You can sell a device used to test, but you can't market it directly to consumers as an "AIDS test" for example, until it's been through FDA approvals. But you could still make and sell it under other more limited conditions.

Take a pregnancy test as another example. Those work by testing for the presence of certain levels of hormones. If you wanted, you could sell a test as long as all you said was "Tests for the presence of hormone X", but the second you say "It checks for Pregnancy" you need FDA approval.

Re:Entirely Reasonable

[Anonymous Coward]

'FDA is concerned about the public health consequences of inaccurate results from the PGS device,' says the agency. 'The main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work.'

And what the FDA doesn't tell you and the media as well is how many drugs the worthless FDA stamp end up getting yanked off the market, or ones that get pulled years after the FDA was warned the drugs caused disease and or infection. This has nothing to do with "freedom" this has everything to do with why the FDA is a waste of time and money, and should be a public ran body, instead of a body that is just as bad as the bribed politicians.

So the above quote is laughable coming from the FDA. "Concerned" that's classy....

Re:Entirely Reasonable

[jd]

Direct proof? Yes. I have had sections of my DNA sequenced by 3 different groups, using 3 different sequencers, including the whole of my mitochondrial DNA and various chromosomes from my nucleic DNA (Y is the easiest one to get sequenced multiple ways).

So far, differences detected: Zero.

So they are giving me valid SNPs everywhere I can double check.

Can I confirm SNPs I haven't had tested elsewhere? No, but sequencers only cost around $15 million, so if you could loan me the money, I can easily verify the rest. I would even be happy to verify results for anyone else who asked, at cost in electricity to run a batch divided by the number in that batch. I'll deal with the other costs.

Now, how fair is that? Total verification of the raw data results from any genome research group.

In fact, I don't care who supplies the cash. The FDA can, for all I care. I will then give you verification of any of these start-ups for slightly under the cost of the run itself, complete with statistical confidence limits because no test is 100% perfect.

I'm willing to sacrifice my time and effort on building an ultraclean room and buying the rest of the hardware and enzymes needed to take you from one anecdotal account to a full, absolutely independent (including of any existing lab) facility that can provide an accurate scientific assessment in a manner that is compliant with my ethos of science verified by scientists and observed by the public, nothing hidden, nothing obscured, no trade secrets, no concealing statistics by hiding behind certainties.

The Gates Foundation could provide the initial funding, for all I care. And as a long time Slashdotter, I don't say that lightly.

So who's game? Reply with who you sent the grant/funding request to and how I can check the progress. Anyone?

Re:Entirely Reasonable

[Anonymous Coward]

Being the skeptic that I am, would it be too distrusting of this administration to conclude that perhaps this company has not yet made the appropriate contributions to those who are campaigning for the "right" party. Once the donations have been made, the administrative road blocks may suddenly and miraculously go away?

Re:Entirely Reasonable

[Anonymous Coward]

Why should they need FDA approval? Is there anything in the constitution that gives the Feds authority to control such a test (the answer is no)? How is it that the US has transformed into a country where you are free to do what you want as long as you don't harm others to a country where you can only do what you have been given permission to do from the Feds? Do your own research into the test and buy it if you want it and are satisfied with the offer and don't buy it if you don't? There have been untold deaths of people who did not have access to treatments because the FDA didn't "approved" them?

Re:Entirely Reasonable

[Anonymous Coward]

The test remains the same regardless of an overcharging doctor being in the middle of things...

Why pay a doctor's office visit, then lab charges, when all you need to do is pay for the test.

I am a diabetic, and I do not need to go to the doctor for daily blood sugar testing, nor do I need to go there for an A1C check, I can buy the tests right off of the shelf, no doctor required.

This is all they are doing, boxing up the analysis, and giving the results of said analysis to the people that pay for it directly.

Just because the doctors and insurance companies make nothing from them, doesn't make them any less valid.

Re:Entirely Reasonable

[Anonymous Coward]

I'll take the bait.

For me, it doesn't matter if those tests are reliable or not. It's my decision. If I want to send my DNA to 23andme, or Google, or my neighbor, or my neighbor's dog, that's my business, because it's my body and my DNA, and not the government's.

If people make poor decisions, it's not the role of the government to save them.

Now, if I decide someone is engaging in fraud, I have every right to sue them. But that's what the courts are for. By extention, the FDA shouldn't deciding what I get to do or not, they should decide whether the business transaction I engaged in is what I agreed to.

I.e., what the FDA should be ensuring is that the procedure 23andme is doing is what they say it is. I should be interpreting the scientific literature regarding its efficacy (note too, that science is about the murkiest thing we have, so the idea that the government should regulate that is ridiculous).

Health care in this country is getting out of hand not [only] because of insurance, or costs, because it's vastly, vastly overregulated. It takes competitive decision making that's every citizen's right and makes it the privlege of a handful of people. It's absurd to me that we have these debates about the safety of 23andme, or cannabis, or prescription drugs from canada, when I could go drink the bleach in my basement if I wanted to. It's totally arbitrary.

Re:Entirely Reasonable

[Anonymous Coward]

For me, the question isn't "why should they just assume it's good because they said so," it's "why shouldn't they assume it's good because they said so?"

If this was any other business transaction, the onus would be on the government to prove harm. But our health care system is so screwed up, you're now in the business of being assumed guilty until proven otherwise.

This is a perfect example of why health care costs are skyrocketing.

You've become so accustomed to the government needing to approve of everything health-care-related that it seems totally natural to you now--you don't even seem to be aware of the costs or the problems it creates, the questions it raises (What's a disease? Does the FDA get to decide what's health-care related? Why? Would this be different if 23andme were just giving you your sequence data at key locations, with links to relevant literature?), or what the alternatives would look like.

Re:Entirely Reasonable

[Anonymous Coward]

Think about what you're saying: "consumers aren't able to judge quality for themselves."

I personally don't want the government deciding what I can judge and can't, unless it's been proven in a court of law that I'm incompetent to make decisions.

In fact, you don't know anything about me. How do you know I'm not able to judge quality for myself? Maybe I have a Ph.D. in molecular genetics, with an emphasis on sequencing disease markers.

Re:Entirely Reasonable

[Anonymous Coward]

I hate to pop you anti-libertarian balloon but you do realize that in our view the government's job is to "protect the people"? So medical devices should be certified and pass independent, 3rd party verification. Doesn't necessarily have to be government run but it needs to be done.

Re:Entirely Reasonable

[Anonymous Coward]

23andMe isn't claiming they are diagnosing anything. They are simply informing you of a scientific fact: you have a particular mutation of a particular gene. This alone says nothing about whether you will get a particular disease or not. It only shows what is defined objectively as your random genetic situation and what would otherwise be as diagnostic as "You have red hair and pale skin so you are prone to skin cancer".

Mostly it's bullshit and overreach on the FDA's side. If I were running 23andMe I'd 1) fight it vigorously as this is not strictly a medical device requiring such approvals, and 2) I'd be moving focus overseas in terms of jobs, operations and markets where regulatory agency are far more sane and rational, and less about racketeering, fraud and protection money.

Re:Entirely Reasonable

[Anonymous Coward]

here ya go

http://vark.blogspot.com/2013/11/the-fda-has-banned-new-sales-by-23andme.html

Can't be true

[0123456]

Someone in another story was just telling us how wonderful the FDA are.

Re:Can't be true

[Anonymous Coward]

Well, they don't come off particularly damning in this article. It seems they would like to know if 23&me has done any evaluation of their test to determine what error rates (false negatives and false positives) it has for the various conditions it's supposed to detect. This seems reasonable, and is something 23&me should do. 23&me has apparently been marketing this test for 5 years without doing any study into it's effectiveness, even after many communications with the FDA. After being told "yeah yeah, we're doing tests we'll have results in a few months" 11 months ago, the FDA has escalated matters. I think if anything the FDA has been too lenient with these guys.

It's not as if this is a toy test either, these test results can have a real effect on your health. Suppose the test falsely claims you have nothing to worry about even though you're at high risk for breast cancer. You may be less likely to notice early symptoms, which if ignored could lead to worse outcomes. Suppose it claims you're at high risk for breast cancer even though you're not. You may go to extreme lengths to mitigate that perceived risk, incurring unwarranted expense, worry, and treatment side effects.

No test is perfect, it will almost certainly make both sorts of errors, but the question is how often? In a test like 23&me you might like to design it for high sensitivity, even at the cost of specificity (erring on the side of identifying false risks rather than ignoring true risks). Consumer education is important in this case though, as if you have many false positives people need to know that they must confirm any positive result with further testing.

Re:Can't be true

[jd]

The FDA actively work with drug companies known to be carrying out unauthorized tests on unwilling human subjects in Africa. They have accepted results from US prisons, where again no consent was ever given. They encourage the suppression of negative results in journals. Corrupt? They are better than certain historical medical authorities, but not significantly.

(No, I don't give a damn that 1960s and 1970s America had no restrictions on non-consensual biological and chemical experiments for medical purposes. They'd been declared a crime against humanity two decades. And outsourcing to Africa is no excuse. Sorry, they are criminals. Whatever right they do should be seen in isolation from their wrongs. They are guilty, the heads should stand trial along with the heads of pharmaceutical companies indulging in data suppression or illegal human experimentation, and a medically sound alternative should be created.)

Re:Can't be true

[jd]

There is nothing to evaluate, except perhaps the lab conditions. The SNPs do not diagnose a condition, 23&Me do not offer any diagnosis, all that is given is a set of percentages relating to the correlation of an SNP with an effect. Correlation is NOT causation.

Re:Can't be true

[Mr. Slippery]

23&Me do not offer any diagnosis, all that is given is a set of percentages relating to the correlation of an SNP with an effect.

That's a diagnosis.

Re:Can't be true

[Mr. Slippery]

Someone in another story was just telling us how wonderful the FDA are.

The FDA sucks. But medical device manufactures, Big Phrama, and the manufactured food industry suck more.

Re:Can't be true

[jd]

What does it diagnose? It doesn't tell you that you have condition X, it doesn't tell you that you will ever have condition X, and since correlation is NOT causation, it doesn't tell you that condition X is even possible.

I see no diagnosis, I see raw data and I see correlations (most of which are borderline noise level) but I see no statement to the effect that anything specific has happened, is happening or will ever happen. Where is the diagnosis?

That should be a simple one to answer, even for you.

Upsetting the Apple Cart

[ponraul]

I can see why cheap and reliable genetic testing you can do without the intervention of medical industry is frightening. For one hundred dollars you can find out if you have markers that put you at elevated odds of hundreds of conditions. If this came from the traditional medical, you would have to go to a doctor who would release the results to your insurance company, it would cost about $1000, and you wouldn't even get to see the results yourself unless the doctor wanted to show you something.

I've done the 23andMe testing and it has been of value. I'm not in close contact with much of my extended family and have almost no contact with the family on my father's side. It doesn't claim to diagnose or treat diseases or traits. What it does do is tell you if you're at elevated odds for a few select conditions, along with heritable traits. This is can be invaluable if you don't know that much about the medical history of your family.

Re:Upsetting the Apple Cart

[Jeng]

And you are apparently perfectly ok with the possibility that they could be completely wrong.

Nobody is saying that inexpensive dna testing is bad, just that the process needs to be verified that it works before it should be sold to the individual.

Re:Upsetting the Apple Cart

[Anonymous Coward]

I've done the 23andMe testing and it has been of value. I'm not in close contact with much of my extended family and have almost no contact with the family on my father's side. It doesn't claim to diagnose or treat diseases or traits. What it does do is tell you if you're at elevated odds for a few select conditions, along with heritable traits. This is can be invaluable if you don't know that much about the medical history of your family.

Has it been of value? How do you know that?
What reliable source has shown that this testing is accurate?
I agree, it could provide invaluable information.
It is upon the manufacturer to demonstrate to the regulatory agency that the test does what it says on the tin.
Until then, relying on the information provided by the test is at best foolish, and quite possibly very dangerous.

Re:Upsetting the Apple Cart

[Quince alPillan]

The FDA has a point, though. If the test isn't accurate and gives false negatives or isn't clear about what the results really mean, it can lure people into overconfidence and that can be dangerous if they really are at risk for one of the diseases.

