
23andMe bows to FDA, drops all medical information from new tests - Jtsummers
http://arstechnica.com/science/2013/12/23andme-bows-to-fda-drops-all-medical-information-from-new-tests/
======
yoloswaggins
I don't see why they can't just put up a disclaimer that's like "This is only
an indication of medical issues you may have. Always consult a doctor." Or
something like that.

How come they try to make these guys shut down, but largely leave homeopathy
alone? I would say homeopathy is way more damaging than seeing whats in your
genes.

Why does the FDA have to be jerks? (that's rhetorical. I know why they have to
be jerks. It just sucks.)

~~~
potatolicious
Because 23andMe can't run a disclaimer like that without being either:

\- totally disingenuous

\- defeating the core marketing angle of their product

Either they are issuing the disclaimer in good faith, in which case their
marketing becomes "we don't really know for sure, this is just a for-fun
thing, do not base any health decisions off this". This is antithetical to
what 23andMe is _trying_ to do.

Or they issue the disclaimer in bad faith - i.e., they claim certainty in
their information, they claim reliability, and they market the product as a
medical tool, and then slap a shitty disclaimer on the bottom like the small-
print of a crappy infomercial purely for legal reasons.

The latter approach is just creative mislabeling, like calling vibrators
massagers.

~~~
erifneerg
I was listen to an old episode of Radio lab
([http://www.radiolab.org/story/91713-famous-
tumors/](http://www.radiolab.org/story/91713-famous-tumors/)) and they had an
ad for 23andme. The ad most talked about how you can use this information and
talk it over with doctor. The ancestry reports was just a side thing mentioned
at the end.

------
throwaway_yy2Di
Next week:

 _Show HN: Saliva Road -- genomics as a Tor hidden service. We accept
Bitcoins!_

 _-DreadPostdocRoberts_

~~~
AsymetricCom
Somehow I feel safer with a random pirate having my DNA in a database than
Google.

~~~
swalsh
It probably is safer in that, you will pretty much assume it will be use for
nefarious purposes eventually. So going in you probably have the right mind
set to protect yourself.

~~~
jonlucc
I'd like to announce here to HN before the rest of the world my new service:
the Twitter of personal genomes. It will publish all the data to the web. No
expectation of privacy? No problem! I will call it genr.

------
imjoshdean
Well, this makes the fact that I asked for this for Christmas awkward AND
useless...

~~~
gwern
My sentiment exactly. 2 days ago I put it on my wishlist, reasoning that even
if they weren't _marketing_ , the results would still be interesting. What if
I get a kit now? Do I manually look up everything in SNPedia or something?

~~~
sitkack
I have an unused kit from the 99$ sale years ago... Crap. Will they still
provide all of the data? One could create a 3rd party service to give the same
analysis?

~~~
chewmieser
From their FAQ:

I purchased a kit as a gift before November 22nd, but have not given it to the
recipient. Will they still receive health results when they send it in? Yes.
Access to health-related results is based on the purchase date of the kit. Any
kit purchased before November 22, 2013 and returned to our lab will receive
health-related results.

That being said, aren't the kits only good for a year?

------
pbreit
They need to buckle down, work with the FDA and fully recognize the gravity of
the information they are presenting to people. I can't imagine that they won't
be able to do this.

------
baddox
Obviously most of the blame goes to the FDA here. The only problem I have with
23andMe's handling of the situation is that they continued to sell kits after
November 22 _promising that health information would be available_ and then
retroactively removing that part of the service. I ordered the kit one day
before they announced this, so I guess as soon as it arrives it's going back
in the mail for a refund. They should have immediately removed the promise of
health information on November 22.

~~~
ceejayoz
Why does most of the blame go to the FDA? From their complaint:

> More than five years after you began marketing, you still had not completed
> some of the studies and had not even started other studies necessary to
> support a marketing submission for the [testing service]," the letter
> states. It also says that in January 2013, 23andMe claimed that it was doing
> further testing for its approval application, testing that would take
> several months to complete; nearly a year later, it never submitted the
> results of the testing.

~~~
fennecfoxen
Because the FDA is the one who ultimately wants this removed, and because by
default most of society operates without seeking permission from the
government to do anything.

And maybe because the FDA is stupid and thinks that the risk of people maybe
finding out something inaccurate and going crazy with it is higher than the
reward of people finding out something accurate and taking action to preserve
their health based on this information. Ignorance is the only safe option!

~~~
tptacek
All sorts of things require permission from the government. You can't even
sell meat without a USDA inspection at some point in the process. The idea
that a modern company could reasonably expect to sell medical diagnostic
services without working with the FDA is silly.

~~~
Symmetry
I think that this is actually a very complex issue, and the part that more
informed people are finding problematic isn't that people are regulating
23andme at all. There are lots of genetic laboratories in the US where you can
send in a sample of DNA and they'll tell you things like that you've got the
G:A or A:A variant of Rs601338. A laboratory that does stuff like that is
covered under CLIA[1], administered by CLS which like the FDA is part of the
DHHS.

The FDA's theory here, though, is that since 23andme goes beyond just saying
"You have the G:A variant of Rs601338" to "You are probably as susceptible to
norovirus infection as a typical person" they're not just a medical laboratory
but also a medical device manufacturer, and therefore come under the FDA's
purview with much stricter tests for what they can market and what sort of
tests their product undergoes.

To me, that sounds pretty ridiculous since you can easily just go on SNPedia
to look up the associated information yourself[2].

