
FDA Warning Letter to 23andMe - jefffoster
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm
======
jfasi
This seems absolutely reasonable. The letter indicates that the FDA has
notified 23andMe that their products are not satisfactorily cleared, they're
reached out to them several times, and they've offered assistance through a
group they specifically set up to help companies in this situation.

Meanwhile, 23andMe went ahead and began marketing and selling their product,
despite the FDA's concerns.

Relevant quotes:

> Most of these uses have not been classified and thus require premarket
> approval or de novo classification, as FDA has explained to you on numerous
> occasions.

> However, to date, your company has failed to address the issues described
> during previous interactions with the Agency or provide the additional
> information identified in our September 13, 2012 letter for (b)(4) and in
> our November 20, 2012 letter

> To date, 23andMe has failed to provide adequate information to support a
> determination that the PGS is substantially equivalent to a legally marketed
> predicate for any of the uses for which you are marketing it; ...

> ...we have proposed modifications to the device’s labeling that could
> mitigate risks and render certain intended uses appropriate for de novo
> classification.

> As part of our interactions with you, including more than 14 face-to-face
> and teleconference meetings, hundreds of email exchanges, and dozens of
> written communications, we provided you with specific feedback on study
> protocols and clinical and analytical validation requirements, discussed
> potential classifications and regulatory pathways (including reasonable
> submission timelines), provided statistical advice, and discussed potential
> risk mitigation strategies...

> Thus, months after you submitted your 510(k)s and more than 5 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 PGS.

~~~
dnautics
Not all of it is reasonable, at all:

"For instance, if the BRCA-related risk assessment for breast or ovarian
cancer reports a false positive, it could lead a patient to undergo
prophylactic surgery"

Uh, you don't think the surgeon is going to demand a second BRCA test be done
before performing the surgery?

~~~
numbsafari
Without an appropriate study to determine reasonable efficacy, it is possible
that the diagnostic technique could result in a large number of false
positives.

This could result in a large number of unnecessary follow-up BRCA tests which
could potentially increase the waiting time for test results or unduly raise
costs for lots of patients. Not to mention the stress of feeling like you may
be suffering from a potentially expensive and life-threatening illness.

So: totally reasonable.

~~~
grandalf
Your verdict of reasonableness depends on the idea that physicians are not
going to be able to properly advise patients who they think might have gotten
a false positive result.

Considering that over half of American adults believe Elvis is alive, I think
the small percentage who may slightly overreact to the kind of presentation
that 23andme gives of these kinds of results is a complete non-issue.

~~~
capnrefsmmat
Many physicians are terrible at interpreting results of screening tests:

[http://www.bmj.com/content/333/7562/284](http://www.bmj.com/content/333/7562/284)

For screening tests where the problem being screened for is rare, most results
will be false positives, but the result is not intuitive.

~~~
grandalf
Doctors being lousy Bayesians is (if anything) an argument in favor of
services like 23andme!

~~~
pdabbadabba
Right. IF 23 And Me can show that its test are accurate. But they can't (or
have refused to do so). That's the whole point.

~~~
nickff
23 And Me should only have to prove that it is better than the alternative,
not that it is accurate (to determine whether the service is of net benefit to
the public). Depending on the counter-factual, 23AM could provide a relatively
inaccurate test that would still be better than no test.

Unfortunately for us, the FDA is on a quest for "safety"; the agency does not
try to help the citizenry live longer or happier.

~~~
taybin
Safety isn't part of a long and happy life?

------
k-mcgrady
Am I the only one this seems completely reasonable to? There are probably
people who take action over the results they get from the service and if the
results are incorrect the actions could have negative impact on their health.
Therefore the service should have to prove the results are accurate before
advertising it as a first step in prevention.

~~~
crusso
23andMe offers a very low cost way to open the door to a whole new world of
having people understand something about their genetic makeup and the possible
impact upon their lives.

The work that they're doing to show how genetic features correlate with the
observed tastes, behaviors, and propensities of users of the site seems
remarkably useful.

The FDA is doing exactly what it always does, stifling innovation while
justifying its existence using the voluminous laws created by politicians
justifying their existences.

If the FDA were useful, it would be helping 23andMe rather than trying to take
them down.

~~~
rayiner
> The work that they're doing to show how genetic features correlate with the
> observed tastes, behaviors, and propensities of users of the site seems
> remarkably useful.

Oh man are you going to be upset when we regulate all that out of existence.
Trying to correlate genetics to tastes, behaviors, and propensities, while
scientifically interesting, is a total political non-starter.

> The FDA is doing exactly what it always does, stifling innovation while
> justifying its existence using the voluminous laws created by politicians
> justifying their existences.

