20 ms·

FDA Warning Letter to 23andMe

338 points by jefffoster 13y ago

wheaties 13y ago
When the FDA sends you a letter like this, you either pay a fine and change tactics or you embark on one of the most frustrating approval processes known to the world (all for people's protection.) Good luck with that.
carbocation 13y ago
> Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device. No joking around.
guylhem 13y ago
As usual, the government is trying to meddle with companies. Read the letter, but make no mistake - the "kind" tone, especially when reminding how they did they best to get in touch, have meetings, help insuring compliance etc. is just a decoy. The truth is with "must immediately discontinue marketing the PGS". The gov wants to decide what's best for the people. Should the people decide differently, using their wallets for example, this anomaly will be quashed. This trend is especially strong in the medical field - gov approval required everywhere, then people wonder why medical things are so damn expansive. I use 23andme and I'm happy with the information provided. I know it's not reliable - it's not a lab test anyone will use to base important decisions on, since it is not a full sequence of genes. Yet, by being commercially available and easy to use, it is paving the way for commercial offers of full genome sequencing, which I damn well intend to use when they reach the $500 threshold. However, gov actions like this one may very well make that impossible, making sure the only full genome sequencing offers there will be will be "FDA cleared" at a huge markup. Suggestions to "medical" like companies - get out the gov eye. Move your business to Asia, the caribbean or wherever the gov will not get in your way like this. I want to keep using (and recommending) your products!
- oddevan 13y ago
  > I know it's not reliable - it's not a lab test anyone will use to base important decisions on, since it is not a full sequence of genes. If they made that more clear, then they wouldn't have had to send the letter. It's why you see "This is not intended to diagnose, treat, or cure any disease" on all the non-FDA-approved supplements/energy drinks. My money is on them paying the fine and scaling back the marketing. The purpose behind these FDA rules are to make sure things aren't marketing as "cures" when they aren't. People's health is serious business; there's no room for failure. If 1.0 doesn't work (or makes things worse), then the people that need it might not live to see 1.1.
  - deleted 13y ago
    [deleted]
    - ForHackernews 13y ago
      That's true, but it's not a slam-dunk case for rushing ahead without sufficient testing. There's a reason that "first, do no harm"[1] is considered one of the fundamental principles of medical ethics. Medical interventions can have disastrous side effects.[2] [1] https://en.wikipedia.org/wiki/Primum_non_nocere https://en.wikipedia.org/wiki/Primum_non_nocere [2] https://en.wikipedia.org/wiki/Thalidomide#Birth_defects_crisis https://en.wikipedia.org/wiki/Thalidomide#Birth_defects_cris...
      - twoodfin 13y ago
        I'm curious, are there any other examples than Thalidomide? It's a true horror story, but there should be a limit to how much precaution one disaster justifies in the future. Many other drugs with ultimately fatal but initially undiscovered side effects have made it through FDA approval, too.
        ForHackernews 13y ago
        > are there any other examples than Thalidomide? A whole lot of people have died from contaminated blood transfusions: http://articles.latimes.com/1994-08-31/news/mn-33183_1_aids-epidemic http://articles.latimes.com/1994-08-31/news/mn-33183_1_aids-... That's another case of a medical intervention ending up doing more harm than good.
geetee 13y ago
I understand the FDA getting pissy if I'm consuming/injecting a substance that may or may not harm me, but why this? I spit in a tube and get some results which may or may not be accurate. Go away, FDA.
- DanBC 13y ago
  People take action based on the results of the tests. There are different ways to mitigate risk - ensure there's adequate genetic counselling and proper easy to understand information available for anyone taking the tests would be one way. I lean towards favouring tight regulation of medical products. One person's 23andMe genetic test is another person's quackery - see some of the nonsense offered as medical advice by the quacks on other websites.
  - ajcarpy2005 13y ago
    Academic science somehow manages to police itself fairly well with peer review processes. Wouldn't this type of paradigm work better than paying for the FDA to go through its approval process? The FDA could still take action if they see that a company is doing something & claiming something that is not properly peer-reviewed and proven. But why create extra red tape for everyone from the get-go?
- seehafer 13y ago
  For the same reason that the FDA tends to care if an MRI or a CT scanner displays accurate results. People make life/death decisions based on diagnostics.
- geetee 13y ago
  I don't know how they can be any clearer: "The laboratory may not be able to process your sample, and the laboratory process may result in errors." "You should not change your health behaviors solely on the basis of information from 23andMe." "23andMe Services are for research, informational, and educational use only. We do not provide medical advice." "Genetic research is not comprehensive." All from: https://www.23andme.com/about/tos/ https://www.23andme.com/about/tos/
sqrt2 13y ago
This reminds me of a blog post in German [1] by a person who due to a software bug had been falsely diagnosed by 23andMe with limb-girdle muscular dystrophy. (Fortunately, he was able to identify that it was a misdiagnosis.) It appears that in this case potential misdiagnoses aren't just a theoretical problem. [1] http://www.ctrl-verlust.net/23andme-wie-ich-fur-todkrank-erklart-wurde-und-mich-wieder-gesund-debuggte/ http://www.ctrl-verlust.net/23andme-wie-ich-fur-todkrank-erk...
- evan_ 13y ago
  23andMe is very clear at every step of the way that it is not diagnosing anything.
  - sqrt2 13y ago
    This is what 23andMe said about that person's genome: "Has two mutations linked to limb-girdle muscular dystrophy. A person with two of these mutations typically has limb-girdle muscular dystrophy." Of course this not a diagnosis in a technical sense, but to a lot of people it will sound like it is. Specifically, I don't see how this is "very clearly" not a diagnosis.
  - arrrg 13y ago
    Well, the FDA seems to think that 23andMe does market its product as diagnosing something. That’s what this whole letter is about.
  - anigbrowl 13y ago
    https://www.23andme.com/store/cart/ https://www.23andme.com/store/cart/ Knowledge is power. 23andMe empowers you to better manage your health and wellness. $99 [Add a kit] There are no disclaimers on this page, just an aphorism, an assertion, and a call to action. Now I like the idea of 23andme, I like the company, and I'm educated and skeptical enough to enjoy some fluffy scientism for a hundred bucks, but don't tell me they're not selling the hell out of this.
- mntmn 13y ago
  Hi. Original author of that article here. I decided to finally translate the article to english: http://mntmn.com/pages/23andme.html http://mntmn.com/pages/23andme.html
labaraka 13y ago
> 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. I cannot imagine someone getting surgery or chemo solely based on a 23andme heads up warning and without consultation with a specialist physician. As someone working in medical devices, this dramatic language is extremely frustrating.
- alanctgardner2 13y ago
  That example is a bit severe, but I think the Warfarin compliance example is spot-on. You receive a prescription for a drug, but your magic internet test tells you to take a lower dose, because you're "sensitive". Then you die of an aneurysm because the test was wrong. People are completely stupid when it comes to medical issues. I heard a woman complaining that she couldn't eat honey because she was allergic to fructose. I work with at least 3 "gluten-sensitive" people (it's pretty unlikely they all have Celiac disease, it's not a big office), because it's a hip thing to do. Hell, didn't Angelina Jolie have a prophylactic double mastectomy? edit: Since everyone is jumping on the Angelina Jolie example. I don't think her decision was made based on a single spit test. And I think she had doctors advising her. But the amount of publicity it got makes me worry that it could become needlessly popular based on self-diagnosis (like not eating gluten).
  - RobAtticus 13y ago
    >Hell, didn't Angelina Jolie have a prophylactic double mastectomy? The placement of this in your post seems to imply you think she was being stupid with her decision, or thought it was in some way "hip" to do. She has a family history of breast and ovarian cancer and has a defective gene that made her chances of getting breast cancer 87%. As she's pretty wealthy, I'm going to guess that she has pretty good doctors and didn't make the decision on a whim. Also since it was major surgery I'm going to also assume some doctor saw her at least once before the surgery and s/he didn't just take her word for it that the surgery was in her best interest. Yes there are plenty of people who don't have a clue when it comes to medical issues, but I'm not sure why you felt the need to lump Jolie in with your other examples.
slashdotaccount 13y ago
Is there a list of government agencies IP addresses? I would like to block them from accessing my sites. And write in the ToS that they are not allowed to browse and read more.
- jchung 13y ago
  I am not a lawyer but... I don't think that's going to have the effect you think it will
