>>> SEPTEMBER 2008: A STATEMENT BY
BRIAN DEER <<<
 |
|
The
MMR-autism crisis
- our story so far
Left: British
former gut surgeon Andrew Wakefield |
"It has been proposed that
my role in this matter be investigated
by the General Medical Council. I not only
welcome this, I insist on it"
- Andrew Wakefield, February 2004.
|
By
Brian Deer
Immense human
suffering is being exported across the world, caused
by claims, born in Britain, linking the triple measles,
mumps and rubella vaccine
with autism. In 2008, measles
outbreaks - explicitly linked by doctors to these
claims - are being reported across Europe, the United
States, Canada, Australia, Japan and South Africa, as
well as in the UK, where in June a 17-year-old West
Yorkshire boy died, and the government's Health
Protection Agency declared measles to be once again
"endemic".
"Most people
have forgotten, but measles was once an uncontrolled
scourge that infected three million to four million
Americans annually," noted the New York
Times in an editorial titled "Measles
returns" on 24 August 2008. "In
bad epidemic years, some 48,000 Americans were
hospitalized, 1,000 more were chronically disabled,
and 400 to 500 died."
Today meanwhile - and
no less seriously - countless thousands of mothers
and fathers of autistic children are being tormented
with the unwarranted guilt of being misled into
thinking that they made a catastrophic mistake
in agreeing to vaccination, and that [in a blame-game
reminiscent of discredited "refrigerator mother" theories] they may be
responsible for their own child’s disability.
Young parents, in their millions, now agonize about
risks whenever a son or daughter falls due for shots.
Since the early 1970s
in the United States, and 1988 in the United Kingdom,
the three-in-one live virus MMR
vaccine has been routinely administered to almost all
children, soon after they're one year old. Along with
other immunisations - such as that against polio, and
the combined diphtheria, tetanus and pertussis shot -
MMR has become a mainstay of public health,
protecting against infectious diseases.
But, now a decade
ago, a UK medical journal, the Lancet,
unleashed a devastating assault on confidence in the
vaccine: suggesting that independent researchers had
discovered a possible link with the development of a
new "syndrome", combining regressive
autism and inflammatory bowel
disease. This startling allegation came in a
five-page paper [pdf version], dated 28 February 1998,
authored by Dr Andrew Wakefield, Professor John
Walker-Smith, Dr Simon Murch, and ten others, based
at a medical school attached to the 1,000-bed Royal
Free hospital, in the Hampstead district of north
London.
Media reaction at the
time to these claims was swift. "A medical study
suggests today that there could be a link between the
measles, mumps and rubella vaccine (MMR) given to
children in their second year of life and
inflammatory bowel disease and autism,"
reported, for example, The Guardian,
on page 1 of its issue of 27 February 1998.
"They also found that the behavioural changes in
the children which are typical of autism, such as
forgetting the basic language they had just learned,
began within days of their MMR vaccination."
The Lancet paper
reported on just 12 anonymous
children, aged 3-10, who
had previously been diagnosed at other centres with a
variety of developmental disorders, and who the paper
said had symptoms of a variety of bowel complaints
[later revealed mainly to be constipation]. These dozen kids were
referred for tests at the hospital's paediatric
gastroenterology unit - allegedly consecutively
- in late 1996 and early 1997.
Although, in July
2007, a General Medical Council [GMC] panel began hearings
into the ethical issues, the published study's
principal "finding" was an alleged
association between MMR vaccination
and what the Wakefield group claimed to be the sudden
onset of developmental disorders in eight
- two-in-three - of the 12 children. This
"finding", and massive publicity that the
Royal Free hospital and medical school encouraged for
it [through a press release, video news release and a
televised press conference] launched a worldwide
scare over the vaccine's safety, triggering falls in immunisation rates [for
year-on-year stats see the foot of this report], outbreaks of potentially fatal or
disabling diseases, and an epidemic of agonising self-recrimination among many parents of
autistic children.
"Any mother who
has a child wants it to be normal," said, for
example, Karen Prosser, who featured
with her autistic son Ryan in the hospital's video,
voicing sentiments repeated many times over the
years. "To then find out your child might be
genetically autistic, is tragic. To find out that it
was caused by a vaccine that you agreed to have done
is just devastating."
But, despite its
extraordinary impact - particularly on such parents -
even superficial examination of the Lancet report
revealed crude errors,
inconsistencies and omissions, which might properly
have been challenged by the journal's editor, Dr Richard Horton, a former Royal Free
colleague of Wakefield's. Horton, however, vehemently
supported the paper, and shrugged off mounting concerns.
"Progress in medicine depends on the free
expression of new ideas," he wrote in its
defence, in 2003. "In science, it was only this
commitment to free expression that shook free the
tight grip of religion on the way human beings
understood their world."
In addition to
errors, inconsistencies and omissions, however, the
paper was also marred by a striking departure from
journal conventions over the "inflammatory bowel
disease" Wakefield claimed to have discovered.
This was diagnosed primarily by the appearance of
multiple small bumps in the last part of the small
bowel - technically named ileal-lymphoid nodular
hyperplasia - which represented an activation of the
local “immune tissue” frequently seen in
normal children, and by what he and his associates
claimed was "non-specific colitis" [in the
large bowel]. But, although the report was, in fact,
titled "Ileal-lymphoid-nodular hyperplasia,
nonspecific colitis, and pervasive developmental
disorder in children," nowhere did it discuss,
or even cite previous literature on,
the key phrase: "ileal-lymphoid-nodular
hyperplasia".
Such shortcomings -
and a principal finding concerning the sudden onset
of behavioural disorders in the children which was,
at face value, unbelievable - caused
widespread concern among those who understood the
paper, and alerted Brian Deer [pictures] [British Press Award] to the need for an
investigation. This was eventually instigated, in
September 2003, by editors of The Sunday Times of
London. [See The Sunday Times reports listed]
The
Lancet paper
Following Brian
Deer's investigation, and charges laid against
Wakefield, Walker-Smith and Murch by the General
Medical Council, numerous of the Lancet authors would
deny that the paper was ever about MMR at all. But
the text, tables and references were all thick with
issues concerned with the vaccine, and the paper's
most important passage - the "findings"
- stated:
“Findings.
Onset of behavioural symptoms was associated by
the parents with measles, mumps, and rubella
vaccination in eight of the 12 children...”
In the
no-less-critical “results” section,
the paper elaborated on the findings, alleging an
extraordinary 14-day timeframe:
“In
these eight children the average interval from
exposure to first behavioural symptoms was 6.3
days (range 1-14).”
It was this purported
"finding" and "result"
- suggesting that the Wakefield group may have
stumbled upon evidence of a potential health disaster
- that set off the worldwide MMR scare, which has
caused parents anxiety ever since.
With medical research
increasingly dominated by the agendas of drug
companies and other commercial interests, the
reported study drew particular strength from its
apparently independent support. Under a customary
section for such papers headed “acknowledgements”,
it said:
“This
study was supported by the Special Trustees of
Royal Free Hampstead NHS Trust and the
Children’s Medical Charity.”
No other source of
support was cited, although the charity, which had
been set up to fund experiments with vitamin B12 at
another London hospital, had ceased operations in
1995 due to an ethics and publication controversy.
