Inside 23andMe founder Anne Wojcicki's $99 DNA Revolution
The $126 million genetic-testing company can tell you how to live smarter, better, and longer. It can also tell you what might kill you.
By: Elizabeth Murphy
http://www.fastcompany.com/3018598/for-99-this-ceo-can-tell-you-what-might-kill-you-inside-23andme-founder-anne-wojcickis-dna-r
Would you want to know about yourself or your children?
I might do it the next time I have $99 to burn, whenever at might be.
I have been extremely interested in doing this test. The downside is and it is a big downside, will it cause excess/compulsive worry. For example, if the test indicates a greater than normal risk of a disease like ALS, one can't just erase that from memory.
On the other hand, there are some diseases that I do believe with forewarning, one can take steps to stave off or minimize - potentially. If the test shows a propensity to Alzheimers, I would proactively take Tumeric daily.
They are seriously overstating the usefulness of their results at this point. With the exception of a very few genes, such as for Huntington's Chorea or the BRAC genes, we really don't know how the genes and the environment interact, if they will ever be expressed, and if they are, how much.
I wouldn't waste my time or money. If there are serious issues in my family, I would go see a genetic counselor.
Sharon
I actually would like to do it. Yes, I know it can cause worry, but I also think that I already worry about stuff. For example, an Aunt with Parkinsons? Am I going to get it? A Grandmother with extreme gestational diabetes, moi?
At least I think I would know for sure what is possible.
I would love to do it. I'm an information junkie and would love to able to read news reports of genetic research and know what my genome held. Having a gene doesn't make things worse than they already are. Always seems like more knowledge is better. Some day when I don't have a more urgent need of $99, I may spring for it.
My spit tube was just received by the lab. ;)
I did it out of curiosity. My mother was into genealogy and I'm a scientist at heart so I went for it :D
I did notice that Sjogrens was one of the diseases they can "test" for. I am not sure what they look for in that regard.
Do they ask you what current diseases you have? I think it would be interesting to say none, then see if it comes back with what we know we have already.
The sample can be sent in with just your name and birth date. They do have surveys on the website, I have been resisting giving them any information though ;)
It makes me curious since I have biopsy confirmed Linear Morphea if it would show I had a high % chance of developing it :)
"Your sample was received at our laboratory on 10/19/2013 and is currently in the queue to go through DNA extraction and amplification." Hope I don't have to wait the 4 weeks...
Cool, let us know what you get back to the extent you are comfortable or at least your impression of the findings, such as whether you felt it worthwhile, categories of results, etc,that do not divulge anything too personal.
If I get a holiday bonus this year I will do this to satisfy my curiosity factor.
Dee
When I get back from vacation and through the holidays, I think I'm just curious enough to try it too.
"Now for the good stuff! We started analyzing your DNA on 11/01/2013.
Analysis may take 1 to 3 weeks."
Yeah! :D
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
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?
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 . :D
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
I think I just heard that the FDA just shut them down until they have more proof.
Sorry. I missed the earlier post.
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
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.
"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.
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.
...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
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
MedPage Today had a poll on whether FDA was too hard on 23andme. 62% voted yes.
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.
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.
I just read a story on a news website about a class action lawsuit against this company.
Caveat emptor.
http://www.nbcnews.com/health/23andme-faces-class-action-lawsuit-california-2D11691043
They may be a horrible company and up to no good at all. Not so long ago however, the public would of taken care of them. Post articles, word of mouth and no more 23 & me. I see no reason for government oversight here. Law and order does not stretch as far as what I choose to spend, invest and even waste my money on.
I don't know how many people decided to post on this thread but all of us made informed and personal decisions about whether or not we wanted to do this. None of us need(ed) the government to "help" us. They have no place here.
I guess what I'm confused about is that when I went and read everything about their test, when this thread first started, I didn't feel mislead by anything. Everything I read said they were offering me a risk assessment, not a diagnosis. I found that no different than my Doctor asking about family history and then telling me I had a 50% chance of developing Diabetes because it's rampant on both sides of my family. He wasn't saying that I was going to get it...just that I had a higher risk than someone that doesn't have it in their family, so something to pay attention to for me. I also read the whole section where they said they were going to sell to third parties for medical research, etc.
Who knows. They may be the biggest scammer ever. I'm just always leery of someone that files a lawsuit on stuff like this. I think people are so sue happy now that it makes it hard to know when someone really has a legitimate case versus people just trying to make some easy money (a.k.a. McDonalds Hot Coffee lawsuit). I'm not a very trusting person of people anymore.
P.S. I didn't say anything about the FDA because I don't trust them either. One day something is ok, the next not...then it is...then it's not.....pssssshhhh
I think the lawsuit is more about what the company does with our medical and personal information after they do the testing than about what they're actually testing for.
I paid the $99 and I knew they were using my dna for research. What is the big deal. It is a for profit company...
Interesting Article in the NYTimes today.
The author had her genetic profile done by three companies. With three different sets of results! Some of them were completely contradictory.
http://www.nytimes.com/2013/12/31/science/i-had-my-dna-picture-taken-with-varying-results.html?ref=science
Buyer beware!
Hugs, Elaine
I don't think the FDA should be involved. In my opinion, The kit is not a "medical device" and does
not diagnose anything.
The goverment just wants control... they are chomping at the bit to get the genetic information into their greedy hands and don't like the idea of someone else profitting from it.
I look at 23 & Me as something more akin at this stage as talking to a phone psychic. If it hadn't cost $99 that I didn't have, I would have liked , out of curiosity sake, just to see how close they come to medical conditions I ALREADY have.
Kinda pissed that the GOV/FDA got involved. Americans have the right to spend their money however they wish. Merely putting a statement out there like they do for supplements With the disclaimer "not FDA approved" would have been enough for people to make their informed decision. No lawsuits needed.