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Geier D.A.,The Institute of Chronic Illnesses Inc | Geier D.A.,Commonwealth Edison | Kern J.K.,The Institute of Chronic Illnesses Inc | Kern J.K.,Commonwealth Edison | And 2 more authors.
Journal of Trace Elements in Medicine and Biology | Year: 2017

Background Thimerosal is an organic-mercury (Hg)-containing compound (49.55% Hg by weight) historically added to many multi-dose vials of vaccine as a preservative and still added to some vaccines today. Concerns about the toxic effects from Thimerosal-containing childhood vaccines and the risk of an atypical autism diagnosis were evaluated in this study. Methods A hypothesis-testing, prospective longitudinal, case-control study assessed exposure to Hg from Thimerosal-containing hepatitis B vaccines (TM-HepB) among cases diagnosed with atypical autism (n = 164) and controls (n = 15,216). Automated medical records for subjects born from 1991 to 2000 and continuously enrolled in the Vaccine Safety Datalink (VSD) database were examined. Results Cases diagnosed with atypical autism were statistically significantly more likely to have received greater overall and dose-dependent exposures to Hg from TM-HepB vaccines administered within the first month of life, first two months of life, and first six months of life than the controls. Similar phenomena were observed when cases and controls were separated by gender. Conclusions Routine childhood vaccination is an important public health tool to reduce infectious diseases. The present study provides important epidemiological evidence significantly associating increasing Hg exposure from Thimerosal-containing childhood vaccines and the subsequent risk of atypical autism diagnosis, and suggests that Thimerosal should be eliminated from vaccines. © 2017 Elsevier GmbH


Geier D.A.,The Institute of Chronic Illnesses Inc | Geier D.A.,Commonwealth Edison | Kern J.K.,Genetic Consultants of Dallas | Kern J.K.,University of Texas Southwestern Medical Center | And 5 more authors.
Medical Science Monitor | Year: 2011

Background: L-carnitine was proposed as a potential treatment for patients diagnosed with an autism spectrum disorder to improve mitochondrial dysfunction, but no prior randomized controlled trials have been conducted. Material/Methods: Thirty subjects diagnosed with an ASD were randomly assigned to receive a standardized regimen (50 mg L-carnitine/kg bodyweight/day) of liquid L-carnitine (n=19) or placebo (n=11) for 3-months. Measures included changes in professionally completed Childhood Autism Rating Scale (CARS), hand muscle testing, and modified clinical global impression (CGI) forms; parent completed Autism Treatment Evaluation Checklist (ATEC), treatment adherence measurement (TAM), frequency and intensity of side effect rating (FISER)/global rating of side effect burden (GRSEB)/patient report of incidence of side effects (PRISE) forms; and lab testing. Results: Significant improvements were observed in CARS (-2.03, 95% CI=-3.7 to -0.31), CGI (-0.69, 95% CI=-1.1 to -0.06), and ATEC scores. Significant correlations between changes in serum free-carnitine levels and positive clinical changes were observed for hand muscle strength (R2=0.23, P=0.046), cognitive scores (R2=0.27, P=0.019), and CARS scores (R2=0.20, P=0.047). Study subjects were protocol- compliant (average adherence was >85%) and generally well-tolerated the L-carnitine therapy given. Conclusions: L-carnitine therapy (50 mg/kilogram-bodyweight/day) administered for 3-months significantly improved several clinical measurements of ASD severity, but subsequent studies are recommended.


Geier D.A.,Commonwealth Edison | Jordan S.K.,The Institute of Chronic Illnesses Inc. | Geier M.R.,The Institute of Chronic Illnesses Inc.
Medical Science Monitor | Year: 2010

