MMR Vaccine

? This note - which has been put together by the parent of a child who became autistic after immunisation - sets out the concerns of parents whose children have degenerated into an acquired-autistic state after MMR or other vaccines, and attempts to summarize the debate over thimerosal (or thiomersal) preservative used in vaccines other than MMR, and to highlight possible links between this mercury-based preservative and autism. It is possible that the MMR and thimerosal factors overlap in the cause of late-onset degenerative autism.

? These are immense and complex subjects. This briefing does not attempt to cover every single piece of the available scientific literature for or against an MMR/autism or thimerosal/autism link, but it reviews about one hundred of the most recent, most pivotal, or most frequently-quoted studies and papers.

? Its key finding is that there has not been a single credible study that can robustly refute the claims of the parents that their children’s acquired autism has been caused by MMR or related vaccines. Each of the studies that seeks to “disprove” an MMR/autism link can be argued to be flawed in design or ambiguous in results. These flaws are discussed in detail in the text.

? It also notes that all but one of the studies that seek to disprove an MMR/autism or a thimerosal/autism link did not look at the actual children themselves, but rather were based upon statistical analyses of the medical records of the wider population. Such epidemiological studies are not appropriate to the identification of relatively-rare adverse outcomes.

? Such studies also fail to address the problem - what was it that damaged the specific children that became autistic after MMR or thimerosal-containing vaccines?

? The one MMR study that has both claimed there is no MMR/autism link and also actually looked at information extracted from the medical records of a sub-set of UK damaged children was unable to prove or refute the suggested association with MMR on the basis of the information available - although it went on, despite this, to insist that MMR was safe. And - note - this was still not a clinical study. No children were actually examined.

? Parents who have scrutinised the studies quoted by the Department of Health as “proof” of there being no link between MMR or thiomersal and autism have found that such studies crumble away easily when pressed. To give just one example, the Finnish study by Patja, Peltola et al was very loudly heralded at the start of 2001 by the UK Department of Health as convincing and conclusive proof that MMR was safe. After intense critical scrutiny by parents and media, by the end of 2001 the Medical Research Council was forced to admit that Patja, Peltola et al’s original 1998 paper “did not examine the relationship of MMR and autistic spectrum disorders.....and does not therefore provide useful evidence on this point.” Of the subsequent paper by Patja, Peltola et al, the MRC admitted: “The findings need to be interpreted with some caution, as cases of autistic spectrum disorder or bowel disorders not considered at the time attributable to MMR would not necessarily have been reported”. Quite a retreat. Yet the study still continues to be regularly quoted by medical commentators and professionals as “proof” that MMR is safe.

? In contrast, the parents find that there is a considerable, and growing, number of studies that suggest that MMR and/or thimerosal preservative (routinely used in very many vaccines until very recently, and still in widespread use in 2004) could be causing acquired autism (or “autistic enterocolitis”) in significant numbers of children.

? Contrary to the claims of the authorities, particularly in the UK, not all of these studies originate from only one group of researchers (the former Wakefield team at the Royal Free Hospital London, and then Dr. Wakefield since his departure), as has sometimes been asserted by those who defend MMR. The studies that point to a link have involved a growing number of research teams, in several countries. Other studies, whilst not specifically targeting MMR or thimerosal-containing vaccines, offer further clues as to what may be happening, and are consistent with an MMR and/or thimerosal involvement.

? Furthermore, many of the studies that suggest that there is an MMR/autism or a thimerosal/autism link are based upon the scientific analysis of data gathered from detailed individual medical examination, and upon medical samples taken from the children concerned. These are the studies that actually seek to address the two key questions, “what is the damage sustained by this specific child, and what exactly precipitated the damage to this specific child?”.

? A “house of cards” has thus been constructed by the UK Department of Health, the US Government health system and by other authorities and commentators in the medical establishment over the past five years, with repeated assurances being given to the public, but with these being based upon a lop-sided, highly partisan and culpably selective gathering and interpretation of the available evidence.

? This briefing note also finds that there are other related concerns - from the regulatory bodies themselves - about the risk of permanent developmental damage from thimerosal-containing (or thiomersal-containing) vaccines, though it is not yet completely understood as to how these problems are directly interlinked biologically to the MMR/autism problems (we are told that MMR in itself does not contain thimerosal). Class-action lawsuits are now under way in the US (see later sections) over thimerosal/thiomersal and autism, just as they have been (or still are) in the UK and Ireland over MMR and autism.

? Although complete and precise scientific proof of how the children have been damaged by vaccines and become autistic is still emerging, there have been numerous vital clues over the past six years and more - clues that all too often have been ignored, or, worse still, have been rejected out of hand by the authorities.

? The medical establishment has repeatedly asked itself the wrong question. It has asked itself “Is MMR safe?”, and “is thimerosal safe?”, hoping for an affirmative answer. In contrast, researchers and parents have asked two very different questions: “What precisely is wrong with this child?”, and “Why did this child change from being healthy to being autistic?”. It is answering these latter two questions that should be the key issue.

? The safety trials of MMR were undoubtedly very poor. That is an established fact. For the thimerosal issue, the picture is even more stark. The product appears to have had no proper safety trials since its introduction about 75 years ago, and its use appears to have lacked any appropriate back-checks on safety.

? The children that have been damaged have had their lives ruined. They were previously completely healthy. They now have seventy or eighty years of mental handicap ahead. Whether their sacrifice is justified in the interests of wider public health is not the point at issue. What is at issue is, what changed for these children, through what processes, involving what susceptibility factors and trigger factors. And how can further cases of damage be headed-off?

? This briefing note also poses a number of unanswered questions about MMR, about thimerosal, and about the children that are believed to have been severely damaged by vaccine administration. The damage involved is not confined to regressive autism.

? Finally, it is emphasized that this note is the result of a search of the published (and sometimes unpublished) studies and other information. It does not offer medical advice. Parents considering vaccinating their children with MMR or with thimerosal-containing vaccines must form their own conclusions as to whether to proceed, and are urged to gather the maximum amount of hard information before making their own choice. It is hoped that this Briefing Note offers a useful start, and is useful for journalists.

PART A

A NOVEL SYNDROME

1: What Is Acquired Autism/Autistic Enterocolitis?

? Autism is not an illness in itself, so much as a manifestation of a dysfunction in certain parts of the central nervous system, particularly affecting language, cognitive and intellectual development and the ability to relate to others. It is an effect, and a consequence, not a cause in itself. Everything has a cause. Autism is not some mysterious illness that comes out of the sky, to strike children at random. It is a global term, all too loose, to describe a set of characteristics.

? The “classic” form of autism was first described by Dr. Leo Kanner. These children were different from normally-developing children from birth.

? However, a very different form of autism, formerly a minority variant, has now begun to predominate. In this, children develop normally, passing all their developmental milestones, and then later acquire an autistic-like condition. They lose their previously-demonstrated speech, learned behaviour and social skills. In effect, they dissolve into a state of mental impairment, of varying severity. Often the damage is severe or very severe, and usually the damage appears to be permanent, although some remedial treatments are claimed to be able to reverse some aspects of damage to a modest degree.