Granted, they probably wouldn't have known about these conditions in the first place, but if, as an example, the rest of their family is known for heart disease due to a genetic defect and they get a false negative, they might be overconfident in their chances for heart disease, leading to possible death because they didn't go to a doctor to get checked out.

Re:Upsetting the Apple Cart

[ponraul]

It confirmed things I knew about my health and ancestry. It's not like they're running a faith healing operation here. All they had to go on was a vial of spit and a barcode.

Re:Upsetting the Apple Cart

[Anonymous Coward]

And you think that filling out the right paperwork for the FDA (read bribe the right people) makes those tests effective?

Me thinkest that word doesn't mean what you think it means.

Re:Upsetting the Apple Cart

[ponraul]

Yeah, you will run into the case where a condition is so rare that an imprecise test will give you more false positives that the population size of what you're testing for. I don't see that as a failure of the test, just a consequence of probability.

Re:Upsetting the Apple Cart

[Jeng]

Trust, but verify.

Re:Upsetting the Apple Cart

[Anonymous Coward]

All the FDA personnel want is their bribe, that's all they're whining about.

Re:Upsetting the Apple Cart

[OverlordQ]

> And you are apparently perfectly ok with the possibility that they could be completely wrong.

Yes. It's not a diagnostic tool. It's a "Hey 5 out of 7 people wearing red shirts die in star trek. You're wearing a red shirt, you've got good odds you might die"

Re:Upsetting the Apple Cart

[Anonymous Coward]

> And you are apparently perfectly ok with the possibility that they could be completely wrong.
They could just be making shit up. Or it could be polygrapgy-like in that they are testing for something, but it has no correlation to what they say it does. The whole point of the FDA is to evaluate their claims and say whether it does what they claim it does.

Re:Upsetting the Apple Cart

[Anonymous Coward]

It's not about "filing the right paperwork." It's about actually showing some evidence that they can do what they say they do.

Re:Upsetting the Apple Cart

[Anonymous Coward]

How much does it matter though? If you get test results back and it shows you have an elevated risk for , you don't self-treat, you go to a doctor and talk to him about it. The doctor can order a battery of tests, i.e. approved ones, to find out if something is *really* the matter or not.

You might waste time and money if 23andMe is wrong, but that should be a problem solved by the free market. If 23andMe's tests are horrendously inaccurate, then word gets out. There is no need to regulate companies like 23andMe - there is no public health risk at all.

Re:Upsetting the Apple Cart

[Anonymous Coward]

The difference is that 23andMe tests are not used in the medical community. If the test shows you have a risk for something, a doctor would not use it as the basis to begin a treatment. It's a genetic analysis tool based on genetic data points gathered from aggregated research showing correlations between some markers and some diseases.

I think 23andMe's only duty is to make it clear that this is an emerging field and that any suppositions it gives you about being at risk for some condition should not be considered entirely accurate right now.

I really cannot see any moral reason why a test that tells you that you MIGHT be susceptible to some disease or condition should be outlawed.

Re:Upsetting the Apple Cart

[jd]

A high level of confidence of a correlation between an SNP and a condition means that two independent genetic studies have produced the same results AND members of the site who have agreed to allow their data to be used for research purposes (not all do) show the same correlation.

Ok, I wouldn't do it that way, I would indicate reliability as a percentage asymptotic to 100% (you can never be certain) where their high confidence would be somewhere around 50%. But it's a good indication of reliability. Most associations are not marked as high confidence. They have either not been in a repeat study or there is no basis in the "natural" sample set from users. Such results should be ignored. They are given because there is a vague possibility and therefore interesting to those looking at the research process and trends. Users know this.

Re:Upsetting the Apple Cart

[stenvar]

And you are apparently perfectly ok with the possibility that they could be completely wrong.

My doctor could be completely wrong too. So could be FDA-approved tests and medicines. It's medicine, not classical mechanics.

Re:Upsetting the Apple Cart

[Jeng]

And what is the reason you are not going to a doctor to be checked out in the first place?

Re:Upsetting the Apple Cart

[Jazari]

If you're saying that only a fully verified test is allowable, then you're saying that low cost test are illegal. It is not possible for a company to sell such a comprehensive test for such a low cost. I for one am willing to take a chance that some of the results might be wrong (but probably aren't) in exchange for a very low cost.

Re:Upsetting the Apple Cart

[Jeng]

Why do you think that accuracy is going to cost more?

Re:Upsetting the Apple Cart

[Jazari]

Submitting your test platform to new and extensive quality controls, running double-blind tests, hiring additional quality control personnel... none of this is free. To "prove" that a test is reliable to the FDA costs lots of money. This is (one of the reasons) why it's estimated that it costs 1 billion dollars to develop a new drug.

Re:Upsetting the Apple Cart

[Anonymous Coward]

Every 23andMe result is a potential false negative, even if 100% accurate! (Chew on that.)

What they do is something called whole genome scanning, as opposed to whole genome sequencing. Scanning means that they test for millions of SNPs. Some SNPs strongly _correlate_ with a particular gene, but the SNP might not even be on the gene it correlates with. And the lack of a particular SNP marker doesn't mean that you lack the gene. AND 23ANDME TELLS YOU THIS UP FRONT! Albeit in simpler language which reasonable people can understand. (Nor is it hidden, either.)

Some people--like my genetic biologist friend--consider 23andMe "useless", but that's because he can have any bit of DNA sequenced for free. For my $99, I found 23andMe incredibly cool--partly useful and informative, mostly just cool. And the fact that the FDA is going after them because of concerns about accuracy I find ludicrous--go back to my first sentence above--and more than a little suspect.

Re:Upsetting the Apple Cart

[Anonymous Coward]

23andMe doesn't manufacture the machines. They purchase the machines from the same place everybody else does.

The FDA's problems with reliability and accuracy are suspect. See my above comment which starts with "Every 23andMe result is a potential false negative, even if 100% accurate!" And then I explain how that makes the FDA claims stupid without diminishing the usefulness of 23andMe's service.

Essentially the FDA has problems with the way 23andMe market's their service, but in effect if they can shut down 23andMe, then they'll have destroyed the entire self-service genetic information industry. But as someone else pointed out, Free Software might help save the day.

Re:Upsetting the Apple Cart

[Anonymous Coward]

If this came from the traditional medical, you would have to go to a doctor who would release the results to your insurance company, it would cost about $1000, and you wouldn't even get to see the results yourself unless the doctor wanted to show you something.

I've been tested for a number of markers and what you said here is just not true.

Re:Upsetting the Apple Cart

[Rockoon]

You are going to go to your doctor and ask to be screened for everything that you might have a genetic disposition to, rather than find out what things you do have a genetic disposition to and then screen for those?

here is what I think: You dont know what you are talking about, at all, but clearly you think that you do. Take the time to find out why you don't, rather than the time to spread complete crap all over the internet.

Re:Upsetting the Apple Cart

[Jeng]

If you don't have any medical issues why are you trying to figure out if you have problems on your own?

Also, here is what I think: You dont know what you are talking about, at all, but clearly you think that you do. Take the time to find out why you don't, rather than the time to spread complete crap all over the internet

Re:Upsetting the Apple Cart

[TechyImmigrant]

>I've done the 23andMe testing and it has been of value.

Do they sequence your nuclear DNA and give you a 2Gbyte file? Or do they scan for a whole bunch of markers and tell you which ones hit?

I'd quite like the file.

Re:Upsetting the Apple Cart

[Anonymous Coward]

>I've done the 23andMe testing and it has been of value.

Do they sequence your nuclear DNA and give you a 2Gbyte file? Or do they scan for a whole bunch of markers and tell you which ones hit?

I'd quite like the file.

Not sure if that's sarcasm or a real question. But you can, in fact, download your "raw" data file from 23andMe. As you imply, they don't do full sequencing. Instead they test for certain specific variants - e.g. a change from an "A" to a "G" at position 452676 on chromsome 14.

Regarding file sizes, a couple gigabytes really isn't that much these days. And that's if you want all the individual (overlapping) reads - either by themselves with a quality score in fastq format - or aligned to the reference genome in bam format. If all you want is the variant calls relative to a version of the reference genome then we're down into megabytes.

And on cost, full sequencing these days will run you about $5K (e.g. Illumina's "Understand Your Genome" events). But you can get just the expressed regions of you genome ("exome" sequencing) for around $1K these days. And then there's all the geneology sites selling various kinds of genotyping (what 23andMe does) down in the hundred dollar range.

Re:Upsetting the Apple Cart

[Anonymous Coward]

Have you ever had to pay for genetics or dna testing? Even the "medical professionals" say it's not 100%.... And it's expensive as hell, plus once your insurance company pays for it, who's to say they don't just cancel your insurance because of the elevated risk?

Re:Upsetting the Apple Cart

[Anonymous Coward]

Doctors make misdiagnosis all the time. It's up to the patient to advocate for themselves, and obtain information.

Re:Upsetting the Apple Cart

[Anonymous Coward]

I did it, and yes I am perfectly OK. I'm glad I did mine before this happened.

Here is the problem with what the FDA wants, and why 23 and me can't comply without completely trashing their model. 23 and me uses the latest studies and rates results with a confidence level based on some weighting of number of studies and results. So if the hb123a marker shows elevated risk for left handedness in one study it will show up in your results with a 1 star low confidence. If there are 50 studies and they are all pretty conclusive, then it will show up with 4 stars.

The FDA will insist through process that the tests be static. If you have A you get result B repeatedly and those results "work". How do you define that? How do you nicely fit free and open results with strict criteria for effectiveness, particularly if you are changing your results ALL THE TIME.

I am 100% confident that the results of the 23 and me testing are exactly what they say. They just don't say what the FDA want's to hear.

This is a huge slap in the face of the medical establishment who want to be gatekeepers of all your test and results. Ever get an x-ray or go get an ultrasound with your significant other? Ask the tech for results? Is my leg broken? "Sorry, I can't tell you. You have to wait and see the doctor to interpret the results."

Re:Upsetting the Apple Cart

[ponraul]

Yes. You can download the raw data as an ascii file. People have written their own scripts that generate their own genealogical reports from that file.

Re:Upsetting the Apple Cart

[TechyImmigrant]

It was a real question.

If you count each base pair as 2 bits, there is about 1.5GBytes in the human genome. But you also need to count the methylated base pairs, which it appears the worst case would add up to another 50%.

I'd like a copy of my full genome because 1) I'm a geek. 2) As new knowledge about new parts of the genome appears, I will be sure to have those parts sequenced. 3) The sequencing is a bit error prone (1% for the previous generation of sequencers according to by google search). With the full sequence it would be easy to correct errors with a couple more sequences when it gets cheaper.

Re:Upsetting the Apple Cart

[Anonymous Coward]

If you count each base pair as 2 bits, there is about 1.5GBytes in the human genome. But you also need to count the methylated base pairs, which it appears the worst case would add up to another 50%.

But, in addition to standard compression (gzip), you only actually need to list those places where your genome sequence differs from the reference genome. Granted, if you want extra stuff then it can add up fast. But, on the other hand, if you're only concerned with the exome (expressed parts) then things can get pretty small. For example, just now I'm looking at a file that lists differences relative to the reference genome from exome sequencing that clocks in at only 8.5MBytes uncompressed (2MBytes gzipped).

Re:Upsetting the Apple Cart

[Anonymous Coward]

WHy does that bother you? Why do you think you have the right to interfere with my free choice? If you don't trust it don't use it but stay the hell out of my way if I choose to use the service.

Re:Upsetting the Apple Cart

[Anonymous Coward]

Or the FDA can approve a highly addictive drug like oxycontin that is passed out like candy by doctors and creates a massive problem of opiate addiction? Or the FDA can delay approving drugs for treatment of things like cancer and heart disease for people who are soon to be terminal because they fear making a mistake more than they fear having anonymous people die. Why do you fear freedom and why do you have absolute trust in government?

Re:Upsetting the Apple Cart

[SecurityGuy]

If this came from the traditional medical, you would have to go to a doctor who would release the results to your insurance company, it would cost about $1000, and you wouldn't even get to see the results yourself unless the doctor wanted to show you something.

Nope. My test results are reported in full on my medical record, which I have access to. I usually get my results within hours of them leaving the lab. For imaging studies, I usually get a copy on CD if I want it. In one case, they told me I'd have to go to medical records and pay $10. At least in my part of the medical world, the days when doctors knew everything and told you what they thought you should know seem to be gone.

