ArticlePDF Available

Revisiting Excess Diagnoses of Illnesses and Conditions in Children Whose Parents Provided Informed Permission to Vaccinate Them

Authors:
  • The Institute for Pure and Applied Knowledge

Abstract and Figures

Controversy over a reported increase in office visits specifically scheduled for illnesses and conditions in children has stalled progress in understanding adverse outcomes associated with an increasingly crowded schedule of pediatric vaccines. Studies finding associations between vaccines and adverse conditions have been targeted for retraction. Here, we revisit data from one such study, comparing the increase in office visits for conditions independent of the routine “well-child” visits (hereafter, Health Care Visits; HCVs). The retraction occurred after >1/4 of a million people had read the peer-reviewed study. It was targeted by one anonymous reader who complained he did not believe the published results. His complaint hinged on the supposition — unsupported by any data — that vaccinated children made their scheduled HCVs more regularly than unvaccinated, implying that those unkept appointments led to fewer diagnoses. We show, here, new data from the same practice that the opposite is true. When the data for vaccinated versus unvaccinated children are examined, the critic’s claim is exactly reversed. Relative Risk and Odds Ratios sustain and augment the original report. Additional office visits, beyond scheduled HCVs, are quantified, controlling for variation in kept HCVs and age/days of care. Estimates of Health Care Incidence (HCI) show that visits above regular HCVs increase due to vaccination by 2.56 to 4.98 per year. Blocking and multiple linear regression analysis of interactions indicate both that the unvaccinated are keeping scheduled HCVs more often than the vaccinated, and that vaccination comes with a net increase in non-routine office visits, i.e., not “well-baby visits” but trips to the doctor for reasons other than vaccination. Taking account of the complexities of healthcare-seeking with measured covariates and outcomes, especially adverse health events, suggests that vaccination may be driving the increased need for non-routine office visits for specific health complaints. Meanwhile, one reader’s unsupported and false criticism of the former study, reflects a pervasive bias leading to systematic removal of many well-designed studies attributing adverse outcomes to vaccines. Hiding such well-designed and faithfully reported, not to mention peer-reviewed and published research, clears the way for marketing programs bought and paid for by vaccine manufacturers and the Centers for Disease Control and Prevention (CDC).
Content may be subject to copyright.
International Journal of Vaccine Theory, Practice, and Research 2(2), September 26, 2022 Page 603
https://doi.org/10.56098/ijvtpr.v2i2 https://doi.org/10.56098/ijvtpr.v2i2.59
Revisiting Excess Diagnoses of Illnesses and
Conditions in Children Whose Parents Provided
Informed Permission to Vaccinate Them
James Lyons-Weiler, PhD1,2 and Russell L. Blaylock, MD3
1Institute for Pure and Applied Knowledge
2IPAK-EDU LLC
3Theoretical Neuroscience Research, LLC
Abstract
Controversy over a reported increase in office visits specifically scheduled for illnesses and conditions in
children has stalled progress in understanding adverse outcomes associated with an increasingly crowded
schedule of pediatric vaccines. Studies finding associations between vaccines and adverse conditions have
been targeted for retraction. Here, we revisit data from one such study, comparing the increase in office visits
for conditions independent of the routine “well-child” visits (hereafter, Health Care Visits; HCVs). The
retraction occurred after >1/4 of a million people had read the peer-reviewed study. It was targeted by one
anonymous reader who complained he did not believe the published results. His complaint hinged on the
supposition unsupported by any data that vaccinated children made their scheduled HCVs more
regularly than unvaccinated, implying that those unkept appointments led to fewer diagnoses. We show, here,
new data from the same practice that the opposite is true. When the data for vaccinated versus unvaccinated
children are examined, the critic’s claim is exactly reversed. Relative Risk and Odds Ratios sustain and
augment the original report. Additional office visits, beyond scheduled HCVs, are quantified, controlling for
variation in kept HCVs and age/days of care. Estimates of Health Care Incidence (HCI) show that visits above regular
HCVs increase due to vaccination by 2.56 to 4.98 additional office visits for vaccine-related health issues per unit increase in
vaccination per year. Blocking and multiple linear regression analysis of interactions indicate both that the
unvaccinated are keeping scheduled HCVs more often than the vaccinated, and that vaccination comes with a
net increase in non-routine office visits, i.e., not “well-baby visits” but trips to the doctor for reasons other
than vaccination. Taking account of the complexities of healthcare-seeking with measured covariates and
outcomes, especially adverse health events, suggests that vaccination may be driving the increased need for
non-routine office visits for specific health complaints. Meanwhile, one readers unsupported and false
criticism of the former study, reflects a pervasive bias leading to systematic removal of many well-designed
studies attributing adverse outcomes to vaccines. Hiding such well-designed and faithfully reported, not to
mention peer-reviewed and published research, clears the way for marketing programs bought and paid for by
vaccine manufacturers and the Centers for Disease Control and Prevention (CDC).
Keywords: chronic illness, pediatric health, relative incidence of office visits, RIOV, scheduled pediatric vaccines, well-baby visits
Introduction
Long-term vaccine safety studies have been restricted to observational, retrospective studies due to
supposed concern over the alleged unethical nature of randomized clinical trials in which some candidates
International Journal of Vaccine Theory, Practice, and Research 2(2), September 26, 2022 Page 604
https://doi.org/10.56098/ijvtpr.v2i2 https://doi.org/10.56098/ijvtpr.v2i2.59
would not receive the claimed benefits of vaccination. This position, however, begs the question of the net
risk-to-benefit ratio of vaccinations and their effects on human health.
Contrary to media reports and biased online, non-peer-reviewed summaries produced by agencies such as
the US CDC and FDA, past studies of vaccination have not universally supported the narrative claiming
that childhood vaccines are safe (and effective). Here our focus is on the purported “safety” of childhood
vaccines in the schedule. Studies conducted and funded by US agencies, such as the Centers for Disease
Control and Prevention, are alleged by media outlets to have shown that vaccines in the CDC’s
recommended vaccine schedule are safe for every child, but that claim is an exaggeration of the conclusions
of those studies. The accuracy of claims published on the CDC website, such as “Vaccines Do Not Cause
Autism”, are impossible to assess because the question of association has not been addressed for most of
the pediatric vaccines in the CDC schedule, nor have the interactions between them been systematically
addressed. Likewise, most such studies base their conclusions on a lack of a mechanism to explain such a
link, when in fact well-designed studies conducted independently of vested interests in the vaccine industry
that is, without influence from government funding or pharmaceutical-supported marketing tend to
find a surprisingly higher rate of undesirable health outcomes associated with vaccination (Mogensen et al.,
2017; Aaby et al., 2018; Mawson et al., 2017, Hooker & Miller, 2020) than are reported in the mainstream
sanitized literature bought and paid for by a multi-trillion dollar industry (E. P. I. C. Magazine, 2017; Liu et
al., 2017; Wong et al., 2017; Dal-Ré et al., 2019; Niforatos et al., 2020). The massive financial conflicts of
interest in the American Academy of Pediatricians (AAP) and its members were enumerated by Lyons-
Weiler and Thomas (2021).