Background: In vaccines/biologics, preservatives are used to prevent microbial growth. Material/Methods: The present study examined: (1) the comparative toxicities of commonly used preservatives in US licensed vaccines to human neurons; and (2) the relative toxicity index of these compounds to human neurons in comparison to bacterial cells. Results: Using human neuroblastoma cells, the relative cytotoxicity of the levels of the compounds commonly used as preservative in US licensed vaccines was found to be phenol <2-phenoxyethanol < benzethonium chloride < Thimerosal. The observed relative toxicity indices (human neuroblastoma cells/bacterial cells) were 2-phenoxyethanol (4.6-fold) < phenol (12.2-fold) < Thimerosal (>330-fold). In addition, for the compounds tested, except for 2-phenoxyethanol, the concentrations necessary to induce significant killing of bacterial cells were significantly higher than those routinely present in US licensed vaccine/biological preparations. Conclusions: None of the compounds commonly used as preservatives in US licensed vaccine/biological preparations can be considered an ideal preservative, and their ability to fully comply with the requirements of the US Code of Federal Regulations (CFR) for preservatives is in doubt. Future formulations of US licensed vaccines/biologics should be produced in aseptic manufacturing plants as single dose preparations, eliminating the need for preservatives and an unnecessary risk to patients. © Med Sci Monit, 2010.


Geier D.A.,The Institute of Chronic Illnesses Inc. | Geier D.A.,Commonwealth Edison | Geier M.R.,The Genetic Centers of America | Geier M.R.,ASD Centers LLC
Toxicological and Environmental Chemistry | Year: 2010

The effects of methylcobalamin (vitamin B12) injection (75 μgkg-1) on cobalt levels in autism spectrum disorders (ASDs) and potential toxic effects of cobalt on human neurons were evaluated. A cohort of ASDs (n=72) presenting to the Genetic Centers of America were evaluated for the frequency of methylcobalamin injections and cobalt levels using Laboratory Corporation of America (LabCorp) testing. Potential toxic effects of cobalt (cobalt(II) nitrate hexahydrate) to human neurons grown in vitro were evaluated. Methylcobalamin injections significantly increased the mean levels of plasma cobalt (6.83-fold) and urinary cobalt (51-fold) in comparison to unexposed subjects, and significant positive correlations were found between the frequency of methylcobalamin injections and the levels of plasma and urinary cobalt (injections every second day induced cobalt levels in excess of the LabCorp cobalt occupational maximum exposure limits). The LC50 in human neurons following 24 h incubation with cobalt is 559 μM. Research must be conducted to determine optimal therapeutic methylcobalamin doses. © 2010 Taylor & Francis.


Geier D.A.,The Institute of Chronic Illnesses Inc. | Geier D.A.,Commonwealth Edison | Young H.A.,George Washington University | Geier M.R.,ASD Centers LLC
Indian Journal of Medical Research | Year: 2010

Background & objectives: The US Agency for Toxic Substances and Disease Registry (ATSDR) reports that mercury (Hg) is a known endocrine disruptor and it adversely affects the steroid synthesis pathway in animals and humans, and may interact to enhance the risk for a child developing premature puberty. An association between premature puberty and exposure to Hg from thimerosal-containing vaccines (TCVs) was evaluated in computerized medical records within the Vaccine Safety Datalink (VSD). Methods: A total of 278,624 subjects were identified in birth cohorts from 1990-1996. The birth cohort prevalence rates of medically diagnosed International Classification of Disease, 9th revision (ICD-9) premature puberty and control outcomes were calculated. Exposures to Hg from TCVs were calculated by birth cohort for specific exposure windows from birth-7 months and birth-13 months of age. Poisson regression analysis was used to model the association between the prevalence of outcomes and Hg doses from TCVs. Results: Significantly increased (P<0.0001) rate ratios were observed for premature puberty for a 100 μg difference in Hg exposure from TCVs in the birth-7 months (rate ratio=5.58) and birth-13 months (rate ratio=6.45) of age exposure windows. By contrast, none of the control outcomes had significantly increased rate ratios with Hg exposure from TCVs. Interpretation & conclusions: Routine childhood vaccination should be continued to help reduce the morbidity and mortality associated with infectious diseases, but efforts should be undertaken to remove Hg from vaccines. Additional studies should be done to evaluate the relationship between Hg exposure and premature puberty.


