This fact
sheet concentrates on the medical, scientific and ethical issues relating to
the MMR/MR vaccines in the context of possible legal claims. It has been
prepared to help those who believe their children have been damaged by these
vaccines.
Nothing in
this fact sheet should be taken to be medical advice. Vaccination decisions
should be made only after proper consultation with your medical adviser.
The
information in this fact sheet is not now up to date. Investigations have moved
on, and further relevant information has come to light. For additional material
please refer to our web site at www.alexharris.co.uk
The Medicines
Control Agency (the body in charge
of vaccine safety) were invited to comment on the fact sheet. A few minor
corrections have been made in response to their representations. Where there
are two sides to the argument, we have left in our version, and in the
interests of balance have added their views as footnotes.[1]
Contents
Introduction
Background: Setting the illnesses in context
The vaccines
Safety and effectiveness of the vaccines
Side effects: the official view
Side effects: our investigations
Conclusion
Introduction
In this fact
sheet we give specific information about the MMR and MR vaccines and their side
effects. Our objective is two-fold. Primarily we have to operate within the
English Legal System, which in this context functions only in terms of
financial compensation. Our aim therefore is to help families whose children
have been affected by the vaccines to obtain proper compensation for their
injuries. We are using law that was introduced into this country in 1988 as a
result of European Community directives. This law (the Consumer Protection Act 1987) imposes strict liability on the
manufacturers of products which are unsafe.
The MMR
vaccine is claimed to cause serious side effects in only one in a million
children. Even if that were the case, the risk to the children who are affected
is not one in a million, but 100%. An American court[2]
has decided that there can be no acceptable level of the incidence of serious
side effects from vaccines, and has stated that compensation should be paid in
any case where it is proved that the side effect was caused by the
vaccine.We would hope that English
courts would adopt the same approach.
Because
vaccines are such an emotive issue, we have gone further and tried to set the
whole subject in context. What follows is an overview of the vaccines, which we
hope will give full information not only to the families we are seeking to help
but also to those (including medical practitioners) who have found it difficult
to obtain detailed information about these childhood diseases and immunization
against them.
We have tried
to keep a balanced view about the benefits and risks of immunisation, but as we
have researched deeper into the issues it has become harder to do so.
We have read and heard many harrowing accounts of the injuries that
children (and adults) have suffered after the vaccines have been administered.
We have listened to the dismissive comments from representatives of the
Government and some members of the medical profession. We are now worried that
the safety information about these vaccines may not be entirely accurate.
We are also
seriously concerned that safety monitoring for these vaccines appears to fall
far short of what the public is entitled to expect and we believe that the
information given to parents is certainly lamentably incomplete.
We are
concerned that risks associated with the actual illnesses may have been
exaggerated, perhaps to frighten people into having their children vaccinated.
Some have suggested that we underplay the risks of the illnesses themselves.
There is no doubt that, of the three illnesses (mumps, measles, rubella),
measles should be regarded as the most serious, but we find it difficult to
reconcile the claims now made about the illness: "complications have been
reported in one in 15 notified cases."[3]
with the reassuring statement we quote in the next section: "In the vast
majority of children who catch measles the disease disappears within 10
days" [4], [5]
We have also included references to and quotations from source
material.This represents a tiny
fraction of the information we hold, which runs to hundreds of papers and
thousands of references on MMR and vaccines generally. Feel free to show this
fact sheet to your medical advisors. We believe that we can substantiate every
statement made in this fact sheet from mainstream medical literature or
official sources. Where possible we have given the source material in
footnotes. It is quite significant that many of the medical and scientific
findings we have researched are not new: the information about the mechanisms,
which cause side effects, was available to the medical and scientific community
years ago. We will be happy to supply more information either to you or to your
doctor.
Background:
Setting the illnesses in context
The "official" perception of the childhood
diseases which are the subject of the MMR or MR vaccines (Measles, Mumps,
Rubella) has modified over the years with descriptions of the diseases
increasingly emphasising their seriousness.
It is instructive to put the three diseases into perspective. The
following extracts and summaries are from two family health guides published 13
years apart:
the
MacMillan Guide to Family Health, an authoritative health manual edited
by Dr. Tony Smiththe deputy editor of
the British Medical Journal and published in 1982 [6];
and
the British
Medical Association Complete Family Health Encyclopaedia published in
1995 (first published 1990). This is also edited by Dr. Tony Smith.
We have chosen
the firstpublication because it came
out some yearsbefore MMR vaccines were
introduced into this country. Contrast the entries in the two publications:
Mumps
From the MacMillan Guide to Family Health 1982:
"Mumps is a common infectious
disease caused by a virus. After an incubation period of 2-4 weeks the salivary
glands swell, the parotid gland (just in front of the ear) is particularly
infected. Swellings are usually accompanied by a raised temperature and a
general feeling of illness. It is probably the most common childhood infectious
disease but not as contagious as measles.
"A fairly common risk of mumps is
the swelling of testes in a boy or the ovaries in a girl. This is much more
common in an adult. Invariably the swelling goes down after a few days leaving
no after effects. It is excessively rare for the swelling to cause sterility. A
rare complication is acute pancreatitis, which passes within a few days.
"Mumps is
generally a mild disease. The usual outcome is complete recovery within about
10 days."[our emphasis]
In contrast From the British Medical Association Complete
Family Health Encyclopaedia 1995:
"Mumps is an acute viral illness mainly of childhood... Serious
complications are uncommon. However, in teenage and adult males, mumps can be a
highly uncomfortable illness in which one or both testes become inflamed and
swollen... Most infections are acquired at school or from infected family
members. In the US, where many states require proof of mumps vaccination for
school entry, the incidence has dropped markedly over the last 20 years. In the
UK by contrast, before routine immunisation was introduced in 1988, mumps
affected a large proportion of the population at sometime in their lives,
usually between the ages of 5 and 10. An occasional complication of mumps is
meningitis... A less common complication of mumps is pancreatitis, which causes
abdominal pain and vomiting. In males after puberty, orchitis (inflammation of
the testis) develops in about a quarter of the cases. Subsequently the affected
testis may shrink to smaller than normal size. In rare cases, mumps orchitis
affects both testes leading to infertility."
[The book also contains strong warnings
about the consequences of older people coming into contact with those infected
with mumps.]
Rubella (German Measles)
From the MacMillan Guide to Family Health 1982:
"This is
a very mild infectious disease in the majority of children who catch it, it
causes no more inconvenience than a common cold. The incubation period is 14‑21
days and the first symptoms are a slightly raised temperature, swollen glands
behind the ears and a rash appearing on the first or second day first on the
face and then spreading to the rest of the body. By the fourth or fifth day,
all symptoms have faded away.
It is slightly less common than
measles and not as highly contagious so does not occur in epidemics in quite
the same way.
Like other childhood infectious
diseases, German measles carries the risk of encephalitis though this occurs in
only one case in 6000. A more common complication, particularly in adults is stiff
swollen joints (infectious arthritis).
Because German measles is such a mild
disease, little specific treatment is required but the disease is known to
cause damage to babies developing in the uterus. It is therefore essential to
contact any pregnant woman who has been exposed to German measles."
The British
Medical Association Complete Family Health Encyclopaedia 1995: The book does
not emphasise the seriousness of the illness as much as it does in respect of
measles and mumps but does state that vaccines are long lasting in their
effect.
Measles
From the MacMillan Guide to Family Health 1982:
"Measles
is a highly contagious disease which chiefly affects the skin and respiratory
tract. It is a notifiable disease. The incubation period is 10-14 days. The
first symptoms are raised temperature, runny nose, red watering eyes, dry cough
and sometimes diarrhoea. By the third day the temperature falls and tiny white
spots like grains of salt appear inside the mouth. On the fourth and fifth days
temperature rises again and the characteristic measles rash appears, starting
on the forehead and behind the ears and gradually spreading to the rest of the
body but not usually the limbs. By the sixth day the rash is fading and by the
seventh day all the symptoms have gone.
"In the vast majority of children who catch
measles the disease disappears within 10 days and the only after effect is
lifelong immunity to another attack"[7]
[our emphasis]
In contrast
1995 from the British Medical Association
Complete Family Health Encyclopaedia 1995:
The following are quotations from the book. Note the difference in
emphasis and detail.
"A potentially dangerous viral
illness that causes a characteristic rash and a fever Measles was once very
common throughout the world occurring in epidemics. It is now less common in
developed countries due to immunisation.
Prevention of measles is important
because it can have rare but serious complications.... It can also be serious,
and sometimes fatal, in children with impaired immunity (such as those being
treated for leukaemia and those infected with AIDs virus). In developing
countries measles is still common, accounting for more than one million deaths
every year, especially in malnourished children whose defences against infection
are seriously impaired."
"The most common complications are
ear and chest infections. Diarrhoea vomiting and abdominal pain also occur.
Febrile convulsions are common with measles and are not usually serious. A
serious complication, occurring in about one in a thousand cases is
encephalitis (inflammation of the brain).... Seizures and coma may follow
sometimes leading to mental retardation or even death. Very rarely (in about
one in a million cases) a progressive brain disorder, known as SSPE, develops
years after the acute illness. Measles during pregnancy results in death of the
foetus in about one fifth of the cases."
"Immunisation against measles is
usually offered at about 15 months of age and produces immunity in about 97% of
the cases. Side effects of the measles vaccine are generally mild."
[no mention of any serious side effects
of the vaccine]
Measles viewed in 1967
Another
example of the apparent change in the nature of measles is this extract from a
paper by Christine Miller BM B.Ch, of the National Institute for Medical
Research London published in 1967 one year before the measles vaccine was
introduced on a wide scale.
"MEASLES is now the commonest
infectious disease of childhood in the United Kingdom.It occurs in biennial epidemics in which the
total number of cases usually exceeds half a million, and between these peaks
there is a continuous substantial incidence.There is no doubt that most of these cases in England today are mild,
last only for a short period, are not followed by complications and are rarely
fatal, but this is not the whole picture and other factors have to be
considered.
"OPPOSING
VIEWS:Measles is always a social
nuisance whenever it occurs and nearly always an unpleasant episode for the
child and the family.Most children
develop measles during preschool or early school life, and when more than one
child is infected at the same time it is an exhausting and trying period for
the mother, especially if she goes out to work.Outbreaks in schools and hospital wards also cause waste of time
and inconvenience, and there have been severe outbreaks in the Armed
Forces.To the doctor an epidemic of
measles means an increase in work in the late winter and early spring when he is
already especially busy.A recent survey
in a number of areas in this country (unpublished) showed that the majority of
measles cases are visited at least twice by the general practitioner, and in
many cases more than twice. This is a heavy burden on the National Health
Service, which also bears the cost of antibiotics with which most cases are
treated.
