Slashdot Mirror


Genetic Testing Coming To a Drugstore Near You

Hugh Pickens writes "The Chicago Sun-Times reports that Walgreens is slated to begin selling genetic-testing kits priced from $20 to $30 apiece that can tell people whether they're likely to get breast cancer, Alzheimer's disease, become obese, or suffer from a range of other maladies. However, to get the results of various tests, shoppers will have to fork over an additional $79 for drug-response results, $179 for 'pre-pregnancy planning' results, $179 for health condition results, or $249 for a combination of the three. Pathway Genomics and other companies already offer such tests online, but Walgreens will be the first brick-and-mortar retailer to sell them. FDA spokeswoman Karen Riley says Pathway overstepped its bounds when it announced its plans to market the tests directly to the consumer at 6,000 of Walgreen's 7,500 stores and wants Pathway Genomics to submit data showing that its tests give accurate results. 'The claims have limitations based on existing science,' says Riley, 'and consumers should not be making important medical and lifestyle decisions based on these tests without first consulting a health-care professional.' Walgreen responded that FDA clearance is not required to sell the kit in its stores; and anyway, the drugstore chain already sells other diagnostic and testing products such as pregnancy tests, paternity tests, and drug tests."

19 of 110 comments (clear)

  1. Pathway Genomics Agreement by eldavojohn · · Score: 5, Informative
    Here's some required reading if you are contemplating this. Most importantly:

    5. Services Limitations. The Services provided by Pathway Genomics are solely for research and educational purposes and uses. Although based on scientific research, the Services, including all information about genetic findings and probabilities, have not been fully validated and shall not be relied upon by you or any other person to diagnose, treat or prevent any disease or health condition. You should consult with a physician or other appropriate health care professional regarding the diagnosis, treatment and prevention of any disease or health condition.

    Emphasis mine. I knew that'd be in there along with point 13 (the indemnity clause). On the plus side they've got this:

    9. Proprietary Rights. You own all Genetic Information derived from your saliva or other biological material. Genetic Information means the As, Ts, Cs, and Gs at particular locations in your genome.

    If you submit or post content on the Pathway Genomics website or otherwise using the Services, (a) you retain any copyright rights that you hold in this content, and (b) you grant Pathway Genomics a nonexclusive, perpetual, irrevocable, royalty-free, worldwide license to copy, modify, translate, publicly display and distribute this content. This license grants Pathway Genomics the right to use this content to provide the Services and to provide this content to other companies and individuals affiliated with Pathway Genomics. You warrant to Pathway Genomics that you have the right, power and authority to grant this license.

    Of course we all would think that would go without saying but you never know these days and in bullet 12 they follow that up with you have permission to send them this sample. I shudder to think that someone might grab some of their significant other's saliva in order to see what their genetic tests reveal and call the whole thing off based on the fact that their offspring would have a 5% higher chance of getting breast cancer according to The Super Deluxe Cancer Finder 3000.

    --
    My work here is dung.
    1. Re:Pathway Genomics Agreement by ledow · · Score: 4, Interesting

      I think the biggest problem with your last comment is that it should be a good thing... if you are with someone "significant" who calls the whole thing off because of things like that, then you're much, much better off without them, surely? More dangerous would be something like you sending off a workmate's saliva to see if they have HIV and then using that information to force them out of a job, etc. That's the sort of casual mis-use that we *don't* need.

    2. Re:Pathway Genomics Agreement by L4t3r4lu5 · · Score: 4, Informative

      HIV can be transmitted by saliva, but the virus isn't typically concentrated there to the same degree as sexual fluids, or the bloodstream. Anecdotally (from my Biology teacher at school), it was guessed at around one litre of saliva would have to be ingested to pose a serious risk of infection.

