Lancet - Statements by all on Dr Wakefield's study


"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
werereferred 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. "
Andrew Wakefield

http://www.thelancet.com/journals/lancet/article/PIIS0140673604156997/fulltext

06 March 2004

1. Lancet Statement
2. Simon Murch Statement
3. John Walker-Smith Statement
4. Andrew Wakefield Statement
5. Royal Free and University College Medical School and The Royal Free
Hampstead NHS Trust Statement


http://www.thelancet.com/journals/lancet/article/PIIS0140673604156997/fulltext

The Lancet 2004; 363:820-821

DOI:10.1016/S0140-6736(04)15699-7
A statement by the editors of The Lancet

Richard Horton

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 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 multiparty legal action prior to
publication, a fact that was not disclosed to the editors of The Lancet.
(6).

That Dr Wakefield received 55000 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

The editors of The Lancet have seen and reviewed the documentary evidence
available 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 coauthors. 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.
References

1. Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular
hyperplasia, non-specific colitis, and pervasive developmental disorder in
children. Lancet 1998; 351: 637-641. Abstract | Full Text | PDF (758 KB) |
MEDLINE | CrossRef

2. In 1998, The Lancet required that: "The Editor needs to be informed [of
any conflicts of interest] and will discuss with you [the authors] whether
or not disclosure in the journal is necessary. All sources of funding must
be disclosed, as an acknowledgment in the text."

3.
http://www.publicationethics.org.uk/cope1999/gpp/dealing.phtml
.

Affiliations

a. The Lancet, 32 Jamestown Road, London NW1 7BY, UK

**********
http://www.thelancet.com/journals/lancet/article/PIIS0140673604157085/fulltext
The Lancet 2004; 363:821-822

DOI:10.1016/S0140-6736(04)15708-5
A statement by Dr Simon Murch

Simon Murch

These allegations concerning our 1998 study are extremely serious, and
clearly require immediate clarification. I welcome the opportunity to do
so. My comment relates to the alleged lack of Ethical Practices Committee
approval. I refute the allegation absolutely on the basis of extensive
documentary evidence.

The protocol for the 1998 Lancet paper was submitted on September 16, 1996,
to what was then termed the Ethical Practices Sub-Committee. It was
entitled "A new paediatric syndrome: enteritis and disintegrative disorder
following measles/rubella vaccine". It was signed by Andrew Wakefield as
lead investigator. Named consultants were John Walker-Smith and myself,
with signed collaborators Peter Harvey, for the department of neurology,
and Mark Berelowitz, for the department of child psychiatry. The
application was initiated due to findings at colonoscopy of two children
with behavioural disorders, which would now be classified within the
autistic spectrum, and a history of chronic gastrointestinal symptoms, and
recognition of a broadly similar clinical history among other referred
patients. Specifically, for several years previously we had looked after an
autistic child with severe ulcerative colitis who eventually required
colectomy (not included in the study), and the second child colonoscoped
(on September 2, 1996) had ileitis of sufficient extent that a diagnosis of
probable Crohn's disease was made. Following this diagnosis, the child had
been entered in good faith by our inflammatory bowel diseases fellow into
an ongoing (ethically approved) study of polymeric enteral nutrition. He
had already made remarkable symptomatic improvement, including apparent
cognitive advance. We, thus, appeared to be dealing with a condition of
significant severity, and had seen clinical improvement unprecedented in
this child's history. News of this improvement was rapidly disseminated
among parents of autistic children, which I believe led to many further
referrals. This child was included in the study, with additional
investigations performed after ethics approval was obtained.

The title of this submitted application is a point of contention, and
should be clarified. Having taken initial advice from our psychiatric
colleagues on the basis of referral letters, it was considered that these
children demonstrated a form of autism called disintegrative disorder
(Heller's disease). After full psychiatric assessment of each child seen,
it was later concluded that the more accurate description for the submitted
paper should be pervasive developmental disorder. Our working title for
these cases had, however, remained disintegrative disorder, while some
parents referred to their child as autistic, and others did not. The whole
area of nomenclature in autistic spectrum disorders was notably difficult
at that stage. As we saw more patients, we moved towards a more inclusive
label of autism, which was used in subsequent correspondence after
February, 1998, to the Ethical Practices Committee. Measles and rubella
were singled out in the application since these conditions, but not mumps,
had been linked to autism in previous isolated reports.

