
Anne Wojcicki Speaks Out About the F.D.A. Crackdown on 23andMe - specialp
http://bits.blogs.nytimes.com/2013/12/04/anne-wojcicki-speaks-out-about-the-f-d-a-crackdown-on-23andme/
======
tokenadult
One of the comments on the submitted article on its website nails it:

"What 23 and me is saying is not accurate. The reason why the FDA has a
problem with them is not the fact that they are decoding DNA for people, it is
the fact that they are interpreting the results to diagnose specific medical
conditions direct to the public.

"This is against FDA regulations unless it is waived (CLIA waived). In order
for a test to be CLIA waived it has to be 'simple laboratory examinations and
procedures that have an insignificant risk of an erroneous result.' Examples
include glucose tests and pregnancy tests. DNA testing is FAR from that.

"I am a member of 23 and me and they scour scientific research papers to
assign medical conditions to certain genomes. They rate the quality of the
research from 1 to 4 stars based on how established the research is. How they
determine this is unknown. Genomics is rapidly expanding and it is often hard
to determine disease correlation with a genetic marker."

Hear. Hear. I have a local friend whom I grew up with who is an electrical
engineer who works on medical devices. By any reasonable reading of the FDA
regulations adopted under statutory authority from Congress, the product and
service combination on offer from 23andMe falls within the scope of FDA's
regulatory authority, and the company's consumer-facing product claims are
extraordinary claims for which the company has not provided evidence. That's
bad.

An article from Fast Company previously submitted to HN and discussed here
points out that 23andMe's business model is basically to gather a lot of cell
samples and a lot of personal health data from consumers, and then gradually
infer genetic relationships to disease risk that might be valid and
actionable. But that's not how it is marketing itself to consumers today.

[http://www.fastcompany.com/3018598/for-99-this-ceo-can-
tell-...](http://www.fastcompany.com/3018598/for-99-this-ceo-can-tell-you-
what-might-kill-you-inside-23andme-founder-anne-wojcickis-dna-r)

~~~
cromwellian
Creating hyperlinks between genes and research papers is not what I'd call
diagnosing. You find evidence of ABCD gene, you search all research papers
that cite ABCD, you curate and rank papers by quality, summarize related
conditions with statistical correlations.

This is just a high-tech version of me using WrongDiagnosis.com, typing in 5
or 6 symptoms, and having it return all possible articles that cite those
symptoms, ranked by number of simultaneous occurrences.

The potential hack to defeat the FDA here is to simply split the company in 2
parts.

Company #1 sells a $99 service which gives does the test. Company #2 is a
partner of Company #1 through an API. Consumers can elect to OAuth access of
their gene data from Company #1 to Company #2.

Company #2 takes gene data over an API and sells you linked and ranked reports
on it. Company #2 sells no devices, performs no tests. They are pure software
bioinformatics. They take standard file formats and produce reports.

Consumers can elect not to use Company #2's services, get their own private
data in raw format and write their own python scripts if they want.

Or, consumers can buy Company #2's services, but supply their own data from
any company that offers personal genomics raw-data dumps.

The idea that me reading ranked reports to research papers linked to my
personal health data is 'extraordinary claims' and a danger to me is frankly
offensive. I would hope that a company offering software that parsed and
processed genetic data and turned it into linked reports from crawled research
papers could be considered a first amendment right.

But if not, the github approach is certainly a worthwhile approach.

Again, as I said in other posts, the FDA doesn't regulate supplements, doesn't
regulate Dianetics/Scientology, didn't stop "The Secret" from killing people
with heat-stroke therapy. It's enormously offensive to me that the government
spends so much time going after stuff like this, pot smokers, et al, instead
of massively beefing up enforcement over the hundreds or thousands of
hucksters selling harmful bullshit health products on radio and late night TV
ads.

Does no one remember
[http://en.wikipedia.org/wiki/HeadOn](http://en.wikipedia.org/wiki/HeadOn) ?
Coldeze? Five Hour Energy, which may have actually killed people, and still
gets away with deceptive ads.

What about Hoodia? Yeah, the FDA advises people not to purchase it, but does
nothing to stop consumers from buying it based on false claims of efficacy.

People don't like this style of reasoning, but in my opinion, the government
regulatory agencies have limited resources. I want the SEC going after big
banks and investment firms, not small time insider traders. I want the IRS
auditing people who avoided millions or billions in taxes, not the guy who
owes $1000. I want the FDA going after things which are much much more likely
to be ripping off and harming consumers, either financially, or physically,
and on the scale of possible things that can harm you, this is way way down
the list based on a really loose theory of someone avoiding treatment by false
negative, when in reality, if anything, the majority of people are going to be
having more conversations with their doctor over this product.

It's like complaining about the people who lost under Obamacare and ignoring
the fact that tens of millions more couldn't get any health insurance in the
first place.