In spite of these factors, some
physicians consider that measles is so mild a complaint that a major effort at
prevention is not justified.On the
other hand, others believe that, on the whole, the implications of an epidemic
are serious and that the disease should be prevented if possible. These
opposing views are of topical importance in considering what use should be made
of measles vaccines"[8].
Measles viewed in 1979
In the well
respected publication The Theory and
Practice of Public Health[9]
it is stated:
"While the infectivity of measles
is still very high in all types of population and environment, the results of
infection vary greatly. In Britain and many other developed countries today
measles has lost much of its severity, but the disease can still sweep through
virgin populations with great ferocity... On the other hand immunity is
probably lifelong, and when measles has invaded an isolated community, older
members have been protected by immunity acquired over sixty years earlier. In
developing or underdeveloped countries measles may still cause serious
complications and carry a fatality rate of up to 25 per cent."[10]
In
contrast 1994 from: MEASLES why every child in school needs to be protected
from measles this autumn. 1994 [Health Education Authority/Department of Health
Publication][11]
"Unfortunately, measles can be
much more serious than most people think. School-age children who get it are
likely to be very ill. These
children will have a high temperature, a rash, a cough, a cold and sore eyes.
Other symptoms are headaches and not liking bright light. 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.
This is known as 'encephalitis'. Worryingly, four out of ten children who get
this kind of encephalitis will suffer long-term brain damage."
Our reason for
emphasising this apparent change in the perception of the illnesses is to raise
a question‑mark over the rationale for MR or MMR vaccines.
Vaccination is
an invasive procedure. Children, once vaccinated, are inevitably put on direct
risk (however large or small that risk might be) of vaccination side effects. On
the other hand, if nature is allowed to take its course, they may never catch
all or any of the illnesses, and they certainly won't catch all three at the
same time; and if they do catch any of the illnesses, the evidence suggests
that their immunity to further attacks will be far greater than is provided by
any vaccine.
Furthermore,
there is some evidence that catching measles actually protects children against
some conditions, such as allergies. A recent trial in Guinea-Bissau found that
25.8% of participants who had the measles vaccine suffered from allergies, as
opposed to 12.8% who had the wild measles.[12]
In the
Immunisation Awareness Newsletter of December 1991, other advantages of
catching measles are considered, as this passage shows:
"The advent of complications
during these diseases essentially depends on the age and the health of the
child, as well as on treatment.We have
lost the common sense and the wisdom that used to prevail in the approach to
childhood diseases.Too often, instead
of reinforcing the organism's defences, fever and symptoms are relentlessly
suppressed.This is not always without
consequences over the development of the disease.On the other hand, given the depth to which the child's organism
is affected by the disease measles, for example, there can also be positive
consequences.For the child's organism
to defeat a disease by its own means, enables it to mature its immune system
and develop increased resistance.The
latter will be useful for the organism against other diseases during childhood,
and likewise in adulthood.Over many
generations, parents, doctors, and educators have noted that children may go
through an important stage of their development thanks to a childhood disease.Conditions in which heredity is a factor,
such as eczema, asthma, or recurring infections of the respiratory system, may
be improved or even cured after measles.
"This 'cure potential' of
childhood diseases can be demonstrated by an example.There is a serious childhood disease affecting the kidneys, the
nephrotic syndrome, in which the kidneys lose their vital excretion function as
a result of disturbed immunological processes.Up until the 1960s, at the Bale University Paediatrics Clinic, artificial
infection with the measles was used to treat this syndrome; this brought about
at least an improvement in most cases."[13]
The process of
vaccination involves submission to a medical procedure for the benefit of a
community; not just for oneself or one's immediate family. Therefore, for a
vaccination to be justified, there must be:
_a serious threat from the
disease(s),and
_a significant benefit from the
vaccine.
If the
diseases are not as serious as they are now claimed to be (and we have found no indication that any of them has become more
serious in the past 15-20 years quite the reverse)[14];
and if the vaccines are more dangerous than they are admitted to be, then the
risk/benefit ratio is altered. At the very least, parents should know about it.
Behind the
scenes, it is acknowledged that vaccines are indeed not as safe as they could
be:
"The goals of immunization are to
eradicate infectious diseases while minimizing morbidity caused by the vaccine,
particularly to prevent neurological damage. The object of the study is to
evaluate neurological complications associated with the immunization.
Immunization is an important public health measure. Acute reactions warrant
support for development of improved vaccines."[15]
There is always room for improvement in any product, but these
references to "neurological damage" and "Acute reactions"
indicate that in the minds of some there is need for considerable improvement.
The vaccines
MMR Vaccines
The MMR
vaccines were introduced in October 1988, as part of a campaign to reduce
childhood illness. They are a triple vaccine, using the mumps, measles and
rubella live viruses.
Problems with MMR vaccines
Until September 14 1992 there were three types
of MMR vaccine available:
Vaccine
Details
IMMRAVAX
Manufactured
by Merieux UK Ltd
PLUSERIX-MMR
Manufactured
by SmithKline Beecham/ Smith Kline French Laboratories
MMRII
Manufactured
by Merck Sharpe and Dohme; distributed by Wellcome (On recent data sheets
this product is now shown as being distributed by Pasteur Merieux MSD Ltd)
Pluserix-MMR
and Immravax vaccines contain the Urabe strain of mumps vaccine virus; MMRII
vaccine contains the Jeryl Lynn strain of mumps vaccine virus.
On 14
September 1992 the Chief Medical Officer announced that there were to be
"Changes in the supply of vaccine". From that date onwards, only
MMRII would be available. The following is an extract from his letter giving
the reasons for withdrawal:
"This change in vaccine supply arrangements has been
considered prudent following reports of generally mild transient meningitis
caused by the mumps vaccine virus in some children who recently received the
Urabe mumps vaccine containing products, Pluserix-MMR or Immravax. The rate of
post-immunisation meningitis following Jeryl Lynn mumps vaccine (which MMRII
contains) is much lower.
Incidence of
mumps virus meningitis:
"Meningitis
after natural mumps has been reported to occur at a rate of approximately 1 per
400 cases.
"Studies
recently undertaken in one Public Health Laboratory, and supported by similar
studies in several other Public Health Laboratories, suggest that the incidence
of virus positive post-immunisation meningitis from the Urabe strain of mumps
vaccine virus may be approximately 1 in 11,000[16]
immunised children. This rate of vaccine-associated meningitis is appreciable
(sic) lower than that reported after natural mumps infection
.
"Vaccine-associated
meningitis occurs around three weeks after immunisation generally. In those
instances reported so far it appears to be a milder and more transient illness
than meningitis from wild virus. This is what one might expect with an
attenuated virus. The risk benefit ratio therefore remains strongly in favour
of the immunisation of all children with any MMR vaccine. However the MMRII
vaccine is preferred where this is available because of the much lower risk of
vaccine associated meningitis."[17]
Even though
the Chief Medical Officer mentioned only "changes in supply", both
Immravax and Pluserix have subsequently been withdrawn altogether.[18]
We are
troubled that there seems to be a certain amount of massaging of the figures.
In the passage just quoted, side effects of one in 11,000 are mentioned. Later,
it will be seen that they were brought down to 1/4000[19].
But even that is not the end of the story as this extract from a Japanese study
about the safety of MMR vaccines (with the Urabe mumps strain) will show:
"During the 8‑month period
extending from April to October, 1989, in Gunma Prefecture, 11 750 children
received MMR vaccination according to information supplied by the prefectural
public health center.The incidence of
MMR meningitis was estimated to be 1.1/1000 (0.11%) in the virus‑positive
group and 3/1000 (0.30%) in the three groups.2640 and 1320 children received MMR vaccination in September and
October, respectively.Twelve children
in the virus‑positive group, 10 in the serum‑positive group and 6
in the clinical group received vaccination in these 2 months.The incidence of virus‑positive, serum‑positive
and clinical meningitis in these 2 months was 3/1000 (0.3%), 2.5/1000 (0.25%),
and 1.5/1000 (0.15%), respectively (total, 7.1/1000 (0.71%))."[20]
We have a
letter from the Japanese Department of Viral Disease and Vaccine Control which
indicates that from April 1993 the use of the MMR vaccine (all types) was
stopped in Japan and that vaccines would be available only in their monovalent
form (i.e. single virus)[21]
Comment:
The Japanese findings indicate that
adversereactions to these types of MMR
vaccine were up to78times as frequent as our Government's Chief Medical
Officer of Healthhas admitted[22].
If those figures are correct, then the vaccine is more dangerous than the
illness; and it does not give a great deal of confidence that the Government
has got its figures (or information about safety or side effects) right.Note
also that this article was published in March 1991. Yet the two brands of
MMR implicated with these side effects were not withdrawn until September 1992,
some 18 months later.
Indeed TRIVIRIX (a MMR vaccine containing
the Urabe strain virus) was withdrawn in Canada in May 1990.[23]
Why did the UK Government take till 1992 to withdraw it?
The arrival on the scene of the MR Vaccine
In the autumn
of 1994 it was announced that the Government feared an epidemic of measles and
that it aimed to vaccinate all children between the ages of 5 and 16 with the
Measles/Rubella vaccine.
Not everyone
agrees that an epidemic was imminent or that such a widespread vaccination
campaign was necessary.[24]
The story goes back further than that - to the MMR vaccines.
The two brands
of MR Vaccine which were used in the schools campaign are produced by the same
manufacturers as were the two brands of MMR vaccine which have now been
withdrawn (see above):
Merieux UK Ltd (Measles Rubella Vaccine Live Pasteur)
and SmithKline Beecham (Eolarix)
As far as we
can tell the active constituents of these two vaccines are exactly the same as
those in their withdrawn MMR vaccines, except that the mumps component has been
removed.Both brands of MR vaccines
each contain 2 viruses - to provide protection againstMeasles and Rubella.
A new MMR vaccine
In 1997 a new
version of MMR was introduced - Priorix
manufactured by Smithkline Beecham. We have no information at present about the
performance or safety of this vaccine.
Safety of the vaccines.
