Mumps, Measles and Rubella (MMR) Vaccines - Fact Sheet

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Mumps, Measles and Rubella (MMR) Vaccines

and Measles Rubella (MR) Vaccines

 

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 Smith  the 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 first  publication because it came out some years  before 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 adverse  reactions to these types of MMR vaccine were up to  78  times as frequent as our Government's Chief Medical Officer of Health  has 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 against  Measles 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 recombination’s 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 doses  and 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 the  MR (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]

Behaviour and learning problems  [175]

Arthritis  and  arthralgia (including crippling juvenile rheumatoid arthritis) [81]

Deafness in one or both ears [49]

Diabetes  [29]

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.

 

 

Arthritis:[45]

 

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]

 

Inflammatory Bowel Disease (including Crohn's Disease)

      

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 been  chance 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 vaccine  can 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 large  excess 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 owing  to 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:

1     The children all had the MMR vaccine.

2     Before 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.

3     After 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'.

4     It 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]

5     It 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 suggests  that 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?

 

First of 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 those  where 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 MR  vaccine 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."

    [15]              Immunizations and brain damage. Iannetti‑P; Spalice‑A; Terenzi‑S; Raucci‑U; Parisi‑P.  PEDIATR‑OGGI‑MED‑CHIR. 14/3‑4 (31‑36) 1994

    [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 low  as 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 1991   Volume 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 1993  Volume 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 1995  pages 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

    [48]              Chronic rubella vaccine‑associated arthropathy.  Mitchell‑LA; Tingle‑AJ; Shukin‑R; Sangeorzan‑JA; McCune‑J; Braun‑DK.  ARCH‑INTERN‑MED. 153/19 (2268‑2274) 1993

    [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 year  x  16 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