This action is the FDA acting within the core of its jurisdiction, and within
the core of a law that was passed with tremendous public support. This is not
to say that agencies don't do what you're describing, but in this case, it's
pretty much the FDA's job to control this sort of "innovation."

~~~
crusso
_Oh man are you going to be upset when we regulate all that out of existence_

I guess you're being sarcastic, but it's not that I fear progress will stop.
What I see instead is a great deal of needless friction that prevents
efficiency. When you consider how innovations and businesses build on one
another over the years - any friction in the process compounds the amount of
time for "the future" to be here.

I doubt anyone here on HN doesn't realize that in the future our genetic code
will be understood and manipulated like we do with computers and software
today. Will this golden age of genetic self determination be 50 years from now
or 500 years from now?

Roadblocks we put in front of progress now will mean many decades of delay for
the advances down the road that are dependent upon today's advances and the
intervening thousands of others.

 _law that was passed with tremendous public support_

Doesn't at all make it right, good, or mean I won't bitch about it.

~~~
rayiner
> I guess you're being sarcastic, but it's not that I fear progress will stop.

I'm not being sarcastic. Any technology that tries to correlate genetic
markers with behavioral characteristics will be regulated out of existence.
I'm not taking a position one way or the other as to whether this is a good
idea, but I'd bet money on it being the outcome.

> Doesn't at all make it right, good, or mean I won't bitch about it.

Sure. But what it does mean is that it's an intended consequence, rather than
an unintended consequence as your characterization suggested.

~~~
crusso
_Any technology that tries to correlate genetic markers with behavioral
characteristics will be regulated out of existence_

I'm sure that there are those who would like to make all such pursuits
illegal. Such a slippery slope, though. Where will that line be drawn? Which
23AM style correlation question should be illegal for inclusion in their
correlation determination system?

    
    
      1. Do brussel sprouts taste bitter and unpleasant?
      2. Are you more active in the mornings?
      3. Do you prefer blondes to brunettes?
      4. Do you carry debt on your credit cards month-to-month or pay them off?
      5. Did you graduate college?
      6. Do your joints ache after rigorous exercise?
      7. Have you ever been arrested for a felony?
      8. Are people with a great deal of money more lucky than clever?
      9. Does hard work tend to lead to financial success?

~~~
rayiner
4, 5, and 7, obviously.

~~~
marris
not obvious

~~~
Intermernet
Fairly obvious: 4, 5 & 7 request factual answers. The rest are asking for
opinions.

~~~
nickff
Strictly speaking, the others are not opinions, they are subjective.

------
pilom
Summary: 5 years ago, 23andMe started marketing a test for among other things
a BCRA indicator

July and Sept 2012 - 23andMe submits a form to the FDA saying "our test isn't
really useful for diagnosis and thus shouldn't fall under these rules"

Nov 2012 - FDA says we don't agree with you you need to either prove your
effectiveness or change your marketing

Jan 2013 - 23andMe says "it will take us a couple months to do the tests,
we'll get back to you"

Nov 2013 - FDA says, "its been 11 months and you never got back to us. Stop
selling and let us know within 15 days what you're going to do explicitly
because you ignored us for close to a year"

~~~
seehafer
Exactly. I am no fan of the FDA, but what 23andMe did here was extraordinary:
they essentially ignored the agency. If Anne Wojcicki was CEO of a similarly-
sized medical device company she would have gotten her walking papers today.

~~~
duncan_bayne
Extraordinary, and praiseworthy IMO.

~~~
pilom
Why is ignoring a government agency when they ask you to follow the law
praiseworthy? The law says you cant market a diagnostic test without testing
to know the accuracy of the test. I don't want to praise the snake oil
salesmen who would also want to break this law so why should I praise what
23andMe did?

~~~
duncan_bayne
Because, in this case, the Government agency and the laws they enforce are
unconstitutional, and actually harm the people they're supposed to be
protecting.

~~~
thelambentonion
Care to explain how the FDA is harming the people it should protect? It seems
to me that they're simply trying to get 23AndMe to accurately market their
product. Since 23AndMe is making claims of a _medical_ nature, it falls neatly
under the jurisdiction of the FDA as granted by Congress.

~~~
duncan_bayne
Care to explain where in the Constitution the Federal Government is granted
the power to regulate medicine? I think you'll find that that power is
reserved for the states. With respect to harm, take a look at how many people
are killed by delays in drug availability caused by the approval process.

Nothing the FDA does that is legitimate couldn't be better handled through the
courts at a state level. And you wouldn't have to ignore the Constitution in
the process.

------
saalweachter
I'd like to point out that -- as much as I'm sure most people love 23andMe --
it's not really a scrappy start-up. It's a nearly 8 year old company which has
received something like a hundred million in funding.

So this isn't really a case of the gov't stomping on the little guy before he
has a chance to grow; 23andMe has had its chance to grow into a fairly big
deal, and now it's time to start playing by the rules.