Geier D.A.,The Institute of Chronic Illnesses Inc | Hooker B.S.,Simpson University | Kern J.K.,The Institute of Chronic Illnesses Inc | Kern J.K.,University of Texas Southwestern Medical Center | And 3 more authors.
Translational Neurodegeneration | Year: 2013

Background: Autism spectrum disorder (ASD) is defined by standardized criteria of qualitative impairments in social interaction, qualitative impairments in communication, and restricted and stereotyped patterns of behavior, interests, and activities. A significant number of children diagnosed with ASD suffer a loss of previously-acquired skills, which is suggestive of neurodegeneration or a type of progressive encephalopathy with an etiological pathogenic basis occurring after birth. To date, the etiology of ASD remains under debate, however, many studies suggest toxicity, especially from mercury (Hg), in individuals diagnosed with an ASD. The present study evaluated concerns about the toxic effects of organic-Hg exposure from Thimerosal (49.55% Hg by weight) in childhood vaccines by conducting a two-phased (hypothesis generating/hypothesis testing) study with documented exposure to varying levels of Thimerosal from vaccinations.Methods: A hypothesis generating cohort study was undertaken to evaluate the relationship between exposure to organic-Hg from a Thimerosal-containing Diphtheria-Tetanus-acellular-Pertussis (DTaP) vaccine in comparison to a Thimerosal-free DTaP vaccine administered, from 1998 through 2000, for the risk of ASD as reported in the Vaccine Adverse Event Reporting System (VAERS) database (phase I). A hypothesis testing case-control study was undertaken to evaluate the relationship between organic-Hg exposure from Thimerosal-containing hepatitis B vaccines administered at specific intervals in the first six months of life among cases diagnosed with an ASD and controls born between 1991 through 1999 in the Vaccine Safety Datalink (VSD) database (phase II).Results: In phase I, it was observed that there was a significantly increased risk ratio for the incidence of ASD reported following the Thimerosal-containing DTaP vaccine in comparison to the Thimerosal-free DTaP vaccine. In phase II, it was observed that cases diagnosed with an ASD were significantly more likely than controls to receive increased organic-Hg from Thimerosal-containing hepatitis B vaccine administered within the first, second, and sixth month of life.Conclusions: Routine childhood vaccination is an important public health tool to reduce the morbidity and mortality associated with infectious diseases, but the present study provides new epidemiological evidence supporting an association between increasing organic-Hg exposure from Thimerosal-containing childhood vaccines and the subsequent risk of an ASD diagnosis. © 2013 Geier et al.; licensee BioMed Central Ltd.


PubMed | The Institute of Chronic Illnesses Inc
Type: Journal Article | Journal: Translational neurodegeneration | Year: 2013

Autism spectrum disorder (ASD) is defined by standardized criteria of qualitative impairments in social interaction, qualitative impairments in communication, and restricted and stereotyped patterns of behavior, interests, and activities. A significant number of children diagnosed with ASD suffer a loss of previously-acquired skills, which is suggestive of neurodegeneration or a type of progressive encephalopathy with an etiological pathogenic basis occurring after birth. To date, the etiology of ASD remains under debate, however, many studies suggest toxicity, especially from mercury (Hg), in individuals diagnosed with an ASD. The present study evaluated concerns about the toxic effects of organic-Hg exposure from Thimerosal (49.55% Hg by weight) in childhood vaccines by conducting a two-phased (hypothesis generating/hypothesis testing) study with documented exposure to varying levels of Thimerosal from vaccinations.A hypothesis generating cohort study was undertaken to evaluate the relationship between exposure to organic-Hg from a Thimerosal-containing Diphtheria-Tetanus-acellular-Pertussis (DTaP) vaccine in comparison to a Thimerosal-free DTaP vaccine administered, from 1998 through 2000, for the risk of ASD as reported in the Vaccine Adverse Event Reporting System (VAERS) database (phase I). A hypothesis testing case-control study was undertaken to evaluate the relationship between organic-Hg exposure from Thimerosal-containing hepatitis B vaccines administered at specific intervals in the first six months of life among cases diagnosed with an ASD and controls born between 1991 through 1999 in the Vaccine Safety Datalink (VSD) database (phase II).In phase I, it was observed that there was a significantly increased risk ratio for the incidence of ASD reported following the Thimerosal-containing DTaP vaccine in comparison to the Thimerosal-free DTaP vaccine. In phase II, it was observed that cases diagnosed with an ASD were significantly more likely than controls to receive increased organic-Hg from Thimerosal-containing hepatitis B vaccine administered within the first, second, and sixth month of life.Routine childhood vaccination is an important public health tool to reduce the morbidity and mortality associated with infectious diseases, but the present study provides new epidemiological evidence supporting an association between increasing organic-Hg exposure from Thimerosal-containing childhood vaccines and the subsequent risk of an ASD diagnosis.


