PubMed
is a service of the US National Library of Medicine (NLM) of the US
National Institutes of Health. According to its main page, “PubMed
comprises more than 20 million citations for biomedical literature
from MEDLINE, life science journals, and online books. Citations may
include links to full-text content from PubMed Central and publisher
web sites.”
On March 25,
2011, I accessed PubMed and searched for “thimerosal, vaccine”.
I found 396 citations, the most recent of which (listed as # 1-
PMID: 21350943) published on-line February 25, 2011. It was
titled “Integrating
Experimental
(In
Vitro
and
In
Vivo)
Neurotoxicity
Studies
of
Low-dose
Thimerosal
Relevant
to
Vaccines” and authored by Dr. J G
Dórea
of the Faculty of Health Sciences, Universidade de Brasília,
Brazil.
This article will be discussed in some detail later.
Readers
interested in following this discussion may want to access PubMed at
http://www.ncbi.nlm.nih.gov/pubmed/.
Alternative
searches
for
“thimerosal
vaccine”,
“vaccine,
thimerosal”
or
“vaccine
thimerosal”
will
also
lead
to the same listing.
The 396 titles
with authorship and publication details are listed 20 per page on 20
pages.
[http://www.ncbi.nlm.nih.gov/pubmed?term=thimerosal%2C%20vaccine]
As of March 25, 2011, there were only three listings for the year: #3
(PMID: 21252391), #6 (PMID:
21185424) and the Dórea paper.
Not all 396 listings deal with the safety vs. neurotoxicity of
Thimerosal or of Thimerosal-containing vaccines (TCV), the subject of
this three-part series. For example the article listed as # 2 is a
report from France of a “case of allergic contact dermatitis three
weeks after the H1N1 vaccine, probably involving thimerosal
additive.”
***
The reason for this tedious exercise,
probably the first of its kind, is simply to try to determine when
peer-reviewed articles related to toxicity /neurotoxicity of
Thimerosal-containing- vaccines (TCV) - both pro and con – were
first published. The fact that Thimerosal causes allergic reactions
such as reported in the publication listed as #2 has been known and
reported for decades and is not relevant to this review.
As mentioned in Part 1
and II,
the
CDC,
the
FDA
and
WHO
usually
start
a
discussion
of the issue of
Thimerosal in vaccines by mentioning that the mercury preservative
has been used since the 1930s, thus suggesting that it must have been
safe and effective.
What those agencies are careful not to ever mention is that the
very first article related to Thimerosal in vaccines on PubMed
(presently listed as # 396 (PMID: 14249458) was
published in October 1964, thirty
four years after
the 1930s.
[I
started practicing pediatrics in 1964 and was just as interested in
vaccines then as I am now. I can safely say that I had never heard of
the Journal of Pharmaceutical Sciences (Elsevier) where that article
was published and that it certainly was not readily available to most
practicing US pediatricians at the time.]
The next listed article (presently listed as # 395 (PMID:
14253616)
was by the same authors and was published in the
following issue of the same journal in November 1964: “Thimerosal
as a preservative in biological preparations. 3. Factors affecting
the concentration of thimerosal in aqueous solutions and in vaccines
stored in rubber-capped bottles.
For
some reason, the second part of that apparent 3-part series was not
listed.
Those
two Birner & Garnet articles were followed by a very long silence
probably because no US pediatrician in his right mind, including this
writer, could have ever dreamed that FDA-licensed pediatric vaccines
on the market contained any more than an infinitesimally
small and innocuous amount of the mercury preservative.
Listing # 394 (PMID:
4283530) was a German article published
in 1974-1975, ten years after the Birner & Garnet articles that
reported allergic reactions to injected gamma globulin.
There were four articles published in 1975,
presently listed as # 393 (PMID:
1053237), 392,
391 and 390. The latter published in
the Journal of Clinical Microbiology
in December 1975 was by John R.
Pemberton, of the Veterinary Services Laboratories, Animal
and Plant Health Inspection Service, U.S. Department of Agriculture,
Ames, Iowa.
[http://www.ncbi.nlm.nih.gov/pmc/articles/PMC275220/?tool=pubmed]
It
is titled “Retention of mercurial preservatives in dessicated
biological products” and is the very first full length article on
the subject available for downloading.
[http://jcm.asm.org/cgi/reprint/2/6/549?view=long&pmid=1420]
The
last paragraph of the article should make anyone shiver thirty six
years later.
“The data reported here and in
previous
reports (2,
3) indicate that a large percentage of formaldehyde, phenol and
mercurial preservative is retained by biological products during the
usual lyophylization process. These preservatives are not
proportionately removed with the liquid portion of the product as
might be expected. Investigators should be cautious when using
preserved and lyophilized biological products in
preservative-sensitive systems. Caution should also be exercised with
products intended for certain immunological uses, as these
preservatives evidently concentrate in the micro-environment of
lyophilized antigenic material, which could denature the antigen.”
