The Scientific Record: Examining Some of the Claims and Counterclaims in the MMR Saga
Preprint. https://www.preprints.org/manuscript/202303.0401/v1
The Scientific Record: Examining some of the claims and counterclaims in the MMR saga
Comparison of the Lancet with the BMJ
The claim the Lancet paper reported 9 children with ‘regressive autism’ is incorrect.
Concerning these children, the term 'regressive autism' is used only in the BMJ. The Lancet
explicitly states that the diagnosis of ‘autism’ was made earlier elsewhere before admission.
Lancet: '…all had been assessed professionally elsewhere, so these assessments were
used as the basis for their behavioural diagnosis.'
The behavioural diagnoses were autism (8 children) and autistic spectrum disorder
(1 child) and ? autism or disintegrative disorder (1 child). 'Regressive autism' is not reported
in any of these children in the Lancet. Table 2 of the Lancet paper lists these behavioural
diagnoses.
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This column is reproduced in the Table below with the corresponding column from
the BMJ where 'regressive autism' replaces the term autism. Next to it is a column where,
according to the BMJ author, NHS records document the features of regressive autism in
only one of those children. The last two columns list the references in the GMC transcripts
to the diagnosis of autism and the references to regression noted in individual children.
Verification of Facts from the GMC Transcripts
Child numbers 6, 7 and 12 were claimed in the BMJ as not having autism diagnosed
at all. The GMC transcripts however report they had autism. The GMC transcripts show
9 of 11 children (for whom records were available to the GMC) had been diagnosed with
autism and that includes the child noted in the Lancet as having autism spectrum disorder
and the child diagnosed as having possible autism ("?autism or disintegrative disorder").
Search for the word 'regressive' in the Lancet
How this switch from the diagnosis of 'Autism' in the Lancet paper to 'Regressive
Autism' in the BMJ could have happened was examined. The Lancet paper reported developmental
regression in 12 children.
Lancet: "We investigated a consecutive series of children with chronic enterocolitis
and regressive developmental disorder"
The BMJ article conflated 'developmental regression' and 'autism' and misleadingly
reported "regressive Autism". The term "regressive autism" was not used in the Lancet
paper as a presentation or diagnosis in any of the 12 children. The BMJ, by substituting
autism reported in the Lancet with the term 'regressive autism,' which was not reported
in the Lancet or the children’s medical records, created non-existent discrepancies between
the Lancet paper and the medical records. The GMC transcripts show that the label
of autism recorded in the clinical notes of individual patients was reported truthfully in
the Lancet.
Allegation 2. "Despite the paper claiming that all 12 children were "previously normal,"
five had documented pre-existing developmental concerns."
Paraphrased, the BMJ holds that 5 children had developmental concerns in early life
and so it was wrong to state that all 12 were "previously normal".
Comparison of what the Lancet says against what is reported in the BMJ
The Lancet article states:
"Prospective developmental records showed satisfactory achievement of early milestones
in all children. The only girl (child number eight) was noted to be a slow developer
compared with her older sister. She was subsequently found to have coarctation of the
aorta. After surgical repair of the aorta at the age of 14 months, she progressed rapidly
and learnt to talk. The speech was lost later. Child 4 was kept under review for the first
year of life because of the wide bridging of the nose. He was discharged from follow-up
as developmentally normal at age 1 year."
The Lancet documents there were some early developmental concerns in two children,
but all the babies had caught up developmentally and they were normal for their
age before they started to regress and lose acquired skills including language. Given this
background, it is obvious the Lancet authors use the term 'previously normal' to signify
the point of time just before the start of regression. The last column of the Table shows the
GMC transcripts' references to the children’s medical records confirming regression following
previously normal development for all eleven children for whom medical records
were available.
The BMJ is claiming that by 'previously normal' the Lancet is implying that there
were no developmental concerns ever, with regard to these babies. The BMJ interpretation
is incompatible with the text of the Lancet article where the 'early concerns' are documented.
