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
Third
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.
Lastly,
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.
Thursday, June 24, 2010
No more 23andMe blog posts. The Sherpa has achieved his goals.
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8 comments:
So the end of an era?
Now you have freed up 90% of your time I look forward to your opinion on other providers - e.g. EG (Evidence Genetics). I'm gradually getting through the book, not sure if I will review it - depends how the plot develops. So far there are some good things (e.g. we don't know anywhere near anything, but we have enough to start now) and there are some not so good things (variants that "are known to cause ... love handles").
Also it is clearly a big advert for the authors own products and services - since that is pretty clear in the text it's not such an issue,although it does mean that it cannot be considered to be an objective dispassionate account of personal genetics and the commercial offerings available.
Really, I think that these types of services also need watching very carefully - I am absolutely not saying there is anything wrong with EG, but this area as a whole (products and services created and delivered by MDs) is so opaque that it needs scrutiny. In fact regarding EG I am glad that it has launched itself with high profile marketing - that in itself will help with scrutiny and transparency.
You have listed a lot of "I told ya so's above". Fair enough, also a lot of us have been saying for several years that transparency is the key - even if FDA step in. But it needs to be the same everywhere - we don't want to go back to the days of docs selling their own back-room medicinal concoctions.
@Keith,
Oh, I agree. I will be reviewing the services. That is a guarantee. I will look under the hood, just like I am doing now with labs for GeneticHub.
oops: "e.g. we don't know anywhere near anything" should have been "e.g. we don't know anywhere near everything" of course!
A word of advice: these kinds of posts would have greater impact, and be easier to take seriously, if they came with even a smidgen of modesty, especially given your non-scientific background. You're one worker in the field; simply because I write a blog saying the sun should rise tomorrow doesn't mean I should gloat when it does.
@Anonymous,
Duly noted. But I will add that no one pushed these guys harder for these things than I.
" if they came with even a smidgen of modesty, especially given your non-scientific background. You're one worker in the field; simply because I write a blog saying the sun should rise tomorrow doesn't mean I should gloat when it does."
That being said.....
Non-scientfic? How about the educational research I do? Or how about the scientific research boards I sit on? Or how about the....well, I am not going to go on here.
Listen, after reading again, you clearly have an axe to grind with clinician scientists.....
That being said, smugness is not becoming and I agree. But the rest of your veiled attempt to discredit all the hard work I do and the fact that I predicted just about all of this with DTCG did not go unnoticed that long.
I even told the president elect of ACMG that he shouldn't support it because it trivialized the field without having clinicians involved.
Do your comments mean you place science above actually caring for human life?
Or are you part of a DTCG "research revolution"?
Even if you are a clinician, you are gravely mistaken if you think I am not involved in the science.
Further, you are gravely mistaken to minimize the voice of a clinician who does personalized medicine every day.
I am an expert in PM. End of Story.
Anon has a point about your style (but that's not news), as for the rest Anon is wrong to assume things he/she is ignorant of, it happens too often in comments that the commenter makes negative assumptions about the poster or other commenter.
Also it's not good style to hide behind "Anonymous"
Anon should not get grief for being "anon". What he said was true (Murphy adopts an arrogant tone in his blog, out of proportion to his scientific expertise), and that's all that counts.
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