Journals that seek favor and compensation from agencies and advertisers feel pressure either to not publish
studies that find issues with vaccines, or, if they do publish any such study, the authors and editors may
expect pressure to retract it later on (Shaw, 2020). There has been an increase in the practice of targeted
retractions, often following a non-reviewed letter by an anonymous critic. This form of post-publication
threat to a publication due to its results, with no evidence of fraud, nor hard evidence of the alleged
problems with the published study, has been addressed by a group of Israeli criminology scientists, who
found that authors of such retracted studies felt targeted (Elisha et al., 2020).
The retraction of studies due to variance from the outcomes predicted by the mainstream vaccine marketing
narrative will, of course, bias the resulting literature, preventing meta-analyses that might pick up a systemic
pattern of adverse effects. For vaccination studies, the anonymous readers’ comments leading to a retraction
of the initial publication in the instance at issue here can only be seen as a “ghouling” bias. Anonymous
individuals targeting studies because they do not like or agree with the results of a study produce an
unwelcome double jeopardy of dubious necessity. Such a practice is patently unfair: the reader’s comments
were not themselves subject to formal critical peer-review, and thus a power imbalance exists. Such post-
publication anonymous attacks permitting a single reader’s guesswork to overrule the recommendations of
the original peer-reviewers is not consistent with any reasonable ethical standard for publishers. Journals
should instead publish statements of concern following peer-review, allowing the authors to either defend
their research or withdraw their study if the concerns expressed are true and bring valid issues to light that
have been overlooked or misunderstood. Such rational discourse is part of the staid and honored practice in
genuine science, allowing individual scientists and the community to engage in a transparent manner
consistent with honor and integrity. Many legitimate journals allow readers to comment at the end of the
article, thus encouraging useful scientific debate.
In this study, we examine the likelihood of alleged bias in the publication of the first round of results in the
study “Relative incidence of office visits and cumulative rates of billed diagnoses along the axis of
vaccination” (Lyons-Weiler & Thomas, 2020, retracted). That study reported an increased risk of the need
International Journal of Vaccine Theory, Practice, and Research 2(2), September 26, 2022 Page 605
https://doi.org/10.56098/ijvtpr.v2i2 https://doi.org/10.56098/ijvtpr.v2i2.59
for medical attention for many conditions among the more vaccinated cohort compared to that required by
the less vaccinated children in the same practice. For convenience, we will refer to the two groups as
“vaccinated” and “unvaccinated” throughout this paper. The original study in question was retracted after an
anonymous reader communicated the unsubstantiated opinion, evidently a personal suspicion, that the
results were due entirely to variation in the health-seeking behavior of parents who provide informed
permission for their children to be vaccinated compared to those who refuse to provide informed
permission. That reader gave no evidence or explanation as to why such variation would necessarily exist.
The concern might be interpreted as a seemingly reasonable hypothesis. The logic is as follows: if
vaccinated parents go to the “well-child visits more frequently, physicians have more opportunities to find
undesirable conditions, leading to higher diagnosis rates in the vaccinated. However, the critical reader
provided no data to support such an idea, which had already been addressed during peer-review. An entire
set of results had already been generated during the prior peer-review process showing that the reader’s
supposition was likely to be false.
The study in question had remarkable results. For example, the data analyzed by Lyons-Weiler and Thomas
(2020) found zero cases of ADHD in the unvaccinated group (a condition usually diagnosed outside the
practice). This result could not be due to methodological irregularities; the data are the data. No means of
adjustment for covariates or methodological manipulation could change zero cases of ADHD in the
unvaccinated into a non-zero number of cases. Lyons-Weiler and Thomas (2020) also reported the
distinctive signal of Dr. Thomas’ practice honoring the parent’s decision to refuse to provide informed
permission to vaccinate their child (or children) as required for human subjects research by the United States
Code of Federal Regulations 45 CFR 46). That is the code governing the conduct of post-market,
retrospective vaccine “pharmacovigilance” studies of patient whose data could be used in long-term vaccine
safety studies regarding vaccine safety. Similarly, he abided by parent refusal to consent to vaccination as a
medical procedure for all or any individual vaccinations, or for the cessation of vaccinations, as required by
Oregon State law governing informed consent.
Materials and Methods
There are three options for studying variation that might be associated with healthcare-seeking behavior.
The first is blocking groups on healthcare check-up “well-child visits, referred to here and throughout as
Health Care Visits (HCVs). The second is to match, patient per patient, vaccinated children to unvaccinated
children that are most similar in age and in keeping up with their scheduled HCVs. The third option is to
“adjust” for HCVs in a multivariate setting. The details for each of these analyses are as follows.
BLOCKING STUDY
To define three groups (blocks) of patients based on HCVs, patients were ranked irrespective of vaccination
status and separated into the top, middle and lowest thirds; these define high, intermediate, and low HCV
groups. Health outcomes were then compared between vaccinated and unvaccinated patients within each of
these groups using the Relative Incidence of Odds Ratio (RIOV) a method described by Lyons-Weiler
and Thomas (2020).
MATCHING STUDY
Matching patients in different exposure groups can reduce variation associated with suspected confounders.
To be effective, matching must be performed without prior knowledge of or reference to health outcomes.
To meet this requirement, a total of 561 vaccinated patients were chosen to match the unvaccinated using a
minimum Euclidean distance computed by considering the variables Days of Care and HCVs. Importantly,
International Journal of Vaccine Theory, Practice, and Research 2(2), September 26, 2022 Page 606
https://doi.org/10.56098/ijvtpr.v2i2 https://doi.org/10.56098/ijvtpr.v2i2.59
because all the patients in the study were born into the practice, the independent variable Days of Care is
essentially the same measure as Age but accounts for differences among patients who may have moved out
of the practice. In this process, a patient with the next-smallest Euclidean distance was selected if a
vaccinated patient had already been chosen as a match for a prior patient. To ensure unbiased matching, no
other information was referenced or considered in the otherwise blinded selection of the 561 matched
vaccinated patients.
EFFECTS OF VACCINE CESSATION
In the original study, we noted that because physicians in the practice would review the vaccine information
sheets with parents at each Health Care Visit, and also would be responsive to parents concerns over
seizures and developmental delays, the data appeared to show a lower rate of neurodevelopmental disorders
in the vaccinated than in the unvaccinated; i.e., opting out of vaccination would enrich the non-vaccinated
group for family members who might have a risk of developmental delay.
To address this aspect of the data on other health effects, we calculated the relative risk of the vaccinated
(>0 vaccines), and older children (1,500 days of age) in two groups: the Low Vaccine Adoption” group
(<0.015 vaccines per Day of Care [DOC]; N=390) vs. the vaccinated High Vaccine Adoption” group
(>0.02 vaccines per DOC; N=467). Health outcome differences between these groups would reflect the
effect of vaccine cessation on overall health. It could also supply information on the effects of various
vaccines on specific developmental windows during the vaccination period and the health effects of
avoiding further injections on later developmental windows.