- Sanddancer 13y ago
  No. Also, the government has the right to claim sovereign immunity in cases, especially in any sort of civil/criminal investigation.
- ChikkaChiChi 13y ago
  There are assigned blocks, but this will not do what you think it will.
deleted 13y ago
[deleted]
javert 13y ago
More evidence that we live in a very mixed economy, not under free market capitalism. Government agencies empowered to weild regulatory force against citizens are a threat to everyone, and this is case in point.
- gnaritas 13y ago
  Good.
  - javert 13y ago
    You don't have the right to boss me around. You are advocating putting up roadblocks between me, and my pursuit of values, and you should feel bad. (I do mean this with a hint of jocularity.)
    - gnaritas 13y ago
      Says you, but we don't live in a society where everyone gets to make their own rules. As a country, we've decided we do have the right to boss you around, so we do. :)
      - javert 13y ago
        There is no logical chain of facts, starting with concrete perception of reality, that leads to the conclusion that society gets to coerce me. So, no, you do not have the right to coerce me. However, there is a logical chain of facts, starting with concrete perception of reality, that leads to the conclusion that we should establish government for protection from coersion. Society can pass a law to coerce people---at its own peril.
        gnaritas 13y ago
        I see your problem, you think logic matters, it doesn't, this isn't that world. In this world, numbers matter, votes, not logic. Rights are a social construct, we have whatever rights we've all agreed we have and no more. Any talk about natural rights and logic and positive vs negative rights is just that, meaningless talk; policy comes from those who acquire power, not those with the best arguments and facts. > Society can pass a law to coerce people---at its own peril. Look around, turns out it's not really perilous at all. It's actually the normal way the world works.
sethbannon 13y ago
The tone of the letter was surprising to me. I wouldn't expect the FDA to go quite so far in explaining the why behind the desist letter. I suppose that's because it was written just as much for public consumption as it was for 23andMe.
- rayiner 13y ago
  It's written for consumption by 23andMe's lawyer. This format is typical.
- jfasi 13y ago
  The most common sort of cease and desist letters we tech people are accustomed to are DMCA and patent-related. These letters are typically meant as precursors to private litigation. They are often sent out with commercial considerations in mind, and so tend to be light on details in order to be more threatening. The FDA is a regulatory agency, which implies that their mission is less about intimidation and more about protecting the public good. Hence the more open tone, I suspect.
- dragonwriter 13y ago
  > The tone of the letter was surprising to me. I wouldn't expect the FDA to go quite so far in explaining the why behind the desist letter. Its fairly typical of formal regulatory notices (or even informal notices -- much of the language is very similar to the 2010 letter in which the FDA first raised issues with the product) -- because they are typically directed at corporations with substantial legal resources and they are designed to convince them that they should voluntarily comply with the agencies direction because if they fail to do so regulatory action will be initiated which will be costly and unlikely to be reversed by subsequent litigation, so they lay out all the facts and authorities necessary for the recipient (and the recipient's counsel) to come to the desired conclusion.
btilly 13y ago
Silicon Valley "It is better to ask for forgiveness" culture meets the worst of government "We'll need that in triplicate 5 years in advance of starting to look at the paperwork." This should be interesting, if you have the patience to watch the fallout in slow motion.
- seiji 13y ago
  At least the FDA has teeth even if the SEC lets startup financiers play billionaire shenanigans all the time and get away with it.
SCAQTony 13y ago
Never once did they attack the technology but rather the potential for error or the consequences if the public "can't handle the truth." The closest they come to calling her a "quack" is when they state "...We still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses..." The bigger question is why is the FDA having a seizure over this? Could it be the potential for added treatment and preventative healthcare measures that insurers vis a vis the Affordable Care Act and not looking forward to paying for? (Not a rhetorical question, just asking)
- rafcavallaro 13y ago
  False. Read the letter carefully. They're specifically concerned with false positives and false negatives - these are both very real possibilities - one is documented up thread.
- aeturnum 13y ago
  I think the line of reasoning makes sense: people will make medical decisions based on this information, but 23andme has never given us any reason to (or not to) believe their tests are accurate. Without someone reviewing their process, their error rate is unknown. That can be dangerous. This is similar to the problem with many alternative medicine claims. 'Alternative medicine' may be very helpful to an individual, but it's important not to overstate its effectiveness or reliability.
  - dnautics 13y ago
    how would you define 'error rate'? Do you mean "lab handling error rate"? Or "information presenting" error rate? The way 23andMe works, is they run your DNA and they show "percentages" based on already done studies. Then they throw in caveats (like, if you're not of the correct race relative to what the study was done in). So what would you suggest? That the service track all of their users over a long-term and then see whether the percentage of their users that get condition X matches the percentage they predicted? And then do some sort of statistical analysis on a possibly moving number (because 23andMe updates their information if academic science improves) with a population that might turn out to have differing biases...? And then prove this information over what, 100000 SNPs on the chip? What you are basically arguing is that 23andMe should not be allowed to offer its service.
crb002 13y ago
CMS/HHS will look like idiots as mRNA sequencing dips below the $100 per test price point and doctors for the first time will have a histogram of genes turned on for use in their diagnosis. Instead of whinging, FDA needs to partner with NIST to come up with quality control protocols so doctors know the error distribution in data that they receive.
rmrfrmrf 13y ago
Anyone who thinks the FDA is overreaching here has little awareness of how stupid the majority of the world's population is. The people that this protects don't know how to even read this statement from the FDA. Perhaps the startup echo chamber has more respect for unchecked opportunism; if that's the case, someone should make a startup called 23andMeFree (monetized by ads, duh) that has you spit in a tube, send it to some PO Box, then randomly generate positive and negatives across the board. If you wanted the scam to last longer, you could even generate random values based on statistics of certain characteristics. A true libertarian must support such a business.
- webXL 13y ago
  As part of the world's population, isn't there a high chance that the FDA contains some fraction of the "stupid" majority? Is it possible that a majority of the FDA could be labeled "stupid"?
- jessaustin 13y ago
  A true libertarian must support such a business. I'm not sure that libertarianism is coherent enough to admit the existence of "true" adherents, but surely you mean to say that a "true libertarian" must not support the outlawing of such a business? Typical libertarians often display preferences among businesses. E.g., a libertarian might prefer Taco Bell to Panera Bread.
  - Xdes 13y ago
    It's a matter of libertarianism being very broad rather than incoherent. They are more divided on economic issues than social issues.
    - webXL 13y ago
      The classic definition is what most people think of: socially liberal, fiscally conservative. These two ideas are coherent because they both require minimal intervention on the part of the state. But libertarians are often attacked for not supporting equal individual rights, which does require forceful intervention by a state. This dichotomy is what non-libertarians have trouble understanding. And when something is poorly understood, it is often vilified. Edit: this should have been posted under the post above, but I meant to take issue with your comment on the division on economic issues. The only division I've seen is tactical, not philosophical. Can you provide an example of a deep philosophical division?
saalweachter 13y ago
I'd like to point out that -- as much as I'm sure most people love 23andMe -- it's not really a scrappy start-up. It's a nearly 8 year old company which has received something like a hundred million in funding. So this isn't really a case of the gov't stomping on the little guy before he has a chance to grow; 23andMe has had its chance to grow into a fairly big deal, and now it's time to start playing by the rules.
- ig1 13y ago
  The average drug costs around a billion dollars to bring to market and decades in development and approval. 23andme might not be a small fish by internet standards, but they are by medical industry standards.
  - icegreentea 13y ago
    But 23andme do not make drugs. They do diagnostic tests. The cost of development for those are much lower. 23andme aren't giants in that field for sure, but they're pretty big. It's absolutely nonsensical to compare them to a drug company.
