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California Cracks Down On Genetic Testing 165

Posted by kdawson
from the first-salvo-in-a-long-campaign dept.
genie-out-of-the-bottle writes "California's Department of Public Health has sent cease-and-desist notices to 13 companies that market genetic testing directly to consumers. (We discussed these services when they launched.) Allegedly, under state law, California residents must submit a doctor's order to have a genetic test run. It will be interesting to see if the government will actually succeed in putting the genetic genie back in the bottle, given that all you need for testing is a few drops of saliva. The effort closely resembles US government attempts to block export of strong encryption product back in '90s." A Wired editor has up an opinion piece arguing that his DNA is his business and none of the government's.
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California Cracks Down On Genetic Testing

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  • by Reverend528 (585549) * on Tuesday June 17, 2008 @04:47PM (#23829791) Homepage

    Regulation should protect me from bodily harm and injury, not from information that's mine to begin with.

    Sorry Tom, but the information isn't yours. Much of "your" DNA is patented. If you don't intend to pay the licensing fees, then you should expect to receive a C&D shortly.

    • Re: (Score:2, Insightful)

      by thedak (833551)
      Is that not more the duty of the company offering such a service and not ours? If they're willing to pony up the licensing fees to offer such a service to us, and the consumer is willing to pay prices in line with that then how is it the government's business. It's just a perpetuation of the nanny state if you ask me.

      -- note: no I'm not interested in said service, no I don't really think it's that great of an idea, or feel any desire to use it. But it's still an issue of freedom.
      • by stranger_to_himself (1132241) on Tuesday June 17, 2008 @06:01PM (#23831137) Journal

        A lot of commercial genetic testing is scientifically worthless, even harmful if they give you bad information about what your genetics actually means for you or your children. There needs to be some kind of regulation (regarding claims they can make, information supplied to customers, actual evidence for the disease-test relationship they claim etc), but at the moment the public health people can't agree on what form that regulation should take, so there might be a lot of this 21st century snake-oil around for a long time.

        I don't know anything about California, but it could be that the government is trying to protect people from possible harms of bad and unnecessary testing.

        • I don't know anything about Democrats, but it could be that the government is trying to protect people from themselves and other Democrats.
          There, fixed that for you.
        • by mveloso (325617)
          "A lot of commercial genetic testing is scientifically worthless, even harmful if they give you bad information about what your genetics actually means for you or your children"

          Do you have any actual data that backs this up?
          • by stranger_to_himself (1132241) on Tuesday June 17, 2008 @07:34PM (#23832293) Journal

            Do you have any actual data that backs this up?

            The US Government Accountability Office compiled a report of genetic testing that is available here [gao.gov], although it's only a smallish snapshot of the current situation.

            Both the positive and negative implications for widespread genetic testing are favourite subjects of Ron Zimmern and Muin Khoury, and if you're interested you'll find a lot of discussion of genetic test regulation by searching for them. There's a newspaper report of a study by Khoury here [guardian.co.uk], but annoyingly I can't find the original work.

            • Re: (Score:3, Informative)

              by mveloso (325617)
              Interesting study!

              "To complete our work, we investigated a nonrepresentative selection of four Web sites selling nutrigenetic tests.

              What's amusing is that they only had two DNA samples, from a 9-month old girl and a 48-year old man...but they submitted them 16 times to four separate sites with different profile information.

              The short of it is: the four sites in question seem to base their results off of your profile questions, not your DNA. In addition, they attempt to cross-sell supplements to you.

              I wish th
              • by Boogaroo (604901)

                What's amusing is that they only had two DNA samples, from a 9-month old girl and a 48-year old man...but they submitted them 16 times to four separate sites with different profile information.

                The short of it is: the four sites in question seem to base their results off of your profile questions, not your DNA. In addition, they attempt to cross-sell supplements to you.

