Sir
I have a number of queries for the authors of this paper.
1. There is evidence that thimerosal was present in vaccines given to
Quebec children up to 1997, not only to 1996. Documents such as the
Advisory Committee Statement in the Canada Communicable Disease Report
Volume 29 of 1st March 2003 evidence that there were various possible
thimerosal sources still available for children and adults after 1996 –
not least Hepatitis B vaccines given to immigrant children, travel
vaccines available for families holidaying abroad, multidose vials of what
would otherwise be thimerosal free single vaccines, Flu vaccines given to
alleged “at risk” persons including children. The authors fail to
demonstrate that ANY of the uncontrolled subject cohorts with or without
PDD diagnoses were free of these vaccines, or the additional mercury load
such vaccines would induce. During 1997/98 in Quebec there was an outbreak
of Hepatitis A in the Jewish community for which medical authorities
intervened with HAV shots, some known to carry thimerosal? Were there were
no Jewish children registered at the schools during the survey period?
About 25% of the Quebec population are immigrants, therefore may have had
additional mercury through Hepatitis B shots; a substantial number of
children might be statistically expected as suffering from “at risk”
conditions whereby flu shots could have been given to children over the
age of 6 months. Such additional thimerosal/mercury loading would surely
invalidate the authors’ claim to a “thimerosal-free” period from 1996
onwards, thus invalidating the research.
2. The more severe forms of autism can render sufferers incapable of
remaining in schools, other than special schools, of which none were
included in this study. It is commonly acknowledged that many afflicted
children may either be unable to sustain a place in a public school or are
eventually excluded, or may not even find a place suitable for placement.
Government statistics in the UK shows that over 25% of children with
autism have been excluded from schools. Placements at special schools are
at a premium, whilst many children home to be educated and cared for when
there are no suitable placements. In a cohort of 27,000 children from
which only 180 PDDs are identified, were 25% of autistic children already
excluded from the schools in question therefore missing from
identification through registration, how could a cohort of only 180
remaining identified children provide sufficient statistical power to form
meaningful conclusions? Some parents may exclude their children preferring
a special school placement for which they may move state, some may be
excluded school or vaccination by virtue of religion, some children
already believed damaged by vaccines could have been excluded by parental
choice and the most severely damaged – if still living and capable of
sustaining a school place – maybe of older cohorts - may also have been
exempted from further vaccination. These probabilities appear to have been
ignored statistically by the authors who have not made an effort to try
assess what impact these confounders could have by obtaining information
about them, ignorance preferred. Significantly none of the 55 schools are
special schools yet all the schools gain handsomely from PDD diagnoses for
which funding is at a premium. Would not therefore alternative diagnoses
that are borderline PDD, eg ADHD, non-PDD behavioural problems be less
preferable to the more heavily funded PDD diagnoses? Could this skew
figure or must the authors assume all diagnoses are made without fear or
favour? The 55 schools are 45 elementary and 10 secondary, a 4.5:1 bias
towards the former and therefore leaves a small cohort of 180 PDDs drawn
from a “biased towards elementary” 27,749 children. Therefore a relatively
small number of secondary school children for general analysis; a split
that is further compromised by the exclusion of 10 secondary school
students with a PDD diagnosis who were 17 years old or over as they “could
not be related to a meaningful denominator”. The exclusions of about 6 %
of the secondary school PDD cohort representing a significant number of
11th Graders, leaves a remainder still represented in the charts and
tables.
3. Can the short period of time the study covers (1987 thro’ 1998)
for so few children with PDD (180) – or as little as perhaps 6 in one
birth year from which to elucidate PDD development – coupled with major
alterations and variations in vaccine schedule, diagnostic criteria, major
school transitions for ages specified, vaccine types and amounts each
child receives for that short period, that makes for an absolutely
confusing and confounding set of individual circumstances mean that the
statistics employed can never be expected to elucidate accurately? How can
the authors expect any rational analysis with such limited cohort sizes,
insufficiency of real data thence substituted by guesswork, so many
vaccine schedule changes during an 11 year period, major changes to
diagnostic policy that threw adjudicators from principles that inevitably
identified more autistics than probably existed (DSM-III-R from 1987 to
1994), to ICD-10 from 1992 onwards that conflicted with DSM-III-R and DSM-
IV, and DSM-IV from 1994 which inevitably reduced the numbers of autistic
persons diagnosed, and introduced Aspergers into the equations – yet the
authors make no attempt to evaluate the impact of these issues on total,
or small cohorts, per 11 year or single grade period?
4. Does the omission from the study of any form of evaluation of the
double dose of MMR after 1996 (only the general rate of uptake of “an MMR
vaccine” adorns the study chart and evaluations, whereas it might be more
accurate to show a “double uptake” after 1996) affect the study integrity?
Clearly various vaccines were in use during the study period. I have
already established that thimerosal containing vaccines were (and are
still) in use long after the authors claim there were none. How do
different makes, batches, ingredients, schedules, doses per child, total
adjuvants injected, weight per child, alternative sources of intake of
potentially toxic heavy metals aluminium and mercury from environmental,
dietary such as sea food, and dental amalgams in older children that would
add substantially to the amount and statistical spread of these toxins
throughout the authors’ tables and charts? Without any attempt to
ascertain exact vaccination analyses for ANY child or group of children
from which to be more certain of their published findings the authors
appear to be failing in a basic duty of care to children required by
ethical bodies where research for children is enacted – by ignoring
obvious confounders and making no attempt to quantify the potential power
for these omissions to confound results, the lack of specific vaccine
status for every subject child, despite there being so few that individual
records ought to be available if only for a small subgroup to ascertain
typical status instead of assumed, could seriously affect the integrity of
the study and impact seriously on all children for whom government policy
may be borne out of such impudence.
