Transcript The Proper Use of Clinically Relevant Laboratory Testing

The Proper Use of Clinically Relevant
Laboratory Testing and Biochemical Individuality
Mark Schauss, MBA, DB
How I Choose Lab Tests
• People ask me about how I go about determining whether a
test is valuable or not.
• Above all, it must have clinical relevance.
– If Aunt Martha comes in complaining of fatigue and the
test I use doesn’t address this issue, there is no reason to
run it.
• If the results change the way the patient is treated, then it
may be valuable.
– This is utilizing the concept of biochemical individuality
• Does the test and the use of the results have scientific
backing.
– In the case of Fatty Acids, targeting the imbalances and
making changes based on those results have not been
shown to be an efficient way of balancing the fatty acid
results
How I Choose Lab Tests
• Measuring an item in the blood or within a
cell and applying a reference range to it may
not reveal anything about the functionality of
said item.
• Say two people do a test to measure the
amount of magnesium in their cells.
• The reference range is 10 – 50 with a mid
point of 30.
• Both people get a 30 yet person A is
magnesium deficient and person B is not.
• How is this possible?
How I Choose Lab Tests
• When we do a functional test, say looking at the
level of Ethanololamine in a Plasma Amino Acid
test.
• It is a strong marker for the presence of a functional
magnesium deficiency.
• If person A shows up for a number of functional
magnesium deficiencies than maybe the level of
magnesium present in the sample of their cells may
not be adequate due to genetic or environmental
reasons.
• Person B may not need as much magnesium to
function as efficiently compared to Person A.
• In order to get the best clinical outcomes, I look at
the test in a true functional way.
How I Choose Lab Tests
• Lab competence is critical.
• I typically visit the lab, talk to their lab directors and
talk to practitioners about their experiences.
• In an interview in Lab Interpretation’s CD and
podcast series, Laboratory Medical Update, I talked
to Mark Newman, Assistant Lab Director for ZRT
Labs in Oregon about this issue.
• I have seen lab results that made me believe that
the lab used a random number generator to come
up with the results.
• If the results cannot be trusted, what good is the
interpretation?
Why Another Lecture About Lab Testing?
• Albert Einstein once said when told his final
exam he had given his students was the
same as last years, “True, but this year the
answers are different.”
• In laboratory testing, we learn new things
from new research every day.
• We find new ways of testing, new results we
can interpret and better techniques of testing
things we already know about.
• We also find new meanings about results
causing paradigm shifts in treatment
protocols.
Why Another Lecture About Lab Testing?
• An example of a new interpretation for a pair of well
known test variables.
• Vanilmandelic acid is the main metabolite of
catecholamines and Homovannilic acid is the main
dopamine metabolite are both urinary metabolites .
• Vanilmandelate is related to phenylalanine and
homovanillate to tyrosine.
• A few labs use these two to recommend the
appropriate amino acid complex as well as the use
of these two amino acids alone.
• This may be contraindicated because of newer
research that has come to light.
Why Another Lecture About Lab Testing?
• According to research published in the last year,
both or either of these variables being elevated in
urine have been correlated to environmental toxins
such as heavy metals and petrochemical solvents
and pesticides.
• Extremely elevated levels of these two metabolites
may be indicative of tumor growth and possibly the
onset of a myocardial injury.
• Toxins are implicated in a number of cancers so
here may be one of the early warning flags before
the disease presents itself.
Reference Ranges
• Labs typically run a number of tests on a
wide variety of people in order to determine
the reference range for a result.
• The range is where 95% of the test subjects
results are.
• In some cases the reference range is
overwritten by the medical director in order
to propose a new definition of healthy.
• There are significant problems with these
two scenarios.
Reference Ranges
• In the case of the 95%, there is a problem
when the population is not healthy.
• This is the case with Ultra-Sensitive Thyroid
Stimulating Hormone (TSH).
• The typical lab range is .5 – 5.5 uIU/mL.
• Unfortunately, an estimated 25-30% (it could
be higher) of the population is hypothyroid
and fall into this range.
• Research has suggested that the proper
reference range for TSH should be 1.1 – 2.5.
Reference Ranges
• The journal Circulation has an editorial that pointed
out the risks for many diseases goes up when Total
Cholesterol is below 160 mg/dL.
– Hulley, S., J. Walsh, et al. (1992). "Health Policy
on Blood Cholesterol: Time to Change
Directions." Circulation 86(4): 1026-1029.
• The pressure put upon the editorial staff of
Circulation by the pharmaceutical industry was
immense for obvious reasons.
• Still, within the alternative supplement industry,
there is a great deal of marketing money put into to
the lowering of cholesterol paradigm despite
evidence that it may not be beneficial in the
prevention of coronary heart disease.
