Andrew Wakefield & MMR Controversy

STATEMENT FROM DR. ANDREW WAKEFIELD

February 2004

Received from Dr. Andrew Wakefield -
PERMISSION GIVEN & APPROVAL TO SEND AROUND THE PLANET BY DR. ANDREW
WAKEFIELD
OK to forward
Please read carefully
Sheri

Statement from Dr Andrew Wakefield


Serious allegations have been made against me and my colleagues in
relation
to the provision of clinical care for children with autism and bowel
disease, and the subsequent reporting of their disease.

These allegations have been made by journalist Brian Deer who has
expressed, in front of witnesses, his aim of destroying me.

All but one of the allegations, which are grossly defamatory, have been
shown to be baseless. One allegation remains against me personally.

That is, that I did not disclose to the Lancet that a minority of the
12
children in the 1998 Lancet report were also part of a quite separate
study
that was funded in part by the Legal Aid Board .

It is the Lancet's opinion but not mine that such a disclosure should
have
been made since it may have been perceived as a conflict of interest.
This
is despite that fact that the funding was provided for a separate
scientific study.

It needs to be made clear that the funds from the Legal Aid Board were
not
used for the 1998 Lancet study, and therefore I perceived that no
financial
conflict of interest existed.

The Lancet defines a conflict of interest as anything that might
embarrass
the author if it were to be revealed later. I am not embarrassed since
it
is a matter of fact that there was no conflict of interest. I am,
however,
dismayed at the way these facts have been misrepresented.

Whether or not the children's parents were pursuing, or intended to
pursue
litigation against the vaccine manufacturers, had no bearing on any
clinical decision in relation to these children, or their inclusion in
the
Lancet 1998 report.

It is a matter of fact that there was no conflict of interest at any
time
in relation to the medical referral of these children, their clinical
investigation and care, and the subsequent reporting of their disease
in
the Lancet.

As far as the 1998 Lancet report is concerned, it is a matter of fact
that
we found and reported inflammation in the intestines of these children.

The grant of £55,000 was paid not me but to the Royal Free Hospital
Special
Trustees for my research group to conduct studies on behalf of the
Legal
Aid Board. These research funds were properly administered through the
Royal Free Hospital Special Trustees.

The Legal Aid research grant to my group was used exclusively for the
purpose of conducting an examination of any possible connection between
the
component viruses of the MMR - particularly measles virus - and the
bowel
disease in these children. This is entirely in line with other studies
that
have been funded by the Legal Aid Board (latterly the Legal Services
Commission) and reported in the BMJ . If and when this work is finally
published, due acknowledgement will be made of all sources of funding.

It is unfortunate that, following full disclosure of these facts to the
editor of the Lancet, he stated that in retrospect he would not have
published facts pertinent to the parent's perceived association with
MMR
vaccine in the 1998 Lancet report. Such a position has major
implications
for the scientific investigation of injuries that might be caused by
drugs
or vaccines, such as Gulf War Syndrome and autism, where possible
victims
may be seeking medical help and also legal redress.

Health Secretary John Reid has called for a public enquiry. I welcome
this
since I have already called for a public enquiry that addresses the
whole
issue in relation vaccines and autism.

It has been proposed that my role in this matter should be investigated
by
the General Medical Council (GMC). I not only welcome this, I insist on
it
and I will be making contact with the GMC personally, in the
forthcoming
week.

This whole unpleasant episode has been conflated to provide those
opposed
to addressing genuine concerns about vaccine safety with an opportunity
of
attacking me - an attack that is out of all proportion to the facts of
the
matter.

I stand by everything that I have done in relation to the care,
investigation and reporting of the disease that I and my colleagues
have
discovered in these desperately ill children.

My family and I have suffered many setbacks as a direct consequence of
this
work. As a family, we consider that our problems are nothing compared
with
the suffering of these children and their families. For the sake of
these
children, this work will continue.

Lancet -Retraction of an interpretation - RETREACTION of an
INTERPRETATION
(MMR/Autism/1998 Study)

REMINDER.......contrary to how this has been portrayed in the media -
the ONLY THING retracted was the interpretation attributed to it but
others..............but because everyone is now blocked at every turn
when trying to find the truth, trying to do more studies, we may never
know until parents continue to demand truth in even larger numbers!
Meantime children suffer.
Sheri

"We wish to make it clear that in this paper no causal link was
established between MMR vaccine and autism as the data were
insufficient. However, the possibility of such a link was raised and
consequent events have had major implications for public health. In
view of this, we consider now is the appropriate time that we should
together formally retract the interpretation placed upon these findings
in the paper, according to precedent.4 "

http://www.thelancet.com/journals/la...57152/fulltext

Retraction of an interpretation

The Lancet 2004; 363:750

DOI:10.1016/S0140-6736(04)15715-2
Retraction of an interpretation

Simon H Murch email address a, Andrew Anthony b, David H Casson e,
Mohsin Malik f, Mark Berelowitz c, Amar P Dhillon b, Michael A
Thomson a, Alan Valentine d, Susan E Davies g and John A
Walker-Smith a

See Commentary
http://www.thelancet.com/journals/la...57140/fulltext

This statement refers to the Early Report "Ileal-lymphoid-nodular
hyperplasia, non-specific colitis, and pervasive developmental disorder
in children",1 published in The Lancet in 1998. It is made by 10 of
the 12 original authors who could be contacted. It should be noted that
this statement does not necessarily reflect the views of the other
co-authors.

The main thrust of this paper1 was the first description of an
unexpected intestinal lesion in the children reported. Further evidence
has been forthcoming in studies from the Royal Free Centre for
Paediatric Gastroenterology and other groups to support and extend
these findings.2,3 While much uncertainty remains about the nature of
these changes, we believe it important that such work continues, as
autistic children can potentially be helped by recognition and
treatment of gastrointestinal problems.

