12.2.04
Dear Mr Deer,
I am sorry that I am
writing this letter from the US and
outside office hours. I hope that
having read the letter, you will
understand why I have written, not
least so that you may be able to read
this several times and give due
consideration to what I have said.
At the same time I am
frustrated that having requested, via
Abel Hadden, written questions or
allegations more than eight weeks
ago, I am left to respond at a few
hours notice, from Flintrock Texas,
without access to the necessary paper
records that are of relevance to your
allegations.
Your allegations appear
to focus upon two issues:
(i) the accusation
of inappropriate investigation of
children with autism; and,
(ii) apparent
misappropriation/misuse of funds
from the Legal Aid Board
I will deal with these
in turn.
On the first issue you
are completely mistaken. Children
with developmental disorders and
undiagnosed gastrointestinal symptoms
were referred to Professor
John-Walker Smith or his junior
Consultant colleagues, and not to me.
Since I was a Reader in the
Department of Medicine (not
Paediatric Gastroenterology) and my
work was exclusively research based,
with no clinical commitment, at no
time was I responsible for the
clinical care of these children, or
for making the decision to perform
ileo-colonoscopy or upper
gastrointestinal endoscopy on these,
or any other children.
All decisions to
undertake these procedures were based
solely on clinical indications due to
the children's symptoms and were not
in any way influenced by whether the
child was part of the MMR class
action litigation. Professor
Walker-Smith and his colleagues were,
at this time, strongly opposed to the
litigation and any involvement in it.
To suggest that "these
procedures were not clinically
indicated" is factually
incorrect and impugns the reputation
of some of the country's most
respected paediatric
gastroenterologists. My contract with
the Legal Aid Board (LAB) was in no
way, nor could it have ever been, the
indication for the clinical
procedures carried out on these
children. Neither I nor my medical
colleagues would ever countenance the
clinical investigation of a patient
in the absence of a clinical
indication. The indications in this
case were specificallv and
exclusively the symptoms from which
these children suffered - regressive
encephalopathy and gastrointestinal
symptoms, following viral exposure -
and the decision to conduct these
clinical investigations rested not
with me, but with the paediatric
gastroenterologists responsible for
their care. As an indication of this,
both MRIs and cerebrospinal fluid
analysis were stopped during the
course of the study of the first 12
children since they were not
informative and therefore, deemed no
longer clinically indicated.
You seem to be unaware
of the fact that our collaborative
effort at the Royal Free has made an
important discovery - a novel
inflammatory bowel disease in
children with autism, a group of
children that had been effectively
discarded by the medical profession
as hopeless and untreatable. The
evidence for this discovery has been
peer-reviewed and published in
eminent medical journals and has been
confirmed by physicians and
pathologists at several centres in
the US including Harvard Medical
School, the University of Maryland
Medical School and Lennox Hill and
Mount Sinai Hospitals, New York. For
your information, I have included
details of these studies below'. To
suggest, as you do, without
qualification, that the appropriate,
necessary and compassionate
investigation of these children was
"not clinically-indicated"
is an extraordinary statement coming
from a newspaper journalist and it
has absolutely no basis in fact. It
also explicitly accuses all the
clinicians involved in the care and
treatment of these unfortunate
children of grossly unethical medical
practice. I insist that you withdraw
this accusation in its entirety.
As far as Ethical
Practices Committee approval is
concerned, this was sought as soon as
it became apparent that the children
with autism who were undergoing
appropriate medical investigation for
their clinical symptoms actually had
an inflammatory intestinal disease.
There is absolutely no requirement
for Ethical Practices approval for
the investigation of a patient on
clinical grounds. At the point at
which the clinical findings justified
a more detailed study of the
underlying pathology with a view to
publication, the relevant approval
was sought and obtained. Pending the
approval of the proposed study it
remained entirely reasonable to
follow normal practice and continue
with the clinical investigation of
potentially affected children. It
was, however, necessary to obtain
Ethical Committee approval for the
purposes of reporting our findings.
This approval was duly obtained. As
stated in the Lancet paper,
therefore, the study of these
children was approved by the Ethical
Practices Committee of the Trust.
This issue has been discussed by
Professor Walker-Smith with the
Editor of the Lancet and resolved to
their complete satisfaction.
Once again, although I
was involved in the preparation of
the Ethical submission, the senior
clinician with overall responsibility
for this process was Professor
Walker-Smith and it was to him that
correspondence and documentation was
referred. The process of designing
the studies, writing and amending the
Ethical Practices submission and
writing the papers that derived from
the studies was the shared
responsibility of all of those
involved, and was conducted with full
cooperation of the relevant parties.
To single me out in this process
demonstrates a clear misunderstanding
of the processes involved.
Let me now turn to the
issue of my involvement with Richard
Barr and the Legal Aid Board (now the
Legal Services Commission).
In 1996 I was approached
by Richard Barr and Kirsten Limb of
Dawbarns solicitors, who had become
aware of my group's interest in
children with inflammatory bowel
disease, measles virus and, for some
children, developmental regression
leading to autism. It is important to
state that the first clinical
referrals of children with regressive
autism and gastrointestinal symptoms
to Professor Walker-Smith had started
in 1995, some time before I ever
became aware of the existence of
Richard Barr and the MMR litigation.
