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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. Firestormm

    Firestormm Senior Member

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    But, Alex, as you said yourself, this is not meant to be a diagnostic test. And anyway, how can doctors possibly be expected to translate the results of a $99 kit, when they have received no training, and the results appear to be interpreted by reliance on unquoted research? Indeed, and to judge only by the threads on this forum, there is great confusion over what the results do mean: and yet 23andMe are providing recommendations - see links in my post above.
    aimossy and barbc56 like this.
  2. barbc56

    barbc56 Senior Member

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    Just because the test is cheap is no excuse for it being unreliable.:lol:

    The above is not orignal, but I forgot where I read it.:D
  3. taniaaust1

    taniaaust1 Senior Member

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    I'd like to point out that genetic genie is actually free to get ones detox and methylation results based on raw DNA data which can be gotten from 24andME. Yeah the FDA could probably go and block that too by saying it poses a danger!! (which would suck as genetic genie is working on soon doing free full summary of detox gene issues like it currently does with the methylation ones and not just list the problem ones like it does now) .

    And with the FDA wanting companies to jump throu their hoops to be approved by them.. costs will greatly increase :(
    Iquitos and S.A. like this.
  4. taniaaust1

    taniaaust1 Senior Member

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    Barb I can say for myself that my 23andME results have certainly helped me.

    1/ I get bad drug reactions to soo many different drugs, even so bad that one time I was hospitalised for a week after taking a drug and the reaction it gave me.

    By my 23andME test, I now think I know why and I also now know what drugs I probably should be avoiding rather then being scared every time I have to trial a drug. My 25andME raw DNA data when I ran it thou the genetic genie detox panel.. came up that half of my detox panel SNPs are mutated including 5 to do with cytochrome 450 which is the enzymes to do with the breakdown of xenobiotic drugs (which make up more then 25% of pharma drugs). And all the drugs Ive reacted to bad when I looked them up online.. were xenobiotic drugs!!!


    Its also actually warned me of certain drugs which could kill me so at least now I could consider those a lot more if a dr wanted me to take one of those.

    I can also confirm many of my other results I got are correct eg
    2/ my doctors had already tested me for MTHFR so I already knew I had a couple copy and what type.

    3/ So many of the illnesses which came up on my report that I was at a higher risk of, I actually do have family members with.

    4/ Many people use 23andME for ancestory stuff rather then for the medical info. I can say they certainly have some of that right. Thou my 23andME results and their site, I found someone who had the same great, great, great, great, great, great grandparents as I do (then confirmed by my families history book and with her known history). 23andME "estimate" (they put it as an estimate) of my and the other I worked out where she was related to me, generation history was out by 2 generations (she went back 2 further then they estimated).

    Anyway I can say that for me, nothing in my report Ive found was wrong but many things Ive found were correct. They do warn people not to take their info as medical advice and to see ones doctor if one is concerned over anything they said.
    ................

    Ive also came across in the past year .. 2 people (maybe 3) who had the 23andME test done (1-2 was at this website.. someone else was at another site) more then once under different names to see if the results came up all the same. They said they did. I know one could say its anedotal when people say that but I find it hard to disbelief it when on rare occassion Ive had someone say that.

    If the 23andME test is used by people as a guide.. there shouldnt be an issue. It helps one to know other things which should be considered eg my test came up that I was a carrier for a genetic disease to do with iron overload (which can cause organ failure).. fortunately not the very bad one and the fact I only have one gene of it, i dont have to worry much of it. It would only be a concern if I passed it on and my children esp if male had two copies of it. I havent gone to the doctor to get vertification as Im not concerned but its still good to know I probably do carry this due to my 23andME results.

    My test also came up saying I had a 40% higher chance of getting Alzeiheimers from the age of 50. This was good to know as for the past year Ive been strongly suspecting that my grandmother has this. Knowing I carry genes which give me a far higher risk has me trying harder to figure out more what to do about my grandmother and her current issues.

    23andME doesnt just give risk factors but they also have info and give ratings on how strong the studies are in each area (and also provides info on the studies to back up things).

    It doesnt just give risks but also tells people how to lower the found risk of things eg something like Alzeimers has several things one can do to help lower a persons current risk eg exercise (which unfortuantely I cant do).

