4 ms·

Because the FDA is the one who ultimately wants this removed, and because by default most of society operates without seeking permission from the government to

Because the FDA is the one who ultimately wants this removed, and because by default most of society operates without seeking permission from the government to do anything. And maybe because the FDA is stupid and thinks that the risk of people maybe finding out something inaccurate and going crazy with it is higher than the reward of people finding out something accurate and taking action to preserve their health based on this information. Ignorance is the only safe option!

tptacek 13y ago
All sorts of things require permission from the government. You can't even sell meat without a USDA inspection at some point in the process. The idea that a modern company could reasonably expect to sell medical diagnostic services without working with the FDA is silly.
- Symmetry 13y ago
  I think that this is actually a very complex issue, and the part that more informed people are finding problematic isn't that people are regulating 23andme at all. There are lots of genetic laboratories in the US where you can send in a sample of DNA and they'll tell you things like that you've got the G:A or A:A variant of Rs601338. A laboratory that does stuff like that is covered under CLIA[1], administered by CLS which like the FDA is part of the DHHS. The FDA's theory here, though, is that since 23andme goes beyond just saying "You have the G:A variant of Rs601338" to "You are probably as susceptible to norovirus infection as a typical person" they're not just a medical laboratory but also a medical device manufacturer, and therefore come under the FDA's purview with much stricter tests for what they can market and what sort of tests their product undergoes. To me, that sounds pretty ridiculous since you can easily just go on SNPedia to look up the associated information yourself[2]. [1]http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/ http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA... [2]http://snpedia.com/index.php/Rs601338 http://snpedia.com/index.php/Rs601338
  - pak 13y ago
    You realize that SNPedia is basically the equivalent of Wikipedia for SNPs, and I can edit it to say whatever I want? Would you want a physician picking your drug regimen based off of what Wikipedia says on some particular day? Would you like your implanted defibrillator to change its algorithm based on something Wikipedia says? If not, then you've discovered the crux of the issue. There's a bright line between "data that someone put online yesterday" and "rigorously tested and proven effective". That's the whole point of FDA regulation on what gets to be marketed as a medical device, or what drugs can be prescribed for an indication.
eli 13y ago
They didn't ask for it to be removed... they asked (repeatedly) for proof that it does what 23 claims it does.
- dragonwriter 13y ago
  Well, they eventually demanded 23andMe stop marketing it when they failed after an extended period to either provide support or even provide a plan for gathering the required support. But that wasn't the starting point.
saraid216 13y ago
> because by default most of society operates without seeking permission from the government to do anything So I take it you don't drive, don't own a residence, don't have a bank account, don't own a business, ...?
dmazin 13y ago
There are cases when you're wrong: ignorance is better than very, very, very severe information without context. I chose not to view whether I have risk for Alz, Parkinson's, and carry BRCA because I will not be able to process that information, as a human, and I can't act on it anyway - all it can do is harm me. Because I'm being downvoted, I feel the need to take a stronger stance: sometimes, information is more harmful to a person because we do not always act well on it.
- penrod 13y ago
  I find this perspective interesting. What information about yourself do you think you would act badly on if it were made available to you? And who would you trust to make the decision about withholding information, and to not abuse their authority?
  - dmazin 13y ago
    Thank you for asking. I decided not to view information about Alzheimer's and Parkinson's because the abnormality they reveal is a genetic variant that you cannot, like, read crossword puzzles to avert. It's just bad news. If I find out that I don't have the variants then all I've done is crossed two variants of two diseases of thousands. It's not worth the spin of the roulette wheel. Normally this would be revealed by a genetic counselor and context given. Personally, I wouldn't view this information no matter what. BRCA is another issue. I think BRCA is _very_ important information, since a mastectomy and possible hysterectomy can greatly reduce chances of the resulting cancer. But this information needs to be given with immediate context and guidance, and now how 23andme presents it. I was also kind of astounded that 23andme doesn't even prompt you whether or not you want to find out if you're a Tay-Sach's carrier or not. That can be enormously significant news. I turn out to have the variant that tends to test false positive, but I was still unhappy to be given that information without my prompt.
    - penrod 13y ago
      These are good examples of information that you rationally choose not to learn. The second part of my question was whether you believe some third party should be able to require that the information be withheld from you even if you want to learn it.
dragonwriter 13y ago
> Because the FDA is the one who ultimately wants this removed, The FDA wanted it removed or justified -- assuring this with regard to medical devices is one of the things FDA is charged by Congress with doing. So, unless you can point to how the FDA isn't doing what it is charged to do, the blame either goes to 23andMe or to Congress, depending on how view the appropriateness of Congress's charge to the FDA.
- baddox 13y ago
  That's not exactly correct. The FDA creates its own regulations. It doesn't just follow laws passed by Congress.
  - dragonwriter 13y ago
    > That's not exactly correct. Yes, it is. > The FDA creates its own regulations. It doesn't just follow laws passed by Congress. It creates regulations (and enforces them) as a means to executing the role Congress has given it. So, again, if you don't have an argument for how what the FDA is doing is inconsistent with the statutory purpose it has been given by Congress, your beef is with Congress, not the FDA.
pak 13y ago
> the risk of people maybe finding out something inaccurate and going crazy with it is higher than the reward of people finding out something accurate and taking action to preserve their health based on this information I don't think this balance is as cut and dry as you claim it to be. There are very few "actionable" results that you can get from a 23andMe test right now, whatever they say to the contrary. The meat of the report that they currently provide is a list of alleles and associations to various properties, but there are thousands of alleles (and likely millions more not tested for lack of known associations) that sum to your particular phenotype. The math and science behind that summing process is severely lacking at this point, simply because we have not characterized the billions of interactions between them. The FDA's problem with 23andMe is that they are not properly communicating this uncertainty in their marketing. Relevant to this issue is whether the reports can be called "medical" information or not. In order for things to live up to the standard of "medical" devices or therapies in the US, they have to pass a certain measure of QC, accuracy, and demonstrated efficacy. 23andMe hasn't done the legwork for any such tests, and from most accounts, it seems like the FDA has given ample effort to accommodate them so far. This is not about hiding data from ignorant people. 23andMe will likely go on testing and providing reports. It just can't advertise it as "medical" until it passes the same standards as other medical products, just the same way I can't sell "Grade A" Beef unless it passes certain standards, or sell "bourbon" in the US unless it's aged in a charred-oak barrel. That is because we've decided as a society to link certain labels with standards, and the label would be pointless if it weren't applied consistently.

