23 sounds like terrible science and irresponsible application of medical technology. Whatâs urinalysis Maggie?
Iâm honestly a trifle surprised that they got away with it for this long⌠Just because the âDietary Supplement Health and Education Act of 1994â says that they have to put up with the âTeehee! âBackpaincuritrexâ has not been approved to diagnose, treat, or prevent any disease, just a dietary supplement!â from the pill pushers, doesnât mean that the FDA likes doing that, or that they are happy to see a fairly high profile outfit dancing between âAw, shucks, for entertainment purposes onlyâŚâ and âWell, we do (without any particularly well-verified accuracy and controls in place) test for Seriously Clinically Relevant stuff. For, yâknow, entertainment purposes onlyâŚâ
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.
23andMe was set up because Sergeyâs mother had Parkinsonâs. Itâs 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, itâll be interesting to see if she just lets the company die a slow death or changes the strategy moving forward.
Actually, their new ads are pretty explicit in recommending 23&Me for disease diagnosis. http://www.youtube.com/watch?v=JB5NJs9WxdI
@fuzzyfungus Do you even know what 23 and me is? Have you ever seen a real profile? They donât MAKE health claims. They donât 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.
They still seem to be taking online orders for their spit kits.
âI would not base decisions for surgery or chemo on the results of the 23andme spit kit alone, and I canât imagine any sensible patient or doctor doing so.â
Who are these âsensible patientsâ of whom you speak? We seem to be in dreadfully short supply of anything resembling that description.
Do bear in mind that thereâs 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 didnât 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.
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.
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.
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 theyâre 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
As a genomics researcher Iâm 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? Itâs not like they have a background in genomics.
I absolutely agree that quack medicines need to be stopped by the FDA but this isnât the same thing at all â nobody is claiming that the SNP analysis provided by 23andMe is faulty, only that it is dangerous for the public to see it. And thatâs just bogus.
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. Theyâd been that way all his life, apparently a basic metabolic thing that the specialists heâd gone to had no clue about, but he wasnât suffering any effects from it and it wasnât affecting his health in any way. If youâre not a doctor and got that kind of test result back without any further medical history or the background to know that a result thatâs so at odds with the patientâs actual health needs cross-checked to make sure itâs a real problem, you end up on a wild goose chase taking meds and getting treatments that arenât needed and wonât help the problem.
The FDA can fuck right off. They are a seriously useless bunch of dickbags.
Its all industry insiders, taking huge piles of dough to âfasttrackâ 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.
Donât think the FDA had much choice here - I think theyâve been more patient with them than they are with many device manufacturers. (A test is a âdeviceâ to FDA, who donât 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 âcompleting the additional analytical and clinical validations for the tests that have been submittedâ and is âplanning extensive labeling studies that will take several months to complete.â 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.[âŚ]FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns,[âŚ] an increasing list of indications, show that you plan to expand the PGSâs uses and consumer base without obtaining marketing authorization from FDA.
Thatâs the most seriously-worded warning letter Iâve ever seen. FDA may be dickbags, I agree, but their job is to stop people marketing âdevicesâ 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 âlabsâ 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 donât agree that laboratories are allowed by law to market tests - they call us not having to submit to them their âenforcement discretionâ which they say they can remove at any time. Many lawyers are getting rich off this argument as I write.
WTF does 23andMe being âbacked by Googleâ have to do with anything in this case? Linkbait?
23andMe didnât 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.
This is an informed and well-reasoned post and gosh darnit, will NOT be tolerated here.
These the boingboing forums for chrissakes.
The FDA is saying that the analysis has not been shown to be anything but faulty. Itâs the vendorâs responsibility to submit that information. They were warned repeatedly. They still havenât 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.
