Epidemiological studies cannot be relied upon, which promote the safety
of MMR vaccine or dismiss any other environmental triggers, against any
causal connections with autistic spectrum disorder(ASD)

See http://bmj.bmjjournals.com/cgi/eletters/326/7380/71#28684
"Environmental factors such as the effect of synergistic action between
the three combined live virus components of MMR vaccine on gut and
neurological immune processes , cannot be so confidently dismissed by
epidemiological population studies of medical database records , as ASD
is a disorder with no single phenotype, rather than a disease with a
root cause and outcome." Borne out by the following researchers(Chi-Tai
Fang, Wen-Yi Shau ) in The Lancet,20 July 2002.

They write " that the validity of observational research depends on the
validity of existing knowledge about the cause of the studied
disease.(Note: not disorder) In other words, causal association cannot
be established by data from observational research alone. Supportive
evidence from experimental research, including basic science and
randomised trials, is essential rather than optional for causal
inference in medicine."

Richard Miles
Autism Campaign for Health (ARCH)
arch@btclick.com


References:

The Lancet Volume 360, Number 9328 20 July 2002
Epidemiological research


Sir--Kenneth Schulz and David Grimes (Jan 19, p 248)1 review bias and
causal associations in observational research. However, they do not
clearly point out that the validity of observational research depends on
the validity of existing knowledge about the cause of the studied
disease. In other words, causal association cannot be established by
data from observational research alone. Supportive evidence from
experimental research, including basic science and randomised trials, is
essential rather than optional for causal inference in medicine.

In observational research, such as cohort study and case-control study,
compared groups can differ in many features and are thus not truly
comparable. Whether this built-in limitation can be overcome depends on
whether all major confounding factors can be identified and
appropriately controlled. Recognition and identification of confounding
factors, however, require a comprehensive and in-depth understanding
about the complex biological mechanism in pathogenesis. If the mechanism
of a disease is poorly understood, some unexpected confounders probably
remain unidentified and uncontrolled. As a result, the measured effect
of exposure on disease occurrence is probably biased.

On the other hand, if the mechanism of a disease has been well
clarified, a well-designed observational study can control all of the
major confounding factors and yield an unbiased estimation of the effect.

In the first case, data from observational research alone are not
sufficient to establish or falsify a causal link. In the second case,
the cause of the disease has been clarified by other sources of evidence.

Observational research is not, however, useless. Data from observational
research just cannot be used as the sole evidence to advocate or deny a
causal link. But they are useful to generate hypotheses, by pointing out
associations between exposure and diseases to be further tested in
experimental research or to be used as an interim guide of action for
the purpose of public health. Once the cause of a disease has been
clarified, observational research is also useful in quantification of
the relative
importance of various causal factors in real life rather than clinical
trial scenarios.
*Chi-Tai Fang, Wen-Yi Shau



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*Department of Internal Medicine, National Taiwan University Hospital,
Taipei, Taiwan; and Graduate Institute of Clinical Medicine, College of
Medicine, National Taiwan University (e-mail:fangct@ha.mc.ntu.edu.tw)

See also Professor John Walker-Smith's letter in The Lancet Volume 359,
Number 9307 23 February 2002 (e-mail:johnwalker_smith@hotmail.com)

"There has been much criticism of Wakefield and colleagues' work. His
results have been said to be refuted. Much of this criticism has been
epidemiological. Yet, as Morris and Aldulaimi6 in their comment on the
Dublin data state, "Epidemiology is a pretty blunt tool and the studies
done do not rule out the possibility that there are at risk groups where
a real link with [measles, mumps, rubella vaccine] MMR and autism/bowel
inflammatory condition exists".

