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HISTORICAL PERSPECTIVE

By Andrew Wakefield, MB, BS, FRCS, FRCPath

Andrew Wakefield, MB, BS, FRCS,


FRCPath, is an academic gastroenterologist.
He graduated in Medicine from St.
Mary’s Hospital (part of the University
of London) in 1981, pursuing a career in
gastrointestinal surgery with a particular
interest in inflammatory bowel disease. He
qualified as Fellow of the Royal College of

O
Surgeons in 1985, and in 1996 was awarded
n February 28, 1998, twelve Background
a Wellcome Trust Traveling Fellowship to
study small-intestine transplantation in
colleagues and I published From the late 1980s, my team at the Royal
Toronto, Canada. Discoveries made during a case series paper in The Free Medical School, the Inflammatory
his work in Canada led him to return to the Lancet, a respected medical journal, as Bowel Disease Study Group, published
United Kingdom to pursue the study of an “Early Report”1. The paper described extensively on possible causes and
inflammatory bowel diseases such as Crohn’s the clinical findings in 12 children with mechanisms of inflammatory bowel disease
disease and ulcerative colitis. In 1998, Dr. an autistic spectrum disorder (ASD) (e.g., Crohn’s disease). This involved
Wakefield and his colleagues at the Royal occurring in association with a mild- examination of a possible causal role for
Free Hospital in London reported a novel to-moderate inflammation of the large measles and measles vaccine. In May 1995,
inflammatory bowel disease in children with
intestine (colitis). This was accompanied parents started contacting me with the
developmental disorders such as autism; the
condition later became known as autistic
by swelling of the lymph glands in the story that their normally developing child
enterocolitis. He was awarded the Fellowship intestinal lining (lymphoid nodular had regressed into autism or an autism-like
of the Royal College of Pathologists in hyperplasia), predominantly in the last state, with onset in the majority of cases
2001. Dr. Wakefield is involved in many part of the small intestine (terminal ileum). soon after MMR vaccine. At around the
scientific research collaborations in the Contemporaneously, parents of 9 children same time, the children had developed
United States and abroad centering on the associated onset of symptoms with MMR chronic gastrointestinal (GI) symptoms
immunologic, metabolic, and pathologic exposure, 8 of which were reported in the similar to those described by Dr. Lenny
changes occurring in inflammatory bowel original paper (see also Child PH’s story Gonzalez in the July 2009 edition of The
diseases such as autistic enterocolitis,
on following page). The significance of Autism File2 . Despite what were often
links between intestinal disease and
neurologic injury in children, and the
these findings has been overshadowed by debilitating intestinal symptoms, many
possible relationship of these conditions to misunderstanding, misrepresentation, and indicative of abdominal pain, few of
environmental causes, such as childhood a concerted, systematic effort to discredit these children had undergone physical
vaccines. During the course of his work on the work. This effort, and specifically the examination, let alone been investigated.
childhood developmental disorders, Dr. complaint of a freelance journalist and an Mention of the MMR vaccine had often
Wakefield was increasingly convinced of the intense political desire to subvert enquiry into alienated parents further from their child’s
need for a research-oriented, integrated issues of vaccine safety and legal redress for health care providers. Many doctors
biomedical and educational approach vaccine damage, culminated in the longest attributed the onset of symptoms to
to these disorders, in order to translate
running and most expensive fitness to coincidence and were content to leave it
clinical benefits for affected children into
measurable developmental progress; this
practice case ever to come before the United at that. Conversely, at the Royal Free a
is the driving aim of Thoughtful House Kingdom’s medical regulator, the General systematic plan of clinical care and research
Center for Children in Austin, Texas. He Medical Council. At this point, the evidence was designed in order to help affected
has published over 130 original scientific is in and the outcome is awaited. Now, and children.
articles, book chapters, and invited scientific only now, with all of the contemporaneous The first report on these children
commentaries. documentation available, is it timely to review appeared in February 1998. The purpose of
both the original paper and its legacy. this series of articles is to review The Lancet
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C hild *PH’s story, as originally told by his mother, did
not cite MMR as the culprit. Eighteen months of
normal development was followed by regression, giving rise
What Child PH’s mother did not tell us in 1996 was that,
contemporaneously, she too had linked her son’s problems
to MMR vaccine. Our description of this child in The Lancet
to what several doctors labeled “secondary autism.” Loss faithfully reiterated the onset of symptoms following an
of developmental milestones was accompanied by loss of episode of otitis media as his mother had reported but made
coordination (he could no longer throw and catch a ball), his no mention of the MMR. The reason for this discordance in the
gait became, “awkward and stiff like an old man,” and he could narrative provides a valuable lesson: the reaction of successive
no longer go from sitting to standing unaided. He lost the doctors to the suggestion that MMR might have been involved
twenty words that he had gained and developed secondary ranged from patronizingly dismissive to outright hostile.
fecal incontinence. At eighteen months of age, severe Mentioning the vaccine was beginning to negatively impact
episodes of abdominal pain started that were associated with their ability to get help for their son. By the time they came
screaming and drawing his knees to his chest. He developed to the Royal Free Hospital, the father had urged his wife not
a pattern of chronic loose bowel motions with undigested to mention the MMR again in order to avoid discrimination by
food from two years of age. He went from the 97th centile doctors who considered her to be crazy.
for weight at 1 year of age to the 50th by age 2. His diet went So it was that a potentially important element of the clinical
from being varied to very restricted, consisting of refined history in this child had been corrupted by the arrogance of
carbohydrates and at least ten 200ml cartons of orange- those who “knew better.”
flavored drink per day. *Initials have been changed.