PubMed | Commonwealth Edison, The Institute of Chronic Illnesses Inc and Simpson University
Type: | Journal: Journal of child neurology | Year: 2014

It was recently postulated that because increased genetic load and increased parental age are both purportedly associated with the risk to develop an autism spectrum disorder, there must be a linkage between increasing genetic load and increasing parental age in autism spectrum disorder pathogenesis. The present study examined the hypothesis that if increased genetic load from increasing paternal age is important to autism spectrum disorder pathogenesis, then there should be a significant relationship between increasing parental age and increasing autism spectrum disorder phenotypic severity. Outpatient clinical records were retrospectively examined to identify a consecutive cohort of subjects diagnosed with an autism spectrum disorder (n = 351). Increasing autism spectrum disorder phenotypic severity was found not to be associated with increasing maternal/paternal age. The present study failed to support the hypothesis that increasing parental age was associated with increasing autism spectrum disorder phenotypic severity, but future studies should examine the relationship between genetic mutations in subjects diagnosed with an autism spectrum disorder and increasing parental age.


PubMed | Commonwealth Edison, The Institute of Chronic Illnesses Inc and Simpson University
Type: | Journal: Frontiers in pediatrics | Year: 2015

Previously, investigators suggested that diagnostic substitution from other diagnoses, e.g., mental retardation (MR) and/or cerebral palsy (CP) to pervasive developmental disorder (PDD) is a driving factor behind increases in autism. This study evaluated potential diagnostic substitution among subjects diagnosed with PDD vs. MR or CP by examining birth characteristic overlap.SAS() and StatsDirect software examined medical records for subjects within the Vaccine Safety Datalink database who were Health Maintenance Organization-enrolled from birth until diagnosed with an International Classification of Disease, 9th revision (ICD-9) outcome of PDD (299.xx, n=84), CP (343.xx, n=300), or MR (317.xx, 318.xx, or 319.xx, n=51).Subjects with PDD had significantly (p<0.01) increased: male/female ratio (PDD=5.5 vs. CP=1.5 or MR=1.3), mean age of initial diagnosis in years (PDD=3.13 vs. CP=1.09 or MR=1.62), mean gestational age in weeks at birth (PDD=38.73 vs. CP=36.20 or MR=34.84), mean birth weight in grams (PDD=3,368 vs. CP=2,767 or MR=2,406), and mean Appearance-Pulse-Grimace-Activity-Respiration scores at 1min (PDD=7.82 vs. CP=6.37 or MR=6.76) and 5min (PDD=8.77 vs. CP=7.92 or MR=8.04), as compared to subjects diagnosed with CP or MR.This study suggests diagnostic substitution cannot fully explain increased PDD prevalence during the 1990s within the United States.


Thimerosal is an organic mercury (Hg)-containing compound (49.55% Hg by weight) historically added to many multi-dose vials of vaccine as a preservative. A hypothesis testing case-control study evaluated automated medical records in the Vaccine Safety Datalink (VSD) for organic Hg exposure from Thimerosal in Haemophilus influenzae type b (Hib)-containing vaccines administered at specific times within the first 15months of life among subjects diagnosed with pervasive developmental disorder (PDD) (n=534) in comparison to controls. The generally accepted biologically non-plausible linkage between Thimerosal exposure and subsequent diagnosis of febrile seizure (n=5886) was examined as a control outcome. Cases diagnosed with PDD received significantly more organic Hg within the first 6months of life (odds ratio (OR)=1.97, p<0.001) and first 15months of life (OR=3.94, p<0.0001) than controls, whereas cases diagnosed with febrile seizure were no more likely than controls to have received increased organic Hg. On a per microgram of organic Hg basis, cases diagnosed with a PDD in comparison to controls were at significantly greater odds (OR=1.0197, p<0.0001) of receiving increasing organic Hg exposure within the first 15months of life, whereas cases diagnosed febrile seizure were no more likely than controls (OR=0.999, p>0.20) to have received increasing organic Hg exposure within the first 15months of life. Routine childhood vaccination is an important public health tool to reduce the morbidity and mortality associated with infectious diseases, but the present study provides new epidemiological evidence of a significant relationship between increasing organic Hg exposure from Thimerosal-containing vaccines and the subsequent risk of PDD diagnosis in males and females.

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