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Thimerosal in Childhood Vaccines,

Neurodevelopment Disorders, and


Heart Disease in the United States
Mark R. Geier, M.D., Ph.D. neurodevelopment disorders is not Finally, we analyzed data from the US
DavidA. Geier established and rests on indirect and Department of Education on the number of
incomplete information, primarily from children of various ages in US schools who
analogies with methylmercury and levels of were reported with various types of
Abstract maximum mercury exposure from vaccines disabilities in comparison to the mercury
In this study, we evaluated doses of given in children. They concluded that the dose that children received from thimerosal
mercury from thimerosal-containing hypothesis is biologically possible, but the in their childhood vaccines.
childhood immunizations in compari- possible relationship between thimerosal
son to US Federal Safety Guidelines from vaccines and neurodevelopment Methods
and the effects of increasing doses of disorders of autism, attention defi-
cit/hyperactivity disorder (ADHD), and EPA/FDAExposure Limits
mercury on the incidence of
speech or language delay remained
neurodevelopment disorders and In this study, the amount of mercury
seriously suspect.7
heart disease. This study showed that children received as part of their routine
Since the publication of the IOM report,
children received mercury from this childhood immunization schedule and the
we published the first epidemiological
source in excess of the Federal Safety evidence showing a direct association EPA and FDA maximum permissible doses
Guidelines for the oral ingestion of between thimerosal-containing childhood for the oral ingestion of methylmercury
methylmercury. Our analyses showed vaccines and neurodevelopment disorders were determined from the IOM report.7
increasing relative risks for in children.8 We showed that there was The maximum permissible doses for the
neurodevelopment disorders and from a 2 to 6-fold increased incidence of oral ingestion of methylmercury by the EPA
heart disease with increasing doses of neurodevelopment disorders following an and FDA are 0.1 µg /kg body weight/day
mercury. This study provides strong additional 75-100µg dosage of mercury and 0.4 µg /kg body weight/day, respec-
epidemiological evidence for a link from thimerosal-containing childhood tively. The average size of infants at various
between mercury exposure from vaccines in comparison to thimerosal-free ages was determined from Geigy Scientific
thimerosal-containing childhood childhood vaccines. Tables.1 0
vaccines and neurodevelopment As the first part of this study, we
evaluated the doses of mercury that The VAERS Database
disorders.
children received from thimerosal-
containing vaccines, as part of the routine The incidence of neurodevelopment
Introduction
US childhood immunization schedule, in disorders and heart disease following
Many sources now confirm an autism
comparison to the US Federal Safety thimerosal-containing DTaP and DTwcP
epidemic in the United States. The
Guidelines for the oral ingestion of vaccines in comparison to thimerosal-free
prevalence of autism has risen from one in DTaP vaccines was based upon analysis of
about 2,500 children in the mid-1980s to methylmercury. In 1999, the US Food and
Drug Administration (FDA) determined the VAERS database, using Microsoft
one in about 300 children in 1996.1 , 2 , 3 Access.®
that under the recommended childhood
Several studies report that there is an T h e VA E R S d a t a b a s e i s a n
immunization schedule infants might be
association between mercury exposure and exposed to cumulative doses of epidemiologic database maintained by the
an increased risk of heart disease.4 , 5 Many
,6
ethylmercury that exceed some federal Centers for Disease Control and Prevention
in the scientific/medical community have, safety guidelines established for the oral (CDC) since 1990.All adverse reactions are
initially, been highly skeptical that ingestion of methylmercury.9 to be reported to the VAERS database as
thimerosal, an ethylmercury preservative, Secondly, in order to analyze the effects required by US law. The CDC requires
in childhood vaccines could be associated of thimerosal in vaccine recipients, we written and telephonic confirmation of
with neurodevelopment disorders. analyzed the incidence rates of serious adverse reactions and follows up
Thimerosal is an organic mercury neurodevelopment disorders and heart these patients one year later. The FDA
compound. It is metabolized to disease reported following thimerosal- inquires into deaths reported to the VAERS
ethylmercury and thiosalicylate and has containing vaccines in comparison to database by contacting the patient's
been present since the 1930s as a preserva- thimerosal-free vaccines based upon healthcare provider and physician. The
tive in many vaccines and pharmaceutical analysis of the Vaccine Adverse Events FDA also continually monitors reports to
products to prevent bacterial and fungal Reporting System (VAERS) database. We the VAERS database to determine whether
contamination. analyzed thimerosal-containing any vaccine or vaccine lot has a higher than
In 2001, the Institute of Medicine Diphtheria-Tetanus-whole-cell-Pertussis expected incidence rate of events. The
(IOM) of the US National Academy of (DTwcP) and Diphtheria-Tetanus- VAERS Working Group of the CDC, the
Sciences concluded that the hypothesis that acellular-Pertussis (DTaP) vaccines in FDA, and we analyze and publish
exposure to thimerosal-containing comparison to thimerosal-free DTaP epidemiologic studies based upon analysis
vaccines could be associated with vaccines. of the VAERS database.