~~~
maratd
> So this isn't really a case of the gov't stomping on the little guy

Last time I checked, the US federal government had an _annual_ funding rate of
$3.45 trillion compared to "a hundred million in funding" total for 23andMe.

So yeah, government stomping on the little guy definitely fits the picture.
Then again, it would fit the picture no matter who the government decided to
stomp on. Perhaps we should focus on less stomping and on more cooperative
behavior?

~~~
gress
By your argument any action the US government takes against anyone is
'stomping on the little guy'.

How is a generic anti-government argument relevant here?

------
sqrt2
This reminds me of a blog post in German [1] by a person who due to a software
bug had been falsely diagnosed by 23andMe with limb-girdle muscular dystrophy.
(Fortunately, he was able to identify that it was a misdiagnosis.) It appears
that in this case potential misdiagnoses aren't just a theoretical problem.

[1] [http://www.ctrl-verlust.net/23andme-wie-ich-fur-todkrank-
erk...](http://www.ctrl-verlust.net/23andme-wie-ich-fur-todkrank-erklart-
wurde-und-mich-wieder-gesund-debuggte/)

~~~
evan_
23andMe is very clear at every step of the way that it is not diagnosing
anything.

~~~
sqrt2
This is what 23andMe said about that person's genome:

"Has two mutations linked to limb-girdle muscular dystrophy. A person with two
of these mutations typically has limb-girdle muscular dystrophy."

Of course this not a diagnosis in a technical sense, but to a lot of people it
will sound like it is. Specifically, I don't see how this is "very clearly"
not a diagnosis.

------
guylhem
As usual, the government is trying to meddle with companies. Read the letter,
but make no mistake - the "kind" tone, especially when reminding how they did
they best to get in touch, have meetings, help insuring compliance etc. is
just a decoy. The truth is with "must immediately discontinue marketing the
PGS".

The gov wants to decide what's best for the people. Should the people decide
differently, using their wallets for example, this anomaly will be quashed.

This trend is especially strong in the medical field - gov approval required
everywhere, then people wonder why medical things are so damn expansive.

I use 23andme and I'm happy with the information provided. I know it's not
reliable - it's not a lab test anyone will use to base important decisions on,
since it is not a full sequence of genes.

Yet, by being commercially available and easy to use, it is paving the way for
commercial offers of full genome sequencing, which I damn well intend to use
when they reach the $500 threshold.

However, gov actions like this one may very well make that impossible, making
sure the only full genome sequencing offers there will be will be "FDA
cleared" at a huge markup.

Suggestions to "medical" like companies - get out the gov eye. Move your
business to Asia, the caribbean or wherever the gov will not get in your way
like this. I want to keep using (and recommending) your products!

~~~
revscat
> The gov wants to decide what's best for the people. Should the people decide
> differently, using their wallets for example, this anomaly will be quashed.

Wallets are incredibly poor judges of medical efficacy. The FDA rules are in
place for very good reasons, namely to prevent snake-oil salesmen and other
unscrupulous merchandisers from foisting their -- potentially harmful --
products upon an unsuspecting public.

I would much rather have FDA clearance for medical products and devices than
the alternative that you seem to be proposing.

~~~
Symmetry
I don't think anyone is going to argue about the FDA's role in ensuring drugs
are safe, but most countries don't require positive proof of effectiveness
and, frankly, have better health outcomes than the US. Doctors are quite
capable of reviewing the evidence to see if drugs are effective, and the FDA
doesn't in practice do anything to prevent the sail of non-poisonous snake
oil.

~~~
seiji
Doctors encompass the entire range of people (from morons to geniuses). As a
group, they aren't some magnificent godlike all knowing figure.

"Programmers are quite capable of reviewing the evidence to see if code is
effective" — yet, we end up with thousands of people using MongoDB based off
fad and hype and losing data by the day.

(Wait, did I just advocate for a government-level code approval board? In the
right hands it would probably help if it prevented more Mongos and Hadoops
from entering the world.)

~~~
jbooth
Losing data when you're a professional who should have known what you're doing
is one thing.

Losing your life when you're a layman in the medical field is another.

------
labaraka
> For instance, if the BRCA-related risk assessment for breast or ovarian
> cancer reports a false positive, it could lead a patient to undergo
> prophylactic surgery, chemoprevention, intensive screening, or other
> morbidity-inducing actions, while a false negative could result in a failure
> to recognize an actual risk that may exist.

I cannot imagine someone getting surgery or chemo solely based on a 23andme
heads up warning and without consultation with a specialist physician.

As someone working in medical devices, this dramatic language is extremely
frustrating.

