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FDA Was Right to Block 23andMe


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A few techno-libertarians are up in arms over the FDA’s letter warning the genetics company 23andMe to stop selling its personalized genome services kit. But a quick search of the Food and Drug Administration’s admittedly user-unfriendly website shows federal regulators have been targeting various low-cost genetic testing ventures to provide the necessary analysis that goes along with a proper genetic screening for at least the past three years.

At present, getting raw data about your personal genome is worse than useless, as Nancy Shute pointed out in a Scientific American article that I edited back in 2012. “[E]ach individual’s genetic readout must be compared with lots and lots of other people’s readouts for doctors to understand which genetic patterns are important indicators of disease and which can be safely ignored,” she wrote.

Shute further quoted Euan A. Ashley, an assistant professor of cardiology at the Stanford University School of Medicine as saying, ‘ “Generating the sequence now is fast and cheap. . . But the analysis? Wow. That’s not going to be fast, and that’s not going to be cheap.’ ”

Using home gene kits to imagine where your ancestors might hail from is one thing. That’s basically the 21st century equivalent of looking up your horoscope–entertaining but not really a matter of life and death. Cheap sequence data from 23andMe and other gene testing companies has much greater potential to harm without the proper interpretation of the results, which is still quite difficult and expensive in most cases.

About the Author: Christine Gorman is the editor in charge of health and medicine features for SCIENTIFIC AMERICAN. Follow on Twitter @cgorman.

The views expressed are those of the author and are not necessarily those of Scientific American.





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  1. 1. Christine Gorman 2:17 pm 11/25/2013

    Some of the comments I’ve seen on Twitter and Facebook include:
    “I hate the busybody FDA” and “we have no right to learn about our own DNA?”

    Link to this
  2. 2. Arbeiter 2:32 pm 11/25/2013

    The only important question is “did somebody lease FDA affections to target competitors’ successes?” The most wondrous and remarkably safe antifungal is terbinafine (Lamisil), first synthesized in Australia. It tore through the Old World ending vaginal candidiasis, athlete’s foot, jock itch, ringworm, toenail fungus, and saving lives of immune-compromised patients. The FDA compassionately excluded terbinafine from America for a decade – remarkably coincident with, ah, let’s say vigorous marketing by manufacturers of substantially inferior antifungals.

    02 July 2007 – FDA approval granted for generic Lamisil. Remaining patent or exclusivity for Lamisil expired on 30 June 2007. Remarkable timing.

    Link to this
  3. 3. terribletony 3:01 pm 11/25/2013

    I was never interested in the genetic screening part of 23andme (As suggested here, I suspected it was worthless) but the genealogical background stuff was intriguing.

    How accurate was that part? I know it’s just trivia, but that can still be fun.

    Link to this
  4. 4. arralite 3:14 pm 11/25/2013

    The more DNA 23andme collect the more the hardcore scientists have in data. The idea of DNA history is good enough for me for theprice. FDA leave them alone.

    Link to this
  5. 5. rossm 4:15 pm 11/25/2013

    Has the National Geographic’s Genographic Project received a similar approach from the FDA?

    Link to this
  6. 6. Christine Gorman 4:26 pm 11/25/2013

    rossm: Genographic project is collecting data to understand where various human populations come from; how they’ve migrated over the years. Not relevant to FDA. https://genographic.nationalgeographic.com

    On the other hand, 23andMe says directly on their website that they will help you “Understand your genetic health risks” — that’s FDA territory.

    https://www.23andme.com

    Link to this
  7. 7. keithl 4:27 pm 11/25/2013

    A genome is not a diagnosis, a diagnosis is not a cure, a cure is not the same as happiness (really!). But it isn’t all about the cures we have in 2013. Many 23andMe customers learn fascinating things, far more than they can learn from an extra $100 spent on college, and some will make discoveries that change everything. This is ultimately about knowledge; why is the FDA promoting ignorance?

    While most 23andMe risk predictions are weak, some are strong, and are strong motivators to change behavior, prepare for problems down the road, participate in and even fund research.

    Sergey Brin, ex-husband of 23andMe founder Anne Wojcicki, learned of his high risk of Parkinson’s Disease decades hence, and has donated a lot of money to P.D. research.

    23andMe reveals APOE4 status, a strong predictor of Alzheimer’s, and studies of possible cures are recruiting from the pool of identified APOE4/4s. Finding those 4/4s using family history and $1000 tests might cost 50 times as much. Indeed, some families with APOE4 do not show frequent AD, because cerebral amyloid angiopathy (another consequence of APOE4) can cause fatal cerebral hemmorhage first.

