Meanwhile, 23andMe went ahead and began marketing and selling their product, despite the FDA's concerns.
> Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.
> However, to date, your company has failed to address the issues described during previous interactions with the Agency or provide the additional information identified in our September 13, 2012 letter for (b)(4) and in our November 20, 2012 letter
> To date, 23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it; ...
> ...we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification.
> As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies...
> Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS.
See, e.g., this one from June 10, 2010:
All the FDA wants in this letter is some kind of understanding that their genetic tests are actually valid and correct, since they are making medical claims regarding their accuracy:
> 23andMe has never submitted information on the analytical or clinical validity of its tests to FDA for clearance or approval. However, your website states that the 23andMe Personal Genome Service™ is intended to tell patients in advance how they will respond to certain medications including warfarin and clopidogrel. It also states that the data generated from the 23andMe Odds Calculator, a feature ofthe 23andMe Personal Genome Service™, includes the contribution of single-nucleotide polymorphisms (SNPs) to disease risk. Consumers may make medical decisions in reliance on this information.
The FDA then establishes its ability to regulate this (remember, it's legally required to do this):
> During a meeting between 23andMe and FDA on July 29, 2009, you described the 23andMe Personal Genome Service™ as consisting of a software program that analyzes genetic test results that are generated by an external laboratory in order to generate a patient specific test report. Thus, the 23andMe Personal Genome Service™ is a diagnostic device and subject to all applicable requirements of the Act.
They then very helpfully point them to all the forms, documents, etc., necessary to satisfy the legal requirements:
> For a device requiring premarket approval, the notification required by section 510(k)of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b).
There's even a helpful mailing address and fax number:
> Please direct your questions and response to: James L. Woods, Food and Drug Administration, 10903 New Hampshire Avenue, W066-5688, Silver Spring, MD 20993
Honestly, this sounds like 23andme has been getting away with something for a while and the FDA is tired of giving them leeway.
There is a bit of a contradiction here that "natural supplements" get this huge pass from the FDA, but applying some math to very, very natural genetic data doesn't.
The DSHEA of 1994 (authored by Orrin Hatch) explicitly forbids the regulation of dietary supplements by the FDA so long as they do not make health claims. Unless that bill is repealed, the FDA has no authority over supplements.
The issue with incorrect diagnosis is might lead to incorrect or ineffective treatments. "Natural supplements" are the incorrect or ineffective treatments themselves: the unregulated claims they make is very similar in substance and effect to the quasiregulated claims that 23andme is making.
If you look at the FDA's mandate, it is pretty strongly oriented to products for treatment, not medical diagnosis. The medical diagnosis angle is mostly there due to certain forms of quackery.
In any case, the FDA right now doesn't just want a change of copy. By "cease marketing", I presume they don't mean advertise it differently, they mean stop offering the product to customers - period.
While the FDA certainly appears to be taking issue with the specific marketing copy, they seem to be more annoyed that 23andMe has basically failed to complete the regulatory submission process - amongst other things failing to provide evidence to the FDA that their product actually works as intended.
Incidentally, the FDA is lagging a lot of other criticism and restrictions on the 23AM service; for instance, you can't even buy the service in Maryland, which forbids any home lab testing for health conditions not administered by licensed professionals. Similarly, there have been many critiques in the media and elsewhere about the lack of rigor in the 23AM analysis, relative to the importance of some of the conditions the service is implicated in.
Well, you don't get this far into trouble with a regulatory agency without having a contact within the agency that you are working with. So, I'm fairly certain that 23andMe probably knows what the FDA wants, but they might disagree. I'll be disappointed in the company if they have ignored the FDA all these years when it was obvious that they'd need to have some sort of approval (even if it was an FDA acknowledgement that they didn't fall under regulation).
What I really want to know is what 23andMe's response to the FDA will be. They must have known this was coming and should have a press release today.
"For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery"
Uh, you don't think the surgeon is going to demand a second BRCA test be done before performing the surgery?
This could result in a large number of unnecessary follow-up BRCA tests which could potentially increase the waiting time for test results or unduly raise costs for lots of patients. Not to mention the stress of feeling like you may be suffering from a potentially expensive and life-threatening illness.
So: totally reasonable.
Considering that over half of American adults believe Elvis is alive, I think the small percentage who may slightly overreact to the kind of presentation that 23andme gives of these kinds of results is a complete non-issue.
For screening tests where the problem being screened for is rare, most results will be false positives, but the result is not intuitive.
Unfortunately for us, the FDA is on a quest for "safety"; the agency does not try to help the citizenry live longer or happier.
23andMe isn't even doing that.
The 23andme product explains explicitly how it should be used by a physician, and there are all kinds of warnings and checkboxes before the user is shown any data that falls into the area of overlap.
('carbocation has already expressed some tacit support for FDA's action, but I'm not qualified to interpret it in the context of this particular subthread).
Generally, for diagnostic tools, drugs, etc., it is not enough that the product labelling explains how it should be used, but it is required to demonstrate to the FDA that there is evidence that it works as marketed when used according to those directions. The FDA Warning Letter specifically calls out 23andMe's failure to either identify existing approved products on the market to which the product is equivalent (which wouldn't reduce the requirements for proving this) or to meet the requirements for demonstrating the effectiveness of their offering as a new product without existing, approved equivalents.
There are at least three different products in the space and to claim similarity would be to likely invite over-regulation:
- "full scan" companies, that do a full genetic scan and do not limit the scan to SNPs
- personal genomics companies that focus on SNPs
- medial diagnostics like the MSAFP test
I don't know enough about 23andMe's operations and those of what appear from the outside to be generally similar services to answer that. Assuming that they really are an innovative service, they would need to conduct and provide the studies supporting the validity of their innovative service.
Any doctor educated in the past two decades
is well versed in genetic testing
any doctor specializing in areas where genetic testing
is a frequently used aspect of planning/diagnosis
(such as OB/GYN) will be highly familiar even if trained long ago.
If physicians are forced to waste huge amounts of time and effort to console an influx of patients who have been wrongly told they have some terrible disease, this is going to reduce the amount of time they have available to work with patients with actual terrible diseases.
If other medical device/diagnostic makers have to comply with the law, so should 23andme.
If we really cared about public health we'd have a drastically different system.
In any case I think it's hard to make a persuasive argument that if the members of the public were only kept more naive about their own health risks, public health would improve.
This is an extreme example, and I have no knowledge that it ever happened, but it is possible.
This might not even require a technical fix with the test, but rather a marketing and reporting of results.
That's a hugely significant difference vs. actually being diagnosed with a life-threatening condition. I don't think people would commit suicide or become unduly despondent if they learned they have a gene. They would just know they need to take action, get further testing, be vigilant, etc. It's not much different (in spirit) from knowing that your family history predisposes you to a certain condition.
That could be one area that the FDA might be trying to address.
But, you know, there are in-home HIV tests that are FDA-approved. They tend to stress professional counseling and/or follow-up testing, etc. They also explain such somewhat-technical details as the window between infection and antibody formation, so it's an education process there as well. But, I think the availability of such a test is testament to the fact that easier access to important knowledge re: one's status may be worth the risks.
