O An COMHCHOISTE
um SHLÁINTE agus LEANAÍ
JOINT COMMITTEE
on HEALTH and CHILDREN
Report on
childhood immunisation
Minutes of
Evidence of 22 March, 2001
An Comhchoiste um
Shláinte agus Leanaí Dé Déardaoin
22 Márta, 2001.
Joint Committee on Health and
Children Thursday 22 March, 2001.
The Joint Committee met
at 9.40 a.m.
Members Present:
Deputies Senators
M. Ahern M. Jackman
B. Allen *P. Moylan
J. Gormley
B. Kenneally
L. McManus
G. Mitchell
D. Neville
M. Ring
*In the absence of Deputy P.
Bradford.
Deputy T. Killeen was also in
attendance.
The Joint Committee commenced in
Private Session and went into Public
Session at 9.45 a.m.
Deputy B. O'Keeffe in the chair
Chairman: Last July, the
Committee agreed to consider the
issue of child vaccination to include
an examination of the current
vaccination policy and practice, the
poor take-up rates and the public
concerns about the risks and the
adverse effects. Written submissions
were invited from the general public,
the medical profession, the health
boards and others. To date over 100
submissions have been received. The
Committee also agreed that it would
invite selected correspondents to
address it in person. At today's
meeting we will hear the views of Dr.
Andrew Wakefield of Royal Free and
University College Medical School,
University of London and Professor
John O'Leary from the Coombe Women's
Hospital in Dublin. Both Dr.
Wakefield and Professor O'Leary have
carried out widely reported research
into the association between autism
and the MMR vaccine. The Committee is
grateful to both of you for appearing
before us today, particularly in view
of the fact that we caused you some
inconvenience by the late
cancellation of a previous meeting. I
now call on Dr. Wakefield and
Professor O'Leary to make an opening
presentation of approximately 15
minutes after which the matter will
then be thrown open to the Members of
the Committee for questions and
further discussion.
Before they commence, I
remind everyone that Members of the
Committee are covered by privilege,
others who are appearing before the
Committee, do not have that same
privilege. I call on Dr. Wakefield to
open the proceedings.
Dr. Wakefield:
It is a pleasure to be here and no
apology is necessary for the delay in
this meeting. I am a reader in
experimental gastro-enterology at the
Royal University College Medical
School in London. Contrary to
reports, I am an entirely
conventional physician. I have been
in charge of a group called the
inflammatory bowel disease study
group for the past 12 years. Our
principal interests are in Krohne's
disease and osticolitis, two
classical inflammatory bowel
diseases, and in particular the
possible role of measles virus in the
causation of these two diseases,
which are becoming increasingly
common.
In 1995/96, I was
approached by a group of parents with
a remarkably consistent story about
the demise of children into autism.
Firstly, I wish to give you some
terms of reference from my
perspective. We are dealing with a
sub-set of children with autism,
which has many causes. We do not know
the size of this particular sub-set.
That knowledge will only come with
time and investigation. Today's
presentation is based entirely on
scientific data, which have been
peer-reviewed and published. I assure
you that I am not in any way
anti-vaccine. This is not an
anti-vaccine argument. In fact,
paradoxically, it is a pro-vaccine
argument and if I fail to get that
point through during this
presentation, I would be grateful if
somebody would remind me.
The issue concerns the
safest way of protecting children
against the infections in question
and against the possible adverse
consequences of the vaccines
themselves. Most importantly, the
work is not based on assumptions. Let
me explain that. Many of the parents
concerned have told their physicians
that their child deteriorated into
autism after receiving the MMR
vaccine. The physicians dismissed
this as coincidence. That is an
entirely reasonable argument if one
has excluded an association, i.e. if
one has investigated that child to
the best of one's ability, to
establish whether it is coincidence
or not. Otherwise, that is not good
medical practice. This is not an
isolated opinion. It has been put
about that this is just one maverick
doctor in London, putting forward
this idea. That is not the case.
There are at least five highly
reputable groups in the United States
who have worked on this, made the
same association and published. The
work is based on conventional
medicine, as practised from the 5th
century BC by Hippocrates and others,
by taking at face value the patient's
story, or the parents' story about
their child, and interpreting it to
the best of the doctor's ability.
That is my duty as a clinician - not
to "buy into it," not to
believe it from the outset, but to
establish the validity of the story
through due scientific investigation,
and not to dismiss their claims
because they may conflict with some
of my fondly held precepts,
particularly in the context of public
health.
We have now seen over
170 children, having initially set
out to look at 10, to check for any
problem with their gastro-intestinal
tracts. The children
came with a history of normal
development, as substantiated by
contemporaneous documentation from
health visitors and doctors, as well
as videos and photographs. Then,
shortly after their MMR vaccination,
they had regressed. They had lost
their acquired skills of speech,
language and socialisation. They had
become ataxic. For example, they had
become unsteady on their feet and
would fall over. They could no longer
eat with a utensil, whereas they had
been able to do so previously.
Children who had been continent of
urine, lost that continence. Clearly,
there was a neurological problem
involved.
In addition, the
children had gastro-intestinal
symptoms, clear in some cases and
subtle in others. The doctors would
say "Your child is bound to have
bowel problems, because he/she is
autistic." As a
gastro-enterologist, the logic of
that completely eludes me. The story
which I got was so consistent that I
went to Professor John Walker Smith,
who is the most experienced
paediatric gastro-enterologist in the
world. He is recently retired. He has
seen more inflammatory bowel disease
in children than anyone else on this
globe. We decided that, with our
paediatric psychiatrists, we would
look at these children and try to
establish whether the parents' story
was right and whether there was a
bowel problem underlying their
children's developmental regression.
We have now published
three peer-reviewed major original
scientific papers, which confirm
beyond doubt that these children have
a bowel disease problem. That is a
fact, whatever its relationship to
MMR. The disease is idiosyncratic and
it is neither Krohne's disease nor
ulcerative colitis. When the last
paper was published, there was a very
supportive editorial in the Journal
of Paediatrics last week. The
characteristics of the bowel disease
include inflammation or swelling of
the lymph glands in the gut. They
also include a colitis and an
enteritis. That means that there is
an inflammation throughout the gut
lining. Those features are entirely
consistent with a viral cause. In
fact, the swelling of the lymph gland
is rather like swelling of lymph
glands anywhere in the body when one
has an infection, such as a sore
throat. Because they happen to be in
the small intestine, they produce
swelling, obstruction, pain and,
therefore, symptoms in their own
right.
For the first time with
this disease, we had somewhere to
focus our attention when looking for
the cause, because, as I said, this
reaction is a localising reaction to
infection. If one is looking for
infection, that is where to look. In
a moment, I will come to the possible
link between the gut and the brain.
The other feature which the parents
described was that their children
often had recurrent refractory upper
respiratory tract and ear infections.
In other words, when the family got
an infection, the child with autism
also got it but could not shake off
that infection.