Obviously most of us caring for babies never particularly followed
veterinary research at the time and the Journal of Clinical
Microbiology was not exactly a journal pediatricians often picked up on
a lazy Sunday afternoon in the seventies.
Only seven more articles were published during the 70’s, # 389
(PMID: 799865) to # 383 (PMID: 118635)
There were 26 PubMed-listed publications on the subject during the
1980’s, starting with PMID: 6447032 and 25
publications from 1990 to 1999 (PMID: 2137393-9447766)
In all, there were 64 PubMed listings related in some way to
Thimerosal from the 1930s to 1999, an average of 1 publication a
year. The first two articles listed in 1999 were reports of allergic
reactions to Thimerosal and not relevant to this discussion.
The very first publication about the present Thimerosal in vaccines
controversy was “Notice to Readers: Thimerosal in Vaccines: A Joint
Statement of the American Academy of Pediatrics and the Public Health
Service”, published on July 9, 1999 and presently listed as # 329
(PMID: 10418806)
[http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4826a3.htm]
Over 300 articles on issues related to Thimerosal in vaccines were
written, peer-reviewed and published in the last 12 years. On
average, there was 1 publication per year from the late 1930’s to
1999 vs. more than 25 publications per year from 1999 to April 2011.
***
Just to compare publication dates and listings, I searched PubMed for
“Vaccine” and found 163,872 listings, the first about an article
in the BMJ published on May 9, 1903. For those readers interested,
that complete article, “A lecture on therapeutic inoculations of
bacterial vaccines and their exploitation in the treatment of
disease” by A E Wright is available at
[http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2513394/?tool=pubmed]
A similar search for “Disease” yielded 2,572,961 listings,
starting with “On a diminution, in consequence of Disease, of the
Area of the Aperture, by which the left Auricle of the Heart
communicates with the Ventricle of the same side” by John
Abernethy. This article published in 1809
in
Medico-Chirurgical Transactions is available at
[http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2128803/pdf/medcht00073-0049.pdf]
Lastly
a PubMed search for “Thimerosal” yielded 1405 listings, the first
of which “Infrared
method
for
the
determination
of
ethanol
and
acetone
in
thimerosal
tincture
N.F.” by Gronau et al. published in 1962,
also in the Journal of Pharmaceutical
Sciences.
Listing
# 1404, “Studies
on immunity in anthrax. X. Gel-adsorbed protective antigen for
immunization of man” by Puziss & Wright was published in
January 1963.
For
those interested in the Anthrax vaccine saga, the full article is
available at
[http://www.ncbi.nlm.nih.gov/pmc/articles/PMC278112/?tool=pubmed]
That very first publication reporting
on the use of the mercury preservative in a vaccine was not exactly a
vote of confidence. According to the authors:
“Gel-adsorbed anaerobic antigens
preserved with
1:10,000 thimerosal were unstable on storage at 4 C; replacement of
this preservative with 1:40,000 benzethonium chloride produced a more
stable product. Addition of 0.0009% formalin further increased the
stability during accelerated aging at 37 C.”
Listing # 1403 was the above-discussed October 1964
study by Birner & Garnet.
Given the fact that pediatric vaccines
have been recommended and used “since the 1930’s”, the paucity
of research for decades into a key vaccine ingredient is at best
shocking and at worst damning.
***
Dr. Jose Dórea who wrote the most recent PubMed thimerosal in
vaccines paper (listed as #1 as of March 25, 2011) authored and/or
co-authored 9 other peer-reviewed PubMed-listed publications.
Most relevant to this presentation were the following two older
publications reporting some very carefully conducted research:
Hair
mercury
in breast-fed infants exposed to thimerosal-preserved
vaccines. Marques
RC,
Dórea JG, Fonseca MF, Bastos WR, Malm O. Eur
J Pediatr.
2007 Sep;166(9):935-41. Epub 2007 Jan 20.
PMID: 17237965
“…the Hg exposure
corrected for body weight at the day of immunization was much higher
from thimerosal- EtHg (5.7 to 11.3 microgHg/kg b.w.) than from
breastfeeding (0.266 microgHg/kg b.w.). While mothers showed a
relative decrease (-57%) in total hair-Hg during the 6 months
lactation there was substantial increase in the infant's hair-Hg
(446%). We speculate that dose and parenteral mode of thimerosal-EtHg
exposure modulated the relative increase in hair-Hg of breast-fed
infants at 6 months of age.”
