FDA Orders Genetic Testing Firm 23andMe to Halt Sales

http://money.cnn.com/2013/11/25/technology/fda-23andme/

by wikiburner • 13 years ago

79 73 13 years ago

money.cnn.com

DigitalSea• 13 years ago

Completely understandable and it's a fair point people might undergo unnecessary surgery as a result of a false positive (like having breast tissue removed preemptively after false positives for chances of contracting breast cancer). 23andMe is a nice idea, but you can't beat an old fashioned regular trip to the doctor and blood test to check for these things.

jfoster• 13 years ago

Unless 23andme start selling the surgery as well, doctors will be involved before any surgery happens.

gkoberger• 13 years ago

Think about the opposite, though -- most people don't get tested for anything, especially weird/uncommon conditions. Tests like 23andme aren't something your local doctor does every checkup.

For $100, people who otherwise would have been clueless know if there's something they should ask their doctor about. In this case, I think some false positives are better than ignorance.

Worst case, you think "oh no, I'm predisposed to ___!" for a few days until you make it to a doctor who can tell you for sure.

It's fair to say 23andme has saved far more lives than it's hurt.

mikevm• 13 years ago

It's fair to say 23andme has saved far more lives than it's hurt.

Please back this statement with evidence, otherwise it's just hot air.

felipe• 13 years ago

Tests like 23andme aren't something your local doctor does every checkup.

Fair enough. So why not let FDA go through their process, do their investigation, and once approved people could safely rely on 23andme.

dreamdu5t• 13 years ago

Just as there will be people who get surgery due to false positives (which happen with regulated testing too), there are lots of people who otherwise have no preferred means of testing if it's regulated away.

teraflop• 13 years ago

The FDA doesn't appear to be trying to shut down 23andMe, just trying to force them to file the appropriate documentation and follow the same rules as everyone else regarding how they advertise their services.

berberous• 13 years ago

The idea that someone is going to get their breast tissue removed based on 23andMe alone strikes me as unbelievable. A doctor would be consulted, who would likely order more appropriate diagnostic tests first. I would imagine any doctor that jumped straight into surgery based off of a 23andMe print out would eventually be sued for negligence.

dangero• 13 years ago

Has 23andMe told their side of the story yet? The FDA's press release made it sound like 23andMe was very negligent, but there has to be more to it than that. I can't imagine a company just ignoring the FDA's requests.

fjarlq• 13 years ago

They posted this to Facebook:

Hi everyone, Many of you have seen and been asking about this morning's news.

Here's the statement we've issued to the media: "We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."

We'll continue to keep you updated here as we know more. Thanks for all the messages of support!

https://www.facebook.com/23andMe/posts/10152374363517802

bcl• 13 years ago

From the 23andme TOS:

"You should not change your health behaviors solely on the basis of information from 23andMe. Make sure to discuss your Genetic Information with a physician or other health care provider before you act upon the Genetic Information resulting from 23andMe Services. For most common diseases, the genes we know about are only responsible for a small fraction of the risk. There may be unknown genes, environmental factors, or lifestyle choices that are far more important predictors. If your data indicate that you are not at elevated genetic risk for a particular disease or condition, you should not feel that you are protected. The opposite is also true; if your data indicate you are at an elevated genetic risk for a particular disease or condition, it does not mean you will definitively develop the disease or condition. In either case, if you have concerns or questions about what you learn through 23andMe, you should contact your physician or other health care provider."

https://www.23andme.com/about/tos/

Karunamon• 13 years ago

This is what I don't get. It's not like this is hidden. The site is completely upfront about what they are and what they do, what studies and results have more confidence and which less.

Maybe I'm just a little cynical here, but it seems the FDA would have better things to do with their time. That in mind, I wonder what spurred this...

gcb1• 13 years ago

its just a matter of knowing the game. big farma kills millions, nothing happens. small company still not pleasing the right people, huge fine/closed/etc

yes, i am implying the gov is corrupt. it is.

and this the reason everyone pays hundreds of dollars for catheters and such, and any company that tries to improve the design and price of those items are all in legislation or royalties limbo.

laurenstill• 13 years ago

There is some speculation that the recent ruling regarding taxation of FDA-approved medical devices has something to do with this.

