Dear Patient, This handbook contains the results of your recent Primal Health evaluation. I have highlighted specific groups of laboratory findings for analysis and you will find additional educational discussion and explanations for your results. I have also included my treatment recommendations for hormone optimization and treatment with other pharmaceutical and supplement options where appropriate. The results and recommendations belong to you and are yours to do with as you please. If you would like to enroll in a membership with our clinic please let me know at the end of your evaluation review or contact the clinic at support@primalhealthclinic. com or by calling 360-706-1808. I hope you find this handbook informative and useful towards your pursuit of becoming the best version of yourself. I am grateful for your trust and hope we can help you along your way. Good luck and good health! -Dr Strand Disclaimer: Primal Health and Wellness Clinic, PLLC. and all affiliate healthcare providers and employees cannot claim that the correction of hormone deficiencies will lead to the reversal or improvement in any underlying medical condition, illness, or state. The content of this document is for educational purpose only and cannot be used as support for any medical intervention without the specific assessment and guidance of your physician.
TABLE OF CONTENTS Handbook Chapter Instructions ...................................................................... 3 Chemistry Profile ........................................................................................................ 6 Cardio-Metabolic Profile....................................................................................... 11 Hormone Profile..........................................................................................................16 Suggested Program................................................................................................21 Membership Determination .............................................................................22 Pricing Information* .............................................................................................. 24 Pharmacy and Medication Information ..................................................27 Supplement and Supply Information ....................................................... 28 Membership Cancellation and Termination ....................................... 30 Supplement Review.................................................................................................31 Annex of Legal Documents .............................................................................. 40
Handbook Chapter Instructions Chemistry Profile This section contains information on your blood counts, electrolytes, kidney performance, liver function, and lipid levels. These data give us insight into certain nutrient levels, how you are processing nutrients and toxins, and a general idea of your lipid profile to assess atherosclerotic risk over time. Cardio-Metabolic Profile (If Cardio-Metabolic Add-on Purchased) This section evaluates your risk for cardiovascular disease. These data give us insight into whether or not you are manifesting signs of insulin resistance which is the first step towards developing type II diabetes. We also evaluate you lipid profile in depth, look for genetic markers of disease, and evaluate underlying inflammatory levels which increase your risk of cardiovascular disease. Hormone Profile This section dives into the functioning of the functioning of many of the hormone systems in your body. This includes steroids that are produced and act on the neurons of your central nervous system as well has hormones released from the front of your pituitary gland: thyroid stimulating hormone (TSH), adrenocorticotropic hormone (ACTH), growth hormone (GH), luteinizing hormone (LH), follicle stimulating hormone (FSH), and prolactin. We assess how these hormones interplay with your peripheral glands to create hormone homeostasis in your body. The ranges we use are not related to your age since we have seen that it is common for our hormone levels to decrease as we get older. This decline is not necessarily a reflection of optimal health. What we have seen is that by returning all hormone levels back to a healthier physiologic level between 25-35 years of age seems to improve quality of life without creating adverse reactions. We use a few shorthand indicators to relay information about your levels. LL, L, and LN represent Very Low, Low, and Low Normal respectively. These are all varying degrees of suboptimal hormone levels. HN, H, and HH represent High Normal (optimal), High (elevated), and Very High. Call 360-706-1808 with questions 3 www.primalhealthclinic.com
Suggested Program This is a customized program developed specifically for you after review of your medical history, goals, and laboratory results. It is designed to provide a safe and effective path for you to reach your goals. The program may include both pharmaceutical options for treatment and recommended supplements to achieve your goals. This section also includes estimates prices and membership options that fit most closely with your individualized plan. Membership Determination This chapter outlines your membership level. It discusses our process for determining your required level of membership and provides a copy of our scoring rubric used in membership determination. Pricing Information This section details the costs of your individualized plan. In addition to membership costs for your required participation level, there is information on costs for imaging and labs to reference for your individualized treatment protocol. Pharmacy and Medication Information We work with several compounding and online pharmacies in order to provide you with the best possible pricing on your medications. This section outlines contact information for certain pharmacies. It also has information on establishing accounts with online pharmacies regularly used for generic commercially available medications. Supplements and Supply Information We work with several premium supplement and supply brands to provide you with substantial cost savings over standard retail pricing for members. Your supplements and supplies can be ordered online through our website for your convenience. Membership Cancellation and Termination This chapter provides an overview of our membership cancellation policy including our re-activation policy for canceled memberships. It also provides an overview of cause for membership termination. Call 360-706-1808 with questions 4 www.primalhealthclinic.com
Supplement Review We commonly recommend supplements to augment our pharmaceutical recommendations. These recommendations can greatly enhance traditional medical therapies and in many cases are sufficient by themselves to offer relief of symptoms in a much more natural way. Annex of Legal Documents This is a compiled annex of the legal documents you were required to acknowledge and accept prior to completing your evaluation or joining as a member. Call 360-706-1808 with questions 5 www.primalhealthclinic.com
Chemistry Profile Blood Count around your body. Since transferrin is the main iron-biding protein measuring the (Labcorp # 005009) total amount of iron that can be bound by it is a good indirect indicator of your bodies The Complete Blood Count is a measure of iron stores. This measurement is called the all the blood cell lines which includes red total iron binding capacity (TIBC). Ferritin blood cells, white blood cells, and platelets. is a protein made by almost every cell in The red blood cells deliver oxygen to your response to increased iron. It reflects total organs and tissue, the white blood cells body iron and will be low when there is iron make up your immune system, and deficiency and high when there is excess platelets help with clotting. Some of the iron in the body. markers we use to evaluate your red blood cells are hemoglobin, hematocrit, and The white blood cell count (WBC) is the mean corpuscular volume. The hemoglobin total number of white blood cells in a (Hbg) measures the oxygen-carrying sample of blood. This number accounts for capacity inside each red blood cell. The all types of WBCs including neutrophils, hematocrit (Hct) is the proportion of your lymphocytes, monocytes, eosinophils, and total blood volume that consists of red basophils. There are a wide variety of blood cells. If the Hgb and Hct are lower conditions that can cause elevation of the than expected you are anemic, if they are WBC with the most common being higher than expected then you have infection, stress, and trauma. The final polycythemia. Polycythemia can occur category of cell line evaluated is your when on testosterone therapy and may platelet count (PLT). Platelets, also called require blood donation or decreasing the thrombocytes, are small cell fragments dose of medicine to correct it. The mean that circulate in your blood stream and corpuscular volume (MCV) is the play an essential role in blood clotting. measurement of the average size of your When you have an injury and are bleeding red blood cells and provides a sense of the platelets will come to the site of injury what your body stores of folate, B-12, and and start sticking together to form a iron are. One of the most common reasons temporary plug. Platelet counts may be for a low MCV and anemia is iron deficiency low in liver disease and alcohol abuse. anemia. Iron is an essential nutrient that is required for the production of healthy red Lab Name Result Median Range Units blood cells. Your body can’t produce iron so it must be consumed in foods or Hemoglobin 14.0 15.35 13-17.7 g/dL supplements. Transferrin is the protein that iron binds to in order to be transported Hematocrit 41.2 44.25 37.5-51 % MCV 87 88 79-97 fL WBC 3.5 7.1 3.4-10.8 10e3/uL PLT 167 300 150-450 10e3/uL Call 360-706-1808 with questions 6 www.primalhealthclinic.com
Electrolytes Kidney and Liver Function (Labcorp # 322000) (Labcorp # 322000) Sodium (Na), Potassium (K), Chloride (Cl), Your kidney function tests include a blood and Calcium (Ca) help to regulate how urea nitrogen (BUN) and creatinine (SCr). different compounds enter cellular When your body breaks down proteins they membranes and how cells communicate are turned into ammonia in the liver, which with each other. Deficiencies of these contains nitrogen. The nitrogen then critical electrolytes are typically the results combines with other elements such as of profound dehydration, nutritional carbon, hydrogen, and oxygen to for a deficiencies, or exacerbation of chronic chemical waste product called urea which disease states. Depending on the severity is filtered by kidneys. Creatinine is a or combination of the deficiency you may chemical compound that is left over from experience minor symptoms such as the energy-producing processes in your muscle cramping or you may experience muscles which is also filtered by the an escalating cascade of problems kidneys. The BUN and Scr levels are ranging from confusion, seizures, heart measures of how well your kidneys are arrhythmia, and death. Bicarbonate is an doing their job of waste processing. electrolyte that reflects the level of carbon dioxide (CO2) in your blood and is used as Your liver functions tests include gamma- a proxy to assess the degree of acidity of glutamyl transferase (GGT), aspartate your blood. In can rapidly change for short aminotransferase (AST), alanine periods of time, such as with hyperventilation aminotransferase (ALT), alkaline or acute disease, or it can always be phosphatase (ALP), and albumin. The abnormal due to chronic disease states levels of your liver enzymes are used as (typically of the lung). markers for liver inflammation and damage. They can increase temporarily, Lab Name Result Median Range Units like after alcohol consumption, or be elevated for longer periods of time Sodium 144 139 134-144 mmol/L denoting more chronic damage and scarring. Your liver is also an important Potassium 4 4.35 3.5-5.2 mmol/L synthetic organ. Albumin is the main carrier protein in your blood that helps to Chloride 102 101 96-106 mmol/L give your blood volume, keep water inside of your blood vessels instead of your soft Bicarbonate 28 24.5 20-29 mmol/L tissue (edema), and acts a carrier for vitamins, enzymes, and other important Calcium 9.7 9.45 8.7-10.2 mg/dL substances. Checking an albumin levels helps to assess your nutrition status and Call 360-706-1808 with questions 7 www.primalhealthclinic.com
