do vaccines cause autism? a closer look · which vaccine is most closely linked with autism? a. mmr...

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Do Vaccines Cause Autism? A Closer Look

Jassin M. Jouria, MD

Dr. Jassin M. Jouria is a medical doctor, professor of academic medicine, and medical

author. He graduated from Ross University School of Medicine and has completed his clinical

clerkship training in various teaching hospitals throughout New York, including King’s

County Hospital Center and Brookdale Medical Center, among others. Dr. Jouria has passed

all USMLE medical board exams, and has served as a test prep tutor and instructor for

Kaplan. He has developed several medical courses and curricula for a variety of educational

institutions. Dr. Jouria has also served on multiple levels in the academic field including

faculty member and Department Chair. Dr. Jouria continues to serves as a Subject Matter

Expert for several continuing education organizations covering multiple basic medical

sciences. He has also developed several continuing medical education courses covering

various topics in clinical medicine. Recently, Dr. Jouria has been contracted by the

University of Miami/Jackson Memorial Hospital’s Department of Surgery to develop an e-

module training series for trauma patient management. Dr. Jouria is currently authoring an

academic textbook on Human Anatomy & Physiology.

Abstract

Parents today are facing a confusing array of information when it comes to

vaccines and autism. Vaccine supporters point out that children who are not

vaccinated are at risk for diseases that have been effectively eradicated in

the U.S., while those who believe in a link between vaccines and autism

spectrum disorders say that the only way to eliminate autism is by rejecting

vaccines. Frequently, parents turn to their medical professionals for

guidance on this topic, and this course will provide you with the information

you need to help your patients make sound, thoughtful, fact-based

decisions.


Continuing Nursing Education Course Planners

William A. Cook, PhD, Director, Douglas Lawrence, MA, Webmaster,

Susan DePasquale, MSN, FPMHNP-BC, Lead Nurse Planner

Policy Statement

This activity has been planned and implemented in accordance with the

policies of NurseCe4Less.com and the continuing nursing education

requirements of the American Nurses Credentialing Center's Commission on

Accreditation for registered nurses. It is the policy of NurseCe4Less.com to

ensure objectivity, transparency, and best practice in clinical education for

all continuing nursing education (CNE) activities.

Continuing Education Credit Designation

This educational activity is credited for 1.5 hours. Nurses may only claim

credit commensurate with the credit awarded for completion of this course

activity.

Statement of Learning Need

Health professionals need to be informed on how to best support public

awareness of Centers for Disease Control and Prevention and other health

organization research and reports focused on vaccine safety.

Course Purpose

To provide nursing professionals with knowledge on vaccine safety, risks and

benefits of having vaccines to prevent disease and of not being immunized.


Target Audience

Advanced Practice Registered Nurses and Registered Nurses

(Interdisciplinary Health Team Members, including Vocational Nurses and

Medical Assistants may obtain a Certificate of Completion)

Course Author & Planning Team Conflict of Interest Disclosures

Jassin M. Jouria, MD, William S. Cook, PhD, Douglas Lawrence, MA,

Susan DePasquale, MSN, FPMHNP-BC – all have no disclosures

Acknowledgement of Commercial Support

There is no commercial support for this course.

Activity Review Information

Reviewed by Susan DePasquale, MSN, FPMHNP-BC

Release Date: 1/1/2016 Termination Date: 3/29/2018

Please take time to complete a self-assessment of knowledge, on

page 4, sample questions before reading the article.

Opportunity to complete a self-assessment of knowledge learned

will be provided at the end of the course.


1. Autism typically appears at what age?

a. 9 – 12 months

b. 15 – 18 months

c. 2 – 4 years

d. 5 – 7 years

2. The incidence of autism in boys is:

a. 1 in 12

b. 1 in 24

c. 1 in 52

d. 1 in 112

3. Which of the following individuals was responsible for

developing the Lupron Protocol?

a. Andrew Wakefield

b. Ryan White

c. John Samuelson

d. Mark Geier

4. What is the percentage of mercury present in thimerosal?

a. 10%

b. 25%

c. 50%

d. 75%

5. Which vaccine is most closely linked with autism?

a. MMR

b. Hepatitis B

c. DTAP

d. Influenza


Introduction

In recent years, there has been a strong divide between those who believe

in the benefits of vaccinations and those who are convinced that vaccinations

cause autism. In the anti-vaccine community, there have been a number of

studies attempting to link thimerosal in vaccines to the development of

autism in a number of children. However, in the medical community, there

has been a number of studies that have shown no correlation between





vaccines. As a result, many parents are struggling to decide whether they

should vaccinate their children. Health care providers are often consulted on

this matter and must be able to provide appropriate information that will

help patients make sound, thoughtful, fact-based decisions.

Autism Spectrum Disorders

Autism Spectrum Disorder (ASD) is the term used to define an entire range

of complex neurological disorders that produce some similar behaviors and

symptoms.1 Previously, each disorder included within the umbrella of Autism

Spectrum Disorder, including autism, was identified and categorized

individually.2 However, with the most recent changes to the Diagnostic and

Statistical Manual of Mental Disorders (DSM), all individual disorders are now

classified as Autism Spectrum Disorder.

According to Autism Speaks, an Autism awareness and educational

organization,


“These disorders are characterized, in varying degrees, by difficulties

in social interaction, verbal and nonverbal communication and

repetitive behaviors. They include autistic disorder (sometimes

referred to as “classic autism”), Rett syndrome, childhood

disintegrative disorder, pervasive developmental disorder-not

otherwise specified (PDD-NOS) and Asperger syndrome. ASD can be

associated with intellectual disability, difficulties in motor coordination

and attention and physical health issues such as sleep and

gastrointestinal disturbances.”3

In previous versions of the DSM manual, individual autism spectrum

associated disorders, which includes autistic disorder (autism), Asperger’s

disorder, childhood disintegrative disorder, and pervasive developmental

disorder not otherwise specified, were listed and diagnosed separately.

