http://osiris.sunderland.ac.uk/autism/vaccine.htm#Shattock
Evaluation
of Urinary Profiles obtained from People with Autism and Associated Disorders.
Part 2: The Role of Vaccines in the
Causation of Autism and Related Disorders
Paul
Shattock and Dawn Savery
Autism Research Unit, University of
Sunderland, Sunderland, UK.
Article taken from 1997 Conference
Proceedings "Living
& Learning With Autism:
Perspectives from the Individual, the
Family and the Professional"
The suggestion that autism and
other disorders with serious and lifelong implications could be caused by
vaccinations has been in circulation for many years. There are few rational
texts on the topic and most literature can be placed in one of two categor ies.
Some authors adopt what appears to be a fanatical anti-vaccine stance and so
overstate their case that even the valid points become unbelievable. On the
other hand, orthodox medical literature exhibits such complacency and lack of
willingness to acce pt that any problems could exist that it too becomes
devalued.
There is no doubt that many parents
are totally convinced that their children changed dramatically and quickly
after the implementation of an immunisation programme. To ignore such cases and
assert, without investigating the individual circumstances, that there is no
case to answer is unwise, raises fears and concerns and does nothing to
reassure the public. Questions about the safety of vaccines and about the
desirability of vaccinating siblings of children with autism or of giving
boosters to children w ho are autistic are received, by our research unit, more
often than any other. A complete and thorough review of the efficacy and safety
of the products currently in use is vital.
If the protesters are correct, the
consequences for the lives of many people are extremely serious. If the
protesters are incorrect and the vaccines are completely safe and effective,
public confidence is being severely damaged unnecessarily and the contr ol of
potentially lethal and disabling diseases is being jeopardised by this
complacent and unquestioning attitude.
Some Basic Principles
It is clearly inappropriate, in this
brief presentation, to rehearse all the arguments for and against individual
and mass vaccination programmes. There are, however, certain basic principles
against which all decisionsmust be set.
If the use of a vaccination
programme is to be considered:-
1. There should be a serious threat
from the disease in terms of:-
* consequences of the disease to the
individual;
* numbers of people likely to be
affected.
2. The product should be effective
and protection should be long-term.
(Although there is general
acceptance that vaccination does provide adequate protection against many,
formerly significant, diseases the claims and counter arguments of the sceptics
should be addressed seriously.)
3. Side Effects
* These should be minimal in terms of
severity and frequency.
* When present, adequate compensation
should be available (currently, in the UK the maximal
level is a single payment of £
30,000).
Other Factors
The principle of informed consent
should apply as with any other form of medication. This implies that the full
facts should be available to the practitioner and to the subject of the
programme or, in the case of those unable to give such consent themselv es,
their parents or carers. The practice of paying substantial bonuses to
physicians reaching their targets for vaccination levels could perhaps be
justified under certain circumstances but it is a highly unusual practice in
the medical field. It is not our intention to imply that physicians would be
persuaded to act against their judgments by such financial inducements but were
the same methods to be applied in other areas where medicines are supplied the
legality of the methods would be open to questio n. Legal requirements in many
US states make it very difficult to avoid vaccinations if children are to be
permitted to attend school at all. The intention of controlling diseases which
are a genuine danger to public health is well understood but the prin ciple of
financial inducements is an unfortunate one.
Given the increasing tendency
towards litigation it is a brave physician who risks enormous financial
penalties, via the courts, should his advice to avoid vaccination result in
serious problems from the disease.
Given these legal and financial
pressures it is absolutely necessary that the public be totally confident that
the products they are being forced to use are both safe and effective.
Constituents of Vaccines
The active components of vaccines have
many of the properties of the diseases they are designed to prevent. They are
designed to encourage the bodys defence systems to rapidly recognise any
invasive organism and to produce antibodies of various types whic h will result
in the eradication of the disease.
These antigenic principles may
consist of dead organisms; they may consist of toxoids or extracts from the
organisms which will provoke an immune response or they may consist of
attenuated or mild strains of the disease promoting organism. Although these
organisms, which may be bacterial or viral in origin, are alive and have the
ability to promote an immune reaction, they are so weak in terms of causing
symptoms that these effects can, in a normal individual with a fully competent
immune system, be ignor ed totally.
There are, however, many other
components in vaccines which could, potentially, cause problems in particular,
sensitive, individuals.
Amongst these, particular mention
should be made of the following:-
From the Preparation of the Vaccine
- used to kill bacteria;
* Antibiotics (eg Neomycin)
* Formaldehyde
Adjuvants/Additives
* Aluminium salts;
* Preservatives such as thiomersal
(contains mercury);
* Lactalbumin
Residues from Growth Media
* Eggs;
* African Green Monkey Kidney (Polio
vaccine)
* Other animals
The reports of the isolation of
Stealth Viruses from at least two children with autism cannot be ignored.
Gulf War Victims
Many members of the armed forces who
fought in the Persian Gulf suffer from an extensive range of symptoms. The
precise nature of these symptoms varies with the individuals in both extent and
nature. Many theories have been put forward to explain the caus ation of these
symptoms but there seems little doubt that the intense immunisation programmes
to which the troops were treated in a very short period of time. The precise
nature of the vaccines used to protect the troops is classified information but
the majority were immunised against at least a dozen serious diseases. The list
includes the following.
Anthrax;
Plague (Cutter);
Yellow Fever;
Typhoid;
Botulism;
Hepatitis B;
Cholera;
Hib;
Pertussis;
Polio;
Rubella;
Tetanus.
The Ministry of Defence has admitted
to the inclusion of five or six other organisms but has declined to confirm
their identities.
The effects of such an intense
battery of vaccinations in such a short period of time could be serious indeed
particularly where the immune system is already compromised for any reason.
Factors such as stress and environmental agents such as pesticides or drugs as
well as genetic factors could all result in the compromising of the system.
It is, perhaps, pertinent to note
that French troops, serving alongside the American and British troops have not
experienced such problems. It may also be relevant that they did not undergo
these vaccination programmes in such a compressed time zone and a lso that
different insecticidal agents were used (semi-synthetic pyrethroids as opposed
to the organo-phosphorous compounds favoured by the British and American
authorities.).
The reaction of the public to the
revelations about these schedules is usually one of shock. However, it is worth
considering the vaccination schedules applied to infants in various parts of
the world. The schedules used in the United States of America ar e amongst the
most aggressive and are listed in the accompanying table.
Immunisation Schedules (US October 1996)
Age
Procedure
2
weeks
Hepatitis B #1 (if not given in hospital)
2
months
Diphtheria, Pertussis and Tetanus (DPT) #1,
&
Oral Polio #1, Hepatitis #2; Hib #1.
4
Months
DPT #2; Hib #2; Oral Polio #2.
6 Months
DPT #3; Hib #2; Oral Polio #3.
9
Months
DPT #4; Hib #3; Measles,Mumps and Rubella (MMR)
#1; TB Test
4
years
Boosters for DPT; Oral Polio and MMR.
Thus in the first year of life, the
immune system of an infant, as well as the infant itself, is challenged by
injections, directly into its body, of at least 10 diseases. Many of these are
derived from attenuated strains of living bacteria or viruses. An infant with
an underdeveloped immune system or one which is already challenged or
compromised for any reason must be vulnerable when such an a battery of
vaccinations are used in such a short period of time.
It should also be borne in mind
that these injections are directly into the body so that those elements of the
bodys immune system which rely upon mucous membranes or skin are completely
bypassed. This may be of particular relevance when the effects of th e adjuvants
and additives previously mentioned are considered.
Reported Side Effects
The British Government has a system,
the yellow card system, which encourages physicians (and others involved with
the administration of medicines) to report any adverse reactions to medications
including vaccines. When suspicions are aroused, these are i nvestigated by the
Committee for the Safety of Medicines and the response is usually rapid. The
problem with vaccines is that the side effects are not always immediate and are
only infrequently in such a form that they are immediately recognised as being
attributable to the vaccine.
