I am absolutely done talking about 23andMe.
Yes, you have heard correctly.
That doesn't mean I will stop watching what they are doing.
It means that I have coerced them into doing what's right. For now.
From the very beginning 23andMe had potential, heck Dr. Jeremiah Mahoney told me they came up to Yale to see them.
They must have not liked what Yale said, because they went further up the line and partnered with George Church.
Well, they def. didn't like what I had to say.
I had even conjectured about DTCG and what this landscape may look like and even warn about the shortcomings,
I had been pointing all of you to SACGHS to watch where this regulatory environment may go. The environment was heated with these companies going in.
So I knew I had to pay attention to what they were doing, especially the Google Backed company.....
First when these companies launch
1. I immediately point out 23andMe isn't using a CLIA certified lab which gives me grave concern over the seriousness with which they are doing testing. A-la Garage lab versus proper human sample processing.
2. I complain on Daniel MacArthur's blog about the obvious rookie blunder this company with no healthcare experience in leadership makes
Then 23andMe uses a CLIA certified lab
Second, I tell you that the states who have serious laws against DTC will shut down these companies quickly
Then they shut 'em down for a bit. And I gloat
1. I complain that FDA needs to get their act together and in 2009 23andMe began doing absolute truly clinical testing with BRCA testing.
2. I point out the SACGHS feels the same way too and also complains to the FDA
3. I point out that 23andMe has no clinical clue what they are doing with PGx
Guess what? The FDA finally rules for regulation.
1. I complain about this research revolution akin to Tuskegee or other non IRB approved "research"
2. I point out that Google has off shore servers to hold this data free of US regulation.
3. I say that they are coercing subjects and offering discounts that wouldn't fly in an IRB
Today, they announce they have obtained IRB approval.
But I have my doubts as they have flaunted loopholes in laws And seem to point that out again today, or at least their blogger does.....
"our research technically does not require IRB review."
So I guess I will have to keep posting until these guys stop skirting lines..............Nevermind
The Sherpa Says: Yes, why keep it up if they did what I asked? Because they will do it again, even if it takes an act of Congress. Why do I ask? To protect the patient and consumer from mega corporations whose interest is anything but patient empowerment.