No. I'm not actually a big pro-regulation kind of guy. But there is a knee-jerk reaction favoring tech-ish companies getting regulatory compliance letters that I don't share. Most of the time, it just seems like the agency in question doing its statutorily-sanctioned job. It's not like sympathetic cases where a company falls into a Kafka-esque quagmire of obscure regulations that only tangentially apply to what they're doing. When I see cases like this, or AirBnB, or Uber, they fall directly within the scope of the relevant agency, and the action being taken is justified on the same basis that justifies the agency itself.
No, particularly from an "FDA" rather than "Congress" viewpoint. That is, independently of whether the law should have the FDA regulating devices used to diagnose disease, the facts seem to be:
1) The FDA does have that responsibility under the FD&C Act, 2) 23andMe began the process of getting FDA clearance for a device intended to diagnose a disease, and 3) 23andMe, when the FDA found the application wasn't sufficient and asked for more information to support that the device met the requirements for approval, failed to respond with more information and just accelerated public marketing of the device.
Unless there is substantial dispute over these facts -- which I don't see any indication of -- there doesn't seem to be any basis for criticizing the FDA action.
FDA interest in 23andme is driven solely by rent-seeking incumbents trying to keep 23andme out of the game.
Every single piece of information on 23andme is accompanied by confidence estimate, and most of it is very low confidence. Every single concern mentioned in that letter is clearly and obviously addressed by the site as part of its core functionality.
As a happy 23andme customer I wish the FDA would stop harassing a company I enjoy doing business with so that it can get on with releasing new data and building new features rather than just hiring lawyers.
No, FDA interest in 23andMe is driven by: 1) The fact that 23andMe's product is within the clear scope of what FDA is tasked to regulate under the FD&C Act, and 2) The fact that, having initiated the process of seeking regulatory clearance for their product as required, 23andMe abandoned that process and continued marketing the product.
> Every single concern mentioned in that letter is clearly and obviously addressed by the site as part of its core functionality.
Really? The lack of studies supplied by 23andMe establishing the validity of their process in delivering the outputs it gives is "addressed by the site as part of its core functionality"? How?
To your second point, the site has a few "locked" areas that are described as containing potentially upsetting or confusing information, and the user is advised to consult his/her physician before looking at the results. There is also downloadable information available to physicians.
Reducing the scope of the product would inherently reduce the scope of the FDA involvement, not that that is in any way relevant to any point I made.
> To your second point, the site has a few "locked" areas that are described as containing potentially upsetting or confusing information, and the user is advised to consult his/her physician before looking at the results. There is also downloadable information available to physicians.
I don't see how that's relevant to anything I said. Particularly, its not relevant to either the second point in the first paragraph (which concerns 23andMe abandoning the regulatory clearance process) or the point of the second paragraph (which concerns 23andMe failing to provide studies supporting their claims about the accuracy of the reports).
If you take the raw data and download various utilities that match SNPs with the literature, the result is far more scary and misleading -- and it reveals just how thoughtful and reserved 23andme's approach is.
23andme provides ample links to evidence for every single result. The confidence metric is a function of the study size and reproducibility for the studies pertaining to each and every result. Most have very low confidence.
IMHO the only legitimate beef is with the underlying scientific assumption behind 23andme, which is that statistical genetics is both useful and accurate. I consider it more of a form of entertainment than a likely way of gathering actionable information.
Then no one should be surprised that they are in trouble with a regulatory agency responsible for holding participants in the market they are in to compliance standards.
AirBnB, Uber/Lyft, 23andMe previously (with then-current California regulation requiring tests of the type they provide to be physician-ordered) have all done this with varying degrees of success.
Is this a fair comparison for the FDA? Yes, because in the current system you are guilty until you prove your own innocence to their standard of evidence, which tends to vary based on who you are. One could argue that the potential harm of unregulated supplements is clear and present, yet the FDA chooses not to act.
To whom shall we write our complaints about the unregulated aspects of the food and drugs which have the potential to cause massive harm (but which apparently don't because people on aggregate are not as helpless as they sometimes appear)?
Another customer here, and this has also been my experience. I have found their results presentation very responsible and low-key. A lot of these correlations are quite weak, and they're very clear about that.
I wonder if the real dispute here is over whether giving confidence estimates is good enough. Perhaps the FDA thinks that the general public are not well enough trained to interpret them.
The work that they're doing to show how genetic features correlate with the observed tastes, behaviors, and propensities of users of the site seems remarkably useful.
The FDA is doing exactly what it always does, stifling innovation while justifying its existence using the voluminous laws created by politicians justifying their existences.
If the FDA were useful, it would be helping 23andMe rather than trying to take them down.