A particularly striking example of
this under-reporting of problems with the vaccine used against mumps in the
United Kingdom. Until 1992, the attenuated strain of the virus which was in
common use was the Urabe strain. This combined comparatively mild effects with
a comparatively high antigenic effect. The side effects consisted of what has
been called a mumps induced meningitis. This only became evident between 10
days and 5 weeks after the inoculation. Therefore, any such symptoms, when
seen, were onl y rarely associated with the inoculation.
Records show that the normal yellow
card system, described above, indicated an incidence of side effects (which may
have been very trivial) of around 1 in 250,000 cases. When, with the knowledge
and advantages of hindsight, much more exhaustive investigat ions were made the
incidence of side effects was very much higher.
When notifications of meningitis
from physicians were included; when the vaccine records of hospital cases of
meningitis were included; when cross linkage of vaccine records from laboratory
reports (4 laboratories) was performed and included the figure wa s increased
to 1 in 11,000. It should be noted that in the case of one particular
laboratory, this was 1 in 4,000.)
Since it is possible that there are
many instances where such reaction are not reported at all, because the
symptoms were not sufficiently dramatic or, perhaps, because they were misinterpreted,
it is more than likely that the incidence are a huge under-e stimate of the
seriousness of the problem.
It is interesting to note that the
Urabe strain was withdrawn from regular use in the UK late in 1992 so that the
only vaccine available was from the Jeryl Lynn strain.
Evidence from Evaluation of
Urinary Profiling
As described in Part 1 of this
presentation, we have isolated a compound; trans-Indolyl Acryloyl Glycine (IAG)
in substantial quantities in the urine of an estimated 75% of the subjects with
autism that we have examined. Although other explanations are fe asible, we
speculated that this compound may be the detoxified derivative of a parent acid
which could have severe implications for the permeability of many membranes
throughout the body. In the context of autism and the opioid excess theory,
these effec ts would be particularly relevant for the membranes lining the gut
(in terms of gut permeability to peptides) and the blood brain barrier.
Increased permeability of either or both of these membranes would result in
greatly increased levels of opioid pept ides reaching the CNS with predictable
results.
Examination of the clinical
histories of this remaining 25% of subjects, where IAG is not a very major
component, almost invariable shows that parents strongly suspect some other
factor to be involved. Sometimes this relates to hypoxia or anoxia at birth
but, in the vast majority of these cases, parents strongly suspect, and have
usually already suggested, the involvement of vaccines and, in particular, the
MMR vaccine. We have not collected relevant data on a systematic basis but it
remains our considere d opinion that in some 15-20% of the cases of autism with
which we have come into contact there are strong reasons to suspect a causative
role for vaccines. It must be conceded that there are a number of instances
where parents strongly suspect vaccine in volvement even though the IAG
compound is present in substantial amounts. These situations are not common and
may represent fallacious beliefs on the part of the parent. On the other hand,
it may well be that the vaccines have exacerbated an existing situation.
A full discussion of all the
relevant factors would be inappropriate for this communication but there are a
number of points which are worthy of mention at this juncture.
Clinical Features
The clinical presentation of the
symptoms in children where vaccines are believed, by parents, to be involved
are virtually indistinguishable from those of other children with autism. The
majority of children with autism appear to have shwn regression in terms of
language, comprehension and behaviour so that this alone cannot be taken as
evidence of vaccine damage. The rate of the regression is, according to
reports, very much more rapid in these children and other specific problems are
described below. O ur own preliminary observations would seem to confirm the
view (Gail Gillingham - personal communication) that the incidence of problems
of movement and, in particular, gait, is higher with this group.
Measles Vaccine
The suggestion has been made that, in
some cases of autism, the measles element of the MMR programme could be a
significant factor. Evidence has already been published which links measles
particles with the greatly increased incidence of Crohns Disease wh ich has
been seen over recent years. Work is currently in progress to identify the
presence of these same particles in the lower intestinal walls of some people
with autism. If present, these particles would, certainly, increase the
permeability of the in testinal walls so that increased levels of gut derived
peptides would reach the blood stream and, ultimately, the blood brain barrier.
In those children where such a sequence of events is believed to have take
place, parents report a rapid and serious re action, within hours or at least
within 2 days, to the vaccine. Epileptic fits; coma; incessant screaming; rapid
loss of bowel function and control are all reported and this is concomitant
appearance or increase of autistic behaviours
Mumps Vaccine
In another, smaller, group of
subjects, the clinical picture is different. There is no sudden, rapid or
spectacular event but the child still loses abilities very soon after the MMR
injection. Although it may not have been mentioned initially, subsequent
questioning frequently reveals that there has been a quite serious illness some
weeks afterwards. Meningitis has often been mentioned but, in other cases,
although the indications are that such an infection has occurred no firm diagnosis
has been made. Oc casionally, such as in the case where one young boys
testicles still swell up from time to time, there is strong circumstantial
evidence for the causation of this meningitis being connected to the mumps
element of the vaccine.
Our suggestion is that the
disruption caused to the meninges which form an integral part of the blood
brain barrier is such that high levels of peptides which may be circulating in
the blood can now reach the CNS.
It is worth mentioning that such children
seem to do very much better than the majority of children with autism in the
comparatively short term. It is interesting to speculate that those children
who are reported as making spectacular recoveries might be from this group. It
may well be that, with time, the attenuated strain of mumps is eventually
eliminated by the immune system so that the meninges recover and the blood
brain barrier can operate as effectively as before. Whatever the form of
therapy being employed with such children will be credited with responsibility
for this cure.
The Use of Multi-Component
Formulations
There is little evidence, even
anecdotal evidence, that the older, single component vaccines, could result in
such problems as autism. Reports of such problems appear after the introduction
of the multi-component MMR vaccine (1988 in the UK). If these rep orts are
correct it would seem that it is this combination which is responsible for
these problems. Given the fact that the Measles virus is known to be
immunosuppressant, its inclusion in combination with other disease causing
organisms is, in any case, inherently problematic.
Perhaps the combination of the
effects on the gut wall (measles) and the blood brain barrier (mumps) are
necessary for these effects to become evident. It may be worthy of comment that
for one year (1994) after a scare about the safety of the mumps vaccin e, this
element was withdrawn from the mixture so that only the MR (Measles and
Rubella) elements were included. It has been reported by Dawbarns, the
solicitors working on behalf of children where vaccine damage is suspected,
that they have no cases wher e the MR mixture was employed. Although no data
exist in Spain (or in the UK for that matter), the leading diagnosticians in
that country are unaware of any cases of autism where any suspicion is attached
to vaccines. In Spain. The measles element is give n to infants at around 15
months of age. Rubella is given at around 13 years of age and the mumps
component is not given at all.
Conclusions
1. Suspicions about the role
of vaccines in the causation of autism exist and there is data which suggests
that these suspicions should be treated seriously.
2. A thorough investigation on the
safety and efficacy of the MMR vaccine is a matter of urgency.
3. The
principle of informed consent must be respected.
- Realistic and reliable guidelines
should be provided so that patients and physicians are
in a position to understand the
position. We always advise parents and others who request
advice to consult their General
Practitioner. We would, howev er, suggest that the following
factors be considered before a
decision is made.
- Is there a risk from the disease?
- Is the subject/patient likely to
react abnormally?
- Does the patient already have sufficient
levels of antibodies so as to render unnecessary
the administration of further doses?
- Would it be safer to delay the
process until the child is older? Is it necessary to
inoculate at such a young age?
- Could the risk be reduced by using
single vaccines rather than multiple component
products.
