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It's not in the FDA's remit to be regulating research, that would be an infringement of academic freedom, it can however regulate commercial entities using that

by tfgg 13y ago

It's not in the FDA's remit to be regulating research, that would be an infringement of academic freedom, it can however regulate commercial entities using that research to sell devices to the general population, who don't have the tools to judge the research -- published research isn't absolute truth, just a report by a researcher(/group) of what they've observed and what they think. The extra context they add around the research goes beyond just 'hyperlinking' and it's right to regulate. Do you think quacks should be able to present legit research as supporting their claims?

cromwellian 13y ago
Real quacks present do this all the time and no one stops them, and they are far more dangerous. People are making money selling anti-vax books and videos after all, but we can't regulate those, but we can shown that millions of children have potentially been harmed by these claims far far more than 23andme. Basically what you're saying is, consumers are idiots, so they don't have the rights to judge such information. Really, if a consumer is found to have BRCA, and shown links to academic research that have a statistical correlation between BRCA and breast cancer, what do you think they're going to do, go cut off their breasts themselves? No, they're going to go visit a real doctor and say "look what 23andme said about me, what do you think doc?" And the doctor is going to order more thorough tests. In almost every scenario you can imagine, someone reading a 23andme report about themselves, even one loaded with false positives, is going to generate a visit to a medical professional for interpretation and advice. 23andme is not telling anyone to self-treat based on such information. The only scenario anyone can claim would be truly dangerous would be someone getting a false negative clean profile and going "welp, I'm perfectly healthy, no need to bother with my regular checkup". Now really, do you believe someone who paid $99 to 23andme and is actively seeking personal medical information is the kind of person who avoids doctors? We have lots of problems in this society, and the problems of people avoiding doctors can be boiled down to either a lack of health insurance, or issues surrounding personality that have little to do with 23andme. The FDA is preemptively regulating a new industry based on relatively weak theories of harm, and my point is, they simply have better things to do. At least let 23andme get off the ground and you have actual data on people's response to it before you start hammering them and triggering stupid class action lawsuits from people who haven't even been harmed. The FDA is potentially killing a startup over administrivia.

by tfgg 13y ago

cromwellian 13y ago

Real quacks present do this all the time and no one stops them, and they are far more dangerous. People are making money selling anti-vax books and videos after all, but we can't regulate those, but we can shown that millions of children have potentially been harmed by these claims far far more than 23andme. Basically what you're saying is, consumers are idiots, so they don't have the rights to judge such information. Really, if a consumer is found to have BRCA, and shown links to academic research that have a statistical correlation between BRCA and breast cancer, what do you think they're going to do, go cut off their breasts themselves? No, they're going to go visit a real doctor and say "look what 23andme said about me, what do you think doc?" And the doctor is going to order more thorough tests. In almost every scenario you can imagine, someone reading a 23andme report about themselves, even one loaded with false positives, is going to generate a visit to a medical professional for interpretation and advice. 23andme is not telling anyone to self-treat based on such information. The only scenario anyone can claim would be truly dangerous would be someone getting a false negative clean profile and going "welp, I'm perfectly healthy, no need to bother with my regular checkup". Now really, do you believe someone who paid $99 to 23andme and is actively seeking personal medical information is the kind of person who avoids doctors? We have lots of problems in this society, and the problems of people avoiding doctors can be boiled down to either a lack of health insurance, or issues surrounding personality that have little to do with 23andme. The FDA is preemptively regulating a new industry based on relatively weak theories of harm, and my point is, they simply have better things to do. At least let 23andme get off the ground and you have actual data on people's response to it before you start hammering them and triggering stupid class action lawsuits from people who haven't even been harmed. The FDA is potentially killing a startup over administrivia.