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  • #31
    Originally posted by Richard Finney View Post
    Does a customer need a relatively sophisticated understanding of the internal combustion engine to buy a car? Of the odds that he will die in crash? No.
    The reason is the same as why you can't get all medications over the counter. I assume you were being facetious in not recognising your false analogy.

    Does the purchaser of any good or service require sophisticated knowledge of costs and benefits?
    Yes, see most medical products.

    Can't someone who has the BRCA1 mutation decide "well, I need to start mammograms at age 30", or if they don't "well, I'll wait until later in life"?
    You're assuming that the mutation is actually there. It's expected that there is [BOLD]at least[/BOLD] 1 medically meaningful false positive per run (Lior Pachter ran the numbers on his blog). Do you expect the average consumer to weigh that when seeing all of the findings?

    Breast cancer is at least easy to subsequently screen for (though mammograms aren't without risk, see the recent reasons for the changes in screening), for many other clinically relevant changes this may not be the case. What do we expect people to do when told (possibly incorrectly!) that they're at increased risk for Alzheimer's or Parkinson's? There's no screen for those and the increased risk due to a random SNP is actually going to be quite small. Those will combine to yield some unfortunate results...

    More information is good. People taking personal charge of their health is a good thing.
    While the latter is good, the former isn't always. If we invented a machine that could non-invasively screen every cell in the prostate for cancer we would have maximized the amount of available information available to the patient. We would also find that likely every adult male has prostate cancer, regardless of the fact that this would only become clinically relevant in a small percentage of cases. Information simply for information's sake isn't always good.

    Even if there's strong evidence that knowledge is bad, is it right to outlaw it?
    Nothing is outlawed, it just has to be done correctly.

    Comment


    • #32
      Some fair points.

      23&me remains liable for any fault in their product.

      Market forces might better arbitrate quality of genetic testing than FDA mandate.

      There's little evidence that costs outweigh the benefits at this point. Government intervention and regulation is premature in this case.
      If people were harming themselves based on this information, they might have a case. Regardless, it's information, not a drug. Government trying to control information flow usually doesn't work out too well.

      I'm not sure the general practitioner who got is M.D. in the 1980s, ( i.e., the guy who's going to deal with the questions when the consumer seek counsel), is going to have total grasp of "bonferoni adjusted chi-squared" whatever.

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      • #33
        Originally posted by Richard Finney View Post
        Some fair points.

        23&me remains liable for any fault in their product.

        Market forces might better arbitrate quality of genetic testing than FDA mandate.
        Rational market theory only holds when the market is rational, which I seriously doubt would be the case here :P

        There's little evidence that costs outweigh the benefits at this point. Government intervention and regulation is premature in this case.
        If people were harming themselves based on this information, they might have a case.
        It's partly the FDA's job to avoid harm, not just attend to it after the fact. Also, part of the point of the FDA's complaint was that 23&Me hasn't done enough to demonstrate an actual gain. Granted, much of that is just providing the consumer with the results in a digestible (yet not misleading!) fashion, but there also seems to be more (at least from reading a few different blogs/articles that seem to have a broader knowledge of the reasons than those simply presented in the warning letter).

        Regardless, it's information, not a drug. Government trying to control information flow usually doesn't work out too well.
        It's a diagnostic test, not just harmless information.

        I'm not sure the general practitioner who got is M.D. in the 1980s, ( i.e., the guy who's going to deal with the questions when the consumer seek counsel), is going to have total grasp of "bonferoni adjusted chi-squared" whatever.
        No disagreement there. There would need to be a clinical geneticist involved in the process (see also the analogous discussion over on Biostars).

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        • #34
          Obviously we're going to disagree on this issue.

          I think the consumer is rational. Government intervention, in this case, is "protecting" somebody. But it's probably not the consumer.

          Comment


          • #35
            Why do 23andme also pulled their non-medical traits tests? Are those under FDA jurisdiction?

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            • #36
              It'll be much easier to pull everything from the backend than to selectively remove specific traits. Maybe sometime in the future they'll have a discussion with the FDA about what traits can be added in, modify the display algorithm, and slowly increase the visible traits.