Ileo-colonic
Lymponodular Hyperplasia, Non-specific Colitis and Autistic
Spectrum Disorder in Children: A
New Syndrome? *
Andrew
Wakefield FRCS
Department of Medicine and
Histopathology
Royal Free Hosptial, London, UK
*
In association with the Inflammatory Bowel Disease Group, Royal Free Hospital
Article abstract taken from 1998
Conference Proceedings "Psychobiology
of Autism:
Current Research and Practice
Abstract
Aim: To investigate a consecutive series of
children for a new syndrome comprising chronic enterocolitis and autistic
spectrum disorder.
Patients: 30 children (mean age 6 years : range 3-10
: 28 male) were referred with a history of achievement of normal developmental
milestones followed by a loss of acquired skills, including language, plus bowel
symptoms - diarrhoea, abdominal pai n, and in some cases, food intolerance.
Methods: Children underwent gastroenterological,
neurological and developmental assessment including review of prospective
developmental records. Under sedation ileo-colonoscopy and biopsy, and in some
cases, MRI, EEG and lumbar puncture were perf ormed. Barium follow-through was
undertaken where indicated. Chemistry, haemotology and immunology profiles were
examined.
Results: Onset of behavioural symptoms was
associated, by the parents or referring physician, with MMR vaccination in 11
of the 30 children, and with measles infection in one additonal child, and
otitis media in another. All 30 children had signifi cant intestinal pathology;
this ranged from marked lymphonodular hyperplasia (29/30) to apthoid (2/30) and
linear (1/30) ulceration. Histology revealed patchy chronic inflammation in the
colon in 26 cases and reactive ileal lymphonodular hyperplasia in 2 5 cases,
but no granulomas. Two cases had ileal lymphonodular hyperplasia alone,
diagnosed on barium follow-through.
Conclusion: We have identified significant
gastrointestinal pathology in association with autistic spectrum disorders in a
selected group of previously, apparently normal children. The data provide
further support for a link between autism and the gut.
Reference: Wakefield et al (1998)
Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental
disorder in children. Lancet 351; 637-641. You can access the Lancet
online here ( registration is free).
View related abstract:
'Enterocolitis
in children with developmental disorders'
'Epithelial
damage in children with autism'
'Detection
and sequencing of measles virus'
New study findings linking
viruses and inflammatory bowel disease
Fresh doubts over the mass
vaccination of children for measles and mumps arose today with new suggestions
of a link between the viruses and serious bowel diseases.
Doctors at the Royal Free Hospital
in north London first provoked fierce controversy three years ago when they
suggested there might be a link between the measles, mumps and rubella jab
(MMR) given to children at 15 months of age, and the onset of autism and bowel
problems.
Now a new study by the hospital,
investigating the medical history of more than 7,000 people, shows that
children who catch measles and mumps within a short space of time have more
than a four-fold risk of developing Crohn's Disease, a serious and incurable
bowel disorder.
Although the children in the study
were naturally exposed to theinfections before MMR existed, scientists are
concerned that today's toddlers could suffer the same fate when they receive
modified forms of the viruses through the jab, which delivers three doses in
one vaccine.
The new study does not look at any
possible link with autism, but it is likely to be greeted with dismay by
Government ministers, who are concerned that many parents are still refusing to
have their children vaccinated.
In order to reassure the public,
the Department of Health is shortly to publish a study commissioned from a
group of experts, which has found no proof of a link between autism and MMR.
Health officials are concerned that
if hundreds of parents refuse to have their children vaccinated, there could
eventually be a measles epidemic,leading to children being braindamaged or even
dying. The number of parents taking their child for an MMR jab has fallen from
93 per cent to 87 per cent since the scare in 1995, and it is no longer
possible for families to have the vaccine in three separate doses.
The team at the Royal Free Hospital
has stressed that it is not anti-vaccination, but has concerns about the impact
of exposure to multiple viruses being given through jabs to children.
While the vaccines protect children
from the acute infectious diseases, there is concern that the strains could
interact with each other, to affect the immune system which in turn could
disrupt the gut. They saw no evidence that the single dose jab of measles is
linked to later bowel disease.
Dr Scott Montgomery, the
epidemiologist whose study is published in the journal Gastroenterology, said:
"For millions of years, human beings have been exposed to intense
infections, so our immune system has evolved to respond vigorously to them. But
as civilisation has progressed, living conditions have improved and the way we
meet viruses has changed. We encounter them in a much milder form, but
paradoxically, this appears to be a risk for diseases in later life. This is
the first strong evidence we have of a link between this unusual combination of
viruses and later development of bowel diseases. There is a long delay between
infection and subsequent disease so potentially you are looking at a timebomb."
The cause of inflammatory bowel
diseases, such as Crohn's disease and ulcerative colitis is uncertain, but it
is becoming increasingly common in younger people. By following the lives of everyone
born in one week in 1970 - some 7,000 individuals - Dr Montgomery was able to
look at all potential risk factors.
The only risk identified for
Crohn's disease was a close relationship between measles and mumps infections
between birth and the age of six, but particularly for those between the ages
of four to six who had the infection within one year. Children who caught both
infections before the age of three were seven times more likely to develop
ulcerative colitis, another inflammatory bowel disease for which there is no
cure.
Dr Andy Wakefield, reader in
gastroenterology, said: "We have described a unique pattern of disease
that was completely unexpected when we embarked on this study."
DEPARTMENT OF HEALTH
98/109
Tuesday 24th March 1998
MMR VACCINE IS NOT LINKED TO CROHN'S DISEASE OR AUTISM
Conclusion of an expert scientific seminar
A scientific seminar to review the
work of the Royal Free Hospital Inflammatory Bowel Disease Study Group was held
at the Medical
Research Council (MRC) yesterday. The
seminar was held at the request of Sir Kenneth Calman, Chief Medical Officer.
Sir Kenneth said:
"Based on the views of the
experts at the MRC meeting, and on previous material that I have studied, I
have concluded there is no
link between measles, measles vaccine
or MMR immunisation and either Crohn's Disease or autism.
"I strongly advise parents to
continue to have their children immunised with MMR vaccine, as presently
recommended, and I am
writing to all health professionals
with that advice.
"I am deeply concerned at
reports that some parents are not having their children immunised and therefore
want to stress that:
- MMR is a highly effective vaccine;
- based on the evidence presented at the MRC seminar
yesterday, there is no correlation between MMR and
measles-containing vaccines and Crohn's Disease or ulcerative colitis;
- there is no evidence that giving the component vaccines
separately has any benefit;
- giving the vaccines separately may even be harmful because
it would expose children and their contacts to these
serious diseases over a much longer period;
- no evidence was presented to suggest that MMR vaccination
gives rise to autism, but the age at which MMR is usually
given coincides with the age at which autism is often recognised: this does not
mean that one causes the other."
Sir Kenneth added that a better
understanding is needed of the causes of Crohn's Disease and of autism but
emphasised that he concluded
that MMR vaccine was not in any way
implicated in the cause of these conditions.
NOTES TO EDITORS
1. Sir Kenneth will
also send health professionals a summary of the topics discussed at the
meeting.
2. At the request of
the CMO the MRC convened a group of national and international experts,
including WHO, on 23 March to
consider
recent work on measles, MMR vaccine, Crohn's Disease and Autistic Spectrum
Disorder (ASD). The group included experts
in virology,
epidemiology, immunology, paediatrics, child psychiatry, autism,
gastroenterology and Crohn's Disease.
Unpublished
material was also examined.
[ENDS]
House of Lords debate on MMR
On Question, Motion agreed to.
11 Jan 1999 : Column 55
MMR Vaccine
5.58 p.m.
Lord Clement-Jones rose to ask Her Majesty's
Government whether the Department of Health plan to issue new guidance on MMR
(measles, mumps and rubella) vaccine in the light of new medical evidence and
litigation recently instituted against pharmaceutical companies manufacturing
the vaccine.
The noble Lord said: I initiate
this debate not so much as a Front Bench spokesman but more as the concerned
parent of a small child of 10 months with the need to take a decision on
whether or not to vaccinate in the next few months.