    We discover nothing new if we don’t look for knowledge in new places. New knowledge threatens old knowledge, and the old bureaucrats who depend on the status quo, and on the big pharma consulting positions they will get when they retire from the FDA. Knowledge is power, patented pills are monopolistic dependency. Which outcome does this decision support?

    Link to this
  8. 8. diamost 5:07 pm 11/25/2013

    It would be interesting to know what qualifications Ms. Gorman has that would provide any credibility for her opinion puff piece.

    23andme has as its long term plan the accumulation and analysis of enormous amounts of data in order to have (and profit from) statistical models that link particular genes and combinations of genes and the mutations in those genes to things that beset humankind.

    In the meantime, they reveal, somewhat sparingly and probably even sometimes incorrectly, the conections they have heard about between particular genes and particular traits, drug susceptibilities,and likelihoods of genetic connections to diseases and even longevity.

    There are people who will, we can count on it, misunderstand the plainest of data. That being the case, ought we to simply ban the promulgation of data?

    This battle is about money. Ms. Gorman pretends it’s about something else — protecting we, the unwashed, who surely can’t judge whether the sky is falling or not. This battle is about United Healthcare Insurance Company and their influence with the FDA. This battle is identical, now escalated into a federal case, as that between the Louisiana Casket Companies and the Monks who make and sell caskets.

    The battle is not, as Ms. Gorman would have us believe, on the one hand, between those good people from the Government who are trying to protect your interests and mine, and the “techno-libertarians” (i.e. crackpots)on the other, who likely even believe that adults should be allowed to buy 32 ounce cups of soda, eat Oreo cookies and smoke cigarettes.

    Link to this
  9. 9. Christine Gorman 5:34 pm 11/25/2013

    diamost: Re my credentials, I have given you my full and real name, so if you were interested, you could find out that I studied biology, including genetics and population biology, at Rice University.

    I also happen to believe the Supreme Court was correct in allowing the Trappist Monks to sell their caskets (I also believe in direct cremation), but do not see how that bears on this case.

    I think most Americans have some libertarian in them somewhere. But perhaps I do not fit your definition.

    I do not know you, so I cannot draw any conclusions about your character. But seriously. You see techno-libertarian as a slur? If I had meant crack-pots, I would have said crack-pots. Could that be a tiny bitty chip on your shoulder?

    Link to this
  10. 10. Christine Gorman 6:03 pm 11/25/2013

    keithl: I take your point about apoe4–although am quick to note that the majority of people with apoe4 (perhaps 60%) do not develop Alzheimer’s and they didn’t all die of fatal cerebral hemorrhages. And perhaps if 23andMe had stuck with apoe4 and similar, they might have been okay.

    I get more concerned when I read about the sensitivity tests to warfarin, clopidogrel, etc. I don’t think it’s too much to ask that those particular tests work as claimed or advertised.

    Link to this
  11. 11. diamost 6:53 pm 11/25/2013

    Ms Gorman, the parallel between the Monks’ case and that of 23andme is that Governments tend to demand that some things be done only by licensed and credentialed professionals or organizations. In some instances, those services can be less expensively but as competently provided by skilled and trained but unlicensed or uncredentialed individuals. The trick is to make those distinctions rationally.

    In Louisiana, the Benedictines won in the 5th circuit and the Supremes just last month declined to consider the appeal. The Judge who wrote the opinion for the 5th circuit said “Mere economic protection of a particular industry” is not a “legitimate governmental purpose.””

    And that is what the FDA is attempting to do in the 23andme case, mere economic protection.

    I’m a 23andme customer. They’ve told me my risk from some blood thinners is elevated. They’ve told me that I’m at risk of muscle aches from certain statins. (as if I didn’t know that from first hand experience)

    Now if they’d told me that I had BRCA mutations that I could have passed to my children or whose consequences I could experience myself, I’d be concerned. I’d follow up. And telling me I don’t have those mutations could be a “false negative”, setting my mind at ease when it should not be.

    But I promise you, if I sent my DNA to a huge number of labs, I’d get a variety of results and the results from licensed and credentialed labs would be of neither more nor less accuracy than those from garage based companies (a very big garage) like 23andme.

    I consider myself a reasonably smart consumer. I don’t accept myth and hyperbole as received truth, and I’m even skeptical about things I believe to be true. When I have a stress test from my doctor and am told everything is fine, that does not guarantee that I’ll wake up tomorrow morning.