Reference Ranges
• In the other scenario, medical bias comes into play.
• In a number of labs I have seen, the reference
range for Total Cholesterol is 0 – 199 mg/dL.
• According to Bernard Statland, MD PhD, a world
renowed clinical pathologist states in his book
Clinical Decision Levels for Lab Tests, when
discussing a Cholesterol of 90 mg/dL or below
“Values below this level are often associated with
severe liver insufficiency.”
• So a person is in the reference range can be
deathly ill as often times the prognosis for people at
that level is “poor”.
Tips and Tidbits
• When comparing cholesterol levels you must
do so carefully.
• Levels of cholesterol rise in the fall and
winter and drop in the spring and summer.
• This variance can be as much as 20%
• If you were to set up a clinical trial to test the
efficacy of a drug or supplement in its ability
to lower cholesterol, when would you start
the study and end it?
Type II Diabetes
Type II Diabetes
• With any diabetic, running a comprehensive
blood chemistry should be a given.
• Monitoring blood sugar, triglycerides,
cholesterol with LDL and HDL are critical to
any dietary intervention.
• Electrolyte depletion, particularly sodium,
potassium, magnesium, calcium,
bicarbonates and chlorides are often seen
and need to be addressed if deficient.
• Some of the markers for oxidation like uric
acid are also seen along with elevated
fibrinogen.
Type II Diabetes
• Here is the pattern often seen with people
with Type II diabetes:
– Elevated: Alkaline Phosphatase,
Basophils, Cholesterol, Creatinine,
Fibrinogen, Glucose, GGT, Hemoglobin
A1c, LDL, Triglycerides, BUN, and Uric
Acid
– Decreased: Albumin, CO2, Calcium,
Chloride, HDL, Iron, Phosphorus,
Potassium, and Sodium.
Type II Diabetes
• An Environmental Pollutants Biomarker test
is also very helpful if the person has been
exposed to high levels of a number of toxins.
• Phthalates have been shown to affect insulin
resistance.
– Stahlhut, R., E. Wijngaarden, et al. (2007). "Concentrations of
Urinary Phthalate Metabolites Are Associated with Increased
Waist Circumference and Insulin Resistance in Adult U.S.
Males." Environmental Health Perspectives 115(6): 876-82.
• Chemicals like toluene, xylene, benzene and
styrene have been implicated in a wide array
of endocrine disruption and blood sugar
regulation.
Type II Diabetes
• Many of the chemicals and heavy metals that may
affect the receptors also affect the thyroid.
• People with diabetes who develop hypo- or
hyperthyroidism have a much harder time
controlling their blood sugar.
• Making sure the diabetic patient is controlling their
toxic loads and are becoming good toxin excretors
will go a long way in helping them control their
blood sugar and insulin levels.
• This is why a urine test is so important. It no longer
is a question of whether we have the toxins in our
blood but do we excrete them efficiently.
Type II Diabetes
• As with most disorders, inflammation is a
key component in the progression and/or
control of diabetes.
• Diet is critical.
• Assessing the foods that can trigger
inflammatory reactions is important in
helping your patient achieve optimal help.
• There are a number of good tests on
assessing the inflammatory reactions of
foods.
Type II Diabetes
• Reducing this inflammatory response will
improve the quality of life of the diabetic since
many of them have numerous other
symptoms like arthritis.
• Recent pharmaceutical research is following
the anti-inflammatory direction in the
treatment of type II diabetes.
• Drugs used to treat arthritis like anikinra
(Kinemet) have been shown to help regulate
blood sugar because of their effect on the
cytokine IL-1 (interleukin-1).
Type II Diabetes
• The immune system produces cytokines in
response to inflammation in the body. The
cytokine, Interleuken-1 (IL-1) shows up in
areas of inflammation, like in the joints or
other places in the body. Anakinra blocks the
production of interleukin-1. That's why it's
used to treat arthritis.
• In diabetes, interleukin-1-beta is produced in
the pancreas. High glucose levels appear to
trigger the release of interleukin-1-beta. This
not only reduces the function of beta cells in
the pancreas, but can cause beta cells to selfdestruct.
Infertility/Pregnancy
Infertility/Pregnancy
• At no time in human history has infertility reached
such epidemic proportions.
• The blame clearly has to lie at the feet of our toxic
environment.
• According to the Center for Disease Control’s
National Survey of Family Growth the fastest
growing segment of the population with “impaired
fecundity (infertility) is women under the age of 25.”
• In 2005 the CDC did a survey across America
where the average citizen had the presence of 148
chemicals in their blood. The report is 475 pages
long.
– Third National Report of Human Exposure to Environmental
Chemicals, Centers for Disease Control and Prevention 2005.
www.cdc.gov/exposurereport/pdf/thirdreport.pdf
Infertility/Pregnancy
• One line in the report struck me for different
reasons than it might strike others.
