4 ms·

We can learn a bit more about this dispute from how 23andMe has responded here. Given that 23andMe is still willing to release their raw genotype results, it s

by Steuard 13y ago

We can learn a bit more about this dispute from how 23andMe has responded here. Given that 23andMe is still willing to release their raw genotype results, it seems clear that the FDA isn't objecting to that level of their work. That's comforting: evidently at least that is considered more or less accurate. Instead, they've only redacted "23andMe’s interpretation" of the data from their reports to new customers. My take on this is that the FDA wants some sort of rigorous demonstration that 23andMe isn't making errors in its interpretation of medical data. I'm thinking specifically of stories like this one: "My deadly disease was just a 23andme bug" https://news.ycombinator.com/item?id=6796219 https://news.ycombinator.com/item?id=6796219 It's hard to know (as a simple consumer) how common that sort of error might be: I rely on folks like the FDA to set and enforce quality standards on such things. Similarly, I honestly don't have a great sense of how well 23andMe's interpretations reflected the full current state of known science. For instance, my memory is that they were only able to test for a few of the known breast cancer risk factor genes because others are still covered by patents. How clearly did their interpretation pages convey those gaps in what they were presenting? I hope that 23andMe finds a way to get fully back online before long. But honestly, I'd be happiest if they manage to satisfy the regulators that they really are getting things right. Someone needs to verify claims like that for the rest of us!

bengotow 13y ago
I agree - Here's a company that built a complex software system, loaded it with "if" statements pulled from research papers, and started marketing itself as a predictor of cancer and disease. How did they do their research? What is their threshold for determining if scientific evidence is conclusive enough to merit telling the world they could have a major disease? The FDA wants to know, and so do I.
- cromwellian 13y ago
  So now, people will just export their data and third party companies will provide such interpretation and the FDA won't be able to touch them. How soon until github has an open source project to read and interpret 23andme data-dumps?
  - asdfaoeu 13y ago
    Most likely anyone providing such information would also be in a similar boat with regards to the FDA. Sure you could be overseas providing the data but it's not like the FDA is preventing you from getting overseas treatment.
    - cromwellian 13y ago
      I doubt it, since those people aren't making any medical devices. Moreover, the SNPedia can be used by anyone, so an open source tool can be written and deployed as an app. I highly doubt the FDA will be able to stop that. Trying to stop someone from analyzing their health data dump is about as useless as trying to stop bitcoin transactions. About the only thing the government can try to do is to stop the public from being able to use DNA microarrays, but how long is it going to be before a cheap, consumer grade version of such chips can be made and sold in a way that the FDA can't regulate them?
  - midas007 13y ago
    You can already do that today with downloaded SNPs [1] with Promethease [2]. 1. https://www.23andme.com/you/download/ https://www.23andme.com/you/download/ 2. http://www.snpedia.com/index.php/Promethease http://www.snpedia.com/index.php/Promethease (non-pro version)
- khomenko 13y ago
  a) they never marketed themselves as predictors of cancer or told anyone they have major disease b) the criteria for scientific evidence are here https://23andme.https.internapcdn.net/res/pdf/HIC-SXIYiYqXreldAxO5yA_23-01_Estimating_Genotype_Specific_Incidence.pdf https://23andme.https.internapcdn.net/res/pdf/HIC-SXIYiYqXre... (from https://www.23andme.com/for/scientists/ https://www.23andme.com/for/scientists/)
  - bengotow 13y ago
    Hmm - thanks for the link! Good stuff. I think the complaint I have is that in their advertising (https://www.youtube.com/watch?v=JTIY310FGBU&list=TLdNSueMINqGdQe4Ko381GLLs9i-kP4xbG https://www.youtube.com/watch?v=JTIY310FGBU&list=TLdNSueMINq...), they feature: - An individual for whom 23andMe correctly identified a heart issue that he later had. - An individual who caught his prostate cancer early because 23andMe told him he was likely to have it. In both cases, 23andMe successfully identified the condition before it occurred. That's about as close to marketing yourself as a predictor of disease as you can get. Granted, the word for word text in the video references "elevated risk", but the overall story they're selling to the public is that 23andMe predicts diseases you'll have. At least, that's my impression. Really interested to see how all this pans out.
  - deleted 13y ago
    [deleted]
rosser 13y ago
That's comforting: evidently at least that is considered more or less accurate. I'm not sure you can safely draw that conclusion from the way this has played out. I think it's equally, if not more likely, that 23andMe is able to continue offering raw and ancestry data simply because those things are outside the FDA's purview. Consider, by analogy, the dietary supplement industry: the FDA has incredibly more power over a product that is advertised or marketed as intended to "diagnose, treat, or cure any disease." Notice how the manufacturer explicitly disclaims that exact verbiage on all those sorts of products? That's because anything that is marketed that way is immediately subject to a much higher degree of FDA jurisdiction, under which they can literally shut you down overnight. When 23andMe runs your genome and sees a genotypic match for an arbitrary disease, and then tells you that you have that disease, they're diagnosing you. When they tell you that you're 72.3% Northern European, or give you a ginormous CSV (or however they encode their data dumps), they aren't. That's the only thing I think you can meaningfully read from this situation: they're changing the way their product is marketed, and the services they provide, so as not to be subject to the FDA's nuclear option.
- Steuard 13y ago
  That's a really good point. Rats. So only if they go back to advertising health information after FDA approval will we be able to be confident that their actual genotype results meet FDA standards (as well as their interpretive text).
deleted 13y ago
[deleted]

