32 ms·
I'm surprised at the negativity here. There is nothing conclusive about this test and from what I've seen it does a pretty good job. So one guy got some bad i
by IanDrake 13y ago
I'm surprised at the negativity here. There is nothing conclusive about this test and from what I've seen it does a pretty good job. So one guy got some bad indicators that proved to be nothing, who cares?
My father did 23 and me, without giving any family medical history and it concluded that my father was at a much higher risk factor for things that his mother was ultimately afflicted with. So, it works to some extent.
On the flip side, long story short, I had a CT scan done on my chest that checked out fine, but the doctor that reviewed it said I might have and unrelated problem - Patent Ductus Syndrome. Nothing heart surgery and a lifetime of supply of Coumadin couldn't fix. A few months later I got an Echocardiogram which conclusively said the doctor was wrong.
Quick, stop doing CT scans!!!??? Are we're all so afraid of our own shadow that heroes at the FDA need to protect us?
- bdcravens 13y agoWe expect our employers to triple-check everything they say in the fear that they might say something that could possibly be construed as sexist or racist or harassing. Our teachers aren't allowed to offer our children honest critiques for fear that they'll crush their poor little self-esteems. A genetic diagnostic can completely crush a person's outlook on life. This is suicide-level stuff potentially. As for your doctor, do you still happily use that doctor and recommend them? The scan wasn't the problem; the service provider was. Ditto for 23AndMe. They don't get a free pass because they're a "tech" company.
- FiloSottile 13y agoYeah, all doctors, as humans, and systems, as machines, make mistakes. What counts is statistics, and negligence. Are stats about this test/doctor worryingly bad compared to the average? Are the mistakes caused by negligence? If not, I'll happily use that doctor/service again. I have far more problems with the growing perceived need to have employers triple-check everything they say, teachers avoid honest critiques and distrust any new technology that kills N people when the old one killed 10N (re: Tesla fires).
- mcherm 13y ago> We expect our employers to triple-check everything they say in the fear that they might say something that could possibly be construed as sexist or racist or harassing. Our teachers aren't allowed to offer our children honest critiques for fear that they'll crush their poor little self-esteems. Some people do these things. But I believe that they are overreacting, and from your phrasing so do you. So why are you proposing that health data be held to such absurd (and unhealthy) standards? > A genetic diagnostic can completely crush a person's outlook on life. This is suicide-level stuff potentially. Then the person has serious mental issues. I'm not saying that hearing you are susceptible to a serious disease should slide off like water from a duck's back, but if a person feels that learning a medical diagnosis may cause them to commit suicide, then under no circumstances should they engage a company like 23AndMe that clearly states up front that they will NOT be providing counseling. As far as I can tell, no one INCLUDING 23AndMe is proposing that they get a "free pass". In this case @mntmn reported their error to them and they corrected it, not just for him but for ALL future patients. That is better than most doctors do when THEY find an error.
- veemjeem 13y agoWhen a doctor misinterprets the results, it can be mentally destructive for everyone, even if you're completely stable. When my dad's doctor told him he had cancer, it completely changed all of our family gatherings. Thankfully the diagnosis was wrong (it was some hospital paperwork mess-up), but in a short period of time, all of us were contemplating about losing him. I considered quitting my job so I could stay with him. It's definitely a good thing to get a second opinion from another doctor, but misinformation does have the capability to crush everyone's lives.
- mkopinsky 13y agoThe lesson here is don't use shoddy diagnostics. CT is a proven technology, which gets things right the vast majority of the time, and also has a false positive rate. 23andMe is relying on technologies or algorithms that have not undergone the requisite scrutiny to lose the label (in the FDA's opinion) of "shoddy diagnostics", and are thus far more likely to have a higher false positive or false negative rate.
- fidotron 13y agoIsn't the lesson here not to rely on any one source of diagnosis? There have always been differing medical opinions, so allowing patients to cheaply sample many in order to rapidly get to the end is better than having a one off rarely in practise used test because it's prohibitively expensive. The FDA are simply enforcing the medical industry monopoly on diagnosis. You can expect any potentially disruptive effort along these lines to also mysteriously fail to ever be approved.