I wish to stress that I am not
anti-vaccination as such; but the more I have looked at the facts surrounding
the MMR vaccine, the more perturbed I have become. Many parents share my
concerns. There are now well over 1,800 families who have contacted solic itors
because they believe that their children have been permanently damaged after
being given MMR or MR vaccination. Of those cases, more than 350 have now been
investigated by the solicitors. The common factors are: first, that the parents
are convinced that their children were developing normally before taking MMR
vaccine; that the children were given the vaccine and that the children have
acquired physical injuries and/or disabilities after receiving the vaccine.
The injuries recorded include
conditions such as: autism, bowel problems, epilepsy, encephalitis, behavioural
problems, diabetes and multiple sclerosis. Autism is numerically the greatest.
The cost to society of caring for these injured children could be huge.
The original three MMR vaccines
were: Pluserix, Immravax and MMRII. They were introduced into the UK in 1988.
The Public Health Laboratory Service, when it first tested the vaccines, only
looked at three weeks' experience after receipt of the vaccination. Pluserix
and Immravax vaccines were hastily withdrawn in September 1992, following
evidence from research commissioned by the Department of Health and carried out
at Nottingham which, contrary to the Department of Health's expectations,
demonstrated a st rong link between the Urabe strain of mumps contained in the
former two vaccines and meningitis. MMRII, which contains the Jeryl-Lynne
strain of mumps, continued in use, but some 1,000 cases of injury appear to be
related to this vaccine.
In February 1998, an article in the
Lancet by Dr. Andrew Wakefield of the Royal Free Medical School and others
postulated, but did not--as they acknowledged--prove a link between
developmental and bowel disorders and MMR vaccination based on the study of 12
children.
The Department of Health shortly
thereafter held, under the auspices of the then Chief Medical Officer, Sir
Kenneth Calman, and Dr. John Pattison, a meeting of experts to review and
discuss available evidence. This included neurologists, paediatricians and
immunologists, including Dr. Wakefield.
11 Jan 1999 : Column 56
In its subsequent summary of the
meeting, the Department of Health gave the impression that the meeting
conclusively decided that no linking evidence between measles vaccine or MMR
immunisation and either Crohn's disease or autism had been found.
In fact, however, the evidence was
not treated as conclusive. The Medicines Control Agency set up a working party
to examine links between autism and MMR vaccine which is due to be published
shortly. The MCA clearly had genuine doubts, but did not share t hose doubts
with the general public at the time.
What is the medical evidence we
have so far? The most definitive study was carried out in 1994 for the US
Centers for Disease Control--the Vaccine Safety Datalink Project--which
monitored the progress of half-a-million children. Their key finding was that
the incidence of seizure increased dramatically, by three times the norm, after
MMR vaccinations. This was confirmed by a similar study carried out in the UK
by the Public Health Laboratory Service, but it was withheld until the 1994
vaccination campaign , Operation Safeguard, was over.
Research suggesting a link between
measles vaccine and acute encephalopathy was published by Robert Weibel and
others in paediatrics in the US in March 1998. The most recent published
evidence comes from the University of Michigan College of Pharmacy and has been
published in the peer reviewed journal Clinical Immunology and Pathology. It
was carried out by Drs. Singh and Yang and looked at a study of 48 autistic and
34 normal children and measured the levels of antibodies to measles virus. This
study sug gests that measles or MMR vaccines may in some way prompt some
people's immune systems to act in a negative way to brain tissue.
In research, which is currently
being prepared for publication, Mr. Paul Shattock, director of the autism unit
at the University of Sunderland, has discovered a peptide derived from food in
autistic children's urine. He postulates that the cause of the br ain damage of
all types to the children appears to be the lodging of measles virus in the gut
which causes inflammatory bowel disease. This allows the peptide to cross the
so-called blood-brain barrier and to affect neurotransmission, which leads to
the b ehavioural disorders mentioned.
All those studies, while not
proving a link beyond doubt, certainly provide powerful circumstantial
evidence. It appears to be only a matter of time before further virological
research proves the link. The fact is that our understanding of the immune syst
em, whether in connection with research such as this, or that carried out into
Gulf War syndrome, is still in its infancy.
The medical evidence is backed up
by home video evidence in many cases, which demonstrates the children
developing normally, talking, laughing and then suddenly, after the time of the
MMR vaccine being administered, demonstrating behavioural problems, lac k of
speech and interaction. The most common age to develop autism is between one
year and two years old. The videos show autism developing at much older ages.
11 Jan 1999 : Column 57
The guidance given to GPs on
vaccinations is contained in what is known as the Green Book: Immunisation
against Infectious Diseases. Guidance to the general public is given by the
Health Education Authority. The plain fact is that the dangers of mumps, me
asles and rubella have in recent years been consistently overplayed in recent
guidance and that the dangers of vaccination are underplayed.
Many of us had mumps, measles and
rubella as children, as a matter of course. In the literature of the time,
these were not described as serious or life-threatening diseases, but as being
likely to go away within 10 days, without serious ill effects. Cont rast that
with this extract from a Health Education Authority publication of 1994:
"Unfortunately, measles can be
much more serious than people think. School age children who get it are likely
to be very ill. Measles can cause pneumonia, blindness, deafness and even brain
damage. Measles can also be fatal. In fact it's the disease most likely to
cause inflammation of the brain".
Many people agree that the 1994
campaign--Operation Safeguard--undertaken by the Department of Health to
promote the specific MR vaccine grossly over-dramatised the dangers of mumps,
measles and rubella. The fact is that deaths and serious complications f rom
measles are not now common in developed countries. Current Health Education
Authority literature, MMR--The Facts, makes inadequate mention of the risks of
vaccination and is even misleading.
In some other cases, the Department
of Health has adopted the precautionary principle: animal growth promoters,
human albumen and general anaesthesia for dentists. However, rather than
adopting the precautionary principle here, they appear intent on promo ting the
vaccines in question. GPs are actually being given incentives to vaccinate
their patients. To receive an annual bonus, they need to exceed a minimum 70
per cent. immunisation rate in their practice. They therefore have a direct
incentive to reass ure parents to allow their children to be vaccinated with
MMR against a parent's better judgment.
The UK vaccine compensation scheme
is wholly inadequate. Currently, the 1979 Vaccine Damage Compensation Payment
Act only allows up to £40,000, the figure that was changed last year. It is
wholly inadequate to compensate for the costs of bringing up a dis abled child.
Initially, when the Act was first passed, claimants were limited to £10,000--an
even more inadequate sum.
There are many parents who may
believe that their child has been damaged by a vaccine, but compensation under
the Act is only available when that child is regarded as having its capacities
impaired by more than 80 per cent. Many of the children are now in their 20s
and 30s and are still being looked after by their parents. It is high time that
justice is done for them. We need a scheme which pays compensation on the level
with that in the US and Japan. In the US, over 1 billion dollars have been paid
out over the past 10 years under their no-fault scheme.
The Medicines Control Agency
receives reports under the yellow card scheme by which doctors, pharmacists and
coroners are meant to report adverse reactions to
11 Jan 1999 : Column 58
vaccinations. But there is evidence
that only 5 per cent. of adverse reactions are reported. Has the Department of
Health considered what improvements to the yellow card scheme could be made, to
make it work effectively? Even the Medicines Control Agency has admitted that only
a small percentage of even serious reactions gets reported. Some doctors appear
to be unaware of the system.
One of the key concerns of
campaigners is the fact that very little tracking is done of the incidence of
autism. Although about 350 cases are reported each year, there appear to be as
many as half-a-million children in this country with the condition. Yet this
cannot be confirmed by the Department of Health because it has no central
tracking system, so it is difficult to assess that there has been a growth in
autism across the UK. The fact remains, however, that from problem that was
perceived to affect o nly a small proportion of the population a decade ago,
there is now a huge number of cases in total which cannot be explained by
better diagnosis alone.
