Inside 23andMe founder Anne Wojcicki's $99 DNA Revolution

[wisconsin41]

Results: Some what interesting,  this just the highest risk stuff. Although it said I am at lower risk for lupus and RA.

NAME    YOUR RISK    AVG. RISK     COMPARED TO AVERAGE
Gout   
Established Research: Multiple studies with 750+ participants                             35.7%    22.8%     1.57x   


Chronic Kidney Disease   
Established Research: Multiple studies with 750+ participants
4.2%    3.4%   1.22x   


Type 1 Diabetes   
Established Research: Multiple studies with 750+ participants
4.0%    1.0%   3.92x   


Celiac Disease   
Established Research: Multiple studies with 750+ participants
2.5%    0.1%   21.32x   


Exfoliation Glaucoma   
Established Research: Multiple studies with 750+ participants
2.2%    0.7%   2.90x   


Ulcerative Colitis   
Established Research: Multiple studies with 750+ participants
1.7%    0.8%   2.21x   


Scleroderma (Limited Cutaneous Type)   
Established Research: Multiple studies with 750+ participants
0.13%    0.07%   1.90x   


Primary Biliary Cirrhosis   
Established Research: Multiple studies with 750+ participants
0.10%    0.08%   1.25x   

[Cassi307]

Just curious.. Not sure how to read your results.. Your risk of gout is 35.7 compared to average?

Do you think the test was worth the money? Are you comfortable with what you learned?

[wisconsin41]

I have a 35% chance compared to the normal 22% for a 1.57 greater chance.

     There is a lot of stuff on the report. I am waiting for their computers to spit out the  genealogy portion. I am glad I did it, but I'm a numbers person. There isn't any one particular result that makes my jaw drop.  I am less prone to Alzheimer's and Parkinson's .
 

[quietdynamics]

FDA Tells Google-Backed 23andMe to Halt DNA Test Service, By Anna Edney - Nov 25, 2013 12:52 PM ET

"FDA is concerned about the public health consequences of inaccurate results from the PGS device," the agency said today. "The main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work."
...The FDA decided in 2010 that services claiming to evaluate a customer's risk of disease must be cleared by regulators if the companies sell directly to consumers. Most FDA-cleared genetic tests are for a single disease while 23andMe's would be the first to test for multiple conditions.

23andMe submitted FDA applications in July and September of 2012 for the least stringent of two types of medical device reviews. The FDA said the company failed to address "the issues described during previous interactions."

UnitedHealth Group Inc., the largest publicly traded U.S. health insurer, raised concern in a March 2012 report about the accuracy and affordability of the tests. Such types of genetic tests may become a $25 billion annual market in the U.S. within a decade, highlighting the need to identify which work best, the insurer said at the time.

Fine Print on 23andMe site under TOS/ part K:
k. Waiver of Property Rights: You understand that by providing any sample, having your Genetic Information processed, accessing your Genetic Information, or providing Self-Reported Information, you acquire no rights in any research or commercial products that may be developed by 23andMe or its collaborating partners. You specifically understand that you will not receive compensation for any research or commercial products that include or result from your Genetic Information or Self-Reported Information.

* Folks just not seeing the benefit of paying to give my "body tissue" to a company which will then be able to monetarily profit from me, in whatever way they deem profitable.

Business is business.

Patent #8,543,339 grants 23andMe exclusive rights to genetic and computer technologies that would enable prospective parents to handpick a sperm or egg donor with whom they would be likely to produce a child born with certain traits that they desire.

Supreme Court Case: ASSOCIATION FOR MOLECULAR PATHOLOGY ET AL.V.
MYRIAD GENETICS, INC., ET AL
http://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf

[Helene]

I think I just heard that the FDA just shut them down until they have more proof.

[Helene]

Sorry. I missed the earlier post.

[Carolina]

New York Times today.

http://www.nytimes.com/2013/11/26/business/fda-demands-a-halt-to-a-dna-test-kits-marketing.html?ref=science&_r=0

Hugs, Elaine

[Velcro]

I just read those articles this morning.

As far as not submitting any DNA to a company because they could profit from it, I run the same risk when submitting for research.  Although it will hopefully produce a cure someday, they also could sell it to a medical company to produce medications at some point or sell a book, get money from lecturing at conferences on it, or whatever and profit from it eventually. 

