My deadly disease was just a 23andme bug
mntmn.com
mntmn.com
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?
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.
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).
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.
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.
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.
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.
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.
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.
Eugenics means requiring inferior people to not reproduce. There are some problems implementing this requirement. Do you mean something else?
Diplomacy score of 100
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.
The point, really, is that eugenics itself is not necessarily evil until and unless you attempt to control the reproductive rights of others by your own eugenic criteria.
Which becomes nigh-inevitable once eugenic theories are readmitted to the discourse, because once you postulate that individual reproductive behavior has a detrimental effect on society as a whole, it becomes a public health matter. As is trivially obvious from the history of the century just past, that particular slope is very steep and very slippery, and it leads into a crevasse whose contents are horrifying indeed.
To put it into perspective though, Michael Bloomberg recently attempted to ban the sale of large sodas in New York City. I, as a personal choice, do not drink soda, because I believe it's the devil, basically. That said, that is only a personal choice.
I agree that it's obviously detrimental to society on the whole, but so what? I'm not beholden to society on the whole, nor is society beholden to me. The idea that we should ban soda, even if we know that it is bad for society, and even if we know that it is bad for the individual, is antithetical to freedom, and a practice which I don't support.
All that said, I agree that we live in far too controlling a society, and this is exactly why I oppose the notion of socialized health care; which is that as more of society is involved in my medical choices, more of them have incentive to eliminate every unhealthy thing that I might do (and vice versa). Despite the fact that I am a very healthy individual by most standards, I don't want my freedom to drink the occasional soda evaporated by those who mean well.
That is every situation in which exists something fairly describable under the name "society".
It's only when a society tries to impose value judgements on others, and to be fair, they almost always do, that unfairness creeps in.
Regardless, I think we're fairly far afield of the original discussion, so I'll demur on this.
To circle back around though, the idea that one should optimize for genetic advantage with his or her own offspring is no more offensive than when I volunteer at soup kitchens to help the less fortunate.
Compelling either situation though is (at least in my opinion) quite wrong-headed indeed.
Not necessarily. Saying "you have the BRCA gene... here, have some free birth control pills" would be a eugenic policy, but it's not forcing anything on anyone. The same goes for PGD: It allows parents to have children who lack a "bad gene" and thereby improves the genetic health of the population, but it's not compulsory.
You might want to explain that a bit further, before you get associated with the tragic events of the early 20th century and downvoted into oblivion.
1. Auto-eugenics: the ethical obligation one feels, when one knows they have horrible DNA, to adopt instead of breed.
2. Eugenic engineering: currently, this means "do IVF, look at the zygotes, and pick the healthiest ones to try to implant." In the future, this could involve genetic patches from healthy donors ("gene cleaning") or just plain hacked-in transhuman bonus features.
3. Eugenics, under the original botanical definition of the term: pairing people with really great DNA, and encouraging them to breed as much as possible, and repeating this process over several generations. We already vaguely do this naturally by interpreting health-signals like height or breast size as indicative of mating potential, and we're doing it more explicitly when we select good sperm/eggs from a donor clinic to pair to our own. (The final sci-fi-ish step in this one would be for women to volunteer to/get paid to/pay to (depending on supply vs, demand) "adopt at conception" genetically-"optimized" children matched by the clinics themselves. This would probably be in addition to the gene-cleaning techniques from 2.)
Oh, and I guess I should mention this last one, which is closest to the "problematic" version but which, surprisingly, has been attempted to success (i.e. Nobody being unhappy with the arrangement):
4. Libertarian eugenics: Pay people you'd be afraid of reproducing, to not have kids any more. This could be a state rent-transfer, but it's also possible to make it an entirely bottom-up process: any individual activist with some money to give can do their own "vigilante eugenics," finding, say, crack-addicted mothers and offering a lump-sum to get their tubes tied[1]. And this has happened: http://www.radiolab.org/story/251887-what-if-no-destiny/
Really, "the bad eugenics" is a ghost from the past, more an artefact of Nazi beliefs about racial purity than any productive approach to solving the problem.
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[1] Okay, this is less "eugenics" and more "euteratogenics" plus a little "euepigenics." But we're making people here, not show-grade Dalmatians; we care about more than their potential as good breeding stock.
In particular let's look at OP's example - he has mutations in different genes, so he is not is risk group for the disease that 23andme mistakenly reported him for. However if he would have an an offspring with someone who has complementary mutation in same genes, the offspring would stand much higher chance of inheriting that disease.
Instead, I suppose the suggestion would, "Well, go adopt!", which is a less than satisfactory answer for probably like 99.9% of all of the public, seeing as how nobody bothers to get a "genetic checkup" before they reproduce, and we're pretty much wired to prefer our own offspring to others when it comes to parental investment. All in all, the only context I've ever really heard these sorts of conversations in seem to be surrounding people who have terrible conditions that they are afraid of passing on, not two otherwise healthy individuals who have no idea whether or not their offspring could inherit some kind of genetic disorder that it latent in them. Yes, that is the problem isn't it? Also, given the amount [read:lack] of effort in "planning" that some people seem to put into reproduction, I wouldn't be surprised if this remains the problem...forever.
* Let's say on average you have 10% chance of having your child inherit something bad. If you show only partners that have this value halved over time you will see a positive trend.
For example, you may have heard of Buck v. Bell, a 1927 Supreme Court decision which affirmed the constitutionality of involuntary eugenic sterilization. (Holmes: "Three generations of imbeciles are enough.") The Nazi eugenicists, when brought to account at Nuremberg after the war, mounted a defense which revolved around the American eugenics movement in general and this Supreme Court decision in particular.
For further example, perhaps you share the common misconception that the idea of mass execution for eugenic reasons, and the particular method of using gas chambers for this purpose, originated in some uniquely twisted mind among the Nazi eugenicists. This is not the case; that purpose, and that method by which to achieve it, were first postulated in a 1918 Army textbook, which drew inspiration from a 1911 Carnegie Foundation-funded "Preliminary Report of the Committee of the Eugenic Section of the American Breeder's Association to Study and to Report on the Best Practical Means for Cutting Off the Defective Germ-Plasm in the Human Population."
As you see, the United States has made this mistake once before, even to the extent of enshrining it in our highest canon of law. The Nazi regime, far from originating these ideas we now recognize for the horrors they are, merely took them to their logical conclusion; in judging the entire Jewish race an intolerable blight upon the genetic purity of a nation, and acting in accord with the vanguard of then-modern eugenic theory to prevent that blight from spreading further, the Third Reich demonstrated conclusively and incontrovertibly the fundamental inhumanity of the entire eugenic concept. In that demonstration, the modern objections to eugenic ideas find their origins and their vehemence -- this latter, in particular, perhaps all the more telling in a society whose disinterest in the hard-won lessons of history seems to grow by leaps and bounds.
Consider, too, that the leading exponents of eugenics in decades past were every bit the equal of anyone today in their conviction that they were the intelligent and enlightened wave of the future, and perhaps you may find it easier to understand how your "ghost from the past" could -- given enough arrogant confidence that we know enough not to repeat past mistakes but may this time rely upon ourselves to do it right -- turn out a vicious revenant after all.
However, we never did any eugenics. We thought about it: explored, in all its Consequentialist glory, every facet of the avenues available to us at the time; had our strategists and think-tanks outline hard-nosed evaluations of the pros and cons of such actions; but, then as now, it never came to anything. There was no top-down governmental push to force sterilization, or death, by active selection from the population. And as far as I can tell, with the way the US government is designed, there could be no such push; there isn't an arm of the government from which it could legitimately originate.