    I think most people who are critizing it, havent had the test so havent seen how the info is actually put.
    Last edited: Nov 26, 2013
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  5. taniaaust1

    taniaaust1 Senior Member

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    I paid 4 times the amount for a lyme test and it is known that lyme testing isnt always reliable. Actually Ive found many tests arent always realiable even things like celiac testing is sometimes wrong.
    Ruthie24, jeffrez and Valentijn like this.
  6. taniaaust1

    taniaaust1 Senior Member

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    There is the research included and links off their website to it.

    The doctors dont need training with most of ones results (unless one has taken SNPs from ones raw data and does research on each SNP there oneself, then one may be getting into too hard for doctors areas). The reported results give the medical names for the things you are at more risk for so you could go to any doctor and get tested for that thing if the 23andME test said you are at high risk of having or carry a genetic disease. It should actually make things easier for doctors and they may be able to get you tested and diagnosed for something you would of otherwise had to go and see a specialist to know what test to run.
    Waverunner and Valentijn like this.
  7. taniaaust1

    taniaaust1 Senior Member

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    You are very lucky then!! My boyfriend was about to buy a tests for him and wife and family for xmas so is very disappointed on hearing this news (they are highly into the geonology side of things too so really wanting it for that)

    I think you'll be fine with getting your info as they are just stopping the sale of the tests.

    23andME got my test results back far faster then I was expecting from the estimates, so yours shouldnt be long. Ive printed off all my results and got my DNA raw data copied off too, I suggest people to do the same in case the FDA closes the site down sometime in the future (I doubt that would happen at all fast even if they were going to do so).

    Dont forgot to keep copies of all your raw DNA even if you dont currently understand how to go throu it. In the future I think people will be paying A LOT for this (once things are regulated etc) and it will be a medical essential in the future I believe.
    Waverunner and alex3619 like this.
  8. Firestormm

    Firestormm Senior Member

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    Thanks :)

    I think it only fair to repeat in large part what I said to you in conversation following your kind offer.

    Since these kind of tests appeared on the forum, and results began being discussed, it is something I have wanted to try and understand better: because I don't.

    And not understanding, at least in part, may be responsible for my skepticism/caution. But, I don't like to see marketing making promises from things that can't deliver. That's really what this FDA ruling is all about in a nutshell. And the connection to Google - frankly - raised concerns with me when it all hit the press.

    Other companies offering similar have failed - why I don't know without looking - but Google-sponsored 23andMe continues. If this 'science' was so affordable and so standard I can't see why more are not doing it. To me it still looks like and feels like it needs to jump through more hoops in terms of regulation and validation.

    But, I don't have the time to properly try and understand even the results people are posting and talking about on the forums, and this ignorance on my part may well be influencing my cautionary stance. Fair enough.

    However, you mentioned that 23andMe while providing links to the research apparently supporting the results, and rating said research - giving it a star rating you said - are still interpreting that research as being meaningful. And that's fine if you want to trust 23andMe or are competent enough to read the research and decide for yourself what it means.

    I still feel that we are seeking answers to our issues and clutching at anything that appears to support an explanation. Not to say we shouldn't or that we are wrong - I have done it myself for many years most especially before coming on the internet with my skeptical outlook which was acquired from being let down consistently by promises made by experts: including "rest up and recover".

    This gene testing, has the veneer of science - but should we trust it simply because of that? I don't know. Maybe the question is wrong or unfair, but I am afraid what with my commitments to this forum and elsewhere I don't have the time to properly try and understand what it is you and others are talking about in detail.
    aimossy, peggy-sue and barbc56 like this.
  9. maryb

    maryb iherb code TAK122

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    I'm presuming you have to be in the USA to sign the petition. Blasted governments, they jump on small companies like this because they're easy to'get'. If you don't want the test DON'T GET IT........When you think of all the really bad stuff going on...... We're not stupid people, maybe we can't be helped by the info this test provides but hey if its worth $99 to you then go for it, they're not promising cures, treatment etc.
    Give the public choice? Not likely. Anything remotely linked to to medicine is the SOLE domain of the medical profession, they won't have it any other way.
    Same here in the UK.
    Jobsworths
    Waverunner and Valentijn like this.
  10. juniemarie

