Gary S Goldman - Academia.edu (original) (raw)

Papers by Gary S Goldman

Research paper thumbnail of Neonatal, Infant, and Under Age Five Vaccine Doses Routinely Given in Developed Nations and Their Association With Mortality Rates

Cureus, Jul 20, 2023

In 2011, using 2009 data, we published a study demonstrating that among the most highly developed... more In 2011, using 2009 data, we published a study demonstrating that among the most highly developed nations, those requiring the most vaccine doses for their infants tended to have the least favorable infant mortality rates (r = 0.70, p < .0001). Twelve years later, we replicated our original study using 2019 data. Linear regression analysis corroborated the positive trend reported in our initial paper (r = 0.45; p < .002). Herein, we broaden our analyses to consider the effect of vaccines on neonatal and under age five mortality rates. Objective We performed several investigations to explore potential relationships between the number of early childhood vaccine doses required by nations and their neonatal, infant, and under age five mortality rates. Methods In this ecological study, we conducted linear regression analyses of neonatal, infant, and under age five vaccine doses required by nations and their neonatal, infant, and under age five mortality rates. All analyses were based on 2019 and 2021 data. We also stratified nations by the number of neonatal vaccine doses required and conducted a one-way ANOVA test and a post hoc Tukey-Kramer test to determine if there were statistically significant differences in the group mean neonatal, infant, and under age five mortality rates of nations that administered zero, one, or two neonatal vaccine doses. Results Linear regression analyses of neonatal vaccine doses required by nations in our 2021 dataset yielded statistically significant positive correlations to rates of neonatal mortality (r = 0.34, p = .017), infant mortality (r = 0.46, p = .0008), and under age five mortality (r = 0.48, p = .0004). Similar results were reported using 2019 data. Utilizing 2021 data, a post hoc Tukey-Kramer test indicated a statistically significant pairwise difference between the mean neonatal mortality rates, mean infant mortality rates, and mean under age five mortality rates of nations requiring zero vs. two neonatal vaccine doses. There was a statistically significant difference of 1.28 deaths per 1000 live births (p < .002) between the mean infant mortality rates among nations that did not give their neonates any vaccine doses and those that required two vaccine doses. Using 2019 and 2021 data, 17 of 18 analyses (12 bivariate linear regressions and six ANOVA and Tukey-Kramer tests) achieved statistical significance and corroborated the findings reported in our original study of a positive association between the number of vaccine doses required by developed nations and their infant mortality rates. Conclusions There are statistically significant positive correlations between mortality rates of developed nations and the number of early childhood vaccine doses that are routinely given. Further investigations of the hypotheses generated by this study are recommended to confirm that current vaccination schedules are achieving their intended objectives.

Research paper thumbnail of Comparison of VAERS fetal-loss reports during three consecutive influenza seasons

Human & Experimental Toxicology, Sep 27, 2012

The aim of this study was to compare the number of inactivated-influenza vaccine-related spontane... more The aim of this study was to compare the number of inactivated-influenza vaccine-related spontaneous abortion and stillbirth (SB) reports in the Vaccine Adverse Event Reporting System (VAERS) database during three consecutive flu seasons beginning 2008/2009 and assess the relative fetal death reports associated with the two-vaccine 2009/2010 season. The VAERS database was searched for reports of fetal demise following administration of the influenza vaccine/vaccines to pregnant women. Utilization of an independent surveillance survey and VAERS, two-source capture-recapture analysis estimated the reporting completeness in the 2009/2010 flu season. Capture-recapture demonstrated that the VAERS database captured about 13.2% of the total 1321 (95% confidence interval (CI): 815-2795) estimated reports, yielding an ascertainment-corrected rate of 590 fetal-loss reports per million pregnant women vaccinated (or 1 per 1695). The unadjusted fetal-loss report rates for the three consecutive influenza seasons beginning 2008/2009 were 6.8 (95% CI: 0.1-13.1), 77.8 (95% CI: 66.3-89.4), and 12.6 (95% CI: 7.2-18.0) cases per million pregnant women vaccinated, respectively. The observed reporting bias was too low to explain the magnitude increase in fetal-demise reporting rates in the VAERS database relative to the reported annual trends. Thus, a synergistic fetal toxicity likely resulted from the administration of both the pandemic (A-H1N1) and seasonal influenza vaccines during the 2009/2010 season.

Research paper thumbnail of Relative trends in hospitalizations and mortality among infants by the number of vaccine doses and age, based on the Vaccine Adverse Event Reporting System (VAERS), 1990–2010

Human & Experimental Toxicology, Apr 24, 2012

In this study, the Vaccine Adverse Event Reporting System (VAERS) database, 1990-2010, was invest... more In this study, the Vaccine Adverse Event Reporting System (VAERS) database, 1990-2010, was investigated; cases that specified either hospitalization or death were identified among 38,801 reports of infants. Based on the types of vaccines reported, the actual number of vaccine doses administered, from 1 to 8, was summed for each case. Linear regression analysis of hospitalization rates as a function of (a) the number of reported vaccine doses and (b) patient age yielded a linear relationship with r 2 ¼ 0.91 and r 2 ¼ 0.95, respectively. The hospitalization rate increased linearly from 11.0% (107 of 969) for 2 doses to 23.5% (661 of 2817) for 8 doses and decreased linearly from 20.1% (154 of 765) for children aged <0.1 year to 10.7% (86 of 801) for children aged 0.9 year. The rate ratio (RR) of the mortality rate for 5-8 vaccine doses to 1-4 vaccine doses is 1.5 (95% confidence interval (CI), 1.4-1.7), indicating a statistically significant increase from 3.6% (95% CI, 3.2-3.9%) deaths associated with 1-4 vaccine doses to 5.5% (95% CI, 5.2-5.7%) associated with 5-8 vaccine doses. The male-to-female mortality RR was 1.4 (95% CI, 1.3-1.5). Our findings show a positive correlation between the number of vaccine doses administered and the percentage of hospitalizations and deaths. Since vaccines are given to millions of infants annually, it is imperative that health authorities have scientific data from synergistic toxicity studies on all combinations of vaccines that infants might receive. Finding ways to increase vaccine safety should be the highest priority.