      --
      Finally had enough. Come see us over at https://soylentnews.org/
    3. Re:Pathway Genomics Agreement by orgelspieler · · Score: 3, Insightful

      Funny that they claim you retain copyright to your genetic information, just so they can claim you've given them permission to distribute it. In order for something to be copyrighted, it has to have creative content. That means you can't keep them from publishing it based on copyright law, but you can't grant permission based on copyright law either. They're trying to use this as an end-run against privacy and non-discrimination laws (HIPAA and GINA).

      The service limitation clause is more of the same. They're pretending they're not providing a medical service, so they won't be held accountable. HIPAA privacy rules only apply to medical service providers. Very sneaky, these guys.

      It's sad to think that people were mocking congress when they passed the genetic discrimination law. Now it appears they didn't go far enough. Maybe they should have made a genetic information protection law. The Supreme Court (or was it a federal court?) recently ruled that they can't patent genes (BRCA). So maybe there's hope.

    4. Re:Pathway Genomics Agreement by gstoddart · · Score: 2, Informative

      Insurance companies, head hunting agencies, 3-letter government agencies, your employer, etc.

      In short, anyone they choose to share it with .... nonexclusive, perpetual, irrevocable, royalty-free, worldwide license to copy, modify, translate, publicly display and distribute this content is pretty much everyone.

      --
      Lost at C:>. Found at C.
  2. can't blame them by castironpigeon · · Score: 3, Insightful

    If they were going to wait for FDA approval before selling these things they'd have to wait... a year? 5 years? 10 years? And how much money would they have to sink into validation testing? I can't blame them for slapping a disclaimer on the thing and selling it as is.

    --
    mmmm...forbidden donut
  3. Re:What's the point? by fuzzyfuzzyfungus · · Score: 4, Insightful

    They gypsy certainly has better applied psych skills; but, for a great many genetic(or suspected but not yet fully elucidated) conditions, there is a way that is cheaper and more effective.

    Family history.

    With the exception of (not-nonexistent; but quite rare) conditions caused by a mutation or mutations that originated with you, not earlier in the line, or a fairly small number of well developed genetic tests, most of which you aren't going to get over the counter at CVS, you'll have a better chance of learning about the likely phenotypic consequences of your genes by looking at mommy and daddy, keeping their environment in mind(daddy's lung cancer probably doesn't count as "family history" if he was a chain-smoking asbestos miner, it probably does if he wasn't).

    DNA sequencing has, certainly, gotten cheap enough that you might actually get a fairly accurate reading of a subset of your genome for a hundred bucks through the mail. However, I'd be quite surprised if, when it comes to predicting the consequences, which are what people actually care about, the method is going to outperform just looking at family history. In a lot of cases, the science simply isn't settled, at any price. Even where it is, you are going to be getting some mail merge algorithm, not a geneticist, or even a genetic counselor, for your hundred bucks.

  4. Re:people never change by fuzzyfuzzyfungus · · Score: 3, Informative

    The question, of course, is to what degree lifestyle is influenced by genetic factors...

    Unless we are going to cling to the (intuitively satisfying; but rather silly) theory that humans have some sort of extra-material "free will" floating around in the aether, we pretty much have to concede that behavior has a biological basis. And, if something has a biological basis, the odds of it having a genetic and/or epigenetic component are pretty decent.

  5. Could be worse by Moraelin · · Score: 3, Insightful

    It could, and probably will, be worse. I can see this kind of thing used by companies when they're supposedly testing for drugs, and it'll just so happen that down the line there'll be some "restructuring" in which everyone who is slightly more probable to need sick days down the line is silently let go. And God have mercy on you if someone does a statistic to the effect of "people with gene XYZ show a 2% higher chance of depression / drug use / paedophilia / having problems with authority / whatever."

    --
    A polar bear is a cartesian bear after a coordinate transform.
    1. Re:Could be worse by AndersOSU · · Score: 2, Informative

      There are laws against using genetic information for hiring/firing decisions and health insurance purposes.

      Laws aren't perfect, so it's conceivable and perhaps even probable that a few people will be negatively impacted by insufficiently private genetic testing, but systematic abuse of this kind of information opens you up to law suits that are far more serious than slightly elevated group insurance rates.