? This late onset of autism typically follows the receipt of MMR vaccination, but also appears to sometimes follow measles-containing vaccines such as monovalent (so-called “single”) vaccine, or measles-rubella (MR) vaccine, and sometimes other vaccines such as DPT (diptheria-pertussis-tetanus).

? It does not necessarily occur immediately after MMR - onset of autism is not in any case an “acute” reaction - and there are now grounds for believing that onset following vaccination may be very gradual indeed, spread over at least many weeks, more probably several or many months, or even in some cases several years. The rate of deterioration seems to vary considerably. It has been a consistent error of the medical authorities to view autism as an alleged acute, immediate, reaction, although many parents have certainly reported than some form of immediate or near-immediate (within 24 hours) adverse reactions, such as high-pitched screaming and high temperatures, have occurred. Some parents have reported a rapid change in their child’s behaviour, whereas others have seen a slower decline. Typically, the child’s mood has changed, they have become quiet and withdrawn, speech has been lost and skills have vanished. Sleep patterns have often disintegrated.

? Crucially, the onset of this acquired form of regressive autism is accompanied by other visible and associated physical manifestations of problems. These include bright red ears and dark rings under the eyes after certain foods, acute gluten and casein intolerances, prolonged hyperactivity, night sweating and loss of temperature control, and chronically poor sleep patterns.

? The arrival of these problems and the degeneration of the child into autism as a “package” strongly suggests that they are interconnected

? The timing of onset following vaccination - not just MMR - is described by the UK Department of Health as a coincidence. Their argument is that autism is “noticed” around this time, because this is a time when child development is most rapid, and therefore any failure most noticeable. The thinking behind this stance appears to be that either autism was always there, all along, or that it is akin to some sort of delayed-action genetic “bomb”, primed in certain individuals to detonate just after receipt of MMR or thimerosal-containing vaccines, or around that time.

? The gross implausibility of this argument, that it is highly unlikely in the extreme that previous problems would have been missed, and at a time where children receive constant devoted attention and close scrutiny regarding their development, is ignored. The concept that genetics alone could be responsible for sudden devastating decline in a developing infant is equally implausible.

? Photographic and video evidence, together with child health and developmental records and the accounts of relatives, friends and visitors, that contradicts the authorities’ arguments, is also routinely ignored, without even a superficial investigation to verify their accuracy.

? However, very significantly, much older children have also degenerated into autism after MMR or other vaccination. If degeneration in affected children always follows immunisation with MMR or measles-containing vaccine, regardless of the age of the child, then it implies that the link is not coincidental.

? Also, no cases are known, at least to campaigning parents, of any children who have rapidly become autistic just before MMR or thimerosal-containing vaccines. This clearly implies that such cases are much fewer in number.

? Also, it is not simply a failure to develop. The children have developed normally, then inexplicably acquired their autistic state. This protracted event has been directly observed by parents and relatives, and in many cases recorded on photographs and video footage.

? There is also the issue of double-regression, where children have been normal, have been vaccinated, have regressed, have made some remedial progress, have been re-vaccinated (as a booster) and have severely regressed again. This principle is known as challenge-rechallenge. The US Institute of Medicine has stated that evidence of challenge-rechallenge would constitute powerful support for a causal link between vaccines and regressive autism. There are many UK children (and presumably US children, too) who offer such evidence, but the IoM has not yet accepted that its self-declared criteria has been fulfilled.

? No credible alternative explanation for why a previously-healthy child should become severely autistic has been put forward. The unheralded acquisition of a state of severe disability, in a substantial number of hitherto-healthy children, has to have a significant causal trigger. A growing number of scientists, as well as parents, believe that the trigger is either MMR, or thimerosal, or both acting in synergy.

? Undoubtedly there are other factors involved, pointing to a predisposition of certain children to be vulnerable to damage, of varying severity. Research should be trying to pinpoint those factors, but patently is not. Research is being held up by the refusal of the medical establishment in the UK and US to recognise the problem, or even to recognise the reality of a steep increase in autism.

? Also coinciding with the late onset of autism in many of the children (or other severe damage - autism is not the only manifestation of there being a problem), has come gastrointestinal problems such as alternating bouts of diarrhoea and constipation, chronic abdominal pains and bloating.

? Examination of children, initially but not exclusively at the Royal Free Hospital, London, has identified a novel form of inflammatory bowel disease, ileal-lymphoid nodular hyperplasia. This has emerged after ileocolonoscopy of affected children and analysis of samples. The pioneer research the Royal Free has now been confirmed by researchers at other centres in Ireland and the US.

? The simultaneous onset of these problems after a normal early development suggests that it is highly likely that these other elements are linked into the biological explanatory sequence of autism, notably through the pathway of gut damage and either the penetration of the blood-brain barrier or the triggering of some other process, such as serious myelin damage (in basic terms, the myelin sheath is the “insulation” around the neurons or “wires” of the brain).

? Research reported by Dr. Jeff Bradstreet to the US Institute of Medicine on 9th February 2004 found that, when the cerebrospinal fluid of 28 regressive-autistic children was analysed, measles virus was found in 19 of the 28 cases. When 37 non-autistic control-group children were analysed, only one child was found to have measles virus. All 65 of these children had received MMR, and none had any recorded history of wild measles infection. This more recent research is powerful statistical evidence of a measles virus complicity in the pathogenesis of regressive autism. This research therefore strongly endorses the anecdotal evidence of the parents, that their children became autistic after MMR. For many children, MMR thus remains the prime suspect.

2: The New Syndrome

This is a very brief summary of the new syndrome of autistic enterocolitis:

? In a 200-strong cohort of children examined through ileocolonoscopy at the Royal Free Hospital, London, an almost 100% incidence of ileal-lymphoid nodular hyperplasia has been found. This condition manifests itself as swollen lumps throughout the intestinal tissue of autistic children. The condition is very rare in non-autistic children.

? The condition is believed to have developed in each case in the period following MMR immunisation

? Because of the swollen and hyperplasic condition of the intestinal wall, undigested toxins , having not been stopped by either the intestine or the liver (which can also be damaged) may then be able to attack the central nervous system. The evidence for the complete pathway of damage is uncertain at present, due to lack of research.

? An alternative pathway of damage may be that the virus(es) in the vaccine, or other constituents of the vaccine, may be inflicting the actual damage, or interfering with the brain’s further development by damaging myelinisation. Comprehensive studies to determine this have also yet to be undertaken.

? It is also possible that thimerosal, a mercury-based preservative that has been routinely used in a number of vaccines, may have played a role. The resultant damage closely resembles that of mercury poisoning. Again, adequate research has not yet been done.

? Damage may in the event be via a combination of these pathways.