However, rather than continue with the individual categories of diagnosis,

the DSM-5 has combined all disorders into the one broad, singular category

of Autism Spectrum Disorder.4

In the DSM-5, the new diagnosis of Autism Spectrum Disorder includes a

broad range of behaviors associated with the different disorders, such as

social communication, restricted interests, and repetitive behaviors.5 In

addition to including all of the disorders under one umbrella term, patients

are now evaluated on levels of severity, which are based on the amount of

support the individual needs.4 The use of one umbrella term and different

severity levels to diagnose a patient is expected to enable clinicians to better

diagnose a patient and to ensure consistency among different doctors.6


Autism

Autism, or autistic disorder, is one of the disorders included under the

general umbrella of Autism Spectrum Disorder. According to the National

Institute of Neurological Disorders, autism is a neurodevelopmental disorder

that is “characterized by social impairments, communication difficulties, and

restricted, repetitive, and stereotyped patterns of behavior. Autistic disorder,

sometimes called autism or classical ASD, is the most severe form of ASD.”7

Diagnosis Trends

Over the past seven years, the number of Autism diagnoses has increased

approximately 40 percent. Currently, 1 in 88 children is diagnosed with

autism spectrum disorder, with more incidences occurring in boys than

girls.2

Boys are currently diagnosed at a rate of 1 in 54, while girls are diagnosed

at a rate of 1 in 252.8 The increase in the diagnosis of autism spectrum

disorder is difficult to explain. Some consider it a result of increased

awareness about the disorder and the ability to diagnose individuals. Others

consider it to be a result in an increase in the number of individuals afflicted

with the disorder. However, the most common explanation is that the

increase in diagnosis is the result of a combination of both factors.9

While the exact cause of the increase in diagnosed cases of autism spectrum

disorder is difficult to identify, the Center for Disease Control has compiled a

list of the most common risks and diagnosis trends, which are listed below.10

Risk Factors and Characteristics

Studies have shown that among identical twins, if one child has an

ASD, then the other will be affected about 36-95% of the time. In non-


identical twins, if one child has an ASD, then the other is affected

about 0-31% of the time.

Parents who have a child with an ASD have a 2%–18% chance of

having a second child who is also affected.

ASDs tend to occur more often in people who have certain genetic or

chromosomal conditions. About 10% of children with autism are also

identified as having Down syndrome, fragile X syndrome, tuberous

sclerosis, and other genetic and chromosomal disorders.

The majority (62%) of children the ADDM Network identified as having

ASDs did not have intellectual disability (intelligence quotient <=70).

Children born to older parents are at a higher risk for ASDs.

A small percentage of children who are born prematurely or with low

birth weight are at greater risk for having ASDs.

ASD commonly co-occurs with other developmental, psychiatric,

neurologic, chromosomal, and genetic diagnoses. The co-occurrence of

one or more non-ASD developmental diagnoses is 83%. The co-

occurrence of one or more psychiatric diagnoses is 10%.

Diagnosis

Research has shown that a diagnosis of autism at age 2 can be

reliable, valid, and stable.

More children are being diagnosed at earlier ages—a growing number

(18%) of them by age 3. Still, most children are not diagnosed until

after they reach age 4. Diagnosis is a bit earlier for children with

autistic disorder (4 years) than for children with the more broadly

defined autism spectrum diagnoses (4 years, 5 months), and diagnosis

is much later for children with Asperger Disorder (6 years, 3 months).

Studies have shown that parents of children with ASDs notice a

developmental problem before their child's first birthday. Concerns


about vision and hearing were more often reported in the first year,

and differences in social, communication, and fine motor skills were

evident from 6 months of age.

Thimerosal

Thimerosal has been used as a preservative in vaccines since the 1930’s. It

is comprised primarily of mercury (49.6%) and it metabolizes into ethyl

mercury and thiosalicylate after injection.11 In vaccines, thimerosal is

present in concentrations of approximately .003% to .01%.12

Studies have shown that the presence of thimerosal at these levels is

effective in eliminating a number of pathogens, which helps prevent infection

during vaccination.13 The concentration levels of thimerosal, and

subsequently mercury, are at levels that are considered safe and effective

and that have been shown to have no adverse effects on patients. In fact, in

the eighty-three years that thimerosal has been used as a preservative in

vaccinations, there has been no evidence of ill effects or complications

caused by the preservative.13

In addition to vaccines, thimerosal is also used in other products to prevent

infection. Thimerosal is most commonly used in the following products:14

immune globulin preparations

antivenins

skin test antigens

ophthalmic products

nasal products


In recent years, there has been rising concern regarding the neurotoxicity of

thimerosal and its connection to autism. Therefore, even though thimerosal

has been deemed safe and effective, the FDA is working to eliminate the

preservative from all vaccines.15 Currently, all vaccines that are intended for

children six years of age and younger are thimerosal free or contain only

trace amounts of the preservative. However, all versions of the influenza

vaccine contain thimerosal.16

Thimerosal Content of Vaccines Routinely Recommended for Children 6 Years of

Age and Younger

Vaccine Trade name

(Manufacturer)

Thimerosal

Status

Concentration** (Mercury)

Approval Date for

Thimerosal Free or

Thimerosal / Preservative

Free (Trace Thimerosal)***

Formulation

DTaP

Infanrix

(GlaxoSmithKline Biologicals)

Free

Never contained more than a

trace of thimerosal, approval

date for thimerosal-free formulation 9/29/2000

Daptacel

(Sanofi Pasteur, Ltd.)

Free Never contained Thimerosal

Tripedia

(Sanofi Pasteur, Inc.)

Trace(≤0.3 µg

Hg/0.5mL

dose)

03/07/01

DTaP-HepB-

IPV

Pediarix


Free

Never contained more than a

Trace of Thimerosal, approval

date for thimerosal-free formulation 1/29/2007

DTaP-IPV/Hib Pentacel (sanofi

pasteur Ltd.) Free

Approved June 20, 2008, never

contained thimerosal

DTaP-IPV

KINRIX (Glaxo

SmithKline Biologicals)

Free Approved October 8, 2009,

never contained thimerosal


Pneumococcal

conjugate

Prevnar

(Wyeth

Pharmaceuticals Inc.)