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Allegation 3. "Some children were reported to have experienced first behavioural
symptoms within days of MMR, but the records documented these as starting some
months after vaccination".
Comparison of what the Lancet says against what is reported in the BMJ
The Lancet reports, "In eight children, the onset of behavioural problems had been
linked, either by the parents or by the child's physician, with measles, mumps, and rubella
vaccination. Five had had an early adverse reaction to immunisation (rash, fever, delirium;
and, in three cases, convulsions). In these eight children, the average interval from exposure
to first behavioural symptoms was 6·3 days (range 1–14)."
It can be seen that the first behavioural symptoms recorded in the Lancet (occurring
within 1-14 days) are presentations such as rash, fever, delirium and convulsions. These
are not symptoms of autism. They were the first adverse effects noticed by the parents and
some doctors.
The Lancet goes on to state:
"In some cases, the onset and course of behavioural regression was precipitous, with
children losing all communication skills over a few weeks to months"
The Lancet reports ‘behavioural symptoms’ like post-vaccination delirium happened
within 14 days but ‘behavioural regression’ took weeks to months in the most precipitous
cases, and by inference, even longer in the others.
Search for the words that could have resulted in the misunderstanding
It would appear that the confusion can have happened because of the use of the expression
'behavioural problem' which the BMJ has probably equated with ‘behavioural
regression’. The Lancet authors make it clear that they are referring to changes in behaviour
such as fever and delirium when they refer to the early adverse reactions to immunization
(within a mean of 6.3 days). They have used the expression behavioural regression
for loss of acquired developmental skills. The BMJ author may have confused these two
terms used by the Lancet authors. The Lancet authors do not say that developmental regression
happened in days and there is no substance to this BMJ allegation.
Allegation 4. "In nine cases, unremarkable colonic histopathology results—noting no
or minimal fluctuations in inflammatory cell populations—were changed after a medical
school "research review" to "non-specific colitis".
According to the BMJ, nine cases with little or no pathology were reported wrongly
(by the medical school experts) as having colitis.
In the formulation above, the expression 'reported wrongly' is used because, without
it, there is no 'allegation'. It cannot be an allegation that an expert has more expertise than
a generalist. It is merely a statement of fact. Generalists refer to the expert and seek their
opinion and advice for this very reason. The expert is better qualified to report a histopathology
slide and his opinion may differ from that of a person with no specialist experience.
The general pathologist who saw only minimal fluctuations sent the slides for the
expert opinion of specialist gastroenterology pathologists. The experts found evidence of
colitis and reported it. If one is uncharitable, one can fault the generalist for missing the
evidence of colitis but there can be no case against the specialist for finding this evidence.
Verification of facts from the GMC Transcripts
The evidence of Professor Simon Murch on oath recorded in the GMC transcripts
confirmed the histopathological diagnoses published in the Lancet were agreed at a meeting
of Professor Simon Harry Murch, Dr Susan Elizabeth Davies, Professor John Angus
Walker-Smith, Dr Michael Thomson, Dr Andrew Anthony, Dr Amar Dhillon, Dr Robert
Heuschkel, Dr David Howard Casson, Dr Mohsin Malik, Dr Andrew Jeremy Wakefield,
and Dr Alan Phillips [8]. [GMC Transcripts D113/43-44].
This was not a fabrication by one rogue gastroenterology histopathologist but the
diagnosis in each case was the consensus opinion of a team of highly qualified experts.
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Allegation 5. "The parents of eight children were reported as blaming MMR, but 11
families made this allegation at the hospital. The exclusion of three allegations—all giving
times to onset of problems in months—helped to create the appearance of a 14-day temporal
link".
It is alleged that:
a) the Lancet wanted to create the appearance of a "14-day temporal link".
b) The stories of 3 children who blamed MMR but developed symptoms outside the
two-week time window were not disclosed because they did not fit the 14-day narrative.
