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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. Source


Geier D.A.,The Institute of Chronic Illnesses Inc. | Geier D.A.,Commonwealth Edison | Young H.A.,George Washington University | Geier M.R.,Centers
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. Source


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.,Centers
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. Source


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. Source


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. Source

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