Slashdot Mirror
FDA Tells Google-Backed 23andMe To Halt DNA Test Service
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'."
Suppose I started marketing an HIV test, or a Hepatitis C test, or a tuberculosis test without demonstrating the test was effective? The FDA would be on me like shit on stink, and rightly so. Same here: suppose they incorrectly tell someone they have Huntington's Disease, or carry BRCA?
Now cue all the Slashbertarians ranting about how restricting unproven medical testing is an assault on freedom...
Regulating this seems reasonable to me, as does the logic in the FDA letter...
"Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. 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, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. 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. For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect. These risks are typically mitigated by International Normalized Ratio (INR) management under a physician’s care. The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported."
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.
I can see why cheap and reliable genetic testing you can do without the intervention of medical industry is frightening. For one hundred dollars you can find out if you have markers that put you at elevated odds of hundreds of conditions. If this came from the traditional medical, you would have to go to a doctor who would release the results to your insurance company, it would cost about $1000, and you wouldn't even get to see the results yourself unless the doctor wanted to show you something.
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.
The problem is that 23andMe started making medical claims. As the FDA says, "your company's website at www.23andme.com/health ... markets the PGS for providing "health reports on 254 diseases and conditions," including categories such as "carrier status," "health risks," and "drug response," and specifically as a "first step in prevention" that enables users to "take steps toward mitigating serious diseases" such as diabetes, coronary heart disease, and breast cancer." Those are health claims. Those have to be clinically tested.
The history of their web site shows the health claims becoming more blatant over time.
Their advertising thus shows a progression from marketing to the technically curious to marketing to parents worried about their kids. That's what properly concerns the FDA.
Uhhh..you might want to look up the history of the FDA friend as its one of the government services that has a DAMN good reason for existing!
You see back in the 1920s, soon after the discovery of Radium and X-Rays...and you just KNOW when a sentence starts like that its gonna end badly..a bunch of companies started selling "Health restoring radium water" which of course not only had zero oversight since there wasn't an FDA but also had zero standards when it came to doses. Needless to say several people died most horribly, including on industrialist whose jaw literally rotted off and who ended up so damned radioactive that they had to bury him in a lead casket to keep him from contaminating the entire area, and THAT is the event that caused the birth of the FDA.
Now if you want to argue that this shouldn't be under their jurisdiction? Fine and dandy although I would argue that a bad test result could cause folks to die as they might ignore symptoms because "The test says I'm not at risk for X", not to mention we have ZERO proof that their labs are even monitored in any way. Don't forget that there was a gal at a state crime lab recently that got busted for just tossing samples and telling cops what they wanted to hear and who knows whether or not they have any bad apples at this place so...yeah I kinda want their to be oversight when it comes to DNA testing, especially since more and more things like insurance and jobs could very well be affected by bad results.
ACs don't waste your time replying, your posts are never seen by me.
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.
They being 23andMe. If they market it as a diagnostic service then they are providing a medical test regulated by the FDA.
These comments are my own and do not necessarily reflect the views or opinions of my employer or colleagues...
If doctors were actually using these mail-order tests to make medical decisions, that would be a concern.
I don't think it's realistic to expect that anybody would for example get a double mastectomy/ovarectomy on the basis of this test. No licensed doctor in the US would operate on a woman on that basis.
(In fact, a doctor in Australia wrote an article about that in the New England Journal of Medicine. A woman had gone to a "free screening" at a "health fair" and the "alternative medicine practitioner" told her that she had cancer, and sold her a few thousand dollars worth of "alternative medicines" to treat it. This woman went to this real doctor, an oncologist, demanding to be treated for cancer. The oncologist kept telling her, "but you don't have cancer!")
Similarly, I can't follow the FDA's argument that this test could affect a patient's use of warfarin (although I give them credit for trying to make a case).
The FDA seems to give a free hand to companies selling some dubious tests http://www.hairanalysiskit.com/glink/1a.htm?gclid=COTshpbjgLsCFQbNOgodGUMAbQ so there are some legitimate questions.
Regulators protecting us from dangerous health fraud? Or jack-booted thugs restricting our freedom? You decide.
At the rate things are going it is likely to soon become cost effective to sequence everything for what 23andMe is charging now and simply hand customers a DVD with their fully sequenced DNA.
When that happens the cat is out of the bag all you need is software to do analysis for any and all aliments you want using nothing more than software which can be downloaded and used freely by anyone. Software no government is going to have much luck restricting people from getting their hands on it.
I am all for FDA regulations but they need to evolve or they will find themselves on the loosing end of a war they cannot win (See also drugs, smokes and alcohol)
A couple of suggestions:
1. Carve a space in regulatory regime allowing for speculative technologies provided any test outcomes must be validated by an FDA approved method before actionable decisions are made by a doctor. e.g. what is most likely to happen currently anyway as a result of any 23andMe diagnosis.
2. Setup a scoring framework and information system allowing people to get statistical information on the accuracy of tests as results are confirmed so they can make up their own minds whether tests are worth their time. Enabling the market to drive accuracy is a win for everyone.
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
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.
If even half of the FDA's letter is correct (and I see no reason to doubt it), they've been bending over backwards to work with 23andMe for years. The company made a deliberate decision to both ignore the regulators and (more damningly) fail to study the effectiveness of their own product, and now they're paying for it. Here's the relevant section of the letter:
Visit the
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.
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.
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.