Issues Raised by the
Sunday Times and the Channel 4 Dispatches
Programme
A statement
by Dr Andrew Wakefield
The
Sunday Times and the Dispatches programme
of 18th November raise a number of issues
in relation to MMR, autism and events at
the Royal Free Hospital. Since many of
the claims by journalist Brian Deer have
been demonstrably false and there in no
objectivity in the manner of their
intended portrayal, I declined to
participate in any way in the making of
the Dispatches programme. In addition,
vulnerable parents have complained of
being "tricked" into
participating in the programme. [This
is false. No participants in the
programme complained of being tricked, or
made any complaint whatsoever - Brian
Deer]. I was not invited
to comment on the Sunday Times article
prior to its publication.
The
claim appears to be that, whilst at the
Royal Free Hospital, I was developing a
new vaccine to compete with MMR and that
I conspired to undermine confidence in
MMR vaccine in order to promote this new
vaccine, and that this represented a
conflict of interest. This is untrue. The
facts are that:
no
vaccine or anything resembling a vaccine
was ever designed, developed or tested by
me or by any of my colleagues at the
Royal Free Hospital;
it
has never been my aim or intention to
design, produce or promote a vaccine to
compete with MMR;
my
genuine concerns about the safety of MMR
are wholly unrelated to any desire or
opportunity to develop a competing
vaccine;
there
was no conspiracy as insinuated by the
Sunday Times article;
there
was no conflict or interest, actual or
perceived.
In
contrast, it was our intention, at one
stage, to conduct a formal therapeutic
clinical trial of a compound that might
have the ability to promote the
body’s immune response to measles in
order to assess the effects of this
therapy upon the disease in children with
regressive autism and bowel disease. This
compound is known as Transfer Factor and
whilst there is a large scientific
literature on this subject, the nature
and mechanism of action of Transfer
Factors are largely unknown.
The
Transfer Factor that was intended for use
in the trial was to be against measles
virus. I have urged and continue to urge
parents to have their children vaccinated
against measles using the current
vaccines. This would be in direct
conflict with the intentions that are
part of the claim that I was developing a
new vaccine to bring onto the market.
Whether a Transfer Factor could ever
protect children against measles is
entirely speculative and is something
that was never studied or pursued by me
or any of my colleagues.
The
Channel 4 programme implies commercial
aspirations for personal gain. In fact,
the aim of the patent was to generate
funding for the research programme and a
new Centre for Gastroenterology at the
Royal Free Hospital. This can be
substantiated by contemporaneous
documentation.
The
patent application was motivated by two
main factors. First, it was felt that
there may be difficulty in raising
traditional grant funding for cutting
edge, controversial work that was
vulnerable by virtue of the fact that it
might conflict with perceived wisdom and
the commercial interests of others.
Secondly, there was, and is, a
government-led emphasis on commercial
exploitation of discoveries within the
medical school.
Transfer
Factor (TF)
A
clinical trial of measles-virus specific
transfer factor was planned in order to
determine whether there was benefit to
children with regressive autism and
inflammatory bowel disease. It is not
known at this stage whether this therapy
would work. The purpose of the trial was
to start to answer exactly this question
as well as to monitor the safety of TF in
these children.
This
was a treatment trial, not a vaccine
trial. A trial of TF was based upon an
extensive scientific literature,
demonstrating safety and efficacy of TF
in different diseases. I consulted widely
with experts in the UK and US on the
history and scientific background to TF
both prior to and in the planning of the
trial.
The
protocol was extensively peer-reviewed
with written endorsement from experts in
the UK and US. The trial protocol was
submitted to, and subsequently approved
by, the Ethical Practices Committee of
the Royal Free Hampstead NHS Trust. The
trial protocol was approved by the
participating physicians. The trial was
funded by charitable foundations after
independent peer-review.
The
trial was cancelled due, in part, to my
departure from the Royal Free.
The
Patent
A
provisional patent filing was made for
the use of measles virus-specific TF in
regressive autism and inflammatory bowel
disease (Regressive Bowel Disease; RBD).
The
reference to the possible use of TF to
protect children against measles
infection – the thrust of the Sunday
Times’ conspiracy theory – was
put in as an afterthought in the patent.
It was entirely speculative and never
pursued in any shape, manner or form.
The
provisional patent filing was
entirely speculative and was for a
possible therapy; as such, it had no
bearing on the 1998 Lancet paper.
It
constituted no potential conflict until
the patent was awarded. When the patent
was later awarded, this fact was
communicated directly to the Editor of
the Lancet in order that it might
accompany a letter, written in response
to a paper by Taylor et al that claimed
to find no evidence of a link between MMR
vaccine and autism. The editor did not
consider the patent disclosure of
sufficient significance to publish it
alongside my letter.
Since
it was awarded, the patent has been
disclosed in relevant publications. The
claims have since been abandoned.
Drs
Nick Chadwick (NC) and Ian Bruce (IB):
measles virus detection in intestinal
biopsies.
NC
was employed as a post-graduate
researcher in my laboratory, studying for
a PhD. He investigated various
technologies for measles virus detection
using gene amplification. Due to problems
within the laboratory with contamination
and the need for additional expertise, we
collaborated with IB at the University of
Greenwich. IB and NC developed a
technique that increased the sensitivity
of measles virus detection over standard
methodology from approximately 1 million
viral copies in a reaction to 10,000
copies. In other words, even with the
enhanced technique, the technology could
not detect this virus when present below
10,000 copies.
We
published the fact that we could not
detect measles virus in Crohn’s
disease using this technique. This
publication went ahead on my
recommendation, despite some resistance
to publishing negative data. I considered
that failure to publish negative data was
inconsistent with good scientific
practice and proceeded to publication.
By
the time we applied the viral detection
technology to the intestinal tissues of
children with autism, new and more
sensitive technology had come to my
attention. This includes the technique of
TaqMan PCR and was state-of-the-art
technology being used by a few expert
centres, including that of Professor John
O’Leary (JO’L), then at Cornell
University in New York. I went to New
York to meet with JO’L. He presented
evidence that his technique could detect
down to 2 viral copies, compared with
NC’s 10,000.
The
advantages were obvious and the
possibility that NC’s results were
falsely negative (i.e. that the virus was
present in the tissues but at very low
levels that NC’s technique could not
detect) could now be addressed by the new
technology.Using JO’L’s
technology the virus was detected in
controlled studies and these results were
published. They confirmed that our
previous results were falsely negative
due to the limitation of the technique we
were using. TaqMan PCR, one of the
techniques used by JO’L to detect
measles virus in the autistic children,
is now the gold-standard and the
technology used by NC has been abandoned.
On entirely scientific grounds I was
proven correct on this occasion. The
facts stated above can be supported by
contemporaneous documentation.
AJW