PART B

THE COSTS OF AUTISM

3: The Financial Costs - Autism Is Costing The Taxpayer ЈЈЈЈЈЈЈ$$$$$$$$Billions

Quite apart from the immense social costs of autism for individual families, there are the huge financial costs. Autism effects every UK and US taxpayer, not just the families with the children. In the UK, the costs comprise:

? Health costs - specialist hospital visits, GP visits, prescriptions, exclusion diet costs - passed on to the taxpayer

? Major education costs - special schools, extra teachers, extra teaching assistants, extra training, management - passed on to the taxpayer

? Transport costs for schooling and respite - taxis plus drivers and escorts, plus local authority management costs, plus environmental/congestion costs of extra traffic - passed on to the taxpayer

? Significant childhood social services costs - respite care staff costs, management, inspection, reviews - passed on to the taxpayer

? Later special transport costs in adult life (during lifelong care) - funded by the taxpayer, as the person with autism will almost certainly have no income

? The immense costs of sheltered accommodation during adult life (lifelong costs), again including social services, management, inspection, and also including furniture and other allowances, all passed on to the taxpayer

? The immense loss of earnings of the affected person (lifelong)

? The loss to the Government of their national tax revenues (lifelong)

? The loss to local government of their Council Tax revenues (lifelong)

? Loss of earnings of parents whilst acting as carers

? Loss of the parents’ tax revenues whilst caring

? Carers allowances (paid to parents when they are acting as carers), the costs of which are passed on to the taxpayer

? Disability living allowances, often at the higher rate (lifelong), including care and mobility components, passed on to the taxpayer

? Incapacity benefit (lifelong beyond age 16), passed on to the taxpayer

? Wider economic costs - other losses of gross domestic product and other non-financial contributions to the national economy

It would be interesting to know if the UK (or US) Treasury had a view on these costs, and whether sufficient resources were being devoted to investigating acquired autism and other forms of autism, as they represent a massive loss to the local and national taxpayer and the national economy. These costs will grow as more and more children become autistic and as more of the existing children reach adulthood and leave home. The affected people almost certainly won’t be paying these costs as children, nor even as adults, as they almost certainly won’t have any income. And once the children reach adulthood, the parents won’t be paying them, either.

As these costs soar, the question becomes, “is autism too important to be left to the Department of Health, a Department that has done virtually nothing to investigate its causes”? - or to its counterparts in the US and elsewhere? Is this just a private matter for the medical community, or a matter for a wider audience? And, for the medical safety regulators, “who guards the guards”? Does a Minister control his/her advisers, or do his/her advisers control the Minister?

4: Overall Cost Estimates

In June 2000 a study for the UK Mental Health Foundation found that

? the annual costs of autistic disorder in the UK were at least Ј1 billion

? individual lifetime costs per child affected could run to Ј2.94 million each.

The full costs, taking into account wider economic costs, are probably considerably higher still.

If one reduces the Ј2.94m per child by an arbitrary 33%, to allow for the fact that many children are less severely damaged than the maximum, and will thus cost less to care for, one is still facing a bill of Ј2m for lifelong care, not counting other wider costs such as loss of tax revenues from the autistic person an (when their parents care for them) their carers, plus other costs such as carers’ allowances (a UK scheme). The degree of severity and precise costings could be debated at length, but are clearly extremely large for severe cases.

Another way of looking at it is to compare the UK with the US, which has hard State-collected data. According to the Individuals With Disabilities Education Act data, the US autism numbers (with four times the population) stood at 120,000 in early 2003 (amongst 6-21 year olds in full time education).

If UK cases currently run to around a quarter of this figure, 30,000 to 35,000, then total economic costs for the UK could be immense. A reasonable estimate would be that 35,000 cases would cost the UK taxpayer somewhere between Ј35 billion and Ј100 billion spread over perhaps seven decades, or between Ј500m and Ј1.4 billion per annum. A mid-range answer probably lies in the Ј20 billion to Ј40 billion-plus range, spread over five to six decades, and even that latter figure works out at Ј700 million per year. And that is only for the UK.

Even if these costs are being seriously overestimated here, they are still immense. And they could represent an underestimate, especially if there is economic damage from the milder cases that are probably not included in the statistics. There is also the prospect of cases being added to the total, all the time, now. Any annual increase in cases of, say, ten per cent would lead to all these estimates having to be re-doubled a decade on.

And this is wholly irrespective of any MMR-autism or thimerosal-autism link being proved, because the children already exist, even if the cause of their illness remains disputed. The children are out there, now, and these bills are being passed to the taxpayer, now, today. The costs meter is already running, but the immense scale of the bill is partly obscured by it being spread amongst many central and local government (or Federal and State) budget headings, and amongst numerous lesser authorities.

5. Failure To Monitor Increases In UK Autism Numbers

? There has been a consistent argument on the part of the authorities, and those seeking to defend MMR, that the apparent rise in autism may be largely a matter of better recognition. This has received some backing from autism researchers. But where hard UK or US data is available, increases are far too steep, and in far too short a timescale, to be credibly ascribed to better recognition alone..

? For this to be “better recognition” or “improved diagnosis”, this would have required these children to have been missed, simultaneously, by their parents, their relatives, their doctors and their teachers in the past This is simply not credible. For example, the increase in autism 1992-99 in Wakefield, West Yorkshire, UK, local education authority was from 5 cases to 111 cases. If increased autism is down to better recognition, it would mean that, back in 1992, there really were 111 cases, but only 5 were recognised, and the remaining 106 were missed, and by all the parties - parents, doctors, health visitors, teachers - concerned. This is completely implausible.

? Undoubtedly there has been some degree of better recognition and reclassification, following introduction of ICD-10 (international classification of diseases/disorders) criteria in 1992, and DSM-IV (diagnostic statistics manual) criteria in 1995. But this will account for only a minority of the growth.

? The UK Department of Health has failed to monitor autism, and is still failing to (despite a specific 1997 recommendation of the House of Commons Health Committee to do so). Is it now afraid of what it might find? If it does decide to monitor autism, will it find that numbers are high and then claim it has always historically been so?

? UK Health Boards/Authorities are also failing to monitor autism locally. Health Boards/Authorities have little data and no consistent approach. At the health authority level, official figures vary wildly, by factor of 300-fold, i.e. 300-times (not 300%). The data is an extraordinary mess.

? In fact, most UK data is actually non-existent. In the year 2000, only 1 in 6 UK Boards/Authorities had any credible figures at all. Most used estimates from textbooks.

? The Scottish schools census now includes autism. The census commenced in 1998. The 1998 figure was around 750, but by year 2000 this had climbed steeply to about 1,250, and by 2002 it stood at approaching 2,200.

? There are other indications of the level of increases: Kaye et al paper (see later) found a sevenfold increase 1988-99 in UK. An unpublished 1999 paper by Dr. Fiona Scott, Autism Research Unit, Cambridge, indicated autism at eleven times the expected level (1 in 174) - see later.

? The 2001 Medical Research Council review found autism to be at 1 in 166, many times higher than hitherto thought. Sixteen studies published between 1966 and 1991 found rates of between 1 in 3030 and 1 in 625. A rate of 1 in 166 is nearly four times higher than 1 in 625, itself the highest of these sixteen, and only from a relatively-recent study in 1983. If you take a rate of 1 in 1830 as being the mid-point of these historic rates, then a rate of 1 in 166 is eleven times higher.

The repeated official line that the apparent increase is down to better recognition is little more than a counsel of complacency.