We wish to make it clear that in this paper no causal link was
established between MMR vaccine and autism as the data were
insufficient. However, the possibility of such a link was raised and
consequent events have had major implications for public health. In
view of this, we consider now is the appropriate time that we should
together formally retract the interpretation placed upon these findings
in the paper, according to precedent.4

We were unable to contact John Linnell.
References

1. Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, Malik M,
Berelowtiz M, Dhillon AP, Thomson MA, Harvey P, Valentine A, Davies SE,
Walker-Smith JA. 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. Murch S. MMR and autism: the debate continues. Lancet 2004; 363:
568-569. Full Text | PDF (60 KB) | CrossRef

3. Horvath K, Perman JA. Autistic disorder and gastrointestinal
disease. Curr Opin Pediatr 2002; 14: 583-587. MEDLINE | CrossRef

4. Zhang L, Lopez P, He T, Yu W, Ho DD. Retraction of an
interpretation. Science 2004; 303: 467.
Back to top

Affiliations

a. Centre for Paediatric Gastronenterology, Royal Free and University
College Medical School, RoyalFree Campus, London NW3 2PF, UK
b. Department of Histopathology, Royal Free and University College
Medical School, Royal Free Campus, London NW3 2PF, UK
c. Department of Child Psychiatry, Royal Free and University College
Medical School, RoyalFree Campus, London NW3 2PF, UK
d. Department of Radiology, Royal Free and University College Medical
School, RoyalFree Campus, London NW3 2PF, UK
e. Institute of Child Health, Royal Liverpool Children's Hospital,
Liverpool
f. Department of Paediatrics, Queen Elizabeth the Queen Mother
Hospital, Margate, Kent
g. Department of Histopathology and Cytology, Addenbrooke's Hospital,
Cambridge, UK

See Commentary
http://www.thelancet.com/journals/la...57140/fulltext

Lancet - Commentary assesses the lessons to be learnt from the MMR
debate.

Please read very carefully and share.....

"Vaccine safety
In a review of the unintended effects associated with MMR, Jefferson
and colleagues10 found that the reporting of safety outcomes in MMR
vaccine studies was inadequate. Here is a constantly repeated scenario
in health-technology assessment (another example: the row over the
safety of calcium-channel blockers). A product undergoes limited
testing for efficacy and safety. It is license"

"............public-health officials have disparaged as "poor
science" evidence that appears to contradict their official message.
This approach has a cost. The reason that today's retraction is partial
and not total is that the discovery of a possible link between bowel
disease and autism is a serious scientific idea, as recognised by the
MRC,8 and one that deserves further investigation. Although dismissing
the entire 1998 Lancet paper as poor science gives a clear and correct
message to the public about the status of any claim regarding the
safety of MMR, in scientific and clinical terms it is both wrong and
damaging. The autism-bowel disease link was considered part of a series
of physiological observations judged by the MRC to be "interesting
and in principle worth investigating". Subsequent research has
yielded conflicting findings.13,14 "

"Third, there has been an effort to starve critics of legitimacy by
refusing to engage them face-to-face. For example, when the drama Hear
the Silence was broadcast on British television in December last year,
there was a boycott of a subsequent discussion by many of those who
could have best articulated the case for MMR. The reason advanced was
that rational debate would not change the minds of an extreme few who
believed MMR to be unsafe no matter what the evidence presented to
them. Also, the composition of the panel discussion did not reflect the
large measure of consensus that MMR is safe. Instead, it portrayed the
issue as a finely balanced scientific exchange, when in truth there is
very little scientific uncertainty "

********

http://www.thelancet.com/journals/la...57140/fulltext

Commentary
06 March 2004


The Lancet 2004; 363:747-749 DOI:10.1016/S0140-6736(04)15714-0

The lessons of MMR

Richard Horton a

panel: Future strategic themes in autism research8



This week, The Lancet prints a partial retraction-a retraction of an
interpretation1-from the majority of authors of a paper published in
February, 1998, by Andrew Wakefield and colleagues.2 Wakefield and one
other co-author, Peter Harvey, have not signed this retraction
statement. We hope to publish their response very shortly. The original
report2 made clear that the authors "did not prove an association"
between measles, mumps, and rubella (MMR) vaccine and a newly described
syndrome of bowel disease and autism. But the authors did raise the
possibility of a link, on the basis of parental and medical histories,
and they suggested that "further investigations are needed to examine
this syndrome and its possible relation to this vaccine". This
interpretation of their data, together with a suggestion made by
Wakefield during a separate press conference held at the Royal Free
Hospital that there was a case for splitting the MMR vaccine into its
component parts, triggered a collapse in confidence in the UK's MMR
vaccination programme. It is the interpretation expressed about a
connection between the vaccine and the new syndrome that is now being
retracted. Today's retraction comes after debate following the release
of new information 2 weeks ago about the circumstances surrounding the
publication of this work.3 An enormous amount of effort has gone into
reviewing and analysing the events before and after publication of the
1998 article. It is now time to look forward.
Autism research

In 1943, Leo Kanner described 11 children with a condition that
differed "markedly and uniquely from anything reported so far".4 He
believed that the characteristics of these children, the fundamental
feature of whom was their "inability to relate themselves in the
ordinary way to people and situations from the beginning of life",
constituted a syndrome, one that he described as "an extreme autistic
aloneness". The recognition of such a distinct clinical entity was
important, even urgent at that time. Kanner described how several of
the children who had been introduced to him were inappropriately
labelled as "idiots or imbeciles". One lived in a "state school
for the feebleminded, and two had been previously considered as
schizophrenic".