    - VLM 13y ago
      "They do diagnostic tests." More specifically they are busted for interpreting diagnostic tests not doing the tests. If they were two cooperating companies, and one did tests and squirted out results and the other sold diagnostic and interpretive services, the diagnostic services company would be busted but the test company would not be in trouble, as I interpret it at this time. Skip all the exotic genetic issues and think about personal experiences with something boring, like blood pressure. No legal problem with testing someones blood pressure and giving them numerical results and maybe a medically sane set of typical ranges. My local pharmacy has a machine that does it for free. However, it would be a big issue for a non-MD using that data to diagnose high blood pressure, or a high likelihood of it anyway, then providing some treatment plans. The issue seems to be selling services. If they just did testing, and provided a free downloadable immense data set and some statistical analysis tools and let the user come up with their own interpretations, they'd probably be in the clear (at least with respect to this individual problem). Now having a cloud service to hold the data and do the math is getting gray area ish but probably still OK as long as its the end user drawing the conclusions and not "the company" drawing the conclusions.
k-mcgrady 13y ago
Am I the only one this seems completely reasonable to? There are probably people who take action over the results they get from the service and if the results are incorrect the actions could have negative impact on their health. Therefore the service should have to prove the results are accurate before advertising it as a first step in prevention.
- wissler 13y ago
  As if the FDA were qualified to make such determinations.
- Glyptodon 13y ago
  Probably. I think most people view their service as fun thing that comes back with results that, if revealing of a concern, would cause you to seek proper and more detailed testing from a real medical practitioner. It's not like a physician prescribes a 23 & me writeup.
  - rayiner 13y ago
    > I think most people view their service as fun thing that comes back with results that, if revealing of a concern Take this thought, and replace "some people" with "my mom" and see if it still results in the same conclusion.
    - Glyptodon 13y ago
      Yep. I'm pretty sure she'd view it along the same lines as one of those 'reveal the breeds of your mutt' dog DNA tests.
    - crusso 13y ago
      Literally, my mom is the one who got me to send off my spit to 23andMe. She thinks it's fun and interesting but at no point has she indicated that she's thinking of it as a medical service - especially not one that replaces seeing a doctor.
  - dragonwriter 13y ago
DennisP 13y ago
I wonder whether a company could bypass the FDA by simply giving people their genome data, without any interpretation or diagnosis, which could be left up to people's doctors, opensource software, etc.
- judk 13y ago
  That is a far less marketable product. Most customers couldn't interpret that data.
boonez123 13y ago
Owner is married to the founder of google. I think they'll be okay. :)
- RankingMember 13y ago
  Was
- judk 13y ago
  Divorcing.
drakaal 13y ago
The back story is 23andMe declined a federal request for a customers DNA. This was the government backlash as a result of protecting user privacy.
- dkordik 13y ago
  Source?
- ben1040 13y ago
  Do you have a source for this?
- ska 13y ago
  That is highly improbable. This action is a core function of what the FDA does.
  - drakaal 13y ago
    And the FDA has been in talks with them since 2009, and with out notice changed its position.
    - ska 13y ago
      That's not true. The FDA position is unchanged. They have been in talks since 2009 to help 23andme understand what they need to file, and how to do it. 23andme has (repeatedly, it sounds like) failed to do that. This notice is a standard corrective action taken by the FDA after failure to complete 510(k) submissions.
ChikkaChiChi 13y ago
If you believe 23andMe is a sound source for the clinical diagnosis of medical conditions, you're probably not going to read the fine print telling you otherwise.
aabalkan 13y ago
It's been years since 23andMe is out and FDA just noticed? Or am I getting it wrong?
- mmcnickle 13y ago
  It's generally considered good form to read the article before posting. It's clear from the notice that the FDA known about 23andMe from the outset.
- carbocation 13y ago
  If you read the article, you will see the large paragraph outlining the dozens of in-person meetings and hundreds of emails that the FDA has exchanged with 23andMe. What you are noticing is a government agency that has exercised restraint for years, not one that was aloof.
pilom 13y ago
Summary: 5 years ago, 23andMe started marketing a test for among other things a BCRA indicator July and Sept 2012 - 23andMe submits a form to the FDA saying "our test isn't really useful for diagnosis and thus shouldn't fall under these rules" Nov 2012 - FDA says we don't agree with you you need to either prove your effectiveness or change your marketing Jan 2013 - 23andMe says "it will take us a couple months to do the tests, we'll get back to you" Nov 2013 - FDA says, "its been 11 months and you never got back to us. Stop selling and let us know within 15 days what you're going to do explicitly because you ignored us for close to a year"
- seehafer 13y ago
  Exactly. I am no fan of the FDA, but what 23andMe did here was extraordinary: they essentially ignored the agency. If Anne Wojcicki was CEO of a similarly-sized medical device company she would have gotten her walking papers today.
  - duncan_bayne 13y ago
    Extraordinary, and praiseworthy IMO.
    - pilom 13y ago
      Why is ignoring a government agency when they ask you to follow the law praiseworthy? The law says you cant market a diagnostic test without testing to know the accuracy of the test. I don't want to praise the snake oil salesmen who would also want to break this law so why should I praise what 23andMe did?
      - duncan_bayne 13y ago
        Because, in this case, the Government agency and the laws they enforce are unconstitutional, and actually harm the people they're supposed to be protecting.
        13y ago
jfasi 13y ago
This seems absolutely reasonable. The letter indicates that the FDA has notified 23andMe that their products are not satisfactorily cleared, they're reached out to them several times, and they've offered assistance through a group they specifically set up to help companies in this situation. Meanwhile, 23andMe went ahead and began marketing and selling their product, despite the FDA's concerns. Relevant quotes: > Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions. > 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 > 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; ... > ...we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification. > 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... > 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.
- tptacek 13y ago
  Moreover, it appears from the letter that the concerns are about marketing; ie, presumably the FDA was simply asking for 23AM to clarify their copy to remove any implication that you could use the product as a substitute for a doctor's assessment of your e.g. cancer risk.
  - icegreentea 13y ago
    It's actually kind of hard to tell -exactly- what the FDA wants without reading the original 510(k) submission. The claims by the FDA directly tie into the original claims by 23andMe as their intended use. In any case, the FDA right now doesn't just want a change of copy. By "cease marketing", I presume they don't mean advertise it differently, they mean stop offering the product to customers - period. While the FDA certainly appears to be taking issue with the specific marketing copy, they seem to be more annoyed that 23andMe has basically failed to complete the regulatory submission process - amongst other things failing to provide evidence to the FDA that their product actually works as intended.
FrankenPC 13y ago
Magic sentence: "For entertainment purposes only"
- smackfu 13y ago
  Well yeah, they could totally get rid of the health part of their product and only report on ancestry, and I think the FDA would be perfectly fine with that.
bhartzer 13y ago
You would think that before putting in so much money, time, and effort into 23andMe they would have had discussions with the FDA and actually responded with more information. I'm amazed that it didn't happen.
tomelders 13y ago
Well I suppose that now that all the food is safe to eat, they've got time on their hands to take down the sinister corporate bad guys behind 23&Me.
jheriko 13y ago
I have to agree that this seems completely reasonable... glad to see so few commenters jumping to the expected conclusion that this is some kind of government oppression.
deleted 13y ago
[deleted]
mkramlich 13y ago
When evaluating startup risks/events there needs to be a standard term or acronym for "doesn't matter; spouse is multi-billionaire."
patrickg_zill 13y ago
Crap... I better buy the test for an older relative (84) like I have been saying I would, pronto. Before the FDA gets its hooks into it and the price goes up...
logfromblammo 13y ago
It is only reasonable in the context of the standard operating procedures of the FDA. As this is essentially prior restraint upon speech and/or trade, it is unreasonable, but no more unreasonable than anything else the FDA does. Ideally, the FDA would have independently-generated evidence indicating that the product in question is unreasonably dangerous or ineffective for some intended purpose before issuing a cease and desist order. Instead, they simply assume guilt and place the burden of proof upon the vendor. Given that the FDA has vastly more resources than 23andMe, and companies like it, this makes the FDA seem like bullies against microbusinesses, and like the captured servants of agricultural and pharmaceutical megabusinesses.