But the cagey behavior from 23AM has been going on for longer.

lylebarrere• 13 years ago

This is much better than the other FDA story today where the FDA declared walnuts a medicine because a manufacture made the factual statement "Omega-3 Fatty Acids found in walnuts have been shown to have health benefits."

http://www.fda.gov/iceci/enforcementactions/warningletters/u...

wissler4• 13 years ago

In our era, it doesn't matter if two consenting parties agree, what matters is whether the judge or regulatory agency approves of the agreement.

edmccard• 13 years ago

From the 23andme TOS:
... Make sure to discuss your Genetic Information ... before you act upon the Genetic Information

The problems are not about what someone might do with their "Genetic Information", but with the accuracy of the "Genetic Information" in the first place. The false positives/false negatives mentioned in the FDA's warning letter[1] are not referring to misdiagnoses based on the 23AndMe's results, but to misidentification of genes in those results (as the letter describes it, "false genotype results")

In a nutshell: 23AndMe claim that the genetic variants in their results are (to some degree of accuracy) genetic variants that you actually have; the FDA says that 23AndMe have not provided enough evidence for these claims.

[1] http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2...

bebop• 13 years ago

The TOS is perfectly valid. It is a solid document advising people to take any results up with a medial professional. The service tells people that the product is not a medical diagnosis, however the service does provide medical information. This clearly puts said service in the realm of the FDA. Therefor compliance should be sought.

Really this goes for any company building medical services. Consulting someone on HIPAA compliance, as well as, FDA standards and practices is a must.

Is this fair in this case? Who knows. It is irrelevant. Resistance is futile.

taspeotis• 13 years ago

Previous discussion https://news.ycombinator.com/item?id=6794122

    317 points by jefffoster 14 hours ago | flag | cached | share | 377 comments

djjose• 13 years ago

The crux of their troubles comes from this paragraph in the Warning Letter: "However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” 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. It is now eleven months later, and you have yet to provide FDA with any new information about these tests."

The FDA, while being a pain in the rear at times, will actually work with you to meet compliance. But you have to show work and be continually in touch with them and show progress (and document everything according to your own procedures, complying to regulations of course). You can't just say you're working on compliance and then not follow through and show evidence. The issue for 23andMe is the on-label use of the product "in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body." They market the product this way. If you want to market your product as such, you have to show proof to the FDA and receive approval to label the medical product in this manner. It looks like 23andMe is either not working towards compliance (and is misleading the FDA) or is doing a terrible job documenting their work towards compliance and keeping the FDA abreast (my guess is this is what's happening). That in itself will get you in trouble, but then expanding your marketing for even more on-label use of the product - which hasn't been submitted to the FDA apparently - while at the same time not having FDA approval for the original use is just plain stupid.

dpe82• 13 years ago

I used to work as a state legislative aid; one of my duties was helping constituents work with state agencies on regulatory matters. I learned from that experience most regulators (at least at the state level, I imagine federal is similar) usually care much more about compliance than enforcement. As long as you aren't doing something egregious and make a good faith effort to work with them they'll often be pretty reasonable within the confines of the law. However if you ignore them, they'll come down on you like a ton of bricks.

It sounds like 23andMe has been ignoring them.

maratd• 13 years ago

As long as you aren't doing something egregious and make a good faith effort to work with them they'll often be pretty reasonable within the confines of the law. However if you ignore them, they'll come down on you like a ton of bricks.

This is how all government works, in general. There will always be multiple opportunities to bring yourself into compliance, since it's in the government's interest for you to comply.

Contrary to popular belief, the government would prefer compliance over a fight.

23andMe on the other hand ... is either grossly incompetent or they're looking for a fight.

FDA's regulatory oversight over this new industry is not established. If 23andMe wanted to challenge them in court, this would be the way to do it. They need standing.

snitko11• 13 years ago

FDA as always sticking their nose into something they shouldn't. Let the people decide whether they want to use this particular service or not. People ought to be free to choose. Otherwise it's not consumer protection, it's consumer dictatorship.