• Under Public Health Uses of the Report it
states “To establish reference ranges that
can be used by physicians and scientists to
determine whether a person or group has an
unusually high exposure.”
Infertility/Pregnancy
• This will somehow be used to allow for an
“acceptable level” of toxicity for each of you
and your patients.
• Some chemicals have an effect at low levels
only.
• Polymorphisms in genes coding for
metabolizing enzymes contribute to
interindividual variability and may vary by
more than 50-fold in humans (Guengerich et
al. 1991).
• What is a poison for you may not be for me.
Infertility/Pregnancy
• In the 1970’s, Danish researcher Niels Skakkebaek
of the Copehagen University Hospital showed links
between testicular cancer in adults and
abnormalities in genital development.
• At 3 months, baby boys experience a surge of
testosterone.
• In a study of 65 infants published in 2006, they
discovered that the higher the level of phthalates,
the greater the evidence of anti-androgenic
hormonal activity.
• By depressing the testosterone surge, the likelihood
of a male to develop testicular cancer as an adult
rises dramatically.
Infertility/Pregnancy
• If the findings that chemicals like Bisphenol A (BPA)
and phthalates are found in the drinking water,
house dust, and ambient air are true and at tiny
levels they can affect estrogen receptors think of
the types of cancers our children will have.
• In the 1950’s a woman’s lifetime risk of breast
cancer was 1 in 22.
• Today it is 1 in 7.
• It is not a genetic epidemic, it is environmental, it is
due to endocrine disruption.
• BPA is worth $100 million an hour.
• Banning it will take enormous guts.
• Becoming good detoxifiers forever is critical.
Infertility/Pregnancy
• When it comes to testing strategies, with all people,
male or female, it is imperative to do an
Environmental Pollutants Biomarker test.
• Phthalates, xylene, toluene, benzene, styrene, and
dimethylbenzene are all developmentally toxic.
• Phthalates can damage male DNA in sperm.
• It can also cause shortening of pregnancies by up
to two weeks and according to research full-term
babies have markedly higher cognitive scores later
in life (Larroque, et al, The Lancet, Vol 371, pg
823).
• Urinary markers of phthalates are vastly superior to
serum.
–
Hogberg, J., A. Hanberg, et al. (2008). "Phthalate diesters and their metabolites in human breast milk,
blood or serum, and urine as biomarkers of exposure in vunerable populations." Environmental Health
Perspectives 116(3): 334-9.
Infertility/Pregnancy
• For women, I would highly suggest doing two
additional tests.
• A Whole Blood Elements test would be #1 as quite
often women trying unsuccessfully to have a child
are very mineral deficient.
• Also, any toxic heavy metal load could decrease the
chances for a healthy pregnancy.
• In the March 2008 EHP journal, researchers led by
Leasure, et al, showed that gestational lead
exposure produced permanent male-specific effects
including an increase in obesity as well as motor
deficit, and altered dopamine.
• The responses were dose-dependent.
Infertility/Pregnancy
• Secondarily, a Plasma Amino Acid test often times
show broad deficiencies in both essential and
conditionally essential amino acids.
• With women, there have been some issues with
increased tryptophan and elevated serotonin
(especially with 5-HTP) and an increase in
miscarriages, dysmenorrhea and tubal spasms.
• With males, it may improve sperm viability.
• In a study by Schacter in 1973, 4 grams of arginine
was used on 178 men and 111 had significant
improvement, 21 moderate and only 25 showed no
improvement in sperm motility and sperm counts.
Infertility/Pregnancy
• A urine iodine challenge is another critical
test to do for pregnant women.
• In the autism pesticide study (Roberts, et al,
2007 EHP), iodine deficiency may be the
mechanism by which the incidence of autism
rose to exposed mothers.
• Since many environmental toxins affect the
thyroid and the lack of iodine can adversely
affect the fetus, this is another very
important test to run.
• If there is a hesitation to do all of the testing here are
a few tried and true general recommendations.
• Since we all have petrochemically based toxins in our
system, both the mother and the father should begin
using a broad spectrum amino acid complex with at
least one gram of glycine per serving.
• Women should be put on a broad spectrum trace
mineral supplement.
• They should also be put on a balanced electrolyte.
• Add DHA/EPA combination.
Autism
Autism
• In my many years of work, it is striking that in the field of
autism more unnecessary tests are run on autistic
children than any other disease or syndrome which
testifies to the desperation of parents of autistic children.
• My goal is to provide the least number of tests
necessary to make the greatest impact on children with
autism.
• Another important issue is not putting the children
through traumatic testing more often than is necessary.
• Testing should direct treatment, not illuminate the health
care practitioner mind.
• Conservation of resources while improving outcome is
essential and should be the overriding principle.
