They had asked to see such proof starting in 2009 and the company refused. Maybe 23andMe figured all that money spent on campaign contributions was going to get them a free-pass, it is difficult to know, but by 2013 the FDA was not having it, sending them a letter threatening "seizure, injunction, and civil money penalties" unless they pulled their marketing claims or submitted evidence for review, the same as every other medical 'device' must do.
After that, 23andMe backed off its aggressive and unproven statements and reverted to more 'for entertainment purposes only' marketing regarding whether or not people might be related to Charlemagne while they prepared their FDA mea culpas and reconfigured to something they could back up - and it worked, the FDA is now allowing them to market a public carrier screening test for Bloom syndrome, which affects 1 in 50,000 people, mostly of Ashkenazi Jewish descent and that results in being small in stature, under five feet tall, along with higher cancer risk. A baby step, and 1 of 250 conditions that they claimed to help screen for by analyzing users' genetic code in the past, but it is something they could prove.
That they made the effort at all is a sign of a culture change within the company, and that means they might get 50 more tests validated. Prior to being told to stop with the marketing claims by the FDA, they had run afoul of ethical informed consent rules, by publishing personal health data without getting permission and hiding behind the legal wrinkle that since no one physically came to their offices (the investigators had not 'met' the subjects) they were not bound by informed consent rules. Legally, they were correct, but like in anything else when someone defends an ethical violation because of a legal loophole, it looks bad.
That sort of disdain for the rules of science was eventually going to get a backlash, and it did. Jeffrey Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health, pulled no punches when they finally put the brakes on 23andMe:
FDA is not standing in the way of 23andMe selling tests intended to help consumers trace their ancestry, identify relatives and tell them why they like or don’t like the taste of cilantro.Translation: You are the WWE of genetic testing so stop calling yourself a sport.
Regardless whether WWE is a sport or not, its participants are world-class athletes and 23andMe likewise has the ability to show what it can do, so it is good news that they finally learned to play by the same rules everyone else must follow, and not just organize trips to Washington, D.C. to lobby Democrats to try and pressure the FDA into giving them a free pass.
The big question remains, can the public understand the test results? That has to be part of the awareness campaign. Prior to 23andMe getting slapped by the FDA, in talks I had with genetic experts and MDs, the biggest concern was that all of those screening companies were scaring people, and a GAO investigation busted 15 genetic testing companies, which made claims like that they can repair DNA damage or their supplements can cure all kinds of diseases.
False positives in tests clearly scare a lot of people and a misread genetic test, along with promoting understanding that a risk factor is not 'you have an X% chance of getting Y', is going to be key as these become more popular.
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