~~~
alanctgardner2
That example is a bit severe, but I think the Warfarin compliance example is
spot-on. You receive a prescription for a drug, but your magic internet test
tells you to take a lower dose, because you're "sensitive". Then you die of an
aneurysm because the test was wrong.

People are completely stupid when it comes to medical issues. I heard a woman
complaining that she couldn't eat honey because she was allergic to fructose.
I work with at least 3 "gluten-sensitive" people (it's pretty unlikely they
all have Celiac disease, it's not a big office), because it's a hip thing to
do. Hell, didn't Angelina Jolie have a prophylactic double mastectomy?

edit: Since everyone is jumping on the Angelina Jolie example. I don't think
her decision was made based on a single spit test. And I think she had doctors
advising her. But the amount of publicity it got makes me worry that it could
become needlessly popular based on self-diagnosis (like not eating gluten).

~~~
RobAtticus
>Hell, didn't Angelina Jolie have a prophylactic double mastectomy?

The placement of this in your post seems to imply you think she was being
stupid with her decision, or thought it was in some way "hip" to do. She has a
family history of breast and ovarian cancer and has a defective gene that made
her chances of getting breast cancer 87%. As she's pretty wealthy, I'm going
to guess that she has pretty good doctors and didn't make the decision on a
whim. Also since it was major surgery I'm going to also assume some doctor saw
her at least once before the surgery and s/he didn't just take her word for it
that the surgery was in her best interest.

Yes there are plenty of people who don't have a clue when it comes to medical
issues, but I'm not sure why you felt the need to lump Jolie in with your
other examples.

~~~
alanctgardner2
I don't think she did it to be hip - I'm sure she had many doctors advising
her, and she underwent many tests before making her decision. But it was
heavily publicised, and it set a dangerous precedent that people with less
access to medical resources will send away this $100 test, see "cancer risk",
and start pushing for unnecessary surgery.

~~~
RobAtticus
I mean, it is major surgery. There is a pretty big difference from somebody
cutting out gluten from their diet and somebody getting surgery. If I decide
one day I'm allergic to gluten, I can stop eating it without consulting a
doctor. Similarly, as the sibling comment mentions, if McCarthy thinks
vaccines cause autism she can stop getting them for her and her children
without consulting a doctor. Sure, maybe some women will start pushing for
unnecessary surgery, but they will also have to find a doctor who is willing
to accommodate them and perform the surgery in the absence of evidence (or
perform it based on a website).

It just doesn't jive with me that they are remotely the same thing. I think
Jolie is a particularly poor example here and serves as a distraction for an
otherwise decent point.

------
rmrfrmrf
Anyone who thinks the FDA is overreaching here has little awareness of how
stupid the majority of the world's population is. The people that this
protects don't know how to even read this statement from the FDA.

Perhaps the startup echo chamber has more respect for unchecked opportunism;
if that's the case, someone should make a startup called 23andMeFree
(monetized by ads, duh) that has you spit in a tube, send it to some PO Box,
then randomly generate positive and negatives across the board. If you wanted
the scam to last longer, you could even generate random values based on
statistics of certain characteristics. A true libertarian must support such a
business.

~~~
VLM
WRT to libertarianism, you can't have a free market if virtually all of one
side of a contract are too ignorant to participate rationally. If its designed
to not be a free market and doesn't involve rational decisions, there's not
much libertarian commentary on the topic. That political stance is orthogonal
to the discussion.

~~~
nickff
One might easily argue that the majority of the population is too ignorant to
participate in the computer market, the handheld device market, the automobile
market, the housing market, the super-market, or any other market. Ignorance
alone is not evidence that government intervention will improve outcomes in
any situation.

------
geetee
I understand the FDA getting pissy if I'm consuming/injecting a substance that
may or may not harm me, but why this? I spit in a tube and get some results
which may or may not be accurate. Go away, FDA.

~~~
DanBC
People take action based on the results of the tests.

There are different ways to mitigate risk - ensure there's adequate genetic
counselling and proper easy to understand information available for anyone
taking the tests would be one way.