Neonate
exposure
to thimerosal mercury from hepatitis B vaccines. Dórea
JG, Marques RC, Brandão KG. Am J
Perinatol. 2009 Aug;26(7):523-7. Epub 2009
Mar 12. PMID:19283656
“Infant exposure to
ethylmercury (EtHg) has not only increased but is starting earlier as
a result of the current immunization schedule that uses
thimerosal-containing vaccines (TCVs). Although vaccination schedule
varies considerably between countries, infants in less-developed
countries continue to be exposed to EtHg derived from more affordable
TCVs. We studied the exposure of newborns to EtHg from hepatitis B
vaccines; hospital records (21,685) were summarized for the years
2001 to 2005 regarding date of birth, vaccination date, and birth
weight. Most of the vaccinations occurred in the first 24 hours
postdelivery; over the 5 years, there was an increase in vaccinations
within hours of birth (same day), from 7.4% (2001) to 87.8% (2005).
Nearly 94.6% of infants are now being vaccinated within the first 24
hours. Range of mercury exposure spread from 4.2 to 21.1 microg
mercury/kg body weight for those receiving TCVs with the highest
thimerosal concentration; these exposure levels are conservative for
2% of children receiving vaccines within 2 to 3 postnatal days, when
they are still going through physiological postnatal weight loss.
Because of the particular timing (transitioning from in utero to ex
utero metabolism) and specific aspects of exposure (i.e., parenteral
mode, bypassing gastroenteric barriers) and dose (related to vaccine
manufacturer and with variation in birth weight), this study reveals
critical issues that can modulate toxicokinetics and toxicodynamics
of organomercurials in neonates.
*****
This latest Dórea publication is impressive and the culmination
of
years of research.
Dr. Jose Dórea serves on the Faculty of Health Sciences at the
Universidade de Brasilia (UnB), one of Brazil’s largest and most
prestigious universities.
UnB’s motto, “A universidade que
inspira”, is itself inspiring, as is evidently the research going
on within its walls with more than 250 research-groups investigating
close to 890 different areas in 400 laboratories. The university
offers 61 undergraduate, 49 Master’s and 27 Doctoral programs.
Dr. Dórea’s pro-vaccine stance is evident in the first sentence
of
his concluding remarks “Without
vaccination it would be
impossible to eradicate or control infectious diseases that otherwise
would be devastating to children…” and his research was
supported by a grant by The National Research Council of Brazil.
Because of its conclusions, the publication must have been
peer-reviewed up and down and sideways several times.
The author selected and attached 81 references some of which I had
not previously seen. Twenty eight of those references were published
in 2009-2010.
Because of copyright issues, I am unable to feature the full
publication on Vaccination News but I certainly encourage everyone to
get it, read it and keep it for future reference.
I will attempt to do this great review justice.
***
Dr. Dórea started his abstract by stating:
“There is a need to interpret
neurotoxic studies to
help deal with uncertainties surrounding pregnant mothers, newborns
and young children who must receive repeated doses of
Thimerosal-containing vaccines (TCVs). This review integrates
information derived from emerging experimental studies (in vitro and
in vivo) of low-dose Thimerosal (sodium ethyl mercury
thiosalycilate.)”
After carefully reviewing the literature and selecting the most
appropriate and convincing articles, the author concluded that:
- The selected studies revealed activity of low doses of
Thimerosal
against isolated human and animal brain cells consistent with mercury
neurotoxicity
- Doses “relevant to TCV exposure possess the potential to
affect
human
neurodevelopment”
- Animal studies reveal that exposure to the mercury in
Thimerosal
can
lead to accumulation of inorganic mercury in the brain
- There were no studies on the neurotoxicity of ethyl mercury
in
the
presence of Aluminum, an adjuvant added to some TCVs now in use
This careful literature review also indicated that:
- Thimerosal in concentrations such as those presently in
pediatric
vaccines still used in many countries “is toxic to cultured human brain
cells and to laboratory animals”
- The present use of TCVs in developing countries “is
counterintuitive to
global efforts to lower Hg exposure and to ban Hg in medical products”
- The continued use of TCVs requires evaluation of “a
sufficiently
nontoxic level of ethylmercury compatible with repeated exposure
(co-occuring with adjuvant –Al) during early life.”
The author ended by appropriately pointing out that more studies
were
urgently needed because “despite demonstrable toxicity of Ethyl
Mercury”, Thimerosal-containing vaccines were still being used in
increasing quantities in developing countries even though real concerns
about pregnant women and newborns receiving such vaccines existed.
