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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'."
You can market all you want to the Bahama market then. Marketing related to health in the U.S. is faced with certain proscriptions.
Where's that damn "Good!" cat when you need him?
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
_Respect_ _Ma_ _A-Tor-A-Tay_!!!
Grease my palms and we'll let you proceed.
Sorry 'bout that.
This is what regulatory agencies do. They 'decide' if the product or service or what not falls under their jurisdiction. They are typically (and in this case, the FDA specifically) given legal powers to compel companies to follow rules and regulations.
Of course, the companies are not without recourse. There are detailed rules on how the regulations are enforced (go ahead, read them, that should keep you occupied for some time, be sure to stock up on adequate quantities of Doritos and Diet Dr. Pepper). The last letter in the summary is quite interesting. The FDA details an entire page of attempts to work with 23&me at various times and venues. Apparently, the company's response has been pretty minimal. If you read between the diplomatic legalese, the FDA sounds pretty annoyed at the company.
Don't get all bunched up about how we 'didn't elect' the FDA / FAA and even the NSA. We elect the people that write the enabling legislation and believe me, Congress is forever trying to meddle into details they really shouldn't (cf, the 10 million exceptions to everything in Medicare / Medicaid regulations and the horrid legislative quagmire that the ACA* is trying to create). Further, the involved companies can directly petition the regulatory agencies and even sue them.
There are plenty of checks and balances. Hardly perfect and always subject to argument about where the various lines should be drawn, but it is never a regulatory free fall, despite what Limbag wants you believe.
* ACA - Affordable Care Act - aka Obamacare
Faster! Faster! Faster would be better!
Won't matter, people in the US will hear about it, send for a kit, send it back - all perfectly legal without having to bribe the FDA uphishals.
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...
Most of us Progressives understand that Congress created the FDA (Food and Drug Administration), and gave it power to regulate the safety of foods, and the effectiveness of drugs and medicines.
When a person thinks the FDA should not regulate a given item, they can sue, and that court case might expand or limit the FDA's overall authority.
For the FDA to decide that a DNA test, which claims to tell a person what risk they have for diseases, without a physician's help or expertise, needs to be checked to make sure it isn't providing bad information, seems to be right in their purview.
Note: the FDA has been successfully limited in the past; if an item is a 'Nutritional supplement' then it's not regulated as a drug, and only needs to be safe to eat. If it's a 'vitamin' or 'treatment', then the seller must prove it does help / cure what it says it cures.
This is the way it's supposed to work.
It can come to court as soon as they actually make the decision to include it in their purview. If the courts find the law disagrees, the manufacturer would be free to continue.
In fact, if the review of powers itself were enough of a problem, it would grant standing for taking it to court before the decision had been made. The 3 step process in the US of "legislation, executive action, court review" is pretty good, except for all those hundreds of times that all 3 steps fail in their duty.
Not if the law doesn't clearly state they have the power to regulate said diagnostic. That puts the FDA in the same boat as a dictator - my powers are what I say they are.
And the statements are clearly labelled as "Indicators that you carry have been found in 73% of cases of X disease, you may want to get a full diagnostic from your doctor."
Nuff said.
Someone in another story was just telling us how wonderful the FDA are.
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."
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.
the FDA already regulates every diagnostic test and device in the USA
that's why medicine is so expensive, everything has to be tested before you can sell it with claims about what the gizmo or test does
and customs will just seize them when they enter the USA
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.
I figure that a product which makes claims about its ability to predict (note that they won't say diagnose) your potential for developing certain diseases later in life should fall under the FDA's purview. I've been interested in 23andme for a long time. The first time I heard about them, the test and resulting reports ran something like $500. I added it to my "wish list" way back then and nobody bit. It's apparently down to the $99 mark now and is being marketed on television in time for the holiday season.
I'm a fairly intelligent individual and I'd be absolutely sure to take anything they reported about my genetic profile with a grain of salt. However, the FDA exists to protect your average Joe out there, who believes those TV commercials that say taking Penalis will give you a raging boner, and that lady who was on "Las Vegas" really does have an amazing non-surgical facelift procedure that will remove 20 years from your face.
A lot of these products get away with using a very blatant disclaimer that "these statements have not been evaluated by the FDA" etc. I'm not entirely sure why 23andme can't just put that disclaimer in there as well, and be all good. But the fact is, FDA has been trying to work with them for several years to get them into whatever is considered to be FDA marketing compliance, and the company apparently hasn't cooperated.
If they'd not put commercials on TV, they probably wouldn't be in any trouble. I just checked their site and can't immediately find the old list of stuff that they said they'd test your DNA for (and there was a big list). Not saying they've taken it down, but I didn't see it with a quick glance.
All of that said, the 23andme spit-and-get-results thingy is still on my wish list.
Thanks to the War on Drugs, it's easier to buy meth than it is to buy cold medicine!
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"?
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".
The current diagnosis model is probabilistic fitting, where a self-confessed list of symptoms is matched against a list of possible conditions. The doctor starts with "try this, see if it clears up" and moves to the next condition if it doesn't. (And heaven help you if you get a rare condition.)
I don't see how a diagnostic test, even an inaccurate one, could be worse than what we have now. A false positive would have to be confirmed by more accurate testing, and a false negative wouldn't be any different from not taking the test (ie - you'd wait for symptoms to appear). Maybe instead of the FDA requiring companies to prove perfection, it should be up to the FDA to prove that something *doesn't* work. They would eliminate all the obvious scams and swindles, and allow companies to try new things(*).
(*) With normal legal protections - companies would still be liable for damages.
It definitely isn't a food or medicine. I don't think this is a health test (phenotype versus genotype) unless you think that genes are unhealthy. (I recall some fascists once thought like that.) It is arguably a medical test -- but so is measuring weight, BP, temperature, pulse, and examining an individual for albinism, eye color, and gender. I guess all companies who state, "You have high BP and you are male; you are at higher risk of cardiovascular disease" and back it up with research should be shut down too.
No, and no.
So then how exactly does the FDA justify a claim to jurisdiction here?
Perhaps this should instead fall under the aegis of the CDC?
So a bunch of un-elected bureaucrats decided whether same un-elected bureaucrats had the power to regulate a product or service?
Science based legislation is enforced through science based administrative law and procedures.
The history of the FDA can be traced to the latter part of the 19th century and the U.S. Department of Agriculture's Division of Chemistry. Under Harvey Washington Wiley, appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market. Wiley's advocacy came at a time when the public had become aroused to hazards in the marketplace by muckraking journalists like Upton Sinclair, and became part of a general trend for increased federal regulations in matters pertinent to public safety during the Progressive Era.
The 1902 Biologics Control Act was put in place after diphtheria antitoxin was collected from a horse named Jim who contracted tetanus, resulting in several deaths.
In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, also known as the "Wiley Act" after its chief advocate.] The Act prohibited, under penalty of seizure of goods, the interstate transport of food that had been "adulterated". The act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the United States Pharmacopoeia or the National Formulary.
The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry. Wiley used these new regulatory powers to pursue an aggressive campaign against the manufacturers of foods with chemical additives, but the Chemistry Bureau's authority was soon checked by judicial decisions, which narrowly defined the bureau's powers and set high standards for proof of fraudulent intent.
In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide organization. This name was shortened to the Food and Drug Administration (FDA) three years later.
By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products that had been ruled permissible under the 1906 law, including radioactive beverages, the mascara Lash lure, which caused blindness, and worthless "cures" for diabetes and tuberculosis.
The resulting proposed law was unable to get through the Congress of the United States for five years, but was rapidly enacted into law following the public outcry over the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent.
President Franklin Delano Roosevelt signed the new Food, Drug, and Cosmetic Act (FD&C Act) into law on June 24, 1938. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove fraudulent intent. Soon after passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of "prescription-only" drugs was securely codified into law by the 1951 Durham-Humphrey Amendment.
Food and Drug Administration
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.
Democracy is a sheep and two wolves deciding what to have for lunch. Freedom is a well armed sheep contesting the issue
I am intrigued by your ideas and wish to subscribe to your news mailings, kind Sir!
Well, it's not the first time that a genetic test led to a divorce ...
Well, considering that the FDA told the Walnut Marketing Association, that any marketing of "health benefits" regarding walnuts would classify them as "drugs" and thus they are not allowed to even promote Proven benefits of Walnuts, this makes perfect sense. They are, after all, protecting us from the boogie man of health.
We need a government approved, ObamaCare Certified doctor our plan approves of, in order to tell us anything medical. "We are from the Government, we are here to help."
Of course they are a bunch of un-elected bureaucrats. THAT is why we keep voting for (R) and (D)s who keep giving us more Bureaucracy, never less. And queue the Republicrat response of "Somalia is a Libertarian dream" in 3 - 2 - 1 .... (And by the same measure North Korea is a Bureaucrat dream!)
Agent K: A *person* is smart. People are dumb, stupid, panicky animals, and you know it.
Its not a democracy, it's a republic. If, we, the people, don't like what they are doing we simply need to elect people who will change the law. The check on the fda, is congess and the courts. In this case, I think it's actually good policy.
Well.. maybe. Or Maybe not. But Definitely not sort of.
Turning over your DNA to Google is just plain stupid. Believing you have some semblance of privacy with them is even more stupid.
Stupid, stupid, stupid.
Wow, so if you got the test results back and it said you had dick cancer, would you just be hacking it off yourself or would you be going to a doctor to have your dick removed?