Research paper thumbnail of Vaccination to prevent varicella

Human & Experimental Toxicology, Nov 25, 2013

Background: There is increasing evidence that herpes zoster (HZ) incidence rates among children a... more Background: There is increasing evidence that herpes zoster (HZ) incidence rates among children and adults (aged <60 years) with a history of natural varicella are influenced primarily by the frequency of exogenous exposures, while asymptomatic endogenous reactivations help to cap the rate at approximately 550 cases/ 100,000 person-years when exogenous boosting becomes rare. The Antelope Valley Varicella Active Surveillance Project was funded by the Centers for Disease Control and Prevention in 1995 to monitor the effects of varicella vaccination in one of the three representative regions of the United States. The stability in the data collection and number of reporting sites under varicella surveillance from 1995-2002 and HZ surveillance during 2000-2001 and 2006-2007 contributed to the robustness of the discerned trends. Discussion: Varicella vaccination may be useful for leukemic children; however, the target population in the United States is all children. Since the varicella vaccine inoculates its recipients with live, attenuated varicella-zoster virus (VZV), clinical varicella cases have dramatically declined. Declining exogenous exposures (boosts) from children shedding natural VZV have caused waning cell-mediated immunity. Thus, the protection provided by varicella vaccination is neither lifelong nor complete. Moreover, dramatic increases in the incidence of adult shingles cases have been observed since HZ was added to the surveillance in 2000. In 2013, this topic is still debated and remains controversial in the United States. Summary: When the costs of the booster dose for varicella and the increased shingles recurrences are included, the universal varicella vaccination program is neither effective nor cost-effective.

Research paper thumbnail of Review of the United States universal varicella vaccination program: Herpes zoster incidence rates, cost-effectiveness, and vaccine efficacy based primarily on the Antelope Valley Varicella Active Surveillance Project data

Vaccine, 2013

In a cooperative agreement starting January 1995, prior to the FDA's licensure of the varicella v... more In a cooperative agreement starting January 1995, prior to the FDA's licensure of the varicella vaccine on March 17, the Centers for Disease Control and Prevention (CDC) funded the Los Angeles Department of Health Services' Antelope Valley Varicella Active Surveillance Project (AV-VASP). Since only varicella case reports were gathered, baseline incidence data for herpes zoster (HZ) or shingles was lacking. Varicella case reports decreased 72%, from 2834 in 1995 to 836 in 2000 at which time approximately 50% of children under 10 years of age had been vaccinated. Starting in 2000, HZ surveillance was added to the project. By 2002, notable increases in HZ incidence rates were reported among both children and adults with a prior history of natural varicella. However, CDC authorities still claimed that no increase in HZ had occurred in any US surveillance site. The basic assumptions inherent to the varicella cost-benefit analysis ignored the significance of exogenous boosting caused by those shedding wild-type VZV. Also ignored was the morbidity associated with even rare serious events following varicella vaccination as well as the morbidity from increasing cases of HZ among adults. Vaccine efficacy declined below 80% in 2001. By 2006, because 20% of vaccinees were experiencing breakthrough varicella and vaccine-induced protection was waning, the CDC recommended a booster dose for children and, in 2007, a shingles vaccination was approved for adults aged 60 years and older. In the prelicensure era, 95% of adults experienced natural chickenpox (usually as children)-these cases were usually benign and resulted in long-term immunity. Varicella vaccination is less effective than the natural immunity that existed in prevaccine communities. Universal varicella vaccination has not proven to be cost-effective as increased HZ morbidity has disproportionately offset cost savings associated with reductions in varicella disease. Universal varicella vaccination has failed to provide long-term protection from VZV disease.

Research paper thumbnail of Reaffirming a Positive Correlation Between Number of Vaccine Doses and Infant Mortality Rates: A Response to Critics

Cureus

A positive correlation between the number of vaccine doses and IMRs is detectable in the most hig... more A positive correlation between the number of vaccine doses and IMRs is detectable in the most highly developed nations but attenuated in the background noise of nations with heterogeneous socioeconomic variables that contribute to high rates of infant mortality, such as malnutrition, poverty, and substandard health care.

Research paper thumbnail of Bailey’s Reanalysis Fails to Debunk, and Inadvertently Supports, Miller-Goldman’s Positive Correlation between Number of Vaccine Doses and Infant Mortality Rates

Background—In 2011, Miller and Goldman published a study in Human and Experimental Toxicology tha... more Background—In 2011, Miller and Goldman published a study in Human and Experimental Toxicology that found a counterintuitive, positive correlation, r = 0.70 (r2 = 0.49, p < .0001), demonstrating that as nations require more vaccine doses for their infants, infant mortality rates (IMRs) tend to increase (worsen). The dataset (n = 30) included the United States, a nation that required the most vaccines for their infants, and all nations with better IMRs than the United States. Dr. E. Bailey, a professor at BYU, and her students, recently read the Miller-Goldman study and found it "troublesome that this manuscript is in the top 5% of all research outputs" and falsely claimed that its findings were due to "inappropriate data exclusion," i.e., failure to analyze the "full dataset" of all 185 nations. The "Bailey reanalysis," titled Infant vaccination does not predict increased infant mortality rate: correcting past misinformation, was posted to t...

