5 ms·

"There are several thousand papers about genetics, linking specific genes to everything from eye color to intelligence to chance of developing colon cancer. Som

by timr 13y ago

"There are several thousand papers about genetics, linking specific genes to everything from eye color to intelligence to chance of developing colon cancer. Some of these papers are no doubt correct, others will no doubt in time be found incorrect. However, I worry you want 23andMe to independently validate each of these results before informing customers about them." As they should. If they can't show that the associations they're reporting are valid, what purpose does it serve to report them? That's the whole point. It's not like drug regulation at all, because most of this stuff isn't settled science (and hey, not for nothing...we do test the effectiveness of the antibiotics that get sold at your local pharmacy. A doctor should know that.) Tell you what: send me your saliva and $80, and I'll write you up a really nice genetic report. It'll tell you all sorts of great stuff, and it'll be $20 cheaper than 23andMe. But don't try to force me to certify that I'm not making everything up -- that would be stifling my innovation! After all, I'm providing a cheap service. Disruption! For a community that goes absolutely crazy with skepticism about every scientific study (i.e. "correlation! not cause!"), there sure seems to be a lot of credulity to go around on this issue.

lucraft 13y ago
23andMe can't possibly run independent replication studies of every genetic link they want to report on. Nor should they have to, any more than your doctor should have to personally run a study replication in order to inform you about the results of your blood test.
- timr 13y ago
  You're just repeating the original argument, and it wasn't a good argument the first time. First, 23andMe isn't working in the realm of established science -- most of this stuff is highly speculative, at best. Blood tests are not speculative precisely because they're regulated by the process that you're arguing 23andMe should be able to ignore. Second, the "your doctor shouldn't have to run the study" argument is the reddest of herrings. Your doctor doesn't have to do that (anymore...) because the regulatory system has provided a network of providers who do it more reliably. Third, your doctor really does have to know how to interpret the results of your blood test. She can do that because the science is well-established, and the results are directly correlated to certain clinical outcomes. For most of this genetic testing, there's no equivalent interpretation. That's why you need genetic counselors, who know enough to know when an association study is total garbage. Or if a "50% change in risk" is meaningless in a larger context. In short, it isn't especially onerous to want 23andMe to report only those genetic variations that are based on clinically relevant data, for which their tests are accurate and precise. That's just the basic standard for medical testing.
  - deleted 13y ago
    [deleted]
Symmetry 13y ago
Is your genetic lab certified by the CLIA[1]? 23andme's is and I don't think anybody is arguing that they shouldn't be regulated as a genetics laboratory. It's the FDA's decision to regulate them as a medical device that people think is inappropriate. [1]http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/ http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA...
- timr 13y ago
  Read the letter from the FDA. That's not what they're doing at all. They're requiring a company that sells a direct-to-consumer medical test to certify the safety and validity of that test. I don't think anyone is concerned that they're cross-contaminating their samples or working in a filthy lab over at 23andMe -- they're concerned that the whole design of the test is broken. Again, most of this stuff is sketchy science. You can do the microarray experiments in a proper (e.g. "CLIA certified") lab, and still have a useless, dangerously misleading test.
crusso 13y ago
If they can't show that the associations they're reporting are valid, what purpose does it serve to report them? Showing correlations and study information related to markers found in your genes doesn't serve a purpose? Shouldn't that be up to people to decide with their $99? Tell me that this information and their method of finding correlations isn't doesn't have huge potential benefits: https://www.23andme.com/about/factoids/ https://www.23andme.com/about/factoids/
- kohanz 13y ago
  Nobody is denying that there is potentially a lot of value in 23andMe's genetic reporting. The point is, like all other medical tests before them, they need to go through the proper regulatory channels to ensure their safety and validity. It decidedly should not be "up to the people to decide" because we know that society at-large is not informed enough to make these decisions. What makes 23andme different from all of the other medical tests and technology out there?!
  - crusso 13y ago
    society at-large is not informed enough to make these decisions So we're smart enough to vote for our overlords and trust that they'll put in FDA bureaucrats who have our best interests at heart and will watch out for us -- but we're not smart enough to receive information on the genes in our bodies. Besides the lack of logic in such a system of decisionmaking... besides the lack of freedom of such a system of information control... the system you seem to want is a self-fulfilling prophecy in that the more people are shielded from the black art of medicine, the more that ignorance will grow as information sources are kept from the masses. What makes 23andme different from all of the other medical tests and technology out there The fact that they're not marketed as a clinical tool for diagnoses? The fact that they are not marketing themselves as a substitute for seeing your doctor and in fact encourage you to seek out your doctor if you have real health concerns?
    - kohanz 13y ago
      The fact that they're not marketed as a clinical tool for diagnoses? From the 23andme homepage: "A simple DNA test led to an unexpected diagnosis for a mother and daughter, changing their lives forever.". Obviously the key is the "led to" phrasing, but you can't deny how that wording is trying to position the product. The fact that they are not marketing themselves as a substitute for seeing your doctor and in fact encourage you to seek out your doctor if you have real health concerns? As I mentioned in another 23andme thread, basic take-home pregnancy tests are regulated by the FDA. Certainly, when one of those tells you that you are pregnant, your actions don't stop there and you will eventually follow up with a medical professional. What differentiates 23andme's genetic testing from a pregnancy test? (on a side-note, I would appreciate an explanation for the down-vote on my earlier post in this thread. Are we supposed to down-vote people we disagree with, or was there something wrong with my wording?)
deleted 13y ago
[deleted]

