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FDA Orders 23andMe to Stop Providing Genetic Analysis.

Discussion in 'Genetic Testing and SNPs' started by wdb, Nov 25, 2013.

  1. Sea

    Sea Senior Member

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    Barb it is not the validity of the test itself that is in question. False negatives or false positives are always possible in any testing but that is not the area of concern here for the FDA.

    It is the scientific interpretation of the results ie calling a result "positive" or "negative" for a certain health condition that concerns the FDA. They question the scientific evidence and the "clinical" validity to make those judgement calls, ie does the test show what 23andme say it does? 23andme does not yet have the authority or approval to make those claims even though they are getting their information from published research.

    I think the true value of the testing lies in the raw data that we can research for ourselves and I hope access to that is not blocked
     
  2. DadgummedShango

    DadgummedShango

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    'In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.'

    - FDA Warning Letter 22 Nov 2013

    Got to say that seems reasonable. I think what's implicit in the FDA's argument concerning false positives is that with FDA et al approved diagnostic tests the probability of false positive or negative results is acceptably small, or in the case of less accurate diagnostic tests, suitability understood (as with skin prick testing), or reduced by further tests. 23&Me can't speak to that kind of data so both parties are blind as to likelihood of result accuracy.

    Further, false negatives are a similarly significant concern, as are drug response results that can't be otherwise verified and may lead to patients abandoning treatment regimens to the detriment of their health - the Warfarin example in the FDA Warning Letter conveys an effective elucidation of this issue.

    I'm a longtime follower of the home biotech movement and all for innovation that empowers patients, but agree that this falls within FDA remit and should be rregulated as such.

    Finally (and off topic, so general apologies), @Dreambirdie - have you seen the FDA inspection findings recently published for the Burzynski clinic? They're exceptionally damning. He isn't worthy of your support.
     
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  3. Ema

    Ema Senior Member

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    Science is supposed to be innovative and there will always be people who want to be at the forefront of innovation. Science is not supposed to be static. It shouldn't take an average of 17 years for research to make it into clinical practice. This is not progress. And if people demand a faster pace, it does not make them all slick and greedy by definition.

    Or we can just give up and pander to the lowest common denominator. We see how well that is working in our schools as we drop further and further in the world rankings thanks to "No Child Left Behind". We should just call it "No One Allowed to Get Ahead Because It's Not Fair To The Idiots".

    The FDA sounds like a whiny child in that letter. And they are left out, increasingly so, because they aren't worth much as a regulatory body. If anyone should be taken to task for bias and conflict of interest, it is the FDA. Can they prove that they are making us safer in any meaningful way?

    Let's start there instead.
     
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  4. barbc56

    barbc56 Senior Member

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    Ah, yes, that brings back memories. We called it "No Teacher Left Standing" .:lol:
     
  5. Sea

    Sea Senior Member

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  6. jeffrez

    jeffrez Senior Member

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    Doctors in our medical system do that every day, whether through the ignorance you mention, the lack of critical thinking skills that many of them display, or through belief in "proof" that is often funded and paid for by the pharmaceutical industry.

    Why aren't any of the other companies being told in "unusually stern" letters (or any letters at all) to stop selling their tests? Why only 23andme? Seems like the AMA lobby doesn't particularly like the idea of patients having the ability to find out information about themselves.
     
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  7. Ema

    Ema Senior Member

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    And there it is, right there:

    Because it is strange how these type of situations get resolved when the right type of political "support" is applied.
     
  8. Ema

    Ema Senior Member

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    Amen @jeffrez!

    CA-125 comes to mind...where are the warning letters to LabCorp et all?
     
  9. PhoenixBurger

    PhoenixBurger Senior Member

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    Just signed the petition. Hope everyone else here does as well.

    Maybe the original poster can put this link into the Original Post as well. @wdb

    A lot of people here rely on these test results for direction. I think only stupid people would do what the FDA is implying, with their results.