                Your DNA is only part of your risk factors for diseases. It will vary over time and change with your behavior and environment as well. I don'

        • by RDW (41497) on Tuesday June 17, 2008 @08:00PM (#23832613)
          'I don't know anything about California, but it could be that the government is trying to protect people from possible harms of bad and unnecessary testing.'

          The interesting thing is that this technology is evolving so rapidly that the type of testing California is cracking down on is going to look quaintly prehistoric in just a few years. Roche is expected to launch a commercial high resolution version of its 'sequence capture' platform in the next few months which, combined with a 'next generation' sequencing system (like Roche's own 454 machine), should allow complete human 'exomes' (all the well-defined mature gene transcript sequences in a sample) to be completely sequenced for a few thousand dollars. But this, of course, is just the first step. One or more of the future sequencing technologies currently in development is likely to bring entire human genome sequences into this price range:

          http://genomics.xprize.org/ [xprize.org]

          with the eventual Holy Grail of a '$1000 genome' now seeming pretty much inevitable. But some of the teams competing for the genomics X-prize don't intend to stop there - e.g., Reveo claims to be aiming to produce a practical nanotechnology-based instrument 'in 5-10 years that will cost less than $1000 and sequence the whole genome and simultaneously the epigenome (methylation code) nearly error free in a minute for pennies per genome.'

          So what happens if it's possible to buy an extreme throughput sequencer for the price of a laptop, and decode a genome as effortlessly as cracking CSS on a DVD? Is this particular genie really likely to stay in the bottle? And is it in any case defensible that knowledge of an individual's genome should ('for his own good') remain the province of an exclusive medical priesthood, rather than of the individual himself?
          • Is this particular genie really likely to stay in the bottle? And is it in any case defensible that knowledge of an individual's genome should ('for his own good') remain the province of an exclusive medical priesthood, rather than of the individual himself?

            I don't know. It's a difficult question but as you rightly say one we'll have to deal with. But think about it like this: At the moment you could very easily get a complete blood test similar to what is routinely done for hospital admissions. They'll test maybe sodium, potassium, blood sugar, possibly white blood cell counts, and other stuff that I can't remember. Then add BMI, blood pressure, and heel ultrasound. These tests are all available now, are cheap, and will tell you far more about your

          • by Tanktalus (794810)
            The holy grail here isn't the testing of the genome. It's the *interpretation* of it. Personally, I wouldn't want anyone other than a qualified medical professional (i.e. MD, preferably specialised in the study of the genome) to try to tell me what it means. Anything else is no different than going to your local psychic to get your palms read.
            • by torkus (1133985)
              I hate to get involved in the comparison game...but well i'm going to do it anyway.

              I wouldn't compare it to a local psychic. I would however, agree that getting raw data and trying to interpret it yourself (or a non-trained person) is akin to trying to diagnose disease via medical textbooks. 'Hmm, the rash kind of looks like 1a and 5c but 5c is cause by AIDS - OH NOES /wrists'.

              It's why the lab tech generally will never "read" your MRI/CAT/XRAY even when it's stupidly obvious and he's 3 months from getting
              • I can see someone fighting this on the grouns that your DNA is to be considered medical records and you are entitled to them with no exceptions.

                I don't object to people knowing their genotypes. I only object to your genotype being sent to you by The Internet Genotype Company along with half truths and lies about the implications and guidelines for the $2000 per year 'supplements' that you need to buy from them to prevent your untimely death.

        • by robertjw (728654)

          I don't know anything about California, but it could be that the government is trying to protect people from possible harms of bad and unnecessary testing.

          Bad testing I can agree with, and the proper way to go about this would be to prosecute the testers for fraud.

          There is not really any such thing as unnecessary testing. If a company can conduct a test, and the results are accurate and as promised to the customer, how can that be construed as unnecessary? The only time I've every seen the concept of "unnecessary testing" come into play is when medical treatment is limited by cost, due to involvement by insurance companies and inflated medical costs. N

        • by torkus (1133985)
          Protect me from the harm of testing that requires some saliva. That doesn't seem too invasive.

