MMR vaccine introduced into UK vaccination schedule 1988:
Three brands of MMR vaccination were introduced into the UK childhood
vaccination programme in October 1988. The vaccines were heralded as a
one-off, life-long immunisation against three serious diseases, measles,
mumps and rubella. The manufacturers' were SmithKline Beecham, brand name
Pluserix , Merieux, brand name Immravax and Merck Sharpe, Dohme, brand name
MMRII.
SmithKline Beecham and Merieux used Schwartz strain measles, Wistar RA27/3
strain rubella and Urabe AM9 strain mumps. Merck Sharpe Dohme used Enders'
Edmonston strain measles, Wistar RA 27/3 strain rubella and Jeryl Lynn
strain mumps.
JABS group founded in 1994 as serious vaccine problems were reported:
When the JABS group was founded in January 1994 parents contacted us with
their concerns about their children's serious ill health following childhood
vaccinations. We asked parents to complete questionnaires on the vaccines
given and to describe in detail their children's experience.
We were astounded by the responses. Parents stated the number of days after
MMR vaccination when their children had started to become ill and in many
cases the number of days quoted were consistent with the incubation period
of the vaccine viruses given. Many of the symptoms described were listed in
the vaccine manufacturers' own product sheets.
The parents reported that their children had suffered serious consequences
after the initial symptoms and had not recovered to the health point they
had had before the vaccination was given. The most remarkable aspect of this
is that the long term serious health problems that the children now have
were also, in the main, listed in the same drug product sheets as the 'rare'
events known to be associated with the vaccine.
The UK adverse event surveillance system - 'yellow card':
We asked each family if their child's doctor or consultant had reported the
symptoms and change in the child to the UK's Committee on Safety of
Medicines, using the adverse events surveillance mechanism known as the
'yellow card' scheme. The vast majority responded that the health
professional had declined to use the reporting system as he/she had
dismissed the link with the vaccination as 'just a coincidence'. Therefore,
the suspected reactions had not been put forward to the central body for
detailed investigation.
In theory the system should work to flag up any serious problems with drug
products - the guidelines note that all suspected reactions should be
reported. In practice the system was largely ineffective because health
professionals made their own arbitrary decisions on whether to report the
problems.
The Health Protection Agency in its former role as Public Health
Laboratory's Service is on record in the Lancet (Vol. 345. March 4, 1995)
stating ''....there is an urgent need to find more reliable methods of
adverse event surveillance.'' The point being that unless all reactions are
put forward to a central body instead of being dismissed as ''unrelated'' or
''just a coincidence'' the central database will never hold accurate
information on adverse events. How many coincidences are needed before it
becomes meaningful enough to warrant scientific, clinical investigation?
Investigations:
Families have urged their medical practitioners who are dealing with their
children's problems to investigate the suspected connection with the
vaccinations. Some parents have also reported that the doctor/consultant was
not interested in finding the reasons for the child's ill health, stating
that their role was to treat the problem and, therefore, they did not want
to be involved in this aspect.
During the course of the JABS group investigations we have discovered that
the UK pre-introductory trials for MMR were inadequate in that they failed
to follow up adverse reactions for more than just a few weeks. Serious
degenerative conditions are known to take weeks and/or months to develop.
Withdrawn MMR brands:
Proof of inadequacy is in the knowledge that it took the Department of
Health four years to identify problems and withdraw two of the three
original MMR brands that had been introduced into the UK vaccination
programme in 1988. These two brands, Pluserix and Immravax were withdrawn
by September 1992 because they contained a mumps strain known as Urabe which
had caused mumps meningitis in some children. Many of the badly affected
children known to JABS have had these brands of MMR. It is also of concern
that this problem must have been known by the UK's Department of Health
Chief Medical Officer: The licence for the MMR vaccine containing the Urabe
strain in Canada was revoked from May 1990. In Japan it was banned in 1993.
A version of this vaccine made by Chiron was also withdrawn from use in
Italy in March 2006.
Drug manufacturers' product sheets:
The drug manufacturers of MMR vaccines have provided the Government's
vaccine policy makers with product sheets which list the adverse reactions
known to be associated with their vaccines. These lists are virtually
identical from each of the drug companies. They state the minor side effects
which doctors are happy to describe to parents: namely - rashes, raised
temperature etc. These same sheets also state reactions only recently
acknowledged in public by the Health Protection Agency e.g. febrile
convulsions, blood disorders (ITP). The information sheets also state the
severe adverse events: to name but a few - diarrhoea, nerve deafness,
arthritis, Guillain-Barre syndrome (a paralysis syndrome), severe vision
problems, seizures and encephalitis. Encephalitis (inflammation of the
brain) can lead to a range of disabilities such as epilepsy, loss of speech
and communication and acquired autism.
Responsibility for vaccine damage:
Richard Ley, of the Association of British Pharmaceutical Industries said in
the Daily Express (May 18 2000): 'The Government implemented the
vaccination programme knowing in full detail what the possible side-effects
were. They knew what they were taking on, the damage is therefore their
responsibility and they should compensate people accordingly.'