What I was trying to say was that that class of test should be easier to use and get a definitive yes/no answer with a smaller false positive rate.
What if the gene essentially means "you and your husband shouldn't have children?"
If the testing was wildly inaccurate, then that's another issue. It almost becomes more an FTC consumer protection-type matter at that point. But, there is no indication that this is the problem. They go on to state that their testing is done in CLIA-certified laboratories:
https://www.23andme.com/howitworks/ (near bottom of page)
BTW, I'm not really defending the service, per se. In fact, I have issues with it that are more along the privacy lines. I just don't see where there's any proof that it has an outsized chance of ruining lives any more than, say, in-home HIV testing.
If you dump a bunch of information in front of people who may or may not be prepared from an intellectual or emotional perspective to deal with it, they may take dramatic and unwarranted action.
Organizations like the FDA and EPA were created in response to very real failings. The problem for many of us who grow up benefitting from these safety nets is that we don't have a sense of how hard-won these battles were. Life is good and so we start chipping away at the "nanny state" to get a tiny little bit more freedom. Actually more like a lack of inconvenience, not really freedom.
I've been thinking about this a lot lately. Is this just a natural social cycle?
The ideology that inspired the construction of these safety nets is gone for the most part -- we've degraded to bread and circuses. The political machinery on one side focuses on handing out stuff in exchange for votes, and the other side focuses on vilifying "those people". Nobody believes in anything anymore.
Public health isn't nanny statism.
I work for a large Medical Device manufacturer and questions like this come up all the time when we do Hazard Analysis. While the physician (or lab rules) may require a second confirmatory test, and that may give us warm fuzzies, it really can't be considered to be a hazard mitigation. It's still up to the manufacturer to not make the mistake in the first place.
Thanks for the info.
The primary path to approval to market for a new device or drug is the PMA (pre market approval). This is fairly extensive an costly for the company (e.g. clinical trials). A 510(k) filing allows you to take a short cut by identifying a "predicate device" that is "substantially equivalent". In other words you are saying "we do the same as X but we [also do Y/do this differently/etc.]". At least, you are claiming this for the scope of your "indications for use" (which are the only uses you can market your device for).
This doesn't let you off the hook entirely at all. You still need to demonstrate safety and efficacy, perform risk analysis, follow standard manufacturing and product development methodologies (e.g. ISO13485, IEC60601, etc. ), but it is a lot faster and less involved than a PMA.
If you don't use one of these accelerated paths, you'll need a PMA before you can market your product in the US.
The key issue here is that 23andme has filed one or more 510(k)'s, but have failed to support them properly.
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?
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)?
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.
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.
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. Newman points out that screening mammography does not reduce death overall, but causes significant harm by inflicting cancer scare and unnecessary surgical interventions. 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.
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.
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.
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.
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.
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.
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 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".
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.
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.
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.
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.
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.
FDA has tried to help 23andme. 23andme declined the help.
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.
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.
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.)
Cool. 23andMe should sell it like that. It seems most of the FDA letter is about how the tests are being sold.
Take this thought, and replace "some people" with "my mom" and see if it still results in the same conclusion.
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...
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.
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)
> 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.
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.
I find your argument invalid. If they get an approval from FDA, is it going to change their data processing logic or data set?
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.
It (or the marketing) would have to change if they don't get an approval. That's the whole point.
Whether there is the appropriate support to make those claims about a product marketed to consumers as a diagnostic tool is the question here.
July and Sept 2012 - 23andMe submits a form to the FDA saying "our test isn't really useful for diagnosis and thus shouldn't fall under these rules"
Nov 2012 - FDA says we don't agree with you you need to either prove your effectiveness or change your marketing
Jan 2013 - 23andMe says "it will take us a couple months to do the tests, we'll get back to you"
Nov 2013 - FDA says, "its been 11 months and you never got back to us. Stop selling and let us know within 15 days what you're going to do explicitly because you ignored us for close to a year"
Nothing the FDA does that is legitimate couldn't be better handled through the courts at a state level. And you wouldn't have to ignore the Constitution in the process.
So this isn't really a case of the gov't stomping on the little guy before he has a chance to grow; 23andMe has had its chance to grow into a fairly big deal, and now it's time to start playing by the rules.
More specifically they are busted for interpreting diagnostic tests not doing the tests. If they were two cooperating companies, and one did tests and squirted out results and the other sold diagnostic and interpretive services, the diagnostic services company would be busted but the test company would not be in trouble, as I interpret it at this time.
Skip all the exotic genetic issues and think about personal experiences with something boring, like blood pressure. No legal problem with testing someones blood pressure and giving them numerical results and maybe a medically sane set of typical ranges. My local pharmacy has a machine that does it for free. However, it would be a big issue for a non-MD using that data to diagnose high blood pressure, or a high likelihood of it anyway, then providing some treatment plans.
The issue seems to be selling services. If they just did testing, and provided a free downloadable immense data set and some statistical analysis tools and let the user come up with their own interpretations, they'd probably be in the clear (at least with respect to this individual problem). Now having a cloud service to hold the data and do the math is getting gray area ish but probably still OK as long as its the end user drawing the conclusions and not "the company" drawing the conclusions.
Actually, the device used to take the blood pressure reading, if I understand things right, did have to be approved by the FDA.
The FDA's letter keeps referring to 23andme as a 'device', so it seems like the FDA's authorization/responsibility is specifically to regulate devices rather than services, actually, but they've decided 23andme can be technically classified as a 'device' under the relevant laws/regulations.
If it was instead considered a 'service'... I wonder if there'd instead be a problem with practicing medicine without a license, if it's not MD's who are providing the 'service'!
that is true, the FDA would bust a mfgr of a device that claimed to report blood pressure but instead did astrology. This specific example of 23andme is, as near as I can tell, getting busted for interpreting the results, not for using 'cat /dev/urandom' to generate the results and then interpreting them.
Kind of like the same FCC that gets excited about out of band RF interference also got sorta excited by janet jackson's halftime show.
23andme is a 'device' that takes a bodily fluid sample as input, and provides genetic information as output.
A an automated blood pressure cuff is a device that, well, I don't know how it works, but wikipedia says it "They do not measure systolic and diastolic pressures directly, per se, but calculate them from the mean pressure and empirical statistical oscillometric parameters", whatever that means, and produces some blood pressure numbers as output.
23andme is obviously a much more complex 'device'. Both both take some sort of measurement of your person, and then provide medical information.
Even if you could somehow draw a line at some point in this process of translation from physical measurements to medical information, some point at which the 'interpretation' begins, I'm not sure why one would suggest that either side of that line would be exempt from FDA regulation!
I don't think that's true, which is the problem. They don't just provide genetic information. They provide information detailing the impact of those genes, as medical science understands them.
>Even if you could somehow draw a line at some point in this process of translation from physical measurements to medical information, some point at which the 'interpretation' begins, I'm not sure why one would suggest that either side of that line would be exempt from FDA regulation!
Neither side would be exempt, but the physical side would be trivially approved as "yes, this does in fact measure those genes, good work everyone, pop the champagne".
Last time I checked, the US federal government had an annual funding rate of $3.45 trillion compared to "a hundred million in funding" total for 23andMe.