Prevnar 13

(Wyeth

Pharmaceuticals Inc.)

Free Approved February 24, 2010,


Inactivated

Poliovirus

IPOL

(Sanofi Pasteur, SA)


Varicella

(chicken pox)

Varivax

(Merck & Co, Inc.) Free Never contained Thimerosal

Mumps,

measles, and rubella

M-M-R-II

(Merck & Co, Inc.) Free Never contained Thimerosal

Mumps,

measles,

rubella and varicella

ProQuad (Merck &

Co., Inc.) Free

Approved September 6, 2005,

never contained thimerosal.

Hepatitis A

Havrix


Free Never contained thimerosal

Vaqta (Merck &

Co., Inc.) Free Never contained thimerosal

Hepatitis B

Recombivax HB

(Merck & Co, Inc.) Free 08/27/99

Engerix B


Free

03/28/00, approval date for

thimerosal-free formulation 1/30/2007

Haemophilus

influenzae

type b

conjugate (Hib)

ActHIB

(Sanofi Pasteur,

SA)

OmniHIB

(GlaxoSmithKline)


PedvaxHIB

(Merck & Co, Inc.) Free

Approval date for thimerosal

free formulation 08/99

HIBERIX


Free Approved August 19, 2009,



Hib/Hepatitis

B combination

Comvax

(Merck & Co, Inc.)


Seasonal

Trivalent

Influenza

Fluzone (multi-

dose

presentation)

(Sanofi Pasteur, Inc.)

0.01% (12.5

µg/0.25 mL

dose, 25 µg/0.5 mL dose)2

Fluzone (single-

dose

presentation)

(Sanofi Pasteur,

Inc.)3

Free 12/23/2004

Fluvirin (multi-

dose

presentation)

(Novartis Vaccines

and Diagnostics Ltd.)

0.01% (25

µg/0.5 mL dose)

Fluvirin (single

dose

presentation)

(Novartis Vaccines

and Diagnostics

Ltd.)

(Preservative

Free)

Trace (<1ug

Hg/0.5mL dose)

09/28/01

Fluarix (single-

dose

presentation)


Free Approved 10/19/09, never


Afluria (multi-dose

presentation)

(CSL Limited)

0.01% (24.5

µg/0.5 mL dose)

Afluria (single-

dose

presentation) (CSL Limited)

Free Approved 11/10/09, never


Seasonal

Influenza, live

FluMist

(MedImmune Vaccines, Inc.)



Rotavirus

RotaTeq (Merck

and Co., Inc.) Free

Approved February 3, 2006,


Rotarix

(GlaxoSmithKline

Biologicals)

Free Approved April 3, 2008, never


** Thimerosal is approximately 50% mercury (Hg) by weight. A 0.01% solution (1 part per

10,000) of thimerosal contains 50 µg of Hg per 1 mL dose or 25 µg of Hg per 0.5 mL dose.

*** The term "trace" has been taken in this context to mean 1 microgram of mercury per

dose or less. 1 HibTiITER was also manufactured in thimerosal-preservative containing multidose vials but

these were no longer available after 2002. 2 Children 6 months old to less than 3 years of age receive a half-dose of vaccine, i.e., 0.25

mL; children 3 years of age and older receive 0.5 mL. 3 A trace thimerosal containing formulation of Fluzone was approved on 9/14/02 and has been replaced with the formulation without thimerosal.16

Ethyl Mercury

Ethyl Mercury (etHg) is the metabolized by product of thimerosal and occurs

in a concentration of approximately 50% in the preservative.11 When an

individual is injected with a vaccine that contains thimerosal as a

preservative, he or she is exposed to mercury. In larger doses, mercury is

considered a dangerous substance, and it is recommended that individuals

avoid contact with it. However, in the amounts it is present in thimerosal

containing vaccines, the element is considered safe.13

Measles Mumps Rubella Vaccine

Many individuals, including some medical professionals, have attempted to

link the Measles, Mumps, Rubella (MMR) vaccine to autism. According to

these individuals, the thimerosal and mercury by-product in the MMR

vaccine are responsible for the onset of autism in a high percentage of

children.17 This connection is due to the fact that the MMR vaccine is given


between 12 – 15 months of age, and autism is often first identified and

diagnosed when a child is 15 – 18 months of age. However, most health

care professionals and research scientists argue that there is no association

between the two.18 A number of autism advocacy websites have published

information regarding the connection between the MMR vaccine and autism.

These are listed below.

Measles-Mumps-Rubella Vaccine Finally Linked to Autism in Multiple

Court Cases:

http://www.trueactivist.com/measles-mumps-rubella-vaccine-finally-

linked-to-autism-in-multiple-court-cases/.

Breaking: Courts discreetly confirm MMR vaccine causes autism:

http://www.naturalnews.com/041897_mmr_vaccines_autism_court_ru

ling.html.

To counter the anti-vaccine information, a number of medical websites have

created informational pages regarding the lack of connection between the

MMR vaccine and autism. These are listed below.

MMR Vaccine and Autism:

http://www2.aap.org/immunization/families/mmr.html

Autism Spectrum Disorders:

http://www.cdc.gov/ncbddd/autism/topics.html.