          OHHHHHH you mean from what their 'conclusions' are. (sarcasm) well if the company doing the testing sells the data as verified accurate then they're accountable. If they sell the data as 'entertainment purposes' or similar then people need to use their brains and understand that. Hell, if you believed everything on the news you'd be afraid to breathe because it might kill you (News at '11, Tune in and Don't Miss
    • by MiniMike (234881) on Tuesday June 17, 2008 @04:52PM (#23829911)
      I bet they'll want the first instance of derivative works too...
    • by oodaloop (1229816) on Tuesday June 17, 2008 @04:54PM (#23829927)
      Patenting DNA was a problem maybe 10 or so years ago, but since then much of the patents and patentable information on DNA has been collected in open repositories of information. Drug companies have found it much more lucrative to open up this information and share it with other companies rather than keep it to themselves - shouldn't be too surprising to open-source enthusiasts. Instead, they have been concentrating on deriving income further downstream from the drugs produced from the DNA data. Right now, most of your DNA is open-source.
      • by MightyMartian (840721) on Tuesday June 17, 2008 @05:01PM (#23830075) Journal
        The issue is that these companies did not create the DNA. It was yet another abuse of the patent system, and the courts and the government didn't have the balls to ban it outright. If it ain't an invention, it shouldn't be patentable.
        • by lgw (121541)
          I say let companies patent the entire genome. In 17 years we'll be free of this nonsense forever.
        • by WaltBusterkeys (1156557) * on Tuesday June 17, 2008 @06:17PM (#23831315)
          It's a pretty common misperception that somehow humans would have to pay license fees for use of DNA.

          What was being patented was a purified sequence of DNA for use in a diagnostic test. It's not the DNA itself--there's 10 million years of prior art for that--but the use of a particular sequence of DNA for diagnostics.

          The total human genome is over 3 billion base pairs. Companies were racing to figure out which small sequences (100 or so pairs) would be useful in diagnostics and possibly in therapy. The use of DNA for that purpose was completely new at the time.

          For example, check out this DNA patent application [uspto.gov]. The application refers to a specific DNA sequence, but the patent itself is for the use of that particular sequence for a specific kind of therapy.

          It's still perfectly legal to reproduce, sell your DNA in a bottle, and so forth. The only thing the patent covers is the use of one very short sequence in a particular kind of therapy.

          It might still be bad policy, but it's not as if you don't own your DNA.
          • Did the companies have anything to do with the creation of those sequences? If they didn't, they should have been fined for fraudulent patent applications.
            • They never claimed they created the sequences.

              They claimed that they found a new procedure using them. If I were the first person to invent the Chevy El Camino ("it's a car and it's a truck") I would be able to patent the invention of a car/truck combination, even if I didn't invent wheels, headlights, doors, windshields, etc.

              The only thing the patent covered was a new diagnostic test. They invented the never-before-seen diagnostic test by combining existing elements. Combining existing things is a perfe
            • Re: (Score:3, Informative)

              I don't think you understand what patents are and how they work.

              There are 3 types of patents:

              Utility Patent - protects the way that your "invention" is used and works. Your "invention" does not have to be a machine or something tangible. It can be a business method or a process of doing something. For example, you can patent a method for making a pepperoni pizza so long as your method is novel. You did not have to have invented pepperoni pizza.

              Design Patent - protects the way something looks. I'm not 100% c
      • Re: (Score:2, Funny)

        by VEGETA_GT (255721)
        Wiggum: What do you got, the whole town's DNA on file?