It also appeared from
the text that Wakefield and his colleagues had
complied with the Lancet's editorial requirements
with a declaration on institutional oversight. Under
the heading “Ethical approval and
consent”, the paper said:
“Investigations
were approved by the Ethical Practices Committee
of the Royal Free Hospital NHS Trust, and parents
gave informed consent.”
Authoritative
biomedical journals will not accept for publication
research involving human subjects without statements
of such a nature.
Finally, in the
paper's pivotal conclusions section
[known in the Lancet and many other biomedical
journals as the "interpretation"], the
authors summarised their purported findings:
” Interpretation.
We identified associated gastrointestinal disease
and developmental regression in a group of
previously normal children, which was generally
associated in time with possible environmental
triggers.”
Brian
Deer’s Sunday Times findings
The paper suggested
that the eight children whose parents were reported
as blaming MMR were merely routine referrals from
general practitioners and hospital doctors to the
Royal Free's paediatric bowel unit. Under the heading
"patients and methods", it
stated:
”12
children, consecutively referred to the
department of paediatric gastroenterology with a
history of a pervasive developmental disorder
with loss of acquired skills and intestinal
symptoms (diarrhoea, abdominal pain, bloating and
food intolerance), were investigated.”
But The Sunday Times
investigation unearthed a different story, which left
the integrity of the research in ruins. Long before
publication, almost all of these children [through
their parents] were actually clients
and contacts of a small-time UK
solicitor, Richard Barr, who had been attempting to
raise a speculative lawsuit - financed
through the British government's legal aid fund -
against drug companies which manufactured MMR.
Although doomed from
the outset to fail [as all previous such actions in
the UK against drug companies have failed], this
lawsuit was the origin and engine
of the MMR scare: both in Britain and throughout the
world. First spun from publicity surrounding the UK
government's withdrawal in September 1992 of an early
version of MMR [due to the mumps component being
linked with rare cases of viral meningitis], it
quickly evolved into a fishing expedition for any
allegation critical of the vaccine.
Vaccination rates
were unaffected by by the 1992
withdrawal, and there was no wider public alarm. But
a campaign was started by a Wigan housewife, Jackie
Fletcher, alleging a link with developmental
disorders - but not autism, at this time - one of
which afflicted her son, Robert Fletcher. With such
disorders still poorly understood, and with problems
typically manifesting at around the age of routine
vaccination, alarmist media suggestions of a link
with MMR became amplified like pyramid
selling. And, as Barr's name got around as
the "MMR lawyer", his key clients, led by
Fletcher, began a campaign to deploy frightening, but
generally unverified, "mother and child"
vignettes: winning new converts to the litigation.
Eventually this would register 1,600 claimants, all
of whom have since discontinued.
Barr's early efforts
ran along similar lines to failed legal claims,
mounted in Britain during the 1980s, over the triple diphtheria, tetanus and
pertussis [DTP]
vaccine. Those claims involved [subsequently
discounted] allegations that DTP sometimes caused
permanent brain damage to children - and specifically
[albeit rather arbitrarily] within 14 days
of vaccination. The same time-frame - 14 days
- was also tabulated in a landmark 1981 British
epidemiological survey, the National Childhood
Encephalopathy Study, which not only included data
concerning events after DTP, but also after the
administration of single measles
vaccine.
But Barr - working
with assistant and future wife Kirsten Limb
- had no medical or scientific experts to mount a
similar attack on MMR. The mumps meningitis cases
appeared to resolve without long-term problems for
sufferers, and [although drug industry lawyers would
later express amazement that no serious legal
challenge was raised with respect of vaccine products
withdrawn on government orders] any serious
side-effects were evidently so rare that they
couldn't offset the advantage of vaccination. The
risk-benefit profile of the triple shot seemed clear,
and Barr's lawsuit looked likely to founder.
In 1995,
however, the position changed, with the emergence of Andrew
Jeremy Wakefield, a former gut surgeon doing
research at the Royal Free medical school. The son of
a prosperous neurologist father and general
practitioner mother, from the west of England town of
Bath, Wakefield was ambitious and was determined to
make his mark. And, although employed full-time at
the school since November 1988, he'd already
developed a taste for business ventures, registering
private companies from external addresses, and filing
patents on work done at the school.
The most bizarre was
"Wakefield's box": an "apparatus and
process for performing a chemical reaction",
filed with the London patent office in December 1993.
This was a cabinet, fitted with microwave heater and
fan system, to heat and cool materials for
experiments.
Target
was Crohn's disease
But Wakefield
nurtured a more ambitious "big idea": that
he had discovered the cause of Crohn's
disease. This terrible, and sometimes even
fatal, inflammatory bowel disease, is a major medical
mystery, with numerous theories as to why some people
get it. The gut surgeon's speculation was that it was
caused by measles virus, and in March 1995, he
patented this claim, from his home address, without
the knowledge of the medical school, his employer. So
if this virus - specifically involving live strains
in vaccines - caused Crohn's, there were prospects of
him garnering fame and wealth.
Theories about in
medicine about major diseases being caused by common
infectious agents. They almost always turn out to be
wrong. But just two weeks after the mumps meningitis
problem had triggered the withdrawal of two brands of
MMR, in October 1992 Wakefield began
phoning and writing to officials at the department of
health in an extraordinary, almost menacing, tone.
Although the brand withdrawals were over mumps,
not measles virus
in the vaccine, and he was only a lecturer at a north
London medical school, he demanded top-level
meetings, and for his work to be government-funded,
with veiled suggestions about media involvement.
"My concern is
that although measles, and in particular the vaccine
may have no association with Crohn's disease
whatsoever, what will be picked up by the press is
the apparent association between the increasing
incidence of disease and the vaccine," he wrote
to Dr David Salisbury, chief of the
vaccine programme.
Two-and-a-half years
later, Wakefield made good on this warning when in
April 1995 [one month after filing his Crohn's patent
application] he held a press conference at the Royal
Free hospital. This event announced the publication -
also in the Lancet - of a low-grade, much-challenged
statistical paper, seeking to mine some kind of epidemiological
association between vaccine use and in the incidence
of Crohn's. He appeared on television and in
newspaper reports. These caught the lawyer's eye.
"Children who
have been vaccinated against measles are three times
more at risk of developing serious bowel disease in
later life, a study suggests," reported Daily
Mail journalist Jenny Hope, in publicity
from the Crohn's press conference. "Dr Andrew
Wakefield, of the Royal Free Hospital School of
Medicine in North London, said the increased risk
could be due to the use of live virus."
It was this 1995
publicity which first caused the public to become concerned
about MMR. And, although Wakefield would subsequently
repudiate his theory, his first forays into autistic
children was to prove the cause of Crohn's. Although
some parents would believe that he was a champion of
families struggling with autism, evidence later
presented to the General Medical Council suggests
that this was initially far from the case. He simply
wanted to get into the guts of children - any
children might do it - to prove that measles virus
persisted. But such research on healthy kids would
never be permitted: it would be unethical to expose
them to the risks. Through Barr, however, he saw an
unparalleled opportunity: to perform the tests on
those with brain disorders. These uniquely vulnerable
children of Barr's desperately worried clients might
thus allow the research to go ahead. As Prof
John Walker-Smith would later tell the GMC:
"The
heart of the matter - this all began with Dr
Wakefield's idea that Crohn's disease was
triggered by MMR, and measles was the important
factor."
