
23andme has suspended health-related genetic tests - Taeram
https://www.23andme.com/ancestry-only-notice/
======
Afforess
This seems to be the nuclear option. As a (now fortunate) previous purchaser
of 23andme, I still have my health information. The information is really
valuable, and considering the price ($99!) it is cheaper than a lot of
standard medical exams and bloodwork. Obviously not a replacement for any of
those things, but it's amazing they can offer DNA health results for so
little.

The FDA seems to be mostly concerned that the results of 23andme could be
misinterpreted, or wrong. As far as I am aware, 23andme was advertising the
health assessment as the first step in prevention - not a one stop shop for
diagnosis. I am not very impressed with the FDA.

~~~
timr
Here's the deal: you have a report. You have no way of knowing if the
information in the report is correct, or not. You may have paid $99 for
something that's completely fictional. You just don't know.

Is that your "right"? Sure, to some extent. A sucker is born every minute, and
if you desperately want to be one of them, the US Government is mostly content
to let it happen. We'll even let companies do _patently absurd_ things like
sell you pills that are supposed to make your dingus larger. We just _limit
what they can say_ when they're selling them to you, to protect the most
credulous among us.

Like it or not, our society has decided that certain forms of charlatanism are
so egregious that we act proactively to prevent them. Medicine is one area
where we are strict, because our country has survived a rather nasty era where
unfettered "medical innovation" was allowed to kill large numbers of people. I
have a vintage Merck manual sitting on my desk, and it recommends such
wonderful treatments as oral arsenic for hair loss (to be fair, you probably
care a lot less about being bald when you're dead...) and vinegar (via
injection!) as a cure for cancer. That's "medical innovation" without
regulation to enforce safety and effectiveness, and I don't particularly want
to go back to it. Maybe you do.

The FDA is doing its job rationally here, it is well within its mandate, and
as far as anyone who _knows what they 're talking about_ can tell (including
the leaders of the company), 23andMe is just clearly in the wrong on this
issue. So if you don't like the laws we've set up to protect consumers against
medical malpractice, I guess that's your opinion, but it's obviously dumb to
blame the FDA for doing exactly what it's supposed to be doing.

~~~
patrickaljord
This is ridiculous, you take extreme examples to prove your point. So let's
see, you can still read about all this and worse on the internet, do we still
have people taking arsenic en masse to cure baldness? No. Because most people
are responsible and giving them the freedom to do what they want with their
body is more important than anything else. Plus, if someone is ignorant enough
to drink arsenic to cure baldness, he'll probably find other ways to hurt
himself anyway, FDA or no FDA.

So let's go back to the FDA, is it so effective? Here is the FDA authorizing a
drug that killed lots of people [http://www.undergroundhealth.com/fda-
approved-prescription-d...](http://www.undergroundhealth.com/fda-approved-
prescription-drugs-kill-hundreds-of-thousands-of-people-annually/) Also, the
time the FDA takes to approve a good drug can take more than 10 years, how
many people die because of this unseen consequence?
[http://en.wikipedia.org/wiki/Criticism_of_the_Food_and_Drug_...](http://en.wikipedia.org/wiki/Criticism_of_the_Food_and_Drug_Administration#Alleged_problems_in_the_drug_approval_process)
Not to forget its reluctance to approve drugs for political reasons (canabis).

So let's see, many people die because of wrongly approved drugs and many die
as it takes too long to approve good ones because of the FDA. Now let's
imagine a world with no FDA, many people would still die, but at least they'd
have the choice to do so on their own decision and not have to wait on a nanny
state bureaucracy to tell them what's good or bad for them and many times
wrongly so. Why not let people freely decide what they can do to their own
body when not doing so still kills a lot of people too? Plus, allowing so
would make it much faster to detect when a drug works or not and save way more
lives. If you don't even own your own body, what do you own?

~~~
timr
_" do we still have people taking arsenic en masse to cure baldness? No."_

Yeah, we have things called "clinical trials" that pretty much put an end to
the bad old days of patent medicine. Guess who enforces that stuff?

The rest of your post is a straw-man. Does the FDA make mistakes? Sure. That
doesn't invalidate the need for the agency. Is it your right to do stupid
things with your body? See previous comment.

