

What Really Drove 23andMe And The FDA Apart - jerryhuang100
http://www.fastcompany.com/3022891/innovation-agents/exclusive-what-really-drove-23andme-and-the-fda-apart

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macspoofing
23andMe is incredibly naive.

>The FDA has been asking 23andMe for specific studies on the reliability and
efficacy of its DNA test results as well as specific clinical analysis
regarding health claims (for example, the risk of developing a condition that
is associated with a genetic marker).

Makes sense. You're making certain medical claims, you darn better have
something to back it up. What's their answer? Well:

>23andMe says it is working on satisfying those mandated requirements and
admits it wishes its efforts were farther along.

Well, then you can't make those claims!!! What the heck did you expect the FDA
to do!? Give you a break? Just this one time?!

> At the same time, 23andMe contends that the reliability of its test kits and
> data adheres to the highest standards, that its process matches that of a
> DNA test one would get through a physician.

PROVE IT! The reason why they haven't, I'm sure, is because it's expensive and
time consuming. And possibly because the regulations around commercial DNA
testing is out of date, maybe, but it is what it is.

>Last spring 23andMe began to ramp up the marketing efforts behind its DNA
kits. This included TV and video ads and a direct-marketing campaign.

Of course that would be a problem. How you market your medical product factors
greatly in whether or not you're going to be audited! Is this surprising to
anyone at 23andMe !?!?

>Given the long history of dialogue with the FDA, you might imagine that
23andMe would have sought feedback about these initiatives--to see if any
concerns surfaced or tweaks were requested

The FDA doesn't works like that. You're not going to get an a priori go ahead
from them. The way it works is YOU have all YOUR homework done and ready, then
go and market, and then if you get audited (and the FDA reserves the right to
audit you anytime) the onus is on you to prove that your claims are sound and
backed-up by proper evidence, that your quality system is in place and that
your product is correctly classified and registered. If you don't have that,
you get shut-down, and possibly more.

>The FDA, in turn, took no steps in the wake of this marketing wave to reach
out to 23andMe and suggest caution or areas of concern.

The FDA is not your personal auditor or adviser. They don't work on your
schedule. They aren't there to hand-hold 23andMe while they take their product
to market.

Sometimes when you release a product in a new category, it may take the FDA a
long time to come up with the right procedures and to amend the proper
regulations, but them's apples. You don't go out, do what you want, and then
be surprised when you get shut-down.

~~~
wtbob
> You don't go out, do what you want, and then be surprised when you get shut-
> down.

That's how it _ought_ to be in a free republic.

~~~
smacktoward
Not all "freedoms" are alike. As the saying goes, your freedom to swing your
fist ends at the tip of my nose. And your freedom to make unproven medical
claims for a product you're selling ends at my freedom to buy medical products
with confidence that they are safe and will do what they claim to do.

~~~
tolmasky
Without getting into a semantics argument about whether your example is even
really a freedom or not (just like I could say "clearly my freedom to read
minds isn't respected because it doesn't even work!!!!"), I think there is a
huge, ridiculous, and obvious difference between physically assaulting someone
and giving you data about your genome.

I am an adult, I paid for 23andme with _my money_ , and I understand the
limitations of their data. If I'm worried about something in particular I'll
go to the doctor, since they spell it out all over the place that none of this
stuff is final (not to mention the fact that the only thing they even ever
tell you is like "1% elevated risk"). I don't need mama government stepping in
and making sure I'm not being mislead (which is hilarious because it is on the
other hand 100% legal to be a fortune teller and tell someone not to worry
since that pesky cancer won't be terminal according to these tarot cards).

~~~
exelius
Yeah, but you have to think of the precedent: if 23andme doesn't have to
provide proof that their results are accurate, there's nothing stopping me
from starting a company that reads the lines on your palm and tells you if you
will develop cancer. Regardless of the number of disclaimers they attach,
people will use it to make medical decisions, and 23andme was aggressively
advertising capabilities they had not proven. There is (and should be) a
higher standard of proof for medical services/devices/etc.

