4 ms·

To this point: > Most of 23andme's customers were early adopters, especially when the price was much higher, I find it hard to believe the plantiffs in this la

To this point: > Most of 23andme's customers were early adopters, especially when the price was much higher, I find it hard to believe the plantiffs in this lawsuit were duped into thinking it does anything more than claimed. You've actually hit on exactly why the FDA decided to initiate enforcement action on 23andMe. The FDA has always taken the position that what 23andMe was doing was not necessarily permitted, but used regulatory discretion and did not stop them. The rationale was that since 23andMe did not do mass-marketing, the people using the tests were seeking 23andMe out and were educated on what the tests were. 23andMe has made some stupid choices, like not engaging with the FDA over the course of a number of months on this issue, and this was all brought to a head when 23andMe broke the implicit agreement with the FDA and started mass-marketing. And on this point: > that doesn't really promise anymore than a statistical printout of your DNA. Their profiles now have a "key health recommendations" section if you've taken the test (I have), which, again, is a big no-no, and part of the reason that the FDA decided to initiate enforcement.

cromwellian 13y ago
Lots of websites make key health recommendations based on family history/ancestry, and behavioral questionnaires. Why are they exempted? Why can someone make a website that asks you about age, drinking, smoking, activity levels, height, weight, etc and then make health recommendations, but if it comes from sampling DNA instead of verbal questioning of potential heredity traits, it's magically different and bad?
- epistasis 13y ago
  There's a significant amount that can go wrong in the laboratory when generating test results. So congress passed laws saying the FDA must regulate these laboratories. 23andMe chose not to comply with these regulations, to not collaborate with the FDA. Blaming the FDA is quite misplaced. If you want the laws to be different, congress is the part of the government with power to change the regulations. The FDA seems to be attempting to do the minimal amount required by law, and does not appear to be in the least bit overzealous with 23andMe. That 23andMe has not complied with basic QA and analytic reassurances should concern you greatly, and doubt the quality of 23andMe. What 23andMe is doing is somewhat equivalent to writing code and not having any unit tests, integration tests, or any QA team. Or perhaps they're doing all that, but don't want to report to the FDA. In any case, quite shady.
  - Symmetry 13y ago
    23andme complies with all the rules governing genetics laboratories. It's the offering the results to consumers and the interpretation that the FDA says makes it the equivalent of a medical device rather than a medical laboratory, and which puts it under a separate, much tougher regulatory regime. EDIT: Of course Congress tells the FDA how it is to regulate genetics labs, and how it is to regulate medical devices. But I think the decision to regulate 23andme as a medical device is very much something the people in charge at the FDA had some leeway in.
    - timr 13y ago
      "23andme complies with all the rules governing genetics laboratories." You're misunderstanding the difference between "runs a competent lab" and "provides a genetic test that's useful for diagnostics". You can run a perfectly clean, professional lab, and still offer a useless (or dangerously misleading) test. The FDA, in this case, is more interested in the latter question than the former, and it's the most important question of all. The FDA is doing exactly what it should be doing here -- questioning the validity of the test itself, not the logistics of the lab doing the test.
      - cromwellian 13y ago
        Genetic tests are useful for many things, some people have used them for ancestry, especially African Americans who have traced history that had been obscured by slavery. I think "test" is even the wrong terminology. A better one would be "picture" or "snapshot". A photo can be used for many purposes, one of which is to make medical diagnoses. Personally, what I want from 23andme is not a diagnosis, I just want a dump of my DNA hyperlinked with relavent scientific artifacts on suspected function or links to diseases. The FDA can't prove that this information isn't useful, and the fact that the utility of information is unknown is not cause to ban its acquisition. IMHO, Personal Genomics is a personal right, in the same way that consensual sex, or recreational drugs are. As I mentioned elsewhere, the FDA should prioritize going after stuff that is actually proven dangerous or fraudulent/malevolent, not preeemptively trying to cut the kneecaps off of a potentially revolutionary new cottage industry. If they want to impose some silly advertising disclosure, fine, but I don't think the FDA should be in the business of banning this. Hopefully eventually someone makes a version which can be built by hackers, so people can shotgun analyze DNA at home and it becomes impossible to control.

cromwellian 13y ago

Lots of websites make key health recommendations based on family history/ancestry, and behavioral questionnaires. Why are they exempted? Why can someone make a website that asks you about age, drinking, smoking, activity levels, height, weight, etc and then make health recommendations, but if it comes from sampling DNA instead of verbal questioning of potential heredity traits, it's magically different and bad?

epistasis 13y ago
There's a significant amount that can go wrong in the laboratory when generating test results. So congress passed laws saying the FDA must regulate these laboratories. 23andMe chose not to comply with these regulations, to not collaborate with the FDA. Blaming the FDA is quite misplaced. If you want the laws to be different, congress is the part of the government with power to change the regulations. The FDA seems to be attempting to do the minimal amount required by law, and does not appear to be in the least bit overzealous with 23andMe. That 23andMe has not complied with basic QA and analytic reassurances should concern you greatly, and doubt the quality of 23andMe. What 23andMe is doing is somewhat equivalent to writing code and not having any unit tests, integration tests, or any QA team. Or perhaps they're doing all that, but don't want to report to the FDA. In any case, quite shady.
- Symmetry 13y ago
  23andme complies with all the rules governing genetics laboratories. It's the offering the results to consumers and the interpretation that the FDA says makes it the equivalent of a medical device rather than a medical laboratory, and which puts it under a separate, much tougher regulatory regime. EDIT: Of course Congress tells the FDA how it is to regulate genetics labs, and how it is to regulate medical devices. But I think the decision to regulate 23andme as a medical device is very much something the people in charge at the FDA had some leeway in.
  - timr 13y ago
    "23andme complies with all the rules governing genetics laboratories." You're misunderstanding the difference between "runs a competent lab" and "provides a genetic test that's useful for diagnostics". You can run a perfectly clean, professional lab, and still offer a useless (or dangerously misleading) test. The FDA, in this case, is more interested in the latter question than the former, and it's the most important question of all. The FDA is doing exactly what it should be doing here -- questioning the validity of the test itself, not the logistics of the lab doing the test.
    - cromwellian 13y ago
      Genetic tests are useful for many things, some people have used them for ancestry, especially African Americans who have traced history that had been obscured by slavery. I think "test" is even the wrong terminology. A better one would be "picture" or "snapshot". A photo can be used for many purposes, one of which is to make medical diagnoses. Personally, what I want from 23andme is not a diagnosis, I just want a dump of my DNA hyperlinked with relavent scientific artifacts on suspected function or links to diseases. The FDA can't prove that this information isn't useful, and the fact that the utility of information is unknown is not cause to ban its acquisition. IMHO, Personal Genomics is a personal right, in the same way that consensual sex, or recreational drugs are. As I mentioned elsewhere, the FDA should prioritize going after stuff that is actually proven dangerous or fraudulent/malevolent, not preeemptively trying to cut the kneecaps off of a potentially revolutionary new cottage industry. If they want to impose some silly advertising disclosure, fine, but I don't think the FDA should be in the business of banning this. Hopefully eventually someone makes a version which can be built by hackers, so people can shotgun analyze DNA at home and it becomes impossible to control.