Myths: The Lancet paper


 was funded by the Legal Aid Board (LAB)4
False – Not one penny of LAB money was spent on The Lancet paper. An LAB grant was provided for a separate viral detection
study. This latter study, completed in 1999, does disclose the source of funding. The Lancet paper had been submitted for
publication before the LAB grant was even available to be spent.
 my involvement as a medical expert was kept “secret”5
False – at least one year before publication, my senior co-authors6, the head of department and the dean of the medical school7,
and the CEO of the hospital were informed by me. This fact was also reported in the national press 15 months prior to publication8.
 children were “sourced” by lawyers to sue vaccine manufacturers5
False – Children were referred, evaluated, and investigated on the basis of their clinical symptoms alone, following referral from the
child’s physician9.
 children were litigants10
False – at the time of their referral to the Royal Free, the time material to their inclusion in The Lancet paper, none of the children
were litigants.
 I had an undisclosed conflict of interest11
False – The Lancet’s disclosure policy at that time was followed to the letter. Documentary evidence confirms that the editorial staff
of The Lancet was fully aware that I was working as an expert on MMR litigation well in advance of the paper’s publication12.
 did not have Ethics Committee (EC) approval5
False – The research element of the paper that required such an approval, detailed systematic analysis of children’s intestinal
biopsies, was covered by the necessary EC approval13.
 I “fixed” data and misreported clinical findings14
False – There is absolutely no basis in fact for this claim and it has been exposed as false15.
 findings have not been independently replicated12
False – The key findings of LNH and colitis in ASD children have been independently confirmed in 5 different countries16.
 has been retracted by most of the authors17
False – 11 of 13 authors issued a retraction of the interpretation that MMR is a possible trigger for syndrome described. This
remains a possibility and a possibility cannot be retracted.
 the work is discredited18
False – Those attemping to discredit the work have relied upon the myths above. The findings described in the paper are novel and
important19.