MULTIVARIATE STUDY ADJUSTING FOR SUSPECTED CONFOUNDERS
Multiple linear regression (MLR) is classically used to help those studying the relationships among
independent variables via model comparison, and the study of predictor variable effects, changes in effects
in the presence of other independent variables, and interactions. Therefore, MLR was used to study the
effect of variation that might be attributed to healthcare utilization, age, and “natural” lifestyle choice. To
accomplish this, the compound variable “Health Care Visits per Day of Care” (HCV/DOC) was used as an
independent measure to study, among the vaccinated, the effect of parameter inclusion in a model of the
effects of vaccination exposure (number of vaccines) on requiring an office visit for any condition other
than vaccination. Breastfeeding, a correlate of lifestyle choice, was also included to further study the effects
of adjusting for the organic/natural lifestyle suspected to explain health differences among the more
compliant “vaccinated” group and the group referred to as “unvaccinated” in which one or all vaccines were
refused.
Results
In all our analyses, the remarkable outcome of zero ADHD cases among the unvaccinated, but 168 office
visits for ADHD in the vaccinated were, of course, repeated. The health outcome of ADHD was not
included in the results within each outcome but remains one of the most important findings given the data.
BLOCKING STUDY
The blocking design revealed differences between high, medium, and low health care visit (HCV) blocks,
specifically in the average age of patients (Figure 1). The groups also varied concerning the differences in
HCV, with the high HCV group exhibiting a difference in health care visit use (HCU in the figure) between
the vaccinated and “unvaccinated patients (Figures 2a, 2b, and 2c). The difference is attenuated in the
Medium HCV group, and non-existent in the Low HCV group. Given that the unvaccinated participated in
International Journal of Vaccine Theory, Practice, and Research 2(2), September 26, 2022 Page 607
https://doi.org/10.56098/ijvtpr.v2i2 https://doi.org/10.56098/ijvtpr.v2i2.59
HCVs with a greater frequency in the High and Medium HCV blocks, higher risks of adverse health
outcomes are not expected in the comparisons of vaccinated and non-vaccinated patients within these
blocks.
Figure 1. Average age in days of groups within HCV blocks.
Concern over confounding can be addressed by setting the baseline via the comparison of HCV itself as an
outcome: the ratio (V/UV) of HCV in the three HCV blocks are as follow: High (0.71), Medium (0.842),
and Low (1.016).
Figure 2a. RIOV-type analysis of Health Check Visit use in the High healthcare use block.
ASSESSMENT OF SUSPECTED CONFOUNDING VARIATION IN HEALTHCARE-SEEKING BEHAVIOR
Many vaccine studies adjust for covariates, whether functional relationships of the covariate, the main effect,
and the health outcomes have been determined to be confounding (in reality) or not. They often consider
and interpret the results as if the covariates themselves are, in fact, confounding without providing evidence
of the causality of the suspected effect. In other words, the level of evidence used to show causality of
alleged confounders falls far below that required for inferring causality for the main effect. This is a serious
flaw in the paradigm of adjusting for alleged, unproven confounders; as covariates, they may, in fact, prove
International Journal of Vaccine Theory, Practice, and Research 2(2), September 26, 2022 Page 608
https://doi.org/10.56098/ijvtpr.v2i2 https://doi.org/10.56098/ijvtpr.v2i2.59
to be co-predictors. Further, interaction terms are universally ignored in studies that adjust for alleged
confounders, and the significance of the main effect (vaccines) can be hidden in an unstudied or unreported
interaction term. To check on whether HCVs were, in fact, confounding in the study of health outcomes
associated with variation in vaccination status, we calculated and compared the rate of keeping scheduled
HCVs between the vaccinated and unvaccinated.
Figure 2b. RIOV-type analysis of Health Check use in the Medium healthcare use block.
Figure 2c. RIOV-type analysis of Health Check use in the Low healthcare use block.
Highest Health Care Visit Use
In the class with the highest use of Health Care Visits, there were a total of 16,264 HCVs in the 1,105
vaccinated children. In the same class, there were 213 HCVs in the non-vaccinated group of children. That
accounts for 14.71 HCVs per vaccinated patient, and 21.3 HCVs per non-vaccinated patient in the class with
the highest use of Health Check days.
There was an average of 2,316 days of duration of enrollment in the practice among the vaccinated children
in this class, and an average of 2,133 days of duration of enrollment in the practice among the children
whose parents opted out of vaccinations offered.
There were more HCV days per total days of enrollment in the non-vaccinated children in the class (1% of
days of enrollment were HCV days) compared to the vaccinated children (0.63% of DOC were HCV days).
Mid-Level Health Visit Use
In the class with the mid-level use of Health Care days, there were a total of 11,964 HCVs in the 1,018
vaccinated children. In the same class, there were 1,144 HCVs in the non-vaccinated children. That accounts
for 11.75 HCVs per vaccinated patient, and 13.95 HCV per non-vaccinated patient in the class with the mid-
level use of Health Check days.
International Journal of Vaccine Theory, Practice, and Research 2(2), September 26, 2022 Page 609
https://doi.org/10.56098/ijvtpr.v2i2 https://doi.org/10.56098/ijvtpr.v2i2.59
There were slightly more HC days per total day of enrollment in the non-vaccinated children in the mid-
class (0.928% of days of enrollment were HC days) compared to the vaccinated children (0.905% of DOC
were HC days).
Lowest Health Care Visit Use
In the class with the lowest use of Health Check days, there were a total of 4,472 HCs in the 640 vaccinated
children. In the same class, there were 3,632 HCs in the non-vaccinated children.
That leads to 6.99 HCVs per vaccinated patient, and 7.74 HCVs per non-vaccinated patient in the class with
the lowest use of Health Check days.
There was a slightly, but not significantly, higher percentage of HC days per total days of enrollment in the
non-vaccinated children in the lower block (1.35% of days of enrollment were HC days) compared to the
vaccinated children (1.33% of DOC were HC days).
All Patients
Considering all the patients in the study, the vaccinated spent 0.77% of their DOC attending HCVs, and the
Unvaccinated spent 1.07% of DOC attending HCV.
The average age of those vaccinated was 751 days with an average of 8.87 HCVs per patient; the average
age of non-vaccinated patients was 750 days with an average of 8.86 HCV per patient.
Similarly, the average DOC of the vaccinated was 746, and the average DOC in the non-vaccinated patients
was 741.
These would rule out HCV use bias as an explanation for the increased numbers of diagnoses; HCV is not a
confounder in a manner that could explain the results.
COMPARISON OF HEALTH OUTCOMES, VACCINATED VS. UNVACCINATED WITHIN BLOCKS
Blocking necessarily reduces sample size and can reduce statistical power. Comparisons between vaccinated
and non-vaccinated patients in each of the three HCV blocks led to variation in which healthcare outcomes
were increased in the vaccinated population (Table 1). The health conditions where the vaccinated
individuals received more health care visits than the unvaccinated in that block are the ones in which the
ratio of Non-Routine Office Visits are bolded in the table. These are the conditions where the children
whose parents chose to go along with the CDC vaccine schedule in the particular block named at the top
row of the table, required a higher number of Non-Routine Office Visits. Evidently, in the bolded entries,
the more heavily vaccinated individuals had health complaints more frequently than the individuals who
received fewer of the shots in the CDC vaccine schedule.
It is noteworthy that certain health conditions, such as Edema, for instance, had zero cases in the non-
vaccinated patients in any Block. Other conditions, such as Digestive Tract Issues, and the four conditions
following that one, had no unvaccinated individuals in the High Block.
