Memorandum by Mr David Thrower - continued|
57. In basic terms, the parents believe
that the most recent, detailed investigative research, which is
compatible with other previously-published work that hypothesises
that there may be a link and which is fully compatible with their
personal experience with their child, should be taken proper notice
of. The parents also believe that some of the "evidence"
that the Department quotes to prove that there is no link is suspect.
58. In complete contrast, the Department
appears to embrace any evidence that supports its case and to
marginalised or heavily criticise material to the contrary:
"The arguments you have developed are based
on a number of assumptions that are in some cases highly speculative
. . . the quotes that you provide from Binstock and Schwartz (separate
researchers) are highly speculative, are not based on objective
evidence and make unfounded assumptions" (source: letter
of Department of Health Immunisation and Communicable Disease
Branch, 19 March 1998).
59. The Department's view, which does not
since appear to have changed, was expressed in a letter of 10
October 1997 from the Minister of State for Public Health, Tessa
Jowell MP, to Helen Southworth MP:
"There is no good evidence that the frequency
of autism has increased since the introduction of MMR vaccine
. . . The Department of Health and other international authorities
are still not aware of any scientific evidence supporting such
60. Despite the growing body of opinion
and research that indicates that there may be a link between MMR
and autism, and despite the direct documented experiences of parents,
and despite the growing evidence that autism is far more prevalent
than was considered to be the case only a decade or two ago, the
Department has issued an "MMR Factsheet", which is discussed
in a later section (and in Appendix V). This was issued to all
Members of Parliament with the following remarkable company letter:
"The UK Health Departments have been working
on producing publicity material for parents and their medical
advisers . . . The aim is to provide a factual briefing
on the issues to enable parents to make an informed choice
about the MMR vaccine . . . I enclose a copy of this material
which you might find useful in answering constituents' queries"
(source: letter of Minister of State for Public Health of 16 September
1998, my emphasis)
61. Neither the letter nor the MMR Factsheet
included reference to:
any research in support of there
being a link between vaccination and degeneration into autism
or other serious conditions, other than the "Early Report"
of February 1998 of Dr Andrew Wakefield and colleagues at the
Royal Free Hospital;
the research vacuum identified by
Professor Sir John Pattison in March 1998;
the many hundreds of cases of families
taking legal action;
the acknowledged numbers of yellow
card reports in relation to MMR, or the acknowledged level of
estimated under-reporting; and
the significant numbers of claims
against MMR that have been paid out in the United States under
their country's scheme.
"Dual Standards" Applied to Robustness
62. The greatest concern is that different
standards are being applied by the authorities towards "evidence
for" a link and "evidence against".
63. An example of "evidence against"
was provided by the Minister of Public Health, Tessa Jowell, in
a letter to Margaret Ewing MSP dated 22 January 1999:
"I attach for your information a recent
publication by Professor Christopher Gillberg on the subject of
MMR and autism, from the journal "Autism". Professor
Gillberg, like each of the independent expert groups that have
looked at this question before him, concludes that there is no
evidence of a link".
64. However, the research by Gillberg could
at best be described as statistically vulnerable. Gillberg looked
at just 55 cases with DSM-III-R disorder in Goteborg and Bohuslan,
Sweden, first studied in the late 1980s. Gillberg argued that
children born beyond July 1980 might be argued (if there was a
link) to be at increased risk, and allocated the children born
before and after this date pro-rata by time period, to see what
a pro-rata split produced in terms of cases of autism. He then
looked at the actual cases and their ages, and concluded that
there was no "fit", and that, as there were more older
(pre-MMR) children with autism than younger children, the theory
of a link did not stand.
65. However, this analysis is sensitive
(in what adds up to only one busload of children in total) to
getting the sample wrong by only a few children. In other words,
if Gillberg had come across only a few more infant/young child
cases of autism, and a few less older-child cases (very small
numbers involved), it would have neutralised or even reversed
66. In his study of atypical autism, Gillberg's
conclusions were even more vulnerable, as he only looked at just
19 cases (down to a minibus-load). A difference of a bare handful
of child cases in his sample would again have reversed his conclusions.
67. This seems to imply that the outcome
of the study by Gillberg is questionable, yet it is being quoted
by the Minister, many years later and in another part of Europe,
presumably as the best evidence to hand. This implies the Department's
standards of "evidence" favourable to its stance are
extremely low, by any standard.
68. In complete contrast is the tone adopted
towards evidence that threatens the Departmental stance. As the
Department states in a letter from Tessa Jowell of 10 October
"The Department is always ready to consider
any new evidence and subject it to the same rigorous scrutiny
as was given to the evidence on which the advice to parents on
protecting their children through MMR vaccination is based."