by Steuard 13y ago

bengotow 13y ago

I agree - Here's a company that built a complex software system, loaded it with "if" statements pulled from research papers, and started marketing itself as a predictor of cancer and disease. How did they do their research? What is their threshold for determining if scientific evidence is conclusive enough to merit telling the world they could have a major disease? The FDA wants to know, and so do I.

cromwellian 13y ago
So now, people will just export their data and third party companies will provide such interpretation and the FDA won't be able to touch them. How soon until github has an open source project to read and interpret 23andme data-dumps?
- asdfaoeu 13y ago
  Most likely anyone providing such information would also be in a similar boat with regards to the FDA. Sure you could be overseas providing the data but it's not like the FDA is preventing you from getting overseas treatment.
  - cromwellian 13y ago
    I doubt it, since those people aren't making any medical devices. Moreover, the SNPedia can be used by anyone, so an open source tool can be written and deployed as an app. I highly doubt the FDA will be able to stop that. Trying to stop someone from analyzing their health data dump is about as useless as trying to stop bitcoin transactions. About the only thing the government can try to do is to stop the public from being able to use DNA microarrays, but how long is it going to be before a cheap, consumer grade version of such chips can be made and sold in a way that the FDA can't regulate them?
- midas007 13y ago
  You can already do that today with downloaded SNPs [1] with Promethease [2]. 1. https://www.23andme.com/you/download/ https://www.23andme.com/you/download/ 2. http://www.snpedia.com/index.php/Promethease http://www.snpedia.com/index.php/Promethease (non-pro version)
khomenko 13y ago
a) they never marketed themselves as predictors of cancer or told anyone they have major disease b) the criteria for scientific evidence are here https://23andme.https.internapcdn.net/res/pdf/HIC-SXIYiYqXreldAxO5yA_23-01_Estimating_Genotype_Specific_Incidence.pdf https://23andme.https.internapcdn.net/res/pdf/HIC-SXIYiYqXre... (from https://www.23andme.com/for/scientists/ https://www.23andme.com/for/scientists/)
- bengotow 13y ago
  Hmm - thanks for the link! Good stuff. I think the complaint I have is that in their advertising (https://www.youtube.com/watch?v=JTIY310FGBU&list=TLdNSueMINqGdQe4Ko381GLLs9i-kP4xbG https://www.youtube.com/watch?v=JTIY310FGBU&list=TLdNSueMINq...), they feature: - An individual for whom 23andMe correctly identified a heart issue that he later had. - An individual who caught his prostate cancer early because 23andMe told him he was likely to have it. In both cases, 23andMe successfully identified the condition before it occurred. That's about as close to marketing yourself as a predictor of disease as you can get. Granted, the word for word text in the video references "elevated risk", but the overall story they're selling to the public is that 23andMe predicts diseases you'll have. At least, that's my impression. Really interested to see how all this pans out.
- deleted 13y ago
  [deleted]

rosser 13y ago

That's comforting: evidently at least that is considered more or less accurate. I'm not sure you can safely draw that conclusion from the way this has played out. I think it's equally, if not more likely, that 23andMe is able to continue offering raw and ancestry data simply because those things are outside the FDA's purview. Consider, by analogy, the dietary supplement industry: the FDA has incredibly more power over a product that is advertised or marketed as intended to "diagnose, treat, or cure any disease." Notice how the manufacturer explicitly disclaims that exact verbiage on all those sorts of products? That's because anything that is marketed that way is immediately subject to a much higher degree of FDA jurisdiction, under which they can literally shut you down overnight. When 23andMe runs your genome and sees a genotypic match for an arbitrary disease, and then tells you that you have that disease, they're diagnosing you. When they tell you that you're 72.3% Northern European, or give you a ginormous CSV (or however they encode their data dumps), they aren't. That's the only thing I think you can meaningfully read from this situation: they're changing the way their product is marketed, and the services they provide, so as not to be subject to the FDA's nuclear option.

Steuard 13y ago
That's a really good point. Rats. So only if they go back to advertising health information after FDA approval will we be able to be confident that their actual genotype results meet FDA standards (as well as their interpretive text).

deleted 13y ago

[deleted]