Re:Upsetting the Apple Cart

[TechyImmigrant]

That makes sense. Thank you.

Re:Upsetting the Apple Cart

[Rockoon]

If you don't have any medical issues why are you trying to figure out if you have problems on your own?

Maybe its the "once you experience symptoms, with his particular problem its too late to save you" thing that concerns people.

Let me know how that pancreatic cancer treatment works out for you.

Does the kit consist of food or drugs?

[Anonymous Coward]

No, and no.

So then how exactly does the FDA justify a claim to jurisdiction here?

Perhaps this should instead fall under the aegis of the CDC?

Re:Does the kit consist of food or drugs?

[Jeng]

A doctor does more than just prescribe drugs, they also diagnose illnesses. People could die from a misdiagnoses.

If I tell you that you have prostate cancer and you have your prostate removed and then you find out I was wrong, wouldn't you be a bit upset?

Re:Does the kit consist of food or drugs?

[Richy_T]

Perhaps. But you miss his point.

Re:Does the kit consist of food or drugs?

[Jeng]

Was his point that the FDA should be called the FDA and everything else that involves medicine?

This is in their jurisdiction, just because the name is the Food and Drug Administration, that doesn't mean that they only handle Food and Drugs.

A brief history of the FDA

[westlake]

So a bunch of un-elected bureaucrats decided whether same un-elected bureaucrats had the power to regulate a product or service?

Science based legislation is enforced through science based administrative law and procedures.

The history of the FDA can be traced to the latter part of the 19th century and the U.S. Department of Agriculture's Division of Chemistry. Under Harvey Washington Wiley, appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market. Wiley's advocacy came at a time when the public had become aroused to hazards in the marketplace by muckraking journalists like Upton Sinclair, and became part of a general trend for increased federal regulations in matters pertinent to public safety during the Progressive Era.

The 1902 Biologics Control Act was put in place after diphtheria antitoxin was collected from a horse named Jim who contracted tetanus, resulting in several deaths.

In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, also known as the "Wiley Act" after its chief advocate.] The Act prohibited, under penalty of seizure of goods, the interstate transport of food that had been "adulterated". The act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the United States Pharmacopoeia or the National Formulary.

The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry. Wiley used these new regulatory powers to pursue an aggressive campaign against the manufacturers of foods with chemical additives, but the Chemistry Bureau's authority was soon checked by judicial decisions, which narrowly defined the bureau's powers and set high standards for proof of fraudulent intent.

In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide organization. This name was shortened to the Food and Drug Administration (FDA) three years later.

By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products that had been ruled permissible under the 1906 law, including radioactive beverages, the mascara Lash lure, which caused blindness, and worthless "cures" for diabetes and tuberculosis.

The resulting proposed law was unable to get through the Congress of the United States for five years, but was rapidly enacted into law following the public outcry over the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent.

President Franklin Delano Roosevelt signed the new Food, Drug, and Cosmetic Act (FD&C Act) into law on June 24, 1938. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove fraudulent intent. Soon after passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of "prescription-only" drugs was securely codified into law by the 1951 Durham-Humphrey Amendment.

Food and Drug Administration

Re:A brief history of the FDA

[sjames]

So if they'd like to check that the cheek swabs aren't toxic, that would be within their mandate.

Old boys' network

[EmperorOfCanada]

I am 100% sure that this is because 23 and me are cutting out layer upon layer of the traditional health network. Cable would shut down Netflix if they could claim "It's for the children" like the health industry can.

Off the top of my head the layers cut out would include: Doctors, HMOs, Lab techs, companies that distribute the tests, the companies that make the tests, and most importantly the various government departments that deal with all these people. It is not like 23 and me are going to destroy traditional medicine but the last thing that the health industry wants are for their "customers" to grow comfortable going to cheap efficient companies for their medical needs.

Re:Old boys' network

[Jeng]

Wow, so if you got the test results back and it said you had dick cancer, would you just be hacking it off yourself or would you be going to a doctor to have your dick removed?

Re:Old boys' network

[stdarg]

How did you deduce that, considering OP said "It is not like 23 and me are going to destroy traditional medicine?"

Re:Old boys' network

[Manfre]

You clearly don't understand what the service provides, but I'm glad that doesn't inhibit you from responding as if you do!

Using your example, they don't test you for dick cancer. They check your DNA for indicators that you might be more likely to get dick cancer. The appropriate response to the results is to keep that in mind and every so often have a doctor check to make sure you don't have dick cancer.

Re:Old boys' network

[ColdWetDog]

No, it's not because they are cutting out layers of the traditional health network. It's because the service falls into a category that they are supposed to regulate. You can argue that 1) The categorization is over broad or unreliable or has other issues 2) The FDA SHOULD NOT do these sorts of things (in which case you can lobby your congresscritters to de enable the FDA's jurisdiction over such tests or 3) the FDA is being over harsh / demanding of 23&me compared to other companies with similar services.

But there is no need to get all conspiratorial. The FDA has been very, very conservative about letting complex medical information out to the public. There are huge internal and external debates about the wisdom of that - some of which comes from people with vested interests both in the status quo and with interest in changing business as usual. They tend to act like the very careful deliberative committee that they are. They are hardly perfect.

But the interesting thing about the articles in TFS is that 23&me has been very uncooperative. For a company with the level of financial backing and sophistication that they are presumed to have, I find it puzzling. I would like to hear what they have to say about the demand letter.

Re:Old boys' network

[Anonymous Coward]

Sure, and the unregulated wildcat off-the-shelf serum cholesterol test kit doesn't tell you you're going to have a heart attack, only that you have elevated LDL and other lipoprotein levels that indicated a potential risk for chronic cardiovascular illness.

Oh, wait, there's no such thing as an unregulated off-the-shelf serum cholesterol kit. They're regulated by the FDA. Interesting.

I suppose you should 'splain how one type of diagnostic tool can be unregulated even though others are?

Re:Old boys' network

[Jeng]

How did you deduce that, considering OP said "It is not like 23 and me are going to destroy traditional medicine?"

Um, from this.

Off the top of my head the layers cut out would include: Doctors, HMOs, Lab techs, companies that distribute the tests, the companies that make the tests, and most importantly the various government departments that deal with all these people

Sounds to me like he is a very DIY kind of guy when it comes to his health. Doesn't want any of that nasty regulation getting in his way.

Re:Old boys' network

[Jeng]

What I understood from reading his comment was that he wanted to be very DIY when it came to his healthcare.

Yes, the service only diagnoses problems, but considering he was talking about removing doctors and everyone else with an education from his medical care I wanted to know how far he was willing to go.

Re:Old boys' network

[Anonymous Coward]

23andMe service DOES NOT diagnose problems. It doesn't _tell_ you if you have disease X. It only tells that you may have a genetic predisposition for something. But it doesn't even rule out a predisposition. Just because you don't have a known SNP marker for condition X doesn't mean you don't actually have the gene. And they tell you that.

If I tell you that you're likely to die within the next 80 years, am I "diagnosing" your death? If I tell you that you have a known gene for prostate cancer, am I "diagnosing" your non-existent prostate cancer?

The FDA is doing this because entrenched interests are getting pissed off. And because some doctors and geneticists think that everybody is an idiot; and they believe that 23andMe customers are getting duped. But 23andMe is very up front that what they provide is limited. Some tests are slam dunks, like for Parkinson's. Most are extremely equivocal, and that's blatantly clear by both the data and actual disclaimers in plain wording littered throughout the site.

23andMe is extremely cool. You can't call yourself a geek unless you 1) fork over the $99, 2) are desperately poor, or 3) wear a tinfoil hat. Any other excuse is lame. (Note that I have respect for the tinfoil hat crowd).

In practice there's no way 23andMe can screw you over, even if their accuracy and reliability sucks. As state before, they cannot rule out a predisposition. If you show a serious predisposition, you're going to go straight to a real doctor. Finally, they're the only game in town doing whole genome scanning for $99. Also, they're doing real science with their results, and part of their business plan is to make money off the bulk data, and doing that requires reliable data.

I'm solidly Democratic and quite liberal, but the reasons for the FDA doing this are obvious. Also, this kind of service is about to explode market wise, and they're trying to set a precedent early on to make sure they get some of the spoils--i.e. regulatory territory. It sucks from every angle--self-interested special interests, and FDA regulatory overreach.

Re:Old boys' network

[EmperorOfCanada]

One of the interesting test results is if you should avoid certain things such as opiates(due to a propensity to become addicted) , malaria, etc. You might think that you should avoid those anyway but it allows you to simply say after back surgery, "I don't want any opiate based drugs so as to avoid becoming dependent" and with travel plans you would doubly avoid countries with even fairly low levels of malaria. So Italy instead of Costa Rica. Not exactly home surgery but allows you to make your own informed choices for $99.

I can't imagine what the same bevy of tests would cost at my family doctor? I am going to throw out that it would be no less than $1,000 to end up with the same results.

Re:Old boys' network

[TechyImmigrant]

People work around the system. I get my blood tests done for a fraction of the cost at the doctor's office by booking it at walkinlabs.com. A paid off doctor in nowheresville robosigns it and I walk into a testing lab nearby, where a woman who does nothing but pulls blood all day, pulls my blood. She never misses. I get the results emailed to me a few days later.

If I'm going to the doctor, I take my latest results in. However I follow the research and I get the tests I want (NMR lipoprofile, CRP and HbA1c) which tell me more useful things about my health than the standard cholesterol tests, like LDL size and number, glycation levels and inflammation status.

The only way that this is different is that Walk in labs decided to put a robosigning doctor in the loop so the FDA couldn't complain.

Re:Old boys' network

[russotto]

But the interesting thing about the articles in TFS is that 23&me has been very uncooperative. For a company with the level of financial backing and sophistication that they are presumed to have, I find it puzzling. I would like to hear what they have to say about the demand letter.

I would speculate that they intend to claim that their product is NOT a diagnostic device, and therefore does not fall under the purview of the FDA. If that's their claim, any co-operation with the FDA would tend to undermine it.

The FDA has been very, very conservative about letting complex medical information out to the public.

Yeah, don't really need a nanny protecting me from dangerous information. Might even be a first amendment issue there.

They tend to act like the very careful deliberative committee that they are.

"Hey Ms Wojcicki, could you shut down your company for 10 or 15 years while we decide whether it's OK for the public to be able to learn about their own genetics"

They are hardly perfect.

Well, they're also bastards who don't consider pain relief to be something worthy of consideration; no amount of pain relief can balance even the smallest risk of shortening life. And thus the COX 2 inhibitors were banned and millions with arthritis lived slightly longer lives which felt a whole lot longer. But that's another story.

Re:Old boys' network

[stdarg]

Yeah, it would cut out those layers from the process of buying and using a cheap non-invasive test. It wouldn't cut them out of the medical system entirely. So when you surmise that he would saw his own dick off because he doesn't want doctors to exist, that is not at all supported by the evidence right?

Unlisted subtext

[phayes]

The FDA states that false positives & false negatives are a major part of the reason that they are outlawing direct sales of these tests to consumers. Because a false positive on the breast cancer gene could lead to "prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions". Yeah, because Physicians using the existing tests never have false positives & even were there to be one, malpractice suits always punish doctors guilty of errors of interpretation...

Because you see, people would be performing surgery, chemo, etc all by themselves without the assistance of healthcare professionals alerted to the possible presence of a problem by one of these simple tests...

To my eyes, outlawing these tests is above all a defense of the existing expensive testing industry. We cannot have people having simple inexpensive tests. That would undercut profit margins.

Re:Unlisted subtext

[Todd Knarr]

The thing is, doctors using these tests know and understand the possible erroneous results, how to screen for them and how to confirm them. I've rarely had a doctor prescribe treatment for a complex condition based on the results of just one test, there's usually two or three additional tests to confirm the results. Negative results are checked against symptoms, and if the symptoms clearly contradict the test results then additional tests are run to find out why. This isn't what happens with 23AndMe's tests. They're advertised as being the kind of test results you'd expect to get from a doctor. Yet 23AndMe doesn't do any of the cross-checking and retesting, they just send the results to an untrained person to interpret.