Don't know something? Look it up. Still don't know? Then ask.
Unlikely - many things that are technically illegal to import/export but not particularly interesting get through customs easily. At worst they'll have to insure against the 1% seizure rate.
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?
"I opened my eyes, and everything went dark again"
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)
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.
So the only problem with democracy is that the people are allowed to vote. Take that away and you can accomplish anything -- even making the trains run on time.
I think the black market potential of low-cost DNA kits can't really hold out where there are other legal DNA tests available.
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.
You brought up the founding fathers, so riddle me this.
Amendment 10 (paraphrase from memory) All powers not listed within the Constitution are to be handled by the states.
Now please point to me where the "founding fathers" put in the FDA in the Constitution, or which amendment it was added in.
If you want to argue individual states have this power, I can agree. What state is the FDA under?
Seems to me most of the issues with the Federal Government could easily be cleared up by Congress, Executive Branch, Supreme Court, being forced to READ the 10th amendment and the 14th amendments every day out loud and if what they are proposing does not fit, toss it out.
The original article, which is talking about the FDA pulling the plug on a medical service due to its operator not addressing some red tape with respect to safety standards, is a good illustration of the interventionist form of "statism". Subsidized health care doesn't necessarily dictate what the medical industry can do in the same way, but taxing people and spending the money on certain kinds of health programs is definitely an economic intervention that pushes the medical industry in a certain direction. What do you think, Mr. Anon.? Did you have this similarity in mind when you wrote your post?
..and want to help" Frequently the last words a great idea ever hears.
Organization? You must be joking..
Interstate commerce. If you think 23andme selling a product over the internet, which is then mailed to consumers, typically in different states, and then mailed back, typically to a different state, and then the results are transmitted via the internet, across all sorts of state lines, isn't interstate commerce, I'm not sure what is.
Which isn't to say interstate commerce isn't abused, but 23andme is certainly engaging in it.
The FDA jurisdiction over medical tests (as opposed to therapeutic drugs) is interesting.
I once researched this. The manufacturer has to give the FDA enough information that the FDA has to certify that tests used for medical purposes are accurate.
Question: Exactly what do they accurately measure?
Take this test, for example: http://www.walgreens.com/store/c/at-home-drug-test,-marijuana/ID=prod375983-product
Is it enough to measure the presence of marijuana (with 99.9% accuracy)?*
Or is the medical question whether the person being tested has marijuana abuse, which means that marijuana use is interfering with education, recreation, social functioning, or some important life function?
Suppose a parent tests his teenager for marijuana, and beats her if she fails the test. Does the FDA have to consider those broader results of testing?
The FDA had a bit of trouble with these tests, and finally decided that their responsibility ended at certifying that it accurately indicated the presence of marijuana.
In 23andme, the FDA seems to be saying that it's not enough to report the results accurately (or within the stated accuracy), but they have to consider the consequences of finding out the results.
__________
*Slashdot readers will immediately recognize that if the false positive rate is 0.1%, it will falsely accuse a 1 out of 1,000 subjects, which is a lot.
They need to justify their billions and billions of dollars budget.
Just who is damaged by 23 and Me.
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.
So there just *might* be someone who electively undergoes invasive, serious, expensive medical treatment without getting a second opinion (viz. diagnosis) and that is somehow the responsibility of 23andMe? Is that what the FDA and you are claiming? Are you also claiming that FDA approved channels *never* make mistakes and therefore people obtaining those results can completely trust them and should not seek a second opinion (viz. diagnosis)?
No, this smacks of the FDA wanting to be expansive and control everything - possibly even an expensive competitor using the FDA as a way to quash competition. This also smacks of a huge number of people not understanding that *I* am responsible for my own body and get to seek information and treatment for it through any and every channel I deem useful.
You and the FDA are tyrants for trying to tell me how to treat my body and taking away useful tools for doing such.
P.S. It is quite coincidental that the capta text for submitting this is "rights". How apropos.
Fortunately for the rest of us, you're one of the dimwits without a voice.
How is this a medical device? Answer: because they say so.
Gamingmuseum.com: Give your 3D accelerator a rest.
Nope, the FDA banned them this morning.
Gamingmuseum.com: Give your 3D accelerator a rest.
You have to realize that there is an entire industry running on "press releases". The mere fact that they meet with, and "negotiated" with, the FDA created buzz and made eager investors pump up money in the company. In the end, when they close shop, they will say: "It's not our fault. We have a great product. Unfortunately, the FDA decided not to approve it for [some technicality/political reasons/you name it]." -- and then pocket a few extra million dollars to start up a new company. "It’s a dream, a frightful dream life is"
It's neither.
It's a genetic test that tells you which markers you have, that have been linked (by healthcare professionals and researchers) to illnesses and conditions.
They aren't making a diagnosis, they aren't telling you that you have anything, they just tell you what markers you have, and what the potential links are.
This is just the FDA trying to protect their wallets.
How did you deduce that, considering OP said "It is not like 23 and me are going to destroy traditional medicine?"
Any diagnostic test can be wrong, and the public and medical community is OK with that.
The problem isn't the test, it's that there's no way to verify that the recipient of the results has any idea what the results mean. If a human being is involved, at least you can pretend that someone attempted to make sure the person in question understood the results.
Personally, I think 23 and me is fine as it was. OTOH, the FDA has to deal with "the public", who is invariably stupid.
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...
Government agencies love their power, it seems you need permission to do just about anything now days. Unless there is a danger to the testing, I am not sure I get why the FDA would be involved in analysis like this. Times have changed.
You clearly don't understand what the service provides, but I'm glad that doesn't inhibit you from responding as if you do!
Using your example, they don't test you for dick cancer. They check your DNA for indicators that you might be more likely to get dick cancer. The appropriate response to the results is to keep that in mind and every so often have a doctor check to make sure you don't have dick cancer.
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.
Once again, what the hell does this have to do with Obama? Man, these anti-Obama people are fucking dillusional.
Based on a "hold-on" request at an ethics conference a few years ago, and a "sorry, we go where the money is" response from 23addme, I don't expect this FDA request will do too much. 23andme will probably find a way around this, perhaps initially by not offering their DNA marker analysis to people in the US, and then eventually working out some way to skirt around the rules. Maybe their US kit won't actually include the swab stuff, and you'll have to go to informed consent showrooms to get the swabs.
And correctly done at that. This would be better fodder for it's own Ask Slashdot.
So the party that currently is in control of the executive branch would be to blame here.
Drug tests usually test for compounds the drug is metabolized into, not the actual drug. For example if you had not used cocaine, then snorted a couple of lines and immediately took a drug test, you would still test negative. I'd have few moral issues with drug tests if they tested for intoxication at the time of the test.
I really shouldn't have used someone else's email address for this account.
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!!
It's a very simple question, why is answering a simple question so hard for you people?
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.
No, it's not because they are cutting out layers of the traditional health network. It's because the service falls into a category that they are supposed to regulate. You can argue that 1) The categorization is over broad or unreliable or has other issues 2) The FDA SHOULD NOT do these sorts of things (in which case you can lobby your congresscritters to de enable the FDA's jurisdiction over such tests or 3) the FDA is being over harsh / demanding of 23&me compared to other companies with similar services.
But there is no need to get all conspiratorial. The FDA has been very, very conservative about letting complex medical information out to the public. There are huge internal and external debates about the wisdom of that - some of which comes from people with vested interests both in the status quo and with interest in changing business as usual. They tend to act like the very careful deliberative committee that they are. They are hardly perfect.
But the interesting thing about the articles in TFS is that 23&me has been very uncooperative. For a company with the level of financial backing and sophistication that they are presumed to have, I find it puzzling. I would like to hear what they have to say about the demand letter.
Faster! Faster! Faster would be better!
Just under what legal theory before the FDA was poisoning people a legitimate business ?
And just what stops people from selling something similar as a nutritional supplement ?
If you don't recall
http://www.nemsn.org/Articles/summary_tryptophan%20Fagan.htm
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.
FDA just wants to protect the breasts.
Present and accounted for! The FDA has been on a power binge for far too long, expanding their domain at every opportunity and no excuse too thin. meanwhile they have been neglecting the core of their charter. They should be focusing on proper regulation of drugs (like making sure people don't get fungus injected into their spines) and other things that actually get put in to people.
Really, their regulatory authority should end with the swab.
As for progressives with any actual political clout, good question.
Sure, and the unregulated wildcat off-the-shelf serum cholesterol test kit doesn't tell you you're going to have a heart attack, only that you have elevated LDL and other lipoprotein levels that indicated a potential risk for chronic cardiovascular illness.
Oh, wait, there's no such thing as an unregulated off-the-shelf serum cholesterol kit. They're regulated by the FDA. Interesting.
I suppose you should 'splain how one type of diagnostic tool can be unregulated even though others are?
I think the wording of the law is "diagnose or treat."
Informing someone of a predisposition to a disease may not fall under that authority.
I'm glad that Sergy Brinn's ex-wife has enough money to take it to court to get a fully-argued resolution.
How did you deduce that, considering OP said "It is not like 23 and me are going to destroy traditional medicine?"
Um, from this.
Off the top of my head the layers cut out would include: Doctors, HMOs, Lab techs, companies that distribute the tests, the companies that make the tests, and most importantly the various government departments that deal with all these people
Sounds to me like he is a very DIY kind of guy when it comes to his health. Doesn't want any of that nasty regulation getting in his way.
