Should You Be Allowed to Know What’s in Your DNA?
“You can’t handle the truth!”
That’s the federal government’s latest message to Americans seeking to learn the content of their own DNA.
Recent advances in biotechnology have allowed private companies to offer affordable genetic testing directly to consumers, to help them determine their risks of developing problems such as diabetes, heart disease, and various forms of cancer. In response, the U.S. government has told these companies that their tests must be approved by FDA regulators before they can be sold because, in the government’s words, “consumers may make medical decisions in reliance on this information.”
These restrictions thus represent a new level of government paternalism over the citizenry. In the name of “protecting” us, the government seeks to prevent willing consumers from learning medically useful information about their own bodies that could tell them which diseases they may develop — and help them make important treatment, prevention, and lifestyle decisions.
Ten years ago, Dr. Francis Collins and Dr. Craig Venter announced the first successful (independent) sequencings of the human genome. Since then, the cost of genetic sequencing has fallen dramatically in a biotechnology equivalent of Moore’s Law. Mapping the first human genome took years and cost $3 billion. Now it takes only 8 days and $10,000. Industry analysts predict that in three years, it will take only 15 minutes and a mere $1000 — comparable to many routine medical tests.
As prices have fallen, several companies had started offering direct-to-consumer genetic tests which would give customers partial information about their DNA.
In May 2010, San Diego-based Pathway Genomics struck a deal with Walgreens to sell test kits at 6,000 stores nationwide. Customers would spit into a small vial, then mail the sample back to the company for analysis. For $79, customers could learn how their bodies were “likely to respond to 10 substances, including caffeine, cholesterol-lowering drugs called statins, the blood thinner warfarin and the breast cancer drug tamoxifen.” For $249, customers could be tested for their risk for 23 conditions “including heart attack, high blood pressure, leukemia, lung cancer and multiple sclerosis.”
The FDA immediately warned Pathway to either show that it had FDA approval or “prove why it should be sold without the agency’s blessing.” Walgreens then suspended its plans. In June 2010, the FDA sent letters to five other personal genomics companies warning that their direct-to-consumer tests would also require FDA approval as “medical devices.” The FDA’s logic was because customers might base medical decisions on their test results, Americans’ access to these tests must be restricted until the government gave its approval — for our own good.
Esther Dyson, a director of one of the affected companies (23andMe.com), has described such government restrictions as “appallingly paternalistic.” Customers wish to learn their personal genetic information precisely because it may help them make important medical and lifestyle decisions.
For instance, scientist Seong-Jin Kim learned from his genetic test that he had a “tenfold increased risk of macular degeneration, the leading cause of blindness in people over age 60.” As a result, he is taking “high doses of antioxidants, which have been shown to slow progression of the disease, has regular eye exams, and avoids activities that tend to overexert the eyes.”
Genetic testing can reveal important information about how quickly an individual’s body metabolizes certain drugs, such as the widely used blood thinner Coumadin. Such genetic information could help doctors tailor a dosage individualized for each patient, potentially reducing the chances of undertreatment (with continued risk of developing blood clots) or overtreatment (with risk of internal bleeding). Similarly, the FDA has already issued a recommendation that patients of Asian descent be tested for a specific genetic variation before they take the anti-seizure medicine carbamazepine, because that genetic mutation could greatly increase their risk of certain serious side effects.
Of course, like any technology still in its infancy, consumer genetic testing is imperfect. Craig Venter and colleagues performed an interesting experiment where they sent duplicate saliva samples from five different individuals to two separate testing services to see how the results compared. They found that the companies reported essentially identical results with respect to the subjects’ raw genetic data, but did show some variations in how they interpreted their medical significance. Venter and colleagues then made several recommendations on how to improve the quality and consistency of such commercial tests — recommendations which notably did not call for increased government regulations.
Fledgling technologies like genetic testing require a free market to thrive and mature — a market free from onerous regulations. As we’ve repeatedly seen with products such as home computers, DVD machines, and MP3 players, new consumer technologies follow a typical market trajectory. The initial products are expensive and often flawed, appealing only to “early adopters.” But these early adopters help establish a viable market for the product, creating incentives for existing manufacturers to lower costs and improve their quality, and for new manufacturers to enter the market. This attracts new “middle adopter” customers, which in turn spurs further innovation, attracting yet more customers in a virtuous cycle.