So yeah, government stomping on the little guy definitely fits the picture. Then again, it would fit the picture no matter who the government decided to stomp on. Perhaps we should focus on less stomping and on more cooperative behavior?
How is a generic anti-government argument relevant here?
aka 'Please accord the following assertions the weight of fact*.
"Has two mutations linked to limb-girdle muscular dystrophy. A person with two of these mutations typically has limb-girdle muscular dystrophy."
Of course this not a diagnosis in a technical sense, but to a lot of people it will sound like it is. Specifically, I don't see how this is "very clearly" not a diagnosis.
Knowledge is power.
23andMe empowers you to better manage your health and wellness.
$99 [Add a kit]
There are no disclaimers on this page, just an aphorism, an assertion, and a call to action. Now I like the idea of 23andme, I like the company, and I'm educated and skeptical enough to enjoy some fluffy scientism for a hundred bucks, but don't tell me they're not selling the hell out of this.
The gov wants to decide what's best for the people. Should the people decide differently, using their wallets for example, this anomaly will be quashed.
This trend is especially strong in the medical field - gov approval required everywhere, then people wonder why medical things are so damn expansive.
I use 23andme and I'm happy with the information provided. I know it's not reliable - it's not a lab test anyone will use to base important decisions on, since it is not a full sequence of genes.
Yet, by being commercially available and easy to use, it is paving the way for commercial offers of full genome sequencing, which I damn well intend to use when they reach the $500 threshold.
However, gov actions like this one may very well make that impossible, making sure the only full genome sequencing offers there will be will be "FDA cleared" at a huge markup.
Suggestions to "medical" like companies - get out the gov eye. Move your business to Asia, the caribbean or wherever the gov will not get in your way like this. I want to keep using (and recommending) your products!
Wallets are incredibly poor judges of medical efficacy. The FDA rules are in place for very good reasons, namely to prevent snake-oil salesmen and other unscrupulous merchandisers from foisting their -- potentially harmful -- products upon an unsuspecting public.
I would much rather have FDA clearance for medical products and devices than the alternative that you seem to be proposing.
It looks like they do sell this in Europe. Although I'm not sure if that's because it's approved at all, or just because Europe considers it some kind of novelty product rather than a medical device; the FDA and EU categorization of drugs/devices/etc. is a bit different.
"Programmers are quite capable of reviewing the evidence to see if code is effective" — yet, we end up with thousands of people using MongoDB based off fad and hype and losing data by the day.
(Wait, did I just advocate for a government-level code approval board? In the right hands it would probably help if it prevented more Mongos and Hadoops from entering the world.)
Losing your life when you're a layman in the medical field is another.
There's some important context in the comments.
So are bureaucrats who are subject to the influence of lobbyists. Snake-oil salesmen and peddlers of alternative medicine do sell their stuff under the current system, while true innovation is crushed, as is evident in this case.
There's a number of other offerings that have been made in the same general space, as well.
There is snake oil for sale in every store, and no one has ever been hurt from their test.
There are huge information asymmetries involved when it comes to medical drugs, and also huge barriers to experimenting with different products. "Voting with your wallet" is appropriate for determining which cell phone should be popular, not which medical drugs or medical tests.
We as a society have determined that the appropriate risk versus innovation trade-off when it comes to medicines and drugs is less risk at the potential cost of less innovation. The FDA exists to safeguard that policy.
It's funny that you mention Asia, because the trend in Asian countries is to follow the American/European model. Asians have had enough of thinking "is this rat meat?" every time they bite into a lamb kebob, and are regulating their food and drug industries. And by "asians" I mean the Chinese, because the Japanese and Koreans have adopted the Western regulatory model long ago.
This is what the FDA should be doing. Correcting information asymmetries. With labeling requirements, unbiased PSAs, drug pamphlets and literature. Not telling people what they can and can't put in their bodies, or what businesses can and can't sell on the open market.
In fact, I'd say most government regulatory functions should be set up this way. Clearly inform and educate your citizens, don't opaquely dictate the behavior of your subjects.
For any reasonable requirement, if people/companies don't comply then it has to escalate to [threats of] harsher actions in order to force the reasonable thing to actually happen.
I know you're responding to a more general point, but I don't think any of your post applies to this situation. This is about marketing materials, and more importantly the factual information therein.
If they made that more clear, then they wouldn't have had to send the letter. It's why you see "This is not intended to diagnose, treat, or cure any disease" on all the non-FDA-approved supplements/energy drinks. My money is on them paying the fine and scaling back the marketing.
The purpose behind these FDA rules are to make sure things aren't marketing as "cures" when they aren't. People's health is serious business; there's no room for failure. If 1.0 doesn't work (or makes things worse), then the people that need it might not live to see 1.1.
This example is rather famous in the legal world because a) the drug was off-patent for many years before the problems were identified, and so there were many different manufacturers, and b) the problems were often not apparent until decades after exposure had occurred - two factors which make it very difficult to fairly ascribe liability to those who suffered avoidable injuries. This led to some innovative thing in damages/liability allocation which is now an essential part of understanding tort law.
I mention this because I've had some conversations with libertarian legal thinkers where they bring up this same argument of Thalidomide vs. opportunity cost - and its true that the barriers to approval were so low back in the late 50s that it's very unlikely such a drug could ever get on the market these days. Also, the effects were so drastic that that they were quickly noticed, and the number of birth defects ascribable to Thalidomide are in the low 10,000s. By contrast, millions of people are living with the impact of DES, and the magnitude of the affected class is also a factor in the legal significance of the damages formula. So any lawyer who's talking about balancing innovation and regulation in the drug market without addressing DES is being a bit disingenuous, and you should weight your judgment accordingly.
To take the latter point first, drug consumers are generally in a poor position to evaluate the risks of a given medication. If I set up a wheel manufacturing business, and sell square wheels, you are in a poor position to complain about the resulting bumpy ride  because the superiority of round wheels is so glaringly obvious. Unless you hold a medical or pharmaceutical degree, though, your ability to evaluate a drug's safety and efficacy is probably very limited. I'm smart enough to read and get the gist of a biochemistry paper to have an idea of what a drug does, but nowhere near knowledgeable enough to review or spot all but the most egregious errors. So while I am the sort of person who reads all the fine print on drug labels and sometimes digs into the academic research, in the end I'm taking a great deal on faith whenever I take medicine. by contrast, the drug manufacturer has not just one biochemical expert, but whole teams of them. This certainly puts them in the best position to foresee and even look for potential problems.
Now back to the first point: drug discovery is not the exact science we'd like it to be due to the gaps in our knowledge. Accordingly, drug companies must be given some leeway, compared to other manufacturers who enjoy a greater degree of foreseeability. suppose I set up a ladder company, but the ladders I manufacture employ such thin metal rungs that they cannot bear any weight above 100 pounds. They look good enough, but soon consumers begin suffering accidents when using them. I could not claim the accidents were unforeseeable since the tensile properties of metals are so well known and the tests are so easy to perform, that I should have realized the risk when designing my product, never mind before shipping it! It would be unfair to hold drug manufacturers to that degree of liability, but on the other hand a) experimental protocols exist precisely to address this problem and are widely understood within the drug industry, and b) since DES was on sale from 1941 onwards and class action lawsuits were brought against manufacturers in the late 1960s, more than enough time had elapsed for industry participants to have apprised themselves of the risk and limited the risk to consumers to a greater extent than they did.