Even without the Nazi example to reflect upon, the deepest into depravity the American system would likely have sunk would be something like sterilizing entrants into our dystopian prisoner-industrial complex. :)
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Seperately, I must just point out, your last paragraph reeks of Reactionism[1] -- just because we were wrong, does not mean that we will be wrong in perpetuity, and there is no reason to flinch away from even evaluating the consequences of things like eugenics when those consequences are constantly changing alongside advances in technology.
There may come a point where there will be no negative consequences at all -- a point when, say, a mother can just take a pill to ensure that from then on she will conceive completely genetically-healthy children. To flinch away at that point would be madness. The question is, how close must we be before flinching away is not madness, but just sub-optimal in the net-present-value of global DALY[2]? And how close are we now?
[1] http://slatestarcodex.com/2013/10/20/the-anti-reactionary-fa... or to summarize http://dresdencodak.com/2009/09/22/caveman-science-fiction/
[2] http://en.wikipedia.org/wiki/Disability-adjusted_life_year
I always hate, in argumentation, to approach the realm of personalities -- but you strain credulity, not to mention Hanlon's Razor, far beyond bearing. Did you read the article I linked in the comment to which you replied? Have you ever read anything on the subject of the American eugenics movement? Or do you argue from this blatantly false premise in support of some ulterior motive? Perhaps you are ignorant; perhaps you are malicious; perhaps you are both. The facts of the matter being what they are, you cannot possibly be neither.
"We never did any eugenics."
Your third paragraph beggars belief even further. Perhaps you aren't aware that in California, the eugenic sterilization of prisoners was not made illegal until 1979 -- and the practice itself continued until three years ago.[1] And there's far worse in the history of American eugenics -- circa twenty thousand free men and women sterilized, at the order of eugenics boards which judged them unfit to reproduce, in the state of California alone. Twenty thousand! Are they not enough for you to acknowledge this atrocity for what it is? How many more do you require?
"We never did any eugenics."
The most generous assumption I can make is that your argument originates in a combination of dewy-eyed optimism regarding the advancement of human knowledge, and abysmal ignorance regarding history so recent it's barely left the category of current events. Even then, your argument remains morally repugnant in the extreme -- you argue, in essence, that the American eugenics movement was and remains utterly blameless, pure and innocent of any wrongdoing, because after all it was the Third Reich, not the United States, who in accord with the soundest eugenic theory committed enormities hideous enough to rate among the very foulest blemishes of our species' far from stainless history.
Had the Nazi eugenics programs arisen de novo, had they been the entire invention of Nazi theorists working from Nazi first principles without any relation to the eugenic theories then in American vogue, you would have a point. But they did not; ignore it though you may, it remains established and incontrovertible fact that Nazi eugenics were in every sense an outgrowth from, and a development of, American eugenics -- and not merely in the realm of pure theory; the early Nazi eugenics programs received not merely intellectual support, but actual funding, from such luminaries as the Rockefeller and Carnegie foundations.
American eugenicists trained Nazi eugenicists, collaborated with them, supplied them with funds, encouraged and abetted them in every possible fashion on their way to enormities such as "Action T4" -- a bloodless name for the eugenic murder of a third of a million unfortunates, that of course being only the figure known with certainty and very probably short of the real number of victims -- and even the scourging of the Jewish race itself.
On an individual level, such behavior might be called complicity to murder, perhaps conspiracy to murder, perhaps accessory before the fact of murder -- among the very gravest of crimes, even on that small scale. The same, scaled up to the level of whole societies, beggars description. And there you stand, bright-eyed and smiling, and blithely insisting that American eugenicists, American progressives, are pure as the driven snow, smirched by not the tiniest drop of the lakes and rivers and oceans of blood spilled in the name of their abominable theories. Our forebears, in their foolishness, unleashed horror beyond description and beyond compare. When they saw the enormities that resulted, it made them wise, and they laid down the tool which had turned so disastrously in their hands. Yet there you stand, smiling, ready to pick that tool up again. Tell me, how many millions will it take this time, to make you as wise as those who've gone before?
Oh, but of course, you cry, it won't happen that way this time! After all, we're so much better and smarter now than anyone before, and we will be ever so careful not to repeat the Nazi horror! And I have no doubt that's true. After all, we're so much better and smarter now than anyone before! And so, too, will be the new horror you unleash, and always with the most unimpeachable of good intentions:
"We never did any eugenics."
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Precisely what you mean by "Reactionism" I am not sure. I am no longer young enough to love chaos, and I am reasonably familiar with recent history; I suppose this might make me look reactionary on some subjects and from a certain point of view, but I have never since childhood dreamt of dignifying any opinion I might hold with a name involving either a majuscule or an "-ism".
Your links, I'm afraid, shed little light on the matter. The comic strip, while well executed in a technical sense, had no obvious point; I did get a little way into the Slate Star Codex page, but found myself unable to continue past the point where its author, for the sake of narrative convenience, defined "violent dispute" in such fashion as to exclude the American Civil War.
[1] http://www.theguardian.com/commentisfree/2013/nov/08/califor...
For god's sake, it's like saying you're a proponent of Nazism because you think model rocketry is a good hobby. And you wonder why people are confused?!?!?!
"the study of or belief in the possibility of improving the qualities of the human species or a human population, especially by such means as discouraging reproduction by persons having genetic defects or presumed to have inheritable undesirable traits (negative eugenics) or encouraging reproduction by persons presumed to have inheritable desirable traits (positive eugenics)"
Of course in a health system where every check and scan can involve large amounts of profit...
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_...
But no-one is going to remember "solve x for (1-(.95^x)) > 50" the purpose of the 95% & 20 is that it's easy for people to remember.
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).
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.
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.
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.
The FDA should focus on requiring disclosure of relevant information and the accuracy of that information, rather than guaranteeing safety or making value judgments.
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.
What's in question is the validity of 23andme's analysis, and that's an entirely different matter. Bioinformatics is, again, an emerging science -- expanding at an amazing rate, to be sure, and full of enormous promise for the improvement of human health overall, but nonetheless still in its nascency. Treating bioinformatic analysis as an established part of medicine, to the extent of making "highly confident" (23andme's words, not mine) predictions of future medical concerns based on analysis of a relative handful of SNPs, strikes me as flagrantly optimistic at the very best, and potentially verging upon fraudulence at the worst.
That's the FDA's concern, and if anything it is only reinforced by the OP's experience. Were 23andme's analysis and predictions anywhere near the level of reliability the company claims on their behalf, it would not be necessary for one of their customers, having been terrified half out of his mind by the results of 23andme's analysis of his genome, to develop sufficient understanding of sequence analysis to replicate their process and identify their error.
I've heard this argument but I don't buy it - not at all. I consider it better to know than to be ignorant.
If everyone has something that looks like rubella scarring, why is something that looks like rubella scarring considered worthy of investigation?
If the risk of something worse justifies investigation, then it's better to know from the CT scan so that you can have it properly investigated. If there's no such risk, then no problem.
But the "risk" only exists because of the CT scan, which is returning junk data.
Because a doctor has seen the junk scan, has seen the shadows on the junk scan, they now have to recommend follow up scans to rule out any disease. That subjects the patient to risk - hospitals are not safe places to be in. (Hospital acquired infections kill many people! Clinician errors kill many people! Traffic accidents getting to hospital kill many people!) Just being worried about the tests is going to cause a deterioration in most people's lives. And there's zero benefit for almost all of those people.
Early intervention is not always better.