Since Kanner's report, autism and autism-like conditions have become
common diagnoses5 and exercise much media attention.6 There is a strong
underlying genetic basis to autism. But the idea of a "late-onset"
variant7 raised a possibility that there might be psychological and
organic factors contributing to autism's cause and course. One
unexpected consequence of the debate surrounding MMR has been a
redirection of public attention to a condition that has often been
neglected by medicine. In a review of the epidemiology and causes of
autism, for example, the UK's Medical Research Council (MRC) summarised
existing knowledge and identified strategic themes deserving further
investigation (panel).8 There are large and surprising gaps in our
knowledge of a condition that affects as many as 6 per 1000 young
children.
panel: Future strategic themes in autism research8


The UK Government announced a further £2·75 million of new and
ring-fenced money for autism research in 2002. The first funding
decisions by the MRC are expected in May this year. The MRC is strongly
committed to autism research, presently funding seven research projects
at a cost of over £4 million. To make the best of what are still
limited resources, it is important that the Council's steering group
set up to implement the findings of its 2001 report, together with
other major national and international grant-giving bodies, establish a
funders' forum for autism research to fine-tune strategy and avoid
unnecessary duplication of research effort. The UK Government should
extend its initial and welcome commitment to autism by pump-priming
research with a further ring-fenced lump sum to the MRC of at least
£12·5 million-£2·5 million annually over 5 years. Such sustained
investment is vital if properly designed longitudinal studies to
examine genetic and environmental factors in autism are to be
constructed. Compare these modest sums of funding, for example, with
the US National Institute of Health's budget for autism research of $70
million by 2003. NIH is also committed to creating STAART (Studies to
Advance Autism Research and Treatment) centres-eight of which have
been launched in the past 2 years, at a cost of $65 million, spread
over 5 years. This approach might well have merit in the UK.
Research integrity

The latest debate surrounding Wakefield and colleagues' paper has been
enormously confusing. Public inquiries have been sought into the way
ethics committees operate, how the legal services commission makes its
decisions, and even, once again, into the safety of vaccines. A
preliminary investigation by the UK's General Medical Council is
underway. A furious debate about the actions of almost all protagonists
has taken place. The press has become the courtroom for this very
public dispute. But the media cannot be the only place to charge,
investigate, prosecute, defend, judge, and pass verdicts on those who
have been accused of research misconduct.

In 2000, a group representing the UK's Committee on Publication Ethics
(COPE) drew attention to a collective institutional failure to take
allegations of research misconduct seriously.9 The absence of formal
mechanisms within many universities and at a national level to
investigate claims with visible due process means that publicly aired
allegations leave everybody involved scrambling to respond in the best
way they can. COPE has produced helpful guidance on how to deal with
allegations of misconduct. But with no national body to which one can
refer these allegations, the danger is that in any ensuing media furore
good people are hurt by smear and innuendo. The appearance of
institutions investigating themselves, while accepted as the norm in
science and medicine, does little to strengthen public trust in a
system that has such critical societal influence, and thus which
requires transparent lines of accountability.

Present scientific and medical institutions have failed to act after
years of encouragement and embarrassment. It is now up to Government to
step in to create Britain's first Council for Research Integrity.
Please, ministers, do so and do it now.
Vaccine safety

In a review of the unintended effects associated with MMR, Jefferson
and colleagues10 found that the reporting of safety outcomes in MMR
vaccine studies was inadequate. Here is a constantly repeated scenario
in health-technology assessment (another example: the row over the
safety of calcium-channel blockers). A product undergoes limited
testing for efficacy and safety. It is licensed. A signal of concern is
thrown up. There is no valid set of safety data to which one can turn
to answer these queries. Public concern grows and confidence in the
technology may be jeopardised. Appropriate studies are hastily
completed to confirm or refute the original signal of potential risk.
An answer eventually comes, but too late to have prevented a great deal
of anxiety.

Jefferson has suggested a solution to this problem.11 He recognises
that vaccines pose particular challenges to investigators given their
frequently universal coverage, which precludes the possibility of any
controlled long-term experimental assessment. Instead, he proposes
creating a library of evidence, drawing together widely dispersed data
from published papers, manufacturers' technical reports, and
researchers' personal files. In this way, loss of crucial information
would be minimised and gaps in existing evidence could be identified
and filled early on. This idea is sensible and deserves further
consideration.
Public engagement

Many doctors and public-health officials have been frustrated by the
debate over MMR. I have shared this frustration. One newspaper
fancifully called our recent statement (see page 820) about the 1998
Lancet paper part of an "orchestrated campaign" to bolster MMR
programmes.12 In fact, the events leading to today's partial retraction
were sudden, sparked by an investigation by a newspaper, The Sunday
Times. Our response was to determine answers to very specific
allegations. We have had no contact with anybody at the Department of
Health or elsewhere in Government, vaccine manufacturers, or lawyers
involved in ongoing litigation. There was no orchestrated campaign.

But there are fair questions to be asked about the style of government
and expert response to claims about the safety of MMR. Three reactions
have been discernable. First, there has been an appeal to evidence. The
Department of Health's www.mmrthefacts.nhs.uk website contains a superb
collection of materials designed to help parents make the "decision
in your own time and on your own terms". The difficulty is that in a
post-BSE era, where government advice is no longer immediately taken on
trust, the weight of accumulated evidence carries less force if it
comes from government than it once did.

Second, public-health officials have disparaged as "poor science"
evidence that appears to contradict their official message. This
approach has a cost. The reason that today's retraction is partial and
not total is that the discovery of a possible link between bowel
disease and autism is a serious scientific idea, as recognised by the
MRC,8 and one that deserves further investigation. Although dismissing
the entire 1998 Lancet paper as poor science gives a clear and correct
message to the public about the status of any claim regarding the
safety of MMR, in scientific and clinical terms it is both wrong and
damaging. The autism-bowel disease link was considered part of a series
of physiological observations judged by the MRC to be "interesting
and in principle worth investigating". Subsequent research has
yielded conflicting findings.13,14 This work should be supported.