mac1175 13y ago
I JUST bought the kit yesterday. The FDA is right though. Imagine making extreme decisions (e.g., double masectomy to avoid breast cancer) based upon the information. This is making me consider cancelling my order.
- logfromblammo 13y ago
  If you are screening for something, the first test should have a low rate of false negatives. Anyone testing positive on that test should take a second--possibly more expensive--test with a low rate of false positives. If you remove big blobs of flesh from yourself on the basis of a single test, you are not making your medical decisions wisely. The only decision you should be making on the basis of 23&Me results is whether to take another test that is more specifically targeted at the potential problem. If 23&Me says you have BRCA, you don't get a double mastectomy. You talk to your doctor. You perform self-exams more often and more thoroughly. You get additional screenings that are not cost-effective for the general public with a lower risk profile. That's the whole point of consumer-grade genetic screening.
  - mac1175 13y ago
    If I did see something that suggested a possibility of something, I would go the direction of what you mentioned in the last paragraph. Although I agree with the FDA's actions, a consumer getting a thorough genetic exam is possibly what prompted this. Check out the artidcle http://www.bloomberg.com/news/2013-11-25/fda-tells-google-backed-23andme-to-halt-dna-test-service.html http://www.bloomberg.com/news/2013-11-25/fda-tells-google-ba.... Turns out United Healthcare raised a concern which I believe is might be money-related. If your test results suggest a high possibility of some health issue from an non-FDA approved company and you requested a more accurate test, then I can see the health insurance companies getting involved.
- esMazer 13y ago
  you would not take serious action in any condition based on an cheap DNA test, would you? I would suspect that it might serve as a possible flag and then you can talk to your doctor to further investigate any issue. Plus 23andme is clear when showing the results that everything is based on probabilities, there's not a single %100 change of anything, it just tells you that people with similar DNA markers (in X, Y or Z study) seem to have a higher/lower chance of X or Y.
matponta 13y ago
That could get interesting... Lots of statups are popping up everywhere with DNA related products..
mbreese 13y ago
Is there anyone else that sees this as a positive thing for the company? They've lived under the cloud of potential FDA regulation for a while, and I'm a bit surprised that it took this long for the FDA to step in. Obviously, it would have been preferable to have the company and FDA work together to announce how FDA regulations apply before an enforcement action. But, now that it has happened, the process has started. If the company can come out of this with some kind of FDA approval, then that cloud will be lifted and they can keep on working. And then the company will know exactly what rules they'll have to play by. So, depending on how things work out, it could end up being a positive for the company. Now that the FDA has played their hand, I'm very curious to know how the company will respond.
FDAnotourfriend 13y ago
If you are changing your meidicene dosage as a result of this test, then please go ahead, and get the STUPID out of the gene pool. Someone has been promised something here and the FDA is getting involved in order to make it happen. Real world example....A small biopharmaceutical company had invented a delivery mechanism to deliver a dopamine agonist (well studied and been around for years) that provided constant drug delivery, relieving the up and down symptoms of Parkinson's disease. There was 98% retention in the Phase 3 trials. The "drug" was submitted to the FDA, along with the $1 million to look at the application, and never approved in the US. Conveniently other well-known US big pharma companies came out with a similar delivery system with new drugs. Someone has the FDA in there hip pocket in this case somewhere.
seehafer 13y ago
I'm most curious to see how 23andMe is going to respond to this, because the more technical-regulatory language in this letter says essentially that in FDA's opinion the device is Class III (the highest risk of all medical device/diagnostics) and would require a PMA, unless 23andMe provides the evidence that allow FDA to de novo classify the device as Class II. A Class III ruling would destroy the personal genomics market, because it would mean extensive clincial testing and documentation about the development of the device. I hope it doesn't stand.
- esMazer 13y ago
  Thank you, and this is the heart of the argument. I also wonder who's behind this push from the agency. It took them 40 years to get the labeling for tylenol right.. http://www.thisamericanlife.org/radio-archives/episode/505/use-only-as-directed http://www.thisamericanlife.org/radio-archives/episode/505/u... They are moving rather quickly on this one... my only question is, why/how??
  - dragonwriter 13y ago
    > It took them 40 years to get the labeling for tylenol right.. [...] > They are moving rather quickly on this one... my only question is, why/how?? You are comparing apples and oranges. It didn't take them 40 years to get to the point where Tylenol had to go through the procedure requiring FDA approval for marketing a drug (which is generally similar in origin to the parallel requirement for medical devices.) Likewise, its quite possible that 40 years from now, there'll have been several rounds of changes to how an equivalent personal genomics kit will be marketed based on changes to what we know between now and then.
mankypro 13y ago
This is simply the result of the medical lobby. This pressure is being put on them simply because it takes power from the gods of medicine. If I order my own bloodwork, (from the same labs that my medical foundation does), somehow the same bloodwork costs me 20% of what it would otherwise. This is about taking away the ability to monitor your own health, in order to enrich the medical community. This will simply result in this type of testing to move beyond FDA borders. Great job FDA, you're helping kill a successful and profitable US company. Un-F-ing-believable.
kefka 13y ago
Why not just put a disclaimer like one you'd see on a late night psychic ad service? "This service is intended for entertainment purposes only." No disclaimer about medical anything. And people pay more than 99$ for psychic services.
brosco45 13y ago
Yeah, that is why we need a Health Freedom Constitutional Amendment.
Sephr 13y ago
Obviously 23andMe results are not a diagnosis from your physician. You should use 23andMe in conjunction with a real physician. For example, I used 23andMe back in 2010 and it told me I had a high risk for a certain genetic condition which I recalled one of my family members having, so I went to see my physician for a real diagnosis, armed with this newly found information. 23andMe helped me catch this early enough with the assistance of my physician that I was able to get treatment long before I would have developed symptoms. If I never used 23andMe I probably would not have had this diagnosed until years later.
- rossjudson 13y ago
  Given https://www.23andme.com/health/all/ https://www.23andme.com/health/all/, I don't think you're considering the negative case properly. If 23andMe's results say you don't have something on their list of 250+ things they're checking for, you might decide against certain treatments or tests based on that. I think it's reasonable for the FDA to tell 23andMe that if they're going to interpret the results for their customers, they need to be able to guarantee the chain of processing is there, and they need to be able to justify each "detection point" their marketing claims. Your outcome is positive. But positive is not the only possibility.
  - Sephr 13y ago
    You are equating false negatives to harmful information, when in reality it is the same as simply not taking the 23andMe test. The only thing 23andme enables you to do is act sooner on things they get right, and any false negatives are irrelevant—you didn't ask for a diagnosis and they aren't claiming to give you a diagnosis. You cannot be harmed by a false negative any more than you will be harmed by not buying a 23andMe kit. > you might decide against certain treatments or tests based on that Since you are mentioning treatments means, you must misunderstand what the purpose of the test is for. If you have current medical problems that you need treatment for, you wouldn't use 23andMe's statistics in order to chose a treatment, you ask your physician to help you get the treatment you need. If 23andMe had a false negative on my condition instead of the true positive, I would still get diagnosed once I started developing symptoms eventually. Nobody who starts having health problems thinks "I should first consult my 23andMe results for things that I should specifically mention to my physician that I don't have".
cliftonk 13y ago
I'm not sure if 23andme's management team is totally out of touch or if they have genuinely mislead the public about their product's effectiveness. I'd assume the latter. They could have easily done periodic check-ins with the FDA to throw them a bone while gathering longitudinal data to support their claims.