If you read Judge Mosk's opinion, in footnote 24  he summarizes a 7-point test for establishing (rather than allocating) liability. The answer you seek is there:
The suggested requirements are as follows:
1. There existed an insufficient, industry-wide standard of safety as to the manufacture of the product.
2. Plaintiff is not at fault for the absence of evidence identifying the causative agent but, rather, this absence of proof is due to defendant's conduct.
3. A generically similar defective product was manufactured by all the defendants.
4. Plaintiff's injury was caused by this defect.
5. Defendants owed a duty to the class of which plaintiff was a member.
6. There is clear and convincing evidence that plaintiff's injury was caused by a product made by one of the defendants. For example, the joined defendants accounted for a high percentage of such defective products on the market at the time of plaintiff's injury.
7. All defendants were tortfeasors.
It's difficult to measure how many lives were saved or made substantially more livable because the FDA was not more cautious than it has been. Surely that number is not zero, and perhaps it's greater than the net harm done by drugs whose effects might have been caught by more prolonged testing. I don't think we know.
BTW these are not made up names although they look like it. Google them for a good time if you're bored. I'm more interested in the chemistry issues than the politics or biochemisty, so I'd be more comfortable (authoritative?) talking about the location of the methyl groups than liver toxicity, but my first paragraph has no known intentional errors (although it probably has some unintentional errors LOL).
I guess the point of this ramble is if a company exists to provide highly personalized customized services, then using a metric of "joe average" is probably not overly meaningful. The response of joe average to a disease percentage is maybe not relevant to the response of someone with a high percentage to the same result.
We have a pretty good medical system designed for joe average, and its intersection with radically personalized services is unsurprisingly going to be an epic disaster.
A whole lot of people have died from contaminated blood transfusions: http://articles.latimes.com/1994-08-31/news/mn-33183_1_aids-...
That's another case of a medical intervention ending up doing more harm than good.
I would guess you're asking to google for list of withdrawn drugs which lead me to
Another interesting side effect is most mass shooters were on anti-depressants, although that's probably not the kind of direct fatal side effect you're looking for. Its a challenging google game to track down the toxicology reports for each mass shooter weeks after the smoke clears and identify which anti-depressant they were on at the time. Sometimes its a different kind of med, sometimes they're not on any med at all, although thats kind of rare.
That one is easy: don't fast track drugs that are only marginally better than their peers, if at all, because by definition they aren't as important.
I don't have as clear an answer for pregnancy, other than exempting pregnant users from the fast track approval, but I'm not sure how a slower process actually protects pregnancies in the first place.
I'm moderately on the side of government not interfering where possible. But medicine and medical devices is one area in which such interference is quite likely a positive influence, on the whole.
Fact is, we don't want a return to the era of patent medicines. For every user of 23andme who is well-informed enough to know that the information is not reliable, experience shows that there will be another who is not. And these people will base life- and health-affecting decisions on the results provided by unregulated products. Then maybe they'll get sick or die.
That's why there are regulatory standards for medical devices and services. These standards don't prevent the sale of 23andme's services, but require that they are either a) regulated and proven to work, or b) explicitly and clearly described as not being so.
Yes, there are rampant inefficiencies within this system. But I'd wager that it's probably better than the alternative.
The funny thing here, is that barring lab errors, which I think are highly unlikely unless they are being incredibly shoddy, which would take effort, the information that 23andMe provides is very reliable. Now it is debatable as to whether the individual's interpretation is (for example in the Alcohol Dehydrogenase gene, many, many, many caucasian users don't bother to read that the test is only informative for asians, but it's definitely there, in bold letters, etc.)
Could you explain a scenario where basing life and health decisions on 23andMe's product could lead to sickness and death? Maybe it's "because I'm sophisticated", but this biochemist can't really see that happening.
That's the point of certification - is the process reliable? Are the warnings clear? I won't cast any aspersions on the product (because it's pretty awesome), but I do see these as risks and requirements.
Could you explain a scenario where basing life and health decisions on 23andMe's product could lead to sickness and death?
"I've got all these symptoms of diabetes. But 23andme said I had a low risk! It's probably nothing. Guess I'll eat another pie."
If 23andme has shoddy lab practices, or unclear explanation of the limitation of their testing, then that's a risk. The process of certification involves managing that risk.
(this study is about mammograms of healthy women, another example of a health screening tool)
We found that breast cancer mortality was an unreliable outcome that was biased in favour of screening, mainly because of differential misclassification of cause of death. The trials with adequate randomisation did not find an effect of screening on cancer mortality, including breast cancer, after 10 years (RR 1.02, 95% CI 0.95 to 1.10) or on all-cause mortality after 13 years (RR 0.99, 95% CI 0.95 to 1.03).
Numbers of lumpectomies and mastectomies were significantly larger in the screened groups (RR 1.31, 95% CI 1.22 to 1.42) for the two adequately randomised trials that measured this outcome; the use of radiotherapy was similarly increased.
So women who get more screening get more treatment but didn't live longer (unnecessary treatment)
This means that for every 2000 women invited for screening throughout 10 years, one will have her life prolonged and 10 healthy women, who would not have been diagnosed if there had not been screening, will be treated unnecessarily. Furthermore, more than 200 women will experience important psychological distress for many months because of false positive findings. It is thus not clear whether screening does more good than harm. To help ensure that the women are fully informed of both benefits and harms before they decide whether or not to attend screening, we have written an evidence-based leaflet for lay people that is available in several languages on www.cochrane.dk.
A mammogram is a screening test. 23andMe is another type of screening test. You aren't getting extra mammograms because of 23andMe, they are the same thing.
Mammogram can screen you for early detection of a serious disease. 23andMe can do the same (they advertise - this is what the FDA has a problem with).
More screening for all diseases doesn't mean better outcome, and can be harmful, depending on the test, the people screened, the disease, etc., etc. and can lead to more disease (needless treatment). Throwing more screening at the wall for every disease doesn't do more good all the time. Especially when we learn that some diseases (prostate cancer) cause no symptoms most of the time. Treating these asymptomatic prostate cancers is very harmful, because they are harmless unless they progress. The treatment is risky and has serious side effects (impotence!)
Every time we have a screening test, we have to look at the science. What are we screening for? What is the good? What is the bad? Who is helped? Who is harmed? Do the positives outweigh the negatives?
Another outdated screening tool is the breast self exam - it was found (in scientific studies) it didn't do any good and caused harm (http://en.wikipedia.org/wiki/Breast_self-examination) Lots of over treatment without a reduce in cancer rates. Also, just learning about it increases women's worry and anxiety about breast cancer. This is a harmful screening tool. This was studied and abandoned.
BRCA test has nothing to do with this example.
