3 ms·

23&Me was using a medical test to give users data regarding their risks of certain diseases without sufficiently proving to the FDA that that data was accurate.

by lfuller 11y ago

23&Me was using a medical test to give users data regarding their risks of certain diseases without sufficiently proving to the FDA that that data was accurate. It's not a stretch to imagine someone acting on that information with potentially dangerous results; taking extra unneeded supplements, having elective surgery, dramatically changing their lifestyle to reduce the risk of some condition, etc.

Karunamon 11y ago
I'm so happy the FDA was there to prevent this company from doing the things with my genetic information that I asked them to do. Thank god for government.
- dekhn 11y ago
  Nobody prevented me from having Illumina sequence my genome (they gave me a hard drive with all the files along with medical interpretation). The difference is that Illumina did things legally (including hiring clinical genetics analysts who pored over the details and made a number of calls about what was significant). 23&Me did not. They were doing something that they would have known was illegal. The FDA explained this to them, and 23&Me blew them off. Failing to respond to an accusation from the government is an amateur move and 23&Me deserved what they got. They only went back and negotiated afterwards. You're complaining the government was restricting your freedoms but we have more than adequate evidence that 23&Me was acting irresponsibly.
  - ethbro 11y ago
    Out of interest, did you use the "TruGenome Predisposition Screen" offering? (Just looked up Illumina: I've been interested, but the 23&Me pricing/privacy concerns squicked me out)
    - dekhn 11y ago
      I did Understanding Your Genome http://www.illumina.com/company/events/understand-your-genome.html http://www.illumina.com/company/events/understand-your-genom... and I'm not 100% sure it's the same thing. Then I promptly uploaded my genome including the VCF files they used for risk screening, https://my.pgp-hms.org/profile/hu80855C https://my.pgp-hms.org/profile/hu80855C Anybody on the internet is free to analyze my genome.
      - ethbro 11y ago
        Thanks for the link. They seem to offer a number of different products ranging from the $1,000 "Here's your genome" to $10k "Here's your genome and a detailed analysis of what we've found in it." What's been your experience with analysis? Something that can be picked up, or something that the professional insights you got were far more useful?
        dekhn 11y ago
        My experience was interesting. The uyg clinical geneticists said I had zero genetic predisposition risk! That's a bit surprising it me. II also manually inspected the results and found that most of the risk variants they did see were just genic and I had only one of the snps out of several that are necessary for diseases such as types of cancer. Personally I found it less than useless, since I can't reasonably conclude I have no risks. I know enough genomics to conclude that beyond a few well understood cases, genomes have little medical predictive ability.
      - devonEnlis 11y ago
        Here is your data in a format for Enlis Genome Personal: https://s3.amazonaws.com/enlisinstallfiles/customerFiles/PG0001217-BLD.genome.zip https://s3.amazonaws.com/enlisinstallfiles/customerFiles/PG0... https://www.enlis.com/download.html https://www.enlis.com/download.html
- SapphireSun 11y ago
  Well to be fair, you can also ask a snake oil salesman for his snake oil, but there's a reason we regulate these things. The first users might be high information, but once something starts to get popular, people start making bad decisions. You can argue that people can ask for whatever they want (and they can) but whether you can sell anything you want has long precedent, especially in health related areas where misleading information leads to dramatic decisions being made.
  - jschwartzi 11y ago
    And, to be fair, the reason the FDA came into existence was because companies used to sell things that would seriously injure or kill you, and because there were no regulations they wouldn't advise you of the risks. Caveat Emptor doesn't help you if you have no way to become informed in the first place.

by lfuller 11y ago

Karunamon 11y ago

I'm so happy the FDA was there to prevent this company from doing the things with my genetic information that I asked them to do. Thank god for government.

dekhn 11y ago
Nobody prevented me from having Illumina sequence my genome (they gave me a hard drive with all the files along with medical interpretation). The difference is that Illumina did things legally (including hiring clinical genetics analysts who pored over the details and made a number of calls about what was significant). 23&Me did not. They were doing something that they would have known was illegal. The FDA explained this to them, and 23&Me blew them off. Failing to respond to an accusation from the government is an amateur move and 23&Me deserved what they got. They only went back and negotiated afterwards. You're complaining the government was restricting your freedoms but we have more than adequate evidence that 23&Me was acting irresponsibly.
- ethbro 11y ago
  Out of interest, did you use the "TruGenome Predisposition Screen" offering? (Just looked up Illumina: I've been interested, but the 23&Me pricing/privacy concerns squicked me out)
  - dekhn 11y ago
    I did Understanding Your Genome http://www.illumina.com/company/events/understand-your-genome.html http://www.illumina.com/company/events/understand-your-genom... and I'm not 100% sure it's the same thing. Then I promptly uploaded my genome including the VCF files they used for risk screening, https://my.pgp-hms.org/profile/hu80855C https://my.pgp-hms.org/profile/hu80855C Anybody on the internet is free to analyze my genome.
    - ethbro 11y ago
      Thanks for the link. They seem to offer a number of different products ranging from the $1,000 "Here's your genome" to $10k "Here's your genome and a detailed analysis of what we've found in it." What's been your experience with analysis? Something that can be picked up, or something that the professional insights you got were far more useful?
      - dekhn 11y ago
        My experience was interesting. The uyg clinical geneticists said I had zero genetic predisposition risk! That's a bit surprising it me. II also manually inspected the results and found that most of the risk variants they did see were just genic and I had only one of the snps out of several that are necessary for diseases such as types of cancer. Personally I found it less than useless, since I can't reasonably conclude I have no risks. I know enough genomics to conclude that beyond a few well understood cases, genomes have little medical predictive ability.
    - devonEnlis 11y ago
      Here is your data in a format for Enlis Genome Personal: https://s3.amazonaws.com/enlisinstallfiles/customerFiles/PG0001217-BLD.genome.zip https://s3.amazonaws.com/enlisinstallfiles/customerFiles/PG0... https://www.enlis.com/download.html https://www.enlis.com/download.html
SapphireSun 11y ago
Well to be fair, you can also ask a snake oil salesman for his snake oil, but there's a reason we regulate these things. The first users might be high information, but once something starts to get popular, people start making bad decisions. You can argue that people can ask for whatever they want (and they can) but whether you can sell anything you want has long precedent, especially in health related areas where misleading information leads to dramatic decisions being made.
- jschwartzi 11y ago
  And, to be fair, the reason the FDA came into existence was because companies used to sell things that would seriously injure or kill you, and because there were no regulations they wouldn't advise you of the risks. Caveat Emptor doesn't help you if you have no way to become informed in the first place.