Third, there has been an effort to starve critics of legitimacy by
refusing to engage them face-to-face. For example, when the drama Hear
the Silence was broadcast on British television in December last year,
there was a boycott of a subsequent discussion by many of those who
could have best articulated the case for MMR. The reason advanced was
that rational debate would not change the minds of an extreme few who
believed MMR to be unsafe no matter what the evidence presented to
them. Also, the composition of the panel discussion did not reflect the
large measure of consensus that MMR is safe. Instead, it portrayed the
issue as a finely balanced scientific exchange, when in truth there is
very little scientific uncertainty.
panel: Future strategic themes in autism research8


How should we debate and discuss matters of public health concern?
Certainly, with all the evidence before us. But perhaps this evidence
is best provided by neutral and trusted third parties-not the
Government. In the UK, one might turn to the Consumers' Association,
which publishes the respected Drug and Therapeutics Bulletin.
Certainly, with strong public-health messages. But care must be taken
not to dismiss important work that deserves continued support. And
certainly robustly. But also directly, recognising that wider public
trust is best fostered neither by referring to abstract evidence alone
nor by official pronouncements of reassurance, but by explaining
face-to-face15 in transparent, human, even anecdotal terms with
personal stories, why a particular course of action is being advocated.

Persuading the public to support vaccination is not only a matter of
winning an argument. It is also about understanding the reasons why
parents are and are not inclined to take their children for
immunisation.16 The complexity of this decision demands a more nuanced
response from the public-health community than it has so far received.
Publishing controversial new ideas

It seems obvious now that had we appreciated the full context in which
the work reported in the 1998 Lancet paper by Wakefield and colleagues
was done, publication would not have taken place in the way that it
did. These are difficult judgments to make in hindsight. For example,
our sensitivity to potential conflicts of interest is very much higher
today than it was in 1998.17-19 What we will not do is to become
profoundly conservative in our decision making about original ideas. A
forum to raise new and sometimes unpopular thinking, even on the basis
of what at first might appear flimsy evidence, is important20-and
often vitally so for clinical medicine and public health.21 How we
discuss this new thinking then becomes the central question to
answer,22 not whether we should publish it or not.

Information that once could be confined to a small community of
professionals is now open to wider distribution and
comment-accurately or otherwise. No matter how many qualifying
phrases or parallel reassuring editorials an editor might run, a new
finding or a controversial claim is impossible to control. This places
great responsibility on editors, scientists, and press and
public-relations professionals to avoid encouraging anybody to go
beyond the data or interpretations described in a paper. It is the job
of journalists to tempt scientists to do otherwise. But we can all do
better to adjust the volume of our message according to the validity of
the information before us. Editors have a responsibility to be involved
in all aspects of a paper's dissemination, whether in the pages of a
medical journal or on the platform of a press conference.

Finally, what of the calls for a public inquiry into this entire
affair? An inquiry would certainly provide an opportunity to
investigate, once again, all the issues that have made this matter such
a troubling one for so many. To that extent it would be welcome. But
public inquiries are easy to demand, and less easily able to deliver on
expectations. They can sometimes entrench division rather than relieve
it. Would it not be better to create a more positive process that
emphasises reconciliation, progress, and partnership? A collaborative
consultation, perhaps, between equals: members of the autism lay
community (including parents and possibly in conjunction with the
Consumers' Association, which has a strong interest in public
information and, through the DTB, MMR23), clinicians responsible for
the care of children with autism and related disorders, the MRC, and
the Health Protection Agency. Call it, say, "MMR and autism: learning
the lessons". For there are, indeed, lessons to be learned.
References

1. Murch SH, Anthony A, Cassen DH, et al. Retraction of an
interpretation. Lancet 2004; 363: 750. Full Text | PDF (39 KB) |
CrossRef

2. 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

3. Horton R. A statement by the editors of The Lancet. Lancet 2004;
363: 820-821. Full Text | PDF (56 KB) | CrossRef

4. Kanner L. Autistic disturbances of affective contact. Nervous Child
1943; 2: 217-250.

5. Volkmar FR, Pauls D. Autism. Lancet 2003; 362: 1133-1141. Abstract |
Full Text | PDF (220 KB) | CrossRef

6. Goode E. Autism cases up; cause is unclear. New York Times Jan 26
2004; A1.

7. Volkmar FR, Cohen DJ. Disintegrative disorder or "late onset"
autism. J Child Psychol Psychiatry 1989; 30: 717-724. MEDLINE

8. MRC review of autism research: epidemiology and causes. London: MRC,
2001:.

9. Farthing M, Horton R, Smith R. UK's failure to act on research
misconduct. Lancet 2000; 356: 2030. Full Text | PDF (44 KB) | MEDLINE |
CrossRef

10. Jefferson T, Price D, Demicheli V, et al. Unintended events
following immunisation with MMR: a systematic review. Vaccine 2003; 21:
3954-3960. MEDLINE | CrossRef

11. Jefferson T. Informed choice and balance are victims of the
MMR-autism saga. Lancet Infect Dis 2004; 4: 135-136. Full Text | PDF
(104 KB) | MEDLINE | CrossRef

12. Editorial. This orchestrated campaign must not be allowed to stifle
real debate on MMR. The Independent Feb 24 2004; 16.

13. Torrente F, Anthony A, Heuschkel RB et al. Focal enhanced gastritis
in regressive autism with features distinct from Crohn's and
Helicobacter pylori gastritis. Am J Gastroenterol (in press).