Prior to meeting with
Richard Barr, I had had no experience
of medical litigation whatsoever. We
discussed, at great length, the
commonalities between the children
whose parents had approached them
describing regression after MMR
vaccination with concomitant bowel
symptoms and the children that we
were seeing in the clinic at the
Royal Free. Some of the children that
were referred to the Royal Free for
clinical investigation were also
involved in the emerging litigation
against the vaccine manufacturers; it
was this group that was to form the
basis of the LAB contract. It is
important to state that by the time
of my meeting with Richard Barr
several children with this disorder
had already been investigated and
diagnosed at the Royal Free. During
the course of my discussions with
Richard Barr, I was asked what it
would take to establish whether MMR
vaccine had either caused or
materially contributed to the
syndrome of bowel disease and
autistic regression from which these
children suffered. The intestinal
disease was consistent with a chronic
viral pathology, a finding that has
been endorsed by all of the
observations made in follow-up
studies cited above. The areas of
swollen lymphoid tissue were
potentially a nidus (nest) for the
persistence of any causal virus.
Measles virus can cause similar
swelling of the lymph glands in the
intestine and therefore this was an
appropriate place to start looking
for measles and other possible viral
agents. I proposed that an initial
scientific approach would be to use
the technique of
immunohistochemistry, which seeks to
detect and localize specific viral
proteins in the biopsy tissue. I
proposed that intestinal biopsies
from children with autism should be
compared with similar biopsies from
developmentally normal children also
undergoing investigation of
gastrointestinal symptoms. Richard
Barr asked me what it would take to
perform such studies. The simple
answer was funding, in order to pay
the salary of a suitably qualified
laboratory scientist and cover the
cost of the reagents.
I was asked to budget
the likely associated costs of the
viral studies, and in addition, the
costs of any further expenses that
might possibly be incurred in the
investigation of these children and
putting the relevant findings into a
legal context. Since I had no
experience of litigation or the Legal
Aid Board (LAB), I was assisted in
defining possible expenditure by
Richard Barr.
Agreement was reached
with John Baker of the LAB, Richard
Barr and myself; a laboratory
scientist was duly employed and the
viral detection work was started.
Ethical Committee approval for the
studies was obtained and the protocol
was agreed upon by the researchers
involved. This work provided positive
evidence of measles virus protein in
the tissues of the autistic children
at a significantly higher frequency
than in control, developmentally
normal children. Although the studies
more than consumed the funding
provided by the LAB, the results were
sufficiently compelling that the work
was expanded to involve larger
numbers of children and the use of
complementary viral detection
techniques. The funding received by
the LAB was used exclusively to fund
this aspect of the study - virus
detection - which, in the event was
considerably underbudgeted. The
confirmatory aspects of this study
were subsequently funded by research
grants. The results of these studies
were duly presented to the LAB. In
addition the results of these studies
have been presented to scientific
meetings following peer-review, and
have been submitted for full
peer-review publication and have been
provisionally accepted for
publication in 2004. Due
acknowledgement of the funding
received from the LAB for the
preliminary aspects of this work and
all other sources for its completion,
will accompany the paper.
So far as I recall, The
LAB did not fund any of the
investigations reported in the Lancet
1998 publication and consequently the
LAB received no acknowledgement in
this paper.
It should be stated
explicitly, that none of the viral
investigations described above, were
in any way routine services provided
by the NHS, nor were they available
from any routine diagnostic
laboratory. These studies did not
constitute part of the standard of
care for children undergoing
gastrointestinal investigation, nor
were any of these investigations
funded from NHS resources. The
studies constituted strictly
scientific research that was designed
to test the hypothesis that measles
virus protein was present in the
autistic children and not in
developmentally normal controls.
Absolutely no funding
provided by the LAB was used for
routine clinical investigations,
including ileo-colonoscopy. Although
this procedure was included in the
comprehensive list of possible
projected costings outlined to the
LAB, it was clear that since the
procedures were clinically indicated
they were covered as part of the
children's routine investigation as
NHS patients. At the conclusion of
our investigations no claim for
reimbursement of these aspects of the
work were made, and none received.
All matters related to the
investigations were the subject of
ongoing discussions between Richard
Barr and me, as the investigations
progressed. The conclusion of this
aspect of work from the LAB's
perspective, was a detailed report
submitted by me in 1999 that
described the findings and
conclusions. The LAB was fully aware
of the report's findings and appear
to have been entirely satisfied with
the outcome. At no time have any
questions on the above matter been
referred to me or received by Richard
Barr. If the LAB has any questions in
relation to these matters, I will be
happy to deal with them directly.
In summary therefore
your letter of 10th February 2004
while directed to me, contains
allegations of the gravest nature.
You have cast aspersions on the
reputations of all the many doctors
and scientists involved in this work
at that time. You have called into
question the moral and ethical
commitment of doctors and researchers
in a most critical field: appropriate
and ethical investigation of autistic
children who more than any others
have no voice to be heard. You make
the point yourself that childhood
immunisation is a vital matter of
public concern and that research into
this area requires those involved to
be careful, thorough, open and
honest. I fully accept and adhere to
this vital principle and continue to
strive, though diligent research and
publishing of papers in peer reviewed
journals to elucidate the
relationship between the MMR
vaccination and the new variant
inflammatory bowel disease identified
in these children with regressive
autism. Adherence to strict medical
and ethical principles has cost me
and my colleagues dear. I believe
that a similar duty weighs on those
investigating and reporting on this
controversial area in the media.
You seem to imply, in
closing, that the "facts"
that you seek to reveal will in some
way make redundant, all the science
that has been conducted by me, my
colleagues, and other researchers
around the world and in some way
influence the risk of a measles
epidemic. Your demonstrably false
accusations in no way diminish the
scientific validity of our findings.
Furthermore, it is science and
science alone that is necessary in
order to counter the existing basic
and clinical evidence in favour of
some form of an association between
the MMR vaccine and autism in some
children.
Yours sincerely,
Andrew J Wakefield
MB.BS, FRCS, FRCPath
c.c. Richard Barr, Abel
Hadden, Kirsten Limb, John
Walker-Smith, Robert Sawyer,
Wakefield AJ, Murch
SH, Anthony A,, Linnell J, Casson DM,
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