International Journal of Vaccine Theory, Practice, and Research 2(2), September 26, 2022 Page 610
https://doi.org/10.56098/ijvtpr.v2i2 https://doi.org/10.56098/ijvtpr.v2i2.59
Table 1
Ratio of the Incidence of Office Visits for Health Outcomes in by Health Care Use Blocks
Comparing Vaccinated (V) to Unvaccinated (U)
Block
N = total in block,
nV and nU = subtotal for each
group in the named block)
High
N = 1,115
nV = 1,105 & nU = 10
Mid
N = 1,099
nV = 1,018 & nU = 82
Low
N = 1,108
nV = 640 & nU = 469
Routine Health Care Visits,
Baseline
Value for Each Block*
0.71
0.842
1.016
Condition
Fever
1.37
1.47
1.77
Gastroenteritis
2.18
1.147
1.517
Allergic Rhinitis
0.769
1.288
0.183
Edema
Infinite
Infinite
Infinite
Anemia
3.081
1
2.335
Otitis media
2.029
0.493
1.465
Eczema
1.197
0.501
2.564
Digestive Tract Issues
Infinite
0.241
0.977
Nausea/Vomiting
Infinite
0.278
0.732
Allergy - Food
Infinite
0.4833
0.732
Pain
Infinite
0.467
0.814
Seizure
Infinite
0.201
N/A
Diarrhea
1.511
0.461
0.879
Breathing Issues
0.771
0.724
1.116
Urticaria
0.434
Inf
0
Ear Pain
0.366
1.02
0.366
Asthma
0.898
0.322
0.977
Dermatitis
0.326
0.38
0.56
Conjunctivitis
0.552
0.511
0.792
*Bolded entries are those in which the ratio of vaccinated individuals in the “Block” exceeds the baseline value for office
visits of the non-routine kind, whereas the unbolded entries are ones in which the ratio is less than or equal to the
baseline.
In these instances the ratio would be infinitely great because there are no unvaccinated individuals being seen for the
named condition in any non-routine office visit. The value, of course, is incalculable because a ratio cannot contain a zero
as its denominator.
International Journal of Vaccine Theory, Practice, and Research 2(2), September 26, 2022 Page 611
https://doi.org/10.56098/ijvtpr.v2i2 https://doi.org/10.56098/ijvtpr.v2i2.59
MATCHING STUDY
Both the RIOV and classical odds ratio analyses showed that many of the health conditions were elevated.
Examples are shown in Figure 3. The least controversial of these, Fever, is a well-established side effect of
vaccination. Odds ratios for office visits scheduled for each condition shown in Figures 3a to 3f are all
significant (p<0.01).
Figure 3. RIOV diagram for Fever following matching for Health Care Visits and Days of Care (age).
Odds ratios for all conditions (except for ADHD) are shown in Figure 4. For reference, the odds ratio of
Health Care Visits (0.99) is shown. Some of the rarer conditions were difficult to study due to small sample
sizes (e.g., no cases of autism were found among the matched sample of 561 vaccinated persons due to its
overall rarity).
International Journal of Vaccine Theory, Practice, and Research 2(2), September 26, 2022 Page 612
https://doi.org/10.56098/ijvtpr.v2i2 https://doi.org/10.56098/ijvtpr.v2i2.59
Figure 4. Odds ratio of office visits for specific health issues in the comparison of 561
unvaccinated and 561 vaccinated patients in the matched analysis.
Multivariate Study
Multiple regression analysis allows the study of relevant variables in the context of the question, “Does
overall vaccine uptake correlate with number of office visits for poor health outcomes?” Thus, the analysis
involved the study of the number of vaccines per year (1, main effect) vs. the number of non-vaccine-
related office visits (Y, the dependent variable).
For this study, the specified fixed intercept model then becomes
Y = 1 + e
where 1 = number of vaccines, and 2 = HCV.
The effect of each variable is studied by its slope and the regression coefficient, R2.
Since the data were already arranged into High, Medium, and Low HCV, these parameters can be studied for
the full data and within block in a fixed intercept model (Table 2).
International Journal of Vaccine Theory, Practice, and Research 2(2), September 26, 2022 Page 613
https://doi.org/10.56098/ijvtpr.v2i2 https://doi.org/10.56098/ijvtpr.v2i2.59
Table 2
Linear Regression Model Parameter Values Within HCV Blocks
Any Visit
Any Visit Excluding
Vaccinations
HC Use
Slope
𝑹𝟐
Slope
𝑹𝟐
High
7.96
0.914
6.96
0.890
Mid
6.45
0.924
5.45
0.897
Low
6.47
0.805
5.47
0.747
From this analysis, we can see that the number of office visits for any condition excluding vaccination is
weaker than the relationship for any visit, but each model still has a substantial R2 value showing a strong
and robust shared variance. From this analysis, the following estimates result:
High Between 6.03 and 7.96 health care issues (HCIs) resulting per unit increase in vaccination
Mid Between 4.38 and 6.45 HCIs resulting from vaccination
Low Between 3.79 and 6.47 HCIs resulting from vaccination.
In a multiple regression context, the variation attributed to Health Care Visits and Age can be combined
appropriately in the compound variable HCV/Age, and the independent variable Breastfeeding can be
studied via the following model
Y = 1 + 2 + 3 + e
where 1 = number of vaccines, 2 = HCV, and 3 = breastfeeding (binary, not duration)
Figure 5a. Model one: Number of Vaccines, Health Care Visits, and Breastfeeding
International Journal of Vaccine Theory, Practice, and Research 2(2), September 26, 2022 Page 614
https://doi.org/10.56098/ijvtpr.v2i2 https://doi.org/10.56098/ijvtpr.v2i2.59
Figure 5b. Model one: Analysis of Variance table
The effect of each variable is studied by its slope and the regression coefficient, R2, and p-value. Adding the
compound variable HCV/Age and Breastfeeding results in a far less impressive model (Figures 5a and 5b),
and the specific parameter values reverse sign.
However, the model is not fully specified, given that the interactions among terms have not been studied.
The lack of consideration of interaction terms in vaccine studies has been previously noted (Kulldorf,
2013). Adding the appropriate interaction terms (Figures 6a and 6b) leads to a positive and significant slope
for Vaccines even after variation associated with HCV, Age, and Breastfeeding, and interactions among
vaccines and HCV/Age are considered. The slopes of the other terms are also provided.
Figure 6a. Model two: Study of interaction between “Number of Vaccines” and “Health
Care Visits Per Days of Age”
Figure 6b. Model one: Analysis of Variance table
In the parlance of vaccine epidemiologic studies, after “adjusting” for HCV/age, vaccine exposure was still
significant. This result highlights the logical flaw in considering the mere suggestion of hypothetical
alternative factors as definitive positive evidence of the effect of vaccines on health outcomes. Per the
interaction analysis, “Number of Vaccines” increase the number of office visits required for health issues in
a manner that is independent of any effect of the covariates HCV/Age and Breastfeeding and also interacts
significantly with HCV/Age.
International Journal of Vaccine Theory, Practice, and Research 2(2), September 26, 2022 Page 615
https://doi.org/10.56098/ijvtpr.v2i2 https://doi.org/10.56098/ijvtpr.v2i2.59
EFFECTS OF VACCINE CESSATION
The comparison of the High- and Low-vaccinated patients aged 1,500 days or more shows that vaccine
cessation leads to a reduction in many conditions (thus the increased relative risk in the vaccinated patients;
Figure 7). The odds ratio of Health Check in this unmatched analysis (1.2) is shown to provide a baseline
for comparison.