The MMR vaccine contains three live attenuated viruses; their major
disadvantage is a danger of reversion of the virus strains to more reactive
and virulent forms. In plain terms, if the wild virus can cause inflammation
in the brain, joints, spine, eyes, ears and bowel then so can the
vaccine-virus and to quote an extract from a letter published in the Times
(February 9 2002) from Dr David Hall, President of Royal College of
Paediatrics and Child Health : 'Some children develop encephalitis (brain
swelling) when they catch measles, mumps or rubella viruses and may be left
with a variety of handicaps, including physical and mental impairment,
deafness, internal organ damage and autism.....'
Raising the issues with UK Government Minister and Health Chiefs:
In October 1997 Dr Andrew Wakefield and Professor Walker-Smith from the
Royal Free Hospital, London, JABS and its legal representatives, took part
in a meeting with the then Health Minister, Tessa Jowell, also the Chief
Medical Officer, Principal Medical Officer and others. During the course of
the one hour meeting a full list of children, then affected, was presented.
We asked that the Government should instigate a scientific investigation of
the children believed to have been damaged which could have been useful on
at least two fronts:
i. To answer the question of MMR safety.
ii. If the vaccine was found to be causing harm it may have been possible to
identify ''at-risk'' groups which may have led to a screening programme with
the potential to have improved vaccine safety for all children
The Health Minister at the time stated she was willing to look at all
scientific evidence but as parents it is very difficult for us to produce
this. That is why we believe the current claims by the vaccine policy-makers
that there is no scientific evidence to show the MMR vaccine is unsafe will
continue to be made. Until the Government instigates a full investigation of
the children believed to have been damaged, the ''scientific evidence''
required by the Department of Health is unlikely to emerge.
Vaccine Damage Payment Act 1979:
The Government is well aware that vaccines sometimes cause severe damage;
there is a branch of the Department of Social Security known as the Vaccine
Damage Payment Unit. It was set up in 1979 following the Vaccine Damage
Payment Act 1979. MMR vaccine damage payments have been awarded for various
adverse effects including: epilepsy, Guillain-Barre syndrome (a paralysis
condition), SSPE (a brain-wasting condition), neurological problems,
profound deafness and death.
Some of the children who received payments are detailed in the following
article: Click here
US experience:
Any debate on vaccine damage will have Department of Health officials
quoting the massive number of doses given to children in the United States.
What is never stated by UK officials is that in the US they have a National
Vaccine Injury Compensation Programme. In the last 18 years this programme
has paid out hundreds of millions of dollars in payments to vaccine damaged
children of which a 14% share has been paid out for MMR or its components.
The drug companies have to contribute to the programme and up to August 1997
they had to pay an excise tax on each dose using a risk-based formula. The
DTP and MMR were taxed at $4.56 and $4.44 respectively, polio vaccines at
$0.29 and DT (diphtheria/tetanus) vaccines at $0.06. This must surely give
an indication of which vaccines carry the highest risk of a serious adverse
reaction.
The problems associated with childhood vaccines are also being reflected in
the United States as has been reported on the JABS web pages and on US
sites: Click Here
Japanese experience and compensation:
The MMR vaccine was introduced into the Japanese health programme in April
1989. Shortly after its introduction Japanese parents started to complain to
the authorities that their children were suffering severe neurological
damage. The Japanese Government failed to act. Many parents started to
reject the MMR vaccination for their children and the Japanese Government
continued to ignore public concern. Outbreaks of measles then occurred and,
unfortunately, it was the most vulnerable group in society, babies under
twelve months of age and too young to receive a measles vaccine, that were
hit hardest and 69 deaths were recorded.
The Japanese Government banned the MMR vaccine in 1993 and introduced a
policy of separate measles and rubella vaccines. (The single Urabe mumps
vaccine would not have been accepted as it had been held responsible for the
neurological damage when combined in the Japanese MMR vaccine.) The Japanese
MMR court cases were heard in March 2003. Over 1,000 children were awarded
MMR damages against the Japanese Government and the Research Foundation for
Microbial Diseases at Osaka University in Suita, Osaka Prefecture.
MMR and Autism:
The statement that the health secretary, John Reid, made on GMTV in November
03: "It is unequivocal that there is no evidence at all that MMR is linked
to autism." needs to be challenged. World experts in the field of virology
and pathology have replicated results found by Dr Wakefield's team when he
was at the Royal Free Hospital, London and other independent Japanese
scientists have also duplicated the findings. (Ref. 1 below)
Children who have developed autism, epilepsy and other neurological
conditions were progressing normally before they were vaccinated, had passed
all milestones and had acquired skills appropriate to their age.
* They did not simply fail to progress; they actually regressed,
losing skills which they had already attained. In many instances this is
borne out by videos taken of the children before and after they were
vaccinated.
* They showed other physical changes at the time that they became
autistic (such as sleep patterns, appetite changes, temperature control etc.
in addition to many of them suffering bowel problems).
* The development of autism and other conditions are closely linked in
time to the administration of the vaccine. The onset of this condition
generally started within about a month of vaccination whenever the
vaccination took place. In other words, it would be later for children
vaccinated at 18 months than those vaccinated at 12 months. On top of that,
a substantial proportion of the children had an immediate reaction to the
vaccination, and the change which came over them dates directly from that
reaction.