338 points by jefffoster 13y ago

When the FDA sends you a letter like this, you either pay a fine and change tactics or you embark on one of the most frustrating approval processes known to the world (all for people's protection.) Good luck with that.

carbocation 13y ago

> Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device. No joking around.

guylhem 13y ago

As usual, the government is trying to meddle with companies. Read the letter, but make no mistake - the "kind" tone, especially when reminding how they did they best to get in touch, have meetings, help insuring compliance etc. is just a decoy. The truth is with "must immediately discontinue marketing the PGS". The gov wants to decide what's best for the people. Should the people decide differently, using their wallets for example, this anomaly will be quashed. This trend is especially strong in the medical field - gov approval required everywhere, then people wonder why medical things are so damn expansive. I use 23andme and I'm happy with the information provided. I know it's not reliable - it's not a lab test anyone will use to base important decisions on, since it is not a full sequence of genes. Yet, by being commercially available and easy to use, it is paving the way for commercial offers of full genome sequencing, which I damn well intend to use when they reach the $500 threshold. However, gov actions like this one may very well make that impossible, making sure the only full genome sequencing offers there will be will be "FDA cleared" at a huge markup. Suggestions to "medical" like companies - get out the gov eye. Move your business to Asia, the caribbean or wherever the gov will not get in your way like this. I want to keep using (and recommending) your products!

oddevan 13y ago
> I know it's not reliable - it's not a lab test anyone will use to base important decisions on, since it is not a full sequence of genes. If they made that more clear, then they wouldn't have had to send the letter. It's why you see "This is not intended to diagnose, treat, or cure any disease" on all the non-FDA-approved supplements/energy drinks. My money is on them paying the fine and scaling back the marketing. The purpose behind these FDA rules are to make sure things aren't marketing as "cures" when they aren't. People's health is serious business; there's no room for failure. If 1.0 doesn't work (or makes things worse), then the people that need it might not live to see 1.1.
- deleted 13y ago
  [deleted]
  - ForHackernews 13y ago
    That's true, but it's not a slam-dunk case for rushing ahead without sufficient testing. There's a reason that "first, do no harm"[1] is considered one of the fundamental principles of medical ethics. Medical interventions can have disastrous side effects.[2] [1] https://en.wikipedia.org/wiki/Primum_non_nocere https://en.wikipedia.org/wiki/Primum_non_nocere [2] https://en.wikipedia.org/wiki/Thalidomide#Birth_defects_crisis https://en.wikipedia.org/wiki/Thalidomide#Birth_defects_cris...
    - twoodfin 13y ago
      I'm curious, are there any other examples than Thalidomide? It's a true horror story, but there should be a limit to how much precaution one disaster justifies in the future. Many other drugs with ultimately fatal but initially undiscovered side effects have made it through FDA approval, too.
      - ForHackernews 13y ago
        > are there any other examples than Thalidomide? A whole lot of people have died from contaminated blood transfusions: http://articles.latimes.com/1994-08-31/news/mn-33183_1_aids-epidemic http://articles.latimes.com/1994-08-31/news/mn-33183_1_aids-... That's another case of a medical intervention ending up doing more harm than good.

geetee 13y ago

I understand the FDA getting pissy if I'm consuming/injecting a substance that may or may not harm me, but why this? I spit in a tube and get some results which may or may not be accurate. Go away, FDA.

DanBC 13y ago
People take action based on the results of the tests. There are different ways to mitigate risk - ensure there's adequate genetic counselling and proper easy to understand information available for anyone taking the tests would be one way. I lean towards favouring tight regulation of medical products. One person's 23andMe genetic test is another person's quackery - see some of the nonsense offered as medical advice by the quacks on other websites.
- ajcarpy2005 13y ago
  Academic science somehow manages to police itself fairly well with peer review processes. Wouldn't this type of paradigm work better than paying for the FDA to go through its approval process? The FDA could still take action if they see that a company is doing something & claiming something that is not properly peer-reviewed and proven. But why create extra red tape for everyone from the get-go?
seehafer 13y ago
For the same reason that the FDA tends to care if an MRI or a CT scanner displays accurate results. People make life/death decisions based on diagnostics.
geetee 13y ago
I don't know how they can be any clearer: "The laboratory may not be able to process your sample, and the laboratory process may result in errors." "You should not change your health behaviors solely on the basis of information from 23andMe." "23andMe Services are for research, informational, and educational use only. We do not provide medical advice." "Genetic research is not comprehensive." All from: https://www.23andme.com/about/tos/ https://www.23andme.com/about/tos/

sqrt2 13y ago

This reminds me of a blog post in German [1] by a person who due to a software bug had been falsely diagnosed by 23andMe with limb-girdle muscular dystrophy. (Fortunately, he was able to identify that it was a misdiagnosis.) It appears that in this case potential misdiagnoses aren't just a theoretical problem. [1] http://www.ctrl-verlust.net/23andme-wie-ich-fur-todkrank-erklart-wurde-und-mich-wieder-gesund-debuggte/ http://www.ctrl-verlust.net/23andme-wie-ich-fur-todkrank-erk...

evan_ 13y ago
23andMe is very clear at every step of the way that it is not diagnosing anything.
- sqrt2 13y ago
  This is what 23andMe said about that person's genome: "Has two mutations linked to limb-girdle muscular dystrophy. A person with two of these mutations typically has limb-girdle muscular dystrophy." Of course this not a diagnosis in a technical sense, but to a lot of people it will sound like it is. Specifically, I don't see how this is "very clearly" not a diagnosis.
- arrrg 13y ago
  Well, the FDA seems to think that 23andMe does market its product as diagnosing something. That’s what this whole letter is about.
- anigbrowl 13y ago
  https://www.23andme.com/store/cart/ https://www.23andme.com/store/cart/ Knowledge is power. 23andMe empowers you to better manage your health and wellness. $99 [Add a kit] There are no disclaimers on this page, just an aphorism, an assertion, and a call to action. Now I like the idea of 23andme, I like the company, and I'm educated and skeptical enough to enjoy some fluffy scientism for a hundred bucks, but don't tell me they're not selling the hell out of this.
mntmn 13y ago
Hi. Original author of that article here. I decided to finally translate the article to english: http://mntmn.com/pages/23andme.html http://mntmn.com/pages/23andme.html

labaraka 13y ago

> 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. I cannot imagine someone getting surgery or chemo solely based on a 23andme heads up warning and without consultation with a specialist physician. As someone working in medical devices, this dramatic language is extremely frustrating.

alanctgardner2 13y ago
That example is a bit severe, but I think the Warfarin compliance example is spot-on. You receive a prescription for a drug, but your magic internet test tells you to take a lower dose, because you're "sensitive". Then you die of an aneurysm because the test was wrong. People are completely stupid when it comes to medical issues. I heard a woman complaining that she couldn't eat honey because she was allergic to fructose. I work with at least 3 "gluten-sensitive" people (it's pretty unlikely they all have Celiac disease, it's not a big office), because it's a hip thing to do. Hell, didn't Angelina Jolie have a prophylactic double mastectomy? edit: Since everyone is jumping on the Angelina Jolie example. I don't think her decision was made based on a single spit test. And I think she had doctors advising her. But the amount of publicity it got makes me worry that it could become needlessly popular based on self-diagnosis (like not eating gluten).
- RobAtticus 13y ago
  >Hell, didn't Angelina Jolie have a prophylactic double mastectomy? The placement of this in your post seems to imply you think she was being stupid with her decision, or thought it was in some way "hip" to do. She has a family history of breast and ovarian cancer and has a defective gene that made her chances of getting breast cancer 87%. As she's pretty wealthy, I'm going to guess that she has pretty good doctors and didn't make the decision on a whim. Also since it was major surgery I'm going to also assume some doctor saw her at least once before the surgery and s/he didn't just take her word for it that the surgery was in her best interest. Yes there are plenty of people who don't have a clue when it comes to medical issues, but I'm not sure why you felt the need to lump Jolie in with your other examples.