This is often indicative
of an underlying immuno-deficiency -
that the immune system is not up to
par. We investigated that also and,
again, the parents were right. These
children did have an
immuno-deficiency and that
immuno-deficiency was characteristic
of a chronic viral infection. So,
there was a bowel disease consistent
with a viral infection, an
immuno-deficiency consistent with a
viral infection and a group of
children who had regressed in the
face of a vaccination. We then looked
for evidence of the virus in tissues
from these children, specifically in
swollen lymph glands from the bowel.
I am not going to present the raw
data here today. Professor O'Leary
will present the molecular data,
which are far more succinct and,
indeed, far more persuasive.
To summarise, in my
laboratory we sought evidence of
specific proteins of measles virus.
In addition, we used appropriate
controls, i.e. children who were
developmentally normal and were
referred to us with bowel symptoms.
We also looked for other viruses, not
just measles virus. We looked for
herpes simplex 1 and 2 and a whole
range of other common childhood
illnesses. Within the group of
children whom we looked at, there was
a highly significant increase in the
presence of measles virus protein in
the lymph glands, but we could find
no evidence of any other viruses in
there. That is interesting. It does
not mean that it is the cause, but it
is certainly a very important piece
of the jig-saw which goes towards
answering the question.
We also found that the
children had an exaggerated antibody
response to measles virus in their
blood, compared with age-matched
controls. We did not find that for
mumps virus, for rubella or for other
common childhood infections. This is
another interesting piece of the
jigsaw, which starts to point towards
a possible conclusion.
We have looked at the
matter from the individual child's
perspective, looking at the organic
pathology in these children and
establishing the facts. There have
been a number of epidemiological
studies which have sought to
exonerate the vaccine and to show
that there is no link. These were
best summarised by a meeting of the
National Academy of Sciences in
Washington last week, which said
that, on the basis of the current
epidemiological studies, it is
impossible to rule in, or rule out,
an association. In other words, those
epidemiological studies have not
taken us any further forward. Why?
Because we are looking at a sub-set
of autistic children. If you take the
whole autism group, of which the
sub-set represents but a fraction,
then you may well miss an effect. The
only way of establishing a causal
relationship is to look at the
individual children and the actual
disease process within those
children.
Why are we here? Why has
this problem arisen? It comes back to
the issue of vaccination. Only a tiny
fraction of children have regressed
following the single measles vaccine.
The regression appeared to occur
after the polyvalent
measles/mumps/rubella vaccine. The
same is true if one interview
patients in the United States or in
Canada or Sweden or elsewhere. It
does not seem to be a function per se
of the monovalent measles vaccine. My
group has published compelling
studies showing that a child who
experiences concurrent measles and
mumps infection together is at much
greater risk of inflammatory bowel
disease. The virus may be sequestered
in the gut and produce inflammation.
That data was accepted by the MRC
review committee in 1998.
Are we looking at the
possibility of a synergistic
interaction between two or three
component viruses? In other words,
will the combination of measles,
mumps and rubella produce something
very different? To understand the
origins of this, we must go back to
the original safety studies of
measles, mumps and rubella in 1969.
They showed without doubt that there
was an interaction between the
viruses and the vaccine that altered
the clinical response - the rash and
the fever. That was not followed up
on until 1974 when the Japanese
showed exactly the same thing.
Interference between the component
viruses altered the immune response.
If you alter the immune response then
potentially you alter the ability of
the body to get rid of the virus and
to clear it. Dr. Minikawa summarised
this by saying the question needed
further investigation yet further
studies were never done. We believe
that there may be a synergistic
interaction between the components of
this vaccine which increases the risk
of an adverse event.
Why is this
paradoxically a pro-vaccine argument?
We do not wish to see the return of
these infections. Specifically, we do
not wish to see measles epidemics
return. I am not anti-vaccine in any
way. My children have been
vaccinated. There is no doubt that
there is a question mark over the
vaccine, not because I have raised
such a question mark but because
parents have raised it with me. As
part of my duty as a physician, I
have addressed that issue and
confirmed that thus far they are 100
per cent wrong. We have the ability
with the single vaccines, not only to
protect against the acute diseases of
measles, mumps and rubella, but also
to prevent this overlap - this
interaction between the viruses - by
artificially disassociating them. For
example, we can give the measles
vaccine first and the rubella vaccine
afterwards. There is no formula for
that, it is purely empirical.
We have the ability to
separate them out but more important
perhaps, in a democracy, is the fact
that there is a question mark over
the safety of this vaccine. Otherwise
we would not be having this meeting
and we would not have had the
meetings at the Institute of Medicine
and Cold Spring Harbour in the United
States - the pinnacle of American
science.
Physicians in the United
States would not be investigating
this issue if there were no question
marks. In a democracy, parents
deserve a choice until these
questions are resolved.
Professor
O'Leary: The purpose of this
testimony is to report the scientific
results in a series of children with
a condition termed "autistic
enterocolitis" which has been
explained to the committee by Dr.
Wakefield. By its nature, this
submission is technical, but I will
be happy to explain any technical
questions that arise, during the
course of my submission.
Autistic enterocolitis
is a recently described condition of
children with regressive type autism,
in which there is lymphoid
hyperplasia of the terminal ileum and
a low grade chronic inflammatory
infiltrate in the colon. The precise
pathological description is
"ileocolonic lymphonodular
hyperplasia and non-specific
enterocolitis."The condition was
described in The American Journal of
Gastroenterology, in September 2000.
Figure 1 on the submission before the
committee shows the characteristic
lesions of gut in children autistic
enterocolitis. The left panel shows
the histopathological appearance
while the right panel shows
endoscopic appearance which we would
see using an endoscope looking at the
terminal ileum of these children. The
Committee can see that it is swollen
and that lumps and bumps are visible.
At the outset, I wish to
state that children must be
vaccinated and nothing in this
testimony should be considered as
anti-vaccine. Vaccination strategies
have proven to be an outstanding
public health measure and provide
protection for our children. Indeed,
vaccination strategies support our
Constitution which enshrines equality
for all of our children. The
scientific studies were undertaken
following an approach made to my
laboratory by Dr. Andrew Wakefield,
who has just submitted independent
testimony. Dr. Wakefield is a reader
at The University of London.
The studies represent a
transnational multi-disciplinary
research programme aimed at
elucidating the causes and
pathogenesis of inflammatory bowel
diseases, a sub-set of which is this
novel form of inflammatory bowel
disease in the setting of co-existent
developmental disorder of childhood.
The findings detailed in this
statement, have recently been
presented at the world renowned Cold
Spring Harbour laboratories, New
York, USA at a specially convened
meeting of world experts in the field
of autism and autism research. Our
description of measles virus
identification in this sub-set of
children was not challenged at this
meeting. It was accepted by delegates
from the NIH and CDC. The data from
this meeting are to be published in a
special supplement of Molecular
Psychiatry published by Nature group
publishers.
Biopsy material for this
study was provided by Dr. Wakefield
and presented to my laboratory using
"blinded protocols". Unique
accession numbers were assigned to
each case to maintain patient and
diagnostic anonymity. Senior
scientists and technicians have
carried out the research work at two
dedicated state of the art molecular
biology sites here in Dublin. In
addition, independent confirmation
was also sought at a laboratory in
the United States, using similar
technologies as applied here.