For more information on MMR, Thiomersal, Autism connection please refer to
the home page of JABS (www.jabs.org.uk <http://www.jabs.org.uk> ) and
http://www.putchildrenfirst.org/
MMR Legal Cases:
Unfortunately, the UK MMR victims had their legal aid stopped just six
months before the cases were to be heard at the High Court in April 2004. In
some cases legal aid had been provided for nearly ten years to children with
wide ranging health problems including autism, epilepsy, loss of speech and
communication skills, chronic arthritis and deafness.
Each family had to personally apply to try and prevent their child's legal
aid certificate from being discharged. In the interest of justice, these
children deserve to have the issue of MMR safety resolved in court and for
this reason families need the help of legal aid.
* Many parents believe that the withdrawal of legal aid prior to the
court cases being heard was another way to delay or prevent access to
justice for vaccine damaged children. The families' representatives were
able to present to the legal aid appeal committee (the Funding Review
Committee) evidence not only that measles virus had been found in cerebro
spinal fluid (CSF) taken from three out of six of the test cases, but also
that it had not been found in 19 out of 20 controls. If the measles virus is
in the CSF then it must almost certainly be in the brain. Bearing in mind:
* that these children, like all autistic children, suffer from a form
of brain damage,
* that measles is known to be able to cause brain damage and
* that no other cause of autism has been suggested for the
overwhelming majority of the families involved
Adding to the stress of this situation, one of the MMR drug companies had
sent some parents a letter offering not to seek costs against the child or
them if they signed an undertaking "not to issue any further proceedings
arising out of vaccination with MMR against them in this or any other
jurisdiction''.
The MMR court cases were and still are vital not only to the families
involved in the pursuit of justice for their children, but for all parents
who are concerned about whether the vaccines they are giving their healthy
children are safe. JABS believes the Government can no longer claim that MMR
is the "safest way to protect your child" as they have denied the parents an
opportunity to have all the information out in the open and heard properly.
Until the evidence is formally presented in court the question mark over the
issue remains.
At the moment (April 2006) a small number of parents have had MMR legal aid
certificates re-instated for their children. Also, ten families who lost
their appeal plan to take their children's cases to the European Court of
Human Rights.
Single vaccines:
The Government's Chief Medical Officer needs to reconsider the availability
of single dose vaccines as a matter of choice. If there is a potential for
measles epidemics they must provide a real choice for those parents who have
lost confidence in the combined MMR but still want to vaccinate against the
separate illnesses. It should not have to be MMR or nothing situation.
It does not require new legislation it just needs the Department of Health
to place orders with the drug companies currently supplying the UK market
with the MMR vaccines.
When the MMR vaccine was introduced into the childhood vaccination schedule
the doctors' Green Book, 'Immunisation against Infectious Disease' clearly
stated: 'MMR vaccine will replace measles vaccine in the second year of
life, or after this age if appointments have been missed. For children whose
parents refuse MMR vaccine, single antigen measles vaccine will be
available.' (Page 60, 10.2 Recommendations) Reference to this choice
appeared in the 1988, 1992 and 1996 editions of this book. Why has this
option been quietly removed without explanation?
Cochrane Review:
A study by the respected Cochrane Library (October 2005) has said, on the
basis of 31 pieces of research into the possible side effects of MMR, that
it found no association between MMR, autism, Crohn's disease and long-term
disability.
The Department of Health is hailing it as another 'final nail' in the MMR
controversy but there is another side to this that they have missed.
Since the MMR vaccine was introduced in 1988 many parents have complained
publicly that they believe their children have been seriously damaged by MMR
vaccine. Each time the Department of Health have cited many reports as being
conclusive proof that the vaccine is both safe and effective. It is
important to note that the authors of the Cochrane Review have scrutinised
5,000 related studies and in this context found the majority lacking. Only
31 of the 5,000 studies were thought to "possibly fulfill their inclusion
criteria".
The Cochrane Review is a significant piece of work because it actually
exposes all the 5,000 related studies as being inadequate in some way, as
all fail to find any link with long-term disability for which compensation
has been paid or acknowledged by the vaccine manufacturers in their own
product sheets.
Of course the MMR vaccine is responsible for long-term disability in some
children. All drug products have the potential to cause both minor and
serious adverse reactions one has only to read the manufacturers' product
information sheets to be aware of this.
Vaccine damage, and in this case, MMR vaccine damage has been recognised by
Governments, three examples are:
1. The US Government has a National Vaccine Injury Compensation Programme
and 14% of all claims have been paid out to children damaged by MMR
vaccination.
2. The Japanese authorities have paid out substantial compensation to
parents of MMR vaccine damaged children after a successful court case in
March 2004. (There is an on-going UK case.)
3. The UK Government has a Vaccine Damage Payment Unit which has paid out
hundreds of thousands of pounds to children affected by childhood vaccines
including MMR vaccine.
Many children who suffer adverse reactions are individually assessed by
Government doctors panels. These panels determine the reported adverse event
and association with vaccination (known to the manufacturers) and make
recommendation for compensation for the individual. The criteria used is
extremely high and compensation awards are not made lightly.