    23andme appears to me to be testing competently, appears to be reporting straightforwardly, seems to be making no outlandish claims, is providing great value for the price paid. Shutting them off is no different from shutting off a toothpaste vendor who is selling for 10% of the price of other vendors though the toothpaste is comparable, and is no different from telling one group of casket makers they may not sell, but telling another that thay may — at a multiple of the first group’s price.

    So no, the FDA wasn’t right. They are dead wrong. DNA testing is neither food nor drug, it is information.

    Link to this
  12. 12. Steve Heilig 12:13 am 11/26/2013

    The FDA was indeed right. Not to say “I told you so,” but just last week: http://www.huffingtonpost.com/steve-heilig/commercialized-genomics-c_b_4215551.html

    Link to this
  13. 13. DangerRick 1:07 am 11/26/2013

    Christine, do you not think that this initial round of “light-weight” genetic information is essential for the market to establish a proven funding model and to drive costs down? Individual health quantification is happening regardless of these genomics testing companies… From the old polar HRM’s to the Garmin Forerunners, to fitbits and the rest. No one is doing a perfect job of aggregating and evaluating any of the data, but why slam the door before perfection is achieved?

    I would equate the FDA’s stance on this as the whole “perfection is the enemy of completion.” As companies aim to better their competition, the superior analysis we desire will follow along. As you no doubt know, 23andme claims that they will continue to send “updates on your DNA as discoveries are made.” I don’t understand why that’s not enough.

    Link to this
  14. 14. mercurialpony 2:20 am 11/26/2013

    This is myopic and more importantly inaccurate. It’s through large scale, low cost genetic sequencing that correlations between data sets can be identified and accuracy established (thanks 23andme). Sure, they can add a disclaimer, but oh wait they already do. If nothing else, they identify aspects of your genome that you may want to follow up on.

    But no, SciAm has taken the totalitarian approach to personal data. I’m hugely disappointed!

    Link to this
  15. 15. Christine Gorman 10:21 am 11/26/2013

    mercurialpony: Disclaimers do not cure everything. If this were a hip implant company, you’d accept a certain amount of risk (of surgery, of anesthesia, even of weird organometallic reactions). But you wouldn’t accept a hip that had never been tested just on someone’s say-so.

    Read the warning letter. If the FDA were acting in a totalitarian way, it would not have offered so many different potential plans of action to 23andMe or spent so much time on the phone or in email conversations with them.

    Link to this
  16. 16. mercurialpony 12:00 pm 11/26/2013

    @Christine Gorman: Certainly right, disclaimers do not cure everything, however this is not a medical device nor is posturing as a remedy for any ailment. Their service provides information that most people would not normally have access to nor would they have considered scrutinizing. Annual checkups are not sufficient for preventative medicine, as the physicians – short of symptoms – don’t normally perform additional testing. In fact, we are moving away from “unnecessary & expensive testing.”

    They don’t claim you should act on the data provided, nor do they ever imply that the information is actionable in any form. Surely positive ramifications result from erring on the side of caution and empowering individuals to ask follow up questions to their physicians. Please see below:

    From the 23andme TOS:
    “You should not change your health behaviors solely on the basis of information from 23andMe. Make sure to discuss your Genetic Information with a physician or other health care provider before you act upon the Genetic Information resulting from 23andMe Services. For most common diseases, the genes we know about are only responsible for a small fraction of the risk. There may be unknown genes, environmental factors, or lifestyle choices that are far more important predictors. If your data indicate that you are not at elevated genetic risk for a particular disease or condition, you should not feel that you are protected. The opposite is also true; if your data indicate you are at an elevated genetic risk for a particular disease or condition, it does not mean you will definitively develop the disease or condition. In either case, if you have concerns or questions about what you learn through 23andMe, you should contact your physician or other health care provider.”
    https://www.23andme.com/about/tos/

    Link to this
  17. 17. Christine Gorman 1:21 pm 11/26/2013

    @mercurialpony. Now, we’re getting somewhere! I agree with you that there is a larger issue about access to your own medical/genetic information. But the point I’m trying to make is that you have to know on what basis that information is validated.

    If I get a home kit for a pregnancy test, cholesterol test or blood sugar test, I want to know that the readings I’m getting actually mean something. (Even if, in some cases, I go on to double check.) Heck, I might even want to know how far apart the error bars are. Same is true for genetic tests; probably even more so, given how much more value could potentially be in the information. Saying we’re going to give you information about your health risks–as 23andMe does on their website–and then kissing off any responsibility about the results with a broad disclaimer is not right.