Comparison of what the Lancet says against what is reported in the BMJ
There does not appear to be any effort to propagate a 14-day narrative. The Lancet
reports that behavioural regression and the loss of communication skills took at a minimum
(in the most precipitous cases,) of weeks to months. Others took even longer. The
early symptoms which appeared within the first 2 weeks were rash, fever, delirium and
convulsions and these are not symptoms of autism.
If there is no '14-day' narrative, that cannot be the reason for excluding the link made
by parents or doctors of 3 children with MMR. The BMJ claims that parents of 11 children
blamed the MMR vaccine for their child's condition "at the hospital" whereas the Lancet
says the association was suspected in 8 cases by family and/or doctors. The GMC transcripts
will have to be relied on to determine which of the two assertions is factually correct.
Verification with facts from the GMC hearing
The GMC transcripts record that the GMC's prosecutor Sally Smith QC confirmed
the parents of Children 5, 9, 10 & 12 did not link the MMR vaccine to their children's conditions(
8). [GMC Transcript D97/2 Sally Smith QC GMC Prosecutor]
The GMC transcripts record that in one case, Child 5, parents made the allegation of
association with the vaccine only after reading about it in a newspaper [8]. [GMC Transcripts
D4/17 Sally Smith QC GMC Prosecutor]
The allegation in the BMJ is incorrect.
Allegation 6. "Patients were recruited through anti-MMR campaigners, and the
study was commissioned and funded for planned litigation"
The allegation pivots on whether a 'study' (commissioned research) was conducted,
or whether the Lancet authors were merely documenting investigations done as part of
medical practice.
The basic definition given in the January 1990 guidance of the Royal College of Physicians
in the report entitled "Research involving patients" [12] (which Judge Mitting
quoted) is as follows:
"What constitutes research in patients?
When an activity is undertaken solely to benefit an individual patient, and where
there is a reasonable chance of success, the activity may be considered to be part of "medical
practice". The progressive modification of methods of investigation and treatment in
the light of experience is a normal feature of medical practice and is not to be considered
research.
In contrast, where an activity involving a patient is undertaken with the prime purpose
of testing a hypothesis and permitting conclusions to be drawn to contribute to general
knowledge, this is "research". The fact that some benefit expected or unexpected may
result from the activity does not alter its status as research".
The GMC claimed Walker-Smith and his team were carrying out a research project
under a research protocol [ref: 172/96] without ethics approval which constituted serious
professional misconduct. The doctors' case was they were treating children according to
clinical needs.
The findings of the GMC's Panel were appealed by Professor Walker-Smith to the
English High Court and heard by Judge Mitting.
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Following detailed consideration of all the evidence, the Court could not uphold the
contention of the GMC. The children did not qualify for inclusion in the alleged research
project. They were not subjected to procedures under a research project. The charge that
this was a study and research project could not be sustained and was quashed by the Court
[10].
Judge Mitting's findings lay to rest this allegation.
Discussion
The BMJ's six main allegations [enumerated in the Box in the BMJ article] were selected
for scrutiny and not every line of the article. The comparison and analysis suggest
that each of the six main allegations of the BMJ article is incorrect and therefore should be
corrected.
Selecting the issues mentioned in the Box was felt to be fair because the author and
editors would have distilled the main points of their case to highlight in the Box. It was
also convenient to focus on these main allegations when presented with a somewhat rambling
5-page article.
If the allegations in the box needed to be paraphrased the paraphrased points were
made explicit. This was done to ensure that if any might be thought strawmen, they were
clearly identifiable, to be challenged by the BMJ.
Conclusions
There are significant differences between what was reported in the Lancet paper and
what was alleged to be there by the BMJ. The allegations made in the BMJ article appear
to be misleading but these have not been retracted to date.
The authors of the 1988 Lancet paper did not say there was a causal association between
MMR vaccination and autism. This article aims only to point to errors in the BMJ
article, to set the record straight.
Acknowledgments: The author acknowledges with gratitude the help and inputs received from
Vera Sharav, Clifford Miller and Meryl Nass. He however takes full responsibility for the veracity