6 Journal of American Physicians and Surgeons Volume 8 Number 1 Spring 2003


The neurodevelopment disorders and
heart disease conditions we analyzed were
autism, speech disorders, and heart arrest.
These categories of adverse events were
based upon descriptions of adverse
reactions by those reporting them and by
defined fields contained in the VAERS
database. In addition, as control adverse
events we analyzed the number of febrile
seizures, fevers, pain, edema, and vomiting
following each of the vaccines under study.
We determined the number of each type of
adverse event reported following doses for
two groups of patients, the first receiving an
average of 37.5 µg of mercury and the
second, an average of 87.5 µg of mercury.
This grouping allowed us to be able to
ascertain larger numbers for our analyses.
We hypothesize that DTaP or DTwcP
vaccines, whether containing thimerosal or
not, should have a similar incidence rate of
adverse events. The assumption of similar
reactogenicity following the vaccines
under study forms the basis of our null
hypothesis.
We analyzed DTaP and DTwcP
vaccines by manufacturer, so that we could
compare thimerosal-containing DTaP and
DTwcP vaccines administered from 1992
through 2000 against thimerosal-free DTaP
vaccines administered from 1997 through
2000. We used denominators obtained from
the Biological Surveillance Summaries of
the CDC to determine the number of doses
of each manufacturer administered. Based
upon this information, we were able to
calculate incidence rates of adverse events
following vaccination. Table 1. A summary of the instantaneous mercury exposure levels of US infants at various
We are precluded from giving incidence times as part of their childhood immunization schedule in comparison to the maximum daily
rates, the number of doses administered, or EPA established limits.
types of DTaP or DTwcP vaccine, because
this information could reveal the identities
analyzed was zero micrograms of mercury based upon the Biologic Surveillance
of the manufacturers and the CDC claims
and had a relative risk of one. Summaries of the CDC. Then the preva-
that this information is proprietary.11 lence of the various conditions analyzed
We compared the incidence rates of United States was plotted against the amount of mercury
adverse events following thimerosal- Department of Education Report that each child received.
containing DTaP and DTwcP vaccines
against thimerosal-free DTaP vaccines in The 2001 US Department of Education Results
order to determine relative risk. The report was analyzed to determine the Table 1 presents a summary of the
relative risk value was obtained by dividing number of children at various ages who had instantaneous mercury exposure of US
the incidence rate of the adverse event developed various conditions. 1 2 The infants at various times as part of their
following thimerosal-containing DTaP or conditions analyzed included: autism, childhood immunization schedule in
DTwcP vaccines by the incidence rate of speech disorders, orthopedic impairments, comparison to the EPA established limits.
the adverse event following thimerosal-free visual impairments, and deaf-blindness. This table shows that the instantaneous
DTaP vaccines. The relative risks of the We determined the prevalence of each of relative excess mercury that US children
adverse events analyzed were plotted these conditions based upon the number of received from their childhood immuniza-
against the amount of mercury that each births in each birth cohort as per the CDC's tions ranged from 11 to 150-fold at a given
child had received. By definition, since we yearly live birth surveillance data.1 3 The age in comparison to the US EPA safety
assume that the populations under study are birth cohort years analyzed were 1984, guidelines for the daily maximum oral
similar and we are tracking only the amount 1985, 1990, 1991, 1992, 1993, and 1994. ingestion of methylmercury. In addition,
of mercury that children received from the We then calculated the amount of these data show that children received an
thimerosal-containing or thimerosal-free mercury that had been administered on instantaneous relative excess mercury
vaccines under study, the initial point average to each child in a birth cohort, doses in comparison to the FDA safety
Journal of American Physicians and Surgeons Volume 8 Number 1 Spring 2003 7
Figure 1. (A) Neurodevelopment disorders and heart disease conditions reported following thimerosal-containing DTaP in comparison
to thimerosal-free DTaP vaccines for increasing mercury dosage that children received from thimerosal; (B) Control adverse events
reported acutely following thimerosal-containing DTaP in comparison to thimerosal-free DTaP vaccines for increasing mercury dosage
from thimerosal