- DanBC 13y ago> The FDA are simply enforcing the medical industry monopoly on diagnosis. 23andMe could sell their product as not being diagnostic. Since 23andme chose to sell their product as being diagnostic it's fair enough that their held to the same level of regulation as everyone else in the sector.
- nkriegel 13y agoThey explicitly did not. From their TOS: As a result of the current state of genetic knowledge and understanding, our Services are for research, informational, and educational purposes only. The Services are not intended to be used by the customer for any diagnostic purpose and are not a substitute for professional medical advice.
- domdip 13y agoThe TOS is irrelevant if they're elsewhere making diagnostic claims.
- hacker789 13y agoIf the banning of CT scans would save just one innocent life, it would be worth it.
- FiloSottile 13y agoHow many innocent lives the banning of CT scans would kill?
- IanDrake 13y agoAnd now you're starting to get it.
- outworlder 13y agoOnly if the ban didn't kill more people than it saved, which it likely would.
- TrainedMonkey 13y agoYes well done, seeing that article actually made me order scans for entire family. Why? Because at this point technology seems fairly stable if public outcry is directed at easily correctable and easy to miss during implementation bug. This is `future` tech right here - you get a glimpse into your own DNA. What kind of Engineer would I be if I was not a little bit curious about it? Note: I am firm believer in Eugenics, so I might be a bit biased. Edit: there seems to be a confusion about Eugenics, so to clarify I do not believe in Negative Eugenics/Positive Eugenics (which is not letting people breed/letting only fittest breed). What I believe in that if given a choice of 2 partners (Does not matter who, your choice), if you pick the one who will minimize risk of the offspring inheriting genetic diseases, that is enough to make positive progress in Humanity's gene pool. If at least fraction of people follows that logic, it should be possible to measurable reduce inheritable diseases within few generations.
- conanite 13y ago> I am firm believer is Eugenics Eugenics means requiring inferior people to not reproduce. There are some problems implementing this requirement. Do you mean something else?
- vehementi 13y ago> There are some problems implementing this requirement. Diplomacy score of 100
- bmelton 13y agoI am not into eugenics, and I'm not the poster you're responding to, but eugenics, as a theory, is perfectly harmless, until such time as one begins imposing eugenic criteria for others. Given his interest in his own genetic data, and his interest in eugenics, it could well just be that he sees himself as less likely to reproduce if doing so would be to pass along a detrimental illness or genetic abnormality.
- TrainedMonkey 13y agoOr you pick a partner with DNA to minimize chance of inheritable genetic diseases by offspring.
- adwf 13y agoI'm told this is why doctors don't typically go on "fishing expeditions". They could order an array of tests every time you go for a checkup. But given the false positive rate combined with only vague symptoms (eg. occasional headache, stomach ache, joint pain), which could be almost anything - it's frowned on to go looking unless there are very specific symptoms or large degrees of discomfort/pain. Of course in a health system where every check and scan can involve large amounts of profit...
- hashmymustache 13y agoDefinitely true that labs/imaging without good pretest probability or indications are frowned upon. The check everything mentality, at least to me, seems to reflect liability concerns for serious missed diagnoses as opposed to profit scheming. Many of these fishing expeditions are in emergent care settings where the hospital ends up eating most of the cost.
- adwf 13y agoYeah I was probably being a little snarky there. I'm sure that the vast majority of doctors, even in profit-making systems, are just trying to do the right thing. But there's no reason the less scrupulous ones couldn't be doing it for both reasons ;)
- Amadou 13y agoI'm sure that the vast majority of doctors, even in profit-making systems, are just trying to do the right thing. This 2009 article looks at what happens when doctors invest in medical facilities. It doesn't even have to be overt, it's just an incentive that can warp the perspectives of even the most patient-focused doctors. McAllen Texas has the 2nd highest medicare costs in the country, but the next town down the road is much closer to the norm. Guess what the difference is... http://www.newyorker.com/reporting/2009/06/01/090601fa_fact_gawande?currentPage=all http://www.newyorker.com/reporting/2009/06/01/090601fa_fact_...