~~~
dragonwriter
> The potential hack to defeat the FDA here is to simply split the company in
> 2 parts.

The easier "hack" is to just stop making unwarranted health claims. Or, if the
claims are not unwarranted, to provide the support for them.

> Again, as I said in other posts, the FDA doesn't regulate supplements

Yes, it does, but the scope of its regulatory authority set by Congress over
supplements is different than the scope it has over food, drugs, and medical
devices.

> doesn't regulate Dianetics/Scientology

Dianetics/Scientology is neither a food, drug, supplement, medical device, nor
anything else vaguely related to the FDA's scope of regulatory authority.

> didn't stop "The Secret" from killing people with heat-stroke therapy.

As with Dianetics/Scientology, this is not within the scope of FDA's
regulatory authority.

> It's enormously offensive to me that the government spends so much time
> going after stuff like this, pot smokers, et al, instead of massively
> beefing up enforcement over the hundreds or thousands of hucksters selling
> harmful bullshit health products on radio and late night TV ads.

I don't think the government is actually spending all that much time on the
things you are complaining about (I think you are confusing the amount of time
that people spend on the internet _talking_ abou thte government doing
something with the amount of time/effort the government spends doing it), but
if you want to advocate that Congress should expand the FDA's regulatory
authority so that the things you complain that they aren't doing are actually
within their scope fo regulatory authority, feel free.

I still don't see that as an argument that the FDA shouldn't act thoroughly
within the domain they are _charged_ with regulating now.

~~~
cromwellian
>Yes, it does, but the scope of its regulatory authority set by Congress over
supplements is different than the scope it has over food, drugs, and medical
devices.

It does a piss poor job of it. Stop wasting time on 23andme, and pour
resources in that. The FDA admitted that a whopping 70% of all supplements
violate their rules.

>Dianetics/Scientology is neither a food, drug, supplement, medical device,
nor anything else vaguely related to the FDA's scope of regulatory authority.

Point is, these things make unwarranted health claims and cause consumers of
them to take actions which directly harm themselves. If someone published
health recommendations that tell people to drink bleach to "cleanse"
themselves, the FDA can do nothing, but if someone tells them they have the
BRCA gene and here's a link to resource that shows it increases risk of breast
cancer, well then, shut em down.

> I still don't see that as an argument that the FDA shouldn't act thoroughly
> within the domain they are charged with regulating now.

Right, the law says smoking pot is illegal, so there are millions of people
who have had their lives ruined by the criminal justice system because of that
rule, and millions more who have to pay billions for prison funds. But yes,
that is not an argument that cops and judges shouldn't prosecute pot smokers
to the fullest extent of the law and not prioritize, because, well, it's the
law! Ditto for illegal immigrants. Just ship em all back because it's the law.
Obama has been asked to de-prioritize going after pot smokers and illegals, do
you think that is a bad idea and instead, he should prosecute them to the
fullest extent of the law up until the last minute when the law is changed?

The law can be wrong. In this case, the FDA has been given the power to
regulate something that straddles an entirely new industry and they are
preemptively intervening before any harm has been shown. My argument is,
regardless of the law, one can shift around one's priorities. The FDA claims
70% of supplement makers are violating rules. Companies like Ranbaxy are
shipping adulterated generics. These are actually harming people and the FDA
has at least some authority.

There's an entirely new industry cropping up around the "Quantified Self".
Individuals are gaining more and more power to monitor their biological
systems, and personal genomics are just another in a long line of this
evolution. The traditional power structures in the medical community do not
like this decentralization towards consumers being able to get medical
information about themselves without consulting doctors first, without doctors
ordering tests, without doctors first interpreting the results.

I am stone cold libertarian on this. When it comes to my body, I demand the
right to do anything to it, even if it may be bad for me, and to have any
information on it, and to contract with those who can provide such
information. My own concern is real fraud, that is, if someone says here's a
blood pressure monitor, that doesn't actually measure BP, or here's someone
selling a DNA test, which actually gives me a totally false randomized DNA
profile. My concern is not over someone giving my a dump of my DNA and then
generating a series of correlated links to potential diseases. I will
ultimately take that information and do the research myself. Anymore than I am
not concerned with a health site that takes my medical records or personal
survey, and gives me a bunch of self-diagnoses diseases that match.

In short, where you and the FDA see "health claims", I see a search engine.

~~~
dragonwriter
> Stop wasting time on 23andme, and pour resources in that.

AFAICT, the time wasting that has gone on with regard to 23andMe has been the
FDA bending over backwards to try to help them get into compliance.

I agree that the FDA, in retrospect, shouldn't have done that and should have
spent that time more productively.