69. The above is revealing, because it illustrates
where the Department is coming from:
first, it has adopted MMR based upon
trials that only followed the children for three weeks afterwards,
and almost certainly missed any autism cases, the numbers of which
might have been very easily missed as they could well have only
been in single figures and spread over months afterwards (perhaps
not finally diagnosed for years afterwards), and with varying
degrees of damage, and unconnected at that time with vaccination
due to lack of research;
it has then gradually slipped into
a mode of "vaccination is safe unless you (the parents) can
prove otherwise, with epidemiological back-up in profusion; and
it has then adopted a "Fortress
Department" stance, adopting what it itself describes as
a rigorously-critical approach to new evidence.
70. The above has resulted in an "innocent
until proven guilty" Departmental viewpoint, which is not
appropriate in an area of complex scientific uncertainty, and
in a field where Professor Sir John Pattison has himself publicly
called for more research to fill what he clearly sees as a research
Failure to Acknowledge Scientific Uncertainty
71. An example of how the Department fails
to take a balanced view, where scientific uncertainty prevails,
is the case of the American Institute of Medicine review in 1994.
The review concluded that there was insufficient evidence to reach
a conclusion for or against a link, and that further research
was needed. Yet the letter of the Department of Health of 19 March
1998, alluding to the AIM review, stated:
"Inadequate evidence cannot be interpreted
as supporting the possibility of a link" (my emphasis).
72. In other words, the Department does
not even acknowledge the possibility of a link until hard evidence
(presumably replicated in a large number of studies by different
researchers) is available. This demonstrates a virtually-closed
Departmental mind, and an unbalanced perception of "the possible".
73. The above may, with time, prove to have
been the defining crux of the Department's misjudgement of the
pattern of reports of autism following vaccination.
74. The Department does not appear to want
to recognise other research in support of the Royal Free team:
"A major investigative effort of our laboratories
has been directed to the study of food allergy and the immunological
involvement of the gut as a central focus for injury of other
target organs (skin, lungs and gastro-intestinal tract). We have
noted a striking appearance of ileal-lymphoid nodular hyperplasia
in patients with non-IgE-mediated food allergy who present asthma,
atopic dermatitis and attention-deficit-hyperactivity disorder
. . . Our findings obtained by colonoscopy of their terminal ileum
. . . match with those reported by Wakefield and co-workers."
(source: Sabra, Bellanti and Colon, Ileal Lymphoid Nodular Hyperplasia,
Non-Specific Colitis and Pervasive Developmental disorder in Children,
letter and comment, Lancet, vol 352, July 18 1998, pp 234-5).
75. The above, offering specific corroboration
of the Wakefield et al findings, has never been referred to, to
my knowledge, by the Department of Health, either in correspondence,
Parliamentary answers, publicity or press releases.
76. Before the Royal Free Hospital "Early
Report" by Wakefield et al of February 1998, measles
virus and measles vaccination had been identified as a risk factor
for Crohn's Disease, and persistent chronic measles vaccine-strain
virus infection had also been found in children with autoimmune
hepatitis. As another parent, Laura J Ruede has put it:
"That the intestinal and "autistic"
behavioural pathologies occurred together in these children might
have happened by chance, but for the uniformity of the intestinal
signs and the findings of intestinal dysfunction in previous studies
of autistic children. Extensive metabolic dysfunction in autism
had also been described previously, and in great detail . . .
Researchers such as Fudenberg and Gupta and others had previously
commented on similar developments in children in relation to vaccination.
The February 1998 Wakefield et al paper did not demonstrate
a link between vaccine and autistic enterocolitis . . . (the name
given to this suspected syndrome), but underlined clearly the
need for further research." (source: Laura J. Ruede, Is There
An Association Between Vaccination and Autism, A Biographic Essay,
77. The Department itself admits that "evidence",
that there is no problem with MMR, would not be reliably obtained
from even quite large samples. For example, in relation to the
fact that MMR was trialled with 10,000 children, and the follow-up
period was only three weeks, the Department stated in its letter
of 19 March 1998:
"The follow-up time for the MMR vaccine
study of 10,000 children was based on knowledge of the replication
rates of the vaccine viral components . . . it is of course recognised
that such a study could not establish a causal relationship with
extremely rare events".
78. But this then raises a question in the
minds of parents. If a detailed study of 10,000 children is conceded
by the Department to be insufficiently large to be depended upon
for identifying rare events, why the Department is so ready to
repeatedly quote the (favourable to the Department) Gillberg study
of only 55 autistic cases and of only 19 atypical-autism cases.
