The FDA had a problem with the company’s marketing of the product because, as Consumerist put it, the company decided to say that it’s the “‘first step in prevention’ that enables users to ‘take steps toward mitigating serious diseases’ like diabetes, coronary heart disease, and breast cancer.” 23andMe also submitted applications at one point to the FDA for review and then never actually followed through on providing the requested follow-up information. I find it boggling that people are willing to justify this behavior just because they like the product. I doubt people would be jumping up to argue that the FDA is just protecting the insurance companies’ interests because we should just be able to do all our own blood and urine tests at home, even if they saw a similar ad to 23andMe’s for at home labwork. Fun Fact: the FDA approves home drug tests and you can still take them - they just have to be tested and approved first. Otherwise, what would stop people from creating their own pseudo-scientific tests and promising to diagnose people with illnesses for profit?
Additionally, while people may not immediately go and have a mastectomy due to a false-positive BRCA result, they may wind up spending hundreds or thousands of dollars on secondary testing, not to mention the psychological toll.
I also don’t understand why everyone is assuming that a billionaire’s wife must be totally innocent and pure of heart and the FDA must be full of heartlessly conniving evil monsters.