Mammograms are currently very common in women a certain age >40 or >50. Most women get them every few years as part of their health maintenance to check for the presence of cancer, tumors or lumps. Right now there is research coming out that is questioning that practice, but the practice hasn't caught up to the research and most doctors say "get your mammogram" without informing patients of the risks, they treat it like it is "all good." That was the point of this research to ask "are we doing the right thing here by screening all these healthy women with mammograms? Let's study that."
I will personally opt out of the mammogram hype when I reach the mammogram age. I'm also going to inform my mother of the current research on the matter, I know she's already had a few mammograms herself.
Certainly, there is science to support certain claims of the class made in the reports 23andMe provides being made with some degree of reliability based on the kind of inputs 23andMe takes in. Whether what 23andMe actually does from end-to-end makes the actual reports they provide reliable in real world condition is...well, exactly the question they have seem to have decided not to expend the effort to answer even after initiating the process of getting clearance from the FDA to market their diagnostic product.
I'm with you. I'd much prefer a bunch of people die first so the rest of us can "vote with our wallets" instead of having a government agency step in and try to fix things before anyone gets hurt. I mean, my start-up is going to sell baby food laced with arsenic because I once heard that arsenic makes babies smarter and I think I once ingested some accidentally and I didn't die. If it really does end up killing babies, well, the market will eventually correct itself. And no harm, no foul, man. Except the dead babies. But at least I wouldn't have some nebbish bureaucrat knocking at my door trying to tell this American how to live his life.
There have been a bunch of concerns in this thread that are valid -- e.g., people might have to deal with bad news, or may see false positives, etc., that could cause them some inconvenience (though I would argue that 23andMe doesn't tell you that you have cancer, just maybe whether or not you're likely to).
Regardless, the idea that I could die from a 23andMe test is about as far-fetched as one can get.
Liability for defective (whether through malice, negligence, or in some cases on a strict liability basis) products is government intervention in the marketplace, and is specifically designed to address one of the ways that reality does not align with the presuppositions under which an unregulated "free market" is ideal, to wit, that people generally do not, in fact, act with perfect knowledge of the outcomes of economic decisions when they engage in them.
It is no different than many other government interventions in the marketplace in its basis.
> And also, the FDA is not some magic fairy dust that will shield you from bad products. Mountain Dew still has BVO in it, for example.
That does not mean that its approval procedures (and procedures for reviewing products already on the market) do not have utility in providing clearer information on products within its regulatory domain and helping consumers avoid bad products.
You have unwittingly affirmed the very argument you are attempting to refute. Their inability to make accurate functional predictions from genomic data has much less to do with the technology (sequence vs. array) than it does with the fact that, isolated instances aside, nobody knows how to do this well. I am a 23andMe user myself and, knowing a bit about statistical genomics, I was surprised how credulously the results of one or two GWAS papers are presented as an almost-diagnosis on their website. GWAS are plagued by all sorts of confounding issues and the statistical evidence in favor of their conclusions is often extremely weak. This is not something that the general public appreciates, so I can see why FDA might get involved.
So actually you can't buy elixir sulfanimide anymore. Because it was poisonous. It resulted in more than 100 deaths in 1937. This was before the FD&C Act, requiring safety tests. The founder of Massengill refused to take responsibility for the results: "We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part." It should be noted that there was a sulfanimide craze on at the time, as the first commercial antibiotic, so there was much money to be made.
One woman wrote to President Roosevelt, about her dead daughter: "The first time I ever had occasion to call in a doctor for [Joan] and she was given Elixir of Sulfanilamide. All that is left to us is the caring for her little grave. Even the memory of her is mixed with sorrow for we can see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. ... It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such a bleak outlook on the future as I have tonight."
Massengill paid a minimum fine and continued on until it was acquired in 1971.
I don't mind that we have set up an agency to make sure that medical products and devices are safe to use and do what they say they are going to do. It's far more efficient than having to do it individually. And there's always, evidently, people who won't, because they trust their doctor or the brand. And, being medical products and devices, sometimes those people or their loved ones die.
Look how smallpox vaccine was discovered. Edward Jenner inoculated a young boy with cow pox, then attempted to infect him with smallpox a dozen times. Obviously we can't go around convincing young children to take infectious doses of deadly viruses. But we also cant send FDA thugs after every Silicon Valley startup pushing the boundaries of genomics research. So where do we draw the line?
But in this specific case, seems FDA isn't being totally unreasonable. For example, from the letter
"Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS"
seems like a good idea to require companies to do this
So either the government ensures the above or it does not get accomplished? There are no third parties that could take this on? I find that hard to believe.
In fact, I would venture they are worse because they have to be paid somehow, and if they are paid by industry, you are ripe for regulatory capture. It can be difficult to get consumers to pay for it unless you include some kind of tax in the product they buy in which case you've arrived at a pseudo-government agency.
You might be able to find countries where regulation is less strict or non-existent but I'd imagine that people's trust in medicine in said countries is less than in the regulated ones (as you most certainly would have rouge players abusing the lack of regulation).
edit: Added last sentence in 1st paragraph
Yet their adverting makes it sound like it is. Specifically talking about how it can be used find un-diagnosed disease and health problems.
Copy and paste and argument from the internet if you can't form one on your own. Don't pretend "herp derp Rand Paul" is valid.
I cannot imagine someone getting surgery or chemo solely based on a 23andme heads up warning and without consultation with a specialist physician.
As someone working in medical devices, this dramatic language is extremely frustrating.
People are completely stupid when it comes to medical issues. I heard a woman complaining that she couldn't eat honey because she was allergic to fructose. I work with at least 3 "gluten-sensitive" people (it's pretty unlikely they all have Celiac disease, it's not a big office), because it's a hip thing to do. Hell, didn't Angelina Jolie have a prophylactic double mastectomy?
edit: Since everyone is jumping on the Angelina Jolie example. I don't think her decision was made based on a single spit test. And I think she had doctors advising her. But the amount of publicity it got makes me worry that it could become needlessly popular based on self-diagnosis (like not eating gluten).
The placement of this in your post seems to imply you think she was being stupid with her decision, or thought it was in some way "hip" to do. She has a family history of breast and ovarian cancer and has a defective gene that made her chances of getting breast cancer 87%. As she's pretty wealthy, I'm going to guess that she has pretty good doctors and didn't make the decision on a whim. Also since it was major surgery I'm going to also assume some doctor saw her at least once before the surgery and s/he didn't just take her word for it that the surgery was in her best interest.
Yes there are plenty of people who don't have a clue when it comes to medical issues, but I'm not sure why you felt the need to lump Jolie in with your other examples.
It just doesn't jive with me that they are remotely the same thing. I think Jolie is a particularly poor example here and serves as a distraction for an otherwise decent point.
I really hope she had more information than a 23andme result.
As I understand it she has a strong family history, and the mutated gene. Prophylactic surgery can reduce risk in those cases.
Most people don't understand what "risk reduction means" so I hope she had doctors who were able to explain it to her.
This website http://www.cancer.gov/cancertopics/factsheet/Therapy/risk-re... describes it as a 95% reduction in risk.
Very very few people are going to understand what that means for them. Gerd Gigerenzer has a book that's a useful discussion of why presenting risks as percentages is bad.