Dr. Wakefield initially
posed three questions to our group in
relation to autistic enterocolitis
having firstly carried out detailed
tests in order to establish the
pathogenesis of bowel changes in
these children. Was measles virus
present in gut biopsies of affected
children? Where was measles virus
located in gut biopsies of affected
children? How much virus was present
in gut biopsies of affected children?
In addition, the following questions
were added. Could measles virus
genomes, that is the genetic material
from the virus, be sequenced from gut
biopsies from children with autistic
enterocolitis? Could different
molecular technologies be employed to
detect measles virus genomes in
affected children?
Before commencement of
the project a standard operating
procedure was written in relation to
handling of samples, extraction of
nucleic acid and performance of
molecular virology screening assays.
This is available upon request to any
interested party. The assays used in
this study were: In-situ
hybridisation; RT In-cell PCR;
solution phase PCR; TaqMan
quantitative PCR; and DNA sequencing.
I recognise that I am speaking to
non-experts but I hope to clarify
these technologies for the Committee.
Specific regions of the
measles RNA genome were selected as
detection targets. These included the
Haemagluttinin, Nucelocapsid and
Fusion genes, known as H, N and F
regions, of the measles genome.
Strict anti-contamination procedures
were adopted throughout the study to
prevent false positive results being
generated. These included separate
and isolated facilities for nucleic
acid extraction, PCR amplification,
in-situ hybridisation and DNA
sequencing.
Our laboratories have
over 13 years experience in the area
of viral gene detection and have a
substantial body of peer reviewed
publications in journals such as
Nature, Nature Medicine, The Lancet,
Annals of Oncology etc. In addition,
our group has hosted major
international workshops in the area
of low copy gene detection in
clinical samples and has established
an international reputation in PCR
technology, in-cell PCR and PCR
robotics.
I will now detail the
technologies, the first of which is
in-situ hybridisation. This technique
allows localisation and visualisation
of genetic sequences in cells and
tissue sections so that we can see
the sequence down the microscope. The
in-situ hybridisation assays used in
this study, employed cloned fragments
of the H, N and F region of the
measles virus genome. These cloned
fragments were labelled with biotin
and /or digoxigenin labels using
standard technologies. We then
hybridised probes to the target
sequences in cells and tissues using
conventional chemistries. We detected
the formed hybrid, where the probe
sticks on to its complementary
sequence present in the tissue
section, and we achieved this using
standard immunocytochemical
techniques. In all cases tyramide
signal amplification or TSA was
applied to increase detection
sensitivity.
That is a novel form of
chemistry to detect RNA in tissue
sections.One-step immunocytochemical
detection has a sensitivity of 50
genome copies per cell, which means
that we can pick up 50 copies of the
virus of one cell. With three step
immunocytochemical detection,
however, there is a sensitivity of
ten to 15 copies per cell. The TSA
technology achieves single copy viral
gene detection, so if the virus is
there we will identify it.
In-situ hybridisation
assays were performed on multiple
serial sections of gut biopsies from
affected children. Hybridisation
efficiency was assessed using a
conserved human repeat sequence that
is present in us all called alu.
Negative control probes included
human papilloma virus, which is
involved in cervical cancer, and
human herpes virus eight, which is a
virus I discovered in 1995.
Optimisation experiments were carried
out using measles virus infected vero
cells and brain biopsy material from
patients affected with sub-acute
sclerosing pan-encephalitis (SSPE),
which is a devastating condition
caused by measles virus.
Any Members that have
read the soft medical or scientific
literature will have heard of the
polymerase chain reaction technique.
This technique allows the
investigator to amplify, or make
copies of, DNA and RNA in cells and
tissue sections. It has a detection
sensitivity of one viral or mammalian
genome copy per cell. It is
effectively like a photocopier making
multiple copies within the cell. In
addition, problems with DNA and RNA
contamination are not encountered
using this method, because only DNA
or RNA present in tissue sections,
either inside or outside cells, will
be amplified and localised.
In the cases that were
examined, measles virus RNA was
amplified using RT in-cell PCR, also
known as reverse transcriptase
in-cell PCR. This technology employs
a polymerase chain reaction (PCR) in
order to make copies of the RNA
molecule and a hybridisation step,
very much like in-situ hybridisation,
using a labelled probe to detect the
newly formed amplicon, or gene
copies.
Optimisation experiments
were carried out using measles virus
infected vero cells and brain biopsy
material from patients affected with
sub-acute sclerosing pan-encephalitis
(SSPE), which is caused by measles
virus. Four to six serial sections of
gut biopsies from affected children
were examined for the presence of
measles virus, while including
appropriate controls.
Solution phase PCR was
carried out in select cases where
frozen biopsy material was available.
We looked for the H, N, and F regions
of the measles virus genome.
Optimisation experiments were carried
out once more. The detection
sensitivity of single round PCR is 15
viral copy RNA equivalents in 105 RNA
sequences. Members should understand
that this is extremely sensitive
technology with an absolute detection
sensitivity of
one viral genome copy per cell.
Deputy G.
Mitchell: Not only do we not
understand what Professor O'Leary is
saying, but we are in danger of not
having any time to question him.
Professor
O'Leary: It is extremely
important that I am allowed to read
my statement in to the record. It is
vital when a professional scientist
like myself is asked to give
testimony.
Deputy G.
Mitchell: It is very
important that we who do our job as
legislators conduct our job as we see
fit. If those who come before the
Committee are offered 15 minutes to
give evidence, they should be able to
do so. If Professor O'Leary wants to
put something on the record, I am
sure the whole document can be
entered. Other parliamentary matters
need attention, and we need to find
time to question both Dr. Wakefield
and Professor O'Leary, just as every
other witness before the Committee is
questioned. There is quite a lot of
the document still to be read.
Chairman:
We have a time constraint.
Professor
O'Leary: I accept the
Deputy's point, and I therefore
propose that we move to the results.
Is that acceptable?
Chairman:
Please.
Professor
O'Leary: Using RT in-cell
PCR and in-situ hybridisation
technique, we were able to identify
measles virus genomes in follicle
centres of lymphoid aggregates of gut
biopsies from children with autistic
enterocolitis. The signals obtained
are illustrated in figures three,
four and five of the document I have
distributed. Localisation of measles
virus genomes was confirmed on serial
sections from the same patient. In
the biopsy, one to three areas of
amplification were identified.
Ileal lymphoid tissues
were examined from 77 affected
children with a median age of six,
and they ranged from three to 14
years; 65 of the children were male.
Of the 77 affected children, 73 had
received MMR, three monovalent
measles vaccine, but details were not
available for one. Sixteen had
received a booster measles containing
vaccine, and none had suffered
documented measles disease.