Andrew Wakefield Study

In 1998, Andrew Wakefield and his colleagues conducted a study involving a

number of children in England, in an attempt to determine if there was any

link between the MMR vaccine and autism. As a result of his study,

Wakefield published an article entitled “Ileal-lymphoid-nodular hyperplasia,

http://www.trueactivist.com/measles-mumps-rubella-vaccine-finally-linked-to-autism-in-multiple-court-cases/

http://www.trueactivist.com/measles-mumps-rubella-vaccine-finally-linked-to-autism-in-multiple-court-cases/

http://www.naturalnews.com/041897_mmr_vaccines_autism_court_ruling.html

http://www.naturalnews.com/041897_mmr_vaccines_autism_court_ruling.html

http://www2.aap.org/immunization/families/mmr.html

http://www.cdc.gov/ncbddd/autism/topics.html


non-specific colitis, and pervasive developmental disorder in children.” The

article appeared in the Lancet and it immediately caused a rise in the

number of anti-vaccine proponents.19 According to the article, MMR was

directly responsible for the onset of autism, as it caused a number of

common complications in patients, which include: 20

intestinal inflammation

loss of intestinal barrier function

entrance into the bloodstream of encephalopathic proteins

consequent development of autism

Twelve children in the study presented with neurodevelopmental delays, and

of those twelve, eight were diagnosed with autism.17 All of the eight children

developed gastrointestinal problems and received a diagnosis of autism

within one month of receiving the MMR vaccination.21

Wakefield’s study, and published article, immediately received criticism as

many medical professionals argued that the study was flawed. A primary

argument was that the connection between the MMR vaccine and the onset

of autism occurred because 90% of children in England had received an MMR

vaccine, including many who already had autism, but had not yet received a

diagnosis.17 A primary concern amongst critics was that the study failed to

assess the incidence of autism in vaccinated and unvaccinated children,

which would have made the connection more concrete.19 Critics also argued

that the sample size was too small to produce accurate and reliable results,

and that it lacked appropriate controls. The article was retracted in 2010 due

to its lack of reliability. In fact, by the time the article was retracted, it had

been determined that Wakefield’s research and subsequent findings were

fraudulent.19


Mark Geier Study

Over a number of years, Mark Geier was involved in studies that attempted

to link the combination of the mercury present in childhood vaccinations and

testosterone to the onset of autism. Geier also attempted to develop a

treatment protocol that reduced testosterone levels in children as a means

of reducing the symptoms of autism.22 Geier’s hypothesis was that mercury

and testosterone bind together in the human body in a way that causes the

development of autism.11 In an attempt to support his hypothesis, Geier

published the following articles:

A Case-Control Study of Mercury Burden in Children with Autistic

Spectrum Disorders

(http://www.vaccinationnews.org/sites/default/files/DailyNews/2003/September/07/

Bradstreet7.pdf)

An assessment of the impact of thimerosal on childhood

neurodevelopmental disorders:

(http://informahealthcare.com/doi/abs/10.1080/1363849031000139315)

Using his theory as a basis, Geier then developed the Lupron Protocol, which

was a treatment regimen that used drug leuprolide, followed immediately by

chelation, to reduce the levels of testosterone and mercury in the

individual’s body.23 Geier argued that this reduction would reduce, or

eliminate, autism in the patients he was treating.24 Leuprolide, or Lupron, is

used to treat early puberty, as well as for IVF treatment. When Geier began

his treatment protocol, he intentionally misdiagnosed autistic children with

early puberty so that he could use the medication without having to justify

using it “off label.”25 This allowed parents to use insurance to cover the

treatment.26

http://www.vaccinationnews.org/sites/default/files/DailyNews/2003/September/07/Bradstreet7.pdf

http://www.vaccinationnews.org/sites/default/files/DailyNews/2003/September/07/Bradstreet7.pdf

http://informahealthcare.com/doi/abs/10.1080/1363849031000139315


On July 17, 2012, a petition for disciplinary action was filed against Geier,

and a hearing was held on February 5, 2013. Dr. Geier did not appear for

the hearing, but the following key findings, which were taken from previous

suspension cases, were still delivered.28 According to the findings, Geier had

misdiagnosed autistic children with precocious puberty and other genetic

abnormalities and treated them with potent hormonal therapy ('Lupron

therapy') and chelation therapy, both of which had a substantial risk of

adverse side effects, thus exposing children to needless risk of harm. In

addition, he failed to conduct adequate physical examinations of patients in

several instances before starting Lupron therapy; and, he failed to obtain

adequate informed consent from the parents of autistic children he treated.

There were a myriad of other findings, all of which eventually led to all

twelve of Geier’s medical licenses being suspended or revoked.27

American Association of Pediatrics Response

When Geier published his original articles linking mercury and autism, he

received a great deal of criticism, especially from the medical community.

The American Association of Pediatrics immediately responded in an article

directly addressing the issue of thimerosal and autism. The following article

is the American Association of Pediatrics (AAP) response to Geier’s study:30

Study Fails to Show a Connection Between Thimerosal and Autism

The American Academy of Pediatrics provides the following information for clinicians who

may be aware of recent press surrounding an article that claims to show a correlation

between thimerosal and autism. This paper uses data from the Vaccine Adverse Event

Reporting System (VAERS) inappropriately and contains numerous conceptual and

scientific flaws, omissions of fact, inaccuracies, and misstatements.


The most important weakness of the article is the reliance on VAERS data to draw

conclusions about adverse event associations or causality. VAERS is a passive surveillance

system for reporting possible vaccine adverse events that depends on health care

professionals, patients, and others to file reports. Health effects reported to VAERS as

being associated with vaccines may represent true adverse events, coincidental

occurrences, or mistakes in filing.

Inherent limits of VAERS include incomplete reporting, lack of verification of diagnoses,

and lack of data on people who were immunized and did not report problems. Data from

VAERS are useful for hypothesis generation (raising questions) but should not be used for

research aimed at determining whether vaccines cause certain health problems

(hypothesis proving), as was done in the article by Geier and Geier. For example, VAERS

worked well to quickly alert investigators to the possibility of intussusception after

rotavirus immunization but could not prove the association. Proof required numerous

controlled studies to document the nature and frequency of this association.

The original concern regarding thimerosal in vaccines was sparked not by any trends

identified in the VAERS system after 70 years of experience with thimerosal use as a

vaccine preservative but by theoretic concerns about total exposures infants might

receive from all mercury sources in the environment, including vaccines. Research to date

involving refined, controlled studies in large populations of patients has failed to

demonstrate any association between vaccines that may have used thimerosal as a

preservative and neurodevelopmental disorders including autism. The authors failed to

acknowledge the inherent limitations of the VAERS database when drawing conclusions of

adverse event associations contained in this report and their other publications. They are

equally unclear as to how their data were generated, thus preventing accurate review of

their methods and replication of their outcomes.