acts as a proxy for your liver’s ability to Vitamins and Minerals create proteins. (Labcorp # 081950) Bilirubin is a waste product that is (Labcorp # 001800) produced from the breakdown of red blood cells. Your liver is your detoxification organ Vitamins and minerals are essential and bilirubin levels rise when your liver’s substances that our bodies need to ability to adequately process certain waste develop and function normally. Vitamin D material is overloaded. This can occur is a nutrient that is produced in the skin acutely or chronically and the speed of its when exposed to sunlight and ingested in accumulation in relation to other liver foods and supplements. It is necessary for function tests can provide clues to what building and maintaining healthy bones, type problem there is. strong immunity, and cognitive health. It is also anti-inflammatory and has antioxidant Lab Name Result Median Range Units and neuroprotective properties. The CDC 17 13 6.0-20.0 mg/dL estimates that only two-thirds of the U.S. BUN population has sufficient Vitamin D. Zinc is 0.66 1.01 0.76-1.27 mg/dL a vital mineral that is necessary for the SCr 18 20 0-40 IU/L activity of over 300 enzymes that aid in 10 22 0-44 IU/L metabolism, digestion, nerve function, AST 59 82.5 44-121 IU/L immunity, and growth. It is the second most abundant trace mineral in your body ALT 0.5 0.6 0.0-1.2 mg/dL after iron. Supplemental zinc, especially when deficient, can decrease the amount ALK PHOS 4.7 4.5 4.0-5.0 g/dL of testosterone conversion to DHT thus Bilirubin, leading to lower DHT levels and higher free total testosterone levels. Albumin Lab Name Result Median Range Units ng/mL Vitamin D 74.4 65 30-100 ug/dL Zinc 101 79.5 44-115 Call 360-706-1808 with questions 8 www.primalhealthclinic.com
Lab Name Result Median Range Units Insulin Resistance Cholesterol, total 191 150 100-199 mg/dL (Labcorp # 004333) Triglycerides 96 75 0-149 mg/dL (Labcorp # 322000) HDL 81 >39 mg/dL Glucose is a type of sugar that provides energy for the brain and body. It is also LDL-c 93 50 0-99 mg/dL known as blood sugar. Insulin is a peptide hormone released from your pancreas that Cholesterol Ratio 4.6 <3.5 facilitates the movement of glucose into your cells so that it can be used for energy. Diabetes results from your pancreas not being able to produce enough insulin for your body’s needs or your body’s tissues becoming resistant to the constant release of insulin because of too much carbohydrate consumption over time. In later stages of insulin resistance blood sugar will begin to stay at mildly elevated levels throughout the day and you will have bigger spikes of glucose in your blood after meals. A fasting blood glucose level between 100-125 mg/dL is prediabetic and over 126 mg/dL is diagnostic for diabetes. The homeostasis model assessment of insulin resistance (HOMA-IR) is a calculation designed to assess the relationship between insulin and glucose in your body. Your goal should be to be as insulin sensitive as possible. Loss of insulin sensitivity is what ultimately leads to diabetes and cardiovascular disease. A healthy HOMA-IR score is 0.5-1.4. Above 1.9 indicates early insulin resistance and above 2.0 indicates significant insulin resistance. Call 360-706-1808 with questions 9 www.primalhealthclinic.com
Lipid Profile (Labcorp # 303756) Lipids are a class of molecules that are not soluble in water; its like trying to dissolve oil in water. Lipids are essential to every cell in your body so in order to move around your blood and get to the organs and tissues where they are needed the lipids need a vehicle to protect them from the plasma. The protective coating for the lipids are call lipoproteins. Lipoproteins act as cargo submarines for lipids, mostly in the form of triglycerides, so they can be transported in your plasma to get where they need to go. We can identify different types of these cargo submarines by how much they float or sink and we know that certain densities of lipoproteins are more dangerous to your blood vessels and cardiovascular health than others. A total cholesterol level is a measure of all the cholesterol in your blood whereas high-density lipoproteins (HDL) and low-density lipoproteins (LDL) are measures of specific types of cholesterol. Triglycerides are fats that are the predominant cargo carried by lipoproteins such as HDL and LDL. Traditionally, LDL has been considered a “bad” cholesterol and HDL a “good” cholesterol. This characterization if far from accurate and more nuanced testing with fractionated lipoproteins, apolipoprotein(A1), apolipoprotein(B), and lipoprotein(a) offer greater cardiovascular risk stratification. Lab Name Result Median Range Units Insulin 2.9 13.75 2.6-24.9 uIU/mL Glucose 88 82 65-99 mg/dL HOMA-IR 0.6 Call 360-706-1808 with questions 10 www.primalhealthclinic.com
Cardio-Metabolic Profile Resistance The homeostasis model assessment of insulin resistance (HOMA-IR) is a calculation (Ref # 004333) designed to assess the relationship (Ref # 322000) between insulin and glucose in your body. (Ref # 102525) Your goal should be to be as insulin sensitive as possible. Loss of insulin sensitivity Glucose is a type of sugar that provides is what ultimately leads to diabetes and energy for the brain and body. It is also cardiovascular disease. A healthy HOMA- known as blood sugar. Insulin is a peptide IR score is 0.5-1.4. Above 1.9 indicates early hormone released from your pancreas that insulin resistance and above 2.0 indicates facilitates the movement of glucose into significant insulin resistance. your cells so that it can be used for energy. Diabetes results from your pancreas not Lab Name Result Median Range Units being able to produce enough insulin for your body’s needs or your body’s tissues Insulin 7.1 13.75 2.6-24.9 uIU/mL becoming resistant to the constant release Glucose 124 82 65-99 of insulin because of too much carbohydrate HOMA-IR 2.2 mg/dL consumption over time. In later stages of HbA1c 6.8 5.2 4.8-5.6 insulin resistance blood sugar will begin to stay at mildly elevated levels throughout the day and you will have bigger spikes of glucose in your blood after meals. A fasting blood glucose level between 100-125 mg/dL is prediabetic and over 126 mg/dL is diagnostic for diabetes. Blood glucose varies during the day. However, when it stays elevated in the blood for an extended period of time it will attach to hemoglobin proteins in your red blood cells. Measuring the amount of glycosylated hemoglobin (sugar attached to hemoglobin) provides an assessment of what your average blood sugar is over a period of 2-3 months. This test is called a hemoglobin A1c (HgbA1c). Call 360-706-1808 with questions 11 www.primalhealthclinic.com
Standard Lipid Profile Lab Name Result Median Range Units (Ref # 303756) Cholesterol, 323 150 100-199 mg/dL Lipids are a class of molecules that are not total 84 75 0-149 mg/dL soluble in water; its like trying to dissolve oil Triglyceride 100 >39 mg/dL in water. Lipids are essential to every cell in 210 your body so in order to move around your s 50 0-99 mg/dL blood and get to the organs and tissues HDL <3.5 where they are needed the lipids need a vehicle to protect them from the plasma. LDL The protective coating for the lipids are call Cholesterol lipoproteins. Lipoproteins act as cargo submarines for lipids, mostly in the form of Ra�o triglycerides, so they can be transported in your plasma to get where they need to go. We can identify different types of these cargo submarines by how much they float or sink and we know that certain densities of lipoproteins are more dangerous to your blood vessels and cardiovascular health than others. A total cholesterol level is a measure of all the cholesterol in your blood whereas high-density lipoproteins (HDL) and low-density lipoproteins (LDL) are measures of specific types of cholesterol. Triglycerides are fats that are the predominant cargo carried by lipoproteins such as HDL and LDL. Traditionally, LDL has been considered a “bad” cholesterol and HDL a “good” cholesterol but this is too simplified a categorization to be useful in assessing your risk for cardiovascular disease and total wellness in general. Call 360-706-1808 with questions 12 www.primalhealthclinic.com
Apolipoproteins (Ref # 216010) As mentioned previously in the “Standard Lipid Profile” section, lipids are not water soluble. In order for lipids to move through your bloodstream they must be transported in cargo ships called lipoproteins (e.g. LDL and HDL). The surface of the LDL and HDL cargo ships is reinforced with proteins called apolipoproteins which help provide structural integrity and solubility, serve as co-factors for enzymatic reactions, and help with binding to receptors on target cells. Two of the most important classes of apolipoproteins are apolipoprotein A-I (apo(A1)) and apolipoprotein B (apoB). Virtually all of the apo(A1) is found on the outside of HDL particles and the apoB is on VLDL, IDL, and LDL particles. Measurement of apo(A1) and apoB serve as markers for the amount of particles including remnants and fragments of HDL and low/intermediate density lipoproteins (VLDL/IDL/LDL) respectively. The ratio of apoB:A1 particles further quantifies future cardiovascular risk. Lab Name Result Median Range Units apo(A1) 254 163 116-209 mg/dL apoB 142 <90 mg/dL apo(A1), B, ra�o 0.6 0.3 0.0-0.6 Call 360-706-1808 with questions 13 www.primalhealthclinic.com
stages in the development of atherosclerotic disease. Inflammatory Markers Lipoprotein(a) (Lp(a)) is a genetically (Ref # 120766) inherited protein that attaches to the apoB (Ref # 123283) protein that fortifies the outside of LDL (Ref # 123023) particles. This protein forms a “tail” that (Ref # 120188) hangs off of the LDL cargo ship which we think makes it more likely to catch on artery Cardiovascular disease is ultimately a walls and become lodged thereby disease of chronic inflammation. Insulin increasing the amount of chronic resistance and elevated LDL particles are inflammation and thus leading to causes of chronic inflammation, but so are increased cardiovascular disease risk. A obesity, smoking, environmental toxins, recent study from India found that people diabetes, and many others. The most with an Lp(a) greater than 50mg / dL were commonly used marker to assess the 2-3x more likely to develop heart disease degree of underlying chronic inflammation than those with normal levels. While there is the high sensitivity c-reactive protein are some medications being studied as a (hs-CRP). This doesn’t show the cause of treatment for high Lp(a) there are currently inflammation so it must be interpreted in no pharmaceutical options specifically the context of your other risk markers. A hs- designed for treatment. CRP > 2.0 mg/L may place you at higher risk of developing heart disease. Estrogen replacement therapy in post- menopausal women has demonstrated a When cholesterol particles collide and 50% reduction in Lp(a), but there remains embed into your artery walls, immune cells no great option for the population at large. such as macrophages and mast cells If you have an elevated Lp(a), then you react to repair the damage. These want to focus your efforts on eliminated inflammatory cells produce and release an insulin resistance, maintaining a healthy enzyme called Lp-PLA2 which oxidizes fatty body weight and muscle mass, and acids leading to worsening inflammation reducing the LDL-P preferably through and development of arterial plaques. We permanent diet and lifestyle changes. can also measure the amount of oxidized LDL which is the atherogenic form of LDL cholesterol found specifically through all Lab Name Result Median Range Units hs-CRP 0.25 1.5 0.00-3.00 mg/L Lp-PLA2 204 112 0-224 nmol/ Oxidized LDL 280 min/mL 90 10-170 ng/mL Lp(a) <75 nmol/L Call 360-706-1808 with questions 14 www.primalhealthclinic.com