Discussion
These data provide a valuable resource for the study of the impact of variation in parents granting informed
permission to pediatricians for vaccinations recommended per the CDC schedule. Nevertheless, five days
after the Lyons-Weiler and Thomas study was published, the Oregon medical board suspended Dr. Thomas’
license under an “emergency” action, without due process. As a condition of temporary reinstatement of
his license, Dr. Thomas was prevented from doing further studies. Were it not for this consideration, Dr.
Thomas would have been invited to participate in this analysis. Instead, he was specifically left out of the
design of the analyses, the interpretation of the results, and the writing of the manuscript. One must ask
why would anyone consider such an action to be linked with suspension of his medical license based on
“clinical suspicious of malfeasance”? Where is the link to scientific studies based on presented and openly
analyzed data?
These actions represent maneuvers to discredit Dr. Thomas and the original study, to discourage other
physicians from participating in independent (non-government-funded) research on the health effects of
vaccines on the pediatric population, and to keep the information about the impacts of variation in vaccine
acceptance on the total health of the pediatric population.
Months following the suspension of Dr. Thomas’ license, the journal retracted the study, after >250,000
people had read it. The original publishing journal had received one letter of complaint that alleged (without
providing any data or evidence) that the results of the published study must have resulted due to differences
between the vaccinated and unvaccinated populations with respect to adherence to “well-child” visits.
The facts are as follows:
(1) The unvaccinated visit: Dr. Thomas’ unvaccinated pediatric patients kept their Health Check visits
with a higher regularity and higher frequency than the vaccinated, overall, in HCVs thirds, and
regardless of age. Variation in healthcare-seeking behavior cannot explain the increased need for
office visits for health conditions outside of HCVs.
(2) The sole reader’s imagined concerns were unfounded, and the Lyons-Weiler and Thomas study
should not have been retracted.
International Journal of Vaccine Theory, Practice, and Research 2(2), September 26, 2022 Page 616
https://doi.org/10.56098/ijvtpr.v2i2 https://doi.org/10.56098/ijvtpr.v2i2.59
Figure 7. The age-matched effects of vaccine cessation. High Relative Risk values denote
increased risk of a given health outcome in patients receiving more vaccines in the older age
group (>1,500 days of age). The black bar shows the Relative Risk of HCV between these
groups as a baseline.
(3) There is no way to interpret the data as showing that, overall, the unvaccinated are less healthy than
the vaccinated. This addresses the medical board’s request to answer this question.
(4) The analysis of vaccinated vs. unvaccinated within HCV blocks shows that vaccinated patients have
a higher disease burden overall in the high HCV block for many conditions.
(5) For most of the conditions, the vaccinated have a higher disease burden even when patients are
matched for age, days of care, and healthcare utilization behavioral differences.
International Journal of Vaccine Theory, Practice, and Research 2(2), September 26, 2022 Page 617
https://doi.org/10.56098/ijvtpr.v2i2 https://doi.org/10.56098/ijvtpr.v2i2.59
(6) Multivariate analyses show that consideration of interaction terms is necessary for the useful
retrospective study of the impacts of vaccination on human health.
The method developed by Lyons-Weiler and Thomas (RIOV; 2020) was new and was shown to have more
intrinsic statistical power than odds ratios or relative risk estimates. This is because the use of rates of a
given diagnosis, which is how the data are usually presented to odds and relative risk ratio analysis, are lossy
transforms of the rates of office visits required to address health issues related to the diagnoses. RIOV has a
higher dynamic range and represents an analytic advance toward a more sensitive measure of the degree of
illness related to a given diagnosis than OR or RR compared to methods limited to the presence of absence
of a diagnosis.
We have shown, using a variety of exhaustive methods, that the anonymous readers concerns that led to the
retraction of Lyons-Weiler and Thomas (2020) were unfounded. Given the insensitivity of the evidence to
methodological differences, we conclude that the paper was wrongfully retracted and for other reasons than
the alleged problem originating from a single reader using unscientific reasoning. At this point, unless the
journal in question reinstates the study, the journals reputation as an objective publication outlet will remain
forever suspect.
The medically important findings in these data should not be ignored. These include the possibility of
developmental effects of vaccine aluminum-induced anemia, gastrointestinal disorders, and increased risks
of these medical conditions secondary to vaccine-induced dysfunctions of various elements of the immune
system. Such mechanisms adverse effects and their probable, and in some cases certain, causes have been
well demonstrated in the scientific literature as cited in multiple articles in this journal (e.g., see the
immediately preceding entry by Blaylock and references there).
References
Aaby P., Mogensen S.W., Rodrigues A., Benn C.S. (2018). Evidence of increase in mortality after the introduction of
diphtheria-tetanus-pertussis vaccine to children aged 635months in Guinea-Bissau: A time for reflection?
Frontiers in Public Health, 6(79). https://dx.doi.org/10.3389/fpubh.2018.00079
Dal-Ré, R., Caplan, A. L., & Marusic, A. (2019). Editors’ and authors’ individual conflicts of interest disclosure and
journal transparency. A cross-sectional study of high-impact medical specialty journals. BMJ Open, 9(7),
e029796. https://doi.org/10.1136/bmjopen-2019-029796
Elisha, E., Guetzkow J., Shir-Raz, Y. & Ronel, N. (2020). Retraction of scientific papers: The case of vaccine research.
Critical Public Health, 32(4), 533-542. https://doi.org/10.1080/09581596.2021.1878109
E. P. I. C. Magazine. (2017, December 2). Vaccines are big business. Pharma is a trillion-dollar industry with vaccines
accounting for $25 billion in annual sales. The Centers for Disease Control’s decision to add a vaccine to the
schedule can guarantee its manufacturer millions of customers and billions in revenue with minimal
advertising or marketing costs and complete immunity from lawsuits. E.P.I.C. Empowering People, Inspiring
Community. http://epicmag.org/vaccines-big-business/
Hooker B.S. & Miller N.Z. (2020). Analysis of health outcomes in vaccinated and unvaccinated children:
Developmental delays, asthma, ear infections and gastrointestinal disorders. SAGE Open Medicine, 8, 1-11.
https://doi.org/10.1177%2F2050312120925344
Kulldorf, M. (2013). Appendix D: Study designs for the safety evaluation of different childhood immunization
schedules. In Committee on the Assessment of Studies of Health Outcomes Related to the Recommended
Childhood Immunization Schedule; Board on Population Health and Public Health Practice; Institute of
Medicine, The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies.
National Academies Press (US). https://www.ncbi.nlm.nih.gov/books/NBK206950/
International Journal of Vaccine Theory, Practice, and Research 2(2), September 26, 2022 Page 618
https://doi.org/10.56098/ijvtpr.v2i2 https://doi.org/10.56098/ijvtpr.v2i2.59
Liu, J. J., Bell, C. M., Matelski, J. J., Detsky, A. S., & Cram, P. (2017). Payments by US pharmaceutical and medical
device manufacturers to US medical journal editors: Retrospective observational study. BMJ, 359, j4619.
https://doi.org/10.1136/bmj.j4619
Lyons-Weiler, J. & Thomas, P. (2020). Relative incidence of office visits and cumulative rates of billed diagnoses along
the axis of vaccination. International Journal of Environmental Research and Public Health, 17(22): 8674-8698.
https://www.mdpi.com/1660-4601/17/22/8674 (Retraction by the journal published 2021, International
Journal of Environmental Research and Public Health, 18, 7754.)