And here's an example from the book http://imgur.com/zO4zkl4
And I certainly hope you have at least done some research on fructose metabolism before writing that woman off as a kook. Even if it is all in her head, you can make her at least happier, if not healthier by suggesting that she also avoid foods with sucrose or monomeric fructose, and substitute them with alternatives such as xylitol, glycerol, maltose, or ordinary glucose corn syrup.
If the patient is ignorant, that is a condition the doctor should be expected to cure. If the patient is stupid, they should find a less arrogant personal physician.
Low-cost screenings, such as 23&Me mail-in swab tests, elimination diets, or common blood and urine tests are a great way to start building up that objective evidence without first doing harm to your patient's wallet.
When you receive a Warfarin prescription, you begin very close monitoring that involves daily then weekly then monthly blood tests (for the rest of your life) to determine your dose and monitor the effect of the drug in your body. Someone choosing to take a lower dose because of 23andme results would be blatantly and intentionally disregarding the results of testing and the advice of their Drs. The 23andme result that you may be sensitive to Warfarin is something to mention at the outset of your treatment, and nothing more. Also, taking a lower than therapeutic dose of Warfarin would not cause an aneurysm, but would be more likely to cause a clot.
1) I dont see how 23andme results for Warfarin would in practice negatively effect a patients drug regime.
2) You seem to know very little about Warfarin and should take that into consideration when commenting on issues surrounding it.
Perhaps the startup echo chamber has more respect for unchecked opportunism; if that's the case, someone should make a startup called 23andMeFree (monetized by ads, duh) that has you spit in a tube, send it to some PO Box, then randomly generate positive and negatives across the board. If you wanted the scam to last longer, you could even generate random values based on statistics of certain characteristics. A true libertarian must support such a business.
I'm not sure that libertarianism is coherent enough to admit the existence of "true" adherents, but surely you mean to say that a "true libertarian" must not support the outlawing of such a business? Typical libertarians often display preferences among businesses. E.g., a libertarian might prefer Taco Bell to Panera Bread.
Edit: this should have been posted under the post above, but I meant to take issue with your comment on the division on economic issues. The only division I've seen is tactical, not philosophical. Can you provide an example of a deep philosophical division?
The deepest divide (of American libertarianism) is probably deontological (natural rights) versus consequential (pragmatic) libertarianism. Most of the branch ideologies originate from one of the two.
A good read on the subject. The Ethics of Liberty by Murray Rothbard .
Since I have long been "socially liberal, fiscally conservative" I did for a time wonder if I were libertarian. However, enough libertarians have subsequently explained how my opposition to most military action, to drug prohibition, to immigration limits, and to financial bailouts is counter to their libertarianism that I am left confused. (I occasionally call myself anarchist but that seems to annoy "true" anarchists even more than "true" libertarians!)
Thus my skepticism of libertarianism's coherence. I certainly don't intend to "vilify" anything, but up above I tried to correct what I felt to be a misrepresentation of even the amorphous understanding of libertarianism I do have. That is, it's clear to me that libertarians don't "support" all business interests without question. Any particular business might be objectionable or simply uninteresting in any number of ways.
On the other hand, governance by the FDA is tantamount to punishing for a crime not committed. It'd be like putting cameras in your home because you might abuse your children someday. And surely, a lot of stupid people abuse their children, right?
This is going to stifle innovation.
There are different ways to mitigate risk - ensure there's adequate genetic counselling and proper easy to understand information available for anyone taking the tests would be one way.
I lean towards favouring tight regulation of medical products. One person's 23andMe genetic test is another person's quackery - see some of the nonsense offered as medical advice by the quacks on other websites.
The FDA could still take action if they see that a company is doing something & claiming something that is not properly peer-reviewed and proven.
But why create extra red tape for everyone from the get-go?
"The laboratory may not be able to process your sample, and the laboratory process may result in errors."
"You should not change your health behaviors solely on the basis of information from 23andMe."
"23andMe Services are for research, informational, and educational use only. We do not provide medical advice."
"Genetic research is not comprehensive."
All from: https://www.23andme.com/about/tos/
Ideally, the FDA would have independently-generated evidence indicating that the product in question is unreasonably dangerous or ineffective for some intended purpose before issuing a cease and desist order. Instead, they simply assume guilt and place the burden of proof upon the vendor.
Given that the FDA has vastly more resources than 23andMe, and companies like it, this makes the FDA seem like bullies against microbusinesses, and like the captured servants of agricultural and pharmaceutical megabusinesses.
The FDA is a regulatory agency, which implies that their mission is less about intimidation and more about protecting the public good. Hence the more open tone, I suspect.
Its fairly typical of formal regulatory notices (or even informal notices -- much of the language is very similar to the 2010 letter in which the FDA first raised issues with the product) -- because they are typically directed at corporations with substantial legal resources and they are designed to convince them that they should voluntarily comply with the agencies direction because if they fail to do so regulatory action will be initiated which will be costly and unlikely to be reversed by subsequent litigation, so they lay out all the facts and authorities necessary for the recipient (and the recipient's counsel) to come to the desired conclusion.
23andMe helped me catch this early enough with the assistance of my physician that I was able to get treatment long before I would have developed symptoms. If I never used 23andMe I probably would not have had this diagnosed until years later.
I think it's reasonable for the FDA to tell 23andMe that if they're going to interpret the results for their customers, they need to be able to guarantee the chain of processing is there, and they need to be able to justify each "detection point" their marketing claims.
Your outcome is positive. But positive is not the only possibility.
> you might decide against certain treatments or tests based on that
Since you are mentioning treatments means, you must misunderstand what the purpose of the test is for. If you have current medical problems that you need treatment for, you wouldn't use 23andMe's statistics in order to chose a treatment, you ask your physician to help you get the treatment you need. If 23andMe had a false negative on my condition instead of the true positive, I would still get diagnosed once I started developing symptoms eventually. Nobody who starts having health problems thinks "I should first consult my 23andMe results for things that I should specifically mention to my physician that I don't have".
A Class III ruling would destroy the personal genomics market, because it would mean extensive clincial testing and documentation about the development of the device. I hope it doesn't stand.
It took them 40 years to get the labeling for tylenol right..
They are moving rather quickly on this one... my only question is, why/how??
> They are moving rather quickly on this one... my only question is, why/how??
You are comparing apples and oranges. It didn't take them 40 years to get to the point where Tylenol had to go through the procedure requiring FDA approval for marketing a drug (which is generally similar in origin to the parallel requirement for medical devices.)
Likewise, its quite possible that 40 years from now, there'll have been several rounds of changes to how an equivalent personal genomics kit will be marketed based on changes to what we know between now and then.
Government agencies empowered to weild regulatory force against citizens are a threat to everyone, and this is case in point.
Yes! How dare those jack-booted thugs infringe on my freedom to sell "Dr." Smacktoward's Bona-Fide Health Elixir and Youth Restoring Tonic (99% water, 1% radium) to anyone dumb enough to buy it!
It's turning into a dang police state, I tell you!
Whether or not you see this as a horribly unjust burden imposed by an unfeeling government will probably depend on whether you are the inventor or the person the inventor was planning on selling it to.