~~~
patrickaljord
>> "do we still have people taking arsenic en masse to cure baldness? No."

> Yeah

No, we don't. I said "en masse", that is to say, do we have a massive amount
of people taking arsenic everyday to cure boldness? No we don't, and yet
anyone can read about it on the web.

> Does the FDA make mistakes? Sure. That doesn't invalidate the need for the
> agency.

Yes it does, I've just explained that the FDA is responsible for more death
than if we had no FDA while taking away people's freedom do cure themselves
the way they want.

> Is it your right to do stupid things with your body? See previous comment.

Well, according to you, only if the FDA approves so, the same FDA responsible
for countless deaths. No thanks.

------
Steuard
We can learn a bit more about this dispute from how 23andMe has responded
here.

Given that 23andMe is still willing to release their raw genotype results, it
seems clear that the FDA isn't objecting to that level of their work. That's
comforting: evidently at least that is considered more or less accurate.

Instead, they've only redacted "23andMe’s interpretation" of the data from
their reports to new customers. My take on this is that the FDA wants some
sort of rigorous demonstration that 23andMe isn't making errors in its
interpretation of medical data. I'm thinking specifically of stories like this
one: "My deadly disease was just a 23andme bug"
[https://news.ycombinator.com/item?id=6796219](https://news.ycombinator.com/item?id=6796219)
It's hard to know (as a simple consumer) how common that sort of error might
be: I rely on folks like the FDA to set and enforce quality standards on such
things.

Similarly, I honestly don't have a great sense of how well 23andMe's
interpretations reflected the full current state of known science. For
instance, my memory is that they were only able to test for a few of the known
breast cancer risk factor genes because others are still covered by patents.
How clearly did their interpretation pages convey those gaps in what they were
presenting?

I hope that 23andMe finds a way to get fully back online before long. But
honestly, I'd be happiest if they manage to satisfy the regulators that they
really are getting things right. _Someone_ needs to verify claims like that
for the rest of us!

~~~
bengotow
I agree - Here's a company that built a complex software system, loaded it
with "if" statements pulled from research papers, and started marketing itself
as a predictor of cancer and disease. How did they do their research? What is
their threshold for determining if scientific evidence is conclusive enough to
merit telling the world they could have a major disease? The FDA wants to
know, and so do I.

~~~
cromwellian
So now, people will just export their data and third party companies will
provide such interpretation and the FDA won't be able to touch them. How soon
until github has an open source project to read and interpret 23andme data-
dumps?

~~~
asdfaoeu
Most likely anyone providing such information would also be in a similar boat
with regards to the FDA.

Sure you could be overseas providing the data but it's not like the FDA is
preventing you from getting overseas treatment.

~~~
cromwellian
I doubt it, since those people aren't making any medical devices. Moreover,
the SNPedia can be used by anyone, so an open source tool can be written and
deployed as an app. I highly doubt the FDA will be able to stop that.

Trying to stop someone from analyzing their health data dump is about as
useless as trying to stop bitcoin transactions. About the only thing the
government can try to do is to stop the public from being able to use DNA
microarrays, but how long is it going to be before a cheap, consumer grade
version of such chips can be made and sold in a way that the FDA can't
regulate them?

------
downandout
Since they are discontinuing their interpretation of the data, they should
just open source the interpretation engine and dataset. People still have to
pay the $99 for the tests to get the data to interpret, so it wouldn't harm
their business. It would keep their service out of the FDA's crosshairs, while
keeping the service as useful as ever. In fact, it would likely improve it
over what it will become with this latest development.

~~~
Afforess
They are not discontinuing it. It is simply not available for new purchasers.
I imagine once the FDA is appeased it will return.

~~~
cperciva
New purchasers, or people who purchased in the past two weeks...

------
khomenko
If you think that's dumb, here are a couple of petitions you can sign:

[http://www.change.org/petitions/fda-administrator-
margaret-h...](http://www.change.org/petitions/fda-administrator-margaret-
hamburg-don-t-ban-home-genomics-kits)

[https://petitions.whitehouse.gov/petition/overrule-fdas-
deci...](https://petitions.whitehouse.gov/petition/overrule-fdas-decision-
bar-23andme-selling-their-potentially-life-saving-diagnostic-kits/96BRCYNB)

~~~
jonnybgood
I think those petitions are highly dubious. Neither of them accurately
references the FDA's issue with 23AM.