I lean towards favouring tight regulation of medical products. One person's
23andMe genetic test is another person's quackery - see some of the nonsense
offered as medical advice by the quacks on other websites.

~~~
ajcarpy2005
Academic science somehow manages to police itself fairly well with peer review
processes. Wouldn't this type of paradigm work better than paying for the FDA
to go through its approval process?

The FDA could still take action if they see that a company is doing something
& claiming something that is not properly peer-reviewed and proven.

But why create extra red tape for everyone from the get-go?

------
wheaties
When the FDA sends you a letter like this, you either pay a fine and change
tactics or you embark on one of the most frustrating approval processes known
to the world (all for people's protection.) Good luck with that.

------
logfromblammo
It is only reasonable in the context of the standard operating procedures of
the FDA. As this is essentially prior restraint upon speech and/or trade, it
is unreasonable, but no more unreasonable than anything else the FDA does.

Ideally, the FDA would have independently-generated evidence indicating that
the product in question is unreasonably dangerous or ineffective for some
intended purpose before issuing a cease and desist order. Instead, they simply
assume guilt and place the burden of proof upon the vendor.

Given that the FDA has vastly more resources than 23andMe, and companies like
it, this makes the FDA seem like bullies against microbusinesses, and like the
captured servants of agricultural and pharmaceutical megabusinesses.

------
sethbannon
The tone of the letter was surprising to me. I wouldn't expect the FDA to go
quite so far in explaining the why behind the desist letter. I suppose that's
because it was written just as much for public consumption as it was for
23andMe.

~~~
jfasi
The most common sort of cease and desist letters we tech people are accustomed
to are DMCA and patent-related. These letters are typically meant as
precursors to private litigation. They are often sent out with commercial
considerations in mind, and so tend to be light on details in order to be more
threatening.

The FDA is a regulatory agency, which implies that their mission is less about
intimidation and more about protecting the public good. Hence the more open
tone, I suspect.

------
Sephr
Obviously 23andMe results are not a diagnosis from your physician. You should
use 23andMe in conjunction with a real physician. For example, I used 23andMe
back in 2010 and it told me I had a high risk for a certain genetic condition
which I recalled one of my family members having, so I _went to see my
physician_ for a real diagnosis, armed with this newly found information.

23andMe helped me catch this early enough _with the assistance of my
physician_ that I was able to get treatment long before I would have developed
symptoms. If I never used 23andMe I probably would not have had this diagnosed
until years later.

~~~
rossjudson
Given
[https://www.23andme.com/health/all/](https://www.23andme.com/health/all/), I
don't think you're considering the negative case properly. If 23andMe's
results say you _don 't_ have something on their list of 250+ things they're
checking for, you might decide _against_ certain treatments or tests based on
that.

I think it's reasonable for the FDA to tell 23andMe that if they're going to
interpret the results for their customers, they need to be able to guarantee
the chain of processing is there, and they need to be able to justify each
"detection point" their marketing claims.

Your outcome is positive. But positive is not the only possibility.

~~~
Sephr
You are equating false negatives to harmful information, when in reality it is
the same as simply not taking the 23andMe test. The only thing 23andme enables
you to do is act sooner on things they get right, and any false negatives are
irrelevant—you didn't ask for a diagnosis and they aren't claiming to give you
a diagnosis. You cannot be harmed by a false negative any more than you will
be harmed by not buying a 23andMe kit.

> you might decide against certain treatments or tests based on that

Since you are mentioning treatments means, you must misunderstand what the
purpose of the test is for. If you have current medical problems that you need
treatment for, you wouldn't use 23andMe's statistics in order to chose a
treatment, you ask your physician to help you get the treatment you need. If
23andMe had a false negative on my condition instead of the true positive, I
would still get diagnosed once I started developing symptoms eventually.
Nobody who starts having health problems thinks "I should first consult my
23andMe results for things that I should specifically mention to my physician
that I _don 't have_".

------
seehafer
I'm most curious to see how 23andMe is going to respond to this, because the
more technical-regulatory language in this letter says essentially that in
FDA's opinion the device is Class III (the highest risk of all medical
device/diagnostics) and would require a PMA, unless 23andMe provides the
evidence that allow FDA to de novo classify the device as Class II.

A Class III ruling would destroy the personal genomics market, because it
would mean extensive clincial testing and documentation about the development
of the device. I hope it doesn't stand.

~~~
esMazer
Thank you, and this is the heart of the argument. I also wonder who's behind
this push from the agency.

It took them 40 years to get the labeling for tylenol right..
[http://www.thisamericanlife.org/radio-
archives/episode/505/u...](http://www.thisamericanlife.org/radio-
archives/episode/505/use-only-as-directed)

They are moving rather quickly on this one... my only question is, why/how??

~~~
dragonwriter
> It took them 40 years to get the labeling for tylenol right.. [...]

