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.