    Link to this
  18. 18. Christine Gorman 2:10 pm 11/26/2013

    @Steve Heilig. Good post. Thanks for the link.

    Link to this
  19. 19. lyndarva 3:29 pm 11/26/2013

    I am a 23andme client. Years ago I was referred to a medical school genetics department for a specific test as I have a lot of health difficulties and complicated family history. That test cost the insurance company thousands. I paid $99 for the 23andme test and I was focused on the health profile, not the ancestry part, though that is interesting.

    The $99 test provided raw data that I can use for various reviews by independent people including genetic counselors. 23andme does suggest a genetic counseling firm and that people see a genetic counselor. The test has provided valuable information for me, specifically input on drugs and how my body metabolizes specific drugs.

    I understand that many people don’t understand genetic tests, whether it is through 23andme or another company. 23andme uses Labcorp, a nationally well-known laboratory company and recognized by the medical community. I understand that environment, my actions and a lot of other factors are tied to my health and just because something is or isn’t indicated for me doesn’t mean it will affect me.

    I understand that this is a rapidly evolving process and outcomes of the analysis changes as genes, mutations etc. are linked to new conditions or corrections are made.

    As a patient, why shouldn’t I be allowed to have data about my body that I can use to change my life? Finding out high cholesterol is not because of my family makes me work harder to lower it. Finding out caffeine is not metabolized well in my body helps me to lower my caffeine intake. I can go on and on about the positive outcomes of having this test. I have found out some medications aren’t recommended for me or how others should be prescribed in lower or higher dosages because of the way my body metabolizes them.

    The FDA allows a lot of junk to go on, for medications to be approved that cause a lot of dangerous side effects, it allows the major money corporations to have genetically modified and engineered crops that are dangerous to our health and endanger the other crops.

    $99 for any type of health information is amazing. In the age of talking about the need to lower health costs, why are we beating up a company that could help a lot of people? It is my business if I want to spend $99 on my body.

    I downloaded my raw DNA data from 23andme in case I won’t be allowed access to it any longer.

    Link to this
  20. 20. ToxinMD 3:51 pm 11/26/2013

    Ms. Gorman:

    Thank you for your insightful comments regarding 23 and Me. As a physician and medical toxicologist who has had a career in academic medicine, I respectfully disagree with your opinion. I believe that the FDA decision is wrong and possibly politically motivated. 23 and Me provides useful and relevant personal genetic risk information, at least in my limited investigation. Why is having knowledge about a quantitative health risk useless? I have read the company’s disclaimer and find it to be ethical and fulfilling the basic requirements of informed consent. Also, the Standford cardiologist in your article was referring to sequencing, not genetic risk and susceptibility testing, so his opinion should be ignored since he was discussing completely different testing. I have reviewed some of the specific scientific peer reviewed literature used by 23 and Me and have found it to be a reasonable basis for comparative genetic risk analysis. 23 and Me uses published snp studies of populations that have identified quantitative risks. I have yet to find scientific fault with the company’s testing and results, again in my limited investigation. If anything, I would recommend that the company use more comparative snp’s in certain disease risks to better refine the risk. If a person were to seek such testing in a UnitedHealth Care contracted clinic the costs would likely be in the hundreds of dollars, not $99, the test procedures would likely be the same, but the information would be controlled by the health care provider/insurer. So, the matter is really control of information and privacy, and the billions to be made by health care insurers if direct to consumer testing is terminated. I believe that it was UnitedHeath that was involved in the FDA’s decision. Your readers would enjoy an investigation into this potential ethical conflict if it is true. However, the question still remains, Do we or do we not have a right to personal genomic and genetic information? Our DNA is one medical record that HIPPA does not yet control. I suspect many of your readers have felt the frustration regarding “ownership” of testing information when they seek consultation from their physicians and return of such information. While I have concerns about establishing the “peoples republic of the genome” by 23 and Me, I have more concerns about an FDA that might have a conflict of interest and is unjustified in their decision regarding 23 and Me.

    Thank you

    Link to this
  21. 21. TeanaTeenaTine 11:54 pm 11/26/2013

    Christine:

    I went to a local genetic firm that the court authorizes for paternity and other family-related genetic verification. I paid $500+ to prove that a woman was in fact my half-sister.