------
diydsp
Some interesting perspectives in this article:

First, calling the FDA "a very important partner" is overly glib. The FDA is
not a "partner" in the sense that they will accompany you or assist you on
your journey. They are only there to put the brakes on you. They are not
merely "important," they are _vital_.

Second, the article is skewed to make it sound like people aren't entitled to
our own DNA information. That's not what is contested. Of course, you can have
access to your own DNA data, as long as the proper checks are made to ensure
you're actually getting an accurate reading.

The issue is whether telling you have a disease with life-scale consequences
requires validation of these claims.

There is something to be said for their tactic of giving a large number of
answers instead of validating single tests, but it still requires a thorough
level of validation to protect people from exploitation and it wouldn't hurt
their cause to present themselves more respectfully to the authorities.
Perhaps they're trying to fake casualness, that's certainly my reading, but I
hope they don't screw this all up but not thinking it through and throwing
around lots of bullshit.

For example, comparing themselves to Google is ludicrous. First, google's
indexing search engine HAD been doing before, by altavista, webcrawler, etc.,
etc. Second, there was no question that whether what they were doing could
negatively influence people's health and well-being. Perhaps the scholar/books
scanning was a bit controversial. Perhaps some were surprised at Streetview,
but that was actually legal and in both cases, they took several key measures,
voluntarily, to keep themselves well inside the law. BTW, I'm no google
fanboy, but to compare their IT stunts and magic tricks with potentially
delivering low-quality information about life-threatening health conditions
"isn't in the same ballpark. It isn't even the same goddamn sport." -Jules.

~~~
sanxiyn
Is anyone actually contesting that 23andMe doesn't get an accurate enough
reading of DNA? I thought the problem was all with interpretation.

[https://www.23andme.com/more/science/](https://www.23andme.com/more/science/)
states "Data quality starts with the laboratory that processes your DNA. Our
contracted laboratory is licensed by the federal government to perform
clinical testing. It uses standardized processes and procedures that ensure
highly accurate genetic data." and so far I haven't seen anyone contesting
this. That is, DNA reading part is already regulated.

~~~
diydsp
Yes. The FDA is contesting that 23andMe doesn't get an accurate enough reading
of DNA. FTFA:

"Last week, the F.D.A. ordered 23andMe to stop marketing its genetic test
because it said the company had not provided adequate evidence that the tests
were accurate,"

~~~
sanxiyn
"genetic test (of diseases)" is quite different from reading DNA, and
presumably includes interpretation. I don't understand how can reading DNA
part can be inadequate, given that it's the same lab doing the same process as
other clinical testings. 23andMe is using off-the-shelf SNP array, it's not
like it's doing anything special with respect to reading DNA.

------
kevinh
How long before 23andMe sells your personal DNA information up the river to
advertisement corporations?

Don't trust corporations with your personal information because, with few
exceptions, they are more than willing to sell you out to make a quick buck.
And then they claim that their slogan is 'Don't be evil.'

~~~
specialp
I believe one of their goals is to crowd source medical information and
possibly sell the results. Right now they have a "23 and We" research program
where you can voluntarily opt in. Even if you don't when you go on their site
they try to get you to answer questions about yourself from time to time. I
have never answered them and they seem very innocuous such as is your earwax
wet?. I am not sure if they dig deeper if you answer those questions in future
questions

------
wiT0
Philip Greenspun (of the famous "tenth rule of programming"!) had an
interesting question [1]:

 _Question: would it be illegal for 23andme to relocate to Singapore, for
example, and have people mail DNA samples to Singapore and then email them the
results? The company’s web site indicates that customers in Singapore (and a
bunch of other countries) can send their DNA to have it tested. Would the FDA
have jurisdiction to prevent a Singapore-based company from accepting packages
from consumers in the U.S.?_

[1] [http://blogs.law.harvard.edu/philg/2013/11/25/good-
example-o...](http://blogs.law.harvard.edu/philg/2013/11/25/good-example-of-
regulatory-risk-23andme/)

------
mentat
You really trust a large government bureaucracy that's been beholden to large
pharmaceuticals to get this right? Really? The danger of the information is
that great? I'm just not buying it and the comments in this thread so pure
"anti-disruption" bias which apparently is the new hipster anti-hipster
sentiment. 23andme provides information that can be used in conversation
qualified professionals. You might was well shut down every medical related
forum, Yahoo Answers, WebMD and the rest if you really think that information
or misinformation is the danger. Really people take a step back the current
memeset at look at the facts.

~~~
carbocation
I think this comment is conflating "regulation" with "shutting down".

As a society, in the USA, we have created the FDA and empowered it to cast a
watchful eye over certain types of marketing and manufacture. Regulation
limits the rate of innovation in exchange for attempting to limit harm.

~~~
mentat
Except that that function has been completely perverted by economic dynamics.

