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