This application (172-96) was for permission for in-depth analysis of
25patients, referred either by general practitioners or the vitamin B12
unit at the Chelsea and Westminster Hospital, who had been studying B12
absorption in children with regressive neurological disorders. The
selection criteria explicit in this application were the presence of
disintegrative disorder, symptoms and signs suggestive of gastrointestinal
disease, and parental request for investigation. All patients reported met
these criteria. The consultant paediatricians responsible for the
children's care decided on the investigations, although advice was taken
from colleagues at other centres. We determined that these investigations
were required clinically, not only to characterise gut inflammation but
also to exclude primary neurological diseases. We had in particular taken
advice for the neurological investigations, since some of the referrals
appeared to have suffered an encephalitic illness, and specifically the
inclusion of lumbar puncture was suggested to us as important for assay of
cerebrospinal fluid lactate, to exclude mitochondrial cytopathies that can
cause both neurological regression and bowel disease. Several of these
cases had not been investigated to exclude a primary cause of their
regression, and we thought it important to ensure that we were not missing
underlying metabolic or genetic abnormality. Proposed investigations thus
included ileocolonoscopy and upper endoscopy, barium follow-through if
ileitis was identified, lumbar puncture (if sufficient fluid remained after
lactate assay, serology and/or cytokine testing would be performed),
magnetic resonance imaging of the brain to exclude structural defects,
electroencephalography to exclude covert epilepsy, electrophysiological
testing, and a panel of standard laboratory tests, with isolation of DNA
for complement genotyping, since C4 deficiency had been reported to be an
association.

The protocol was referred back at first submission in November, 1996, with
clarifications and amendments suggested, and was approved in December,
1996. This protocol formed the basis for all children investigated in the
1998 Lancet paper, and all were investigated. We had no idea at the time of
our Ethical Practices Committee application that lymphoid hyperplasia would
prove so common, although it was a prominent part of the final report.

It is important to document where the protocol differed from the
submission. First, neither I nor my fellow endoscopist, Mike Thomson,
eventually considered it justified to perform upper gastrointestinal
endoscopy in most patients-there was then no published evidence of upper
gastrointestinal pathology, and we were performing these procedures under
sedation, as was then our practice. Getting the precise level of sedation
is not easy in children with such behavioural difficulties, and we felt
this was not appropriate at that time, although our policy altered in later
years. Second, in the event, we did not continue with this extended
protocol for the full 25 patients, again because of the clinical concerns
of myself and my colleagues, since we had found no evidence of underlying
metabolic abnormality in any case and did not consider that lumbar puncture
of further cases was indicated. Other children subsequently seen were thus
not subjected to this extended protocol, and investigated by testing of
inflammatory markers and abdominal X-ray, with endoscopies performed if
thought clinically indicated, unless there were clear clinical reasons to
perform additional tests.

Following the publication of the initial report, John Walker-Smith sought
guidance from the Ethical Practices Committee about further investigation
of future cases, stating "I would like formally to request Ethical
Committee approval for our clinical research analysis of these children who
we are continuing to see by clinical need". In a letter to the ethics
committee, further studies were referred to under the title "autism and
non-specific colitis and Lymphoid Nodular Hyperplasia" since that was the
clinical entity that the earlier study had defined. This was reviewed on
July 22, 1998, and data collection from clinically indicated investigations
was approved. This was for study of subsequent patients investigated on the
basis of gastrointestinal symptoms and initial assessment, and in no way
relevant to the 1998 Lancet paper, which had been conducted entirely
according to the 1996 approval. Thus, there was no change in the name of
the ethical approval requested for the 1998 paper, as mistakenly alleged.

A local review initiated by the Royal Free medical school in July, 1998,
confirmed that the application had been fully considered by the ethics
committee, and that assurance had been given that the investigations were
clinically indicated. It was also apparent that the continuing
investigation of those children had been reviewed by the ethics committee
in July, 1998, and appreciated that investigation of children seen after
publication had become less extensive, and usually restricted to
gastroenterological testing as thought clinically appropriate.

