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Runninghead:THYMEROSAL IN IMMUNIZATIONs
Thimerosal in Immunizations: Parents Perspectives, Scientific findings & Controversies.
Senior Thesis Project
Pavel Stupakov
Dominican University of California
3/15/2016
Spring
Dr. Luanne Linnard- Palmer
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THYMEROSAL IN IMMUNIZATIONS
Thimerosal in Immunizations: Parent's perspectives, Scientific Findings & Controversies
Authors: Pavel Stupakov
Abstract
Immunizations have been around for quite some time, and throughout recent history have
been scientifically proven to be effective and efficient in preventing contraction and spread of
communicable diseases. Vaccines are distributed across the globe and a lot of them require
preservatives to remain effective. Thimerosal, a mercury based preservative used in vaccines has
been found to have neurotoxic effects. Concerns have been expressed over possibilities of this
chemical causing autism and other chronic neurologic disabilities. The goal is to explore parent's
knowledge and perspectives of this chemical, research scientific findings that either support or
disprove this relationship and explore any controversies around the addition and administration
of this compound; thus, debunking the ultimate question of whether this chemical has any
continued health effects on children.
This paper will explore the negative impacts of Thimerosal exposure in the prenatal and
infancy stages on neurologic development as well as its links to autism spectrum and Attention
Deficit Hyperactivity Disorder in childhood which continues to be influential on whether
families immunize their kids.
The model/framework that will be used is the Health Belief Model. This paper will be
exploring parents perspectives on Thimerosal by incorporating the parent's perceived
susceptibility, severity, benefits, and barriers that they may believe or experience.
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Acknowledgements: A thank you to Dr. Palmer for the influence to stick with this very
interesting topic.
Table of content:
Abstract............................................................................................................................................2
Introduction......................................................................................................................................3
Problem Statement...........................................................................................................................5
Purpose Statement/Aim...................................................................................................................5
Literature Review............................................................................................................................5
Conclusion/Summary.....................................................................................................................13
Theoretical Framework..................................................................................................................13
Research Proposal..........................................................................................................................14
References......................................................................................................................................19
Introduction
Thymerosal, "an organic-mercury (Hg) based compound, used as a preservative in many
childhood vaccines," (Hooker, 2014) has been found to be harmful by a large number of studies
throughout the years. As stated by David A. Geier in the review of Thimerosal, (2007) It was
first developed in 1927 and was originally marketed as an antimicrobial agent. He stated that
some of its most important uses were for preserving vaccines and injectables such as the Rho(D)
immune globulin. Geier mentioned that evidence predated back to the 1930 which stated that this
product was "potentially hazardous" (Geier, 2007) to humans. Directed studies "were conducted
to specifically examine the effects of Thimerosal on human infants or children with reported
outcomes of death; acrodynia; poisoning; allergic reaction; malformations; auto-immune
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reaction; Well’s syndrome; developmental delay; and neurodevelopmental disorders, including
tics, speech delay, language delay, attention deficit disorder, and autism." (Hooker, 2014) In very
contrasting opinions, the United States Center for Disease Control and Prevention stated that
Thymerosal is a safe additive and that there are no relationship between Thimerosal-containing
vaccines and autism rates in children. (CDC, 2012) Geier stated that it wasn't until the 1980's that
Thymerosal was viewed as harmful and began to be recognized by the Food and Drug
Administration as toxic which caused restrictions of it in vaccines given to pregnant women and
infants; however, some forms of vaccines (multi-strain) still utilize Thymerosal as a preservative
until this day. With these alarming discrepancies in epidemiologists reporting's, it has become
increasingly important to delve into the realm of vaccinations and debunk the ultimate question
of whether this chemical has any continued health effects on children. The primary health effects
that will be discussed are on prenatal and infancy neurologic development, its links to Autism
Spectrum disorder and ADHD, because positive correlations of Thymerosal and these specific
disorders are being very influential on a portion of families decisions of immunizing their kids.
Three primary concepts will be utilized to explore Thimerosal and any negative impacts
it may or may not have. The first is to explore parents and families knowledge and perspectives
on vaccinations, as well as vaccinations that contain Thimerosal while incorporating the health
belief model into the research process and comprehension of these facts. The second is to
research scientific findings that either support or disprove the relationship of Thimerosal and
negative health effects; a number of studies will be utilized to look at positive and negative
correlations. Finally the third will be to explore controversies around the addition and
administration of this compound in order to answer the question previously stated of whether or
not this chemical has a continued effect on children and their development.
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Problem statement
The negative impact of Thimerosal exposure in the prenatal and infancy stages on
neurologic development and its links to autism spectrum and ADHD disorders in childhood
continues to be influential on whether families immunize their kids.
Purpose Statement or aim
Thimerosal, a mercury based preservative used in vaccines has been found to have
neurotoxic effects. Concerns have been expressed over possibilities of this chemical causing
autism and other chronic neurologic disabilities. The goal is to explore parent's knowledge and
perspectives of these chemical, research scientific findings that either support or disprove this
relationship and explore any controversies around the addition and administration of this
compound; thus, debunking the ultimate question of whether this chemical has any continued
health effects on children. Nurses have the responsibility to inform the population about current
research and trends of preventive care as well as protect their patient population from harm. It's
important for nurses to know the relationship between Thimerosal and negative health effects.
Literature review
Links to Health Effects
Prenatal and infancy neurologic development is highly affected by drugs that interact
with the mother prenatally and the infant while he or she is at their vital developmental stages. It
is well and widely known that the way a child develops in utero and during the first years of life
will set the tone for the rest of the child's neurologic and psychological expression. If these
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developmental stages are negatively impacted in any way, the child can develop Autism
Spectrum disorder as well as ADHD (Attention Deficit Hyperactivity Disorder) among many
other horrible conditions; in this case, the discussion and review will focus on the two. Autism
Spectrum Disorders are "a continuum of conditions that includes autism, Asperger's syndrome,
and other pervasive developmental disorders which are characterized by problems with social
interactions, communication, and stereotyped (repetitive or ritualistic) behaviors." (Marner,
2015) ADHD is a condition marked by inattention, hyperactivity, and impulsivity. (Marner,
2015) "It is primarily a disorder of self-regulation and executive function — skills that act as the
'brain manager' in everyday life," says Mark Bertin, M.D., a developmental behavioral
pediatrician and the author of The Family ADHD Solution. The mercury based compound
Thimerosal has been found to have adverse effects on psychomotor development index (PDI)
(Budzyn, 2012) of one and two year-olds due to neonatal exposure. "The overall deficit in the
PDI attributable to neonatal TCV (Thimerosal Containing Vaccines) exposure measured over the
course of the three-year follow-up was significantly higher in TCV group." (Budzyn, 2012)
"Although a measurable number of epidemiological studies have been conducted to clarify the
associations between mercury exposure during embryo or early infancy and later incidences of
autism spectrum disorders (ASD) or attention-deficit hyperactivity disorder (ADHD), the
conclusion still remains unclear." (Yoshimasu, 2014) The meta-analysis conducted by
Yoshimasu and associates stated that "There were no material associations between vaccination
Thimerosal exposures and autism or ADHD;" however, "mercury exposure caused by air
pollution was significantly associated" (Yoshimasu, 2012) with these two risks. The study also
stated that "Methylmercury exposure caused by maternal fish consumption was significantly
associated with an increased risk of offspring's ADHD. Thus; links between mercury compounds
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effecting ADHD and Autism diagnoses have been found yet not directly related to vaccines
containing Thymerosal.