Developmentally normal
paediatric controls, where there are
44 patients with a median age of ten,
ranging from zero to 16 including 31
males were examined. There were 17
children with normal ileal or small
ball biopsies and six with ileal
lymphoid nodular hyperplasia, which
is very like the lesions we see in
these children, but is not found in
autism. Children who had been
investigated for abdominal pain were
included, as were 21 children who had
undergone appendicectomy for
abdominal pain including
appendicitis. Thirteen of the 23
normal and lymphoid hyperplasia
controls had received MMR, one had
received monovalent measles vaccine,
but details were not available for
one. Ten children had received a
measles-containing booster vaccine
and one had suffered measles virus
disease. Eight children served as
measles virus unexposed controls. All
appendix tissues were from children
born at least five years after the
introduction of MMR vaccination,
although vaccination records were not
available at the outset. I can now
inform the Committee that all of
these children had received MMR.
Positive control material was
included, as before.
Overall, 73 of 77, or 95
per cent, of affected children
harboured measles virus genomes in
ileal lymphoid tissue compared with 5
of 44, or 11.4 per cent, of controls.
The relative odds ratio for the
presence of measles virus genome in
affected children compared with
controls was 284.70, which is
statistically highly significant.
Using different molecular biological
technologies we have been able to
identify, localise, quantitate, and
sequence measles virus genomes in gut
biopsies of children with autistic
enterocolitis. I wish to point out
strongly that the findings presented
here represent an association between
measles virus and this disease
phenotype. Disease association in
science implies segregation of two
variables in a disease state, but
does not imply necessarily disease
causation.
The results of this
research have been submitted for peer
review publication. Studies are now
underway to define the effects of
measles virus on the gastrointestinal
system using a transgenic mouse model
of measles virus infection. In
addition, the precise molecular
characterisation of the genes
involved in autistic enterocolitis is
now being carried out at our
laboratories using cDNA array and SNP
chip technology. I thank you for your
time and attention.
Chairman:
I thank Dr. Wakefield and Professor
O'Leary for their presentations and
apologise for the time constraints.
Hopefully some of the issues that are
of interest to us can be teased out
through further questions. Two
documents were made available to us
from the Irish Pharmaceutical
Healthcare Association prior to this
meeting. The first of these is a
statement from the World Health
Organisation, obviously strongly
endorsing the MMR vaccine. I hope Dr.
Wakefield will respond to the claim
made that his study does not meet the
scientific criteria required to
suggest that the MMR vaccine causes
the condition we have referred to.
The other document that was made
available to us was the British study
which found no co-relationship.
Dr. Wakefield:
I will break the first point in two.
Firstly, we have made it quite clear
here, in testimonies elsewhere and in
published data that we have not said
this is the cause. That annuls the
question immediately. To say that our
scientific data do not meet criteria
is therefore true. Everything we have
published, however, has gone through
a formal process of peer review and
presentation in a major scientific
journal and therefore, by definition,
has met the criteria.
Due to the continuous
nature of the work, it has been
extremely rigorously reviewed, not by
two reviewers, as is typical, but by
four in almost every case. The work
has been accompanied by editorials
which is a great privilege and
endorsement, so I refute that point.
Deputy G.
Mitchell: I do not know if
it is possible to answer all of
Professor O'Leary's document, on the
record. Though, we got most of it
perhaps we could put it all on the
record since it is an important
study.
Chairman:
All of the Professor's report will be
placed in the Houses of the
Oireachtas. As such, it will be
placed on the record.
Deputy G.
Mitchell: Dr. Wakefield
suggests, and I do not know if
Professor O' Leary supports it, that
separate MMR would be desirable. They
are not against vaccination, but is
there any international experience,
with separate vaccination, which
shows this to be a safer approach? I
ask the Doctor and the Professor what
the main recommendation of this
Committee should be.
Dr. Wakefield:
There have not been any formal
studies of sufficient size comparing
the safety and efficacy of single
vaccines of measles, mumps and
rubella, to the component vaccines.
The perception of the regulatory
authorities in the USA, of Dr. Neil
Halsey, is that these studies should
be done. If there was a reason to
suspect that there might be
interference between the component
viruses of a vaccine then, it was
indicated by Dr Neil Halsey in 1995,
comparative studies should be done.
They would be large and expensive but
they should be done. In other words,
you compare single measles, mumps and
rubella with the triple vaccine.
Clearly at that time , in 1969 and
1974, he was unaware that clear
evidence of interference had been
demonstrated in two independent peer
reviewed studies. The data suggests
that there is every reason to conduct
those studies but sadly they have not
been performed. What should be the
regime?
It is impossible to say,
it is pure empiricism, but parents
deserve the choice until we have
resolved this issue scientifically. I
would strongly endorse a committee
recommendation of further energetic
research into this association to
establish whether it is causal or
just coincidental.
Deputy G.
Mitchell: Dr. Wakefield,
meantime, seems to come down on the
side of measles, mumps and rubella
vaccinations a year apart. Giving
parents the choice seems a very big
step to take on the basis that there
is not really any evidence. On what
basis would I, as a parent, choose?
What would be the basis on which a
lay-person would choose?
Dr. Wakefield:
From the histories we have, of 170
children, there are certain features
which may act as susceptibility
factors, that is a strong family
history of auto-immune disease,
particularly in the mother. If the
mother has diabetes, thyroid disease,
multiple sclerosis, inflammatory
bowel disease there appears to be an
associated risk and the Americans are
published on this as well. Children
who have intercurrent viral
infections, children who receive more
than one vaccine at the same time,
children who have been on a recent
course of antibiotics are the
children to whom the vaccination
should be offered singly, or for whom
it should be deferred, if they have
an intercurrent illness. The choice
must rest with the parent. The
emphasis must be on education and the
need for the protection of children,
but I recommend that the measles
vaccine continues to be given at 15
months, as per the MMR, and there
should be no discussion of mortality
or the return of measles epidemic.
That need not occur, but we do need
to be absolutely honest with parents
and say that there is a question mark
at the moment. Until it is resolved
they deserve the choice.
Deputy McManus:
I welcome Dr. Wakefield and Professor
O'Leary. Their contribution has been
very valuable to our deliberations
and I particularly welcome their
statement of support for vaccination
because, and possibly Dr. Wakefield
does not realise, we have had measles
epidemics. We lost two babies in 2000
to measles and no health board has
achieved the target level of
vaccination which is a matter of
great concern. It is the context in
which these deliberations take place.
The issue is that children deserve
protection.
The idea of separate
vaccines is an attractive
proposition, but I want to know what
the inherent dangers are. There are
clearly problems if there is a year
between the vaccines being
administered. Are the children not at
risk in that period when we know we
can protect them with vaccines but we
deliberately delay because of the
possibility, as yet unproven, of
autism? The point was made that it is
a question of working out as best we
can what is best for children. Are
there not risks in withholding
vaccinations for a year where parents
choose in the context where many
parents are not even getting their
babies vaccinated out of choice, as
well as for other reasons? It is an
extremely difficult situation in
terms of protecting children.
Dr. Wakefield:
It is an extremely important point.