Research paper thumbnail of Examples of Outcome Reporting Bias in Vaccine Studies: Illustrating How Perpetuating Medical Consensus Can Impede Progress in Public Health

Cureus

Introduction: Outcome reporting bias in vaccine studies is a widespread problem among all researc... more Introduction: Outcome reporting bias in vaccine studies is a widespread problem among all researchers who have a tendency to report selective results and conclusions that support their beliefs and values or those of sponsoring agencies. Especially during the COVID-19 pandemic, this bias surfaced through the unprecedented proliferation of conflicting vaccine studies. Many researchers strongly recommend and report on the safety and effectiveness of the COVID-19 vaccine. Those researchers who embrace the COVID-19 vaccine and vaccines, in general, are often dismissive of other researchers who present views that differ from medical orthodoxy and oppose medical consensus. Methods: The aim of this analysis is to critically evaluate seven vaccine studies using qualitative and/or quantitative approaches to identify outcome reporting bias and assess its potential impact on the stated conclusions that align with medical consensus. Four studies claim to have found no association between autism and (a) blood levels of mercury, (b) measles, mumps, and rubella (MMR) vaccine, and (c) thimerosalcontaining vaccines. Three other studies claim no association exists between infant mortality rate and the number of vaccine doses, universal varicella vaccination and herpes zoster, and pandemic influenza vaccines and fetal losses. Results: The presence of outcome reporting bias and independent reanalysis demonstrated an impact on both the direction and magnitude of the observed effect-raising questions concerning the robustness of the original study design and conclusions and challenging the current medical consensus. Medical consensus has exonerated vaccines as having any causal relationship to autism spectrum disorders (ASDs), yet no other reasonable cause has been proposed. Medical consensus attributes significant ASD increases to better case ascertainment and broadened clinical diagnosis. According to 2018 data, an estimated 1 in 44 eight-yearolds has been identified with ASD. From 1990 to 2019, there have been an estimated two million new cases of ASD in the US, with lifetime social costs exceeding $7 trillion (in 2019 dollars). Can perpetuating medical consensus impede the advancement of public health? Or has it already done so? Conclusions: Conflicts of interest (e.g., financial) that abound between health regulatory agencies and the pharmaceutical industry impact what is ultimately reckoned as medical consensus. Outcome reporting bias that is inherent to all researchers to some degree, obscures medical and scientific truth. Advancement of public health requires that researchers have integrity and an openness and willingness to collaborate to resolve contradictory findings. In fact, it is usually through meticulous, rigorous, scientific investigation of contradictory findings that medical science has advanced and contributed to improvements in public health-since medical consensus and orthodoxy can be incorrect.

Research paper thumbnail of COMMENTARY The Case against Universal Varicella Vaccination

In 1995, the United States became the first country to implement

Research paper thumbnail of Response to letter to editor by Jumaan: Goldman's role in the Varicella Active Surveillance Project. Author's reply

Vaccine, 2004

served as the sole research/ analyst for the Antelope Valley Varicella Active Surveillance Projec... more served as the sole research/ analyst for the Antelope Valley Varicella Active Surveillance Project (VASP) from the start of data collection in January 1995 through October 2002. At an office in High Desert Hospital located in Lancaster, California, Goldman worked for eight years alongside the project director and one to two assistants who were chiefly responsible for conducting telephone interviews to collect demographic and clinical data on reported cases of varicella. Two co-principal investigators located offsite were involved in other activities associated with the Los Angeles County Department of Health Services (LACDHS), Acute Communicable Disease Control Unit, with a small percentage of their time devoted to this project. In 1995, Goldman was initially presented with a rough draft form to be used in telephone interviews to gather clinical information from parents concerning their child's case of varicella. This was the sole input from the LACDHS and CDC at the time. There were no established standards, databases, or protocols, and A. Jumaan, D. Schmid, P. Gargiullo, and J. Seward of the National Immunization Program (NIP), CDC, Department of Health and Human Services were not as yet associated or assigned to the varicella project. Throughout the project, Goldman designed and implemented some 125 programs to automate the input, analysis, and reporting of data. Such programs included analysis of (a) breakthrough varicella cases, (b) secondary family attack rates (SFAR) among vaccinated and unvaccinated household members, (c) vaccine efficacy, (d) herpes zoster (HZ) recurrence rates, (e) verified, pending, excluded and probable cases by month, (f) adolescent survey data, (g) varicella outbreaks, (h) primary, co-primary, and secondary varicella cases, and numerous other investigative reports. Goldman proposed a standard for all surveillance sites as early as 1995/1996. Goldman was invited to participate in coordination meetings held at the CDC in Atlanta, Georgia. His work served as a model to help guide CDC in the development of project standards. Dr. Goldman's classification specified such duties ଝ doi of the original article

Research paper thumbnail of Constructing Stylish Characters on Computer Graphics Systems

Research paper thumbnail of Press Release: Rise in shingles cases linked to universal varicella vaccination program

Medical Veritas: The Journal of Medical Truth, 2004

Research paper thumbnail of Infant mortality rates regressed against number of vaccine doses routinely given: Is there a biochemical or synergistic toxicity?