~~~
winterswift
> highly dubious

See: most things on Change.org.

------
cromwellian
I wonder if another nuclear option is to just move the whole shebang to say,
the Cayman Islands, China, or some jurisdiction outside the reach of the FDA
and European regulators. Re-incorporate as a non-US entity.

Unlike buying medicine from foreign soil that can be interdicted, this is all
electronic: shipping spit, and getting back HTML.

~~~
mithras
So you'd like your genome to be in the hands of a Cayman Island company?

~~~
cromwellian
And just what are they going to do with it? Target me with a biologically
engineered virus? I'm shedding DNA with every breath. Your DNA is currently
private thanks to security through obscurity, but if you've ever watched
GATTACA, that security will disappear as DNA testing becomes faster, cheaper,
accurate, and ubiquitous.

People really need to get over paranoia over this and focus on what matters:
laws against discrimination based on genetics.

------
cperciva
In fact, they've not only suspended health-related genetic tests, but they've
done so _retroactively_. If you signed up for 23andme in the past two weeks,
you're not getting what you paid for.

~~~
winterswift
Nearly ordered myself a test before discovering this mess on the day the FDA
sent their letter. I would really hope they'd provide some sort of
compensation to those who're being screwed...doubtful that'll happen though.

~~~
khomenko
Everyone who has ordered since November 22nd is offered a refund. The details
are on the website and will come in the email. Have some faith, dude. Of
course they have to do that.

~~~
winterswift
Ah, well that's good then.

------
johnbpetersen
Well this sucks. I was going to pay for the test this weekend.

Anyone have any idea how useful the health data is without the 23andme
interpretation? I'm guessing it will be basically useless.

~~~
sanxiyn
You can get the basically same report running Promethease on 23andMe data
dump. There is a website even providing automatic 23andMe data import using
23andMe's API.

~~~
midas007
Get SNPs via
[https://www.23andme.com/you/download/](https://www.23andme.com/you/download/)
and then process with
[http://www.snpedia.com/index.php/Promethease](http://www.snpedia.com/index.php/Promethease)

------
bausson
I am wondering, what about foreigners? Is it possible to get the full test and
analysis if the results are shipped to, say, Europe, or is it locked for us
too?

European regulation is supposed to be harsher than US one, so it is highly
unlikely, but I didn't found the information on the website.

------
elwell
Time to open source 23andme health-risk analysis code so we can run our raw
data through it?

------
robomartin
Government, once again, deciding they know what is best for you. I really hope
people are paying attention and vote with their intelligence during the next
several elections. We need less government. Everywhere. Not more.

~~~
johnpowell
Or they could have worked with the FDA which it appears they were more than
willing to do (FDA that is).

But fuck it. Libertarian nerd rage. Disrupt!! There is a reason people outside
your bubble think you are assholes.

------
daeken
I bought 23andMe ages ago and haven't sent in my test yet. Because I purchased
it quite a while ago, will I still be able to get all the info? If not, I'm
gonna be pretty disappointed.

~~~
bengotow
I don't think you'll get your results - at least not soon. The FDA said they
needed to back up their claims that their assessment methodologies are
accurate, and since they failed to respond to those requests they've been
prohibited from performing the genetic tests and giving you the insights that
you paid for. Don't think it matters when you bought the kit :-(

~~~
khomenko
"Customers who purchased kits before November 22, 2013 will continue to have
access to all the reports they’ve always had."

~~~
bengotow
Ahh interesting. At first I'd read that to mean that they weren't taking data
down, and existing customers would still be able to access their reports. I
figured that only applied to people who had already had a report generated.

------
billpg
Great. How about the FDA deal with the claims made by homeopaths next?

~~~
streptomycin
They would love to, but they are limited in the scope of their authority.
Homeopathy companies tend to label their products as "dietary supplements" so
they don't fall under FDA drug regulations. When they slip up with their
marketing, the FDA does get involved
[http://news.discovery.com/human/health/homeopathy-takes-
hits...](http://news.discovery.com/human/health/homeopathy-takes-hits-in-
europe-us-120821.htm) (see "Skirting Drug Regulations").