        DNA guy: Y'uh huh. If you've ever handled a penny, the government's got
                          your DNA. Why do you think they keep 'em in circulation?
      • Right now, most of your DNA is open-source.
        I think you're right, I know this because I GPL'd some of my DNA all over my keyboard last night when I found out Valve was releasing the Pyro update Thursday.
      • "Right now, most of your DNA is open-source."
        Now, previously, and forevermore, all DNA is open-source (I fixed that for you.)
    • so now we have the GIAA Genetic Industry Association of America to worry about

      thanks dude!
      • by Gat0r30y (957941)
        Oh man, I don't even want to know how people plan to pirate my DNA.
        Unless of course instead of bit torrent they send a hot blonde
      • I thought it was the Genetic Nomological Association of America, or GNAA .... they have been causing trouble around here for a while.
    • True, the information in my genetic code is not my personal property, intellectual or otherwise. However, that does not mean that companies, individuals or governments have the right to do what they please with that information.

      If you think otherwise, try getting your hands on, and using to your advantage, the genetic information of some important or influential person. Say a CEO or a politician. How long after they discover your actions to you think you will keep your supposed rights?
    • What you said has nothing to do with reality, or my genetic code.

      I am the SUM if my genetic code, which is for all intents and purposes, unique. That the mortar and blocks and drywall and carpet are patented by someone else means nothing when I undeniably own the patent on the house.

      "If you don't intend to pay the licensing fees"

      What exactly am I going to be paying licensing fees for? Or did you throw this bit of fearmongering out there without really having any idea what it meant?
    • by GuyverDH (232921)
      You cannot patent something which exists in nature. This is the main reason that pharmaceutical companies ignore plant based drugs and go for deadly chemical cocktails that give side effects worse than the condition it treats.

      You can, however, get a copyright on a particular sequence, if it were unique, and identified a specific variation, enhancement, cure that never existed before in written form.

      There are only so many DNA sequences, which are then put together, like letters in an alphabet are used to cr
  • There have been a lot of initiatives like this that are designed to make money for doctors.
    • Re: (Score:3, Insightful)

      by MBCook (132727)

      While there are some half-decent arguments (reactionist people taking tests then making up their own "treatment" plan for their 1% chance of developing condition X), I agree this is for doctors.

      These kind of rubber stamp things (since I assume most doctors would just say "yes" to simplify their lives) just raise health care costs. By requiring this signature you take up the doctor's time and it's harder for you to compare and get things done.

      This seems like regulation for the sake of regulation to me.

      • by Robert1 (513674) on Tuesday June 17, 2008 @05:12PM (#23830347) Homepage
        Actually it won't be rubber stamped. Unless the individual has some family history of the genetic disease or symptoms which are suggestive of it genetic testing is NOT OFFERED by physicians.

        Likewise if a family member has such symptoms or his side of the family has these traits, genetic testing is disallowed unless the person actually agrees to it. I.e. a wife wants to know if her husband has Huntington's, she cannot force him to take a test or bring a sample to a physician and ask for it to be tested. Even if she only wants the information for future conception, the doctor won't allow it.

        What's to keep someone - anyone - your wife, boss, insurer, whoever, from taking that toothpick you used after lunch and sending it in to one of these companies?

        I think the law is intended to protect YOU from others, not from yourself. If you actually have some problem then you can go to a physician and have total confidence that the only person who will know the result is you and him. Hell, you can even withhold it from him if you wish. As it is now a person can send in ANYONE'S DNA and get their result.

        I'd rather go to a doctor than leave that second option as a possibility. That's the option that leads down the road to real Gattaca-style shit. It's a future I'd rather NOT live in.
        • by flyingsquid (813711) on Tuesday June 17, 2008 @05:36PM (#23830833)
          What's to keep someone - anyone - your wife, boss, insurer, whoever, from taking that toothpick you used after lunch and sending it in to one of these companies?

          Please, that will never happen. You're just being paranoid. And of course, such irrational paranoia is exactly the type of behavior I would expect, given that you have a repeating ATTCAGGGATTAG sequence on your chromosome 3, which results in a 500% increase in the risk of developing paranoid schizophrenia.

        • Re: (Score:3, Insightful)

          If you actually have some problem then you can go to a physician and have total confidence that the only person who will know the result is you and him. Hell, you can even withhold it from him if you wish.

          RRRRRight.