We deal below with side effects, but we are
disturbed at the lack of evidence of long-term safety trials. At the risk of
repetition we set out again the extract from the publication referred to in our
vaccines general information fact sheet:
"In the course of its review, the
committee encountered many gaps and limitations in knowledge bearing directly
and indirectly on the safety of vaccines.These include inadequate understanding of the biologic mechanisms
underlying adverse events following natural infection or immunization,
insufficient or inconsistent information from case reports and case series,
inadequate size or length of follow-up of many population-based epidemiological
studies, and limited capacity of existing surveillance systems of vaccine
injury to provide persuasive evidence of causation.The committee found few experimental studies published in
relation to the number of epidemiological studies published.Clearly, if research capacity and
accomplishment in these areas are not improved, future reviews of vaccine
safety will be similarly handicapped."[25]
So far, most
of the safety trials which we have identified, have monitored the children for
just 3 weeks after the vaccine was administered; and the longest we have so far
been able to find is a monitoring period of six weeks. It means that any adverse effect which occurred after the monitoring
period would not have been observed. The safety trials, in the main, have been of the separate
components of the vaccines (i.e. Mumps, Measles and Rubella). Trials of the
combined vaccine appear to be even thinner on the ground. This is admitted by
the Committee on Safety of Medicines:
"Before
measles, mumps, rubella (MMR) vaccine was introduced in this country, we
carried out a large scale study where adverse events were monitored in the
three week period following vaccination in approximately 12,000 children."[26]
This is
troubling because there special considerations should be given when more than
one live virus is administered as a vaccine at the same time. There is evidence
that the measles virus (or vaccine) can cause immunosuppression[27],
which in turn might allow opportunistic infection to develop from one of the
other viruses (such as rubella).Other
concerns have also been expressed:
"Modern
vaccine programs seem to ignore the high potential for mutation of viruses. It
was established in 1986 that a mixture of non-virulent viruses can produce a
disease by means of complementation or recombination. A team from the
University of California (Los Angeles) inoculated mice with two strains of
non-virulent herpes simplex virus type 1. Most of those that received a 1:1
mixture of viruses died. But the animals which received a 100 fold higher dose
of only one strain of virus survived. Virulent recombinations had been
produced. As early as 1984 R de Long warned that mass immunization with several
live viral vaccines might increase the probability of genetic recombination and
might result in new diseases."[28]
If anyone can help us to identify longer-lasting safety trials we
would be grateful to receive details.
We have asked the
Committee on Safety of Medicines to supply us with details of long term safety
monitoring of vaccines and they have so far been unable to supply them.
Side effects:
the official view
There is a
concept in medical cases called "informed consent". In simple terms,
has a patient been given adequate information to be able to make an informed decision about whether or not
to have a particular type of treatment?Because a child does not need to be vaccinated there must be a
duty to give very comprehensive information, so that parents can decide. Even
chances of several thousand to one against side effects may be unacceptable,
particularly as a child is put at risk of side effects as soon as a vaccine is
administered.
Yet little
information is made available about the side effects of the vaccines. They are
always played down, and in the booklets encouraging parents to have their
children vaccinated; they are hardly mentioned at all. In the booklet given to
families at the time of the Measles Rubella campaign in 1994 the following is
the entire information relating to safety of the vaccines:
Will
my child have any side effects after the injection
Side effects
are uncommon. They are usually very mild and disappear quickly. A few children
may get a mild fever, a rash, sore or aching joints, or feel a bit 'off-colour'
a week to ten days after the jab. But this should only last two or three days.
Children with these symptoms cannot give anyone measles or rubella.[29]
No other information giving details of side effects
is contained in any part of the booklet.
As can be seen, side effects do certainly exist:
"Reactions
from the live [measles] vaccine are usually mild, although convulsions and rare
cases of encephalopathy[30]
have occurred in connection with vaccination campaigns, but with the
improvement in vaccine production reactions are becoming less common. The risk
is certainly acceptable in countries where measles is still a killing
disease."[31]
We realise that this passage was written in 1979,
but by then measles vaccine had been widely used in this country for more than
10 years. It is rather odd, therefore, that the author is talking about an
"acceptable risk" in countries where measles is still a killer
disease. The same argument can be applied (justifiably) about vaccinations
against AIDS, where the risks from the illness are very severe. But deaths from
measles in this country have remained low since the 1950s.
The following
is the list of side effects taken from the datasheet for one of the brands of
MMR vaccine (MMRII). It should be emphasised that this too plays down the
incidence of vaccine side effects, but it does give much more information than
is generally available to the public:
From the MMR datasheet
"Because the vaccine is slightly acidic (pH 6.2‑6.6),
patients may complain or burning and/or stinging at the injection site for a
short time."Adverse reactions associated with MMRII are similar to those
to be expected from administration of monovalent vaccines given separately.
These may include malaise, sore throat, headache, fever and rash, nausea and
vomiting; mild local reactions such as erythema, induration, tenderness and
regional lymphadenopathy; parotitis, orchitis, nerve deafness, thrombocytopenia
and purpura; allergic reactions such as wheal and flare at the injection site
or urticaria; polyneuritis; and arthralgia and/or arthritis (usually transient
and rarely chronic). Cough, coryza and pharyngitis have also occurred.
"Moderate fever
(38.3'C/101'F) or high fever (above 39.4'C/103'F) may occur following
vaccination, predominantly between days 5 and 10. On rare occasions, children
developing fever may exhibit febrile convulsions. Rash occurs infrequently and
'Is usually minimal, but rarely may be generalised.
"Forms
of optic neuritis, including retrobulbar neuritis, papillitis and retinitis
have infrequently been reported one to three weeks after inoculation with some
live virus vaccines.
"Very
rarely, encephalitis and other CNS reactions have been associated with measles,
mumps, and rubella vaccines when given individually. These reactions might be
reported with MMRII.
"Experience
from more than 80 million doses of all live measles vaccines given in the USA
up to 1975 indicates that significant central nervous system reactions such as
encephalitis and encephalopathy, occurring within 30 days after vaccination,
have been temporally associated with measles vaccine approximately once for
every million doses. In no cases has it been shown that reactions were actually
caused by vaccine[32].
The risk of such serious neurological disorders following live measles virus
vaccine administration remains far less than that for encephalitis and
encephalopathy caused by natural measles (one per two thousand reported
cases).
"There
have been isolated reports of both the Guillain‑Barre syndrome[33]
being seen after vaccination and ocular palsies occurring 3‑24 days after
vaccination with a live attenuated measles virus vaccine, but no definite
causal relationship between the vaccine and the disease syndromes has been
established. Isolated cases of polyneuropathy, including Guillain‑Barre
syndrome, have also been reported after immunisation with rubella‑containing
vaccines.
"There
have been reports of subacute sclerosing panencephalitis (SSPE) in children who
did not have a history of natural measles but did receive measles vaccine. Some
of these cases may have resulted from unrecognised measles in the first year of
life or possibly from the measles vaccination. Based on estimated nationwide
measles vaccine distribution in the USA, the association of SSPE cases to
measles vaccination is about one case per million vaccine doses distributed.
This is far less than the association with natural measles: 6‑22 cases of
SSPE per million cases of measles.
"A
study suggests that the overall effect of measles vaccine has been to protect
against SSPE by preventing measles with its inherent higher risk of SSPE.
"Local
reactions characterised by marked swelling, redness and vesiculation at the
injection site of attenuated live virus measles vaccines, and systemic
reactions including atypical measles have occurred in vaccinees who had
previously received killed measles vaccine.
"Rarely,
there have been reports of more severe reactions, including prolonged high
fevers and extensive local reactions requiring hospitalisation. Panniculitis
has also been reported rarely following vaccination with measles vaccines.
"Arthralgia
or arthritis, or both, are usually transient and rarely chronic features of
natural rubella. Like the polyneuritis that is also a feature of natural
infection, their frequency and severity vary with age and sex, being greatest
in adult females and least in prepubertal children. This type of involvement as
well as myalgia and paraesthesiae have also been reported with the separate use
of the rubella vaccine.
"The
chronic arthritis associated with natural rubella has been related to virus
and/or viral antigen found in body tissues. Only rarely have vaccinees
developed chronic joint symptoms.
"Following
vaccination in children, reactions in joints are uncommon and generally of
brief duration. In women, incidence rates for arthritis and arthralgia are
generally higher than those seen in children (children: 0‑3%; women: 12‑20%)
and the reactions tend to be more marked and of longer duration. Symptoms may
persist for a matter of months or, on rare occasions, for years. In adolescent
girls, the reactions appear to be intermediate in incidence between those seen
in children and in adult women. Even in older women (35‑45 years) these
reactions are generally well tolerated and rarely interfere with normal
activities."[34]
In a letter to
doctors (not released to the general public) the Government's Chief Medical
Officer gave details of the expected side effects of the Measles Rubella
vaccination.[35] These are
reproduced here. The following is another list of concerns:[36]
Under
reporting of side effects
It is a
requirement that side effects to vaccines and other pharmaceutical products are
reported to the Medicines Control Agency/Committee on Safety of Medicines using
the so-called "Yellow Card" system.
It is widely
accepted that the adverse reactions to all pharmaceutical products are
seriously under reported, and that possibly only a tenth of all reactions are
ever reported.[37]
"Reporting to CSM is inevitably
incomplete: standardised criteria are not used, and there is no clinical follow‑up
to determine the outcome of reported reactions"[38]
In Vaccines and their Future Role in Public
Health. Parliamentary Office of Science and Technology July 1995 further
concern is expressed:
"Sometimes, concerns over the
safety of vaccines have turned out to be justified, as illustrated by recent
experience with the Urabe strain of MMR vaccine ‑ one of a number of new
strains of mumps virus developed in response to increasing demand in the
1980s.All the strains were based on
the wild‑type mumps virus, but differed slightly depending on the attenuation
procedure used.The Urabe strain was
thought to be slightly more efficient at stimulating immune responses, and was
licensed for use in the UK, Canada, France and a number of other countries.Meanwhile, the longer‑established
Jeryl Lynn strain continued to be used in the USA and Scandinavia and also to a
limited extent in the UK.