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HISTORICAL PERSPECTIVE
paper for what it was, what it did and didn’t
say, and to examine the legacy of the paper
The legacy of in the light of subsequent events.
The Lancet paper Study design
The Lancet paper – the first in a series
The first demonstration of of related papers – is a case series: This
intestinal pathology in ASD is stated explicitly in the first line of the
GI symptoms are common in children paper: “...a consecutive series of children
with autism, and these symptoms are with chronic entero-colitis and regressive
frequently associated with intestinal developmental disorder”1. A typical
inflammation. example of how basic epidemiological
Treatment of GI inflammation may textbooks define and describe a case series
lead to symptomatic improvement in is found in Hennekens and Buring3:
both GI and behavioral symptoms21.
“Case series studies describe the
The first demonstration experience of a single patient or a group
of abnormal vitamin B12 of patients with a similar diagnosis.
These types of study, in which typically
metabolism in ASD an astute clinician identifies an unusual
Now the subject of major clinical and feature of a disease or a patient’s case series, we went beyond what would
research activities in autism, ranging history, may lead to formulation of normally be required and did include
from study of genetic differences in a new hypothesis… At that time an controls – 19 age-matched children (5 for
B12/folate metabolism to treatment analytic study (most frequently using microscopic examination of tissues and 14
with active forms of B12. a case-control approach), can [then] for measurement of urinary methylmalonic
be done to investigate possible causal acid [MMA]). This would have been
The first study to report factors.” [emphasis added] evident upon a proper reading of the
a re-challenge effect of a paper.
measles containing vaccine The crucial design feature which Finally, Hennekens and Buring3 make
(MCV) differentiates the case series from other the crucial point that the purpose
Follow up indicates that intestinal designs is its lack of requirement to select of a case series is to generate new
inflammation is significantly worse participants on the basis of either the hypotheses about potential causation.
in re-challenge ASD children than exposure (e.g., MMR) or the outcome of It is not designed to investigate possible
children receiving only one measles- interest (e.g., autism). A case series does causality. The Lancet paper was hypothesis
containing vaccine (MCV)22 . not require – and should not employ – generating; it stimulated a series of
strict inclusion or exclusion criteria. Rather, subsequent papers – rarely if ever
it should function to observe similar acknowledged by critics – that confirmed
First study to seek evidence presentations in groups of patients that and characterized the bowel disease as
of a mitochondrial disorder appear to share other common features in novel, relatively frequent, and potentially
by measurement of lactate: order to raise hypotheses that later may treatable and tested ideas about
pyruvate in cerebrospinal be tested in the appropriate study design causation19. Among the critics there has
fluid framework (e.g., a case-control study). been some confusion on this point, which
The Lancet paper does exactly what is evident, for example, in a widely quoted
“Mito” disorders appear to be is required of a case series. It states analysis of the paper by Professor Trisha
common in ASD children and may immediately what the report sets out to Greenhalgh20 that raises and attempts to
be acquired. The U.S. government do: no particular developmental disorder answer a series of questions, including:
conceded that vaccines triggered was stated, no particular features or timing
autism in Hannah Poling, of onset were required, no particular Was the research hypothesis clearly
a child with “mito” initial exposure was necessary, no specific stated?
disorder24 . outcome was predicted, and no causal She observes, “The paper does not state
association was claimed. a research hypothesis at all.” This is quite
Of note, we have been criticized for true. Case series studies are neither
not having controls in the study; that required nor expected to do so. Having
is, developmentally normal children established that there was no hypothesis,
included for the purpose of comparison. Professor Greenhalgh goes on to pose the
While controls are not usually part of a ridiculous question:
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Was this design an appropriate way what can only be described as a complete
to test the research hypothesis? misunderstanding of The Lancet study’s
Meticulous attention should
She concludes that the study design design, is cause for concern. In turn, be paid to the parental
was not an appropriate way to test “the the failure of the Department of Health history, and the practice
research hypothesis.” However, since she (whose Web site directed people via the of claiming coincidence
has already identified the fact that no National Health Service Executive to without first excluding
hypothesis was stated, she rather begs her analysis) to appreciate the potential
the question as to which hypothesis impact of this deeply flawed document
possible causes has no
the study was not designed to test. on the perceptions of many thousands of place in clinical medicine.
It soon becomes clear that it was her worried parents is alarming.
hypothesis that the study did not test. Notwithstanding Professor the practice of claiming coincidence
Her conclusion that “the study design was Greenhalgh’s follies, one should never without first excluding possible causes
incapable of proving the [MMR] link one underestimate the importance of the has no place in clinical medicine. Where
way or the other” is, of course, entirely case series as a starting point for medical an infection such as herpes simplex or
accurate as we had already indicated in discovery. It is the tried and tested mode Epstein-Barr virus (mono) has preceded
the paper on page 641, paragraph 2, lines of the description of human disease autistic regression, the medical literature
1 and 21 : syndromes, including Kanner’s autism, shows that extensive testing has been
Asperger’s syndrome, and Heller’s disease undertaken, the cause identified, and the
“We did not prove an association (disintegrative disorder). One final word child treated accordingly25. In contrast,
between measles, mumps and on the matter endorses this perspective: when MMR vaccination has preceded
rubella vaccine and the syndrome autistic regression, little, if any, attempt
described…” “Clinical situations in which a case has been made to investigate children
report or case series is an appropriate appropriately. The case of Bailey Banks
and paragraph 5, lines 4-6: type of study include the following: is one of those rare instances where
a doctor notices that two babies this has been done and for whom the
Further investigations are needed born in his hospital have absent limbs United States vaccine court ruled that
to examine this syndrome and its (phocomelia). Both mothers had MMR caused his ASD26 . Bailey’s MRI,
possible relation to the vaccine.” taken a new drug (thalidomide) in performed 16 days post-MMR for
early pregnancy. The doctor wishes encephalopathy, revealed abnormalities
Professor Greenhalgh ventures even to alert his colleagues worldwide to of brain myelin consistent with acute
further off course when she asks: the possibility of drug related damage disseminated encephalomyelitis (ADEM),
as quickly as possible (McBride, in an autoimmune brain inflammation that
Were the study’s conclusions The Lancet 1961). Anyone who thinks can follow measles or a measles vaccine.
supported by the data? ‘quick and dirty’ case reports are The lesson is that every attempt should
It is not clear whether Professor never scientifically justified should be made to evaluate children during the
Greenhalgh is referring to the authors’ remember this example.” course of their regression since, as in the
conclusions – i.e., that the data do not case of ADEM, abnormalities of brain
demonstrate a causal link between the And the source of this invaluable piece myelin may be transient and not evident
disorder and MMR exposure and that of advice? Dr. Trisha Greenhalgh, author on an MRI performed two years after
further research is required, or whether of “How to Read a Paper”24 . exposure. The fact that the parents of
she is asking if the data support her The Lancet children described loss of
own hypothesis. In the former case, the “Coincidence” fecal and/or urinary continence in four
data clearly support our conclusions. Coincidence – often the first resort cases and ataxia (clumsiness) in six – the
Not surprisingly, they do not support of skeptical physicians – refers, in this latter being a reported adverse reaction
Professor Greenhalgh’s hypothesis – that context, to the chance occurrence of to MMR vaccine 27 – is more than enough
MMR causes the syndrome described. autistic symptoms being identified in indication for thorough neurological
She continues: the second year of life, at around the workup. The history of regression with
same time as MMR is given. Regularly loss of acquired skills in a previously
If the answer to [the question above] advanced as an explanation for the normal or near-normal child should ring
is “no,” would a more robust study parents’ story, coincidence is a conclusion alarm bells and initiate a systematic
design have been practically possible of last resort – one that should be approach to differential diagnosis. It
to test the study’s main hypothesis? arrived at only after diagnostic due was with this in mind that Professor
Having inserted her own hypothesis, diligence has excluded alternative Walker-Smith, one of the world’s leading
Professor Greenhalgh answers her causes for neurological deterioration pediatric gastroenterologists and senior
question with a resounding “yes.” That in a child. Meticulous attention should author of The Lancet paper, wrote in
she does appear satisfied, on the basis of be paid to the parental history, and 1997:
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HISTORICAL PERSPECTIVE