Wakefield's theories
on Crohn's, however, proved a road to nowhere: even criticised by the Royal Free medical
school. But, evidently on the principle that "my
enemy's enemy is my friend", Barr and Wakefield
made common cause against MMR: bolting together a
novel, elaborate, and wholly unsubstantiated, theory
that measles virus in the vaccine
somehow damaged the gut, which somehow
released so-called "opioid peptides" from
food into the bloodstream, which somehow
damaged the brain. Boom-boom.
Although the 1998
"MMR" Lancet paper remained silent on other
pivotal matters, this "opioid excess
theory" of autism, was set out in surprising
detail. In a customary section for biomedical texts
headed "Discussion", for
example, Wakefield recounted how a number of [fringe]
sources [not all of whom were even doctors or
scientists] argued that autism could arise from digestive
problems:
"The
'opioid excess' theory of autism, put forward
first by Panksepp and colleagues, and later by
Reichelt and colleagues and Shattock and
colleagues proposes that autistic disorders
result from the incomplete breakdown and
excessive absorption of gut-derived peptides from
foods, including barley, rye, oats, and casein
from milk and dairy produce."
As an explanation for
autism, however, the theory was absurd: an almost
Christmas cracker level of science. Although not
publicly nailed until authoritative research was published in March 2008,
it had first been set out in July 1979 in a fringe
"point of view" article by a psychologist,
Jaak Panksepp. Without any clinical evidence
whatsoever, but rather based on observations of rats,
this article began:
"We have
approached the possible neurochemical causes of
autism by assuming that the fundamental problem
of the autistic child is emotional. Some of the
earliest observed symptoms of autism include a
lack of crying during infancy, a failure to cling
to parents, and a generally low desire for social
companionship, which, we believe, shows that the
autistic child is constitutionally unable to feel
properly the emotions arising from social
relationships. Injections of low doses of
morphine can generate such behaviour patterns in
animals..."
Although, three
decades later, such views sound laughable, any
other possible mechanisms by which the vaccine might
cause autism were shunted to one side by such
notions. And as hundreds of parents
of disabled children joined the lawsuit - with all
the uncertainty and stress that litigation always
brings to people's lives - this would be a vital link
in the purported chain of causality to be set out in
the legal claims. Here's a typical paragraph, for
example, from documents later submitted by Barr to
the High Court:
"In
susceptible children, the presence of measles
vaccine viral material in the tissues of the gut
causes immune dysregulation and/or immune
reactions and/or autoimmune reactions which cause
or materially contribute to the development of an
inflammatory bowel disorder, which in turn
initiates a biochemical cascade and in turn leads
to the egress of products of digestion and
neuroactive/neurotoxic agents (including an
excess of opioid peptides) into the circulation
damaging the brain so as to cause autism/an
autistic spectrum disorder."
But the key to the
strategy was to find concrete examples: test cases to
be tried in court. Since any vaccine-damaged
individuals have no known distinctive physical or
behavioural features, it was essential to Barr's
lawsuit [Sayers & Ors v SmithKline Beecham &
Ors] to propose a fingerprint of
damage. So, in February and June 1996, Barr wrote to [possibly
hundreds of] his MMR clients and contacts -
overwhelmingly people who'd got in touch with him
following publicity for his campaign - and advised
them that those whose children had any of a list of
possible symptoms of Crohn's disease [such as bouts
of diaorrhea, gut pain or even mouth ulcers] should
contact him for possible referral to
Wakefield.
It was a means of
finding subjects for Wakefield's research, but, by
selection, created a false impression. Using
recruitment methods never publicly disclosed before
Brian Deer's investigation, the appearance of a
potential link between [1] MMR vaccination, [2] bowel
problems, and [3] autism, was artificially created by
soliciting and sorting from a larger group of
children, recruited from publicity, a small number in
whom all three issues coincided.
Logically, it was like selecting vaccinated kids with
developmental disorders and rotten teeth, and sending
them to a dentist who offers the opinion that
vaccination causes caries, leading to autism.
Legal
aid contract
The risk of creating
a spurious connection was obvious. But Barr had made
up his mind. "Needless to say both Kirsten and I
are satisfied that the link between vaccines and the
injury to our individual clients is not a fanciful
one, but one of direct causation," he wrote in June
1996. "Unfortunately the experience of
many of our clients is that even in the face of quite
an obvious link between the vaccine and the injury,
doctors are dismissive and say that the cause is
anything but the vaccine."
While Barr appealed
to his clients for symptoms, he helped Wakefield
draft a proposal to the British government's Legal
Aid Board to pay for him to prove his theory.
Attaching a copy of a Royal Free research protocol -
later filed with the hospital's ethics committee -
the two men submitted to the board detailed costings
for procedures, and a statement of Wakefield's intentions.
In terms devastating to any possible claim that
Wakefield was employed to be an independent scientist
pursuing objective research, before any of the
children were admitted for his project, or even seen
at the hospital as outpatients - and more than 18
months before the Lancet paper was published
- they wrote:
"It is
hoped that using the testing protocol attached it
will be possible to establish the causal link
between the administration of the vaccines and
the conditions outlined in this proposed protocol
and costing proposals. The standard of proof
aimed for will be at least the balance of
probabilities but it is hoped that in many
respects the level of proof will reach certainty
or near certainty."
So seriously did
these preparations for the lawsuit impact the Lancet
study published in February 1998 that, even before
the last of the 12 children was admitted to the
hospital for Wakefield's research, the parents of six
had already been issued with legal aid numbers through Barr's then-law firm,
Dawbarns of Norfolk. Moreover, even before the last
child in the series was admitted to the Royal Free,
[one year before the paper was published], Walker-Smith knew that the study was
contaminated. On 20 February 1997, he wrote to
Wakefield, in a letter marked as copied to Murch:
"It is
clear that the legal involvement by nearly all
the parents will have an effect on the study as
they have a vested interest... I would have been
less concerned by legal involvement if our work
were complete and we had a firm view. Never
before in my career have I been confronted by
litigant parents of research work in progress. I
think this makes our work difficult, especially
publication and presentation."
In the event, at the
date of publication, the parents of ten
of the children, whose anonymised apparent details
were included in the paper, had legal aid to sue
manufacturers. One more was American, and therefore
not entitled to sue. And the twelfth eventually
changed her mind - four years after going to the
hospital - and blamed MMR for her child's
neurological problems after she was visited at home
by a lawyer.
Wakefield and Barr
were working together. But third parties were also
key. In addition to being lawyer's clients and
contacts, parents arriving at the Royal Free to
vocally accuse the vaccine of causing developmental
disorders were members or contacts of the British
campaigning organisations JABS and Allergy-Induced
Autism: both run by Barr clients [respectively
Jackie Fletcher and Rosemary Kessick], who were collaborating with
Wakefield behind the scenes. No wonder that,
eventually, the parents of all 12 -
an incredible 100% - of the Lancet
children, who Wakefield repeatedly held out to the
world as being nothing more than consecutive, routine
clinical referrals to the paediatric bowel unit of
the hospital [which didn't even boast a reputation as
a centre for developmental disorders], were on the
record as blaming MMR.