14. DeFelice ML, Ruchelli ED, Markowitz JE, et al. Intestinal cytokines
in children with pervasive developmental disorders. Am J Gastroenterol
2003; 98: 1777-1782. MEDLINE | CrossRef

15. Shapin S. A social history of truth. Chicago: University of Chicago
Press, 1995:.

16. Roberts KA, Dixon-Woods M, Fitzpatrick R, Abrams KR, Jones DR.
Factors affecting uptake of childhood immunisation: a Bayesian
synthesis of qualitative and quantitative evidence. Lancet 2002; 360:
1596-1599. Abstract | Full Text | PDF (77 KB) | MEDLINE | CrossRef

17. Davidoff F, DeAngelis CD, Drazen JM, et al. Sponsorship,
authorship, and accountability. Lancet 2001; 358: 854-856. Full Text |
PDF (59 KB) | MEDLINE | CrossRef

18. James A, Horton R. The Lancet's policy on conflicts of interest.
Lancet 2003; 361: 8-9. Full Text | PDF (53 KB) | CrossRef

19. James A, Horton R, Collingridge D, McConnell J, Butcher J. The
Lancet's policy on conflicts of interest-2004. Lancet 2004; 363: 2-3.
Full Text | PDF (62 KB) | CrossRef

20. Editorial. Dissent must be aired. Times Higher Educational
Supplement Feb 27 2004; 14.

21. McBride WG. Thalidomide and congenital abnormalities. Lancet 1961;
ii: 1358.

22. Calman KC. Communication of risk: choice, consent, and trust.
Lancet 2002; 360: 166-168. Full Text | PDF (69 KB) | MEDLINE | CrossRef

23. Anonymous. MMR vaccine-how effective and how safe?. Drug Ther
Bull 2003; 41: 1-6April. MEDLINE
Back to top

Affiliations

a. The Lancet, London NW1 7BY, UK

Lancet - Statements by all on Dr Wakefield's study

Long but please read thoroughly - maybe this will answer things that
have been muddy for some of you

"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/la...56997/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/la...56997/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 a

(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/.../dealing.phtml
..

Affiliations

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

**********
http://www.thelancet.com/journals/la...57085/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/la...57097/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/la...57103/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/la...57115/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

FURTHER STMT by A WAKEFIELD -The Smearing Of Andrew Wakefield

E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER
Vienna, Virginia http://www.nvic.org

* * * * * * * * * * * * * * * * * * * * * * *
UNITED WAY/COMBINED FEDERAL CAMPAIGN
#9119
* * * * * * * * * * * * * * * * * * * * * * *

"Protecting the health and informed consent rights of children since
1982."

================================================== ========================================
BL Fisher Note:

The extent to which the forced vaccination proponents have gone to
smear Andrew Wakefield and the meticulous biological mechanism research
he has conducted into MMR-vaccine associated autism is in direct
proportion to the fear they have that his hypothesis is correct: MMR
vaccine can cause a persistent vaccine strain measles virus infection
in genetically vulnerable children that leads to chronic inflammatory
bowel disease and autistic behaviors. It is unfortunate they are so
frightened of the scientific truth Dr. Wakefield is pursuing that they
find it necessary to behave like a band of thugs out to score a hit.

For the past 22 years, NVIC co-founder Kathi Williams and I have
watched abies die and be horribly crippled by vaccine reactions while
officials in industry, public health agencies and medical organizations
have refused to support the kind of biological mechanism research that
Dr. Wakefield is doing so that parents and doctors can have more
information about children at high risk for suffering vaccine reactions
and find ways to spare their lives.

Parents around the world are not fooled by the ignorant, inhumane
behavior of forced vaccinaton proponents, whose zealous defense of
one-size-fits-all vaccine policies injure and kill innocent children.

The truth will shine bright and clear in the end.


THE LANCET
Published online February 23, 2004

To read the full PDF version of a Statement by the Editor's of Lancet
go to:

http://image.thelancet.com/extras/st...Feb2004web.pdf

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
12reported 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, orwhether 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 awyers) 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
knowledgeof 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 indings 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 hrough, 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
amenormously 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

Sheri Nakken RN, MA, Hahnemannian Homeopath wrote:
FURTHER STMT by A WAKEFIELD -The Smearing Of Andrew Wakefield

E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER
Vienna, Virginia http://www.nvic.org

* * * * * * * * * * * * * * * * * * * * * * *
UNITED WAY/COMBINED FEDERAL CAMPAIGN
#9119
* * * * * * * * * * * * * * * * * * * * * * *

I wonder if all those federal employees realize that their money is
being used to promote anti-vac liars like Wakefield?

"Sheri Nakken RN, MA, Hahnemannian Homeopath"
wrote in message
ups.com...
FURTHER STMT by A WAKEFIELD -The Smearing Of Andrew Wakefield

E-NEWS FROM THE NATIONAL VACCINE MIS-INFORMATION CENTER
Vienna, Virginia http://www.nMISvic.org

.....

So you approve of lawyer funded research. They have something you like...
Start with a conclusion, then pick and choose the data that fits (including
providing the kids for an evasive study):
http://briandeer.com/mmr/andrew-wakefield.htm

So what is the homeopathic remedy for encephalitis caused by measles? You
know, like what caused blindness and paralysis in these young men:
http://www.timesonline.co.uk/article...061838,00.html

It is ok to have "scientific" studies on homeopathy with a mindset to
prove homeopathy false as in the Lancet latest effort?

You can't have it both way.

There are many remedies in homeopathy for encephalities of any kind.

Jag.

HCN wrote:

"Sheri Nakken RN, MA, Hahnemannian Homeopath"
So you approve of lawyer funded research. They have something you like...
Start with a conclusion, then pick and choose the data that fits (including
providing the kids for an evasive study):
http://briandeer.com/mmr/andrew-wakefield.htm

So what is the homeopathic remedy for encephalitis caused by measles? You
know, like what caused blindness and paralysis in these young men:
http://www.timesonline.co.uk/article...061838,00.html

wrote in message
ups.com...
It is ok to have "scientific" studies on homeopathy with a mindset to
prove homeopathy false as in the Lancet latest effort?

You can't have it both way.

There are many remedies in homeopathy for encephalities of any kind.

Okay, what are they and how effective are they? Point out some case studies
where homeopathy worked for encephalitis.



Jag.