The FDA was started because companies were making medicines that either didn't
work or weren't safe and people were relying on them. Consumers lost faith in
the health care industry, so we have a much higher standard of care. I
understand that it's expensive, difficult and time consuming to fulfill this
higher burden of proof, but the alternative applied across the entire market
really just shifts those costs to the consumer while degrading confidence in
the market for medical services overall.

~~~
tolmasky
_> Yeah, but you have to think of the precedent: if 23andme doesn't have to
provide proof that their results are accurate, there's nothing stopping me
from starting a company that reads the lines on your palm and tells you if you
will develop cancer_

Hate to break it to you, but this is already the case, and it had nothing to
do with the "precedent" of 23andme. Go walk into a church of scientology or go
read "The Secret" and tell me that's not what they're offering. Sure, they
don't use the word "medical", but it _doesn 't matter_. You are suffering from
an _educational bias_ , your worldview is completely divorced from that of the
people you are trying to "protect". Most people don't understand that the term
medical is no a mere colloquialism, nor do they understand that the lack of
that term is a negative implication on the substance at hand. I speak from
experience, my aunt died because she went to see quacks instead of a real
doctor, despite all the information in the world available to her. Its
perfectly legal to tell someone that doctors are full of shit and crystals are
the real way to cure something. And you know what? At some point you need to
just be OK with that. If not its just white man's burden all over again
rebranded as "rich man's burden".

 _> The FDA was started because companies were making medicines that either
didn't work or weren't safe and people were relying on them._

Hilarious. You want further proof of what I'm talking about? Go to the
supplements isle at a grocery store. All that stuff is bullshit and often even
_specifically says_ "not approved by the FDA". Guess what? Its still a billion
dollar business, and there are people who swear by that stuff and don't trust
doctors. No one notices, cares, or understands. Again, your problem is that
you are attacking this from a rational position and think that that is how
other people operate as well, its not. You are kidding yourself if you think
the FDA has succeeded in this goal.

 _> I understand that it's expensive, difficult and time consuming to fulfill
this higher burden of proof_

Ah and now we reach the best part about the FDA: that it effectively makes
even educated people worse at making decisions. Despite the fact that the FDA
has repeatedly been shown to be corrupt or in bed with certain companies,
"approved by the FDA" is still a considered a trusted metric not requiring
much further thought. Its not. The FDA has no competition and, like any
government agency, incredibly rarely suffers consequences for being corrupt or
making mistakes. Most people don't know "the burden of proof" required (and if
you read about how bad doctors are at understanding statistics you wouldn't
trust that burden of proof anyways).

~~~
gamblor956
The FDA did propose regulations to restrict the advertising of "vitamins" and
other supplements. In response, the industry convinced Congress to pass a law
preventing the FDA from issuing such regulation.

The FDA would love to regulate the supplement market. They simply can't.

Also, "approved by the FDA" isn't a trust metric that anyone relies on. It's a
very basic, _fundamental requirement_ for all medical drugs, devices, and
procedures.

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kghose
This is a fairly even and well thought out piece but the author does seem to
be a fan of 23andme: the author suggests that the FDA should have contacted
23andme semi-formally before because 23andme has a high turnover and their
senior management is having a tough personal time. This is a bit funny. The
author is basically suggesting that the management of 23andme is incompetent
and the FDA needs to make allowances for this incompetence.

Otherwise the article nicely lays out the tensions between consumer advocacy,
scientific rigor and sales.

~~~
fudgekludge
It seems as though the author may be making up for some embarrassment on the
part of the editors for putting 23 on the cover of fast company recently.

~~~
macspoofing
Fastcompany and its editors are not at fault here. It's up to 23andMe to be
prepared.

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tvladeck
This really got me:

> or a recognition from the FDA that, given turnover at 23andMe (and
> Wojcicki’s distraction due to her public separation from husband Sergey
> Brin), the task of initiating outreach fell to them.

That's laughably ludicrous.

~~~
dnautics
You've never had to deal with a three letter agency as a corporation, have
you? It's very difficult to ascertain when they want you to take a proactive
step to "initiate outreach" and when you're supposed to contact them. And when
there's a delay, who knows.

In registering my nonprofit with the IRS, I sent in my 1024s, and promptly got
a letter back, "we will get back to you in 90 days." It's been 180-ish days.
Static. What now? Who contacts whom?

~~~
tvladeck
I must confess that your first sentence aggravates me. It comes across as an
accusation that I am not qualified to have made the comment that I did. With
that in mind, yes, I have.

But that's irrelevant.

Anyway, you missed my point. My comment did not imply that it was obviously
not the FDA's responsibility to make contact. (Nevermind the fact that at the
end of the day, it was in fact the FDA that did reach out to 23andMe.) I did
imply, however, that turnover at 23andMe and Anne's marital issues were
ludicrous reasons for it to have been the responsibility of the FDA.

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micro_cam
To me (software engineer working genetic research) the biggest issue is that
23andme is being represented as a cutting edge genomic tech while offering a
test on an simplistic, outdated tech (a genotype array).