Re:Unlisted subtext

[Anonymous Coward]

The FDA states that false positives & false negatives are a major part of the reason that they are outlawing direct sales of these tests to consumers. Yeah, because Physicians using the existing tests never have false positives.

It's that the FDA want's to know what the false positive and negative rates are for the test. It's true, nearly every test has false positives and false negatives. However, it does make a difference what the rate is and communicating and understanding that accuracy is extremely important. In a doctor's office, the doctor receives some statistical training to aid in the interpretation and presentation of these error probabilities. For 23&me, there's no trained doctor explaining that the test is not perfect and what, if anything, that means you should do next. Three ways of saying I tested positive for the breast cancer gene:

"You have gene ABC which has been found to increase breast cancer risk" (23&me)
vs
"You tested positive for gene ABC which has been found to increase breast cancer risk. There is a 35% chance that you tested positive by mistake" (not an unreasonable false positive rate for some disease screening tests!)
vs
"You tested positive for gene ABC which has been found to increase breast cancer risk. There is a 0.1% chance that you tested positive by mistake"

or the other way around:
"You do not have gene ABC which has been found to increase breast cancer risk" (23&me)
vs
"You tested negative for gene ABC which has been found to increase breast cancer risk. There is a 2% chance that you have gene ABC and tested negative by mistake"
vs
"You tested negative for gene ABC which has been found to increase breast cancer risk. There is a 0.001% chance that you have gene ABC and tested negative by mistake"

Re:Unlisted subtext

[gatfirls]

There is most likely a corporate play in action here but I can see if the test in some way makes someone who can't afford medical testing/treatment off themselves because they know how terrible X disease can be then it's probably worth review. Or the inverse, someone not treating a very serious issue because the test came back ok (which is probably more likely).

Just look how many people show up at the doctor because they have convinced themselves their (low blood sugar) symptoms are 100% a brain tumor according to WebMD.

Re:Unlisted subtext

[TechyImmigrant]

>In a doctor's office, the doctor receives some statistical training to aid in the interpretation and presentation of these error probabilities.

I can guarantee that my grasp of statistical inference is better than my doctor's. She couldn't anover herself out of a paper bag.

Re:Unlisted subtext

[phayes]

My main point was that from the story & linked article, the FDA banned this inexpensive direct to consumers test for reasons that they do not use to ban existing, more expensive tests. An article at Ars states that the ban is because of a total lack of feedback by the company on the accuracy of their tests, something that isn't clear from either the story or TFA & could have been addressed by even a relatively small clinical trial.

Re:Unlisted subtext

[phayes]

Riiiight, and we al think that the cheap test bought off the internet is a complete replacement for doctor ordered tests... The thing is that nobody would be able to self chemo or perform surgery on themselves so people, would need to go through an MD who would indeed screen using other tests which renders TFA's justifications ridiculous.

Having a cheap multi-target test would be good even if it does have a higher false positive/negative rate -- if, as an Ars technical article makes clearer, the company explains just what their error rates are.

Re:Unlisted subtext

[Todd Knarr]

Well, that's what 23AndMe's advertising these as. Which is why the FDA's upset with them. If they were advertising them as "here's your genome sequenced, you'll need a doctor to interpret it and tell you what it means" they'd probably be in the clear. But they're advertising it as "here's your genome and what it means", which implies they've had a doctor interpret it in light of your personal biology/physiology and medical history when in fact they haven't. To me it's the same thing as someone selling me a car and then delivering not a car but a box of parts that can be turned into a car with a lot of assembly, painting etc.. Even if everything's included and there's clear instructions and all the tools, a box of unassembled parts is not what the seller was claiming was being sold.

Re:Unlisted subtext

[phayes]

No, they never said that their tests were validated by a doctor, that's a red herring the FDA & you are attempting to throw in.
At the price point they were selling it at, no-one with half a brain could conclude that results were validated by a doctor. To further your analogy, the FDA just outlawed a kit car because they concluded that no-one is capable of understanding that some assembly is required and that there is no legal market because no one beyond it's licensed practitioners knows how to do so correctly anyway.

As I have said otherwhere, Ars tech's take on the affair is more understandable: They were asked repeatedly for reliability stats on their tests & never answered. I would not buy a kit car unless I knew that one had been assembled according to the instructions & had been judged road worthy.

Genetic testing

[Anonymous Coward]

Well, it's not the first time that a genetic test led to a divorce ...

FDA is doing you a favor

[EmagGeek]

Turning over your DNA to Google is just plain stupid. Believing you have some semblance of privacy with them is even more stupid.

Stupid, stupid, stupid.

Re:FDA is doing you a favor

[Chelloveck]

Turning over your DNA to Google is just plain stupid. Believing you have some semblance of privacy with them is even more stupid.

But now I have a backup in case I die...

Re:FDA is doing you a favor

[heteromonomer]

This. Mod parent up please. Now where are my mod points? I haven't had them in a while!!

Re:FDA is doing you a favor

[Jazari]

Thanks, but I don't need such favors from the FDA. I knew exactly what I was doing when I gave my DNA, and I've gotten valuable and entertaining information as a result.

Re:FDA is doing you a favor

[WillAffleckUW]

Thanks, but I don't need such favors from the FDA. I knew exactly what I was doing when I gave my DNA, and I've gotten valuable and entertaining information as a result.

Sorry, that wasn't your DNA your girlfriend got, it was mine.

Re:FDA is doing you a favor

[Pigeon451]

While 23andme is a for-profit company, I think they will really accelerate genetic-based medicine. They will find many new insights into how people are predisposed to certain diseases, and ultimately open the door for better medical treatment. Once they've created their massive database, they can use their algorithms to find relations that regular academic researchers could not find due to time and cost constraints. I bet they're going to eventually become a very profitable company.

Take for instance certain genes that are known to cause cancer or other diseases with high probability -- I bet there are many more. They discuss specifically Parkinsons, who Sergey Brin has a 30-75% chance of getting according to stats (this will likely be narrowed down as they do more tests and find better correlations).

Re:FDA is doing you a favor

[ClioCJS]

Being so paranoid as to not use science to enhance your life is far stupider.

Fuck these government pricks

[Anonymous Coward]

Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment

In other words, the FDA wants to be the sole provider and arbiter of this information. The scientists are 23andme are too fucking stupid to possibly get anything right unless they have the FDA bureaucrats looking over their shoulder.

I am a 23andme member and my genetic test showed that I am sensitive to warfarin. That's something I never knew before. If I ever get into a situation where that drug is used, having informed the doctor of this potential problem just might have saved my life. There is no possibility that this information could result in any harm, because if the doctor gives a lower than normal dose and it's not effective, he can simply give more. But that doesn't matter to the FDA, because obviously 23andme, the doctor, and myself are all too stupid to utilize this information without Big Brother's help. We can't decide anything for ourselves, so we need Uncle Sam to do all our thinking for us.

The fact that people are on here making excuses and saying "they don't see anything wrong with this", is exactly why our country is so fucked. Look in the mirror: you assholes are what is wrong with this country. Every. Single. Person in the FDA, or anyone who apologizes for their fucking stupid actions, deserves to burn in the same pit of hell they are destined for.

--- shiftless (410350)

Re:Fuck these government pricks

[AlphaWolf_HK]

Probably not good to post your name and UID if your goal is to prevent overzealous moderation - some moderators like to go looking for old posts of yours and downmod them to hit your karma score anyways. It's an asshole thing to do, but they do it anyways. Just part of how slashdot's moderation system is broken, just yesterday I had a post get moderated "redundant" because somebody disagreed with it, and I get moderated "overrated" all the time for the same reason.

Re:Fuck these government pricks

[Fwipp]

my genetic test showed that I am sensitive to warfarin. That's something I never knew before. If I ever get into a situation where that drug is used, having informed the doctor of this potential problem just might have saved my life. There is no possibility that this information could result in any harm, because if the doctor gives a lower than normal dose and it's not effective, he can simply give more.

Weird that you think there can be no ill-effects from under-prescribing something intended to save your life. Unless you're gunning for a stroke/heart attack, that is.

Re:Fuck these government pricks

[Anonymous Coward]

Perhaps he has mod points and wishes to participate in the discussion.

Re:Fuck these government pricks

[Impy the Impiuos Imp]

I would freakig love access to Slashdot's database to do data mining to discover if there are clusters of political downmodders, and call it to light. I've had a number of +5s that, after several days, suddenly go to +4.

Is this the work of a stalker? Is it some concentrated cabal? There was just that story of a company that hired a PR firm to rip up people -- could a political version of this not exist already, with paid or self-appointed dogooders?

Re:Fuck these government pricks

[scheme]

I am a 23andme member and my genetic test showed that I am sensitive to warfarin. That's something I never knew before. If I ever get into a situation where that drug is used, having informed the doctor of this potential problem just might have saved my life. There is no possibility that this information could result in any harm, because if the doctor gives a lower than normal dose and it's not effective, he can simply give more.

What if the test is incorrect? You claim that there's no risk because the doctor can just titrate the dosage up, but if you have a time sensitive condition then the extra time required to adjust the dosage up could result in irreparable harm to your health. E.g. you get a stroke or thrombosis while the dosage is being adjusted.

Re:Fuck these government pricks

[Anonymous Coward]

So we have scientists vs bureaucrats. I could easily call it business executives vs physicians. Note the FDA has no financial interest in delaying approval of a product. The company on the other hand has a lot to lose by not being able to market their product in the US. A good general rule before issuing a tirade is to ask who benefits or in other words FOLLOW THE MONEY.
Sadly those afflicted by medical ailments are easy prey for the greedy.

Re:Fuck these government pricks

[Anonymous Coward]

I am a 23andme member and my genetic test showed that I am sensitive to warfarin. That's something I never knew before. If I ever get into a situation where that drug is used, having informed the doctor of this potential problem just might have saved my life.

Warfarin isn't very fast acting, so even if your dose was too high, the initial startup regime would catch that. The dosage is very individual anyway: things like diet, exercise and having a flu can affect it.

Disclaimer: I'm on warfarin and I have the genetic sensitivity marker. My dosage is on the higher end of the scale.

Re:Fuck these government pricks

[BradMajors]

How do you know that 23andme isn't simply making these results up with no scientific basis whatsoever for their claims?

Re:Fuck these government pricks

[sjames]

I don't see how the doctor being aware of a potential need for extra caution is anything but a good thing. If the doctor goes off the deep end and treats it as an absolute contraindication, that would be a problem, but not with the test.

Re:Fuck these government pricks

[WillAffleckUW]

Also, why are you taking warfarin? Is it the only drug you are taking? Most people prescribed warfarin are also taking other medications, and the interaction of those drugs may behave differently from warfarin by itself. The dosage levels may be different.

Do not make medical decisions about which drug to take by yourself, it's a bad idea.

Re:Fuck these government pricks

[ausekilis]

Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment

I am a 23andme member and my genetic test showed that I am sensitive to warfarin. That's something I never knew before. If I ever get into a situation where that drug is used, having informed the doctor of this potential problem just might have saved my life. There is no possibility that this information could result in any harm, because if the doctor gives a lower than normal dose and it's not effective, he can simply give more.

First, it's not that the FDA wants a monopoly on genetic tests. Their interest is in the safety and education of the populous (queue conspiracy theorists). They focus on making sure the public is getting accurate, validated information on treatments/drugs that do only what they advertise.

Second, you are putting your trust into something that may or may not be peer-reviewed and ensured to be accurate. Just because your genetic makeup says you may have a sensitivity doesn't mean you actually do. Would you really risk not having a surgery if you discovered through a mail-order cheek swab that you "may be sensitive" to penicillin?

Third, sensitivities and allergens are certainly not something to be played with. The difference between mild rash to anaphylactic shock can be pretty small for some people and some allergens. I know people that are resistant to the standard anasthesias, and in some cases the only way to get them numb is to get dangerously close to an LD50 injection (sometimes an alternative doesn't work or is not available).

I'm not belittling the information that you received from them or that it may have been useful to you. What the FDA is doing is making sure that the claim of someones sensitivity to something is accurate and informative for that individual. Too many people out there will find out they are sensitive to wheat, then go out of their way to make sure not only do they not eat wheat, but they purge their houses of wheat, refuse to touch flour or wheat products, then start some non-profit organization to start feeding fear to the populous that wheat is a poison that must be purged.