Reference Interval NMR LipoProfile Percentile 20th 50th 80th 95th nmoI/L Low Moderate Borderline High Very High 1000 - 1299 High 1600 - 2000 > 2000 LDL-P 1603 < 1000 1300 - 1599 (LDL Particle Number) Lipids mg/dL Optimal Near or Above Borderline High Very High 140 < 100 Optimal High 160 - 189 190 LDL-C 100 - 129 130 - 159 (calculated) mg/dL mg/dL mg/dL HDL-C 46 Triglycerides 174 Total Cholesterol 217 Desirable > 40 Desirable < 150 Desirable < 200 Historical Reporting LDL-P 500 600 700 800 900 1000 1100 1200 1300 1400 1500 1600 1700 1800 1900 2000 2100 2200 2300 1603 (9/15/2022) LDL-C 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 210 220 230 140 (9/15/2022) Particle Concentration and Size Lower CVD Risk Higher CVD Risk low Percentile in Reference Population moI/L high 75th 50th 25th 31.8 HDL-P (total) 34.9 30.5 26.7 nmoI/L low 25th 50th 75th high 704 117 527 839 SMALL LDL-P nm LDL SIZE 21.1 23.0 Large (Pattern A) 20.6 20.5 Small (Pattern B) 19.0 Insulin Resistance Score Insulin Sensitive Insulin Resistant Percentile in Reference Population 0-100 insulin sensitive 25th 50th 75th insulin resistant 75 27 45 63 LP-IR SCORE** ** The LP-IR score is a laboratory developed index that has been associated with insulin resistance and diabetes risk and should be used as one component of a physician's clinical assessment. The LP- IR score has not been cleared by the US Food and Drug Administration . Call 360-706-1808 with questions 15 www.primalhealthclinic.com
Hormone Profile Precursors Progesterone also inhibits 5-alpha reductase which can help lower DHT levels (Ref # 140707) and increase free testosterone. It can also (Ref # 004317) reduce estrogen levels and improve (Ref # 500161) erectile dysfunction in certain patients. Another example of the importance of the The production of steroid hormones begins various metabolites in steroid production is with cholesterol. Pregnenolone, colloquially DHEA/DHEA-s. DHEA and DHEA-s have wide referred to as “the mother of all hormones”, ranging effects over the heart, immunity, is the first steroid compound produced neuronal health, and cognition. from the metabolism of cholesterol in the mitochondria. By itself it is a neurosteroid Lab Name Result Status Median Range Units involved in enhancing learning, memory, and mood. As a pro-hormone it has three Pregnenolone 16 LN <151 ng/dL major pathways that it can take in your body. First, it can be converted into Progesterone 0.1 LN 12.85 1.8-23.9 ng/mL progesterone which will in turn be used to synthesize your stress hormones cortisol, DHEA-s 60 LN 197 22-372 ug/dL cortisone, and aldosterone. Second, it can be converted into DHEA and DHEA-s (the Prolactin active form) which is used for production of sex hormones; androstenedione and (Ref # 004465) testosterone which are further metabolized to DHT, estrone, and estradiol. The final Prolactin is one of the hormone released major pathway is conversion into from your anterior pituitary. It is the allopregnanolone which is a potent positive hormone that is primarily responsible for allosteric activator of GABA receptors and the production of breast in women. In men has neuroprotective, anti-depressant, and temporary increases in prolactin contribute anti-anxiety effects. to the refractory period of erections. This is the amount of time after ejaculation before All of the metabolites in the process of another erection can be achieved. converting cholesterol to steroid hormones Sustained elevations of this hormone can play an active role in how your body lead to low testosterone levels. A common functions and how you feel. For example, cause of persistently elevated prolactin progesterone plays an important role in levels is a prolactinoma, a non-cancerous repairing the protective sheath covering tumor of pituitary gland. your nerve cells and can reduce inflammation and swelling in brain trauma. Lab Name Result Status Median Range Units Prolac�n 11.7 N 11.25 4.1-18.4 ng/mL Call 360-706-1808 with questions 16 www.primalhealthclinic.com
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Gonadal Axis for healthy bone maintenance, strength and muscular endurance, elevated mood, (Ref # 028480) and libido. Sex hormone binding globulin (Ref # 070038) (SHBG) is produced in the liver and binds (Ref # 500142) the most amount of testosterone (Ref # 082016) preventing it from being biologically active. (Ref # 004564) Decreased levels of SHBG can lead to (Ref # 140244) increased amounts of free testosterone which can lead to acne, excess body hair, The hypothalamic-pituitary-gonadal and irregular periods. In addition to being (ovarian) axis controls follicle maturation aromatized into estrogen, testosterone is and ovulation as well as the synthesis and converted into dihydrotestosterone (DHT) secretion of female sex steroids, specifically through the enzyme 5-alpha reductase. progesterone (see “Precursors”) and Elevated concentrations of DHT in the skin estradiol (estrogen). Follicle stimulating are associated with hair thinning and hormone (FSH) acts on the ovary during balding. Estradiol is the primary estrogen the follicular phase, or first part of your in the body and is created through the cycle. It stimulates the growth of a follicle enzyme aromatase in the ovaries and (which contains an egg) and increases peripheral tissue, particularly subcutaneous aromatase activity which causes a fatty tissue. Estrone (E1) is a less potent corresponding increase in estradiol form of estrogen that can be created from production. As you reach the midpoint of androstenedione, which is a precursor to your cycle the increase in estrogen causes testosterone, or directly from estradiol (E2). a decrease in FSH and a spike in luteinizing Is acts as a sort of estrogen reserve, ready hormone (LH) which leads to ovulation. to provide more bio-active estradiol when Once the egg has been released from the your body needs it. follicle the remnant cyst (corpus luteum) releases progesterone through the latter Lab Name Result Status Median Range Units part of your cycle (luteal phase) which prepares the lining of your uterus for FSH 56.9 N 4.7 1.7-7.7 mIU/mL implantation and maintenance of a fertilized egg. If pregnancy does not occur LH 39.4 N 6.2 1.0-11.4 mIU/mL there is no hCG production and the corpus luteum degrades leading to a sudden drop Total Test 24.1 LN 32.5 10.0- ng/dL in progesterone and menstruation. 55.0 Testosterone (Total Test, Free Test) is the 0.10- necessary precursor to estrogen. In Free Test 0.51 N 0.48 0.85 ng/dL women it is present in substantially lower concentrations than in men but performs DHT 14.2 N 13 4.0-22.0 ng/dL many of the same functions. It is necessary SHBG 71.3 N 73.3 24.6-122 nmol/L Estrone 10 LN 129 27-231 pg/mL Estradiol 3 LN 185 70-300 pg/mL Call 360-706-1808 with questions 18 www.primalhealthclinic.com
Growth Hormone Axis Normal aging is associated with a decline in GH and lower circulating levels of IGF-1. (Ref # 004275) This decline contributes heavily to the (Ref # 010363) frailty associated with aging; decreased (Ref # 140152) muscle mass, decreased lean body mass, increased abdominal fat, and decreased Growth hormone (GH) is essential for exercise tolerance (aerobic capacity). growth and development. It helps to Some adults suffer from premature regulate the rate at which your body deficiency in GH which has been produces energy from food (metabolism) associated with early cardiovascular and makes fats, proteins, and sugar disease, reduced bone density, central (glucose). It is also essential in the obesity, decreased muscle mass, production of red blood cells, muscle mass, depressed mood, elevated LDL levels, poor and recovery. Growth hormone is released wound healing, fatigue, reduced exercise from the pituitary in a pulsatile fashion with tolerance, and poor immune system the bulk being released in the early functioning. morning hours while you are asleep. It stimulates the production of insulin-like Lab Name Result Status Median Range Units growth factor (IGF-1) which is primarily produced in the liver. In an normal early GH 0.4 LN 5 0.0-10.0 ng/mL morning blood draw we would expect the GH to be low and the IGF-1 levels to be IGF-1 109 LN 224 101-347 ng/mL normal to high-normal. IGFBP-3 3630 LN 4707 2855-6559 ug/L In response to GH, IGF-1 stimulates growth of bone, muscle, and other body tissues. It also plays an active role in non-growth activities such as sugar and fat metabolism and deficiencies of IGF-1 have been implicated in the development of metabolic syndrome. IGF-1 has a very short-half life of about 10 minutes which means that your body tissue must use it quickly or it will degrade. In order to keep IGF-1 around longer so it can be used throughout the day 98% of your circulating IGF-1 is bound to one of six binding proteins (IGFBP). The most abundant of these binding proteins is IGFBP-3. Call 360-706-1808 with questions 19 www.primalhealthclinic.com
Adrenal Axis (Ref # 004440) (Ref # 004051) Adrenocorticotropic hormone (ACTH) is a hormone released from the pituitary gland that stimulates the production of cortisol from your adrenal glands. Normally, ACTH levels should increase in periods of acute stress which, in turn, leads to increased adrenal production of cortisol. Cortisol plays a critical roll in your body’s ability to fight infection, regulate blood sugar, maintain blood pressure, and control your metabolism. Specific medical conditions such as Cushing’s disease (too much cortisol) or Addison disease (too little cortisol) represent the ends of a spectrum of stress hormone related dysfunction which includes hypopituitarism (e.g. TBI, Sheehan syndrome) and adrenal insufficiency. Lab Name Result Status Median Range Units ACTH 31.9 LN 35 7.2-63.3 pg/mL Cor�sol 9.2 LN 15 6.2-19.4 ug/dL Call 360-706-1808 with questions 20 www.primalhealthclinic.com
Suggested Program 1. Prescription Medications 3. Additional Studies Current Dose Status Recommended Indication Location Coronary CT Cardiovascular risk stratification Recommended Dose Pharmacy 4. Follow-up Visits Testosterone 60mg every 3 Emp or Com days Visit Month Anticipated Diagnostic Enclomiphene 50mg every 3 Emp Evaluation hCG days UCP 1-mo Rapid check (ECLIA/E2) Sildenafil Cycled MCCPD 3-mo 6-mo Standard Testosterone (LC/MS) 50mg PRN 12-mo Standard Testosterone (LC/MS) 2. Supplements Standard Testosterone (LC/MS) Current Status Recommended Dose Brand Berberine 1 cap daily Double Wood Vitamin D 10k IU daily Thorne DHEA 10mg nightly Pure Enc. Pregnenolone 30mg nightly Pure Enc. DIM 1 cap daily Thorne Saw Palmetto 1 cap daily Pure Enc. Secretropin 2 spray nightly UCP Quercetin 1 cap twice daily Double Wood Continue Continue if desired Stop Call 360-706-1808 with questions 21 www.primalhealthclinic.com
Membership Determination Membership level is determined by the highest scored domain in our membership rubric: Scoring Domains Foundations Flex Flagship Therapeutic Intervention 2 3 4 or more Controlled Substances No CMRP Yes Yes Low Moderate High Your membership level is: PRIMAL FOUNDATIONS PRIMAL FLEX PRIMAL FLAGSHIP Primal Health and Wellness Clinic (Primal testosterone for gonadal axis, peptides for Health) is a membership-based practice with three membership tiers: Primal growth hormone axis, etc.). The ideal way Foundations, Primal Flex, and Primal Flagship. During your initial evaluation or intake to optimize peripheral hormone production examination your provider will determine your required membership level based off and health-span over the long-term is to the intensity and complexity of your programming. The contributors to your optimize metabolic health. Direct membership determination are the number of primary and secondary therapeutic pharmacologic interventions that manage domains addressed, the number and severity of co-morbid medical conditions and/or optimize metabolic health thus you have, and whether or not controlled substances are used as part of your indirectly improving peripheral hormone programming. production are secondary therapeutic The providers at Primal Health specialize in health-span management through a domains. Secondary therapeutic domains functional and integrative approach to hormone and cellular optimization. As commonly overlap with conditions that are such, the primary therapeutic domains addressed in our programming focus on addressed through a primary care provider optimization of various peripheral hormone axes which include the thyroid axis, growth such as high blood pressure, high hormone axis, adrenal axis, and gonadal axis. Management of a primary therapeutic cholesterol, and diabetes. However, there domain is when a direct pharmacologic intervention in an axis is made (e.g. are some secondary domains that may not have common overlap with your PCP, such as weight management, anabolic support, and treatment of sexual dysfunction. The therapeutic intervention scoring domain in our membership rubric is derived from the combined total of primary and secondary domains addressed in your programming. Another determinate of membership level is your co-morbid medical condition risk profile (CMRP) which is a determination based on cumulative severity and complexity of co-existing medical conditions. A co-morbid medial condition is a medical Call 360-706-1808 with questions 22 www.primalhealthclinic.com