Don't know something? Look it up. Still don't know? Then ask.
Why would the FDA have a problem with this? Why don't they stop all the dopey infomercials...those are truly rotten.
The real problem is that you people who buy these tests will incorrectly interpret what they say.
DNA is really only about 99.5 percent correct using PCR, for one thing.
Carrying a risk allele that is triggered by environmental conditions or requires other actions to trigger is another.
But the worst thing is you all incorrectly ascertain risk.
You overreact, and when you overreact, in medical studies without effective genetic counseling, and even in some of those cases, you almost always do the exact wrong thing.
Should you be able to order such a test? Yes.
Should you react to the test without proper genetic counseling? Never.
-- Tigger warning: This post may contain tiggers! --
What I understood from reading his comment was that he wanted to be very DIY when it came to his healthcare.
Yes, the service only diagnoses problems, but considering he was talking about removing doctors and everyone else with an education from his medical care I wanted to know how far he was willing to go.
Don't know something? Look it up. Still don't know? Then ask.
Regulating this seems reasonable to me, as does the logic in the FDA letter...
Because the peasants are so stupid that they need to be protected from themselves, or because you enjoy having tyrannical bureaucrats dictating every aspect of people's lives?
"Somebody has to do something. It's just incredibly pathetic it has to be us."
--- Jerry Garcia
Just under what legal theory before the FDA was poisoning people a legitimate business ?
Bit of a strawman argument there. Snake oil isn't "poisoning" people, it's a specialized form of fraud. You rely on whatever snake oil you are selling to be beyond the technical understanding of your average consumer. They assume it's safe because you're the "expert." People back then had zero experience with radiation. Even the experts were blissfully unaware of the dangers, see the Curies. The FDA was established to make sure people did their homework and correctly tested products before selling them to the public, not to stop murder.
In this case though, this seems to be overstepping the legitimate goals of the FDA. I mean, it's a blood test. Any fallout from the tests are going to be social, not health related. The FDA might as well ban people from going online: they might read Andrew Wakefield and conclude that vaccinations were bad. Unless 23 and me is promising things it doesn't deliver (sequencing results), this seems to be bullshit.
Maybe their should be a button to fork and exec a sub-topic that develops in an interesting direction. I'm not actually saying that this branch is particularly interesting, but, given the beta-period, I was interested in the possibility of interesting-ness.
So can we just order the kits from Canada as usual?
Heck, with Google so much in bed with the US gov't, this could be a easy way for Sergey to cut off Anne in the most polite way--via a 3rd party, the FDA. I mean rich folks have 99% of the cash, 99% of the spoken word in gov't... If I were rich, why not?
I mean FDA would have figured this out and questioned the service 2 years ago. Why now?
There is research behind it. It's just not research that the FDA likes. For example, the FDA is worried that people receiving positive DNA tests are going to run out to demand additional tests from their doctors. Those tests may well make sense from an individual point of view, but the FDA doesn't like them because they don't make sense in an average cost/benefit analysis across all insured.
Yes, but why should the FDA have the power to regulate these tests in the first place?
"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."
Show that the level of false positives/negatives is higher with genetic testing than with conventional testing, and you might have a point. Otherwise, alarmist "OMG MY BREASTS!" scare mongering.
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."
Correct, but -- again -- irrelevant unless the error rate is higher than in hands-on testing that's currently being used.
"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..."
Ahh...THERE it is. We can't have patients going around getting informed about what's in their own bodies and making decisions based on that information. That's the purview of PROFESSIONALS.
Kind of like auto mechanics telling you they're the only ones that should be allowed to read the OBD messages from your car.
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
That reasoning is utter and complete bullshit. Tests aren't just "positive". When these genes are reported in the literature, the strength of the correlation between markers and disease is reported as well. Doctors and patients can evaluate their risk based on that information. They aren't going to undergo "prophylactic surgery" unless it makes medical and financial sense to them, based on all available data.
What the FDA is really afraid of is that people with a positive test demand costly follow-up tests, costs that would be quite inconvenient for Medicare/Medicaid and (now) the new Obamacare programs.
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.
Which is just the same as carrying a BRCA mutation that increases your likelihood of breast cancer. Yet almost every medical authority would agree you should only get BRCA testing done alongside counseling from an appropriately trained genetic counselor.
Are members of the public equipped to interpret a 55% or greater chance of their child developing Alzheimer's Disease?
It's not about withholding the test. It's about making sure the test results are accurate, that the recipient understands what the test may uncover, and that they are equipped to rationally process the result.
The Founding Fathers never imagined or desired a federal government that regulates every aspect of our lives and runs 25% of the economy. They certainly did not imagine or want anything like the FDA, DEA, or other such institutions. The federal government is supposed to defend the nation and make sure that nobody interferes with free trade between the states, that's all.
Yes, and health care, education, drug laws, etc. should not be national matters.
And it's high time that we kick representatives with that kind of arrogant attitude out of office.
It says that these products must prove that they work IF selling to directly to consumers. Implying that if they sell to a hospital it can be bollocks. An interesting distinction...
Except they HAVEN't done anything about the boner pills. While less frequent, I still see the commercials pop up from time to time, including the old Enzyte commercials.
Should Tarot cards be regulated by the FDA? What of crystal balls?
I haven't seen any commercials for 23 and me.
I wouldn't mind if the FDA forced them to put a label saying that it was not FDA approved, or that it was not "conclusive", but to just say you can't sell this period is where it gets annoying.
The potential harm is that somebody may act on the information without further testing in a way that harms only themselves.
The potential good is that somebody doesn't die because they found out they were at risk, and didn't know that before.
I kind of think that the good outweighs the bad, and that proper labeling solves the problem.
I think the "to a hammer every problem looks like a nail" approach is what they are doing here.
The bureaucracy of hoop-jumping paperwork is a big reason our government is so inefficient. Just ask the VA
I don't load plugins here at work, and I choose not to disable advertising here on Slashdot, so today I got this deliciously ironic gem while browsing this article:
http://superb-owl.com/images/mythosaz/23andmeirony.jpg
"... not to mention we have ZERO proof that their labs are even monitored in any way."
Or that their labs are even testing people. Seriously, without oversight, they could be handing people any information Google cares to (as we all know that is who really holds the bag here. Sergey's wife for pete's sake). Is Google invested in Big Pharma? Are they simply steering people to drugs they've invested in? Steering people away from competitor's products?
This is the exact shit that is driving our healthcare "system" into the ground--unmitigated GREED disguised as innovation.
Let 'em have San Francisco--maybe they'll all be there when everything west of the San Andreas falls into the Pacific. (Anonymous Coward Prophecy #621)
Yes. I am claiming these tests aren't effective.
Then you're an idiot. I had my DNA tested by 23andme and not only did they confirm things I already knew, they taught me some new things as well. Such as I am immune to the stomach flu, because my body does not have the receptors necessary for this virus to latch on. I did not know that, although it makes sense, because I have never once had any flu or stomach flu in my life!
If I want to make medical decisions based on information that an organization like 23andme gives me, that is my GOD GIVEN RIGHT, and FUCK YOU for trying to take that right from me.
Now cue all the Slashbertarians ranting about how restricting unproven medical testing is an assault on freedom..
That's exactly what it is, DUMB ASS!
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.
If you poison people by irresponsibly selling something that harms them, you are already liable. The FDA might well give advice to companies on what labeling would protect them from legal liability, but there is no justification for making these tests unavailable.
How many stupid, wealthy people do you think kill themselves with FDA-approved drugs every year? How many people do you think doctors kill each year with FDA-approved drugs? Nobody has ever shown that FDA oversight survives a cost/benefit analysis.
As long as they are honest about what they are selling, I don't see the problem. If they properly disclose what's known about the test and you draw the wrong conclusions, that should be your problem, not theirs.
Apologies for posting as AC, but I don't necessarily want my health information in the public domain.
I ran my spit through 23andme and it identified that I had one or two (the test is not more specific) mutations associated with haemochromatosis (high iron levels.) I told this to my haematologist, who up to that point believed my condition was the result of other factors, and he said, "well, this changes everything." (Interestingly, I didn't do the 23andme for this reason, it just worked out that way.)
He promptly referred me for a targeted genetic test (quite expensive, as I understand) that confirmed that I did indeed have the double mutation.
He also told me afterward that the 23andme certainly did seem to be money well spent, and that because it was relatively cheap (at $99) he would most likely tell other patients about it.
So, for me, 23andme really has helped.
Me, until I see evidence to the contrary I'm going to assume that this test is every bit as accurate as calling Miss Cleo. No more, no less. At least her commercials had to have a "For entertainment purposes only" disclaimer at the bottom. IMHO, unless 23andMe are going to stick that phrase on the boxes I'm all in favor of the FDA requiring that they demonstrate accuracy. (And yes, I wish the FDA did that with herbal supplements and other snake oil. Or at least make manufacturers prove that the contents of the pill match the label on the box.)
Chelloveck
I give up on debugging. From now on, SIGSEGV is a feature.
You're probably right, no doctor would perform a mastectomy on the basis of the test. On the other hand, what if the test said you did not have the gene for breast cancer, when in fact you do? Are you and your doctor going to trust that result? If you do, you are no better off than you were before you took the test (in fact, you may be worse off if you forgo other testing). If you don't trust the result, then what have you done besides waste $99? And that is exactly what the FDA is trying to prevent - people being fleeced out of their money for 'medical advice' that has no value and may actually cause harm.