He concludes "Am I too naive to ask all people of goodwill on both sides
of this debate to speedily agree on an independent research agenda that
will finally resolve this matter? Such an agenda must involve
non-epidemiological research, focusing on the bowels of these children.
It is self-evident that this whole question is going on far too long and
is causing so much heart-ache in parents. Although the original
observation has been extended and refined with additional evidence,
resolution of this matter seems as far off as it did then. Studies
reported lately provide evidence that measles virus might have a role.
There is now a case to be answered. This study finding needs urgent
confirmation and elaboration of its importance"

And yet UK Health Minister,John Reid, in The Birmingham Post,Mar 5 2004
said that he repeated the Government still had no intention of
commissioning independent research to allay parental fears once and for
all.

This has been Government policy all along.Not a penny, nor a cent has
been spent by the UK Government on clinical research into the causes of
ASD or the subgroup of, so far ,examined children with detected MMR
vaccine measles RNA in gut, blood and cerebrospinal fluid samples.


See also David Thrower's letter of Volume 359, Number 9323 15 June 2002,
also in The Lancet

"Increasingly, it has become a battle between the crude science of
epidemiology and the forensic science of clinical examination. The cause
of those who seek to shore up public confidence in childhood
immunisation by placing all their faith in epidemiology, much of it
based on children's medical records that probably contain little of
relevance to the issue, will be more than ill served if they are
eventually proved wrong."

Sir--John Walker-Smith's call1 for a programme of non-epidemiological
research is justified and timely.

The people who overlook these concerns do not observe the first rule in
clinical medicine--listen to the patient. Parents of the children in
question have described their children's ailment with extraordinarily
little effect on the commissioning of clinical research, which suggests
to me a deep resistance to hear what they are saying.

The Department of Health is adamant that autism is typically noticed
around the time of vaccination, but presents no cases in which autism
was acquired after a normal infancy just before MMR, nor seeks to
explain autism developing in older children who received MMR after
several years of normal development.

Although no evidence of a link between MMR and autism has been reported
in reviews, absence of evidence is not evidence of absence. Confusing
the two may yet prove to be medicine's fatal error.

Most of the reviews that are quoted as evidence of non-involvement of
MMR in acquired autism have since been overtaken by further clinical
research. For example, Singh2 reported that, in 75 of 125 autistic
children, there was an unusual MMR antibody that was related to the
measles haemagglutinin antigen of MMR. None of 92 controls had this
feature. In addition, more than 90% of MMR antibody-positive autistic
sera were also positive for myelin basic protein autoantibodies, which
Singh interprets as suggesting a causal association between MMR and
brain autoimmunity in autism.

Such findings suggest that the concerns raised by Walker-Smith, and by
Wakefield and co-workers,3 are well founded. These findings are also
consistent with the reports of parents.

The US Institute of Medicine's lmmunisation Safety Review Committee has
stated that it was unable to address the concern about exposure of
susceptible children to multiple immunisations in the developmental
period, since no epidemiological study addresses this issue.4 The UK
Department of Health does not seem to share their candour about the lack
of research. They have slightly increased autism research funding.
However, there has been no clinical research. The Scottish Chief Medical
Officer, Mac Armstrong, has even stated that calls to fund clinical
research into MMR and autism would be resisted.

Increasingly, it has become a battle between the crude science of
epidemiology and the forensic science of clinical examination. The cause
of those who seek to shore up public confidence in childhood
immunisation by placing all their faith in epidemiology, much of it
based on children's medical records that probably contain little of
relevance to the issue, will be more than ill served if they are
eventually proved wrong.
David Thrower



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49 Ackers Road, Stockton Heath, Warrington, Cheshire WA4 2DZ, UK
(e-mail:David@ThrowerWarrington.freeserve.co.uk)


1 Walker-Smith J. Autism, bowel inflammation, and measles. Lancet 2002;
359: 705-06. [Text]


2 Singh VK, Nelson C. Abnormal measles serology and autoimmunity in
autistic children. J Allergy Clin Immunol 2002; 109: (abstr 702).


3 Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular
hyperplasia, non-specific colitis, and pervasive developmental disorder
in children. Lancet 1998; 351: 637-41. [Text]


4 National Vaccine Information Center. Press release. 2002; Feb 20.



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