- deleted 13y ago[deleted]
- booyaa00 13y agoI think the takeaway here is stop worrying about your health at such a silly level. Live a good healthy lifestyle, free from stress, smoking, have a balanced diet, plenty of exercise. If you go in search of a "diagnosis", you'll get one. Everyone will. 23 and me is an awful thing to do IMHO. It preys on people and turns them into hypercondriacs (For a fee).
- robododo 13y agoUnless you're adopted and you want some sort of information where you have none. In that case, isn't it prudent to attempt to gather data on your genetics? It's extremely frustrating when doctors/nurses/PAs ask me about family history and I tell them I was adopted. It shuts out an entire channel of potentially helpful information.
- DanBC 13y ago> So one guy got some bad indicators that proved to be nothing, who cares? The people who get incorrect results and who then go and do things based on those results - don't have children or do have surgery or etc. > Quick, stop doing CT scans You have a CT scan when there's something wrong and you need a diagnosis. Pre-emptive CT scans are not recommended. That's because there's so much stuff that might show up but which is totally harmless. But, because you've seen it now you need to do something about it, and those tests carry some risk. Just the stress of "shadows" is considerable. See, for example, CT scans that show rubella scarring, which is something the patient would not know about until they get the CT scan.
- maratd 13y ago> The people who get incorrect results and who then go and do things based on those results A person who makes life decisions based on tests conducted through the Internet is gullible. No amount of government intervention will keep this person from a world of pain and misery.
- smackfu 13y agoMuch of the FDA's purview is protecting these kind of people.
- maratd 13y agoYup. It's a Sisyphean task. You can't protect a person from themselves. The FDA should focus on requiring disclosure of relevant information and the accuracy of that information, rather than guaranteeing safety or making value judgments.
- jstandard 13y agoIt sounds like you misunderstand the 23andMe service. TESTS aren't conducted "through the internet" they're conducted in the 23andMe lab by analyzing your saliva and hence your DNA. Your RESULTS are available "through the internet", which is the equivalent of a clinic emailing you the results of your blood tests. I think it's fair to question the validity of their technology (if the Illumina chips and matching algos are doing their job), but that's a different argument.
- niels_olson 13y ago> Are we're all so afraid of our own shadow that heroes at the FDA need to protect us? Hi, physician here. No, that's not why you need the FDA. You need the FDA to protect you for all sorts of reasons. It is not possible for a non-physician to be an informed healthcare consumer. Everything from not marketing methamphetamine to high school students, to ensuring your brain doesn't get cooked by a bug in a CT scanner's software. There are a lot of ways to die. But on a scale of 1 to 10, death is an 8. Wait till it's your kid. I had a conversation with a libertarian friend of mine recently: Me: "If you like libertarianism so much, why not just move to Somalia?" Him: "Hey, just make sure you're the one with an AK" Me: "Who's standing watch when you sleep? Where are they looking?"
- COMS 13y agoHow does Somalia represent classical liberalism? (If you assume that libertarianism is a subset of classical liberalism.) Also, how does saying that the federal government doesn't have the authority to create the FDA or manage healthcare imply that I'm against traffic lights? (To reference another commonly said argument.) I like the FDA and federal healthcare services but I believe, technically, there should be an amendment to the Constitution for them to exist.
- IanDrake 13y ago>It is not possible for a non-physician to be an informed healthcare consumer. Are you sure, because I used webMD to diagnose my spontaneous pneumothorax. Went to the clinic told them as much, they laughed. Finally ended up doing a chest x-ray after which a very stern faced doc walked up to me and said, "Sorry, we've never seen this here before. You need to go to the hospital right now." That was the longer part of the story about the ct scan which was done post-recovery to look for blebs.