Parents Knowledge/Perspectives
Until the beginning of this century, every tetanus-containing vaccine in the US (e.g., the
DTP, tetanus toxoid (TT), diphtheria–tetanus (DT), and diphtheria–tetanus–acellular-pertussis
(DTaP)), Haemophilus influenza type b (Hib), hepatitis B (HepB), and a polysaccharide
meningococcal meningitis A, C, Y, and W-135 vaccine contained Thimerosal, many at a
concentration of 0.01% Thimerosal. (Geier, 2015) The use of Thimerosal is widespread and in
order to understand the proportion of people that use them and the impact it may have
on children, we need to be able to explore parental and families knowledge and perspectives on
vaccinations as well as vaccinations which contain Thimerosal. In order to do that, the
incorporation of the Health Belief Model was utilized in order to view the perspectives related to
it as well as the parental health action that the model proposes. "The model suggests that
decision-makers make a mental calculus about whether the benefits of a promoted behavior
change outweigh its practical and psychological costs or obstacles. That is, individuals conduct
an internal assessment of the net benefits of changing their behavior, and decide whether or not
to act." (Green, 2014)
Through Emily Bronson's application of grounded theory, "a general decision-making
process was identified. Stages in this process included: awareness, assessing and choosing,
followed by either stasis or ongoing assessment." (Brunson, 2013, p. 5467) The biggest
variation that occurred was during the assessment/assessing stage which involved parents
examining vaccination-related issues to make subsequent decisions. (Bronson, 2013) Research
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began to suggest that there were 3 major assessment groups: acceptors, who rely primarily on
general social norms to make their vaccination decisions; reliers, who rely primarily on other
people for information and advice; and searchers, who seek for information on their own,
primarily from published sources. (Bronson, 2013) Results suggest that a one-size-fits-all
approaches to vaccination interventions are inappropriate. Instead, this research suggests that
interventions must be targeted to parents based on how they assess vaccination. In order to apply
the Health Belief Model, a distinguishing fact about the parental assessment group needs to be
made to apply them as acceptors, reliers, or searchers. From this study, it looks like 1/3 of the
parents studied used research as their basis for vaccinating their families and children thus only
1/3 would directly know about the effects of Thimerosal in these vaccinations on their children.
Scientific Evidence/Findings
A very important realm of Thimerosal exposure and its effects leads one to explore the
scientific findings among multiple studies of the research on Thimerosal and its addition to
vaccines. Is there supported scientific evidence to state that mercury based compounds in
vaccines are harmful to children or not? Many studies have been conducted over the years to sort
this mystery out. "Ethically and legally, the direct study of the effects of Thimerosal or ethyl-Hg
compound exposure on fetal/infant/childhood death in humans is proscribed;" (Geier,
2014) however, "on a theoretical basis, a number of previous researchers have investigated the
potential toxicokinetics of Hg exposure from Thimerosal in pregnant women" (Geier, 2014) in
hopes of useful findings. In an example: Goldman showed in his analysis of exposure to Hg from
Thimerosal during pregnancy (assuming 50% of the total dose would accumulate in the fetus)
that "administration of a single Thimerosal-preserved influenza vaccine (25 μg Hg per dose) in
comparison to the US EPA Hg safety limit would result in a fetus of average weight receiving a
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Hg dose that could be ≥ 125,000 times the EPA Hg safety limit if it was administered at
≤ 8 weeks of gestation and, by 42 weeks of gestation, result in a fetus of average weight
receiving a Hg dose 34 times the EPA Hg safety limit." (Goldman, 2013) Utilizing the
assumption that Goldman made previously, "50% of the total dose would accumulate in the
fetus, that administration of a single Thimerosal-containing influenza vaccine with 1 μg Hg per
dose in comparison to the US EPA Hg safety limit would result in a fetus of average weight
receiving a Hg dose ≥ 5000 times the EPA Hg safety limit if it was administered at ≤ 8 week
gestation and, by 42 week gestation, result in a fetus of average weight receiving a Hg dose 1.4
times the EPA Hg safety limit." (Goldman, 2013) In similar results to Goldman, Brown and
Austin evaluated fetal exposure to Hg from one Thimerosal-preserved influenza shot during
pregnancy (25 μg Hg per dose). (Geier, 2014) "Doses of Hg exposure from administration of a
single Thimerosal-preserved influenza vaccine during pregnancy resulted in a developing fetus
receiving a dose of Hg in excess of the US EPA Hg safety limit from between 1,000,000 times to
10,000 times that safety limit at 1 week of development to 7.6 times to 0.1 times that limit at
38 weeks of development" (Brown, 2012, p. 1618). What these results mean is that the fetus is
receiving much higher levels (even if these levels were eliminated by 99% by the placenta, these
levels would still be above the recommended amount of Thimerosal exposure which in turn will
cause negative effects on the fetus and the future-born child.
"Overall, both Brown and Austin and Goldman concluded their toxicokinetic studies by
suggesting that, given the magnitude in excess of the EPA Hg safety limits presented by
exposure to a dose of Thymerosal-preserved vaccine during pregnancy, it is biologically
plausible for such exposures to result in fetal/infant death and developmental disability." (Geier,
2014)
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In another much older example, Axton reported "two adults and four children were
injected (accidently) with abnormally large quantities of Thimerosal from inappropriately
prepared chloramphenicol-containing preparations. The children (aged between 6 weeks-old and
7 years-old) received between about 35 milligrams (mg) Hg per kilogram (kg) bodyweight and
162 mg Hg per kg bodyweight. All but one of them died within about 1 month (mortality
rate = 75%)." (Axton, 1972, p. 417) This example is rather old yet it still shows how extremely
fatal large doses of Thymerosal can be. In more recent studies, which compared a group of
infants at 6 months of age from communities with different fish-eating habits (rural communities
in comparison to urban infants) who were simultaneously exposed to methyl-Hg and ethyl-Hg
found that urban infants, who had the highest ethyl-Hg exposure from Thimerosal-containing
vaccines and relatively lower methyl-Hg in comparison to rural infants, also had the highest risk
of developmental delays (Dorea, 2012).
In another study, "among a cohort of infants with multiple exposures to neurotoxic
substances," (Geier, 2015, p. 216) "those showing the most severe neurodevelopmental delays in
psychomotor developmental index scores between 6 and 24 months of age were the ones with
exposure to higher levels of ethyl-Hg from Thimerosal-containing vaccines." (Marques, 2014, p.
135)
Finally another 2-phase study conducted by Geier in 2013 which examined the possible
"association between Hg exposure from Thimerosal in vaccines and the risk for an ASD
diagnosis in the US," (Geier, 2015, p. 218) came out with very conclusive results. In the first
phase of the study, "a hypothesis generating cohort study was conducted to examine the possible
relationship between exposure to Hg from a Thimerosal-containing DTaP vaccine in comparison
to Thimerosal-free DTaP vaccines and the risk of an ASD diagnosis in the VAERS database."
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(Geier, 2013) And the second phase, a "hypothesis testing case–control study in the accessible
Vaccine Safety Datalink (VSD) database was conducted to examine the relationship between Hg
exposure from Thimerosal-containing hepatitis B vaccines given during specific time periods in
the first six months of life among cases diagnosed with an ASD and controls without such
exposures." (Geier, 2013) The results of the first phase of the study revealed a significantly
increased risk ratio for the incidence of an ASD diagnosis following the receipt of Thimerosal-
containing DTaP vaccine compared to the receipt of Thimerosal-free DTaP vaccine. While the
Results of the second phase stated that cases diagnosed with an ASD were significantly more
likely to have received increased mercury from Thimerosal-containing hepatitis B vaccine doses
given within the first, second, and sixth month of life than controls. (Geier, 2013) All these
results are pretty substantial and show a correlation between Thimerosal and
negative developmental effects on children as well as negative effects on all other populations.
