3 ms·

Lots of websites make key health recommendations based on family history/ancestry, and behavioral questionnaires. Why are they exempted? Why can someone make a

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.
      - timr 13y ago
        "Genetic tests are useful for many things" Nobody is arguing that they aren't. The point is, you know nothing about the accuracy or precision of the test in question. Just because it's "genetic" doesn't mean it's a valid test. "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." That's just Not Even Wrong. The FDA's mandate isn't to prove that a drug or test isn't useful before regulating (an impossible bar) -- otherwise, we'd be back in the bad old days of patent medicines. The FDA is there to ensure that the risks of drugs and medical tests are balanced by their benefits.

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.
    - timr 13y ago
      "Genetic tests are useful for many things" Nobody is arguing that they aren't. The point is, you know nothing about the accuracy or precision of the test in question. Just because it's "genetic" doesn't mean it's a valid test. "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." That's just Not Even Wrong. The FDA's mandate isn't to prove that a drug or test isn't useful before regulating (an impossible bar) -- otherwise, we'd be back in the bad old days of patent medicines. The FDA is there to ensure that the risks of drugs and medical tests are balanced by their benefits.