    2. Re:Could be worse by denzacar · · Score: 2, Insightful

      There are laws against using genetic information for hiring/firing decisions and health insurance purposes.

      You don't fire someone because he/she is likely to get sick, is homosexual or a lower race.
      You find something else to fire them for. See this instructional video.

      --
      Mit der Dummheit kämpfen Götter selbst vergebens
    3. Re:Could be worse by Idiomatick · · Score: 2, Informative

      "The anti-discrimination authorities may get interested, if your old barber was Black, but the new one is White... "

      I've been able to tell the difference between black and white folks without genetic testing for my whole life. But if I switched from a black barber to a white one I really doubt that the authorities would care.

      I find it fascinating that the dsytopic future you warn against has already been proven not to pass. I'm sure you could have thought of some form of government control that actually happens. Sheesh.

  6. Re:The FDA is the one overstepping its bounds by vlm · · Score: 4, Insightful

    This is just a diagnostics test. It won't kill anyone.

    Hopefully you'll never be in the market for a blood sugar test kit.

    --
    "Science flies us to the moon. Religion flies us into buildings." - Victor Stenger
  7. HIV is Not a Genetically Inherited Disease! by eldavojohn · · Score: 4, Insightful

    More dangerous would be something like you sending off a workmate's saliva to see if they have HIV and then using that information to force them out of a job, etc. That's the sort of casual mis-use that we *don't* need.

    Why would you use a genetics test to test for HIV? While you can now test for HIV with saliva, Pathway Genomics does not check for HIV as it's not a genetically inherited disease. It can be passed from mother to offspring prior to or during birth but it's not inherit to the genetic material. These tests at Walgreens are not to check for HIV or AIDS.

    if you are with someone "significant" who calls the whole thing off because of things like that, then you're much, much better off without them, surely?

    Depends, relationships are all about compromise. You meet the perfect someone but they're a hypochondriac when it comes to cancer. Oh well, you can work past that until they get their hands on this test and demand you take it or, like I said, send in your sample without your consent. No one's perfect. Someone worrying now about their offspring's future is not a bad thing. The bad thing is proceeding without consent. Your fears, however, make absolutely no sense.

    Someone with a genetically inherited disease working next to you does not pose a risk unless you plan on them becoming your father or mother.

    --
    My work here is dung.
  8. This is BS Voodoo by quixote9 · · Score: 4, Informative

    Scientists don't know yet which genes in which combinations cause Alzheimers or heart disease or cancer. (Trust me. This type of thing was my job.) All scientists know at this point is a few genes which are associated with chronic diseases.

    You'd have a better chance of a true prediction of your fate using astrology. We don't know enough to make a yes/no test for those diseases. We do know enough to make a yes/no test for pregnancy or drugs. (Actually, not always on the latter. Don't eat any poppy seed buns the day before.)

    The difference between a drugstore test and a doctor's is that there is some chance the doctor will be aware of the complexity, of what the testing cannot do, and of how much it really means for your future.

    The drugstore test is just a way to take your money.

  9. Re:More harm than good... by interkin3tic · · Score: 2, Insightful

    "So many things wrong with this" and you could only come up with three?

    I don't know the specifics of this test, but genetic analysis is generally done multiple times, since it's not like DNA is limited in quantity. This lowers the error rate and mitigates both of your points. If the first run of the test indicates you have a marker for a disease, and you don't actually, you'd expect that the next run will disagree with that, and then next one too.

    While chances aren't zero that a false positive would make it through multiple rounds, they do decrease, and the odds of that are easy enough to figure out. Out of self-interest, the company is going to make sure that is a low figure. False positives will also likely be discovered in followup if the disease is bad enough in some cases. If I were to get news that I had a marker for a bad disease, the first thing I would do would probably be get independent confirmation, not immediately jump into expensive preventative care.

  10. Here's the catch by nbauman · · Score: 3, Informative

    there is a way that is cheaper and more effective.