One of the key problems also
encountered by parents and others wishing to understand more about MMR and its
consequences is secrecy. The advice and recommendations of the Committee on
Safety of Medicines and the Joint Committee on Vaccination and Immunisa tion
are secret. Information held by them on cancellation of product licences is
commercially confidential. That is not so in the States. It is high time that
this was remedied by a freedom of information Act.
What can parents do now? As a result
of doubts about MMR and MR vaccines many parents seek to have their children
vaccinated with single vaccines. The experience of helplines in this area is
that many parents distrust MMR and believe that doctors are pres suring them to
accept vaccination to fulfil their targets. The experience of parents, however,
is that it is virtually impossible to obtain them in the UK except via
enlightened pharmacists and a friendly doctor. Parents have to sign a
disclaimer and even now they make trips to France to get their children
vaccinated.
In the face of the desire of
parents to obtain the single vaccine the statement in April by the then CMO
was:
"There is no evidence that it has
any benefit and indeed may be harmful".
This seems to be based on the fact that
children may have one injection a year rather than all in one go and are
therefore "at risk" of contracting mumps, measles and rubella for
rather longer. But how can the Department of Health explain the incredibly l ow
incidence of any problems with the single measles vaccine in the 21 years
before 1988? The UK appears to be the only EU country where single vaccines are
not available.
In summary, what do I seek in
initiating this debate? It is clear that a number of key steps must be taken by
the department. First, there must be much more balanced guidance from the
Department of Health to doctors and the public about the merits of the MMR
vaccine and the risks of mumps, measles and rubella. Secondly, there must be a
comprehensive programme of research to establish the links between MMR
vaccination and
11 Jan 1999 : Column 59
damage. Thirdly, a decision should
be taken by the Department of Health to allow GPs to prescribe single vaccines
for mumps, measles and rubella. Patients should not have to travel abroad or
get these vaccinations for their children privately. Fourthly, t here must be a
much better system for tracking adverse reactions to vaccines such as MMR
publicised so that parents are clearly aware of what they can do to report
problems. We need a comprehensive database of those children already believed
to have been damaged so that it can be analysed fully. Fifthly, there must be
an end to the secrecy of the Committee on Safety of Medicines and the Joint
Committee on Vaccination and Immunisation so that it is clear to the public
when there are problems with vaccines or the formulation of them is changed.
They should be championing children's health not commercial interests
Sixthly, there should be a major
improvement to the terms of the Vaccine Damage Payments Act so that the
compensation payable is higher and parents of vaccine-damaged children can
obtain compensation without having the current burden of proof which requir es
over 80 per cent. impairment. In addition, the levels of compensation paid out
to vaccine-damaged children to date should be reviewed. Seventhly, the
Department of Health should start immediate discussions to see if the current
litigation between the d rug companies and parents of children damaged by MMR
vaccines since 1988 can be settled with proper compensation to the children.
Eighthly, the department should cease giving incentives to GPs to immunise
using the MMR vaccine. I look forward to the Minis ter's response.
6.13 p.m.
Lord Winston: My Lords, I have
great sympathy with the noble Lord, Lord Clement-Jones. Some years ago I took
my febrile child to the casualty department of the Royal Free Hospital--the
same hospital from which Dr. Wakefield emanates. The child had just ha d a
convulsion having been vaccinated 24 hours earlier. I was convinced that I had
damaged the child. It was only afterwards that it became quite clear that the
viral infection that my child had had nothing to do with the vaccination but
had been picked u p three days earlier from contact with another infant. That
is exactly the problem here. We are looking at something that has been reported
in an extremely anecdotal fashion. While parents are quite justifiably worried
about vaccination, a close look reve als a great lack of evidence that there is
a serious cause for any concern.
These fears are extremely
reminiscent of those relating to pertussis vaccine in the early 1970s. When
pertussis vaccination in this country fell from about 81 per cent. to 30 per
cent., there was a great rise in whooping cough and in consequence children who
could have been saved died. This happened not only in this country but in
several others. In other countries the reduced coverage of this vaccine
resulted in a very serious crisis, with many children being lost who need
11 Jan 1999 : Column 60
not have died. There is a very
close parallel between what happened in the mid-1970s and what could happen if
we look at MMR vaccination in the wrong way.
The evidence relating to
inflammatory bowel disease and MMR was based initially on a study of women in
pregnancy. It showed that in pregnancy women who contracted measles were more
likely to give birth to children with inflammatory bowel disease. A larger
study showed that this was purely anecdotal and that there was no real evidence.
The studies by Wakefield published in The Lancet, which are the most crucial
ones in this area, probably should not have been published, certainly not in
the form of an earl y report. An early report is to an extent hypothetical.
In 1978 I published an early
hypothesis in The Lancet which turned out to be totally wrong. Very often The
Lancet is happy to publish preliminary data which may spark debate that
influences how people think about a particular medical situation. I believe
that the publication of Wakefield with regard to bowel disease contains so many
flaws in both the histological methodology--the way that bowel biopsies were
viewed through the microscope to see whether or not the virus was present--and
the selection of th e 12 children who were studied in this anecdotal report
that it might have been better to look at more comparative data. The truth is
that when that study has been repeated with a much more precise look at the
RNA--the molecular fingerprint of the virus-- we have not been able to find any
evidence of it in the bowels of children with Crohn's disease or inflammatory
bowel disorders.
Nor is there any clear evidence of
a link between autism and MMR. After all, MMR has been in use in the United
States for 25 years, with some 200 million doses of MMR having been given.
There is simply no evidence that autism has increased during that tim e. A
detailed study on this very issue which has taken place in Sweden has also
proved negative. Studies have been made to try to link both inflammatory bowel
disease and autism. These have also not shown any significant rise, which would
be expected in p opulations where this vaccine was in use.
I should like to quote from a paper
by Duclos and Ward published within the last three weeks in Drug Experience.
These people have no vested interest in this matter. This does not have a
financial aspect. I regret that a suggestion has been made that ther e may be
some financial motive behind the suggested need for vaccination. I am sure that
the noble Lord, Lord Clement-Jones, did not intend to say that. However, here
we are talking about the protection of children worldwide. Duclos and Ward say:
"During 30 years of worldwide use
measles vaccination has proven to be one of the safest and most successful health
interventions in the history of medicines. It is not a 'perfect' vaccine but
the benefits far outweigh the risks even in countries with a low incidence of
measles and a higher rate of measles vaccine coverage".
Let us consider the risks. If a
child has measles its chances of contracting otitis media, which can be very
serious, are between 7 and 9 per cent. With this vaccination, the chances are
nil. One's chances of getting pneumonia are between 1 and 6 per cent . With
vaccination, the chances are nil. The chances of getting
11 Jan 1999 : Column 61
diarrhoea are 6 per cent. but with
vaccination the chances are nil. With measles the chances of getting
encephalomyelitis are between 0.5 and one per 1,000 children, which is a very
high incidence. If one has the vaccine, the chances are one in 1 million. The
chances of getting thrombocytopenia--admittedly, a condition that results in
the loss of blood platelets temporarily--are nil with the infection and about
one in 30,000 with vaccination. The chances of getting an anaphylactic reaction
with the inject ion of any protein is a possibility, but it is not a very great
one and it has never been fatal.
The chances of death with measles
are something between 0.1 and 1 in a 1000 children. That is a very high incidence.
In the developing world the chance of dying from measles may be as high as
between 5 and 15 per cent. The chance with the vaccination is n il: no deaths
have been reported with vaccination.
I do not think that we should base
very serious medical decisions on anecdotal data. The noble Lord referred to
the meeting of the Medical Research Council, which included a string of experts
of great repute. He said that their findings were equivocal. Th e main
conclusions of the meeting were as follows:
"(a) That the balance of
available biological and epidemiological evidence was against
the persistence of measles in Crohn's
disease.
"(b) There was no correlation
between measles or mumps infection alone and Crohn's
disease or ulcerocolitis.