For the medical authorities now to conclude that this review gives the MMR
vaccine a clean bill of health does a great injustice to all those children
who have been awarded vaccine damage payments by ignoring their existence.
It will also bolster those that sustain the failed passive vaccine reaction
surveillance system which continues to ensure very few reactions are put
forward or recorded in medical data. It is this poor data that was used in
many of the reports reviewed by Cochrane which they identified as
inadequate. Therefore a continued cycle of failure by the medical
authorities to identify and reduce vaccine adverse events in children will
be assured.
For the Department of Health to continue trying to convince parents, many of
whom have family and friends with children believed to have been affected by
MMR vaccine, exposes them to being blind to the reality.
World Health Organisation (WHO) - Causality of Adverse Events:
"Since the inception of vaccination, it has been recognized that adverse
events following immunization (AEFIs) will occur." (Ref. 2 below)
The WHO gives criteria to be considered when an adverse event is reported:
1. Consistency.
The association of a purported adverse event with the administration of a
vaccine should be consistent, i.e. the findings should be replicable in
different localities, by different investigators not unduly influencing one
another, and by different methods of investigation, all leading to the same
conclusion(s).
As already mentioned problems following MMR vaccination have been reported
and accepted in Japan and the United States. A report from Finland described
the immunization of 1.8 million individuals and gave rise to 173 potentially
serious reactions claimed to have been caused by MMR vaccination. In all, 77
neurologic, 73 allergic and 22 miscellaneous reactions and 1 death were
reported. (Ref. 3) Furthermore most of these cases were not followed up for
more than a few weeks. And this Finnish study "did not examine the
relationship of MMR and autistic spectrum disorders.....and does not
therefore provide useful evidence on this point." Medical Research Council
December 2001.
2. Strength of the association.
The association should be strong in the magnitude of the association (in an
epidemiological sense), and in the dose-response relationship of the vaccine
with the adverse effect.
JABS has been contacted by thousands of families who believe their children
have suffered severe damage or have died following the MMR/MR vaccination.
In the main, doctors cannot give any other medical explanation for the
child's deterioration or death. It must be remembered that many of the
children have been given the now withdrawn Urabe containing MMR vaccines
which were known to cause inflammation of the brain. Furthermore, many of
JABS children shared the same batches of MMR vaccine and subsequently
suffered the same long term effects.
3. Specificity.
The association should be distinctive and the adverse event should be linked
uniquely or specifically with the vaccine concerned, rather than its
occurring frequently, spontaneously or commonly in association with other
external stimuli or conditions.
The three viruses, measles, mumps and rubella, are known to be linked with
the children's conditions in their wild state. The vaccines contain the live
viruses.
4. Temporal relation.
There should be a clear temporal relationship between the vaccine and the
adverse event, in that receipt of the vaccine should precede the earliest
manifestation of the event or a clear exacerbation of an ongoing condition.
For example, an anaphylactic reaction seconds or minutes following
immunization would be strongly suggestive of causality; such a reaction
several weeks after vaccination would be less plausible evidence of a causal
relation.
A substantial proportion of the children had an immediate reaction to the
vaccination, and the change which came over them dates directly from that
reaction.
5. Biological plausibility.
The association should be coherent; that is, plausible and explicable
biologically according to known facts in the natural history and biology of
the disease.
The viruses are known to be linked with the health problems when caught as
the wild diseases. The vaccine manufacturers' acknowledge this by recording
these problems as the 'rare' adverse events associated with their products.
Many of the children have had a variety of medical tests and examinations to
rule out other causes.
The WHO continues with:
a. The requirement for biological plausibility should not unduly
influence negatively a consideration of causality. Biological plausibility
is a less robust criterion than the others described. If an adverse event
does not fit into known facts and the preconceived understanding of the
adverse event or the vaccine under consideration, it clearly does not
necessarily follow that new or hitherto unexpected events are improbable.
Biological plausibility is most helpful when it is positive; it is less so
when negative.
This is an important statement as it makes it quite clear that just because
something has not been recognized as linked with the vaccine in the past
doesn't mean it isn't linked. This supports our concern that with the
failure of the post-vaccination adverse event surveillance system to collect
data on unexpected reactions and therefore a failure to investigate them
could be allowing a serious problem to go undetected.
This could lead to a catch 22 system; because the problem hasn't been linked
with MMR vaccine before, further reports of the same problem are not put
forward because they are not known to be linked with the MMR vaccine.
b. Consideration of whether the vaccine is serving as a trigger
(trigger in this context is an agent that causes an event to happen which
would have happened some time later anyway). When acting as a trigger, the
vaccine may expose an underlying or pre-existing condition or illness. An
example of the latter would be an auto-immune condition triggered
non-specifically by the immune stimulus of the vaccine.
This is an interesting point. Many of the parents report that their child's
health problems are not known in the family's medical history but they have
been told by their medical practitioner that the vaccine acted as a trigger
to reveal the underlying condition.