Human and Experimental Toxicology, 2011

The infant mortality rate (IMR) is one of the most important indicators of the socio-economic wel... more The infant mortality rate (IMR) is one of the most important indicators of the socio-economic well-being and public health conditions of a country. The US childhood immunization schedule specifies 26 vaccine doses for infants aged less than 1 year-the most in the world--yet 33 nations have lower IMRs. Using linear regression, the immunization schedules of these 34 nations were examined and a correlation coefficient of r = 0.70 (p < 0.0001) was found between IMRs and the number of vaccine doses routinely given to infants. Nations were also grouped into five different vaccine dose ranges: 12-14, 15-17, 18-20, 21-23, and 24-26. The mean IMRs of all nations within each group were then calculated. Linear regression analysis of unweighted mean IMRs showed a high statistically significant correlation between increasing number of vaccine doses and increasing infant mortality rates, with r = 0.992 (p < 0.0009). Using the Tukey-Kramer test, statistically significant differences in mean IMRs IMRs were found between nations giving 12–14 vaccine doses and those giving 21–23, and 24–26 doses. A closer inspection of correlations between vaccine doses, biochemical or synergistic toxicity, and IMRs is essential.

Research paper thumbnail of Insights on the Impact of External and Internal Boosting on Varicella-Zoster Virus Reactivation Based on Evidence From the First Decade of the United States Universal Varicella Vaccination Program

Research paper thumbnail of The power wheel &#8212; Electromotive torque for vehicular applications

28th IEEE Vehicular Technology Conference

The Power Wheel is a compact, self-contained motor in a wheel that establishes a torque drive. Du... more The Power Wheel is a compact, self-contained motor in a wheel that establishes a torque drive. Dual-functioning circuitry that performs brushless commutation and polyphase rectification is also contained entirely within the wheel. Thus, with a substantial reduction in both the number of external control system components and mechanical drive-system couplings, this electric motor can power a 4-wheel-drive electric vehicle in

Research paper thumbnail of Letters to the Editor: Varicella vaccination

Research paper thumbnail of Constructing Stylish Characters on Computer Graphics Systems

Coed Transactions, Nov 1, 1980

Research paper thumbnail of Adverse effects of varicella vaccination are under-reported in VAERS, mitigating against discover of the true cost-benefit

Medical Veritas: The Journal of Medical Truth, 2005

Varicella vaccination is generally considered safe but there are usually no prescreening tests to... more Varicella vaccination is generally considered safe but there are usually no prescreening tests to determine whether an adverse reaction is likely to occur. The literature contains a surprising number of adverse reactions following varicella vaccination including vaccine-strain herpes-zoster (HZ) in children and adults. The Advisory Committee on Immunization Practices (ACIP) states, "VAERS data are limited by underreporting and unknown sensitivity of the reporting system, making it difficult to compare adverse event rates following vaccination reported to VAERS with those from complications following natural disease. Nevertheless, the magnitude of these differences makes it likely that serious adverse events following vaccination occur at a substantially lower rate than following natural disease." Since follow-up is not conducted, it may be argued that some reports may not be attributed to or associated with vaccination and therefore the true rate of adverse events is essentially unknown. Nevertheless, adverse reactions reported in VAERS have typically been shown to be only 5% or 10% of the true rates. Cost-benefit analyses of the universal varicella vaccination program appear to be optimistic, especially when adverse vaccine reactions are completely ignored or excluded.

Research paper thumbnail of High incidence of shingles among children with prior chickenpox: an inadvertent consequence of the universal varicella vaccination program?

Medical Veritas: The Journal of Medical Truth, 2004

Active surveillance for herpes zoster (HZ) was conducted during three years, 2000-2002, in a geog... more Active surveillance for herpes zoster (HZ) was conducted during three years, 2000-2002, in a geographically distinct high desert region known as Antelope Valley, California among 53,756 children aged 1 to 9 years during which time 92 cases were reported with an estimated 50% reporting completeness based on capture-recapture methods. The ascertainment-corrected crude (population) HZ incidence rate is 114 per 100,000 person-years (184/161,268). The cumulative (2000-2002) true HZ incidence rate is 481 per 100,000 person-years based on an ascertainment-corrected 156 cases during an observation time of 32,410 person-years among children with a previous history of natural varicella. By comparison, a survey conducted among school children in the same study area with nearly 100% enumeration of HZ cases yielded an estimated crude and true HZ incidence rates of 72 and 145 cases, respectively, per 100,000 person-years in the pre-licensure era. The postulate is presented that the high crude HZ incidence among children with a previous history of natural varicella in the post-licensure period corresponds to a dramatic 70-80% decrease in varicella cases since 1995 and concomitant loss of exogenous re-exposures (boosts) that previously served to suppress the reactivation of HZ.

Research paper thumbnail of Simplified lesson in capture-recapture methods and controversy regarding their epidemiological application

Medical Veritas: The Journal of Medical Truth, 2004

Capture-recapture methods, while not providing exact results, are an inexpensive approach to esti... more Capture-recapture methods, while not providing exact results, are an inexpensive approach to estimating the under-reporting of a given disease. Especially since 1980, capture-recapture has been commonly used in many surveillance and epidemiological studies. Most studies derive estimates of disease incidence rates based solely on the number of cases enumerated. These rates are typically biased low since 100% enumeration of cases is rarely achieved and more typically varies from 10% to 80%. The incidence rates in such studies are virtually uninterpretable and merely reflect the degree of reporting completeness. However, when two or more ascertainment sources are utilized to obtain reports of cases, the duplicate cases found in the ascertainment sources can be used to derive ascertainment-corrected incidence rates. It is then possible to compare results obtained in one study with that of other studies that have likewise derived ascertainment-corrected incidence rates, even though the percentage of reporting completeness may very in the different studies. When only two sources are used in capture-recapture methods, the estimate should be checked against a criterion ("gold") standard to validate the result. Public health officials were initially skeptical of application of capture-recapture methods to varicella disease due the seasonal distribution of cases; application of the method to herpes zoster cases also met with resistance due to the comparatively few cases reported.