In December 2002, a Parliamentary Written Question (84502) confirmed that there is now in place a “Good Practice Guidance on Autistic Spectrum Disorders”, in the UK, published by the Government’s Departments of Education & Skills and of Health. This is intended to raise awareness amongst schools and local education authorities. However, it is probably just one of many thousands of such well-intentioned documents, is non-statutory, and is probably lost in the stream of paper raining down on local government from central government.

UK schools and local education authorities have a duty to identify, assess and make suitable provision for children with special educational needs. However, there seems to have been no duty upon either the health authorities at the local level or the Department of Health at Government level to improve the data position over autism - doubtless to the latter’s relief. Perhaps centrally-collated figures showing steep increases would beg uncomfortable questions as to the causes. The UK Department of Health seems to regard autism as a problem for local education authorities - not for the Department.

It is understood that from January 2004, a first survey in England will be undertaken of disabilities amongst children receiving special needs education. This will be the UK (England-only) Pupil Level Annual Schools Census (PLASC). English local education authorities and the schools in their areas have to supply data about the numbers of pupils with different types of special educational need, including autistic-spectrum disorders.

However, it may be some time before data is available, and obviously it will be several years before any clear trend emerges. Any past steep rise during the 1988-2004 period will therefore of course have been missed, although some idea of increases may be available if data is stratified by age (this is not known at time of writing).

6. “Now Almost Everyone Knows Someone Who’s Autistic”

Autism was a very rare condition, but is now almost regarded as commonplace. Very many cases are now of late-onset autism, whereas almost all used to be cases from birth. We have to ask why this is.

Some UK research noted the sharp increases in autism in the 1990s. A paper by Powell et al, Department of Public Health and Epidemiology, University of Birmingham, UK, Changes in the Incidence of Childhood Autism and Other Autistic Spectrum Disorders in Pre-School Children from Two Areas of the West Midlands, UK, was published in Developments in Medicine and Child Neurology, September 2000. This looked at the incidence of childhood autism and ASD in pre-school children between 1991 and 1996.

The study found that there were year-on-year increases in classical autism during this period of 18%, but for “other ASDs” the annual increase was no less than 55%. But the study then concluded that this was due to clinicians being increasingly able or willing to make a diagnosis. The possibility of an underlying genuine increase, and any follow-on question as to causes, does not appear to have occurred to the study team.

But parents of children believe to have been damaged by MMR strongly believe that part of the increase is down to a new phenomena, autistic enterocolitis.

It is not the autism of the past. Such a severe acquired regressive syndrome after a normal early childhood would have been noticed at once in the past by parents, and recognised medically, and also reflected in much higher historic rates of prevalence/incidence. Regressive autism used to be a minority variant: Now it is clearly the predominant form, by a very wide margin. Dr. Bernard Rimland, President of the US Autism Research Institute, has concluded, after a thorough analysis of the ARI database: “Late onset autism (starting in the second year) was almost unheard of in the 1950s, 1960s and 1970s. Today, such cases outnumber early onset cases by five to one, with the increase paralleling the increase in required vaccines”.

In the parents’ view, there is clear evidence of recent dramatic rates/increases in autism:

? Some UK examples - an East Surrey 1/69 rate amongst three year old boys, 1/139 rate amongst three year old boys+girls combined (source: personal communication of 10/6/99 from Caroline Clark, Commissioning Manager, Learning Disability Services, East Surrey Health Authority). The letter from East Surrey stated: “In the remaining half of the District, it is estimated that there are at least 50 children on the autistic spectrum under the age of five. A special needs audit has been undertaken of children aged three by the community paediatrician. This is the age where the paediatrician expects to identify children at the more severe end of the autistic spectrum. Thirty-six children have been identified during the last two years as presenting with autism, of which twenty-nine were between the ages of two and three, with seven children slightly older. The general population is around 2,500 children (born) per year in this part of the District. The prevalence of autism indicated by the audit is 0.72% (1 in 139) but with 1.44% (1 in 69) for young boys.”

? Bromley Autistic Trust figures show a 1990-94 increase of 280% over 1980-84 figures (source: personal communication of 16/9/99 from Miss C. M. Povey, Services Director, Bromley Autistic Trust)

? A local survey carried out in the Inverness area in 2003 found that 1 in 49 children was on the autistic spectrum.

? Wakefield LEA autism pupils rose from 5 to 111 in seven years (source: survey by David Brown, a specially-seconded headmaster from the Park School, Wakefield, on behalf of Wakefield Local Education Authority, 1999)

? Telford health data up from 4 new cases per year in 1990 to 17 per year 1998 and again 1999 (source: personal communication of 20/11/00 by Dr F. R. J. Hinde, Consultant Paediatrician, Princess Royal Hospital, Telford)

? As noted, Scottish schools census, repeatedly up year-on-year, and by a large margin each year; from around 750 in 1998 to well over 2000 in 2002 (source: Scottish Annual School Censuses, available from Scottish Education Office, tel 0131 556 8400)

The problem isn’t confined to autism. On December 22nd 2002, the (UK) Observer newspaper carried a report on the apparent epidemic of behavioural problems amongst UK schoolchildren. Whilst not autism (the report cited hyperactivity and attention-deficit disorder), the Observer’s report suggested a steep rise in the incidence of problems. Figures obtained by the newspaper suggested that numbers of schoolchildren with attention-deficit disorder (ADD) or attention-deficit hyperactivity disorder (ADHD) had reached 345,000, and that one child in twenty between the ages of 6 and 16 years had one or other condition. The Observer also found out that prescriptions for Ritalin, to counter these disorders, had increased markedly, from 91,100 in 1997 to 208,500 in 2001.

In the US, the Brown University Child & Adolescent Behavioural Letter (18(3): 1: 304, 2002) carried the following details:

? A study into attention deficit hyperactivity disorder (ADHD) was undertaken, based on parent and teacher reports concerning 6,099 children in 17 public elementary schools. The study was undertaken by researchers working for the National Institute of Environmental Health Sciences in North Carolina

? When the researchers surveyed parents in a typical county of rural and suburban communities - Johnston County, North Carolina - the parents reported that more than 15% of boys in grades 1st through 5th had a diagnosis of ADHD, with about 10& (i.e. two-thirds of those diagnosed) receiving medication.

Although ADHD is not autism, it may share some common causal pathways, particularly multiple food allergies and gut permeability. The finding is thus of interest to the MMR/autism debate.

7. Is Autism Increasing Due To Changes In Criteria?

It has frequently been asserted by Governments, some researchers and elements of the medical establishment that the apparent increases in numbers of children with autism can be ascribed to “looser” criteria for inclusion. This latter point is demonstrably not the case. The criteria have in fact tightened-up.

Kanner’s original concept of autism included five diagnostic features:

* A profound lack of affective contact

* obsessive desire for the preservation of sameness

* Fascination for objects

* mutism or language that does not seem suited to interpersonal communication

* feats of memory, or skills in performance tests

Kanner and Eisenberg, in 1956, emphasized two diagnostic criteria:

* profound lack of affective contact

* repetitive ritualistic elaborate behaviour

They considered that if these two key features were present, the other typical features would also be found.