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              • #37
                I recently had a physical with a round of blood/urine tests. All the data were stored on a secure web site I could access and browse with some guides as to what the numbers meant. If my doctor could put results of genetic tests there as well that would be good. I also wouldn't have a problem with going to a minute clinic type facility at a pharmacy to have the tests performed, why do the genetics tests need to be anymore accessible? I don't really see how requiring that the tests work, prevents me from interpreting the results. Furthermore, when it comes to genetic tests as a consumer, I am willing to tolerate zero wiggle room on the business diagnostics end. After all my health is about me not their business model. The concept that people want to allow Joe Random Plumber's market forces to regulate the genetics field is a little disconcerting, we've seem how well that works take insurance for example. A test with little regulation, would do nothing but mandate future confirmation tests. Why not, get the test right in the first place?

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                • #38
                  Originally posted by rskr View Post
                  Why not, get the test right in the first place?
                  This can cause the prices to go sky high. Think about the $100K per year cancer targeted therapy drug that you can have at $1K if it were Indian generics.

                  It will also postpone the development of the test if every step needs to be FDA-approved. As we all know, MiSeq V2 just become the first NGS
                  machine to be FDA approved.

                  Having said that, diagnostic tests are in general much more lax in regulation compare to medicine. The key is to get a physician involved to turn it into an LDT. But 23andme still thinks that's too much trouble.

                  Comment


                  • #39
                    Originally posted by ymc View Post
                    This can cause the prices to go sky high. Think about the $100K per year cancer targeted therapy drug that you can have at $1K if it were Indian generics.

                    It will also postpone the development of the test if every step needs to be FDA-approved. As we all know, MiSeq V2 just become the first NGS
                    machine to be FDA approved.

                    Having said that, diagnostic tests are in general much more lax in regulation compare to medicine. The key is to get a physician involved to turn it into an LDT. But 23andme still thinks that's too much trouble.
                    I don't see how administering more less effective tests would improve the cost. Since, a certain amount of money would be wasted on the test which wasn't provably conclusive. I wouldn't want to see a situation where the bad tests drive the good out.

                    Comment


                    • #40
                      When you shift from single (or targeted) tests to whole genome, you're moving from a targeted model system to a probabilistic association. It's not possible to measure and account for every single interaction that happens across the genome, but it is quite possible to use genomic association tests to filter out obviously bad candidates (i.e. screening tests). I wouldn't want to use genome-wide tests for proof, but a single genome-wide analysis will be much cheaper for screening than targeted systematic tests for every disease under the sun.

                      Comment


                      • #41
                        From 23andme's blog, I learned that they recently switched from V3 chip to V4 chip and the SNP count will reduce from 967K to 602K. I suppose that helps them to lower the cost significantly with the expense of some accuracy and application of some future GWASes (which they probably care less now).

                        Comment


                        • #42
                          Good article on the public's misunderstanding of genetic testing:

                          By Katherine Borges Director, International Society of Genetic Genealogy You'd have to be living in a cave to not know about the media...


                          - Genohub

                          Comment


                          • #43
                            Originally posted by Genohub View Post
                            Good article on the public's misunderstanding of genetic testing:

                            By Katherine Borges Director, International Society of Genetic Genealogy You'd have to be living in a cave to not know about the media...


                            - Genohub
                            I kept reading, but I didn't see any content in it. Other, than the article was attempting to correct some people about I'm not quite sure what, and shun the media for thinking that 23andMe was selling their data when they were only innocently selling aggregate data, and that the iTunes consent form protected this upright practice, and to maintain that selling aggregate genetic data was not in fact creepy, just like selling de-identified aggregate online iTunes tracking data to marketers is not also kind of creepy.

                            Here is an interesting article, that discusses the just not a little creepy angle.

                            We should be glad the FDA put a temporary stop to its marketing but we need a far broader public debate on how to ensure that consumers don't give up valuable personal data in general without being fully informed of its value and creating the option for consumers to opt out of data sharing and aggregation all together.


                            Something I am now wondering about, since they are able to still provide ancestry services, are they able to sell aggregate medical data, as long as they aren't providing a medical service? Something smells fishy.
                            Last edited by rskr; 01-01-2014, 06:26 AM.

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