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After FDA Objections, 23andMe Won't Offer Health Information 146

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

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

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

    • Re:smart (Score:4, Informative)

      by Albanach (527650) on Friday December 06, 2013 @09:24PM (#45623857) Homepage

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

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

        • by Anonymous Coward

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

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

          Not a very good way to m

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

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

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

            • by citizenr (871508)

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

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

          • by pegr (46683)

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

        • by ceoyoyo (59147)

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

      • Re:smart (Score:5, Informative)

        by pepty (1976012) on Friday December 06, 2013 @09:36PM (#45623919)

        Those are the results of individual FDA approved genetic tests.

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

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

        • by Anonymous Coward

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

          • by pepty (1976012)
            Actually if the research involves human subjects and is intended to support a product that would require FDA approval an IRB is required even if the funding is all private. The FDA has rules about how IRBs must be formed, but I dont' think they certify them. 23andMe and the companies it sells data/research services to might be exempt though since they could claim the data wasn't collected for any particular study: the data just happened to be available after customers plonked down their $99.
        • by swillden (191260)

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

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

          • by pepty (1976012)

            but if you just want to tell people stuff

            Telling people stuff is fine, but once you charge for the service you open yourself up to regulation. For years I've thought that the direct-to-consumer genetic testing industry would end up split into companies that charged to sequence your DNA on the one hand and free software that interpreted the data on the other. Originally I thought this would be the way to avoid infringing the thousands of patents on DNA tests a paid service would run afoul of, but now that DNA patents have been sharply limited I thi

        • by aurizon (122550)

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

      • by Belial6 (794905)
        I don't know if I would go that far. U.C. Davis does genetic testing for pregnant women, and I got the joy of talking to one when my wife was pregnant. The 'Genetic Counselor' had no idea what the data meant. Every question I asked was met with a blank stare and the repeating of the line from the script she was given. It was awfully similar to calling an Indian tech support line.
        • You should ask for a refund.... Good genetic counselors are hard to find. It's not a very sexy field and it's hard work explaining complicated subjects - including the most dreaded subject of all - statistics - to lay people of varying degrees of sophistication.

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

          • by pepty (1976012)
            Ask for a refund - but first give them a quick quiz on conditional probability.
    • by russotto (537200)

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

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

      Note that: in isolation. That's what 23and Me was peddling. Hospitals and genetic counselors and doctors are doing something else. They have the whole medical history. They have, or should have, enough training to understand population genetics, statistics, and where somebody's DNA data fits in to all that. (Although a comment
      • Re: (Score:3, Insightful)

        by Anonymous Coward

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

        Everybo

  • by PapayaSF (721268) on Friday December 06, 2013 @09:13PM (#45623795) Journal

    From snpedia.com [snpedia.com]:

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

    • by jd (1658)

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

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

      In fact, if 23&Me just moved their health system to an external website w

  • good riddance (Score:5, Interesting)

    by ljw1004 (764174) on Friday December 06, 2013 @09:15PM (#45623801)

    Good.

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

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

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

      • Re:good riddance (Score:5, Insightful)

        by PCM2 (4486) on Friday December 06, 2013 @09:53PM (#45623987) Homepage

        Perhaps this is why the FDA put the kabosh on it

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

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

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

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

        • by E++99 (880734)

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

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

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

          • Re:good riddance (Score:4, Insightful)

            by PCM2 (4486) on Friday December 06, 2013 @10:22PM (#45624097) Homepage

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

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

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

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

            • Re:good riddance (Score:4, Informative)

              by E++99 (880734) on Friday December 06, 2013 @11:51PM (#45624473) Homepage

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

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

              • How is that different from your doctor saying "You most likely have Leukemia." All diagnosis and advice is based on a probability scale. If you have an 88% chance of developing cancer that's almost as good as saying you have cancer.

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

              So does the local palm-reader.

              The point appears to be that you can provide medical advice if you are completely unscientific about it, but as soon as you try to offer even a little bit (even of experimental or tenuous) fact, then you have to go whole hog.

