About the title — that’s the FDA talking, not me. It’s their apparent attitude toward people who dare learn about their genes.
For $99, 23andMe analyzes your saliva and tells you about your DNA. Their site includes plenty of caveats about the possible emotional impact of the information, the possibility of errors, the limits of what one can infer about health tendencies, the advisability of taking no remedial action without further testing and consultation.
Nevertheless, the FDA has sent a WARNING LETTER to 23andMe co-founder and CEO Ann Wojcicki expressing concern that customers may, for example, rush to have dangerous prophylactic surgery like breast removal if they learn about some genetic risk factor. The company must stop marketing its product until it satisfies FDA regarding false positives, recipients with no common sense, etc. Otherwise, the agency just may have to seize 23andMe and impose penalties.
Yet, as Harry Binswanger notes, “A false positive does not force you to obey it.”
Wojcicki has now spoken up about the FDA’s letter, allowing that 23andMe is “behind schedule” in providing FDA with information, calling the bullying agency a “very important partner,” and in general speaking very carefully while stressing that new technology is not per se a bad thing.
What she doesn’t say is that any FDA interference with our ability to buy and evaluate information about our DNA, and Wojcicki’s right to discover and sell it to us, would be a very bad thing.
This is Common Sense. I’m Paul Jacob.