My hypothesis is that having more information cannot result in a worse average outcome, given a rational response to the information (correctly accounting for relative risk). As a doctor, I do not have to recommend follow up scans if the cost is greater than the benefit, but I should still seek to use the information from those once they've been done.
I suggest that the above holds true even if there is some known chance that the information is junk.
To put it more simply, early intervention is always better.
Rational response to shadows on the lung in a CT scan is more scanning and more testing. The results of the further tests carry a risk. The benefits are zero for anyone without a disease, and low for anyone with a disease. That's a worse than average outcome for almost everyone taking those extra un-needed tests.
> No, early intervention is not always better.
There are many men who've had traumatic treatment for prostate cancer because of the results of early intervention style treatments. Many of those men would have died with, not of, prostate cancer. Thus, their lives have suffered because of a rational response to an early intervention.
From a $100 test? I hope not. In my father's case, he wears sun block now. What he didn't do was run out and have every mole on his body removed because he's at greater risk of Melenoma.
>Just the stress of "shadows" is considerable.
I lived with that stress for a few months. I'll admit it was in the back of my mind, but I was fine.
Afterwards I was telling a friend about the ordeal and he actually said "Man, is there anything worse than being told you have something terrible wrong with you, living with that, then finding out it was a false alarm". Uhm, yeah. How about finding out it wasn't?
Look at Morgellon's; Mercury Chelation; Anti-vaccination; etc etc etc.
There are very many people willing to sell tests, and very many people happy to sell quack cures based on those tests. (I'm not saying that 23andMe are quacks!)
> "Man, is there anything worse than being told you have something terrible wrong with you, living with that, then finding out it was a false alarm". Uhm, yeah. How about finding out it wasn't?
That's happened to a few people. You get told you're HIV+ (in the late 90s, when this means it's a death sentence.) You lose your job (because people are arseholes), you stop showing your 8 year old son affection (because you're scared of the infection), you have unprotected sex with people with HIV (you're already +, so what does it matter?) and then you get told that there was a mistake with the original test and you're actually negative.
http://www.amazon.com/Reckoning-Risk-Learning-Live-Uncertain...
That is a bad idea, even if you are 100% certain the result was correct.
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?"
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.
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.
I'd argue the same. But that's not in the slightest how 23andme presents itself.
I never fail to find myself astonished that people in a highly technical field, which is extremely refractory to the layman, nonetheless commonly feel themselves perfectly competent to operate in another highly technical field, entirely orthogonal to their own. The Renaissance man, made obsolete by complexity, is one with history; specialization is the order of the day.
There is no controversy in the statement that not everyone is, or can be, equipped to serve as his own programmer or systems administrator; indeed, the very existence of the field in which most of us find our vocation suffices to demonstrate that fact. Yet many of these very same people consider the mere suggestion, that the same should be true of the field of medicine, as nigh unto an insult direct -- as though it carried some imputation of essential incompetence, rather than being a statement of trivially evident fact. I despair of ever understanding why this should be, live however long I might.
It's also not possible for a physician to be informed about every possible condition. I have type 1 diabetes, and I know a lot more about it than my GP does -- odds are she's only going to see a handful of T1Ds in her career. When I'm talking to her about my diabetes, I'm educating her rather than vice versa. (So she sends me to an endocrinologist, and he's as far ahead of me as my GP is behind me in knowledge of diabetes.)
You are absolutely right. The one thing we definitely know is that we're still a long ways off from even having the books written on it all, let alone any one human having even majority of the information in their brain. I'm in pathology, sort of the end of the diagnostic road. We have the molecular tests and microscopes. And we still don't know. In fact, we're best positioned to see the vast ocean of unknown before us. We can't even see the other side.
Sorry to hear about the diagnosis, you've done extraordinary things despite it and I hope more patients can emulate your success. I am constantly educated by my patients.
You're not Canadian, are you? The GP vs endocrinologist issue is actually well-studied there. Unsurprisingly, the specialist-treated patients fair better.
This is a bit offtopic, but how about "because it was terrible before the collapse of their government, and still is terrible?"
And yet libertarians don't move there. It's baffling. Every single U.S. libertarian talks a great game, but not one of them is willing to put their money where their mouth is.
And yet leftists don't move there. It's baffling. Every single U.S. big government liberal talks a great game, but not one of them is willing to put their money where their mouth is.
The difference is that you can actually find people with some frequency who espouse the virtues of extremely small or entirely absent government, while it's pretty hard to find someone who espouses the virtues of a totalitarian, all-controlling state.
Or maybe you are retired, etc.
I don't see how that follows. Extraordinary claims require extraordinary evidence. You got out of North Korea by hand-waving that nobody explicitly wants a "totalitarian, all-controlling state" - yet the libertarian argument is that the constant push to have the government control more and more parts of society constitutes clear, if inadvertent, steps towards exactly that.
Also, the point raised isn't about whether Somalia/North Korea is a libertarian/statist paradise, it's why libertarians/statist don't move there. The answer is in almost all cases, "because I don't want to".
That said, Somalia being unpleasant has a lot more to do with it being extremely poor and ravaged by civil war than is has to do with a lack of government. But in the stateless period, a good number of things improved significantly, despite the lack of government: http://en.wikipedia.org/wiki/History_of_Somalia_(1991%E2%80%...
I'm not sure if you're serious. If you're not, I apologize.
If you are, please show me someone claiming that "no government absolutely implies an excellent, beautiful place." Most of the libertarians I know recognize that a place without a government can still be a hellhole. Like Somalia.
In many areas Somalia did significantly improve compared to it's past government and is better off than the countries around it.
https://www.youtube.com/watch?v=3TTOsWym-dI
Additionally only a small percent of libertarians are anti-statists and want the government gone completely.
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.
It may not work, but we want an agency to protect us.
Lots of people make similar comments regarding the TSA.
There is also the very solid argument to be made that by choosing to lessen risk, you stifle innovation and produce an overall much worse system in terms of beneficial outcomes.
Lessening risk is far more important than not stifling innovation
I don't think this unqualified statement makes sense. Shouldn't the opportunity cost of the benefits of innovations not produced, weighed against the risks present in allowing a market to produce them, play a factor? And this would no doubt be different for each and every possible innovation.
No. They are robots. Robots that know better. How dare you ask such good questions! You now owe us 40$ for violating my authority citizen!
> Lessening risk is far more important than not stifling innovation
Again, would the OP rather live in a world with 100% risk, 100% innovation, or 0% risk, 0% innovation. I know what I'd choose. There's a pretty common theme in some sci-fis that living without risk isn't even life. Something to think about...
I took it more as being 100% responsible for your actions. But also yielding 100% control of those decisions/creations.
But your point stands. Both options yield death. One instant and real, the other grey and indifferent.
> I don't think this unqualified statement makes sense.
It wasn't unqualified, it had a context that you removed, I'm specifically talking about the medical market, not just any random innovation.
That con men don't disappear with regulations. They simply become regulators and monopolists.
> The mistake in your argument is assuming people are good
So let us give control over some people, to others! That fixes the problem with the human condition (http://en.wikipedia.org/wiki/Human_condition)...
> without oversight innovation isn't the result, scams are, by the truck load.
I'd take thousands of small, grassroot scams, that can be corrected through communal means (boycotting and community awareness) than by one huge one. If the Fed sanctions a pharmaceutical drug that kills thousands, is that worse than a few peddlers selling whatever drugs they want like what currently exists under the nose of the Fed? If you ask me, some illegal drugs are less harmful than legal ones! And that's pure free market with a dash of mafiosa government resistance (guns, extortion, other things to become powerful to fight the powerful).