Autism
• Here are a few tests I would avoid for the treatment
of most autistic children.
• RBC fatty acids
– Fatty acids are typically abnormal in most autistic
children but there is no evidence that targeting
fatty acids through a test is beneficial.
– Co-factors such as magnesium and vitamin B6
can lower arachidonic acid which is not
uncommonly high in autistic.
– There are better tests not requiring a blood draw
that can give you the same information.
– One researcher has astonishingly claimed that
autistic children have higher Omega 3 to 6
levels!
Autism
• Fatty acid metabolism can be negatively affected by
environmental toxins.
• Affecting the fatty acids does not address the
toxicity issue.
• It is minimally beneficial in removing heavy metals
or pollutants.
• When dealing with autistic children, if we can avoid
a blood draw, you reduce the stress on these
children.
• A traumatic draw can change the results on a test.
– Levels of liver enzymes, hormones, electrolytes,
blood cell counts can all be negatively affected
by the way the draw is done.
Autism
• Urinary porphyrin testing is the latest rage.
• It is theoretically useful if the specimen is handled
correctly.
• There lies the rub.
– Porphyrin’s are highly light and air sensitive.
– Pee into a bucket with a fluorescent light and half
the analyte is gone.
– Shaking instead of gently rocking the specimen
can cause depletion of the porphyrin analyte.
• There is a very high incidence of false negatives with
this test.
• Even with proper handling, the false negative rate
reduces clinical utility.
Autism
• Urine heavy metal challenge tests are also
commonly used with children with autism.
• It’s clinical utility is questionable.
• The risk of developing side-effects due to the
use of a chelating substance is substantial.
• It does not indicate the burden and/or the
disruption of biochemical pathways due to
mercury or other heavy metals.
• A hair elements test, using the counting method
developed by Dr. Andrew Cutler and spelled out
in his books Hair Test Interpretation and
Amalgam Illness (available at
www.noamalgam.com) is safer and superior.
Autism
• According to the data from the DAN website,
chelation therapy has a very high positive outcome
with a low negative and relatively low no effect rate.
• http://www.autism.com/treatable/form34qr.htm
• Out of 803 cases reported the positive response
rate was 74% with negative results being at 3% and
no response being the lowest of all treatments at
23%.
• With those numbers I would suggest chelating
using the Cutler method over testing for heavy
metals.
Autism
• Cutler method
– DMSA ¼ mg per pound per dose along with the
same for Alpha Lipoic Acid every 3 to 4 hours no
more than 1 mg per lbs. Three days on four or 11
days off.
– DMPS ¼ mg per pound per dose every 8 hours
with Alpha Lipoic Acid every 3-4 hours. Again 3-4
days in a row then skip several days.
• Each day you chelate, you remove between ½ to
1% of the mercury in the brain.
• According to Cutler (pg 90 Amalgam Illness) it
would take between 70-140 days to remove 50% of
the mercury in the brain.
Autism
• Urine Organic Acids (OAT) along with an
environmental pollutants biomarker test is a
non-invasive, helpful test to assess
abnormal biochemical pathways in autistic
children.
• Yeast markers among these children using
an OAT test has been vastly over blown.
• The markers Tartarate and Citramalic acid
are not markers for yeast.
• Tartaric Acid actually kills yeast and is not a
byproduct of yeast.
Autism
• So why do children with autism improve using antifungals if yeast is not so prevalent?
• Many children with autism have upregulated Phase
I detoxification pathways and down regulated
Phase II.
• The intermediary chemicals created in Phase I are
more neurologically toxic than the original chemical,
especially with petrochemical solvents.
• Anti-fungal drugs down regulate Phase I which
allows Phase II to catch up.
• This is also why they do so poorly after removing
the drugs.
• Improving Phase II through the use of amino acids
such as Glycine will help upregulate Phase II.
Autism
• I see a high percentage of autistic children,
especially boys with high urinary phthalate
levels.
• They also often times have other solvents
such as xylene, toluene, styrene, and
benzene.
• Detoxifying these ubiquitous chemicals
seems to lower many of the common traits
such as stimming, head banging and hand
flapping.
• This may be due to the upregulation of
Phase II detoxification.
Autism
• A Plasma, Blood Spot or Urine Amino Acid
test would be beneficial in assessing these
important builders of neurotransmitters.
• A customization of a broad spectrum amino
acid base has been shown to be clinically
useful in helping autistic children.
• We see a number of children with autism
with dramatically abnormal amino acid
profiles.
• Taurine is typically low and autistic children
benefit greatly from its supplementation.
Contact Information
Dr. Mark Schauss, DB
Lab Interpretation LLC
18124 Wedge Parkway, Ste 432
Reno, NV 89511
775-851-3337
[email protected]
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