    Family history.

    With the exception of (not-nonexistent; but quite rare) conditions caused by a mutation or mutations that originated with you, not earlier in the line, or a fairly small number of well developed genetic tests, most of which you aren't going to get over the counter at CVS, you'll have a better chance of learning about the likely phenotypic consequences of your genes by looking at mommy and daddy

    You are correct.

    I just went through a stack of articles on this so let me see if I got it right.

    There are two kinds of genetic diseases.

    First there are the extremely rare diseases which are caused by a single mutation, like Gaucher disease. If it was in your family, you'd almost certainly know it, or you'd at least know that you have a problem in your family, because you would have had relatives who had it. Like most of the rare diseases on that list http://www.pathway.com/more_info/full_list_of_conditions (all of which you can look up in Wikipedia) it's a pretty dramatic disease.

    One of them in the news lately was Charcot-Marie-Tooth disease, which is worth looking up http://www.nytimes.com/2010/03/11/health/research/11gene.html http://en.wikipedia.org/wiki/Charcot-Marie-Tooth_disease just because it's so interesting.

    Second there are the more common diseases like breast cancer, colorectal cancer, coronary artery disease, diabetes, etc., which most of us will die from.

    There are a few single-gene mutations that will usually result in cancer, like the BRCA1 or BRCA2 gene for breast cancer, which occur in about 1 or 2% of the population.

    But most of the other genes that are associated with those diseases only confer an additional 1% (or less) risk of the disease. That's the big frustration in genetic medicine. The doctor tells you, "You've got a genetic variation that, other things being equal, gives you a 1% increased risk of getting diabetes." How is that information going to change your life in any way?

    Scientists think they're doing pretty well if they discover a gene that increases the risk of a common disease by 10%. Now 10% is the *relative* risk. If 5% of the population gets a particular disease, that gene will increase the risk to 5.5%, which is not much greater. So you've found out that you have an increase in the *absolute* risk of 0.5% from that one gene. (But you don't know anything about the dozens of genes affecting that disease that they haven't discovered yet.)

    One of the problems with BRCA1 and BRCA2 is that those genes were patented by Myriad Genetics, which was charging $3,000 or more to test for that one gene. Many of the most important genes were patented, and one of the disadvantages of that was that it made it impossible to put together a cheap screen of all the common disease-associated mutations. Myriad just lost a patent lawsuit, and if that decision is upheld, we will be able to get genetic screens with every important known mutation. http://www.aclu.org/free-speech/brca-genes-and-patents But I can't tell from Pathway's web site whether they include BRCA1 and BRCA2 screening in their test.

    Another problem is that mutations are caused by a defect in DNA. There are lots of defects. The Pathway test may be testing for one breast cancer mutation, while you have a different mutation somewhere else along the DNA strand that gives a protein with a different but equally damaging defect.

    Now that I look at it again, I see that they don't include Charcot-Marie-Tooth disease in their genetic screen. http://www.pathway.com/more_info/full_list_of_conditions (Maybe that's

  11. Umm, yes by Moraelin · · Score: 3, Interesting

    Union-lovers, would you accept your nanny's refusal to stay an extra 10 minutes, when your train is late, because union's rules forbid her from "overworking"?

    Once you accept that she too is a human being, has a family, etc, and isn't there just as some accessory to your wellbeing -- a notion that sadly some nerds seem to have trouble understanding -- then, yes, it makes sense to worry about her work conditions too. Negotiate first. And I'm sure that if it happened once that you need her to stay some more, and it really is 10 minutes, you can agree to some compromise. If you need her to do several hours of overtime every day, now that's where I damn hope that the union has something to say.

    Besides, I'm in a country where unions are everywhere (Germany) and contrary to the libertarian BS I hear from over the ocean, it didn't result in either bankruptcy or slavery yet. It also turns out that the unions aren't this evil thing hell-bent on causing disruption and preventing work getting done. Most of those people still want to work, it turns out. They don't want to be shafted, but that's a whole different issue.