> For every innovator freed by lack of regulation thousands of con men exist that'll flood the market with crap that hurts people, far more than any possible innovation is likely to save.
And yet, while the FDA didn't exist in the centuries preceding 1906, the formation of the FDA, we see innovations saving lives, and more and more people living meaningful existences. I doubt any community of people would be stupid enough to continue to consume harmful chemicals to degree that harms more than of it harms us now. These organizations exist, yet childhood obesity is the highest it's ever been. Americans consume alcohol, tobacco, fast food, and drugs live they always have. These things haven't be struck a blow one bit by regulation. They've simply become more expensive, and the big man in town takes their cut.
> Lessening risk is far more important than not stifling innovation because the simple indisputable fact is that bad people vastly outnumber innovative people.
Big red flag that we're not arguing with someone logical. "Bad people"... Like who? The Nazis? Or maybe the Jews? You can use this hatred/disgust/mistrust/contempt/negative energy for so much evil/bad/badder/worse!
Why is lessening risk more important that innovation? We've reduced a tremendous amount of risk in the last 100 years. From labour laws to life expectancy to homicide. Can we please stop feeling like we need bureaucrats to run our lives? I'd love to ask gnaritas whether they would prefer a society with no risk and innovation, or a society with massive risk and massive innovation. Arguing even for the status quo puts you in the more favourable side IMO at the get go.
I also love how they class people as either bad, or innovative, as I'm sure they dream of some sort of utopia where you either create something of worth before the age of 12, in which you would become a part of the ruling, innovative class, or not, in which case you are controlled by that class.
But yes gnaritas you're right. Please pass more laws, more regulations, and create more prisons and fines so we can deal with all of these bad people! In fact, I think I just violated regulation g.r.a. 101 - You cannot challenge the authority of someone who knows whats best for you!
I'm not sure that's the best way to get your agument taken seriously. The FDA are conmen now?
I just believe in freedom and liberty: http://en.wikipedia.org/wiki/Libertarian_socialism.
Not all policemen are corrupt, not all politicians are stooges, not all regulators are conmen. Quite often they are people who know how the system works and feel that they can bring their knowledge to bear to make it work better and ensure that things are done right.
This is why personally I think it would be better if we released medicines and simply had "FDA approved" status post release/post approved by the institution, which would give people the choice to only use FDA approved products, but also give me the choice of utilizing other drugs I can research and make decisions about on my own.
We gave up the monarchy system (to a degree in Western Politics) because a privileged class can never truly choose the correct course of action for subclasses.
We replaced this with a pseudo monarchistic, pseudo technocratic, representative democracy, yet all our problems with War, Poverty, Oppression, and Moral Decay continue unabated.
We're at a pivotal point in our history, where we're coming to the realization that democracy doesn't work, and that we're either going to have to commit to some consistent narrative, or perish while we convulse with confusion over the increasing chaos.
If you ask me I wasn't saying this system was by any means proficient in it's duties to any degree. I was just pointing out that some/many people simply don't care, in other words, they are apathetic. And why not? Individuals can't communicate at the communal level like they used too, and we have no power against bureaucracy.
That said, we only live once. It's no use trying to make the world a better place for the next generation, the one after that, or the one after that. Humans will go extinct in the future. Nothing will remember us on this mortal plane after 1 million years. The things we bicker about are profoundly insignificant to the universe. IMO, we don't merit existence outside of this planet if we can't feed the people we have on this one. Let's not spread suffering amongst the stars with us.
I meant the decay of the family during child rearing. The skyrocketing divorce rates since the 2nd world war. The increasingly consumerist yet more alienated individual. Our society that tells our children that women are sex objects, and that ALL men are perverts or rapists. A society that cares more about celebdom than the starvation and suffering within it's borders. A society that disdains racism/intolerance, yet still disenfranchises millions of Native Americans and black African Americans.
I'm not trying to say you subscribe to those things. Just clarifying my point that our competitive/psychopathic society has consequences. As someone who cares about morals (not an American republican, but rather a Canadian Leftist) I think this will only carry our system forward.
Trust me I don't really care if we're lead as a society by authoritarianism, it's just that I'd rather we utilise that system of government's speciality (efficiency) and attempt to use the current resources we have to develop space technology that can mine efficiently. If not, then let's just live freer happier lives while we can?
I'm not disagreeing with governance, just federalism/nationalism/globalism. Let's just run cities? More of a say, more of an impact, and no one else to blame but your own community. Besides, I know that where I live, towns nearby won't raid us. In fact, we'd probably form some confederacy, and share some- dammit! I created a federal government again...
I don't have the answers. But there's plenty of problems (the first step is admitting it!). If you can't see a bleaker future than our grandparents did, than you're not seeing what I see in the next 40 years.
Most of the rest of your points are subjective and verging on nonsense.
I won't argue that the system sucks a great deal, but the fact is that things are improving and have been for quite a long time.
War, Poverty, Oppression, and Moral Decay are more of a problem than ever. Don't mix up my points with social progress, which is an awesome achievement of our society. My moral decay lies more in trust in general and in the institutions we have to trust to function effectively.
War is continuous, with constant tension to this day. Iran and US peace deal for 6 months? Well, looks like Saudia Arabia and Isreal have teamed up to change that? Eastern European Rocket Grid for Rogue States in the area, justification Iran not needed says "Putin"? Fuck you says US/American Narrative of not liking Russians. Chinese and Japanese conflict over islands? Better not attack Japan China, The US has a defensive treaty with them. That would not be a good thing for anyone.
Poverty is continuous. Personally, I find it despicable that some people can live as billionaires with some thousands of children dying needlessly from diarrhea and malnutrition. Sure donating helps, but surely a system that allows such disparity surely something like this isn't shocking... Not to mention the increasing amount of individuals in the US who rely on food assistance (which may be cut by this improving system)...
Oppression need not even be mentioned. Surveillance, Propaganda, the Prison Industrial Complex... You may have heard about the innocent man being forcefully given cavity searches / colonoscopy surgery / etc without probably cause in the US this past month? If not, http://www.youtube.com/watch?v=YWg_JyJJqaU. System is definitely improving. Who needs the 4th amendment...
And lastly, again, moral decay. I'll modify my point to be less nonsensical for you. The fact that this all happens, and people like you say things are improving, given what we see as innovation everyday? That sounds like a decent amount of cognitive dissonance to me! The first step to a non philosophical based moral ground, that can justify/defend a horrifically immoral system, because fuck everyone else, it's comfortable here where I live. To bring up a popular meme, you should check your privilege.
But you seem to be immune to facts....
But you would think it's more important that we have a lower per 1000 rate would you? Personally, every death to me is a shame, and 40,000,000 in WW2 alone, and us having continual war since 2001 creates an outlook of more war in the future. Don't fool yourself into thinking we couldn't beat that record...
On the particulars -- the TSA has never caught an actual terrorist. The FDA has stopped potentially harmful and/or ineffective drugs from coming to market. Anything could be improved and, given drug research costs, there's probably a lot of room for improvement at the FDA. But "let's abolish it because ideology" doesn't fly. In 23andme's particular case, they seem to have an extremely mild and common-sense set of requests that could be fixed at the disclaimer level.
Bingo. Mistakes happen, but different government agencies, different companies, different individuals do have varying degrees of success or failure.
This is an excellent example of the "seen" vs. the "unseen". Sure, the FDA has stopped harmful and/or ineffective drugs from coming to market. But the FDA has also stopped plenty of effective drugs from coming to market, both directly (e.g. no more Vioxx because it might slightly elevate your risk of heart attack) and indirectly (the billions of dollars it costs, directly due to FDA requirements, to bring a drug to market).