The key must be to protect children
and it has to be done on the basis of
trust rather than coercion. I am sure
the Deputy agrees that a relationship
of trust must be established between
consumer and provider. If we breach
that trust then we do so for all
vaccines. Measles is the disease of
particular concern and we do not want
it to come back because if it does it
will affect infants as they are the
unprotected ones. Therefore measles
should be the vaccine that is given
from 15 months.
Mumps is much less
transmittable, is far less
pathogenic, a far less serious
disease and the mean age for
vaccination of mumps in the UK was
about seven. If the vaccination was
deferred for one year it is extremely
unlikely that the disease will be
contracted. The risk is theoretical
and it is worth doing the
calculations to establish what that
risk might be and that is something
that the Public Health Laboratory
Service in the UK might do.
Rubella is given to
protect pregnant mothers from
exposure to epidemics of it. It is an
extremely valuable practice which I
fully endorse, but if there is a very
high uptake of the vaccine among
children of three years we should not
see a return of rubella epidemics. We
should see high herd immunity and
protection and those calculation can
be done. I have just been given the
latest data from the USA from the
education department on the
prevalence of autism in children
between six and 18 years. In some
states it is as high as one in 32
children and I do not want that to be
the future for this country or the
United Kingdom. That is an
extraordinary level of disease which
was unheard of some ten to 20 years
ago. It was so rare that a physician
could go through his whole
professional life without
encountering a case. I have grave
anxieties that, if we do not address
this issue here and now, we will find
ourselves in a similar situation
before too long.
Deputy McManus:
Those figures are pretty staggering.
There is a significant increase in
autism which has not been explained
but there has not been the same
increase of MMR over the same period.
Is it possible to say what is causing
the increase?
Dr. Wakefield:
I have my suspicions. That is the
reason we are here.
Deputy McManus:
So do I.
Dr. Wakefield:
-----and that is the reason we are
here. If one takes the
epidemiological data as it stands,
one sees a flat line that suddenly
takes off. There was a wonderful
article in the Irish Independent the
other day which showed a striking
increase in the incidence of the
disease from the point of
introduction of the MMR and the
authors concluded that there was no
association. I would be extremely
worried if I had generated that data.
The question is why it
continues to increase. If it was MMR,
it should step and plateau. If 1 per
cent of the population was
susceptible in subsequent birth
cohorts, why does it continue to
increase? That is a complex question.
We are dealing with a subset of
children, so the issue is what
proportion of that increase they
represent. Another point is that we
cannot assume that the background
susceptibility of children remains
constant. As I said, we have a
history of children who have
intercurrent antibiotic use and
atopic disease. Their mothers have
auto immune disease so all the
background vulnerability factors have
gone up dramatically over time. We
cannot assume the background
susceptibility of children to an
adverse outcome possibly from a
vaccine has remained static. When we
design epidemiological studies, these
aspects must be taken into account. I
hope this makes sense because it is a
complex area.
Deputy Gormley:
I welcome Dr. Wakefield and Professor
O'Leary and I thank them for their
contributions. Dr. Wakefield said he
had his suspicions and the figures he
gave the committee appear to tally
with what we heard previously that
there appears to be an epidemic of
autism in Ireland also. Will he
elaborate on those suspicions? I am
interested in his views on that
matter. Will he also outline what he
means by the subset and how it
differs from those who suffer from
autism? Dr. Wakefield also said he
has noticed that children can regress
from a single measles vaccine. Does
he link the single measles vaccine
directly or it is the case that it
cannot be fully explained at this
stage?
Dr. Wakefield:
We cannot explain it fully. Of the
170 children, two had the single
vaccine. One of them was definitely
ill at the time he received it. If
can dissect out these vulnerability
factors, one could say that the
children should not be vaccinated in
the presence of a current illness.
This is already standard practice
and, in that incidence, the GP did
not take account of it. This does not
argue for causation, but it should be
considered.
Regarding the types of
autism, historically Kanner described
children who were never right from
the beginning. They were never
cuddly, they did not look at people
and they were often quiet babies.
They never gained skills and that was
classical Kanner autism.
Interestingly, there are studies that
show children exposed to measles,
mumps and rubella in utero when their
mother was pregnant are at greater
risk of autism. Children exposed
during the perinatal period to those
infections are at greater risk of
autism. There was already a
historical link between atypical
patterns of common childhood
infection and autism. Those children
would never have been right from the
beginning.
However, the pattern of
exposure may now have changed where
the child undergoes 15 to 18 months
of normal development and then
regresses. It is interesting that, in
the United States, the prevalence of
that type of regressive autism has
gone up dramatically. We are dealing
with a subset of regressive autistic
children. There may or may not be a
specific cause in that group, but
they have certain clinical
characteristics that distinguish them
from the typical Leo Kanner type
autism described in the 1960s.
Deputy Gormley:
The World Health Organisation has
noted that other scientists have not
been able to reproduce the results
claimed by Dr. Wakefield and his team
regarding measles virus in the gut.
Will Dr. Wakefield comment on that
aspect?
Dr. Wakefield:
It is a very interesting comment. We
published many papers on the
detection of the protein of measles
virus in the gut. We test hypotheses
in my group and we publish the
results whether we are right or wrong
and whether it supports the
hypothesis or otherwise. That is one
of the fundamental rules of my group,
but many people do not do that. We
then use the amplification technology
that Professor O'Leary described and
we could not find it. Our
amplification technology was
sensitive to 10,000 copies of a virus
in a test tube. Less than that, we
could not find it and that is no
good. Professor O'Leary could detect
it down at 50 copies so he had orders
of magnitude for more sensitivity.
We published the paper
saying we could not find it and other
people published the same thing. In
other words, they reproduced our
findings. They did not contradict
them - they reproduced them. I am
slightly confused by that comment.
Nonetheless, using more sensitive
technologies in Chron's disease and
entero-colitis, others have now been
able to find the virus, including
Professor O'Leary and a group in
Montreal who are public health
doctors. This data about the
detection of measles gene in children
with Chron's and entero-colitis was
presented in the American Academy of
Paediatrics last year. It has moved
on now to another level, but people
have not really attempted to
reproduce what we have been doing.
They have been testing different
hypotheses.
Senator Jackman:
I thank the representatives for their
presentations. Dr. Wakefield is
considered a controversial figure.
That was how the Committee was
introduced to him before it met him.
Where else in Europe are doctors and
scientists doing the same research
and are they collaborating with Dr.
Wakefield? Parents want to find out
why their child is suffering from
autism and they may think the views
he expressed are the reason for their
child's autism and their subsequent
children do not receive the vaccine.
What is Dr. Wakefield's advice?
Should subsequent children receive
the vaccine because frightened
parents may not take that route? The
debate in Ireland is whether one
should or should not vaccinate,
particularly regarding parents whose
first child has autism.
Dr. Wakefield:
They are important questions. We will
do everything we can to help any
committee such as this to endorse the
need to protect children against
these infections. This should not be
construed as anti-vaccine or
dichotomized into pro and anti
vaccine. It is about establishing the
safest way and in the context of
subsequent children of parents who
already have one autistic child, I
recommend the single vaccines. If the
child encountered those wild
infections concurrently, he or she
may be at risk of similarly
regressing and developing the
problem. The same argument pertains.