In 1980, the DSM-III (Diagnostic and Statistical Manual III) criteria were introduced. These included:

* “pervasive developmental disorder” for the general category of autism

* “infantile autism”

The category of infantile autism was defined as:

* lack of responsiveness to others

* language absence or abnormalities

* resistance to change and/or attachment to objects

* the absence of schizophrenic features

* onset before age 30 months

In 1994, DSM-IV criteria were introduced. These criteria are more restrictive than DSM-III, and so an increase in numbers between the DSM-III era and the DSM-IV era cannot be explained by looser criteria, as the very opposite is the case. For example, in Washington State, autism numbers actually fell when DSM-IV was introduced.

It is worth setting out in detail the criteria for autism and relating autistic-spectrum disorder (ASD) conditions:

8. Autistic Disorder

For DSM-IV, a total of six or more items from the following lists of (1), (2) and (3) is necessary, with at least two items having to come from (1), and one each from (2) and (3):

(at least two from)

(1) Qualitative impairment in social interaction as manifested by:

* marked impairment in the use of multiple non-verbal behaviours, such as eye-to-eye gaze, facial expression, body postures and gestures to regulate social interaction

* failure to develop peer relationships appropriate to developmental level

* a lack of spontaneous seeking to share enjoyment, interests or achievements with others (eg by a lack of showing, bringing or pointing-out objects of interest

* lack of social or emotional reciprocity

(at least one from)

(2) Qualitative impairments in communication, as manifested by at least one of the following:

* delay in, or total lack of, the development of spoken language (not accompanied by an attempt to compensate through alternative modes of communication such as gesture or mime)

* in individuals with adequate speech, marked impairment in the ability to initiate or sustain a conversation with others

* stereotyped and repetitive use of language or idiosyncratic language

* lack of varied, spontaneous make-believe play or social imitative play appropriate to developmental level

(at least one from)

(3) Restricted, repetitive and stereotyped patterns of behaviour, interests and activities as manifested by at least one of the following:

* encompassing preoccupation with one or more stereotyped and restricted patterns of interest that is abnormal either in intensity or focus

* apparent inflexible adherence to specific non-functional routines or rituals

* stereotyped and repetitive motor mannerisms (eg had or finger-flapping or twisting or complex whole-body movements)

* persistent preoccupation with parts of objects

9. Pervasive Development Disorder - Not Otherwise Specified

The DSM-IV criteria also included criteria for “pervasive development disorder-not otherwise specified”, or PDD-NOS. This category applies to cases where there is a severe and pervasive impairment in the development of reciprocal social interaction or verbal and non-verbal communications skills, or when stereotyped behaviour, interests and activities are present, but the criteria are not met for a specific pervasive developmental disorder, or schizophrenia, or schizotypal personality disorder, or avoidant personality disorder.

For example, PDD-NOS includes “atypical autism”, presentations that do not meet the criteria for autistic disorder because of late age of onset, atypical symptomatology, or sub-threshold symptomatology, or all of these.

10. Asperger’s

The DSM-IV criteria for Asperger’s Disorder (or syndrome) are as follows:

Qualitative impairment in social interaction as manifested by at least two of the following:

* marked impairment in the use of multiple non-verbal behaviours such as eye-to-eye gaze, facial expression, body postures and gestures to regulate social interaction

* failure to develop peer relationships appropriate to developmental level

* lack of spontaneous seeking to share enjoyment, interests or achievements with other people

* lack of social or emotional reciprocity

Restricted, repetitive and stereotyped patters of behaviour, interests and activities as manifested by at least one of the following:

* encompassing preoccupation with one or more stereotyped and restricted patterns of interest that is abnormal in intensity or focus

* apparently inflexible adherence to specific nonfunctional routines or rituals

* stereotyped and repetitive motor mannerisms such as had or finger-flapping or twisting, or complex whole-body movements

* persistent preoccupation with parts of objects

The disturbance causes clinically-significant impairment in social, occupational or other important areas of functioning. There is no clinically-significant general delay in language, eg single words are used by age two years, communicative phrases used by age three years). There is no clinically-significant delay in cognitive development or in the development of age-appropriate self-help skills, in adaptive behaviour (other than in social interaction) and in curiosity about the environment in childhood. Criteria are not met for another specific pervasive developmental disorder, or schizophrenia.

11. University of Cambridge Research

On 18/2/01, the UK Sunday Telegraph reported on research undertaken by Dr. Fiona Scott at the Autism Research Centre at the UK University of Cambridge. The research, Prevalence of Autism Spectrum Conditions in Children Aged 5-11 Years in Cambridgeshire UK, by Scott, Baron-Cohen et al, which is due to be published shortly, was undertaken across schools in Cambridgeshire.

The study aimed to establish prevalence of the broader autistic spectrum, including Asperger syndrome in 5-11 year olds in Cambridgeshire, UK. Cases of diagnosed autism spectrum condition in children who were in Cambridgeshire schools and aged 5-11 on 31st December 1999 were sought out using public records, screening instruments, educational psychology and special educational needs coordinator records.

It found that:

? One in 175 (58/10,000) children was autistic, whereas previous studies had pointed to a rate of 1 in 2000 (5/10,000)

? This was 11 times higher than the rate of classic autism, but in line with other recent national and international rates for the broader spectrum.

? In responding mainstream schools, the prevalence was 1 in 300. In the responding special schools, the prevalence was 1 in 8.

? Extrapolated across the UK, that would imply 30,000 primary school (age 5-11) children with autism

? The overall sex ratio of the children was 4 to 1 male to female, but in mainstream schools it as 8 to 1.

? Linking these rates to estimated costs of education and care for sufferers would give a figure of as high as Ј5 billion per year, year after year. The Cambridge autism figures were described as “if anything an under-estimate”. They included only children with a definite clinical diagnosis. Any child who had only been “statemented” (= educational needs-assessed) as autistic, but not yet clinically diagnosed, was not counted

? One in eight children with special educational needs was suffering from some form of autistic spectrum disorder. The increase of actual numbers over previously-assumed numbers would have enormous cost implications for central and local Government

? A year-2000 report for the UK Mental Health Foundation by Professor Martin Knapp for the UK Institute of Psychiatry used the earlier “textbook” rate of autism of 5/10,000 to put the total UK economic cost of autism at Ј1bn. The Knapp report estimated the lifetime cost of a severely-affected child at Ј3m, for a high-functioning autism child at Ј0.8m, and for an Asperger’s syndrome child at Ј0.5m. The revised Ј5bn per year estimate is based upon these costs.

12. University of Sunderland Research

An unpublished study by the UK University of Sunderland found a tenfold increase in diagnosis of autism, during the years 1989-93.

13. UK National Autistic Society Estimates

The NAS issued a factsheet in early 1997 which gave the following prevalence rates:

? People with Kanner syndrome (IQ less than 70) 5/10,000, or 1 in 2,000

? Other spectrum disorders (IQ less than 70) 15/10,000, or 1 in 666

? Asperger’s (IQ 70 or above) 36/10,000, or 1 in 278

? Other spectrum disorders (IQ 70 or above) 35/10,000, or 1 in 286

Combined total of above four groups 91/10,000, or 1 in 110

The above implies a very high level of autism in the UK, and the previously-described studies seem to bear this out.

