FDA Orders 23andMe to Stop Providing Genetic Analysis.

[maryb]

A quote from the BBC article.

"The FDA said it was particularly concerned about the potential health consequences of false positive or false negative assessments by the PGS for genetic risk related to breast cancer and to adverse drug responses.
It said consumers might make important health decisions based on inaccurate information. Likewise, a false negative could result in a failure to recognise and act on an actual risk"

you see this is the root of the problem, the authorities don't like the public having information like this, they don't trust them...............They want to keep them ill-informed(or only receiving info via govt approved sources) and most important of all folllow programs like sheep.
They really need to wake up - the technology is here - those who want to access it will, the others will do whatever.

Via this test I was shown to have an increased risk for breast cancer, did this make me run to the doc - er no......
I will continue on with the screening program and self check regularly, nothings changed.
Okay so if someone was shown to have a decreased risk - would that make them drop out of the screening program and stop self checking? er no..........
People can act sensibly, do have common sense, and are able to take some control over their health - governments should wake up to that.

And yes if I was offered the drug for Hep C which the test says is contra-indicated for me , I would refuse it, the onus is then on the health authorities to prove why it would be safe.
Oh dear more work for them instead of re-designing manager's office they'd have to do some proper health work........

 

[Bob]

A government ban on 23andMe's genetic testing ignores reality
The FDA is regulating 21st century technology with 20th century policy. There is a role for consumer-driven medical research
http://www.theguardian.com/commentisfree/2013/dec/04/23andme-consumer-genomics-fda-ban-regulation

 

[Firestormm]

Science: DNA Testing Company Won't Offer Health Information Anymore
6 December 2013 1:45 pm

 

[barbc56]

I believe open access to all our medical information is our right. I don't buy into the argument about the consequences with the interpretation of these tests because of people taking drastic measures are valid arguments against this type of test nor would influence a physician to order something like a prophylactic mastectomy, based solely on this test.

But I do have serious concerns about the 23andme test. Sometimes I think that no test is better than an invalidated test.

The SNP chip method that 23andMe uses was never very good at providing useful genetic information. Its advantage has been its low cost. But as sequencing gets cheaper and cheaper, SNP chips have already largely become obsolete for most genetic testing.

http://blogs.law.stanford.edu/lawandbiosciences/2013/11/25/the-fda-drops-an-anvil-on-23andme-–-now-what/#.UpRl9xU5pKM.twitter

Arguments rage all over the place on this one, but the short answer is that
SNP tests—which is the kind of DNA scan 23andme relies upon— don’t tell us
all that much (yet). They analyze a million genes out of three billion total and
the impact those million play in long term-health outcomes is still in dispute.
For example, the nature/nurture split is normally viewed at 30/70—meaning
environmental factors play a far more significant role in long-term health

Though I don't entirely agree with this article as it involves a bit of hyperbole (maybe), I think it's an interesting take on the issue and it does make an interesting a point.

23andMe Is Terrifying, but Not for the Reasons the FDA Thinks
The genetic-testing company's real goal is to hoard your personal data

http://www.scientificamerican.com/article.cfm?id=23andme-is-terrifying-but-not-for-reasons-fda

 

[roxie60]

Got email stating they will still test but will not give out the 'health' information they usually give. Will still give raw data and will give ancestorial info.

 

[Lala]

So, who will now interpret data, when 23andme does not?

 

[Ema]

Interview...

Anne Wojcicki discusses future of 23andMe

http://www.sfgate.com/technology/article/Anne-Wojcicki-discusses-future-of-23andMe-5502875.php

Love this part:

Q: How much do physicians know right now?

A: Genetics is just not really part of health care right now. We had a physician who complained once that the problem with 23andMe is we generate nonbillable questions. I can't blame them for that. It's part of the reason why 23andMe tries to create even more resources for individuals, so they're not as reliant on physicians but can learn a lot from the community.

 

[juniemarie]

@Ema Oh thats really rich

 

[Sparrowhawk]

Egads, OK so 23andMe doesn't fit your 19th century business model? GREAT, that should be a big clue -- then update your business model so you actually address current medical science.

Sheesh!

 

[barbc56]

But a test that is not valid only gives a false impression that it's part of health care.

Bottom line is they are making a lot of money with a test that doesn't take a look at the whole picture nor does it take into consideration environmental factors.

You need a geneticist who has had years of training to interpret any results and I would think a clinician would only make any predictions withas much information as possible. This test doesn't do this.

We don't have those skills so any interpretation is like a shot in the dark.

Meanwhile the money keeps rolling in.

Barb

 

[Valentijn]

But a test that is not valid only gives a false impression that it's part of health care

Bottom line is they are making a lot of money with a test that doesn't take a look at the whole picture nor does it take into consideration environmental factors.

Validity is quite high. Incompleteness does not negate positive results found in the data which is provided.

You need a geneticist who has had years of training to interpret any results and I would think a clinician would only make any predictions withas much information as possible. This test doesn't do this.

We don't have those skills so any interpretation is like a shot in the dark.

Actually you just need to have a lot of spare time, the willingness to learn how to read and understand the research, and access to the research to read it. The research paper says a certain version of an SNP causes a disease or contributes a little to the risk of it. You check your results, and see if you have than version of the SNP.

It's all pretty simple really.

 

[barbc56]

It's all pretty simple really.

That's the problem. It's not simple.

Barb

 

[Valentijn]

That's the problem. It's not simple.

Why not?

