False information in DeStefano/Rhodes response to M. Geier 24 March 2004

From Mark & David Geier

Dear Everyone,
 
Please, find below a copy of the letter to the Editor regarding the
Verstraeten et al. study in Pediatrics that we have written that is now
posted at:

http://pediatrics.aappublications.org/cgi/eletters/112/5/1039
 
   
 Study Misses Link Between Thimerosal and Neurodevelopmental Disorders 23
February 2004
 Previous P3R  Top 
 Mark R. Geier,
Geneticist and Vaccinologist
The Genetic Centers of America,
David A. Geier of Medcon, Inc.

Send letter to journal:
Re: Study Misses Link Between Thimerosal and Neurodevelopmental Disorders
 
Email Mark R. Geier, et al.
 

 

Letter to the Editor:

The recent article, "Safety of Thimerosal-Containing Vaccines: A Two-
Phased Study of Computerized Health Maintenance Organization Databases," by
Verstraeteten et al. [1], which failed to find a consistent association
between thimerosal in childhood vaccines and neurodevelopmental disorders,
has a number of issues that need to be further addressed.

First, the head author, Dr. Thomas Verstraeten, has for the past several
years worked for GlaxoSmithKline, a vaccine manufacturer of
thimerosal-containing vaccines. In addition, Nancy Pekarek, a company
spokeswoman for GlaxoSmithKline, has written that Verstraeten, since
leaving the Centers for Disease Control and Prevention (CDC), has worked as
an adviser as the study was finalized and prepared for publication.
Presently, GlaxoSmithKline, potentially, faces a large number of lawsuits
on the very issue that the paper discusses.

Second, this very study was the topic of secrete-closed meetings between
members of the CDC and other government organizations, as well as members
of the vaccine manufacturers held at Simpsonwood, Georgia from 7-8 June
2000. The transcript of this meeting has been obtained under the Freedom of
Information Act. This transcript reveals that the study initially found
statistically significant dose-response effects between increasing doses of
mercury from thimerosal-containing childhood vaccines and various types of
neurodevelopmental disorders. The transcript documents that the data was
real and statistically significant for many types of neurodevelopmental
disorders, but that the meeting participants expressed that the data had to
be "handled." Despite, discussion about how to "handle" the data, some
participants expressed concern that the work that had already been done
would be obtained by others through the Freedom of Information Act. In this
event, even if professional bodies expressed the opinion that there was no
association between thimerosal and neurodevelopmental disorders, it was
already too late to do anything. In addition, other participants expressed
that the vaccine manufacturers were in a horrible position to be able to
defend any lawsuits alleging a relationship between thimerosal and
neurodevelopmental disorders, since no one would say with the available
data that there was no relationship between thimerosal and
neurodevelopmental disorders. Even Verstraeten, in an email following the
Simpsonwood meeting, expressed surprise that the data was to be
manipulated, stating that ones desire to disprove an unpleasant theory
should not interfere with sound scientific methods to evaluate the
relationship between thimerosal and neurodevelopmental disorders.