The FDA regulates medical devices.. Loosely.. anything that touches a person and/or reveals a physiological parameter is a medical device. Latex gloves are a medical device. A thermometer intended to read body temperature is a medical device. Note carefully: intended to read body temperature.. using your IR thermometer intended to read the temp of your steak isn't a medical device. The exact same device, if advertised/marketed/etc as something that can tell if you or you kid has a fever is a medical device.
Show that the level of false positives/negatives is higher with genetic testing than with conventional testing, and you might have a point.
I think you have that backwards. It is up to the company performing the tests to demonstate what the false positive/negative rates are. That is, in fact, what the FDA wants them to do.
Blah blah blah. You deregulation types don't tone down until you've been had by quacks a few times. Do you realize how hard it is to judge quality in these services and products? Even experts in one area find it hard to make a call about another area.
What about the potential harm because somebody does not act because the test said all was good when in fact it was not? Proper labelling does not solve anything. All proper labelling would do is let you know the test is worthless because you can not trust either positive or negative results.
The FDA had a recent argument for existing in the early half of the 20th century, notwithstanding constitutional quibbles.
But that argument is significantly diminished in the 21st century. It's _far_ easier to find reliable information these days. The FDA still nominally protects idiots, but many of us are being held back. Like, wju isn't modafinil saleable over the counter? It's almost as safe as candy--if you read the research experiments, which have proliferated since modafinil went off-patent, that's how the scientists treat it.
Also, harm is easier to prove these days because our science is better, and we also have these things called class action lawsuits. Why Republicans dislike them, I'll never understand, because class action law suits allow you to reduce government regulation. Their aversion to class actions belies their interest in only helping the rich by manipulating government.
If some drug causes a teensy bit of harm to each individual, it used to be that the only way to stop the large, net social harm was government regulation. But now society can police itself through class action lawsuits. That means bad drugs get punished, and drugs that can't be proven to cause harm can still be freely marketed.
(Yes, class lawsuits can be costly even if you did nothing wrong, but on the whole they're less costly than a huge government bureaucracy sticking their thumb in everybody's eye, and you can buy insurance up front to cover the expected costs. And unless you did something truly odious lawyers will only go after big corporations, because their expected return drugs which cause uncertain harm is less, so smaller companies have fewer risks. Also, unequivocally helpful drugs--like vaccines--are already immune from all lawsuits.)
Diminishing the FDA means turning everybody into guinea pugs, but we're already all guinea pigs, we just don't know it.
The only thing the FDA should be doing in the modern world is 1) enforcing strict transparency laws and 2) being a first-responder agency, which can quickly react with temporary measures when a product has actually exhibited a significant risk of harm. Everything else is ludicrous.
Yeah! Like we did with slavery!
"That principle is, that the sole end for which mankind are warranted, individually or collectively, in interfering with the liberty of action of any of their number, is self-protection. That the only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others. His own good, either physical or moral, is not sufficient warrant. He cannot rightfully be compelled to do or forbear because it will be better for him to do so, because it will make him happier, because, in the opinion of others, to do so would be wise, or even right... The only part of the conduct of anyone, for which he is amenable to society, is that which concerns others. In the part which merely concerns himself, his independence is, of right, absolute. Over himself, over his own body and mind, the individual is sovereign." - John Stuart Mill
"We fought for freedom, and all we got was democracy" - Pieter-Dirk Uys
Prove anything by multiplying Huge Number times Tiny Number
That's faulty logic.
An HIV or Hepatitis C test that delivered false negatives would be worse than useless, potentially giving positive patients a false sense of security. With that faulty sense, those holding incorrect results could leave their diseases untreated and risk exposing others. However, false negatives from 23andMe—provided a small advisory to its users—would leave them ignorant of conditions like Huntington's or BRCA the same as if they had never submitted a sample, whereas false and true positives would both prompt additional investigation on the part of the customer. In other words, if 23andMe gives a negative result, you still don't know what you didn't know before. If it gives a positive result, you'll be inclined to seek a medical opinion from a professional.
It's a pretty clear-cut case of regulation overreaching its boundaries and bearing on an innovative product that's helping to promote mainstream genetic testing.
"Are you kidding? I just told you like a minute ago."
I think we should be able to make any kind of independent test we want to make, and not be beholden to a priesthood of medicine, where only the doctors are privy to the details on your medical chart. The information provided is not something that you could get from a normal doctors visit. It gives you an estimate about your health risks, though it may not be 100% accurate, They are pretty clear about this in their documentation. I resent how medicine works in the US in general, and often feel those that I encounter are ether overwhelmed and overburdened, or are technicians that know next to nothing that are trained to draw blood or make measurements that will be interpreted later. Independent testing, cross checking, knowing your risk factors, etc are always useful.
I had a professor in college who's wife noticed a new mole on his back. He went to two different doctors that inspected it and told him he was fine. Not satisfied, he went directly to see a dermatologist without an appointment. He was informed to cancel his schedule for the next day, and that they were going to operate on him. It was an aggressive skin cancer that had not reached down far enough to spread all over his body. He's fine to this day, but every 6 months they inspect his whole body, and remove all of his moles..
I don't trust doctors to pay enough attention to my long term health interests.. They have hundreds of other patients to take care of.
I have no affiliation to 23andMe except as a satisfied customer. I have found 23andMe's services very useful and low cost to me, and hope that they are not destroyed by this FDA action. https://petitions.whitehouse.gov/petition/overrule-fdas-decision-bar-23andme-selling-their-potentially-life-saving-diagnostic-kits/96BRCYNB
It's a complex issue, and simplistic thinking like "get rid of it entirely" is foolish. That would create larger problems than the ones we have now.
The most obvious is counterfeit drugs. It's already a problem, removing the FDA is a good way to ensure a choice of thousands of cheap sugar pills, and absolutely no real drugs. Pharmaceuticals could move into the herbal supplement market and shut down their research entirely. They already mostly repackage old pills rather than develop new effective treatments.
Actually, you'd be lucky to get sugar pills. Those won't kill you.
Not what he said at all. Just that it was founded as a representative republic, not a democracy. You choose people you trust for a term to collectively make decisions rather than voting on every issue. In kind, of course, the national level government didn't have anywhere near the power it does today, so it wasn't as big a sacrifice.
Take California's ballot initiative system. Raising taxes will always be unpopular, and cutting services will be unpopular and both fail as individual measures. And yet, you need someone to make those decisions.
Your Nazi (Fascist?) analogy is a little overkill.
Mmm, Kin(d)er Joy Bud.
So if you can't afford to get this low cost and effective test ($99) then you should get nothing at all? Their test is more than reliable enough for most purposes. And if you're planning on getting a double mastectomy, obviously your surgeon will do a specific follow up test.
Which is just the same as carrying a BRCA mutation that increases your likelihood of breast cancer. Yet almost every medical authority would agree you should only get BRCA testing done alongside counseling from an appropriately trained genetic counselor.
Are members of the public equipped to interpret a 55% or greater chance of their child developing Alzheimer's Disease?
It's not about withholding the test. It's about making sure the test results are accurate, that the recipient understands what the test may uncover, and that they are equipped to rationally process the result.
Here's a fact. If you're female, you're at greater risk to develop AD, even accounting for age.
And, another thing, most impacts of AD are highly linked to other things - which these tests won't show you.
Yes, Apolipoprotein-E is a significant risk allele, but it's not the whole story. You'd be far better off getting enough sleep and moderate exercise and laying off the typical American diet.
-- Tigger warning: This post may contain tiggers! --
Nobody is forcing you to submit your samples to 23andMe. Of course there should be standards for police DNA evidence labs. But 23andMe is basically an entertaining service that also provides some health information. Why shouldn't consenting adults be allowed to submit their DNA to it? Especially when there is no health hazard at all (unlike "radium water").
No doctor would make a decision on the basis of this test.
The main benefit of BRCA testing is that some women have breast cancer in their family. BRCA has such a high likelihood of developing into breast and ovarian cancer at a relatively young age that many women decide that they'd rather have a bilateral mastectomy and ovarectomy first and (probably) escape that risk. But if they don't have the relative's gene, then they don't have that risk of breast or ovarian cancer, so they don't have to worry about it.
The current recommendations for BRCA testing is that it's only indicated for people who already have breast cancer in the family. The person with breast cancer has to be tested (as they usually have been for treatment purposes).
If the person with breast cancer has the BRCA gene, then other people in the family can get tested.
If a relative has the gene, she's at risk and can consider a prophylactic mastectomy/ovarectomy.
If a relative doesn't have the gene, she's not at risk. The gene passed her over. A prophylactic mastectomy/ovarectomy would be pointless.
But a relative who is really at risk of breast cancer, and under treatment by a doctor, would use an FDA-approved test kit, not 23andme.
There may be a situation in which the relative can't afford an FDA-approved test kit, but can afford $99 for 23andme. You could say, 23andme is better than nothing. But if the relative can't afford the FDA-approved test kit, she couldn't afford a prophylactic mastectomy/ovarectomy either.
BTW, BRCA (or rather, BRCA1 and BRCA2) is just the most common gene. There are others. If the person with breast cancer tests negative for BRCA, she still has other genes she could test for. There are new genes being discovered regularly, so if she couldn't find the gene, she should keep testing.
I'm glad the FDA is looking out for me. I don't think they've made the case yet that DIY testing can be harmful, but I don't understand why 23andme didn't take care of the paperwork.
