FDA orders 23andMe, backed by Google, to halt sales of DNA test service


#1

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#2

23 sounds like terrible science and irresponsible application of medical technology. What’s urinalysis Maggie?


#3

I’m honestly a trifle surprised that they got away with it for this long… Just because the “Dietary Supplement Health and Education Act of 1994” says that they have to put up with the ‘Teehee! “Backpaincuritrex” has not been approved to diagnose, treat, or prevent any disease, just a dietary supplement!’ from the pill pushers, doesn’t mean that the FDA likes doing that, or that they are happy to see a fairly high profile outfit dancing between “Aw, shucks, for entertainment purposes only…” and “Well, we do (without any particularly well-verified accuracy and controls in place) test for Seriously Clinically Relevant stuff. For, y’know, entertainment purposes only…”


#4

The insurance industry is probably worried that people will ask their doctors to do(expensive) medical tests if they find out their genome has issues.


#5

23andMe was set up because Sergey’s mother had Parkinson’s. It’s always been about getting as many people as possible to test so they can do genetic research on that particular disease. Now that Anne and Sergey are kaput, it’ll be interesting to see if she just lets the company die a slow death or changes the strategy moving forward.


#6

Actually, their new ads are pretty explicit in recommending 23&Me for disease diagnosis. http://www.youtube.com/watch?v=JB5NJs9WxdI


#7

@fuzzyfungus Do you even know what 23 and me is? Have you ever seen a real profile? They don’t MAKE health claims. They don’t sell cures, or snake oil. They sell DNA sequencing, and perform correlative research.

The test includes a lot of markers, including the key breast cancer markers, as well as markers for other genetic diseases and predispositions. Still, they are quite careful to share the limits of the data and to refer you to a real doctor if you have further concerns… and they provide you with the fully detailed sequencing results for additional analysis.

Do you have any actual data to support your conclusion? Can you articulate any real, meaningful criticism, or are you just making assumptions?

… and for the record, yes, I am a happy customer. The test prompted me to ask my doctor about some metabolic abnormalities that turned up, and I am much happier now that I have changed my diet. The actual diagnostic tests to confirm cost me about $75. To have a full panel done without 23 and me would have cost almost $1500 - and that assumes that either of us even thought to consider them - which we had not.


#8

They still seem to be taking online orders for their spit kits.


#9

“I would not base decisions for surgery or chemo on the results of the 23andme spit kit alone, and I can’t imagine any sensible patient or doctor doing so.”

Who are these “sensible patients” of whom you speak? We seem to be in dreadfully short supply of anything resembling that description.


#10

Do bear in mind that there’s a world of difference between performing DNA tests in a non-clinical context, where the consequences of messing up are fairly mild and easily remedied by sending out another spit flask and repeating the sequencing, and a clinical context, where it can cause a lethal error in medical treatment. Like you said, you didn’t have $1500 for a full panel, so it was moot for you. But 23andme need to be a lot mroe careful in how they describe their service to customers, and make it clear that tests for actual clinical applications should be done in labs operating for clinical purposes.


#12

Perhaps the insurance industry thinks this will cost them more money if people do these tests.

Also, I would not be surprised if a large competitor, who stands to lose money b/c of competition from a cheaper service, put the pressure on FDA to go after 23andMe.


#13

Money was not the issue. There was no indication that I needed to have those tests done. I did 23 and me out of curiosity more than anything. That I got to fix my methylation issues was pure bonus.


#14

It sounds like you have a good relationship with your doc and the spit kit was useful as a starting point. I think the FDA is concerned that people will take the test, see nothing worrisome in the results and then assume they’re totally fine.

OTOH, this may have been prodded by segments of the medical industry that likes to charge large sums for similar tests or from doctors and hospitals who like to have full control over medical information. /shrug


#15

As a genomics researcher I’m dismayed by this decision. I think it is another case where the medical profession and science are in conflict. What 23andMe provided was not a medical diagnostic, but a dataset in which variations in your genome which are associated with various phenotypes were noted. Some of them were, yes, correlated with disease, but not all of them. And even in the case where they are, what makes physicians think they have any more insight in such scientific findings than everybody else? It’s not like they have a background in genomics.

I absolutely agree that quack medicines need to be stopped by the FDA but this isn’t the same thing at all – nobody is claiming that the SNP analysis provided by 23andMe is faulty, only that it is dangerous for the public to see it. And that’s just bogus.


#16

Worse: people who take the test, see potentially bad results and take action based on those results without consulting a doctor (eg. changing medication dosages, starting/discontinuing medication, etc.). The problem is a lot of results are ambiguous and need extra checking. For instance, one doctor my family had for treatment for a long while had cholesterol levels that were sky-high. They’d been that way all his life, apparently a basic metabolic thing that the specialists he’d gone to had no clue about, but he wasn’t suffering any effects from it and it wasn’t affecting his health in any way. If you’re not a doctor and got that kind of test result back without any further medical history or the background to know that a result that’s so at odds with the patient’s actual health needs cross-checked to make sure it’s a real problem, you end up on a wild goose chase taking meds and getting treatments that aren’t needed and won’t help the problem.


#17

The FDA can fuck right off. They are a seriously useless bunch of dickbags.

Its all industry insiders, taking huge piles of dough to ‘fasttrack’ drug approvals by getting pharma companies to pay billions for testing, billions they get from exorbitant fees charged to Americans via insurance, and all the while blocking good drugs that treat the same things that are generic in other countries.

Maybe the #1 government agency responsible for the highest number of deaths in the US, through denying medical care to people via for-profit regulations. They are the governmental arm of big pharma. They are the reason drugs in the US are priced 10x higher than drugs in Europe.

A black market of smugglers exists to run therapeutic life saving drugs to the USA because of the FDA. They do a better job of protecting the American people from affordable healthcare than they do from anything else.


#18

Don’t think the FDA had much choice here - I think they’ve been more patient with them than they are with many device manufacturers. (A test is a “device” to FDA, who don’t speak English.) This paragraph:

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.[…]FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns,[…] an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.

That’s the most seriously-worded warning letter I’ve ever seen. FDA may be dickbags, I agree, but their job is to stop people marketing “devices” without validating their accuracy and precision first.

Disclaimer: I worked for many years in clinical laboratories, which are allowed by law to market tests without submission to the FDA[1]. (We come under CMS and follow their rules for validation.) We have watched as FDA has attempted to shoot down a number of fly-by-night “labs” trying to market genetics tests, and companies such as 23andMe which may have a better foundation for its tests, but who really knows until the clinical and analytical performance of the test has been validated and reviewed?

[1]Edit: Before FDA weighs in, I better say that they don’t agree that laboratories are allowed by law to market tests - they call us not having to submit to them their “enforcement discretion” which they say they can remove at any time. Many lawyers are getting rich off this argument as I write.


#19

WTF does 23andMe being “backed by Google” have to do with anything in this case? Linkbait?

23andMe didn’t play by the rules, and FDA seems to have given them more than ample leeway and second chances to come across with the requested materials. They finally had enough and brought down the hammer. The only blame her is on 23andMe.


#20

This is an informed and well-reasoned post and gosh darnit, will NOT be tolerated here.

These the boingboing forums for chrissakes.


#21

The FDA is saying that the analysis has not been shown to be anything but faulty. It’s the vendor’s responsibility to submit that information. They were warned repeatedly. They still haven’t done so. The FDA is being unreasonably generous in giving them one last chance (15 days) to do so before they shut it down completely.