> They are moving rather quickly on this one... my only question is, why/how??

You are comparing apples and oranges. It didn't take them 40 years to get to
the point where Tylenol had to go through the _procedure_ requiring FDA
approval for marketing a drug (which is generally similar in origin to the
parallel requirement for medical devices.)

Likewise, its quite possible that 40 years from now, there'll have been
several rounds of _changes_ to how an equivalent personal genomics kit will be
marketed based on changes to what we know between now and then.

------
javert
More evidence that we live in a very mixed economy, not under free market
capitalism.

Government agencies empowered to weild regulatory force against citizens are a
threat to everyone, and this is case in point.

~~~
rimantas

      > not under free market capitalism
    

I am so glad of this. Without regulatory force we would se much more threats
to everyone from other citizens (and that's why regulations came into being).

~~~
fogonthedowns
sometimes I think/believe I've accidentally stumbled upon a Ron Paul forum.

~~~
javert
I'm actually an Objectivist---I agree with the philosopher who had 5% of her
system ripped out of context and stolen by the libertarians (i.e. Ron Paul
people).

~~~
sanskritabelt
He is too impatient to toil slowly through the years for the things he wants.
Too uncompromising to succeed in the way of the popular men who know how to
get along with those in power. Too intolerant to “get along” with anybody. Too
passionate not to burn with disgust for life as he sees it and with
humiliation at not being above the mob, crushing it under his feet, giving it
orders instead of trying to satisfy it, of crawling before it for its good
graces. He is unable to understand how he can act and live as an equal with
those he knows to be inferior to him, those he despises and had a right to
despise.

~~~
sanskritabelt
For the record, that was Ayn Rand talking about (one of?) her favorite serial
killers, who became the basis for a character in an unfinished novel, about
whom she wrote: "[he] is born with a wonderful, free, light consciousness --
[resulting from] the absolute lack of social instinct or herd feeling. He does
not understand, because he has no organ for understanding, the necessity,
meaning, or importance of other people ... Other people do not exist for him
and he does not understand why they should."

~~~
javert
You are taking this completely out of context, and it is a dishonest slander
of the lowest kind.

As evidence (to anyone else reading---no point in dealing with dishonesty), I
present Atlas Shrugged, The Fountainhead, and Objectivism.

Ayn Rand is the only modern philosopher who can even present a reality-
oriented reason _not_ to partake in a life of crime. i.e., a reason not based
on religion or appleal to emotion or simple common sense (though common sense
is also correct on this issue and worth having).

~~~
sanskritabelt
I'm not sure what sort of context can explain away this real-life Randian
superman. (and it's interesting that you mention Rand and crime and the
Fountainhead, given that Howard Roark blew up Courtlandt Homes with dynamite)

This is some interesting reading that goes deeper into Rand's writing:
[http://michaelprescott.freeservers.com/romancing-the-
stone-c...](http://michaelprescott.freeservers.com/romancing-the-stone-
cold.html) All these are Rand's own words: "The first thing that impresses me
about the case is the ferocious rage of a whole society against one man. No
matter what the man did, there is always something loathsome in the 'virtuous'
indignation and mass-hatred of the 'majority.'... It is repulsive to see all
these beings with worse sins and crimes in their own lives, virtuously
condemning a criminal..."

And in regards to Hickman's jury: "Average, everyday, rather stupid looking
citizens. Shabbily dressed, dried, worn looking little men. Fat, overdressed,
very average, 'dignified' housewives. How can they decide the fate of that
boy? Or anyone's fate?"

"Other people have no right, no hold, no interest or influence on him. And
this is not affected or chosen -- it's inborn, absolute, it can't be changed,
he has 'no organ' to be otherwise. In this respect, he has the true, innate
psychology of a Superman. He can never realize and feel'other people.' "

"He shows how impossible it is for a genuinely beautiful soul to succeed at
present, for in all [aspects of] modern life, one has to be a hypocrite, to
bend and tolerate. This boy wanted to command and smash away things and people
he didn't approve of."

~~~
javert
> I'm not sure what sort of context can explain away this real-life Randian
> superman. (and it's interesting that you mention Rand and crime and the
> Fountainhead, given that Howard Roark blew up Courtlandt Homes with
> dynamite)

Well, if you want to be sure, read The Fountainhead and Atlash Shrugged.

The Fountainhead is actually an explicit repudiation of Neitzche (though it is
more than that).

There is a Nietzschean hero in the book---and he is driven almost to suicide,
and is completely destroyed.