Research paper thumbnail of Neonatal, Infant, and Under Age Five Vaccine Doses Routinely Given in Developed Nations and Their Association With Mortality Rates

Cureus, Jul 20, 2023

In 2011, using 2009 data, we published a study demonstrating that among the most highly developed... more In 2011, using 2009 data, we published a study demonstrating that among the most highly developed nations, those requiring the most vaccine doses for their infants tended to have the least favorable infant mortality rates (r = 0.70, p < .0001). Twelve years later, we replicated our original study using 2019 data. Linear regression analysis corroborated the positive trend reported in our initial paper (r = 0.45; p < .002). Herein, we broaden our analyses to consider the effect of vaccines on neonatal and under age five mortality rates. Objective We performed several investigations to explore potential relationships between the number of early childhood vaccine doses required by nations and their neonatal, infant, and under age five mortality rates. Methods In this ecological study, we conducted linear regression analyses of neonatal, infant, and under age five vaccine doses required by nations and their neonatal, infant, and under age five mortality rates. All analyses were based on 2019 and 2021 data. We also stratified nations by the number of neonatal vaccine doses required and conducted a one-way ANOVA test and a post hoc Tukey-Kramer test to determine if there were statistically significant differences in the group mean neonatal, infant, and under age five mortality rates of nations that administered zero, one, or two neonatal vaccine doses. Results Linear regression analyses of neonatal vaccine doses required by nations in our 2021 dataset yielded statistically significant positive correlations to rates of neonatal mortality (r = 0.34, p = .017), infant mortality (r = 0.46, p = .0008), and under age five mortality (r = 0.48, p = .0004). Similar results were reported using 2019 data. Utilizing 2021 data, a post hoc Tukey-Kramer test indicated a statistically significant pairwise difference between the mean neonatal mortality rates, mean infant mortality rates, and mean under age five mortality rates of nations requiring zero vs. two neonatal vaccine doses. There was a statistically significant difference of 1.28 deaths per 1000 live births (p < .002) between the mean infant mortality rates among nations that did not give their neonates any vaccine doses and those that required two vaccine doses. Using 2019 and 2021 data, 17 of 18 analyses (12 bivariate linear regressions and six ANOVA and Tukey-Kramer tests) achieved statistical significance and corroborated the findings reported in our original study of a positive association between the number of vaccine doses required by developed nations and their infant mortality rates. Conclusions There are statistically significant positive correlations between mortality rates of developed nations and the number of early childhood vaccine doses that are routinely given. Further investigations of the hypotheses generated by this study are recommended to confirm that current vaccination schedules are achieving their intended objectives.

Research paper thumbnail of Comparison of VAERS fetal-loss reports during three consecutive influenza seasons

Human & Experimental Toxicology, Sep 27, 2012

The aim of this study was to compare the number of inactivated-influenza vaccine-related spontane... more The aim of this study was to compare the number of inactivated-influenza vaccine-related spontaneous abortion and stillbirth (SB) reports in the Vaccine Adverse Event Reporting System (VAERS) database during three consecutive flu seasons beginning 2008/2009 and assess the relative fetal death reports associated with the two-vaccine 2009/2010 season. The VAERS database was searched for reports of fetal demise following administration of the influenza vaccine/vaccines to pregnant women. Utilization of an independent surveillance survey and VAERS, two-source capture-recapture analysis estimated the reporting completeness in the 2009/2010 flu season. Capture-recapture demonstrated that the VAERS database captured about 13.2% of the total 1321 (95% confidence interval (CI): 815-2795) estimated reports, yielding an ascertainment-corrected rate of 590 fetal-loss reports per million pregnant women vaccinated (or 1 per 1695). The unadjusted fetal-loss report rates for the three consecutive influenza seasons beginning 2008/2009 were 6.8 (95% CI: 0.1-13.1), 77.8 (95% CI: 66.3-89.4), and 12.6 (95% CI: 7.2-18.0) cases per million pregnant women vaccinated, respectively. The observed reporting bias was too low to explain the magnitude increase in fetal-demise reporting rates in the VAERS database relative to the reported annual trends. Thus, a synergistic fetal toxicity likely resulted from the administration of both the pandemic (A-H1N1) and seasonal influenza vaccines during the 2009/2010 season.

Research paper thumbnail of Relative trends in hospitalizations and mortality among infants by the number of vaccine doses and age, based on the Vaccine Adverse Event Reporting System (VAERS), 1990–2010

Human & Experimental Toxicology, Apr 24, 2012

In this study, the Vaccine Adverse Event Reporting System (VAERS) database, 1990-2010, was invest... more In this study, the Vaccine Adverse Event Reporting System (VAERS) database, 1990-2010, was investigated; cases that specified either hospitalization or death were identified among 38,801 reports of infants. Based on the types of vaccines reported, the actual number of vaccine doses administered, from 1 to 8, was summed for each case. Linear regression analysis of hospitalization rates as a function of (a) the number of reported vaccine doses and (b) patient age yielded a linear relationship with r 2 ¼ 0.91 and r 2 ¼ 0.95, respectively. The hospitalization rate increased linearly from 11.0% (107 of 969) for 2 doses to 23.5% (661 of 2817) for 8 doses and decreased linearly from 20.1% (154 of 765) for children aged <0.1 year to 10.7% (86 of 801) for children aged 0.9 year. The rate ratio (RR) of the mortality rate for 5-8 vaccine doses to 1-4 vaccine doses is 1.5 (95% confidence interval (CI), 1.4-1.7), indicating a statistically significant increase from 3.6% (95% CI, 3.2-3.9%) deaths associated with 1-4 vaccine doses to 5.5% (95% CI, 5.2-5.7%) associated with 5-8 vaccine doses. The male-to-female mortality RR was 1.4 (95% CI, 1.3-1.5). Our findings show a positive correlation between the number of vaccine doses administered and the percentage of hospitalizations and deaths. Since vaccines are given to millions of infants annually, it is imperative that health authorities have scientific data from synergistic toxicity studies on all combinations of vaccines that infants might receive. Finding ways to increase vaccine safety should be the highest priority.