79. The 19-cases study is particularly interesting
to parents because it is stated that these were atypical autism,
and therefore possibly closely related to the autistic-colitis
degenerative cases being investigated by parents.
80. It is suggested here that again it is
a matter of the Department applying dual standards.
Failure To Update Departmental Pronouncements
81. The Department also fails to update
its own pronouncement on whether there is evidence of a link between
vaccination and autism or not. In its letter of 22 January to
Margaret Ewing MSP, signed by the Minister for Public Health,
the Department states:
"(Our) main concern is that the best independent
experts investigate the possibility of a link between measles,
measles-containing vaccines (such as MMR) and inflammatory bowel
disease and/or autism. This has happened (my emphasis)....there
is no evidence of a link . . . I am sorry thatMr Thrower cannot
accept the conclusions of eminent independent experts."
82. However, only two months later, the
Medicines Control Agency wrote:
"May I also take this opportunity to thank
you for the material, including reference to the work of Dr Singh,
which has been considered in our assessments of this issue, provided
in your letter of 17 December (1998)".
83. The work of Dr Singh referred to is
Singh et al, Serological Association of Measles Virus, Clincal
Immunology and Immunopathology, 1998; 89 (1): 105-108, which
was described by its authors as the first to report an association
between measles virus and autism. As this paper was published,
and was even circulated by myself to the Medicines Control Agency,
well in advance of the Department's letter, it is questioned why
the Department was still assuring Margaret Ewing in late January
1999 that there was ". . . no evidence of a link".
84. The Medicines Control Agency letter
of 29 March 1999 also included an Appendix listing six other research
papers or publications over the period 1996-98, under the heading
"Supporting The Hypothesis" (of a link). Their list
is not exhaustive, but what is significant is that these papers
are clearly regarded as credible support, for there being a link,
by the MCA. The MCA still expresses the same view as the Department,
based upon the MRC seminar of March 1998, but there is a candour
about its approach that seems wholly lacking in the letter of
the Department of Health.
85. Key Conclusion: There is a growing body
of evidence to suggest that vaccination and degeneration into
autism may be linked. In contrast, the body of "evidence"
to refute this possible link is not growing, and some of the existing
"evidence" is questionable. The Department does not
yet acknowledge this, and continues to play-up references to articles
(many of them outdated) that refute parents' claims, whilst seeming
to ignore emerging research that supports the views of parents.
86. Issues For Discussion
clarification is needed as to how
the Department weighs-up opposing evidence, and treats incoming
evidence that runs counter to its interests;
does the Department's approach to
"uncomfortable" evidence and any patterns of parents'
anecdotes need independent audit?
do "factual" briefings
to Members of Parliament and others need to be more balanced,
and to acknowledge doubt and contradictory evidence, and how can
these be set out in an unbiased and dispassionate quasi-academic
how can equitable and balanced standards
of robustness be more rigorously applied to all evidence, with
no suggestion of "playing up" or denigrating evidence
on a partisan basis?
does the Department need to move
away from an "innocent until proven guilty" stance over
alleged damage causes, into a position where it acknowledges greater
why does the Department not even
acknowledge the possibility that (in the case of degeneration
into autism) the parents may be proved to be right in the long
should the Department regularly update
pronouncements, such as the outcome of the March 1998 MRC review
into MMR/autism, whenever additional research is published, even
when new evidence is unfavourable to its viewpoint?
87. Suggested Recommendations For Action
the way the Department treats "evidence",
including systematic parental anecdotal evidence, should be made
the subject of audit and independent review;
Departmental briefing material needs
to be wholly objective and balanced, and again this requires regular
where scientific uncertainty exists,
the Department should be under an obligation to formally acknowledge
and publicise it; this may require independent audit and regulation;
there needs to be a commitment from
the Department to regularly update publicity and briefing material
in the light of new research.
88. If autism was linked to vaccination,
one of the first actions that any enquiring mind would want to
take would be to monitor the incidence of autism. Yet, despite
the devastating nature of the condition, its effects on both victims
and families, its frequency of reporting, and its direct relationship
to the debate as to whether autism and vaccination are linked,
the Department of Health does not monitor the incidence of autism,
and still has no current plans to do so.
89. Because the incidence of autism is very
close to the debate as to its causes, and therefore of direct
relevance to parents trying to obtain a response from the Department
of Health as to how the child degenerated, the subject is considered
here in some detail.
90. It is a source of the most intense concern
that no lead is being provided by the Department in monitoring
autism. This failure appears very difficult for the Department
to continue to defend intellectually.