    A few years later, on a whim, I also purchased a $99 kit from 23andme.com to learn some basic info about my ancestry. I encouraged my half-sister to try it out as well, and she did. We used separate accounts, under separate names and signed in from different cities. There was no way for 23andme.com to know that we were relatives EXCEPT for the DNA info.

    And you know what? The $99 test accomplished the same thing the $500+ test had: it verified we were close relatives, sharing 23.3% of our DNA (the next closest in the entire world is a fourth cousin with .074%).

    If the FDA wants proof that 23andme’s tests are accurate, they need only contact us. They have a right to check into the company’s claims, but as a registered member, I can tell you that nowhere on the site does it, for example, read: “You absolutely, definitively have Warfarin sensitivity.” All they do is provide a “confidence” level based on an amalgam of studies with more than 750 participants.

    The health-related items of mine that carry a four-star (out of four) confidence level include: Type 2 diabetes, Psoriasis and Celiac Disease. There is a history in my immediate family for all of these.

    It’s unfair for a publication like Scientific American to totally discount the accuracy of 23andme’s tests without looking at the data the company provides. I have, and am quite pleased with 23andme’s service.

    Link to this
  22. 22. david7777 3:12 am 11/27/2013

    I am glad the FDA is looking into their wild promises. The field of genetic screening and counseling is just not “there” yet, much less the commercialization of it with $99 specials. Your health is not all in your genes. The FDA sent a similar letter to 8 companies five years ago, including Illumina. 23&me stands alone now. BTW, this action does not affect the genetic genealogy sector of the DNA testing industry, which is unregulated. Companies like DNA Spectrum and DNA Consultants sell ancestry analyses, not medical information, and they do not use scare tactics to get you to buy a test. Recreational use of DNA should not be extended to medicine.

    Link to this
  23. 23. edprochak 10:21 am 11/27/2013

    In all the discussion about whether 23andme has a right to sell this service with claims of knowing your genetic risk (watch their TV ad), another important issue is being overlooked. (I think the FDA is making a good decision BTW.)

    here it is —
    From arralite:
    “The more DNA 23andme collect the more the hardcore scientists have in data. The idea of DNA history is good enough for me for theprice. FDA leave them alone.”

    This is the comment that scares the hell out of me.

    The more DNA data 23andme has, the more it potentially owns. With court rulings that DNA is patent-able, this wholesale collection of DNA data is one more factor in big business watching over all of us. This does not bode well for personal freedom IMO.

    Link to this
  24. 24. StephanieEDS 10:31 am 11/27/2013

    This part of the article you edited is incorrect:
    “Nancy Shute pointed out in a Scientific American article that I edited back in 2012. “[E]ach individual’s genetic readout must be compared with lots and lots of other people’s readouts for doctors to understand which genetic patterns are important indicators of disease and which can be safely ignored,” she wrote.”

    In fact, the value of 23andme reports is they have done the work of finding the very best research with stringent, high quality statistics. Many articles published in peer reviewed journals are not of high enough quality to be included in the reports 23andme gives each customer. If your article writer had actually read through how the scientists at 23andme had gathered the studies they use, they would know this.

    I’d have to look it up, as your writer should have done, but I believe they only use studies with more than 2000 genomes analyzed which have been replicated more than once, and which are published in peer reviewed journals. I wouldn’t expect a medical doctor to understand this, but I do expect staff at Scientific American to have the background required.

    Scientific American should be ashamed to have this article on their blog. This is not the quality I expect to see here.

    Link to this
  25. 25. Enoughalready 2:35 pm 11/27/2013

    Once again, the gov’t busy bodies are sticking their nose where it doesn’t belong. They want to tell us what we can eat, drink, say and now whether or not we’re capable of handling a DNA test by ourselves. A DNA test is NOT a medical device. Period. There is not one thing the gov’t gets involved in that isn’t ruined. And now they’ve got a new cause to sink their teeth into. Once again, it’s the “people” that will suffer because of the gov’t “help.” I’ve had enough of gov’t at every turn. DNA testing has been running fine without gov’t intervention for several years, and we don’t need it now.