Controversies
Finally the exploration of controversies around the studies and administration of
Thimerasol are important to address in order to answer questions of whether this chemical has
continued effects on children and their development; and the following is one of the main
controversies to this day. A review article written by Hooker and associates in 2014 stated that
malfeasance and controversy in research existed in order to show that Thimerosal in vaccines is
safe: In 2010, the CDC published another epidemiology study on Thimerosal and autism.
(Hooker, 2014) This case-control study was conducted using the records from three managed
care organizations (MCOs) consisting of 256 children with an ASD diagnosis and 752 controls
that were matched by birth year, gender, and MCO to the children with an ASD diagnosis.
Exposure to Thimerosal in vaccines and immunoglobulin preparations was determined from
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electronic immunization registries, medical charts, and parent interviews. (Hooker, 2014) Study
stated that Prenatal Thimerosal exposure for the children within the study arose from the
Thimerosal-preserved inactivated-influenza vaccine given during pregnancy and the Rho
immunoglobulin administered to pregnant women to prevent Rh-factor incompatibility injury to
the developing child. (Price, 2010) Evidence from the background CDC report regarding the
Price study showed a significant risk of regressive autism due to prenatal Thimerosal exposure
levels, at exposure levels as low as 16 μg of Hg. However, the risk of regressive autism due to
prenatal Thimerosal exposure reported in that paper was 1.86 and yielded a value of 0.072 which
was deemed as insignificant based on the authors’ “cut-off” value of P." (Hooker, 2014)
However, hooker also stated that values between 0.05 and 0.10 are “marginally significant”
(Price, 2010) and should merit further study. In addition to this information, "upon further
analysis, it was found that the 2009 background report to the Price et al. study showed that the
prenatal Thimerosal exposure model was run in six different ways and that the most reliable
methods (those that factored out the postnatal Thimerosal exposure effects) found highly
statistically significant relative risks of up to 8.73 (P=0.009) for regressive ASD due to prenatal
Thimerosal exposures from Thimerosal-containing influenza vaccines and Rho immunoglobulin
products relative to no such prenatal Thimerosal exposures. Curiously, these more compelling
results were not reported in the paper. Withholding these data from the publication and, instead,
reporting a significantly lower value could appear to constitute scientific malfeasance on the part
of the authors of this study." (Hooker, 2014)
Summary/Conclusion:
In conclusion, Thimerosal, on multiple counts, ahs been found to be very dangerous on
the human body, especially on the development of neonates and infants. The effects of
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Thimerosal are described with the current scientific findings and the results veer toward the
direction that administration of this dangerous compound has negative health effects on children
in that it has been shown to evoke conditions along the Autism Spectrum and other related
conditions such as Attention Deficit Hyperactivity Disorder. Parents need to be taught about
these chemicals and need to be influenced to do reading for themselves so they can make
educated decisions about their families lives and well being. The goal is not to say that
vaccinations are to be avoided, but to inform the population that Thimerosal-free vaccinations
exist and that they are much safer for their children's development than ones that do contain this
dangerous compound.
Theoretical framework: Health belief model
The health belief model is the exact theoretical framework that is required for such
findings due to it showing and influencing how adults and families choose their healthcare and
preventive care options. As stated previously, "The model suggests that decision-makers make a
mental calculus about whether the benefits of a promoted behavior change outweigh its practical
and psychological costs or obstacles. That is, individuals conduct an internal assessment of the
net benefits of changing their behavior, and decide whether or not to act." (Green, 2014) "The
model identifies four aspects of this assessment: perceived susceptibility to ill-health (risk
perception), perceived severity of ill-health, perceived benefits of behavior change, and
perceived barriers to taking action. The concept of self-efficacy, or the perceived ability to
actually take a recommended action, was later recognized as an important component or factor."
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(green, 2014) This model is perfect for this topic and it helps understand the thought process
involved around ones health decisions.
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Methodss
Researchquestions/Hypothesis:
Is there a relationship between Thimerosal containing vaccines administered at infancy
(cumulative amount of exposure by 3 months of age) and neurologic developmental disorders in
children ages 6-10 years old?
Target population:
Children who are 6-10 years old at the time of the study.
Subjects:
Children who are 6-10 years old at time of study and mothers and fathers who have
extensive information on their children’s vaccination history. Will focus on the groups exposures
to Thymerosal that occur at the earliest stages of life: at birth, and up to the 3rd month of life. The
study may also include cumulative exposure at later ages to avoid limitations.
Sample size:
Sample size will be approximately N=3,000.
Sampling procedures:
The Thimerosal exposure groups will be of equal size and will al be asked to sign a
consent form notifying them of everything the study entails and the benefits of this study for the
population. The Children will be between 6 and 10 years old at the time of the study. The
participants will be randomly chosen for each exposure group which will be controlled by age.
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First group will be chosen at random with an N=1000 (approximately). This group will have an
exposure of <25 mg ethyl mercury from cumulative Thimerosal exposure by 3 months of age.
Second group will be chosen at random with an N=1000 (approximately). This group will have
an exposure of > 25 mg, but < 62.5 mg ethyl mercury (cumulative) by 3 months of age. And
finally the third group will be chosen at random with an N=1000 (approximately). This group
will have an exposure of >62.5 mg ethyl mercury (cumulative) by 3 months of age. Total
N=3000. Approximately half of each of these exposure groups would ideally be exposed to
Hepatitis Vaccines. Exclusions of participants would include any severe or chronic prenatal
disorders, specific congenital disorders, low birth weights of less than 2,000 grams or a
gestational age of less than 37 weeks.
Concepts/constructs:
The study will include psychological, psychosocial, and behavioral domains. These
domains will be primarily based on exposure to methylmercury in early stages of life. Domains
will include verbal abilities, spatial/visual capabilities, attention and functioning abilities, short
term memory, fine and gross motor tasks as well as task achievements. Diagnostic outcomes may
lead to ADHD, Language alterations, or speech deficits and Autism spectrum diagnoses.
Operational definition
Instrument: Neuropsychological testing will be performed on all participants in the
study, and results will be measured based on set standards for a normally developing child based
on age and the expected developmental level.
Reliability/Validity:
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Firstly, must have normative and reasonable standards of development for 6-10 year old
age group; preferably one that is used by psychologists and other health care professionals. The
neuropsychological test must have a clear track record of use and proven usefulness by
practicing MD’s such as psychologists, psychiatrists, developmental specialists as well as
educators. This instrument should be able to assess and diagnose susceptibility and exposure to
organic mercury as well as psychological disorders such as Autism spectrum, ADHD, and other
developmental alterations. Testing time must also be endurable by the participating children and
parents. (Have the tests be no more than 1-2 hours.)
Step by step procedures to collect data:
Proposed statistical analysis: The proposed outcome measures will consists of 2 parts.
First is results which are gathered after administering neuropsychological tests, and the second
part results are the confirmation of specific Neurodevelopmental disorders.
Results:
Part 1:
This part will identify children with indications of specific neurodevelopmental disorders.