What is particularly worrying is that the child usually has more than one,
supposedly, rare condition that started at the same time e.g. autism and
bowel problems, epilepsy and loss of speech and communication and a failure
to move on mentally from the point of vaccination. Some children developed
health problems when vaccinated at four years of age or ten years of age or
sixteen years of age after many years of good health and development
progress.
c. In the case of live attenuated vaccines, if the adverse event may be
attributable to the pathogenicity of the attenuated vaccine microorganism
and thus not be distinguishable (except, perhaps, in severity) from the
disease against which the vaccine is being administered, a causal connection
is more plausible. Identification of the vaccine organism in diseased tissue
and/or in the body fluids of the patient in such a situation would add
weight to causality. There are exceptions to both these above points.
Measles virus has been found in the spinal fluid - and therefore the brain -
in three of the six children at the centre of the huge UK high court battle
over the safety of the vaccine. It has also been found in 18 children in the
United States who developed autism after receiving MMR.
Financial cost:
Letter submitted to the Lancet (Spring 2004) by David Thrower
Sir,
AUTISM
As one of the parents who, through enforced circumstance, has become
involved in the controversy surrounding the causes and consequences of
autism, I wish to respond to your commentary (1).
As you imply, the 2002 UK autism research funding of $2.75m was lamentably
inadequate, and should be set against the very considerable economic costs
of autism. It has previously been estimated that just one severe case of
autism will cost the community up to £3m over that person's lifetime. The
degree of severity and consequent precise costings could be debated at
length. Costs include special needs education, home-to-school taxiing,
escorts, daily respite care, overnight respite breaks, transport, health
care, attendance and disability allowances, carer's allowance, and loss of
tax revenues from the parent who has to cease work to become the child's
carer. From age 16, you can add-on independent living fund payments and
incapacity benefit. From age 19, schooling costs cease, but most of the
other costs continue for life, and you also have to add in the lost tax
revenue from the autistic person. In these circumstances, the estimate of
£3m for the costs of a severe case of autism may well be an underestimate.
But let us stay with £3m, for the sake of simplicity. So the 2002 autism
research grant, for the UK, was actually less than the lifetime cost of just
one severe case of autism.
And then you can try to estimate the numbers of UK cases. The recent
unsuccessful UK High Court action alone involved 1,300 families. There have
been many attempts at trying to gauge the numbers of UK autism cases. But
hard State-collected data from the US Individuals With Disabilities
Education Act database points to there being 120,000 children and young
people ages 6-21 in full time education in the US with a primary diagnosis
of autism, so a pro-rata application of those figures to the UK would give
around 35,000 cases in the UK within that age-band. Obviously, not all cases
are severe, but a reasonable estimate would be that an assumed 35,000 cases
would cost the taxpayer somewhere between £35 billion and £100 billion over
the next seven decades, or between £500m and £1.4 billion per annum. This,
of course, excludes any future cases that enter the autistic population over
that time, plus the present existing small numbers of autistic adults. If
autistic children continue to emerge at the rate now being recorded across
the US, then the UK taxpayer could be facing an immense autism bill of
several billion pounds per annum, within a couple of decades.
On those terms, even your sought-after £12.5m for autism research therefore
seems grossly inadequate to research a condition that is clearly already
creating an economic burden, and one that seems set to increase. And these
future autism costs will apply wholly irrespective of the current
controversy about autism's actual detailed causes. The children already
exist now, today, for whatever reason. The economic stakes over seeking
autism's causes are therefore extremely high.
I would also strongly support the efforts of Dr. Tom Jefferson in bringing
adverse event surveillance out of the nineteenth century and into the
twenty-first (2). But I would ask, how genuinely keen is our Department of
Health, and government departments in other countries, to actively seek out
every potential case of vaccine damage, and to analyse the data proactively?
There seems to have been a marked lack of enthusiasm to date. The Medicines
& Healthcare Products Regulatory Agency's existing Yellow Card system has
been admitted by its predecessor, the Medicines Control Agency, to record
only 10%-15% of even serious adverse events, yet the Agency seems quite
content to live with that. In other areas of life, it is very difficult to
imagine (say) the Vehicle Inspectorate being content with such a poor system
for vehicle inspections, so why is medicine's Yellow Card scheme's
inadequacy tolerated so readily? Perhaps the Agency lacks the determination
that parents of damaged children have to investigate adverse outcomes.
Finally, as you rightly point out, "the discovery of a possible link between
bowel disease and autism is a serious scientific idea......and one that
deserves further investigation." The original Royal Free team paper was in
February 1998. It is now Spring 2004. It is the continued abject failure to
fund clinical research in this area, based upon the detailed examination of
regressive-autism cases, that is the least acceptable aspect of the autism
controversy, and I would welcome some candid explanation from the relevant
authority, the Medical Research Council, as to what it has - or has not -
been doing over the past six years.
Yours faithfully,
David Thrower
49, Ackers Road, Stockton Heath, Warrington, Cheshire WA4 2DZ 01925 264156
References
(1) Commentary, The Lessons of MMR, Lancet, 2004, 363
(2) Jefferson T, Price D, Demicheli V et al. Unintended events following
immunisation with MMR: a systematic review. Vaccine 2003; 21: 3954-60
(PubMed)
Summary:
In our opinion the current Government has failed in its duty of care. At the
meeting in 1997 the Health Minister should have instigated a scientific
study of the children believed to have been damaged to discover why the
children's lives changed so dramatically within such a short time of MMR/MR
vaccine being given. Since that meeting the reports of MMR/MR damaged
children to JABS has greatly increased.
