Sick Building Syndrome is a distinct clinical entity: we have the proof
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1 Sick Building Syndrome is a distinct clinical entity: we have the proof Senate Health, Education, Labor and Pension Committee 1/12/06 Ritchie C. Shoemaker MD Center for Research on Biotoxin Associated Illnesses Pocomoke, Md
2 Proof of Causation Koch s Postulates Repetitive exposure trials Double blinded, placebo controlled trials Prospective hyperacute acquisition studies Reproducibility at multiple sites Peer-reviewed publications EVIDENCE-BASED MEDICINE!
3 Treatment leads to definition Prior studies showed there were health problems in patients exposed to water-damaged buildings hosting toxigenic organisms, including fungi Effective therapy, beginning with cholestyramine, gives us the ability to correct and then study the disease Multiple sequential steps
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5 Application of causation Case definition Individual cases Screening Documentation of acquisition of illness Risk management High risk occupations New hires in water-damaged buildings Verify effective remediation occurred
6 Case definition patients /43 buildings (Brescia, Italy) 156 patients /150 buildings (Saratoga, NY) 21 patients/ 5 buildings (NT and T) 288 patients /125 buildings (ASTMH) 26 patients/5 buildings (DB-PC trial) 20 patients in hyperacute model (ASM biodefense conference) 40 patients, eight year follow-up 152 patients, age under 19
7 Case definition-2 FIRST TIER Potential for exposure Multisystem, multisymptom illness Absence of confounders Differential diagnosis
8 SECOND TIER Case definition-3 Genetic susceptibility; HLA DR by PCR Hypothalamic impairment; low MSH Neurotoxic illness; VCS deficit Cytokine activation; MMP9 elevation Pituitary involvement ACTH/cortisol ADH/osmolality
9 Why use such unusual tests? Biologically produced neurotoxins activate innate immune responses NOT acquired immune responses Illness is hidden by looking only at standard lab tests Illness is obvious to anyone when looking at what is wrong Tests might look unusual, but are readily available to any physician; insurance approved, Medicare approved
10 Is mold illness rare? NO! We see 10 new patients a week Total in treatment data base exceeds 2900 mold illness patients Total biotoxin illness patients exceeds 5000 We have data on over 4000 controls
11 Rev. 10, The Biotoxin Pathway In genetically susceptible people, biotoxin binds to fat-cell receptors, causing continuing, unregulated production of cytokines. Capillaries High cytokine levels in the capillaries attract white blood cells, leading to restricted blood flow, and lower oxygen levels. Reduced VEGF leads to fatigue, muscle cramps, and shortness of breath (may be over-ridden by replacement with erythropoietin). Body acquires biotoxins or toxin-producing organisms from food, water, air, or insect bites Biotoxin (not HLA susceptible) Biotoxin (HLA susceptible) Removal from the body In most people, biotoxins are either removed from the blood by the liver or attacked by the immune system, broken down, and excreted harmlessly. In people who don t have the right immune-system genes, however, biotoxins can remain in the body indefinitely. G. Alexander 2004 Biotoxin (HLA susceptible) Nerve cell Surface ( Toll ) receptor Biotoxins have direct effects, including impairment of nerve cell function. One result is poor performance on contrast sensitivity test. Sleep disturbance Production of melatonin is reduced, leading to light, nonrestorative sleep. Chronic pain Endorphin production is suppressed. This can lead to chronic, sometimes unusual, pain. Gastrointestinal problems Lack of MSH can cause malabsorption in the gut, resulting in diarrhea. This is sometimes called leaky gut and resembles (but is not) celiac disease. Patients must avoid gluten, whey, and amylose. Fat Cell Increased Cytokines Excessive cytokine levels can damage leptin receptors in the hypothalamus. Prolonged illness Increased Leptin White blood cells lose regulation of cytokine response, so that recovery from other illnesses, including infectious diseases, may be slowed. Leptin receptor Hypothalamus VIP Reduced MSH Increased Cytokines Fat cells then produce more leptin, leading to obesity (which doesn t respond to exercise and diet). AVP Resistant Staph bacteria Colonies of Staph bacteria with resistance to multiple antibiotics may develop in mucous membranes. The bacteria produce substances that aggravate both the high cytokine levels and low MSH levels. Damaged leptin