None of this
underbelly was revealed in the paper, or reported in
surrounding publicity. Although the Lancet text
opaquely referred to possible "selection bias in
a self-referred group", this possibility was
dismissed in the same sentence, and nowhere was the
children's extraordinary status and manner of
recruitment disclosed. Rather, Wakefield misled the
public by laundering into the medical literature, as
apparently scientific findings and results,
what were, in reality, highly-motivated
[and usually poorly-substantiated] allegations from a
group of parents who had an overpowering emotional
and economic need to believe that MMR was at fault.
The apparent parental
allegations, moreover, were written up in terms that
misled. Where Wakefield spoke in the paper of
behavioural symptoms within 14 days of MMR, the true
position was that the parents [usually after advice
from lawyers or activists, and always after being
advised by Wakefield] had generally reported [if
anything] common, benign, consequences of
vaccination, such as crying, fever,
rash, irritability, and even sometimes [also
benign] febrile convulsions. No
competent doctor, acting professionally, could
describe these as "behavioural symptoms",
much less hold them out as potential markers for the
onset of regressive autism.
In fact, Wakefield's
tabulated finding - linking MMR with the sudden onset
of regressive autism in two thirds of a consecutive
series of 12, seen routinely at a children's bowel
unit within the space of a few months - was both
biologically implausible and statistically
impossible. It simply could not happen.
No paper or article
has ever subsequently been published proposing
anything like this scenario. Indeed, faced by
urgently-commissioned research, and a review of cases
by the Committee on Safety of
Medicines,
which showed no such temporal association, the
lawsuit-driven anti-MMR campaign moved off in a
different direction. The argument quickly changed to
allege that the emergence of autistic disorders after
MMR wasn't sudden at all, but delayed
and insidious. By
August 2001, other retained experts, working for Barr, led by
Canadian epidemiologist Walter Spitzer and British
psychologist Kenneth Aitken, published a paper
reporting, among other things, that they'd found only
two out of 493
[0.4%] children then enrolled for Barr's lawsuit [who
were vaccinated between January 1988 and November
1998, and thus including Wakefield's series] where
MMR had been given less than 30 days
before the appearance of behavioural symptoms. In
striking contrast, however, Wakefield had claimed in
the Lancet paper that eight out of 12
[66.6%] had received MMR within 14 days
of symptoms. Moreover, Spitzer and Aitken reported
that the median time to the onset of symptoms among
Barr's clients was 1.1 years, while
Wakefield had claimed a median time of only 6.3
days.
Wakefield's
"finding" and "result" were thus
abandoned by history, with only the sting of his
attack remaining. In due course, he would up the
stakes, issuing a string of false claims, ranging
from baseless comparisons between California and
London autism data, published with Royal Free
sidekick Scott Montgomery Ph.D in November 1999 [again
in the Lancet], to a bogus review of vaccine
research, published with Montgomery in January 2001
[in Adverse Drug Reactions and Toxicological
Reviews]. Analysis of these texts reveals motive: to
attack MMR, with little heed for truth or
consequence. But, with regard to the February 1998
Lancet paper, his claims were a charade: by a former
surgeon with insufficient training in general
medicine and paediatrics to realize that what he'd
claimed was impossible.
It was a similar kind
of story with the "inflammatory bowel
disease" Wakefield claimed to have discovered.
Later, he would grandly dub this "autistic
enterocolitis", as if it were something
distinctive to these children. Even the British
Medical Journal, attending the launch of the Lancet
paper in 1998, took this to be a pivotal insight.
"The study is the first of five new papers to be
published on the new syndrome, which the team have
named ileal lymphoid nodular
hyperplasia,"
the journal reported on 7 March 1998.
But within weeks of
the Lancet paper's publication, the clinicians
admitted that they'd seen something else: very common both to children with
developmental disorders, and to those with learning
difficulties. "Plain radiography confirms severe
constipation with acquired megarectum [solid
blockage] in almost all affected children,"
Walker-Smith and Murch wrote in a letter to the
journal, published on 21 March 1998.
"Most parents note a honeymoon period of
behavioural improvement after the bowel preparation
for colonoscopy and this is maintained if recurrent
constipation can be prevented."
"Constipation"
was nowhere mentioned in the paper, but was this
related to the ileal-lymphoid hyperplasia? In fact,
this term [meaning swelling of glands near the end of
the small intestine, near the appendix] didn't refer
to an "inflammatory bowel disease" at all,
but to a common gut feature, often seen in children,
regarded by specialists as usually benign.
Although, oddly, the Lancet paper contained no
explanation, discussion or literature citations
whatsoever about this feature, even a panel of 20
specialists, including Wakefield and his supporters,
convened in October 2006 by a US group, Autism
Speaks, concluded:
"The
clinical significance of LNH in children with
autism is unclear given that similar findings
have also been reported in children with typical
development as well as children with food
allergies and immune deficiencies."
Besides
lymphoid-nodular hyperplasia being a frequent, benign
finding in all kinds of children seen at hospitals -
and not, as Wakefield had claimed, a new disease
linked to autism - Walker-Smith would later admit in
confidential papers that most children that he
claimed to have "autistic enterocolitis"
didn't have enterocolitis [meaning inflammation of
both the large and small intestines] at all. And
experts also found "unremarkable" signs in
the children's colons. "These
colonoscopic findings of increased vascularity and
granularity are entirely subjective," wrote one
experienced gastroenterologist in a report.
"These are appearances that can occur following
bowel preparation for colonoscopy and they are of no
diagnostic significance."
No wonder that, in September
2003, Barr's lawsuit collapsed, when public funding was
stopped, immediately following expert reports being exchanged between the parties. Although
Fletcher's JABS group would blame the government, the
Legal Services Commission, the judiciary, and even
Brian Deer [who at the time had never published
anything whatsoever about MMR] for the failure, it
was the children's own lawyers - the
QCs Jeremy Stuart-Smith, Simeon Maskrey and Augustus
Ullstein - who had advised the commission that,
notwithstanding the vast investment of public money
in trying to undermine MMR, the attack based on
Wakefield's theories was unlikely to succeed. As Lord
Justice May summarised the events, in a February 2006
appeal court judgment:
"The
actions proceeded and expert evidence was
exchanged. At this stage, three leading counsel
for the claimants in the group action produced a
lengthy advice. They advised that, as the
evidence stood, there was no reasonable prospect
of establishing that the MMR vaccine could cause
ASD."
Ten years had been
wasted on Wakefield's claims. Parents had gained
nothing but heartache.
He
who paid the piper...
To understand
Wakefield's conduct, it's hard to overlook his hidden
financial interests. To the later declared surprise
of his colleagues [mp3 audio], two years
before the Lancet paper was published, his research
on the children had begun, not just with a desire to
collaborate with Barr, but with a lucrative financial
contract to join the team preparing
the lawsuit. In February 1996, Wakefield agreed to
work for Barr at a rate of £150 an
hour - a great deal of money for a retained expert at
that time - in addition to his Royal Free salary. And
as the Sunday Times investigation revealed in February 2004, the
proposal submitted to the Legal Aid Board [now the
Legal Services Commission] in June 1996 meant money
to support Wakefield's work.