"As the MMR campaigns gathered
momentum in the late 1980s and early 90s, evidence began to accumulate that the
Urabe vaccine might be associated with a higher risk of meningitis 2‑5
weeks after vaccination, and suspicions were raised by the finding that virus
particles isolated from cerebrospinal fluid of affected patients were from the
Urabe strain. One country (Canada) stopped using the Urabe strain as early as
1989. In the UK however, alternative strains of mumps vaccine were not so
readily available, and several studies were set up to establish whether there
were increased risks involved. Studies based on voluntary reports gave
reassuringly low estimates in the region of 1 case of meningitis per 143,000
(39) to 250,000 (40) doses of Urabe vaccine (Table 9).But when greater efforts were made to
identify cases ‑ for instance by cross‑linking laboratory reports
or hospital diagnoses to vaccination records ‑ the risk rose to between 1
case per 4,000 dosesand 1 in
21,000.These findings suggested
significant under‑reporting of Urabe vaccine‑associated meningitis,
and led to the withdrawal of the vaccine from the market in 1992[39].All UK MMR vaccine now contains the Jeryl
Lynn mumps strain [See table below]
"What lessons can be learnt from
the failure of the Yellow Card surveillance system to detect the scale of the
problem?This system is inevitably
prone to a certain degree of under‑reporting because it relies on doctors
to make the connection between a particular set of symptoms and recent
immunisation, and report it to the CSM as an adverse event.However, the Urabe experience shows that
making a connection can be very difficult when there is an extended (2‑5
week) delay between vaccination and the onset of symptoms.Attention has thus turned to finding
alternative methods of monitoring for adverse reactions.[40]
A paper in the
Lancet records the failure of passive surveillance to detect an unacceptably
high risk of aseptic meningitis with measles/mumps/rubella vaccines that
contained the Urabe mumps strain.[41]
Our own
clients' experience has been that doctors have declined to report vaccine
reactions, even when they have occurred within a very short time of the vaccine
being administered. This is an incorrect approach. The guidance given to doctors is this:
"Doctors are
asked to report all suspected reactions to both new and established vaccines.
The balance between risks and benefits needs to be kept under continuous
review."
Our own direct
experience is that there has been substantial under-reporting of the side
effects following theMR (Measles
Rubella) schools campaign.
The Department
of Health reported that 80 children had suffered adverse reactions[42],
but JABs[43]has
122 cases on its database, and we have 140 on ours. There is some overlap, but
our guess is that the incidence of side effects known to us and JABs totals at
least 150, and almost certainly these will not include all the cases reported
to the Department of Health. It can therefore be safely said that the true
incidence of side effects is double the DoH figures and quite possibly
substantially more than that.
Ironically
there can also be over reporting of the incidence of measles (which can distort
the picture just as much):
"In a study of measles
notifications in 18 districts during 1991-3 Brown et al. show that surveillance
based on clinically diagnosed cases is now inaccurate and that detection of IgM
in saliva could provide an effective alternative to using serum samples for
laboratory confirmation.
"Our findings have implications
for vaccination policy. For example, the recent increase in the proportion of
notified cases in children under a year old may be spurious as infection was
confirmed in only 11% of cases in this group.[44]
Side effects: our investigations.
What you have told us
Clients (and those who have contacted us) have reported to us a
number of problems with the vaccine. To date we are aware of more than 800
instances of side effects following the MMR and MR vaccines. The figures in
[square brackets] give the numbers reported in respect of side effects so far
(as at May 1998). Note that some children will have more than one adverse
reaction. The side effects include:
Symptoms [number]
Autism[926]
Bowel
problems [309]
Epilepsy[199]
Other forms
of brain damage (including meningitis, cerebral palsy, encephalopathy,
encephalitis etc.) [107]
Behavioural
and learning problems (in older children) [110]
Myalgic
encephalomyelitis (ME) and chronic fatigue [41]
Guillain‑Barré syndrome [9]
Idiopathic
thrombocytopaenic purpura (and other purpuras) [6]
Subacute
Sclerosing Panencephalitis (SSPE) [3]
Wegener's
Granulamatosis [2]
Leukaemia
[1]
Multiple
sclerosis [3]
Deaths [22]
Alexander
Harris figures May 1998
Note: some of these figures overlap because some children
have more than one symptom.
What we have found
There is ample
confirmation in the medical literature of complications caused by the vaccines.
Curiously,
whilst mild reactions are admitted in the datasheets, and in the government
leaflets, serious adverse events are always dismissed as having nothing to do
with the vaccines.
If on the
other hand a child develops a serious condition after contracting the natural
diseases, there is no doubt in anyone's mind that the disease caused the
condition.
It is
therefore revealing to look in the medical literature which does reveal
concerns about serious (as well as mild) reactions.
Here is a selection only of what we have found.
There is plenty more evidence. We now have copies or summaries of thousands of
articles and reports on vaccine reactions.
The following are extracted from papers on the
subject.
"The main major complication of rubella vaccination is
arthralgia and arthritis... Occasionally particular effects may become both
prolonged and recurrent... Since joint symptoms occur at the same time as
productions of antibodies to virus, then they could be immune complex mediated
and the association with circulating immune complex as demonstrated would tend
to support this. Of course it is also possible that local replication of the
virus in joint tissues could be responsible for joint symptoms..."
"There have been a number of
reports of complications seen in combined vaccines including a rubella
component."[46]
"Nevertheless, immunisation with
measles, mumps and rubella vaccine carries a risk of first ever episodes of
joint symptoms, particularly in children under 5 years and in girls. The most
severe cases of arthritis were interestingly seen in older boys."[47]
"Rubella immunization or infection
is an uncommonly recognized cause of acute, recurrent, or persistent
musculoskeletal manifestations. After routine rubella immunization, two women
presented with the onset of polyarthralgia, arthritis, maculopapular rash,
fever, paresthesia, and malaise with persistent or recurrent manifestations
lasting longer than 24 months after vaccination. The patients expressed rubella
virus RNA in peripheral‑blood leukocytes 10 and 8 months after
vaccination, respectively, in contrast to repeated negative results in
asymptomatic rubella‑immunized controls. One patient developed
significantly depressed antibody responses to rubella virus after vaccination
and experienced a prolonged clinical improvement after a 3‑ month course
of intravenous immune globulin. The second patient had normal antibody
responses to rubella virus and underwent no clinical improvement during or
after intravenous immune globulin therapy. Rubella immunization or infection
should be considered as additional causative factors in evaluation of acute and
continuing musculoskeletal syndromes."[48]
Convulsions:
The table
(above) and the following are extracts from a paper giving details of findings
of a surprising increase in the incidence of convulsions, over what had been
previously considered to be the rate associated with the vaccines.
"Our
studies showed that there was an attributable risk of one in 2600 doses of a
febrile convulsion 15-35 days after giving the Urabe MMR vaccine."
See table
reproduced above, and note that the rate is high for the Jeryl Lynn strain too.[49]
Diabetes
A disorder caused by insufficient or absent production of
the hormone insulin by the pancreas.[50]
It has
recently been reported that diabetes is increasing at a rate of more than 10% a
year among children under 5, and that the increase has been noticed over the
past 10 years. This of course corresponds with the date of introduction of MMR
vaccines.[51]
Published
papers have suggested a possible link with the vaccine. One paper, published in
Finland, has suggested:
"Further studies are required to
determine if the vaccine virus, like natural mumps, could trigger the clinical
onset of Type 1 diabetes in young children"[52]
"Induction of Type I diabetes
mellitus: A total of 20 cases had been reported. The earliest case occurred 3
days after the receipt of vaccine and the latest 7 months after immunization.
Twelve cases were diagnosed within 30 days of immunization. The authors
considered the cases of diabetes mellitus to have a temporal relationship to
mumps immunization. For every 5 million children immunized against mumps 50
spontaneous cases of diabetes mellitus are to be expected by mere coincidence
within a period of 30 days after immunization. In fact, only 12 cases were
reported within 30 days after immunization."[53]
In Adverse Events Associated with Childhood
Vaccines the link between the mumps element of the vaccine and diabetes is
considered in detail. Inevitably the book records that there have been no
clinical trials, and it concludes that the evidence is inadequate to accept or
reject a causal relation between measles or mumps vaccine and diabetes.[54]
Crohn's disease is an inflammatory bowel disease which can
affect any part of the digestive tract causing mouth ulcers, stomach pains,
episodes of diarrhoea and vomiting. Surprisingly it can also be accompanied by
joint pains and swelling, and conjunctivitis of the eyes. It can take many
years to develop, but with children the first symptom is often malabsorption
and failure to thrive.
There is
convincing evidence of a connection between the vaccination and inflammatory
bowel disease (including Crohn's disease).[55]It is a serious lifelong illness
which has affected a large number of our the children we are helping. We are
working with Dr. Andrew Wakefield of the Royal Free Hospital London. He is
investigating this condition.
There is a
disturbing increase in childhood Crohn's disease, which seems to coincide
precisely with the introduction of the measles vaccines.
Autism (or
autistic features)
A condition which manifests itself in severe difficulties in
communicating and forming relationships with other people, in using languages
and abstract concepts. It is characterised by repetitive and obsessive patterns
of behaviour. Parents also report that their children lose co-ordination or
motor skills as well. Its cause is not understood, but it has been associated
with brain damage.
"Autism is one of the
developmental disorders of brain function; as in the others, there are several
causes. In most cases the cause is unknown.... There may be an inherited
susceptibility to some environmentally determined stress. In a few cases, there
is evidence of tuberous sclerosis, hypomelanosia of Ito, fragile X,
phenylketonouria, congenital rubella, neonatal herpes simplex, hydrocephalus,
malformation, or other static encephalopathy"[56]
The word
"autism" in relation to its present meaning did not enter the
language until about the same time as wide scale vaccinations were introduced[57].
About 350 new cases are reported each year[58]
A substantial
number of parents have reported that their children have become autistic (or
developed autistic symptoms)[59]
following administration of the vaccine (notably the MMR - as opposed to the MR
- vaccine)[60]. Autism is
far and away the most common side effect notified to us. More than two fifths
of all side effects associated with MMR involve autism.
It is important to emphasise that autism (or atypical autism) is the
manifestation of a condition. It is not an illness in itself. The descriptions
we have received are remarkably consistent. This is what one mother has written
to us:
Thomas[61]
has gone from being a happy fun-loving sociable child to a quiet introverted
and aggressive child. I have a little person who is locked up within himself.
And that person within holds the only key to comprehending what makes his world
revolve. Our world is one of confusion to Thomas and outside the home
environment every place, person and activity sparks off anxiety.
It is
important to stress that what we appear to be dealing with is cases of children
who did not have any of the typical signs of autism before they were vaccinated
- children who were developing normally in every way. If there are signs that a
child was not developing normally before being vaccinated, then
obviously the vaccine will not be implicated.
However, the
textbooks indicate that generally the signs are there to be seen even from a
very early age though sometimes it takes hindsight to identify them:
"Many children with autism are
extremely behaviourally deviant even during this first year of life. They may
engage in stereotyped hand movements and be completely passive, not interested
in exploring their environment, indeed showing no initiative whatsoever, and
perhaps already fiercely protesting when demands are made or routines changed.