The early adopters who purchased the first Apple iPods in 2001 spent $400 for a device with only 5 GB memory. But because of the market created by the early adopters, in 2004 middle adopters could buy a $400 iPod with 40 GB memory. Today in 2010, customers can buy an iPod Classic for only $250 containing a whopping 160 GB memory.
But what if government regulators had prevented early adopters from purchasing the initial crude iPods? They would have strangled the infant iPod market in its cradle, to the detriment of millions of future iPod customers. Yet that is precisely what the government is threatening to do with the infant consumer genetic testing industry.
Thwarting the early adopters for consumer genetic testing could also thwart important future medical innovations. In September 2008, Google co-founder Sergey Brin stunned the technology world when he announced that genetic testing had revealed a mutation which increased his chance of developing Parkinson’s disease. As a matter of rational self-interest, he has chosen to donate $50 million of his fortune to Parkinson’s disease research which may someday bring enormous benefits for himself — and for millions of Parkinson’s disease patients around the world.
Admittedly, Brin is an unusual early adopter. According to Wired, he is “likely the first who, based on a genetic test, began funding scientific research in the hope of escaping a disease in the first place.” But he may not be the last.
If government regulators had prevented Brin from gaining access to this information, who knows what future medical advances might never be discovered?
Opponents of direct-to-consumer genetic testing typically raise three standard objections, including: (1) the test results may be inaccurate; (2) even if the results are accurate, customers will not know what to do with the information; and (3) customers may learn about genetic defects that could make health insurance prohibitively expensive or impossible to purchase. However, a truly free market in health services and health insurance would address all of these concerns.
Customers concerned about the reliability and accuracy of their test results are best served by a free market that subjects products to the pitiless scrutiny of consumers seeking the best value for their money. Of course, if an unscrupulous company makes fraudulent claims about its services, it should be punished to the fullest extent of the law. Protecting consumers against fraud is one of the proper functions of government. But if personal genomics companies otherwise truthfully describe the capabilities and limitations of their tests, then the early adopters should be left free to exercise their best judgment as to whether they wish to purchase those services.
Over time, competition between genetic companies making truthful claims about their products will spur innovation as they seek to address customers’ needs for accurate results. Furthermore, independent reviewers would also spring up to assess the quality of these services, much along the lines of the above-mentioned Venter experiment — just as there are already countless independent reviewers to help customers purchase computers, cars, or camping gear.
With respect to potentially confusing test results, in a free market genetic counseling services would quickly spring up to help customers understand and interpret their significance. These genetic advisors may vary in quality, just as financial advisors currently vary in quality — some may be excellent, whereas others may be mediocre. But a free market would allow customers to find advisors that best suited their needs and preferences. Because genetic science is evolving so rapidly, it is each individual’s responsibility to perform his due diligence and consult with his personal physician before making major medical decisions based on a genetic test result.
Finally, concerns about so-called “genetic discrimination” would also be addressed by a fully free market in health insurance services. George Mason University professor Alex Tabarrok has proposed allowing people to purchase “genetic insurance,” where they pay insurers a premium prior to getting tested in exchange for promise of payments to cover higher health and/or life insurance costs if they subsequently learn that they have an unfavorable genetic profile.
University of Chicago professor John Cochrane has proposed a variant known as “health status insurance,” where customers could pay their insurers an additional small fee now to lock in their ability to purchase insurance in the future, even if future test results or other changes in their health status might otherwise render them uninsurable.
(Those who are interested in further discussion of such issues might also enjoy the paper by Manson and Conko of the Competitive Enterprise Institute, “Genetic Testing and Insurance: Why the Fear of ‘Genetic Discrimination’ Does Not Justify Regulation.“)
Although these concerns raised by the opponents of direct-to-consumer genetic testing are legitimate, they would be addressed in a free market, precisely because service providers (e.g., testing companies, genetic counselors, and insurance companies) would have a powerful economic incentive to meet the demands created by customers seeking to better their lives and their health.
In summary, the central issue is whether you should be free to acquire knowledge about yourself that will help you act according to your best judgment for your benefit — in particular, by helping you treat, mitigate, or prevent bad diseases.