Shunning competing
explanations for how MMR might cause injuries, and
without any medical or scientific review, Barr was
authorised to pay Wakefield a maximum of £55,000
from public funds - on top of his hourly rate - to
perform the research in the June 1996 proposal. This
was to provide for "clinical and
scientific" tests on ten client
children in the hunt for evidence for the lawsuit.
Interviewed by Brian Deer in 2004, Barr - by now
working for the larger law firm Alexander Harris -
confirmed that he'd arranged finance [mp3 audio] for the study published in
the Lancet of February 1998. But then, after public
uproar followed the first Sunday Times reports, he
avoided any further comment.
Even some of
Wakefield's closest collaborators voiced concern over
this new information. "We were shocked by the
revelations in the Sunday Times," said Professor
John O'Leary, a controversial
Dublin-based Wakefield associate, and former business
partner, in a statement issued through his lawyer.
"We were not made aware, nor were we aware, of
any liaison between Dr Wakefield and Mr Richard Barr
of Alexander Harris Solicitors that apparently
existed since 1996. In addition, we had never been
informed that the LSC had funded Dr Wakefield."
Walker-Smith
also denied all knowledge, despite being the study's
senior clinical investigator. In an email, circulated
at the Royal Free on 27 February 2004, in response to
The Sunday Times investigation, he said:
"No
financial details of Andy's work was ever
discussed with me by anyone and I was totally
unaware of the grant of £55,000 that had been
paid to him in an NHS Trust Fund, until Deer told
me to my astonishment in December 2003."
The explosive
revelation about Wakefield's £55,000, however, only
scratched the surface of his pecuniary advantage. On
the legal front, in December 2006, the Legal Services
Commission answered a Freedom of Information Act
request from Brian Deer with a spreadsheet of fees to paid witnesses in the MMR lawsuit, stating
that, since joining Barr ten years previously,
Wakefield had been paid £435,643
[about $780,000], plus expenses, for his role in
backing the generic case against MMR. This money -
which is believed to have been augmented by yet
more, still undisclosed, for work on
individual children's records - was drawn against the
cash-limited UK legal aid fund, intended to help poor
people gain access to justice. During this
period, Wakefield and his wife built a house on land purchased adjacent to their
home, which was offered for sale in March 2007 priced
£2,950,000 [$5,677,550].
Like many biomedical
journals, the Lancet had strict rules requiring
authors to report potential conflicts of interest.
But neither the nature of the collaboration with
Barr, the money Wakefield received, nor the
children's litigant status, were disclosed to the
journal and its readers. Nor did Wakefield reveal the
true situation when repeatedly offered the chance. In
March 1998, for instance, at a
meeting convened by the UK Medical Research Council, he was asked where he got
the children. The minutes of the exchange accurately
reflect a full transcript, in Brian Deer's
confidential possession:
"Members
were interested in how the children had come to
be referred to the RFHMS team, as this had a
bearing on the issue of bias in the generation of
the case series. Mr Wakefield explained that
originally the parents of the children had come
to the group without any connection through any
other organisation. Latterly, following media
attention, parents had heard of the RFHMS group's
work either directly or through other
organisations. All patients who had been reviewed
to date had been referred by their general
practitioner or paediatrician by the standard
route."
In May 1998, two
months after this meeting, the Lancet published a
reader's letter speculating that lawyers were involved [pdf version]. Then, in April 2000,
Wakefield was asked at a US congressional committee, with reference to material
he'd presented, which included the
Lancet 12:
"Who
funded your study?"
And, in March 2001,
he was asked again at an Irish parliamentary committee to identify the source of his
finance. When Wakefield dodged the
question, a deputy pressed him:
"I
genuinely wanted to know who is funding the
research."
On any of these
occasions, Wakefield might have made the position
clear: that a lawyer employed him to
produce evidence against the vaccine.
Ethical
issues
The Sunday Times
investigation also revealed anomalies over the
project's institutional review. Under the terms of
the Declaration of Helsinki of June 1964 [with later
revisions], and other rules, such review is an essential
prerequisite to research on humans: aiming to protect
the rights of subjects, to prevent exploitation of
the vulnerable - especially children
and the mentally incapacitated - and
to ensure that the true facts [including sources of
funding and subjects] are independently approved as
ethical. The spur to the declaration were abuses by
Nazi doctors, exposed after the World War II. Other
20th century atrocities included the Tuskegee syphilis experiment, which saw infected black men
left untreated.
But after the Lancet
report was published, its claim that
“investigations were approved by the Ethical
Practices Committee” was questioned by a senior British doctor,
and denied both by the chair of the
Royal Free's ethics committee, and by the dean of its
medical school. In fact, the committee had challenged
Wakefield and Walker-Smith in 1996 over the purpose
of their investigations, which included a battery of hazardous, invasive
procedures of questionable clinical justification.
These procedures were set out in two protocol
documents describing the clinical and scientific
research to be undertaken, titled "A new
paediatric syndrome: enteritis and disintegrative
disorder following measles/rubella
vaccination". One of these documents
was a 20 page narrative, outlining the
proposed project. The other was an ethics committee
question-and-answer pro-forma of 11 pages, completed and signed by the
researchers.
After written and
verbal questions to Wakefield and Walker-Smith, the
ethics committee was led to believe that the
procedures to be undertaken - including general
anaesthesia, ileocolonoscopies, MRI brain scans,
EEGs, and even lumbar punctures - were merely routine
clinical evaluations, which would have been carried
out even if there had been no study. But, in fact,
they were part of the regime specified in the deal that Wakefield had reached
with Barr. Having been set out in a research protocol
and proforma [which, oddly, spoke of an alleged
"new syndrome" in advance of any research],
moreover, the procedures were determined before
children were even seen at the hospital, much less
had their individual histories, symptoms and signs
evaluated by appropriate doctors.
Years later, at the
General Medical Council hearing in 2007 and 2008, the
doctors would claim under oath that the
investigations were all clinically-indicated, with
decisions to perform them taken after
the children were examined at the hospital. But in
January 2004, prior to the GMC's charges being laid,
Brian Deer had interviewed Dr Simon Murch, who
clearly recalled the decisions to perform the
procedures being taken before, as
part of a research exercise. By agreement, the
interview was recorded.
BRIAN DEER:
“So up front somebody had a rubber stamp
that said they’ll all have MRIs et
cetera.”
SIMON MURCH:
“Exactly.”
Murch
added:
“We
had meetings, and in our research planning
meetings we had all these referrals, and we felt
that they - having seen the few we had
taken histories from - they had had no
investigations. The doctors’ label
applied. One or two had been investigated
at the time, but this was, ‘Okay, how are we
going to do this properly?’ And so
that was a prospectively-planned research to do a
defined number of children, just in terms of
assessing the limits of what we were
having.”
He was in no doubt,
moreover, that the study was ethically
approved. Deer read him the ethical
statement in the Lancet - "Investigations
were approved by the Ethical Practices Committee of
the Royal Free Hospital NHS Trust, and parents gave
informed consent - ” and then continued.