- ogreyonder 13y agoSame thing here. Personal story short, I discovered--thanks to the internet--that having hypothyroidosis and taking L-Carnitine [1] can cause rhabdomyolysis and acute kidney damage. 3 doctors completely missed huge warning signs and prescribed strong antibiotics in spite of the fact that there was no evidence of infection. It was only thanks to my being an informed healthcare consumer that I prevented a very bad weekend. I think it's possible for non-physicians to make informed decisions. I would also say that many want to have someone to blame. In my case, though, blaming someone doesn't help much when your kidneys die. I'd argue that a $100 DNA test is not a diagnosis tool. It's like a friend looking at your skin and saying 'hey, you should get that mole checked out'. [1] In the form of Pantothen, the "Natural Acne Cure". Yeah.
- ska 13y agoFor what little it's worth am somewhat surprised at the naive misrepresentation shown by many here of what the FDA does, how they do it, and what they are actually expressing in this case.
- mikeash 13y ago"Are we're all so afraid of our own shadow that heroes at the FDA need to protect us?" Well, yes. You can try to make it look like a bad thing by using loaded language, but yes, the whole point of the FDA is to protect us from problems like this. Medicine is complicated. It's also a very poor fit for free markets, because it tends to be filled with monopolies and because free markets require informed participants and the extreme complexity of medicine makes that impossible for most. Historically, large numbers of people and companies have had no compunctions with taking advantage of this to defraud a lot of people, frequently while causing them pain or death. The FDA is intended to fix that. It may not succeed, or may not succeed well, but yes, this stuff is dangerous and we are afraid of it to the extent that we want an agency to protect us.
- crusso 13y agoIt may not succeed, or may not succeed well, but yes, this stuff is dangerous and we are afraid of it to the extent that we want an agency to protect us. It may not work, but we want an agency to protect us. Lots of people make similar comments regarding the TSA.
- tokenizer 13y agoOr any agency. A mother state isn't wrong. It doesn't do things without some merit for some people. It's just that the hand holding is frustrating to the more independent of us (including me) who would rather take risks and be freer.
- gnaritas 13y agoFinally, some honestly; yes it's frustrating, but given that the vast majority of the population aren't like you, it makes sense that they set up a society to cater to their needs, and it's pretty clear most prefer a paternalistic government simply to remove the need to think about so much stuff. Most people don't want a world where a bad decision about something they don't have the knowledge to even make correctly can kill them.
- AsymetricCom 13y ago>So one guy got some bad indicators that proved to be nothing, who cares? >Quick, stop doing CT scans!!!??? Are you really this stupid? I think you're pretending to be stupid. Yes, bad diagnosis is kind of a big deal. Yes, new, unlicensed, untested medical devices are kind of a big deal. Thanks for your completely unrelated, probably fictional, personal anecdotes though. I'm sure someone was swayed by your emotionally charged, whatever story about something whatever, but I'm surprised, because one time I got a rental car and it told me it was out of gas but it was wrong, I went to another dealership and there was gas! Quick, stop filling up cars at the pump! Who upvotes this shit? Seems like there is a conspiracy to prevent legitimate and intelligent conversation around any medical issue by stupid, distracting comments and pointless bickering about issues that aren't even remotely related to the OP.
- IanDrake 13y agoStrange, I looked for your intelligent comments, but found nothing. Have you taken the 23 and me test? Seen the results? Are you adopted and know nothing about your families medical history? Have you ever been misdiagnosed by a board certified doctor using an FDA approved test that costs thousands of dollars? Ever use webMD to self diagnose a condition that nearly killed you? So you have something intelligent to say, great, tell us. Maybe include some experiences that inform your opinion so we can better understand where you're coming from.
- AsymetricCom 13y agoStrange, All I see is more ads for 23andme.com and a lame attempt to scare me into using it.
- IanDrake 13y agoStill waiting...
- Alex3917 13y agoThe difference here is that even though CT scans might be useless, at least the pictures themselves are accurate. Whereas 23andme told me that my ancestry was a mix of Nigerian, Japanese, and Iranian. Then suddenly two years later they decided I was 99.9% white. No explanation given, they didn't even send me an email, I just showed up one day and found out that I was a different race, and suddenly the genetic risks of what I was supposed to be worrying about were completely different.