Research paper thumbnail of Vaccination to prevent varicella

Human & Experimental Toxicology, Nov 25, 2013

Background: There is increasing evidence that herpes zoster (HZ) incidence rates among children a... more Background: There is increasing evidence that herpes zoster (HZ) incidence rates among children and adults (aged <60 years) with a history of natural varicella are influenced primarily by the frequency of exogenous exposures, while asymptomatic endogenous reactivations help to cap the rate at approximately 550 cases/ 100,000 person-years when exogenous boosting becomes rare. The Antelope Valley Varicella Active Surveillance Project was funded by the Centers for Disease Control and Prevention in 1995 to monitor the effects of varicella vaccination in one of the three representative regions of the United States. The stability in the data collection and number of reporting sites under varicella surveillance from 1995-2002 and HZ surveillance during 2000-2001 and 2006-2007 contributed to the robustness of the discerned trends. Discussion: Varicella vaccination may be useful for leukemic children; however, the target population in the United States is all children. Since the varicella vaccine inoculates its recipients with live, attenuated varicella-zoster virus (VZV), clinical varicella cases have dramatically declined. Declining exogenous exposures (boosts) from children shedding natural VZV have caused waning cell-mediated immunity. Thus, the protection provided by varicella vaccination is neither lifelong nor complete. Moreover, dramatic increases in the incidence of adult shingles cases have been observed since HZ was added to the surveillance in 2000. In 2013, this topic is still debated and remains controversial in the United States. Summary: When the costs of the booster dose for varicella and the increased shingles recurrences are included, the universal varicella vaccination program is neither effective nor cost-effective.

Research paper thumbnail of Review of the United States universal varicella vaccination program: Herpes zoster incidence rates, cost-effectiveness, and vaccine efficacy based primarily on the Antelope Valley Varicella Active Surveillance Project data

Vaccine, 2013

In a cooperative agreement starting January 1995, prior to the FDA's licensure of the varicella v... more In a cooperative agreement starting January 1995, prior to the FDA's licensure of the varicella vaccine on March 17, the Centers for Disease Control and Prevention (CDC) funded the Los Angeles Department of Health Services' Antelope Valley Varicella Active Surveillance Project (AV-VASP). Since only varicella case reports were gathered, baseline incidence data for herpes zoster (HZ) or shingles was lacking. Varicella case reports decreased 72%, from 2834 in 1995 to 836 in 2000 at which time approximately 50% of children under 10 years of age had been vaccinated. Starting in 2000, HZ surveillance was added to the project. By 2002, notable increases in HZ incidence rates were reported among both children and adults with a prior history of natural varicella. However, CDC authorities still claimed that no increase in HZ had occurred in any US surveillance site. The basic assumptions inherent to the varicella cost-benefit analysis ignored the significance of exogenous boosting caused by those shedding wild-type VZV. Also ignored was the morbidity associated with even rare serious events following varicella vaccination as well as the morbidity from increasing cases of HZ among adults. Vaccine efficacy declined below 80% in 2001. By 2006, because 20% of vaccinees were experiencing breakthrough varicella and vaccine-induced protection was waning, the CDC recommended a booster dose for children and, in 2007, a shingles vaccination was approved for adults aged 60 years and older. In the prelicensure era, 95% of adults experienced natural chickenpox (usually as children)-these cases were usually benign and resulted in long-term immunity. Varicella vaccination is less effective than the natural immunity that existed in prevaccine communities. Universal varicella vaccination has not proven to be cost-effective as increased HZ morbidity has disproportionately offset cost savings associated with reductions in varicella disease. Universal varicella vaccination has failed to provide long-term protection from VZV disease.

Research paper thumbnail of Reaffirming a Positive Correlation Between Number of Vaccine Doses and Infant Mortality Rates: A Response to Critics

Cureus

A positive correlation between the number of vaccine doses and IMRs is detectable in the most hig... more A positive correlation between the number of vaccine doses and IMRs is detectable in the most highly developed nations but attenuated in the background noise of nations with heterogeneous socioeconomic variables that contribute to high rates of infant mortality, such as malnutrition, poverty, and substandard health care.

Research paper thumbnail of Bailey’s Reanalysis Fails to Debunk, and Inadvertently Supports, Miller-Goldman’s Positive Correlation between Number of Vaccine Doses and Infant Mortality Rates

Background—In 2011, Miller and Goldman published a study in Human and Experimental Toxicology tha... more Background—In 2011, Miller and Goldman published a study in Human and Experimental Toxicology that found a counterintuitive, positive correlation, r = 0.70 (r2 = 0.49, p < .0001), demonstrating that as nations require more vaccine doses for their infants, infant mortality rates (IMRs) tend to increase (worsen). The dataset (n = 30) included the United States, a nation that required the most vaccines for their infants, and all nations with better IMRs than the United States. Dr. E. Bailey, a professor at BYU, and her students, recently read the Miller-Goldman study and found it "troublesome that this manuscript is in the top 5% of all research outputs" and falsely claimed that its findings were due to "inappropriate data exclusion," i.e., failure to analyze the "full dataset" of all 185 nations. The "Bailey reanalysis," titled Infant vaccination does not predict increased infant mortality rate: correcting past misinformation, was posted to t...