The NAS reach its 91 in 10,000 or 1 in 110 rate by taking the Wing & Gould study (Camberwell, London) of 1979, which looked at children with an IQ of under 70 and found a rate of 20 per 10,000, and adding this to the study by Ehlers & Gillberg (Sweden) of 1993 which looked at autistic children with an IQ of over 70 and found a rate of 71 per 10,000 (1 in 141).

The 91/10,000 rate is thus “merged data”, collected in two different countries and some years apart, and thus needs to be treated with caution, particularly if rates have since been rising further. The Wing & Gould study is now over two decades out of date, and also pre-dates MMR introduction into the UK.

14. Report by Fiona Loynes, UK All-Party Parliamentary Group on Autism, Dec. 2001

The purposes of this report included:

? To establish numbers of children with autistic spectrum disorders

? To learn whether UK local education authorities believed there had been a recent increase in the last five years

? To ascertain whether LEAs routinely collected data

The findings included the following:

? 100 out of 115 LEAs reported an increase in autism in the past five years. Some reported small increases, others reported far higher increases, in one case by 77%.

? The study compared the expected prevalence rate of all autistic spectrum disorders in each LEA (91 in 10,000 or 1 in 110) with the actual recorded number of children with ASD and a Statement of Educational Needs (21 in 10,000 or 1 in 476). If the estimated numbers are correct, then the implication is that 75% of children with autism do not become included in the Statement data, because they have no Statement.

? Only 44 out of the 100 LEAs reporting an increase had actual data. Some of these reported dramatic increases, up to 400% in four years.

15. Report, “Autism In Schools - Crisis or Challenge”, National Autistic Society UK, May 2002

This report was complied from the findings of a survey carried out in seven local education authorities across England, Wales and Scotland, although the Scottish findings were reported separately. The England and Wales survey involved 373 individual surveys, with a response rate of over 30%, covering a pupil population of 133,000. The study found that:

? 1 in 86 children in mainstream schools had special educational needs that were related to ASD.

? The rate of ASD is three times higher in primary than in secondary schools. In primary it is 1 in 80, in secondary it is 1 in 268.

? This is in addition to children with ASD in special schools. In special schools, 1 in 3 children has ASD-related needs.

16. Is Autism Increasing? - Some Recent UK Pronouncements

These are some recent, and sometimes self-contradicting, statements:

? “There is no good evidence that the frequency of autism has increased since the introduction of MMR” - Tessa Jowell, then Minister for Public Health, October 1997 (personal communication to David Thrower)

? “The true incidence of autism is uncertain” - Sir Kenneth Calman, then Chief Medical Officer, March 1998

? The apparent rise in autism in the UK began more than ten years before the introduction of MMR” - Tessa Jowell, in June 1998

? “Rates of autism are rising, but not because of MMR” (Committee on Safety of Medicines, June 1999)

? “There is no robust data on the prevalence of autism before and after MMR’s introduction” - Brent Taylor, in a June 1999 study heavily quoted by the Department of Health

? “Numbers of cases of autism are rising, but the reason for this is unclear” - John Hutton, Minister for Public Health, December 2000

? “Methodological differences between studies, changes in diagnostic practice and public and professional awareness are likely causes of increases in prevalence. Whether these factors are sufficient to account for increased numbers of identified individuals, or whether there has been a rise in actual numbers, is as yet unclear” - Medical Research Council 2001 review, quoted by the Scottish Parliament Expert Group May 2002.

? “Two thirds of (surveyed) teachers felt that there were more children with ASD now than five years ago. This (is) consistent across age groups and in all types of education provision, special and mainstream” (Report of the National Autistic Society, May 2002)

? “The vast majority of the increase is due to the fact that we’re much better at detecting autism now (and) we include many more things in the spectrum for autistic spectrum disorders.....There’s a far wider spectrum, so that’s one of the factors.” - Dr. Stephen Ladyman, Health Minister for England, in Epolitix, 14th October 2003

But then Dr. Ladyman hedged his bets a little.....

? “And underlying that, I think there may well be some sort of underlying increase in the number as well.....But what I am as certain of as I can be is that it has nothing to do with MMR and there is no reliable piece of science that links MMR and autism.”

and

? “In my view, it is clear from the literature available that more people with autism have bowel disorders compared to the rest of the population” (extract from All Party Parliamentary Group On Autism minutes, address by the Minister).

17. Autism In The USA

The UK Department of Health is fond of saying how MMR is safely used in 32 countries, including the USA, as though its use elsewhere is proof, in itself, that it is safe. Recent claims have even referred to 100 countries. A similar attitude prevails over thimerosal.

But the USA, at least, has clear evidence of an autism epidemic. Other countries may also be becoming aware of increases, for example Finland, where a 400% increase in cases has been alleged since was MMR introduced.

The US has IDEA (Individuals with Disabilities Education Act). This picks up numbers of schoolchildren with developmental problems. Autistic pupils ages 6-21 are up from 12,222 to 118,602 between 1992-1993 and 2002-2003 (Source: US IDEA State data).

Since the introduction of the more restrictive DSM-IV criteria from 1994 onwards, the rise in US numbers has continued unabated:

*year*	95-96	96-97	97-98	98-99	99-00	00-01	01-02	02-03
*cases*	28,813	34,082	42,487	53,561	65,391	78,717	97,847	118,602

(source: Individuals With Disabilities Education Act)

? To the above total also has to be added the further cases of autism amongst children aged 3-5 years. As at year 2000, this was 15,581 (this number will have since increased further).

? There were huge increases in some States between 1992-1993 and 2002-2003 - up 968% in Connecticut, 779% in Florida, 1,131% (repeat: one thousand one hundred and thirty-one per cent) in Idaho, 1,086% in Kansas, 1,291% in Minnesota, all in just ten years (Source: US State data, Individuals with Disabilities Education Act). The rises have continued into 2004.

? Many of the increases in individual States can only be described as alarming. A selection of States is included here:

Florida, ages 6-21

*Year*	*Number of diagnosed cases in IDEA*
1999-2000	3,114
2000-2001	3,626
2001-2002	4,328
2002-2003	5,117
2003-2004	5,915

Illinois, ages 3-5

*Year*	*Number of diagnosed cases*
2000-01	670
2001-02	660
2002-03	841
2003-04	956

Illinois, ages 6-21

*Year*	*Number of diagnosed cases*
2000-01	3,103
2001-02	3,802
2002-03	5,080
2003-04	6,005

Indiana, ages 3-5

*Year*	*Number of diagnosed cases*
2000-01	456
2001-02	533
2002-03	632
2003-04	678

Indiana, ages 6-21

*Year*	*Number of diagnosed cases*
2000-01	2,621
2001-02	3,262
2002-03	3,975
2003-04	4,749

Massachusetts, ages 3-5

*Year*	*Number of diagnosed cases*
2000-01	231
2001-02	770
2002-03	887
2003-04	1,080

Massachusetts, ages 6-21

*Year*	*Number of diagnosed cases*
2000-01	575
2001-02	2,681
2002-03	3,193
2003-04	4,007

Minnesota, ages 3-5

*Year*	*Number of diagnosed cases*
2000-01	345
2001-02	452
2002-03	618
2003-04	762

Minnesota, ages 6-21

*Year*	*Number of diagnosed cases*
2000-01	2,448
2001-02	3,270
2002-03	4,116
2003-04	5,076

New Jersey, ages 3-5

*Year*	*Number of diagnosed cases*
2000-01	397
2001-02	447
2002-03	464
2003-04	570

New Jersey, ages 6-21

*Year*	*Number of diagnosed cases*
2000-01	2,925
2001-02	3,526
2002-03	4,180
2003-04	4,933

Ohio, ages 3-5

*Year*	*Number of diagnosed cases*
2000-01	326
2001-02	334
2002-03	334
2003-04	344

(note: these figures show a minimal increase, and are out of line with other States. The reason for this is not known).