***
The studies that Dr. Dórea carefully selected and on which he
based
his conclusions and recommendations were listed in two tables:
Table 1: “Summary of toxicity
studies
of low-dose Thimerosal (or
ethyl mercury) and aluminum in human and animal
cultured-neural-cells.”
Studies by: Geier et al. (2009), Geier et al.
(2010), James et al. (2009), Herdman et al. (2006), Parran et al. (
2005), Yel et al. (2005), James et al. (2005), Humphrey et al.
(2005), Waly et al. (2004), Toimela and Tahti (2004), Baskin et al.
(2003), Lawson et al.(2007), Ueha-Ishibashi et al. (2004), Jin et al.
(2004), Song et al. (2000), Chanez et al. (1989), Wyrembek et al,
(2010), Minami et al. (2009, and Rush et al. (2009).
Table 2: “Animal studies of
neurotoxic
preservative-thimerosal and
adjuvant-Al at doses relevant to vaccines.”
Studies by: Blair et al. (1975), Burbacher et al.
(2005), Hewitson et al. (2010), Hewitson et al. (2010), Gassett et
al. (1975), Olczak et al. (2009), Olczak et al. (2010), Olczak et al.
(2010), Orct et al. (2006), Minami et al. (2010), Minami et al.
(2007), Hornig et al. (2004), Berman et al. (2008), Petrik et
al. (2007), Shaw and Petrick (2009), Hunter et al. (2010).
The following are quotes from some of the above-listed publications:
[2004] Hornig et al.:
“We hypothesized that autoimmune propensity influences outcomes in
mice following thimerosal challenges that mimic routine childhood
immunizations. Autoimmune disease-sensitive SJL/J mice showed growth
delay; reduced locomotion; exaggerated response to novelty; and
densely packed, hyperchromic hippocampal neurons with altered
glutamate receptors and transporters. Strains resistant to
autoimmunity, C57BL/6J and BALB/cJ, were not susceptible. These
findings implicate genetic influences and provide a model for
investigating thimerosal-related neurotoxicity.” [PMID:
15184908]
[2009] James et al.:
Lymphoblastoid cells (LCLs) derived from
autistic children and unaffected controls were used to assess
relative concentrations of reduced glutathione (GSH) and oxidized
disulfide glutathione (GSSG) in cell extracts and isolated
mitochondria as a measure of intracellular redox capacity. The
results indicated that the GSH/GSSG redox ratio was decreased and
percentage oxidized glutathione increased in both cytosol and
mitochondria in the autism LCLs. Exposure to oxidative stress via the
sulfhydryl reagent thimerosal resulted in a greater decrease in the
GSH/GSSG ratio and increase in free radical generation in autism
compared to control cells. Acute exposure to physiological levels of
nitric oxide decreased mitochondrial membrane potential to a greater
extent in the autism LCLs, although GSH/GSSG and ATP concentrations
were similarly decreased in both cell lines. These results suggest
that the autism LCLs exhibit a reduced glutathione reserve capacity
in both cytosol and mitochondria that may compromise antioxidant
defense and detoxification capacity under prooxidant conditions.
[PMID: 19307255]
[2010] Hewitson et
al.: “This longitudinal, case-control pilot study examined amygdala
growth in rhesus macaque infants receiving the complete US childhood
vaccine schedule (1994-1999)…Vaccine-exposed and saline-injected
control infants underwent MRI and PET imaging at approximately 4 and
6 months of age, representing two specific timeframes within the
vaccination schedule. Volumetric analyses showed that exposed animals
did not undergo the maturational changes over time in amygdala volume
that was observed in unexposed animals… results suggest that
maturational changes in amygdala volume and the binding capacity of
[(11)C]DPN in the amygdala was significantly altered in infant
macaques receiving the vaccine schedule.”[PMID:
20628439]
[2010]
Olczak
et al.: “Numerous
neuropathological changes were observed in young adult rats which
were treated postnatally with thimerosal. They included: ischaemic
degeneration of neurons and "dark" neurons in the
prefrontal and temporal cortex, the hippocampus and the cerebellum,
pathological changes of the blood vessels in the temporal cortex,
diminished synaptophysin reaction in the hippocampus, atrophy of
astroglia in the hippocampus and cerebellum, and positive caspase-3
reaction in Bergmann astroglia. These findings document neurotoxic
effects of thimerosal, at doses equivalent to those used in infant
vaccines or higher, in developing rat brain, suggesting likely
involvement of this mercurial in neurodevelopmental disorders.”