The federal government wants to deny you that freedom, essentially saying, “You can’t handle the truth. Instead, we’ll decide what’s best for you.”
Any self-respecting adult who wishes to exercise his responsibility (and his right) to manage his own life as he sees fit should be offended by this paternalistic attitude. Our lives are our own. Americans already know this. Let’s demand that our government recognize it as well.
Good blog. Obviously correct. The feds shouldn’t be involved in healthcare any more than they should be involved in the regulation of drywall spackle.
It’s interesting that they want to control DNA testing because we may make erroneous decisions about our healthcare needs, but have no interest in home-use thermometers or bathroom scales. OOPS.
Or all the OTC drugs out there. (there are more every year.)
Good point, Robert
Allow the Feds to regulate health care and next they will want to decide what drugs work and what drugs don’t
What medical procedures are real and which are false
There will be no stopping them
Typical .gov stupidity.
You’d think they’d be happy to have me make medical decisions based on the info found through my DNA testing. After all, if I found out I was susceptible to diabetes or heart disease I could make informed choices about my diet and lifestyle to greatly reduce the chances of me actually developing the condition, thereby saving the .gov a ton of money they’d have to spend on me through Obamacare.
Except that’s not the point. Obamacare is about government control, not about health care. And besides, they will be making the dietary choices for me anyway in telling me what I can and can’t eat.
Should I be *allowed* to know what’s in my own DNA? Allowed? This is outrageous,though up to the FDA’s usual autocratic standards. Another nail in the coffin of personal control over healthcare. I want to be responsible for my own healthcare, and make my own decisions with the help of professionals and products that *I* choose.
I think that there is a more sinister reason behind their desire: DNA debunks evolution, showing intelligent design/creation.
This author’s argument is completely flawed. The FDA isn’t saying ‘you can’t handle the truth’. The FDA is saying that you should be able to have consumer confidence in a product with as serious ramifications as this one.
The author uses the iPod as an example, but it isn’t fitting because an iPod causes no harm for anyone. The author seems to say that it would be best to let the market sort out any new product like say, baby formula. Consumers will figure out where to spend their money. They’ll learn quickly which formulas contain poison. Sorry for those people who found out the hard way, but at least we didn’t have the FDA stomping all over our freedom!
Seriously, Aaron; what would YOU rather, the marketplace sorts things out and resolves issues under the guidelines established by an independent supervisory organization of industry experts and professionals, or the government deciding what it will or will not “allow” you and the industry to to do?
For example, the FDA recalls a drug every month that they had approved beforehand. People are having strokes, heart attacks and liver diseases after taking FDA approved drugs. So, how do you LIKE the government-run everything model so far??? If you ask me, it has been proven to be unworkable! I’m ready to try something different! In my opinion, it could HARDLY be worse!
Bubblehead- I don’t think anyone from a specific industry should be called upon to regulate said industry. Itd be like letting the wolf guard the henhouse. It makes no sense.
John- no strawman here. Though DNA isn’t ingested, its sole purpose is to help the patiant decide what to ingest, so it still seems relevent to me.
BVW- wow! what an accurate depiction of my life, or your point, or, uh, something.
Georgefells- what a nice take on the debate. I agree with much of what you said. I also appreciate a more nuanced take on the situation than “arg! Freedom good! Government evil!”.
I’m not against government regulation, but this one seems to be overreaching a bit. Not an expert, but I can see two broad categories of “harmful” medical stuff that the gov should be protecting us from: poison and quackery. A poison is any drug or treatment that can hurt you. Quackery is any drug or treatment that doesn’t do what its purveyors say it does. Regulating both of these categories protects the public from harm. I don’t see how genetic test results – as long as they’re described honestly by those peddling them – fit into either of those categories. It’s just information – same as the crap you find on the Internet. I could self-diagnose using info I found on some websites and then order some herbal remedies online. I might get better or I might die. That doesn’t mean the FDA should be allowed to regulate medical content on the Internet.
People, do you realize these pro-government people always advocate “nuanced view” in favor of the government regulations, and NEVER against it?
How about we take a “more nuanced view” in an argument AGAINST the government regulations?