slashdotaccount 13y ago

Is there a list of government agencies IP addresses? I would like to block them from accessing my sites. And write in the ToS that they are not allowed to browse and read more.

jchung 13y ago
I am not a lawyer but... I don't think that's going to have the effect you think it will
Sanddancer 13y ago
No. Also, the government has the right to claim sovereign immunity in cases, especially in any sort of civil/criminal investigation.
ChikkaChiChi 13y ago
There are assigned blocks, but this will not do what you think it will.

deleted 13y ago

[deleted]

javert 13y ago

More evidence that we live in a very mixed economy, not under free market capitalism. Government agencies empowered to weild regulatory force against citizens are a threat to everyone, and this is case in point.

gnaritas 13y ago
Good.
- javert 13y ago
  You don't have the right to boss me around. You are advocating putting up roadblocks between me, and my pursuit of values, and you should feel bad. (I do mean this with a hint of jocularity.)
  - gnaritas 13y ago
    Says you, but we don't live in a society where everyone gets to make their own rules. As a country, we've decided we do have the right to boss you around, so we do. :)
    - javert 13y ago
      There is no logical chain of facts, starting with concrete perception of reality, that leads to the conclusion that society gets to coerce me. So, no, you do not have the right to coerce me. However, there is a logical chain of facts, starting with concrete perception of reality, that leads to the conclusion that we should establish government for protection from coersion. Society can pass a law to coerce people---at its own peril.
      - gnaritas 13y ago
        I see your problem, you think logic matters, it doesn't, this isn't that world. In this world, numbers matter, votes, not logic. Rights are a social construct, we have whatever rights we've all agreed we have and no more. Any talk about natural rights and logic and positive vs negative rights is just that, meaningless talk; policy comes from those who acquire power, not those with the best arguments and facts. > Society can pass a law to coerce people---at its own peril. Look around, turns out it's not really perilous at all. It's actually the normal way the world works.

sethbannon 13y ago

The tone of the letter was surprising to me. I wouldn't expect the FDA to go quite so far in explaining the why behind the desist letter. I suppose that's because it was written just as much for public consumption as it was for 23andMe.

rayiner 13y ago
It's written for consumption by 23andMe's lawyer. This format is typical.
jfasi 13y ago
The most common sort of cease and desist letters we tech people are accustomed to are DMCA and patent-related. These letters are typically meant as precursors to private litigation. They are often sent out with commercial considerations in mind, and so tend to be light on details in order to be more threatening. The FDA is a regulatory agency, which implies that their mission is less about intimidation and more about protecting the public good. Hence the more open tone, I suspect.
dragonwriter 13y ago
> The tone of the letter was surprising to me. I wouldn't expect the FDA to go quite so far in explaining the why behind the desist letter. Its fairly typical of formal regulatory notices (or even informal notices -- much of the language is very similar to the 2010 letter in which the FDA first raised issues with the product) -- because they are typically directed at corporations with substantial legal resources and they are designed to convince them that they should voluntarily comply with the agencies direction because if they fail to do so regulatory action will be initiated which will be costly and unlikely to be reversed by subsequent litigation, so they lay out all the facts and authorities necessary for the recipient (and the recipient's counsel) to come to the desired conclusion.

btilly 13y ago

Silicon Valley "It is better to ask for forgiveness" culture meets the worst of government "We'll need that in triplicate 5 years in advance of starting to look at the paperwork." This should be interesting, if you have the patience to watch the fallout in slow motion.

seiji 13y ago
At least the FDA has teeth even if the SEC lets startup financiers play billionaire shenanigans all the time and get away with it.

SCAQTony 13y ago

Never once did they attack the technology but rather the potential for error or the consequences if the public "can't handle the truth." The closest they come to calling her a "quack" is when they state "...We still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses..." The bigger question is why is the FDA having a seizure over this? Could it be the potential for added treatment and preventative healthcare measures that insurers vis a vis the Affordable Care Act and not looking forward to paying for? (Not a rhetorical question, just asking)

rafcavallaro 13y ago
False. Read the letter carefully. They're specifically concerned with false positives and false negatives - these are both very real possibilities - one is documented up thread.
aeturnum 13y ago
I think the line of reasoning makes sense: people will make medical decisions based on this information, but 23andme has never given us any reason to (or not to) believe their tests are accurate. Without someone reviewing their process, their error rate is unknown. That can be dangerous. This is similar to the problem with many alternative medicine claims. 'Alternative medicine' may be very helpful to an individual, but it's important not to overstate its effectiveness or reliability.
- dnautics 13y ago
  how would you define 'error rate'? Do you mean "lab handling error rate"? Or "information presenting" error rate? The way 23andMe works, is they run your DNA and they show "percentages" based on already done studies. Then they throw in caveats (like, if you're not of the correct race relative to what the study was done in). So what would you suggest? That the service track all of their users over a long-term and then see whether the percentage of their users that get condition X matches the percentage they predicted? And then do some sort of statistical analysis on a possibly moving number (because 23andMe updates their information if academic science improves) with a population that might turn out to have differing biases...? And then prove this information over what, 100000 SNPs on the chip? What you are basically arguing is that 23andMe should not be allowed to offer its service.

crb002 13y ago

CMS/HHS will look like idiots as mRNA sequencing dips below the $100 per test price point and doctors for the first time will have a histogram of genes turned on for use in their diagnosis. Instead of whinging, FDA needs to partner with NIST to come up with quality control protocols so doctors know the error distribution in data that they receive.

rmrfrmrf 13y ago

Anyone who thinks the FDA is overreaching here has little awareness of how stupid the majority of the world's population is. The people that this protects don't know how to even read this statement from the FDA. Perhaps the startup echo chamber has more respect for unchecked opportunism; if that's the case, someone should make a startup called 23andMeFree (monetized by ads, duh) that has you spit in a tube, send it to some PO Box, then randomly generate positive and negatives across the board. If you wanted the scam to last longer, you could even generate random values based on statistics of certain characteristics. A true libertarian must support such a business.

webXL 13y ago
As part of the world's population, isn't there a high chance that the FDA contains some fraction of the "stupid" majority? Is it possible that a majority of the FDA could be labeled "stupid"?
jessaustin 13y ago
A true libertarian must support such a business. I'm not sure that libertarianism is coherent enough to admit the existence of "true" adherents, but surely you mean to say that a "true libertarian" must not support the outlawing of such a business? Typical libertarians often display preferences among businesses. E.g., a libertarian might prefer Taco Bell to Panera Bread.
- Xdes 13y ago
  It's a matter of libertarianism being very broad rather than incoherent. They are more divided on economic issues than social issues.
  - webXL 13y ago
    The classic definition is what most people think of: socially liberal, fiscally conservative. These two ideas are coherent because they both require minimal intervention on the part of the state. But libertarians are often attacked for not supporting equal individual rights, which does require forceful intervention by a state. This dichotomy is what non-libertarians have trouble understanding. And when something is poorly understood, it is often vilified. Edit: this should have been posted under the post above, but I meant to take issue with your comment on the division on economic issues. The only division I've seen is tactical, not philosophical. Can you provide an example of a deep philosophical division?

saalweachter 13y ago

I'd like to point out that -- as much as I'm sure most people love 23andMe -- it's not really a scrappy start-up. It's a nearly 8 year old company which has received something like a hundred million in funding. So this isn't really a case of the gov't stomping on the little guy before he has a chance to grow; 23andMe has had its chance to grow into a fairly big deal, and now it's time to start playing by the rules.