Results will show comparison in the mean difference among exposure groups on
neuropsychological test results, as well as the results themselves. These tests would be very
sensitive for identifying children (participants) with possible neurodevelopmental disorders as
well as provide results of the specific disorder.
Part 2:
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This part will provide a confirmatory diagnosis of a specific neurodevelopmental
disorder. Confirmatory neuropsychological tests and interviews will be used to diagnose the
impairment that is found within the participant. The results will compare the 3 exposure groups
and show prevalence of the specific neuropsychological disorder. Highly specific result for
confirming true cases of specific Neurodevelopmental disorders and their links to the exposure
of Thimerosal would be available after performing neuropsychological tests and exploring the
amounts of cumulative exposure.
Discussion
Based on findings that Thimerosal exposure has continued negative health effects on the
development of children, this proposed research would put forward results that support the
hypothesis that Thimerosal exposure from infancy to 3 months of age has negative health
impacts on neurodevelopmental disorder exacerbation in children ages 6-10. Children were
divided into 3 random groups of N = 1000 and will be designated into groups of none/low of
cumulative exposure of Thimerosal (<25 mg) containing vaccines, medium cumulative exposure
of >25 mg but less than 62.5 mg of Thimerosal containing vaccines, and finally a third group of
High exposure of Thimerosal containing vaccines of more than 62.5 mg of cumulative
Thimerosal exposure. Results will be based on a 2 part process: 1st part results will be based on
the administration and interpretation of standardized set of neuropsychological tests, and the 2nd
part’s results will be based on the evaluation and confirmation of specific neurodevelopmental
disorders found within the groups of participants.
Limitations:
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Some limitations of this study include specificity of the neuropsychological tests that will
be performed. Another limitation is based on the age range that Is being studied as well as the
narrow range of infancy (birth to 3 months) that is being studied. Involvement of other
substances was not taken into account by this study, including alcohol, drugs (licit and elicit),
and tobacco use. Another limitation is that exposure to other neurotoxins such as arsenic or
pesticides are not being measured.
Implications for Nursing Practice:
Nurses have the responsibility to inform the population about current research and trends
of preventive care as well as protect their patient population from harm. It's important for nurses
to know the relationship between Thimerosal and negative health effects. By conducting such a
study, nurses will have direct access to evidenced based research that will help them spread
information about potentially dangerous compounds that our children and the rest of the
population are exposed to. Providing teaching is a primary prevention and with this evidence
based study, we would provide nurses with the tools necessary to provide this front- line illness
prevention.
Suggestions for further research
Further research on this topic would be beneficial to the public if it focused on other age
ranges of children, as well as health impacts of Thimerosal on adolescent neurodevelopment.
Including other potentially harmful substances as well as keeping in mind and implementing
other at-risk populations into the “participants/subjects” group of the study (such as participant’s
parents with prenatal complications) would yield more results and would help either support or
disprove whether Thimerosal containing vaccines have negative health effects on the population.
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The Study Design written and made by Paul A. Stehr-Green (2000), helped the
formulation of these similar methods of the study. Variables were changes and the study
population of children as well as the break-down of sample size and groups studied (participants)
were changed. Source listed in the reference section of paper.
References:
David A. Geier, Lisa K. Sykes, Mark R. Geier (2007) A review of Thimerosal (Merthiolate) and
its Ethylmercury breakdown product: Specific Historical Considerations Regarding
Safety and Effectiveness, Journal of Toxicology and Environmental Health, Part B
10:575-596.
Brian Hooker, Janet Kern,, David Geier, Boyd Haley, Lisa Sykes, Paul King, and Mark Geier
(2014) Methodological Issues and Evidence of Malfeasance in Research Purporting to
Show Thimerosal in Vaccines Is Safe, BioMed Research International, Vol. 2014:8.
CDC Website, Centers for Disease Control and Prevention, Vaccine Safety
http://www.cdc.gov/
Kay, Marmer. (2015) Is it ADHD or Autism? Or Both?, ADDitude Magazine, article 10236.
Mrozek-Budzyn, Majewska R, Kieltuka A, Augustyniak M. (2012) Neonatal Exposure to
Thimerisal from vaccines and child development in the first 3 years of life. Neurotocivol
Teratol, 34(6):592-7. doi: 10.1016/j.ntt.2012.10.001
Edward C. Green, Elaine Murphy. (2014) Health Belief Model Study, The Wiley Blackwell
Encyclopedia of Health, Illness, Behavio,r and Society. D
OI: 10.1002/9781118410868.wbehibs410
Emily K. Brunson (2013) Study on: How Parents Make Decisions About Their Children's
Vaccinations. Vaccine, Vol. 31 Issue 4.6 p.5466-5470.
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G. Goldman, (2013) Comparison of VAERS fetal-loss reports during three consecutive influenza
seasons: was there a synergistic fetal toxicity associated with the two-vaccine ,Hum Exp
Toxicol, 32, pp. 464–475
I.A. Brown, D.W. Austin, (2012) Maternal transfer of mercury to the developing embryo/fetus:
is there a safe level? Toxicol Environ Chem, 94 , pp. 1610–1627
David A. Geiera, , Paul G. Kingb, , Brian S. Hookerc, , José G. Dóread, , Janet K. Kerna, , , Lisa K.
Sykesb, , Mark R. Geier, (2015) Thimerosal: Clinical, epidemiologic and biochemical
studies, Clinica Chimica Acta. Vol. 444 p. 212-220. doi:10.1016/j.cca.2015.02.030
J.H. Axton, (1972) Six cases of poisoning after parenteral organic mercurial compound
(Merthiolate), Postgrad Med J, 48 , pp. 417–421
C. Price, A. Robertson, and B. Goodson, (2009) Thimerosal and Autism, ABT Associates. No
specified pages.
C. S. Price, W. W. Thompson, B. Goodson et al., (2010) “Prenatal and infant exposure to
thymerosal from vaccines and immunoglobulins and risk of autism,” Pediatrics, vol.
126, no. 4, pp. 656–664
J.G. Dorea, R.C. Marques, C. Isejima, (2012) Neurodevelopment of Amazonia infants: antenatal
and postnatal exposure to methyl- and ethylmercury, J Biomed Biotechnol, 2012, p.
132876
R.C. Marques, J.V. Bernard, J.G. Dorea, R. de Fatima, M. Moreira, O. Malm, (2014) Perinatal
multiple exposure to neurotoxic (lead, methylmercury, ethylmercury, and aluminum)
substances and neurodevelopment at six and 24 months of age, Environ Pollut, 187, pp.