These children should be protected,
but I would use the single spaced
vaccines.
Other groups are
investigating the link between the
gut and autism around the world. We
collaborate with the professor of
epidemiology in an institute in
Stockholm and Dr. Scott Montgomery.
Other independent groups who are
looking at these children include
Hans Hilderbrand in Rotterdam. A
paediatric gastroenterologist in
Stockholm is investigating these
children. Professor Quigley in Cork
is also working in this area. Other
groups in the United Kingdom have
endoscoped these children, visualised
the gut, biopsied it and had the same
findings. Groups from the children's
hospital in Manchester and south
Wales have found the same thing. We
also received a number of biopsies
from children in the United States in
whom gastroenterologists have made
the same finding.
Apart from the MMR
issue, the gut link is now becoming
well established. Whatever else we
do, these children deserve a
diagnosis and appropriate
investigation. The medical profession
thus far has failed them. It
has not treated them as it would
treat gastro intestinal symptoms in
other children because they are
autistic. These children
need appropriate investigation
because there is something we can do.
We have a great deal of
experience in treating the gut lesion,
for example, inflammation in Chron's
and colitis. These children can
improve. Undoubtedly, the members
have heard about diet. We find that
helps enormously in some children.
Whatever else, these children deserve
to be appropriately investigated and
cared for.
Deputy Allen:
From the documentation, it appears it
predominantly occurs in boys. Why is
that the case?
Dr. Wakefield:
Nobody knows. People have looked for
x-linked genes - where the boy has
one and the girl has two, and,
therefore, if it is on the x gene the
girl is likely to be protected - but
thus far nothing has been found.
Professor O'Leary is an expert in
molecular genetics and he may have
something further to say.
Professor
O'Leary: The statement that
Dr. Wakefield, has made - that it is
a predominantly male disease - is a
very important one. As a collective
group of disorders, autism is a
predominantly male disease. All I can
tell the Committee at the moment is
that we have started examining and
mapping changes in the x chromosome.
We will be moving on to the next
stage, looking at family members and
examining a technique called linkage
analysis to see if there are disease
loci possibly segregating the
disease. At the moment, however, it
would be premature to say anything
more than that. It is a good
observation by Dr. Wakefield,
however, and one that needs to be
followed up.
Deputy M. Ahern:
I must confess that I did not
understand Professor O'Leary's paper
but, of course, I am not a medical
person. I thank both Professor
O'Leary and Dr. Wakefield for
appearing before the Committee. As we
all know, autism is becoming a
prevalent disease. Autistic centres,
such as the one in Carrigtuohill
would have been unheard of a few
years ago. Given the number of people
attending that centre now, it is
evident to the public that autism is
a problem that has increased in our
society.
I have been asked to
pose one or two questions and
Professor O'Leary and Dr. Wakefield
may, or may not, want to comment on
them. On the onset of autism, if a
parent reports DPT and polio, will
anything show up in tissue? I do not
understand the question, but perhaps
Professor O'Leary and Dr. Wakefield
do.
Dr. Wakefield:
I think this question relates to the
United States' experience, where a
number of parents have said that
their children had problems with the
DPT vaccine, which is often
administered together with the polio
vaccine. We have not encountered that
in the group of children we examined.
That is not to say that the
experience is not genuine, but there
are no footprints; one cannot find
remnants of DTP in tissue because
they are fragments of the original
bacteria. Polio is a virus and it is
possible to find elements of it, but
we have no reason to suspect that
polio vaccine is in any way linked to
this.
Professor.
O'Leary: We have not looked
for that specifically, Deputy,
because we have not encountered it.
There is a possibility that one may
identify polio. My hunch is that
pertussis would probably not be
identified, but I have no scientific
basis for that answer
Deputy M. Ahern:
Is either Professor O'Leary or Dr.
Wakefield aware of research in other
areas associated with vaccine damage?
Professor.
O'Leary: We have developed a
trans-gene mouse. Normally, mice are
not susceptible to the measles virus
so we put a gene called CD46 into
these mice which makes them
susceptible to it. We are currently
going through these animals,
examining them in terms of where the
measles virus has gone in their
tissues. I am examining the gut, in
particular. We can identify the
measles virus in the transgenic
animals, but we do not find it in
normal controls that are
non-transgenic. Yes, we do find
measles virus in the guts of these
mice and they do have inflamed guts,
very much like the children's. We are
very much on the bottom rung of the
escalator, however. We are trying to
characterise the genes and do a
comparative analysis between what is
happening with mice and humans. The
scientific endeavour usually follows
that path, moving from an animal
model to a human one, making direct
extrapolations and categorising
diseased groups and types based on
those findings. That is continuing in
collaboration with a research
institute in the United States.
Deputy G.
Mitchell: From his
experience, what does Professor
O'Leary think the main recommendation
of this Committee should be? What can
we do to advance this scientific
research? Specifically, given his
knowledge of Irish medicine, what
happens at present if a parent goes
to her GP, for example, and says
"I would like my child to have
the MMR vaccines separately"?
Chairman:
A single vaccine?
Deputy G.
Mitchell: What would the
GP's response be in that case? What
is the general approach?
Professor.
O'Leary: This is out of my
area of expertise, but I understand
the current approach is that the
single vaccine is not offered. That
is my understanding, although I am
not a general practitioner. The child
has to be immunised. I am not an
expert in vaccination. As Dr.
Wakefield has explained, I understand
there have not been widespread
population studies in relation to
monovalent vaccines, so I cannot make
a scientific comment on that matter.
Deputy G.
Mitchell: Both Professor
O'Leary and Dr. Wakefield said they
were in favour of vaccines. Does that
mean they are both specifically in
favour of the three-in-one system
continuing?
Professor.
O'Leary: If we have nothing
else to offer parents, vaccination
has got to continue. It would be
ludicrous for me to say anything
else. Children must be vaccinated,
Deputy. We must decide whether to do
this by three-in-one or monovalent
vaccines. I am not a vaccination
expert and am not aware of
substantial, published literature on
monovalent vaccines. However, in
relation to these children, I think
they deserve to be investigated. That
is the line I am taking.
Deputy G.
Mitchell: Earlier, the
Chairman referred to a study on
mumps, measles and rubella vaccine,
and the incidence of autism recorded
by general practitioners. That time
trend analysis was done by James
Akay, epidemiologist, Maria Delmar
Meloremontes, epidemiologist, and
Hercheld Gyk, associate professor of
medicine for the Boston collaborative
drugs surveillance programme at
Boston University. The setting was in
general practices in the United
Kingdom, and the subjects were
children aged 12 years or younger,
diagnosed with autism in the 1988-99
period, with further analysis of boys
aged two to five years, born 1988-93.
