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.