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 u. IU/m. L. • 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/d. L. – 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/d. L. • According to Bernard Statland, MD Ph. D, a world renowed clinical pathologist states in his book Clinical Decision Levels for Lab Tests, when discussing a Cholesterol of 90 mg/d. L 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 A 1 c, LDL, Triglycerides, BUN, and Uric Acid – Decreased: Albumin, CO 2, 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 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 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 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 B 6 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 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/form 34 qr. 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 marks@labinterpretation. com www. labinterpretation. podhoster. com www. Mark. Schauss. com www. Toxic. World. Book. com www. whatifhistory. podhoster. com