<p>This is so stupid. You’re not going to get a preventative mastectomy based on a 23andme test. </p>
<p>I was planning on ordering some this on Friday (hoping for a deal) for a few people for Christmas.</p>
<p>I got a kit as a birthday present. I shoul send a swab in.</p>
<p>I sent samples into 23andme a couple of weeks ago. I’m looking for health and ancestry information. I can’t wait to see.</p>
<p>Romani, the FDA shutting sown this shady outlet is not stupid. Of course, no one is going to undergo mastectomy right away - it is a typical case of bad journalistic oversimplification and exaggeration.</p>
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<p>“Low probability” does not mean 0. There is a “low probability” that any given person will win the state lottery. And yet, hundreds of people do win. </p>
<p>I also did 23andme and it reported me as having low probability for a allergic condition that I did have as a child. But I actually found it very educational to go through the results and also look at some of the scientific references for the various genetic tests. </p>
<p>I realized that the science is still in its infancy – it is like having 150 random pieces of a 100,000 piece jigsaw puzzle. </p>
<p>That being said, there was a lot that the report got right. It reported a generally lower risk for most forms of cancer, with one exception: I have a heightened risk for the relatively unusual type of cancer that killed my grandfather. I take the lowered risk part with a grain of salt: perhaps there are yet-to-be-discovered genes that also play a role. </p>
<p>Although not affected myself, I apparently carry a gene for male pattern baldness. This fact will come as no surprise to my 30-year-old son.</p>
<p>I personally don’t agree with the FDA’s apparent decision. I would think it appropriate for the FDA to require that the results include clear disclaimers so that people don’t misinterpret results. There are the usual issues with percentages --an increased risk of a a particular disease could mean that the average person has a 2% risk of contracting that disease, and the person with increased risk has a 3.8% risk of getting the same disease. Higher than average, but not exactly something to lose sleep over.</p>
<p>I get it, I understand numbers and percentages and like thinking about statistics. But perhaps others don’t. </p>
<p>But I also do like the fact that I could get this information on my own, for a reasonable cost. My daughter went through extensive genetic testing via a research program at NYU – there was no particular need for testing, but there was no charge to her so she opted to participate. Only, it turned out that the project wanted to bill her insurance first, to see if they would pay. Her policy wouldn’t, but that in turn meant that we saw all the bills – and I think the billed amount was several thousand dollars, for testing that was probably more accurate but less comprehensive. </p>
<p>I also like the fact that there is a web site with all the information presented in a clear and informative way. If I had a need for medical genetic testing, I might see nothing more than a report indicating whether the test for the specific gene was positive or negative – or I might get a piece of paper with a bunch of incomprehensible numbers on it. </p>
<p>23andme gave me a quick, fun, and informative way to learn a lot about myself. I’m sorry if others will lose that opportunity in the future. (Though after visiting the 23andme.com web site, I really think that they are deliberately trying to set up a test case – there’s a video about a woman with celiac disease that is pretty much waving a red flag to the FDA.)</p>
<p>No, BB, that is what the FDA said:</p>
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<p>[The</a> Letter: FDA Orders 23andMe to Halt Sales - Corporate Intelligence - WSJ](<a href=“http://blogs.wsj.com/corporate-intelligence/2013/11/25/the-letter-fda-orders-23andme-to-halt-sales/]The”>http://blogs.wsj.com/corporate-intelligence/2013/11/25/the-letter-fda-orders-23andme-to-halt-sales/)</p>
<p>I know women with the BRCA gene. I know one just a few years old than me that has actually undergone the double mastectomy after her aunt passed away at a very, very young age. No woman is going to undergo prophylactic surgery or even slightly less extreme measures over a 23andme test. I think the FDA is being absolutely ridiculous.</p>
<p>I agree with you romani – the important thing is that no DOCTOR would perform any of those procedures based on the 23andme test. What would happen is that the initial 23andme test might be the basis for the person to see a doctor and arrange for a confirming test.</p>
<p>I felt that 23andme did a good job of handling the potentially scary stuff. I couldn’t just see the results for the BRCA test or the alzheimer’s gene – the results were “locked” and I had to read a specific statement and acknowledge that I had read it before “unlocking” the results. I remember that the BRCA information was very clear that there were multiple variants of the gene and more than one test, and that 23andme had the results of only one. </p>
<p>I think that putting this sort of information in the hands of consumers will help more people than it will harm-- it’s giving people more information about their own health status. I can see the harm if people misinterpret or misunderstand results – for example if someone mistakenly thought that the fact that they didn’t have the BRCA gene meant that she couldn’t get breast cancer, and then chose to forego mammograms or ignore a lump – but I think the more likely result is that a woman who sees she has an above-average risk of breast cancer might finally get around to scheduling a mammogram she has being putting off. In other words, the benefits outweigh the risks.</p>
<p>I’m disappointed in the FDA with this one. They let all kinds of crazy stuff through as long as it tells you that it is just a “supplement” or that some test is not to be used for medical diagnosis.
According to my genetics professor, 23andme is about the only one of these tests out there (at least as of two years ago) that provides some legitimately useful information, not just some really terrible estimates of where your ancestors might be from. With the cost having come down so much, I would think about doing it if the FDA had not decided to squash it. There is a history of some strange diseases in my family, especially from my grandmother, who was adopted and whose heritage we do not know. There have also been 5 cancers across 4 grandparents, and my mother had cancer, so I am curious if something like this would turn up any clues.</p>
<p>For those who have taken the test, can you talk about the psychological effects? I understand that some information might be legitimately useful-I guess if you have a heightened risk of colin cancer you might be extra diligent about being screened or you might change your diet?