A few reject body contact. Many prefer to be left alone"[62]
The same point
is echoed in a fact sheet from the National Autistic Society:
"In almost all children with
autistic spectrum disorders, the triad of impairments emerges in the first 2‑3
years of life.Some seem to be
developing normally in the first year or two (in rare cases even longer than
this) before the unusual behaviour begins. But in many, perhaps most, there are indications of
developmental problems within the first year of life.Many parents recall these early indications when interviewed,
though they may not have known their significance."[63]
The picture which is emerging is that the children who have become
"autistic" after being vaccinated were doing everything they should
before being vaccinated, and were showing none of the signs mentioned in the
above extract.
Is autism on the increase?
Anecdotal
evidence suggests that there has been a huge rise in cases of childhood autism
throughout the country. Using the rates of autism quoted above[64]
there should currently be only about 5600 cases of autism in the whole country
among children up to school leaving age[65],but we have heard that one county alone has
10,000 cases. One paediatrician exasperatedly asked a client of ours (the
mother of an autistic child): "Where
are all these cases coming from?"
We have a copy
of an extract of minutes of an extraordinary meeting of an education authority
which express extreme concern over the increased numbers of autism cases, and
the difficulty in coping with them.
A small branch
of the Norfolk Autistic Society is reported as having been told to expect only
three or four sufferers in their area, but there are already 46 "and the
numbers are growing daily".[66]
The Sussex
Autistic Society has told us that there appears to be a higher incidence of
children on the autistic spectrum being diagnosed.[67]
An American
Paediatrician, Dr. Michael J Goldberg writing on the Internet states:
While training as a pediatrician, I was
told if I saw one autistic child in a lifetime of practice it would be one too
many.What I am seeing today is not the
autism I learned about in medical school twenty years ago.What was once a relatively rare disorder is
now twenty times more likely to occur.Before, "autism" was 1‑2 per 10,000 births.Now, current statistics suggest a frequency
of 20 per 10,000 births (rates of 40 per 10,000 or higher have been suggested).[68]
Figures
published by the National Autistic Society suggest a huge increase in the
incidence of autism:
"The grand total for the whole
autistic spectrum is 518,000, an estimated prevalence of 91 people in every
10,000. These new figures reflect the widening definition of the autistic
spectrum. They cannot be taken as evidence for an increase in incidence of
these disorders. The question of whether the numbers are rising can be answered
only by a large-scale, detailed (and expensive) long term study."[69]
Even though the National Autistic Society seems to ascribe the
increase to better diagnosis, we are far from convinced. In any event a figure
of nearly one percent of the population with some form of autism is disturbing
Medical and
other carers who have spoken to us appear to be puzzled by this, and are
apparently seeking the cause.
All our cases
occur after October 1988 (the date when MMR was introduced). The first autistic
side effect we know about occurred in January 1989.
We have
details of a smaller number of cases involving the measles (only) vaccine. Our
sample is admittedly too small to be statistically significant (10 to date) but
it seems curious that autism cases among those given the measles monovalent
vaccine (which was available from 1967 to 1988 - 21 years) are so few compared
to those associated with MMR.
If the link
with autism is purely a chance one, then we would have expected there to have
beenchance connections with other
conditions made by parents whose children were vaccinated at around a year of
age. In some cases, the onset of autistic features takes a few months to show,
but in others it is only a matter of days before the child develops changes in
behaviour patterns.
We have used
the umbrella heading of "autism" but there are also children who,
whilst not coming within the definition of autistic, have developed behavioural
and/or learning problems after being given the vaccine.
If the MMR
vaccine is directly linked with autism then there is potentially a very serious
problem. We are surprised that (perhaps because there appears to have been no
adequate long-term follow up) so little of the current medical literature
(apart from that mentioned below) makes the connection with the vaccine.
Biological Mechanisms of the link between the vaccine and
autism
Damage to children does not just happen. There
is always a cause, though sometimes doctors are unable to find it.
"It is difficult to grasp the
plausibility of the biological theory when faced with the apparent
contradiction that in many children there may be no apparent medical condition
that has caused the autism, and no mental handicap or epilepsy. However when groups of children with autism are
studied, various medical conditions are found in association with autism more often
than one would expect. The implication then is that in all cases some biological cause is likely to lie behind the autism,
although currently this is only identifiable in a minority of cases."[70]
Indeed with
autism the medical experts freely acknowledge that they do not know what causes
it. The textbooks also indicate that late onset autism is unusual even within
the complexity of the various autistic syndromes:
"Cases with documented set-back
after a period of normal development are rare, but their relative frequency
within the whole group is not known."[71]
....And that of course is the
problem. As far as we can tell (and this book confirms) there have been very
few studies at all into late onset autism.
We have
therefore been considering how the vaccine can be linked with autism. Our
investigations indicate that there are biological mechanisms by which the
components of the MMR vaccinecan cause
encephalopathy which leads to autism.
It may be
caused by immune complexes (molecules of antigens and antibodies linked
together)blocking small blood vessels
in the brain[72].See, for instance, this extract from the
Practitioner of October 1967:
"Classical immuno‑chemistry
is based on the property many antibodies have of forming insoluble precipitates
with homologous antigens. If a largeexcess of antigen is added to such a precipitate the mixture becomes
soluble. These soluble antigen‑antibody (immune) complexes have important
biological effects. When injected into animals they can produce necrotizing vascular
lesions and severe damage to glomeruli. Immune complexes of this nature can
also be formed in vivo by simple immunization procedures; if the animal does
not produce too much antibody and the dose of antigen is correct, soluble
immune complexes are elaborated and serum sickness results. The nature of the
antigen and antibody may be entirely unrelated to the affected organ: for
example, complexes comprised of bovine albumin and anti‑bovine albumin
can be highly nephrotoxic. Apparently, some physico‑chemical property of
the immune complex is responsible, at least in part, for the tissue damage.
This can be demonstrated quite dramatically by an intradermal injection of
soluble immune complexes. Within a few hours, a haemorrhagic, necrotic skin
lesion (the Arthus reaction) appears.
"Two factors in addition to the
immune complex are important in the evolution of this lesion: polymorphonuclear
leucocytes and complement. The complexes have powerful chemotactic effects,
and, soon after their deposition, attract numerous granulocytes. These cells
contribute to the lesion by releasing numerous lytic enzymes from their
lysosomal granules. Complement is also drawn to the scene and, since it, too,
has enzymatic activity, further damage results. This mechanism is extremely
important in the production of various forms of glomerulonephritis and
vasculitis. The streptococcus may be the antigen in some cases of post‑scarlatinal
nephritis in man. In systemic lupus erythematosus there is important new
evidence that a complex comprised of the antinuclear antibodies characteristic
of that disease and DNA can provoke nephritis. There are now ample reasons for
believing that any antigen‑whether exogenous or endogenous‑capable
of eliciting the formation of a precipitating antibody, and hence a soluble
immune complex, can form the basis of serious immune injury. Bacteria, viruses,
chemicals, and drugs are certainly candidates in this important group of
diseases."[73]
Another possibility
Another
mechanism (which may be present at the same time) is the formation of
antibodies to myelin basic protein.
Myelin basic
protein acts like an insulating sheath around the nerve (not unlike the
insulation around an electrical cable). Without this insulation, complex
neuronal networks cannot be developed (and those that are developed will not
work correctly).
The process
starts soon after birth and continues until ten years of age, but most of the
myelin is laid down between the ages of 0 and 5 years.
The
distinguished neurologist Dr. Charles M Poser has drawn the link between the
vaccines and demyelination.
Almost any... vaccination can lead to a
non infectious inflammatory reaction involving the nervous system... The common
denominator consists of a vasculopathy that is often... associated with
demyelination.[74]
Myelin basic
protein is also found in the chick embryos in which the vaccine is cultured.
An
inflammatory reaction or the production of antibodies against traces of myelin
in the vaccine[75] can set up
an autoimmune response against the body's own myelin. The effect of this would
be a regression in development:
"At present, a cause or effect
relationship between antibodies to myelin basic protein and autism cannot be
defined very well.... We hypothesise that the development of humoral immune
response to myelin basic protein should be regarded as the proponent of
immunopathogenisis in a subset of autism.
"....if an immunological assault
perhaps secondary to a virus infection were to occur prenatally or postnatally
during infancy or early childhood, it could possibly result in poor myelination
or abnormal function of the neuron-axon myelin. The latter may be a critical
factor in the development of neurobehavioural problems in some cases of the
syndrome and should be worthy of future research for the understanding of a
pathological basis of autism."[76]
Similar views are expressed in a fact sheet on acute disseminated
encephalomyelitis produced by the Encephalitis Support Group:
"The association of the disease
with an antecedent infection or immunisation suggests an immunological process
and detailed laboratory studies involving measurement of anti-brain antibodies
and of cellular immune responses to specific myelin antigens have shown that
these patients indeed have mounted an allergic response against their own brain
constituents."[77]
A study of
autistic patients made by an immunologist in the USA, Dr. H H Fudenberg
included these findings:
"Fifteen of the TA [true autism]
patients developed symptoms within a week after immunization with the measles,
rubella and mumps vaccine (MMR): 3 had high fevers (up to 106o) and convulsions
within one day of administration; in the other 7 TA the symptoms gradually
worsened in severity (e.g. gradual rather than sudden loss of vocabulary) with
onset of clinical abnormality beginning between 15 and 18 months of age."
"Antibodies to myelin basic
protein were present in 20/22 TA and in 4/18 PAS [Pseudo autistic syndrome]
patients."[78]
The second extract in our view is extremely significant, because it
provides a strong indication that the mechanism put forward in this part of the
fact sheet could well provide an explanation for the link between the MMR
vaccine and autism.
Another
researcher in the field has reached a similar conclusion:
In conclusion the in vivo activation of
IL‑12 [interleukin‑12] and IFN‑g [interferon‑gamma] in
patients provides an important clue to the mechanism of autoimmunity, a
pathogenic factor for autism. Based on a regulatory feedback between IL‑12
and IFN‑g (a cytokine of Th‑1 cells) it is suggested that antigenic
stimulation of TH‑1 cells may be involved in autoimmune pathogenisis of
autism. In this respect, brain-derived myelin basic protein (MBP) may serve as
a candidate autoantigen since it induces macrophage-inhibition factor (Weizman et
al. 1982), autoantibodies (Sing et al. 1993) in many autistic children. This
however is one possibility while others remain to be investigated."[79]
Other authors have suggested a link between autoimmunity and
vaccines:
"Vaccines against infectious
diseases are in widespread use all over the world and are considered as
standard care in preventive medicine for children, specific groups of patients
(e.g. elderly or immune compromised patients) and health care personnel. In
recent decades, although it has been suggested in case reports that some
vaccines might trigger autoimmune disorders the subject has received
comparatively little attention in clinical and laboratory studies....