91. Parents of children who degenerated
into autism following vaccination need to be assured that the
Department is monitoring the condition that their own child is
infrom whatever causesystematically and methodically.
92. In the case of alleged degeneration,
parents will want to be assured that there is categoric evidence
of there not being an unexplained increase in autism. In the case
of MMR, if they are to be convinced that there is not a serious
syndrome of degeneration associated with MMR, then parents will
want to know how monitoring is undertaken, and what the trends
are. This approach has professional support:
"At least 40 per cent of parents report
that their infant or toddler, whose development may or may not
have been entirely normal up to then, experienced a regression.
Many speculations have been offered . . . to explain autistic
regression . . . Data needs to be collected to investigate these
speculations" (source: Margaret L Bauman and Thomas Kemper,
The Neurobiology of Autism, John Hopkins Press, 1994, pp 13-14).
93. This is particularly the case where
there is a very strong pattern of parents' reports of degeneration
following vaccination. What parents need to know, to be confident
that the authorities are taking their reports of adverse outcomes
does the Department of Health or
their local Health Authority (and other authorities) have accurate
data, or is it/are they seeking data?
do they monitor incidence on a rolling
does the Department work with other
Departments such as Social Security (which funds carers' and disability
living allowances) and Education?
what are the actual numbers/rates
are there signs of a real underlying
if there is, what is the explanation
for it, and is their child part of this increase and therefore
what implication might this have for what the causes of their
child's degeneration might be?
94. It is useful here to quote from the
NHS's own documents:
"Accurate accessible information is required
to assess health needs, to monitor the health and development
of children" (source: Child Health In The Community
A guide to Good Practice, NHS Executive, September 1996, p9).
"Good quality data are required . . . to
ensure that all children . . . receive . . . child health surveillance"
(same source, p28)
95. The following is also relevant:
"Preventative health services . . . extend
beyond the remit of child health surveillance. . . . to encompass
positive efforts to . . . promote good health . . . (including)
. . . reducing disabilities" (source: Health For All Children,
NHS Executive, January 1996, p31, my emphasis in each case).
The Need For A Proper Monitoring Strategy
96. The lack of a national database on autism
has already been criticised recently by the Health Committee.
In the Session 1996-97, the Health Committee stated:
"We are concerned at the failure of the
DoH to collect information centrally on autistic children and
to issue specific guidance on services for such children. We recommend
that the DoH should take the necessary steps to redress these
deficiencies, and should work with the DEE to ensure that the
most suitable ways of assisting the development of children with
autism are adopted" (source: Second Report on the Specific
Health Needs of Children and Young People, Volume I, para
97. It is wholly unacceptable to parents
investigating their child's degeneration that no action has apparently
been taken in response to this criticism, and the Department apparently
still has no plans to alter course. The recommendation of the
Health Committee is dismissed thus:
"Mr Thrower's letter refers to the recommendations
made by the Health Select Committee of the previous Government.
The Department of Health is continuing to work with the Department
for Education and Employment to encourage the relevant authorities
in the early identification of the needs of children with autism
and the development of the most appropriate services to meet them.
Mr Thrower's concern is that data should be collected centrally
on the numbers of children with autism. However, there is no specific
requirement to register children diagnosed with autism, and because
of the nature of autistic spectrum disorders and the lack of a
widely agreed definition of autism, it would be very difficult
to do so" (source: letter from the Parliamentary Under Secretary
of State for Health, 27 July 1998, to Helen Southworth MP, my
98. The above wholly misses the Health Committee's
point, that there is a vacuum of information in terms of autism
as a health issue, and that the centrepiece of this vacuum is
the absence of data on incidence. Defending the absence of data
by stating that there is no specific requirement to register cases
of autism is a circular "no data, no data" argument.
99. The view of the Department was earlier
spelt out in a letter on 19 March 1998:
"The classification of autism and its sub-types
can be confusing and this is exactly why it is very difficult
to maintain useful records of the prevalence of the condition.
. . . . Any database of prevalence would only record those children
who have been diagnosed and could not guarantee that proper criteria
have been used. Therefore information about the incidence and
prevalence is best provided by large scale epidemiological surveys
with consistency in the classification system used" (source:
letter of Department of Health).
100. But the Department has not commissioned
any such surveys. Presumably it has no plans to do so, unless
its hand is forced by mounting evidence of high prevalence. This
appears completely unacceptable. The Department appears to be
failing in its fundamental aims, and may even technically be acting
outside the law, by its refusal to take action. It is possible
that this will be subject to future legal challenge.