Ohio, ages 6-21

*Year*	*Number of diagnosed cases*
2000-01	2,217
2001-02	3,057
2002-03	4,017
2003-04	5,146

Oregon, ages 3-5

*Year*	*Number of Diagnosed Cases*
2000-01	429
2001-02	506
2002-03	588
2003-04	630

Oregon, ages 6-21

*Year*	*Number of diagnosed cases*
2000-01	2,516
2001-02	2,847
2002-03	3,339
2003-04	3,760

Virginia, ages 3-5

*Year*	*Number of diagnosed cases*
2000-01	222
2001-02	266
2002-03	363
2003-04	418

Virgina, ages 6-21

*Year*	*Number of diagnosed cases*
2000-01	1,983
2001-02	2,365
2002-03	2,966
2003-04	3,533

Wisconsin, ages 3-5

*Year*	*Number of diagnosed cases*
2000-01	306
2001-02	334
2002-03	340
2003-04	410

Wisconsin, ages 6-21

*Year*	*Number of diagnosed cases*
2000-01	1,823
2001-02	2,247
2002-03	2,739
2003-04	3,259

(note: increases in the younger ages are often lower than increases in the older ages, due to growing delays in diagnosis)

? It is also interesting that individual towns such as Round Rock, Texas, are reported to be up from 6 cases to 115 cases in eight years - very much like Wakefield Local Education Authority in West Yorkshire UK (up from 5 to 111 in seven years). This suggests that UK increases may very closely match those in the USA.

? It has been alleged that Brick Township (New Jersey) has manifested an “autism cluster”. Some 40 of Brick Township’s 6,000 3-10 year olds have autistic spectrum disorder. It has made Brick Township the “autism capital of the USA” (but note, East Surrey rates in the UK are higher still). In Brick Township, Federal investigators collected data on surface and ground water, sites of industrial spillages and waste dumping, and also ensured that there had been correct diagnosis of the actual children. They have found nothing untoward. Their findings were reported in April 2000.

? The following is taken from the statistics produced by the Department of Education in the United States, for numbers of children aged 6-21 served by IDEA (Individuals With Disabilities Discrimination Act) who have autism. It compares the increase over the ten years between 1992-93 and 2002-03, including separate figures for 2001-02 to reveal the most recent-year rise that was available when this table was compiled:

*State*	(1991-92)	*1992-93*	*2001-02*	*2002-03*
Alabama		68	904	1,096
Alaska		8	223	259
Arizona		199	1,348	1,689
Arkansas		30	774	912
California		1,605	13,257	16,093
Colorado		14	538	688
Connecticut		164	1,470	1,754
Delaware		15	294	345
District of Columbia		0	144	179
Florida		582	4,328	5,117
Georgia		262	2,462	3,057
Hawaii		52	380	528
Idaho		39	356	480
Illinois		5	3,802	5,080
Indiana		273	3,262	3,975
Iowa		67	554	1,148
Kansas		74	743	878
Kentucky		38	1,022	1,171
Louisiana		409	1,297	1,493
Maine		37	552	675
Maryland		28	2,396	2,692
Massachusetts		493	2,681	3,193
Michigan		288	4,719	5,463
Minnesota		296	3,270	4,116
Mississippi		0	461	537
Missouri		336	1,953	2,254
Montana		20	197	232
Nebraska		4	415	481
Nevada		5	518	684
New Hampshire		0	404	491
New Jersey		446	3,526	4,180
New Mexico		16	265	311
New York		1,648	7,023	8,274
North Carolina		786	3,095	3,518
North Dakota		9	144	178
Ohio		22	3,057	4,017
Oklahoma		31	785	829
Oregon		37	2,847	3,339
Pennsylvania		346	3,969	4,836
Puerto Rico		266	518	531
Rhode Island		19	384	471
South Carolina		141	1,012	1,168
South Dakota		36	250	285
Tennessee		304	1,103	1,359
Texas		1,444	7,099	8,576
Utah		105	723	843
Vermont		6	248	247
Virginia		539	2,365	2,966
Washington		476	1,972	2,344
West Virginia		101	374	429
Wisconsin		18	2,247	2,739
Wyoming		15	117	132
*Total*	5,415	12,222	97,847	118,602

(Source: Individuals With Disabilities Education Act data, US Department of Education. Note: Where increases are from a very low base figure, these have been expressed as “almost infinite”.)

? For every single case there was in 1992, by the close of the school year 2002-03 there were 22 cases......

? The 2002 MIND study by Byrd et al (see later) proved that these increases were not ascribable to either better recognition or greater awareness.

? It seems obvious that the US has an autism epidemic. The UK has a very similar health regime to the US, so it also seems reasonable to conclude that the UK probably has an autism epidemic, too, but just hasn’t yet realised it.

? Dr Bernard Rimland of the US Autism Research Institute, San Diego: “Some supposed experts will tell you that the (US) increase reflects only greater awareness. That is nonsense. Any paediatrician, teacher or school official with 20 years experience will confirm there is a real increase, and the numbers are huge and growing”.

As in the UK, health officials in the US have tried to explain away these increases as being the result of greater awareness, better recognition and broader diagnostic definition. Doubtless these play some minority part, but the authorities seem to want to use these factors to explain all the increase, without having any hard evidence to support their stance.

The criteria changes have been as follows:

? 1956, Kanner and Eisenberg propose that just two essential diagnostic features were required to make a diagnosis of autism. These were from areas covering profound lack of affective contact and repetitive ritualistic elaborate behaviour

? In 1978, Rutter proposed that a definition of autism in children required four criteria: (1) impaired social development out of keeping with the child’s intellectual level; (2) impaired language development out of keeping with the child’s intellectual level; (3) stereotyped play patters, abnormal preoccupations and resistance to change; and (4) onset before the age of 30 months.

? In 1980, DSM III (Diagnostic & Statistical Manual of Mental Disorders, third edition) criteria were introduced. Its classification for infantile autism required five criteria (1) lack of responsiveness to others, (2) language absence or abnormalities, (3) resistance to change or attachment to objects, (4) absence of schizophrenic features, and (5) onset before 30 months

? In 1980, the diagnostic criteria for autism were revised once again, to DSM III-R, and a definition of pervasive developmental disorder (PDD) was also introduced.