Figure 2. (A) Neurodevelopment disorders and heart disease conditions reported following thimerosal-containing DTwcP in
comparison to thimerosal-free DTaP vaccines for increasing mercury dosage that children received from thimerosal; (B) Control
adverse events reported acutely following thimerosal-containing DTwcP in comparison to thimerosal-free DTaP vaccines for increasing
mercury dosage from thimerosal

guidelines for the oral ingestion of containing DTaP vaccines slightly raised DTaP vaccines for different mercury doses.
methylmercury, ranging from 2.7 to 37-fold the rate of adverse events compared to We found that administration of
at a given age. thimerosal-free DTaP vaccines, but the thimerosal-containing DTwcP vaccines
Figure 1A plots the relative risk of increased relative risks did not correlate significantly raised the rate of adverse
speech disorders, autism, and heart arrest with the total amount of mercury the events compared to thimerosal-free DTaP
reported after thimerosal-containing DTaP children received. vaccines, but the increased relative risks did
in comparison to thimerosal-free DTaP Figure 2A shows the relative risk of not correlate with the total amount of
vaccines for increasing doses of mercury. speech disorders, autism, and heart arrest mercury the children received.
We found that the data points for each reported after thimerosal-containing Figures 3A-B show the prevalence of
condition closely followed exponential DTwcP in comparison to thimerosal-free autism and speech disorders as a function of
distributions. DTaP vaccines for increasing dosage of the mercury dose that children received
Figure 1B plots the relative risks of mercury. We found that the data points from thimerosal contained in their child-
febrile seizure, fever, pain, edema, and hood vaccines. We found that the condi-
closely followed exponential distributions.
vomiting reported after thimerosal- tions analyzed closely followed linear
Figure 2B shows the relative risk of distributions with an increase of about one
containing DTaP in comparison to febrile seizure, fever, pain, edema, and case of autism per 100,000 children for
thimerosal-free DTaP vaccines. We found vomiting after thimerosal-containing every microgram present in childhood
that administration of thimerosal- DTwcP in comparison to thimerosal-free vaccines and about one case of speech

8 Journal of American Physicians and Surgeons Volume 8 Number 1 Spring 2003


A B

Figure 3. (A) Autism disabilities reported in comparison to the


average mercury dosage from thimerosal in childhood vaccines;
(B) speech disorders reported in comparison to the average
mercury dosage from thimerosal in childhood vaccines; (C)
visual impairment, deaf-blindness and orthopedic impairment
(control disabilities) in comparison to the average mercury
dosage from thimerosal in childhood vaccines