(The finance sector is even much worse than the FDA in this regard---for example Bernie Madoff was regulated, leading people to think their money was safe with him---but in some ways, the FDA is just as bad.)
Of course it can help, some. I'm not going to deny the obvious. But it's highly imperfect, and it often hurts.
In any case, the only hurdle to selling should be "does it do harm?", and "does it work as advertised?" can be determined later, if and only if there is any doubt among the consumers.
Elsewhere in consumerland, the product is sold, and independent testing is performed on off-the-shelf samples. Think Consumer Reports or Underwriters' Laboratories. If a problem is found, a recall may occur. If none are evident, the testing body grants its approval to use its trademarks on the product. People look for that trademark from the trustworthy third party.
If the FDA did not apply prior restraint, and tested products already available to the consumer, it could regulate the usage of the phrase "FDA-approved" and make perfectly safe everyone who buys only the medicines bearing that approval for the purposes which have been tested.
Laws don't operate under the principle of what should be, they are past agreements hammered out by negotiation, not logic. You don't get to say what the hurdle "should" be, that's already been agreed upon and set and it's unlikely to change because a few don't like it.
> Elsewhere in consumerland, the product is sold, and independent testing is performed on off-the-shelf samples. If a problem is found, a recall may occur.
Sometimes, sometimes not, it entirely depends on the law in those areas. Recalls don't help people who are dying from bad medication, the FDA's role is preventative, not reactionary.
> If the FDA did not apply prior restraint
That's their job, it's why they exist.
> and tested products already available to the consumer,
Then they'd be useless.
> it could regulate the usage of the phrase "FDA-approved" and make perfectly safe everyone who buys only the medicines bearing that approval for the purposes which have been tested.
Sorry, but their job is to protect people who don't have the information/brains to protect themselves, which in the field of medicine is practically everyone. This solution is simply a libertarian fantasy that has no chance of working in the real world. As the other poster said, see homoeopathy as an example, consumers aren't smart enough to not kill themselves with idiocy, even the rich ones like Steve Jobs.
Do you really think I can start legally marketing a car seat or a crib without safety testing it first? Wrong.
Federal law requires manufacturers and importers to test many consumer products for compliance with consumer product safety requirements. Based on passing test results, the manufacturer or importer must certify the consumer product as compliant with the applicable consumer product safety requirements in a written certificate that it must provide to retailers, distributors and, upon request, to the government.
My point was that it doesn't have to work in the way that the FDA (and other examples of other regulatory agencies) currently function, and your response did not address that.
"does it work as advertised?"
The scientific community regards homeopathy as nonsense, quackery or a sham, and homeopathic practice has been criticized as unethical. The axioms of homeopathy are long refuted and lack any biological plausibility. Although some clinical trials produce positive results, systematic reviews reveal that this is because of chance, flawed research methods, and reporting bias. The postulated mechanisms of action of homeopathic remedies are not only scientifically implausible but precluded by the laws of physics.
"does it do harm?"
yes, it exists, so it prevents people from accessing real medicine. It is a distraction.
Steve Jobs is a good example...
"Despite his diagnosis, Jobs resisted his doctors' recommendations for medical intervention for nine months, instead consuming a pseudo-medicine diet in an attempt to thwart the disease. According to Harvard researcher Ramzi Amri, his choice of alternative treatment "led to an unnecessarily early death." Cancer researcher and alternative medicine critic David Gorski "disagreed with Amri's assessment," stating, "My best guess was that Jobs probably only modestly decreased his chances of survival, if that." Barrie R. Cassileth, the chief of Memorial Sloan–Kettering Cancer Center's integrative medicine department, said "Jobs’s faith in alternative medicine likely cost him his life.... He had the only kind of pancreatic cancer that is treatable and curable.... He essentially committed suicide." According to Jobs's biographer, Walter Isaacson, "for nine months he refused to undergo surgery for his pancreatic cancer – a decision he later regretted as his health declined." "Instead, he tried a vegan diet, acupuncture, herbal remedies and other treatments he found online, and even consulted a psychic. He also was influenced by a doctor who ran a clinic that advised juice fasts, bowel cleansings and other unproven approaches, before finally having surgery in July 2004."
Yet, it still exists, and people are still buying it, using it, and buying into it. That is an indication the free market doesn't work in drugs. I can go on and on and on, but we need to be protected from ourselves.
I can make my own decisions. Just like 99% of rational people, who are able to judge for themselves that homeopathy is nonsense.
> Just like 99% of rational people, who are able to judge for themselves that homeopathy is nonsense
Rational people fall for pseudo science too, especially if it has a good salesperson behind it. Most people believe what others tell them without questioning. Very few look at the world skeptically. We need to blame the scam artist not the victim.
To the extent that approval requirements applied by the FDA under the Food, Drug, and Cosmetics Act do that with remedies (which aren't at issue in this case, as it is about a diagnostic device not a tretment), that isn't what happened here, as demonstrated by the fact that the FDA allowed 23andMe to continue to operate for years after issuing the June 2010 letter in which they first raised the issue that the PGS fell within the FDA's regulatory ambit and that various approvals were needed to continue marketing it the way it was marketed.
The "stop now" letter wasn't set until 23andMe stopped working with the FDA toward meeting the requirements, so 23andMe in fact was able, had it chosen to do so, to use the funds from selling its device to test it.
> and no one other than the inventor can test it, because the product cannot be sold until after it is tested.
The FD&C Act doesn't prevent covered "remedies" (etc.) from being sold before they are tested, it prevents them being sold to prevent, treat, or diagnose disease until they've been tested. Products can be sold for, e.g., research purposes before being approved (and, in fact, often are -- one of the suppliers to 23andMe and other genetic testing services was dinged by the FDA for knowingly selling to 23andMe and other genetic testing services products for diagnostic use which were not yet cleared for such use but which were allowed for research use .)
> In any case, the only hurdle to selling should be "does it do harm?", and "does it work as advertised?" can be determined later, if and only if there is any doubt among the consumers.
This approach was tried in the health space for many, many years, and the results were deemed unacceptable. Of course, you may have a different opinion of what is desirable than that which motivated the Food, Drug, and Cosmetics Act, but simply asserting that the rules should be different is unconvincing.
> Elsewhere in consumerland, the product is sold, and independent testing is performed on off-the-shelf samples. Think Consumer Reports or Underwriters' Laboratories.
That's true for some consumer products, and its not true for others, generally driven by perceived risk levels.
> not under free market capitalism
As evidence (to anyone else reading---no point in dealing with dishonesty), I present Atlas Shrugged, The Fountainhead, and Objectivism.
Ayn Rand is the only modern philosopher who can even present a reality-oriented reason not to partake in a life of crime. i.e., a reason not based on religion or appleal to emotion or simple common sense (though common sense is also correct on this issue and worth having).
This is some interesting reading that goes deeper into Rand's writing: http://michaelprescott.freeservers.com/romancing-the-stone-c...
All these are Rand's own words:
"The first thing that impresses me about the case is the ferocious rage of a whole society against one man. No matter what the man did, there is always something loathsome in the 'virtuous' indignation and mass-hatred of the 'majority.'... It is repulsive to see all these beings with worse sins and crimes in their own lives, virtuously condemning a criminal..."