130–135
D.A. Geier, B.S. Hooker, J.K. Kern, P.G. King, L.K. Sykes, M.R. Geier, (2013) A two-phase
study evaluating the relationship between Thimerosal-containing vaccine administration
and the risk for an autism spectrum disorder in the United States, Transl Neurodegener, 2
(1), p. 25
21
THYMEROSAL IN IMMUNIZATIONS
Paul A. Stehr-Green (2000), Conceptual Framework for Follow-up Study of Thimerosal
containing Vaccines and Neurologic Developmental Disorders.
http://www.nationalacademies.org/hmd/~/media/2A500D4003334207A5AFCAC94AA1
F4F7.ashx (Research proposal source)

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Senior Thesis 2016 By Pavel Stupakov-FINAL

  • 1. 1 Runninghead:THYMEROSAL IN IMMUNIZATIONs Thimerosal in Immunizations: Parents Perspectives, Scientific findings & Controversies. Senior Thesis Project Pavel Stupakov Dominican University of California 3/15/2016 Spring Dr. Luanne Linnard- Palmer
  • 2. 2 THYMEROSAL IN IMMUNIZATIONS Thimerosal in Immunizations: Parent's perspectives, Scientific Findings & Controversies Authors: Pavel Stupakov Abstract Immunizations have been around for quite some time, and throughout recent history have been scientifically proven to be effective and efficient in preventing contraction and spread of communicable diseases. Vaccines are distributed across the globe and a lot of them require preservatives to remain effective. Thimerosal, a mercury based preservative used in vaccines has been found to have neurotoxic effects. Concerns have been expressed over possibilities of this chemical causing autism and other chronic neurologic disabilities. The goal is to explore parent's knowledge and perspectives of this chemical, research scientific findings that either support or disprove this relationship and explore any controversies around the addition and administration of this compound; thus, debunking the ultimate question of whether this chemical has any continued health effects on children. This paper will explore the negative impacts of Thimerosal exposure in the prenatal and infancy stages on neurologic development as well as its links to autism spectrum and Attention Deficit Hyperactivity Disorder in childhood which continues to be influential on whether families immunize their kids. The model/framework that will be used is the Health Belief Model. This paper will be exploring parents perspectives on Thimerosal by incorporating the parent's perceived susceptibility, severity, benefits, and barriers that they may believe or experience.
  • 3. 3 THYMEROSAL IN IMMUNIZATIONS Acknowledgements: A thank you to Dr. Palmer for the influence to stick with this very interesting topic. Table of content: Abstract............................................................................................................................................2 Introduction......................................................................................................................................3 Problem Statement...........................................................................................................................5 Purpose Statement/Aim...................................................................................................................5 Literature Review............................................................................................................................5 Conclusion/Summary.....................................................................................................................13 Theoretical Framework..................................................................................................................13 Research Proposal..........................................................................................................................14 References......................................................................................................................................19 Introduction Thymerosal, "an organic-mercury (Hg) based compound, used as a preservative in many childhood vaccines," (Hooker, 2014) has been found to be harmful by a large number of studies throughout the years. As stated by David A. Geier in the review of Thimerosal, (2007) It was first developed in 1927 and was originally marketed as an antimicrobial agent. He stated that some of its most important uses were for preserving vaccines and injectables such as the Rho(D) immune globulin. Geier mentioned that evidence predated back to the 1930 which stated that this product was "potentially hazardous" (Geier, 2007) to humans. Directed studies "were conducted to specifically examine the effects of Thimerosal on human infants or children with reported outcomes of death; acrodynia; poisoning; allergic reaction; malformations; auto-immune
  • 4. 4 THYMEROSAL IN IMMUNIZATIONS reaction; Well’s syndrome; developmental delay; and neurodevelopmental disorders, including tics, speech delay, language delay, attention deficit disorder, and autism." (Hooker, 2014) In very contrasting opinions, the United States Center for Disease Control and Prevention stated that Thymerosal is a safe additive and that there are no relationship between Thimerosal-containing vaccines and autism rates in children. (CDC, 2012) Geier stated that it wasn't until the 1980's that Thymerosal was viewed as harmful and began to be recognized by the Food and Drug Administration as toxic which caused restrictions of it in vaccines given to pregnant women and infants; however, some forms of vaccines (multi-strain) still utilize Thymerosal as a preservative until this day. With these alarming discrepancies in epidemiologists reporting's, it has become increasingly important to delve into the realm of vaccinations and debunk the ultimate question of whether this chemical has any continued health effects on children. The primary health effects that will be discussed are on prenatal and infancy neurologic development, its links to Autism Spectrum disorder and ADHD, because positive correlations of Thymerosal and these specific disorders are being very influential on a portion of families decisions of immunizing their kids. Three primary concepts will be utilized to explore Thimerosal and any negative impacts it may or may not have. The first is to explore parents and families knowledge and perspectives on vaccinations, as well as vaccinations that contain Thimerosal while incorporating the health belief model into the research process and comprehension of these facts. The second is to research scientific findings that either support or disprove the relationship of Thimerosal and negative health effects; a number of studies will be utilized to look at positive and negative correlations. Finally the third will be to explore controversies around the addition and administration of this compound in order to answer the question previously stated of whether or not this chemical has a continued effect on children and their development.
  • 5. 5 THYMEROSAL IN IMMUNIZATIONS Problem statement The negative impact of Thimerosal exposure in the prenatal and infancy stages on neurologic development and its links to autism spectrum and ADHD disorders in childhood continues to be influential on whether families immunize their kids. Purpose Statement or aim Thimerosal, a mercury based preservative used in vaccines has been found to have neurotoxic effects. Concerns have been expressed over possibilities of this chemical causing autism and other chronic neurologic disabilities. The goal is to explore parent's knowledge and perspectives of these chemical, research scientific findings that either support or disprove this relationship and explore any controversies around the addition and administration of this compound; thus, debunking the ultimate question of whether this chemical has any continued health effects on children. Nurses have the responsibility to inform the population about current research and trends of preventive care as well as protect their patient population from harm. It's important for nurses to know the relationship between Thimerosal and negative health effects. Literature review Links to Health Effects Prenatal and infancy neurologic development is highly affected by drugs that interact with the mother prenatally and the infant while he or she is at their vital developmental stages. It is well and widely known that the way a child develops in utero and during the first years of life will set the tone for the rest of the child's neurologic and psychological expression. If these