              • by PCM2 (4486)

                So does the local palm-reader.

                The point appears to be that you can provide medical advice if you are completely unscientific about it, but as soon as you try to offer even a little bit (even of experimental or tenuous) fact, then you have to go whole hog.

                Seriously? So in your book, a doctor who has spent years at medical school and practiced in the field for years more is a "palm reader," but whichever unlicensed, unregulated nobody who reads you your 23andMe test results is a "scientist"? I guess in the unmitigated bullshit stakes, that makes you a dean of medicine.

        • by ceoyoyo (59147)

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

        • Re:good riddance (Score:5, Insightful)

          by tlambert (566799) on Saturday December 07, 2013 @12:30AM (#45624645)

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

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

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

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

          • The FDA made them stop because doctors dislike being cut out of the loop, and insurance companies like being cut out of the loop even less than the doctors, and they would prefer to have you get the data through a disclosure mechanism which gives your insurance company better actuarial information.

            This sounds like one of those ads at the bottom of blogs "New service that doctors hate!!1". Seriously though, do you have any evidence for these claims?

            The FDA asked a 23andMe a simple question - show us the evi

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

          You say that "false positives" are catastrophic

        • by paulpach (798828)

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

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

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

          So, by the same logic, let's shut down:

          • wikipedia.org - plenty of medical information there
          • RXList.com
          • WebMD.com
          • WrongDiagnosis.com
          • Healthatoz.com
          • DrKoop.com
          • Merck Manual at www.merck.com/pubs/mmanual/
          • ...and about 1000 more

          Oh noes! Medical information out in the open! How dare those peasants make decisions for themselves! We must protect them from themselves! ...etc.

          Yeah, let's deny information (however flawed it may be, it's better than nothing) to people with a capacity for independent thought, for the s

      • by sumdumass (711423)

        The FDA endorses false and misleading information all the time. For instance, look at their line on smoking in which they claim or support others making claims about the number of people with lung cancer who smoked showing you have a high risk of getting it if you do. They almost say it is a certainty that if you smoke or even be around people who smoke, you will get cancer and die. But the facts are that fewer then 10% of life long smokers will get lung cancer and to that, cancer deaths from smoking only m

    • by Anonymous Coward

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

    • by jd (1658)

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

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

      In the case of Alzheimer's, where external chemicals (aluminium being one) are involved, the indicators mean nothing until you exceed toxic levels of the chemicals. There is nothing to trigger. 100% probabili

      • by ljw1004 (764174)

        When I was looked I was unable to find the SNPs. This might be because I did it as soon as 23andMe reduced prices to $200 for the first time, before they'd cleaned up their website.

        Turning "probability of alzheimers disease" into a single percentage is a meaningless project. Alzheimers has an age likelihood - so at age 50, some portion of the population will have the pre-clinical precursor, some portion will have mild symptoms, some moderate, some severe. By age 60, and 70, and 80 and 90, the proportions ch

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

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

    • Re:good riddance (Score:5, Insightful)

      by Mashdar (876825) on Saturday December 07, 2013 @01:01AM (#45624775)

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

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

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

      • Sen. Orrin Hatch (R-UT) would like to speak with you about how your health can enjoy the benefits of herbal supplements!

      • Don't blame the FDA...
        Due to the structure of the 1938 Food Drug and Cosmetic act which established the FDA, it is not permitted to regulate homeopathic drugs in the same way as "normal" drugs [fda.gov]. This is a registry of homeopathic drugs and if a drug is on there but is not a "normal" drug, the FDA can only regulate that it is manufactured safely, similar to food, not whether it is effective at treating disease. That is why you see this kind of labeling on such products:

        A product's compliance with requirements of the HPUS, USP, or NF does not establish that it has been shown by appropriate means to be safe, effective, and not misbranded for its intended use.

        All the FDA can do is go after compani

      • Absolutely. It's "the tyranny of the moron over the intellectual" - because a few idiots might misinterpret/misuse/get hurt by something, let's BAN it for EVERYONE.
    • So let me get this straight. 23andme provided you with DNA sequencing and even provided a nice set of data (along with links to the original studies), and you're...mad that they didn't spoon feed it to you and tell you exactly what to do with it?