[PMID 21225508]
[2010] Wyrembek et
al.: Many neurotoxic effects of thimerosal have been described… We
examined, using electrophysiological recordings, thimerosal effects
on GABA and NMDA-evoked currents in cultured hippocampal neurons...
following exposure for 60-90 min to 1 or 10 μM thimerosal, there was
a significant decrease in NMDA-induced currents (p<0.05) and
GABAergic currents (p<0.05). Thimerosal was also neurotoxic,
damaging a significant proportion of neurons after 60-90 min
exposure; recordings were always conducted in the healthiest looking
neurons…The results reveal complex interactions of thimerosal and
mercuric ions with the GABA(A) and NMDA receptors... The neurotoxic
effects of both mercurials are interwoven with their modulatory
actions on GABA(A) and NMDA receptors, which most likely involve
binding to these macromolecules. [PMID:
21224507]
***
Two other publications not listed in
the Dorea paper deserve mentioning:
Young et al. [2008 - GWU – PMID:
18482737]:
“The study evaluated possible associations between
neurodevelopmental disorders (NDs) and exposure to mercury (Hg) from
Thimerosal-containing vaccines (TCVs) by examining the automated
Vaccine Safety Datalink (VSD). A total of 278,624 subjects were
identified in birth cohorts from 1990-1996 … Consistent
significantly increased rate ratios were observed for autism, autism
spectrum disorders, tics, attention deficit disorder, and emotional
disturbances with Hg exposure from TCVs. By contrast, none of the
control outcomes had significantly increased rate ratios with Hg
exposure from TCVs…
Kempuraj et al. [2010 -Tufts U -
PMID: 20222982]:
“Mercury is known to be
neurotoxic, but its effects on the immune system are less well known.
Mast cells are involved in allergic reactions, but also in innate and
acquired immunity, as well as in inflammation. Many
patients with Autism Spectrum Disorders (ASD) have “allergic”
symptoms; moreover, the prevalence of ASD in patients with
mastocytosis, characterized by numerous hyperactive mast cells in
most tissues, is 10-fold higher than the general population
suggesting mast cell involvement.
Human leukemic cultured LAD2 mast cells and normal
human umbilical cord blood-derived cultured mast cells (hCBMCs) were
stimulated by HgCl2 (0.1-10 μM) for either 10 min for
beta-hexosaminidase release or 24 hr for measuring vascular
endothelial growth factor (VEGF) and IL-6 release by ELISA... HgCl2
induced a 2-fold increase in b-hexosaminidase release, and also
significant VEGF release at 0.1 and 1 μM (311 ± 32 pg/106 cells
and
443 ± 143 pg/106 cells, respectively) from LAD2 mast cells
compared
to control cells (227 ± 17 pg/106 cells, n = 5, p < 0.05).
Addition of HgCl2 (0.1 μM) to the proinflammatory neuropeptide
substance P (SP, 0.1 μM) had synergestic action in inducing VEGF
from LAD2 mast cells. HgCl2 also stimulated significant VEGF release
(360 ± 100 pg/106 cells at 1 μM, n = 5, p < 0.05) from hCBMCs
compared to control cells (182 ± 57 pg/106 cells), and IL-6
release
(466 ± 57 pg/106 cells at 0.1 μM) compared to untreated cells
(13 ±
25 pg/106 cells, n = 5, p < 0.05). Addition of HgCl2 (0.1 μM) to
SP (5 μM) further increased IL-6 release...
The results of the present study support the
biological plausibility of how mercury could contribute to ASD
pathogenesis by inducing VEGF and IL-6 release from mast cells, and
as a result disrupt the BBB and thus permit brain inflammation.”
*****
On February 9, 2004 the Institute of Medicine (IOM) Immunization
Safety Review Committee met to dispose once and for all, of the wild
notion that autism was somehow related to MMR vaccination and or
Thimerosal-containing vaccines.
On Wednesday March 30, 2011, I accessed the information still
available on the IOM web site and found the following:
Immunization Safety
Review: Vaccines and Autism
Released: May 14, 2004
Type: Consensus Report
Topics: Children,
Youth
and
Families, Public
Health
Activity: Immunization
Safety
Review
Board: Board
on
Population
Health
and
Public
Health
Practice
This eighth and final report of the Immunization
Safety Review Committee examines the hypothesis that vaccines,
specifically the measles-mumps-rubella (MMR) vaccine and
thimerosal-containing vaccines, are causally associated with autism.
The committee reviewed the extant published and unpublished
epidemiological studies regarding causality and studies of potential
biologic mechanisms by which these immunizations might cause autism.
The committee concludes that the body of
epidemiological evidence favors rejection of a causal relationship
between the MMR vaccine and autism. The committee also concludes that
the body of epidemiological evidence favors rejection of a causal
relationship between thimerosal-containing vaccines and autism. The
committee further finds that potential biological mechanisms for
vaccine-induced autism that have been generated to date are
theoretical only.