          With all the paperwork for insurance companies (both your health insurance and the doc's liability insurance) nobody takes your privacy seriously in the medical profession. Sure they claim to adhere to HIPPA, but that's not the same thing. True privacy would mean that:

          1) The fact that you requested a test is never recorded
          2) The sample being tested is not associated with you in any way
          3) The results of the test are not recorded with any identifiable information
          4) You can retrieve the results wit

        • by jmichaelg (148257)
          "If you actually have some problem then you can go to a physician and have total confidence that the only person who will know the result is you and him."

          I think you have it backwards. I was deficient in B12 a few years ago and suffering memory problems as a result. While my doctor and I were talking about possible causes, she was taking notes on an insurance form. She said, "If I mark 'memory problem' on this chart, it'll follow you the rest of your life." so she marked fatigue as the reason for the blood
        • by Hao Wu (652581)

          I think the law is intended to protect YOU from others, not from yourself.

          Yes.

          The "Wired" editor arguing that his DNA is only his business is a fool. Your DNA is also your parents', your kids', siblings and other relatives.

          Information wants to be free right? Well the information from your genetic test determines whether other family members are at risk, sometimes with 100% certainty.

          Not telling your daughter that she should be closely watched for breast cancer (or any treatable disease that depends o

      • Re: (Score:3, Insightful)

        by bperkins (12056)
        (since I assume most doctors would just say "yes" to simplify their lives)

        While this _would_ increase the number of office visits, it's likely that it would not generate a great deal of revenue, since it would likely be coded at the lowest level.

        I know a number of primary care physicians, and this just isn't the type of visit that they would try to encourage. Furthermore, most physicians I know (IMHO all responsible ones) would discourage unwarranted genetic testing, as well as any other type of medica
        • Re: (Score:3, Interesting)

          by cduffy (652)
          What's that about "outcome"? If you're getting an informational test done -- without the intent or expectation that it will diagnose or treat any disorder, but in the interest of getting a CD with interesting statistical information (with the explicit understanding that that interesting information isn't to be used in relationship towards diagnosis or treatment, and that the relationship between the data provided and any expected implications thereof will evolve/change over time as the science improves)...
          • by stranger_to_himself (1132241) on Tuesday June 17, 2008 @06:15PM (#23831307) Journal

            $1000 is not much money, and I'd find it interesting to have access to the data out of sheer intellectual curiosity -- and I find it offensive that anyone would find it to be their responsibility to "protect" me from doing that. What's next, "protecting" people from blowing their money on space tourism, or on visiting museums?

            It's a case of balancing the risks against the rewards. Sure you might find it interesting, but a lot of people will get tests which are often meaningless medically and which they will base lifestyle or health choices on.

            I'm not sure on which side of the argument I'm on at the moment, but I'm very nervous about the prospect of people selling tests for disease genes without any requirement for evidence of the disease-gene interaction, and for the correct information for the implications to be supplied to customers.

            Would you like to know your SORL1 genotype? What if I told you it was possibly liked to Alzheimer's disease? What if I told you it was definitely liked to young onset Alzheimer's disease, but I was lying? Would you like your wife's genotype? How would you interpret the information? I understand the intellectual curiosity and freedom points of view but this can do harm as well as good.

            • by cduffy (652)
              If the folks in question were selling very specific tests, I would agree that this would be of concern. They're not -- they're selling fairly broad partial sequencing, and bundling services which allow their customers to stay up-to-date with regard to new research related to the outcome of those tests; explicit in the offer of those services is a statement that interpretation of the results is not fully a known quantity and continues to develop.

              "Tests for disease genes" would be a problem -- but that's a st
              • "Tests for disease genes" would be a problem -- but that's a strawman here. Broad sequencing, marketed as informational, is quite a different matter.

                Are you sure? I just copied this from the Navigenics (one of the companies mentioned in TFA and the first one I bothered to check) website:

                Navigenics Health Compass helps you understand what your genes have to say about the future of your health, and gives you action steps to take control of your health today - so you can have a healthier tomorrow.