The issue of safety surrounding the MMR vaccine has not yet been resolved.
The Department of Health have relied on epidemiological studies as their
basis for stating the vaccine is safe. These studies are not designed to
collect data on 'rare' events.
The Department of Health has failed to adopt the precautionary principle.
Until the question of MMR safety is resolved the option of single dose
vaccines should be made available for parents who have lost confidence in
the combined vaccine.
A question that must be asked of the present Health Minister is: if the drug
companies have informed the Department of Health's doctors of the known
vaccine problems and parents have informed the doctors that these problems
are occurring. Why is the Department of Health denying the problems and
ignoring the parents?
It could be argued that the vaccine manufacturers have a duty to provide
compensation, as they have to in the United States by contributing to the US
National Vaccine Injury Programme. The pharmaceutical industry profits from
the supply of vaccines to the UK and also, ironically, from the victims
because they produce the anti-convulsants, pain killers and other medical
products these children need. At the moment however, in the UK, they do not
contribute financially in any way to the vaccine damage payment scheme.
The UK Vaccine Damage Payment Act 1979 has gone some way to address the
issue. Unfortunately, because the criteria are so strict most families
cannot access justice for their children through this Government scheme and
therefore it is relatively ineffective. Until a compensation programme
similar to the US scheme is implemented in the UK, parents will seek redress
through the courts and for this reason families need the support of legal
aid to pursue justice. Legal aid should be re-instated.
Critics of the JABS group must think of this: If our members had been
anti-vaccine lobbyists our children would not have been taken for vaccines
and subsequently damaged. We are parents who put our faith in the UK
healthcare system; our children have reacted usually in the time frame known
to the manufacturer and, in the main, are living with long term problems
also known to the manufacturer. We want the children to be recognised and
compensated and clinically investigated to help develop a screening
programme to improve vaccine safety.
JABS believes in a safe vaccination programme but the emphasis is on safe
and reducing risk wherever possible.
Acknowledgements:
We are extremely grateful to:-
David Thrower for his input
Parents who submitted the JABS questionnaire.
References:
Ref. 1:
MMR and Acquired Autism (Autistic Enterocolitis) - A Briefing Note by David
Thrower March 2006 http://www.jabs.org.uk/pages/Autism_Review.pdf
Relevant Extracts:
93. Paper by Uhlmann, Sheils et al, Measles Virus In Reactive
Lympho-Nodular Hyperplasia and Ileo-Colitis of Children, (publication date
not known), Department of Pathology, Coombe Womens' Hospital, Dublin,
Trinity College Dublin and Royal Free Hospital London.
This paper noted that measles virus nucleoprotein (N antigen) had been
detected in association with follicular dendritic cells (FDC) in patients,
and sought molecular confirmation of this result. It found that:
* Solution phase RT PCR yielded specific MV N gene amplification in affected
children (10/10)
* Distinct measles virus genome was identified in FDC reactive follicular
centres by in-cell RNA amplification
* None of the normal controls showed any evidence of measles virus genome
* The data highlighted a possible causal link between measles virus
infection and ileo-colonic lymphoid nodular hyperplasia in affected children
96. Paper Presented to US Congressional Oversight Committee on Autism and
Immunisation, Professor John O'Leary, Dublin Womens Hospital, April 2000
This paper reported a study using biopsy material from children examined at
the Royal Free in London. Dr. Wakefield at the Royal Free had posed three
questions to the O'Leary team,
(1) was measles virus present in gut biopsies of affected children?
(2) where was measles virus located in the gut biopsies of the affected
children?
(3) how much virus was present?
* The O'Leary team used in-situ hybridisation (with/without tyramide signal
amplification), in-cell PCR, solution-phase PCR, TaqMan quantitative PCR and
DNA sequencing to determine the answers to these questions.
* Using TaqMan PCR the team was able to quantify the measles virus copy
number per 1,000 mucosal cells using gene dosage correction formulations.
The copy number of measles virus in gut biopsies from children with autistic
enterocolitis was low, at approx. 30-50 measles virus genomes per 2,000
mucosal cells (inc. Gut, epithelial, lymphoid and dendritic cells).
* Confirmation of the presence of measles virus genomes was achieved using
positive and negative strand sequencing of cDNA measles amplicons.
* The results were that 24 out of 25 (96%) of the autistic children were
positive for measles virus, including 2 children from the USA who were
included in this analysis
* In the controls, only 1 of the 15 children (6.6%) was positive for measles
virus.
* The study therefore localised, quantified and sequenced measles virus
genomes in gut biopsies of children with autistic enterocolitis. The study
team then posed the question, "how did it get there?".
