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