Even intelligent, technically minded people get taken in thinking they have
"had there genome sequenced" when they are getting tested for a small number
of single nucleotide polymorphisms (SNPs).

The scientific reality is that, while there are some well established
correlations between SNPs and disease, the explanatory power of such simple
tests and validity of studies based on them is in question [1].

Getting a genotype for 99 bucks is a cool service but I worry that the
marketing that goes along with it is doing more to misinform than educate. I
wish they had pushed more towards offering actual sequencing to consumers as
prices fall.

[1] [http://en.wikipedia.org/wiki/Genome-
wide_association_study#L...](http://en.wikipedia.org/wiki/Genome-
wide_association_study#Limitations)

~~~
huherto
What about the ancestry information? Is that more useful?

~~~
tijs
Nope. Me and my Dad did tests at 23andme and a British university lab and
according to the 23andme test i'm not a family member of well.. myself (nor my
dad). If a test is not good enough to predict family members or even the same
person i would not hold any of their other 'conclusions' in high regard
either.

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ChuckMcM
I wonder if there was a bit of 'tech' clash with old school 'medicine' clash.
Basically tech folks take the position of move forward and fix things that
break, rather than wait until you are 99.999% nothing will break and then move
forward. If that were the case, I could imagine a product manager getting
incentivised to get the kits out the door and testing ramped up in spite of
FDA reservations because 'hey it isn't like its something people take or
anything.'

It would make an interesting short story (fiction of course) of a Doctor who
invents a cure for cancer and starts giving it to people in his family who
have cancer, and curing them but gets thrown into jail by a regulator, whose
spouse dies of cancer during the clinical trials. The character conflict of
someone who is doing the right thing at great personal cost, compared to
someone who did the wrong thing for personal benefit, vs the overall 'right vs
wrong' of the entire system. If someone picks up this story line add a thank
you to me in the forward :-)

~~~
micro_cam
There is a somewhat proud history of Doctors self experimenting:

[http://en.wikipedia.org/wiki/Self-
experimentation_in_medicin...](http://en.wikipedia.org/wiki/Self-
experimentation_in_medicine)

~~~
Crito
I doubt the FDA would find the time to care if the people at 23andMe were just
sitting around diagnosing themselves like a bunch of hypochondriacs. Their
interaction with the public is what has gotten the FDA's attention.

There is a rather shameful history of doctors experimenting on others in an
improper fashion.

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mdturnerphys
It looks like the article may have been taken down. Here's Google's cached
copy:
[http://webcache.googleusercontent.com/search?q=cache:http://...](http://webcache.googleusercontent.com/search?q=cache:http://www.fastcompany.com/3022891/innovation-
agents/exclusive-what-really-drove-23andme-and-the-fda-apart)

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tensafefrogs
? This link now seems to redirect to an unrelated article[1]... very
confusing...

[1]
[http://www.fastcodesign.com/node/1840715](http://www.fastcodesign.com/node/1840715)

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digitalsushi
Every modern car as an 'ODB2' connector under the dashboard, which allows
anyone with 99 dollars to monitor the statistics of their vehicles - engine
temperature, fuel efficiency, air pressure, et al.

Thought experiment: If everyone all of a sudden had all this information on
their dash tonight, how many would change their natural driving habits because
of the visible information, even if no metric was any different than the every
day before it?

I won't speculate. It's just a metaphor.

~~~
eli
I don't think anyone here is saying the concept of personal genetic testing is
bad.

~~~
booyaa00
I would. The only use case I can see for it is if you're adopted and so don't
know family history. Other than that, it can only lead to bad things.

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patrickmay
This is another example of why the FDA should be privatized and operate more
like Underwriters Labs. If a company chooses not to seek FDA certification and
still has customers willing to pay for its products, the bureaucrats should
butt out.

If 23andMe is making demonstrably fraudulent claims, that's an issue for the
courts. Otherwise, the government shouldn't be using force to interfere with
voluntary transactions that harm no one else.

~~~
aestra
I don't understand why naive people won't understand there is real potential
to do harm here.

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japaget
Article has apparently been taken down; the link redirects to a
fastcodedesign.com article on Bitcoin. Does anyone have a copy of the original
article on 23andMe?

~~~
mdturnerphys
[http://webcache.googleusercontent.com/search?q=cache:http://...](http://webcache.googleusercontent.com/search?q=cache:http://www.fastcompany.com/3022891/innovation-
agents/exclusive-what-really-drove-23andme-and-the-fda-apart)