"(c) There was no current
evidence linking bowel disease or autism with MMR vaccine and
that there was thus no reason arising
from the work considered for a change in the current
MMR vaccination policy."
Two Scientists Debate MMR-Autism
Study - 1
Monday, June 14, 1999
["No MMR Connection to
Autism" is the conclusion of a hotly controversial study published last
Friday in Lancet. Two scientists who are connected to autism, Paul Shattock
from the Autism Research Unit, UK, and Judy Badner in the US discuss the study
and its weaknesses. This exchange, below in three parts,illuminates important
details on this controversial issue. Published originally on the SJU Autism
list.
INTRODUCTIONS
Paul Shattock: I work at the
University of Sunderland; am chairperson of ESPA and Hon Secretary of Autism
Europe. I am a supporter of Tottenham Hotspur and of Sunderland Football Clubs.
I am a member of the Abbey National Building Society but these interpretations
of the data are my own and may not reflect the views of the above.
Judy Badner: I am a psychiatrist
and statistical geneticist, affiliated with National Institute of Health (NIH)
and the University of Chicago. I am also intimately connected with autism (as I
know you are too, Paul) in avariety of facets of my life. My conclusions above
are my own and are not meant to represent any of the institutions I'm involved
with.
Commentary on Taylor B., Miller E.,
Farrington CP., Petropoulos M-C., Favot Mayaud I., Li J., Waight PA.
"Autism and measles, mumps and rubella vaccine: no epidemiological
evidence for a causal association" Lancet Vol 353 June 12th 1999 p
2026-2029
PS: The data from official records
are, as the authors admit, flawed. Given the limitations of the methodology and
their own acknowledgement of the fact it is pointless to add to the authors'
own comments. It was clearly collected with as much care and attention as
possible. No criticisms there.
Unfortunately, the actual numerical
data are not fully presented except in graphical form so it is difficult to
evaluate fully.
JB: Another problem with the
graphical data is that only the number of autistic individuals are presented.
In order to know whether there was a real increase in rate, the total number of
births in this region would have to be known. If the birth rate was static,
then there is a real increase for whatever reason. But if there was a lot of
population growth in this region, then the rate of increase is less than it
appears.
PS: I am pretty sure that any population
increase would be less that the 1,700% (or it could be 2,500%) increases in
levels shown in the "prevalence" figures for autism.
For those not able to obtain the
paper it is, therefore, difficult to picture these results but the incidence of
autism in this particular region appears to increase from a level of (about) 3
born in 1979 to (about) 50 born in 1992. Some might feel that this is a
dramatic increase. The authors accept that this could be a real increase in
incidence but that better awareness and diagnosis are very pertinent factors.
One must assume that before 1979
the "incidence" would be fairly static. In particular, it is unlikely
to drop below zero and so the line would be fairly horizontal (no data
presented). When we come to the children born in 1985 or 1986 the increase
begins and then it becomes very steep indeed.
The authors report that the
increase started before the MMR was introduced in 1988 and so was unrelated in
any way. Just think about it. Children born at the end of 86 and then from 87
would have been given no choice but to have the combined MMR vaccine. The
children born in 83 and 84 would have been given the injections separately as
was the custom here. What of those children born in 85 and 86? They would (and
did) have the monovalent measles vaccine at the usual time (13-15 months).
Then, a year or even two later, when they went back for their rubella and mumps
jabs what were they given? They were given the combined MMR vaccine. Thus the
beginning of the increase would begin earlier that the authors have stated.
The levels continued to increase
until 1992 (births). The authors maintain that the uptake of MMR was fairly
constant throughout that period UP TO THE AGE OF TWO. What of the children
(virtually all of them) who were given shots at age 3 and 4 as "catch up
or pre-school shots" and then became autistic? Would these not result in
an increase?
JB: The increase began before 1985.
To me it looks like there were 2 born in 1979 but I could accept 3. For 1985,
it looks like there were 8-9 cases. So, that is an increase in number of cases
of 3-4 fold. Now, without knowing the birth rate, it is hard to know what to
make of that but there was definitely an increase in number of cases before
even the earliest estimates of when the MMR was introduced. The problem with
picking a specific year to determine an increase is that there is a lot of
random fluctuations between years (which is generally what happens with data).
So, depending on the year that is picked, very different results can arise. The
number of cases in 1985 appears to be slightly decreased from 1983 and 1984.
Why? Who knows. From 1985 to 1986, the number of cases do appear to increase
from 8-9 to 12-13 but there is no or little increase in 1987 as compared with
1986 at a time of presuming increasing MMR coverage. Then there does seem to be
a steady increase from 1987 to 1990 (from 12-13 to 28-29) but is this really
different from the increase from 1979 to 1985 (pre-MMR)? That's really hard to
say. From 1990 to 1991, there is a plateau and then an increase from 1991 to
1992.
PS: I agree totally with your point
about based incidence figures on one year (1979) but that is precisely what the
authors have done. It would have been great to have a whole series of figures
as with the California study. The point is that, as far as reported prevalence
goes something happened around that time. Better identifications systems?
Change in vaccination policy? Mrs. Thatcher becoming Prime Minister? Who can
say? Incidentally, you try putting the California figures and the Lancet
figures on the same axes (but with different actual numbers). The similarities,
including the slight changes in slope with time are impressive. The Californian
rise started several years before the UK one though. When was MMR introduced in
California? It would be really useful to have those figures for before 1979 and
post 1992. Shame they were not reported. The authors describe (no figures
given) a drop subsequent to 1992 and ascribe this to problems in diagnosis.
This could, of course be true but it could also reflect the fact that the
British government withdrew the Urabe strain of mumps which had been available
up until this date and replaced it with the Jeryl Lyn strain because of
identified dangers with the Urabe strain. Time will tell - I really do not
know.
JB: Neither do I. But since higher
functioning forms of autism are diagnosed late frequently, it is not
unreasonable to assume that a younger group of children (born after 1992) would
have a lower rate of diagnosed autism.
PS: Got you on this one! They said
they included only those children diagnosed before the age of 60 months. The
data would, therefore, be as complete as any of it is.
UPTAKE OF THE VACCINE
Paul Shattock: The DoH makes great play
in their press release that there is "no difference in the immunisation
rates between those children with autism and the general population".
Given that the general uptake was about 95% this really is a bit silly.
(Incidentally, the Press Release also claims "no increase in autism since
the introduction of MMR in 1988". That would seem to be an absolute
contradiction of their figures but I assume it's an error.)
Judy Badner: It would be hard to
detect if the rate of immunizations among autistic children were significantly
increased over 95%. But there didn't seem to be any difference in percentage of
autistic versus non-autistic immunizations during the time that the number of
autistic cases was increasing.
PS: It may be worth commenting that
in 1987/88 (for some reasons the figures cover the tax year, April 1st - March
31st, rather than calendar year.) the authors report a 58% uptake in their
study (autistic) group compared to about 82% overall. Would that result in a
slightly depressed figure for 88?
JB: I suspect we agree more than
disagree on this. I agree that this study can't be used to prove that MMR is
never associated with autism. But of the data that is presented in this study,
I think there is little to support the hypothesis of MMR causing autism.
Actually, it is 1987 that has the slightly depressed figure, not 1988. And if
you're going to take into account children who were vaccinated after age 2,
then it is hard to know if whether there really was a lower uptake in the
autistic group. It could be that the vaccine was delayed in this group because
they were showing signs of autism.
PS: OK but why would MMR have been
delayed for this group when no suspicions had been raised about a connection at
this time?
JB: Because the MMR was a new
vaccine at the time and some doctors may not have wanted to give it to
neurologically impaired children until there was more experience with it. I'm
not saying this must be true and there really is no evidence for or against
this hypothesis. It just seemed odd that the rate of vaccination was so much
lower in the autistic group that year. The percentage of autistic vaccination
was about the same or decreased from 1988/89-1990/91 and yet the rate of autism
was increasing during this period.