    juniemarie Senior Member

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    If scientific/medical research companies, FDA,CDC,NIH, pharmaceutical companies etc. , outfits and organizations who put on the face that our health and well being is their primary concern, were really here for our benefit, there would be no Phoenix Rising or all the other multitude of health forums all of us frequent looking for answers. There would be no need. We are here because we don't and can't trust or depend on them, and they have proved that over and over
    Look what it takes to even get them up to speed to begin to consider that our illness could possibly be real. It takes years and years of us pounding on their door. We educate them. We alert them We tell them what we need We tell them they are operating on a lack of knowledge We tell them that we are ill and want and need someone to pay attention. It always comes from the grass roots efforts. It's kind of like the guy who when asked why did you hit the mule in the head with a board….I want to get his attention.
    If there is no money in it they have to be hit in the head with a board.
    If a glitzy ad can't be put on TV promising all sorts of bogus results that make what ever claims 23&me make pale in comparison, they have no interest.
    When the FDA rushes some drug to market, not based on its safety or effectiveness, and later, if & when it makes people ill, kills sometimes, or just simply does not work, the FDA says sorry we won't do that again, but in the meantime a whole lot of money was made.
    How about, if everyone on this forum who puts faith in these outfits main objective being their/our protection quits taking all the herbs and supplements that are recommended daily by the PR community….these treatments have not been sanctioned by any of the government/medical/scientific/cooperate community. As a matter of fact if they have their way they will take away our ability to get these OTC treatments. Why? Not because of what they say, that its not safe for us to take the treatment of our illness into our own hands. Wakeup Its because with the internet, places like PR and the huge grassroots movement of people taking more control of their health/illnesses, OTC, herbs, supplements has become a huge moneymaking industry, and thats the thing that gets their attention. They want a piece of the action. They hate it when we find ways around them
    Everyone is well aware of the hubbub about antibiotic resistance. Frontline did a show about the subject recently. No research is being done to come up with new antibiotics for these so called super bugs and the reason, as was pointed out ,is there's no money in it.
    Make no mistake, money is the oxygen on which the entire medical word depends. Academic, governmental & cooperate.
    Iquitos, Waverunner and maryb like this.
  11. Valentijn

    Valentijn Activity Level: 3

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    On the subject of useful information - looking at the rare genes for a member of Phoenix Rising showed that they have a pathogenic missense mutation which causes permanent deafness in reaction to certain antibiotics. While these antibiotics aren't commonly used (due to the reaction in some people), they do get used sometimes - and as various antibiotics aren't an uncommon drug used by ME/CFS patients, I would say that is extremely useful information.

    The mutation involved was on mitochondrial DNA, which means that the patient knew that all of her relatives sharing a maternal lineage (her children, her siblings, her maternal nieces, nephews, cousins, etc) would have exactly the same problem with those antibiotics. Hence she was able to warn them about it, without it even being necessary for them to be tested.

    Now if it somehow becomes absolutely necessary for any of them to use that antibiotic, I suppose a doctor could test again. But it's nice to know that there is an extremely good reason to avoid certain drugs, instead of flying blind.
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  12. jeffrez

    jeffrez Senior Member

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    I think it would be a better use of the FDA's time and resources (i.e., our money) to look into the hundreds of thousands of deaths caused every year in the US by prescription drugs that the FDA has approved than to worry about a $99 online genetic test that only provides information. Somehow they never get around to investigating all those drug deaths, or shining the light of scrutiny on their own practices and the harm their approvals cause.

    It's all so obviously political, and I think they're going after 23andme specifically because that co. is tied to Google, which gives the FDA and their egos more publicity and a bigger chance of registering with the public. "Look how powerful we are, we're telling Google what to do." :rolleyes: If 23andme weren't associated in some way with Google, this wouldn't even make the minor headlines it's made.
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  13. Dreambirdie

    Dreambirdie work in progress

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    What he said.

    There's very little ethics or intelligence that goes into what the FDA approves of. Until the corporations and their lobbyists get their influence out of our government agencies, things will never change.
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  14. ggingues

    ggingues $10 gift code at iHerb GAS343 of $40

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    I just have Hope and Change! Ooops, that was 2008, that will be read in the media or froma reporter also.LOL
  15. Firestormm

    Firestormm Senior Member

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    Are you suggesting 23andMe isn't a corporation funded almost entirely by Google, or that 23andMe and/or Google do not have lobbying power?
    barbc56, aimossy and golden like this.
  16. ggingues

    ggingues $10 gift code at iHerb GAS343 of $40

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  17. alex3619

    alex3619 Senior Member

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    I don't disagree with any of these points, though with the caveat that it depends on what you mean by diagnostic. The snp data is based on fairly sound science, though its hard to say what their quality control is. Its a comprehensive test (though I don't know if they are using it correctly, the quality control thing) and its diagnostic of snps, not disease burden or risk. The rest is scientific summary. Its suggestive, and neither science nor medical diagnosis.