tptacek 13y ago

All sorts of things require permission from the government. You can't even sell meat without a USDA inspection at some point in the process. The idea that a modern company could reasonably expect to sell medical diagnostic services without working with the FDA is silly.

Symmetry 13y ago
I think that this is actually a very complex issue, and the part that more informed people are finding problematic isn't that people are regulating 23andme at all. There are lots of genetic laboratories in the US where you can send in a sample of DNA and they'll tell you things like that you've got the G:A or A:A variant of Rs601338. A laboratory that does stuff like that is covered under CLIA[1], administered by CLS which like the FDA is part of the DHHS. The FDA's theory here, though, is that since 23andme goes beyond just saying "You have the G:A variant of Rs601338" to "You are probably as susceptible to norovirus infection as a typical person" they're not just a medical laboratory but also a medical device manufacturer, and therefore come under the FDA's purview with much stricter tests for what they can market and what sort of tests their product undergoes. To me, that sounds pretty ridiculous since you can easily just go on SNPedia to look up the associated information yourself[2]. [1]http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/ http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA... [2]http://snpedia.com/index.php/Rs601338 http://snpedia.com/index.php/Rs601338
- pak 13y ago
  You realize that SNPedia is basically the equivalent of Wikipedia for SNPs, and I can edit it to say whatever I want? Would you want a physician picking your drug regimen based off of what Wikipedia says on some particular day? Would you like your implanted defibrillator to change its algorithm based on something Wikipedia says? If not, then you've discovered the crux of the issue. There's a bright line between "data that someone put online yesterday" and "rigorously tested and proven effective". That's the whole point of FDA regulation on what gets to be marketed as a medical device, or what drugs can be prescribed for an indication.

eli 13y ago

They didn't ask for it to be removed... they asked (repeatedly) for proof that it does what 23 claims it does.

