4 ms·
> the risk of people maybe finding out something inaccurate and going crazy with it is higher than the reward of people finding out something accurate and takin
by pak 13y ago
> the risk of people maybe finding out something inaccurate and going crazy with it is higher than the reward of people finding out something accurate and taking action to preserve their health based on this information
I don't think this balance is as cut and dry as you claim it to be. There are very few "actionable" results that you can get from a 23andMe test right now, whatever they say to the contrary. The meat of the report that they currently provide is a list of alleles and associations to various properties, but there are thousands of alleles (and likely millions more not tested for lack of known associations) that sum to your particular phenotype. The math and science behind that summing process is severely lacking at this point, simply because we have not characterized the billions of interactions between them.
The FDA's problem with 23andMe is that they are not properly communicating this uncertainty in their marketing. Relevant to this issue is whether the reports can be called "medical" information or not. In order for things to live up to the standard of "medical" devices or therapies in the US, they have to pass a certain measure of QC, accuracy, and demonstrated efficacy. 23andMe hasn't done the legwork for any such tests, and from most accounts, it seems like the FDA has given ample effort to accommodate them so far.
This is not about hiding data from ignorant people. 23andMe will likely go on testing and providing reports. It just can't advertise it as "medical" until it passes the same standards as other medical products, just the same way I can't sell "Grade A" Beef unless it passes certain standards, or sell "bourbon" in the US unless it's aged in a charred-oak barrel. That is because we've decided as a society to link certain labels with standards, and the label would be pointless if it weren't applied consistently.