condition that simultaneously, but independently exists with another condition OR a medical condition that causes, is caused by, or is otherwise related to another condition in the same patient. For example, low testosterone or hypogonadism is a commonly treated medical condition in our practice. If a patient being treated for low testosterone is also obese, that is one co-morbid medical condition (low testosterone + obesity). If the patient is obese with sexual dysfunction and high blood pressure, those are three co-morbid medical conditions (low testosterone + obesity AND sexual dysfunction AND high blood pressure). A more important consideration in the CMRP is the complexity and severity of the co-morbid medical conditions. For example, a patient with obesity and high blood pressure may have no identifiable coronary artery disease on coronary artery calcium (CAC) scoring, a CAC < 100, and CAC > 100, or have had a previous heart attack with or without stent. The latter is associated with a significant increase in overall management risk, so the membership requirements are higher even if the underlying co-morbidities are not managed by our providers. Your membership tier can be upgraded at anytime if you require or request additional services in your programming. You must spend at least 12 months at a specified tier before you are eligible for a membership downgrade if you request services to be removed from your programming. Call 360-706-1808 with questions 23 www.primalhealthclinic.com
Pricing Information* Estimated 1st Year Pricing Practice Membership (billed monthly) Foundations Flex Flagship Labs $75 $100 $135 Medications Supplements Supplies Imaging We offer a 10% membership discounts for first responders, military, and trades. In network referrals through the Millennium Health Network are also eligible for additional membership discounts. Primal Labs Common Bundles Labcorp ID Retail Foundations 5% Flex 10% Flagship 15% Standard Testosterone (LC/MS) N/A $222.00 $210.90 $199.80 $188.70 Standard Testosterone (ECLIA) N/A $166.00 $157.70 $149.40 $141.10 Standard Thyroid N/A $87.00 $82.65 $78.30 $73.95 Standard Growth Hormone N/A $107.00 $101.65 $96.30 $90.95 Standard Adrenal N/A $66.00 $62.70 $59.40 $56.10 Vitamins and Minerals N/A $116.00 $110.20 $104.40 $98.60 Cardiovascular Check-In N/A $183.00 $173.85 $164.70 $155.55 Common Follow-up Additions Labcorp ID Retail Foundations 5% Flex 10% Flagship 15% $36.00 $34.20 $32.40 $30.60 apo(A1), B, ratio 216010 $32.00 $30.40 $28.80 $27.20 $113.83 $108.14 $102.45 $96.76 DHEA-S 004020 $51.07 $48.52 $45.96 $43.41 $29.80 $28.31 $26.82 $25.33 DHT 500142 $10.82 $10.28 $9.74 $9.20 $7.50 $7.13 $6.75 $6.38 Estradiol, sens 140244 $54.92 $52.17 $49.43 $46.68 $12.08 $11.47 $10.87 $10.26 FSH/LH 028480 $24.97 $23.72 $22.47 $21.22 HBa1c 102525 Insulin 004333 Pregnenolone 140707 Prolactin 004465 Vit D, 25-hydroxy 081950 Call 360-706-1808 with questions 24 www.primalhealthclinic.com
Labs Continued… Test Name Labcorp ID Retail Foundations 5% Flex 10% Flagship 15% 17-OH progesterone 070085 $33.20 $31.54 $29.88 $28.22 ACTH, plasma 004440 $48.00 $45.60 $43.20 $40.80 ANA 164855 $7.50 $7.13 $6.75 $6.38 Androstenedione 004705 $35.18 $33.42 $31.66 $29.90 Anti-Smooth Muscle 006643 $15.82 $15.03 $14.24 $13.45 apo(A1), B, ratio 216010 $36.00 $34.20 $32.40 $30.60 B-12 001503 $9.00 $8.55 $8.10 $7.65 CBC 005009 $8.00 $7.60 $7.20 $6.80 CMP 322000 $8.00 $7.60 $7.20 $6.80 Cortisol 004051 $10.52 $9.99 $9.47 $8.94 Cystatin C w/ eGFR 121265 $160.00 $152.00 $144.00 $136.00 DHEA-S 004020 $32.00 $30.40 $28.80 $27.20 DHT 500142 $113.83 $108.14 $102.45 $96.76 EPO 140277 $11.65 $11.07 $10.49 $9.90 Estradiol, sens 140244 $51.07 $48.52 $45.96 $43.41 Estrone 004564 $60.08 $57.08 $54.07 $51.07 Fe + TIBC 001321 $12.25 $11.64 $11.03 $10.41 Ferritin 004598 $9.00 $8.55 $8.10 $7.65 Ferritin 004598 $8.40 $7.98 $7.56 $7.14 Free T4, Direct 001974 $11.00 $10.45 $9.90 $9.35 FSH/LH 028480 $29.80 $28.31 $26.82 $25.33 GC/Ch 183194 $58.25 $55.34 $52.43 $49.51 GGT 001958 $6.17 $5.86 $5.55 $5.24 Growth hormone 004275 $16.00 $15.20 $14.40 $13.60 HAV, HBV, HCV 144445 $72.72 $69.08 $65.45 $61.81 HBa1c 102525 $10.82 $10.28 $9.74 $9.20 HCV Ab 140659 $10.07 $9.57 $9.06 $8.56 HDL-P (Total) 818542 $35.00 $33.25 $31.50 $29.75 Hemachromatosis DNA 511345 $150.00 $142.50 $135.00 $127.50 HIV ab w/ reflex 083935 $11.27 $10.71 $10.14 $9.58 Homocysteine 706994 $56.00 $53.20 $50.40 $47.60 hs-CRP 120766 $15.00 $14.25 $13.50 $12.75 IGF-1 010363 $39.00 $37.05 $35.10 $33.15 IGFBP-3 140152 $45.00 $42.75 $40.50 $38.25 Insulin 004333 $7.50 $7.13 $6.75 $6.38 Iron + TIBC 001321 $13.00 $12.35 $11.70 $11.05 JAK2 V617F 489422 $299.00 $284.05 $269.10 $254.15 LDL, direct 120295 $13.28 $12.62 $11.95 $11.29 Lipid 303756 $8.00 $7.60 $7.20 $6.80 Lp(a) 120188 $20.00 $19.00 $18.00 $17.00 Lp-PLA2 123283 $61.67 $58.59 $55.50 $52.42 Macroprolactin 500324 $133.30 $126.64 $119.97 $113.31 Magnesium, RBC 080283 $66.78 $63.44 $60.10 $56.76 Methylmalnoic acid 706961 $35.00 $33.25 $31.50 $29.75 NMR+Lipid+IR 884000 $80.00 $76.00 $72.00 $68.00 NMR+Lipid+IR+Graph 123686 $164.75 $156.51 $148.28 $140.04 Oxidized LDL 123023 $63.33 $60.16 $57.00 $53.83 Pregnenolone 140707 $54.92 $52.17 $49.43 $46.68 Progesterone 004317 $16.53 $15.70 $14.88 $14.05 Call 360-706-1808 with questions 25 www.primalhealthclinic.com
Labs Continued… Test Name Labcorp ID Retail Foundations Flex 10% Flagship 15% 5% Prolactin 004465 $12.08 $11.47 $10.87 $10.26 PSA 010322 $8.50 $8.08 $7.65 $7.23 Reverse T3 070104 $43.00 $38.70 $36.55 RPR, Rfx Qn 012005 $4.98 $40.85 $4.48 $4.23 SHBG 082016 $36.00 $4.73 $32.40 $30.60 Testosterone 070038 $71.00 $34.20 $63.90 $60.35 Total T (ECLIA) 004226 $15.02 $67.45 $13.52 $12.77 Total T (LC-MS-MS) 070001 $50.07 $14.27 $45.06 $42.56 TPO 006676 $10.88 $47.57 $9.79 $9.25 Triiodothyronine T3 010389 $16.00 $10.34 $14.40 $13.60 TSH 004259 $9.98 $15.20 $8.98 $8.48 TT + FT LC/MS-MS 070195 $60.08 $9.48 $54.07 $51.07 Venipuncture 998085 $7.00 $57.08 $6.30 $5.95 Vit D, 25-hydroxy 081950 $24.97 $6.65 $22.47 $21.22 Zinc, plasma 001800 $8.30 $23.72 $7.47 $7.06 $7.89 Flagship 15% Primal Imaging $144.50 $1,402.50 Study Retail Founda�ons 5% Flex 10% $1,530.00 $161.50 $153.00 $212.50 Coronary CT Scan $170.00 $1,567.50 $1,485.00 $191.25 $1,710.00 $1,620.00 CT Abdomen and Pelvis w/wo contrast $1,650.00 $237.50 $225.00 $213.75 $202.50 MRI Brain w/wo contrast $1,800.00 Pelvic Ultrasound $250.00 Tes�cular Ultrasound $225.00 Call 360-706-1808 with questions 26 www.primalhealthclinic.com
Pharmacy and Medication Information In order to provide maximum cost savings to our members we send medications to a variety of pharmacies. We use a combination of national and local compounding pharmacies, large on-line retailers, and local commercial pharmacies to get you the best pricing. Sometimes, in order to get the best pricing, you may have different medications sent to different pharmacies. We frequently use specialty, personalized medications with our optimization programs. While we work with a number of compounding pharmacies, the primary pharmacies your prescriptions will be sent to are Empower Pharmacy (EMP), Hallandale Pharmacy (HALL), Harbor Health and Apothecary (HHA), and University Compounding Pharmacy (UCP). EMP and HALL prioritize processing of prescriptions that are billed directly to a clinic account and NOT to a patient. We have traditionally stayed away from acting as a third party in prescription transactions due to the moral hazard it creates; however, due to the processing priorities of these pharmacies, this policy caused unnecessary headaches and shipping delays to our members. As a result, we have stepped in to help our members and all EMP and HALL prescriptions will be billed through Primal Health directly to your card on file when we receive notification that the prescription has shipped. In order to reduce the moral hazard this creates we will only charge what each pharmacy charges patients directly if ordered through patient pay. HHA and UCP do not prioritize clinic accounts, so all prescriptions sent to these pharmacies will be billed directly to the member. When possible, we will utilize generic, commercially available medications. If the medication is available through Mark Cuban's Cost-Plus Drug Co. (MCCPD), then we will send it there unless you specifically ask for it to be sent to a local pharmacy. Even if you have insurance, medications through MCCPD are typically significantly cheaper than going through a commercial pharmacy. In order to have your medications filled through MCCPD you need to create an account online by following this link: https://costplusdrugs.com/ create-account/. When you first create an account, please allow up to 48 hours for your prescription medication to sync before you try and check out. Depending on your insurance policy, if you have one, there may be some medications for which it is more financially advantageous to send to a local commercial pharmacy for pickup. If there are any non-compounded, commercially available medications that you would like to be sent to commercial pharmacy please let your provider know. Most brand- name medications will need to be sent to a local commercial pharmacy for pickup, regardless of your insurance status. Your provider will always let you know which pharmacy usual medications have been sent to. Call 360-706-1808 with questions 27 www.primalhealthclinic.com
Supplement and Supply Information Supplements are profoundly useful in optimizing your health and performance. Well made, third party tested nutraceuticals are used to help with disease prevention and treatment. They are typically able to achieve treatment goals with little to no side effects and most possess potent positive allosteric effects. Pharmaceuticals, on the other hand, exert significant effect on your body but generally come with a host of unwanted or troublesome side effects. Our position is that wherever possible a nutraceutical should be used in place of a pharmaceutical. We recommend supplements with very specific goals in mind and frequently reassess and check blood work to make sure those goals are being attained. We do not routinely recommend supplements “because they are good for you”. The effects must be testable and if we are not achieving the desired goal then we will develop an alternative treatment pathway for you. Supplements can easily become one of the most expensive aspects of a treatment program. You can buy your supplements through any supplier of your choice. We generally recommend Pure Encapsulations, Thorne, Metagenics, and Double Wood products, but there are a number of reputable brands at different price points. In order to mitigate the cost for supplements that our members pay we have contracted with several high-quality suppliers so that we may provide discounts off of retail pricing. We also offer injection supplies (needles, syringes, and alcohol wipes) through the practice. While not as expensive as supplements, we are still able to offer discounts off retail pricing for members to try and keep costs down as much as possible. By offering supplements and injection supplies through the practice we are able to reduce the costs to our members and make getting everything you need for your program as convenient as possible. In order to take advantage of your member discounts please use our online Member Shop which is available from the website home page or at https://shop.primalhealthclinic.com/. Primal Foundations members are eligible for a 5% discount by using discount code FOUNDATIONS5. Call 360-706-1808 with questions 28 www.primalhealthclinic.com
