23andMe gets censored by the FDA. Its about time

I’ve commented on here before that 23andMe should be put out of business. Their science is flawed and the information they provide adds nothing to improve ones health and may in fact lead to bad health decisions. Finally the FDA agrees.
http://www.npr.org/blogs/health/2013/11/25/247198237/fda-tells-23andme-to-stop-selling-popular-genetic-test?ft=1&f=103537970

I’m fighting an uphill battle on this one on facebook. I am appalled at their ‘science’. I did test with them, and the only ‘medical testing’ I agree with is that I carry G6PD deficiency–easy to test for, and my blood type is O+ which is something any hospital would retest if it mattered. The rest is pure speculation. They have not presented how they determine their results, nor published peer reviewed papers that allow others to scrutinize their methodology. While I recommend the testing for genealogy connections, I always tell people to throw a large handful of salt on the other testing.

How is their science flawed? All they are doing is a correlational study. I don’t see what’s flawed about that. If people like you, macgyver, a doctor on top of it all, don’t understand that, it is you who is the problem, not 23andMe. How does their study differ from, say, the study on the Mediterranean diet? It doesn’t at all, although that one you were okay with. Identifying a mutation that may (may!) lead to develop a breast cancer is not the same thing as screening for the disease, a fact 23andMe is quite clear about.

They have not presented how they determine their results, nor published peer reviewed papers that allow others to scrutinize their methodology.
This is simply not true. See HERE] how 23andMe conducts their studies. Just because you may not be aware of it doesn't imply that they "don't present how they determine their results." Or are you just going to make up lies like director Shuren of the FDA’s CDC] did when he tried to mislead a congressional hearing?

23andMe has no science George, just unsubstantiated claims.

If anyone got their DNA sequenced through 23andMe I suggest you download the raw data] (before the government bankrupts the company) instead of listening to the nonsense here from Darron, macgyver and asanta.

George, you have apparently forgotten that peer review is part of science.

George, you have apparently forgotten that peer review is part of science.
Who told you their results are not based on peer-reviewed studies? From their site:
We provide both established and preliminary research reports to ensure that you have the latest information about a disease or condition. Established reports are defined by genetic associations supported by multiple, large, peer- reviewed studies. Preliminary reports are based on peer-reviewed, published research with findings that still need to be confirmed by the scientific community. New discoveries in genetics are published all the time, and we’re constantly updating our reports to give you the latest information on genetics and health.
23andMe makes it quite clear what are established reports and mere preliminary reports. They are not the same as some kind of snake-oil company selling lies or promising a cure. I wouldn't expect you to know that since you have probably never visited their site and have no idea what you're talking about.

Look, the problem is not 23andMe here. It is the ignorant public and a few hypochondriacs who have no idea what this whole thing is all about.

Check out all the warnings and references to peer-reviewed material regarding (randomly picked) oral contraceptives, hormone replacement therapy and risk of venous thromboembolism.

George there are several problems with 23andMe. First, they are practicing medicine without a license and don’t care. They are being irresponsible and care about nothing but making money.
In medicine we never give patients medical reports without also providing them with the counseling required to interpret those results. Nowhere is this more true than with genetic counseling. The average person does not have the education or the tools needed to understand the implications of genetic risk information without some guidance from a person who is well versed in this area.
Genetics is not destiny for so many different reasons. Aside from the fact that environment plays a big role in many diseases and traits, most traits are not even influenced by a single gene. Many traits and illnesses are a factor not only of the interaction between environment and a gene but the interaction between different a gene and many other genes.
I can tell you from many years of experience that if you tell someone they have a 30% increased risk of cancer X developing there is a pretty good chance that this is going to have a negative impact on their life. Even if its accurate, giving someone that sort of information without providing the appropriate counseling is completely irresponsible. Counseling needs to take place BEFORE the testing so the patient knows what to expect and can decide if this information is really something they will find helpful. People often have unrealistic expectations about what genetic testing can do for them and dont realize that they may be left with more ambiguity than they are prepared to deal with when they get the results. Counseling certainly needs to be available AFTER the testing as well so the patient can be taught how to use the information in a way that makes sense. Providing raw data without expert counsel is just plain irresponsible.
All of this assumes that the science they use to come up with their statistics and probability are accurate. There are lots of questions about this data when it comes to 23andMe which is a big reason why the FDA is going after them. They have refused to provide much of the data they use to back up the claims they are making.
Finally, and I think most importantly, much if not all of the information provided by 23andMe isn’t useful. They provide very little actionable information that will lead to improved health for the most part. If you are told you have a 25% increased risk of ovarian cancer what are you going to do with that information? There are no effective screening tests for this disease. If you are told your risk of cardiac disease is 50% higher are you gong to quit smoking, lose weight, eat better? You should have been doing those things anyway. the test results change nothing. And if you are told conversely that your risk of heart disease is 50% lower than average are you going to give yourself a pass on some of those thing? That would not be a prudent thing to do but many people would if given that information.
There are cases where genetic data can be helpful. Some genetic defects are 100% predictive and may allow you to plan for the future even if you cant change the outcome, but those situations are not common and usually involve prenatal testing and decisions about termination. BRCA testing when positive puts a woman at much greater risk of breast cancer, but before we order such a test we always have an in depth conversation with the patient about the risks, benefits and choices. Some woman who find out they are BRCA + will without reservation have a bilateral mastectomy. For them the test is useful. Others would never consider such a thing and the knowledge alone might result in never ending anxiety and depression. For them such a test could be devastating.
The bottom line is that genetic testing is not a toy and shouldn’t be treated as such but that is exactly what 23andMe is doing without any regard for the people who may be harmed.