HCN wrote:

"Sheri Nakken RN, MA, Hahnemannian Homeopath"
So you approve of lawyer funded research. They have something you
like...
Start with a conclusion, then pick and choose the data that fits
(including
providing the kids for an evasive study):
http://briandeer.com/mmr/andrew-wakefield.htm

So what is the homeopathic remedy for encephalitis caused by measles?
You
know, like what caused blindness and paralysis in these young men:
http://www.timesonline.co.uk/article...061838,00.html

Lancet - Commentary assesses the lessons to be learnt from the MMR
debate.

Please read very carefully and share.....

"Vaccine safety
In a review of the unintended effects associated with MMR, Jefferson
and colleagues10 found that the reporting of safety outcomes in MMR
vaccine studies was inadequate. Here is a constantly repeated scenario
in health-technology assessment (another example: the row over the
safety of calcium-channel blockers). A product undergoes limited
testing for efficacy and safety. It is license"

"............public-health officials have disparaged as "poor
science" evidence that appears to contradict their official message.
This approach has a cost. The reason that today's retraction is partial
and not total is that the discovery of a possible link between bowel
disease and autism is a serious scientific idea, as recognised by the
MRC,8 and one that deserves further investigation. Although dismissing
the entire 1998 Lancet paper as poor science gives a clear and correct
message to the public about the status of any claim regarding the
safety of MMR, in scientific and clinical terms it is both wrong and
damaging. The autism-bowel disease link was considered part of a series
of physiological observations judged by the MRC to be "interesting
and in principle worth investigating". Subsequent research has
yielded conflicting findings.13,14 "

"Third, there has been an effort to starve critics of legitimacy by
refusing to engage them face-to-face. For example, when the drama Hear
the Silence was broadcast on British television in December last year,
there was a boycott of a subsequent discussion by many of those who
could have best articulated the case for MMR. The reason advanced was
that rational debate would not change the minds of an extreme few who
believed MMR to be unsafe no matter what the evidence presented to
them. Also, the composition of the panel discussion did not reflect the
large measure of consensus that MMR is safe. Instead, it portrayed the
issue as a finely balanced scientific exchange, when in truth there is
very little scientific uncertainty "

********

http://www.thelancet.com/journals/la...40673604157140...

Commentary
06 March 2004

The Lancet 2004; 363:747-749 DOI:10.1016/S0140-6736(04)15714-0

The lessons of MMR

Richard Horton a

panel: Future strategic themes in autism research8

This week, The Lancet prints a partial retraction-a retraction of an
interpretation1-from the majority of authors of a paper published in
February, 1998, by Andrew Wakefield and colleagues.2 Wakefield and one
other co-author, Peter Harvey, have not signed this retraction
statement. We hope to publish their response very shortly. The original
report2 made clear that the authors "did not prove an association"
between measles, mumps, and rubella (MMR) vaccine and a newly described
syndrome of bowel disease and autism. But the authors did raise the
possibility of a link, on the basis of parental and medical histories,
and they suggested that "further investigations are needed to examine
this syndrome and its possible relation to this vaccine". This
interpretation of their data, together with a suggestion made by
Wakefield during a separate press conference held at the Royal Free
Hospital that there was a case for splitting the MMR vaccine into its
component parts, triggered a collapse in confidence in the UK's MMR
vaccination programme. It is the interpretation expressed about a
connection between the vaccine and the new syndrome that is now being
retracted. Today's retraction comes after debate following the release
of new information 2 weeks ago about the circumstances surrounding the
publication of this work.3 An enormous amount of effort has gone into
reviewing and analysing the events before and after publication of the
1998 article. It is now time to look forward.
Autism research

In 1943, Leo Kanner described 11 children with a condition that
differed "markedly and uniquely from anything reported so far".4 He
believed that the characteristics of these children, the fundamental
feature of whom was their "inability to relate themselves in the
ordinary way to people and situations from the beginning of life",
constituted a syndrome, one that he described as "an extreme autistic
aloneness". The recognition of such a distinct clinical entity was
important, even urgent at that time. Kanner described how several of
the children who had been introduced to him were inappropriately
labelled as "idiots or imbeciles". One lived in a "state school
for the feebleminded, and two had been previously considered as
schizophrenic".

Since Kanner's report, autism and autism-like conditions have become
common diagnoses5 and exercise much media attention.6 There is a strong
underlying genetic basis to autism. But the idea of a "late-onset"
variant7 raised a possibility that there might be psychological and
organic factors contributing to autism's cause and course. One
unexpected consequence of the debate surrounding MMR has been a
redirection of public attention to a condition that has often been
neglected by medicine. In a review of the epidemiology and causes of
autism, for example, the UK's Medical Research Council (MRC) summarised
existing knowledge and identified strategic themes deserving further
investigation (panel).8 There are large and surprising gaps in our
knowledge of a condition that affects as many as 6 per 1000 young
children.
panel: Future strategic themes in autism research8

The UK Government announced a further £2·75 million of new and
ring-fenced money for autism research in 2002. The first funding
decisions by the MRC are expected in May this year. The MRC is strongly
committed to autism research, presently funding seven research projects
at a cost of over £4 million. To make the best of what are still
limited resources, it is important that the Council's steering group
set up to implement the findings of its 2001 report, together with
other major national and international grant-giving bodies, establish a
funders' forum for autism research to fine-tune strategy and avoid
unnecessary duplication of research effort. The UK Government should
extend its initial and welcome commitment to autism by pump-priming
research with a further ring-fenced lump sum to the MRC of at least
£12·5 million-£2·5 million annually over 5 years. Such sustained
investment is vital if properly designed longitudinal studies to
examine genetic and environmental factors in autism are to be
constructed. Compare these modest sums of funding, for example, with
the US National Institute of Health's budget for autism research of $70
million by 2003. NIH is also committed to creating STAART (Studies to
Advance Autism Research and Treatment) centres-eight of which have
been launched in the past 2 years, at a cost of $65 million, spread
over 5 years. This approach might well have merit in the UK.
Research integrity

The latest debate surrounding Wakefield and colleagues' paper has been
enormously confusing. Public inquiries have been sought into the way
ethics committees operate, how the legal services commission makes its
decisions, and even, once again, into the safety of vaccines. A
preliminary investigation by the UK's General Medical Council is
underway. A furious debate about the actions of almost all protagonists
has taken place. The press has become the courtroom for this very
public dispute. But the media cannot be the only place to charge,
investigate, prosecute, defend, judge, and pass verdicts on those who
have been accused of research misconduct.