Re:Fuck these government pricks

[TsuruchiBrian]

Being aware of false information can have a negative impact, in the same way that bogus leads can hinder a police investigation.

That said, I think the FDA should be allowed to put their stamp of approval on things, but they shouldn't be allowed to prevent people from deciding what medical tests and procedures they do to themselves.

Re:Fuck these government pricks

[mlw4428]

The problem has nothing to do with the FDA trying to regulate how you think. It has everything to do with asking 23andme to provide documentation, which can be checked, that shows that the test is accurate to a respectable degree and the method(s) used in calculating that accuracy.

To play devil's advocate -- that test may cost you your life, because it's not accurate. There's no proof either way and the FDA is simply doing the reasonable thing, presumably, until said proof is submitted.

Re:Fuck these government pricks

[sjames]

I agree.

Re:Fuck these government pricks

[mythosaz]

Perhaps people should follow the rules and choose between moderating a discussion and participating in it.

Re:Fuck these government pricks

[chromas]

As far as I can tell, checking the AC box still wipes any moderating you do in the thread—you just don't get the warning (though you can still mod after posting).

Re:Fuck these government pricks

[FussionMan]

If the FDA cares about safety why do they approve pink slime and transfats (until recently), anti-biotics in farm animals, etc?

Re:Fuck these government pricks

[Anonymous Coward]

Being aware of false information can have a negative impact, in the same way that bogus leads can hinder a police investigation.

That said, I think the FDA should be allowed to put their stamp of approval on things, but they shouldn't be allowed to prevent people from deciding what medical tests and procedures they do to themselves.

There has to be a line beyond which you can not practice medicine. Without that line we would have thousands of quack 'doctors' performing cosmetic surgery in hotel rooms. There would be people giving cancer "tests" using actual litmus strips. Maybe what we have now is too strict. I would argue that the FDA should be clamping down harder on the "supplements" market. You can argue about where the line should be. However, a libertarian system where anybody can practice medicine, anybody can sell any kind of pill claiming anything they want, but the real doctors are "certified" is not a system I want to be part of.

Re:Fuck these government pricks

[The Snowman]

I am a 23andme member and my genetic test showed that I am sensitive to warfarin. That's something I never knew before. If I ever get into a situation where that drug is used, having informed the doctor of this potential problem just might have saved my life. There is no possibility that this information could result in any harm, because if the doctor gives a lower than normal dose and it's not effective, he can simply give more.

What if the test is incorrect? You claim that there's no risk because the doctor can just titrate the dosage up, but if you have a time sensitive condition then the extra time required to adjust the dosage up could result in irreparable harm to your health. E.g. you get a stroke or thrombosis while the dosage is being adjusted.

If I were going to use a test like this, I would use the test, then go talk to my primary care physician with the results along with my known, diagnosed family history and my own medical history before I need urgent care. That way we can look it over and decide what the best course of action is. Maybe this is saying "thanks captain obvious, two people in my family died from this, it was a known risk at birth." Maybe the answer is "this is plausible, it requires further testing using more accurate methods." Maybe the answer is "this is batshit insane, forget about it." Regardless, this is not taking the results at face value, but reviewing them carefully, one by one, with a trained physician along with my family and personal history.

That being said, half the time medicine is a crapshoot anyway. January 2013 I wound up in the ER due to a probable allergic reaction to Amoxicillin. I was suffering anaphylaxis, stopping short of the most severe symptom (throat closure) due to quick reaction and prompt administration of drugs. This could have been a one time occurrence, or it could have been a drug allergy that I developed all of a sudden. I spoke with a specialist who basically said "I can test you but it will cost money, is not very accurate, and in the end you're best off just not taking Amoxicillin and assuming you are allergic." So, meh. Even the "real" medical tests are not 100% accurate and worthwhile.

Re:Fuck these government pricks

[The Snowman]

January 2013 I wound up in the ER due to a probable allergic reaction to Amoxicillin. I was suffering anaphylaxis...

I forgot to mention this in my original post, but my wife gave me the best diagnosis that day as she drove me to the ER in blizzard conditions: "Wreck-It Ralph hands." They almost had to cut my wedding ring off my hand.

Re:Fuck these government pricks

[darronb]

Wow... supplements. Especially the wackier new age ones... listing everything under the sun as cured by them and as long as there's a "for entertainment purposes only" on the bottle it's okay.

I asked my mother about that label once, she said "Oh, it's just something the government makes them put there. These really work." Most people buying that garbage think the same thing.

The web sites are WAY worse... but then I'm not sure what could be done about that.

Re:Fuck these government pricks

[Curunir_wolf]

Being aware of false information can have a negative impact, in the same way that bogus leads can hinder a police investigation.

That said, I think the FDA should be allowed to put their stamp of approval on things, but they shouldn't be allowed to prevent people from deciding what medical tests and procedures they do to themselves.

There has to be a line beyond which you can not practice medicine. Without that line we would have thousands of quack 'doctors' performing cosmetic surgery in hotel rooms. There would be people giving cancer "tests" using actual litmus strips. Maybe what we have now is too strict. I would argue that the FDA should be clamping down harder on the "supplements" market. You can argue about where the line should be. However, a libertarian system where anybody can practice medicine, anybody can sell any kind of pill claiming anything they want, but the real doctors are "certified" is not a system I want to be part of.

The FDA is not involved in the qualification process for doctors. In fact, the Federal government is entirely uninvolved qualifying or licensing physicians.

Primarily, the FDA is a group that ensures profits for specific pharmaceutical corporations. This can be used to explain pretty much explains every decision they make.

Re:Fuck these government pricks

[Curunir_wolf]

Do not make medical decisions about which drug to take by yourself, it's a bad idea.

That's a horrible stance. Get as much information as you can from whatever "experts" you can consult. But the decision about what to put in your body should be entirely and solely your own.

Re:Fuck these government pricks

[Curunir_wolf]

A good general rule before issuing a tirade is to ask who benefits or in other words FOLLOW THE MONEY.

I followed your advice and came to a different conclusion. Apparently FDA approval means your product will cost at least 10 times as much.

Are we to assume that the FDA has no interest in protecting the corporations that provide their funding?

Re:Fuck these government pricks

[LordNacho]

The FDA isn't entirely free from distorting incentives. Suppose you're the FDA boss. Do you want some scandal about some guy dying due to a false test? Of course not. Simpler just to ban it. But what if the test is sound? Well, nobody will know that some other dude died due to not being diagnosed because the test wasn't administered.

It would have made more sense to make sure consumers understood that the FDA had not yet finished it's product approval, while letting them continue. People can decide for themselves how to react to a test.

Re:Fuck these government pricks

[rocket rancher]

Do not make medical decisions about which drug to take by yourself, it's a bad idea.

Hmmm. Bad medical decisions that *you* make stop when your heart stops. The alternative is for some other person to make medical decisions on your behalf. This other person is immune to the consequences of a badly grokked medical decision, which leaves him free to continue dispensing bad advice. How is this not a bad thing, as well? Is there a middle course between these two choices?

Re:Fuck these government pricks

[WillAffleckUW]

I think your sig says it all.

I stand by my statement

Re:Fuck these government pricks

[WillAffleckUW]

in actual practice, MDs are actually quite bad at making medical decisions on their own treatment too.

The problem is that your frame of reference shifts. You magnify certain aspects and minimize others when it's yourself.

Everyone does it.

Re:Fuck these government pricks

[Luckyo]

You just took a big shit on the entire medical profession. As someone who had a pleasure to work with doctors for about a year's stint in the army, I would like to tell you a heartful "fuck you asshole".

Most of the people who go into medical profession take it very seriously. And unlike assholes like you, they actually have the knowledge, real scientific one, not based on hearsay, google and self study without context. As a result, they are in a far, FAR better position to make medical decisions on your behalf, unless you hide things from them, denying them knowledge necessary for your treatment. Which is often the case with your type, as you "do not trust the doctors", causing them to make bad judgments by not providing them with relevant information, which you use as a reason to trust them even less. A self feeding delusion.

Frankly, I do not mind you hurting yourself in this way. It's your body, if you want to shove your dick in the shredder shouting "I trust my judgment over the safety manual, I have a dick of titanium and balls of steel!" it's your choice. If you want to choose to ignore professional medical advice in favor of unproven methods, go ahead. Again your choice. The only people I do feel sorry for are the people who will be influenced by your stupidity and may end up suffering needlessly as a result.

Re:Fuck these government pricks

[Luckyo]

I'm yet to see any evidence that that particular meat based glue is actually harmful in any way. The only argument against it was "it looks disgusting". No one ever argued that it was harmful - not even the certain celebrity cook who made a lot of money of the controversy.
The problem here is consumer protection, and the reason why EU has banned all mechanically separated meat, including "pink slime" type is because it's considered to be a meat of much lower quality than what it was sold added to without labeling. As a result, consumer was fooled into buying meat that was of much lower quality (mechanically separated meat of any kind) than what was assumed based on what is stated on the label (meat separated by conventional methods).
The only health based issue ever raised with it was Canadian problem with using ammonia during production of the meat, which was forbidden for entirely different reasons and just happened to extend to this particular product. There is no peer reviewed evidence that mechanically separated meat is a health problem. It's a consumer protection problem however, and should be treated as such.

Transfats are considered harmful when consumed in large dosage (they are legal in EU as well for example, within limits). FDA has typically been more conservative than its EU colleagues in regulating food over statistical increase from large scale consumption, due to different concepts of personal freedom across the regions as well as different levels of corporate pressure.

Antibiotics in farm animals are not harmful to humans and are in fact beneficial by suppressing most virulent strains that are more likely to infect humans. This has been proven long ago. The issue that is often raised is that having so much antibiotics fed to farm animals causes development of resistant strains of bacteria, that might be able to jump species and infect humans, causing severe potential epidemic as a result as antibiotics would be inefficient on these types of bacteria. FDA, like its EU counterparts does not issue bans based on incomplete evidence, and real evaluation of the risk is yet to be done due to extreme complexity of the analysis.
At the same time there is work done, within those agencies and outside to find a solution to the issue, ranging from different farming practices to split species and prevent chances of cross-species infection (mutation) which is one of the main reasons why most of the highly efficient farms are actually a much lower risk of starting an epidemic than small scale "many species in one place" farms that are often advertised as being better at it in PR. AFAIK almost all known outbreaks so far have been traced to such small farms.
There's also some very promising work with other forms of animal biome management, such as feeding them probiotics that empower benign and beneficial bacteria which will occupy harmful bacteria's niche protecting the animal. So they are working on the long term solution, while the short term solution in place (animal splitting and efficient farming) has proven to hold quite well so far. As a result, there's no reason for outright ban.

Re:Fuck these government pricks

[Curunir_wolf]

...and, unfortunately, you are likely to die by it too.

Medical claims

[Animats]

The problem is that 23andMe started making medical claims. As the FDA says, "your company's website at www.23andme.com/health ... markets the PGS for providing "health reports on 254 diseases and conditions," including categories such as "carrier status," "health risks," and "drug response," and specifically as a "first step in prevention" that enables users to "take steps toward mitigating serious diseases" such as diabetes, coronary heart disease, and breast cancer." Those are health claims. Those have to be clinically tested.

The history of their web site shows the health claims becoming more blatant over time.

• From 2008: "Find out what current research can tell you about your genes."
• From 2013: "Living well starts with knowing your DNA. Our genes make us who we are, so naturally they impact our health. By knowing your DNA, you can take steps toward living a healthier life. Find out if your children are at risk for inherited conditions, so you can plan for the health of your family. Order now."

Their advertising thus shows a progression from marketing to the technically curious to marketing to parents worried about their kids. That's what properly concerns the FDA.

Re:Medical claims

[Anonymous Coward]

I agree. Personally I think that 23andme has value has value as some sort of experimental club.
You care about genetics, you want to help out, you want to get noisy feedback that needs to be taken with a grain of salt. Then it's perfect and might be very helpful someday (when they have 100 million members that can answer questionnaires from scientists in a matter of days, or report they got the flu or how long it took them to lose weight or that they stutter or whatever, there is a chance they might build some actual knowledge).
The diagnostics feature is unfortunately weak and disappointing :
  - they talk about increased risks of 50% 50 years down the line (e.g. Alzheimer risk) and they want all your DNA to give you such useless information.
  - alternatively, you could just get free advice on best practices with 0 info about you and get more useful info (eat vegetables, sleep 8 hours, avoid sugar, drive safely, have friends, go for a walk etc.)
So they are currently hyping the feature that has the lowest value.
But I guess scaring parents can bring more people in and the investors must be starting to want ROI....