"Some vaccines consist of an
attenuated virus, others contain highly immunogenic substances. It is
conceivable that attenuated viral vaccines could induce autoimmunity in a
manner that is similar to the mechanisms that have been proposed to explain the
viral-autoimmunity association. Self limited viral infections might induce autoimmune
disorders long after the infecting agent itself has vanished.[80]
We have also
found this observation from Dr. Sudhir Gupta:
"One of the striking features in
all autistic patients that we have studied is a strong association between
immunization with MMR and the development of autism (regressive autism)"[81]
Dr. Gupta has also stated in a paper:
"We theorised that the high titers
of rubella antibody(>1280 vs.
normal <320) present in mothers of children with autism would be
transplacentally transferred and may also persist for a prolonged period in the
child. When such a child gets MMR immunization, rubella antigen may complex
with preexisting antibodies and such complexes might play a role in the
pathogenisis of autistic features."[82]
One possible
reason for a child's immune system being incapable of coping with the vaccine
might be a genetic deficiency in one of the complement proteins[83]
which are essential for the triggering of a normal immune reaction.
"Conceivably, human subjects one
or two C4B null alleles [a deficient form of complement C4B gene] may not be
able to clear certain viruses completely or before the viruses affect the
central nervous system...... It seems possible that C4B deficiency is
associated with a sub-group of autistic patients."[84]
The link with
disease (particularly rubella) is also acknowledged in The Biology of Autistic Syndromes:
"Rubella in utero has been shown
to cause an altered immune response in some infants owingto the prenatal viral insult (South and
Alford 1973, Fuccillo et al.1974). Lack of an antibody response to a previous
vaccination is helpful in diagnosing retrospectively an episode of prenatal
rubella. Stubbs (1967) checked rubella titres in 13 children with autism who
had had a previous rubella vaccination. In contrast to controls, five of the 13
children with autism had undetectable titres in spite of a previous
vaccination. However, in the same study, a rubella vaccine challenge did not
differentiate children with autism from the control subjects."[85]
This chapter
in the book concludes:
"A great deal more work is needed
before it is fully understood how the immunological factors in patients or
families could predispose to the infectious aetiology of autism..."[86]
We would
agree, but we would also repeat that it is clear the Department of Health are
in no position to assert that a vaccine containing the measles mumps and
rubella viruses has no link with the late development of autism.
Clearly a number of researchers
have independently begun to point to immunisation (particularly with rubella)
as a risk factor.
A US Court case involving autism.
We have a copy
of the judgment of the United States Court of Federal Claims of Lassiter v
Secretary of the Department of Health and Human Services.[87]This case involved the DPT vaccine but the biological mechanism of damage
is identical. We quote below from the judgment:
"Doctors Steffenburg and Gillberg
list many disorders, 22 in all, which have been associated with autism. They
conclude that autism is not a disease but 'represents a behavioural syndrome
with multiple etiologies.... Autism can be the final common expression of
various contributory/etiological factors.' They explain further that genetic
factors are in operation in some cases. 'Disease entities or pre- and perinatal
damage leading to destruction /dysfunction in certain brain areas can cause
autism in others.' 'The Etiology of Autism,' [88]Diagnosis and Treatment of Autism, Gillberg, ed., Proceedings of the
State-of-the-art-Conference on Autism: held May 8-10 1989 in Goteborg Sweden.
"Dr. Gerhard Bosh states in his
treatise on 'Infantile Autism' that various factors or noxae working together
can cause autistic symptoms, either triggering the autistic behaviour or
intensifying the effect.[89]He explains further that as a result of 'cerebral affections suffered in
early childhood a clinical picture could develop that would be
indistinguishable from that of infantile autism.' He cites case reports in
which insults to the brain were followed by onset of infantile autism. 'Autism
can occur or be closely simulated in children with known organic brain damage.'
Other etiologic factors include complications at birth, prenatal damage,
infectious diseases, encephalitis. 'In one case an indeterminate post-natal
feverish illness occurred, after which the development of the child is said to
have changed.... Symptomatologically equivalent cases of autism [can be caused]
by cerebral-organic damage.'[90]
"In his treatise entitled 'Recent
Neurobiological Findings in Autism,' Luke Y Tsai also lists a similar variety
of established neurologic disorders reported in autism including viral
infections and other toxic or environmental causes of brain damage. He explains
that it is now well accepted that autism results from dysfunction in certain
parts of the central nervous system (CNS) that affect language, cognitive and
intellectual development, and the ability to relate. He believes that autism
may be 'the common pathway of a diverse range of organic brain conditions'
including both prenatal and post-natal infections or injuries, the latter accounting for those whose
autism is manifested 'after a period of apparently normal development'[91](Our emphasis)
The enigma of autism - some thoughts of our own.
The apparent
link between autism and the MMR vaccine troubles us greatly. It is also controversial, with the
Department of Health firmly dismissing any possible link, and the parents of
affected children being convinced of it.
Certain facts seem undeniable:
1The children all had the MMR vaccine.
2Before they were vaccinated they were
(according to their parents) developing perfectly normally, passing all
milestones, demonstrating normal skills, and showing none of the classical
signs of autism. Indeed in many of the cases we have studied in detail, the
children appear to have been advanced in their development.
3After being vaccinated they regressed
(sometimes within only a few days),losing mental, physical and social skills. Many are so severely
handicapped that they have to have constant supervision and are subject to
educational 'statementing'.
4It is quite clear that medical science has,
as yet, no explanation for autism. There are plenty of theories, but no
answers. Late onset autism seems to be particularly perplexing to those investigating
autism, with the strong suggestion that it must have been there from birth, but
was simply not observed (or did not manifest itself until later):
"The abnormality in the brain
which causes autism may well, in certain cases, have been there from before
birth, but before a certain age, the nervous system is able to deal with the
demands posed by development. Gradually, the brain can no longer fully cope
with these demands and the autistic symptoms appear clearly for the first time.
In such cases 'autism', even if congenital, will appear to have its onset after
infancy"[92]
5It is however acknowledged that autism can
be 'caused' by some insult.
"In other cases, however, it is
clear that the autistic syndrome developed after some particular postnatal
brain affliction such as herpes encephalitis"[93]
This seems obliquely to be acknowledged
even by the Government's Chief Medical Officer:
"It is therefore highly unlikely
that MMR vaccine plays a part in the development of autism in children who do
not have significant neurological manifestations after immunisation"[94]
The inference is that he concedes
that MMR does play a part if there is
a "significant neurological manifestation".
Although there is sometimes an
immediate reaction to vaccination, our experience suggeststhat this is not necessary to produce autism
or other adverse reactions. Deafness, for instance, is often not accompanied by
any noticeable reaction.[95]
But, the autism reported to us by parents is showing itself at
about the same time as it did in children before the MMR vaccine was
introduced. It is also appearing in the same ratio (4 to 1 in favour of boys)
as it has always done. If it were happening independently of the vaccinations,
then it would show the same pattern.
What is there
to indicate that autism after vaccination is in any way different from autism
which occurred in the general population before the MMR (and measles) vaccines
were introduced?
Firstof all there is the congenital autism (estimated as
occurring in 80 per cent of cases)[96].
If this percentage is correct, then the majority of autistic children were
doomed from birth to develop the symptoms, which will show themselves in the
normal manner. What we are therefore concerned about is the remainder which
will include thosewhere some event
happened to bring on the autistic symptoms. It is also likely to be a sub-set:
we have already noted that it is described as 'atypical' autism. Many of the
children do not conform exactly to the classical definition of autism. That may
give a clue.
Secondly,in this section of the fact sheet, we have
highlighted the concerns and findings of doctors and scientists investigating
autism and its possible links with MMR vaccine. They certainly have noted a
connection with the vaccine, and with the same viruses contained in the vaccine
(especially rubella).
Thirdly, we have
described ways in which the vaccine might cause autism. In other words, there
is biological plausibility.
Fourthly, we have
noted that there is anecdotal (and sometimes direct) evidence of a significant
increase in autism in this country. If the incidence of autism is rising above
normally expected levels, then something must be causing it.
Fifthly, even though
the link between autism and vaccines is rejected by the government, nobody
knows what does cause it.
No records are
kept centrally of the incidence of autism. This state of affairs was the
subject of criticism by the House of Commons Health Committee:
"We are concerned at the failure
of the DoH [Department of Health] to collect information centrally on autistic
children and to issue specific guidance on services for such children."[97]
What,
inevitably, they must therefore be saying is "We don't know what is
causing it but we know it is not the vaccine" (a difficult argument to
sustain).
Sixthly, we have the
accounts of more than 400 parents who believe that their children were indeed
normal before they were vaccinated, and who can point to nothing (other than
the vaccination) which could account for the deterioration in their children's
condition.
Seventhly, it is often
not just autism which manifests itself after the MMR vaccination. Families have
reported to us that their children changed in other ways too after being
vaccinated. For instance they developed one or more of the following:
_A
raging thirst
_Disrupted
sleep patterns
_Loss
of temperature control
_Appetite/dietary
changes
_Loss
of motor control
_Loss
of previously acquired speech
_Bowel
problems (see below)
It is right to
suggest that some parents may not have noticed if a child was simply not
developing, but it is highly unlikely that parents would have failed to notice
if their children had shown, before vaccination, any of the more dramatic signs
we have mentioned here.
Eighthly we have the
links with inflammatory bowel disease (see below). About half of the vaccinated
children with autism have some form of chronic intestinal problem. Furthermore,
their autism improves (but is not cured) if the bowel inflammation is reduced.
It might well be possible to show involvement with the vaccine virus in respect
of the intestinal conditions. But it goes further than that. We know of experts
who believe that there is a connection between autism and peptides leaking
through the gut wall.
"Our results show that in some
patients with infantile autism damage to tight junctions of the gut mucosa as
evidenced by IPT occurs in the absence of established gastrointestinal
disorders. Such alteration could represent a "possible" mechanism for
the increased passage through the gut mucosa of peptides derived from
foods."[98]
Damage to the gut wall is caused by inflammatory bowel disease, and
it looks likely that we will be able to show that the vaccine causes that
condition. Therefore, through this route alone, it follows that there is a
clear possible link with the vaccine.
Inflammatory bowel disease and Autism
As we have
already mentioned, there also could be a link between the two conditions (IBD
and Autism) AND the measles element of the vaccine. Our work also indicates a
clear biological mechanism for the two conditions. Indeed many children with
autism have chronic bowel disorders. There
have been some striking improvements in the autistic condition of some children
after their bowel problems have been appropriately treated.
