This is interesting - especially the bit about MSBP. Oh what a surprise the parent's were right.
MMR--Responding To The [Lancet] Retraction
www.thelancet.com/journal/vol363/iss9417/full/llan.363.9417.correspon
dence.29323.1
Sir--Almost 6 years have passed since AJW disclosed in a letter
published in The Lancet1 that he was undertaking a pilot study on behalf of
the Legal Aid Board (later to become the Legal Services Commission), a study
that sought to examine the merits of parental claims of an association
between their children's exposure to the measles, mumps, and rubella (MMR)
vaccine and subsequent autistic regression and intestinal symptoms. He wrote
on May 2, 1998, 3 months after the original paper: ?Only one author (AJW)
has agreed to help evaluate a small number of these children on behalf of
the Legal Aid Board.?
There was no attempt at any stage to conceal the fact that the viral
study was ongoing before the publication of the paper in The Lancet in 1998.
Almost 6 years have passed during which The Lancet and our co-authors have
had the opportunity to seek further details and consider their position with
respect to perceived conflicts of interest. We read the absence of any
comment as implying tacit acknowledgment of lack of such conflict, as stated
by AJW at the time. The Lancet requires that the funding source for a study
be declared; our report conformed to this requirement since there was no
external funding for the work relevant to this report. The Lancet disclosure
policy also required that the authors declare anything that would embarrass
an author if it were to emerge after publication. This is, of course, a
subjective definition and we can confirm that this is not an issue which
causes us embarrassment; we are, however, dismayed by the way in which
events have been misrepresented.
Conflict of interest is created when involvement in one project
potentially could, or actively does, interfere with the objective and
dispassionate assessment of the processes or outcomes of another project. We
cannot accept that the knowledge that affected children were later to pursue
litigation, following their clinical referral and investigation, influenced
the content or tone of the 1998 paper which was a description of a possible
new syndrome in the classical mode. We emphasise that this was not a
scientific paper but a clinical report. The laboratory support funded by
Legal Aid for a separate viral detection study had no bearing on the
original paper. No Legal Aid money was used in the preparation of the 1998
paper, and the viral study could not then and indeed, does not now,
influence the ?objective and dispassionate assessment? of the veracity of
the original paper, which we reiterate simply reported a novel clinical
syndrome. There was no conflict of interest. When the viral study is
published, the Legal Aid Board (now Legal Services Commission) funding will
be duly acknowledged.
Various claims were made by agents of the Sunday Times of Feb 22,
2004, against those of us involved in the Lancet 1998 report. These claims
included inappropriate patient referral, inappropriate use of Legal Aid
funding, lack of ethics approval, unmerited clinical investigation, and
keeping secret for 6 years the involvement of the Legal Aid Board in a
separate study. All of these claims have been investigated and we know they
are unfounded and vigorously deny them.
It is worth reiterating that all of the first 12 children reported in
the Lancet study were referred to the Royal Free Hospital exclusively for
the investigation of their intestinal symptoms at a time when none was
involved in Legal Aid litigation. Their pathological findings were
interpreted and reported by clinicians who could have had no knowledge of
any future legal claim. The report itself was a description of the history
as reported to us, and the relevant clinical findings. No claim of a causal
association with MMR was ever made. The opinion on choice of single vaccines
pending scientific resolution of any possible association, expressed by AJW
at the press briefing, was based not on the findings in these children
alone, but on a detailed investigation of the history of MMR vaccine and its
safety. AJW's opinion, then and now, has been restated in Jefferson and
colleagues' subsequent 2003 Cochrane Review2--ie, that ?the design and
reporting of safety outcomes in MMR vaccine safety studies, both pre- and
post-marketing, are largely inadequate?, and furthermore, that Jefferson and
colleagues ?found limited evidence of safety of MMR compared to its
single-component vaccines from low risk of bias studies?. Nonetheless we
regret the furore and polarisation of opinion that ensued from that press
briefing for which AJW bears some responsibility.
Richard Horton is reported to have stated that he would not have
published the paper, had he known about the MMR litigation. As reported,
this clearly has major implications for the valid scientific investigation
and reporting of possible iatrogenic injury in patients who may also be
seeking legal redress. It is notable that subsequent to the aforementioned
Legal Aid pilot study, other university-based studies have been funded by
the Legal Services Commission, and reported in the British Medical Journal.3
On March 6, 2004, some of our ex-colleagues issued a ?retraction of an
interpretation?, not a retraction of the factual content of the paper, as
widely inferred. Since no interpretation of the possible MMR/autism link was
offered in the original 1998 Lancet report, other than to state that the
data did not constitute evidence of an association and suggest that further
research was required, it is difficult to know quite what has been
retracted, particularly in light of Richard Horton's current plea for
further research funding for autism, a plea that we welcome wholeheartedly.
Let us be clear that parents reported gastrointestinal symptoms in
their children that many medical professionals denied and refused to
investigate. Some parents were referred to social services and false claims
of Munchausen's syndrome by proxy were levied. The parents were right; their
children have an inflammatory intestinal disease. The medical profession was
wrong, in some cases shamefully so. In light of this lesson it is imperative
that rather than relying on endless reviews of epidemiological data which
fail to even address the original hypothesis,4 parental claims should be
taken seriously and their children should be investigated on an individual
basis.
More than 6 years on, the original Lancet report should be viewed in
the context of the emerging laboratory and clinical evidence of intestinal
pathology,5-10 measles virus persistence in diseased tissues,11,12 and
abnormal measles immunity13-15 in this specific subset of children with
autistic spectrum disorder. It would be inappropriate to interpret the
events of the past month as exonerating MMR vaccine as a possible cause of
autism.
Andrew J Wakefield (AJW), *Peter Harvey, John Linnell
Brief commentary from ARCH of the UK: It is worth pointing out that
the Lancet uses in part of its argument that the disclosure letter was, in
any event, only published 3 months after the original 1998 Lancet paper.
They would have received his letter considerably earlier and with plenty of
time to have enquired more about his innocuous and perfectly reasonable
statement that he was undertaking a pilot study on behalf of the Legal Aid
Board.
That they should have taken so long to publish his latest letter,
having fast tracked those of some of his former co-workers five Lancet
issues ago on 6 March is another example of double standards, double speak
and double cross.
ALSO:
Scientists come out in support of Wakefield in BMJ. See rapid response
exchanges at: bmj.bmjjournals.com/cgi/eletters/328/7438/483-a#53957