I am tempted to take the test (assuming it becomes available again) because if there are proactive things I can do to increase my health and prolong my life I will do them. I Do many already.</p>
<p>But I can’t help feeling scared that I would discover information about heightened risks that I can’t do anything about. Isn’t that just frightening and depressing? </p>
<p>So torn.</p>
<p>As I understand it, 23and me are not providing the data to support the claims they are making about their genetic testing - the FDA is requiring they provide data to support their claims - essentially, a truth in advertising issue. Don’t see why this is unreasonable, surely this is what the FDA should do and providing they (23&me) have the data this will all go away. FDA has repeatedly asked for this data, it has apparently not been forthcoming thus the current situation.</p>
<p>Here’s another perspective:</p>
<p>[FDA</a> letter to 23andme won’t mean anything in the long run.](<a href=“http://www.slate.com/blogs/future_tense/2013/11/25/fda_letter_to_23andme_won_t_mean_anything_in_the_long_run.html]FDA”>FDA letter to 23andme won't mean anything in the long run.)</p>
<p>Don’t know why BunsenBurner calls 23andme a “shady outlet.”</p>
<p>I would use the info on health risk from 23andme as a reason to talk to my doctor. Not sure why that’s a bad thing.</p>
<p>I ordered the tests for my 23yr old D & I because we both have osteopenia/ osteoporosis, without any other indicators ( besides being white women) & drs don’t seem to know why or what to do about it,(& it is causing problems for both of us) but neither one of us has completed the tests, because of the concerns in this article.</p>
<p>[What</a> Are Genomic Testing Firms Like 23AndMe Really After? | Mother Jones](<a href=“http://m.motherjones.com/environment/2009/11/googles-guinea-pigs]What”>What Are Genomic Testing Firms Like 23AndMe Really After? – Mother Jones)</p>
<p>Here is a pretty good read explaining the upsides and the downsides of DTC genetic testing:</p>
<p>[What</a> is direct-to-consumer genetic testing? - Genetics Home Reference](<a href=“MedlinePlus: Genetics”>MedlinePlus: Genetics)</p>
<p>dadx3, can your doctor do anything on the basis of information that is:</p>
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<p>if you are a company marketing a diagnostic test, you better make sure you follow the FDA guidelines as if they were the bible, and being related to one of the Google founders does not take you off the hook. They do send their testing out to a CLIA certified lab to perform the actual testing, but “analytically validated” only means that they use validated techniques of analysis (sample handling, pipetting, etc.) and NOT that the results they spit out (pun intended) are validated to have a diagnostic value. Many consumers do not understand the difference.</p>
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<p>You can’t blame the FDA for the “supplement” quackery and craziness. FDA was perfectly able and willing to regulate the dietary supplement business, but congress took that power away from them in 1994 in a law pushed through by Sen. Hatch.</p>
<p>When it comes to the question of the out-of-control supplement scene, FDA are not the bad guys. They are the powerless good guys.</p>
<p>Here’s and article about FDA banning 23 and Me from advertising. Worth reading and considering and forwarding to anyone considering this company. </p>
<p>[Genetic</a> Test Service 23andMe Ordered to Halt Marketing by FDA - WSJ.com](<a href=“http://m.us.wsj.com/articles/SB10001424052702304281004579219893863966448?mg=reno64-wsj]Genetic”>http://m.us.wsj.com/articles/SB10001424052702304281004579219893863966448?mg=reno64-wsj)</p>
<p>I have to log in to see the article :/</p>
<p>I’ve been thinking about ordering a test. I’m an adult adoptee and have only very limited knowledge family medical history. Any information on possible risks would be helpful.</p>
<p>Here’s another article about the topic of the FDA ordering the company to stop marketing.</p>
<p>[FDA</a> Tells Google-Backed 23andMe to Halt DNA Test Service - Bloomberg](<a href=“Bloomberg - Are you a robot?”>Bloomberg - Are you a robot?)</p>
<p>Here’s the FDA warning letter:</p>
<p>[23andMe</a>, Inc. 11/22/13](<a href=“http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm]23andMe”>http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm)</p>
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<p>When it comes to the question of the out-of-control supplement scene, FDA are not the bad guys. They are the powerless good guys.<<<</p>
<p>Yes, Coureur is right on this one. Fwiw, the FDA’s biggest problem is not that it is forced to look the other way for dietary supplements but that it blocks plenty of promising “natural” remedies because they do not fit in their usual model of decades of forced chemical analyses that runs in the hundreds of millions in clinical trial. Not to mention how many times, the FDA has approved products that needed to be pulled later. </p>
<p>If the FDA had been around, we might not have penicillin as they might have rejected Alexander Fleming claims.</p>
<p>As far as 23andme, it so happens that we want to believe the results of tests because they come from a computer, and this without much concern for the methodology and existing databases that are used. All in all, medical tests are still suffering from false positives and false negatives. There is a good dose of quackery in many “quick” tests. Take a look at the HPV fast tests for an example.</p>
<p>Bummer. I have had the kit since I got it as a gift 5 mos ago. If I send it in will I get my results??</p>