  • 6. 6 THYMEROSAL IN IMMUNIZATIONS developmental stages are negatively impacted in any way, the child can develop Autism Spectrum disorder as well as ADHD (Attention Deficit Hyperactivity Disorder) among many other horrible conditions; in this case, the discussion and review will focus on the two. Autism Spectrum Disorders are "a continuum of conditions that includes autism, Asperger's syndrome, and other pervasive developmental disorders which are characterized by problems with social interactions, communication, and stereotyped (repetitive or ritualistic) behaviors." (Marner, 2015) ADHD is a condition marked by inattention, hyperactivity, and impulsivity. (Marner, 2015) "It is primarily a disorder of self-regulation and executive function — skills that act as the 'brain manager' in everyday life," says Mark Bertin, M.D., a developmental behavioral pediatrician and the author of The Family ADHD Solution. The mercury based compound Thimerosal has been found to have adverse effects on psychomotor development index (PDI) (Budzyn, 2012) of one and two year-olds due to neonatal exposure. "The overall deficit in the PDI attributable to neonatal TCV (Thimerosal Containing Vaccines) exposure measured over the course of the three-year follow-up was significantly higher in TCV group." (Budzyn, 2012) "Although a measurable number of epidemiological studies have been conducted to clarify the associations between mercury exposure during embryo or early infancy and later incidences of autism spectrum disorders (ASD) or attention-deficit hyperactivity disorder (ADHD), the conclusion still remains unclear." (Yoshimasu, 2014) The meta-analysis conducted by Yoshimasu and associates stated that "There were no material associations between vaccination Thimerosal exposures and autism or ADHD;" however, "mercury exposure caused by air pollution was significantly associated" (Yoshimasu, 2012) with these two risks. The study also stated that "Methylmercury exposure caused by maternal fish consumption was significantly associated with an increased risk of offspring's ADHD. Thus; links between mercury compounds
  • 7. 7 THYMEROSAL IN IMMUNIZATIONS effecting ADHD and Autism diagnoses have been found yet not directly related to vaccines containing Thymerosal. Parents Knowledge/Perspectives Until the beginning of this century, every tetanus-containing vaccine in the US (e.g., the DTP, tetanus toxoid (TT), diphtheria–tetanus (DT), and diphtheria–tetanus–acellular-pertussis (DTaP)), Haemophilus influenza type b (Hib), hepatitis B (HepB), and a polysaccharide meningococcal meningitis A, C, Y, and W-135 vaccine contained Thimerosal, many at a concentration of 0.01% Thimerosal. (Geier, 2015) The use of Thimerosal is widespread and in order to understand the proportion of people that use them and the impact it may have on children, we need to be able to explore parental and families knowledge and perspectives on vaccinations as well as vaccinations which contain Thimerosal. In order to do that, the incorporation of the Health Belief Model was utilized in order to view the perspectives related to it as well as the parental health action that the model proposes. "The model suggests that decision-makers make a mental calculus about whether the benefits of a promoted behavior change outweigh its practical and psychological costs or obstacles. That is, individuals conduct an internal assessment of the net benefits of changing their behavior, and decide whether or not to act." (Green, 2014) Through Emily Bronson's application of grounded theory, "a general decision-making process was identified. Stages in this process included: awareness, assessing and choosing, followed by either stasis or ongoing assessment." (Brunson, 2013, p. 5467) The biggest variation that occurred was during the assessment/assessing stage which involved parents examining vaccination-related issues to make subsequent decisions. (Bronson, 2013) Research
  • 8. 8 THYMEROSAL IN IMMUNIZATIONS began to suggest that there were 3 major assessment groups: acceptors, who rely primarily on general social norms to make their vaccination decisions; reliers, who rely primarily on other people for information and advice; and searchers, who seek for information on their own, primarily from published sources. (Bronson, 2013) Results suggest that a one-size-fits-all approaches to vaccination interventions are inappropriate. Instead, this research suggests that interventions must be targeted to parents based on how they assess vaccination. In order to apply the Health Belief Model, a distinguishing fact about the parental assessment group needs to be made to apply them as acceptors, reliers, or searchers. From this study, it looks like 1/3 of the parents studied used research as their basis for vaccinating their families and children thus only 1/3 would directly know about the effects of Thimerosal in these vaccinations on their children. Scientific Evidence/Findings A very important realm of Thimerosal exposure and its effects leads one to explore the scientific findings among multiple studies of the research on Thimerosal and its addition to vaccines. Is there supported scientific evidence to state that mercury based compounds in vaccines are harmful to children or not? Many studies have been conducted over the years to sort this mystery out. "Ethically and legally, the direct study of the effects of Thimerosal or ethyl-Hg compound exposure on fetal/infant/childhood death in humans is proscribed;" (Geier, 2014) however, "on a theoretical basis, a number of previous researchers have investigated the potential toxicokinetics of Hg exposure from Thimerosal in pregnant women" (Geier, 2014) in hopes of useful findings. In an example: Goldman showed in his analysis of exposure to Hg from Thimerosal during pregnancy (assuming 50% of the total dose would accumulate in the fetus) that "administration of a single Thimerosal-preserved influenza vaccine (25 μg Hg per dose) in comparison to the US EPA Hg safety limit would result in a fetus of average weight receiving a
  • 9. 9 THYMEROSAL IN IMMUNIZATIONS Hg dose that could be ≥ 125,000 times the EPA Hg safety limit if it was administered at ≤ 8 weeks of gestation and, by 42 weeks of gestation, result in a fetus of average weight receiving a Hg dose 34 times the EPA Hg safety limit." (Goldman, 2013) Utilizing the assumption that Goldman made previously, "50% of the total dose would accumulate in the fetus, that administration of a single Thimerosal-containing influenza vaccine with 1 μg Hg per dose in comparison to the US EPA Hg safety limit would result in a fetus of average weight receiving a Hg dose ≥ 5000 times the EPA Hg safety limit if it was administered at ≤ 8 week gestation and, by 42 week gestation, result in a fetus of average weight receiving a Hg dose 1.4 times the EPA Hg safety limit." (Goldman, 2013) In similar results to Goldman, Brown and Austin evaluated fetal exposure to Hg from one Thimerosal-preserved influenza shot during pregnancy (25 μg Hg per dose). (Geier, 2014) "Doses of Hg exposure from administration of a single Thimerosal-preserved influenza vaccine during pregnancy resulted in a developing fetus receiving a dose of Hg in excess of the US EPA Hg safety limit from between 1,000,000 times to 10,000 times that safety limit at 1 week of development to 7.6 times to 0.1 times that limit at 38 weeks of development" (Brown, 2012, p. 1618). What these results mean is that the fetus is receiving much higher levels (even if these levels were eliminated by 99% by the placenta, these levels would still be above the recommended amount of Thimerosal exposure which in turn will cause negative effects on the fetus and the future-born child. "Overall, both Brown and Austin and Goldman concluded their toxicokinetic studies by suggesting that, given the magnitude in excess of the EPA Hg safety limits presented by exposure to a dose of Thymerosal-preserved vaccine during pregnancy, it is biologically plausible for such exposures to result in fetal/infant death and developmental disability." (Geier, 2014)
  • 10. 10 THYMEROSAL IN IMMUNIZATIONS In another much older example, Axton reported "two adults and four children were injected (accidently) with abnormally large quantities of Thimerosal from inappropriately prepared chloramphenicol-containing preparations. The children (aged between 6 weeks-old and 7 years-old) received between about 35 milligrams (mg) Hg per kilogram (kg) bodyweight and 162 mg Hg per kg bodyweight. All but one of them died within about 1 month (mortality rate = 75%)." (Axton, 1972, p. 417) This example is rather old yet it still shows how extremely fatal large doses of Thymerosal can be. In more recent studies, which compared a group of infants at 6 months of age from communities with different fish-eating habits (rural communities in comparison to urban infants) who were simultaneously exposed to methyl-Hg and ethyl-Hg found that urban infants, who had the highest ethyl-Hg exposure from Thimerosal-containing vaccines and relatively lower methyl-Hg in comparison to rural infants, also had the highest risk of developmental delays (Dorea, 2012). In another study, "among a cohort of infants with multiple exposures to neurotoxic substances," (Geier, 2015, p. 216) "those showing the most severe neurodevelopmental delays in psychomotor developmental index scores between 6 and 24 months of age were the ones with exposure to higher levels of ethyl-Hg from Thimerosal-containing vaccines." (Marques, 2014, p. 135) Finally another 2-phase study conducted by Geier in 2013 which examined the possible "association between Hg exposure from Thimerosal in vaccines and the risk for an ASD diagnosis in the US," (Geier, 2015, p. 218) came out with very conclusive results. In the first phase of the study, "a hypothesis generating cohort study was conducted to examine the possible relationship between exposure to Hg from a Thimerosal-containing DTaP vaccine in comparison to Thimerosal-free DTaP vaccines and the risk of an ASD diagnosis in the VAERS database."