Is the assurance that FDA-approved drugs are safe[1] worth the inhibited advancement of medicine? I don’t know, but I doubt it. I think a much wiser approach would be to have potential drugs freely available, and subject to testing by third or quasi-third parties (ala Underwriters Laboratories). Hell, you could even leave the FDA in place if you want to, only limit its ability to restrict drugs to market. For example, you could reverse their decision-making criteria: FDA will only pull drugs from market if it can be shown that the drugs are more harmful than beneficial for their intended use. This would leave the choice to use a certain medication to individuals and their doctors, with guidance from FDA/labs who conduct the same sort of testing the FDA does now.
[1] Note that the FDA’s stamp isn’t really an “assurance” anyway. Vioxx (and loads of other “harmful” drugs) still made it to market.
If you're talking about streamlining the FDA process without significantly increasing the risk of harmful drugs slipping through, I think everybody's in favor of that.
If you're talking about streamlining the process at the cost of higher risk, then that's probably a nonstarter. Why? I (and most people) am not willing to increase my odds of being harmed on behalf of someone else's profit margin. You'd have to be crazy to accept that deal.
Expecting the market to 'just do your research' on drugs is crazy. It takes experts with PhDs a long time to verify a drug as safe, and they still make mistakes sometimes as you indicated... you're expecting me to do it? I haven't taken chemistry since high school.
For me that's not a non-starter. It's the start of a process that involves looking at just how much money gets saved (and by whom), just how much additional risk is borne by those taking the passed medications, and how much faster we're getting new (safe enough and effective enough) drugs on the market.
You're willing to take significantly more risk that a routine drug prescription harms/kills you in order to streamline the process for drug companies? (Note that there already is a process in place for those with advanced diseases that justify a high-risk drug to take experimental drugs with knowledge of the risks).
Any realistic proposal (as in, we have an idea of how much extra risk we're incurring) is going to have a lot of technical details and probably require a huge amount of research to justify it -- it's human lives that we're talking about here. The potential $ savings are big but that doesn't matter if you're dead. Like I said way upthread, there is plenty of room for improvement, but "libertarian pixie dust will make everything better automatically" is the same thought process that led to collective farming and killing 10s of millions in Russia and China.
We need to do what we think is most likely to lead to the best outcome. There's a point beyond which that's no longer "more research", at which point researching more isn't taking it seriously. I have no particularly strong feelings about just where we are in that space - I'm busy saving the world along other lines.
I hate to be that guy, but this is the fallacy of false dilemma, and directly ignores the example I gave above.
>>I (and most people) am not willing to increase my odds of being harmed on behalf of someone else's profit margin. You'd have to be crazy to accept that deal.<<
This isn't the deal. Do you feel that your odds of harm from taking a supplement are significantly too high, since of course supplements are not currently regulated by the FDA or any other government body? Are people who takes supplements crazy?
>>Expecting the market to 'just do your research' on drugs is crazy. It takes experts with PhDs a long time to verify a drug as safe, and they still make mistakes sometimes as you indicated... you're expecting me to do it? I haven't taken chemistry since high school.<<
Why is it crazy to expect the market to do research? This happens with literally every other product available. There are thousands of organizations dedicated to reviewing automobiles, blenders, mattresses, and literally every product you can buy. If people voluntarily want to purchase medicine that has not been evaluated by the FDA or some other testing organization (as is currently the case with thousands of medical supplements that are for sale) why must those people be stopped? Again, the choices aren't FDA approval or no access. There are all sorts of solutions that could be implemented to both increase availability of medicine while still offering consumer protection.
Yes, PhDs make mistakes, but that wasn’t the point of the Vioxx reference. Vioxx was a fantastic pain drug that worked for some people when nothing else would. And that drug was taken away because Vioxx might increase the risk of heart attack. While this may sound fine to you, it was devastating to many people who would have preferred even a large risk of heart attack rather than living with the pain eliminated by Vioxx. (Vioxx was thought to increase the incidence of heart attack a staggering 4 times in one study . . . from .1% to .4%)
Again, nobody is expecting you to do your own research. But that shouldn't limit our options to (1) FDA approval or (2) no drugs for you.
Yeah, just look at what (nearly) free and open markets have done to things like vision correction surgery. Quality has gone up exponentially while prices have dropped by one to two orders of magnitude. Those free markets are awful.
The problem with medicine isn't that it isn't a match for free markets, it's that there are no remotely free markets in the space.
If vision correction surgery is too expensive for you, you can wear glasses or contacts instead and be totally fine. There is actually market pressure to drive prices down and quality up because there'd be less money to make otherwise.
Demand for treatment of a life-threatening, painful, or debilitating disease does not depend on the price or the quality. It's not free market at all because consumers have no choice but to buy at any price.
> Demand for treatment of a life-threatening, painful, or debilitating disease does not depend on the price or the quality. It's not a free market at all because consumers have no choice but to buy at any price.Don't consumers always have a choice at least to the degree with which they have choices of whom to by from?
Government subsidies on the demand side would put upward pressure on prices, but government subsidies on the supply side put downward pressure on prices, and there's a lot of supply-side subsidies.
As someone who had lasik to correct a 9 dioptre astigmatism/myopia, I can tell you there is a world of difference between prosthetic correction and native correction. It's not just in terms of comfort. I can see better than I did with the perfect prescription glasses. I have a much wider viewing angle. I don't have to worry ever again with lens angle rotation.
For high corrections, glasses are anachronic, and should be considered the wrong treatment.
There are plenty of free markets in other sorts of medicine out there, just not in the USA. They are often very good if you have money, thorough information on the provider, and enough time to take advantage of it, and atrocious otherwise. That's not the sort of system I want to have where I live.
Well, no.
Many of us want government out of the way of our own informed decisions. Government is just other people, not deities.
Anyway, you're right and I certainly didn't intend to speak for everyone. I was just pointing out that the attempt to caricature the current state was not really a caricature but just the way we actually do things.
The USA was founded on the premise of liberty: that individuals have rights which may not be dictated by the self-righteous and/or greedy whims of the majority & powerful. Now get government out of my health care, which served me very well during times which I could be dead four times over.
I don't mind a government oversight as a matter of openness and standardization. I do mind government exercising power for its own sake, ordering a business to cease & desist when the service is using new technology to help people be better informed (WITH clear caveats that the information is suggestive, not authoritative).
I worked with your examples (website, consumer victimization, etc) and observed that government is equally as guilty as you construe private business is, and from there questioned why you respect one and demonize the other.
So long as 23AM makes clear their offering is not to be construed as actionable medical advice (suggestive, but not definitive by any means), the FDA should not be ordering them to stop service under threat of penalty/arrest.
Functioning governments (at least, modern "state of the art" republican democracies) also require informed participants, and the extreme complexity of government makes that impossible for most voters (not to mention irrational; see "rational ignorance" on Wikipedia). People often accurately point out well-known inadequacies with markets, but I've never seen an explanation for why people expect republican democracies, which are themselves public goods, to be exempt from the same market failures.
As for the evidence that governments work, despite a satisfactory economic model for why they should be expected to, I don't personally see the evidence. I see a lot of evidence the support the claim that governments are overwhelmingly likely to exist, but not that they are the "best" way to organize society (for any given definition of "best").
[1] http://xroads.virginia.edu/~Hyper2/CDFinal/Lippman/cover.htm...
All monopolies in medicine and insurance are government created.
Your whole argument is based on a near-obvious circular logic.
>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.
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.
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/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?
Whaat?
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.
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.
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.