Third, there are also significant issues about the methods used to
determine the mercury dose that children received from thimerosal-
containing vaccines. The authors, in Table 1 of their manuscript,
completely fail to mention that there were large numbers of thimerosal-
free Diphtheria-Tetanus-acellular-Pertussis (DTaP) vaccines administered to
children in the Health Management Organizations (HMOs) analyzed.
Thimerosal-free DTaP vaccine has been produced by GlaxoSmithKline since
1997. We have personally analyzed the Vaccine Safety Datalink (VSD)
database determining that approximately one-third of the children receiving
DTaP in the VSD from 1997 through 2000 were immunized with this vaccine,
and that the children received thimerosal-free DTaP vaccines in various
combinations, with some receiving four doses of thimerosal-free DTaP, some
receiving three doses of thimerosal free DTaP and one dose of
thimerosal-containing DTaP, some receiving two doses with and two doses
without thimerosal, some receiving three with and one without thimerosal,
and some receiving all four doses of thimerosal-containing DTaP. In order
to evaluate whether Verstraeteten et al., did or did not take this into
account, we analyzed Table 1 from their study for the possible cumulative
mercury exposures at the various ages of immunization. At one month, the
possible mercury exposure was 12.5 micrograms of mercury according to the
authors, which is appropriate because there was no potential thimerosal-
free DTaP vaccine to take into account. At 2-3 months, the possible
cumulative mercury exposure was 37.5-75 micrograms of mercury according to
the authors. These potential possible cumulative mercury exposures could be
generated by DTP and Hib vaccine separated or combined, or by
thimerosal-free DTaP vaccine and Hib (i.e. both DTPH or thimerosal-free
DTaP vaccine and Hib vaccine, resulted in children being exposed to 25
micrograms of mercury). At 5-6 months, the possible cumulative mercury
exposure was 75 or 125 micrograms according to the authors. The fact that
the authors only list these two potential possible cumulative mercury
exposure doses show that the authors failed to take into account the
thimerosal-free DTaP vaccine made by GlaxoSmithKline, since children
receiving one thimerosal-containing DTaP followed by one thimerosal-free
DTaP vaccine, in addition to their two doses of hepatitis B vaccine and two
doses of Hib vaccine received 100 micrograms of mercury, a mercury dose not
mentioned in the table. At 6-7 months, the possible cumulative mercury
exposure was 112.5 micrograms of mercury or 187.5 micrograms of mercury
according to the authors. These potential possible cumulative mercury
exposures show overwhelmingly that there is a significant error in the
study. The intermediate mercury values children were exposed to also
included: two thimerosal-containing and one thimerosal-free DTaP vaccine,
with three doses of hepatitis B vaccine and three doses of Hib vaccine, for
a total of 162.5 micrograms of mercury; and two thimerosal-free DTaP and
one thimerosal-containing DTaP vaccine, with three doses of hepatitis B
vaccine and three doses of Hib vaccine, for a total of 137.5 micrograms of
mercury. These calculations indicate that Verstraeteten et al. did not take
thimerosal-free DTaP vaccine into account in their study, or if they did,
then their paper, as it stands, is replete with inaccurate information.

Additionally, the fact that the VSD data contained large numbers of
children who took thimerosal-free DTaP vaccine and large numbers of
children who took thimerosal-containing DTaP vaccine allows a much more
direct and powerful way to do the study by comparing these two groups,
since this type of analysis would allow for overall evaluation of the
effects of increasing doses of mercury from thimerosal in comparison to
considerably lesser doses of mercury from thimerosal. We have done just
such a study in VSD and found an association between increasing doses of
thimerosal and neurodevelopmental disorders. We have previously
epidemiologically examined the Vaccine Adverse Event Reporting System
(VAERS) for children receiving thimerosal-containing DTaP vaccines in
comparison to thimerosal-free DTaP vaccines and the US Department of
Education dataset, and both showed an overall and dose-response
statistically significant link between increasing doses of thimerosal and
neurodevelopmental disorders [2-5]. It also has been observed that children
with autism fail to excrete mercury in their hair and show large increases
in the amount of mercury in their urine following chelation therapy in
comparison to controls [6,7]. These finding are particularly troubling in
light of the fact that many authors including Slikker [8] from the Food and
Drug Administration have published that thimerosal crosses the blood-brain
and placental barriers and results in appreciable mercury content in
tissues including the brain, and because it has been shown by Baskin et al.
[9] that micromolar concentrations of thimerosal are capable of causing
significant damage to neurons. A recently published report from
Northeastern University, the University of Nebraska, the USDA, and the
Johns Hopkins University has found that thimerosal at picomolar
concentrations is a potent neurotoxin since it inhibits the insulin growth
factor-1 and the dopamine-stimulated methlyation synthase pathways
providing a potential molecular mechanism of how the link between
thimerosal in vaccines and neurodevelpmental disorders, reported in our
studies, actually increased the incidence of autism and how thimerosal in
vaccines through its interaction with the D4 receptor gene may even account
for the increase in ADHD as well [10]. It also is in keeping with the many
hundreds of peer-reviewed articles published over many decades and from
many fields of medicine and science reporting on the harmful effects of
thimerosal in humans, animals, isolated neurons, and other systems.