- refurb 13y agoThe difference between CT scans and 23 and Me is that CT scans have been tested and the rate of false-positives and false-negatives is generally known. In addition, the manufacturers of CT scanners are making claims based on this data. What the FDA is upset about is that 23 and Me is making claims with no scientific basis. Sure, they are measuring gene's known to be associated with certain conditions, however, their tests have not been validated. That is the kicker. The funny thing about this is that HN is notorious for its hatred of the pharmaceutical industry. If a drug company ever did what 23 and Me did, it would have been raided by US Marshall's and had it's door chained shut. The FDA has been incredibly patient with the company so far. Take a look at what pharmaceutical companies have had to put up with: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm054126.pdf http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulat... A simple ad that suggests patients might do better if they switch to Effexor XR, which, in fact, they might. The FDA sent a warning letter because the ad "contributes to the impression that patients who have failed previous antidepressant therapy can expect improvement when switching to Effexor XR when this has not been demonstrated by substantial evidence or substantial clinical experience." This is not regulatory capture or anything of the sort. Pharmaceutical companies have been putting up with the high evidence hurdle for the last few decades. What makes 23 and Me think it can play by different rules?
- latj 13y ago"My father did 23 and me, without giving any family medical history and it concluded that my father was at a much higher risk factor for things that his mother was ultimately afflicted with. So, it works to some extent." Whaat?
- Zoomla 13y agosure, quit doing CT scans if false negatives or, more importantly, if false positives rate are too high.
- InclinedPlane 13y agoThis is a poor argument founded on a handful of anecdotal experiences. The full reality of the situation is not embraced by your caricature of it. I think you might have a bit of a different opinion if you had been incorrectly diagnosed with a more serious disease, such as cancer. As a thought experiment imagine that I am a medical charlatan who is offering a test for women to find out if they have breast cancer. In truth the test is just a random chance of a positive diagnosis, dressed up with some props and procedures. What's the harm in this? Well, the harm is that you put someone through hell when they believe that they have cancer. And worse the harm is that it can often take some very invasive procedures that have a deleterious effect on health to conclusively determine if someone does have cancer or rule it out. Which makes a false diagnosis more than just a mild scare but a very real burden. And also a drain on the health care system and the economy. Someone who undergoes unnecessary procedures, such as biopsies and blood work, will have those costs come out of their insurance most likely. Those costs come out of effectively a pool of money designated for covering procedures, shrinking that pool means that someone else will be denied coverage for some procedure or that premiums will go up for everyone. Now one need not be an intentional charlatan as in the above example to nevertheless lead to the same harmful outcomes unintentionally. And that's the sort of thing that can, and apparently does, happen with 23+me. If people are getting told about "risk factors" for very serious diseases through tests that are not very reliable or diagnostic then that will likely lead to a lot of unnecessary procedures in order to double check those findings. With all of the problems resulting listed above. This is a problem that the medical establishment has to contend with even with highly accurate tests. So yes, it is actually a serious problem with no easy solution. That doesn't mean that 23+me has to stop operating, but they need to be substantially more circumspect about their diagnoses.
- new299 13y ago"I'm surprised at the negativity here. There is nothing conclusive about this test and from what I've seen it does a pretty good job. So one guy got some bad indicators that proved to be nothing, who cares? My father did 23 and me, without giving any family medical history and it concluded that my father was at a much higher risk factor for things that his mother was ultimately afflicted with. So, it works to some extent." In both cases. The plural of anecdote is not data, and it's singular form is equally vague.
- charlieflowers 13y agoI am with you. This is objective information about your own body. The government wants to block it because it assumes you can't handle the information. Ridiculous. They are not selling any proposed cures. No snake oil. Just information derived from your own DNA. And the story speaks WELL of 23andMe. They had a bug. Someone reported it. They fixed it. It's a great report.
- rmrfrmrf 13y agoCT scans cost $500-$4500 in the United States. Heart surgery easily costs over $100,000. Given your cavalier attitude toward the enormous costs of the health care you received, I'd argue that you're not the one that needs protecting.