It's always strange to hear Americans talk about their government like it's an entity removed from themselves.
Most of us here in Scandinavia trust the government. We think it's on our side, against the drawbacks of capitalism.
We see that businesses are excellent at providing goods and services, but also that that's a by-product of their primary purpose: making money.
Left unchecked, businesses will do bad things to maximize profit.
Not because we, their owners, are evil capitalists, or that we, their employees, are without conscience.
It's just the way that humans - and by extension businesses, our most perfectly egoistic creations - work.
I don't mean to troll, but this is what I experience:
I hear your arguments against a strong government, and most of them don't make sense to me.
I see private citizens open their mouths, and out come the words of business representatives. It's like some darn spooky ventriloquism trick.
You identify yourselves with businesses and not with your government.
Truly, to me many Americans seem indoctrinated to mistrust and want to minimize their government (i.e. their own power, as I see it).
It's the only way I can make sense of it.
No sig to see here. Move along.
tobacco.
The phrase "interstate commerce" does not appear in the U.S. Constitution. The exact wording is (emphasis mine):
The Congress shall have Power ... To regulate Commerce with foreign Nations, and among the several States, and with the Indian tribes ....
The purpose of this power was to allow the Federal government to intervene whenever a state imposed a trade restriction upon commerce with other states.
Seriously, they are not a doctor and are not beholden to medical industy standards. I can't understand why this hasn't been shutdown already.
23andMe service DOES NOT diagnose problems. It doesn't _tell_ you if you have disease X. It only tells that you may have a genetic predisposition for something. But it doesn't even rule out a predisposition. Just because you don't have a known SNP marker for condition X doesn't mean you don't actually have the gene. And they tell you that.
If I tell you that you're likely to die within the next 80 years, am I "diagnosing" your death? If I tell you that you have a known gene for prostate cancer, am I "diagnosing" your non-existent prostate cancer?
The FDA is doing this because entrenched interests are getting pissed off. And because some doctors and geneticists think that everybody is an idiot; and they believe that 23andMe customers are getting duped. But 23andMe is very up front that what they provide is limited. Some tests are slam dunks, like for Parkinson's. Most are extremely equivocal, and that's blatantly clear by both the data and actual disclaimers in plain wording littered throughout the site.
23andMe is extremely cool. You can't call yourself a geek unless you 1) fork over the $99, 2) are desperately poor, or 3) wear a tinfoil hat. Any other excuse is lame. (Note that I have respect for the tinfoil hat crowd).
In practice there's no way 23andMe can screw you over, even if their accuracy and reliability sucks. As state before, they cannot rule out a predisposition. If you show a serious predisposition, you're going to go straight to a real doctor. Finally, they're the only game in town doing whole genome scanning for $99. Also, they're doing real science with their results, and part of their business plan is to make money off the bulk data, and doing that requires reliable data.
I'm solidly Democratic and quite liberal, but the reasons for the FDA doing this are obvious. Also, this kind of service is about to explode market wise, and they're trying to set a precedent early on to make sure they get some of the spoils--i.e. regulatory territory. It sucks from every angle--self-interested special interests, and FDA regulatory overreach.
Which is why you want test results on things like this handed over by an expert, not an email.
There are some areas where government regulation is appropriate. This is one of them.
Your contempt for the human race is duly noted.
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.
As opposed to your alternate scheme, where fools elect conmen who then somehow manage to appoint supergeniuses to govern us all. How does that work, exactly?
Never let principles get in the way of your pettiness.
only if you buy them in sufficiently large packaging, though
Unity? Screw that: XFCE. Slashdot Beta? Screw that: SoylentNews. Australis? Screw that: Pale Moon. UX developers DIAF
Now cue all the Slashbertarians ranting about how restricting unproven medical testing is an assault on freedom...
I own my DNA!
Actually, your parents do.
You're not supposed to even be able to enter into a legal contract before the age of 16.
-- Tigger warning: This post may contain tiggers! --
Even better, I can find out if you have the DNA markers when I take the sample without your consent.
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Depends on how gathered. Are we doing random genetic sampling, family study where we know who has which markers and a higher confidence level, how large is our sample (p=512+), how are we ascertaining the diagnoses (survival method, impact), etc.
It's a whole can of worms.
Meanwhile some girl takes a blood sample with her friends at a sleepover, pops it in the mail, thinks she's going to die from breast cancer, and commits suicide.
This is why the FDA gets involved.
-- Tigger warning: This post may contain tiggers! --
Obama and the radical Democrats
Would make me laugh if it wasn't so irritating. He's been compromising on practically everything with the Republicans screaming about his being a Muslim communist and trying to vote it down, and he finally manages to get a single watered-down thing passed that he wanted ("Obamacare"). And after 46+ pointless votes, they're still trying to kill the damn thing. But apparently the Democrats are the radicals. Thanks for explaining that one to me.
this genius, who can barely put words to together to form a coherent sentence
You're really going to use that line after Bush Jr.? Really?!
Oh, and speaking of coherent sentences, you've got an extra preposition there, or stutter or something :)
Unity? Screw that: XFCE. Slashdot Beta? Screw that: SoylentNews. Australis? Screw that: Pale Moon. UX developers DIAF
I was going to take the 23 and me test. I don't care about whether its 100% accurate, but fuck letting google have my genome. HELL NO. Email, phone records, credit card details, locoation, personal contacts, browsing history, sure BUT YOU CAN NOT HAVE MY DNA GOOGLE.
Rocket Surgeon.
What are the procedures 23andme is supposed to use to calibrate and test their equipment?
Other than that, I think the FDA complaints are BS. Certainly looks to me like they do a good job of providing references and giving probabilities -- with the explicit understanding that you will and do see them change as more research becomes available.
The "public" doesn't have the knowledge to have their opinions really matter on most topics.
Nor do our representatives. They get briefed on important issues by lobbyists who care for nothing but their own self interest. They exchange their time for money, so that the only policies they are even able to contemplate are those that favor the extremely wealthy. If someone did have a clue, those monied interests would not support his candidacy, because they could not control him.
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
Whereas the will of our government is malicious, greedy, and easily controlled. You know how poorly you think of your fellow citizens? Now realize that our elected representatives are the most ambitious, self serving bastards among them.
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
No, it's because the will of a tiny but extremely wealthy elite has come to matter much more than the will of the rest of us.
Instead of good people being elected, the slime balls who can most effectively sway the opinion of the ignorant masses gets elected
And the slime ball does that by spending money given to him by the extremely rich, to whom he is then indebted.
Give me Classic Slashdot or give me death!
One of the interesting test results is if you should avoid certain things such as opiates(due to a propensity to become addicted) , malaria, etc. You might think that you should avoid those anyway but it allows you to simply say after back surgery, "I don't want any opiate based drugs so as to avoid becoming dependent" and with travel plans you would doubly avoid countries with even fairly low levels of malaria. So Italy instead of Costa Rica. Not exactly home surgery but allows you to make your own informed choices for $99.
I can't imagine what the same bevy of tests would cost at my family doctor? I am going to throw out that it would be no less than $1,000 to end up with the same results.
I'm an early adopter. I have used 23andMe's services and have found them enlightening, useful and thus far, accurate, in-line with other established tests that I have taken.
For those who haven't used their services before, I would recommend taking a look at the language used in their reports before being overly critical: https://www.23andme.com/health/Warfarin-Coumadin-Sensitivity/ , https://www.23andme.com/health/Breast-Cancer/
I am a reasonably rational person. I stepped into this as an early adopter, knowing that there is an unknown degree of Type I and Type II error. It has provided me with interesting results, and I have found the language used is quite clear that they are not providing a specific diagnosis or recommendation, beyond "think about" or "consider further testing on".
I am not saying that I assume most people would approach this information in the same way. I am not saying that 23andMe should be absolved of their responsibilities to due diligence and complying to regulation.
I am just saying that they do provide a very useful service that I believe will transform how we deal with prevention and wellness. As an early adopter, I hope that they (23andMe and the FDA) are able to find a balance between making this service widely available (in doing so, vastly increasing sample sizes and enabling new findings), at the same time as ensuring that people's responses to and expectations of the data provided (based on marketing claims) are sound.
I have 23andMe results. It just shows the genetic propensity for a disease. There are zero results that I've seen that indicate that I do (or do not) have any specific disease. For example...having a 2-times likelihood of developingType II Diabetes I know in no way indicates whether I currently HAVE diabetes. I don't even know what the FDA is talking about.
You choose people you trust for a term to collectively make decisions rather than voting on every issue.
It's a lot easier to sway the opinions of a small group of ambitious sociopaths than it is an entire nation. What's good for 51% of Congresspeople is only good for 0.00015% of Americans. What's good for 51% of Americans is good for 51% of Americans.
Give me Classic Slashdot or give me death!
Me, until I see evidence to the contrary I'm going to assume that this test is every bit as accurate as calling Miss Cleo...
I work in bioinformatics. I recently had the opportunity to compare 23andMe data with exome sequencing data. Long story short, I didn't find any major discrepencies - i.e. there was overwhelming agreement in the variant calls. I'm sure there will eventually be shady genetic testing companies that are pumping out garbage data. But that's not the case with 23andMe.
And, data quality is not what this particular battle is about. In the past, medicine has mostly opporated in a hand-crafted model: like having a business suit custom made by an individual tailor - or eating at a gourment restaurant with a single set menu decided by the chef. But now technology is making it possible to do the medical equivalent of shopping for clothes at Walmart or eating your lunch at McDonalds. And that raises some interesting questions about the future roll of medicial doctors in medical care - and not all of them like it.