The committee does not recommend a policy review of
the current schedule and recommendations for the administration of
either the MMR vaccine or thimerosal-containing vaccines. The
committee recommends a public health response that fully supports an
array of vaccine safety activities.
In addition, the committee recommends that available
funding for autism research be channeled to the most promising areas.
The committee makes additional recommendations regarding surveillance
and epidemiological research, clinical studies, and communication
related to these vaccine safety concerns.
http://www.iom.edu/Reports/2004/Immunization-Safety-Review-Vaccines-and-Autism.aspx
|
Three questions need to be asked:
- If the IOM committee was not impressed with the biomedical
studies
presented, then why not invite or order researchers in the US and
elsewhere to further investigate the issues? Why close the door and say
“No more research should be done”?
- Since when is theoretical evidence dismissed simply because
it
is
theoretical?
- What scientific argument supports the committee’s assertion
that
epidemiological evidence in questionably funded studies is more
compelling than evidence presented by independent researchers
performing biomedical evaluations and reviews?
***
On May 11, 2005, I wrote a personal letter to IOM President Harvey
V. Fineberg, MD, PhD
questioning the committee’s findings and
requesting a review of the matter.
[http://www.vaccinationnews.com/node/19921]
I also submitted to the IOM President a list of impressive research
on Thimerosal that had been peer-reviewed and published since the
2004 meeting. [References 1-12
attached]
Fineberg never offered me the courtesy of a response!
***
As exposed in Part
II of this series, WHO accepted the IOM
Immunization Safety Review Committee’s 2004 verdict as Gospel truth
and has used it successfully since then to close the door to new
research and to justify the continued use of Thimerosal in vaccines.
Thankfully, independent investigators did not listen to the committee
and persisted in designing and carrying out excellent research since
then.
Without their efforts and Dr. Dórea’s careful review of their
results to date, no one would have known how much more we have
learned on the subject of Thimerosal (and Al) since that supposedly
“final” 2004 IOM Immunization Safety Review Committee meeting and
its contrived findings.
I said “supposedly final" because parents suspecting that their
children were affected by Thimerosal in vaccines should request their
elected officials to call for another meeting, this one by a new Immunization Safety Review
Committee with a different chairperson.
Attorneys who have seen their Thimerosal-autism cases railroaded should
also contact VICP (National Vaccine
Injury Compensation Program) and “lawyer” as best they can to
resume those hearings.
The
unfortunate facts
On January 15,
2004, Congressman Dave Weldon, a physician, wrote to then CDC
Director Julie L. Gerberding MD, MPH asking her to post-pone the
February 9, 2004, Institute of Medicine (IOM) Immunization Safety
Review Committee meeting: “Pressing
forward with this meeting at
this time, I believe, will further undermine the credibility of the
Centers for Disease Control (CDC) on matters of vaccine safety and do
damage to the reputation of the IOM. I believe the proposed date of
this meeting, which you have the ability to change, is in the best
interests of no one who is seeking the truth about a possible
association between vaccines and neurodevelopmental disorders,
including autism"
Dr. Weldon also
stated that he was concerned about the agenda of the meeting and the
fact that the committee was only dedicating one hour to the
MMR/Autism issue and only allowing two witnesses to speak.
The Congressman similarly complained that the “discussion of epidemiology relating to
thimerosal and autism is heavily biased against those who have raised
these concerns and will not allow for a fair and balanced discussion of
the literature. The time set aside for a discussion of the biological
mechanisms of thimerosal and autism is inadequate to allow a full
discussion of the issue.”
He ended his
letter by stating: “To consider two
issues of such significance
in only seven hours does not serve the public interest. To the
outside observer it does not appear to be a serious effort to examine
these critical issues. Any conclusions drawn from this meeting,
including any report issued, will be viewed as suspect given the very
limited time dedicated to examining very incomplete information."
Dr. Gerberding
responded that she had shared Dr. Weldon’s concerns with IOM
President Fineberg and that the meeting will be held as planned. She
wrote: "My own view is that it is
extremely important to have
the IOM conduct an objective review of emerging data when it has a
bearing on vaccine safety as quickly as possible. In addition,
the process should be ongoing at regular intervals, to keep up with
this science of vaccine safety as new information becomes
available.
We intend to renew our agreement with the IOM to ensure continuation
of the safety review process."
Had the conclusions of the IOM been different, i.e., recommending
further MMR and Thimerosal – autism research, Dr. Gerberding’s desire
to “quickly” review the issue might have been less suspicious. Given
the fact that contrary to what she wrote to Dr. Weldon, that the
“process should be ongoing”, the committee’s conclusions were quite the
opposite, the CDC director’s failure to postpone the meeting was
damning indeed.