In their conclusions, the researchers
said that no time correlation exists
between the prevalence of MMR
vaccination and the incidence of
autism in each birth cohort from 1988
to 1993. Specifically, they said: The
incidence of autism in the United
Kingdom has increased markedly over
the past decade. Some have proposed
that this may be related to the
introduction of mumps, measles and
rubella vaccine in 1988. The risk of
autism increased nearly four-fold
among boys aged two to five years,
born from 1988 to 1993, and
registered in the UK general practice
research database where the
prevalence of MMR vaccination was
over 95 per cent and virtually
constant.
So the MMR vaccination
was over 95 per cent and virtually
constant, yet the increase of autism
in boys aged two to five years in the
1988-93 period was fourfold. They
conclude that these data provide
evidence against a causal association
between MMR vaccination and the risk
of autism. What are Professor O'Leary
and Dr. Wakefield's comments on that
research?
Dr. Wakefield:
That comes back to a point I made
earlier. What is striking about this
paper is that the take-off in the
incidents of this condition in boys,
in particular, was when MMR was
introduced. It was in those first
birth cohorts eligible for MMR
vaccine. It comes back to the point
about what characterises the children
we see in the clinic: children who
have an atrophic disease, such as
asthma, eczema or hay fever, when
they are vaccinated; children who are
ill or on antibiotics when they
receive the vaccine; and children who
receive more than one vaccine at the
same time.Rather than a step up and a
plateau which their hypothesis
tested, what would we expect to see
if we are increasing the
vulnerability of successive
generations of children to an adverse
reaction to MMR vaccine?
What have we done in
that time? We have seen a dramatic
increase in atrophic disease in
children, particularly food allergy
disorders. We now have clinics full
of children with food allergy
disorders. What happens to those
children when they receive MMR
vaccine? During the period that study
was conducted, we introduced HIB
vaccine to be given concurrently with
MMR. We changed the recommendations
for exposure to DPT for three, six
and nine months to two, four and six
months. We have altered all the
background factors and we cannot
assume that, therefore, the
background susceptibility to an
adverse response to MMR is constant.
This has not been the case. It is
very naive to think it might have
been the case. I am surprised
Hercheld Gyk and his colleagues did
not come to us and ask the
characteristics of the population at
which they should be looking which
would help them to tease out this
fact in an epidemiological study.
They did not test the hypothesis. The
conclusion of the National Academy of
Sciences is that the epidemiology,
including that paper, is not helpful.
Deputy G.
Mitchell: Is that study
independent or is it funded by
anyone?
Dr. Wakefield:
I have no idea. I would not cast
aspersions on the authors but I think
the setting up of the study was wrong
rather than whether they received
remuneration.
Deputy G.
Mitchell: Do I take it from
what Professor O'Leary said that more
research needs to be carried out?
Professor
O'Leary: I am a pathologist
and electrobiologist. I am in the
middle of what is a very difficult
and emotive situation. This needs
more research. All of us are aware
that autism in terms of incidence
prevalence has exploded for whatever
reason. Autism is a complex series or
set of conditions into which more
research is needed. The gut axis in
terms of the abnormalities in
relation to gut pathology in children
is real and that needs to be
investigated. Given the genetic
make-up of these children, we have no
idea why this is occurring in this
setting. Research is needed in this
area. At the end of the day, families
are looking for physicians to listen,
treat and investigate. That is my job
and it is why I continue to be a
physician.
Chairman:
Do you think, therefore, that the
medical profession, the Department of
Health and Children, the health
boards and the various medical people
are being irresponsible in not acting
with greater care? All the
documentation we have received
encourages the use of the MMR
vaccine. Do you feel you are totally
isolated because of the questions you
are asking?
Professor
O'Leary: I do not feel
isolated. What I am describing as a
pathologist, based on scientific
endeavour and scientific
investigation, public health people
have got to say what they believe as
being correct. I am trying to say
that there is an organic lesion in
the gut of these children which we
have investigated, and this
investigation needs to be continued.
That is all I can say.
Chairman:
The reason I asked the question is
that some of the presentations seemed
to suggest that perhaps there was an
element of irresponsibility in
Professor O'Leary's studies. I wonder
how you viewed the current espousal
of MMR, given the question marks you
are raising.
Professor
O'Leary: What is written in
a statement to this Committee is my
belief. It is not a matter of what
the papers say or what others
extrapolate. From my point of view, I
have been singularly silent on this
issue because it is so important.
That is why I thought it important to
come to this Committee and have this
read into the evidence. I will stand
over what I have said. Our science is
now being corroborated by other
groups and we have sent it for
independent review. We cannot do
anymore. I have been down this road
once before with another virus. It
takes time for the corporate body of
medicine to accept change, which is
the correct attitude.
We need to set
hypothesis, answer questions and
review the findings. That is the
correct way in which scientific
endeavour must be carried out. It
must be peer-reviewed which is what
we are going through. I appeal to
everyone that this issue must not be
fought in the press. It must be
fought in the scientific
peer-reviewed press and we must
respect that.
Deputy Gormley:
Professor O'Leary spoke about the
corporate body of medicine. Will he
agree that at the top of that
hierarchy is the pharmaceutical
industry? Will he accept that he has
been dismissed as a maverick and
irresponsible because the
pharmaceutical industry stands to
lose an awful lot of money if MMR is
implicated in autism?
Professor.
O'Leary: I certainly hope
that the pharmaceutical industry and
the corporate body of medicine are
separate thinking organisations who
have the right to think independently
and criticise one another
independently. I cannot comment any
further.
Dr. Wakefield:
It is an interesting question. I
agree with John, nevertheless, it
would be naive to believe these two
bodies are completely separate. My
anxiety is at the coalface, that is,
that we need to address the concerns
of individuals. The truth will come
out. If we can address appropriately
the scientific issues by taking
parents' stories, interpreting it and
doing the work, the truth will come
out. If this issue is handled
appropriately, the consequences for
public health, the drugs industry and
everyone concerned are not that dire.
Let me give an example. The stories
of many extremely articulate and
intelligent parents have been
dismissed. If the medical
infrastructure continues to dismiss
these stories, people will form
organisations, charities and groups -
the Internet has enabled that
exchange. They will then realise that
people in the United States have the
same problem and they are not alone.
They will then get a voice. If this
happens to politicians' children,
children of celebrities and so on,
which has happened in the United
States, their voice will be heard. It
comes back to the issue of trust
between public health and the
consumer. If that trust is breached
in the context of MMR, it is breached
for all vaccines. The potential
consequences of this would be
catastrophic, therefore, it is
absolutely essential to address these
concerns at the coalface to establish
from the outset their validity or
otherwise. If we are prevented from
doing so - there are huge pressures
to prevent us from doing so - we will
get ourselves into a catastrophic
situation ten or 20 years down the
line. One only has to look at the
United States now with the
extraordinary prevalence of a disease
that no economy, including the Unites
States, can sustain. One in 32
children in one state in the United
States is one in almost 16 boys. That
is an extraordinary price for a
society to pay and we must not allow
ourselves to get into that situation.