ig1 13y ago
The average drug costs around a billion dollars to bring to market and decades in development and approval. 23andme might not be a small fish by internet standards, but they are by medical industry standards.
- icegreentea 13y ago
  But 23andme do not make drugs. They do diagnostic tests. The cost of development for those are much lower. 23andme aren't giants in that field for sure, but they're pretty big. It's absolutely nonsensical to compare them to a drug company.
  - VLM 13y ago
    "They do diagnostic tests." More specifically they are busted for interpreting diagnostic tests not doing the tests. If they were two cooperating companies, and one did tests and squirted out results and the other sold diagnostic and interpretive services, the diagnostic services company would be busted but the test company would not be in trouble, as I interpret it at this time. Skip all the exotic genetic issues and think about personal experiences with something boring, like blood pressure. No legal problem with testing someones blood pressure and giving them numerical results and maybe a medically sane set of typical ranges. My local pharmacy has a machine that does it for free. However, it would be a big issue for a non-MD using that data to diagnose high blood pressure, or a high likelihood of it anyway, then providing some treatment plans. The issue seems to be selling services. If they just did testing, and provided a free downloadable immense data set and some statistical analysis tools and let the user come up with their own interpretations, they'd probably be in the clear (at least with respect to this individual problem). Now having a cloud service to hold the data and do the math is getting gray area ish but probably still OK as long as its the end user drawing the conclusions and not "the company" drawing the conclusions.

k-mcgrady 13y ago

Am I the only one this seems completely reasonable to? There are probably people who take action over the results they get from the service and if the results are incorrect the actions could have negative impact on their health. Therefore the service should have to prove the results are accurate before advertising it as a first step in prevention.

wissler 13y ago
As if the FDA were qualified to make such determinations.
Glyptodon 13y ago
Probably. I think most people view their service as fun thing that comes back with results that, if revealing of a concern, would cause you to seek proper and more detailed testing from a real medical practitioner. It's not like a physician prescribes a 23 & me writeup.
- rayiner 13y ago
  > I think most people view their service as fun thing that comes back with results that, if revealing of a concern Take this thought, and replace "some people" with "my mom" and see if it still results in the same conclusion.
  - Glyptodon 13y ago
    Yep. I'm pretty sure she'd view it along the same lines as one of those 'reveal the breeds of your mutt' dog DNA tests.
  - crusso 13y ago
    Literally, my mom is the one who got me to send off my spit to 23andMe. She thinks it's fun and interesting but at no point has she indicated that she's thinking of it as a medical service - especially not one that replaces seeing a doctor.
- dragonwriter 13y ago

DennisP 13y ago

I wonder whether a company could bypass the FDA by simply giving people their genome data, without any interpretation or diagnosis, which could be left up to people's doctors, opensource software, etc.

judk 13y ago
That is a far less marketable product. Most customers couldn't interpret that data.

boonez123 13y ago

Owner is married to the founder of google. I think they'll be okay. :)

RankingMember 13y ago
Was
judk 13y ago
Divorcing.

drakaal 13y ago

The back story is 23andMe declined a federal request for a customers DNA. This was the government backlash as a result of protecting user privacy.

dkordik 13y ago
Source?
ben1040 13y ago
Do you have a source for this?
ska 13y ago
That is highly improbable. This action is a core function of what the FDA does.
- drakaal 13y ago
  And the FDA has been in talks with them since 2009, and with out notice changed its position.
  - ska 13y ago
    That's not true. The FDA position is unchanged. They have been in talks since 2009 to help 23andme understand what they need to file, and how to do it. 23andme has (repeatedly, it sounds like) failed to do that. This notice is a standard corrective action taken by the FDA after failure to complete 510(k) submissions.

ChikkaChiChi 13y ago

If you believe 23andMe is a sound source for the clinical diagnosis of medical conditions, you're probably not going to read the fine print telling you otherwise.

aabalkan 13y ago

It's been years since 23andMe is out and FDA just noticed? Or am I getting it wrong?

mmcnickle 13y ago
It's generally considered good form to read the article before posting. It's clear from the notice that the FDA known about 23andMe from the outset.
carbocation 13y ago
If you read the article, you will see the large paragraph outlining the dozens of in-person meetings and hundreds of emails that the FDA has exchanged with 23andMe. What you are noticing is a government agency that has exercised restraint for years, not one that was aloof.

pilom 13y ago

Summary: 5 years ago, 23andMe started marketing a test for among other things a BCRA indicator July and Sept 2012 - 23andMe submits a form to the FDA saying "our test isn't really useful for diagnosis and thus shouldn't fall under these rules" Nov 2012 - FDA says we don't agree with you you need to either prove your effectiveness or change your marketing Jan 2013 - 23andMe says "it will take us a couple months to do the tests, we'll get back to you" Nov 2013 - FDA says, "its been 11 months and you never got back to us. Stop selling and let us know within 15 days what you're going to do explicitly because you ignored us for close to a year"

seehafer 13y ago
Exactly. I am no fan of the FDA, but what 23andMe did here was extraordinary: they essentially ignored the agency. If Anne Wojcicki was CEO of a similarly-sized medical device company she would have gotten her walking papers today.
- duncan_bayne 13y ago
  Extraordinary, and praiseworthy IMO.
  - pilom 13y ago
    Why is ignoring a government agency when they ask you to follow the law praiseworthy? The law says you cant market a diagnostic test without testing to know the accuracy of the test. I don't want to praise the snake oil salesmen who would also want to break this law so why should I praise what 23andMe did?
    - duncan_bayne 13y ago
      Because, in this case, the Government agency and the laws they enforce are unconstitutional, and actually harm the people they're supposed to be protecting.
      - 13y ago

jfasi 13y ago

This seems absolutely reasonable. The letter indicates that the FDA has notified 23andMe that their products are not satisfactorily cleared, they're reached out to them several times, and they've offered assistance through a group they specifically set up to help companies in this situation. Meanwhile, 23andMe went ahead and began marketing and selling their product, despite the FDA's concerns. Relevant quotes: > Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions. > 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 > 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; ... > ...we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification. > 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... > 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.

tptacek 13y ago
Moreover, it appears from the letter that the concerns are about marketing; ie, presumably the FDA was simply asking for 23AM to clarify their copy to remove any implication that you could use the product as a substitute for a doctor's assessment of your e.g. cancer risk.
- icegreentea 13y ago
  It's actually kind of hard to tell -exactly- what the FDA wants without reading the original 510(k) submission. The claims by the FDA directly tie into the original claims by 23andMe as their intended use. In any case, the FDA right now doesn't just want a change of copy. By "cease marketing", I presume they don't mean advertise it differently, they mean stop offering the product to customers - period. While the FDA certainly appears to be taking issue with the specific marketing copy, they seem to be more annoyed that 23andMe has basically failed to complete the regulatory submission process - amongst other things failing to provide evidence to the FDA that their product actually works as intended.

FrankenPC 13y ago

Magic sentence: "For entertainment purposes only"

smackfu 13y ago
Well yeah, they could totally get rid of the health part of their product and only report on ancestry, and I think the FDA would be perfectly fine with that.

bhartzer 13y ago

You would think that before putting in so much money, time, and effort into 23andMe they would have had discussions with the FDA and actually responded with more information. I'm amazed that it didn't happen.

tomelders 13y ago

Well I suppose that now that all the food is safe to eat, they've got time on their hands to take down the sinister corporate bad guys behind 23&Me.

jheriko 13y ago

I have to agree that this seems completely reasonable... glad to see so few commenters jumping to the expected conclusion that this is some kind of government oppression.

deleted 13y ago

[deleted]

mkramlich 13y ago

When evaluating startup risks/events there needs to be a standard term or acronym for "doesn't matter; spouse is multi-billionaire."

patrickg_zill 13y ago

Crap... I better buy the test for an older relative (84) like I have been saying I would, pronto. Before the FDA gets its hooks into it and the price goes up...

