FDA Tells Google-Backed 23andMe To Halt DNA Test Service 371
Hugh Pickens DOT Com writes "Bloomberg reports that 23andMe Inc., the Google-backed DNA analysis company, has been told by US regulators to halt sales of its main product, the Saliva Collection Kit and Personal Genome Service, or PGS that tells users whether they carry a disease, are at risk of a disease and would respond to a drug because the kit is being sold without FDA's marketing clearance or approval. 'FDA is concerned about the public health consequences of inaccurate results from the PGS device,' says the agency. 'The main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work.' 23andMe was founded six years ago by Anne Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin. The FDA decided in 2010 that services claiming to evaluate a customer's risk of disease must be cleared by regulators if the companies sell directly to consumers. Most FDA-cleared genetic tests are for a single disease while 23andMe's would be the first to test for multiple conditions. 23andMe submitted FDA applications in July and September of 2012 for the least stringent of two types of medical device reviews but the FDA said the company failed to address 'the issues described during previous interactions'."
Re:Democracy? (Score:3, Insightful)
how is it not in their jurisdiction?
its a company performing a health and medical test. of course they should have research behind their you will get cancer promises
otherwise they need to put for entertainment purposes only
Entirely Reasonable (Score:4, Insightful)
Now cue all the Slashbertarians ranting about how restricting unproven medical testing is an assault on freedom...
Re:Democracy? (Score:4, Insightful)
Is it a health or medical test? Or are they just an information provider? I mean they are not telling me if I have diabetes or heart disease – Just that my genes mark me at a greater risk to get those diseases – in combination with lifestyle and environmental factors.
Re:Entirely Reasonable (Score:4, Insightful)
Suppose I started marketing an HIV test, or a Hepatitis C test, or a tuberculosis test without demonstrating the test was effective?
Is anyone claiming these tests aren't effective? I don't see it in TFS, only claims that they don't have the right paperwork from the government.
Re:Democracy? (Score:5, Insightful)
So a bunch of un-elected bureaucrats decided whether same un-elected bureaucrats had the power to regulate a product or service? Mind you, I'm not questioning whether this is a good product or not-- just whether the FDA should be deciding what's in its jurisdiction. Where are the progressives clamoring for "checks and balances"?
I think you have a badly misguided understanding of how government in the US operates... and was explicitly designed.
There's a reason the "founding fathers" intended that your voice carried no weight at the national level -- or even largely at the state level. The "public" doesn't have the knowledge to have their opinions really matter on most topics. The US form of government was explicitly set up so that you'd elect local officials -- on the basis of local matters that you, presumably, have some understanding of -- up to the level of Governor of your state or commonwealth, but beyond that *those* officials voted on national matters.
And its a DAMN good thing that the dimwit "will of the masses" is not involved in the vast majority of things the government does, because the will of the masses is both ignorant and easily controlled. In fact, IMO, the majority of the problem we've got with the federal government today stems from the fact that the separation between the will of the people and the federal government has eroded over time. Instead of good people being elected, the slime balls who can most effectively sway the opinion of the ignorant masses gets elected -- and then has to spend their time playing politics to keep that position.
Upsetting the Apple Cart (Score:5, Insightful)
I've done the 23andMe testing and it has been of value. I'm not in close contact with much of my extended family and have almost no contact with the family on my father's side. It doesn't claim to diagnose or treat diseases or traits. What it does do is tell you if you're at elevated odds for a few select conditions, along with heritable traits. This is can be invaluable if you don't know that much about the medical history of your family.
Re:Upsetting the Apple Cart (Score:5, Insightful)
And you are apparently perfectly ok with the possibility that they could be completely wrong.
Nobody is saying that inexpensive dna testing is bad, just that the process needs to be verified that it works before it should be sold to the individual.
Unlisted subtext (Score:2, Insightful)
The FDA states that false positives & false negatives are a major part of the reason that they are outlawing direct sales of these tests to consumers. Because a false positive on the breast cancer gene could lead to "prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions". Yeah, because Physicians using the existing tests never have false positives & even were there to be one, malpractice suits always punish doctors guilty of errors of interpretation...
Because you see, people would be performing surgery, chemo, etc all by themselves without the assistance of healthcare professionals alerted to the possible presence of a problem by one of these simple tests...
To my eyes, outlawing these tests is above all a defense of the existing expensive testing industry. We cannot have people having simple inexpensive tests. That would undercut profit margins.
Re:Upsetting the Apple Cart (Score:4, Insightful)
The FDA has a point, though. If the test isn't accurate and gives false negatives or isn't clear about what the results really mean, it can lure people into overconfidence and that can be dangerous if they really are at risk for one of the diseases.