Other flaws in the article include the following:

The law relating to VAERS reporting is misstated. Most VAERS-reported conditions

fall into a category in which voluntary and passive, not mandatory or required,

events after immunization are recorded. Only a specific set of more severe adverse

events are specified as mandatory under the Vaccine Injury Table, and even then,

reporting is inconsistent.


Conclusions of the 2001 Institute of Medicine Immunization Safety Review

Committee report as to what constitutes maximal permissible dose exposures to

mercury are misinterpreted, and misleading statements are made concerning

federal safety guidelines for mercury exposure levels that might be expected to

cause harm.

The authors fail to depict accurately the differences between pharmacokinetics of

and exposure to methyl mercury (found in contaminated food) and ethyl mercury

(found in thimerosal) and make unsubstantiated assumptions about the risks of

the route of exposure (ingested versus injected).

Adult heart disease is included as a possible thimerosal-related condition, although

heart arrest reports in very young children are used in the analysis. Heart arrest in

very young children (a common term used on pediatric death certificates and often

unrelated to the actual cause of death) has nothing to do with adult coronary heart

disease. The authors’ implication that thimerosal in vaccines is a cause of acute

cardiotoxic events is unfounded in any scientific or clinical reports and represents a

misuse of the terminology found in VAERS reports.

The authors fail to reveal how thimerosal exposure was calculated—a critical

omission, because much of the data required to estimate mercury exposure are

not available in VAERS reports. The authors’ stated estimates of exposure

attributable to diphtheria, tetanus, and pertussis combination vaccines (DTaP or

DTwP) do not add up. Some DTaP vaccines never contained thimerosal as a

preservative, and any child may have received 1 or more DTaP doses, which would

have resulted in no ethyl mercury exposure.

The authors claim to have analyzed data from biologic surveillance summaries by

manufacturers, although data regarding specific manufacturers (some of which

incorporated thimerosal as a preservative and some of which did not) and age and

year of birth of vaccine recipients are not available in the publication cited. Data as

to the number of patients receiving vaccines with thimerosal plus the number of

doses of vaccine actually received by patients versus total doses of vaccine

manufactured cannot be derived from biologic surveillance summaries, making the

authors’ claims for baselines of actual vaccine use untenable.

Calculations for incidence rates and relative risk, which require information (age or

year of birth) that is not available from biologic surveillance data, are not shown.


An appropriate comparison is not made between thimerosal exposure and no

thimerosal exposure, which is not possible using VAERS data, because one cannot

be sure whether a child received a thimerosal-containing vaccine at any point

before the event for which the VAERS report was created. Depending on the

manufacturer, many of the children listed in VAERS reports could have received all

vaccines that were free of thimerosal.

Statistical methodology for calculating the relative risk and correlation coefficients

is not stated.

The authors claim to have performed their own analysis of a Vaccine Safety

Datalink (VSD) thimerosal screening study (reference 17 in Geier and Geier),

although the raw data needed to perform an independent analysis are not

available in the document cited. (Note: neither the original preliminary VSD study

of thimerosal and neurodevelopmental disorders nor any of the follow-up

expanded studies identified a “signal” indicating any association between

thimerosal and autism.)

The authors claim that data for thimerosal exposure and autism risk follow an

exponential distribution, although none of the thimerosal exposure categories had

a significantly increased risk of autism. The figures used are confusing and not

supported by an adequate explanation as to how they were constructed.

Comparing the occurrence of late onset, chronic conditions like autism by using

acute vaccine reactions like fever, pain, and vomiting (presumably attributable to

other vaccine components) as controls makes no sense as a measure of relative

adverse event rates.

When comparing early (1984-1985) to late (1990-1994) birth cohorts, the authors

make arbitrary and unlikely assumptions of possible thimerosal exposure for both

groups that are contrary to when thimerosal vaccines were introduced and what

their expected pattern of use in the private and public sector was. The average

level of thimerosal exposure claimed by the authors is not realistic.

The authors claim high correlation coefficients for thimerosal with certain

neurologic disabilities without describing the statistical methods used, which makes

the results highly unreliable.

The authors fail to note that a recently published review by Nelson and Bauman3

casts doubt on the biologic plausibility of symptom similarities between mercury

poisoning and autism.


The authors claim falsely that children in the United States in 2003 may be

exposed to higher levels of mercury from thimerosal contained in childhood

immunizations than any time in the past, when in fact, all routinely recommended

infant vaccines currently sold in the United States are free of thimerosal as a

preservative and have been for more than 2 years

(www.fda.gov/cber/vaccine/thimerosal.htm#1).

No scientific data link thimerosal used as a preservative in vaccines with any pediatric

neurologic disorder, including autism. Despite this, the Centers for Disease Control and

Prevention, American Academy of Pediatrics, National Institutes of Health, and US Public

Health Service have continued to investigate this issue to put theoretic concerns about

this mercury-containing compound to rest.

Thimerosal continues to be used widely as a vaccine preservative in many other parts of

the world where economics and sanitation concerns mandate an effective means to

safeguard vaccines from contamination when stored in bulk in multidose vials. Any

scientific article that can prove a thimerosal link to significant adverse events in children

must be published in respected and widely read journals because of the great general

interest today in vaccine safety. These journals can be expected to apply the highest

standards of critical peer review to the results of any research that purports the existence

of these associations and claims of causality.

1. Geier MR, Geier DA. Thimerosal in childhood vaccines, neurodevelopment disorders and

heart disease in the United States. J Am Physicians Surg. 2003;8:6-11

2. Institute of Medicine, Immunization Safety Review Committee. Immunization Safety

Review: Thimerosal-Containing Vaccines and Neurodevelopmental Disorders. Stratton K,

Gable A, McCormick M, eds. Washington, DC: National Academies Press; 2001

3. Nelson KB, Bauman ML. Thimerosal and autism? Pediatrics. 2003;111:674-679

Posted May 16, 2003


Centers For Disease Control And Prevention Research

In addition to the few studies that linked the mercury found in vaccinations

to the development of autism, there were also a number of studies

conducted that found there was no connection between vaccinations and

autism.31 The following table32 provides information on each of the studies

and the findings from each study.