97. Paper by Kawashima, Takayuki et al, Detection and Sequencing of Measles
Virus from Peripheral Mononuclear Cells from Patients with Inflammatory
Bowel Disease and Autism, Digestive Diseases & Sciences Vol. 45, No. 4,
April 2000, pp723-729
Following reports that measles virus might be present in the intestines of
children with Crohn's Disease, a new syndrome was reported in children with
autism who exhibited developmental regression and gastrointestinal symptoms
(autistic enterocolitis), in some cases after MMR vaccine, was reported (see
papers by Wakefield et al). It was not known whether the virus, if confirmed
as present in these patients, derived from wild strain or vaccine strain.
This study carried out the detection of measles genomic RNA in peripheral
mononuclear cells (PBMC) in 8 patients with CD, 3 patients with UC and 9
patients with autistic enterocolitis. As controls, the study used 8 cases of
either healthy children or children with SSPE, SLE or HIV-1. The results
were:
* 1/8 patients with CD, 1/3 with UC and 3/9 with autism were positive.
Controls were all negative
*The sequences from patients with CD shared the characteristics with
wild-strain virus.
*Sequences from patients with UC and children with autism were consistent
with vaccine strain measles.
*These results were consistent with the exposure history of the patient.
This study is obviously particularly important because it points to
infection with vaccine-strain measles virus
Detection of Measles Virus Genomic RNA in Cerebrospinal Fluid of Children
with Regressive Autism: a Report of Three Children J.J. Bradstreet, M.D., J.
El Dahr, MD, A. Anthony M.B., PhD, J.J. Kartzinel, M.D., A.J. Wakefield,
M.B.
Ref. 2:
http://www.who.int/vaccine_safety/causality/en/
World Health Organisation
Causality assessment of adverse events following immunization
Since the inception of vaccination, it has been recognized that adverse
events following immunization (AEFIs) will occur. The frequency of AEFIs is
directly related to the number of vaccine doses administered. AEFIs can be
causally related to the inherent properties of the vaccine, linked to errors
in the administration, quality, storage and transport of the vaccine
(programmatic errors), but it must be recognized that when large populations
are vaccinated, some serious events that occur rarely with or without
vaccination will be observed coincidentally following vaccination. Thus,
investigating causality of AEFIs, particularly those that are most serious,
is challenging.
The clearest and most reliable way to determine whether an adverse event is
causally related to vaccination is by comparing rates of the event in a
vaccinated and non-vaccinated group in a randomized clinical trial. Such
trials, however, can never be large enough to assess very rare events, and
postmarketing surveillance systems are required to identify events
potentially related to vaccination. Postmarketing surveillance capability is
improving; more countries now have AEFI monitoring systems, and more
importance is attached to the reporting of suspected links between
vaccination and adverse events. These systems have been successful in
bringing to light serious AEFIs after vaccines have been marketed. A recent
example is intussusception after administration of reassortant rhesus
rotavirus vaccine.
Assessments of whether a given vaccine causes a particular adverse reaction
vary from the casual observation to the carefully controlled study. The
majority of individuals are not trained in interpreting such studies and are
unlikely to understand the enormous difference in significance between these
two extremes. Nonetheless, the public frequently forms a decision about a
vaccineís safety based on the information available to them ñ often a report
based on unscientific observations or analyses that fail to stand the
scrutiny of rigorous scientific investigation. Certain reports of AEFIs
published in the medical literature over the past few years have resulted in
controversy. The studies on which these reports are based, while generating
provocative hypotheses, have generally not fulfilled the criteria that would
be needed to be able to draw conclusions about vaccine safety with any
degree of certainty. Yet these reports have had a major influence on public
debate and opinion-making. When this debate spills over to the political
arena, to policy-making and to determining the public acceptance of a
vaccine by balancing the known benefits against possible but unverified
risks, it is clear that a correct assessment of causality is vital.
Submitting a study to a scientific process rather than to partially informed
opinion is crucial in determining whether a vaccine actually causes a given
reaction. If undertaken carelessly or without scientific rigour, the study
results will be inconclusive at best, may result in the inappropriate
withdrawal of a valuable vaccine from use, or at worst may result in the
exposure of a population to a dangerous vaccine. In 1999, WHO launched the
Immunization Safety Priority Project to establish a comprehensive system to
ensure the safety of all immunizations given in national immunization
programmes. The development of mechanisms to respond promptly and
effectively to vaccine safety concerns is a major area of focus of this
project. As part of this effort, the Global Advisory Committee on Vaccine
Safety (GACVS) was constituted by WHO in September 1999. The Committee's
mandate is to enable WHO to respond promptly, efficiently and with
scientific rigour to vaccine safety issues of potential global importance.
1. Consistency. The association of a purported adverse event with the
administration of a vaccine should be consistent, i.e. the findings should
be replicable in different localities, by different investigators not unduly
influencing one another, and by different methods of investigation, all
leading to the same conclusion(s).
2. Strength of the association. The association should be strong in the
magnitude of the association (in an epidemiological sense), and in the
dose-response relationship of the vaccine with the adverse effect.
3. Specificity. The association should be distinctive ñ the adverse
event should be linked uniquely or specifically with the vaccine concerned,
rather than its occurring frequently, spontaneously or commonly in
association with other external stimuli or conditions.