by timr 13y ago

lucraft 13y ago

23andMe can't possibly run independent replication studies of every genetic link they want to report on. Nor should they have to, any more than your doctor should have to personally run a study replication in order to inform you about the results of your blood test.

timr 13y ago
You're just repeating the original argument, and it wasn't a good argument the first time. First, 23andMe isn't working in the realm of established science -- most of this stuff is highly speculative, at best. Blood tests are not speculative precisely because they're regulated by the process that you're arguing 23andMe should be able to ignore. Second, the "your doctor shouldn't have to run the study" argument is the reddest of herrings. Your doctor doesn't have to do that (anymore...) because the regulatory system has provided a network of providers who do it more reliably. Third, your doctor really does have to know how to interpret the results of your blood test. She can do that because the science is well-established, and the results are directly correlated to certain clinical outcomes. For most of this genetic testing, there's no equivalent interpretation. That's why you need genetic counselors, who know enough to know when an association study is total garbage. Or if a "50% change in risk" is meaningless in a larger context. In short, it isn't especially onerous to want 23andMe to report only those genetic variations that are based on clinically relevant data, for which their tests are accurate and precise. That's just the basic standard for medical testing.
- deleted 13y ago
  [deleted]

Symmetry 13y ago

Is your genetic lab certified by the CLIA[1]? 23andme's is and I don't think anybody is arguing that they shouldn't be regulated as a genetics laboratory. It's the FDA's decision to regulate them as a medical device that people think is inappropriate. [1]http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/ http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA...

timr 13y ago
Read the letter from the FDA. That's not what they're doing at all. They're requiring a company that sells a direct-to-consumer medical test to certify the safety and validity of that test. I don't think anyone is concerned that they're cross-contaminating their samples or working in a filthy lab over at 23andMe -- they're concerned that the whole design of the test is broken. Again, most of this stuff is sketchy science. You can do the microarray experiments in a proper (e.g. "CLIA certified") lab, and still have a useless, dangerously misleading test.

crusso 13y ago

If they can't show that the associations they're reporting are valid, what purpose does it serve to report them? Showing correlations and study information related to markers found in your genes doesn't serve a purpose? Shouldn't that be up to people to decide with their $99? Tell me that this information and their method of finding correlations isn't doesn't have huge potential benefits: https://www.23andme.com/about/factoids/ https://www.23andme.com/about/factoids/

kohanz 13y ago
Nobody is denying that there is potentially a lot of value in 23andMe's genetic reporting. The point is, like all other medical tests before them, they need to go through the proper regulatory channels to ensure their safety and validity. It decidedly should not be "up to the people to decide" because we know that society at-large is not informed enough to make these decisions. What makes 23andme different from all of the other medical tests and technology out there?!
- crusso 13y ago
  society at-large is not informed enough to make these decisions So we're smart enough to vote for our overlords and trust that they'll put in FDA bureaucrats who have our best interests at heart and will watch out for us -- but we're not smart enough to receive information on the genes in our bodies. Besides the lack of logic in such a system of decisionmaking... besides the lack of freedom of such a system of information control... the system you seem to want is a self-fulfilling prophecy in that the more people are shielded from the black art of medicine, the more that ignorance will grow as information sources are kept from the masses. What makes 23andme different from all of the other medical tests and technology out there The fact that they're not marketed as a clinical tool for diagnoses? The fact that they are not marketing themselves as a substitute for seeing your doctor and in fact encourage you to seek out your doctor if you have real health concerns?
  - kohanz 13y ago
    The fact that they're not marketed as a clinical tool for diagnoses? From the 23andme homepage: "A simple DNA test led to an unexpected diagnosis for a mother and daughter, changing their lives forever.". Obviously the key is the "led to" phrasing, but you can't deny how that wording is trying to position the product. The fact that they are not marketing themselves as a substitute for seeing your doctor and in fact encourage you to seek out your doctor if you have real health concerns? As I mentioned in another 23andme thread, basic take-home pregnancy tests are regulated by the FDA. Certainly, when one of those tells you that you are pregnant, your actions don't stop there and you will eventually follow up with a medical professional. What differentiates 23andme's genetic testing from a pregnancy test? (on a side-note, I would appreciate an explanation for the down-vote on my earlier post in this thread. Are we supposed to down-vote people we disagree with, or was there something wrong with my wording?)

deleted 13y ago

[deleted]