Study Description Study

Design

Estimated

Publication

Date

Study Objective(s)

Autism and

Thimerosal-

Containing

Vaccines:

Lack of

Consistent

Evidence for

an

Association

This study was prompted by

findings reported to the Institute

of Medicine by Blaxill in July

2001, which showed increases in

autism incidence in California in

association with increases in the

use of thimerosal-containing

vaccines during the 1990s. To

further examine the plausibility

of this finding, this study took

advantage of the cessation of

thimerosal use in Denmark and

Sweden in 1992 to conduct a

before and after comparison of

the incidence or case numbers of

autism. In both countries, autism

increases throughout the years

1987-1999, contrary to the

decrease in autism that would be

expected after 1992 if thimerosal

exposure were related to autism.

Ecological

Cohort

Published in

American

Journal of

Preventive

Medicine,

August

2003

Autism


The increasing trend for autism

is most notable in Denmark

where the number of autism

cases rises substantially even

after the discontinuation of

thimerosal use. The results were

published in the American

Journal of Preventive Medicine

(Aug 2003; 25(2): 101-6).

Thimerosal

Screening

Study

The Vaccine Safety Datalink

(VSD) was used to screen for

possible associations between

exposure to thimerosal-

containing vaccines and a variety

of renal, neurologic and

developmental problems. In the

first phase of this study, CDC

used data from the two VSD

managed care organizations

(MCOs) with automated

outpatient data (where more

subtle effects of mercury toxicity

might be seen). The CDC and

VSD researchers found

statistically significant

associations between thimerosal

and two neurodevelopmental

disorders - language delays and

tics. However, the associations

were weak and were not

consistent between the two

MCOs. No association was shown

with autism.

Cohort Published in

Pediatrics,

November

2003

Language

Delay;

Speech

Delay;

ADHD


In the second phase of the

investigation, CDC investigators

examined data from a third MCO

with similar available automated

vaccination and outpatient

databases to see if these findings

could be replicated. Analyses of

these data using the same

methods as with the first two

MCOs did not confirm results

seen in the first phase.

The results were published in

Pediatrics (Nov 2003; 112(5):

1039-48).

Presented at the July 2001 IOM

Meeting: Thimerosal-Containing

Vaccines and

Neurodevelopmental Outcomes

Thimerosal

Neurological

Development

al Disorders

(NDD)

Follow-up

Study

The Thimerosal Follow-Up Study

examines more rigorously the

hypotheses that increasing

exposure to thimerosal is

associated with neuro-

developmental disorders. In

contrast to the Thimerosal

Screening Study, which utilized

ICD-9 codes, the Thimerosal

Follow-Up Study will objectively

measure the neuro-

developmental disorders of

interest by bringing children

aged 7 to 9 years into a health

Cohort Published in

New

England

Journal of

Medicine,

September

2007

Language

Delay;

Speech

Delay;

ADHD


clinic for a three-hour objective

assessment by staff trained to

administer neuropsychological

test batteries.

The results of the study should

be significantly less vulnerable to

the introduction of health care

seeking bias and will assist in the

interpretation of the results

obtained in the Thimerosal

Screening Study.

The study found only a few

statistically significant

associations between exposure

from thimerosal and

neuropsychological functioning.

The weight of the evidence from

this study does not support an

association between early ethyl

mercury exposure from

thimerosal-containing vaccines

and/or immunoglobulin’s and

neuropsychological functioning at

ages 7 to 10 years.

The results published in New

England Journal of Medicine

(2007 Sep 27; 357(13): 1281-

92). 2001 IOM Recommendation:

Thimerosal 4


Lack of

Association

between

Measles Virus

Vaccine and

Autism with

Enteropathy:

A Case-

Control Study

CDC supported a case-control

study to investigate the

association between MMR

vaccine, gastrointestinal tract

disorders (GI), and autistic

spectrum disorder (ASD) through

examination of intestinal tissue

samples for measles virus

genome. The research was led

by scientists at Columbia

University Mailman School of

Public Health and included

researchers from Massachusetts

General Hospital, Trinity College

Dublin, and CDC.

Laboratories evaluated bowel

tissues from 25 children with

autism and GI disturbances and

13 children with GI disturbances

alone (controls). Only 2 biopsy

samples with measles virus RNA

were found, one in the autism/GI

group and one in the control

group, showing that the

presence of measles virus

sequences was not associated

with an autism diagnosis

(autism/GI group, 4%; control,

8%).

Samples were analyzed in three

separate laboratories blinded to

diagnosis, including one

laboratory wherein the original

Case-

Control

Published in

PLoS ONE

3(9):

e3140.

doi:10.137

1/journal.p

one.000314

0

Autism


findings suggesting a link

between measles virus and

autism had been reported in

1998 (Wakefield, et al.). Results

are inconsistent with a causal

role for MMR vaccine as a trigger

or exacerbator of either GI

difficulties or autism,

The results were published in

PLoS One (September 2008;

3(9): e3140.

doi:10.1371/journal.pone.00031

40) 2001 IOM

Recommendations: MMR/Autism

2 & 3

Italy

Thimerosal

NDD Study

CDC funded this follow-up study

in Italy that compares

neuropsychological outcomes of

children at ages 10-12 years who

were randomly assigned to

receive one of two forms of

diphtheria-tetanus-acellular

pertussis vaccine (DTaP) in the

first year of life, one containing

thimerosal and the other

containing 2-phenoxyethanol.

As a result, children who

received the thimerosal-

containing DTaP vaccines had a

higher cumulative exposure to

thimerosal (137.5 micrograms of

ethyl mercury) in their first year

compared to the other form of

DTaP (62.5 micrograms of ethyl

Clinical

Trial

Published:

Pediatrics,

February

2009

Language

Delay;

Speech

Delay;

ADHD


mercury) during the same age

range. Ten years after

vaccination, the two groups were

tested in school on 24

neuropsychological outcomes.