Troll Food

[rakslice]

The original article, which is talking about the FDA pulling the plug on a medical service due to its operator not addressing some red tape with respect to safety standards, is a good illustration of the interventionist form of "statism". Subsidized health care doesn't necessarily dictate what the medical industry can do in the same way, but taxing people and spending the money on certain kinds of health programs is definitely an economic intervention that pushes the medical industry in a certain direction. What do you think, Mr. Anon.? Did you have this similarity in mind when you wrote your post?

Re:Troll Food

[Anonymous Coward]

Sorry man I honestly do not understand what question it is you are asking, can you restate it?

And yet, what I am asking is pretty simple and clear, this man claims to be non partisan while, of all things, he is out on a fundraising whirlwind tour of Democrat venues including the homes of rich Democrat donors and Hollywood idiots.

I'm just asking if you really buy this crap, and if you do, how do you justify it? I mean the guy is lying right at your face! Really?

Re:Troll Food

[rakslice]

Okay, let me try again:
I see the original post is about medical regulation and your comment is kinda sorta about medical regulation; do you want to connect the dots or do you just want to talk about Obama?

"We're from the government..

[h8sg8s]

..and want to help" Frequently the last words a great idea ever hears.

SHIT HEADS AT THE FDA

[Anonymous Coward]

They need to justify their billions and billions of dollars budget.
Just who is damaged by 23 and Me.

You are a tyrant . . . just like the FDA.

[Anonymous Coward]

So there just *might* be someone who electively undergoes invasive, serious, expensive medical treatment without getting a second opinion (viz. diagnosis) and that is somehow the responsibility of 23andMe? Is that what the FDA and you are claiming? Are you also claiming that FDA approved channels *never* make mistakes and therefore people obtaining those results can completely trust them and should not seek a second opinion (viz. diagnosis)?

No, this smacks of the FDA wanting to be expansive and control everything - possibly even an expensive competitor using the FDA as a way to quash competition. This also smacks of a huge number of people not understanding that *I* am responsible for my own body and get to seek information and treatment for it through any and every channel I deem useful.

You and the FDA are tyrants for trying to tell me how to treat my body and taking away useful tools for doing such.

P.S. It is quite coincidental that the capta text for submitting this is "rights". How apropos.

Yes, but...

[Anonymous Coward]

You have to realize that there is an entire industry running on "press releases". The mere fact that they meet with, and "negotiated" with, the FDA created buzz and made eager investors pump up money in the company. In the end, when they close shop, they will say: "It's not our fault. We have a great product. Unfortunately, the FDA decided not to approve it for [some technicality/political reasons/you name it]." -- and then pocket a few extra million dollars to start up a new company. "It’s a dream, a frightful dream life is"

Any test can be wrong

[mveloso]

Any diagnostic test can be wrong, and the public and medical community is OK with that.

The problem isn't the test, it's that there's no way to verify that the recipient of the results has any idea what the results mean. If a human being is involved, at least you can pretend that someone attempted to make sure the person in question understood the results.

Personally, I think 23 and me is fine as it was. OTOH, the FDA has to deal with "the public", who is invariably stupid.

Re:Any test can be wrong

[sjames]

What about those drug tests for worried parents? How do we verify that parents understand that it's just a screening test? How do we verify that they know a positive for 'opium' could mean the kid ate a poppy seed bagel?

We don't, and the FDA decided that was OK.

Can anyone say "Shakedown"?

[Anonymous Coward]

Government agencies love their power, it seems you need permission to do just about anything now days. Unless there is a danger to the testing, I am not sure I get why the FDA would be involved in analysis like this. Times have changed.

Re:Can anyone say "Shakedown"?

[Anonymous Coward]

You have no idea what you are talking about. If you don't work in healthcare then just please just have a seat.

Re:Can anyone say "Shakedown"?

[Anonymous Coward]

You fill a plastic tube with saliva, so no danger unless you attempt to do so with said tube in throat.

Texasification

[Anonymous Coward]

Based on a "hold-on" request at an ethics conference a few years ago, and a "sorry, we go where the money is" response from 23addme, I don't expect this FDA request will do too much. 23andme will probably find a way around this, perhaps initially by not offering their DNA marker analysis to people in the US, and then eventually working out some way to skirt around the rules. Maybe their US kit won't actually include the swab stuff, and you'll have to go to informed consent showrooms to get the swabs.

Expect this chain to be modded offtopic

[Crashmarik]

And correctly done at that. This would be better fodder for it's own Ask Slashdot.

The FDA is part of the executive branch

[Crashmarik]

So the party that currently is in control of the executive branch would be to blame here.

Re:The FDA is part of the executive branch

[Anonymous Coward]

It's nominally part of the executive branch. Modern regulatory agencies sit in a nether-region between Congressional control and Executive control. It's actually a very complex and sophisticated branch of constitutional law that has been crafted by Federal Courts over the past 80 years.

Democrats tend to be more hands-off, to avoid the look of impropriety by seeming to help certain corporations, but also because when left to their own devices these agencies to be pretty involved, which is what Democrats want to see in areas of regulation.

Republicans tend to be more hands-off, because they _want_ to help their corporate allies and don't care if anybody knows, but also because they want to reel-in those agencies. But there's only so much they can do wrt to the latter, because these agencies have Congressional mandates, while one-off favors for corporations tend to go unnoticed and unchallenged.

Re:The FDA is part of the executive branch

[benzapp]

It's not entirely the party, but the Democratic Party has a major faction that is opposed to genetics, and maintains the fiction that humans are born equal and only propaganda and socialize creates human differences.

Modern genetic research soundly defeats this myth, so the science is suppressed in various ways. This is a surprising one, as so far it usually has focused purely on academic research.

Open source genome sequencing

[WaffleMonster]

At the rate things are going it is likely to soon become cost effective to sequence everything for what 23andMe is charging now and simply hand customers a DVD with their fully sequenced DNA.

When that happens the cat is out of the bag all you need is software to do analysis for any and all aliments you want using nothing more than software which can be downloaded and used freely by anyone. Software no government is going to have much luck restricting people from getting their hands on it.

I am all for FDA regulations but they need to evolve or they will find themselves on the loosing end of a war they cannot win (See also drugs, smokes and alcohol)

A couple of suggestions:

1. Carve a space in regulatory regime allowing for speculative technologies provided any test outcomes must be validated by an FDA approved method before actionable decisions are made by a doctor. e.g. what is most likely to happen currently anyway as a result of any 23andMe diagnosis.

2. Setup a scoring framework and information system allowing people to get statistical information on the accuracy of tests as results are confirmed so they can make up their own minds whether tests are worth their time. Enabling the market to drive accuracy is a win for everyone.

Re:Open source genome sequencing

[tibit]

Software no government is going to have much luck restricting people from getting their hands on it.

If you seriously think that software that makes medical diagnostic claims is not regulated, you're not living in the same world as the rest of us does. If you try to publish such software as a US-based entity and the FDA gets wind of it, if you don't cooperate with them you'll be slammed down with an injunction, your web host will as well, and that'll be the end of it. Same thing will happen in many countries in the E.U.

Re:Open source genome sequencing

[tibit]

Or, to paraphrase: if you think it doesn't need to be regulated just because it's software, you're delusional. It doesn't matter if it's software or not. It provides a diagnostic function. It's no different than if someone offered a "family practitioner" software that makes medical diagnoses for you. It's been tried before, you know.

Re:Open source genome sequencing

[RDW]

If you seriously think that software that makes medical diagnostic claims is not regulated, you're not living in the same world as the rest of us does.

You don't have to use software that 'makes medical diagnostic claims'. You can simply used software designed for research purposes. Everything required to analyse genomic sequences, from alignment of the raw data to detection and annotation of variants of interest, is already freely available under open source or non-commercial academic licences, without regulation by the FDA or anyone else. There's nothing to stop you taking the output of this analysis and comparing it against large databases of disease-associated variants, several of which are also publicly available. All this requires a certain level of technical knowledge (the software and databases are designed for working scientists, and may not be terribly user-friendly), but there's certainly no legal barrier in your way.

This makes no sense...

[Steve_Ussler]

Why would the FDA have a problem with this? Why don't they stop all the dopey infomercials...those are truly rotten.

The real problem is not the tests but the users

[WillAffleckUW]

The real problem is that you people who buy these tests will incorrectly interpret what they say.

DNA is really only about 99.5 percent correct using PCR, for one thing.

Carrying a risk allele that is triggered by environmental conditions or requires other actions to trigger is another.

But the worst thing is you all incorrectly ascertain risk.

You overreact, and when you overreact, in medical studies without effective genetic counseling, and even in some of those cases, you almost always do the exact wrong thing.

Should you be able to order such a test? Yes.

Should you react to the test without proper genetic counseling? Never.

Re:The real problem is not the tests but the users

[tibit]

You shouldn't be able to order such a test if it isn't regulated like any other medical diagnostic lab that tests much simpler things (routine urine and blood tests). You might as well be receiving people's lotto submissions.

Re:The real problem is not the tests but the users

[WillAffleckUW]

You shouldn't be able to order such a test if it isn't regulated like any other medical diagnostic lab that tests much simpler things (routine urine and blood tests). You might as well be receiving people's lotto submissions.

I am quite willing to accept people's lotto submissions. Send them in a manilla envelope to Box IMCHEAT23, Pottstown PA

Fork and Exec

[evought]

Maybe their should be a button to fork and exec a sub-topic that develops in an interesting direction. I'm not actually saying that this branch is particularly interesting, but, given the beta-period, I was interested in the possibility of interesting-ness.

Re:Fork and Exec

[Anonymous Coward]

Whose should be a button?

Canadian Pharmacy

[Anonymous Coward]

So can we just order the kits from Canada as usual?

Rich people's conspiracy

[Anonymous Coward]

Heck, with Google so much in bed with the US gov't, this could be a easy way for Sergey to cut off Anne in the most polite way--via a 3rd party, the FDA. I mean rich folks have 99% of the cash, 99% of the spoken word in gov't... If I were rich, why not?

I mean FDA would have figured this out and questioned the service 2 years ago. Why now?

Sounds like 23andMe gave the FDA the finger

[AdamHaun]

If even half of the FDA's letter is correct (and I see no reason to doubt it), they've been bending over backwards to work with 23andMe for years. The company made a deliberate decision to both ignore the regulators and (more damningly) fail to study the effectiveness of their own product, and now they're paying for it. Here's the relevant section of the letter:

Your company submitted 510(k)s for PGS on July 2, 2012 and September 4, 2012, for several of these indications for use. However, to date, your company has failed to address the issues described during previous interactions with the Agency or provide the additional information identified in our September 13, 2012 letter for (b)(4) and in our November 20, 2012 letter for (b)(4), as required under 21 CFR 807.87(1). Consequently, the 510(k)s are considered withdrawn, see 21 C.F.R. 807.87(1), as we explained in our letters to you on March 12, 2013 and May 21, 2013. To date, 23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it; no other submission for the PGS device that you are marketing has been provided under section 510(k) of the Act, 21 U.S.C. 360(k).

The Office of In Vitro Diagnostics and Radiological Health (OIR) has a long history of working with companies to help them come into compliance with the FD&C Act. Since July of 2009, we have been diligently working to help you comply with regulatory requirements regarding safety and effectiveness and obtain marketing authorization for your PGS device. FDA has spent significant time evaluating the intended uses of the PGS to determine whether certain uses might be appropriately classified into class II, thus requiring only 510(k) clearance or de novo classification and not PMA approval, and we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification. Further, we provided ample detailed feedback to 23andMe regarding the types of data it needs to submit for the intended uses of the PGS. As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies. As discussed above, FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.

However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has n

Re:Sounds like 23andMe gave the FDA the finger

[Anonymous Coward]

I wouldn't be surprised if 23andMe looked at the regulations and economics, then stated amongst themselves, "Oh shit! If we do get this certified by the FDA, it will be a 'medical device' and will instantly cost us $999 to sell, instead of $99, just due medical insurance markups on every single component in the whole supply chain. NOBODY will buy our test for $999!"