Primal Flex members are eligible for a 10% discount by using discount code FLEX10. Primal Flagship members are eligible for a 15% discount by using discount code FLAGSHIP15. Members in our TBI program can use the PHTBI10 discount code when purchasing supplements from the Millennium Health Network at: https://millenniumhealthstore.com/ For your convenience, a cart with all of your supplements and supplies will be created for you after your appointment and the link will be emailed as part of your after visit summary. A 30% discount has already been applied to get you started! Call 360-706-1808 with questions 29 www.primalhealthclinic.com
Membership Cancellation and Termination Membership Cancellation You may cancel your membership with Primal Health and Wellness at any time and for any reason. If you would like to cancel your membership, please provide your request in writing to [email protected]. We would love feedback on your experience, but you are not obligated to provide a reason for cancellation. Your membership will be canceled within 48 hours of receipt of your written request. Per the agreed upon Membership Terms and Conditions (Annex D), any outstanding invoices for services, products, supplies, or medications will be charged to your account on file prior to final termination of the membership. In order to prevent rapid cycling of patients in and out of membership, once a membership has been canceled the member will not be eligible for re-activation of the membership for 12 months following the date of termination. Furthermore, membership in Primal Health and Wellness has limited availability and we maintain no obligation to hold a membership spot pending re-activation eligibility. Membership Termination All members are required to maintain an active, valid payment method on file at all times. Per the agreed upon Membership Terms and Conditions (Annex D) and Payment Authorization (Annex E), all members are responsible for updating their payment information as soon as it changes. Payment for any service (including membership), product, supplies, or medications is deemed late, including but not limited to, any dishonored debit and/or declined payment method. You will not be eligible for membership benefits until your account is brought current, including the payment of any outstanding fees or collection costs. You will have five (5) days to resolve any outstanding balance, or your membership may be terminated. If your membership is terminated, you may be eligible for reinstatement at the sole discretion of Primal Health and Wellness only after your account has been brought current and a reinstatement fee equal to membership dues from date of termination to date of reinstatement has been paid in full. Per the agreed upon Compliance Policy (Annex A), we expect our members to fully comply with all directions, advice, and instructions given by Primal Health team members and medical professionals. If at any time, you demonstrate a pattern of non-compliance with programming, particularly surrounding the use of controlled substances, Primal Health reserves the right to terminate your program immediately, without refund. Call 360-706-1808 with questions 30 www.primalhealthclinic.com
Supplement Review 7-keto DHEA 7-keto DHEA is a hormone produced in the brain, kidneys, and reproductive organs. It is very similar to DHEA, but 7-keto DHEA does not get converted into androgens so it can be supplemented without increasing testosterone or estrogen levels. 7-keto DHEA is most commonly used as a weight loss supplement to increase metabolic rate. Clinically, we have found that 7-keto DHEA commonly helps to reduce estrone (E1) levels in men supplementing with testosterone. Ascorbic Acid (Vitamin C) Vitamin C is widely recognized as one of the most important endogenous free radicals. Humans have lost the ability to synthesize it and must rely on dietary sources for utilization. Vitamin C is distributed throughout the brain and its concentration is about 10-fold higher in the in the cerebrospinal fluid than in blood plasma. As part of the general metabolic dysfunction that occurs in the secondary phase of TBI, tissue levels of vitamin C have been shown to be severely reduced. ADR Adrenal Support ADR is an adrenal support forumlation by Pure Encasulations. It contains a combination of whole adrenal and adrenal cortex extract with B5, asian ginseng, eleuthero, and licorice extract to support healthy adrenal function and those experiencing adrenal fatigue symptoms. Coenzyme Q10 (CoQ10) CoQ10 is the only lipid antioxidant that is synthesizes in all cells. It is an essential cofactor of the electron transport chain as well as a potent free radical scavenger. Supplementation with CoQ10 increases cerebral concentrations which subsequently leads to increased mitochondrial concentrations. Animal models have demonstrated significant reductions in vascular congestion, neuronal loss, nuclear damage, and axonal edema when administering CoQ10 after trauma. Creatine Most people have heard of creatine in the context of weight training because of its ability to enhance quality of workouts and muscle endurance. However, is has remarkable health benefits for the acutely injured brain as well. Call 360-706-1808 with questions 31 www.primalhealthclinic.com
Creatine works by helping create and cycle cellular ATP more efficiently. An integral part of the pathophysiology of neuroinflammation that occurs in TBI is the inability of mitochondrial respiration to maintain energy production sufficient for neuronal repair. This results in generation of reactive oxygen and nitrogen species that further exacerbate the injury leading to persistent levels of neuroinflammation contributing to cognitive symptoms of TBI. Creatine supplementation provides neuronal mitochondria with enhanced ability to cycle ATP in an attempt to keep up with the energy demands of repairing damaged tissue. Curcumin Curcumin is the bioactive compound primarily found in turmeric that gives it its bright color. Curcumin modulates the molecular signaling pathways involved in oxidative stress, inflammation, apoptosis, and autophagy. It also has therapeutic benefit in neuroinflammatory syndromes based on its effect on chemokine production. Chemokines and cytokines are intimately involved in the pathogenesis of a variety of central nervous system disorders accompanied by inflammation. DHEA Dehydroepiandrosterone (DHEA) is a metabolite of pregnenolone and is the precursor to down-stream hormones such as testosterone, dihydrotestosterone, androstenedione, estrone, estradiol. Both DHEA and its sulfonated form, DHEA-s, have significant effects over psychological functioning, generation of myelin from oligodendrocytes, and neuroprotection. The literature is also replete with articles about DHEA and DHEA-s having beneficial affects over the heart, immunity, inflammation, and cognition. DIM DIM stands for di-indolyl-methane and is a compound found naturally in cruciferous vegetables such as broccoli, cauliflower, Brussel sprouts, cabbage, and collards. Xenoestrogens are estrogen mimics that are founds all around us. They are in personal hygiene products, food additives, drinking water, etc. DIM helps the liver to detoxify consumed xenoestrogens. It also acts as a mild aromatase inhibitor which helps to prevent the conversion of testosterone into estradiol (E2). Melatonin Melatonin is produced in the pineal gland and when supplemented readily crosses the blood brain barrier for entry into neurons and glial cells. It is a potent free radical scavenger and has been shown to prevent the initiation and propagation of lipid peroxidation. It also upregulates the synthesis and activity of other antioxidant enzymes including glutathione Call 360-706-1808 with questions 32 www.primalhealthclinic.com
peroxidase, superoxide dismutase, and catalase. Melatonin also offers neuroprotective action at the level of the mitochondria by reducing electron leakage, free radical generation, and increasing ATP production. N-Acetyl Cysteine (NAC) NAC has been commercially available for over 40 years and has been traditionally used for pulmonary diseases and acute acetaminophen overdose. There is substantial evidence that NAC has both antioxidant and anti-inflammatory benefits in TBI. In 2013, NAC was studied in soldiers deployed to Iraq and Afghanistan. When treatment with NAC was initiated within 24 hours there was improvement in headache, confusion, memory loss, and sleep disturbance in those with mild to moderate TBI. At Primal, our preferred formulation of NAC supplementation is a combination powder that includes Glycine. It allows for easier consumption of higher doses and better support for glutathione production. Glutathione is one of the main endogenous antioxidants, acting in the body to recycle other antioxidants and protect the body from free radicals, as well as support detoxification. It is found in virtually every cell of the body and plays a critical role in cell function. Increased glutathione levels have been linked to supporting a reduction in oxidative stress and DNA damage. Cysteine and glycine are necessary precursors for glutathione (GSH) synthesis, and co-supplementation of these nutrients promotes intracellular glutathione levels. The body requires amounts of cysteine and glycine that may not be met by dietary intake alone, particularly as we age. In a small study involving older individuals, two weeks of supplementation with N-acetylcysteine (NAC) and/or glycine indicated that the combination NAC + glycine raised red blood cell (RBC) glutathione levels more effectively than either amino acid alone. In one study, supplementation with the combination of NAC and glycine resulted in 32% higher RBC glycine, 46% higher RBC cysteine and a 53% increase in RBC GSH concentration. There was also a significant improvement in the ratio of reduced (active) GSH to oxidized glutathione (GSSG). Increased GSH was associated with improvement in antioxidant status as measured by F2-isoprostanes, as well as mitochondrial fatty acid oxidation. In another study comparing young and older subjects, elderly subjects had 55% lower RBC glycine, 24% lower RBC cysteine and 46% lower RBC glutathione at baseline, as well as lower reduced (active) GSH to GSSG ratios. Supplementation with NAC and glycine in elderly subjects resulted in RBC levels of glycine, cysteine and glutathione, as well as GSH:GSSG ratio, comparable to young unsupplemented subjects. Call 360-706-1808 with questions 33 www.primalhealthclinic.com
NAC and glycine have been shown to maintain healthy cytokine release during times of metabolic stress. Research suggests that glycine may moderate TNF-a and promote IL-10 to support cytokine balance, and intake has been associated with cardiometabolic health. Studies indicate that supplementation with NAC supports mood and social functioning. It is believed that cysteine influences the reward-reinforcement pathway by modulating the glutamate system. NAC also promotes immune defense and supports respiratory health, acting as a free radical scavenger to support epithelial cell health and healthy cilia activity in the respiratory tract. It has a high affinity for lung tissue, which it supports through mucolytic and antioxidant action. Due to its sulfur content, NAC is able to disrupt disulfide bonds within mucus, thinning and easing its expulsion. In a randomized, double-blind trial involving mostly older individuals, 600 mg of NAC twice-daily showed significant support for respiratory and immune function. Omega Fatty Acids Omega-3 FAs are long-chain polyunsaturated fatty acids (PUFAs) with many documented health benefits, most notably in cardiovascular disease. The two primary omega-3 FAs are ecosapentaneoic acid (EPA) and docosahexaenoic acid (DHA), traditionally isolated from oils separated from fatty fish or a nonmarine microalgae source. DHA is one of the brain’s primary FAs, constituting very high concentrations in the phospholipids of neuronal plasma membranes and synaptic vesicles. Brain trauma can cause both acute and long-lasting perturbations in brain phospholipid metabolism leading to degradation of neuronal and astrocytic membrane phospholipids. This pathologic course contributes to the evolving secondary phase of traumatic brain injury. In TBI animal models omega-3 FA administration has repeatedly demonstrated neuroprotective effects through reduction in hippocampal injury, limiting oxidative damage through inhibition of prostaglandin synthesis, reducing deterioration of membrane phospholipids, and decreasing cumulative stress from reactive oxygen species. Pregnenolone Pregnenolone is referred to as the “mother of all hormones” for being the first steroid generated by the mitochondrial metabolism of cholesterol. It is the key substrate at the head of three very important pathways of steroidogensis. Pregnenolone is also a neurosteroid which is found throughout the brain, but in highest concentrations inside the hippocampus. In its sulfated form is allosterically inhibits GABAa receptors and enhances NMDA receptor function. Supplementation is used to optimize steroid production, improve memory and mood, increased libido, and counteract stress and fatigue. Call 360-706-1808 with questions 34 www.primalhealthclinic.com