Conclusion
We have gone into the matter in some
considerable detail because we feel that it is time to make it clear that
vaccine damage is not some capricious concept, but is very real, and is
demonstrable using scientific principles.
There is no
doubt at all that the children we are helping are now ill or disabled (many
very seriously). All have had the MMR or MRvaccine and in the vast majority of cases there is no event other than
the vaccination which could account for the injury.
We repeat that
this factsheet does not give medical advice, and nor does it seek to persuade
anyone to have, or not to have, a child vaccinated.
If you believe your child has been damaged:
We will be
glad to try to help if you believe your child has been damaged by the vaccine.
We do not want to raise false hopes. It will not be an easy task. There will be
many hurdles to overcome. The only promise we can make is that it will be a
long hard struggle.
Nonetheless we
propose to seek proper compensation in the courts, but we will also help with
applications to the Vaccine Damage Tribunal.
Alternatively
if you have your own solicitor we will be happy to provide assistance to him or
her; we are helping a number of firms of solicitors under our contract with the
Legal Aid Board to investigate claims arising from the MMR and MR vaccines.
The first
thing to do is to get the facts, and then to apply for legal aid (parents'
finances are not taken into account in applications for children). We (or your
own solicitor) will take care of the paperwork. Ask us for more details.
In the interests of balance:
The Department of Health has now produced its own fact sheet on MMR
vaccines. Your GP should be able to supply you with a copy, or alternatively
you can contact the Department of Health,Wellington House, 135-155 Waterloo Road, London SE1 8UG.
If you need any further information (or further copies of this fact
sheet) please feel free to contact our team at Alexander Harris.
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.
[1]Inevitably there are conflicting points of
view when issues relating to vaccines are considered. One high ranking official
at the Department of Health has described the fact sheet in this way in an
email to a client: "the fact sheet you refer to is flawed, unscientific
and misrepresents the weight of evidence available." He is entitled to his
point of view. We are entitled to ours, and parents are entitled to a good deal
more information than is currently made available to them, especially when
normal well adjusted children inexplicably become ill or disabled after
receiving a vaccination designed to protect them.
[2]Merck v Allison
[3]From Immunisation against
infectious diseases (the green book) 1996 edition
[4]From the MacMillan Guide to
Family Health 1982
[5]Comment from the
Medicines Control Agency:
"The fact sheet
dismisses the seriousness of measles and criticises the HEA publication.
However, measles can kill as demonstrated by the 130 deaths among 46,000
reported cases in the USA between 1989-90 (Grindler et al. Epidemiol Rev 1992;
14:270-276)"
[6]The version we quote from is a
1985 reprint.
[7]Contrast with the vaccine, which
clearly does not give lifelong immunity.
[8]The Practitioner November 1967 pg
607. [In fairness, the article still goes on to argue that children should be
vaccinated against measles, but it is interesting that the emphasis seems to be
much more on the poor overworked doctor than the dangers of the disease]
[9]The Theory and Practice of Public
Health Edited W Hobson. 5th Edition. Oxford University Press 1979.
[10]Ibid. at page 236.
[11]This booklet was issued to
millions of families in the autumn of 1994 before the start of the Measles
Rubella vaccination campaign. See later.
[12]S O Shaheen, P Aaby et al. Lancet
29 June 1996. Vol. 347 pp 1792-1796
[12]Comment from the Medicines Control
Agency:
"There
are two studies from Guinea-Bissau. The study by Shaheen et al. in the Lancet
was strongly criticised because of biases and because 25% of the measles cases
died from the disease. The findings of that study have not been confirmed by
other workers. In their second study, Shaheen et al. do not conclude that
"measles actually protects against some conditions"
[13]Immunisation Awareness Society
Incorporated. PO Box 56048, Dominion Road, Auckland, New Zealand. (ISSN
1170-7208). Vol. 4 No 3. Page 7. Those in the medical profession might regard
this passage as being "on the fringe", but the assertions made are
backed up by several references to medical literature(as does the Lancet paper we have just cited). We will be happy
to supply details of those references.
[14]Live measles vaccine: a 21 year
follow up. Miller‑Christine‑BM.The British Medical Journal. 1987 Jul. 4. 295(6589). pp 22‑24.
Note the following extract:
"During the 21 years
doctors assessed more cases of measles as being mild in vaccinated than in
unvaccinated participants.The
difference was highly significant (p < 0.001) between 1964 and 1972, but as
reported cases became fewer the difference was no longer significant.During the last nine years only five cases
(three of them in the unvaccinated group and two in the group vaccinated with
killed and live vaccine) were described as severe, and no complications or
deaths were reported."
[16]See later under the heading
"Under reporting of side effects". The Chief Medical Officer seems to
have got this wrong. One investigation found the incidence of side effects to
be as lowas one in 4000. See also
notes at the end of this section.
[17]Letter date 14 September 1992 to
all Doctors in England from Dr K C Calman Chief Medical Officer
[18]Announcement made in British
National Formulary March 1993. The
Department of Health has told us that the products are still licensed.
Nonetheless they are not being used at all in this country.
[19]COMMENT FROM THE MEDICINES CONTROL
AGENCY:
"We
refute the allegation that there has been "massaging" of the
frequency of the vaccine associated meningitis after Urabe vaccine. You imply
we quoted the frequency of in in 4000 after the figure of 1 in 11,000. The size
of the confidence intervals for such estimates means these are not statistically
significantly different from the other . The first figure resulted from a paper
published in 1992 (Colville et al. Lancet 1992, 34 786) and the second from a
paper in 1993 (Miller et al. Lancet 1993, 341: 979-982). This is the reverse of
what is stated."
[20]A prefecture‑wide survey of
mumps meningitis associated with measles, mumps and rubella vaccine. TAKASHI
FUJINAGA, MD, YOUICHI MOTEGI, MD, HIROSHI TAMURA, MD ANDTAKAYOSHI KUROUME, MD.
Pediatric Infectious Disease Journal (R) March 1991Volume 10, Number 3
COMMENT FROM THE MEDICINES
CONTROL AGENCY:
"You
mentioned the Japanese study with higher frequencies of vaccine-associated
meningitis. This is not comparable to the UK because the vaccines used in Japan
were different formulations to those that were used in the UK"
[21]Letter dated 26 October 1994 from
Akin Yamada of Department of Viral Disease and Vaccine Control.
[22]7.1/1000 = 78.1/11,000.
[23]Canada Diseases Weekly Report
December 15 1990 Vol. 16-50 p253.
[24]See Bulletin of Medical Ethics No
110 (July/August 1995); See also response from the Public Health Laboratory
Service in the Bulletin of January 1996, pages 16-23.
[25]From Adverse Events Associated
with CHILDHOOD VACCINES Evidence Bearing on Causality (ISBN 0-309-04895-8).
National Academy Press Washington DC. 1994: P316
[26]Extract from letter dated 9
January 1990 from Dr. D M Salisbury at the Committee on Safety of Medicines.
[27]See Paediatric Infectious Disease
Journal (R) June 1993Volume 12, Number
6 Increased mortality after high titer measles vaccines: too much of a good
thing. By Halsey, Neal A.,
[28]Long term effects of early
vaccinations.Dr.
Michel Odent. Publication:
Primal Health Research Vol. 2 No 1. P.6) Date: Summer 1994. The two
studies he refers to are: Javier, R T, Sedarati, F., Steven, J G: Two avirulent
herpes simplex viruses generate lethal recombinations in vivo. Science 7
November 1986 234: 746-47; De Long, R., A possible cause of acquired immune
deficiency syndrome and other new diseases. Medical hypothesis. 1984;
13:395-97.
[29]From: MEASLES why every child in
school needs to be protected from measles this autumn. 1994 [Health Education Authority/Department of Health Publication]
[30]Any disease or disorder affecting
the brain, including chronic degenerative conditions.
[31]from: The Theory and Practice of
Public Health Edited W Hobson. 5th Edition. Oxford University Press 1979. Page
241.
[32]The American version of this
datasheet adds more here:
"The
Center for Disease control has pointed out that 'a certain number of cases of
encephalitis may be expected to occur in a large childhood population in a
defined period of time even when no vaccines are administered'. However the
data suggests the possibility that some of these cases may have been caused by
measles vaccines" [our underlining]
[33]COMMENT FROM THE MEDICINES CONTROL
AGENCY:
"There
is now positive evidence against an association between measles vaccine and
Guillain Barré syndrome (daSilveira et al. Lancet 1997, 349:14-16). We suggest
you mention this study."
[34]Taken from 1990-91 Data Sheet
Compendium
[35]Letter dated 27 September 1994 to
Doctors and Nursing Officers from Dr Kenneth C Calman and from Miss Y Moores.
[36]Table taken from Vaccines and
their Future Role in Public Health. Parliamentary Office of Science and
Technology July 1995 page 40 (see below)
[37]COMMENT FROM THE MEDICINES CONTROL
AGENCY:
"Suspected
adverse reactions to licensed medicines are reported on Yellow Cards. These
reports do not necessarily imply a causal association.
[38]Meningoencephalitis associated
with MMR vaccine: H C Maguire et al. Review Volume 1 Number 6. 24 May 1991.
Page R60.
[39]Our underlining
[40]Table and text taken from:
Vaccines and their Future Role in Public Health. Parliamentary Office of
Science and Technology July 1995pages
40-41.This publication seems to
contradict itself because elsewhere it appears to accept the evidence of the
Yellow Card system when contending that concerns over vaccine safety are unfounded
(page 39)
[41] A new method for active
surveillance of adverse events from diphtheria/tetanus /pertussis and measles
/mumps /rubella vaccines by Paddy Farrington et al. (Public Health Laboratory
Service) Lancet March 4 1995. Vol. 345. Pages 567-569. (Referred to below)
[42]Report in The Times of 21 December
1994 page 5.
[43]Justice Awareness Basic Support; a
support group to help families with vaccine damaged children. Address given in
our Vaccines General Factsheet.
[44]From BMJ Vol. 308 16 April 1994.
Pages 1015-1017 (and "This week in BMJ").
COMMENT FROM THE MEDICINES
CONTROL AGENCY:
"Possible
over-reporting of the incidence of measles was taken into account in the
mathematical modelling justifying a second dose of MMR vaccine. Other misconceptions
about the MR vaccination campaign have been addressed elsewhere (Gay et al. CDR
Review 1995; 5(13): R204-R207)
[45]COMMENT FROM THE MEDICINES CONTROL
AGENCY:
"Although
there are studies showing an association between rubella vaccine and joint
reactions, two studies have failed to show an association between either MMR
vaccine or rubella vaccine and arthritis or joint reactions respectively
(Taranger J et al. Lakartdningen 1984;81:1936-1937; Slater PE et al. Vaccine
1995;13(16)1529-1532). Because joint reactions after rubella vaccine are
related to age, the risks and benefits of this vaccine has been improved by the
decision not to routinely immunise girls aged 10 to 14 years. This change of
policy was the a direct consequence of the successful MR vaccine
campaign."