    The medical system is *reactive*. Never forget that. Doctors don't have the first clue what it means to prevent disease. They don't even believe such a concept exists. All they do is check for disease, and treat disease after it arrives. Reactionary medicine. Preventive medicine is not only imaginary, but its often scoffed at as a waste of time, and insurance dollars. They call it "unnecessary diagnostic testing" .....

    The FDA does not want people running "unnecessary diagnostic testing" because it will cost the insurance companies billions of "unnecessary" dollars. Please remember, insurance companies reward doctors for DISCOURAGING diagnostic testing. Do you really think its a coincidence that every doctor on earth "doesnt feel like" running a lot of exploratory tests? Why they always have to be so begrudgingly forced into ordering things, that you have to sit there like a tool and "convince" them to run? Its because it costs insurance industry money. Im fairly certain that is a huge factor in this FDA action. All this is going to do is skyrocket insurance company costs. Oh well. Tough luck. Maybe if a $20 test didn't cost $2,000 they wouldn't have a problem covering it...
     
    Last edited: Nov 25, 2013
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  10. ggingues

    ggingues $10 gift code at iHerb GAS343 of $40

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    I signed, no fan of big gov't!

    GG
     
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  11. alex3619

    alex3619 Senior Member

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    Medical expert systems, and robotic surgeons, were banned in many places for years. I think they might still be illegal here, though I cannot be sure.

    PubMed is used by many of us to get medical insight. Are they going to ban that too?

    A clear warning on 23andME that they are only the beginning of a process is warranted. I don't think blocking sale of testing is warranted. I think caveats, warnings and disclaimers are warranted. For all the testing, they cannot prescribe treatments. Doctors do.
     
    Last edited: Nov 26, 2013
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  12. alex3619

    alex3619 Senior Member

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    I have no problem with big government. I do have a problem with stupid government. Big government just gives more opportunities for them to be stupid.

    My biggest issue is government lying to the people, failing to get facts right, not releasing data under FOI which should have been public anyway, and so on. Without the people watching government, and with a failure of investigative journalist, all government tends to the stupid. They are not accountable if nobody can see them doing the wrong thing.
     
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  13. alex3619

    alex3619 Senior Member

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    If they stopped doctors, especially psychs, from using irrational and unproven medicine, the entire medical industry would implode.
     
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  14. Freddd

    Freddd Senior Member

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    I have a lot of opinions here for all sorts of reasons. First I strongly believe that we should have access to whatever information such as this that may affect our health as possible. However, l also would like information we can depend on. There is a suggestion that perhaps some of their procedures are not correct. Not producing required paper work gets a company off on the wrong foot. Not doing required studies for labeling gets a company off on 2 wrong feet. When the California Dept. of Corp. wanted a report, my clients were all over me for whatever was needed ASAP. There may have to be no label claims of diagnoses for instance. Wordings may have to be changed. There has to be some kinds of studies documenting what they are doing and how arrived at. The data is likely the sum of all the items a person answers to sign up and any studies they run with selected or specially recruited persons.

    First of all collecting data and doing something with it is something I have been doing since the late 70s, writing HMO and insurance claims paying, membership, antifraud, medical records, data mining and the like. Whatever labels got put on it, that is what I did. I did everything from design screens and paper forms to complex databases and complete HMO systems, claims systems, management reports, audits of many kinds and so on. I saw lots of data. So let's look at what this is about or may be about. There were some definite missing research needed to validate their model of what they are doing. I have no doubt that it at least in part involves the SNPs themselves and the correlation with all those answers each person gave while registering to put their DNA into the system. Having gone through their questionnaire process I choose not to do their program. This whole generation of data they were collecting is flawed, in certain ways to an unknown extent, for at least some uses, in my opinion. One can tell a lot by what they ask or don't ask. A major focus of mine for the past 30+ years is how to design a medical records database to maximize correctness, which for use with patient results considerations for treatment.

    I don't know what the FDA has seen or not seen. I suspect that the claims they appear to be making are not supported by the data or they haven't supplied the studies or modified studies requested by the FDA over an extended period of time. So they will prepare their answers. What concerns me more is if they are getting some of the science wrong It's important they get things correct or say that they don't know. I'm not talking about being a little plus or minus on a percentage but something really outright wrong. That is based on the answers to their questions. There are also answers based on theories of various kinds. How valuable such interpretation has or hasn't been for successful treatment is something each person who has tried it must answer for themselves.