(1) Government can;t get *anything* right.
(2) The Industry organizations described as Wolf to guard the Henhouse is pure nonsense. The former has a vested interest in providing a service/product which will hold market interest in them as long as the end of the world. The government has vested interest in regulating everything under the sun.
(3) The government also has vested in TAXING the excrement out of both the manufacturer AND the consumer (and their great-great-great grandsons). ANY regulatory power we give to the governemnt sooner or later translates into the power to rob.
(4) It is non of the government’s business what information i learn about myself.
(5) Nuance is for retarded people, or for frauds. Truth is usually much simpler than this allegedly ‘nuanced intellectuals’ make it out to be. In fact, ‘nuance’ is their weapon of choice. Muddle the waters so much that people can’t see the sepia-less squid.
(6) We “ingest” a lot of things. Do you want the goverment to tell you what to ingest and what not to ingest? That whole argument is a fake one. Information is information, and it can be accurate or less accurate or not accurate. Who is the goverment to decide what is accurate information (about me) and what is not? Indeed in this case, the information is a boon. And if taken with a consultation with your doctor, it is only going to INCREASE your health, unlike the “poisoned baby formula” analogy, rendering the latter an invalid analogy.
(7) Most of the preventive methods involve NOT ingesting this or that food, medicine, etc. Again rendering the analogy a “nuanced nonsense”. IF my genetic test says i have ten-fold chance of Diabetes, it doesn’t mean that i am going to start INGESTING Metformin Hydrochloride U.S.P. It means i will STOP INGESTING too much sugar, or whatever the doctor tells me could increase my chance of developing diabetes. Folks, be VERY careful of those who insist that things are “much more complex” than your average common-sense can fathom. They are just plain simple lying. Most of the times, things are much LESS complex than they make it out to be.
So aron, is that nuanced enough for you? I can add more nuance as needed, and then stir and simmer till it is cooked to your satisfaction. Not that it would change basic principles, or truth for that matter.
I disagree with Dr. Hsieh, the author of the piece – assuming I’ve understood Dr. Hsieh’s point that is!
If I understand the FDA’s justification for their interference, it is that they don’t want people purchasing genetic counselling data until the FDA is satisfied that this information is accurate. This seems eminently reasonable to me: what good is information that is wrong?
Let’s consider a close analogy: a home pregnancy test. Let’s say your wife or girlfriend bought a home pregnancy test and it gave an incorrect result, either a false positive or a false negative. Either one could lead to serious consequences. Suppose your girlfriend is a young teenager from a devoutly religious family who would tolerate neither an abortion nor having the baby but who knows she’s not ready to marry and is unwilling to give up the baby for adoption for some reason. If she feels completely cornered, she could conceivably commit suicide. Then imagine that the test turns out to be a false positive and she was not pregnant at all. Or consider someone whose test shows that she is not pregnant who then goes and does various things that are risky to her baby before she finally discovers that she is indeed pregnant. It’s not difficult to imagine a baby dying in vitro or being born with severe disabilities, all because a test is inaccurate.
Now, I’m making an assumption here: that FDA approval ensures that the test is indeed reliable before approval is granted. In other words, I’m assuming that the FDA approval will CORRECTLY determine that the test is suitably reliable. If the approval process isn’t sufficiently careful or thorough, it may approve a test that is NOT accurate though and then we’re back to the risk of false negatives and/or false positives.
Please note that I’m NOT saying that getting a test of this kind – either a pregnancy test or a genetic test – necessarily has to be approved by a government agency! Why not have a variety of private firms that specialize in product testing? Let private enterprise figure out the most efficient ways of testing medical tests and treatments. Of course, such firms would need incentives to ensure that they didn’t just approve everything they were given regardless of how good or bad it was. It seems to me that the possibility of being sued for millions and/or going to jail if they approve something too readily would make a pretty good incentive.
Government testing, on the other hand, is naturally pre-disposed to be as hyper-cautious as it can possibly be, probably excessively so. I’m just rewatching Milton Friedman’s Free to Choose (1980 version) and the episode on government regulation makes the point that a government official who lets a drug pass testing without being sufficiently thorough would have his name all over ever major paper if someone died as a result of approving it too readily. But if the same official was much more cautious – again, tending to be OVER-cautious – he puts his career at much less risk. His name isn’t going to be all over the news if he FAILS to approve a drug and someone dies because that drug wasn’t yet approved.