disorders per 1,000 children for every 3 µg thimerosal-containing DTaP and DTwcP ments, as shown in Figure 3C.
of mercury present in childhood vaccines. have higher rates of speech disorders, The lack of correlation between acute
Figure 3C shows the prevalence of the autism, and heart arrest overall, but also events and increasing mercury exposure
control disabilities of visual impairment, that the relative risk of each of these levels in the VAERS data argues against
deaf-blindness, and orthopedic impairment disorders correlated with increasing doses reporting bias or differences in the vaccines
as a function of the mercury dose that of mercury contained in childhood themselves and argues for the specific
children received from thimerosal con- vaccines, as illustrated in Figures 1A and effects of thimerosal on neurodevelopment
tained in their childhood vaccines. We 2A. Figures 1B and 2B show that exposure disorders and heart disease. Likewise, the
found that the prevalence of these condi- to increasing doses of mercury is not lack of correlation between visual impair-
tions did not correlate with the increasing correlated to acute vaccine adverse events ments, deaf-blindness, or orthopedic
total amount of mercury the children including febrile seizures, fever, pain, impairments and the increasing mercury
received. edema, or vomiting. exposure levels in the US Department of
Our demonstration of a significant Education data also argues for the specific
Discussion overall increase in the relative risks of acute effects of thimerosal in childhood vaccines
It is clear from our analysis, shown in adverse events following DTwcP vaccine on the prevalence of autism and speech
Table 1, that US infants are exposed to when compared to thimerosal-free DTaP disorders.
mercury levels from their childhood vaccine is not surprising since our previous As an additional epidemiological
immunization schedule that far exceed the studies have shown that DTwcP vaccines confirmation of our findings, we analyzed
EPA and FDA-established maximum are far more reactogenic than DTaP the CDC's Phase I Thimerosal Vaccine
permissible levels for the daily oral vaccines.1 5 , 1 However,
6
we observed that Safety Datalink (VSD) data.1 7 We found
ingestion of methylmercury. The fact that only those events for which causation by this data showed that the increasing relative
mercury in the vaccines is given by thimerosal is biologically plausible were risk of developmental neurologic disorder,
injection rather than by oral ingestion only found to be correlated with the mercury autism, speech disorder, and attention
makes the exposure levels worse because levels children received in their vaccines. deficit disorder all closely followed
Geier et al. showed that the distribution of Our analyses of a completely independ- exponential distributions with increasing
foreign particles in mice reached several- ent source, the US Department of mercury levels from the thimerosal that
logs higher concentration in organs Education's report on the prevalence of children received as part of their childhood
following intravenous or intramuscular various childhood disease among school immunizations.
injections than via oral ingestion.1 4 children of various ages, showed autism We conducted a MEDLINE (1966-
Our previous studies comparing DTaP and speech disorders were correlated with 2003) search for the terms merthiolate and
with and without thimerosal have shown a increasing mercury from childhood thimerosal and found almost 1,500
statistically and clinically significant vaccines, as shown in Figures 3A-B. No references, primarily about various adverse
increase in neurodevelopment disorders in correlation was seen between increasing outcomes following exposure. Of particu-
those vaccinated with thimerosal- mercury exposure from childhood vaccines lar interest, Bernard et al. have compared
containing vaccines.8 Our current study not and the prevalence of visual impairments, the similar biological abnormalities
only shows that those vaccinated with deafness-blindness, or orthopedic impair- commonly found in autism and the