The only problem I've seen is when practitioners don't link to the research and/or say how big the effect size or risk is. These are concepts which can be easily understood once they are explained. The research results are also quite straight-forward, once you learn how to read them.

 

[barbc56]

That's assuming the test is valid. We just don't know.

We do know reliability is not there as people have sent more than one test and ended up with different results.

Last I heard the data is not reliable for some minority groups.

All the above is certainly problematic.

Barb

 

[ukxmrv]

Sorry Barb, I don't follow you on the reliability? The reports that I have read were that the tests were returning the right results (i.e. the SNP's) but disagreed on the relevance of these to specific conditions because they included different papers. If I am missing something please attach a link so I can have a look please as I am interested.

I'm with Val ion the simplicity of the raw data. I downloaded it easily from 23 and ME and it is straightforward. I can look at different SNP's implicated on the internet and compare to my results quite easily. Not sure why I would need a Geneticist to do this for me. I have compiled a shortlist of things to look at from my results and looked up medical research papers on these subjects. I have even emailed a few researchers who kindly have answered questions for me.

I am / or was ! used to analysing large volumes of data though. It may be something that some of us just have a talent for or the help of a residual ease anyway. Anyone who has worked in several areas of business or academia should be able to do it if they have enough of their brainpower left - obviously with ME that's not always going to be the case.. That is around the brainfog and loss of cognition we get of course! Can be weeks until I can summon enough of this but when I do it is easy, not as easy as before the ME and for weeks I can't do it. Several members of my family including a young IT savvy niece have had a look at the raw data now and think it is a breeze. They are non-ME of course.

Not sure why you would think that it was either hard, problematic or unreliable?

 

[Valentijn]

That's assuming the test is valid. We just don't know.

Sections of it have been validated, and the general rate is 99% or more.

We do know reliability is not there as people have sent more than one test and ended up with different results.

No, people have gotten different results from different companies. This is probably due partially to how results are determined. The 23andMe approach seems to be a true/false approach, for example: if not "G", then "A" is assumed. There used to be one SNP which they definitely reported wrong, because it was coming up on my "very rare" results for ME patients, but also among every other person getting 23andMe results. But that's the only one I came across, despite processing large amounts of data from a dozen or more patients.

Last I heard the data is not reliable for some minority groups.

That is completely incorrect. The raw 23andMe data is just as accurate for every group. The confusion arose because they list the ethnicity of patients in the research which they used to interpret results. This was a somewhat stupid thing to do - a version of an SNP doesn't actually act differently in different races, but small studies will often get different results, and there are likely additional and unrelated factors having a bigger impact.

 

[barbc56]

Reliability is if the test consistency gets the same result. Validity is if the test is measuring what the test purports to be testing.

To my recollection there were some who sent in two samples to 23andme,can't find that but haven't looked through all my files but did find where people had sent different results from two different companies. However, I am not sure if this gives validity to 23andme, as which test should we get for accurate results?

The test very well may be valid but how do we know that? I might have missed this or it could have changed. I thought the FDA cracked down because the validity and over interpretation of what the test means.

http://qz.com/151202/23andmes-problem-isnt-the-fda-its-that-no-one-knows-if-it-works/

Arguments rage all over the place on this one, but the short answer is that SNP tests—which is the kind of DNA scan 23andme relies upon— don’t tell us all that much (yet). They analyze a million genes out of three billion total and the impact those million play in long term-health outcomes is still in dispute. For example, the nature/nurture split is normally viewed at 30/70—meaning environmental factors play a far more significant role in long-term health outcomes than genetics.

http://www.forbes.com/sites/stevenk...nter-of-the-personalized-genomics-revolution/

The SNP chip method that 23andMe uses was never very good at providing useful genetic information. Its advantage has been its low cost. But as sequencing gets cheaper and cheaper, SNP chips have already largely become obsolete for most genetic testing.

http://blogs.law.stanford.edu/lawan...l-on-23andme-–-now-what/#.UpRl9xU5pKM.twitter


Please understand, regardless of my feelings about the test,I am not against people buying it. It's just that there are some points that probably should be considered before buying. It's all about caveat emptor

Barb

Oh, my! I have sited the above references before, some on this very page. I forgot this thread is three months old!!

 

[Ema]

I think we should stop selling bathroom scales too.

I don't think they are calibrated accurately enough and might not be as valid as a scale should be or as a scale might be 50 years in the future.

How do we even know if a scale is accurate at all? Who is regulating the scales? Clearly they are dangerous and should be taken off the market immediately to protect the public from themselves.

And all those greedy little scale-sellers out there, just raking the money in, without any concern for whether or not their device is actually accurate.

Given the importance of weight on other serious health matters, like heart health and diabetes, obviously, scales should only be found in doctors' offices where people with the appropriate amount of training can be trusted to interpret the results and incite or not incite the appropriate degree of panic.

Where does this end???

 

[Sea]

Actually this thread should probably be retitled. Although not deliberate, it is misleading - the FDA did not "order 23andme to stop selling their genetic test". Rather, they ordered them to stop providing medical interpretation (for now).

 

[barbc56]

@Ema

A small error with a scale doesn't have the same impact as an error in a test that may or may not be valid when used for important health decisions..

I think this is the bottom line if we really want to find what treatments are going to help.

No test is perfect but I want any diagnostic test I take as error free as possibe.

I am not saying do not get this test nor use it for treatment. That's a personal choice.

Maybe you are being facetious and I missed that? Wouldn't be the first time.

It's an exciting field and the technology has already started. It will be fascinating to see what will happen in the near future.

Barb