receptors lead to reduced production by the hypothalamus of MSH, a hormone with many functions. Reduced ADH Reduced MSH can cause the pituitary to produce lower levels of anti-diuretic hormone (ADH), leading to thirst, frequent urination, and susceptibility to shocks from static electricity. Reduced sex hormones Reduced MSH can cause the pituitary to lower its production of sex hormones. Changes in cortisol and ACTH levels The pituitary may produce elevated levels of cortisol and ACTH in early stages of illness, then drop to excessively low levels later. (Patients should avoid steroids such as prednisone, which can lower levels of ACTH.) Immune system symptoms Patients with certain HLA genotypes (immunityrelated genes) may develop inappropriate immunity. Most common are antibodies to: -- Myelin basic protein (often from fungal biotoxins; affects nervous-system functions) -- Gliadin (affects digestion) -- Cardiolipins (affects blood clotting) The complement alternative immune pathway may be triggered (detectable as an increase in levels of the proteins C3a C4a). Cytokine-related symptoms High levels of cytokines produce flu -like symptoms: Headaches, muscle aches, fatigue, unstable temperature, difficulty concentrating. High levels of cytokines also result in increased levels of several other immune-response related substances, including TNF, MMP-9, IL-1B, and PAI-1. MMP-9 delivers inflammatory elements from blood to brain, nerve, muscle, lungs, and joints. It combines with PAI-1 in increasing clot formation and arterial blockage. Stage 1: Biotoxin effects Stage 2: Cytokine effects Stage 3: Reduced VEGF Stage 4: Immune effects Stage 5: Low MSH Stage 6: Resistant Staph bacteria Stage 7: Pituitary hormone effects
12 Sx CLUSTER ANALYSIS Fatigue Weak, assimilation, aching, headache, light sensitivity Memory, words Concentration Joint, AM stiff, cramps Unusual skin sensations, tingling Shortness of breath, sinus Cough, thirst, confusion Appetite, body temperature regulation, urinary freq. Red tearing eyes, blurred vision, sweats, mood, ice-pick pains Abdominal pain, diarrhea, numbness Tearing, disorientation, metallic taste Static shocks, vertigo
13 Total Symptoms Controls Pediatric Cases controls Pediatric cases N= Average Symptoms
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15 Testing from Neurotoxicology Visual Contrast Sensitivity (VCS) used over 40 years by DOD (Air Force) and in studies of non-biological toxicants Reproducible, reliable, portable, non- invasive, cheap! Just about the best marker beyond 4 days of biotoxin-associated/cytokine illness
16 Visual Contrast Sensitivity Non-invasive measure of contrast Neurologic function of optic nerve Eliminates near, far, color, static, motion, peripheral vision Visual acuity better than 20/50 Controlled light > 70 foot lamberts Used in prior studies for screening/monitoring
17 VCS Measuring Visual-Pattern Detection Function: Visual Contrast Sensitivity High to Low Contrast Acuity Low to High Spatial Frequency (Cycles per Degree of Visual Arc)
18 VCS results N= A B C D E Controls Cases Pediatric cases Previous cases
19 HLA Disequilibrium, Relative Risk > 2.0 Control Cases HLA-DR ADULT CHILD / B B ABC A OTHER LINKAGES N=
20 RESULTS: Parameters of Diagnostic Significance: p<0.001 Adult Child ill well ill well MSH, mean MMP9, mean VEGF % < VEGF % > ADH/osmo dys ACTH/cortisold ys 65% 44% 14% 6% ND ND ND ND MARCoNS + 80% 3% ND ND
21 RESULTS: Parameters of Diagnostic Significance: p<0.001 Adult Child ill well ill well C3a > C4a IL IL-1B Interferon alpha Erythropoietin % < ND ND ND ND Erythropoietin % > ND ND
22 Cases by Wingspan IgA IgG IgM IgA IgG ACLA AGA MBP CASES WS>HT CASES, n=120 (63%) CONTROLS WS>HT, n=19 (19%) CASES WS<HT, n=72 CONTROLS WS<HT, N=81
23 Pediatric Autoantibodies ACLA AGA IgA IgG IgM IgA IgG Controls N= % 3% 3% Cases N=50 6% 12% 16% 12% 58%
24 Mold toxin illness isn t allergy Mean IgE, by illness, all patients Cases N= IgE Controls No illness Mold cases Confirmed case Asthma cases Inhaled steroids + 1 other med, > 6 months/year Nasal allergy Nasal steroid + 1 other med, > 6 months/year
25 CONCLUSIONS Mold illness is a distinctive, readily recognizable clinical entity in adults and children Significant objective differences exist between cases and controls Findings support inflammatory cascades initiated by toxin exposure in genetically susceptible patients Abnormalities in innate immune responses point the way to additional interventions Use of a predictive model could make diagnosis easier
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