It would be better if 23AM presented medical genomic information in a neutral way, with external links to descriptions of genomic variations but no assertion of diagnostic significance at all, or even a mention of how to obtain a diagnostically significant result.
Unfortunately, the way 23AM is packaged (see the website), they are incentivized to do the opposite; positive results are recognized by their clients as valuable, and, whether 23AM likes it or not, so are the negative results.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2...
> It would be better if 23AM presented medical genomic information in a neutral way, with external links to descriptions of genomic variations but no assertion of diagnostic significance at all, or even a mention of how to obtain a diagnostically significant result.
What you're suggesting would effectively revert the consumer experience about half a step above "go to lab X to sequence your DNA, then hop on over to SNPedia.com to figure out what it all means."
> Unfortunately, the way 23AM is packaged (see the website), they are incentivized to do the opposite...
Perhaps this is more subjective than worth talking about, but that's not the impression I had when using and working on the product. All the more reason they need to be careful, for sure.
Disclaimer: I worked at 23andMe's frontend team briefly, a few years ago. While I have mixed feelings about their engineering practices and other things, I do believe in and support their mission.
You're probably right. Unfortunately it's too easy to create a gap between the public-facing marketing messaging and the real spirit of the product. I can think of many companies who struggle with this.
If you do become a customer, it's evident that they perform an admirable effort to make the results appear as neutrally educational as possible. Every data interpretation is heavily cited and explained, all the while urging further clarification from a medical professional. (Let me know if you'd like some screenshots.)
Personally, this is above and beyond of what I would expect, and there are competitors (especially foreign) who do far less. I can see why the FDA would prefer to have everything that could be interpreted as medical advice to be regulated and controlled, but I'm not convinced that it would yield a net benefit to consumers in this case.
No, it really isn't. It's trying to make a mass-market product that it can sell to unsophisticated end-users who don't have a prayer of understanding what they're seeing. Accuracy and precision are secondary concerns, and without those you're not actually doing genetics, but pseudo-science.
I have a number of friends who have received 23's "analysis", and come to me to interpret all/part of their results. They're garbage. You shouldn't take any of it seriously, in any way. To properly interpret even the simplest parts of their report, you need a background in statistics and genetics that only highly trained people have. And even then, there's usually not enough information -- you need to do tons of digging into the literature to find out that some relative risk increase is highly conditional on population or that the original experiment was flawed in some subtle but important way.
As they say: things should be made as simple as possible, but no simpler. There are things that are complicated for a reason, and you can't just discard the inherent complexity and claim it as a virtue. It's not disruption to be irresponsible.
The liability concern is real: they aren't perfect, they'll goof up tests, and in some measure (though IMHO largely overstated -- the real risk here is a little fear and a needless diagnostic procedure) people will suffer when they do. But that doesn't seem to me to be insoluble. If no one insures that kind of thing right now then maybe they could be induced to, or 23AndMe could work up something on their own via investors.
But arguing that the only viable solution is to shut down a comparatively cheap and (full disclosure: I'm a customer) really quite entertaining service seems wrong to me. It's a net good; some people (hi!) like it.
That's not what's happening. You're not stupid, and I'm surprised you see it this way.
23andMe are being asked not to market their product in the way they are marketing. Or, if they want to continue to market like they are they have to have the same level of regulation as all other medical device suppliers.
Neither of those stop you from using their product.
One way to see this is yours and the FDA's: it's a fairness issue, and they need to play by the same rules. The other is the liberstartuptarian line that the regulatory structure is the thing actually at fault here. In this case, I tend to agree with the latter.
I mean, I had fun with this service, and I wasn't fooled by its marketing: they told me in essence that they'd give me their best guess at my traits and disease risks and drug susceptibilities, etc... And I bought it. A product that just gave me a bunch of genes and markers I could look up on wikipedia wouldn't have gotten my money.
So what's the answer here? Where's the regulatory answer for those of us who want to spit in a tube and get a fun HTML5 experience out of it? It doesn't seem like the FDA has one.
The market can have that, all 23andMe has to do is stop selling their product as a diagnostic test.
They sell it as being able to predict your risk of some diseases. They're not a tiny little startup battling against the industry, they have some pretty big money.
They need to either sell it as a novelty ("Not designed to treat or diagnose any medical condition") or step up and get regulated.
Unfortunately we're in a weird situation where 23andMe get regulated, but wingnuts like Sarah Myhill (in the UK) don't. http://drmyhill.co.uk/wiki/Nutritional_Supplements_-_what_ev...
So I definitely agree that something's wrong.
Or, alternatively, perform and submit the studies to show that, used as directed, it works as a diagnostic test as marketed.
When I click through my profile, it shows me strength of assumptions based on the number of conclusive or inconclusive studies that have been reported. You can easily click through each result and see the studies.
I never once felt that they were making a diagnoses. I don't know where people are getting this from.
Many simple take-home tests that are arguably much more time-tested, reliable, and accurate than 23andMe's DNA services are FDA-regulated. If your basic take-home pregnancy test is FDA regulated, why should 23andMe be exempt? Or would you prefer a world where all of these tests were unregulated?
Not everyone does their research. Not everyone is intelligent enough to understand the implications of medical tests, drugs, and devices - regulation protects the vulnerable among us.
As an aside, I've worked in medical devices for most of my career. All other things remaining equal, engineering teams in these companies are no different, talent-wise and quality-wise, than most teams you'd see in other industries. Take the sloppiest engineering team you've worked with, now imagine them working on a clinical product with the potential to cause real harm to people (physical or psychological).
It is the regulation (FDA and others) that ensures that these teams "raise their quality game", so to speak. It is not perfect by any means, but I don't dare imagine the alternative. Yes, the regulation is a massive pain. I experience it first-hand. It slows things down, has massive associated costs and can even stifle innovation. The general trade-off, however, is worth it, IMHO.
That's an outstanding comparison, one I wish I had thought of.
Your genome doesn't change, and who knows where that data leaks to later? Who knows what healthcare providers will vacuum up such leaks?
Who knows what kind of discriminatory practices will be undertaken by service providers, insurers, or even employers in the future?
Haven't y'all ever watched Gattaca?!
Keep your private information private. Nobody else will do it for you.
EDIT: Oh, and USA PATRIOT too.
Employers, on the other hand...
They can't be considered now. There's nothing to say that a few years down the line that won't change.
They can no longer be grounds for refusing coverage. They certainly are used in determining the price of your premiums.
The ACA is not the panacea that people sometimes seem to think it is. There are tons of ways the insurance company can use any data they have on you in their own best interest[0], making your life miserable in the process. Jacking up premiums is just the tip of the iceberg.
EDIT: As pointed out by aestra, there are other laws protecting use of particular types of information (eg. genetic information). My comment is simply a response to the quoted statement that "pre-existing conditions can no longer be considered for heath-care service [due to the ACA]", which is false.
[0] Which may or may no coincide with your best interest
Doesn't seem any different that how a poor driving record impacts the price of your auto-insurance.
The point of insurance from the consumer's perspective is to mitigate the risks borne by any individual for black swan medical events, not to provide another reason for the already healthy to feel superior and contribute even less money to the collective insurance pool.
Unlike many health conditions, poor driving is something the driver can change, either through conscious choice or through additional driver training.
Imagine if it somehow became possible to predict with perfect accuracy a person's future payouts under a given insurance policy. Bob goes to buy house insurance and they can predict with certainty that he'll eventually get $400,000 paid out (presumably because his house got destroyed somehow) while Steve is predicted to have nothing paid out.