    Link to this
  26. 26. beavis71cox 2:37 pm 11/27/2013

    I really, really can’t believe you are actually an editor at Scientific American. I think they need to re-examine their hiring process, cause you don’t know anything about Genetics. I would like you to cite just one person that has been harmed from the information taken from 23andme…..just one. Medical doctors do not even take this seriously, and there’s not a ingle patient that can order tests or medicine without a doctor. And even if a doctor DID follow health results fom 23andme, they would do so by ordering more tests first. And only then would they make changes to a patients course of treatment. 23andme has offered this service for years, and no one has been harmed. 23andme’s bottom line medico advice, is to talk to your doctor! How can that harm anyone? If you actually read all the stories of people who have actually been helped, not hurt, by the service, then maybe you would understand. There’s people who have found inherited genes, spoke to their doctor, got tested, and found it was positive. That, to me, is actually life saving, not harming. And as far as comparing genetic genealogy to a horoscope, that’s ridiculous. The BGA, (oh I’m sorry, let me explain that to you, it’s Bio Geographical Analysis), that 23andme does, is the exact same thing NatGeo does. So if you compare 23andme to a horoscope, than you are also saying NatGeo is bunk science. And if you think that most of us who use these services aren’t educated enough to know what we are doing, then you are actually calling us stupid. I think people should know how you feel about them, and I think your employer should know how you fel about us “uneducated bumpkins”, because you are essentially saying every customer of 23andme is being duped, and we must be stupid to follow this type of science.

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  27. 27. culbrid 2:48 pm 11/27/2013

    @Christine Gorman

    First off, I really appreciate that you are so responsive to the commentary of your article. Very refreshing.

    I thought I’d focus on your comment here:

    “I get more concerned when I read about the sensitivity tests to warfarin, clopidogrel, etc. I don’t think it’s too much to ask that those particular tests work as claimed or advertised.”

    Maybe you can shed light on what is misleading about it? Here’s the sample warfarin results on the 23&me website (listed in there sample reports). https://www.23andme.com/health/Warfarin-Coumadin-Sensitivity/

    Too me, I see all the logical disclaimers, references to the studies involved, and it seems to make it clear that genetics only play a part and is not the end all for one’s warfarin sensitivity. If anything, it seems like a great source of education and awareness on the subject that makes itself personal to the reader. I’d think that a Doctor would appreciate the heads up if he were prescribing warfarin, given a printout of these results from his patient. After all, in the end, it’s the Doc that’s going to make these decisions, and the best decisions are the most informed ones.

    Link to this
  28. 28. culbrid 2:52 pm 11/27/2013

    Also.. note this quote from the results page for warfarin in regards to my comment on giving the Doc a heads up.

    “In January 2010 the FDA updated warfarin’s label to say that information on these variants can assist physicians in selecting a starting dose of the drug. The agency also provided initial dosage recommendations for patients with different variant combinations. The FDA does not, however, require that genetic testing be done before prescribing warfarin.”

    Link to this
  29. 29. culbrid 3:06 pm 11/27/2013

    Perhaps the proper argument from the FDA’s perspective is not so much that they are misleading, but that they have not proven that the genetic results are reliable. That would be a good point, although as a 23&me member with a biologist sibling (also a member), we’ve seen nothing to cast doubt on the quality of results.

    However, from that perspective, if the FDA merely wants to certify that these public genetic testing operations are operating under proper quality control, I can see their point. Would be rather terrible if 23&me had rat droppings contaminating half the saliva samples. I don’t think they are, and I don’t think they have anything to hide.. but an FDA stamp of approval is intended to keep such things in check. I suspect it’s just a bureaucratic process that needs to get hashed out.

    That said, I don’t think 23&me deserves a lot of the negative criticism I’m hearing around this. And things like.. “What if someone gets there breasts chopped off cause…” is ludicrous.

    Link to this
  30. 30. beavis71cox 3:13 pm 11/27/2013

    See! That is just great……a biologist as a 23andme customer….and you’re not the first I’ve met……I’ve had the pleasure of meeting fellow researchers, scientists, doctors, geneticists, all who are customers of 23andme, and not a single one has cried foul……….thank you cullbrid for sharing…….but then again, we must all have low intelligence markers for following a “horoscope” service

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  31. 31. culbrid 3:46 pm 11/27/2013

    Thanks beavis.

    I’m going to argue with my own comments now with regards to the FDA assuring that quality control is followed:

    23&me’s labs are already CLIA certified. http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/

    Does the FDA really need to be involved to assure quality testing? It’s not a food or a drug, and it seems CLIA should certification is already an entity in place to assure quality of testing.

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  32. 32. bucketofsquid 5:57 pm 11/27/2013

    What a waste of $99 for most people. If you want to know about your genetics risks then talk to your family and ask them. Sure this won’t work for the closed adoption folks but life isn’t designed to be fair. If 23andme is making medical claims then they had better have MDs on staff checking every analysis that has health risk claims. That is what the law requires and they must either comply or get the law changed.