In 2000, a group representing the UK's Committee on Publication Ethics
(COPE) drew attention to a collective institutional failure to take
allegations of research misconduct seriously.9 The absence of formal
mechanisms within many universities and at a national level to
investigate claims with visible due process means that publicly aired
allegations leave everybody involved scrambling to respond in the best
way they can. COPE has produced helpful guidance on how to deal with
allegations of misconduct. But with no national body to which one can
refer these allegations, the danger is that in any ensuing media furore
good people are hurt by smear and innuendo. The appearance of
institutions investigating themselves, while accepted as the norm in
science and medicine, does little to strengthen public trust in a
system that has such critical societal influence, and thus which
requires transparent lines of accountability.

Present scientific and medical institutions have failed to act after
years of encouragement and embarrassment. It is now up to Government to
step in to create Britain's first Council for Research Integrity.
Please, ministers, do so and do it now.
Vaccine safety

In a review of the unintended effects associated with MMR, Jefferson
and colleagues10 found that the reporting of safety outcomes in MMR
vaccine studies was inadequate. Here is a constantly repeated scenario
in health-technology assessment (another example: the row over the
safety of calcium-channel blockers). A product undergoes limited
testing for efficacy and safety. It is licensed. A signal of concern is
thrown up. There is no valid set of safety data to which one can turn
to answer these queries. Public concern grows and confidence in the
technology may be jeopardised. Appropriate studies are hastily
completed to confirm or refute the original signal of potential risk.
An answer eventually comes, but too late to have prevented a great deal
of anxiety.

Jefferson has suggested a solution to this problem.11 He recognises
that vaccines pose particular challenges to investigators given their
frequently universal coverage, which precludes the possibility of any
controlled long-term experimental assessment. Instead, he proposes
creating a library of evidence, drawing together widely dispersed data
from published papers, manufacturers' technical reports, and
researchers' personal files. In this way, loss of crucial information
would be minimised and gaps in existing evidence could be identified
and filled early on. This idea is sensible and deserves further
consideration.
Public engagement

Many doctors and public-health officials have been frustrated by the
debate over MMR. I have shared this frustration. One newspaper
fancifully called our recent statement (see page 820) about the 1998
Lancet paper part of an "orchestrated campaign" to bolster MMR
programmes.12 In fact, the events leading to today's partial retraction
were sudden, sparked by an investigation by a newspaper, The Sunday
Times. Our response was to determine answers to very specific
allegations. We have had no contact with anybody at the Department of
Health or elsewhere in Government, vaccine manufacturers, or lawyers
involved in ongoing litigation. There was no orchestrated campaign.

But there are fair questions to be asked about the style of government
and expert response to claims about the safety of MMR. Three reactions
have been discernable. First, there has been an appeal to evidence. The
Department of Health's www.mmrthefacts.nhs.uk website contains a superb
collection of materials designed to help parents make the "decision
in your own time and on your own terms". The difficulty is that in a
post-BSE era, where government advice is no longer immediately taken on
trust, the weight of accumulated evidence carries less force if it
comes from government than it once did.

Second, public-health officials have disparaged as "poor science"
evidence that appears to contradict their official message. This
approach has a cost. The reason that today's retraction is partial and
not total is that the discovery of a possible link between bowel
disease and autism is a serious scientific idea, as recognised by the
MRC,8 and one that deserves further investigation. Although dismissing
the entire 1998 Lancet paper as poor science gives a clear and correct
message to the public about the status of any claim regarding the
safety of MMR, in scientific and clinical terms it is both wrong and
damaging. The autism-bowel disease link was considered part of a series
of physiological observations judged by the MRC to be "interesting
and in principle worth investigating". Subsequent research has
yielded conflicting findings.13,14 This work should be supported.

Third, there has been an effort to starve critics of legitimacy by
refusing to engage them face-to-face. For example, when the drama Hear
the Silence was broadcast on British television in December last year,
there was a boycott of a subsequent discussion by many of those who
could have best articulated the case for MMR. The reason advanced was
that rational debate would not change the minds of an extreme few who
believed MMR to be unsafe no matter what the evidence presented to
them. Also, the composition of the panel discussion did not reflect the
large measure of consensus that MMR is safe. Instead, it portrayed the
issue as a finely balanced scientific exchange, when in truth there is
very little scientific uncertainty.
panel: Future strategic themes in autism research8

How should we debate and discuss matters of public health concern?
Certainly, with all the evidence before us. But perhaps this evidence
is best provided by neutral and trusted third parties-not the
Government. In the UK, one might turn to the Consumers' Association,
which publishes the respected Drug and Therapeutics Bulletin.
Certainly, with strong public-health messages. But care must be taken
not to dismiss important work that deserves continued support. And
certainly robustly. But also directly, recognising that wider public
trust is best fostered neither by referring to abstract evidence alone
nor by official pronouncements of reassurance, but by explaining
face-to-face15 in transparent, human, even anecdotal terms with
personal stories, why a particular course of action is being advocated.

