[ExI] FDA Tells Google-Backed 23andMe to Halt DNA Test Service

Wed Nov 27 16:32:57 UTC 2013

On Wed, Nov 27, 2013 at 10:59 AM, BillK <pharos at gmail.com> wrote:

>
> It is the medical 'snake-oil' that the FDA doesn't like. And it has a
> lot of medical and scientific support.
>

What medical snake-oil? Do you have a specific example? 23andMe seems to be
very careful about explaining exactly what one's results mean.

For example:
    Restless Legs Syndrome

Imagine what it would be like to crawl into bed every night, ready to catch
some much-needed Zs, only to be struck by an irrepressible urge to move
your legs as soon as you began to relax. No matter how tired you were,
instead of drifting off peacefully, you would be compelled to get up and
move around. It may sound crazy, but this is exactly the situation people
with restless legs syndrome (RLS) experience. Though the symptoms in many
people are milder, it is estimated that about 4% of the U.S. population
suffers from this puzzling disorder.

The following results are based on
<https://www.23andme.com/you/journal/legend2/> *Established
Research* for 1 reported marker, updated July 16th,
2009.<https://www.23andme.com/you/journal/restlesslegs/overview/#last_update>

Learn more about the biology of Restless Legs
Syndrome...<https://www.23andme.com/you/journal/restlesslegs/howitworks/>
Major discoveries in Restless Legs
Syndrome...<https://www.23andme.com/you/journal/restlesslegs/timeline/>
     [image: Not getting enough sleep can cause decreased concentration,
impaired memory, slowed reaction times, and a weakened immune system.] 1 of
3. Not getting enough sleep can cause decreased concentration, impaired
memory, slowed reaction times, and a weakened immune system.
     Your Genetic Data
 » Share your health
results<https://www.23andme.com/user/invitations/invite/?phenotype_id=restlesslegs>
   Show information for assuming
  ethnicity
 and an age range of
         David Sill
1.5 out of 100
men of European ethnicity who share David Sill's genotype will develop
Restless Legs Syndrome between the ages of 0 and 79.
   Average
2.0 out of 100
men of European ethnicity will develop Restless Legs Syndrome between the
ages of 0 and 79.
  What does the Odds Calculator show me?

Use the ethnicity and age range selectors above to see the estimated
incidence of Restless Legs Syndrome due to genetics for men with *David
Sill*'s genotype. The 23andMe Odds Calculator assumes that a person is free
of the condition at the lower age in the range. You can use the name
selector above to see the estimated incidence of Restless Legs Syndrome for
the genotypes of other people in your account.

The 23andMe Odds Calculator only takes into account effects of markers with
known associations that are also on our genotyping chip. Keep in mind that
aside from genetics, environment and lifestyle may also contribute to one's
risk for Restless Legs Syndrome.
  Genes vs. Environment
    54 %
Attributable to Genetics
  The heritability of restless legs syndrome is estimated to be 54%. This
means that genetic and environmental factors contribute nearly equally to
differences in risk for this condition. Genetic factors that play a role in
restless legs syndrome include both unknown factors and known factors such
as the SNPs we describe here. Environmental factors include pregnancy. Low
iron levels, dialysis for end-stage renal disease, and damage to the nerves
of the hands and feet tend to worsen the condition. (sources)

What You Can Do

Assuming the ethnicity setting above is correct, your test results indicate
you are not at increased risk for restless legs syndrome based on your
genetics. Family history and non-genetic factors can also influence your
risk, but note that this condition is fairly rare. Below are some steps you
can take to reduce your risk.

*Keep chronic diseases under control*
Chronic diseases such as kidney failure, diabetes, Parkinson's, and
peripheral neuropathy can exacerbate symptoms of RLS, but managing them can
reduce symptoms of RLS.

*Watch iron levels, and your intake of caffeine, alcohol, and tobacco*
According to the National Institute of Neurological Disorders and
Stroke<http://www.ninds.nih.gov/disorders/restless_legs/detail_restless_legs.htm#154003237>,
caffeine, alcohol, and tobacco may aggravate or trigger symptoms in
patients who are predisposed to develop RLS, as can low iron levels.