logfromblammo 13y ago

It is only reasonable in the context of the standard operating procedures of the FDA. As this is essentially prior restraint upon speech and/or trade, it is unreasonable, but no more unreasonable than anything else the FDA does. Ideally, the FDA would have independently-generated evidence indicating that the product in question is unreasonably dangerous or ineffective for some intended purpose before issuing a cease and desist order. Instead, they simply assume guilt and place the burden of proof upon the vendor. Given that the FDA has vastly more resources than 23andMe, and companies like it, this makes the FDA seem like bullies against microbusinesses, and like the captured servants of agricultural and pharmaceutical megabusinesses.

mac1175 13y ago

I JUST bought the kit yesterday. The FDA is right though. Imagine making extreme decisions (e.g., double masectomy to avoid breast cancer) based upon the information. This is making me consider cancelling my order.

logfromblammo 13y ago
If you are screening for something, the first test should have a low rate of false negatives. Anyone testing positive on that test should take a second--possibly more expensive--test with a low rate of false positives. If you remove big blobs of flesh from yourself on the basis of a single test, you are not making your medical decisions wisely. The only decision you should be making on the basis of 23&Me results is whether to take another test that is more specifically targeted at the potential problem. If 23&Me says you have BRCA, you don't get a double mastectomy. You talk to your doctor. You perform self-exams more often and more thoroughly. You get additional screenings that are not cost-effective for the general public with a lower risk profile. That's the whole point of consumer-grade genetic screening.
- mac1175 13y ago
  If I did see something that suggested a possibility of something, I would go the direction of what you mentioned in the last paragraph. Although I agree with the FDA's actions, a consumer getting a thorough genetic exam is possibly what prompted this. Check out the artidcle http://www.bloomberg.com/news/2013-11-25/fda-tells-google-backed-23andme-to-halt-dna-test-service.html http://www.bloomberg.com/news/2013-11-25/fda-tells-google-ba.... Turns out United Healthcare raised a concern which I believe is might be money-related. If your test results suggest a high possibility of some health issue from an non-FDA approved company and you requested a more accurate test, then I can see the health insurance companies getting involved.
esMazer 13y ago
you would not take serious action in any condition based on an cheap DNA test, would you? I would suspect that it might serve as a possible flag and then you can talk to your doctor to further investigate any issue. Plus 23andme is clear when showing the results that everything is based on probabilities, there's not a single %100 change of anything, it just tells you that people with similar DNA markers (in X, Y or Z study) seem to have a higher/lower chance of X or Y.

matponta 13y ago

That could get interesting... Lots of statups are popping up everywhere with DNA related products..

mbreese 13y ago

Is there anyone else that sees this as a positive thing for the company? They've lived under the cloud of potential FDA regulation for a while, and I'm a bit surprised that it took this long for the FDA to step in. Obviously, it would have been preferable to have the company and FDA work together to announce how FDA regulations apply before an enforcement action. But, now that it has happened, the process has started. If the company can come out of this with some kind of FDA approval, then that cloud will be lifted and they can keep on working. And then the company will know exactly what rules they'll have to play by. So, depending on how things work out, it could end up being a positive for the company. Now that the FDA has played their hand, I'm very curious to know how the company will respond.

FDAnotourfriend 13y ago

If you are changing your meidicene dosage as a result of this test, then please go ahead, and get the STUPID out of the gene pool. Someone has been promised something here and the FDA is getting involved in order to make it happen. Real world example....A small biopharmaceutical company had invented a delivery mechanism to deliver a dopamine agonist (well studied and been around for years) that provided constant drug delivery, relieving the up and down symptoms of Parkinson's disease. There was 98% retention in the Phase 3 trials. The "drug" was submitted to the FDA, along with the $1 million to look at the application, and never approved in the US. Conveniently other well-known US big pharma companies came out with a similar delivery system with new drugs. Someone has the FDA in there hip pocket in this case somewhere.

seehafer 13y ago

I'm most curious to see how 23andMe is going to respond to this, because the more technical-regulatory language in this letter says essentially that in FDA's opinion the device is Class III (the highest risk of all medical device/diagnostics) and would require a PMA, unless 23andMe provides the evidence that allow FDA to de novo classify the device as Class II. A Class III ruling would destroy the personal genomics market, because it would mean extensive clincial testing and documentation about the development of the device. I hope it doesn't stand.

esMazer 13y ago
Thank you, and this is the heart of the argument. I also wonder who's behind this push from the agency. It took them 40 years to get the labeling for tylenol right.. http://www.thisamericanlife.org/radio-archives/episode/505/use-only-as-directed http://www.thisamericanlife.org/radio-archives/episode/505/u... They are moving rather quickly on this one... my only question is, why/how??
- dragonwriter 13y ago
  > It took them 40 years to get the labeling for tylenol right.. [...] > They are moving rather quickly on this one... my only question is, why/how?? You are comparing apples and oranges. It didn't take them 40 years to get to the point where Tylenol had to go through the procedure requiring FDA approval for marketing a drug (which is generally similar in origin to the parallel requirement for medical devices.) Likewise, its quite possible that 40 years from now, there'll have been several rounds of changes to how an equivalent personal genomics kit will be marketed based on changes to what we know between now and then.

mankypro 13y ago

This is simply the result of the medical lobby. This pressure is being put on them simply because it takes power from the gods of medicine. If I order my own bloodwork, (from the same labs that my medical foundation does), somehow the same bloodwork costs me 20% of what it would otherwise. This is about taking away the ability to monitor your own health, in order to enrich the medical community. This will simply result in this type of testing to move beyond FDA borders. Great job FDA, you're helping kill a successful and profitable US company. Un-F-ing-believable.

kefka 13y ago

Why not just put a disclaimer like one you'd see on a late night psychic ad service? "This service is intended for entertainment purposes only." No disclaimer about medical anything. And people pay more than 99$ for psychic services.

brosco45 13y ago

Yeah, that is why we need a Health Freedom Constitutional Amendment.

Sephr 13y ago

Obviously 23andMe results are not a diagnosis from your physician. You should use 23andMe in conjunction with a real physician. For example, I used 23andMe back in 2010 and it told me I had a high risk for a certain genetic condition which I recalled one of my family members having, so I went to see my physician for a real diagnosis, armed with this newly found information. 23andMe helped me catch this early enough with the assistance of my physician that I was able to get treatment long before I would have developed symptoms. If I never used 23andMe I probably would not have had this diagnosed until years later.

rossjudson 13y ago
Given https://www.23andme.com/health/all/ https://www.23andme.com/health/all/, I don't think you're considering the negative case properly. If 23andMe's results say you don't have something on their list of 250+ things they're checking for, you might decide against certain treatments or tests based on that. I think it's reasonable for the FDA to tell 23andMe that if they're going to interpret the results for their customers, they need to be able to guarantee the chain of processing is there, and they need to be able to justify each "detection point" their marketing claims. Your outcome is positive. But positive is not the only possibility.
- Sephr 13y ago
  You are equating false negatives to harmful information, when in reality it is the same as simply not taking the 23andMe test. The only thing 23andme enables you to do is act sooner on things they get right, and any false negatives are irrelevant—you didn't ask for a diagnosis and they aren't claiming to give you a diagnosis. You cannot be harmed by a false negative any more than you will be harmed by not buying a 23andMe kit. > you might decide against certain treatments or tests based on that Since you are mentioning treatments means, you must misunderstand what the purpose of the test is for. If you have current medical problems that you need treatment for, you wouldn't use 23andMe's statistics in order to chose a treatment, you ask your physician to help you get the treatment you need. If 23andMe had a false negative on my condition instead of the true positive, I would still get diagnosed once I started developing symptoms eventually. Nobody who starts having health problems thinks "I should first consult my 23andMe results for things that I should specifically mention to my physician that I don't have".

cliftonk 13y ago

I'm not sure if 23andme's management team is totally out of touch or if they have genuinely mislead the public about their product's effectiveness. I'd assume the latter. They could have easily done periodic check-ins with the FDA to throw them a bone while gathering longitudinal data to support their claims.