[1][http://www.cms.gov/Regulations-and-
Guidance/Legislation/CLIA...](http://www.cms.gov/Regulations-and-
Guidance/Legislation/CLIA/index.html?redirect=/clia/)
[2][http://snpedia.com/index.php/Rs601338](http://snpedia.com/index.php/Rs601338)

~~~
pak
You realize that SNPedia is basically the equivalent of Wikipedia for SNPs,
and I can edit it to say whatever I want?

Would you want a physician picking your drug regimen based off of what
Wikipedia says on some particular day? Would you like your implanted
defibrillator to change its algorithm based on something Wikipedia says?

If not, then you've discovered the crux of the issue. There's a bright line
between "data that someone put online yesterday" and "rigorously tested and
proven effective". That's the whole point of FDA regulation on what gets to be
marketed as a medical device, or what drugs can be prescribed for an
indication.

------
300bps
I guess I will be making screenshots of all the health information in my
23andme account now. Who knows if they'll be allowed to keep it up there
indefinitely?

~~~
jonlucc
I don't yet have one. Is there not a way to download your information? They
should certainly allow some sort of export.

~~~
ideonexus
I have an account. You can export your raw data from the test. I've done so
and actually taken my results to other services for additional analyses. You
can't, however, easily download their interpretations of your results, which
is fair since that's their website. I did actually take the time to go page by
page through their analysis and print them to pdfs.

If you're interested, I did a write-up on everything I've learned through
personal genomics with resources, etc:

[http://ideonexus.com/2012/04/16/adventures-in-personal-
genom...](http://ideonexus.com/2012/04/16/adventures-in-personal-genomics/)

------
mbreese
Prior discussion from last night...

[https://news.ycombinator.com/item?id=6859732](https://news.ycombinator.com/item?id=6859732)

------
jrkatz
I purchased and sent in my kit before they removed medical information from
their website. However, it hasn't processed yet. I expected that medical
information (even though I knew not to trust it). What an awkward position.

~~~
throwaway0094
Yeah, me too. The primary reason I purchased this is that I know I have 50%
odds of having a BRCA mutation (1 of my parents does). I was really looking
forward to that test.

~~~
streptomycin
This is exactly why the FDA is acting correctly here!

Dig deep on the 23andme website and you'll find that they test for a few BRCA
mutations, but not all. It's far from comprehensive, and it's not at all
equivalent to a normal test that you would get from a doctor. From
[https://customercare.23andme.com/entries/23241132-Does-
the-2...](https://customercare.23andme.com/entries/23241132-Does-the-23andMe-
service-include-analysis-of-the-BRCA-gene-) "The BRCA Cancer Mutations
(Selected) report includes 3 selected BRCA mutations. The BRCA mutations
covered by this report are only three of hundreds in the BRCA1 and BRCA2 genes
that can cause cancer."

I've seen several commenters here on HN making the same mistake as you. HN
readers are generally smart and skeptical. If we aren't perceptive enough to
see through the bullshit, how do you think the general public is going to
fare?

~~~
jonlucc
Are the BRCA genetics well enough understood that a deep sequence of that gene
is able to be adequately interpreted?

Ultimately, what you seem to be suggesting is that it is better that we not
get partial data because most people won't understand that it's partial data
and further won't know what to do with it. Most people are not geneticists. I
sort of agree, but there is no doubt in my mind that the future will see the
loosening of the physician-as-gatekeeper, and to what extent is that
acceptable. Would this service be allowed if they taught cursory genetics and
SNPs in the general biology curricula at the high school level?

~~~
streptomycin
_Are the BRCA genetics well enough understood that a deep sequence of that
gene is able to be adequately interpreted?_

It's not my field, but I know they're well enough understood that you can get
far more information from the full sequence than from a few SNPs. Even 23andme
has always said the same thing on their website if you look closely.

 _Ultimately, what you seem to be suggesting is that it is better that we not
get partial data because most people won 't understand that it's partial data
and further won't know what to do with it._

I wouldn't quite say that. I think partial data is perfectly fine. I'm a
23andme customer, despite understanding that it's close to meaningless from a
medical perspective (I think the most valuable medical information I got was
related to male pattern baldness; coolest information is the Neanderthal
stuff). The problem IMHO was 23andme's marketing, which to me seemed almost as
if it was designed to mislead people.

Another example... over thanksgiving I was talking to my cousin. She brought
up the 23andme news because she had recently done it, but hadn't received
results yet. I asked her why she got the test. First answer? BRCA. She had no
idea that the 23andme test was not nearly comprehensive. And she's not just
some average person not smart enough to understand things - she has a PhD from
MIT (albeit not in biology, although her husband has a biology PhD), knows a
lot about breast cancer since her mom had it, and is generally very cynical
about stuff like this.

 _Would this service be allowed if they taught cursory genetics and SNPs in
the general biology curricula at the high school level?_

I think high school curricula are irrelevant to the discussion, for multiple
reasons. The vast majority of high school students don't have the background
to understand this stuff. Even if they did, most wouldn't care enough to
remember it. And even if they did care, the science is changing rapidly - it
won't be too long before we're doing whole genomes and many other things.

------
scotty79
So... opensource tool for healthy interpretation of raw data from 23andme?
Anyone?

~~~
pak
If Valley folks created this, it would be the holy grail that NIH-funded
bioinformatics researchers have been pursuing for the last 20 years. I wish
them the best!

In all seriousness, this is exactly the point of most federally funded
research in genomics, including the projects of the institute I work for.
[http://icahn.mssm.edu/genomics](http://icahn.mssm.edu/genomics)