Pyrroloquinoline (PQQ) PQQ is a micronutrient that is naturally found in foods such as soybeans, parsley, and green pepper. Recent clinical research suggests that as an antioxidant it may influence nerves and neurological health as well as cognitive function by supporting several signal transduction pathways that are important in maintaining mitochondrial homeostasis and oxidative metabolism. Quercetin Quercetin is the most common flavonoid found in nature. It is part of a broad group of natural polyphenolic flavonoid substances that are being investigated for a wide array of health benefits. Quercetin is a powerful antioxidant that has been found to increase mitochondrial biogenesis in muscle and brain tissue which helps to boost mitochondrial function. IGF-1 has a very limited half-life, only lasting for about 10 minutes before degradation. In order for your body to maintain adequate levels of IGF-1 throughout the day it binds the IGF-1 to binding proteins that have a much longer half-life. Most of the IGF-1 is bound to IGFBP-3 which gives it a half-life closer to 24 hours. Quercetin has been shown to increase levels of IGFBP-3 in addition to its beneficial effects on oxidation, inflammation, high blood pressure, and cancer. Saw Palmetto Saw palmetto has been utilized for decades to support healthy prostate and urinary function. In countries like New Zealand, France, Germany and Austria, this herb has been the gold standard for prostate support for many years. Its primary mode of action involves supporting healthy testosterone metabolism, in part by maintaining healthy 5-alpha- reductase enzyme activity and receptor binding thereby reducing DHT concentration. In a recently published JAMA meta-analysis involving 18 randomized controlled trials and almost 3,000 men, results suggest that saw palmetto provides important urologic support by promoting healthy urinary function. In a three-year German study, saw palmetto extract promoted healthy urinary function in volunteers. Secretropin Secretropin is a natural growth hormone secretagogue. It is a non-peptide advanced amino acid formulation in a nanoliposomal delivery system that is used nightly to increase the growth hormone surge that comes during sleep. It works with your body to naturally increase your IGF-1 levels through increased growth hormone production. Increased Call 360-706-1808 with questions 35 www.primalhealthclinic.com
growth hormone levels can help to build muscle, reduce fat, fat diabetes, and speed recovery. Tongkat Ali Tongkat Ali, also known as longjack, is an herbal remedy that has been a part of Southeast Asian medicine for centuries. It has been traditionally used for a variety of ailments including fever, bacterial infection, and fertility. More recent medical studies support its use for stress relief, improvement in body composition, and boosting libido and male sexual function. Tongkat Ali decreases SHGB and increases total testosterone levels. It has also been shown to increase libido, sperm motility, and semen volume. Vitamin D Vitamin D is a fat-soluble secosteroid which is primarily synthesized in the skin through a chemical reaction that is dependent on sun exposure (specifically UVB radiation). The most important type of vitamin D is known as cholecalciferol, vitamin D3. Vitamin D acts both as a co-factor for a wide array of chemical reactions in your body but also as a hormone which influences gene activation and transcription. It has sites of action throughout your central nervous system and is considered a neuroactive steroid. Vitamin D plays a number of vital roles in your body including the reduction of inflammation, modulation of processes of cell growth, neuromuscular and immune function, and glucose metabolism. When supplementing with vitamin D it is important to remember that it is a fat-soluble vitamin. Absorption is best when taken in a nanoliposomal form (e.g. Pure Encapsulation Vesisorb) . If taking a non-nanoliposomal form, which is much cheaper, make sure you take with a meal or snack that has fats in it. The goal is to achieve a serum vitamin D level of 60-100ng/mL. Zinc Zinc is an essential mineral that is naturally present in some foods and available as a dietary supplement. It is found throughout your body and helps your immune system and metabolism function. It is also important in wound healing, protein synthesis, DNA synthesis, and cellular metabolism and division. Zinc helps to inhibit aromatase while simultaneously participating in the release for FSH and LH from the pituitary gland which helps to stimulate testosterone production. Call 360-706-1808 with questions 36 www.primalhealthclinic.com
Clear Mind and Energy (CME) CME is a proprietary liposomal combination product developed by Dr. Mark Gordon. It provides clarity, focus, and greater mental endurance under stress. The four ingredients are: Lepidium meyenii (Maca): also known as Peruvian ginseng. Scientific evidence showed that maca has nutrition, energizer, and fertility-enhancing properties. It acts on sexual dysfunction, osteoporosis, benign prostatic hyperplasia, memory and learning, and protects skin against ultraviolet radiation. Guarana: has been found to have neuroprotective qualities against oxidative stress, as well as mood elevation and cognitive performance. It improves fatigue in cancer patients, and improves sleep quality, anxiety, and depression symptoms Rhodiolarosea: enhances memory and mental energy by its ability to increase the neurotransmitter Acetylcholine by decreasing its destruction by the enzyme acetylcholine esterase. EGCG: epigallocatechin gallate is the active agent in Green Tea. Studies on post-stroke patients and those with dementia and Alzheimer’s disease all benefited with an improvement in cognitive functioning with placed on EGCG. Hesperidin: can effectively protect neurons from damages induced by oxidative stress. Moreover, it enhances cognitive functions through elevating brain derived neurotrophic factor (BDNF) and reversing the disruptive effect of global cerebral ischemia/reperfusion (I/R) injury which can cause cognitive deficits, excitotoxicity, neuroinflammation, oxidative stress and brain edema. B is for Brain (B4B) B4B is a proprietary liposomal combination product developed by Dr. Mark Gordon. It contains one of the most important energy producing components known as PQQ; a sister to Co-Q10 by 100-1000 times more potent. This product is designed to boost mitochondrial functioning and energy production. Ingredients include: Pyrroloquinoline quinone (PQQ): a compound known to influence multiple cellular pathways, including the production of nerve growth factor (NGF). By protecting neurons and stimulating nerve growth in the brain, PQQ also supports cognitive performance, Call 360-706-1808 with questions 37 www.primalhealthclinic.com
including memory and attention. Additional benefits of PQQ are its ability to remove free radicals and lower oxidative stress, increase production of ATP, and to stimulate the production of Mitochondria. Ubiquinone (CoQ10): It is a component of the electron transport chain and participates in aerobic cellular respiration, which generates energy in the form of ATP. Ninety-five percent of the human body's energy is generated this way. Organs with the highest energy requirements—such as the brain, heart, liver, and kidney—have the highest concentrations. The more energy produced the better and clearer the brain functions. Thiamine (B1): is important for production of neurotransmitters, memory, mental clarity, cognition, and steady gait. Vitamin B1 is important for production of energy from carbohydrates. Vitamin B1 can treat symptoms associated with Wernicke-Korsakoff syndrome and reduce oxidative stress. Riboflavin (B2): deficiency is associated with neurodegeneration, peripheral neuropathy, loss of thyroid (T4) metabolism with personality changes. Vitamin B2 might also protect the eyes from Cataracts. Pantothenic acid (B5): functions as the required precursor of coenzyme A (CoA), through which it plays key roles in multiple biological processes, including many that regulate carbohydrate, lipid, protein, and nucleic acid metabolism. Acetyl-CoA is necessary for synthesis of the complex fatty-acyl chains of myelin, and of the neurotransmitter acetyl- choline all for brain functioning. Methyl-Cobalamin (B12): deficiency express itself by a wide variety of hematological, neurological, psychiatric, gastrointestinal, and skin disorders. Nervous system disorders, such as brain atrophy, myelopathy, and neuropathy, are often the earliest and, in some cases, the only clinical symptoms of vitamin B12 deficiency. Ongoing research suggested that the imbalance of cytokines and growth factors may be essential to the pathogenesis of the white matter lesions and thus neuropathy due to cobalamin deficiency. Brain Care II (BC2) BC2 is a proprietary liposomal combination product developed by Dr. Mark Gordon. It supports the body’s ability to address inflammation precipitated by neurotrauma. BC2 contains a blend of: DHA: one of the major building blocks of the brain, the omega-3 fatty acid docosahexaenoic acid (DHA) is critical for optimal brain health and function at all ages. Call 360-706-1808 with questions 38 www.primalhealthclinic.com
Researchers are now finding that DHA provides brain-boosting benefits in infants and aging adults. A key mechanism of DHA is the protection of neural tissue by the production of Resolvins and Protectin D1. Tocopherol: also known as Vitamin E (alpha, delta, and gamma) which has been found to reduce the production of inflammation by downregulating the production of the transcriptional factor NFkB responsible for signaling DNA to manufacture inflammatory chemicals - Cytokines. Ascorbic Palmitate: unique to the different formulations of Vitamin C is this fat-soluble form which can easily enter the blood supply feeding the brain. Once in the brain, Vitamin C is a major anti-inflammatory and free radical scavenger product that reduces inflammation. Vitamin C also increases the enzyme, Glutathione synthetase, that helps to make more brain and liver Glutathione that protects the brain and helps detox from alcohol. Quercetin: this is a natural polyphenolic, flavonoid antioxidant and has several important effects on the metabolism of the brain and reduction of inflammation. First, Quercetin can increase the production of mitochondria starting within 7 days yielding a higher production of energy as ATP (adenosine triphosphate). This ATP is used to run cellular functions which can be perceived as clearing thoughts, more energy and loss of fogginess. Second, Quercetin downregulates the production of the transcriptional trigger for inflammation, the notorious NFkB. Glutathione: functions as the front-line defense against oxidative stress in the brain. After trauma, the levels of Glutathione are reduced, through consumption and damage to the enzyme system that regenerate it, and this allows for the accumulation of free radicles. This increased Oxidative Stress, which damages neurons and alters the molecular chemistry in the brain, is the focus of the Brain Care II product. EGCG: epigallocatechin gallate is the active agent in Green Tea. Studies on post-stoke patients and those with dementia and Alzheimer’s disease all benefited with an improvement in cognitive functioning when placed on EGCG due to its neuroprotection. Brain Rescue 3 (BR3) BR3 is a blend of Clear Mind and Energy, Brain Care II, and B is for Brain. Call 360-706-1808 with questions 39 www.primalhealthclinic.com