Rand greatly admired _one aspect_ of Hickman: that he wasn't influenced by
other people; he was fully himself. The actual hero of The Fountainhead is
like that, but rather than being a destructive parasite (of self and others),
he uses his independence to achieve real goals and values in life in a way
that does not vicitimize anyone.

He did blow up Cortlandt Homes; importantly, nobody was in the building and
nobody was harmed, and he did it because the plans for the building were
essentially stolen from him. He does it to make a point, which he does make.

------
btilly
Silicon Valley "It is better to ask for forgiveness" culture meets the worst
of government "We'll need that in triplicate 5 years in advance of starting to
look at the paperwork."

This should be interesting, if you have the patience to watch the fallout in
slow motion.

~~~
seiji
At least the FDA has teeth even if the SEC lets startup financiers play
billionaire shenanigans all the time and get away with it.

------
crb002
CMS/HHS will look like idiots as mRNA sequencing dips below the $100 per test
price point and doctors for the first time will have a histogram of genes
turned on for use in their diagnosis.

Instead of whinging, FDA needs to partner with NIST to come up with quality
control protocols so doctors know the error distribution in data that they
receive.

------
jheriko
I have to agree that this seems completely reasonable... glad to see so few
commenters jumping to the expected conclusion that this is some kind of
government oppression.

------
ChikkaChiChi
If you believe 23andMe is a sound source for the clinical diagnosis of medical
conditions, you're probably not going to read the fine print telling you
otherwise.

------
carbocation
> Therefore, 23andMe must immediately discontinue marketing the PGS until such
> time as it receives FDA marketing authorization for the device.

No joking around.

------
SCAQTony
Never once did they attack the technology but rather the potential for error
or the consequences if the public "can't handle the truth."

The closest they come to calling her a "quack" is when they state "...We still
do not have any assurance that the firm has analytically or clinically
validated the PGS for its intended uses..."

The bigger question is why is the FDA having a seizure over this? Could it be
the potential for added treatment and preventative healthcare measures that
insurers vis a vis the Affordable Care Act and not looking forward to paying
for? (Not a rhetorical question, just asking)

~~~
aeturnum
I think the line of reasoning makes sense: people will make medical decisions
based on this information, but 23andme has never given us any reason to (or
not to) believe their tests are accurate. Without someone reviewing their
process, their error rate is unknown. That can be dangerous. This is similar
to the problem with many alternative medicine claims. 'Alternative medicine'
may be very helpful to an individual, but it's important not to overstate its
effectiveness or reliability.

~~~
dnautics
how would you define 'error rate'? Do you mean "lab handling error rate"? Or
"information presenting" error rate? The way 23andMe works, is they run your
DNA and they show "percentages" based on _already done_ studies. Then they
throw in caveats (like, if you're not of the correct race relative to what the
study was done in). So what would you suggest? That the service track all of
their users over a long-term and then see whether the percentage of their
users that get condition X matches the percentage they predicted? And then do
some sort of statistical analysis on a possibly moving number (because 23andMe
updates their information if academic science improves) with a population that
might turn out to have differing biases...? And then prove this information
over what, 100000 SNPs on the chip?

What you are basically arguing is that 23andMe should not be allowed to offer
its service.

~~~
epistasis
Ultimately both error rates matter, and are measurable. It's not necessary
that these error rates are zero, it's necessary that they are measured,
controlled, and acknowledged, which is what 23andMe is not doing.

Even the FDA isn't arguing that 23andMe should not offer it's service, just
that it shouldn't _market_ it. And really, given that they don't seem to be
following the basic quality assurance practices of the industry, they should
not be marketing at all.

~~~
dragonwriter
> Even the FDA isn't arguing that 23andMe should not offer it's service, just
> that it shouldn't market it.

They aren't even really arguing that either; they are more arguing that _if_
they are going to market it, _then_ they need to provide studies supporting
the accuracy and take other steps to get it approved to be marketed for the
particular uses it is being marketed.

They are saying in the Warning Letter that 23andMe must stop marketing the
product _because_ 23andMe has abandoned the approval process (and apparently
was not preventing 23andMe from marketing the product as long as they were
working through the approval process), not because the product is _inherently_
unmarketable.

------
mac1175
I JUST bought the kit yesterday. The FDA is right though. Imagine making
extreme decisions (e.g., double masectomy to avoid breast cancer) based upon
the information. This is making me consider cancelling my order.

~~~
esMazer
you would not take serious action in any condition based on an cheap DNA test,
would you? I would suspect that it might serve as a possible flag and then you
can talk to your doctor to further investigate any issue.