Granted, they probably wouldn't have known about these conditions in the first place, but if, as an example, the rest of their family is known for heart disease due to a genetic defect and they get a false negative, they might be overconfident in their chances for heart disease, leading to possible death because they didn't go to a doctor to get checked out.
Re:Change your place of business (Score:4, Insightful)
Do you have any idea how many things that are technically not legal to sell here that get through?
Have you ever bought "kinder joy" or any of the other similar chocolate candies that contain a plastic egg inside the chocolate? My wife enjoys them, so I get them for her when I see them. I know many shops I can buy them at, all over the area....yet, they are not legal products for sale in the US due to.... FDA regulations.
Hell, people have been buying mail order pot seeds and drugs and....you think customs is going to be a barrier to this?
So what exactly is so special here that means this time is going to be different?
Fuck these government pricks (Score:2, Insightful)
Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment
In other words, the FDA wants to be the sole provider and arbiter of this information. The scientists are 23andme are too fucking stupid to possibly get anything right unless they have the FDA bureaucrats looking over their shoulder.
I am a 23andme member and my genetic test showed that I am sensitive to warfarin. That's something I never knew before. If I ever get into a situation where that drug is used, having informed the doctor of this potential problem just might have saved my life. There is no possibility that this information could result in any harm, because if the doctor gives a lower than normal dose and it's not effective, he can simply give more. But that doesn't matter to the FDA, because obviously 23andme, the doctor, and myself are all too stupid to utilize this information without Big Brother's help. We can't decide anything for ourselves, so we need Uncle Sam to do all our thinking for us.
The fact that people are on here making excuses and saying "they don't see anything wrong with this", is exactly why our country is so fucked. Look in the mirror: you assholes are what is wrong with this country. Every. Single. Person in the FDA, or anyone who apologizes for their fucking stupid actions, deserves to burn in the same pit of hell they are destined for.
--- shiftless (410350)
Re:Entirely Reasonable (Score:5, Insightful)
Re:Fuck these government pricks (Score:5, Insightful)
my genetic test showed that I am sensitive to warfarin. That's something I never knew before. If I ever get into a situation where that drug is used, having informed the doctor of this potential problem just might have saved my life. There is no possibility that this information could result in any harm, because if the doctor gives a lower than normal dose and it's not effective, he can simply give more.
Weird that you think there can be no ill-effects from under-prescribing something intended to save your life. Unless you're gunning for a stroke/heart attack, that is.
Re:Entirely Reasonable (Score:2, Insightful)
It's pretty simple. This is a screening test. It's supposed to be inaccurate as silly as that sounds. The point of it is, if there are ANY markers for the disease it's supposed to easily test positive. Then the user is supposed to go to a DOCTOR and verify the results. Even the initial tests they do in hospitals can sometimes give false positives as high as 80 to 90% of the time. So even if you do test positive, you still only have a 10% chance of actually having the disease.
Government regulation should be used to inform the public of the choices they are making to help prevent deception in the marketplace. It should not be used to prevent products the government dislikes from being made available to the public. In this case, the FDA should ask them to place clear and obvious statistics on the results of test. i.e. "You have flagged positive for suchandasuch disease. This is not a definitive diagnoses, and on average only 40% of people that get flagged on this test actually end up having the disease. Please seek a medical professional for a more definitive test and treatment if necessary"
Requiring disclosure is usually easy to comply with, welcome by nearly everyone and a non-controversial topic. If the company does not want to provide those statistics or even worse doesn't even have them yet, then I think the FDA would be in the right in telling them to stop production.
Re:Democracy? (Score:5, Insightful)
They being 23andMe. If they market it as a diagnostic service then they are providing a medical test regulated by the FDA.
Re:Democracy? (Score:4, Insightful)
This is why we can't have "Affordable" care.
This company provides a valuable service to their customers at a very inexpensive price.
Now that the FDA is involved, its likely 23 and me is done. The companies that run through their regulatory gauntlet will likely offer their services for prices that are an order of magnitude larger than 23 and me did.
It is literally the price of regulation. We're not really paying for health care. We're paying for this regulation and that regulation and this insurance rule and that restriction and the doctor's insurance and the clinic's insurance, and that administrator's porsche (because what good is an administrator that isn't payed the big bucks), and this drug company's kickbacks that lead to the regulatory hurdles and that companies kickback's to local politicians to keep new competitor clinics from opening.
No wonder health care costs a fortune. Pretty soon we'll be paying everyone EXCEPT the Doctors!!