                There is also a list of specific conditions they 'test' for. The small print then points out that they don't offer medical advice, although they are certainly claiming that their product will improve your health.

            • by lovebyte (81275) *
              I have had this debate with people for a couple of years already (I work in bioinformatics). My simple opinion is that laws should be made to make it illegal to analyse other people's DNA without their consent, but it is (will be) simply impossible to stop people from having their own DNA analysed. It will in 3 to 5 years become so easy to do that you will just need to send some saliva to some company in, say, Hong Kong or Morocco and get the results in a few weeks. How can you possibly stop that from ha
            • by kmac06 (608921)
              Be aware that you are advocating ignorance (legally mandated ignorance) over knowledge, because of some insignificant chance that the knowledge can cause harm.
  • by locallyunscene (1000523) on Tuesday June 17, 2008 @04:55PM (#23829937)
    I think this has more to do with privacy than "keeping your data from you". Ask it stands now what's to stop you from sending a cheek swab with your neighbor's DNA instead of yours under a false name? If a doctor is involved at least the perpetrator must make a face to face appearance under the fake name with someone who would be "accountable" before being able to carry through with his plan.
    • by MightyMartian (840721) on Tuesday June 17, 2008 @04:57PM (#23829989) Journal

      I think this has more to do with privacy than "keeping your data from you". Ask it stands now what's to stop you from sending a cheek swab with your neighbor's DNA instead of yours under a false name? If a doctor is involved at least the perpetrator must make a face to face appearance under the fake name with someone who would be "accountable" before being able to carry through with his plan.


      Perhaps what should be banned is accepting DNA samples indirectly.
      • Re: (Score:2, Insightful)

        "Perhaps what should be banned is accepting DNA samples indirectly."

        I would hope that's all ready banned. The question is how to enforce that. I would prefer the onus of accountability to be on the DNA analyzing company rather than a doctor, so I think the law could be better in that respect.
        • I would hope that's all ready banned. The question is how to enforce that. I would prefer the onus of accountability to be on the DNA analyzing company rather than a doctor, so I think the law could be better in that respect.

          And how are we to know if a company is violating someone's rights? If someone has given them a sample under false pretenses, they have no way of actually knowing whether or not they're testing who they think they're testing. It seems to me the most logical third party to take the samp

          • by ChilyWily (162187)
            So what's to prevent a doctor from abusing this system by colluding with those who stand to benefit from unauthorized access to such information?
            • So what's to prevent a doctor from abusing this system by colluding with those who stand to benefit from unauthorized access to such information?

              Jail time, fines, the loss of his or her license.

              Perhaps if corporations and their shareholders were more directly responsible, I'd be willing to give them the benefit of the doubt, but as it stands, I'd trust a doctor a helluva lot more than corporate governance.

              Perhaps if fines for this sort of thing were in the order of 50% to 60% of gross earnings+assets, I'd s

              • by ChilyWily (162187)

                I concur on that corporate governance is, for the most part, highly unreliable towards such stuff... but in my anecdotal evidence, doctors aren't much far behind. Villains who twirl their mustaches are easy to spot. Those who clothe themselves in good deeds are well camouflaged.

                50%-60% of gross earnings + assets? LOL. But will such a severe punishment ever become reality? Lesser, more 'reasonable' penalties then open up abuse from the richest companies/doctors etc. ... to them, the penalty is just the co

            • You can't prevent people from doing bad things, you can only set up barriers and enforce punishments.
      • That's what SHE said.
    • by oodaloop (1229816)
      Yeah, maybe if your neighborino was as coop-diddly-operative as Flanders. My neighbor sure wouldn't let me swab his cheek.
    • Ask it stands now what's to stop you from sending a cheek swab with your neighbor's DNA instead of yours under a false name? If a doctor is involved at least the perpetrator must make a face to face appearance under the fake name with someone who would be "accountable" before being able to carry through with his plan.