    Link to this
  33. 33. walla 7:31 pm 11/27/2013

    THUMBS DOWN on your article, Ms. Gorman…

    I am a member of 23andme, and have been for two and one half years. I find that the health reports of all FIVE of my family members who are also members of 23andme are absolutely helpful and very accurate, re; what WE know about the health and death-causes of our ancestors who have passed.

    23andme only COMPARES our genome to the newest and most respected GENETIC HEALTH RESEARCH. THEY DO NOT MAKE any kind of ‘diagnoses’…The ‘health-risk’ ONLY offers one’s ‘THEORETICAL’ medical risks, based ONLY on one’s individual genome when it is COMPARED NEW GENETIC research of OTHER Genomes of people who DID have those actual diseases..…And NEW Research is being published DAILY as this field exponentially EXPANDS…

    I am AMAZED that a ‘Science Writer’ who had actually RESEARCHED this subject would come to the CONCLUSIONS you came to when you wrote this article…

    Nothing in MY health report was either surprising or alarming….Why? I KNEW cancer and diabetes and eye problems and heart disease and kidney disease ‘ran’ in my Maternal family and STROKE and Alzheimer’s in my Paternal family… If there HAD been anything theoretically UNUSUAL: about my genes I would STILL want to pay attention to WHATEVER it might be.
    As in Alzheimer’s:
    My Paternal Grandmother and Paternal Aunt suffered from Alzheimer’s…it is NOT surprising that I too have a more than ‘average’ risk of the same. However, SEEING my actual RESULTS actually MOTIVATED me to ‘do better’ in my lifestyle choices for of my risks, and reminded me to be more CONSCIOUS on ALL fronts…(At 74, MOST of my RISKS have SURFACED and are ACCURATE re: my 23andme theoretical risk figures.
    SEEING my Alzheimer’s risk ‘in print’ gave me ‘head start’, pushed me forward to learning how to protecting my brain. I also donated to further Alzheimer’s RESEARCH for the sake of my progeny who also may have inherited the propensity for this disease. We NEED to KEEP working to understand and CURE these diseases of degeneration….Not stick our HEADS in the SAND…My CHILDREN deserve to have full knowledge of their ‘genes’, whether ‘good or problematic’, that MAKE THEM WHO THEY ARE.

    I am the ‘CARETAKER’, the manager, and the ADVOCATE for MY OWN HEALTH, and I should NOT have to go through a doctor to get the basic information about the ‘ingredients’ of my DNA.…., but my DOCTORS themselves KNOW basically NOTHING about genetics, and they have no right to keep in their ‘domain’ something that they, themselves don’t ‘GET’…Our Drs. OFTEN treat with us drugs that don’t fit us or make other BAD DIAGNOSES that do damage…

    I may not be extra BRIGHT or extra ‘able’ in any way, but I’m NOT STUPID, NOR do I consider ‘risks’ as ‘diagnoses of having a disease!….and but I am FULLY CAPABLE of learning and connecting the DOTS of my own health issues…DOTS my ‘specialists’ don’t seem to EVER connect with EACH OTHER about ME or MY HEALTH concerns….

    Those people who REALLY don’t WANT to know, just don’t get TESTED!…. I WANT to know everything, theoretical or NOT, about my body/DNA.

    Perhaps Ms. Gorman, f you haven’t tried it, perhaps you SHOULD think about getting a DNA test of your OWN from 23andme.com. I can assure you, you will LEARN a LOT…It’s ONLY $100…
    Do it BEFORE the FDA, with YOUR help, shuts 23andme down..

    Link to this
  34. 34. beavis71cox 11:43 pm 11/27/2013

    @bucketofsquid ……..Really?!? Ask your family?!? Are you really that ignorant, or are you just playing it…….there’s lots of people out there that don’t know their family, and even those that do don’t know if they carry a certain gene or not….if you have the cystic fibrosis gene, it would be negligent of you to marry someone else that had the gene because then your child will certainly get it….and just because one or two people in your family had it, doesn’t mean you are a carrier……so “just ask your family” is completely ignorant…….you won’t know if you have it, and neither would a possible spouse, unless you get tested……and I don’t know about you, but to test for every single gene, by a medical testing lab, is something I certainly can’t pay for, and most insurance won’t even cover until its too late………for $99, I got a heck of a service……this is really about money, bottom line, and medical labs are mad that they can’t charge tons of money for these tests anymore, if people are getting them done cheap, and in some cases, absolutely free………and it really shows how much you don’t now, and are just chiming in and trolling about things you don’t even know……because 23andme has scientists, geneticists, AND “MD’s” as you put it, on the payroll……..

