A
STATEMENT BY DR ANDREW WAKEFIELD
Allegation
4 completely misrepresents the facts.
These were two quite distinct issues;
the first a clinical report of 12
cases and the second, a
hypothesis-testing laboratory study
to examine for the presence or
absence of measles virus in autistic
children when compared with
appropriate controls.
A
minority of the children described in
the 1998 Lancet report were
part of the second study that was
funded in part by the Legal Aid Board
(later to become the Legal Services
Commission). The relationship of
these two distinct studies to the
legal status of the relevant children
is set out below. Professor
Walker-Smith has already described
the basis for the referral of these
children according to clinical need.
At
the time that the children reported
in the 1998 Lancet paper were
referred to Professor Walker-Smith
for investigation of their
gastrointestinal symptoms—the
time material to their sequential
investigation and subsequent
inclusion in the report—none of
the 12 reported children was in fact
legally aided, ie, in receipt of
legal aid certificates and therefore
legal aid funding.
Whether
parents perceived an association with
MMR vaccine or not, whether parents
had approached lawyers with the
intent to seek legal redress, or
whether children were in receipt of
legal aid funding or not, had no
bearing whatsoever on their selection
for clinical investigation or
inclusion in the Lancet
report. Since these allegations were
made I have returned to parents (and
where appropriate their current
lawyers) to determine these facts. At
the time the children underwent
ileo-colonoscopy (ie, the time at
which their pathology, as reported in
The Lancet in 1998, was
detected and reported by endoscopists
and histopathologists), one child had
been granted a legal aid certificate.
The authors had no knowledge of this
fact until now.
In
support of this and in view of these
allegations, parents of children in
the 1998 Lancet report have
provided a written signed statement
that (i) they contacted me for help
given their child’s
gastrointestinal symptoms, (ii) their
referral to the department of
paediatric gastroenterology at the
Royal Free was through their
child’s doctor, (iii) that at no
time did I encourage them to seek
legal redress through the courts in
the MMR class action, and (iv) that
their child formed part of the
initial study of 12 children reported
in The Lancet in 1998.
Independently,
I was commissioned through a
solicitor, Richard Barr, to undertake
quite separate virological studies on
ten children. This is entirely in
line with other university-based
studies that have been similarly
funded by the Legal Services
Commission, and reported, for
example, in the BMJ.1
The list of children provided to me
by Richard Barr was based on his
knowledge of an overlap between
patients referred to the Royal Free
and those whose parents had made
contact with Richard Barr. I could
not have constructed such a list
since I had no knowledge of the
litigation cohort or the legal status
of children within this cohort. I was
specifically concerned with
addressing the scientific question in
relation to measles virus—a
perfectly legitimate question in view
of the nature of the intestinal
disease and the sequence of events in
the children. Measles virus infection
of the intestine is a specific
interest of mine.
Once
again, it is important to emphasise
that I had no specific knowledge of
the legal status of the ten children
on the list other than as described
above. Investigations, in light of
the current allegations, indicate
that four of these children (exact
number to be confirmed by Richard
Barr) were among those reported in
the 1998 Lancet paper. The
virological studies on these children
have been submitted for publication.
If and when these studies are finally
published, due acknowledgement will
be made of all sources of funding,
including that from the Legal
Services Commission.
Allegation
5 is an inaccurate misrepresentation
of the facts. The results eventually
reported in the 1998 Lancet
paper were in the public domain long
before their publication in February,
1998, having been presented at
several national and international
scientific meetings. They were
readily available for interested
parties to scrutinise and interpret
as they saw fit. The findings were
not actively made available to the
media until after publication but,
other than this, there was no attempt
to conceal these data.
Such
was the level of concern from the
clinical and scientific team at the
findings in this group of children
with a similar history and an
apparently novel bowel pathology,
that I and Professor Walker-Smith
reported them to a meeting in
October, 1997, convened by the Hon
Tessa Jowell MP, then Minister of
Health, attended by the Chief Medical
Officer Sir Kenneth Calman and other
officials from the Department of
Health in the presence of Richard
Barr of Dawbarns solicitors, and
representatives of interested parent
groups. Barr, for his part, was in
attendance as a lawyer, responsibly
concerned by the sheer numbers of
parents reporting, to him,
developmental regression and
gastrointestinal symptoms in their
children following MMR vaccination.
It
is important to emphasise that the
only aspect of the 1998 Lancet
paper that could have been used to
justify a multi-party action, as in
the foregoing accusation, is the
parents’ perception of a
temporal relationship between MMR
vaccine exposure and onset of
symptoms. This perception was well
known to the lawyers long before we
were even aware of the role of the
lawyers, or the proposed multi-party
action, and certainly long before our
publication in The Lancet in
1998. This publication alone added
nothing further to the issue of
causation than that which was already
well known to the lawyers. The
accusation is therefore specious. My
own report to the Legal Services
Commission on this matter was served
in 1999.
With
respect to allegation 6, as has been
indicated above, these were two
separate matters. One, a report of
clinical investigations, and the
other, a study commissioned quite
independently through Richard Barr.
The latter study was designed in
order to explore the issue of
possible causation. These studies
were concerned with viral detection
in the diseased intestinal tissues of
ten potentially affected children.
This approach is entirely in line
with other university-based studies
that have been similarly funded by
the Legal Services Commission, and
reported in the BMJ.1
Funds received from the Legal Aid
Board were paid into, and properly
administered through, a research
account with the special trustees of
the Royal Free Hampstead NHS Trust.
I
have stated above that the origin of
the list of children was provided to
me by Richard Barr. My involvement
was limited to the legitimate
concern: was measles virus present in
the intestinal tissue of these
children?
As
outlined above, I can confirm that
publication of the relevant
virological studies is still awaited.
An interim submission of a report of
this study (rejected) contained an
explicit acknowledgment of the Legal
Aid funding; this will be made
available as necessary.
If
and when the relevant virological
studies are finally published, due
acknowledgement will be made of all
sources of funding, including that
from the Legal Services Commission.
For
none of these or any subsequent
children has legal status influenced
the need for investigation or the
interpretation of the findings. Where
it is known that children are in
receipt of legal aid certificates or
where studies receive funding from
the Legal Services Commission, this
will be included in any relevant
publication.
The
clinical and pathological findings in
these children stand as reported.
They have now been confirmed
independently by reputable physicians
and pathologists. On the basis of the
molecular detection of measles virus
in the diseased intestine of these
children this issue, too, merits
further study.
I
regret the difficulties that this
issue has caused my colleagues over
the last week and I am grateful to
them for their advice and support. I
am enormously grateful for the timely
manner in which Richard Horton has
dealt with this issue and for his
clarification of the issues
surrounding perception and reality
where conflict of interest may be
concerned.
My
colleagues and I have acted at all
times in the best medical interests
of these children and will continue
to do so.
Dr
Andrew Wakefield
1 Altmann P,
Cunningham J, Dhanesha U, Ballard M,
Thompson J, Marsh F. Disturbance of
cerebral function in people exposed
to drinking water contaminated with
aluminium sulphate: retrospective
study of the Camelford water
incident. BMJ 1999; 319: 807–11.