Annex of Legal Documents A. Compliance Policy B. HIPAA Notice Of Privacy Practices C. Hormone Replacement Therapy (HRT) Informed Consent D. Membership Terms and Conditions E. Payment Authorization F. Treatment Guidelines and Primary Care Requirements Welcome Page 40 of 53
A. Compliance Policy You acknowledge that by purchasing a package of services and products with Primal Health, you agree to fully comply with all directions, advice, and instructions given by team members and medical professionals at Primal Health. You agree to fulfill all prescriptions through pharmacies contracted with Primal Health unless otherwise directed by one of our medical professionals. Your agreement hereto is to ensure that your prescribed plan and treatment is fulfilled to the fullest extent. Failure to comply will interfere with the success of your program. If you choose to not comply with the program, Primal Health reserves the right to terminate your program immediately, without refund. Nothing contained within this policy shall force you to undergo any medical treatment that you do not desire. Rather, the purpose is to ensure strict compliance with a program if you decide to pursue treatment. At anytime during your program, you may ask questions about the program and treatments and have those questions answered. By clicking “I AGREE”, you acknowledge that you understand and agree to the foregoing Compliance Policy. Welcome Page 41 of 53
B. HIPAA Notice Of Privacy Practices This Notice describes how medical information about your medical information may be used and disclosed by Primal Health & Wellness, PLLC (“Company”) in its capacity as a Business Associate to the Company’s affiliated physician who takes care of you (“Physician”), and how you can get access to this information. Please review this Notice carefully. What is your medical information? All the health care related information your Physician and the Company have in your file, including your medical history, current condition, diagnosis, examination notes, test results, and prescriptions. Why are you getting this Notice? The Company is a Business Associate to your Physician and, as such, performs certain administrative functions for your Physician which require access to your medical record. As a Business Associate, the Company must comply with the HIPAA Privacy Rule that requires Company to protect the confidentiality of your medical information. As a medical services provider, your Physician must also comply with the HIPAA Privacy Rule. The Privacy Rule also gives you certain rights with respect to your medical information. This Notice explains both our obligations and your rights under the Privacy Rule. Your rights: Although your physical medical file belongs to your Physician, the information in your file belongs to you. You therefore have the right to: ■ Request that your Physician and the Company restrict the use or disclosure of your medical information for treatment, payment and health care operations. Please note that neither your Physician nor the Company has to agree to the requested restrictions but if it either one does agree, they must abide by the restrictions. Please also note that the Company does is not a medical services provider and does not provide any kind of medical advice or treatment to anyone. The Company is providing this Notice strictly in its role as a Business Associate to your Physician. ■ Request that your Physician and the Company use an alternative means to communicate with you on a confidential basis about your medical information. You may also request that we send such communications to you at an alternative location. ■ Inspect and copy your medical information for as long as your Physician and/or the Company maintain your medical record. Under certain specific circumstances, your Physician and/or the Company may deny your request but this denial is, in most cases, reviewable. Please also note that there is some medical information that you do not Welcome Page 42 of 53
have a right to access, including psychotherapy notes and information prepared in anticipation of civil, criminal or administrative proceedings. ■ Request in writing that your Physician and the Company amend your medical information or record, unless the record is already accurate and complete or neither your physician nor the Company creates the information you wish to amend. The Company will act on your written request within 60 days after receiving it and either make the amendment or provide you with a written denial. ■ Except for certain disclosures, request an accounting of disclosures of your medical information by both your Physician and the Company. ■ Receive a paper copy of this Notice. Company’s obligations: We are required to do the following: ■ Maintain the privacy of your medical information and provide you with this Notice. ■ Abide by the terms of this Notice. ■ Notify you if we cannot agree to a use or disclosure restriction you request. ■ Accommodate your reasonable request to communicate with you via alternative means or at an alternative location. Please note that the Company reserves the right to change its privacy practices and apply the changes to your medical information. If we do change our privacy practices, we will mail you a revised Notice to the address you have provided to us. Uses and disclosures: These are some examples of the uses and disclosures of your medical information that the Company will make: ■ Health care operations: The Company maintains a comprehensive electronic health record (“EHR”) system which your Physician uses to access your medical record and to add information to that record. The Company will use the information in your medical record on the EHR to provide administrative and support services to your Physician, track, locate and load lab test results into your medical record for your Physician to access, keep track of your appointments with your Physician and answer any questions you may have which do not require you to speak with your Physician. ■ Payment: The Company will handle the billing for any laboratory tests your Physician prescribes for you and will collect any amount due from you and make sure that payment is transmitted to the appropriate laboratory. All billing information, including the backup sent with the bill will identify you and will include information about the types of tests the lab performed for you and your test results. Welcome Page 43 of 53
■ Business Associates: The Company may use an outside consultants, including financial, IT and legal consultants, who may, in connection with providing services to the Company, have need to access the EHR system. The Company may disclose your information to these outside consultants for the purpose of enabling them to provide the requested services to the Company. Before Company discloses any of your medical information to such outside consultants, we will require the contractor to sign a Business Associate Agreement in which the consultant agrees to protect the confidentiality of your medical information. ■ We may disclose your medical information as required by law, including worker’s compensation regulations; to the Centers for Medicare and Medicaid Services or other regulatory agency; in response to an order of court or administrative tribunal and as required by a valid subpoena; for law enforcement purposes; for public health purposes; to governmental authorities, including social service or protective service agencies, if we believe you have been the victim of abuse, neglect or domestic violence; to a health oversight agency for oversight activities authorized by law; to avert a serious threat to health or safety; in connection with specialized government functions including military or veteran’s activities, national security and intelligence activities and national security or intelligence activities; or during a medical emergency as necessary to protect your welfare. ■ The Company will make any other uses and/or disclosures of your medical information that are not related to treatment, payment or health care operations only with your prior written authorization. If the Company wishes to use your medical information for any such other purpose (for example, marketing), we will speak to ou first and give you the option of signing an Authorization. You are not required to sign the Authorization and if you do, you may revoke that Authorization at any time. ■ We will contact you to provide appointment reminders but will do so only at the telephone number(s) or e-mail address you provide to us for that purpose. ■ Complaints: If you think your privacy rights have been violated, you may complain to the Compliance Director at Company and/or to the Secretary of Health and Human Services. In order to file a complaint with Company, please speak with the Company’s Privacy Office and s/he will complete a written complaint form with you and follow up on your complaint. The Company will not retaliate against you for filing a complaint. Contact: If you have any questions or complaints regarding your medical information or anything contained in this Notice, please contact the Privacy Officer, Ian Strand at [email protected] Effective date: This Notice is effective as of October 1, 2021 until revised or revoked. Welcome Page 44 of 53
C. Hormone Replacement Therapy (HRT) Informed Consent Hormone Replacement Therapy, also known as \"HRT\" is used to treat or supplement a lack of naturally occurring hormones or to substitute other hormones for naturally occurring hormones and may be prescribed to patients when determined to be medically necessary by a physician or advanced nurse practitioner. HRT may be used to address perimenopause, menopause (decline in estrogen and progesterone levels), adrenal fatigue, andropause (decline in testosterone levels), and thyroid disorder, that are the result of a medical condition or the normal aging process. BENEFITS OF HRT: HRT may help increase energy level, improve mood, maintain weight loss, improve sleep patterns, increase sexual function and libido, and decrease signs of aging. HRT may be administered through injections; transdermal gel, patches or stick, mucoadhesive material applied above the teeth, or subcutaneous pellet. CONTRAINDICATIONS: HRT should not be used in patients who have prostate or breast cancer, severe urinary tract problems, untreated severe sleep apnea, uncontrolled heart failure or at a risk for stroke or any other condition in which HRT therapy may be contraindicated. All patients considering HRT therapy should undergo a thorough medical examination by a medical or osteopathic physician or advanced registered nurse practitioner and have blood or other laboratory screening tests to determine appropriate medical treatment for a patient’s condition prior to starting an HRT regime. RISKS & COMPLICATIONS: In general, HRT is safe; however, it is not known if HRT is safe or effective for patients with low hormone levels due to aging. Some of the Potential Side Effects of HRT include fluid retention; acne; increased urination; breast enlargement; decreased testicle size; worsening of sleep apnea; increased cholesterol levels; decreased sperm count; infertility; prostate abnormalities; increased aggression and mood swings; increased number of red blood cells which can cause an increased risk of blood clots, muscle pain, high blood pressure, blurry vision, or chest pain; or an increased risk of heart attack or stroke. ALTERNATIVES to HRT: Alternatives to HRT are: 1) Do Nothing; 2) Surgical intervention if deemed appropriate; 3) treatment with PDE5 inhibitors such as Viagra, Cialis or Levira; 4) Platelet Rich Plasma (“PRP”) injections (e.g., Priapus or “P” Shot or Orgasm or “O” Shot); or 6) vitamin or herbal supplements. CONSENT: My consent and authorization for this elective procedure is strictly voluntary. By Welcome Page 45 of 53