PS: And all the children were
getting second shots at age 3-4. Some of the cases that are being taken to
court will be of this type. Pure coincidence by chance is going to be difficult
to prove in these cases. Just for the record. In those cases where this has
occurred after MMR 2, the regression is very very rapid (within 48 hours).
JB: But if there were no signs of
autism by age 3-4 and the children began showing autistic symptoms after that,
then they should not have been diagnosed as autistic since symptoms must be
present by age 3. Or is the diagnosis different in that respect in England?
PS: I do not believe that this is
the entire explanation for these increases. Other factors must be involved.
NO LINK IN AGE OF DIAGNOSIS AND
INTRODUCTION OF MMR.
PS: Could anyone actually believe that
there could be? In the UK, one makes an appointment with the physician when one
realises something is wrong. (S)he says "Stop worrying, boys are always
slow talkers - I knew someone who..... Come back in 6 months." Then you
get an appointment with a consultant who passes you to another one as no-one
likes to give you the news. The tendency here is not to diagnose until the
specialist is absolutely sure. Also, we tend to wait months (3-6) to get an
appointment anyway. This situation did not change in 1988 and the data really
are of no relevance whatsoever.
JB: Under this scenario, wouldn't
improved awareness of the different forms of autism and varying functioning
levels lead to increased number of diagnoses? If the specialist only diagnoses when
absolutely sure, having more knowledge would greatly increase the number of
diagnoses.
PS: Possibly but the authors were
claiming that because the age of DIAGNOSIS was the same before and after the
introduction of MMR this demonstrated that the MMR had no causative role. I
fail to see the link.
JB: It would be more accurate to
say that the data failed to demonstrate that the MMR had a causative role. A
correlation between age of onset (or parental concern) and age of MMR would
have been meaningful. A lack of correlation doesn't mean a whole lot.
AGE OF ONSET OF SYMPTOMS.
Paul Shattock: These data are taken
from written records. Rather unsurprisingly there are peaks at 18 months and 24
months. Parents and physicians would tend to speak in terms of half years as is
difficult to be precise from memory. No criticism there.
Judy Badner: This partially
explains the one significant finding they did have (parental concern at 6
months). Another explanation is a statistical one. The more statistical tests
you do, the more likely you are to find a significant finding. It's like
rolling dice. If you roll them enough times, you will get double sixes at least
once.
PS: Can't argue with that but.....
Supposing your child was vaccinated at 14 months. The symptoms become apparent
(according to our data) from one to 5 weeks later. (That is very severe and
dramatic behavioural regression). Shall we say 15 months? Our own data suggests
that around 10% of UK parents suspect MMR involvement in the causation.
Therefore, this 10% would reduce the overall 18 months figure (and that is all
they used) by 9 days. It would not show at all in these data.
JB: I agree if only 10% of autism
is MMR related, then it would be hard to notice a difference in age of
regression or age of onset. It would also be unlikely to cause the dramatic
increases in incidence rates that have been reported.
PS: Of our 2000 or so records post
1988 (in the UK) about 10% of the parents are adamant that this rapid and
dramatic behavioural regression occurred within (say) 30 days of the MMR. Some
of these parents could well be mistaken but by the same token, there are some
cases where the parents have not made the connection (in my opinion). I reckon
10% (5 - 15%) is about it for the UK. I have a nasty suspicion it is higher in
the US on account of your aggressive vaccination policies. Of course, our
sample base could be skewed but not by that much.
JB: Well, let's take the higher
figure (15%) and say that is the proportion of autism due to the MMR. I'm not saying
I believe or disbelieve that but this is just so I can play with the numbers
(I'm a geeky statistician, what can I say). This means that 85% would have
became autistic without the MMR. Therefore the maximum increase in autism due
to the MMR is 1/0.85 = 18% (total, not per year). That can't account for the
multifold increases that have been reported.
BTW, if over 90% of children are
vaccinated in England (I don't remember the exact figure), how much more
coverage can the USA have? I'm not sure access to basic medical care (including
vaccinations) is as equitable here as it is in England but I'm not terribly
knowledgeable about that.
PS: No-one is saying that all
autism is caused by MMR or any other vaccinations. We are suggesting that some
may well be and that it should be investigated appropriately.
JB: It is one thing to say that
small proportion of children may have an abnormal response to the MMR, just
like some people are allergic to penicillin and it is important to try to
identify these children before they are injured. It is another thing to say
that the MMR is a dangerous vaccine and shouldn't be given to anyone. That
would be like eliminating penicillin because a small group has a severe
reaction to it. Population studies like this are designed to refute the idea
that the MMR is dangerous to a large group of people. It is not designed to
determine if a small group has an abnormal reaction to the MMR.
PS: Precisely. It was a complete
and utter waste of time and money. Like all the other studies, it was set up to
disprove hypotheses that no-one has made. (See the Peltola study; the Fombonne
study and the Gillberg study - all of which are totally irrelevant.)
JB: But Wakefield did set up this
hypothesis by claiming, in a study that did not have the methodology to show
this because of the biased selection of cases, that the MMR caused autism in a
large percentage of cases. Although he didn't say it in his paper, he has been
quoted as saying it would be better if all children received monovalent vaccines,
not just children at risk. He has not published any data that supports these
conclusions. I agree that the Peltola study was not relevant. I'm not sure what
Fombonne study you're referring to and I haven't read the Gillberg study yet.
PS: You must remember that in the
UK, monovalent measles vaccine is not a viable option because it has been
withdrawn. If you already had one child with autism would you not prefer to use
the monovalent measles vaccine for subsequent children?
JB: Well, since my niece's autism
shows no relationship to the MMR (or other vaccines), no, I wouldn't have
preferred that her younger sister received monovalent measles vaccine. But had
my autistic niece a severe reaction to the vaccine, then I would have felt
differently. But offering monovalent vaccines to the small proportion of
families that have severe reactions to the MMR is not going to have the same
public health consequences as giving them to everyone who reads a sensational
news story and believes their child is definitely going to become autistic if
the child gets an MMR.
PS: I cannot agree with the
"conclusion" contained in the press release (from the authors) which
states; "We concluded that MMR vaccine does not cause autism." OK, it
did not say that in the actual research paper but that is the authors own press
release. They issued that statement. That is how it is used by the Department
of Health and the medical policy makers I am afraid. that was partly what I was
objecting to. In our local paper there is a headline which says
"Sunderland scientist says information was "manipulated" to
reach conclusions." That is not what I said but, unfortunately, that is
what the perception will be.
JB: Well, that is why I'm somewhat
cynical about news reports. I realize that you weren't quoted in a press
release but I've seen press releases get it wrong too. Remember the press
release about Robert Cade's study that said eliminating milk would cure autism
and schizophrenia? I really doubt that Cade said or intended that. So, when a
press release says something quite different from what the paper said, I tend
to doubt the press release. Press releases about studies in my own field
(genetics) make me crazy because they almost always overstate the findings in
the study. I agree that this [MMR vaccine does not cause autism]is an
inappropriate conclusion. Unfortunately, press releases rarely include all the
caveats in the original study. The conclusion of the actual paper stated:
"Our results do not support the hypothesis that MMR vaccination is
causally related to autism, either its initiation or to the onset of
regression--the main symptom mentioned in the paper by Wakefield and
others." This is a much more conservative conclusion. It does not say that
because they did not find an association, one cannot exist.
PS: This conclusion is not
appropriate to these studies. No-one is saying that these studies demonstrate
that there is a cause and effect relationship but there is not one piece of
evidence which refutes such a connection.