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

    • by heuermh (948407)

      I wrote a java client for the 23andMe APIs available under LGPL version 3 or later here

      https://github.com/heuermh/personal-genome-client [github.com]

      I am using it in several downstream variation analyses, please contact me if interested.

      For the record, I am not affiliated with 23andMe in any way, I'm just an free & open source bioinformatics developer.

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

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

  • by Sean Dunn (2861499) on Friday December 06, 2013 @09:49PM (#45623969)
    As long as people understand that the results are only based on research/papers, 23andme is really awesome. It's best to discuss things with your doctor, and get things double checked, rather than to treat 23andme as some alternate to proper healthcare and checkups.

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

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

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

    • by ceoyoyo (59147)

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

      • So what, fuck them.
        • by ceoyoyo (59147)

          That is one approach. You might change your mind when some unregulated company sells you bad heart medication though. Or contaminated ibuprofen.

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

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

  • by xtal (49134) on Friday December 06, 2013 @10:26PM (#45624105) Homepage

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

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

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

    May we all live in interesting times.

  • by sat1308 (784251) on Friday December 06, 2013 @10:52PM (#45624223)
    One company, for example, offers 166 tests in one of its testing packages where approximately 60% of the tests (99) are categorized as âpreliminary researchâ(TM) because the genetic-association data have not yet been replicated (www.23andme.com/health/all/). These tests are given 1, 2, or 3 stars based on the size of the study that supports the genetic association for which they test. Information for each of these tests cites references for the original ïnding of the genetic association, including the journal where it was published and the study size. It also provides the number of attempted replications and the number of contrary studies that have been published. Although transparent, examination of the scientiïc evidence provided for many of the genetic associations in this category raises the question of whether these tests should even be included in a genetic-testing package. Two of the ïve genetic tests with 1-star status (those for âavoidance of errorâ(TM) and âobsessive compulsive disorderâ(TM)) are based on single studies with fewer than 100 participants (https://www.23andme.com/you/health/). In both cases the variants map to the D2 dopamine receptor, a gene that has repeatedly been associated with human behavioral traits and attracted newspaper headlines, only to have the associations refuted in later studies [8]. Eight of the 37 (22%) available 2-star-rated genetic associations (originating from a single study with less than 750 participants) have a âcontrary studyâ(TM) indicated. Two different 3-star tests, one for Lou Gehrigâ(TM)s Disease (ALS) and another for obesity, utilize variants that have been positively associated with disease in one or two studies, respectively. However, both these variants have failed replication in four additional studies (https://www.23andme.com/you/health/). Although, the company boasts of its 'systematic vetting processâ(TM) used to determine which research ïndings to include in its genetic-testing package, a number of highly questionable tests continue to be offered to consumers.

    http://www.ncbi.nlm.nih.gov/pubmed/20828856 [nih.gov]
    • Whether you have a variant dopamine receptor is certainly a reasonable thing to include in a genetic testing package like 23andMe: even if current studies don't have clear results about what that means, there is a good chance that there will be meaningful associations in the future. If 23andMe only included those tests for which absolutely clearcut associations had been worked out, people would have to get retested constantly.

      The company did what it should have done: it picked a large number of important ma

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

        Let me recast this just a bit to illustrate the problem:

        Fortunately, in the long term, 3D printing will allow people to create their own CT scanners, and there will be a huge number of free tools and websites for searching for tumors, heart defects, and bone density.

        Are you at all worried about what people will do with their homemade CT scanners?
        Perhaps doctors know a little bit about reacting to that kind of data (and the uncertainties in it) and making good decisions about it?

        • by stenvar (2789879)

          Are you at all worried about what people will do with their homemade CT scanners?

          Are you being serious? No, of course I'm not worried, I think it would be great. How could you possibly think it wouldn't be great?

          What's next? Are you going to try to pass laws against skin, testicle, and breast self-exams because people might be confused by the lumps and spots they might discover?