[wisconsin41]

"The agency seemed most concerned about a test for mutations that indicate a woman would have a very high risk of getting breast cancer. It said a false positive on such a test could lead to an unnecessary preventive mastectomy."
 
> Really? They think people are that stupid, let alone the fact that a doctor wouldn't cut your breast off based on a mail-in spit test!

"Scott R. Diehl, director of the center for pharmacogenomics at Rutgers, welcomed the F.D.A. action. He said tests for breast cancer risk and drug side effects required guidance from doctors and genetic counselors, and ?really have no place? being offered directly to consumers."

> Total B.S., being an informed patient is important.
>While I would like to know the accuracy rate, they don't actually tell you that you have a disease. Just what your genetics makeup is and how that relates to previous research. I don't need some government bureaucrat protecting me from my supposed stupidity. Of course the medical community doesn't want informed patients, that way they can keep racking in the cash by pushing unneeded tests and referrals to their buddies.

[quietdynamics]

 I don't need some government bureaucrat protecting me from my supposed stupidity.

That is your choice.

I do not believe to date the US Constitution nor Bill of Rights, limits anyone's right to act upon their individual 'stupidity', nor lack of.

However, in the area of protections under the FDA; the situation of "undocumented medical claims" that have the potential for harm...yes, government, our tax dollars at work, try to protect citizens, and has legal recourse.
Those who do not want "meddling", should harm befall them resultant of their personal decisions...then do not cry "where is my protection or for a whaambulance, class action, after the fact.. please.

The issue is not FDA meddling: It is that this company is out of compliance, has been on notice for years.

FDA Warning Letter to the Company, Everything is and has been spelled out for this company, as it has been for others of its kind.
"This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), .... Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions." http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM215240.pdf

23andme has be formally slapped on the wrist after numerous warnings. They have been told to stop "Marketing" with the unsubstantiated claims they are making, and escalated their marketed while not in compliance.. they are preparing for TV mktg ....they can market it as entertainment, ancestral heritage (of course you could pick up an old copy of National Geographic to go ALL the way back.) But, then they would lose the  potential "fear" target market...a lot of money there.

* They had time and money to invest in expanding website-->attract a larger audience, go higher up in searches on google/ per hit, facebook, interviews, but not take care of due diligence? These are the people you are going to trust? Business entrepreneurs?  A CEO with 10 years exp w firm(s) handling healthcare investing, primarily on biotech companies. Lawyers ,auditors, etc= due diligence. These are not business neophytes ...read those TOS (terms of service)...who reads them anyway.

Perhaps with Google behind and beside the company she felt she was "immune"? Husband, mother and sister with Google, Co-founder, Vp's???
23andMe has investments from Google, which first contributed $3.9 million, Google then added more funds in.

The FDA issue with the "product" is documentation of  "accuracy". As in for example: a woman shows no gene for breast cancer...the test is in error and so she goes about never having regular screening...Hey no gene. I am safe. Perhaps.
(Gene predisposition is only perhaps 30% of the risk.. so a true risk assessment incorporates other variables, and then looks at probabilities).

* 23andMe made sure to have company cross all the "t" and dot all the "i' for patents. ( *See gene patent below)"Anne saw a need for creating a way to generate more information - so that commercial and academic researchers could better understand and develop new drugs and diagnostics.  By encouraging individuals to access and learn about their own genetic information, 23andMe will create a common, standardized resource that has the potential to accelerate drug discovery and bring personalized medicine to the public." 
Hmmm? I did not see the altruistic "F" word in there...free, as in free access?

**Quasi-altruist statement about wanting to collect data...to better society....does not strike me as genuine; Research and Medical Institutions are at the point where they have too much data...and are going the way of collaborative analysis, shared data.

TOS:"Genetic Information" is information regarding your genotype.. generated through processing of your saliva by 23andMe or by its contractors, successors, and assignees; or otherwise processed by and/or contributed to 23andMe.