BRIAN
DEER: “Do you believe that to be true?”
SIMON
MURCH: “Yes.”
BRIAN
DEER: “You believe it’s true?”
SIMON
MURCH: “I do.”
BRIAN
DEER: “You believed it then, and you believe
it now?”
SIMON
MURCH: “Yes.”
BRIAN
DEER:“Investigations?”
SIMON
MURCH: “Yes. The ethical thing, that was
approved for those 12 children. We did not go on
doing lumbar punctures, and we haven’t done
that since. That was for that initial assessment
study. Yes, absolutely."
A month after this
interview, Simon Murch, on behalf of the Lancet
authors, Prof Humphrey Hodgson, on behalf of the Royal Free
and University College medical school, and Dr Richard Horton, on behalf of the Lancet, all
took the same stance, and issued formal statements
insisting that ethical approval was given for the
work published in the journal, according to the
protocol documents submitted in 1996, and extensively
discussed in 1997. But, despite all these
assertions, after the disciplinary charges were laid
against them by the GMC, Wakefield, Walker-Smith and
Murch would change their story and
claim that no research study was carried out on the
children, and hence no approval was required.
In fact, as documents
obtained during Deer's inquiries revealed, the
committee never approved any study
as described in the Lancet of February 1998. A comparison between the project submitted
to the committee - involving proposed research on 25
patients diagnosed with the very rare and serious childhood disintegrative
disorder [and
with what Walker-Smith told the committee was a
"hopeless prognosis"] - was quite different
to the eventual report on only 12 children afflicted
by vastly more common and disparate developmental
disorders, which couldn't responsibly be described as
"hopeless". These disorders not only
included autism, but [although not revealed as such
in the paper] also the "high-functioning",
non-regressive, Asperger's syndrome,
and even pathological demand avoidance.
Moreover, in a
stipulation commonly laid down by ethics committees,
the Royal Free's ruled that any children enrolled
into Wakefield's research prior to the completion of
ethical consideration in December 1996 [which was 7
of the 12 reported in the paper]
must be excluded from the study. Had this
ruling been heeded [which it wasn't], the apparent
results of the research would have been substantially
different to what was published:
embracing many children where a vaccine link was
implausible, or where there was manifestly no claim
of anything like the sudden onset of regressive
autism. Compliance would have torpedoed the 14-day
temporal link, and the health scare would have been
scuppered.
Dr Michael Pegg,
chair of the Royal Free's ethics committee, was
interviewed by Brian Deer in 2003. “If somebody
tells me something, I have to believe them,” he
said of the submissions made to him regarding the
Wakefield project. “If what I am told is
not correct, that is a problem for others, the General
Medical Council and so on.”
The unreliability of
the Lancet data was emphasised in 2005, when Deer
obtained a previous version, showing
that Wakefield had sexed-up his findings.
Side-by-side, the two texts report dramatically different results from the same records of the
same 12 subjects. One child's bowel, for instance,
moves from normal to abnormal
in a simple, manual alteration. The most striking
change, however, concerns the 14-day
time-frame, which morphs from one version to the
next. In a version circulated at the Royal Free
in August 1997, 14 days is cited as the average
time to the onset of "behavioural
symptoms", with the maximum time [range] stated
to be 56 days. In a second version, eventually published,
however, the 14-day time-frame survives, but now as
the maximum, with the reported
average just 6.3 days.
Parents - desperate
for answers, and understandably hoping for financial
help to care for their children - consented to
Wakefield's project. But, in some cases, their
children underwent distressing, painful tests, or
were even injured during futile procedures. For
instance, the mother of one of the Lancet 12 - a
7-year-old boy - said that her son was rushed by
emergency ambulance from his home to
the Royal Berkshire hospital after enduring lumbar
puncture under general anaesthetic at the Royal Free.
Later, during an
extension of the project into a larger number, a
second child, aged 5, was obliged to undergo
emergency transfer from the Royal Free to Great
Ormond Street hospital after his bowel was punctured
in 12 different places during a colonoscopy. In
December 2007, this boy was awarded £482,300 after
the High Court was told that he'd suffered multiple
organ failure, including kidney and liver problems,
and neurological injuries. In allegations denied by
the hospital, the boy's parents are reported to have
claimed that the colonoscopy - not involving
Wakefield - was "not clinically indicated or
justified", that they were not given proper
informed consent, and that the procedure was an "assault"
on their son.
Dispatches: MMR
- What they didn't tell you
After the initial
Sunday Times reports, published on 22 February 2004,
and followed by numerous others in the paper, the
UK's Channel 4 Television network asked Brian Deer to
continue his inquiries. These resulted in further
revelations in a prime-time Dispatches
documentary MMR: What they didn't tell you, broadcast on 18 November
2004, and described in the British Medical Journal as "one of the most
exciting examples of investigative television
journalism you will ever see".
The programme's
findings took The Sunday Times investigation into new
areas of inquiry. Instead of focusing on the legal
money and conflicts of interest, Deer probed other
aspects of Wakefield's secret agenda, and dug into
the basis of his science. Although
Wakefield's associates, business partners and
collaborating parents uniformly declined to
co-operate with the programme-makers, in no instance
was any evidence unearthed suggesting that his claims
had merit.
At the press
conference on 26 February 1998, called to launch the
Lancet paper, Wakefield had urged parents to boycott
MMR in favour of single shots against measles, mumps
and rubella, separated by gaps of one year.
"It's a moral issue for me," he said.
"I can't support the continued use of these
three vaccines, given in combination, until this
issue has been resolved."
Although Wakefield
had performed no clinical research upon which to
credibly base such a recommendation, this attack on
MMR had been orchestrated through a 20-minute video news release, prepared weeks in advance
and issued to journalists by the Royal Free
hospital's press office. In this video, which doctors
knew was likely to cause public alarm, and
damage to immunisation rates, Wakefield four times
claimed that single shots were likely to be safer
than MMR, which he said should be withdrawn
by the government.
In the videotape,
which the Royal Free refused to
release to Channel 4, but which Deer's team obtained
nevertheless, Wakefield said:
"There
is sufficient anxiety in my own mind of the
safety, the long term safety of the polyvalent -
that is the MMR vaccination in combination - that
I think that it should be suspended in favour of
the single vaccines, that is continued use of the
individual measles, mumps and rubella
components."
This call had no
scientific basis. As Wakefield would later admit
during an interview for an online presentation by
London's Science Museum, he didn't know
himself how to justify it. In a text, submitted for
his approval before being posted on the web in June
2003, museum staff asked about his call for single
vaccines. "What's his reasoning?" they
asked.
He said:
"It's
purely empirical - we have no idea. It's the
public health people's job to look into
that."
Wakefield's call in
1998, however, had created the false impression that
it was backed by the "findings" in The
Lancet of 28 February. And it fitted Barr's strategy
for pursuing the litigation - which was rooted in UK
consumer legislation, focused specifically on
combined vaccine products. As a confidential
Barr newsletter, sent to the lawyer's
clients, explained in May 1997:
"If the
MMR vaccines are withdrawn, then that of course
will be a great leap forward for the cases."
