4 ms·

Of all the things that have a clear negative impact on health, 23andme's existence and business practices do not (in my opinion) merit a single hour of agency/b

Of all the things that have a clear negative impact on health, 23andme's existence and business practices do not (in my opinion) merit a single hour of agency/burocratic time. FDA interest in 23andme is driven solely by rent-seeking incumbents trying to keep 23andme out of the game. Every single piece of information on 23andme is accompanied by confidence estimate, and most of it is very low confidence. Every single concern mentioned in that letter is clearly and obviously addressed by the site as part of its core functionality. As a happy 23andme customer I wish the FDA would stop harassing a company I enjoy doing business with so that it can get on with releasing new data and building new features rather than just hiring lawyers.

dragonwriter 13y ago
> FDA interest in 23andme is driven solely by rent-seeking incumbents trying to keep 23andme out of the game. No, FDA interest in 23andMe is driven by: 1) The fact that 23andMe's product is within the clear scope of what FDA is tasked to regulate under the FD&C Act, and 2) The fact that, having initiated the process of seeking regulatory clearance for their product as required, 23andMe abandoned that process and continued marketing the product. > Every single concern mentioned in that letter is clearly and obviously addressed by the site as part of its core functionality. Really? The lack of studies supplied by 23andMe establishing the validity of their process in delivering the outputs it gives is "addressed by the site as part of its core functionality"? How?
- grandalf 13y ago
  I'd address your first point with a simple question: Suppose 23andme did no data analysis/interpretation and simply returned the raw data, would that increase or decrease the scope of appropriate FDA involvement? To your second point, the site has a few "locked" areas that are described as containing potentially upsetting or confusing information, and the user is advised to consult his/her physician before looking at the results. There is also downloadable information available to physicians.
  - dragonwriter 13y ago
    > I'd address your first point with a simple question: Suppose 23andme did no data analysis/interpretation and simply returned the raw data, would that increase or decrease the scope of appropriate FDA involvement? Reducing the scope of the product would inherently reduce the scope of the FDA involvement, not that that is in any way relevant to any point I made. > To your second point, the site has a few "locked" areas that are described as containing potentially upsetting or confusing information, and the user is advised to consult his/her physician before looking at the results. There is also downloadable information available to physicians. I don't see how that's relevant to anything I said. Particularly, its not relevant to either the second point in the first paragraph (which concerns 23andMe abandoning the regulatory clearance process) or the point of the second paragraph (which concerns 23andMe failing to provide studies supporting their claims about the accuracy of the reports).
    - grandalf 13y ago
      It's possible 23andme has been sloppy with its compliance practices. If you take the raw data and download various utilities that match SNPs with the literature, the result is far more scary and misleading -- and it reveals just how thoughtful and reserved 23andme's approach is. 23andme provides ample links to evidence for every single result. The confidence metric is a function of the study size and reproducibility for the studies pertaining to each and every result. Most have very low confidence. IMHO the only legitimate beef is with the underlying scientific assumption behind 23andme, which is that statistical genetics is both useful and accurate. I consider it more of a form of entertainment than a likely way of gathering actionable information.
      - dragonwriter 13y ago
        > It's possible 23andme has been sloppy with its compliance practices. Then no one should be surprised that they are in trouble with a regulatory agency responsible for holding participants in the market they are in to compliance standards.
        13y ago
- jhgorse 13y ago
  Just responding to your first point. The FDA scope of jurisdiction is breathtakingly large and arbitrarily enforced, so the fact that it can fall under their jurisdiction and that they claim it is a weak statement. In policy it is like writing laws which make everyone a criminal and only enforcing it when you feel like it. Is this a fair comparison for the FDA? Yes, because in the current system you are guilty until you prove your own innocence to their standard of evidence, which tends to vary based on who you are. One could argue that the potential harm of unregulated supplements is clear and present, yet the FDA chooses not to act. To whom shall we write our complaints about the unregulated aspects of the food and drugs which have the potential to cause massive harm (but which apparently don't because people on aggregate are not as helpless as they sometimes appear)?
ScottBurson 13y ago
> Every single piece of information on 23andme is accompanied by [a] confidence estimate, and most of it is very low confidence. Another customer here, and this has also been my experience. I have found their results presentation very responsible and low-key. A lot of these correlations are quite weak, and they're very clear about that. I wonder if the real dispute here is over whether giving confidence estimates is good enough. Perhaps the FDA thinks that the general public are not well enough trained to interpret them.