Lyons-Weiler, J. & P Thomas. 2021. Vaccine practice payment schedules create perverse incentives for unnecessary
medical procedures at what cost to patients? IJVTPR 2(1) https://doi.org/10.56098/ijvtpr.v2i1.21
Mawson A.R. & Croft, A.M. (2020). Multiple vaccinations and the enigma of vaccine injury. Vaccines (Basel), 8(4), 676-
692. https://doi.org/10.3390%2Fvaccines8040676
Mawson A.R., Ray B.D., Bhuiyan A.R. & Jacob B. (2017). Pilot comparative study on the health of vaccinated and
unvaccinated 6- to 12-year-old U.S. children. Journal of Translational Science, 3(3), 1-12.
http://dx.doi.org/10.15761/JTS.1000186
Mogensen S.W., Andersen A., Rodrigues A., Benn C.S. & Aaby P. (2017). The introduction of diphtheria-tetanus-
pertussis and oral polio vaccine among young infants in an urban African community: A natural experiment.
eBioMedicine, 17(Mar.), 192-198. https://doi.org/10.1016%2Fj.ebiom.2017.01.041
Niforatos, J. D., Narang, J., & Trueger, N. S. (2020). Financial conflicts of interest among emergency medicine
journals’ editorial boards. Annals of Emergency Medicine, 75(3), 418422.
https://doi.org/10.1016/j.annemergmed.2019.02.020
Shaw, C. A. (2020). Weaponizing the peer review system. International Journal of Vaccine Theory, Practice, and Research, 1(1),
1126. https://ijvtpr.com/index.php/IJVTPR/article/view/1
Wong, V. S. S., Avalos, L. N., & Callaham, M. L. (2017). Industry payments to physician journal editors (e3359v1). PeerJ Inc.
https://doi.org/10.7287/peerj.preprints.3359v1
Editor’s Comment
At the request of the authors of this paper the peer-review process, contrary to our published approach at this link
under Peer Review Process for the IJVTPR , was double-blinded. Reviewers did not know who the authors were
(except for the Editor in Chief) nor were disclosed reviewer identities disclosed to the authors.
Legal Disclaimer
The information on the website and in the
IJVTPR
is not intended as a diagnosis, recommended treatment,
prevention, or cure for any human condition or medical procedure that may be referred to in any way. Users and
readers who may be parents, guardians, caregivers, clinicians, or relatives of persons impacted by any of the morbid
conditions, procedures, or protocols that may be referred to, must use their own judgment concerning specific
applications. The contributing authors, editors, and persons associated in any capacity with the website and/or with
the journal disclaim any liability or responsibility to any person or entity for any harm, financial loss, physical injury, or
other penalty that may stem from any use or application in any context of information, conclusions, research findings,
opinions, errors, or any statements found on the website or in the
IJVTPR
. The material presented is freely offered to
all users who may take an interest in examining it, but how they may choose to apply any part of it, is the sole
responsibility of the viewer/user. If material is quoted or reprinted, users are asked to give credit to the source/author
and to conform to the non-commercial, no derivatives, requirements of the Creative Commons License 4.0 NC ND.
... However, several studies show that reductions in neuronal energy can dramatically amplify excitotoxic injury. [42,[60][61][62] Impairment of mitochondrial function and energy metabolism by aluminum [58,59,63] would thus be expected to increase the sensitivity of neurons to excitotoxicity and accelerate and potentiate neuronal damage. When energy levels are depressed, even physiological levels of glutamate can be excitotoxic. ...
... With adults getting yearly influenza vaccines and a number of other vaccines, such as the hepatitis B vaccine, tetanus vaccines, the shingle vaccine, and the pneumococcal vaccines, to say nothing of the very high level of aluminum in the Gardasil vaccines, one is not surprised that we are seeing the high degree of illness and especially neurodegenerative disease, in our population. [62,72] What concerns me is that these children are receiving a dose of neurotoxic aluminum that is also being deposited in their spinal cord, especially the motor cells. ese cells have a high energy requirement and are thus susceptible to being highly sensitive to excitotoxicity triggered by the aluminum in the neuron as well as the surrounding glia. ...
Article
Full-text available
Much has been learned about the neurotoxicity of aluminum over the past several decades in terms of its ability to disrupt cellular function, result in slow accumulation, and the difficulty of its removal from cells. Newer evidence suggests a central pathophysiological mechanism may be responsible for much of the toxicity of aluminum and aluminofluoride compounds on the brain and spinal cord. This mechanism involves activation of the brain’s innate immune system, primarily the microglia, astrocytes, and macrophages, with a release of neurotoxic concentrations of excitotoxins and proinflammatory cytokines, chemokines, and immune mediators. Many studies suggest that excitotoxicity plays a significant role in the neurotoxic action of several metals, including aluminum. Recently, researchers have found that while most of the chronic pathology involved in the observed neurodegenerative effects of these metals are secondary to prolonged inflammation, it is the enhancement of excitotoxicity by the immune mediators that are responsible for most of the metal’s toxicity. This enhancement occurs through a crosstalk between cytokines and glutamate-related mechanisms. The author coined the name immunoexcitotoxicity to describe this process. This paper reviews the evidence linking immunoexcitotoxicity to aluminum’s neurotoxic effects and that a slow accumulation of aluminum may be the cause of neurodevelopmental defects as well as neurodegeneration in the adult.
Article
Full-text available
Are the promoters of the COVID-19 injections leading, pushing, and even forcing the people of the world to play a global game of Russian Roulette? The actuarial statistics and clinical facts are revealing harmful and deadly consequences on a global scale. For the sake of those still able to choose whether to spin the cylinder and pull the trigger one more time, I am conducting a guided tour. I will show why there are exponentially many more ways for the experimental injections to cause disease and death than health and well-being. Briefly put, valid transcription of mRNA from our own DNA leads to well-formed proteins that work as designed for cytoplasm, organelles, cells, tissues, and functional organ systems of the body. By contrast, the foreign (xeno) nucleic acid sequences, the mXNAs, in the “modified mRNA” in the COVID-19 injectables are more likely to harm the body’s systems than to benefit them. The relevant research shows why the mXNAs are incompetent to communicate effectively with the complex native context in vivo — the human biosignaling systems that are not mechanical but are articulated in multiple layers, interconnected, and for practical purposes, infinitely varied systems of information processing. Survival and longevity depend on valid communications among nuclear and mitochondrial DNA, their RNAs, and the protein language systems specified before a person’s birth. When these complex biosignaling systems fail, disorders and diseases follow. In catastrophic failures, death occurs. The story is not simple and the tour I am conducting is challenging with more than a few twists, turns, and digressions. However, I believe, persons experimented on — almost all of them unknowingly, some with partial knowledge who were unwilling recipients — account for more than half the world population. The stakes are high, even life or death, so I think many of the recipients of one or more injections will take the guided tour.