In addition,
everyone including Dr. Weldon knew that the CDC had funded
epidemiological studies in Denmark and elsewhere and that some CDC
epidemiologists had actively participated and even co-authored some
of the publications presented to the committee. Why the CDC ever
funded epidemiological studies in Denmark where the pediatric
vaccination schedule was different from that of the United States,
where fewer vaccines were administered and where Thimerosal had been
banned for a decade are questions that just beg to be answered.
Regardless, what no
one knew or imagined was that the CDC was also clandestinely
ghost-writing, in a fashion, a review of Thimerosal by a US
academician and that the IOM committee wanted to see that review
before the February 2004
hearing.
To the best of my
knowledge, the following information is made public here for the
first time. As not to embarrass anyone, I have withheld names.
All the letters
were on official CDC stationary with Department of Health and Human
Services --- Public Health Service above the CDC logo.
The letters were written by a Senior Advisor to the Director of the
National Immunization Program (NIP) of the CDC and addressed to an
Assistant Professor at a distinguished university.
July 9, 2003
Dear S.
… Since continuation of the MMR-autism project is
probably not needed, there is an alternate approach. There are 6
articles in press and several published dealing with thimerosal and
autism. I suggest that we shift emphasis to writing a manuscript that
deals with this potential association. I will send you all of the
published and in press articles I have so that you can consider this
change. Since many of these articles are in press, we will be ahead
of the curve if we move rapidly. Another advantage is that with our
experience to date and exclusion of the literature validation aspect,
this article would be much easier to write.
We should establish a strict timeline for this
project. I will be in xxxx on September 21, at which time we can
finalize this manuscript, if you agree.
Sincerely,
|
July 10, 2003.
Dear S
Enclosed are several articles dealing with thimerosal
and autism. There may be a few more that our vaccine safety folks
have. I know of one more ecologic study from Denmark to be published
in Pediatrics. I will obtain a copy. Expect a call from me next week
to discuss the future.
Sincerely,
|
August 28, 2003
Dear S
Enclosed is the thimerosal manuscript upon which I
have made a few edits. In addition there are a few other
considerations
1. I just returned from London where I learned that L
has submitted a manuscript using data from the UK showing no
association between thimerosal and autism. I have contacted L by
e-mail to ask for a copy of this manuscript. So we can include it.
2. I suggest adding the table of the Epidemiologic
studies.
3. I will inquire as to why Denmark removed
thimerosal from the vaccines, and determine if we can obtain
information on the 88 patients mentioned on page 13.
4. The introduction dealing with a history of
thimerosal should be shortened and moved to the discussion
5. I did not spend time on the references -- next
draft
6. I have enclosed a copy of the recent A paper, the
IOM report, and another B article.
Good job. Progress is fast and furious.
Sincerely,
|
[Note by FEY: L was a physician
attached to the UK Public Health Laboratory Service --- The A paper
supported the CDC position and the B paper opposed it]
December 30, 2003
Dear S
Enclosed are several items.
1. A copy of the VAERS article which will appear in
xx
2. An edited version of THE manuscript
You have done an excellent job on the manuscript. I
am meeting with xxx on Wednesday to discuss this version. I suggest
the following:
1. minor edits included
2. move indicated parts of the results section into
the discussion section.
3. I know this will be painful for you, but eliminate
the part of the discussion dealing with review of the history of
thimerosal (22-23)
4. eliminate table 3
5. add a column to table one listing mechanism of ASD
diagnosis
6. add the 1985 A animal data to the discussion
7. I will contact Dr. L to ascertain the status of
references 38 and 39.
8. I’ll develop a list of people we should ask to
review this manuscript before submission
The IOM Safety Review Committee considers autism and
vaccines in February and would like a copy of this paper. Therefore
we need to submit to a journal before then. The end is near!
Sincerely,
|
The above letters obtained with much difficulty from the CDC through
the FOIA show conclusively that the IOM Immunization Safety Review
Committee was shown a manuscript on Thimerosal that was commissioned,
supervised, corrected and promoted by individuals in the National
Immunization Program of the CDC. The letters also show that
individuals at the CDC can somehow review articles before they are
published in medical journals and can force editors of leading
medical journals to accept and fast-track studies they have shaped or
created, while on the other hand, their director convenes a meeting
pronto in order to railroad contrary findings.
Discussion & Conclusions
Even though the
mercury preservative Thimerosal has been added to vaccines since the
1930’s, supposedly to guarantee the sterility of multi-dose vials,
no one ever bothered to check its safety or
question its use for decades.