Oh man are you going to be upset when we regulate all that out of existence. Trying to correlate genetics to tastes, behaviors, and propensities, while scientifically interesting, is a total political non-starter.
> The FDA is doing exactly what it always does, stifling innovation while justifying its existence using the voluminous laws created by politicians justifying their existences.
This action is the FDA acting within the core of its jurisdiction, and within the core of a law that was passed with tremendous public support. This is not to say that agencies don't do what you're describing, but in this case, it's pretty much the FDA's job to control this sort of "innovation."
I'm not sure "interesting" is the word I'd have used. "Unlikely" is probably much, much closer to the truth. It's more or less astrology.
So, correlating the existence of certain genes to propensity of heart disease is mumbo jumbo?
Not really sure why anyone would say such a thing. Maybe you didn't understand what the word "propensities" means?
One has only to glance back to the last century to see overconfident claims along the same lines from eugenicists, for example. Or look at the dreadful state of science journalism and the broken logic that prevails in many internet comment/forum sections to see how easily a statistical correlation can be substituted for fact - to say nothing of poor statistical work in scientific research, where publication strongly favors positive results and replication is often under-prioritized.
Now please return to your preventive custody zone, non-citizen.
Well let's stop this Science nonsense and get on with full blown Political Correctness as our guide to the future we're heading toward.
Your comments are essentially daily mail fare.
I'm just trying to argue in favor of this comment https://news.ycombinator.com/item?id=6794926 , not about whether doing the testing is a spectacularly good idea.
I guess you're being sarcastic, but it's not that I fear progress will stop. What I see instead is a great deal of needless friction that prevents efficiency. When you consider how innovations and businesses build on one another over the years - any friction in the process compounds the amount of time for "the future" to be here.
I doubt anyone here on HN doesn't realize that in the future our genetic code will be understood and manipulated like we do with computers and software today. Will this golden age of genetic self determination be 50 years from now or 500 years from now?
Roadblocks we put in front of progress now will mean many decades of delay for the advances down the road that are dependent upon today's advances and the intervening thousands of others.
law that was passed with tremendous public support
Doesn't at all make it right, good, or mean I won't bitch about it.
I'm not being sarcastic. Any technology that tries to correlate genetic markers with behavioral characteristics will be regulated out of existence. I'm not taking a position one way or the other as to whether this is a good idea, but I'd bet money on it being the outcome.
> Doesn't at all make it right, good, or mean I won't bitch about it.
Sure. But what it does mean is that it's an intended consequence, rather than an unintended consequence as your characterization suggested.
I'm sure that there are those who would like to make all such pursuits illegal. Such a slippery slope, though. Where will that line be drawn? Which 23AM style correlation question should be illegal for inclusion in their correlation determination system?
1. Do brussel sprouts taste bitter and unpleasant?
2. Are you more active in the mornings?
3. Do you prefer blondes to brunettes?
4. Do you carry debt on your credit cards month-to-month or pay them off?
5. Did you graduate college?
6. Do your joints ache after rigorous exercise?
7. Have you ever been arrested for a felony?
8. Are people with a great deal of money more lucky than clever?
9. Does hard work tend to lead to financial success?You're one of those people that rides bicycles without any brakes then, I take it.
Where did I or 23AM indicate that they had a cure for anything whatsoever?
The answers are "nowhere", "nowhere", and "nowhere".
Take down the giants upon whose shoulders we could be standing upon and be happy that no one is so tall that they can fall and hurt someone.
The specific claim made by 23andme, without disclaimers, is: 23andMe empowers you to better manage your health and wellness. This seems to me like a straightforward claim of diagnostic value; the fact that it's non-exclusive is beside the point.
If anything, the supplementary nature of 23andme's test data should make compliance easier, since their burden will drop proportionately under the B<PL formula employed to assess tort liability in the US. http://en.wikipedia.org/wiki/Calculus_of_negligence
I wonder if you and other folks who seem to be espousing this binary approach live in or hail from states with contributory negligence regimes.
23andMe both wants to _say_ they have a totally accurate test, but doesn't want to pay to do the testing to prove it is totally accurate. The FDA is saying you can't have it both ways.
There's a big difference between telling someone they have a 5% chance of something and telling them they have a 25% chance of something - even though both are uncertain.
It's not their mandate to help 23andme, their mandate is to protect the general public. Their enforcement letter clearly spells it out: the FDA had had concerns about the validity of some of their tests, and they gave 23andme opportunity to address there. Since they failed, the FDA is taking action.
FDA has tried to help 23andme. 23andme declined the help.
Did you even read the letter? The FDA is making serious and legitimate claims. Amongst other things, the FDA is claiming that 23andMe has said that they were in the process of completing their validation studies. 23andMe has already submitted their 510(k) (which is the form/clearance required for -any- medical device), but failed to provide the required evidence to back up their claims in their submission.