The overall results of the study

do not support neurological or

developmental harm to children

resulting from thimerosal

exposure. This strong study adds

to the body of scientific evidence

that thimerosal in vaccines is not

harmful to children. The results

are published in Pediatrics (2009

Feb:123(2): 475- 482).

2001 IOM Recommendation:

Thimerosal 2

VSD

Thimerosal

and Autism

Case Control

Study

Exposure to thimerosal has been

hypothesized to be associated

with the risk for autism.

Preliminary results from the VSD

Thimerosal Screening Study

published in 2003 did not find an

association between thimerosal

exposure and autism risk and

recent ecological studies have

not found a correlation between

thimerosal content of vaccines

and autism rates. Autism,

however, can be difficult to

diagnose and the studies to date

have relied on computerized

clinical or administrative

Case-

control

January

2010

Autism


databases in which the validity of

the autism diagnoses have not

been fully validated.

The Thimerosal and Autism

Study is a case-control study

conducted in three U.S. MCOs.

Data collection began in 2005

and took three years to

complete. In this study, children

who were diagnosed with autism

were matched with control

children. The autism diagnosis of

the case samples was confirmed

by a standardized clinical

assessment protocol.

Vaccination histories and

information on other potential

confounding factors were

confirmed by reviewing the

medical records for all children.

In addition, the mothers of both

cases and matched controls were

interviewed. The IOM

Immunization Safety Review

Committee recommended such a

study in 2001.

2001 IOM Recommendations:

Thimerosal 1 & 4


Risks Of Not Immunizing

In recent years, due in part to the publication of studies that falsely link

vaccinations to the development of autism, there has been a growth in the

anti-vaccination movement.17 Many individuals have chosen not to vaccinate

their children for fear of them developing autism or some other neurological

delay.33 However, the risk of not vaccinating children is significant. Children

who are unvaccinated are at risk of developing a number of illnesses that

can be life threatening.34 The most significant risks include the following

illnesses discussed below.

Polio

Polio is a viral illness that is characterized by the severity of the

complications it can cause in individuals who contract it. In some patients,

polio, which is life threatening, will cause paralysis and breathing

difficulties.35 The polio vaccine is responsible for eradicating naturally

occurring cases of the virus, and there have been no reported cases of the

virus in the Unites States since 1979.36 Unfortunately, the virus is prevalent

in other countries such as Afghanistan, India, Nigeria and Pakistan.35

Unvaccinated individuals are at the greatest risk of contracting the virus,

especially when the following conditions are present:36

Travel to an area where polio is common or that has recently

experienced an outbreak

Living with or caring for someone who may be shedding poliovirus

Handling laboratory specimens that contain live poliovirus

A compromised immune system, such as occurs with HIV infection

Having had your tonsils removed (tonsillectomy)

Extreme stress or strenuous physical activity after being exposed to

poliovirus, both of which can depress your immune system


Measles

Measles is a respiratory infection that is caused by a virus that typically

grows in the cells lining the back of the throat and the lungs. It is spread

through the air when someone coughs, sneezes, or breathes.37 When

infected, patients will typically experience the following symptoms:38

Fever

Runny nose

Cough

Rash on the body

Streptococcus Pneumoniae

Streptococcus pneumoniae is the bacteria that causes pneumococcal

pneumonia, which is a severe form of pneumonia.39 Pneumococcal

pneumonia is characterized by its sudden, severe onset. Many patients will

experience a sudden, severe chill followed by the following symptoms:40

High fever

Cough

Shortness of breath

Rapid breathing

Chest pains

Nausea

Vomiting

Headache

Tiredness

Muscle aches

Pneumococcal pneumonia is especially common in unvaccinated children

under the age of five and the elderly. The risk of contracting the illness

increases significantly when an individual remains unvaccinated.41


Haemophilus Influenzae Type b (Hib)

Haemophilus influenza type b (Hib) is a bacterial illness that is responsible

for causing life threatening brain and other infections, primarily in children.42

In more severe cases, the illness will cause the following conditions:43

Meningitis

Bloodstream infections

Pneumonia

Arthritis

Infections in other regions of the body

Prior to the development of a vaccine for Hib, the bacteria was the primary

cause of bacterial meningitis in young children. However, the vaccine has

reduced the number of cases significantly.44 Currently, approximately 1 in

100,000 children contract the bacteria. However, that risk increases

dramatically in unvaccinated children.43

Meningococcus

Meningococcus is the bacteria that causes meningococcal meningitis, which

is an infection of the lining of the brain and the spinal cord.45 In some

instances, the bacteria can also cause other illnesses such as bloodstream

infections.46 The bacteria is spread through respiratory secretions.47

Unvaccinated individuals are at risk of developing severe, life threatening

complication from the bacteria. However, those who are vaccinated have

minimal risk.45


Vaccination Recommendations

To ensure all children are properly vaccinated, the Centers for Disease

Control has developed a vaccination schedule for children 0 – 6 years of age.

In some instances, parents may choose to reduce or delay the vaccinations.

These decisions are typically made in consultation with the child’s health

care provider.

Summary

Parents today are facing a confusing array of information when it comes to





vaccines. Frequently, parents turn to their medical professionals for

guidance on this topic, and it is necessary for these individuals to help

patients make sound, thoughtful, evidenced-based decisions.

Please take time to help NurseCe4Less.com course planners evaluate

the nursing knowledge needs met by completing the self-assessment of Knowledge Questions after reading the article, and providing

feedback in the online course evaluation.

Completing the study questions is optional and is NOT a course requirement.


