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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'."

59 of 371 comments (clear)

  1. Re:Change your place of business by i+kan+reed · · Score: 2, Informative

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

  2. Re:Democracy? by Anonymous Coward · · Score: 3, Insightful

    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

  3. Entirely Reasonable by PvtVoid · · Score: 4, Insightful

    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...

    1. Re:Entirely Reasonable by 0123456 · · Score: 3, Insightful

      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.

    2. Re:Entirely Reasonable by TheSync · · Score: 2

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

      I own my DNA!

    3. Re:Entirely Reasonable by Anonymous Coward · · Score: 3, Interesting

      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.

    4. Re:Entirely Reasonable by Anonymous Coward · · Score: 5, Interesting

      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?

    5. Re:Entirely Reasonable by mindwhip · · Score: 2

      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.

      --
      [The Universe] has gone offline.
    6. Re:Entirely Reasonable by timeOday · · Score: 4, Insightful

      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.

    7. Re:Entirely Reasonable by ColdWetDog · · Score: 2

      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....

      --
      Faster! Faster! Faster would be better!
  4. Re:Democracy? by Anonymous Coward · · Score: 5, Informative

    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."

  5. Re:Democracy? by alexander_686 · · Score: 3, Insightful

    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.

  6. Re:Democracy? by tgd · · Score: 4, Insightful

    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.

  7. Upsetting the Apple Cart by ponraul · · Score: 5, Insightful

    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.

    1. Re:Upsetting the Apple Cart by Jeng · · Score: 4, Insightful

      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.

      --
      Don't know something? Look it up. Still don't know? Then ask.
    2. Re:Upsetting the Apple Cart by Quince+alPillan · · Score: 3, Insightful

      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.

  8. Re:Democracy? by ShaunC · · Score: 3, Interesting

    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.

    --
    Thanks to the War on Drugs, it's easier to buy meth than it is to buy cold medicine!
  9. Re:Democracy? by Okian+Warrior · · Score: 2

    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.

  10. Re:Democracy? by Anonymous Coward · · Score: 2, Funny

    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.

  11. Unlisted subtext by phayes · · Score: 2, Insightful

    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.

    --
    Democracy is a sheep and two wolves deciding what to have for lunch. Freedom is a well armed sheep contesting the issue
  12. FDA is doing you a favor by EmagGeek · · Score: 3, Informative

    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.

  13. Re:Change your place of business by TheCarp · · Score: 3, Insightful

    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?

    --
    "I opened my eyes, and everything went dark again"
  14. Fuck these government pricks by Anonymous Coward · · Score: 2, Insightful

    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)

    1. Re:Fuck these government pricks by Fwipp · · Score: 4, Insightful

      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.

    2. Re:Fuck these government pricks by scheme · · Score: 2

      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.

      --
      "When you sit with a nice girl for two hours, it seems like two minutes. When you sit on a hot stove for two minutes, it
    3. Re:Fuck these government pricks by BradMajors · · Score: 2

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

    4. Re:Fuck these government pricks by ausekilis · · Score: 4, Insightful

      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.

    5. Re:Fuck these government pricks by TsuruchiBrian · · Score: 4, Insightful

      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.

    6. Re:Fuck these government pricks by FussionMan · · Score: 2

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

    7. Re:Fuck these government pricks by The+Snowman · · Score: 2

      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.

      --
      24 beers in a case, 24 hours in a day. Coincidence? I think not!
    8. Re:Fuck these government pricks by Curunir_wolf · · Score: 2

      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.

      --
      "Somebody has to do something. It's just incredibly pathetic it has to be us."
      --- Jerry Garcia
    9. Re:Fuck these government pricks by LordNacho · · Score: 2

      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.

  15. Re:Democracy? by Minwee · · Score: 2

    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.

  16. Medical claims by Animats · · Score: 4, Informative

    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.

  17. Re:Democracy? by nbauman · · Score: 2

    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.

  18. Re:Democracy? by hairyfeet · · Score: 5, Informative

    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.

    --
    ACs don't waste your time replying, your posts are never seen by me.
  19. Re:Democracy? by Bill_the_Engineer · · Score: 4, Insightful

    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.

    --
    These comments are my own and do not necessarily reflect the views or opinions of my employer or colleagues...
  20. Re:Democracy? by nbauman · · Score: 4, Interesting

    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.

  21. Re:Democracy? by JWW · · Score: 3, Insightful

    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!!

  22. Open source genome sequencing by WaffleMonster · · Score: 4, Interesting

    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.

  23. Re:Democracy? by nbauman · · Score: 4, Insightful

    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.

  24. Re:Democracy? by nbauman · · Score: 2

    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.

  25. The real problem is not the tests but the users by WillAffleckUW · · Score: 2

    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.

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  26. Fork and Exec by evought · · Score: 2

    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.

  27. Sounds like 23andMe gave the FDA the finger by AdamHaun · · Score: 5, Informative

    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

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  28. bullshit by stenvar · · Score: 2

    "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.

  29. Re:Democracy? by Anonymous Coward · · Score: 2, Insightful

    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.

  30. Re:Democracy? by Anonymous Coward · · Score: 5, Insightful

    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.

  31. Re:Democracy? by bws111 · · Score: 2

    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.

  32. Re:Democracy? by bws111 · · Score: 2

    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.

  33. Re:Democracy? by heteromonomer · · Score: 2

    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.

  34. Re:Democracy? by Derec01 · · Score: 2

    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.

  35. Re:Democracy? by WillAffleckUW · · Score: 2

    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.

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  36. Re:Democracy? by Jazari · · Score: 2

    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").

  37. Re:Democracy? by nbauman · · Score: 2

    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.

  38. Re:The FDA is part of the executive branch by benzapp · · Score: 2

    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.

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  39. Re:Democracy? by Albanach · · Score: 2

    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.

  40. Re:Democracy? by Hatta · · Score: 2

    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.

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  41. Re:Democracy? by EvilSS · · Score: 2

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

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