    Now it does appear their marketing branch may be making claims they can't fulfill. That is also an issue, its false advertising. So going after them for false advertising may be totally legit.

    This all ties into the clash between evidence based medicine, science, medical science, medical management, and medical economics. There are failures everywhere, including the FDA. Its a right mess, and it needs to be sorted.

    The one good thing about suspending 23andMe testing is that it might lead to a better public debate, especially from scientists and medical genetics experts.

    A lot of what is going on is driven by a desire for certainty, as if certainty guarantees quality. The problem is much certainty in medicine and elsewhere is manufactured, its not reality. Things are declared certain, or not certain, they are not proved for certain. Both the FDA and 23andMe fall foul of this. The FDA thinks the only way to be sure is to have large expensive studies that meet certain technical expectations. 23andMe, especially in marketing, is making claims of certainty they cannot back up as well.

    We need to find better ways to deal with murky uncertain things, particularly in science, though other disciplines like psychogenic psychiatry and economics do too. For more than a century science has advanced by increasing certainty but this leaves vast areas, that require serious science to manage, sitting out there in limbo. We need ways to manage uncertainty not by denial, or dismissal, but by altering the very processes we use to make decisions, and reason about evidence.

    There is a reason my book has a tentative title of Embracing Uncertainty.
    aimossy, WillowJ, Sea and 1 other person like this.
  18. Dreambirdie

    Dreambirdie work in progress

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    "It’s actually the pharmaceutical industry that spends the most each year to influence our lawmakers, forking over a total of $2.6 billion on lobbying activities from 1998 through 2012, according to OpenSecrets.org. To get some perspective on just how big that number is, consider that oil and gas companies and their trade associations spent $1.4 billion lobbying Congress over the same time frame while the defense and aerospace industry spent $662 million, a fourth of Big Pharma’s total.

    (Number two on the OpenSecrets list, by the way, was my old industry, insurance, which spent $1.8 billion. Although health insurers were among the biggest spenders, the list also includes property and casualty and auto insurers.)

    The huge sum of money our nation’s drug makers lavish on Congress each year begs the question, what are they seeking in return? Surely it has something to do with the fact that our nation’s legislators turn a blind eye as pharmaceutical companies engage in predatory pricing practices while enjoying exclusive rights to manufacture drugs for 20 years or more. All at the same time that drug costs and drug price inflation are among of the main drivers of health care costs for individuals and families and threaten the fiscal health of our public health care programs. "

    http://www.publicintegrity.org/2013/02/11/12175/opinion-big-pharmas-stranglehold-washington
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  19. Waverunner

    Waverunner Senior Member

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    What you said is super interesting. On a 12 hour Atlantic flight I was sitting next to a sales person from a company for surgical instruments. We chatted every now and then and of pure interest I asked him why surgical instruments are so expensive. I expected him to say something like "Well, because of their great quality..." but instead he looked at me, smiled and said (like you would tell a child): "Oh no, actually it's more like rip-off. If we had a real market, prices would be 5-times lower." Then he continued watching his movie.

    This is only an anecdote of course but I urge every patient and every PWC to look at reality. Medical costs are through the roof, no chronic disease has been cured, people with chronic diseases have to take their pills for the rest of their lives and many times their health still deteriorates. Despite the fact, that there are millions of people with all kinds of strange diseases like CFS, the medical field doesn't care until these people come down with well regulated diseases like cancer, heart disease, diabetes etc..Where is the innovation in medicine? Where are the breakthroughs we see everywhere else? 23andMe was one of the few breakthroughs. It's demand driven, not regulation driven. They currently only offer SNPs but whole genome sequencing would be the logical next step. Then patients and doctors can conduct their own studies and find possible genetic causes. But instead of going this way the FDA does everything to block demand driven innovation from entering the market.
    Last edited: Nov 26, 2013
  20. Snowdrop

    Snowdrop Senior Member

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    I'm not a fan of mega corp's who are responsible to no one but themselves.

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