The IOM
Immunization Safety Review Committee was influenced by the CDC before
and during its February 9, 2004 meeting. The committee’s decision
concerning Thimerosal and autism was flawed, ill-advised and based on
biased epidemiological studies, several of which funded or instigated
by the CDC and its National Immunization Program. Moreover its timing
was apparently designed to avoid imminent
studies which could have demonstrated a connection between vaccines
and autism.
Since then,
peer-reviewed and published information has clearly indicated:
- That low doses of Thimerosal such as those in TCV are
neurotoxic
- That such amounts of ethyl mercury possess the potential to
affect human neurodevelopment
- That to date, no studies have been carried out on the
neurotoxicity of Thimerosal in the presence of Aluminum-adjuvant
presently in some widely used TCV
- And that exposure to Thimerosal can lead to accumulation of
inorganic mercury in the brain
This presentation strongly suggests that the World Health
Organization should reconsider its present stand of only recommending
TCV in multi-dose vials.
Countries that have the means to buy preservative-free vaccines
should ignore the WHO recommendations and do so. The minute added
cost of preservative-free single dose vaccines is negligible when
compared to the financial and human cost of autism.
HHS should order the Institute of Medicine to create a new Vaccine
Safety Review Committee with a new chairperson to review the subject.
The National Vaccine Injury Compensation Program should be requested
to ignore the IOM recommendations and to review the presently
available information on Thimerosal.
The preponderance of available evidence strongly suggests that
Thimerosal containing vaccines could have indeed caused neurological
and developmental complications in genetically predisposed infants
and children.
In fact, the preponderance of evidence seems overwhelming!
*****
References:
- Hornig M, Chian D, Lipkin WI. Neurotoxic effects of
postnatal
thimerosal are mouse strain dependent. Mol Psychiatry. 2004
Sep;9(9):833-45
- Burbacher TM, Shen DD, Liberato N, Grant
KS, Cernichiari E, Clarckson T. Comparison of Blood and Brain Mercury
Levels in Infant Monkeys Exposed to Methylmercury or Vaccines
Containing Thimerosal
http://ehp.niehs.nih.gov/members/2005/7712/7712.pdf
- Waly M, Olteanu H, Banerjee R, Choi SW, Mason
JB, Parker BS, Sukumar S, Shim S, Sharma A, Benzecry JM,
Power-Charnitsky VA, Deth RC. Activation of methionine synthase by
insulin-like growth factor-1 and dopamine: a target for
neurodevelopmental toxins and thimerosal. Mol Psychiatry. 2004
Apr;9(4):358-70.
- James SJ, Slikker W 3rd, Melnyk S, New E,
Pogribna M, Jernigan S. Thimerosal neurotoxicity is associated with
glutathione depletion: protection with glutathione precursors.
Neurotoxicology. 2005 Jan;26(1):1-8.
- Geier DA, Geier MR. A comparative evaluation of
the effects of MMR immunization and mercury doses from
thimerosal-containing childhood vaccines on the population prevalence
of autism.Med Sci Monit. 2004 Mar;10(3):PI33-9.
- Geier D, Geier MR. Neurodevelopmental disorders
following thimerosal-containing childhood immunizations: a follow-up
analysis. Int J Toxicol. 2004 Nov-Dec;23(6):369-76.
- Geier DA, Geier MR. A two-phased population
epidemiological study of the safety of thimerosal-containing vaccines:
a follow-up analysis. Med Sci Monit. 2005 Mar 24;11(4):CR160-170
- Blaxill MF, L Redwood L, and Bernard
S.Thimerosal and autism? A plausible hypothesis that should not be
dismissed. Medical Hypotheses; 62: 788-794, 2004.
- Humphrey ML, Cole MP, Pendergrass JC, Kiningham
KK. Mitochondrial Mediated Thimerosal-Induced Apoptosis in a Human
Neuroblastoma Cell Line (SK-N-SH). Neurotoxicology. 2005 Apr 30; (Epub
ahead of print)
- Parran DK, Barker A, Ehrich M. Effects of
Thimerosal on NGF signal transduction and cell death in neuroblastoma
cells Toxicol Sci. 2005 Apr 20; (Epub ahead of print)
- Havarinasab S, Haggqvist B, Bjorn E, Pollard
KM, Hultman P. Immunosuppressive and autoimmune effects of thimerosal
in mice. Toxicol Appl Pharmacol. 2005 Apr 15;204(2):109-21.
- Ueha-Ishibashi T, Tatsuishi T, Iwase K, Nakao
H, Umebayashi C, Nishizaki Y, Nishimura Y, Oyama Y, Hirama S, Okano Y.
Property of thimerosal-induced decrease in cellular content of
glutathione in rat thymocytes: a flow cytometric study with
5-chloromethylfluorescein diacetate.Toxicol In Vitro. 2004
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