THE
LANCET PRESS STATEMENT
FOR IMMEDIATE
RELEASE
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A STATEMENT BY
THE EDITORS OF THE LANCET
On February 18, 2004,
serious allegations of research
misconduct concerning an article by
Dr Andrew Wakefield and colleagues
published in The Lancet in February,
1998,1 were brought to the attention
of senior editorial staff of the
journal.
The allegations
[as framed by Dr Richard Horton]
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 his co-authors and was
not.2
The editors of The
Lancet have seen and reviewed the
documentary evidence available
[to Dr Richard Horton]
in support of these allegations. In
acting on this information we have
followed the guidelines on dealing
with alleged misconduct as set out by
the UK Committee on Publication
Ethics, on which representatives of
The Lancet sit.3 We have presented
this evidence to the senior authors
of the 1998 Lancet paper (Dr
Wakefield, Professor John
Walker-Smith, Dr Peter Harvey, and Dr
Simon Murch) in order to seek their
responses. Dr Richard Horton, Editor
of The Lancet, has also shared this
information with Professor Humphrey
Hodgson, vice-Dean and campus
director of the Royal Free and
University College Medical School,
London, the institution at which the
original work took place.
With this notice are
accompanying statements from Dr
Murch, Professor Walker-Smith, and Dr
Wakefield, answering the allegations
of research and publication
misconduct, together with a statement
from the Royal Free and University
College Medical School.
Given these four
statements, together with an
evaluation of the available
documents, we consider that:
Allegation 1
The evidence we have
seen indicates that ethics committee
approval was given for data
collection from clinically indicated
investigations in the children with
an initially undiagnosed illness and
who were described in the 1998 Lancet
paper. This illness was at first
believed to be enteritis combined
with a disintegrative disorder.
Subsequent detailed clinical
investigations eventually showed this
condition to be the syndrome finally
reported in The Lancet. This course
of events was not described in full
in the Lancet paper, although the
similarity of the behavioural changes
with those of a disintegrative
psychosis (Heller's disease) were
commented on in the discussion
section of the 1998 Lancet paper. In
summary, the evidence does not
support this allegation.
Allegation 2
As described under
Allegation 1, detailed clinically
appropriate investigations led to a
re-evaluation of the initial
diagnosis of these children, as set
out in protocol 172-96. The evidence
we have seen indicates that there was
no attempt by investigators to
conduct the study of children
reported in The Lancet in 1998 under
cover of an entirely different
investigation. In sum, the evidence
does not support this allegation.
Allegation 3
Professor Walker-Smith
notes that although the referral
pattern was unusual-direct contact by
patients with Dr Wakefield leading to
referral to the Royal Free-the
children were indeed consecutively
referred. He reports that to the best
of his recollection he did not invite
any children to participate in the
study. Thus, as far as the facts can
be ascertained by a review of the
case notes and from memory, children
reported in the 1998 Lancet paper
were consecutively referred to the
Royal Free and were not deliberately
sought by the authors for inclusion
in their study based on parents'
beliefs about an association between
their child's illness and the MMR
vaccine.
Allegations 4-6
Dr Wakefield had two
roles in this work. First, he was the
lead investigator of a Royal Free
study into the nature of a new
syndrome with bowel and psychiatric
symptoms. Second, he was commissioned
through a lawyer to undertake
virological investigations as part of
a study funded by the Legal Aid
Board. At the time of submission and
eventual publication of his 1998
Lancet paper, this second study had
not been disclosed to the editors of
The Lancet and his co-authors. We
judge that it should have been so
disclosed, irrespective of the number
of children overlapping between the
pilot project funded by the Legal Aid
Board and the Lancet paper. Such a
disclosure would have provided
important information to editors and
peer reviewers about the context in
which this work was taking place-a
context that would have been vital in
making a final decision about
publication. We believe that our
conflict of interest guidelines at
the time should have triggered such a
disclosure, including the fact that a
significant minority of the children
described in The Lancet paper were
also part of the Legal Aid Board
funded pilot project. These
guidelines stated that: "The
conflict of interest test is a simple
one. Is there anything . . . that
would embarrass you if it were to
emerge after publication and you had
not declared it?"
The difficulty of
adopting a dual role as a clinical
investigator and as a participant in
an evaluation on behalf of the Legal
Aid Board is revealed in Dr
Wakefield's response to Allegation 5.
Although it may be correct that
"this [Lancet] publication . . .
added nothing further to the issue of
causation than that that was already
well known to the lawyers", the
perception of a potential conflict of
interest remains. Editors and
reviewers should have had an
opportunity to take his dual role
into consideration when assessing
this paper for publication.
Finally, although the
Legal Aid Board funding referred to a
different aspect of Dr Wakefield's
work from that reported in The
Lancet, the perception of a conflict
of interest nevertheless remains.
This funding source should, we judge,
have been disclosed to the editors of
the journal.
Summary
The first three
allegations of alleged research
misconduct have been answered by
clarifications provided by the senior
authors of this work. The wording in
the published paper regarding Ethical
Practice Committee approval and
patient referral was accurate, yet at
the same time summarised obviously
lengthy and complex institutional and
clinical review and referral
procedures. In the light of the
public controversy surrounding this
work and the allegations made to us,
one could argue that more explanation
could and should have been provided
in the original paper. Although, with
hindsight, this seems a reasonable
criticism, all research papers
published by all journals are
inevitably concise accounts of often
complicated research protocols. We do
not judge that there was any
intention to conceal information or
deceive editors, reviewers, or
readers about the ethical
justification for this work and the
nature of patient referral. We are
pleased to have had the opportunity
to clarify the scientific record over
the matters raised by these serious
allegations.
We regret that aspects
of funding for parallel and related
work and the existence of ongoing
litigation that had been known during
clinical evaluation of the children
reported in the 1998 Lancet paper
were not disclosed to editors. We
also regret that the overlap between
children in the Lancet paper and in
the Legal Aid Board funded pilot
project was not revealed to us. We
judge that all this information would
have been material to our
decision-making about the paper's
suitability, credibility, and
validity for publication.
In considering what
sanctions The Lancet should apply,
the COPE guidelines3 give eight
options in a ranked order of
severity. Given the public-health
importance of MMR vaccination,
together with the public interest in
this issue, we have decided to pursue
a course of full disclosure and
transparency concerning these
allegations, the authors' responses,
the institution's judgment, and our
evaluation. These statements and a
Commentary will be published in The
Lancet as soon as possible.
- Richard
Horton
- Editor,
The Lancet