And in regards to Hickman's jury: "Average, everyday, rather stupid looking citizens. Shabbily dressed, dried, worn looking little men. Fat, overdressed, very average, 'dignified' housewives. How can they decide the fate of that boy? Or anyone's fate?"
"Other people have no right, no hold, no interest or influence on him. And this is not affected or chosen -- it's inborn, absolute, it can't be changed, he has 'no organ' to be otherwise. In this respect, he has the true, innate psychology of a Superman. He can never realize and feel'other people.' "
"He shows how impossible it is for a genuinely beautiful soul to succeed at present, for in all [aspects of] modern life, one has to be a hypocrite, to bend and tolerate. This boy wanted to command and smash away things and people he didn't approve of."
Well, if you want to be sure, read The Fountainhead and Atlash Shrugged.
The Fountainhead is actually an explicit repudiation of Neitzche (though it is more than that).
There is a Nietzschean hero in the book---and he is driven almost to suicide, and is completely destroyed.
Rand greatly admired one aspect of Hickman: that he wasn't influenced by other people; he was fully himself. The actual hero of The Fountainhead is like that, but rather than being a destructive parasite (of self and others), he uses his independence to achieve real goals and values in life in a way that does not vicitimize anyone.
He did blow up Cortlandt Homes; importantly, nobody was in the building and nobody was harmed, and he did it because the plans for the building were essentially stolen from him. He does it to make a point, which he does make.
A system of free-market capitalism is precisely that.
As you go beyond that, you have a system where citizens are coercing each other, with the government's sanction and backing (e.g. the FDA).
(I do mean this with a hint of jocularity.)
However, there is a logical chain of facts, starting with concrete perception of reality, that leads to the conclusion that we should establish government for protection from coersion.
Society can pass a law to coerce people---at its own peril.
> Society can pass a law to coerce people---at its own peril.
Look around, turns out it's not really perilous at all. It's actually the normal way the world works.
Including the fact that I live in a mixed economy.
I am not the one in conflict with reality.
Logic and talk are not meaningless. There are reasons that there once was an Enlightenment, ultimately culminating in the founding of the only contry originally based on the concept of individual rights---the United States.
And hopefully we can get there again. Greater than the tread of mighty armies, is the idea whose time has come.
Of course, to make the time come, much intellectual groundwork will have to be laid.
> Look around, turns out it's not really perilous at all. It's actually the normal way the world works.
It is perilous. For instance, the US is in a perma-recession. In the long run, this is quite dangerous.
You are explicitly advocating that we ignore reality. That should be enough to make my point and probably everything else I just said is just distracting from it.
This should be interesting, if you have the patience to watch the fallout in slow motion.
Instead of whinging, FDA needs to partner with NIST to come up with quality control protocols so doctors know the error distribution in data that they receive.
No joking around.
The closest they come to calling her a "quack" is when they state "...We still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses..."
The bigger question is why is the FDA having a seizure over this? Could it be the potential for added treatment and preventative healthcare measures that insurers vis a vis the Affordable Care Act and not looking forward to paying for? (Not a rhetorical question, just asking)
What you are basically arguing is that 23andMe should not be allowed to offer its service.
Even the FDA isn't arguing that 23andMe should not offer it's service, just that it shouldn't market it. And really, given that they don't seem to be following the basic quality assurance practices of the industry, they should not be marketing at all.
They aren't even really arguing that either; they are more arguing that if they are going to market it, then they need to provide studies supporting the accuracy and take other steps to get it approved to be marketed for the particular uses it is being marketed.
They are saying in the Warning Letter that 23andMe must stop marketing the product because 23andMe has abandoned the approval process (and apparently was not preventing 23andMe from marketing the product as long as they were working through the approval process), not because the product is inherently unmarketable.
Um, they aren't having a seizure. 23andMe was informed of the regulatory requirements in a letter in June 2010 , and (as discussed in the Warning Letter just issued) submitted required documentation to begin the approval process in July and September of 2012. The FDA sent letters identifying issues with the submitted documentation and requesting additional information in order for the approval process to move forward on September 13, 2012 and received no response from 23andMe.
The FDA set follow up letters in March and May of 2013 indicating that due to 23andMe's failure to address the issues raised in the FDA's earlier letter, the applications submitted in 2012 were deemed withdrawn -- which meant that 23andMe was not only not in compliance, but no longer considered to be actively working toward compliance -- but still took no substantive action, giving the company time to begin working toward compliance again.
Now, more than a year since raising issues with 23andMe's original submission, more than 3 years since notifying them that they needed to come into compliance, and 6 months after notifying 23andMe that their failure to respond to the issues raised with their initial submissions had caused those submissions to lapse, they've given 23andMe notice that they will face regulatory action if they don't either stop marketing the products or provide an acceptable plan within 2 weeks.
That's not exactly "having a seizure".
If you remove big blobs of flesh from yourself on the basis of a single test, you are not making your medical decisions wisely. The only decision you should be making on the basis of 23&Me results is whether to take another test that is more specifically targeted at the potential problem.
If 23&Me says you have BRCA, you don't get a double mastectomy. You talk to your doctor. You perform self-exams more often and more thoroughly. You get additional screenings that are not cost-effective for the general public with a lower risk profile. That's the whole point of consumer-grade genetic screening.
Although I agree with the FDA's actions, a consumer getting a thorough genetic exam is possibly what prompted this. Check out the artidcle http://www.bloomberg.com/news/2013-11-25/fda-tells-google-ba.... Turns out United Healthcare raised a concern which I believe is might be money-related. If your test results suggest a high possibility of some health issue from an non-FDA approved company and you requested a more accurate test, then I can see the health insurance companies getting involved.
Plus 23andme is clear when showing the results that everything is based on probabilities, there's not a single %100 change of anything, it just tells you that people with similar DNA markers (in X, Y or Z study) seem to have a higher/lower chance of X or Y.
People are stupid. This isn't a label on a chainsaw saying "don't lick the blade". This is reasonable regulation of a product being marketed as a medical product.
You might not, but some would. Some people take serious action based on what a psychic says. We are in the minority here.
This will simply result in this type of testing to move beyond FDA borders. Great job FDA, you're helping kill a successful and profitable US company. Un-F-ing-believable.
Obviously, it would have been preferable to have the company and FDA work together to announce how FDA regulations apply before an enforcement action. But, now that it has happened, the process has started. If the company can come out of this with some kind of FDA approval, then that cloud will be lifted and they can keep on working. And then the company will know exactly what rules they'll have to play by. So, depending on how things work out, it could end up being a positive for the company.
Now that the FDA has played their hand, I'm very curious to know how the company will respond.
This action is a core function of what the FDA does.
They have been in talks since 2009 to help 23andme understand what they need to file, and how to do it. 23andme has (repeatedly, it sounds like) failed to do that.
This notice is a standard corrective action taken by the FDA after failure to complete 510(k) submissions.
Before the FDA gets its hooks into it and the price goes up...
"This service is intended for entertainment purposes only."
No disclaimer about medical anything. And people pay more than 99$ for psychic services.
What you are noticing is a government agency that has exercised restraint for years, not one that was aloof.