  • 11. 11 THYMEROSAL IN IMMUNIZATIONS (Geier, 2013) And the second phase, a "hypothesis testing case–control study in the accessible Vaccine Safety Datalink (VSD) database was conducted to examine the relationship between Hg exposure from Thimerosal-containing hepatitis B vaccines given during specific time periods in the first six months of life among cases diagnosed with an ASD and controls without such exposures." (Geier, 2013) The results of the first phase of the study revealed a significantly increased risk ratio for the incidence of an ASD diagnosis following the receipt of Thimerosal- containing DTaP vaccine compared to the receipt of Thimerosal-free DTaP vaccine. While the Results of the second phase stated that cases diagnosed with an ASD were significantly more likely to have received increased mercury from Thimerosal-containing hepatitis B vaccine doses given within the first, second, and sixth month of life than controls. (Geier, 2013) All these results are pretty substantial and show a correlation between Thimerosal and negative developmental effects on children as well as negative effects on all other populations. Controversies Finally the exploration of controversies around the studies and administration of Thimerasol are important to address in order to answer questions of whether this chemical has continued effects on children and their development; and the following is one of the main controversies to this day. A review article written by Hooker and associates in 2014 stated that malfeasance and controversy in research existed in order to show that Thimerosal in vaccines is safe: In 2010, the CDC published another epidemiology study on Thimerosal and autism. (Hooker, 2014) This case-control study was conducted using the records from three managed care organizations (MCOs) consisting of 256 children with an ASD diagnosis and 752 controls that were matched by birth year, gender, and MCO to the children with an ASD diagnosis. Exposure to Thimerosal in vaccines and immunoglobulin preparations was determined from
  • 12. 12 THYMEROSAL IN IMMUNIZATIONS electronic immunization registries, medical charts, and parent interviews. (Hooker, 2014) Study stated that Prenatal Thimerosal exposure for the children within the study arose from the Thimerosal-preserved inactivated-influenza vaccine given during pregnancy and the Rho immunoglobulin administered to pregnant women to prevent Rh-factor incompatibility injury to the developing child. (Price, 2010) Evidence from the background CDC report regarding the Price study showed a significant risk of regressive autism due to prenatal Thimerosal exposure levels, at exposure levels as low as 16 μg of Hg. However, the risk of regressive autism due to prenatal Thimerosal exposure reported in that paper was 1.86 and yielded a value of 0.072 which was deemed as insignificant based on the authors’ “cut-off” value of P." (Hooker, 2014) However, hooker also stated that values between 0.05 and 0.10 are “marginally significant” (Price, 2010) and should merit further study. In addition to this information, "upon further analysis, it was found that the 2009 background report to the Price et al. study showed that the prenatal Thimerosal exposure model was run in six different ways and that the most reliable methods (those that factored out the postnatal Thimerosal exposure effects) found highly statistically significant relative risks of up to 8.73 (P=0.009) for regressive ASD due to prenatal Thimerosal exposures from Thimerosal-containing influenza vaccines and Rho immunoglobulin products relative to no such prenatal Thimerosal exposures. Curiously, these more compelling results were not reported in the paper. Withholding these data from the publication and, instead, reporting a significantly lower value could appear to constitute scientific malfeasance on the part of the authors of this study." (Hooker, 2014) Summary/Conclusion: In conclusion, Thimerosal, on multiple counts, ahs been found to be very dangerous on the human body, especially on the development of neonates and infants. The effects of
  • 13. 13 THYMEROSAL IN IMMUNIZATIONS Thimerosal are described with the current scientific findings and the results veer toward the direction that administration of this dangerous compound has negative health effects on children in that it has been shown to evoke conditions along the Autism Spectrum and other related conditions such as Attention Deficit Hyperactivity Disorder. Parents need to be taught about these chemicals and need to be influenced to do reading for themselves so they can make educated decisions about their families lives and well being. The goal is not to say that vaccinations are to be avoided, but to inform the population that Thimerosal-free vaccinations exist and that they are much safer for their children's development than ones that do contain this dangerous compound. Theoretical framework: Health belief model The health belief model is the exact theoretical framework that is required for such findings due to it showing and influencing how adults and families choose their healthcare and preventive care options. As stated previously, "The model suggests that decision-makers make a mental calculus about whether the benefits of a promoted behavior change outweigh its practical and psychological costs or obstacles. That is, individuals conduct an internal assessment of the net benefits of changing their behavior, and decide whether or not to act." (Green, 2014) "The model identifies four aspects of this assessment: perceived susceptibility to ill-health (risk perception), perceived severity of ill-health, perceived benefits of behavior change, and perceived barriers to taking action. The concept of self-efficacy, or the perceived ability to actually take a recommended action, was later recognized as an important component or factor."
  • 14. 14 THYMEROSAL IN IMMUNIZATIONS (green, 2014) This model is perfect for this topic and it helps understand the thought process involved around ones health decisions. --------------------------------------------------------------------------------------------------------------------- Methodss Researchquestions/Hypothesis: Is there a relationship between Thimerosal containing vaccines administered at infancy (cumulative amount of exposure by 3 months of age) and neurologic developmental disorders in children ages 6-10 years old? Target population: Children who are 6-10 years old at the time of the study. Subjects: Children who are 6-10 years old at time of study and mothers and fathers who have extensive information on their children’s vaccination history. Will focus on the groups exposures to Thymerosal that occur at the earliest stages of life: at birth, and up to the 3rd month of life. The study may also include cumulative exposure at later ages to avoid limitations. Sample size: Sample size will be approximately N=3,000. Sampling procedures: The Thimerosal exposure groups will be of equal size and will al be asked to sign a consent form notifying them of everything the study entails and the benefits of this study for the population. The Children will be between 6 and 10 years old at the time of the study. The participants will be randomly chosen for each exposure group which will be controlled by age.