Wakefield worked for
Barr, but there was an even greater self-interest
than the enormous fees he claimed from the lawsuit.
Unknown to the public prior to the Dispatches
investigation, nearly nine months before the press
conference, Wakefield and the Royal Free medical
school had filed the first in a string of patent applications for extraordinary products
which could only have stood any chance of success if
MMR's reputation was damaged. These included,
firstly, a single vaccine against
measles - a potential competitor to
MMR - and, secondly, purported remedies, perhaps even
what Wakefield bizarrely called a "complete cure", for both inflammatory
bowel disease and autism.
One example of
Wakefield's claims was found in a document filed with the London patent
office on 6 June 1997, but never
disclosed prior to Deer's programme:
"I have
now discovered a combined vaccine/therapeutic
agent which is not only most probably safer to
administer to neonates and others by way of
vaccination, but which also can be used to treat
IBD whether as a complete cure or to alleviate
symptoms."
These commercial
interests - which Wakefield privately bragged would
make millions - were based on a fringe technology, devised by a disgraced
American doctor, Hugh Fudenberg, who made bizarre claims when
interviewed by Brian Deer in Spartanburg, South
Carolina. Fudenberg said that he treated autistic
children using a powdered "transfer factor"
remedy, which he explained that he rolled out in a
sheet, three molecules deep, "like pasta",
on his kitchen table. The broadcast portions of the
interview were strange enough, as the following
exchange reveals:
BRIAN DEER:
"Now using this technology, do you believe
that autism can be cured?"
HUGH
FUDENBERG: "Yes."
BRIAN DEER:
"Cured?"
HUGH
FUDENBERG: "Yes... It's cheap, it's oral. No
injections. One pill a day, every other day for
three, six, months."
BRIAN DEER:
"And where does that come from?"
HUGH
FUDENBERG: "From my bone marrow."
BRIAN DEER:
"From your own personal bone marrow?"
HUGH
FUDENBERG: "Yeah."
Despite such oddities
in Wakefield's scientific collaborations - including
joint patents with Fudenberg for rights over possible
miracle cures for autism - the former gut surgeon
started his own private company,
Immunospecifics Ltd [intended to be a
subsidiary of another company, to be called Carmel
Ltd, after his wife, Dr Carmel O'Donovan], involving
collaborators John O'Leary, Robert Sleat, and Roy Pounder. This was intended to make a
fortune from "diagnostic kits" to be sold
off the back of the self-same litigation that he was
promoting. Had these fantastic ambitions been known
about before Deer's programme, Wakefield's then
six-year-old crusade against MMR would surely have
been interpreted differently.
And what of the
integrity of Wakefield's scientific discoveries?
These, too, were investigated for Channel 4. His
theory, invoked to justify what would become a
sustained worldwide campaign against the vaccine, was
based on an unsubstantiated claim that the ultimate
culprit - both for inflammatory bowel disease and the
children's autism - was measles virus
in MMR. Wakefield led parents to believe that it was this
virus, purported to persist in the gut, which caused
the damage that could lead to autism. He then joined
fringe US-based businesses, such as the International Child
Development Resource Center & Good News Doctor
Foundation,
in Florida, which sold expensive, unproven
products, and unusual medical services,
purporting to offer children relief.
Yet, as he'd sat at
the London press conference in 1998 and triggered the
public panic, Wakefield knew that his own laboratory
at the Royal Free had used sophisticated molecular
technologies [RT-PCR and NASBA] to test the children
whose cases he presented in the Lancet as evidence of
his claims. Those tests, which were executed under
his personal supervision, but, yet again, never
reported before Brian Deer's investigation, found no
trace of measles virus [or mumps and rubella
viruses] in any of the children
involved.
This information was
confirmed by Dr Nicholas Chadwick,
who was Wakefield's personal research assistant, and
who tested samples taken from the children.
BRIAN DEER:
"And are these children the same children
that went on to be published in the Lancet,
leading to the MMR scare?"
NICHOLAS
CHADWICK: "Yes, that's right."
BRIAN DEER:
"Did you find measles virus in those
children?"
NICHOLAS
CHADWICK: "No. No single case did I find any
measles virus in those children."
BRIAN DEER:
"You looked at some cerebro-spinal
fluid."
NICHOLAS
CHADWICK: "That's right."
BRIAN DEER:
"By lumbar puncture. Did you find any
measles virus in those?"
NICHOLAS
CHADWICK: "No."
BRIAN DEER:
"So you found no measles virus in the
children who were presented to the public at the
very foundation of the MMR scare, where Dr
Wakefield's theory was that it was measles virus
itself that was responsible for a bowel disease,
and then leading on to some kinds of autism, and
you found no measles virus."
NICHOLAS
CHADWICK: "That's correct."
Andrew
Wakefield's response
Wakefield left his
employment at the medical school in late 2001,
and today continues to live off of the scare he
created: running a Texas-based colonoscopy business
called Thoughtful House, - employing, among others,
endoscopist Arthur Krigsman and assistant Carol Stott. He spends much of his time
travelling the United States, drawing new customers
to this business by campaigning against the vaccine.
From the outset of
Brian Deer's inquiries, Wakefield refused to
co-operate, declining through his publicist Abel Hadden multiple requests for
interviews. He ignored, or rejected through lawyers,
written invitations to address the matters to be
raised in the television documentary. And when
approached by Deer and a film crew at an autism
conference in Indianapolis, in October 2004,
Wakefield attacked the camera and fled.
Nevertheless, either
directly or through lawyers, Wakefield has denied
misconduct, and claimed to have acted properly at all
times. His wife, Carmel O'Donovan, has given
supportive interviews to newspapers involved in
backing his campaign, while litigant-parents and
anti-MMR campaigners working with him have issued press notices denying that
he was ever paid by Barr for research. In April 2004,
Wakefield, with others, claimed that he had properly declared
his legal funding in a 1998 letter to the Lancet: a claim
rejected by the Lancet. Statements by Wakefield, and
other material concerning him, can be found through
an index page at this website.
In response to Brian
Deer's first Sunday Times reports, Wakefield claimed in formal statements that the
legal contract and payments were for a scientific
study "quite separate" to
the research published in the Lancet, although no
such study was ever produced. In response to the
Dispatches programme, Wakefield, again in a formal
statement, denied that he ever planned a
vaccine, which he said was only included in patent
applications as "an afterthought".
But following these claims - taken up worldwide by
his supporters in attacks on Deer's integrity - fresh
documents came to light on both the contract and the vaccine.
In December 2005,
Wakefield's lawyers said in a letter that, contrary to popular
opinion, he was not the cause of the
MMR scare, but that “his hypothesis of a
possible link between MMR and autism was but one
episode in a much longer public health debate about
vaccine safety.” His participation in this
debate, they said, was “conscientious,
reasonable and responsible for a research doctor in
his position”.
The letter said that
his work on MMR, and his connections with the lawyers
Dawbarns and the Legal Aid Board
[now the Legal Services Commission], were “well
known both in the general media and amongst his
colleagues from an early stage”.
In an "open
letter" by Wakefield and others, published in
June 2006 by a tiny rightwing US fringe group
called the Association of American Physicians and
Surgeons, he claimed that:
"Every
aspect of the original 1998 report of the first
12 children with this disorder has been endorsed
by independent research."