The world today is so far removed from anything the Founding Fathers knew that it is absurdly silly to try to weight their intentions on current situations and necessities. Moreover, the moment the Constitution was inked, arguments about what it meant began and have never ceased. Even when they were still alive debates persisted.
But most importantly -- the fact that they created a framework of amendments means that they NEVER intended the Constitution to be a static document. So whether you agree with current interpretations of the Constitution as it is written or not, you should probably avoid saying "The Founding Fathers never would have ...". Totally irrelevant. They built the document knowing full well (or should have known) that one day it could be changed and morphed into something they would NEVER have wanted.
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.
They also intended that the national government's voice carried no weight in your day to day life.
They specifically created a national government of enumerated powers; with very limited authority, that would have no power to intrude on people's daily life, or regulate the affairs of individual citizens ---- for example, regulating what kind of medical devices could be sold would be well outside their power, except congress could pass some laws regulating the commerce, or trading in interestate commerce (trades across state lines, exclusively).
Pregnancy tests were approved for OTC sale in the late 70's. These tests were quite different than what you would find on the shelf today and were composed of test tubes, solutions, and other components that were not something a typical user might be comfortable with. Often the tests would be sent off to a laboratory or other facility to determine results.
The $5 pregnancy test you refer to is entirely self-contained and is a result of decades of research to reduce the complexity of the test so that it could be taken easily at home. I get your point, regulated products aren't *always* expensive; however, consider the sheer amount of products the FDA regulates. Here's a nice tidbit from the FDA themselves:
FDA regulates over 1 trillion dollars worth of products, which account for 25 cents of every dollar spent annually by American consumers.
Someone flopped a steamer in the gene pool.
They didn't invent the wheel here, they are using a bead chip from Illumina. I imagine accuracy information is already readily available.
I browse on +1 so AC's need not respond, I won't see it.
Likely to prevent quacks from diagnosing patients with problems and then charging an arm and a leg to fix the problem. Why they would do with with "sciency" stuff and not with the homeopathic and herbal supplement market confuses me, but government regulation is sometimes fairly illogical.
/* TODO: Spawn child process, interest child in technology, have child write a new sig */
Except they HAVEN't done anything about the boner pills.
I really do have confidence that the commercials for boner pills have been scrutinized and approved by FDA. I haven't seen an ad for Vi[boner]ra in ages, but Ci[boner]is with that low bluesy guitar riff in the background is all over TV in the US. The pills work as advertised and are prescription-based (hahahah yeah I know). Plenty of "if you encounter symptoms such as difficulty breathing, or if you have trouble with your eyesight or hearing, stop taking [boner pills] and seek medical attention right away." And the seemingly requisite "Ask your doctor about [boner pills]."
23andme isn't offering to cure anything, they aren't offering to diagnose anything, and they aren't offering to treat anything. They're advertising a service where you spit in a cup, send it off, and get back some "okay, this shit might be going on in your family lineage" results. They're not telling you that you have sickle cell, or that you're going to die if you eat asparagus, or anything of the sort. But they are making medical-type claims regarding your DNA, such that perhaps your brain isn't receptive to flubber-baz antagonists, which might make you argue with your physician or stop taking such medication altogether, to your own detriment.
Works for me, but if your average Duck Dynasty fan picks one of these up, they might flip the fuck out at what they get back. "YOU SAYIN I GOTS NIGGER IN MAH BLOOD? ANN MAH DICK NEVER GONN' GET GOIN' AFTER AH DRINK BEERS? AHHH'MA CALL UP MY REPRASENTIVE! GET THIS SHIT BANT!"
FDA's issue is very narrow. 23andme is making marketing claims of a medical nature which have not been approved by the FDA. The advertisements do not adequately disclaim that 23andme cannot prove whatever their DNA tests might come up with. If they rebrand themselves as a novelty, or work with FDA to achieve de novo compliance (which is basically FDA saying "hey! let's start it all over and get you compliant! woo! yeah let's do it!"), they should be just fine. I hope. Because I do still want to get that shit done for my spit.
Thanks to the War on Drugs, it's easier to buy meth than it is to buy cold medicine!
Proton Pump Inhibitor (PPI) Metabolism: Ultrarapid or rapid metabolizer. Someone with this genotype typically metabolizes PPIs at a rapid rate. Although the standard dose is usually effective, some people with this genotype may benefit from a different dose, especially if being treated for an H. pylori infection. If you are currently taking a PPI, it is important to talk to your doctor if your symptoms do not improve.
Now, I don't take PPI's but I know enough to not mess with my dosage (if I did) base solely on this info. However I don't trust most others to have the same response, especially since PPIs are now over the counter drugs. The correct response to this info would be to discuss it with your doctor but how many people would see this and just up their dose themselves, based on one test that may indicate that you may metabolize the drug faster than the average population?
I browse on +1 so AC's need not respond, I won't see it.
False positive and negative rates of what?
They arent performing a diagnosis. You don't seem to understand that, yet your argument relies on the very thing that you don't understand.
"His name was James Damore."
Anyone who thinks a 0.1% increased risk in a single SNP when dozens are involved, all of which have to show compatible mutations, means they will surely die of, well, anything is too stupid to live. Frankly, if that's your best objection, I think the test should be provided free across America and Britain. Get rid of at least some of the fools, rather than have them be a burden on society by running banks or whatever.
Good riddance to them. Hope the jumped-up twits die slowly.
(23&Me cannot tell you if you have a disease, or if you will ever get it, it can only give you very rudimentary statistical information on correlations. Anyone confused about correlations and causation should be provided with a HOWTO on suicide and appropriate implements.)
As for the studies, published peer-reviewed studies on genetics do vary in quality. That is why nobody considers them. Only metastudies matter. I would argue a metastudy with a sample size of 2 is low, but even getting a repeat study published is a major feat and genetics hasn't been cheap enough for long enough for the numbers of studies to grow. I like that 23&Me makes an effort to run their own study, giving them a metastudy size of 3, still low but getting into respectable territory.
But, again, what does it matter? Let us say that there are 10 SNPs required, and one SNP has a 0.1% increased risk but no others do, should you worry? One in a thousand chance above normal for anything is so close to normal that you would have to be one of the deserving suicides to think it worth concerning yourself with.
It's a small world and it smells funny; I'd buy another if it wasn't for the money; Take back what I paid (SoM)
Have you ever bought "kinder joy" ?
never heard of it
Anyone who thinks a 0.1% increased risk in a single SNP when dozens are involved, all of which have to show compatible mutations, means they will surely die of, well, anything is too stupid to live. Frankly, if that's your best objection, I think the test should be provided free across America and Britain. Get rid of at least some of the fools, rather than have them be a burden on society by running banks or whatever.
Good riddance to them. Hope the jumped-up twits die slowly.
>
You're assuming that people think logically when presented with results that may indicate severe impacts.
Medical studies have shown that people literally go into shock and don't really retain what it means.
This is yet another reason why you can't just do a one-of DNA test and "trust the system" when the system does not have genetic counseling or interpretation as part of it. People only hear or read part of the message, freak out, and than do drastic things.
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People work around the system. I get my blood tests done for a fraction of the cost at the doctor's office by booking it at walkinlabs.com. A paid off doctor in nowheresville robosigns it and I walk into a testing lab nearby, where a woman who does nothing but pulls blood all day, pulls my blood. She never misses. I get the results emailed to me a few days later.
If I'm going to the doctor, I take my latest results in. However I follow the research and I get the tests I want (NMR lipoprofile, CRP and HbA1c) which tell me more useful things about my health than the standard cholesterol tests, like LDL size and number, glycation levels and inflammation status.
The only way that this is different is that Walk in labs decided to put a robosigning doctor in the loop so the FDA couldn't complain.
I should use this sig to advertise my book ISBN-13 : 978-1501515132.
23&Me is exactly the kind of company Big Pharma (who are in bed with the Federal government - always have been)target. They're a company that's all about prevention of diseases (through knowledge) rather than taking medication. She's a veritable thorn in their side, and has been for years.
More like your ignorant rant about an assault on knowledge...
She talks about her company here, for those who care.
Which is why you want test results on things like this handed over by an expert, not an email.
OK, so in one universe your doctor tells you that you've got the risk allele but it's not the whole story, in a second universe you get an email telling you the same thing, and in a third universe all you get is the raw variant call which you look up in wikipedia to eventually find out the same thing. Why is one better than the other?
It's not as if a mere five minutes in the god-like presence of a medical doctor will somehow suffuse a person with all possible knowledge relating to their condition - that would otherwise take decades of study to fully understand. But perhaps you take a paternalistic view - that most people are too stupid to ever understand what's good for them - so they should have the major decisions in their lives made for them by carefully chosen experts (i.e. medical doctors).
An NIH study shows the cost per genome for sequencing genomes with reference sets is about $8000 in 2013.
So what are they doing for $99?
I should use this sig to advertise my book ISBN-13 : 978-1501515132.
It is literally the price of regulation. We're not really paying for health care. We're paying for this regulation and that regulation
I just compressed a batch of the tablets you/your mom use to stay healthy. I did it in my basement to save money. I put in nearly 99% of the active ingredient on the label. I can cut costs, and you probably won't even notice the slight difference.