If I’ve misunderstood Dr. Hsieh’s objections, I hope someone will clear up my misunderstanding.
What if the information you provide here contains errors? What if a newspaper, a medical book, or a website contains errors. Why not let the government decide first what is correct, and what information you are allowed to get as a consumer?
What should the government allow to go through as the truth: your opinion your that of Hsieh.
And don’t say that this it not about life or death. It is.
Which left/liberal group do you troll for Aaron?
There’s no room for excusing government intrusion AT ALL. Give them an inch, they take a mile. Oh yeah, I forgot… When we don’t complain when they TAKE an inch, the government then OVERREACHES a mile.
We must complain LOUDLY or do what we can to make sure that every centimeter the government encroaches on is noticed/remedied.
Nice strawman Aaron. The author isn’t talking about something we ingest, such as formula, he’s talking about a test that could possibly save a life. In typical government fashion, it’s more important to them to control what we do than to allow us to do what we think is best for us.
The more important question to ask is, who is pressuring the FDA to not allow the tests. Since tests now cost $10,000 and it’s predicted that in 3 years they will cost $1,000, who’s losing out on money if the FDA allowed these over the counter tests? If history is any indicator, those are the people pressuring the FDA to stop these products from being available. Always follow the money.
The governments nose is some place it shouldn’t be, here. But I think it reflects the governments belief that it owns human life within it’s borders, another denial of Gods hand in the creation of mankind and that government provides your Rights not God.
Aaron, awakes in his crib, and cries for his mommy. She’s not there. Why? She is an all-natural product not approved for public consumption or use by the appropriate regulatory agency of your loving government. She could be unsafe. She’s untested. She harbors inappropriate culture programming that would endanger baby Aaron, not to mention her gut, hair and epidermal layers harbor deadly pathogens.
She has been taken away for reprogramming and retraining. That process will take years. When she returns — if she is returned — Aaron will already be a teenager and very wise and healthy because Aaron will have been raised by an FDA approved Robo-mommy, according to all officially approved government protocols of child rearing.
Aaron, mommy would never want anything but the best for her child. Your mother loves you, Aaron, to the maximum degree allowed by the FDA.
Aaron is completely right and most of you are incredible stupid. First the author is completely misconstruing the situation. The government has never ever attempted to say you cannot know your DNA information. Anyone of you could go get your entire DNA sequence right now. Maybe we could then figure out what the sequence for gullible is located. If the DNA technology is not accurate then you would be making humongous life choices on faulty information. The majority of people will want to know the technology is accurate. If your genetic information reveals that you will have Parkinson or multiple sclerosis, this will alter how you plan for the future, and possible whether you have children. It is quite useless to compare this kind of technology to anything else out there. It is just not comparable to drugs or ipods. This is not a drug that will have different effects on each person with unknown future side effects. this is a piece of technology that tells you what your DNA says. This is not like an IPOD because if the Ipod is broken you get a new one. If someone gives you faulty genetic read out you are going to alter your life in reliance on that information.
Brian, if you want to make this about consumer confidence, then fine. I can go there. So who do you want to have in charge of making sure a given product is safe and reliable, the company who makes it or some government bureaucrat? The company will cease to exist if it allows Aaron’s “poison baby formula” or something like it to harm the people who buy its products. They will he vilified by an omnipresent media, investigated to see if force or fraud (legitimate reasons for government to muscle in) were committed, indicted, and it will lose all of its customers, totally screwing over themselves and their investors. So how huge do you think the incentive is for any private company in a free market to produce the best (read: safest) product it can?
Let’s turn to the government bureaucrat. His incentive is to get reappointed or reelected. He bows to the whims of the politicians above him and the pressure groups that surround him. His concern is the “public” good, so he spends his entire life dictating policy for a multitude as if it were an individual. If one person has an accident, he passes blanket laws that effect and restrict ALL people, to try and prevent, with brute force, every possible unfortunate thing that could ever happen to a person. So what happens if his policies are horrendously harmful? What sort of recourse does a person have? Well let’s see… he can vote in the next election for a politician to join the hundreds in Washington in the hopes that enough more people vote for the same sort of politician at the same time as to create enough political currency to, at some point, remove the harmful bureaucrat from his appointed office.
