3 ms·
pay lip service to the FDA, and steadfastly refuse to respond Seems to me that they've been going back and forth with the FDA for some time. My interpretation
by crusso 13y ago
pay lip service to the FDA, and steadfastly refuse to respond
Seems to me that they've been going back and forth with the FDA for some time.
My interpretation is that the FDA wants a strict legal interpretation that the AMA would be happy with. Probably the AMA would only be happy if doctors could get a cut of every genetic "test" being performed by 23AM.
Only by very careful wording, and even then only subjectively so
Subjectively, any interpretation is possible of even short sentences. I've learned that from years of arguing the inerrancy of the Bible and the Koran with fundamentalists for decades.
The takeaway for me is that you admit that they've carefully worded their claims so as to not give the overt impression that they provide tools for clinical medical diagnoses.
All the claims you quoted are well within the realm of possibility based upon the tagging of genetic markers.
For comparison, I'm an EMS provider. We are taught all through school that we don't diagnose
Yeah, but that's actually not because you couldn't be of a huge help with early diagnoses. It's because you have strict liability concerns thanks to a tort system that consistently reinforces suboptimal emergency medical outcomes in the name of risk reduction. I hardly think that your industry's lowest-common-denominator liability concerns are a good basis for how we treat cutting edge genetic tagging and correlation services.
At the end of the day, I didn't pay 23andMe to become a member so that I could learn of the handful of markers and correlations that could pass muster with bureaucrats at the FDA. And if I weren't willing to pay for that handful of markers for $99, I certainly wouldn't want to pay a lot more for a service that couldn't achieve economies of scale at $99 because they had to CYA to such a high degree.
I'm an adult who consents to 23andMe to have my saliva, pull out markers and do their best to show me correlations that might interest me. Why is the desire to have that liberty so difficult to understand?