Re-challenge with Did they read the paper?


a measles vaccine
Child RT* was monitored closely in his
Ari Brown, MD
Spokesperson for the American Academy of Pediatrics and the Immunization
first year due to wide bridging of his
nose. He was discharged from follow Action Coalition
up as developmentally and physically “This flawed study concluded that the rise in autism was related to giving the
normal by 15 months of age. He later combination vaccine of measles-mumps-rubella (MMR).”31
received a single measles vaccine
following which he stopped “cruising” Professor Sir Michael Rutter, FRS
around furniture and regressed to Expert prosecution witness GMC, expert witness on behalf of MMR vaccine
crawling. His learning plateaued and, manufacturers
by 20 months, he had lost words; “Publication of a study claiming a casual relationship between measles, mumps
soon thereafter, he stopped talking and rubella (MMR) vaccine and autism spectrum disorders (ASD) sparked a
altogether. General ill health developed heated debate...”32
in his second year with ear, chest,
and throat infections, and diarrhea Professor Eric Fombonne
with abdominal pain. According to his Expert witness on behalf of MMR vaccine manufacturers
mother’s story, two weeks after an ”Recent reports claim to have identified another variant of autism (called
MMR vaccine, at 4.5 years of age, he ‘autistic enterocolitis’) in children referred to a gastroenterology department. The
“disappeared” and “lost all skills and hypothesis has involved 3 separate claims: 1) that a new phenotype of autism
communication.” While at 10 months of associated with developmental regression and gastro-intestinal symptoms has
age he had been able to build a tower
emerged as a consequence of measles-mumps-rubella vaccination...”33
of bricks, his play skills declined to the
point that, “now he [was] lost as to
what to do with them.” In addition, he
became clumsy, started head banging, exacerbation of existing symptoms and/
“[These children] have not had the or recurrence of transient symptoms
and developed repetitive behaviors.
He lost his self-help skills; for example, level of investigation which we would associated with the first dose is frequently
before the MMR booster he could feed regard as adequate for a child reported. Properly documented, the
himself with a spoon, afterwards he presenting with such a devastating Institute of Medicine’s Vaccine Safety
could no longer even hold a cup. condition.”28 Committee accepts the “re-challenge”
effect as evidence of causation29. In
The history of Child RT’s GI problems
Despite evident neurological symptoms, order to examine this in the setting of
is also instructive. His records state:
despite the proximity of onset to a viral MMR and autistic enterocolitis and to
“The diarrhoea became a problem at
exposure, and despite additional physical overcome the concern about parental
between 1-1½ years of age [after his
symptoms such as pain and diarrhea, a recall of events that may have occurred
single measles vaccine]…it generally
contains undigested food. His diarrhea diagnosis of autism trumped the need many years before, we conducted a study
became significantly worse from 4½ for anything but minimal investigation by comparing the severity of intestinal
years of age [after his MMR]...” “mainstream” autism practitioners for the inflammation between children once-
Failure to thrive, a cardinal sign of majority of these children. vaccinated and those twice-vaccinated
pediatric inflammatory bowel disease, with an MCV. Our hypothesis was that the
was evident from the GP’s records; Coincidence and re-challenge disease should be more severe in those
he was reported to be “dropping off Where a child with regressive autism exposed twice if the disease were caused
centile charts.” This failure to thrive has received more than one dose of by the vaccine22 . There was a significantly
continued and took another downturn a measles-containing vaccine (MCV), higher prevalence of active chronic colitis
at the same time that his diarrhea
worsened, when he was noted to Despite evident neurological symptoms, despite the
have dropped from the 9th to the 2nd proximity of onset to a viral exposure, and despite
centile for weight.
additional physical symptoms such as pain and diarrhea,
Further examination of MMR re- a diagnosis of autism trumped the need for anything but
challenge is currently under way.
minimal investigation by “mainstream” autism practitioners
*Initials have been changed. for the majority of these children.