[46]Complications of Rubella
vaccination. From: "Rubella in Pregnancy" by Nick Sidle MB BS BSc.
Pages 63-65.
COMMENT FROM THE MEDICINES
CONTROL AGENCY:
"The
risk of arthritis was not significantly increased in this study. About 80% of
reported limb or joint reactions were non-specific limb pain. Also, in this
study the relative risks of convulsions, lymphadenopathy fever, rash and
admission to hospital were not increased
[47]Joint and limb symptoms in
children after immunisation with measles mumps and rubella vaccine. C
M Benjamin et al. BMJ
April 25 1992 Vol. 304 no 6834. Pages 1075-1078
[49]A new method for active
surveillance of adverse events from diphtheria/tetanus /pertussis and measles
/mumps /rubella vaccines by Paddy Farrington et al. (Public Health Laboratory
Service) Lancet March 4 1995. Vol. 345. Pages 567-569. Table reproduced by kind
permission of the Lancet.
COMMENT FROM THE MEDICINES
CONTROL AGENCY:
"While
the absolute risk of a convulsion 15-35 days after the vaccine is 1 in 1,700,
the attributable risk is zero. The convulsions reported during the period are
exactly what would be expected from the background rate. This means that no
excess number of convulsions attributable to the vaccine was observed and it is
incorrect to say so."
[50]From: the Complete Family Health
Guide.
[51]Report in the Sunday Times. 19
January 1997.
[52]Decline of mumps antibodies in
type 1 (insulin dependant) diabetic children and a plateau in the rising
incidence of type 1 diabetes after introduction of the MMR vaccine in Finland
Author(s): Article: H Hyoti et al. Publication: (Diabetologia Vol. 36
No. 12: pp.1303-1308) Date: 1993
COMMENT FROM THE MEDICINES
CONTROL AGENCY:
"A
case control study from Sweden found no evidence to suggest any immunisation
increases the risk of insulin dependent diabetes (Blom L et al. Diabetologia
1991;34:176-181). We understand that this conclusion has been substantiated by
a further study which is in press."
[53]Title: The Vaccine Adverse Events
Reporting System (VAERS): A single post‑marketing surveillance system for
vaccines in the United States. Poster presented at: 7th International
Conference on Pharmacoepidemiology, Basel, Switzerland, August 26‑29,
1991. Author: Mullen‑J‑R; Chen‑R‑T; Swint‑E;
Hayes‑S‑W; Rastogi‑S; Knapp‑G. Publication Year: 1991;
Source: Annual 16, page 389
[54]Adverse Events Associated with
CHILDHOOD VACCINES Evidence Bearing on Causality (ISBN 0-309-04895-8). National
Academy Press Washington DC. 1994: Pp 153-159
[55]See Is measles vaccination a risk
factor for inflammatory bowel disease? N P Thompson et al. The Lancet Vol. 345:
pp.1071-1074. Date: April 29 1995
[56]Merritt's textbook of Neurology
9th edition. 1995
[57]Leo Kanner 1943.
[58]Source: Children with Autism by
Colwyn Trevarthen and others. Publisher Jessica Kingsley (1996) page 1
[59]The condition has been described
as atypical autism or a disintegrative disorder. It has features of autism but
normally the signs of autism manifest themselves at a much earlier age _ or at
least can be recognised retrospectively once a diagnosis has been made. For the
sake of simplicity we shall refer to the condition as autism in this factsheet
even though strictly speaking it may not be exactly the same condition as has
come to be given that name.
[60]If the vaccine is a factor, the
reason is probably that the MMR vaccine is given at an earlier age (while the
brain is still in the process of myelination), but behaviour problems have been
reported among older children given the MR vaccine.
[61]Not his real name, but these are
the actual words written by a mother to us.
[62]The Biology of Autistic Syndromes;
Christopher Gillberg and Mary Coleman; Mac Keith Press; 2nd Edition (ISBN (UK)
0 901260 92 4) Page: 57.
[63]From Autistic Spectrum Disorders
an aid to diagnosis by Lorna Wing MD FRCPsych. 1995. P7. Available from the
National Autistic Society.(Our under
lining)
[64]Children with Autism by Colwyn
Trevarthen and others. Publisher Jessica Kingsley (1996)
[65]i.e. 350 per yearx16
years = 5600)
[66]Eastern Daily Press 5 November
1996 page 25.
[67]Letter dated 24 March 1997
[68]"Autistic Syndrome" A
Medical Problem. Dr. Michael J Goldberg, Tarzana, California.
[69]Newsletter from the National
Autistic Society published in May 1997: page 3
[70]From AUTISM THE FACTS by Dr. Simon
Baron-Cohen and Dr. Patrick Bolton. Oxford Medical Publications 1993: Page 27.
[71]The Biology of Autistic Syndromes;
Christopher Gillberg and Mary Coleman; Mac Keith Press; 2nd Edition (ISBN (UK)
0 901260 92 4) Page: 22
[72]Both the brain and intestine are
both richly supplied with blood through a network of very small blood vessels.
[73]Advances in Clinical Immunology by
Robert Schwartz Practitioner October 1967 Pages 514-515.
[74]Poser C M.Neurological syndromes that arise unpredictably.
Consultant. January 1987 pp 45-46
[75]The manufacturers acknowledge the
importance of removing the culture medium from the vaccine, and claim that
modern MMR vaccine is not contaminated by any trace of the chick embryo (that
includes yolk sac and egg albumen).However
if this is the case, why would a hypersensitivity to egg be a contra-indication
to all brands of the MMR and MR vaccines?
COMMENT FROM THE MEDICINES
CONTROL AGENCY:
"Allergy
to egg is no longer a contraindication to MMR vaccine. We are not aware of any
evidence of myelin contaminating MMR or MR vaccines. Please can you justify
this claim."
[76]Antibodies to Myelin Basic Protein
in Children with Autistic Behaviour. V.K.Singh, Reed P Warren, J Dennis Odell,
W Louise Warren and Phyllis Cole:Brain,
Behaviour and Immunity Volume 7 pp97-103 (1993).
[77]Fact sheet No 2: "Acute
Disseminated Encephalomyelitis"; Encephalitis Support Group; Paper written
by Professor Peter O Behan, Professor of Neurology, Glasgow University.
[78]Dialysable lymphocyte extract
(DLyE) in infantile onset autism: A pilot study. By Dr. H H Fudenberg.
Biotherapy 9 (1996): Page 144.
[79]Plasma increase of interleukin-12
and interferon‑gamma: Pathological significance in autism. Vijendra K.
Singh; Journal of Neuroimmunology 2915 [1996].
[80]Vaccine-Induced Autoimmunity.
Arnon Dov Cohen and Yehuda Shoenfeld; Journal of Autoimmunity: (1996)9, 699-703
[81]Immunology and Immunological
Treatment of Autism. Conference paper delivered by Dr. Sudhir Gupta MD PhD,
Department of Medicine, University of California.
COMMENT FROM THE MEDICINES
CONTROL AGENCY:
"The
conference paper by Dr. Gupta to which you refer is not readily available in
the UK and is not an example of "mainstream literature". The other
reference you produced by Dr. Gupta contains no evidence of an association
between MMR and autism. He merely discusses an unsubstantiated theory."
[82]Taken from: Dysregulated Immune
System in Children with Autism: Beneficial Effects of Intravenous Immune
Globulin on Autistic Characteristics by Sudhir Gupta et all. Journal of Autism
and Development Disorders Vol 26 No 4. 1996
[83]Complement forms a system of 18
proteins which are an integral part of the immune system reaction to an antigen
such as a bacterium or virus.
[84]Decreased Plasma Concentrations of
the C4B Complement Protein in Autism Author(s): Warren R P, Burger R A, et al.
Publication: Archives of Pediatrics and Adolescent Medicine Vol. 148 P 180-183)
Date: February 1994.
[85]The Biology of Autistic Syndromes;
Christopher Gillberg and Mary Coleman; Mac Keith Press; 2nd Edition (ISBN (UK)
0 901260 92 4) Page: 134
[86]Ibid. Page 135
[87]Case 90-2036V Filed: December 17
1996.
[88]P Ex 21 at 65, 73-75
[89]P Ex 20 at 130
[90]Ibid. at 132-134
[91]Ibid. at 83-84 P Ex 21. This
extract from judgment in Lassiter v Secretary of the Department of Health and
Human Services taken from pages 7-8. We currently do not have the texts
referred to, but these are on their way, and presumably the judge summarised
the medical literature accurately.
Note: the court found in
favour of the autistic claimant.
[92]The Biology of Autistic Syndromes;
Christopher Gillberg and Mary Coleman; Mac Keith Press; 2nd Edition (ISBN (UK)
0 901260 92 4) Page: 57
[93]The Biology of Autistic
Syndromes;Page: 61. See also the
report on the Lassiter case (above)
[94]Memorandum to all Directors of
Public Health reference EM/CMO/97/3 dated 7 February 1997 from Sir Kenneth
Calman, Chief Medical Officer, Department of Health.
[95]See, for instance: Sensorineural
hearing loss following live measles virus vaccination Author(s): Letter: Watson
J G.Publication: International Journal
of Pediatric Otorhinolaryngology Vol. 19: pp.189-190) Date: 1990
[96]The Biology of Autistic
Syndromes;Page: 22
[97]Commons Health Committee: Second
Report. The Specific Health Needs of Children and Young People; Volume 1; 10
February 1997; Paragraph 105.
[98]Abnormal intestinal permeability
in children with autism: P D'Eufemia et al. Acta Paediatr 85. 1076-9. 1996.
P.1078
"A foolish faith in authority is the worst enemy of truth."
-- Albert Einstein, letter to a friend, 1901
"I know of no safe depository of the ultimate powers of the society but the people themselves, and if we think them not enlightened enough to exercise control with a wholesome discretion, the remedy is not to take it from them, but to inform their discretion by education."
-- Thomas Jefferson, letter to William C. Jarvis, September 28, 1820
"What's the point of vaccination if it doesn't protect you from the unvaccinated?"
-- Sandy Gottstein
"Who gets to decide what the greater good is and how many will be sacrificed to it?"