Re:Democracy? (Score:5, Insightful)
The FDA bears the brunt of all public outrage of anything even tangentially related to medicine. They are bureaucrats who want to avoid responsibility at any cost. The FDA also bears none of the costs of testing new products.
What outcome did you expect?
A different model might take the utility of public safety into account. Instead of "safety at any cost", it might be "more good than harm".
That's not true. I've read the FDA regulations, and I've read transcripts of FDA hearings, which are now online. They have to weigh the benefits of the new drugs against the dangers. They have long debates in the hearings over the benefits and the potential harm. And some of the people on the panel are sympathetic to the industry. It's a difficult balance http://www.reuters.com/article/2013/10/18/us-ariad-cancer-idUSBRE99H0BP20131018 [reuters.com]
There were lots of drugs, like erythropoetin, that the drug companies over-promoted and made lots of money on, even though they were killing people. Their excuse was, "We didn't get a statistical signal." Every time a pro-business administration takes over, the FDA loosens up its regulations, and the bodies start dropping, so they tighten up the regulations again.
The FDA is not allowed to take the financial cost of the new drugs into account. That's not in their legal mandate.
Re:Democracy? (Score:2, Insightful)
Is a bathroom scale a diagnostic device?
Because that's what 23andMe is doing. They're making something that was once part of the expensive and costly medical world and bringing to the masses. They're turning genetic testing into the equivalent of a fancy bathroom scale.
I for one think their service is amazing, particularly because it costs $99. I'm also under no delusion that it's not particularly valuable regarding my health. Part of that is because I have several molecular and genetic biologists friends, but also because 23andMe tells you this.
For the few people out of a thousand who actually find they may have a serious genetic condition, they'll obviously go directly to a doctor. For the rest of us, it's like the 21st century version of a mood ring, except actually based in real science.
Also, the ancestry stuff is cool, although genes don't tell you much about your ancestry, because we think of ancestry in terms of who our Great-Great Uncle Joe was. But within three or four generations your actual genes quickly link you to almost everybody in a sizeable geographic region, while your great old Uncle Joe doesn't really stick out much. Your real, genetic ancestry is exceptionally boring. I found out a very, very white friend have a Y-chromsome from Southeastern China, which had migrated over a thousand years or so North to Siberia and then East to Finland. That's relatively recent genetically, but kinda yawn inducing in terms of what we care about.
Re:Fuck these government pricks (Score:5, Insightful)
Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment
I am a 23andme member and my genetic test showed that I am sensitive to warfarin. That's something I never knew before. If I ever get into a situation where that drug is used, having informed the doctor of this potential problem just might have saved my life. There is no possibility that this information could result in any harm, because if the doctor gives a lower than normal dose and it's not effective, he can simply give more.
First, it's not that the FDA wants a monopoly on genetic tests. Their interest is in the safety and education of the populous (queue conspiracy theorists). They focus on making sure the public is getting accurate, validated information on treatments/drugs that do only what they advertise.
Second, you are putting your trust into something that may or may not be peer-reviewed and ensured to be accurate. Just because your genetic makeup says you may have a sensitivity doesn't mean you actually do. Would you really risk not having a surgery if you discovered through a mail-order cheek swab that you "may be sensitive" to penicillin?
Third, sensitivities and allergens are certainly not something to be played with. The difference between mild rash to anaphylactic shock can be pretty small for some people and some allergens. I know people that are resistant to the standard anasthesias, and in some cases the only way to get them numb is to get dangerously close to an LD50 injection (sometimes an alternative doesn't work or is not available).
I'm not belittling the information that you received from them or that it may have been useful to you. What the FDA is doing is making sure that the claim of someones sensitivity to something is accurate and informative for that individual. Too many people out there will find out they are sensitive to wheat, then go out of their way to make sure not only do they not eat wheat, but they purge their houses of wheat, refuse to touch flour or wheat products, then start some non-profit organization to start feeding fear to the populous that wheat is a poison that must be purged.
Re:Fuck these government pricks (Score:5, Insightful)
Being aware of false information can have a negative impact, in the same way that bogus leads can hinder a police investigation.
That said, I think the FDA should be allowed to put their stamp of approval on things, but they shouldn't be allowed to prevent people from deciding what medical tests and procedures they do to themselves.
Re:Democracy? (Score:5, Insightful)
Pregnancy tests are also regulated as medical devices. They cost $5.
23andMe can grow up and have their work validated clinically. Or they can find an industry where accuracy is not regulated.
Re:Democracy? (Score:2, Insightful)