Lancet - Statements by Dr Wakefield

[Sheri Nakken]

The allegations are:
(1) That, contrary to a statement in the Lancet paper, ethics approval for
the investigations conducted on the children reported in the study, some of
them highly invasive (eg, lumbar puncture), had not been given.
(2) That the study reported in The Lancet was completed under the cover of
ethics approval for an entirely different study of 25 children with "A new
paediatric syndrome: enteritis and disintegrative disorder following
measles/rubella vaccination".
(3) That, contrary to the statement in the Lancet paper that children were
"consecutively referred to the department of paediatric gastroenterology"
at the Royal Free Hospital and School of Medicine, children were invited to
participate in the study by Dr Andrew Wakefield and Professor John
Walker-Smith, thus biasing the selection of children in favour of families
reporting an association between their child's illness and the MMR vaccine.
(4) That the children who were reported in the Lancet study were also part
of a Legal Aid Board funded pilot project, led by Dr Wakefield--a pilot
project with the aim of investigating the grounds for pursuing a
multi-party legal action on behalf of parents of allegedly vaccine-damaged
children, the existence of which was not disclosed to the editors of The
Lancet.
5) That the results eventually reported in the 1998 Lancet paper were
passed to lawyers and used to justify the multi-party legal action prior to
publication, a fact that was not disclosed to the editors of The Lancet.
(6) That Dr Wakefield received £55 000 from the Legal Aid Board to conduct
this pilot project and that, since there was a substantial overlap of
children in both the Legal Aid Board funded pilot project and the Lancet
paper, this was a financial conflict of interest that should have been
declared to the editors and was not.2

************
"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"

http://www.thelancet.com/journal/vol363 ... .statement
.28958.4

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 acknowledgment 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
acknowledgment 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.
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. [PubMed]

***

http://www.thelancet.com/journal/vol363 ... .statement
.28958.5******
Statement
We are entirely satisfied that the investigations performed on the children
reported in the Lancet paper had been subjected to appropriate and rigorous
ethical scrutiny. Because the nature of the condition affecting child
behaviour and gastroenterological symptoms was unknown and required
elucidation, the investigation of these children was properly submitted to
and fully discussed by the Ethical Practices Committee at the Royal Free
Hampstead in 1996. Specifically, that committee was a sub-committee of the
then Camden and Islington Health Authority Research Ethics Committee
(subsequently incorporated into the new Central Office for Research Ethics
Committee arrangements) whose decisions were independent of the university
and hospital. The committee, after clarifying a number of issues including
that the children's investigations were defined by the clinical
symptomatology and diagnostic requirements, and having taken expert advice,
approved the protocol submitted.

The clinical management and investigation of these children was performed
at the Free by a dedicated team of consultant paediatric
gastroenterologists, in full consultation with and agreement of the parents
of the affected children. The investigations were those thought appropriate
in the light of the severity of the children's symptoms according to the
clinician's judgment at the time.

Had the advice of the Institutions been sought at the time concerning
conflict of interest, they would undoubtedly have advised that any
potential conflict should be declared, so that others could judge whether
such conflicts were real.
Professor Humphrey Hodgson
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Vice-Dean and campus director, Royal Free and University College School of
Medicine, London NW3 2PF, UK (e-mail:h.hodgson@rfc.ucl.ac.uk)
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Sheri Nakken, R.N., MA, Classical Homeopath
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