Check out all the warnings and references to peer-reviewed material regarding (randomly picked) oral contraceptives, hormone replacement therapy and risk of venous thromboembolism.
All this does is create questions. There is no real guidance or data on what to do with women who are factor V Leiden deficient. Its not an absolute contraindication to the use of estrogen and OC's. So lets say people get tested for this and they are positive. What then? There was a risk of thromboembolism prior to knowing that result and now its measurably higher. Does that mean the patient cant use these drugs? Without some sort of statistical analysis and cohort data its not helpful. 23andME is just providing the data before we have any good idea about what to do with it. It seems like all they care about is creating a profitable business, not doing any research to make this data useful or provide the data in a way that would be safe ( ie. making sure the patient has before and after counseling).

That’s a big jump, macgyver, from flawed science to being “irresponsible and care about nothing but making money.” 23andMe does offer counseling and even if they didn’t I don’t see how it should be left up to the government to decide if I can have an access to that kind of information. They are my genes after all. What the real bottom line is, is that genetics is here to stay and people will have to learn to live with it. Trust me, it’ll only get worse.

As far as I can tell form their website they do not offer genetic counseling other than to tell you to “discuss it with your doctor or a genetic counselor” and they certainly do not require it as a prerequisite to having the test or a requirement after the results are in. Giving people this sort of information without ensuring that they get the proper counseling and interpretation is completely irresponsible. No physician would ever order a genetic test on a patient without providing or arranging for the necessary counseling. In fact the lab requisition we fill out to order these tests requires us to attest that we will make sure the patient gets such counseling. Its a very short leap to assume the company cares only about making money when they happily accept your fee for the test and make very little effort to ensure that the recipients aren’t harmed by their product.
Nobody is arguing that genetics isn’t “here to stay” but this powerful tool needs to be used responsibly. I already use some of this information now in the limited cases where we have useful data and I look forward to the day when more of our genetic information has matured to become clinically useful. I wholeheartedly disagree with pushing this technology out before it has matured. Until that time the potential for harm may greater than the potential for good. I dont see how the motivation for such action can be anything more than ignorance, impatience, greed or all three.

If you read the FDA letter] and look into the history of the interactions between FDA and the company, it is clear that the company has been unable or unwilling to provide appropriate research evidence to show that all of their tests are accurate and reliable. Apart from the important concerns macgyver raises about what to do with information about specific genetypes, it isn’t even clear that the information the company provides is correct. It is bad enough to tell someone they have a genotype that might affect their risk of a certain disease and then provide them with no reliable information about what this actually means for them or what they should do about it, but it is even worse to do so when they don’t actually have that genotype, which is what is likely to happen if the tests are not properly validated.

I know enough to ignore it, and I tell my relatives to ignore it. As far as I can tell, they take me at my word. I’m tired of arguing with the others.

If you read the FDA letter] and look into the history of the interactions between FDA and the company, it is clear that the company has been unable or unwilling to provide appropriate research evidence to show that all of their tests are accurate and reliable. Apart from the important concerns macgyver raises about what to do with information about specific genetypes, it isn't even clear that the information the company provides is correct. It is bad enough to tell someone they have a genotype that might affect their risk of a certain disease and then provide them with no reliable information about what this actually means for them or what they should do about it, but it is even worse to do so when they don't actually have that genotype, which is what is likely to happen if the tests are not properly validated.
Again, they do provide one with all the necessary information explaining what it all means. They also rate the reliability of the findings and add links to the studies on which the findings are based. As far as I can tell they have done everything they could. The one who is being dishonest here is the FDA as you can see in one of my links above. Keep complaining, guys, but all of what you said here thus far is simply not true. And as I already told macgyver, if you think this type of research is wrong, you will have to apply the same kind of objection to every other correlational study. Nowhere does 23andMe tell one that gene X will cause you to develop disease Y. Nowhere.