We contended then, and still contend now, that these were standard and
appropriate gastroenterological and neurological investigations for the
symptoms reported given the current state of knowledge at that time.
Undoubtedly we now perform endoscopy less frequently, but that is based on
extensive experience. Similarly, a child with coeliac disease in the 1970s
would have had three diagnostic biopsies compared to the one, or even none,
now performed.

Thus, I can confirm that the patients presented in the Lancet study were
investigated in accordance with the ethics committee approval of December,
1996, and that no attempt was made to seek retrospective approval.
Affiliations

a. Senior Lecturer and Consultant in Paediatric Gastroenterology, Centre
for Paediatric Gastroenterology, Royal Free and University College Medical
School, London NW3 2PF, UK
************

http://www.thelancet.com/journals/lancet/article/PIIS0140673604157097/fulltext
The Lancet 2004; 363:822-823
DOI:10.1016/S0140-6736(04)15709-7
A statement by Professor John Walker-Smith

John Walker-Smith

I deny the allegation that there was systematic bias in the pattern of
referral for the children in the 1998 Lancet paper. No children were
invited to participate in the study.

Upon review of the Centre for Paediatric Gastroenterology, Royal Free
Hospital, work book entitled "Biopsies VI 4/9/95 to 21/7/97", we confirm
that the children who were reported in the Lancet paper of 1998 were the
first 12 children consecutively referred to the university department of
paediatric gastroenterology with autism and related disorders, who had
gastrointestinal symptoms requiring ileo-colonoscopy to exclude chronic
bowel inflammation. These children were referred to me at the university
department of paediatric gastroenterology at the Royal Free Hospital from
July 25, 1996, to February 24, 1997-one being referred from the island of
Jersey and one from the USA. By the time the paper was accepted for
publication, as mentioned in an appendix to the Lancet paper, up to January
28, 1998, a further 40 children had been so investigated, 39 with the
syndrome reported in the paper. The children were all investigated
specifically and exclusively by clinical need to determine whether bowel
inflammation was present that could then be appropriately treated.

These children were referred to the Royal Free by their general
practitioner (ten cases) or consultant paediatrician (two cases). Some
parents had heard of Dr Wakefield's previous work on inflammatory bowel
disease and specifically requested referral, but the channel of referral
was always as described above. However, the pattern of referral was often
that the parents of the children approached Dr Wakefield directly knowing
of his work, frequently by telephone. In the case of one patient, in whom
it has been alleged that I contacted a consultant in order for a referral
to be made, he had been asked by the parents of this child to contact me to
explain what investigations were available at the Royal Free for children
with autism and bowel problems. To the best of my recollection, I did not
invite any children to participate in our study.

None of the children at the time of the referral was known by the team of
paediatric gastroenterologists who cared for and investigated these
children to be involved in a pilot project commissioned by the Legal Aid
Board. At the time of consultation, I was aware that some parents were
engaged in legal proceedings. Review of the clinical notes of the 12
children in the 1998 Lancet paper indicate that we had become aware at the
time of publication that one child was involved in litigation proceedings
against the vaccine manufacturers.
Affiliations

a. Emeritus Professor of Paediatric Gastroenterology, Wellcome Trust Centre
for History of Medicine at University College London, London NW1 1AD, UK

************
http://www.thelancet.com/journals/lancet/article/PIIS0140673604157103/fulltext

The Lancet 2004; 363:823-824

DOI:10.1016/S0140-6736(04)15710-3
A statement by Dr Andrew Wakefield

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.
References

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: 807-811. MEDLINE
***

http://www.thelancet.com/journals/lancet/article/PIIS0140673604157115/fulltext

The Lancet 2004; 363:824

DOI:10.1016/S0140-6736(04)15711-5
A statement by The Royal Free and University College Medical School and The
Royal Free Hampstead NHS Trust

Humphrey Hodgson


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.
Affiliations

a. Vice-Dean and campus director, Royal Free and University College School
of Medicine, London NW3 2PF, UK