signing this informed consent form, I hereby grant authority to the physician/practitioner to prescribe or treat me using HRT as discussed during our consultation. I have read this informed consent and certify I understand its contents in full. All of my questions have been answered to my satisfaction and I consent to the terms of this agreement. I agree to adhere to all safety precautions and instructions before, during and after the treatment. I have been instructed in and understand pre-treatment and post treatment instructions and have been given a written copy of each. I understand that medicine is not an exact science and acknowledge that no guarantee has been given or implied by anyone as to the results that may be obtained by HRT treatment. I also understand treatment with HRT is \"elective\" and not covered by insurance and that payment is my responsibility. Any expenses which may be incurred for medical care I elect to receive outside of this office such as but not limited to dissatisfaction of my treatment outcome, will be my sole financial responsibility. Payment in full for all treatments is required at the time of service and is non-refundable. I hereby give my voluntary consent to treatment using HRT Therapy and release Primal Health & Wellness Clinic, PLLC, Dr. Ian Strand, Primal Health & Wellness Clinic, PLLC’s office, its staff and specific technicians from liability associated with HRT treatment as indicated by my signature below. I certify that l am a competent adult of at least 18 years of age and am not under the influence of alcohol or drugs. This consent form shall be binding upon my spouse, relatives, legal representatives, heirs, administrators, successors and assigns. I agree that if I should have any questions or concerns regarding my treatment or results I will notify this office and/or provider immediately so that timely follow-up and intervention can be provided. Welcome Page 46 of 53
D. Membership Terms and Conditions 1. Parties Primal Health & Wellness Clinic, LLC (herein after “Primal Health”) and you agree that by signing this agreement, you are purchasing a membership for services and agree to all the terms in this agreement. The terms “you” and “Primal Health” include heirs, estates, agents, representatives, officers, directors, shareholders, successors, affiliates, subsidiaries and employees. Both parties make this agreement on behalf of, and it binds all these included persons and entities. It is your responsibility to notify Primal Health of any change in your address or phone number. 2. Representations a. Physical Condition. You represent that you are in good physical condition, have read and understand the medical restrictions of each service and have no medical reason or impairment that might prevent you from receiving any of the services offered by Primal Health. If you have any health or medical concerns now or after you join, you agree to discuss them with your primary care physician prior to receiving services. b. Assumption of the Risks and Release of Liability. You recognize that there are certain inherent risks associated with the services and treatments you seek at Primal Health and as such you assume full responsibility for personal injury to yourself, and further release and discharge Primal Health for injury, loss, or damage arising out of your use of or presence upon the facilities of Primal Health, whether caused by the fault of yourself, Primal Health and its representatives, or other third parties. c. Liability for Property. Primal Health is not liable to you or your guest(s) for any personal property that is damaged, lost, or stolen while on or around Primal Health premises including, but not limited to, a vehicle or its contents or any property left in a locker or other waiting area. If you or your guest cause any damage to Primal Health’s facilities, you are liable to Primal Health for its cost of repair and/or replacement. d. Entire Agreement & Enforcement. You acknowledge that neither Primal Health, nor anyone else, made any representations nor promises upon which you relied that are not stated in this agreement. This document contains the entire agreement between you and Primal Health and replaces any oral or other written agreement. If a court declares any part of Welcome Page 47 of 53
this agreement invalid, it will not invalidate the remaining parts, which continue unaffected. If Primal Health does not enforce any right in this agreement for any reason, Primal Health does not waive its right to enforce it later. e. Insurance. You acknowledge and understand that the Services provided under this Membership are not eligible for reimbursement by insurance. Primal Health will not provide an itemized bill for you to submit to your insurance. If you maintain a health savings account or flexible spending account, you will need to confirm with your carrier if such services are eligible for reimbursement. 3. Membership a. General. Your membership permits you to receive certain, limited services performed by Primal Health, subject to all of Primal Health’s policies, rules, and limitations. Your membership gives you no rights in Primal Health, its management, property or operation. Primal Health may assign, transfer, or cancel your membership in its sole discretion. You have no right to assign your membership or this agreement. Primal Health can sell memberships at different rates and terms than yours. Any offer to provide a membership at a rate different than the listed price, or waive any fees, shall only be offered and approved by the Manager who shall provide a signed form acknowledging such changes or waivers. Member understands and acknowledges that a membership at Primal Health is a choice of the member and does not provide any special rights. If member fails to utilize their membership by booking treatments or utilizing services, Primal Health will not assume that member wishes to cancel the membership. Failure to utilize a membership will not entitle member to any refunds whatsoever. Primal Health does not provide a refund to your credit card, bank, or any other payment method. Primal Health will provide, under certain circumstances, exchanges for credit only. b. Terms. Your dues entitle you to but do not guarantee, certain services based on the package you purchase, subject to Primal Health’s availability and subject to Primal Health’s policies, rules, limitations and/or any medical restrictions and/or limitation, regardless of the extent to which you opt to utilize the services. Currently, Primal Health offers the following packages and services, which may be changed at any time in Primal Health’s sole discretion: c. Refunds. In the event you desire to cancel a purchased package or service at any time, Primal Health may approve the cancellation and subject you to a cancellation fee of 25% of Welcome Page 48 of 53
the cost of the purchased package. If a cancellation is granted, you will be returned a pro-rated portion of fees paid minus any services received. Cancellations must be requested in writing. In the event you desire to cancel your package after products or services were ordered by Primal Health, you will be responsible for the full cost of such products or services. After any services for a specific package are rendered, there are absolutely no refunds. d. Non-transferable Membership. Members cannot assign, share or transfer their Primal Health membership for any reason at all. e. Costs after Cancellation. You acknowledge that by purchasing a package of services with Primal Health, you authorize Primal Health to pre-order your program products, including prescriptions, in advance. You understand that certain products have short shelf lives and require timed ordering throughout your protocol. After approving your program, you will be responsible for all costs associated with that portion of your program. In the event you desire to cancel a purchased package at any time, Primal Health may approve the cancellation however you will remain responsible for the full cost of the purchased package including all products, prescriptions, and supplies that have already been ordered. Under no circumstance will a refund be given, due to the pre-ordering of products and prescriptions. In the event you desire to cancel your package after products or services were ordered by Primal Health, you will be responsible for the full cost of such products or services. f. Late Cancellation: Members must give at least twenty-four (24) hours’ notice for any appointment they wish to cancel. Any appointment that is canceled within twenty-four (24) hours of the appointment time shall be automatically charged the individual fee for the treatment. Late cancellation fees are non-refundable. g. Late Payments & Default: Members are responsible for updating payment information as soon as it changes. Payment is deemed late including but not limited to any dishonored debit and/or declined credit card charges. You will not be eligible for membership benefits until your account is brought current, including the payment of any outstanding fees or collection costs. You understand you have five (5) days to resolve any outstanding balance or your membership will be terminated. Default interest at an APR of 18%, or the maximum allowable by law, shall accrue on any outstanding balance until paid in full. In addition, you understand and agree that you will be responsible for all other fees, expenses, and costs of collection associated with your failure to make any payment under this Agreement, including, but not limited to, returned check fees, Welcome Page 49 of 53
reasonable attorney fees, court costs, and other related costs and expenses. h. Changes to membership agreement. Primal Health may, from time to time, make changes to this agreement. Primal Health may, at any time, change the Annual Membership Fee, late fees, or any other fees. Such revisions will be effective on the first of the following membership month. Primal Health will provide member with reasonable and timely notice of such revisions. Your continued use of Primal Health facilities and/or services shall constitute acceptance of these changes. i. Privacy. Primal Health collects, uses and discloses certain personal information of members in accordance with their Privacy Policies. j. Dispute Resolution. In the unlikely event that you and Primal Health are unable to resolve a dispute arising out this agreement or the services provided by Primal Health, you and Primal Health each agree to first attempt to resolve such disputes through mediation in Thurston County, Washington. Primal Health shall have the right to choose the mediator and both parties shall equally bear the costs of mediation, aside from attorney’s fees. By signing this agreement, you acknowledge and agree that you and Primal Health are each waiving the right to a trial by jury and the right to participate in a class action, either in court or in arbitration. In the event a ruling is in favor of Primal Health, Primal Health shall be entitled to recover all legal costs and fees. k. Legal Costs. In the event that You cause Primal Health to engage legal counsel for the defense of any unfounded claims, or to enforce the rights of Primal Health under these Terms and Conditions, or pursue legal claims to preserve the rights of Primal Health, You shall be responsible for all of Primal Health’s reasonable legal costs and fees. 4. Limitation of Liability. Unless controlling legal authority requires otherwise, any award by the arbitrator or a court is limited to actual compensatory damages. Specifically, neither an arbitrator nor a court can award either party any indirect, special, incidental or consequential damages; even if one party disclosed to the other party that they might suffer these damages. 5. Communications. Although Primal Health staff members may discuss concerns, questions and scheduling with you via telephone, only communications via e-mail will be considered final, accurate and legitimate. Members must always follow up phone conversations via e-mail and Welcome Page 50 of 53
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