One of the
signatories to this letter was a London GP, Richard Halvorsen. He was also hired by Barr,
and was one of a small number of undistinguished
doctors who cashed-in on the alarm Wakefield created.
Halvorsen - now running his business out of Harley
Street - sold parents single vaccines, of no
established worth over the free MMR, with prices
given by his business in 2007 as £335 for a course
of three shots, without any consultation. In December
2004, another such GP, David Pugh, was jailed for forging
test results suggesting that children were protected.
Particularly through
his campaigning in the United States, Wakefield has
also won new supporters, including, for example, one
epidemiologist who in November 2007 wrote of the
Lancet research:
"The
paper is actually excellent - a superb case study
that will join the ranks of other famous case
studies, such as the link between rubella
infection and congenital rubella syndrome (Gregg
1941) and between exposure to thalidomide and
embryopathy (McBride 1956)... The paper, once
understood in this light, as case series
analysis, is truly remarkable, well written and
brilliantly documented."
In statements issued
in February 2004, Walker-Smith and Murch also denied
misconduct: a stance they have subsequently restated.
Andrew
Wakefield v Channel 4, Twenty Twenty Productions
& Brian Deer
Brian Deer wasn't the
first to try to get to the bottom of Wakefield's
extraordinary activities. But, as doctors, including
those at the UK's department of health, challenged
him to substantiate his allegations, he threatened
his critics with complaints. In March 2002, for
instance, he formally complained to the GMC, alleging
serious professional misconduct,
over a senior Royal Free consultant who in December
1997 had told a paediatrician:
"There
is a zealot surgeon in our adult gastroenterology
department who thinks that MMR is the cause of
all the problems of the Western world".
Wakefield even
threatened to report the government's chief medical
officer, Sir Liam Donaldson, to the
GMC for having sought from the hospital, in February
2002, a file of ethics committee papers [that Brian
Deer eventually obtained]. Wakefield wrote:
"It has
come to my attention that you have sought details
of our studies from the ethical practices
committee of the Royal Free NHS trust. I infer
from this that faced with an increasingly
compelling scientific case against the MMR
vaccine you are seeking to discredit the
scientists involved. Your attempts to interfere
in the scientific process are unacceptable. Not
only do you have no right whatsoever to this
information without permission, but also your
action has had an indirect but nonetheless
profound effect upon our ability to help these
desperately ill children. I am seeking advice
prior to taking this issue up with the General
Medical Council."
These kind of
harrying attacks weren't only aimed at doctors.
Wakefield also mounted onslaughts against journalists.
Brian Deer, of course, was repeatedly targeted,
beginning with a typically-worded threat. "If
you decide to publish, in spite of our conversations
and all of the written material I have let you have
over the last two days," Wakefield blustered to
the legal manager of Times Newspapers Ltd, on 14
February 2004, "you will leave me no recourse
other than to pursue you through the courts, in order
to protect my reputation."
The most striking
early incident, however, was a purported grievance
lodged with the [former] Broadcasting Standards
Commission over an ITV-1 "Big Story" programme, titled
"A difficult decision". This was
transmitted on 3 October 1996 - more than a year
before the Lancet paper - and offered balanced
coverage of Wakefield's claims at that time that
vaccines against measles caused Crohn's disease.
However, not only was Wakefield's complaint rejected
by the commission [which described the programme as
"a responsible investigation into a matter of
considerable public interest"], but only six
months after a hearing which adjudicated on the
matter, Wakefield admitted at a private meeting that
his own data on Crohn's disease suggested that it
wasn't caused by measles at all.
Wakefield also
revealed a penchant for threatening to sue others who
challenged his conduct. Following Brian Deer's first
Sunday Times reports - and before the extraordinary
sums Wakefield pocketed from the MMR scare were
unearthed - Wakefield instructed libel lawyers Peter
Carter Ruck & Partners [on a contingency fee
arrangement] to threaten both The Sunday Times and
the Lancet, falsely suggesting that he'd properly
disclosed his relationship with Barr's lawsuit. Both
publications, however, rejected his
complaint, and Carter-Ruck wasn't heard from again.
Later, in June 2005,
Wakefield's then-solicitor, Simon Dinnick of the
Medical Protection Society's lawyers Radcliffes
LeBrasseur, was instructed to threaten the Cambridge
Evening News, an English regional newspaper,
which had reported on an aspect of the dispute. Among other
things, Dinnick said that the newspaper's report
alleged that the purpose of the research money from
Barr "was to establish a positive link"
between MMR and autism "thus suggesting a
predetermined outcome and a lack of
objectivity". Demanding an apology and a payment
[which he successfully extracted from the
poorly-advised little newspaper], Dinnick concluded
on his client's behalf:
"There
could hardly be a more serious allegation against
a research gastroenterologist."
Ironically, the paper
was too timid: Barr had hired Wakefield for precisely
this purpose. But in this threat - and others
circulated at the time - Wakefield blustered that he
was suing for libel The Sunday
Times, Channel 4 and Brian Deer, publisher of this
website. He even went as far as having claim forms
issued at the High Court office in London. But this,
he'd later realize, was a big mistake, that some
observers think sealed his fate. Channel 4 -
Britain's independent public service network -
wouldn't be bullied, had the resources to defend
itself, and was determined to stand up to his
threats. Within weeks, Wakefield's lawyers were
trying to freeze the action, pleading for "protection
from the Court" in the face of the
mounting costs of his ploy. But, despite fielding a
QC, Desmond Browne, and a full supporting team,
Wakefield lost at every hearing. And in December
2005, he was ordered by a senior judge, Mr Justice
Eady, to serve the necessary papers on the
defendants: to "put up or shut up," as
Channel 4's leading counsel, Adrienne Page QC, [supported by Matthew Nicklin] expressed it.
Endorsing Channel 4's
position, the judge handed down comments on
Wakefield's behaviour that must surely have proved
unwelcome. Bluntly accusing him of using legal moves
"as a weapon in his attempts to close down
discussion and debate over an important public
issue," Eady said, in the first of three
judgments on the case - [1] [2] [3] - that he was satisfied "that
the claimant wished to extract whatever advantage he
could from the existence of the proceedings while not
wishing to progress them or to give the defendants an
opportunity of meeting the claims."
Many documents were
exchanged during this heavy litigation, as is
required by the UK's civil procedure rules. But the
defendants were surprised by Wakefield's paltry
disclosures, which were backed by signed statements
of truth. If these statements were correct, then
Wakefield - architect, with Barr, of a worldwide
crisis over the safety of a children's vaccine -
possessed almost no data to support
his allegations, and had destroyed
vital records of purported findings. Despite the
earlier claim by Wakefield that the legal money went
into a "quite separate" study to that
published in the Lancet, moreover, no such
study was ever produced, despite two years
of litigation. Indeed, the relevant materials
Wakefield appeared to have accumulated during his
campaign were, by reference to his legal submissions,
less extensive than Brian Deer's journalism. So
striking were the omissions - particularly regarding
alleged virological studies - that the defendants
were prepared to apply to the court, challenging
Wakefield's statements of truth.
What Brian Deer's
Dispatches programme had said