Note that the FDA is that claiming that 23andMe has not provided sufficient evidence (as in they don't like the study you did) rather the FDA is claiming that 23andMe has not submitted the required evidence at all. As in there should be this big ass binder full of test results comparing 23andMe's test results against the ground truth, but that binder doesn't exist.
This is hardly stifling innovation. 23andMe has had 5 years since they started selling their product to produce an analytical or clinical study proving their product's effectiveness, and they failed to do so, despite clearly knowing that it was required, to the point of claiming that they were in fact working on it.
The study that the FDA would have required from 23andMe is to show that the genetic testing provides the correct results at the bare minimal. They would require 23andMe to quantify their actual error rate of their product in use by customers. Depending on 23andMe's claims in their 510(k) submission regarding their intended uses, then the burden of proof may go higher.
The point is that if 23andMe can't actually prove that this test result predicts elevated risk of Alzheimer's (either by their own study, or through other relevant studies) then they sure as hell shouldn't say that their test predicts Alzheimer's risk.
Case in point, clopidogrel response. The link between CYP2C19 and clopidogrel response is well studied. There are already other tests on the market based on this relationship. Given this, 23andMe would not have to prove by themselves that clopidogrel and CYP2C19 are linked, they would merely have to prove their their CYP2C19 test provided correct results.
It's not entirely clear to me that this is what the FDA is demanding. Quantifying the lab error rate is easy, and while it's possible that 23andMe is failing to do so, it's almost like not doing that would take effort.
For example, 23andme ships you a test package, you sample it yourself, send it back and then they process it. While quantifying that last rate is simple (as you say), it's crucial to understand how well the product will work in practice, with an actual customer on the other end.
For something like 23andme, that would likely mean getting a whole bunch of untrained test subjects, having them preform the sample collection as instructed by the instructions shipped with the sample collector, having them shipped over by standard means to the lab, and then processed. The test subjects would likely then have to have their DNA fully sequenced with some gold standard test, and then the results compared. 23andMe would be given leeway, in the sense that inconclusives don't "really" count as a wrong result.
If the FDA were trying to take 23andMe down rather than helping them, they wouldn't have been working with them for several years to get them into compliance and only issued a Warning Letter after 23andMe walked away from the process.
Or at maybe for particular results the company should just refer you straight to a doctor for more information.
These are the questions that I think the FDA will be interested in having the company addressing.
People are screened for the BRCA gene when they have a history of certain cancers in their family. If you get a positive result, there's a small chance its wrong. But, if you took all of American and gave them that test, there'd be thousands of people getting positive results, living in fear, and sometimes taking medical action.
1. Like any screening, their results could be inaccurate.
2. Before making any changes based on their results—aside from eating more healthfully, exercising more, and sleeping better—they really need to talk to a doctor.
... then few people would have a problem with it. And maybe that's all the FDA is trying to do! I don't really know.
Sadly, when an activity or product could result in a bad outcome, certain types of people are incredibly eager to ban (or heavily regulate) it.
Those people don't realize that by doing so, they themselves are actively harming the people who benefit from that activity or product by preventing or heavily limiting their access to it.
Just like we shouldn't ban health discussion boards (and we shouldn't make it illegal to participate in health-related discussions without government-mandated credentials), we shouldn't limit people's freedom to choose services like these. It's wrong.
We just need to make sure the services aren't lying about what they're offering.
It seems clear that FDA does not in fact want to shut 23AM down, but that they do want 23AM to radically change their marketing. Which seems fair, because 23AM's marketing is disquietingly clinical.
I don't think that's accurate either. I think that the FDA views that 23andMe must do one of the following:
1) Provide necessary evidence to support their current marketing claims, or
2) Change the way they are marketing their product, or
3) Cease marketing their product altogether.
I don't see that the FDA necessary has a strong preference as to which manner of complying with the law 23andMe takes.
Things like Prostate-specific antigen screening of healthy men is no recommended by the United States Preventive Services Task Force because "the potential benefit does not outweigh the expected harms." (Source in: http://en.wikipedia.org/wiki/Prostate-specific_antigen)
The jury is still out on mammogram screening of healthy women for breast cancer. (See: http://en.wikipedia.org/wiki/Mamogram)
The Cochrane analysis of screening indicates that it is "not clear whether screening does more good than harm". According to their analysis one in 2,000 women will have her life prolonged by 10 years of screening, however, another 10 healthy women will undergo unnecessary breast cancer treatment. Additionally, 200 women will suffer from significant psychological stress due to false posivitive results.[10] Newman points out that screening mammography does not reduce death overall, but causes significant harm by inflicting cancer scare and unnecessary surgical interventions.[11] The Nordic Cochrane Collection notes that advances in diagnosis and treatment of breast cancer actually may make breast cancer screening no longer effective in decreasing deaths in breast cancer, and therefore no longer recommend routine screening for healthy women as the risks might outweigh the benefits
This is why we use science and do studies and always question if we are doing the right thing.