dragonwriter 13y ago
Well, they eventually demanded 23andMe stop marketing it when they failed after an extended period to either provide support or even provide a plan for gathering the required support. But that wasn't the starting point.

saraid216 13y ago

> because by default most of society operates without seeking permission from the government to do anything So I take it you don't drive, don't own a residence, don't have a bank account, don't own a business, ...?

dmazin 13y ago

There are cases when you're wrong: ignorance is better than very, very, very severe information without context. I chose not to view whether I have risk for Alz, Parkinson's, and carry BRCA because I will not be able to process that information, as a human, and I can't act on it anyway - all it can do is harm me. Because I'm being downvoted, I feel the need to take a stronger stance: sometimes, information is more harmful to a person because we do not always act well on it.

penrod 13y ago
I find this perspective interesting. What information about yourself do you think you would act badly on if it were made available to you? And who would you trust to make the decision about withholding information, and to not abuse their authority?
- dmazin 13y ago
  Thank you for asking. I decided not to view information about Alzheimer's and Parkinson's because the abnormality they reveal is a genetic variant that you cannot, like, read crossword puzzles to avert. It's just bad news. If I find out that I don't have the variants then all I've done is crossed two variants of two diseases of thousands. It's not worth the spin of the roulette wheel. Normally this would be revealed by a genetic counselor and context given. Personally, I wouldn't view this information no matter what. BRCA is another issue. I think BRCA is _very_ important information, since a mastectomy and possible hysterectomy can greatly reduce chances of the resulting cancer. But this information needs to be given with immediate context and guidance, and now how 23andme presents it. I was also kind of astounded that 23andme doesn't even prompt you whether or not you want to find out if you're a Tay-Sach's carrier or not. That can be enormously significant news. I turn out to have the variant that tends to test false positive, but I was still unhappy to be given that information without my prompt.
  - penrod 13y ago
    These are good examples of information that you rationally choose not to learn. The second part of my question was whether you believe some third party should be able to require that the information be withheld from you even if you want to learn it.

dragonwriter 13y ago

> Because the FDA is the one who ultimately wants this removed, The FDA wanted it removed or justified -- assuring this with regard to medical devices is one of the things FDA is charged by Congress with doing. So, unless you can point to how the FDA isn't doing what it is charged to do, the blame either goes to 23andMe or to Congress, depending on how view the appropriateness of Congress's charge to the FDA.

baddox 13y ago
That's not exactly correct. The FDA creates its own regulations. It doesn't just follow laws passed by Congress.
- dragonwriter 13y ago
  > That's not exactly correct. Yes, it is. > The FDA creates its own regulations. It doesn't just follow laws passed by Congress. It creates regulations (and enforces them) as a means to executing the role Congress has given it. So, again, if you don't have an argument for how what the FDA is doing is inconsistent with the statutory purpose it has been given by Congress, your beef is with Congress, not the FDA.

pak 13y ago

> the risk of people maybe finding out something inaccurate and going crazy with it is higher than the reward of people finding out something accurate and taking action to preserve their health based on this information I don't think this balance is as cut and dry as you claim it to be. There are very few "actionable" results that you can get from a 23andMe test right now, whatever they say to the contrary. The meat of the report that they currently provide is a list of alleles and associations to various properties, but there are thousands of alleles (and likely millions more not tested for lack of known associations) that sum to your particular phenotype. The math and science behind that summing process is severely lacking at this point, simply because we have not characterized the billions of interactions between them. The FDA's problem with 23andMe is that they are not properly communicating this uncertainty in their marketing. Relevant to this issue is whether the reports can be called "medical" information or not. In order for things to live up to the standard of "medical" devices or therapies in the US, they have to pass a certain measure of QC, accuracy, and demonstrated efficacy. 23andMe hasn't done the legwork for any such tests, and from most accounts, it seems like the FDA has given ample effort to accommodate them so far. This is not about hiding data from ignorant people. 23andMe will likely go on testing and providing reports. It just can't advertise it as "medical" until it passes the same standards as other medical products, just the same way I can't sell "Grade A" Beef unless it passes certain standards, or sell "bourbon" in the US unless it's aged in a charred-oak barrel. That is because we've decided as a society to link certain labels with standards, and the label would be pointless if it weren't applied consistently.