So, we have 1) a company going out of business in a matter of weeks or 2) many, many years of red tape and posturing while the morass of regulations swells and swells.
I’ll take the free market any day. Markets are voluntary, regulations are forced.
You just created a false choice. One that is not really applicable to this set of facts. You assume that every company has long term goals. While yes, maybe some of them plan on doing such a thing what about those that do not. I set up a llc and have a shoddy machine. I take peoples money transfer funds out of the company and close down after 2 years. People find out 5 years later that my genetic test was faulty, but at this point it is too late. Even in legitimate companies they make cost benefit analysis before recalling products. sometimes it is less costly for them to settle suits. Their sole goal is profit, even at the expense of peoples health. I would rather a neutral party be looking out for my health. It is like asking the coach of the other team to call their own fouls. Here the government is not trying to regulate process but only making sure a product does what it is supposed to do. Should nuclear plants have to undergo some kind of federal safety inspection? The answer is yes of course. Look at the most recent oil spill. Obviously the companies were not self policing, and our regulation was not being enforced. However, enforeced regulation and higher safety standards could have prevent the biggest oil spill in the US.
Brian, now YOU’RE presenting a false alternative. To you, it’s either government meddles into the activities of companies for the public good, OR it allows companies to lie, cheat, and steal their way to enormous profits. What about restraining the government to its proper role–the protection of individual rights? If you own an LLC that scams people, guess what? Unless you escape to a non-extradition country, you’re going to jail. There will be a class-action suit against you and you’ll be up the creek. Or else people will simply learn about it, in a free society, and stop buying your awful products or using your crappy services! So you’re saying that a company does a cost-benefit analysis and comes to the conclusion that the cost of fixing/making safe/improving a product or service is MORE expensive than killing a bunch of people and going completely out of business and possibly facing charges?? What planet is that? And before you throw some obscure example of an evil company that got off in court, that’s a question of the efficacy of the legal system–a different argument altogether. By invoking the “greed” of self-interest, you’re actually proving my point. Bernie Madoff and those like him are a miniscule minority. And he’s in jail right now–fat lot of good lying, cheating and stealing did him, right? He wasn’t selfish–he was self-destructive! The simple fact is that businesses do not make money by harming or cheating people. And those that do, for the vast majority of cases, suffer the consequences. Again, fraud is a crime and will be punished by a proper government. Where you’re wrong, I think, is to unleash the government to set about trying to prevent as many bad things that happen to people as possible, accidental as well as deliberate. And while the State grows bigger and bigger, imposing safety regulations, people will be less free, take less risks, receive less reward, and fewer and fewer technologies like this potential DNA testing will develop.
First, you must have been living in a hole to not realize that companies do cost benefit on your safety. Lets take the Ford Pinto. Fords analysis showed that 180 deaths and 180 serious burns would cost 50 million in out of court suits but that the recall would be around 140 million. They knowingly put dangerous fuel tanks in the cars. 119 Cal. App. 3d 757. See this federal case that has the companies own memo. Remind me, is Ford still around? Did they go out of business as you claim any company with a faulty product would? Is Ford sold on this planet or another, I am confused? According to you no company on this planet would do wrong. As technologies grow there needs to be more regulation because there are newer things out there.
A series of questions …
Aaron, was you mother government approved? Simple question.
Was her DNA vetted by the FDA before your conception?
Would you like to have the DNA of all prospective moms and dads tested before they conceive?
Brian N:
People are MUCH more believable when their sentence structure/spelling is more grammatically correct than not.
…sold without the _blessing of_ the FDA…Oh My Governmental God.
At least, back in the bad old days of bribery of the FDA by Pharma,
one could still obtain Meds under prescription at a higher price;
Now it is almost as if the Feds _want_ people to die…Oh, right;
Never Mind.
Anyone see Lopez tonight when they were DNA checking guest?
Snoop dog was not all black! Lopez wasn’t all Mexican!
what would happen if everyone in America had to change their race because their color didn’t match their DNA?