Plus 23andme is clear when showing the results that everything is based on
probabilities, there's not a single %100 change of anything, it just tells you
that people with similar DNA markers (in X, Y or Z study) seem to have a
higher/lower chance of X or Y.

~~~
DanBC
Have a google image search for "coloidal silver". See the people who have
turned themselves blue. permanently blue - it's not going to change.

People are stupid. This isn't a label on a chainsaw saying "don't lick the
blade". This is reasonable regulation of a product being marketed as a medical
product.

~~~
mac1175
Funny. I had the same argument with someone about this months ago. I told him
to google 'argyria'.

------
mankypro
This is simply the result of the medical lobby. This pressure is being put on
them simply because it takes power from the gods of medicine. If I order my
own bloodwork, (from the same labs that my medical foundation does), somehow
the same bloodwork costs me 20% of what it would otherwise. This is about
taking away the ability to monitor your own health, in order to enrich the
medical community.

This will simply result in this type of testing to move beyond FDA borders.
Great job FDA, you're helping kill a successful and profitable US company. Un-
F-ing-believable.

------
mbreese
Is there anyone else that sees this as a positive thing for the company?
They've lived under the cloud of potential FDA regulation for a while, and I'm
a bit surprised that it took this long for the FDA to step in.

Obviously, it would have been preferable to have the company and FDA work
together to announce how FDA regulations apply before an enforcement action.
But, now that it has happened, the process has started. If the company can
come out of this with some kind of FDA approval, then that cloud will be
lifted and they can keep on working. And then the company will know exactly
what rules they'll have to play by. So, depending on how things work out, it
could end up being a positive for the company.

Now that the FDA has played their hand, I'm very curious to know how the
company will respond.

------
drakaal
The back story is 23andMe declined a federal request for a customers DNA. This
was the government backlash as a result of protecting user privacy.

~~~
ska
That is highly improbable.

This action is a core function of what the FDA does.

~~~
drakaal
And the FDA has been in talks with them since 2009, and with out notice
changed its position.

~~~
ska
That's not true. The FDA position is unchanged.

They have been in talks since 2009 to help 23andme understand what they need
to file, and how to do it. 23andme has (repeatedly, it sounds like) failed to
do that.

This notice is a standard corrective action taken by the FDA after failure to
complete 510(k) submissions.

------
patrickg_zill
Crap... I better buy the test for an older relative (84) like I have been
saying I would, pronto.

Before the FDA gets its hooks into it and the price goes up...

------
cliftonk
I'm not sure if 23andme's management team is totally out of touch or if they
have genuinely mislead the public about their product's effectiveness. I'd
assume the latter. They could have easily done periodic check-ins with the FDA
to throw them a bone while gathering longitudinal data to support their
claims.

------
bhartzer
You would think that before putting in so much money, time, and effort into
23andMe they would have had discussions with the FDA and actually responded
with more information. I'm amazed that it didn't happen.

------
kefka
Why not just put a disclaimer like one you'd see on a late night psychic ad
service?

"This service is intended for entertainment purposes only."

No disclaimer about medical anything. And people pay more than 99$ for psychic
services.

------
DennisP
I wonder whether a company could bypass the FDA by simply giving people their
genome data, without any interpretation or diagnosis, which could be left up
to people's doctors, opensource software, etc.

~~~
judk
That is a far less marketable product. Most customers couldn't interpret that
data.

------
brosco45
Yeah, that is why we need a Health Freedom Constitutional Amendment.

------
matponta
That could get interesting... Lots of statups are popping up everywhere with
DNA related products..

------
FrankenPC
Magic sentence: "For entertainment purposes only"

~~~
smackfu
Well yeah, they could totally get rid of the health part of their product and
only report on ancestry, and I think the FDA would be perfectly fine with
that.

------
slashdotaccount
Is there a list of government agencies IP addresses? I would like to block
them from accessing my sites. And write in the ToS that they are not allowed
to browse and read more.

~~~
jchung
I am not a lawyer but... I don't think that's going to have the effect you
think it will

------
aabalkan
It's been years since 23andMe is out and FDA just noticed? Or am I getting it
wrong?

~~~
carbocation
If you read the article, you will see the large paragraph outlining the dozens
of in-person meetings and hundreds of emails that the FDA has exchanged with
23andMe.

What you are noticing is a government agency that has exercised restraint for
years, not one that was aloof.

------
mkramlich
When evaluating startup risks/events there needs to be a standard term or
acronym for "doesn't matter; spouse is multi-billionaire."

------
boonez123
Owner is married to the founder of google. I think they'll be okay. :)

~~~
judk
Divorcing.

------
tomelders
Well I suppose that now that all the food is safe to eat, they've got time on
their hands to take down the sinister corporate bad guys behind 23&Me.