dragonwriter 13y ago

> FDA interest in 23andme is driven solely by rent-seeking incumbents trying to keep 23andme out of the game. No, FDA interest in 23andMe is driven by: 1) The fact that 23andMe's product is within the clear scope of what FDA is tasked to regulate under the FD&C Act, and 2) The fact that, having initiated the process of seeking regulatory clearance for their product as required, 23andMe abandoned that process and continued marketing the product. > Every single concern mentioned in that letter is clearly and obviously addressed by the site as part of its core functionality. Really? The lack of studies supplied by 23andMe establishing the validity of their process in delivering the outputs it gives is "addressed by the site as part of its core functionality"? How?

grandalf 13y ago
I'd address your first point with a simple question: Suppose 23andme did no data analysis/interpretation and simply returned the raw data, would that increase or decrease the scope of appropriate FDA involvement? To your second point, the site has a few "locked" areas that are described as containing potentially upsetting or confusing information, and the user is advised to consult his/her physician before looking at the results. There is also downloadable information available to physicians.
- dragonwriter 13y ago
  > I'd address your first point with a simple question: Suppose 23andme did no data analysis/interpretation and simply returned the raw data, would that increase or decrease the scope of appropriate FDA involvement? Reducing the scope of the product would inherently reduce the scope of the FDA involvement, not that that is in any way relevant to any point I made. > To your second point, the site has a few "locked" areas that are described as containing potentially upsetting or confusing information, and the user is advised to consult his/her physician before looking at the results. There is also downloadable information available to physicians. I don't see how that's relevant to anything I said. Particularly, its not relevant to either the second point in the first paragraph (which concerns 23andMe abandoning the regulatory clearance process) or the point of the second paragraph (which concerns 23andMe failing to provide studies supporting their claims about the accuracy of the reports).
  - grandalf 13y ago
    It's possible 23andme has been sloppy with its compliance practices. If you take the raw data and download various utilities that match SNPs with the literature, the result is far more scary and misleading -- and it reveals just how thoughtful and reserved 23andme's approach is. 23andme provides ample links to evidence for every single result. The confidence metric is a function of the study size and reproducibility for the studies pertaining to each and every result. Most have very low confidence. IMHO the only legitimate beef is with the underlying scientific assumption behind 23andme, which is that statistical genetics is both useful and accurate. I consider it more of a form of entertainment than a likely way of gathering actionable information.
    - dragonwriter 13y ago
      > It's possible 23andme has been sloppy with its compliance practices. Then no one should be surprised that they are in trouble with a regulatory agency responsible for holding participants in the market they are in to compliance standards.
      - 13y ago
jhgorse 13y ago
Just responding to your first point. The FDA scope of jurisdiction is breathtakingly large and arbitrarily enforced, so the fact that it can fall under their jurisdiction and that they claim it is a weak statement. In policy it is like writing laws which make everyone a criminal and only enforcing it when you feel like it. Is this a fair comparison for the FDA? Yes, because in the current system you are guilty until you prove your own innocence to their standard of evidence, which tends to vary based on who you are. One could argue that the potential harm of unregulated supplements is clear and present, yet the FDA chooses not to act. To whom shall we write our complaints about the unregulated aspects of the food and drugs which have the potential to cause massive harm (but which apparently don't because people on aggregate are not as helpless as they sometimes appear)?

ScottBurson 13y ago

> Every single piece of information on 23andme is accompanied by [a] confidence estimate, and most of it is very low confidence. Another customer here, and this has also been my experience. I have found their results presentation very responsible and low-key. A lot of these correlations are quite weak, and they're very clear about that. I wonder if the real dispute here is over whether giving confidence estimates is good enough. Perhaps the FDA thinks that the general public are not well enough trained to interpret them.