If A man is 53% European, 16% American Indian and 31% black then what race is he?
The POTUS (PBUH) is roughly 50/50 white and black yet is self described as black when his DNA says different.
What effect would this have?
I am reminded of the Chappelle show where the head of the KKK was a blind black man who was raised by whites and thought he was white when he wasn’t.
A feverent anti black racist in heart and soul but in actually sight, black.
DNA for everone would show just how much race purity there is or isn’t in America.
You mean race is not a social construct? It’s real? In the DNA? Not just skin deep?
The horror!
Eh. There’s a lot of thorny issues inside genetic testing that really need addressed.
Q: Should it be illegal to have your own DNA tested? A: Of course not, that’s just silly. You might as well make it illegal to have your own photograph taken, or your kids fingerprints put with your important papers. Now it probably should be regulated a bit, to make sure your results you get back are accurate, but that’s it.
Q: Should the interpretation of these DNA tests be regulated? A: Hell yes, and I say that as a closet Libertarian. The opportunity for fraud here is endless, everything from selling pills to “cure” the problems that your test “show”, to sham medical treatments, to Medicare/Medicaid/Insurance fraud and so on. The ability of hucksters to scare money out of frightened sheep with this is endless.
Q: Should insurance companies be regulated in the way they are permitted to use these tests? Again, hell yes. Insurance companies have a bad habit of yanking people off their policies the moment they sneeze, let along test positive for the possibility that sometime maybe in the future they might have to pay for some expensive procedure.
Q: Should people be able to be forced to take a DNA test? A: No. Just because it’s a good idea, doesn’t mean the government can force us to do it.
Q: How private should DNA testing be? A: As private or more than your bank account number. The government has no need for your DNA unless you are being arrested for a crime and a judge issues a subpoena for it. And if that DNA evidence shows you innocent of the crime, the subpoenaed sample and its records should be destroyed. None of this “we arrested you once and now your DNA lives in our records forever” crap.
Q: Should insurance companies be regulated in the way they are permitted to use these tests?
No. Insurance companies shouldn’t be allowed within a mile of anyone’s DNA results, for any reason whatsoever.
#5 Aaron The FDA is saying that you should be able to have consumer confidence in a product with as serious ramifications as this one.
Horsepuckey. The FDA could easily recommend regulation stipulating that test providers are not allowed in any possible way to share your info or use it to sell you services. Even setting up double blind passthru is simple enough (the tester doesn’t know who you are; Walgreen’s doesn’t ever see the test result.) Any of these simple measures could easily allay consumer fears if *abuse* was the actual reason.
Since even these *simple* measures aren’t implemented it becomes clear that the FDA perceives its role as nanny — we the people are too stupid to be able to deal with the results.
Of course this isn’t a socialist, leftist, or Obama-ist thing: it’s simple turf protection crapola in a bureacracy.
Allston-
Incorrect. The FDA is trying to protect consumers from the possibility that the company that sells them information about THEIR DNA is actually information about THEIR DNA. Which one of the companies involved managed to screw up by making a mistake you wouldn’t expect high school chemisty students to make. The problem is, if I’m buying their service, then I expect the DNA results that say “Aaron” at the top to actually be gleaned from my DNA. THAT is what the FDA is trying to enforce.
Aaron, the MARKET — the free market made up of the billions of humans on this Earth — can REGULATE a business, even a business measuring DNA, far more robustly and thoroughly than a relative handful of government regulators. There are, as others have said to you, already marketplace GENERAL well-tested laws against fraud and ‘fit for intendeded service’ laws. Thus existing laws and customs of business provide all the surety we ADULTS need to be happy and secure in the market.
Trust your fellow humans, Aaron.
I agree with your take on this. Given all the media misrepresentation of science and the poor schooling in science, there are lots of possibilities for dangerous scams. And believe me, it is the charletons who will be running the first ads to rip off the gullible. I don’t necessarily think the government should control every aspect of DNA testing, but there are so many unknowns at the moment about how genes interact, both among themselves and with environmental factors, that it will take some time before doctors can properly interpret a person’s sequence. I know people who work in this field and they are much more humble about what they don’t know than some of the commenters here. For instance, I can’t quite see how a DNA test disproves evolution. Ultimately, doctors should inform patients of the science and help them decide whether sequencing currently offers any benefits for them and how they should procede when they get the results. Some genetics is relatively straightforward–one deletion in a gene means one specific problem–but most is unbelievably complicated.