Journal of American Physicians and Surgeons Volume 8 Number 1 Spring 2003 9


corresponding pathologies arising from The authors estimated that the blood been removed from Rhogam. Pregnant
mercury exposure.1 8 Distinct similarities half-life of ethylmercury was 7 days (95% women and children should avoid eating
were found between autism and mercury confidence interval of 4 to 10 days). The seafood that may contain significant
exposure in their effects upon biochemistry, study was unable to determine the ultimate quantities of mercury. The mean mercury
the immune system, the central nervous disposition of most of the mercury with levels in various seafood species have been
system structure, neurochemistry, and which infants were injected. However, it determined by the Center for Food Safety
2 5
neurophysiology. has been determined that uptake of mercury and Applied Nature Section of the FDA.
A study performed by Magos et al. in in the brain is 5to 7 times greater than in the The FDA currently recommends that
2 0 ,2 3
rats compared the effects of the administra- blood. Therefore, because of the similar pregnant women and those women who
tion of similar doses of ethylmercury and theoretical and experimental toxicities of may become pregnant avoid species with
1 9
methylmercury. They found that higher ethylmercury and methylmercury, and the the highest average amounts of
concentrations of inorganic mercury in the immediate buildup of ethylmercury from methylmercury and that a “balanced” diet
kidneys and brain were present in thimerosal in the tissues of the body, of seafood consumption should be followed
2 6
ethylmercury-treated rats compared to especially the preferential buildup in the so as to keep methylmercury levels low.
methylmercury-treated rats. They deter- brain, there appears to be good biologic Additionally, fetuses may be exposed to
mined that there was little difference in the plausibility for the neurodevelopment mercury from the amalgam used in their
neurotoxicity found in ethylmercury and disorders and heart conditions observed in mother's fillings. Also, patients should be
methylmercury-treated rats when effects on this study. made aware that there are other prescription
the dorsal root ganglia or coordination On July 7, 1999, the American drugs and over-the-counter medications
disorders were compared. The authors also Academy of Pediatrics and the US Public that contain significant amounts of
2 4
determined that microgram quantities of Health Service issued a joint statement thimerosal.
organic mercury alone in the rat brain were calling for the removal of thimerosal from These other sources of mercury, while
in some cases associated with vaccines, prompted by a risk assessment potentially significant, probably had a
neurotoxicity, indicating that the presence 9
from the FDA. The 2001 IOM report stated limited effect on the results of this study
of inorganic mercury was not necessary for that technology is available to manufactur- because the populations analyzed were
neurotoxicity. ers in the US to allow for the removal of large and there should have been equal
It has been reported that administration thimerosal from childhood vaccines in a exposure to other sources of mercury
of thimerosal results in the immediate timely manner and that only a small number among the populations examined.
release of ethylmercury to the surrounding of thimerosal-containing vials remain on
2 0
tissues. The reason for this stems from the the shelf.
7 Conclusion
fact that thimerosal contains the We have recently reviewed the 2003 US This study provides strong epidemio-
ethylmercury radical attached to the sulfur Physician's Desk Reference (PDR) and logical evidence for a link between
atom of the thiol group of salicylic acid. found that some childhood vaccines still increasing mercury from thimerosal-
Generally, mercuric ions bind tightly but containing childhood vaccines and
contain thimerosal. DTaP manufactured by
2 1 neurodevelopment disorders and heart
reversibly to thiol ligands. It is likely, Aventis Pasteur contains 25µg of mercury, disease. In light of voluminous literature
therefore, that the ethylmercury cation will Hemophilus influenza b (Hib) vaccine supporting the biologic mechanisms for
dissociate from the thiosalicylic acid manufactured by Wyeth contains 25 µg of mercury-induced adverse reactions, the
moiety immediately after injection to bind mercury, and pediatric hepatitis B vaccine presence of amounts of mercury in
to the surrounding thiol ligands present in manufactured by Merck contains 12.5 µg of thimerosal-containing childhood vaccines
2 0 2 4
great excess in tissue proteins. mercury. In addition, influenza vaccine exceeding Federal Safety Guidelines for
Rapid deposition of ethylmercury in that is recommended for an increasing the oral ingestion of mercury, and previous
tissues following administration of segment of the pediatric population in the epidemiological studies showing adverse
thimerosal from vaccines is suggested by a US also contains 25 µg of mercury. reactions from such vaccines, a causal
2 2
recent publication by Pichichero et al. Therefore, it is indeed possible that children relationship between thimerosal-
The authors examined the concentrations of in the US in 2003 may be exposed to levels containing childhood vaccines and
mercury in the blood, urine, and stool from of mercury from thimerosal contained in neurodevelopment disorders and heart
3 to 28 days following thimerosal- their childhood vaccinations that are at a disease appears to be confirmed. It is to be
containing vaccines in 40 full-term infants higher level than at any time in the past. hoped that complete removal of thimerosal
aged 6 months and younger in comparison Possible total childhood mercury in 2003 is from all childhood vaccines will help to
to 21 control infants receiving thimerosal- more than 300 µg. stem the tragic, apparently iatrogenic
free vaccines. The mean mercury doses of Because of the data implicating epidemic of autism and speech disorders
the infants exposed to thimerosal were 45.6 thimerosal levels with increasing rates of that the United States is now facing.
µg (range 37.5-62.5) for 2-month-olds and autism, speech disorders, and heart disease,
Dr. Mark Geier has done consulting work and
111.3 µg (range 87.5-175.0) for 6 month- it would seem prudent to completely appeared as an expert witness, and David
olds. Blood mercury in thimerosal-exposed remove thimerosal from all childhood Geier has done consulting worki in cases
2-month-old infants ranged from less than vaccines immediately. The use of single- before the National Vaccine Injury
3.75 to 20.55 nmol/L; in 6 month-old dose vials would alleviate the need for any Compensation Program (NVCIP) and in civil
infants all values were lower than 7.50 preservative in the vaccines. suits involving vaccine adverse reactions. To
nmol/L. Only 15 blood samples from Parents should be encouraged to avoid date, none of these cases have involved
controls contained quantifiable mercury. exposing their children to additional thimerosal.
Concentrations of mercury were low in the mercury from sources other than vaccines.
Until recently, Rh-negative women were Mark Geier, M.D., Ph.D. is President, The
urine after vaccination but were high in the Genetic Centers of America. David Geier, B.A. is
stools of thimerosal-exposed 2-month-old routinely given Rhogam injections, which President of MedCon, Inc. Address correspon-
infants (mean 82 ng/g dry weight) and in 6- contained significant amounts of dence to: Mark Geier, M.D., Ph.D., 14 Redgate
month-old infants (mean 58 ng/g dry thimerosal, several times during their Ct., Silver Spring, MD 20905. Email:
weight). pregnancies. Fortunately, thimerosal has mgeier@erols.com.

10 Journal of American Physicians and Surgeons Volume 8 Number 1 Spring 2003


9 18
There were no sources of funding for this Ball LK, Ball R, Pratt RD. An assessment of Bernard S, Enayati A, Redwood L, Roger H,
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10
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