Re:Sounds like 23andMe gave the FDA the finger

[tibit]

Let me paraphrase for anyone who still doesn't have a clue: as far as I'm concerned, their customers were getting back results generated by a random number generator. That's all they are useful for, even if some fancy biochemical process was used -- it's all unsupervised hokum, and stupid people are falling for it. One that had nothing to do with random processes taking part during the egg fertilization and subsequent zygote division that gave rise to their selves, by the way.

Re:Sounds like 23andMe gave the FDA the finger

[TechyImmigrant]

Random number generators are super useful.

Re:Sounds like 23andMe gave the FDA the finger

[TheSync]

Let me paraphrase for anyone who still doesn't have a clue: as far as I'm concerned, their customers were getting back results generated by a random number generator.

Then why do kids on 23andMe show that all the DNA examined has long continuous regions of half-identical matching SNPs to their parents? (I have personally witnessed this)

Re:Sounds like 23andMe gave the FDA the finger

[tibit]

It doesn't matter that it mostly works. There's absolutely no guarantee it works consistently, or that the results are good for anything. It's a medical diagnostic service and it needs to be regulated like one. Case closed.

Re:Sounds like 23andMe gave the FDA the finger

[Anonymous Coward]

There's absolutely no guarantee it works consistently,...

The 23andMe tests are done in a CLIA certified lab. I've compared 23andMe data to sequencing data, myself, and found overwhelming agreement. And I haven't found anyone else in the genetics community who has found significant problems with their data, either. Whatever this business with the FDA is about, it is emphatically not about data quality.

...or that the results are good for anything.

If they were seeking reimbursement from health insurance companies for their tests, then clinical utility would be a potential issue. But, in a country that's supposed to value freedom, is it really the government's place to prohibit people from spending their own money on things that are not, from the perspective of government bureaucracy, proven to be good for anything?

Re:Sounds like 23andMe gave the FDA the finger

[stdarg]

Medical testing is not required to work consistently. That's why there's a notion of false positives and false negatives to begin with. We KNOW that the tests will have some number of errors when applied to a large population.

And even if you were correct, the logical action would be to go after the suppliers of the sequencing equipment that 23andme is using, since they are the ones making claims that their equipment properly analyzes dna. Or do you think 23andme markets equipment that they developed and certified all by their lonesome? Or on the contrary, do you think every pharmacy in the country has to independently verify the medical claims of every single drug they sell? Obviously not, that would be idiotic.

Also I don't know what you mean by the results being "good" for something. I can go in and persuade my doctor to order any number of unnecessary medical tests for me.

bullshit

[stenvar]

"Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.

That reasoning is utter and complete bullshit. Tests aren't just "positive". When these genes are reported in the literature, the strength of the correlation between markers and disease is reported as well. Doctors and patients can evaluate their risk based on that information. They aren't going to undergo "prophylactic surgery" unless it makes medical and financial sense to them, based on all available data.

What the FDA is really afraid of is that people with a positive test demand costly follow-up tests, costs that would be quite inconvenient for Medicare/Medicaid and (now) the new Obamacare programs.

Re:bullshit

[EvilSS]

I think part of the problem is the results from these test can scare the shit out of the average Joe, and there really is no one sitting there with you explaining that your genetic results do not doom you to all these diseases you may have an increased risk for, according to the test. Sure, the site tries but I can see people freaking out, and how it could lead to unnecessary diagnostics and procedures when they batter their primary with the info.

Don't get me wrong, I think the inexpensive availability of these types of test has value, not to mention the research value of all of the data that they collect. However, I do get where the FDA is coming from. There should be an option to send these to your doctor* or at the very least a phone call before you get the results from a genetic councilor working for the company to walk you through what the tests really mean.

For the record I am a 23 & Me customer. My educational background is such that I understood how to interpret the data they provided (and then some, you can get your full results in a raw form from them as well).

*While protecting that data from being used by your current or future insurance companies. They are barred, in most states, from using it against you UNLESS you volunteer the information (i.e. you get the test yourself and it goes into your medical record vs a doctor orders the test).

Re:bullshit

[Microlith]

What the FDA is really afraid of is that people with a positive test demand costly follow-up tests, costs that would be quite inconvenient for Medicare/Medicaid and (now) the new Obamacare programs.

Actually what they're really afraid of is the return of the ancient aliens that society was built upon. And there's equal evidence for both our conclusions.

Re:bullshit

[stenvar]

Actually what they're really afraid of is the return of the ancient aliens that society was built upon. And there's equal evidence for both our conclusions.

There is plenty of evidence for what I said, because FDA explicitly justifies the rejection of medical tests with "cost/benefit analyses". So you continue to prove that you don't know what you're talking about.

Re:bullshit

[stenvar]

I think part of the problem is the results from these test can scare the shit out of the average Joe

Yes, that's the problem: instead of trusting people to make reasonable decisions for themselves and live with the consequences, an intellectual elite treats everybody as "the average Joe", unable to make decisions for himself. That's true for medicine as well as mortgages and all the other things government has started interfering in over the last few decades. But the people substituting their judgment for that of "the average Joe" are neither impartial, nor do they know the exact circumstances of "the average Joe". For example, they may want to protect the financial interests of existing testing companies, and they can't distinguish between the small minority who would do something stupid with a test result and the vast majority who would use these results sensibly.

The more you treat people as immature children, the more dependent and immature they'll become. It just gets worse and worse over time.

Re:bullshit

[EvilSS]

I would say spend some time on the 23 & Me discussion forums. They are rife with bad interpretations and information. Giving people data without properly informing them how to interpret the data can be a dangerous thing. I do NOT advocate locking the information away, only making sure that the end user fully understands what it does and does not mean. Otherwise you are creating a situation where, at the very least, undue stress and worry is put on the end user.

IF selling to consumers

[Anonymous Coward]

It says that these products must prove that they work IF selling to directly to consumers. Implying that if they sell to a hospital it can be bollocks. An interesting distinction...

Ironic Google Advertising.

[mythosaz]

I don't load plugins here at work, and I choose not to disable advertising here on Slashdot, so today I got this deliciously ironic gem while browsing this article:

http://superb-owl.com/images/mythosaz/23andmeirony.jpg

Shiftless?

[Anonymous Coward]

"... not to mention we have ZERO proof that their labs are even monitored in any way."

Or that their labs are even testing people. Seriously, without oversight, they could be handing people any information Google cares to (as we all know that is who really holds the bag here. Sergey's wife for pete's sake). Is Google invested in Big Pharma? Are they simply steering people to drugs they've invested in? Steering people away from competitor's products?

This is the exact shit that is driving our healthcare "system" into the ground--unmitigated GREED disguised as innovation.

Let 'em have San Francisco--maybe they'll all be there when everything west of the San Andreas falls into the Pacific. (Anonymous Coward Prophecy #621)

That's why you're an idiot

[Anonymous Coward]

Yes. I am claiming these tests aren't effective.

Then you're an idiot. I had my DNA tested by 23andme and not only did they confirm things I already knew, they taught me some new things as well. Such as I am immune to the stomach flu, because my body does not have the receptors necessary for this virus to latch on. I did not know that, although it makes sense, because I have never once had any flu or stomach flu in my life!

If I want to make medical decisions based on information that an organization like 23andme gives me, that is my GOD GIVEN RIGHT, and FUCK YOU for trying to take that right from me.

Re:That's why you're an idiot

[EvilSS]

I really hope this post is subtle sarcasm, otherwise you are just proving the FDA's point. You MAY be RESISTANT to most COMMON strains of norovirus (which, btw, has nothing to do with influenza, aka the flu virus, or your ability to get infected by it). You did read the data for the error rates for the chip they use to do the test with right?

You are an idiot

[Anonymous Coward]

Now cue all the Slashbertarians ranting about how restricting unproven medical testing is an assault on freedom..

That's exactly what it is, DUMB ASS!

It helped me.

[Anonymous Coward]

Apologies for posting as AC, but I don't necessarily want my health information in the public domain.

I ran my spit through 23andme and it identified that I had one or two (the test is not more specific) mutations associated with haemochromatosis (high iron levels.) I told this to my haematologist, who up to that point believed my condition was the result of other factors, and he said, "well, this changes everything." (Interestingly, I didn't do the 23andme for this reason, it just worked out that way.)

He promptly referred me for a targeted genetic test (quite expensive, as I understand) that confirmed that I did indeed have the double mutation.

He also told me afterward that the 23andme certainly did seem to be money well spent, and that because it was relatively cheap (at $99) he would most likely tell other patients about it.

So, for me, 23andme really has helped.

Medical device covers a very wide range

[Anonymous Coward]

The FDA regulates medical devices.. Loosely.. anything that touches a person and/or reveals a physiological parameter is a medical device. Latex gloves are a medical device. A thermometer intended to read body temperature is a medical device. Note carefully: intended to read body temperature.. using your IR thermometer intended to read the temp of your steak isn't a medical device. The exact same device, if advertised/marketed/etc as something that can tell if you or you kid has a fever is a medical device.

23andMe is harmless at worst.

[michael.ahlers]

That's faulty logic.

An HIV or Hepatitis C test that delivered false negatives would be worse than useless, potentially giving positive patients a false sense of security. With that faulty sense, those holding incorrect results could leave their diseases untreated and risk exposing others. However, false negatives from 23andMe—provided a small advisory to its users—would leave them ignorant of conditions like Huntington's or BRCA the same as if they had never submitted a sample, whereas false and true positives would both prompt additional investigation on the part of the customer. In other words, if 23andMe gives a negative result, you still don't know what you didn't know before. If it gives a positive result, you'll be inclined to seek a medical opinion from a professional.

It's a pretty clear-cut case of regulation overreaching its boundaries and bearing on an innovative product that's helping to promote mainstream genetic testing.

too much power, should have access.

[volvox_voxel]

I think we should be able to make any kind of independent test we want to make, and not be beholden to a priesthood of medicine, where only the doctors are privy to the details on your medical chart. The information provided is not something that you could get from a normal doctors visit. It gives you an estimate about your health risks, though it may not be 100% accurate, They are pretty clear about this in their documentation. I resent how medicine works in the US in general, and often feel those that I encounter are ether overwhelmed and overburdened, or are technicians that know next to nothing that are trained to draw blood or make measurements that will be interpreted later. Independent testing, cross checking, knowing your risk factors, etc are always useful.

I had a professor in college who's wife noticed a new mole on his back. He went to two different doctors that inspected it and told him he was fine. Not satisfied, he went directly to see a dermatologist without an appointment. He was informed to cancel his schedule for the next day, and that they were going to operate on him. It was an aggressive skin cancer that had not reached down far enough to spread all over his body. He's fine to this day, but every 6 months they inspect his whole body, and remove all of his moles..

I don't trust doctors to pay enough attention to my long term health interests.. They have hundreds of other patients to take care of.

Petition on Whitihouse.gov is already up

[Jazari]

I have no affiliation to 23andMe except as a satisfied customer. I have found 23andMe's services very useful and low cost to me, and hope that they are not destroyed by this FDA action. https://petitions.whitehouse.gov/petition/overrule-fdas-decision-bar-23andme-selling-their-potentially-life-saving-diagnostic-kits/96BRCYNB

Re:Petition on Whitihouse.gov is already up

[tibit]

I was wondering what the fuck were they thinking in the first place. In the U.S., anything that claims almost any diagnostic ability is subject to regulation. Even if said regulation is some grandfathering rule exempting the device from strong oversight - it's still regulated. Ultimately, those tests are used by people to make potentially life-altering decisions, and I fully welcome that FDA has finally caught up to them.

You won't know whether their services are useful, precisely because they were exempting themselves from regulation. There's absolutely no oversight, they may be telling you results from a random number generator for all we know. You're absolutely crazy to be using their services. I was listening to their ads on various NPR-related podcasts, and was seriously concerned about possible fallout from such services. They are, for all intents and purposes, a medical diagnostic lab. Their customers treat them like one, the regulators should too.

Re:Petition on Whitihouse.gov is already up

[Jazari]

Unless you can cite a single case of a doctor taking action based solely on a 23andMe test, then they are not a medical diagnostic lab. Of course this would be less of a problem if patients were allowed to order some tests on their own, and if those tests were low cost.