I heard the govt is keeping DNA from all newborns in some kind of database- anyone know if this is true or not?
Are govt agencies testing our babies DNA? how can we know what they are doing with it? making clones? using it to identify criminals?
if so it is just creepy that we cannot test our own body material but they can
About the variation in DNA testing results from the two laboratories, what would help, and would keep nanny government out of the picture, is an industry standards organization like ASTM (American Society of Testing Materials). It may even be possible to find a niche in that organization to form a joint industry group which could work out standards.
Good job illuminating this particularly egregious example of government paternalism. The government is the only organization that would have the gall to try and tell us what information we can or cannot have. This moves into the realm of ridiculous when it is information concerning ourselves and our bodies.
Thanks for bringing this information to light in a clear and concise way. Good work.
I have only one thing to say to the federal government and I wish to God they would listen “LEAVE. ME. ALONE!”
How long are we going to tolerate all this nanny statism? The government is infested with people who presume themselves to be our betters. They want to regulate salt, sugar, fast food, soda, and God knows what else. NONE of this is Constitutional. The federal government simply does not have the authority to tell us what we can and cannot do. When will it stop?
First they came for your sale, then they came for your sugar, then they came for you.
You may ignore the actions of the federal government because you, for now, aren’t impacted. But if you don’t stand up for the rights of your neighbors will they stand up for you?
Aaron, there’s no reason that some bureaucrats have to be the ones doing the testing. If you are concerned that the results you receive may be phony and want someone to verify that the testing is legit, then there is no reason why you shouldn’t demand a verification before buying the product. Many private companies have their products certified by an external agency, and such a verification adds value to the product. If the tests aren’t verified by an agency you trust, then just don’t buy the test. No one if forcing anyone to buy DNA testing.
Even if the results ‘DNA-Xperts’ were completely phony, you’d be no worse off following a recommendation to get more frequent tests for XXX in the short time it took before the news hit that the tests provided by DNA-Xperts were faked. Just don’t do anything drastic based on one test. In medicine it’s always a good idea to get a second opinion. That’s especially true if the test is an over-the-counter test, whether for DNA, or for pregnancy. Do we really need the FDA to quadruple the cost of a pre-screen type test?
Absolute tripe. People will base life decisions on all sorts of information. Is the FDA going to outlaw palmistry next?
Wow – thanks for the well researched article on this topic. Based on previous government actions I would guess that it will now be many years before I can go to Walgreens to check my DNA indicators. But at least now I know why the promise of DNA testing may be a while in coming.
It appears DNA is not the most unique genetic fingerpring web possess
Your identity in your poo
Many of you seem to be grossly misinformed about the landscape of genetic testing and the potential dangers to you as a consumer should these tests go unregulated. No one is stopping you from knowing what is in your DNA. Full genome testing will be a commercial reality in less than three years time. One major issue is in the interpretation of the data and what lies/truths these companies will tell you. For example, with many diseases/disorders with genetic causes, there isn’t always a guarantee that you will develop a disease/disorder should you have a specific mutation. This is referred to as the “penetrance” of a mutation. Large studies following individuals for many years are required to fully understand the penetrance of a mutation. Yet, companies will tell you with confidence that you have “X percent” chance of developing a specific disease/disorder. Who verifies this information? The problem of interpretation is further confounded by the fact that there are literally dozens of different ways of sequencing your genome — some of which are more prone to false positives or negatives. Therefore, should a test tell you that you have some life-threatening mutation, wouldn’t you want someone to verify that information? This is exactly the problem. False negatives and positives are extremely common. You need rigid laboratory standards and controls to ensure that the genetic test is in fact correct. Company A could tell you that you’ll develop breast cancer in 10 years because you have mutation X while Company B will tell you that you have no breast cancer risk factors. Once again, I ask you, who will verify this information?
Please stop trying to politicize extremely complicated issues without first understanding what you’re talking about.
to MR B i have done my work i am on the lrst q