Angostura• 13 years ago

But it seems clear that it really shouldn't be used for anything in its current state.

thelambentonion• 13 years ago

This really looks like the FDA sticking their nose into something they should. 23andMe is making false claims about the efficacy of their test in their marketing material and the FDA isn't okay with that. They're not even ordering 23andMe to stop testing, just to stop marketing their service as something it isn't.

jacoblyles• 13 years ago

I'd rather see them shut down the FDA than 23andMe

cscurmudgeon5• 13 years ago

I am not a big fan of possible snake oil even if it comes in hipster startup form.

snitko11• 13 years ago

Great, don't use it then. Why do you believe you have the right to tell other people what to buy for their money?

Michael_Murray• 13 years ago

Of course this happens the week after I submit my sample.... ;-)

shubb• 13 years ago

The problem with 23andmMe is that genetics can't currently tell us much about our risk of developing common genetic diseases.

Some diseases are caused by a single gene. These are rare because people with a dominant copy of that gene are less likely to reproduce, so they are mostly deselected. Many of these monogenic diseases have a pretty major effect. You know if you have them (and probably died in childhood). Pre-natal genetic counseling is where finding these is useful.

Most of the diseases 23andMe talks about are caused by multiple genes (in combination with the environment). The interactions between these genes are often really complicated, and typically the number of genes involved is huge (and the actual contribution of each gene to risk is very small). This has made investigation a nightmare - even the most understood genetic diseases, we only know about say 10-20% of the genes that make up the genetic part of the risk, which may only be 40% of the total risk.

So 23andMe sees you have 1 of the 100 genes that we identified as contributing to a disease. That means you have 1% of 20% of 40%, which is really nothing to get excited about.

I know 23andMe tries to communicate this, but they are also trying to run a buisness. If they stood up and said 'yeah, we can do some tests, and they really won't tell you anything worth knowing', they would get no press coverage. But anything else is... carefully not lying, rather than being honest.

I read other commenters here, who say things like 'Well it's a nice compliment to getting a blood test', and get the feeling they think these tests mean shit.

patrickmclaren• 13 years ago

My comment from the same story on reddit.

For those protesting this decision, carefully read the following:

However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” 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. It is now eleven months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.

It appears that 23andMe is and has been aware of this situation for quite some time. In fact, the FDA has devoted significant time to aiding 23andMe in their process to compliance:

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.

The FDA in fact proposed a relatively simple solution, which was related to the labeling of the product.

FDA has spent significant time evaluating the intended uses of the PGS to determine whether certain uses might be appropriately classified into class II, thus requiring only 510(k) clearance or de novo classification and not PMA approval, and we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification.

Please keep in mind the scenarios in which the FDA attempts to avoid, in this situation. Particularly, a layman could consider their 23andMe results to be conclusive evidence for/against particular diseases and conditions, regardless of the respective error bounds for the data, and take matters into their own hands or simply prefer their results over the advice of medical professionals. Sure, there are T&C on 23andMe which state that this product should not be used in these purposes, this labeling is exactly what the FDA wants to improve. Limitations of assurance or intended use cases for products of this nature should be clearly labeled, and in a consistent manner. A startup (although 23andMe could be considered to be well beyond that stage) should not entrusted to make these decisions alone, and in fact, we do not have one such independent entity within this space, it is a growing arena within which multiple such entities are competing. It is not their business to care about other use cases, it is their business to stay in business.

A particular paragraph on 23andMe's homepage says "Understand your genetic health risks. Change what you can, manage what you can't." I do see many individuals in the Nootropics/Quantified Self community interpreting their own results and indeed taking matters into their own hands. Okay, so perhaps these individuals may be of above average intelligence and are capable of behaving rationally, but this desire to improve oneself is not limited to our circle. Believe it or not, most of the population would love to improve in one aspect or another. We should be very careful in what 'gifts' we present to society, especially gifts of this nature.

rossjudson• 13 years ago

When I read the FDA press release, it states that 23andMe must cease marketing their product. I don't see where it says that they must stop selling it. If I'm right about that, they're free to continue selling the product but have to stop their public statements about it, until the FDA grants them leave to do so.

FDA Orders Genetic Testing Firm 23andMe to Halt Sales

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