Research paper thumbnail of Examples of Outcome Reporting Bias in Vaccine Studies: Illustrating How Perpetuating Medical Consensus Can Impede Progress in Public Health

Cureus

Introduction: Outcome reporting bias in vaccine studies is a widespread problem among all researc... more Introduction: Outcome reporting bias in vaccine studies is a widespread problem among all researchers who have a tendency to report selective results and conclusions that support their beliefs and values or those of sponsoring agencies. Especially during the COVID-19 pandemic, this bias surfaced through the unprecedented proliferation of conflicting vaccine studies. Many researchers strongly recommend and report on the safety and effectiveness of the COVID-19 vaccine. Those researchers who embrace the COVID-19 vaccine and vaccines, in general, are often dismissive of other researchers who present views that differ from medical orthodoxy and oppose medical consensus. Methods: The aim of this analysis is to critically evaluate seven vaccine studies using qualitative and/or quantitative approaches to identify outcome reporting bias and assess its potential impact on the stated conclusions that align with medical consensus. Four studies claim to have found no association between autism and (a) blood levels of mercury, (b) measles, mumps, and rubella (MMR) vaccine, and (c) thimerosalcontaining vaccines. Three other studies claim no association exists between infant mortality rate and the number of vaccine doses, universal varicella vaccination and herpes zoster, and pandemic influenza vaccines and fetal losses. Results: The presence of outcome reporting bias and independent reanalysis demonstrated an impact on both the direction and magnitude of the observed effect-raising questions concerning the robustness of the original study design and conclusions and challenging the current medical consensus. Medical consensus has exonerated vaccines as having any causal relationship to autism spectrum disorders (ASDs), yet no other reasonable cause has been proposed. Medical consensus attributes significant ASD increases to better case ascertainment and broadened clinical diagnosis. According to 2018 data, an estimated 1 in 44 eight-yearolds has been identified with ASD. From 1990 to 2019, there have been an estimated two million new cases of ASD in the US, with lifetime social costs exceeding $7 trillion (in 2019 dollars). Can perpetuating medical consensus impede the advancement of public health? Or has it already done so? Conclusions: Conflicts of interest (e.g., financial) that abound between health regulatory agencies and the pharmaceutical industry impact what is ultimately reckoned as medical consensus. Outcome reporting bias that is inherent to all researchers to some degree, obscures medical and scientific truth. Advancement of public health requires that researchers have integrity and an openness and willingness to collaborate to resolve contradictory findings. In fact, it is usually through meticulous, rigorous, scientific investigation of contradictory findings that medical science has advanced and contributed to improvements in public health-since medical consensus and orthodoxy can be incorrect.

Research paper thumbnail of COMMENTARY The Case against Universal Varicella Vaccination

In 1995, the United States became the first country to implement

Research paper thumbnail of Response to letter to editor by Jumaan: Goldman's role in the Varicella Active Surveillance Project. Author's reply

Vaccine, 2004

served as the sole research/ analyst for the Antelope Valley Varicella Active Surveillance Projec... more served as the sole research/ analyst for the Antelope Valley Varicella Active Surveillance Project (VASP) from the start of data collection in January 1995 through October 2002. At an office in High Desert Hospital located in Lancaster, California, Goldman worked for eight years alongside the project director and one to two assistants who were chiefly responsible for conducting telephone interviews to collect demographic and clinical data on reported cases of varicella. Two co-principal investigators located offsite were involved in other activities associated with the Los Angeles County Department of Health Services (LACDHS), Acute Communicable Disease Control Unit, with a small percentage of their time devoted to this project. In 1995, Goldman was initially presented with a rough draft form to be used in telephone interviews to gather clinical information from parents concerning their child's case of varicella. This was the sole input from the LACDHS and CDC at the time. There were no established standards, databases, or protocols, and A. Jumaan, D. Schmid, P. Gargiullo, and J. Seward of the National Immunization Program (NIP), CDC, Department of Health and Human Services were not as yet associated or assigned to the varicella project. Throughout the project, Goldman designed and implemented some 125 programs to automate the input, analysis, and reporting of data. Such programs included analysis of (a) breakthrough varicella cases, (b) secondary family attack rates (SFAR) among vaccinated and unvaccinated household members, (c) vaccine efficacy, (d) herpes zoster (HZ) recurrence rates, (e) verified, pending, excluded and probable cases by month, (f) adolescent survey data, (g) varicella outbreaks, (h) primary, co-primary, and secondary varicella cases, and numerous other investigative reports. Goldman proposed a standard for all surveillance sites as early as 1995/1996. Goldman was invited to participate in coordination meetings held at the CDC in Atlanta, Georgia. His work served as a model to help guide CDC in the development of project standards. Dr. Goldman's classification specified such duties ଝ doi of the original article

Research paper thumbnail of Constructing Stylish Characters on Computer Graphics Systems

Research paper thumbnail of Press Release: Rise in shingles cases linked to universal varicella vaccination program

Medical Veritas: The Journal of Medical Truth, 2004

Research paper thumbnail of Infant mortality rates regressed against number of vaccine doses routinely given: Is there a biochemical or synergistic toxicity?