Like I said, those people should travel to the top of the nearest tall building and jump. Preferably yesterday. I have no pity for such people, no compassion, no time. The world would be far better off if such people offed themselves. The world needs thinkers, it does not need reactors. Well, other than fusion reactors. We could do with a lot of those.
It's a small world and it smells funny; I'd buy another if it wasn't for the money; Take back what I paid (SoM)
I think you misread or ignored my comment. It's not about denying people the test, it's about making sure they understand it.
I think you'll find most doctors if needing something like a BRCA test for themselves would still consult a genetic counselor first. Why?
Because there are numerous different tests that might be appropriate - do you just need tested for one possible hereditary cancer, or are there others you should be tested for too based upon your family history.
There may be a better person to test than yourself.
The result of the test may be misleading to a non-specialist, even someone who is trained and has a medical degree. For example a negative result might mean another condition is more likely rather than being an all-clear.
Wikipedia is great, but it's not an adequate substitute for proper healthcare.
And it's not like 23andme couldn't provide appropriate counseling before testing and have results handed out by a specialist with a genetic counseling degree.
And it's not like 23andme couldn't provide appropriate counseling before testing and have results handed out by a specialist with a genetic counseling degree.
Sure, let them eat cake.
So 23andMe is going to fly all it's customers from around the world into San Francisco for a nice long in-person chat with a genetic counselor before the testing - and then fly them in again when they receive their results - plus compensate the lost wages from time the customers took off work - all for the low price of $99?
And somehow whatever it is that the genetic counselor might tell them in person would be absolutely impossible to tell them in an email? And there's no possibility to send an email recommending a visit to a genetic counselor under certain circumstances (family history of breast cancer, positive SNP result, etc)?
You, my cowardly friend, are missing out. It is a cheap plastic toy, which usually must be assembled by snapping together some parts. This toy is placed inside a plastic egg. The plastic egg is then coated with a, somewhat annoyingly thin chocolate shell.
The FDA apparently has their panties in a twist about non-food items that are actually inside food. I generally would call this a sensible restriction in form, but.... it is kind of hard to see how these could suffer the same terrible flaw of some other, more unfortunate ideas in candy/toy crossovers.
"I opened my eyes, and everything went dark again"
I understand there is this thing called the telephone. They could use that.
There's also this thing called the internet. Perhaps you've heard of these Google Hangout things. I'm pretty sure they've got enough talented people to set up a securely encrypted hangout for use in a counseling session.
I would speculate that they intend to claim that their product is NOT a diagnostic device, and therefore does not fall under the purview of the FDA. If that's their claim, any co-operation with the FDA would tend to undermine it.
Yeah, don't really need a nanny protecting me from dangerous information. Might even be a first amendment issue there.
"Hey Ms Wojcicki, could you shut down your company for 10 or 15 years while we decide whether it's OK for the public to be able to learn about their own genetics"
Well, they're also bastards who don't consider pain relief to be something worthy of consideration; no amount of pain relief can balance even the smallest risk of shortening life. And thus the COX 2 inhibitors were banned and millions with arthritis lived slightly longer lives which felt a whole lot longer. But that's another story.
They were men of the late-18th century, there is a great deal they could never have imagined. That said, the current state of things has been 200+ years in the making- and it began almost immediately after the country was founded.
To put the FDA in the same ranks as the DEA is ridiculous. The FDA came into existence because corporations and quacks were pushing shit out that was tainted, dangerous, and exploited people's ignorance and penchant for magical thinking. The DEA exists because prudish people beset by an "us vs. them" atmosphere are easily manipulated.
With luck, times will change and the DEA will go away. The FDA needs maintenance, but will remain because it serves a useful purpose.
Maybe in a naive, simplistic view of government. Frankly I rather like not having to deal with corporations on the basis of caveat emptor.
Consenting adults will absolutely be allowed to, once 23andMe complies with the regulations we have empowered the FDA to impose upon corporations acting in a medial scope.
This isn't an impingement on your rights to control you, it's a regulatory burden imposed upon a corporation to defend the validity of its product.
Just under what legal theory before the FDA was poisoning people a legitimate business ?
THE RADIUM WATER IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
Back in the U.S. robber-baron era (1870-1905) it used to be the case that it was your own fault if you put it in your mouth. It didn't matter if the seller marketed it as edible despite knowing or suspecting that the product was poisonous (such as radium water or formaldehyde-preserved milk). As the buyer you were supposed to know better, as summarized by the legal doctrine caveat emptor ("let the buyer beware"). It was only later that caveat emptor was _partially_ overturned by the invention of the "implied warranty", as federally formalized in the Uniform Commercial Code of 1952 (though the concept was kicking around decades earlier than that on a state-by-state basis). In the absence of a warranty (explicit or otherwise), the seller had made no promise to the buyer about the product sold, and with no promise to break there was therefore no fraud on the seller's part. No fraud, therefore no wrong and no restitution: no wrongful death damages, no medical bill expenses, not even a "satisfaction or your money back" refund guarantee.
To this day, there's still quite a bit of caveat emptor in the law. For example, cigarette smoke is poisonous at the intended dosage, full stop. Habitual smoking of cigarettes is known to inactivate hemoglobin by way of carbon monoxide, to reduce lung capacity by accumulation of scar tissue, to damage the cardiovascular system by hardening the arterial walls, and to dramatically increase the risk of lung and other cancers. But despite their documented toxicity, to this day tobacco companies are not held liable for selling them. They have been sued several times, but generally for their advertising, and many of the advertising suits have been for ads that played up false benefits or downplayed real drawbacks -- i.e. they made a promise (implied warranty of fitness) that was then broken (fraud). But so long as the buyer is duly warned (no false advertising, the Surgeon General's Warning is present), the situation reverts to caveat emptor and it's again the buyer's own fault if they put poison in their mouth.
Range Voting: preference intensity matters
The viagra commercials are all over TV where I am and even go so far as to use VERY blue lighting (just like the cvisual distortion they cause in many users). Then there's a zillion ads for definitely not FDA approved boner pills of all sorts.
of course, the uissue of the day seems to be 'low T'.
I wouldn't mind so much if the FDA approval was inexpensive and/or actually meant something other than 'kissed all the right asses'.
Then there';s cases like colchicine. It's been used since before Washington was president. It's efficacy is well known. It has well understood side effects. Na being th*WS* a generic. Then, one company spent $3mil on a completely worthless study and otherwise kissed the FDAs ass and now has an exclusive on it. As soon as they got it, the cost went up several dozen *times* overnight.
Everyone but the FDA and the holder of the exclusivity was far better off before the FDA 'helped'.
I am not one of those "all regulation is evil" nuts by a longshot. I certainly agree that medicine needs regulation. However, it does NOT need the sort of expensive yet shoddy regulation that the FDA provides and we certainly don't need an agency actively straining to increase their domain.
Its mining bitcoins
But that's exactly what many medical doctors are frequently doing. You used to be able at least not to pay the worst of these quacks, but with ACA, everybody is forced to pay them.
A few years back I had a serious lung problem. I visited my doctor, he recognized something is wrong (though he was not sure what it was) and send me to a specialist. The specialist did an X-ray, took blood samples eventually sent me to MRI, etc. etc. He determined that the condition is serious and sent me to a specialized sanatorium/institute that specializes in lung diseases and surgeries - along with the documentation collected so far. And they did their own X-ray, blood samples, and all the other tests. (At the end I ended getting a surgery) That was the standard procedure, and IMHO the right thing to do.
Recently I've seen a lecture explaining the basics of Bayes' theorem. That was first time I've encountered it. What I took away from that is: if you test positive, you don't jump to conclusion. You get the test repeated, you get more tests, you get independent opinion, ...
Why would someone demand or reject a treatment based on a single test not preformed by an expert is beyond me. But if high percentage of population is stupid enough to jump to conclusion based on single test not performed by an expert, then yes, you probably need FDA to regulate 23andMe.
It's one of those many, many problems that could be resolved by people being more educated.
I was responding to "tgd"'s statement about the Founding Fathers and representative government, so don't blame me for bringing this up. And fact is: representative government was intended by the Constitution for districts that were much smaller than what they are today. The fact that representatives today represent districts of nearly a million people makes representative government at the federal level a farce, and means that we should return more power to state and local government, instead of letting more and more decisions be made at the federal level.
You're right that the Constitution should not be a static document, so let's talk about how things have changed. Given the vast increase in the population, complexity, and diversity of the US, it is time that we move power away from the federal government back to the states, many of which are larger and more powerful than the entire US used to be. Creating an unaccountable, uncontrollable super-state that's in the thrall of corporations, like you want, is the wrong direction.
The vast expansion of federal power happened in the 20th century, much of it after WWII. It is neither inevitable nor necessary. And given that many states are now bigger than the US used to be, it makes sense to give more power to the states and counties, instead of creating some unaccountable and uncontrollable mega-government to rule over all of it. The correct response to a bigger and more complex society is not to create ever bigger central institutions, it is to distribute decision making so that historical processes and scales continue to operate.
What's "naive and simplistic" is your belief that the best way of dealing with problems is to create a gigantic, all-powerful central government and elite.
Generally, I would. But if there is to be regulation, it can be at the state level.
Don't even try arguing with intellectual statists, they're too smart to admit they're wrong.
Why do you find it reasonable to use force to prevent me from purchasing someone I want when my purchase of it can do no harm to you or anyone else?