I think most people view their service as fun thing that comes back with results that, if revealing of a concern, would cause you to seek proper and more detailed testing from a real medical practitioner.
It's not like a physician prescribes a 23 & me writeup.
Take this thought, and replace "some people" with "my mom" and see if it still results in the same conclusion.
If they were marketing as an entertainment product, this wouldn't be an issue. They are marketing it as a diagnostic product (and apparently submitted applications for FDA clearance as such, but then just decided to ignore that process and continue marketing it for diagnosing risks.)
Find out if your children are at risk for inherited conditions, so you can plan for the health of your family.
Understand your genetic health risks. Change what you can, manage what you can't.
Arm your doctor with information on how you might respond to certain medications.
Document your family health history, track inherited conditions, and share the knowledge.
Explore your genetic traits for everything from lactose intolerance to male pattern baldness.
This is right there on their website.
Anyways, my comment was a response to the commenter who claimed 23AM was marketed as "entertainment". Horseshit.
Cool. 23andMe should sell it like that. It seems most of the FDA letter is about how the tests are being sold.
The problem is that's not how they are marketing it as others have pointed out. They market it as a serious health evaluation tool you can use as a step in preventing future illness.
Q: Have you eaten fast food more than 3x this week? A: If yes, you may be at risk for obesity (or just plain lazy)! See a medical professional for verification and treatment options! By the way, check out this insurance plan! And these nutritional supplements!
I mean there's a whole industry of publications, websites, media, and more dedicated to getting people to self-diagnose and self-treat all kinds of conditions and doing it without FDA approval...
http://www.diabetesforecast.org/ http://www.weightwatchers.com/shop/mag/ http://www.healthylm.com/ http://www.womenshealthmag.com/life http://www.fitnessmagazine.com/ http://www.foodandnutrition.org/ http://paleomagonline.com/ ... etc.
I don't even think I've gotten to most of the egregious ones because they use trickier to find names. But they're all basically promoting self diagnosis and self-treatment of conditions that may or may not exist or methods of managing or treating conditions that do in fact exist.
It seems like a double standard to me.
Besides this not being part of the FDA's charter, what you're ignoring is that articles assist you (correctly or otherwise!) in self-diagnosis. An article does not in and of itself diagnose you with a disease or condition and thus can't by any stretch of the imagination be considered a Device.
First, they do some genetic mapping.
Second, they do an analysis on the markers found.
The objections are based on the second part (and the marketing for it), which seems by itself to be very equivalent to WebMD. I don't think there's any suggestion that abstract-genetic-marker-finding is the problem here.
In general, products sold to diagnose diseases -- including software products -- may be subject to regulation. See this article (on WebMD cause I found it when googling to answer the original question, heheh)
http://www.webmd.com/news/20130923/fda-sets-rules-for-smartp...
> The U.S. Food and Drug Administration on Monday drew a line between which smartphone medical apps it will regulate and which ones it will not, saying it will focus only on those that turn the phone into an actual diagnostic tool.
> In essence, those applications include software that enables the phone to read a patient's heart rhythm, take a blood pressure reading or measure a person's health in some other way.
> For example, an ECG machine that diagnoses heart rhythms is "still an ECG machine whether it is the size of a breadbox or the size of a smartphone," Shuren said. "It's not about the platform, it's about the functionality. An ECG is an ECG.
Ah, it sounds like it probably wouldn't apply to the 'symptom checker', they've decided their regulatory regime only applies to devices that... actually directly take medical readings themselves, it sounds like? That doesn't seem unreasonable. And, yeah, a service/process/system that takes your saliva as input seems in that category.
I've been in the Medical Device industry for over 10 years as a software engineer. Soon after I started, during one of our mandatory Quality Systems training sessions, it was pointed out that there are many software-only companies whose products were Medical Devices under the FDA definition, but the FDA simply didn't have the manpower to police all of them. In many cases, the companies themselves probably didn't know they fell under FDA regulation.
I find your argument invalid. If they get an approval from FDA, is it going to change their data processing logic or data set?
It (or the marketing) would have to change if they don't get an approval. That's the whole point.
I guess it would depend on if the FDA finds their data processing logic to result in valid and reliable medical determinations, right?
They also might have to change their marketting materials to comply, something specifically mentioned in the FDA letters. Regulation to prevent misleading marketting of medical products is definitely a pretty core part of the FDA's remit.
Whether there is the appropriate support to make those claims about a product marketed to consumers as a diagnostic tool is the question here.