      Also, with a doctor involved, HIPPA would apply, and all the mandatory privacy laws that accompany that. I don't know about non-medical DNA testing.

      And, IANAL, this post is not legal advice.

  • ...behind those restrictions? Do you also need a permission to measure your weight, or to look in the mirror?
    • by Actually, I do RTFA (1058596) on Tuesday June 17, 2008 @05:08PM (#23830261)

      ...behind those restrictions? Do you also need a permission to measure your weight, or to look in the mirror?

      Because it would be very easy for me to collect saliva from someone whom I know in real life, and run tests on their DNA without their knowledge or consent. Also, there is a desire to prevent coersion towards that same goal.

  • by Paranatural (661514) on Tuesday June 17, 2008 @04:59PM (#23830033)
    As I understand it, you don't actually have to be present at their offices to provide the DNA Sample.

    What kind of crap is this? So, basically, I could collect the saliva (Don't ask how) of various people I know, send it in, and have ready access to their genetic information? HIPAA should be all over this like white on rice. With no actual strong safeguards on this stuff anyone could theoretically easily gain access to your genetic profile.

    A better solution is to be able to do it freely, you actually have to show up at the lab and be able to certify you are who you say you are. Perfect? No, but better than how it was being done.
    • Re: (Score:2, Insightful)

      by 1 a bee (817783)

      A better solution is to be able to do it freely, you actually have to show up at the lab and be able to certify you are who you say you are.

      Nice proposal: the part about actually having to show up at the lab. This makes it somewhat harder to spy on other people's genetic information.

      The second part of parent's proposal, though, I think should be the exact opposite: the lab shall not require the identity of the customer. That way, only you have the power to attach a name to your genetic data.

      • I don't know that that would work very well. The thing is, genetic testing isn't quick, it takes a while. You can't exactly get the results while you wait, as I recall. So they'd need a confidential way of giving you the results. It's hard to do that without knowing who you are. Also, I believe pretty much every medical facility is required by HIPAA to keep records on everyone they 'treat'. Can't do that if they don't identify themselves.

  • by sammaverick (771437) on Tuesday June 17, 2008 @05:06PM (#23830183)
    California requires a doctor's order form for not just genetic testing. The company I work for (www.biophysicalcorp.com)(is it kosher for me the link my company here?) does direct-to-consumer blood/ biomarker testing, and for California and about 9 other states, the individual consumer can not just order the test from us, they have to have their doctor sign a order form (Which creates a hassle for us and the client).

    Heck, in a few states (Cali included) we can't even send the client their report, we have to send it to the doctor's office.

    I am pretty sure this law is in effect partially to protect the interests of the doctors in general.
  • by cortesoft (1150075) on Tuesday June 17, 2008 @05:08PM (#23830251)
    I am not usually one to jump on the anti-regulation bandwagon. I appreciate the need for restrictions on many practices, and regulatory agencies to make sure people practicing in the industry are competent and perform their jobs safely. HOWEVER, this seems like something that should be outside the realms of regulation (of this sort). There is no medicine being practiced here; there is no diagnosis, no prescription, no anything of that sort going on. They don't perform an exam, they don't even touch the customer (in fact I am pretty sure these companies don't even SEE their customers). In fact, I find it hard to even classify what they are doing as being in the medical field at all - they don't claim to diagnose or cure any disease. Given the rampant availability of 'natural' cures for things that have no regulatory body overseeing them, why is this something that needs to be regulated? Those 'natural' cures and supplements ARE saying they cure diseases(disclaimers not withstanding), with zero regulatory oversight. How is knowing my DNA sequence more dangerous to me than taking unknown, unregulated herbal supplements? The government's job shouldn't be to require someone act as a filter for my own personal information. My own personal information is not 'dangerous', and I do not need someone holding my hand while I find out about it; if we hold to this view, how is it different than saying "We need to restrict public access to this information about scientology because if people read about it without someone to interpret it for them, they might believe it to be true and that could cause them harm." I can protect myself from this dangerous information, thank you very much.
  • All things biotech are becoming like technology in general: more accessible and cheaper.