    More to the point, I'm not aware of any major union over here which flat out prohibits overtime and demans you exit the door on the exact minute. They might however ask for overtime pay. Especially if it happens regularly, and we're talking a lot more than 10 minutes.

    But, again, once you realize that that nanny is a human being too, it might not be that hard to accept.

    Do you want to have to explain, why you switched your pizza-shop -- if the dumped establishment was owned by someone with cancer, you may be in trouble... Would you be willing to have to justify going to a new barber-shop? The anti-discrimination authorities may get interested, if your old barber was Black, but the new one is White...

    First of all, it's a non-sequitur, since I was talking about genetic testing. If you need genetic testing to realize that your barber is black, you have bigger problems :p

    Second, even as one of those "but the employer has to discriminate because the customers might" excuses, it's a dumb one in this case. If you need a genetic test to determine something about an employee, then rest assured that the customers don't know that. If there was some big "I'm at risk of alzheimer's" sign on the guy's forehead to supposedly warn the customers off, you wouldn't need genetic testing to determine that in the first place.

    Third, I'm not aware of anyone anywhere who was actually sued for switching a pizza shop or barber. Care to point out any actual cases? Or is it one of those BS over-the-top slippery-slope scenarios that some people seem to need to make their case for why shafting others should be ok?

    Fourth, if you'd actually switch a shop because that barber has cancer (it's not contagious, you know?) or because genetic testing has found he's at slightly higher risk of Alzheimer's (ditto, you're not bacteria, you can't just absorb his deffective genes), then you're simply put a complete idiot. Genetic diseases are always non-contagious. It doesn't care if that guy shaved your beard, or handled the dough in your pizza, or even is your lover, you can't become infected with his genes or anything. We may not send the anti-discrimination authorities after you, but don't expect much support or respect there.

    --
    A polar bear is a cartesian bear after a coordinate transform.
  12. More BS? by Moraelin · · Score: 2, Insightful

    If she (or her union) claim, she has to leave anyway, or even simply charge me "overtime" (150%, one hour minimum), I'll start looking for a new nanny immediately. And so will you.

    I'm not aware of any place which rounds upwards to the nearest hour, much less it being a uniform thing for unions generally. So I take it it's another of those BS extra assumptions needed to make the case for why unions are bad. Got any more around?

    At any rate, I think it was libertarians who were into everything being solved by contract not by regulation. Surely you can inquire first hand if that fee is rounded up to integer hours or not, before hiring her.

    But most importantly basically, she has to do unpaid overtime? If you demand extra work from her, she has to make the loss, but god forbid that it costs _you_ anything? WTF? Seriously. You preach at me that we're all employees and employers, but... what, you are more equal than her there?

    Anyway, I'm pretty sure I wouldn't start looking for a new one.

    Why I actually switch a shop is irrelevant! But, if there anything about my old barber, that's "protected", a reasonably zealous anti-discrimination officer may (nay, must!) get interested anyway -- and I'd hate to live in a country, where I'd have to explain all of my, supposedly, free decisions.

    "Hello. We've noticed, that over the past 12 months you've ordered pizza 5 times more often than General Tsao's chicken. We suspect, you are a White bigot discriminating against Asians. Please, hand over all of your purchase-records for a closer audit."

    Let's keep it simple this time: are you aware of such a situation where anyone anywhere was sued for changing their pizzeria, or ordering more Italian than Chinese? Or do you think that repeating the same falsehood three times somehow makes it true, like in Lewis Carroll's The Hunting Of The Snark?

    IOW, if your support for discrimination hinges on such false scenarios -- as it usually tends to -- colour me unimpressed.

    You can shove your "support and respect" where the Sun does not shine, but your promise, that you may not send the authorities after me is insufficient. Because tomorrow you "may" change your mind...

    Aaand there's the third time.

    --
    A polar bear is a cartesian bear after a coordinate transform.