Questionning
the reliability of the studies suggestive of no link between autism and MMR
[Letters
from Vol. 354 No. 9182 11 September 1999 Lancet
Correspondence-MMR vaccination and
autism are addressed to peers and are technical. Lancet is a British medical
journal. Thanks to Ray Gallup.]
http://www.thelancet.com/newlancet/reg/issues/vol354no9182/menu_NOD12.html
Sir--Two
reports (1,2) were published on the same day from which the medical community
and the Department of Health felt able to reassure parents about the safety of
the MMR vaccination, and Jeremy Metters, deputy chief medical officer,
proclaimed bravely "the fact is, MMR vaccination does not cause autism or
Crohn's disease". (3) From the published evidence any link between the
vaccination and autism would seem tenuous at best. However, the data [presented
in the report by the Committee on Safety of Medicines (CSM) (2) working party
does not add anything of value to the debate surrounding MMR and Crohn's
disease. That study seems to be well conceived and
proficiently conducted, but by their
own admission "there were marked limitations in {the study} group"
notably an unavoidable "bias in the selection of cases....and the lack of
any control", resulting in intrinsic limitations as regards assessing {the
data}". (2) However, they still
concluded "that the information
available did not support the suggested casual associations or give cause for
concern about the safety of MMR or MR vaccines". (2)
Drawing such
a definitive conclusion on the basis of tenuous data is at best poor scientific
method, and at worse could be construed as misleading the public. The available
molecular evidence discounting a casual role for persistent measles infection in
Crohn's disease is more than sufficient to allay the fears of parents, and it
is this body of evidence that should be highlighted by the Department of Health
following the example set by the Center for Disease Control and Prevention in
Atlanta, USA.
In their
commentary accompanying the publication of Taylor and colleagues' (1) and the
CSM reports, Frank DeStefano and Robert Chen (4) believed that the two new
reports would attract minimum media coverage by contrast with the media frenzy that
followed the publication of a report suggesting an increased risk of
inflammatory bowel disease among individuals who had naturally acquired measles
and mumps within 1 year of each other. (5) They complained that although
Montgomery et al make no mention of MMR, the media suggested it was important
in the MMR/Crohn's debate. To again draw attention to a possible MMR/Crohn's
link was by no means unreasonable since the attentuated viruses in the vaccine
cause mild doses of their diseases in order to elicit an immune response.
We would
serve both the scientific community and the general public more if we
concentrate on scientific research based on sound data, and addressed the new
concerns such as those raised by Montgomery and colleagues, (5) in a more
appropriate fashion.
Gwyndaf T
Roberts
------------------------------------------------------------------------
Dafarn Gorniog, Llannor, Pwllheli,
Gwynned LL53 5UN, UK
1. Taylor B, Miller E, Farrington
CP, Petropoulos M-C, Favot-Mayaud I,
Li J, Waight PA. Autism and measles,
mumps, and rubella vaccine: no
epidemiological evidence for a casual
association. Lancet 1999; 353:
2026-29.
2. Medicines Commission
Agency/Committee on Safety of Medicines. The
safety of MMR vaccine. Curr Probl Curr
Pharmacovigilance 1999; 25: 9-10.
3. Hall C. Link between autism and
MMR dismissed. The Electronic
Telegraph
(http://www.telegraph.co.uk). Friday, June 11, 1999: 1477.
4. DeStefano F, Chen RT.
Commentary: negative association between MMR
and autism. Lancet 1999; 353: 1987-88.
5. Montgomery SM, Morris DL,
Pounder RE, Wakefield AJ. Paramyxovirus
infections in childhood and subsequent
inflammatory bowel disease.
Gastroenterology 1999; 161: 796-803.
* * *
Letter From Dr Andrew Wakefield
http://www.thelancet.com/newlancet/reg/issues/vol354no9182/menu_nod12.html
Sir--Hypothesis testing and presentation of the outcome--either positive or
negative--is a fundamental part of the scientific process.
Accordingly we have published studies
that both do (1) and do not (2) support a role for measles virus in chronic
intestinal inflammation: this is called integrity. The latest of these studies
was strongly positive (3) and was accepted by the MRC Review in February, 1998.
By contrast, Brent Taylor and colleagues (June 12, p 2026) (4) have ignored the
rules. They are inappropriately didactic in their conclusions, despite the
weakness of their method and the contradictions in their data. A case-series
analysis is unlikely to identify a relation between exposure and disease, in
which the onset is insidious and in which, very often, there is diagnostic
delay.
Taylor et al
tested the hypothesis that there should be no temporal clustering of first
parenteral concerns with measles, mumps, and rubella (MMR) vaccination. They
identified a statistically significant excess risk by 6 months after MMR, which
they dismiss, post hoc, as indicating parential recall bias. Had this been the
case it should have been seen in both of their vaccine groups--those receiving
MMR and those receiving any measles-containing vaccine. The excess risk was
seen only in the MMR group; this is a fundamental flaw. In 1998 the expected
numbers of newly diagnosed autistic children in California should have been
105-263 cases, according to DSM-IV; the actual figure was 1685 new cases. The
temporal trend in north-west London is almost identitical, although the rise is
delayed by about 10 years. The two countries use the same diagnostic criteria.
The sequential trends are consistent with the timing of introduction of MMR to
both regions. * Data from Departmental
of Developmental Services, 1987-98 (www.dds.ca.gov).
However, it
pales into insignificance compared with their failure to declare the fact of an
MMR catch-up campaign that was initiated in 1988 with the introduction of this
vaccine. This campaign was targeted at children, whatever their age, who
presumably had not received monovalent mumps or rubella vaccine whatever their
exposure status. As such it was a novel and, in terms of safety, untested policy.
On the basis of Taylor and colleagues' inclusion criteria, and taking account
of the catch-up campaign, then those first birth cohots who actually received
MMR (circa 1986) were precisely those in whom a doubling of the numbers of
cases of autism were seen.
Thereafter these numbers continue to
increase strikingly. Omission of this essential fact--the catch-up
campaign--requires explanation lest it be misconstrued.
Can the
dramatic increase in autism be ascribed to change in diagnostic practice? Data
from the recent California report from the Office of Developmental Services
belie this contention. The figure juxtaposes the data from California with
those from north-west London. Identical temporal trends are shown, with the
rise in autism from a steady baseline value, coinciding with the introduction
of MMR vaccine as the single strategy in both countries that use the same
diagnostic criteria for autism.
These data
expose the danger of not only setting out to prove, rather than to test, hypothesis
but also presenting the data whether they are supportive or not. The full story
has yet to unfold. In a timely BMJ newspiece, (5) Begg who is described as a
leading virologist, calls for MMR
research to be terminated on the basis
of Taylor and co-workers' report and a non-peer-reviewed so-called analysis in
Current Problems of
Pharmacovigilance. Clearly there are
some things that may end-up being terminated as a consequence of these events:
research into the possible link between MMR, autism, and bowel disease is not
one of them.
Andrew J
Wakefield
------------------------------------------------------------------------
Departments of medicine and
Histopathology, Royal Free and University
College Medical School, Hampstead,
London NW3 2PF, UK
1. Lewin J,
Dhillon AP, Sim, R, Mazure G, Pounder RE, Wakefield AJ.
Persistent measles virus infection of
the intestine: confirmation by
immunogold electron microscopy. Gut
1995; 36: 564-69.
2. Chadwick
N, Bruce IJ, Schepelman S, Pounder RE, Wakefield AJ.
Measles virus RNA is not detected in
inflammatory bowel disease using hybrid
capture and reverse transcription
followed by polymerase chain reaction. J
Med Virol 1998; 70: 305-11.
3. Montgomery
SM, Morris DL, Pounder RE, et al. Paramyxovirus
infections in childhood and subsequent
inflammatory bowel disease.
Gastroenterology 1999; 116: 796-803.
4. Taylor B,
Miller E, Farringdon CP, et al. MMR vaccine and autism: no
epidemiological evidence for a casual
association. Lancet 1999; 353:
2026-29.
5. Bower H.
New research demolishes link between MMR vaccine and
autism. BMJ 1999; 318: 1643.
ALL
INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR
GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE
KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED
AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO
VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU
ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.