4. Temporal relation. There should be a clear temporal relationship
between the vaccine and the adverse event, in that receipt of the vaccine
should precede the earliest manifestation of the event or a clear
exacerbation of an ongoing condition. For example, an anaphylactic reaction
seconds or minutes following immunization would be strongly suggestive of
causality; such a reaction several weeks after vaccination would be less
plausible evidence of a causal relation.
5. Biological plausibility. The association should be coherent; that
is, plausible and explicable biologically according to known facts in the
natural history and biology of the disease.
Building on the seminal work on determining causality of the Surgeon
Generalís Advisory Committee on Smoking and Health (1964),3 the generally
established criteria underpinning vaccine adverse event causality assessment
that the GACVS uses may be summarized as follows:
a. The requirement for biological plausibility should not unduly
influence negatively a consideration of causality. Biological plausibility
is a less robust criterion than the others described. If an adverse event
does not fit into known facts and the preconceived understanding of the
adverse event or the vaccine under consideration, it clearly does not
necessarily follow that new or hitherto unexpected events are improbable.
Biological plausibility is most helpful when it is positive; it is less so
when negative.
b. Consideration of whether the vaccine is serving as a trigger
(trigger in this context is an agent that causes an event to happen which
would have happened some time later anyway). When acting as a trigger, the
vaccine may expose an underlying or pre-existing condition or illness. An
example of the latter would be an auto-immune condition triggered
non-specifically by the immune stimulus of the vaccine.
c. In the case of live attenuated vaccines, if the adverse event may be
attributable to the pathogenicity of the attenuated vaccine microorganism
and thus not be distinguishable (except, perhaps, in severity) from the
disease against which the vaccine is being administered, a causal connection
is more plausible. Identification of the vaccine organism in diseased tissue
and/or in the body fluids of the patient in such a situation would add
weight to causality. There are exceptions to both these above points.
Clearly, not all these criteria need to be present, and neither does each
carry equal weight for a causal relationship between an adverse event and
the vaccine to be determined. In addition to the general principles
mentioned above, there are a number of provisos or considerations that need
to be applied for determining causality in the special field of vaccine
safety. They are:
1. Well-conducted human studies that demonstrate a clear association in
a study design that is determined a priori for testing the hypothesis of
such association. Such studies will normally be one of the following, in
descending order of probability of achieving the objective of the study:
randomized controlled clinical trials, cohort studies, and casecontrol
studies and controlled case-series analyses. Case reports, however numerous
and complete, do not fulfil the requirements for testing hypotheses,
although on occasion such reports can be compelling if there are clear
biological markers of the association, as is the case for vaccine-associated
paralytic poliomyelitis.
2. An association that is demonstrated in more than one human study and
consistent among the studies. The studies would need to have been well
conducted, by different investigators, in different populations, with
results that are consistent, despite different study designs. Demonstrable
association in the studies between dose and the purported adverse effect
(either the dose or the number of doses administered, or both) will, in many
cases, strengthen the causal association between the vaccine and the adverse
event. This is not always the case, especially if there is an immunological
relationship.
3. A strong similarity of the adverse event to the infection the
vaccine is intended to prevent, and there is a non-random temporal
relationship between administration and the adverse incident.
An association between vaccine administration and an adverse event is most
likely to be considered strong when the evidence is based on:
It is important that there should be a strict definition of the adverse
event in clinical, pathological and biochemical terms, as far as that is
achievable. The frequency in the nonimmunized population of the adverse
event should be substantially different from that in the immunized
population in which the event is described, and there would not normally be
obvious alternative reasons for its occurrence that are unrelated to
immunization.
An adverse event may be caused by a vaccine adjuvant or excipient, rather
than by the active component of the vaccine. In this case, it might
spuriously influence the specificity of the association between vaccine and
adverse event. As far as possible, safety issues should be clarified in
premarketing controlled clinical studies, with attention being given in such
studies to safety issues and their monitoring, although with extremely rare
unexpected events, this may not be achievable because of the need for
extremely large sample sizes to detect them.
When adverse events are attributable to a vaccine, it is important to
determine whether there is a predisposed set of subjects (by age,
population, genetic, immunological, environmental, ethnic, sociological or
underlying disease conditions) for any particular reaction. Such
predisposition is most likely to be identified in case-controlled studies.
A systematic effort should always be made to exclude confounding
programmatic errors and variability and aberrations in vaccine manufacture.
The latter quality issues are most likely to be revealed by careful
attention to batch and lot testing.
Since observational studies are not randomized and since individuals who are
ill are generally less likely to be immunized (but more likely to have an
adverse outcome), epidemiological studies on vaccine safety need to pay
special attention to contraindications as potentially confounding factors.
The consequences of this bias may be false-negative studies.
Ref. 3:
Serious adverse events after measles-mumps-rubella vaccination during a 14
year prospective follow up. Pediatr Infec. Dis J. 2000;19:1127_34 Annamari
Patja,MD, Irja Davidkin, MSC, Phd, Tapio Kurki,MD, Phd, Markku J T Kallio,
MD, Martti Valle, MD, Phd and Heikki Peltola, MD, Phd
Briefing note compiled by JABS, 1 GAWSWORTH ROAD, GOLBORNE, WARRINGTON,
CHESHIRE, WA3 3RF