If the insurance company has access to these predictions, they will naturally charge Bob about $400,000, plus a profit margin, while they'll charge Steve next to nothing. In this situation, insurance policies become nothing more than elaborate savings accounts.
On the other hand, if the clients have access to these predictions, Bob will buy the best policy he can find, while Steve will naturally not buy any policy. In this scenario, insurance companies all go out of business instantaneously because it becomes impossible to make any money, or even break even.
Yet both sides have huge incentives to try to approximate these scenarios as best they can. The better insurance companies can predict people's insurance usage, the more profitable they can be. The better clients can predict their own usage, the less they spend. But let both parties achieve their predictive goals and the whole thing falls apart utterly.
Medical science is driving relentlessly toward that goal, to the extent that many people were being shut out. The ACA tries to attack both sides of it, by preventing insurance companies from charging differing prices based on certain predictive information, and by preventing clients from refusing to purchase the product. In theory, this returns you to a flatter risk pool where all people contribute roughly equally and everybody sort of pretends they don't know that Bob's house is going to burn down.
I never said it shouldn't - but people seem to be under the impression that it doesn't. I commonly see statements to the effect of, "I don't care what the insurance companies know about me, since they have to provide me coverage." Maybe that's true if the only thing that matters to you is whether or not you have some form of insurance, at any cost, but that's not the case for most people.
As for whether or not it should be considered, that's a value judgement (and therefore inherently subjective). Do you believe that all people should pay the same amount for insurance that covers events beyond their control (ie, congenital diseases/defects[0])? You might argue that it's unfair to hide that information from the insurance companies or prevent them from acting on that (because information asymmetry in free markets is bad[1]), or you could argue that it's the responsibility of society to care for those who have conditions that require expensive treatment just to stay alive (because letting people die of preventable diseases is bad).
[I don't have an answer for that - I'm just clarifying the question, since you brought it up. :)]
[0] I use the example of congenital diseases because one does have influence over one's own chance of getting lung cancer (ie, if you don't smoke, the chances are far lower), but not for congenital diseases (your mother may have had some influence over that, but you yourself certainly didn't).
[1] Alternative argument: These costs just get spread to everyone who is insured. Assume the country consists of two people (Alice and Bob). If the true (expected) cost of insuring Alice and Bob are $50 and $100, it's unfair to Alice to force them both to "split the difference" and be insured at $75 each.
If a bad driver can't get insurance, they are taken out of the pool of people who are driving. Everyone wins. There are fewer accidents - even the former driver is less of a danger to themselves. It makes the former driver's life a bit more difficult when they need to get around, but they have alternatives like transit. Other people see what happened to the bad driver, and modify their behavior accordingly.
People who have pre-existing health conditions are not immediately taken out of the pool of people who are healthing (i.e. euthanized). There is no alternative to living. If they don't get insurance - or it's harder for them to get insurance - they go on living, with increased misery, until the costs hit everybody with trips to the emergency room. It is very unclear whether that example will influence others to be more healthy - most diseases are effectively random, or strike with the kinds of probabilities that most humans are bad at integrating into their decisions. Even alcoholism has a component of genetic predisposition, and some people might even become addicted as children.
This is, of course, setting aside the moral argument, but this is is HN.
One can certainly argue that this shouldn't be the responsibility of the insurance companies, but that is still a major difference.
Do you have a definitive citation spelling that out (and any possible loopholes)?
The US is not the whole world.
That's not enough. Remember how netflix's "anonymized" data could be substantially de-anonymized by adding in IMDB's public data?
http://www.cs.utexas.edu/~shmat/netflix-faq.html
A similar thing can be done with DNA - if your relatives have given DNA with their names and there is another database somewhere else that lists relatives (ancestry.com or pretty much any of the hundreds of data brokers) then that relatives list cross-referenced with the similarities in the DNA between you and your relatives can be used to de-anonymize your DNA.
http://www.familytreedna.com/landing/family-finder.aspx
If you really need a DNA profile and you are paranoid, it might make sense to pollute any databases by submitting your DNA with someone else's identity information - just don't do a criss-cross where you swap with a friend and you both submit each other's DNA because that would be really easy to reverse programmatically.
FYI, This is illegal in the United States. It is prohibited by the Genetic Information Nondiscrimination Act of 2008.
http://en.wikipedia.org/wiki/Genetic_Information_Nondiscrimi...
You can thank Rep. Louise Slaughter for that one, she tried to get the bill passed for 12.5 years, and never gave up. She declared it "the greatest thing she has done in her time in Congress." She is the only scientist in Congress.
At least, I assume 23andMe would fall under HIPAA regulations, but I'm not so sure. Does anyone know if 23andMe has an IRB?
If someone takes all that data and turns it into a service, then that's something that can be taken down/regulated.
Not true, fortunately.
http://articles.latimes.com/2013/jul/19/opinion/la-oe-timmer...
Parental consent is not required – though with enough advance effort and written request, opting-out is possible.
Further, many states retain the "residual dried blood spots" for more than 6 months and perhaps indefinitely:
http://www.ncbi.nlm.nih.gov/pubmed/16737872
So a sample of your genetic material may already exist in a state government filing cabinet, somewhere. In California, the retained information and sample can be used "for medical intervention, counseling or specific research projects which the California Board of Health approves" and "anonymous research studies". See the section "Storage and Use of Dried Blood Spots" at:
http://www.babysfirsttest.org/newborn-screening/states/calif...
For newborns, the California program currently tests for 79 different disorders:
http://www.cdph.ca.gov/programs/nbs/Documents/NBS-DisordersD...
And the per-disease records are apparently kept for lookup-by-individual without retesting, because there's a routine by-email process for requesting long-ago sickle-cell results (back to 1990) about NCAA student athletes:
http://www.cdph.ca.gov/programs/nbs/Pages/NBSFAQTraitAthlete...
And that's not even considering all the health procedures (blood donations, tests, surgeries) or natural shedding (hairs, skin, saliva, excrement) routine in a normal life. You are a firehose of genetic samples, to any even slightly attentive observer, or even passive observers who take an interest some time later.
So: good luck keeping your genes from the state, if it really wants them.
I guess you assumed that he was a born in a hospital because most are. Thankfully, most != all.
Eventually, policies for people who don't provide DNA will cost as much or more than current Pre-existing Condition Insurance Plans (PCIPs).
I think there are benefits to both approaches of genetic testing; 23andme has a lot of data it collects and can do interesting statistical studies/reporting that other more research-oriented companies cannot. However, like I said before, you can't view a test like that as medically actionable. In the end though, the more testing there is (as long as the messaging is clear and consumers do their homework), the better oFf the world will be.
- privacy
- security of data
- wrongful use of data
- spread of misinformation
- mind fucking that ensues after reading your results
- probably a lot more
Sorry if I seem overly critical about a service like this, but it just doesn't seem worth it to me.
One of the features they provide is ancestry help. They compare your DNA with all other users' DNA and then give you a list of potential relatives. They say "hey, you guys share .6% of the same DNA, you might be 3rd to 5th cousins."
That's cool, right? Especially for someone who is adopted.
The problem is that it takes 2 weeks longer to do the ancestry stuff than it does to do the medical stuff. The medical results showed up in my account about 4 weeks after I sent off my spit-filled test tube. The ancestry results showed up a full month later. In the meantime, between medical results and ancestry results, I'm getting "friend requests" from other users. There are no messages attached to these users, but I presume they believe, somehow, that they are related to me.
How can this be? I hadn't yet received my own ancestry results.
I emailed 23andme.com support, and here's what they said:
> Thank you for contacting 23andMe.
> If you've been genotyped through our service, you can share your genome with other 23andMe users and compare yourself with them using our various features.