Re:Petition on Whitihouse.gov is already up

[tibit]

Unless you can cite a single case of a doctor taking action based solely on a 23andMe test, then they are not a medical diagnostic lab.

Thanks for admitting you have no clue. Whether a doctor uses it or not doesn't fucking matter. A freaking fever thermometer you buy at a grocery store is a regulated diagnostic device. Just as is, say, a pregnancy test. Condoms are medical devices too. And so on.

To simplify the rules for you: if it is marketed specifically as something that lets you make medical decisions, it is subject to regulation. And it fucking better be.

Re:Petition on Whitihouse.gov is already up

[Anonymous Coward]

23andMe uses the same devices as everybody else in the industry. And presumably the FDA can regulate those machines.

Ultimately what it comes down to is that the FDA doesn't even like the mass-market genetic test industry, period. The FDA is in effect restricting the industry to up-or-down genetic tests, plus accuracy and reliability stats. But SNP tests will never pass those sorts of individualized up-or-down criteria. They're pre-pre screening, where pre-screening would be targeted gene sequencing, and screening diagnosing actual disease manifestation.

In a country where tens of millions of idiots overdose on vitamins and minerals every single day, and we let them because of "freedom", it's patently ridiculous to restrict access to something like 23andMe.

Unless you've actually used the service and read their results--which are openly and transparently equivocal, and which nobody in their right mind would confuse with a diagnosis from a trained medical professional--then you should probably shut up.

Re:poisoning people a legitimate business

[Anonymous Coward]

tobacco.

Google does what Google wants?

[Anonymous Coward]

Seriously, they are not a doctor and are not beholden to medical industy standards. I can't understand why this hasn't been shutdown already.

Re:Entirely Reasonable - or is it?

[WillAffleckUW]

Now cue all the Slashbertarians ranting about how restricting unproven medical testing is an assault on freedom...

I own my DNA!

Actually, your parents do.

You're not supposed to even be able to enter into a legal contract before the age of 16.

Re:Upsetting the Apple Cart is it your DNA?

[WillAffleckUW]

Even better, I can find out if you have the DNA markers when I take the sample without your consent.

Re:Upsetting the Apple Cart - correlation

[WillAffleckUW]

Depends on how gathered. Are we doing random genetic sampling, family study where we know who has which markers and a higher confidence level, how large is our sample (p=512+), how are we ascertaining the diagnoses (survival method, impact), etc.

It's a whole can of worms.

Meanwhile some girl takes a blood sample with her friends at a sleepover, pops it in the mail, thinks she's going to die from breast cancer, and commits suicide.

This is why the FDA gets involved.

i used to like the idea of 23 and me

[Dr Max]

I was going to take the 23 and me test. I don't care about whether its 100% accurate, but fuck letting google have my genome. HELL NO. Email, phone records, credit card details, locoation, personal contacts, browsing history, sure BUT YOU CAN NOT HAVE MY DNA GOOGLE.

Technical question

[Anonymous Coward]

What are the procedures 23andme is supposed to use to calibrate and test their equipment?

Other than that, I think the FDA complaints are BS. Certainly looks to me like they do a good job of providing references and giving probabilities -- with the explicit understanding that you will and do see them change as more research becomes available.

Re:Technical question

[TechyImmigrant]

>What are the procedures 23andme is supposed to use to calibrate and test their equipment?

Reference DNA sequences for humans are available.

To calibrate your sequencer you just need to observe that the delta rate with respect to a reference sequence is within expected limits for differences between any two humans and there isn't a systematic bias in the error rate.

When you buy a sequencer, calibration is part of the deal, like any expensive bit of test equipment.

Examples of their reports

[a31415]

I'm an early adopter. I have used 23andMe's services and have found them enlightening, useful and thus far, accurate, in-line with other established tests that I have taken.
For those who haven't used their services before, I would recommend taking a look at the language used in their reports before being overly critical: https://www.23andme.com/health/Warfarin-Coumadin-Sensitivity/ , https://www.23andme.com/health/Breast-Cancer/
I am a reasonably rational person. I stepped into this as an early adopter, knowing that there is an unknown degree of Type I and Type II error. It has provided me with interesting results, and I have found the language used is quite clear that they are not providing a specific diagnosis or recommendation, beyond "think about" or "consider further testing on".
I am not saying that I assume most people would approach this information in the same way. I am not saying that 23andMe should be absolved of their responsibilities to due diligence and complying to regulation.
I am just saying that they do provide a very useful service that I believe will transform how we deal with prevention and wellness. As an early adopter, I hope that they (23andMe and the FDA) are able to find a balance between making this service widely available (in doing so, vastly increasing sample sizes and enabling new findings), at the same time as ensuring that people's responses to and expectations of the data provided (based on marketing claims) are sound.

It's not a medical test

[Anonymous Coward]

I have 23andMe results. It just shows the genetic propensity for a disease. There are zero results that I've seen that indicate that I do (or do not) have any specific disease. For example...having a 2-times likelihood of developingType II Diabetes I know in no way indicates whether I currently HAVE diabetes. I don't even know what the FDA is talking about.

I'm a customer but I get the concern.

[EvilSS]

So I just logged in and noticed a new drug trait posted for my profile:

Proton Pump Inhibitor (PPI) Metabolism: Ultrarapid or rapid metabolizer. Someone with this genotype typically metabolizes PPIs at a rapid rate. Although the standard dose is usually effective, some people with this genotype may benefit from a different dose, especially if being treated for an H. pylori infection. If you are currently taking a PPI, it is important to talk to your doctor if your symptoms do not improve.

Now, I don't take PPI's but I know enough to not mess with my dosage (if I did) base solely on this info. However I don't trust most others to have the same response, especially since PPIs are now over the counter drugs. The correct response to this info would be to discuss it with your doctor but how many people would see this and just up their dose themselves, based on one test that may indicate that you may metabolize the drug faster than the average population?

Re:Upsetting the Apple Cart - correlation

[jd]

Anyone who thinks a 0.1% increased risk in a single SNP when dozens are involved, all of which have to show compatible mutations, means they will surely die of, well, anything is too stupid to live. Frankly, if that's your best objection, I think the test should be provided free across America and Britain. Get rid of at least some of the fools, rather than have them be a burden on society by running banks or whatever.

Good riddance to them. Hope the jumped-up twits die slowly.

(23&Me cannot tell you if you have a disease, or if you will ever get it, it can only give you very rudimentary statistical information on correlations. Anyone confused about correlations and causation should be provided with a HOWTO on suicide and appropriate implements.)

As for the studies, published peer-reviewed studies on genetics do vary in quality. That is why nobody considers them. Only metastudies matter. I would argue a metastudy with a sample size of 2 is low, but even getting a repeat study published is a major feat and genetics hasn't been cheap enough for long enough for the numbers of studies to grow. I like that 23&Me makes an effort to run their own study, giving them a metastudy size of 3, still low but getting into respectable territory.

But, again, what does it matter? Let us say that there are 10 SNPs required, and one SNP has a 0.1% increased risk but no others do, should you worry? One in a thousand chance above normal for anything is so close to normal that you would have to be one of the deserving suicides to think it worth concerning yourself with.

Re:Upsetting the Apple Cart - correlation

[WillAffleckUW]

Anyone who thinks a 0.1% increased risk in a single SNP when dozens are involved, all of which have to show compatible mutations, means they will surely die of, well, anything is too stupid to live. Frankly, if that's your best objection, I think the test should be provided free across America and Britain. Get rid of at least some of the fools, rather than have them be a burden on society by running banks or whatever.

Good riddance to them. Hope the jumped-up twits die slowly.

>

You're assuming that people think logically when presented with results that may indicate severe impacts.

Medical studies have shown that people literally go into shock and don't really retain what it means.

This is yet another reason why you can't just do a one-of DNA test and "trust the system" when the system does not have genetic counseling or interpretation as part of it. People only hear or read part of the message, freak out, and than do drastic things.

Cue initiated

[Anonymous Coward]

23&Me is exactly the kind of company Big Pharma (who are in bed with the Federal government - always have been)target. They're a company that's all about prevention of diseases (through knowledge) rather than taking medication. She's a veritable thorn in their side, and has been for years.

Now cue all the Slashbertarians ranting about how restricting unproven medical testing is an assault on freedom...

More like your ignorant rant about an assault on knowledge...
She talks about her company here, for those who care.

$99 vs. $8000

[TechyImmigrant]

An NIH study shows the cost per genome for sequencing genomes with reference sets is about $8000 in 2013.

So what are they doing for $99?

Re:$99 vs. $8000

[TechyImmigrant]

Missing link here.

http://www.genome.gov/images/content/cost_per_genome_apr.jpg

Re:$99 vs. $8000

[Anonymous Coward]

An NIH study shows the cost per genome for sequencing genomes with reference sets is about $8000 in 2013.

Illumina has those "Understand Your Genome" events where they sequence your genome for $5,000. But that may be somewhat below actual cost. Exome sequencing (just the expressed parts of your genome) is much more common these days - and the going rate is around $1,000 from a variety of different facilities.

So what are they doing for $99?

They do genotyping: for example, they'll look at whether you have a "G" or an "A" at position 435463 on chromosome 5. They test just under a million positions throughout your genome. You can also download your "raw" data if you want. Here's an example, with some changes to protect anonymity:

# rsid chromosome position genotype
rs4477212 1 82154 AC
rs3094315 1 752566 AA
rs6681049 1 800007 --
rs4970383 1 838555 AC
rs4475691 1 846808 GG

Re:Upsetting the Apple Cart - correlation

[jd]

Like I said, those people should travel to the top of the nearest tall building and jump. Preferably yesterday. I have no pity for such people, no compassion, no time. The world would be far better off if such people offed themselves. The world needs thinkers, it does not need reactors. Well, other than fusion reactors. We could do with a lot of those.

Bitcoins

[Anonymous Coward]

Its mining bitcoins

Man

[ThatsNotPudding]

Sending back everyone's spit is gonna suuuck.

I'm offering another free diagnostic test...

[Anonymous Coward]

If you work for the FDA or any other government branch, directly or voted in, then you are 100% likely to be a fucking moron who should be sterilized, neutered or spayed immediately.

That's guaranteed to be 100% accurate, 100% of the time.

Patients should doublecheck this information

[ricketson]

Given the nature of this data, patients should doublecheck it before including it in any medical or lifestyle decision. This is common sense and I would recommend it regardless of the FDA's actions here. However, as long as patients CAN doublecheck their genetic test results, they can evaluate the reliability of service providers like 23andMe (in contrast to the above claims that Joe-drunk-off-my-ass is necessarily a dupe).

By "the nature of this data", I mean a few things:
1) It does not change over our life, so you should be able to get reproducible results even if you repeat the test 10 years from now (assuming that you are not a chimera).
2) It is extremely easy for DNA samples to get contaminated. I've seen it ruin experiments, even when the purification is being done by experts. I really doubt that a home test kit can reliable keep the sample clean.

So, if you are having genetic testing, have it done twice and check that the results match. Use an independently collected sample. As long as you are confirming the integrity of the sample, confirm the integrity of the testing company too by sending the sample to another company (yes, I know there currently is not another commercial company doing this, but there are always medical labs; most likely, the "at home" testing should be the validation of the clinical testing).

With regards to the interpretation, get a second opinion from an expert.

psudo-religous-twist

[JamieIanMacgregor]

just remarket it as a psudo religious service like Scientology does...easy, no regulations for religious services.

This is all about the money!

[Anonymous Coward]

Because 23andMe is an affordable way to do testing that would otherwise cost you (or your insurance company) thousands of dollars the FDA is probably being persuaded to suddenly start trouble. And may I point out, very simple testing (provided you have the equipment). Your DNA has a lot of great information and 23andMe is extremely particular about the way they word things in offering any sort of medical advice. Certainly it would become FDA approved but it will bog this company down with unnecessary fees and red tape from Big Brother if it wants to stay alive. (Certainly no problem for "Google's wife", but on principle this is seriously messed up!) This company is doing a great thing for people everywhere! If not telling people to get medical treatment soon for a degenerative disease that has gone and will go undetected for another 5 years thus saving that person's life, at least promoting awareness that the genomic era is approaching quickly!