          Perhaps doctors know a little bit about reacting to that kind of data (and the uncertainties in it) and making good decisions about

          • No, of course I'm not worried, I think it would be great....

            I am truly stunned by this. A self-interpreted home-made CT scan is an unalloyed good? Notwithstanding the radiation to get there, without serious testing, you have no idea how accurate the thing is (back to the FDA's repeated requests to 23andMe).

            Allowing the heroic assumption that the Garage-scan-o-matic things actually give accurate results, are you also saying you think the majority of people have the education and knowledge to make heads or t

            • by stenvar (2789879)

              I am truly stunned by this. A self-interpreted home-made CT scan is an unalloyed good?

              The "good" is that the diagnostic equipment becomes so cheap that people can make it themselves. They can then decide for themselves whether to use it for good or for bad. People are smarter than you give them credit for: far more people will use it responsibly and benefit from it than people who will misuse it and harm themselves. The only people who would really suffer would be doctors and corporations, who see a lucrati

            • by stenvar (2789879)

              That's not what I propose nor what the FDA is doing. If someone tries to sell an automated system to tell people what those lumps and spots mean (particularly if they use the term "risk") you'd better believe I would demand enforcement of the existing laws that say that the seller must prove that their system works in order to sell it.

              The problem is that you and the FDA define "working" as "high precision and recall", instead of simply a truthful disclosure of what the test result means. 23andMe is saying "

    • So they're new, unproven, and questionable. The alternative is not knowing at all. Given the choice of "incomplete data" vs "NO data", I'll take the 1st, thank you very much.
  • "It would be great to see a secondary market in this kind of analysis emerge"

    Health/Life insurance Co's need to increase profit margins, employers figure out whom to fire first, police departments preventative arrests, - Minority Report-Style, paradise for extortionists getting their hand on those data worth a fortune.
  • The FDA can't guarantee it'll get dangerous foods off the shelves within even a few years. It couldn't halt BP from ditching millions of gallons of neurotoxic, carcinogenic dispersants into the gulf after Deepwater Horizon. But it's sure as sin make sure your life isn't ruined by an unclear genetics report--as if there were any way people could imperil theirselves with the information.
    • by fluffy99 (870997)

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

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

  • Thord party analysis (Score:5, Informative)

    by n6kuy (172098) on Friday December 06, 2013 @11:45PM (#45624449)

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

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

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

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

  • I had taken a 23andme test out of curiosity about ancestry and a type of cancer that ran in the family that is known to have a very strong genetic link. Before taking it though I read reviews/commentary from all over the web and I noticed one glaringly obvious reality. People don’t get statistics very well, and even those that do have a blind spot when it comes to odds that affect them. (lottery methods anyone?)

    All over you see negative comments saying that the test is garbage because it said

  • There are a lot of posts here already saying, "it's 23&me.com, of course you should get a second opinion before: {getting a double mastectomy, getting your balls cut off, ...}". But, that is always the case in the face of a life changing diagnosis. If your local doctor diagnosis you with anything you consider life changing, for me it was an allergy to a common food, you should always get a second opinion. And if it is something major like major surgery, then consider getting a 3rd opinion too.

    I trust

    • Keywords: "learned", "listen", "consider", "reading myself". You're not a moron, so you think about things before making a decision. But, the FDA is not basing their decision on you - they're basing it on the possibility of some idiot doing something rash because they've heard they have a possibility of getting some disease. And, because we live in the age of "tyranny of the moron over the intellectual", their decision is "protect the moron, deny the intellectual".
  • The FDA and the CDC.

    Unless I want a good, bitter, laugh.
  • ...seems to be the ongoing policy of US Government in general, and of the FDA in particular.

    Just as they've held up the approval of 15-minute DIY HIV test kits (Orasure et al), now they're blocking access to this information. Same principle: "Because we're worried that a few morons can't understand the data, we're going to screw EVERYONE indiscriminately".

    Same result: 100,000's of potentially preventable HIV infections occurred in the years the quicktests were delayed, now 100,000's of people will be

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