1. Autism typically appears at what age?

a. 9 – 12 months

b. 15 – 18 months

c. 2 – 4 years

d. 5 – 7 years

2. The incidence of autism in boys is:

a. 1 in 12

b. 1 in 24

c. 1 in 52

d. 1 in 112

3. Which of the following individuals was responsible for developing

the Lupron Protocol?

a. Andrew Wakefield

b. Ryan White

c. John Samuelson

d. Mark Geier

4. What is the percentage of mercury present in thimerosal?

a. 10%

b. 25%

c. 50%

d. 75%


5. Which vaccine is most closely linked with autism?

a. MMR

b. Hepatitis B

c. DTAP

d. Influenza

Correct Answers:

1. b

2. c

3. d

4. c

5. a


References Section

The reference section of in-text citations include published works intended as

helpful material for further reading. Unpublished works and personal

communications are not included in this section, although may appear within

the study text.

1. Miles JH. Autism spectrum disorders--a genetics review. Genet. Med.

2011;13:278–94.

2. Duchan E, Patel DR. Epidemiology of Autism Spectrum Disorders.

Pediatr. Clin. North Am. 2012. p. 27–43.

3. Frequently Asked Questions | What is Autism? | Autism Speaks

[Internet]. Available from: http://www.autismspeaks.org/what-

autism/faq

4. Frazier TW, Youngstrom E a, Speer L, Embacher R, Law P, Constantino

J, et al. Validation of proposed DSM-5 criteria for autism spectrum

disorder. J. Am. Acad. Child Adolesc. Psychiatry. 2012;51:28–40.e3.

5. Volkmar FR, State M, Klin A. Autism and autism spectrum disorders:

diagnostic issues for the coming decade. J. Child Psychol. Psychiatry.

2009;50:108–15.

6. McPartland JC, Reichow B, Volkmar FR. Sensitivity and specificity of

proposed DSM-5 diagnostic criteria for autism spectrum disorder. J.

Am. Acad. Child Adolesc. Psychiatry. 2012;51:368–83.

7. Autism Fact Sheet: National Institute of Neurological Disorders and

Stroke (NINDS) [Internet]. Available from:

http://www.ninds.nih.gov/disorders/autism/detail_autism.htm

8. Mandell DS, Thompson WW, Weintraub ES, Destefano F, Blank MB.

Trends in diagnosis rates for autism and ADHD at hospital discharge in


the context of other psychiatric diagnoses. Psychiatr. Serv. 2005

Jan;56(1):56–62.

9. Schaaf CP, Zoghbi HY. Solving the autism puzzle a few pieces at a

time. Neuron. 2011;70:806–8.

10. CDC - Data and Statistics, Autism Spectrum Disorders - NCBDDD.

11. Geier DA, Sykes LK, Geier MR. A review of Thimerosal (Merthiolate)

and its ethylmercury breakdown product: specific historical

considerations regarding safety and effectiveness. J. Toxicol. Environ.

Health. B. Crit. Rev. 2007;10:575–96.

12. Thimerosal in Vaccines [Internet]. Available from:

http://www.niaid.nih.gov/topics/vaccines/research/pages/vaccines.asp

x

13. Dórea JG, Farina M, Rocha JBT. Toxicity of ethylmercury (and

Thimerosal): a comparison with methylmercury. J. Appl. Toxicol. 2013

Aug;33(8):700–11.

14. Schultz ST. Does thimerosal or other mercury exposure increase the

risk for autism? A review of current literature. Acta Neurobiol. Exp.

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15. Hurley AM, Tadrous M, Miller ES. Thimerosal-containing vaccines and

autism: a review of recent epidemiologic studies. J. Pediatr. Pharmacol.

Ther. 2010;15:173–81.

16. Research C for BE and. Questions about Vaccines - Thimerosal in

Vaccines Questions and Answers. Center for Biologics Evaluation and

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17. Flaherty DK. The Vaccine-Autism Connection: A Public Health Crisis

Caused by Unethical Medical Practices and Fraudulent Science. Ann.

Pharmacother. 2011. p. 1302–4.


18. Mrozek-Budzyn D, Kiełtyka A, Majewska R. Lack of association between

measles-mumps-rubella vaccination and autism in children: a case-

control study. Pediatr. Infect. Dis. J. 2010;29:397–400.

19. Godlee F, Smith J, Marcovitch H. Wakefield’s article linking MMR

vaccine and autism was fraudulent. BMJ. 2011 Jan

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20. Wakefield A. A statement by Dr Andrew Wakefield. Lancet.

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21. Gorski D. The General Medical Council to Andrew Wakefield: “The panel

is satisfied that your conduct was irresponsible and dishonest”

[Internet]. Sci. Med. 2010. Available from:

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22. Geier DA, Geier MR. A prospective study of mercury toxicity biomarkers

in autistic spectrum disorders. J. Toxicol. Environ. Health. A.

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23. Baker JP. Mercury, vaccines, and autism: one controversy, three

histories. Am. J. Public Health. 2008;98:244–53.

24. Blake J, Hoyme HE, Crotwell PL. A brief history of autism, the

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spectrum disorders. S. D. Med. 2013;Spec no:58–65.

25. Desperate for an Autism Cure [Internet]. Available from:

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&ARTICLEID_CHAR=360846CA-237D-9F22-E86342385161B8AD

26. Patel VB, Preedy VR, Martin CR, editors. Comprehensive Guide to

Autism. New York, NY: Springer New York; 2014.

27. Giles J. The lure of a cure for autism. New Sci. 2010;206(2766):42–5.

28. Giles J. US vaccines on trial over link to autism. New Sci. 2007. p. 6–7.


29. Pdf : Maryland revocation papers on Dr. Mark Geier [Internet].

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on-dr-mark-geier/pdf_0cbddb24-0e3a-11e2-825f-0019bb30f31a.html

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39. Mitchell AM, Mitchell TJ. Streptococcus pneumoniae: virulence factors

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40. Van der Poll T, Opal SM. Pathogenesis, treatment, and prevention of

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41. O’Brien KL, Wolfson LJ, Watt JP, Henkle E, Deloria-Knoll M, McCall N, et

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45. Stephens DS. Conquering the meningococcus. FEMS Microbiol. Rev.

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46. Price AA. Meningococcal vaccines. Curr. Pharm. Des. 2007;13:2009–

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47. Maiden MCJ, Frosch M. Can we, should we, eradicate the

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