Deputy McManus:
I fully accept the approach being
taken. Are you saying the three
vaccines - measles, mumps and rubella
- separated out are of value in
protecting children and that the
combined MMR vaccine may have a
causal effect on autism? Is that what
is being said, no more and no less?
Dr. Wakefield:
That is true.
Deputy McManus:
In terms of future work and the fact
that the work is scientifically
based, who funds the work?
Dr. Wakefield:
That is a very short answer. We have
found it extremely difficult to get
funding. The UK, rather like Ireland,
is blessed with a few idiosyncratic
charities where, when the Department
of Health says it is safe, here is
money to help answer this question
because we are not so sure, it is
time to put on one's flatjacket.
Nonetheless, it has been very
difficult. In fact, there have been
deliberate attempts to write-off
funding. We have had to dig very
deep. That is not the way in which
science should be conducted. What
will happen, as always happens, as a
consequence of the Cold Spring
Harbour meeting in the United States
where the NIH person who was sent to
shoot the stand said, "That is
it, you have found the virus".
They will pick this up and run with
it.
The NIH has just
received a budget of £2 billion from
the Bush Administration for autism
research, so they are taking it
extremely seriously. This is as a
consequence of the papers we
published. While that is very good
news for autism, it is not such good
news for us, but that is neither here
nor there. I believe we have an
opportunity to pursue what has been
described as ground breaking research
and come to a conclusion that
satisfies both public health bodies
and parents. It is a very big issue
which will not be resolved by
conflict. It will only be resolved by
debate and discussion.
Deputy McManus:
I genuinely wanted to know who is
funding the research.
Dr. Wakefield:
They will probably mean nothing to
the Deputy but they include the Scott
Reviews Charity, Mr. Samuel Scott,
the Ellermann Foundation and Mr.
Haley Steward. These are small UK
charities which do the work.
Laterally, as part of a class action
in the United Kingdom, there has been
an increment of funding for children
who are legally aided to have their
molecular virological assays
performed. An element of the funding
has come from there. Our duty is to
the courts, not to the claimants or
the defendants.
Professor.
O'Leary: The transgenic work
is paid for by the Mindes Foundation
in the United States, which is funded
by the state of California. Much of
the early day-to-day stuff has come
out of my own pocket within my
practice. I am a practising
pathologist. Even though one must
sometimes believe in what one is
doing, what has been found here is
important for these children. I am
not an expert in autism, but I
believe this is a set within a set.
We may not necessarily find this set
with big epidemiology studies. That
came out of the Cold Spring Habour
meeting. I went there with a very
open mind. I am not a paediatrician
or a vaccinologist, I am a
pathologist who sees things down the
microscope and I can only report on
what I see.
Dr. Wakefield is correct
in saying that it is difficult to get
this kind research funded. I did a
lot of work on cervical cancer, which
is very easy to fund, including
multiple sclerosis, breast cancer or
thyroid cancer. This is a small
element of my research laboratory. It
is very important for the families
who have rights. It is very difficult
to get funding, which is regrettable.
Chairman:
Did you ever seek Government funding
for your research? What funding would
be required on an annual basis to
continue with the work?
Professor.
O'Leary: No, I never sought
Government funding for research. In
terms of an annual ongoing request,
we would probably need to have the
salary of a research technician
covered, that is, approximately
£21,000 or £22,000. A consumer
budget to look at 300 or 400 children
would probably be in the region of
£10,000 to £15,000, which is very
small money. I have 23 research
students who must be kept going on
very small money from national funds.
When something like this comes along,
one must fund it out of one's own
pocket.
Deputy Neville:
Deputy McManus pre-empted what I was
going to say. I was going to ask if
the issue should be investigated
further and funding provided by the
Department of Health and Children? I
believe one of our recommendations
should be that there should be more
detailed research into this area.
Chairman:
It is a bit early for that. The
Deputy can put forward that question
at a later stage. We are in the
process of eliciting information.
Deputy M. Ahern:
There are reports of links between
schizophrenia, teenage depression,
vision loss and so on with MMR. Is
research taking place in this regard?
Professor.
O'Leary: I am not aware of
any such research.
Deputy G.
Mitchell: In regard to
research and best practice, in the
policy document on health which I
published last November on behalf of
my party, one of the things we
recommended was that we would
allocate £10 million to leading
Europe on research in mental health.
Have we the capacity to lead Europe
in this area of research or is best
practice in Europe or in the United
States? Where is the best research in
this area taking place and in what
capacity can we contribute?
Professor.
O'Leary: That is a very
important question. My research group
is multinational. We have many people
from the United States. I have worked
in Cordall University and the
University of Oxford. We are in a
unique position because we have a lot
of cutting edge technology which is
not available in many laboratories in
Europe. On the question of where is
the best research currently being
carried out in relation to this
specific disorder in terms of the
globality of the patient, the Mindes
Institute in California has
specifically set up an institute to
look at autism and the pathogenic
mechanisms behind that. We have a
link to that because we are doing the
transgenic model with it. Ireland
could be at the forefront of this
research. It has led in many areas of
medicine and science in the early
days. There is no reason why Ireland
in 2001 cannot be at the forefront. I
do not see a substantive problem with
that. However, research must always
be transnational or transglobal. I
have offered my labs and protocols to
the CDC, so I cannot do anymore. The
answer to the Deputy's question
is,"Yes, we would welcome
funding and a commitment of £10
million to this study".
Dr. Wakefield:
I endorse what Professor O'Leary has
said. Research is a strange beast in
that it takes people to break the
ice, which is often very
uncomfortable. As a consequence of
the Cold Spring Harbour meeting,
there will be a great deal of effort
going into looking at the molecular
virology in these children. Ireland
is ahead of the game almost
exclusively because of John O'Leary.
It has a unique resource it could
develop to stay ahead of the game.
The future of this issue is not only
in understanding the mechanism of
disease, but why children are
susceptible, the treatment for these
children which is specifically
designed, rather like HIV therapy, to
eliminate the virus in these children
and to test the hypothesis of the
cause. That is where the future of
this research lies and Ireland is in
a unique position to exploit it.
Deputy G.
Mitchell: A major statement
is being made in the House which is
why I was anxious to get through as
many questions as possible. We should
focus on the last piece of evidence
given when we make our
recommendations.
Deputy Gormley:
I thank both gentlemen for their
commitment and courage. If the
Department can fund snooker
championships, it can certainly fund
research into this important issue,
which I recommend.
Chairman:
Unfortunately, there has been
confirmation of an outbreak of foot
and mouth in County Louth this
morning. From the point of view of
Members of the Committee, this has
been an outstanding session. We have
learned quite a lot from it. The
members of the delegation were very
rational and objective in the way
they approached the questions. We
found this very rewarding and thank
them for coming before us. There are
polarised views in regard to this
issue and it is our intention to
bring those views together at a
further session. Obviously we would
like both members of the delegation
to consider making themselves
available again for such a session.
We will give the gentlemen plenty of
notice if they are willing to attend.
That will be the final session before
we decide on our recommendation. We
look forward to seeing both of you in
the not too distant future.
The Joint Committee
adjourned at 11.10 a.m.