  • 15. 15 THYMEROSAL IN IMMUNIZATIONS First group will be chosen at random with an N=1000 (approximately). This group will have an exposure of <25 mg ethyl mercury from cumulative Thimerosal exposure by 3 months of age. Second group will be chosen at random with an N=1000 (approximately). This group will have an exposure of > 25 mg, but < 62.5 mg ethyl mercury (cumulative) by 3 months of age. And finally the third group will be chosen at random with an N=1000 (approximately). This group will have an exposure of >62.5 mg ethyl mercury (cumulative) by 3 months of age. Total N=3000. Approximately half of each of these exposure groups would ideally be exposed to Hepatitis Vaccines. Exclusions of participants would include any severe or chronic prenatal disorders, specific congenital disorders, low birth weights of less than 2,000 grams or a gestational age of less than 37 weeks. Concepts/constructs: The study will include psychological, psychosocial, and behavioral domains. These domains will be primarily based on exposure to methylmercury in early stages of life. Domains will include verbal abilities, spatial/visual capabilities, attention and functioning abilities, short term memory, fine and gross motor tasks as well as task achievements. Diagnostic outcomes may lead to ADHD, Language alterations, or speech deficits and Autism spectrum diagnoses. Operational definition Instrument: Neuropsychological testing will be performed on all participants in the study, and results will be measured based on set standards for a normally developing child based on age and the expected developmental level. Reliability/Validity:
  • 16. 16 THYMEROSAL IN IMMUNIZATIONS Firstly, must have normative and reasonable standards of development for 6-10 year old age group; preferably one that is used by psychologists and other health care professionals. The neuropsychological test must have a clear track record of use and proven usefulness by practicing MD’s such as psychologists, psychiatrists, developmental specialists as well as educators. This instrument should be able to assess and diagnose susceptibility and exposure to organic mercury as well as psychological disorders such as Autism spectrum, ADHD, and other developmental alterations. Testing time must also be endurable by the participating children and parents. (Have the tests be no more than 1-2 hours.) Step by step procedures to collect data: Proposed statistical analysis: The proposed outcome measures will consists of 2 parts. First is results which are gathered after administering neuropsychological tests, and the second part results are the confirmation of specific Neurodevelopmental disorders. Results: Part 1: This part will identify children with indications of specific neurodevelopmental disorders. Results will show comparison in the mean difference among exposure groups on neuropsychological test results, as well as the results themselves. These tests would be very sensitive for identifying children (participants) with possible neurodevelopmental disorders as well as provide results of the specific disorder. Part 2:
  • 17. 17 THYMEROSAL IN IMMUNIZATIONS This part will provide a confirmatory diagnosis of a specific neurodevelopmental disorder. Confirmatory neuropsychological tests and interviews will be used to diagnose the impairment that is found within the participant. The results will compare the 3 exposure groups and show prevalence of the specific neuropsychological disorder. Highly specific result for confirming true cases of specific Neurodevelopmental disorders and their links to the exposure of Thimerosal would be available after performing neuropsychological tests and exploring the amounts of cumulative exposure. Discussion Based on findings that Thimerosal exposure has continued negative health effects on the development of children, this proposed research would put forward results that support the hypothesis that Thimerosal exposure from infancy to 3 months of age has negative health impacts on neurodevelopmental disorder exacerbation in children ages 6-10. Children were divided into 3 random groups of N = 1000 and will be designated into groups of none/low of cumulative exposure of Thimerosal (<25 mg) containing vaccines, medium cumulative exposure of >25 mg but less than 62.5 mg of Thimerosal containing vaccines, and finally a third group of High exposure of Thimerosal containing vaccines of more than 62.5 mg of cumulative Thimerosal exposure. Results will be based on a 2 part process: 1st part results will be based on the administration and interpretation of standardized set of neuropsychological tests, and the 2nd part’s results will be based on the evaluation and confirmation of specific neurodevelopmental disorders found within the groups of participants. Limitations:
  • 18. 18 THYMEROSAL IN IMMUNIZATIONS Some limitations of this study include specificity of the neuropsychological tests that will be performed. Another limitation is based on the age range that Is being studied as well as the narrow range of infancy (birth to 3 months) that is being studied. Involvement of other substances was not taken into account by this study, including alcohol, drugs (licit and elicit), and tobacco use. Another limitation is that exposure to other neurotoxins such as arsenic or pesticides are not being measured. Implications for Nursing Practice: Nurses have the responsibility to inform the population about current research and trends of preventive care as well as protect their patient population from harm. It's important for nurses to know the relationship between Thimerosal and negative health effects. By conducting such a study, nurses will have direct access to evidenced based research that will help them spread information about potentially dangerous compounds that our children and the rest of the population are exposed to. Providing teaching is a primary prevention and with this evidence based study, we would provide nurses with the tools necessary to provide this front- line illness prevention. Suggestions for further research Further research on this topic would be beneficial to the public if it focused on other age ranges of children, as well as health impacts of Thimerosal on adolescent neurodevelopment. Including other potentially harmful substances as well as keeping in mind and implementing other at-risk populations into the “participants/subjects” group of the study (such as participant’s parents with prenatal complications) would yield more results and would help either support or disprove whether Thimerosal containing vaccines have negative health effects on the population.
  • 19. 19 THYMEROSAL IN IMMUNIZATIONS The Study Design written and made by Paul A. Stehr-Green (2000), helped the formulation of these similar methods of the study. Variables were changes and the study population of children as well as the break-down of sample size and groups studied (participants) were changed. Source listed in the reference section of paper. References: David A. Geier, Lisa K. Sykes, Mark R. Geier (2007) A review of Thimerosal (Merthiolate) and its Ethylmercury breakdown product: Specific Historical Considerations Regarding Safety and Effectiveness, Journal of Toxicology and Environmental Health, Part B 10:575-596. Brian Hooker, Janet Kern,, David Geier, Boyd Haley, Lisa Sykes, Paul King, and Mark Geier (2014) Methodological Issues and Evidence of Malfeasance in Research Purporting to Show Thimerosal in Vaccines Is Safe, BioMed Research International, Vol. 2014:8. CDC Website, Centers for Disease Control and Prevention, Vaccine Safety http://www.cdc.gov/ Kay, Marmer. (2015) Is it ADHD or Autism? Or Both?, ADDitude Magazine, article 10236. Mrozek-Budzyn, Majewska R, Kieltuka A, Augustyniak M. (2012) Neonatal Exposure to Thimerisal from vaccines and child development in the first 3 years of life. Neurotocivol Teratol, 34(6):592-7. doi: 10.1016/j.ntt.2012.10.001 Edward C. Green, Elaine Murphy. (2014) Health Belief Model Study, The Wiley Blackwell Encyclopedia of Health, Illness, Behavio,r and Society. D OI: 10.1002/9781118410868.wbehibs410 Emily K. Brunson (2013) Study on: How Parents Make Decisions About Their Children's Vaccinations. Vaccine, Vol. 31 Issue 4.6 p.5466-5470.
  • 20. 20 THYMEROSAL IN IMMUNIZATIONS G. Goldman, (2013) Comparison of VAERS fetal-loss reports during three consecutive influenza seasons: was there a synergistic fetal toxicity associated with the two-vaccine ,Hum Exp Toxicol, 32, pp. 464–475 I.A. Brown, D.W. Austin, (2012) Maternal transfer of mercury to the developing embryo/fetus: is there a safe level? Toxicol Environ Chem, 94 , pp. 1610–1627 David A. Geiera, , Paul G. Kingb, , Brian S. Hookerc, , José G. Dóread, , Janet K. Kerna, , , Lisa K. Sykesb, , Mark R. Geier, (2015) Thimerosal: Clinical, epidemiologic and biochemical studies, Clinica Chimica Acta. Vol. 444 p. 212-220. doi:10.1016/j.cca.2015.02.030 J.H. Axton, (1972) Six cases of poisoning after parenteral organic mercurial compound (Merthiolate), Postgrad Med J, 48 , pp. 417–421 C. Price, A. Robertson, and B. Goodson, (2009) Thimerosal and Autism, ABT Associates. No specified pages. C. S. Price, W. W. Thompson, B. Goodson et al., (2010) “Prenatal and infant exposure to thymerosal from vaccines and immunoglobulins and risk of autism,” Pediatrics, vol. 126, no. 4, pp. 656–664 J.G. Dorea, R.C. Marques, C. Isejima, (2012) Neurodevelopment of Amazonia infants: antenatal and postnatal exposure to methyl- and ethylmercury, J Biomed Biotechnol, 2012, p. 132876 R.C. Marques, J.V. Bernard, J.G. Dorea, R. de Fatima, M. Moreira, O. Malm, (2014) Perinatal multiple exposure to neurotoxic (lead, methylmercury, ethylmercury, and aluminum) substances and neurodevelopment at six and 24 months of age, Environ Pollut, 187, pp. 130–135 D.A. Geier, B.S. Hooker, J.K. Kern, P.G. King, L.K. Sykes, M.R. Geier, (2013) A two-phase study evaluating the relationship between Thimerosal-containing vaccine administration and the risk for an autism spectrum disorder in the United States, Transl Neurodegener, 2 (1), p. 25
  • 21. 21 THYMEROSAL IN IMMUNIZATIONS Paul A. Stehr-Green (2000), Conceptual Framework for Follow-up Study of Thimerosal containing Vaccines and Neurologic Developmental Disorders. http://www.nationalacademies.org/hmd/~/media/2A500D4003334207A5AFCAC94AA1 F4F7.ashx (Research proposal source)