23andMe vs. the FDA in less than 4 minutes

At what point does interesting-but-potentially-incorrect-or-misleading information become a potential threat to health? How do you regulate a product that current regulations were never set up to handle? The University of Michigan's Risk Science Center put together this quick cartoon that neatly summarizes the problems and questions at the heart of the FDA's crackdown on 23andMe, which Xeni wrote about on Monday.

A couple of other smart takes on this that have come out in the past couple of days:
• Genomics expert Michael Eisen delves deeper into the question of how we should regulate personal genetic testing.
Journalist David Dobbs rounded up some diverse opinions. You should pay attention to his blog. He's been doing a lot of great reporting on genetics and culture and is planning on publishing a longer piece on the 23andMe stuff later this week.

Notable Replies

  1. Does anyone know if there's a UK equivalent of 23andme?

  2. Old says:

    Yes, I believe there's a company out there that will translate Cockney Rhyming Slang for a modest fee, so a person can understand how they've just been insulted and make an informed decision with regard to their response.

  3. I think it's completely valid to require some kind of certification for 23andme. If people are going to lop off their breasts after reading a report, someone should make sure that the test is accurate and that the diagnosis is presented in a way that is consistent with the science.

  4. 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.

  5. Point taken. I didn't mean to imply that but it definitely came across that way.

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