*RLS can occur if you're pregnant or taking certain drugs*
If RLS symptoms appear, they usually disappear once the pregnancy is
completed or the drug regimen is stopped.

*Learn your family medical history*
According to the Mayo
Clinic<http://www.mayoclinic.com/health/restless-legs-syndrome/DS00191/DSECTION=causes>,
RLS tends to run in families, especially when it occurs at an early age.
The U.S. Surgeon General's My Family Health
Portrait<http://familyhistory.hhs.gov/fhh-web/home.action>tool can
help you assemble your family medical history.

*Connect with relevant groups*

   - Restless Legs Syndrome Foundation <http://www.rls.org>
   877-INFO-RLS
   - WE MOVE <http://www.wemove.org/rls/>
   800-437-MOV2

*Talk with a genetic counselor*
A genetic counselor specializes in helping people understand genetic
disorders and genetic test results. Learn more about genetic
counseling here<https://www.23andme.com/you/genetic_counseling>
.
 Marker Effects
 What does this chart show?

The chart shows the approximate effects of the selected person's genotype
at the 1 reported marker. Higher, red bars indicate increased risk from the
average, while lower, green bars indicate decreased risk from the average.
The light gray bars show the maximum possible effects for the possible
genotypes at the marker.

Mouse over individual bars to view additional information about each
marker. Click on a bar to view detailed information about that marker
below. You can read more about all markers in the technical
report<https://www.23andme.com/you/journal/restlesslegs/techreport/>.

   BTBD9
Marker:rs3923809<https://www.23andme.com/you/explorer/snp/?snp_name=rs3923809>

The function of this gene is not yet known. Scientists do know that it
belongs to a large family of genes that encode proteins that can influence
activity levels of other genes. The SNP in this gene doesn’t actually cause
a change in the protein sequence of BTBD9. Instead, it lies in a non-coding
part of the gene where it may affect how BTBD9 is turned on or off.

One group found that the A version of this SNP is specifically associated
with PLMS. Because such a large percentage of people with RLS also have
PLMS, this SNP is also a good predictor of RLS risk. There was, however, no
association of the riskier version of the SNP in people with RLS who did
not also have periodic limb movements in sleep (PLMS).

The protein encoded by BTBD9 is found in many different parts of the brain
(in addition to other organs) and is therefore a good candidate for a gene
involvement in other neurological disorders similar to RLS and PLMS. In
addition, even though there is no previously known link between BTBD9 and
iron levels, the riskier version of this SNP was has been associated with
decreased iron stores in the body.

The studies whose data we report as applicable to those of "European"
ancestry confirmed the association between this SNP and RLS in samples from
Germany and Canada.

This association has not been investigated in samples of Asian or African
ancestry.
  Citations
 Stefansson et al.
(2007)<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Search&db=PubMed&term=17634447>.
“A genetic risk factor for periodic limb movements in sleep.” *N
Engl J Med* 357(7):639-47.
 Winkelmann et al.
(2007)<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Search&db=PubMed&term=17637780>.
“Genome-wide association study of restless legs syndrome identifies
common variants in three genomic regions.” *Nat Genet* 39(8):1000-1006.
 Collins et al.
(2001)<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Search&db=PubMed&term=11340155>.
“All in the family: the BTB/POZ, KRAB, and SCAN domains.” *Mol
Cell Biol* 21(11):3609-15.
   The genotyping services of 23andMe are performed in LabCorp's
CLIA-certified laboratory. The tests have not been cleared or approved by
the FDA but have been analytically validated according to CLIA standards.
The information on this page is intended for research and educational
purposes only, and is not for diagnostic use.

I think it is too early to be making health recommendations. We don't
> know enough about how our DNA affects us and how genes interact with
> each other. More research is required.
>

And 23andMe is contributing to that research.

> Maybe if 23andMe enhanced the genealogy side and toned down the
> medical side to vague 'worth asking your doctor about' hints, they
> might keep the FDA happy.

I wouldn't bet on it.

-Dave
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