    Let's say if I have some near-future technology or perhaps today a biochemist friend or two, would the law keep me from running a genetic test on myself?

    Really, how long before a home test becomes viable? After all, one can already do this [utah.edu] at home.
    • by jd (1658)
      Well, they use lab monkeys - err, laboratory assistents with limited training in many of the genealogy DNA testing centres - it's sufficiently automated you don't really need more than that. There are also kits which allow someone who knows what they're doing to field-test DNA in a matter of hours. And finally there are kits which allow you to accurately process contaminated DNA samples (used by forensics experts and by archaeo-biologists).

      Using the ten-year rule (it takes about 10 years for technology to

      • That's damn interesting stuff you said there. Truly the restrictions are pretty dumb in light of this likelihood you illustrate.

        Also, I do wholeheartedly agree with you on the eugenics argument, and the subsequent difficulty in enforcement (perhaps some kind of affirmative action using random employee testing or something might help - but that can is of worms). This hits home as a good friend of mine is not so healthy, surprisingly unattractive and yet so brilliant and friendly...well, friendly to me at lea
  • As long as it is non-invasive, I ought to be able to decide for myself what tests I want. If you need consumer protection then that's up to the FDA to get unsafe and ineffective products off of the market. If anything. being able to self-test will get a person who otherwise wouldn't have gone to the doctor to go if something bad is detected.

    I live in CA and I do want a safety net, but not a nanny state.
    • A nitpick, perhaps, but this isn't so much _the_ Nanny State as _a_ Nanny State. I don't like this policy any more than you do, but I'm glad it's at the state level and not federal. This is the way things ought to be, and it should make it easier for Californians such as yourself to push for a change.
  • Didn't Bush just recently sign in a law that helps protect peoples' genetic rights? What was that about, if not to help with these kinds of issues? (Thought I saw this in Slashdot, but I CFTA.)
  • Duh? (Score:2, Insightful)

    by sexconker (1179573)
    I love this law.

    I don't want people testing my DNA without my consent. When you involve a doctor, you add a barrier against unscrupulous people. Presumably, a doctor will take the sample themselves before sending it off. No worries about someone finding my hair and

    Of course, it will be done anyway, just like when people cheat drug tests. And of course, there are unscrupulous doctors, too.

    The fact that the law is there is a good thing. If someone steals a sample of my DNA, has it checked, and finds out
  • by Shivetya (243324) on Tuesday June 17, 2008 @06:03PM (#23831161) Homepage Journal
    The biggest impasse in having affordable health care are the states and Federal government. From not being able to comparison shop across state borders to having individual plans loaded up with required coverages the majority of people will never need. Then top it off with favorable tax codes to companies offering health care, road blocks to using your health savings accounts at anything but name brand pharmacies, and double standards in care when comparing the quality of government run hospitals and private and the picture cannot be more clear.

    The state (sub federal government) doesn't want you self reliant. If you are then your not beholden to them or subject to their regulation. They foster an entitlement mentality and that of reliance on government by stepping in the way of any private attempt to get the job done. My own doctor refuses new patients covered by government health agencies because the paperwork and forced low fees make even the most virulent HMO look better.

    Don't worry, pretty soon besides not being able to own your own dna you won't even get to pick the doctor who does. worse, many of the people you know will happily go down that road because its one less thing they will have to be responsible for. laziness and lack of self reliance are the truest ways we lose our freedoms
  • The comparison with strong encryption has me worried. I am reminded of the tee shirt that was a "munition" because it had a perl script for string encryption printed on it.

    So does this mean if I try to cross the border with saliva on my tee-shirt they are going to arrest me? Some of us could be in trouble here.

  • I was in a child custody battle years back and my ex was making baseless accusations about my using drugs, so I went to take a drug test at a local lab-only to be told that it had to be prescribed by a doctor. I called my doctor, he phoned in the prescription, I peed in the cup and all was fine.

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