Fourth, there is also a significant issue regarding the inclusion of
children who received whole-cell Diphtheria-Tetanus-Pertussis (DTP) vaccine
and DTaP vaccine. The Institute of Medicine of the United States' National
Academy of Sciences has determined that the evidence is consistent with a
causal relationship between whole-cell DTP vaccine and permanent brain
damage [11, 12]. In addition, despite the claim by Verstraeteten et al.
that encephalopathies following whole-cell DTP occur only rarely, and
therefore, this would be unlikely to have influenced the results of the
study, some authors, such as Strom [13] reported that 1 in 6,000 children
developed a neurological reaction and 1 in 17,000 children died or were
left with a permanent neurological defect, and Pollock and Morris [14] who
reported that 1 in 8,500 children died or had a neurological disorder
following whole-cell pertussis vaccination. Therefore, it is clear that the
assumption by Verstraeteten et al. that whole-cell DTP vaccine would have
limited effects upon the results of their study seems incorrect, but rather
points to a serious confounder present in their study that makes evaluation
of the effect of thimerosal more difficult to discern.

In conclusion, because of a number of very serious issues have been raised
and the critical importance of the issue as to whether thimerosal causes
neurodevelopmental disorders, we respectfully request that Verstraeten et
al. consider withdrawing this study. In order to restore the badly damaged
confidence in our much needed vaccine program, it is necessity that past
errors be admitted, and that open investigations be conducted on vaccines
issues. It is also essential that future vaccine decisions are made by
physicians and scientists without even the appearance of conflicts of
interest.

Dr. Mark R. Geier has been a consultant and expert witness in cases
involving vaccine adverse reactions before the National Vaccine Injury
Compensation Program and in civil litigation.

David A. Geier has been a consultant in cases involving vaccine adverse
reactions before the National Vaccine Injury Compensation Program and in
civil litigation.

References

1. Verstraeten T, Davis RL, DeStefano F, et al. Safety of thimerosal-
containing vaccines: A two-phased study of computerized health maintenance
organization databases. Pediatrics. 2003;112:1039-1048.

2. Geier MR, Geier DA. Neurodevelopmental disorders following
thimerosal-containing vaccines: a brief communication. Exp Biol Med.
2003;228:660-664.

3. Geier MR, Geier DA. Thimerosal in childhood vaccines, neurodevelopment
disorders, and heart disease in the United States. J Am Phys Surg.
2003;8(1):6-11.

4. Geier DA, Geier MR. An assessment of the impact of thimerosal on
childhood neurodevelopmental disorders. Pediatr Rehabil. 2003;6:97-102.

5. 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;10(3):PI33-139.

6. Bradstreet J, Geier DA, Kartzinel JJ, Adams JB, Geier MR. A case-
control study of mercury burden in children with autistic spectrum
disorders. J Am Phys Surg. 2003;8:76-79.

7. Holmes AS, Blaxill MF, Haley BE. Reduced levels of mercury in first baby
haircuts of autistic children. Int J Toxic. 2003;22:277-285.

8. Slikker W. Developmental neurotoxicology of therapeutics: survey of
novel recent findings. Neurotoxicology. 2000;21:250.

9. Baskin DS, Ngo H, Didenko VV. Thimerosal induces DNA breaks, caspase-3
activation, membrane damage, and cell death in cultured human neurons and
fibroblasts. Toxicol Sci. 2003;74:361-368.

10. Waly H, Olteanu H, Banerjee R, et al. Activation of methione synthase
by insulin-like growth factor-1 and dopamine: a target for
neurodevelopmental toxins and thimerosal. Mol Pyschiatry. (in press).

11. Howson CP, Howe CJ, Finebery HV, eds. Adverse Effects of Pertussis and
Rubella Vaccines. Institute of Medicine. Washington, DC: National Academy
Press; 1991.

12. Stratton KR, Howe CJ, Johnston RB, eds. DPT Vaccine and Chronic Nervous
System Dysfunction: A New Analysis. Institute of Medicine. Washington, DC:
National Academy Press; 1994.

13. Strom J. Is universal pertussis vaccination always justified? Br Med J.
1960;2:1184-1186.

14. Pollock TM, Morris J. A 7-year survey of disorders attributed to
vaccination in North West Thames region. Lancet. 1983;1:753-757.

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