Persuading the public to support vaccination is not only a matter of
winning an argument. It is also about understanding the reasons why
parents are and are not inclined to take their children for
immunisation.16 The complexity of this decision demands a more nuanced
response from the public-health community than it has so far received.
Publishing controversial new ideas

It seems obvious now that had we appreciated the full context in which
the work reported in the 1998 Lancet paper by Wakefield and colleagues
was done, publication would not have taken place in the way that it
did. These are difficult judgments to make in hindsight. For example,
our sensitivity to potential conflicts of interest is very much higher
today than it was in 1998.17-19 What we will not do is to become
profoundly conservative in our decision making about original ideas. A
forum to raise new and sometimes unpopular thinking, even on the basis
of what at first might appear flimsy evidence, is important20-and
often vitally so for clinical medicine and public health.21 How we
discuss this new thinking then becomes the central question to
answer,22 not whether we should publish it or not.

Information that once could be confined to a small community of
professionals is now open to wider distribution and
comment-accurately or otherwise. No matter how many qualifying
phrases or parallel reassuring editorials an editor might run, a new
finding or a controversial claim is impossible to control. This places
great responsibility on editors, scientists, and press and
public-relations professionals to avoid encouraging anybody to go
beyond the data or interpretations described in a paper. It is the job
of journalists to tempt scientists to do otherwise. But we can all do
better to adjust the volume of our message according to the validity of
the information before us. Editors have a responsibility to be involved
in all aspects of a paper's dissemination, whether in the pages of a
medical journal or on the platform of a press conference.

Finally, what of the calls for a public inquiry into this entire
affair? An inquiry would certainly provide an opportunity to
investigate, once again, all the issues that have made this matter such
a troubling one for so many. To that extent it would be welcome. But
public inquiries are easy to demand, and less easily able to deliver on
expectations. They can sometimes entrench division rather than relieve
it. Would it not be better to create a more positive process that
emphasises reconciliation, progress, and partnership? A collaborative
consultation, perhaps, between equals: members of the autism lay
community (including parents and possibly in conjunction with the
Consumers' Association, which has a strong interest in public
information and, through the DTB, MMR23), clinicians responsible for
the care of children with autism and related disorders, the MRC, and
the Health Protection Agency. Call it, say, "MMR and autism: learning
the lessons". For there are, indeed, lessons to be learned.
References

1. Murch SH, Anthony A, Cassen DH, et al. Retraction of an
interpretation. Lancet 2004; 363: 750. Full Text | PDF (39 KB) |
CrossRef

2. 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

3. Horton R. A statement by the editors of The Lancet. Lancet 2004;
363: 820-821. Full Text | PDF (56 KB) | CrossRef

4. Kanner L. Autistic disturbances of affective contact. Nervous Child
1943; 2: 217-250.

5. Volkmar FR, Pauls D. Autism. Lancet 2003; 362: 1133-1141. Abstract |
Full Text | PDF (220 KB) | CrossRef

6. Goode E. Autism cases up; cause is unclear. New York Times Jan 26
2004; A1.

7. Volkmar FR, Cohen DJ. Disintegrative disorder or "late onset"
autism. J Child Psychol Psychiatry 1989; 30: 717-724. MEDLINE

8. MRC review of autism research: epidemiology and causes. London: MRC,
2001:.

9. Farthing M, Horton R, Smith R. UK's failure to act on research
misconduct. Lancet 2000; 356: 2030. Full Text | PDF (44 KB) | MEDLINE |
CrossRef

10. Jefferson T, Price D, Demicheli V, et al. Unintended events
following immunisation with MMR: a systematic review. Vaccine 2003; 21:
3954-3960. MEDLINE | CrossRef

11. Jefferson T. Informed choice and balance are victims of the
MMR-autism saga. Lancet Infect Dis 2004; 4: 135-136. Full Text | PDF
(104 KB) | MEDLINE | CrossRef

12. Editorial. This orchestrated campaign must not be allowed to stifle
real debate on MMR. The Independent Feb 24 2004; 16.

13. Torrente F, Anthony A, Heuschkel RB et al. Focal enhanced gastritis
in regressive autism with features distinct from Crohn's and
Helicobacter pylori gastritis. Am J Gastroenterol (in press).

14. DeFelice ML, Ruchelli ED, Markowitz JE, et al. Intestinal cytokines
in children with pervasive developmental disorders. Am J Gastroenterol
2003; 98: 1777-1782. MEDLINE | CrossRef

15. Shapin S. A social history of truth. Chicago: University of Chicago
Press, 1995:.

16. Roberts KA, Dixon-Woods M, Fitzpatrick R, Abrams KR, Jones DR.
Factors affecting uptake of childhood immunisation: a Bayesian
synthesis of qualitative and quantitative evidence. Lancet 2002; 360:
1596-1599. Abstract | Full Text | PDF (77 KB) | MEDLINE | CrossRef

17. Davidoff F, DeAngelis CD, Drazen JM, et al. Sponsorship,
authorship, and accountability. Lancet 2001; 358: 854-856. Full Text |
PDF (59 KB) | MEDLINE | CrossRef

18. James A, Horton R. The Lancet's policy on conflicts of interest.
Lancet 2003; 361: 8-9. Full Text | PDF (53 KB) | CrossRef

19. James A, Horton R, Collingridge D, McConnell J, Butcher J. The
Lancet's policy on conflicts of interest-2004. Lancet 2004; 363: 2-3.
Full Text | PDF (62 KB) | CrossRef

20. Editorial. Dissent must be aired. Times Higher Educational
Supplement Feb 27 2004; 14.

21. McBride WG. Thalidomide and congenital abnormalities. Lancet 1961;
ii: 1358.

22. Calman KC. Communication of risk: choice, consent, and trust.
Lancet 2002; 360: 166-168. Full Text | PDF (69 KB) | MEDLINE | CrossRef

23. Anonymous. MMR vaccine-how effective and how safe?. Drug Ther
Bull 2003; 41: 1-6April. MEDLINE
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Affiliations

a. The Lancet, London NW1 7BY, UK