    Now as many know, my major interest in all this is the whole B12 and folate deficiency universe including CFS, FMS, ME and all the rest. Allow, for the sake of this discussion, that I have an understanding about this specific problem that may be the fundamental foundational understanding of this whole business despite some imperfections. If I am at all correct about the variables needed to solve the MYSTERY DISEASE many of us have (b12/folate deficiency diseases minus everything satisfactorily corrected by CyCbl, HyCbl and folic acid, which leaves 90+% of symptoms in place and improves some mix of the others) they did not ask the correct questions to receive the answers needed to solve our problems.
     
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  15. Firestormm

    Firestormm Guest

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  16. Freddd

    Freddd Senior Member

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  17. Firestormm

    Firestormm Guest

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    A quick look at the website does seem to confirm this:

    There are 4 recommendation examples provided: celiac disease/glutensensitivity; considering a lower dose of warfarin; risk of passing mutations to children; increased risk of paralysis after treatment with choline ester. These are only examples presumably there are many more. You would know better than me I think given you are very aware of these results and apparently what they all mean.

    Who has determined that X result indicates celiac or gluten sensitivity, or that if on warfarin, X result indicates you should consider a lower dose; or paralysis, or a risk of passing something nasty on to children? Somebody somewhere has made these interpretations - but based on what scientific evidence? Do they actually say when provided the results what the interpretation is based on?

    Are the interpretations speculative? Is there any warning that these things should not be taken at face value, and should not lead to any change in prescription, but might be best used in consultation with a doctor?

    I also wonder what effect results are having on the health service. Are doctors now finding increasing numbers of patient arriving with their results concerned that X means something and should lead to XX treatment? Do doctors have any training in interpretation/confirmation of such genetic testing? Should they?

    I see many threads on the forum now from people asking for help interpreting their 23andMe test results. I consider any interpretation to be in danger of constituting medical advice - something that is not permitted on the forum.

    But what to expect from a $99 saliva test kit done in the post? I am new to all this - so have only been reading up over night - but it seems that Google's plan here (the reason for the financial support (other than the personal connection)) was to establish a genetic data-base. Income from the tests is miniscule in comparison to outlay.

    Quite why 23andMe haven't taken down the examples from their website immediately, I really do not know. Perhaps they are planning to take on the FDA though I doubt it. That really would be shooting themselves in the foot!
     
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  18. Firestormm

    Firestormm Guest

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  19. Thinktank

    Thinktank Senior Member

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    Big pharma strikes again!
    Too brainfogged to post a more intellectual comment.
     
  20. alex3619

    alex3619 Senior Member

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    There is no question this issue has been mismanaged. 23andMe could have done better. Yet the basic point I want to make is this: they do not provide medical treatments. Doctors still have to interpret and approve what is said for treatment to occur.

    There is some concern about people using non-medical interventions though. Not all treatments go through a doctor.

    However there is also the issue that the medical profession is woefully unprepared for almost any major innovation in medicine. New drug? Check, can do. New diagnostic? Check, can do. New cutting edge diagnostic unlike anything they have ever been taught? Oh no, we are not competent to interpret it, better raise a stink about it.

    I can see this taking 23andMe to insolvency. That's mismanagement. Yet the question remains as to whether this service is harming more than its helping.

    Remember that similar arguments are being used around the world to ban or limit vitamins and herbs. If some in medical circles had their way most of us would have no treatment or testing at all. Nothing has had the kind of study required, ergo we are allowed nothing. It doesn't matter if its safe, if it works, or whatever, its not allowed if it doesn't meet their requirements.

    However I am well aware that many drugs do not work, or work the way they should, or are unsafe, and have slipped through the system. Millions have probably died. An insufficiently tested drug is one thing though, an advisory service that is clearly still experimental and under development is something else.

    This needs public debate. Maybe it will happen now. I tend to doubt it.
     
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