This is the same argument that kept the VA from releasing information on HIV in blood test results. Some idiots were too afraid that letting a person get the results directly, rather than from a doctor would cause them to freak out. Others argued that by not getting the information the patient would be too upset to ask the relevant questions of the doctor. Both situations could transpire. What is wrong with letting people freely choose based upon their own preferences? What is the justification for letting the government interfere with my freedom of choice?
Sending back everyone's spit is gonna suuuck.
Yes, they should be working at higher standards. You only have to look at their "research" pages: https://www.23andme.com/about/factoids/ and click any of the links. Some are worse than others but all are shit. Click the Parkinson's & cholesterol, for instance. Vague statements and an irrelevant graph. That's the trend throughout those links. It's basically no better than astrology. The markers they test for (which is what the FDA is worried about) is a separate issue, and are more likely to be meaningful, but the fact that their "research" page is the way it is puts me off having their test. They need to explain their false positive and negative rates and say what it is for each test (e.g. penicillin sensitivity). They also need to be clearer on what a positive for particular marker means. e.g. WTF does "Slightly higher odds of developing basal cell carcinoma" actually mean? If you re-read the page more carefully you notice that it's 1.3 times greater odds. But 1.3 times greater than what? One of the basic rules of data analysis is that if you don't know what a proportional change means in absolute terms then you know nothing. i.e. it's bollocks. Yes, I could click on the original publication, but most people don't have the scientific background to understand it. Furthermore, if there are few studies linking gene X with condition Y then you're not even sure how true or how widely applicable the results are. e.g. if the studies were done on white people from Europe then are the results true for a black person from Africa? We don't know and 23andMe don't tell use this is a caveat (which it is).
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They are a lot like libertarians in that respect.
Maybe quite true, actually. The difference is we don't try to impose our "wrong" or "right" values on anyone else; nor do we kidnap and imprison them if they disagree with our values/beliefs.
"Because to take away a man's freedom of choice, even his freedom to make the wrong choice, is to manipulate him as though he were a puppet and not a person." - Madeleine L'Engle
If you work for the FDA or any other government branch, directly or voted in, then you are 100% likely to be a fucking moron who should be sterilized, neutered or spayed immediately.
That's guaranteed to be 100% accurate, 100% of the time.
Yeah, it would cut out those layers from the process of buying and using a cheap non-invasive test. It wouldn't cut them out of the medical system entirely. So when you surmise that he would saw his own dick off because he doesn't want doctors to exist, that is not at all supported by the evidence right?
Given the nature of this data, patients should doublecheck it before including it in any medical or lifestyle decision. This is common sense and I would recommend it regardless of the FDA's actions here. However, as long as patients CAN doublecheck their genetic test results, they can evaluate the reliability of service providers like 23andMe (in contrast to the above claims that Joe-drunk-off-my-ass is necessarily a dupe).
By "the nature of this data", I mean a few things:
1) It does not change over our life, so you should be able to get reproducible results even if you repeat the test 10 years from now (assuming that you are not a chimera).
2) It is extremely easy for DNA samples to get contaminated. I've seen it ruin experiments, even when the purification is being done by experts. I really doubt that a home test kit can reliable keep the sample clean.
So, if you are having genetic testing, have it done twice and check that the results match. Use an independently collected sample. As long as you are confirming the integrity of the sample, confirm the integrity of the testing company too by sending the sample to another company (yes, I know there currently is not another commercial company doing this, but there are always medical labs; most likely, the "at home" testing should be the validation of the clinical testing).
With regards to the interpretation, get a second opinion from an expert.
Yeah, because our choices are obviously between
No Regulation or Massive Regulation
There's absolutely positively no way to exist between these extremes. Of course the person saying they want less regulation is really speaking in code because what they really really want it no regulation.
That their is too much regulation in health care is a fact, that there should be no regulation in health care is not.
Is it at least possible that we are confusing our understanding of the intent of the founding father's organizational skills with simply an impossible stretch of the "Health and Welfare" interpretation? When we invoke the intent of the founding fathers we must be careful to constrain context. I am uncertain this "least common denominator" approach (which frankly seems to have utterly failed) was really a part of the vocabulary of the day. It is quite a modern concept to regulate the many based on risks borne by the few. Correct me if I'm wrong here, but in those days the gov't wasn't really in the business of 3rd order eventualities or perceptions of responsibility...citizens generally understood they bore the risk/consequence of the beliefs/information to which they chose to adhere. It's also a very personal decision when it is appropriate to defend against the reach of governmental, religious, scientific (institutional) authority...as these groups are so wont to reach. For the last few decades, anything short of complete surrender of responsibility for personal health is unerringly frowned upon and regulated...for the benefit of the uninformed? ... or the benefit of the industry? ... or the furtherance of authority?
Federal assumption of such responsibilities smacks of intrusion into personal domains (like scope creep). You might say that becoming a "child of the state" has drawbacks. The transaction cost of outsourcing every decision is possibly unsustainable. AND...as in this case...a new level of control takes a little getting used to...before everyone can get back to sleep.
Under ACA you are forced to pay some insurance company. Most insurance companies allow a choice of doctors, so people aren't forced to pay quack doctors. They chose to.
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Everybody pays for the quack doctors because the costs are socialized and their quack services are part of the ACA coverage requirements.
I don't get the reference, with respect to slavery. We elected a president and some other legislature that the minority didn't approve of because they thought it would end slavery or something along those lines. So a war erupted as some states tried to succeed. The condition of surrender was accepting the constitutional amendments that outlawed slavery. The southern slave owners may have been better off not succeeding from the union and followed the modern republican methods of obstructionism.
With respect to your quote by John Stuart Mill, Who cares what he thinks? I don't. Should I quote a Pope and expect you to suddenly believe it due to his resume, or be swayed by the beauty of language used?
I believe in working for the common good. That isn't code for communism, but a reasonable balance between the rights of the individual versus the good of the whole of society.
Well.. maybe. Or Maybe not. But Definitely not sort of.
Ah, but what is a "reasonable balance"? Is it determined democratically, by the majority? If so, what if the majority decide slavery is reasonable? Or that you have to sit in the back of the bus because of your skin color?
We think slavery and Jim Crow are stupid now, and that not seceding would have been a better choice. But at the time people thought it the best policy.
What you think the obvious best choice on behalf of others today, might seem equally ridiculous in the future. The way to avoid these blind alleys, is to let people decide for themselves. Making the rights of individuals subservient to the nebulous "good of the whole society" eventually leads to good for only those who have the power to manipulate the law - large corporations and their lobbyists and politicians.
Are you talking about the false positive rate of the *actual test* as in, the test shows you have some xyz-gene but x% of the time that is incorrect? Or are you talking about false positive rate as in assuming you definitely have xyz-gene which is a marker for such and such disease, x% of the time that does not actually lead to such and such disease?
If the former, yeah sure. I'd be surprised if they didn't have that information available, at least for the FDA.
If the latter, then obviously that's an impossible standard to meet and you're actually calling for the ban of affordable genetic testing, while hiding behind nice sounding statements like "They also need to be clearer" and "They need to explain." Oh yeah, just be clearer and explain a bit! And with one company independently doing it all, it will only take a hundred years and resources equivalent to the entire US medical R&D industry, which is where these hypotheses about genetic markers for disease come from and are a current and hotly researched area.
just remarket it as a psudo religious service like Scientology does...easy, no regulations for religious services.
I think the UN universal declaration of Human Rights (http://www.un.org/en/documents/udhr/) is a great starting point. A document that was created with the input of many nations with different religions, philosophies and economic systems. Letting people decide for themselves, without referencing any kind of rights of the individual can also lead to slavery and other non desirable outcomes.
Well.. maybe. Or Maybe not. But Definitely not sort of.
Because 23andMe is an affordable way to do testing that would otherwise cost you (or your insurance company) thousands of dollars the FDA is probably being persuaded to suddenly start trouble. And may I point out, very simple testing (provided you have the equipment). Your DNA has a lot of great information and 23andMe is extremely particular about the way they word things in offering any sort of medical advice. Certainly it would become FDA approved but it will bog this company down with unnecessary fees and red tape from Big Brother if it wants to stay alive. (Certainly no problem for "Google's wife", but on principle this is seriously messed up!) This company is doing a great thing for people everywhere! If not telling people to get medical treatment soon for a degenerative disease that has gone and will go undetected for another 5 years thus saving that person's life, at least promoting awareness that the genomic era is approaching quickly!
I think they should have disclaimers that enumerate the false positive rates of the tests (i.e. probability of a positive given that you don't have the mutation) and explain to a scientifically illiterate person what those numbers mean. I haven't seen that on the site as yet, but I haven't looked extensively. If it's there, it should be clearer.
Regarding the second issue, what a positive result means, I think they should be providing more information, more references (not just one), and explaining the caveats in the literature. They can't do anything about those caveats, but they need to be more clear about what a positive result means. They providing lay people with complicated and potentially scary information. They need to be more responsible about that.
To reiterate the example I listed above, if they state that one's chance of getting cancer X is 1.3 times greater than the rest of the population then they need to explain what that number means. i.e. what is is the absolute chance? The relative chance isn't what matters. They list how many people in the US have the disease, but that's not enough. They need to run the numbers for their customers in an easy to digest manner. Use graphs.
They also need to put these risks into context. For instance, people may not be so worried about having mutation X if they know that their absolute risk of getting the disease it's linked to is lower than their chance of being killed by falling down the stairs.
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