>This is of special interest to members who are interested in their family's data.
> Due to the way our computation process works, some of your relatives can actually see you appear in their list of DNA Relatives before all your results are uploaded.
Let me repeat that last part:
> Due to the way our computation process works, some of your relatives can actually see you appear in their list of DNA Relatives before all your results are uploaded.
So get this: my name and some level of my DNA results are shown to complete strangers, and not only that, but they are shown before I even get the information.
That bothers me. That bothers me a lot. I haven't yet decided what to do about it, but believe me, I've spent a great deal of time considering this since it happened.
Please note I'm not saying I disagree, I'm simply asking if you can elucidate the problem further.
The same sort of thing happens to non-adoptees all the time - one's cousins who do family history research may know decades before you that they are your [near] relative.
Aside, it's also interesting WRT privacy of sperm/egg donors. I recently commented in a thread (on Reddit I think) that an egg donor should be aware that it may be quite likely, even if not presently possible, for the child to trace them [the biological mother in that instance] in the future either due to tech or legal changes. This was flatly dismissed as an impossibility; little was I to know it might already be quite possible [in the sense of being attainable by the general public].
1) I don't even have access to my own information at this point. It's like if the doctor were to post a picture of your newborn baby on FB without your permission before you got to hold it.
2) The accuracy of 23andme's ancestry information is suspect. They think we might be related based on vague data. And again, the other people have this vague data before I do.
3) Finally, there is medical information attached to my account. For instance, maybe I have a normal risk of prostate cancer. Now 23andme decides that I'm related to Joe (true or not), and Joe has a super high risk of prostate cancer. What inferences can be drawn about that? What if this kind of data is shared with a third party -- again, without my knowledge -- and that third party can use that against me somehow? (Insurance, whatever.) I'm not okay with that.
In the end, it's the opaqueness of this process. If 23andme wants to say "Hey, we're not 100% done with your ancestry results, but we found a few people we think might be matches" at the same time they say the same thing to the other people, then that would be okay. But at the time, I was getting requests from alleged relatives that I had no way of knowing they were alleged relatives until 23andme gives me my results.
In other words, these other people -- strangers! -- knew something about me that I hadn't yet found out myself, when it should have been made available to me at the same time.
In that case, if you do have a match, obviously both people will have to be notified of the other's identity. It sounds like you want to see whether you have relatives before the relatives get to see it. How is that fair?
Also are you sure these other people are getting your identity? How do you know it's not masking your identity to these only people which only gets unmasked if you accept/reply to the request?
At this point, I have my information and now that I have it, I'm okay with sharing it, because it's my information to do what I wish. But they were sharing it before they shared it with me, and that's not okay, imo.
This isn't true at all. Nobody sees your name unless you specifically set the privacy setting to that which I can't imagine anyone doing.
Nobody has ever seen my name on 23andme and I see maybe 1 out of 1,000 people's names when they say that they've found a possible relative. Those 1 out of 1,000 people have set their privacy settings to allow that for some weird reason.
I surmise from observation that this is a common human sentiment, but I don't understand it. It affects more than just medical information. What aspect of human nature drives many of us to avoid the truth?
One cannot solve a problem of which one is unaware, whether it's climate change or a potentially harmful recessive gene.
It's not just solving a problem of which one is unaware, but it's the possibility of not being able to solve this problem or prevent its occurrence. [Climate change on the other hand is actionable.]
What about the fact that now there's a giant database that's probably not as anonymized as we'd like it to be, which has the potential to be accessed by many government/national/security agencies and hackers that can use the information against us?
With regard to privacy concerns, I agree, and I hope that existing or future regulations like HIPAA protect this information enough that the knowledge gained outweighs the risk of privacy lost.
In my opinion, people who use this service are going to use it because they are genuinely curious about their future health and if it leads to a few false positive, I could live with that and get it checked elsewhere for confirmation.
Libertarian-utopian notions of needless regulatory immurement aside, such requirements exist for reasons amply evident in a study of their origins; in short, without a licensure requirement in such a highly specific and technical realm, incompetents and charlatans of every stripe abound, to the ultimate and severe detriment of all those who would seek the advice of genuine professionals in the field.
All systems have bugs, even the ones which lives depend on. It's cool that the author was able to bring the issue to 23AM's attention, but it's also cool that they were able to correct it.
It's a service built on learning algorithms to correlate features (DNA SNPs) with diseases. As with any learning algorithm, results should be interpreted with care. That doesn't lessen the fact that predictions it provides can be helpful.
As an aside, 23andme has a solid API. It's opened up (with consent) a huge DNA dataset for developers to mine. I'm excited for the science that can be learned from this data.
Hence why you'll be downvoted.
For all the hoopla I keep hearing be attributed to malice regarding 23andMe's results, honestly, I think the results, at the least, encourage people to go to the doctor.
My father-in-law was diagnosed with cancer a couple of years ago, but because he was regular with checkups, they were able to catch it early, and he's been in remission for over a year.
A false positive by 23andMe regarding one's predisposition towards cancer should motivate them to the doctor more often, which would indicate whether they were or were not cancer positive -- but in the event of either, I'd wager that more frequent trips to the doctor would be a net benefit.
Yes, people disagree with their doctors, and yes, sometimes those doctors are wrong, but by and large, the number of people with multiple doctors in agreement, where that agreement is still wrong, are statistical outliers.
Further, and maybe it's just me here, I've learned a lot in this thread already, and I'm not an expert on the subject, but I just fail to see how the idea that I have a higher predisposition to cancer than the statistical norm, even if that information might be wrong, can be harmful.
I mean, I understand the objective, and the idea of preventing the sale of snake oil is one that I see as vlid in this context, but this isn't that. 23andMe doesn't make any curative claims whatsoever, as much as to announce that "hey, there might be snakes." They're far more scientifically sound than a mood ring, but even if they aren't, I just don't personally see the harm in that.
Right, but there is a cost for that. If you have a disease that isn't causing any symptoms, do you treat it, even though it will probably never cause symptoms? There is a risk in all treatments, some more than others. There is a study that most prostate cancers don't show symptoms, ever and our super sensitive cancer diagnostics tests are causing more harm than good. More diagnostics does not mean more good.
See my comment here for more info:
That way we don't have to stress that there is some likelihood that we might get some dreaded disease but our doctor could talk to us if the risk is high enough or if we start having symptoms that match one of our genetic risk factors?
Anyway, it's probably good they're being reined in from making medical claims. I don't think the tech is quite there yet. But, as a tool alongside many others, it's cool. And, I love that they're doing original research with their surveys...it's a super cool idea to combine lots of crowdsourced data and DNA results of thousands of people to find markers for diseases and traits.
I plan to keep recommending 23andme to folks who can afford it and folks who can grasp that a DNA test isn't a reliable indicator of disease and that it is merely a probability indicator.
This incident seems to me like a big win for the 23andme model. They made an error – but followup by a single individual means the same error won't happen again for anyone in their international clientele. Errors in other health systems don't get globally corrected so quickly.
The same people that goes to doctors and dentists for regular check-ups without suspecting anything wrong.
http://allthingsd.com/20131125/fda-tells-23andme-to-stop-mar...
Now, can we see some real-world statistics by the government-licensed medical profession? I wonder what a side-by-side analysis of the errors 23andMe has made vs. those the medical community has made might look like. I wonder how the real-life consequences might stack up.
As far as I know, 23andMe has never accidentally amputated the wrong limb, so it's at least go that going for it.
Interesting tidbit: you can always double-check the reports 23andMe gives to you by getting followup tests someplace else.