Human and Experimental Toxicology, 2011

The infant mortality rate (IMR) is one of the most important indicators of the socio-economic wel... more The infant mortality rate (IMR) is one of the most important indicators of the socio-economic well-being and public health conditions of a country. The US childhood immunization schedule specifies 26 vaccine doses for infants aged less than 1 year-the most in the world--yet 33 nations have lower IMRs. Using linear regression, the immunization schedules of these 34 nations were examined and a correlation coefficient of r = 0.70 (p < 0.0001) was found between IMRs and the number of vaccine doses routinely given to infants. Nations were also grouped into five different vaccine dose ranges: 12-14, 15-17, 18-20, 21-23, and 24-26. The mean IMRs of all nations within each group were then calculated. Linear regression analysis of unweighted mean IMRs showed a high statistically significant correlation between increasing number of vaccine doses and increasing infant mortality rates, with r = 0.992 (p < 0.0009). Using the Tukey-Kramer test, statistically significant differences in mean IMRs IMRs were found between nations giving 12–14 vaccine doses and those giving 21–23, and 24–26 doses. A closer inspection of correlations between vaccine doses, biochemical or synergistic toxicity, and IMRs is essential.

Research paper thumbnail of Insights on the Impact of External and Internal Boosting on Varicella-Zoster Virus Reactivation Based on Evidence From the First Decade of the United States Universal Varicella Vaccination Program

Research paper thumbnail of The power wheel &#8212; Electromotive torque for vehicular applications

28th IEEE Vehicular Technology Conference

The Power Wheel is a compact, self-contained motor in a wheel that establishes a torque drive. Du... more The Power Wheel is a compact, self-contained motor in a wheel that establishes a torque drive. Dual-functioning circuitry that performs brushless commutation and polyphase rectification is also contained entirely within the wheel. Thus, with a substantial reduction in both the number of external control system components and mechanical drive-system couplings, this electric motor can power a 4-wheel-drive electric vehicle in

Research paper thumbnail of Letters to the Editor: Varicella vaccination

Research paper thumbnail of Constructing Stylish Characters on Computer Graphics Systems

Coed Transactions, Nov 1, 1980

Research paper thumbnail of Adverse effects of varicella vaccination are under-reported in VAERS, mitigating against discover of the true cost-benefit

Medical Veritas: The Journal of Medical Truth, 2005

Varicella vaccination is generally considered safe but there are usually no prescreening tests to... more Varicella vaccination is generally considered safe but there are usually no prescreening tests to determine whether an adverse reaction is likely to occur. The literature contains a surprising number of adverse reactions following varicella vaccination including vaccine-strain herpes-zoster (HZ) in children and adults. The Advisory Committee on Immunization Practices (ACIP) states, "VAERS data are limited by underreporting and unknown sensitivity of the reporting system, making it difficult to compare adverse event rates following vaccination reported to VAERS with those from complications following natural disease. Nevertheless, the magnitude of these differences makes it likely that serious adverse events following vaccination occur at a substantially lower rate than following natural disease." Since follow-up is not conducted, it may be argued that some reports may not be attributed to or associated with vaccination and therefore the true rate of adverse events is essentially unknown. Nevertheless, adverse reactions reported in VAERS have typically been shown to be only 5% or 10% of the true rates. Cost-benefit analyses of the universal varicella vaccination program appear to be optimistic, especially when adverse vaccine reactions are completely ignored or excluded.

Research paper thumbnail of High incidence of shingles among children with prior chickenpox: an inadvertent consequence of the universal varicella vaccination program?

Medical Veritas: The Journal of Medical Truth, 2004

Active surveillance for herpes zoster (HZ) was conducted during three years, 2000-2002, in a geog... more Active surveillance for herpes zoster (HZ) was conducted during three years, 2000-2002, in a geographically distinct high desert region known as Antelope Valley, California among 53,756 children aged 1 to 9 years during which time 92 cases were reported with an estimated 50% reporting completeness based on capture-recapture methods. The ascertainment-corrected crude (population) HZ incidence rate is 114 per 100,000 person-years (184/161,268). The cumulative (2000-2002) true HZ incidence rate is 481 per 100,000 person-years based on an ascertainment-corrected 156 cases during an observation time of 32,410 person-years among children with a previous history of natural varicella. By comparison, a survey conducted among school children in the same study area with nearly 100% enumeration of HZ cases yielded an estimated crude and true HZ incidence rates of 72 and 145 cases, respectively, per 100,000 person-years in the pre-licensure era. The postulate is presented that the high crude HZ incidence among children with a previous history of natural varicella in the post-licensure period corresponds to a dramatic 70-80% decrease in varicella cases since 1995 and concomitant loss of exogenous re-exposures (boosts) that previously served to suppress the reactivation of HZ.

Research paper thumbnail of Simplified lesson in capture-recapture methods and controversy regarding their epidemiological application

Medical Veritas: The Journal of Medical Truth, 2004

Capture-recapture methods, while not providing exact results, are an inexpensive approach to esti... more Capture-recapture methods, while not providing exact results, are an inexpensive approach to estimating the under-reporting of a given disease. Especially since 1980, capture-recapture has been commonly used in many surveillance and epidemiological studies. Most studies derive estimates of disease incidence rates based solely on the number of cases enumerated. These rates are typically biased low since 100% enumeration of cases is rarely achieved and more typically varies from 10% to 80%. The incidence rates in such studies are virtually uninterpretable and merely reflect the degree of reporting completeness. However, when two or more ascertainment sources are utilized to obtain reports of cases, the duplicate cases found in the ascertainment sources can be used to derive ascertainment-corrected incidence rates. It is then possible to compare results obtained in one study with that of other studies that have likewise derived ascertainment-corrected incidence rates, even though the percentage of reporting completeness may very in the different studies. When only two sources are used in capture-recapture methods, the estimate should be checked against a criterion ("gold") standard to validate the result. Public health officials were initially skeptical of application of capture-recapture methods to varicella disease due the seasonal distribution of cases; application of the method to herpes zoster cases also met with resistance due to the comparatively few cases reported.