Article
Full-text available
No published assessment of revenue variation associated with variance in pediatric vaccine uptake exists. Using data from patients in a pediatric practice that provides full-service with informed consent, we provide a detailed analysis of the financial realities of respecting informed consent and allowing parents to exercise their legal right to refuse some or all pediatric vaccines. The data from a 30-day period of billing were tracked and analyzed via superbills, noting vaccines that were ordered and those that were refused. Considering that other practice income covered all operating expenses; these numbers reflect actual profits (from vaccines given) and losses (from vaccines refused). Patients in the practice exhibited increased refusal of some or all vaccines over a period of approximately ten years. These real-world data show losses would exceed one million US dollars for a practice that bills out just over 3 million (gross revenue). With pediatric administrative overhead running 60–80%, it becomes clear that the financial incentives to vaccinate are now a matter of survival for pediatric practices.
Article
Full-text available
The long-revered “peer review” process, as it is currently being applied in the health sciences, is increasingly controlled by commercial interests that are in too many instances using it as a tool forcing technical publications in prestige journals and books toward certain outcomes favorable to those interests. The “peer review” process has in the last two decades especially, increasingly become a process to serve the interests of the manufacturers and promoters of drugs and medicines. Although it was conceived as a way to ensure quality in academic and scientific publications it has increasingly, especially in the health sciences, taken on a commercial aspect with power, momentum, and governmental support that enables it to be used to against unwanted outcomes that threaten the bottom line of those commercial interests. This paper examines the process as it was intended to be used and contrasts its good purposes for uses to which some bad actors are presently perverting it. The practical limits of the problem and remedies to staunch the bleeding, so to speak, are plainly laid out. There is no intention to give legal advice, but merely to examine recent experience looking toward what can be done to preserve the good and valid uses of the imperfect process of peer review.
Article
Full-text available
The controversy over vaccines, which has recently intensified following the COVID-19 pandemic, provokes heated debates, with both advocates and opponents raising allegations of bias and fraud in research. Researchers whose work raises doubts about the safety of certain vaccines claim to be victims of discriminatory treatment aimed at suppressing dissent, including the unjustified retraction of their published research. Such practices have previously been discussed in other controversial fields in science (e.g., AIDS, the environment, and water fluoridation) but not in the field of vaccines. The purpose of this study was to analyze, for the first time, the subjective views of researchers whose papers were retracted. Study participants are active researchers, most with international reputations in their respective fields. They perceived retraction as a means of censoring and silencing critical voices with the aim of preserving the pro-vaccination agenda of interested parties. Participants also reported additional measures aimed at harming them personally and professionally. These findings point to the need for a fair, open, and honest discourse about the safety of vaccines for the benefit of public health and the restoration of trust in science and medicine.
Article
Full-text available
A growing number of vaccines are administered at the same time or in close succession, increasing the complexity of assessing vaccine safety. Individual vaccines are assumed to have no other effect than protection against the targeted pathogen, but vaccines also have nonspecific and interactive effects, the outcomes of which can be beneficial or harmful. To date, no controlled trials and very few observational studies have determined the impact of vaccination schedules on overall health. The balance of the risks and benefits from mass vaccination therefore remains uncertain. Recent studies worryingly suggest links between multiple vaccinations and increased risks of diverse multisystem health problems, including allergies, infections, and neuropsychiatric or neurodevelopmental disorders. Here, we propose that, in susceptible persons, multiple vaccinations activate the retinoid cascade and trigger apoptotic hepatitis, leading to cholestatic liver dysfunction, in which stored vitamin A compounds (retinyl esters and retinoic acid) enter the circulation in toxic concentrations; this induces endogenous forms of hypervitaminosis A, with the severity of adverse outcomes being directly proportional to the concentration of circulating retinoids. In very low concentrations, vitamin A and its major metabolite retinoic acid contribute to immune function and to the process of immunization, whereas excess vitamin A increases the risk of adverse events, including common “side-effects” as well as chronic adverse outcomes. The increasing rates of allergy, ear infections, and neurodevelopmental disorders (NDDs) in countries with high rates of vaccination could be related to mass vaccination and to its impact on liver function and vitamin A metabolism, collectively representing endogenous manifestations of hypervitaminosis A. Further studies of health outcomes in vaccinated and unvaccinated groups are urgently needed, to increase understanding of the pathophysiology and treatment of vaccine injury, to identify the risk factors and screen for vaccine injury, to inform public health policy on potential hazards related to vaccination schedules, and to optimize the safety and benefits of vaccines.
Article
Full-text available
We performed a retrospective analysis spanning ten years of pediatric practice focused on patients with variable vaccination born into a practice, presenting a unique opportunity to study the effects of variable vaccination on outcomes. The average total incidence of billed office visits per outcome related to the outcomes were compared across groups (Relative Incidence of Office Visit (RIOV)). RIOV is shown to be more powerful than odds ratio of diagnoses. Full cohort, cumulative incidence analyses, matched for days of care, and matched for family history analyses were conducted across quantiles of vaccine uptake. Increased office visits related to many diagnoses were robust to days-of-care-matched analyses, family history, gender block, age block, and false discovery risk. Many outcomes had high RIOV odds ratios after matching for days-of-care (e.g., anemia (6.334), asthma (3.496), allergic rhinitis (6.479), and sinusitis (3.529), all significant under the Z-test). Developmental disorders were determined to be difficult to study due to extremely low prevalence in the practice, potentially attributable to high rates of vaccine cessation upon adverse events and family history of autoimmunity. Remarkably, zero of the 561 unvaccinated patients in the study had attention deficit hyperactivity disorder (ADHD) compared to 0.063% of the (partially and fully) vaccinated. The implications of these results for the net public health effects of whole-population vaccination and with respect for informed consent on human health are compelling. Our results give agency to calls for research conducted by individuals who are independent of any funding sources related to the vaccine industry. While the low rates of developmental disorders prevented sufficiently powered hypothesis testing, it is notable that the overall rate of autism spectrum disorder (0.84%) in the cohort is half that of the US national rate (1.69%). The practice-wide rate of ADHD was roughly half of the national rate. The data indicate that unvaccinated children in the practice are not unhealthier than the vaccinated and indeed the overall results may indicate that the unvaccinated pediatric patients in this practice are healthier overall than the vaccinated.
Preprint
Full-text available
Objective: To assess industry payments to physician journal editors, and determine how their financial conflict of interest rate compares to all physicians within the specialty. Study Design and Setting: Open Payments is a United States federal program that mandates reporting of medical industry payments to physicians. We performed a retrospective analysis of prospectively collected data, reviewing August 1, 2013 to December 31, 2016 payments using the Open Payments search tool. We collected payments data on “top tier” US-based physician-editors of highly-cited medical journals including 1) total general payments from industry, 2) total “direct” research payments, and 3) associated “indirect” research funding. We compared payments to physician-editors and payments to physicians-by-specialty using existing published data. Results: In 35 journals, 333 (74.5%) of 447 “top tier” editors met inclusion criteria as US-based physician-editors. Of these, 212 (63.7%) received any industry-associated payments in the study period. In an average year during the study period, 141 (42.3%) of physician-editors received any payments directed to themselves (rather than their institutions), 120 (36.0%) received payments >50;66(19.850; 66 (19.8%) received payments >5,000 (the threshold designated by the National Institutes of Health as a Significant Financial Interest); and 51 (15.3%) received payments >10,000.Meanannualpaymentof"totalgeneralpayments"was10,000. Mean annual payment of "total general payments" was 55,157 (standard deviation 561,885, range 10-10,981,153) with median of $3,512. Median general industry payments to physician-editors were mostly higher compared to all physicians within their specialty. Conclusions: A substantial minority of physician-editors receive direct payments from industry within any given year, though most editors received payment of some kind in the study period. There were significant outliers. More robust and specific editor financial COI declarations may be appropriate given the extent of editors’ influences on the medical literature.