But, while 23andme did not have "time" to comply ...they did have time to broaden the wording and venue of marketing and get a patent for an Invention for
Gamete Donner Selection Based on Genetic Calculations
http://pdfpiw.uspto.gov/.piw?docid=08543339

....Just not sitting right with this company.

[quietdynamics]

...And so.
G2019S and about half of all carriers go on to develop Parkinson's Disease. 23andMe, which compiles genetic data from participants, discovered a large cohort of individuals who carried the G2019S mutation but did not have Parkinson's Disease. In examining this cohort, the company discovered the potentially protective nature of the gene SGK1.
Dr Stuart Hogarth, a research fellow at King's College London, has written an open letter to the company where he probes 23andMe's assertion that their patent 'will not prevent individuals from getting access to information or prevent researchers from researching the target'.

One customer wrote: 'I had assumed that 23andMe was against patenting genes and felt in total cahoots all along with you guys. If I'd known you might go that route with my data, I'm not sure I would have answered any surveys'.
http://www.bionews.org.uk/page_148506.asp

So now an "entity" can patent a natural occurrence...

?? Selective gametes...a different kind of baby ..a variant?  Patent and clone...ok I am being ridiculous...? Weclome to the Twilight Zone.

Now where was that National Geographic article about Redheads becoming extinct...I have two.

..and no I do not believe the FDA thinks of citizens as "stupid"...but, they DO know that the average Joe and Jane does not have a boardroom of lawyers interpreting ambiguous statements, nor do on average know the in and outs of corporate law.
And that marketers/corps will walk as close to the fire as need be to make the sale, even if they have to pay a measly million in fines to make more. Use trigger words to prey on peoples 'worst" fear for themselves and/or children...and then say, "Hey Mr/Mrs Consumer didn't you read the fine print? I never said "X,Y,Z" ...YOU must have misunderstood."

Example for your comparison:
What the National Cancer Institute considers with Genes when assessing risk..
http://www.cancer.gov/cancertopics/factsheet/Risk/BRCA

[slccom]

About that "making a profit" bit. Should a company discover something that leads to a treatment or even a cure for some disease, it isn't as if they can just scoop it out of a readily available source and sell it. The costs of research and development is in the millions and hundreds of millions. And the Supreme Court has forbidden the patenting of genes. It isn't as if you "own" your genes, either! You just happen to have them. Without a profit motive, we would have no treatments for our illnesses.

I disagree with the FDA shutting them down. FDA approval testing is limited. And that is why it is only when a drug hits the market and vastly more people are taking it that we can discover some of the more obscure side effects, which does NOT make it a "bad drug," contrary to all those ads by vampire lawyers (I just typed "lowyers," which is a better name for them!)

If 23 and Me can continue to market and gather data, huge benefits could occur. We have a power-mad FDA.

Sharon

[Sooki]

MedPage Today had a  poll on whether FDA was too hard on 23andme.  62% voted yes.

[Ripvanann]

Velcro is right, the things in life that we need the most, are made because a profit is at the end of the stick. The little booklet I Pencil, by Leonard Read http://www.econlib.org/library/Essays/rdPncl1.html is a wonderful little "story" illustrating this beautifully.

The government needing oversight with this is about two things: power and money. This company wasn't aproved by the FDA and they don't like it. Period. The best things in life, the free things (love, family and freedom), those things are what the government makes you pay for.

With regard to the original post, I wouldn't have it done to find out illnesses because I'm all too prone to psychosomatic symptoms. I'd have everything suggested, within a week. I would however, like to know my genealogy bit better. Still they say that this isn't all that precise either.

[quietdynamics]

Since 2010 the FDA has sent out at least 14 similar warning letter to other companies..so 23andme has never been singled out. They have more media coverage.
Letters to Manufacturers Concerning Genetic Tests
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm219582.htm

Class Action Law Suit Filed Against 23andMe, Pharma & Healthcare 12/02/2013, Forbes
(click on article and then it will give full comments)
Comments give both sides.

Then there is the issue of the protection of this 'medical information'?
There are already "Gene Discrimination Laws" in place. So this is an area that was expected by lawmakers.  http://en.wikipedia.org/wiki/Genetic_discrimination#Laws_against_discrimination

All of these issues are clearly in the present.
I simply would have hoped for a more diligent, truthful and open company.