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(involving pus-forming cells) in those
children given an MMR or MR booster The damage done to my reputation and to that of my
compared with those receiving only one colleagues as well as the personal price for pursuing a
dose, supporting a causal association. This valid scientific question while putting the patients’ interests
apparent re-challenge effect is currently above all others is trivial compared with the impact of these
being examined in a large population
falsehoods on the children’s access to appropriate and
of U.S. children to see if the finding is
reproducible. necessary care.

Diligent science
The quest for precision can become a
hostage to fortune, as the microscopic
analysis of The Lancet children’s tissues
was to prove. There are few people in
the world with Professor Walker-Smith’s
knowledge of the microscopic appearances
of inflammatory disease of the intestine in
children. So it was that, in the absence of
a pediatric pathologist expert in this field
at the Royal Free, Professor Walker-Smith
conducted a weekly review of his patients’
tissues and identified the fact that disease
was being missed in some children. In
order to reduce this risk and to standardize
the reporting of the ASD children’s
biopsies, all tissues were subsequently
examined by a single senior pathologist
with expertise in bowel disease. His
findings were recorded on a specially
designed chart to document specific
features of tissue damage30. This record
formed the basis of what was subsequently Paradoxically, the price paid for diligent pharmaceutical company. It has been an
reported in The Lancet. Few case-series go science has been a headline proclaiming effective exercise in public relations and
to this level of precision. fraud. No doubt the intended goal – to selling newspapers. But it will fail – it will
In the hands of someone determined to reinforce the false belief that the work is fail because nature cannot be deceived.
discredit the work, however, discrepancies discredited – has worked for some. It has always been a privilege working
between the routine clinical report (which with these children and their families. It
may have come, for example, from a The damage done is my hope that before too long the tide
pathologist with an interest in brain disease The damage done to my reputation will turn and that, in addition, my teacher
or gynecological pathology) and the and to that of my colleagues as well and mentor Professor Sir Stanley Peart,
standardized expert analysis were falsely as the personal price for pursuing a FRS, will come to realize that I have never
reported in the national media as “fixing” valid scientific question while putting forsaken his instruction.
of the data. I was specifically accused of the patients’ interests above all others In the next edition of The Autism File,
this31, although I had no part in scoring the is trivial compared with the impact Dr. Wakefield will continue his analysis of
reviews. It is notable that despite five years of these falsehoods on the children’s “That Paper” and its legacy.
of investigation by the GMC no charge access to appropriate and necessary
of scientific fraud has been made against care. My experience is intended as a
any of the defendants. The allegation of cynical example to discourage others. As
fraud was made by Brian Deer, the same a consequence, many physicians in the
freelancer who had initiated the GMC United Kingdom and United States will
enquiry, continuing his litany of false not risk providing the care that is due to
allegations. There is no evidence at all that these children. There is a pervasive and
the data had been “fixed” as was alleged, openly stated bias against funding and
and the newspaper in question has failed publication of this work, and I have been
to produce any, despite a request to do so excluded from presenting at meetings
from the Press Complaints Commission. on the instructions of the sponsoring

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HISTORICAL PERSPECTIVE

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