5. Does the lack of any analysis of those children who, through early
vaccination damage, were never registered in such LBPSB schools yet reside
in that area affect the integrity of the study? Ignorance of
individualised child data means the authors were working purely on
relative assumptions, “educated” opinion and guesswork, which surely
cannot benefit Quebec children in the main? Age and weight of children
vary therefore risk of toxicity to mercury, children who travel abroad,
children who suffer coincident “at risk” conditions who receive annual flu
shots, children who are immigrants (there was a significant increase in
immigrant population to Montreal during the period which is not accounted
for, some say as much as 25% influx took place into Montreal) children
with dental amalgam mercury loading coincident with mercury-containing
vaccination, outflows of children whose parents seek special school
placements, children having potentially confused alternative diagnoses (eg
ADHD, schizophrenia, bipolar and various behaviour disorders etc.) that
are easily confused by the DSM and ICD coding systems, can all bear
heavily on analysis – especially where some Grades/years have as little as
about 6 PDD children from which to compare “like with like” from other
years yet may have been confounded by the addition of doubling of MMR
dose, or diagnosis by DSM-IV versus others diagnosed with DSM-III-R or ICD
-10. Should only one or two children be “missed” from such a subset the
whole paper crumbles like a pack of cards – exclusion of said data does
not exclude the probability it exists in sufficient quantity to invalidate
any findings. None of this data is difficult to source so the authors must
have consciously chosen to avoid that essential realism.
6. Fombonne et al use the fact that some of their other studies
arrived at a prevalence rate for all PDDs as about 65/10,000 as some kind
of support for their findings herein, yet it was recently revealed in the
UK that the figure should be nearer 116/10000 children – so their use of
65/10000 to support their findings is at variance with a reality
discovered in recent research at Guys and St Thomas’s, UK, carried out by
Professor Gillian Baird et al. Also some of the authors’ reference studies
are either discounted or have been severely criticised, for example one of
Fombonne’s recent papers was dismissed in a Cochrane MMR Review as
“impossible to interpret”. Out of 5000 similar studies the Cochrane team
found only 6 studies they felt reasonably valid though still shaky, and
many of the references supplied by the authors appear in the 5000.
7. In charts and tables purporting to evidence the MMR and toxic
mercury state of those children the authors identify a “linear” increase
of around 10% over the period shown; this belies the literally mountainous
terrain demonstrated by the figures. The “linear vision” belies obvious
hikes and troughs, perhaps expected were thimerosal and MMR vaccines
damaging children. It is not difficult to visualise how the dramatic hikes
in prevalence from 90-91 and 93-94 might be due to increasing thimerosal
loads; and how the dramatic hike from 97-98 might evolve out of prolonged
(beyond the authors’ stated end of) thimerosal use in vaccines coupled
with doubling of MMR, with perhaps additional mercury from Hepatitis B
shots (especially Jewish children and immigrants) and flu shots for the
“at risk” creating a very substantial potentially toxic overload of
perhaps 300ug ethylmercury along with two MMR jabs, plus standard
scheduled vaccines with attendant adjuvants. Not the mythical “free of
mercury”, “single dose based MMR uptake graph” for what should represent
two MMR shots, topped with the 1994 onwards DSM-IV splitting of a two type
PDD coding (DSM-III-R) into a five type PDD coding dramatically
reassigning many persons with autism to other eg. Aspergers diagnoses.
Without an educated attempt to clarify how much more PDD was identified
from 1994 onwards with DSM-IV diagnostics, and how PDD types were
reassigned with the advent of Aspergers Syndromes, Retts Syndrome and
CDDs, and how the changes are likely to affect the charts one can have no
confidence in the charts, results or conclusions.
The “Guidelines for the ethical conduct of medical research involving
children” (Arch Dis Child 2000; 82:177-182 by the Royal College of
Paediatrics and Child Health: Ethics Advisory Committee) recognises that
“children are unique as a research group for many reasons. They are the
only people in British law on whose behalf other individuals may consent
to medical procedures. Many children are vulnerable, easily bewildered and
frightened, and unable to express their needs or defend their interests….
more needs to be known about how children are affected by their
experiences as patients and research subjects, and what support they
need”. Researchers who indulge in programmes that directly or indirectly
impact on certain types and groups of children have a special duty of care
to ensure that policies, protocols, methodologies, evaluations, analyses
and conclusions are derived through a high level of commitment to
comprehensiveness, accuracy and integrity. One may feel that this and
other similar studies exclude large tracts of realism such that
inappropriate government health, educational and social policy may ensue.
Do the authors consider that the most vulnerable children this study
purports to represent have a right to expect greatest possible accuracy
and objectiveness in determining their current status, and if so, have
they made every effort to honour that right?
Regards
John H.
Conflict of Interest:
None declared
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