    I had thought that I read in the Scientific American front blog page, that editors blogs were supposed to be about news and updates and stuff……NOT her personal opinions…..personal opinions are left at the front door when it comes to science…….or so I thought……and as an editor, she should know this

    Link to this
  35. 35. Jerry Emanuelson 1:22 am 11/28/2013

    I have been a customer of 23andMe for more than 5 years and a staunch enemy of the FDA for most of my life. I have posted my response the the FDA letter of November 22 on my web site at:

    http://www.futurescience.com/fda.html

    I would probably be in a nursing home on my way to an early death right now if I had not gone out of my way to avoid FDA tyranny. I have nothing but the highest level of contempt for the FDA.

    Jerry Emanuelson

    Link to this
  36. 36. beavis71cox 4:10 am 11/29/2013

    Come on lady, I threw you a challenge, and you’ve completely ignored it…….what does that say about you and your opinion?…….I will repeat it, one more time, in case you didn’t read it clearly………show me just one case, just one single case, since 23andme started giving their health reports, where someone was adversely or negatively affected, medically……..the whole point, SUPPOSEDLY, is that people are either getting harmed, or could be harmed…….but it hasn’t happened!

    Link to this
  37. 37. CS Shelton 6:23 am 11/30/2013

    50% of Steve Heilig’s review is shilling for a book that was probably written by a drinking buddy, and it was on a website that has unashamedly hosted antivax articles BY FUCKING CELEBRITIES.

    Meanwhile, the anti-government rhetoric on the other side does indeed smack of libertarianism, which is a corrupt philosophy I will oppose to my dying breath as surely as I have the word Liberty tattooed on my arm.

    So, in short, I think both sides sound hella full of shit, and I will need a tad more convincing. Actually make a case, instead of throwing out unsourced and unsubstantiated opinions.

    You may be dead right, Gorman, but I wouldn’t know it from the article you wrote. More substance plz.

    Link to this
  38. 38. bucketofsquid 1:15 pm 12/2/2013

    @Walla – Randomly yelling certain words in a paragraph just makes you a spastic freak. I started to read your response to the article but I quit reading it because I DON’T LIKE BEING YELLED AT!

    @beavis71cox – I am very familiar with genetic testing and my genetic profile is on an international registry. Perhaps you need to work on reading comprehension. I never said everyone could get what they need by talking to their family. I said most people could get what they need by talking with their family. I stand by that statement. The vast majority of citizens in the USA know who their parents are and are fully able to talk to them. Many people that were adopted also know who their biological parents are and are able to get medical history. I know this because I have helped several adopted people get this information.

    You asked if I am ignorant. I am not but apparently you are. 23andme has been nailed more than once for making false claims. I don’t much care for the FDA but as a student of history I know that most companies are inherently dishonest. Just because an MD is on the payroll (or 100s of MDs) doesn’t mean that every single profile is reviewed by an MD.

    If you are worried about your defective genetics then by all means spend that $99 to get your profile. I don’t need that profile done for my defective genetics because I already know the medical history of my family on both sides going back to the early 1800s. It isn’t a pretty story – heart disease, depression, schizophrenia, anxiety, alcoholism. All of these have genetic components.

    Maybe you fall into the category where contacting your biological family is impossible. Parents die while children are young. Some parents are pathetic excuses for humans and are not there for their children. If so, you have my empathy. I’ve worked with a guy in the latter situation and it was heart breaking. Never the less, life is not fair nor is it designed to be fair. Everyone has challenges to deal with. I won’t bore you with my litany of woes.

    @C S Shelton – You took what would have been an excellent response to the article and turned it into meaningless trash by showing the entire world that you are gutter scum by injecting needless profanity. Shame on you for discrediting yourself so pathetically. Had you made your very valid point like a civilized person, I would have linked to it and shared the wisdom of it very widely.

    Link to this
  39. 39. edprochak 8:02 am 12/9/2013

    There is a similar discussion of 23andme in the medical devices group on Linked In. Interesting that those involved in the industry generally support the FDA action in the comments over there.

    (If you have a linkedin account, the topic is
    What’s your take on FDA’s stance with 23andMe?
    in the Medical Devices group.)

    Link to this

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