Article
Full-text available
Objective The aim of this study was to compare the health of vaccinated versus unvaccinated pediatric populations. Methods Using data from three medical practices in the United States with children born between November 2005 and June 2015, vaccinated children were compared to unvaccinated children during the first year of life for later incidence of developmental delays, asthma, ear infections and gastrointestinal disorders. All diagnoses utilized International Classification of Diseases–9 and International Classification of Diseases–10 codes through medical chart review. Subjects were a minimum of 3 years of age, stratified based on medical practice, year of birth and gender and compared using a logistic regression model. Results Vaccination before 1 year of age was associated with increased odds of developmental delays (OR = 2.18, 95% CI 1.47–3.24), asthma (OR = 4.49, 95% CI 2.04–9.88) and ear infections (OR = 2.13, 95% CI 1.63–2.78). In a quartile analysis, subjects were grouped by number of vaccine doses received in the first year of life. Higher odds ratios were observed in Quartiles 3 and 4 (where more vaccine doses were received) for all four health conditions considered, as compared to Quartile 1. In a temporal analysis, developmental delays showed a linear increase as the age cut-offs increased from 6 to 12 to 18 to 24 months of age (ORs = 1.95, 2.18, 2.92 and 3.51, respectively). Slightly higher ORs were also observed for all four health conditions when time permitted for a diagnosis was extended from ⩾ 3 years of age to ⩾ 5 years of age. Conclusion In this study, which only allowed for the calculation of unadjusted observational associations, higher ORs were observed within the vaccinated versus unvaccinated group for developmental delays, asthma and ear infections. Further study is necessary to understand the full spectrum of health effects associated with childhood vaccination.
Article
Full-text available
Objective To assess the fulfilment of authors’ and editors’ individual disclosure of potential conflicts of interest in a group of highly influential medicine journals across a variety of specialties. Design Cross-sectional analysis. Setting and participants Top-ranked five journals as per 2017 Journal Citation Report impact factor of 26 medical, surgery and imaging specialties. Interventions Observational analysis. Primary and secondary outcome measures Percentage of journals requiring disclosure of authors’ and editors’ individual potential conflicts of interest (CoI). Journals that were listed as followers of the International Committee of Medical Journal Editors (ICMJE) Recommendations, members of the Committee on Publication Ethics (COPE) and linked to a third party (ie, college, professional association/society, public institution). Results Although 99% (129/130) of journals required author’s CoI disclosure, only 12% (16/130) reported individual editors’ potential CoIs. Forty−five per cent (58/130) of journals were followers of the ICMJE Recommendations, and 73% (95/130) were COPE members. Most (69%; 90/130) were linked to a college, professional society/association or public institution. Only one journal did not have policies on individual authors’ and editors’ CoI disclosure. Conclusion Very few high-impact medical journals disclosed their editorial teams’ individual potential CoIs—conversely, almost all required disclosure of authors’ individual CoIs. Journal followers of the ICMJE Recommendations should regularly disclose the editors’ individual CoIs, as this is the only legitimate way to ask the same transparency of authors.
Article
Full-text available
Background Whole-cell diphtheria–tetanus–pertussis (DTP) and oral polio vaccine (OPV) were introduced to children in Guinea-Bissau in 1981. We previously reported that DTP in the target age group from 3 to 5 months of age was associated with higher overall mortality. DTP and OPV were also given to older children and in this study we tested the effect on mortality in children aged 6–35 months. Methods In the 1980s, the suburb Bandim in the capital of Guinea-Bissau was followed with demographic surveillance and tri-monthly weighing sessions for children under 3 years of age. From June 1981, routine vaccinations were offered at the weighing sessions. We calculated mortality hazard ratio (HR) for DTP-vaccinated and DTP-unvaccinated children aged 6–35 months using Cox proportional hazard models. Including this study, the introduction of DTP vaccine and child mortality has been studied in three studies; we made a meta-estimate of these studies. Results At the first weighing session after the introduction of vaccines, 6–35-month-old children who received DTP vaccination had better weight-for-age z-scores (WAZ) than children who did not receive DTP; one unit increase in WAZ was associated with an odds ratio of 1.32 (95% CI = 1.13–1.55) for receiving DTP vaccination. Though lower mortality compared with not being DTP-vaccinated was, therefore, expected, DTP vaccination was associated with a non-significant trend in the opposite direction, the HR being 2.22 (0.82–6.04) adjusted for WAZ. In a sensitivity analysis, including all children weighed at least once before the vaccination program started, DTP (±OPV) as the most recent vaccination compared with live vaccines or no vaccine was associated with a HR of 1.89 (1.00–3.55). In the three studies of the introduction of DTP in rural and urban Guinea-Bissau, DTP-vaccinated children had an HR of 2.14 (1.42–3.23) compared to DTP-unvaccinated children; this effect was separately significant for girls [HR = 2.60 (1.57–4.32)], but not for boys [HR = 1.71 (0.99–2.93)] (test for interaction p = 0.27). Conclusion Although having better nutritional status and being protected against three infections, 6–35 months old DTP-vaccinated children tended to have higher mortality than DTP-unvaccinated children. All studies of the introduction of DTP have found increased overall mortality.
Article
Study objective: We aim to characterize the prevalence of financial conflicts of interest among emergency medicine journal editorial board members. Methods: We conducted a cross-sectional study of editorial board members of leading peer-reviewed emergency medicine journals. A list of highly cited emergency medicine journals was curated with Journal Citation Reports and Google Scholar Metrics. Financial conflicts of interest were obtained by curating the Centers for Medicare & Medicaid Services' Open Payments database for the most recently available data (2017). The outcomes of this study were prevalence of financial conflicts of interest and frequency of disclosure on each journal's Web site. Results: Editorial boards of the top 5 journals were analyzed. Of the 198 unique US-based physician-editors, 60 (30.3%) had a financial conflict of interest documented as general or research-based payments. The 52 editors with general payments had a median of 2 payments (interquartile range [IQR] 1 to 8.25), with a median of 202(IQR202 (IQR 69 to 7,386);themaximumgeneralpaymentwas7,386); the maximum general payment was 115,730 received from industry. For research payments, 26 editors (13.1%) had a median 4 payments (IQR 2 to 9), with a median of 47,095(IQR47,095 (IQR 5,328 to 126,025)andmaximumof126,025) and maximum of 3,590,000 received from industry. Seven editors in one of the emergency medicine journals included in this study publicly disclosed competing interests; dollar amounts were not reported. Conclusion: Nearly one third of US-based editors at leading emergency medicine journals had financial conflicts of interest, although only one journal publicly disclosed the presence of payments. Public disclosure of editorial board members' financial relationships with industry may allow for more transparency related to the content published in these journals.