? Since 1994, the required criteria for autistic disorder has been set out in DSM IV, requiring the meeting of six criteria. Further detailed criteria were also set out for Asperger’s Syndrome (AS) and PDD Not Otherwise Specified (PDD-NOS).

? DSM-IV criteria are more restrictive for autism than hitherto, and when they were introduced, figures for autism in some US States actually fell slightly.

The massive increases in US autism are in marked contrast to the moderate increase in other disabilities recorded by IDEA data:

	*1991-92*	*2001-02*	*% increase*
Autism	5,315	97,847	+1,700%
All disabilities (inc autism)	4,499,924	5,853,830	+30%

(Source for the above: Autism In The United States: A Perspective, by F. Edward Yazbak, MD, FAAP, Journal of American Physicians and Surgeons, vol 8 no 4 Winter 2003)

What this amounts to is that criteria for the mid-1990s onwards became more restrictive. The steep rise in autism witnessed in the US (on the IDEA database) and elsewhere wherever DSM-IV criteria are used (which includes the UK) are thus in the face of this more restrictive eligibility. There is no possibility that increases can be explained away by suggesting that criteria have somehow widened. The increases are real.

In April 2000, giving evidence to the Government Reform Committee hearings into autism’s increase, Dr. Coleen Boyle, Associate Director for Science and Public Health at the Center for Disease Control, stated that UK rates in 1966 had been 4 to 5 per 10,000 (1 in 2,500-2,000). Studies from outside the US since 1985 had indicated 12 per 10,000 (1 in 833). Recent studies had been higher still. There had been only two population-based studies in the US, both in the 1980s, indicating prevalence of 1.2 to 3.3 per 10,000 (1 in 8333 to 1 in 3030).

Two years on, giving evidence to the same Congressional committee, Dr. Coleen Boyle acknowledged the case of Brick Township New Jersey, where the CDC had found a rate of ASD of 6.7 per 1,000 (note: per ONE thousand), or 1 in 149. She stated that the previously-accepted background rate was 1-2 per 1,000 (comment - but this does not square with her evidence in the year-2000 Washington hearings). She stated “We cannot determine whether rates are increasing or not, because we do not have comparable data from earlier years”.

But the thrust of her earlier comments implied that, even if increases were demonstrated, this was down to better awareness etc., and at no point did she appear to confront the possibility that increases were real, and then confront the (very troubling) question, “What was causing the increase?”.

The CDC strategy seems to be to cast doubt upon the increase, and might be summed up as follows:

? Cast doubt upon the accuracy of the data, and thus draw the focus of debate away from the cause of the increase and towards the data issue

? Stress the need for better data (which no one would argue against)

? Announce new comprehensive data-gathering exercises, which will take more time - and thus “buy time”.

By early 2003, other evidence that increases were real was also beginning to accumulate - see next main section.

18. Autism Elsewhere

(Canada)

Information on autism in Canada does not appear to be anything like as comprehensive as that in the US, but press reports are indicating a recent increase. In May 2002, a study by the Ontario government health ministry indicated that numbers were increasing sharply, with 800 children younger than six years of age being newly diagnosed during 1998. This represented a 53% increase over numbers diagnosed two years earlier. The Ontario government study also found that 2,863 children younger than seven were diagnosed with autism between 1991 and 1998. The study was not released until the efforts of a parent, Professor Marianna Ofner-Agostini of the University of Toronto, forced the issue.

In Canada’s Province of Quebec, the number of children with pervasive developmental disorder (note, this is not full autism) in schools increased by 63% in two years, from 1,388 in September 2001 to 2,267 in September 2003, according to the Ministry of Education. (There is a paper on Quebec in the next section)

(New Zealand)

The issue is now being debated in developed countries elsewhere in the world. A New Zealand doctor, Dr. Mike Godfrey, wrote to the UK Scotsman newspaper in early 2002 as follows: “I have so far analysed 866 children’s histories, with 260 being unvaccinated. There are no cases of autism, epilepsy or Crohns Disease and only a handful of other diseases in this latter (unvaccinated) group. There are 16 autistics, 12 epileptics, 8 cases of Crohns, plus cases of other illnesses, in the vaccinated 606 children.”

(Australia)

An early-2004 press report stated that there were 30,000 children in the country with autism, and that there had been a “dramatic increase of more than 200 per cent in diagnoses over the past ten years.” Diagnoses of new cases were reported in 2004 to be running at 17 per week nationally.

In 2004, further information was received as follows: “Early in 1997, a TV information item stated a rate of 1 in 600 in Canberra. By mid-1997, diagnoses for the first six months of 1997 had exceeded the number for the whole of 1996, indicating a rate of 1 in 300. In January 2002 (press reports indicated) the rate to be 1 in 100. In the most recent Canberra Autism Association newsletter, 60 diagnoses were reported to have been made in the previous nine months. With 4,617 births in Canberra for year 2002, that represents one diagnosis for every 58 births (Note: this would appear extremely high, but closely matches the Inverness, Scotland, rate of 1 in 49 being quoted in the Scottish press in early 2004).

(Denmark)

According to a 2004 paper by Dr. Fou Yazbak of the US, the prevalence of autism in children and teenagers under the age of 14 in Denmark, which was 13 per 10,000 in the seven years before MMR was introduced, increased by 542% to 84 per 10,000 in the years 1995-2002 (source: Danish Psychiatric Central Register). The Denmark situation is detailed elsewhere in this Briefing Note.

(Finland)

There was a striking increase in the incidence of autism recorded in the Northern Provinces between 1991 and 1994, with a cumulative incidence in the 5-7 year age range of 20.7 per 10,000 (1 in 483).

(Saudi Arabia)

In Saudi Arabia, which has a population of just under 23 million, there were 42,500 confirmed cases of autism in 2002, and many more cases were believed to remain undiagnosed.

(Jersey, Channel Islands, UK)

Although part of the UK healthcare system, Jersey (a small island off the northern French coast) clearly offers a further insight. There were (as at October 2003) 64 children in Jersey with autism, of which 59 were 16 or under 16. It was reported that a decade earlier, there were only three cases. The under-16 population of the island is 15,664 (2001 census), giving a rate of incidence (discounting undiagnosed cases at the younger end of the age spectrum) of 1 in 265.

PART C:

MMR

19. The Introduction Of MMR

(some of this information relates to the UK only)

Three brands of MMR were introduced into the UK childhood vaccination schedule in October 1988. The vaccines were claimed to be a one-off lifelong protection against the three serious diseases of measles, mumps and rubella. Although it was not made clear at the time, the vaccines’ advantages, according to previous published safety tests, were convenience and economy, rather than greater safety or effectiveness.

The vaccine manufacturers were SmithKline Beecham (brand name Pluserix), Merieux (brand name Immravax) and Merck Sharpe Dohme (brand name MMR-II).

SmithKline Beecham/Pluserix and Merieux/Immravax both used Schwartz strain measles virus, Urabe AM9 strain mumps virus and Wistar RA27/3 strain rubella virus. Merck Sharpe Dohme/MMR-II used Enders’ Edmonston strain measles virus, Jeryl Lynn strain mumps virus and Wistar RA27/3 strain rubella virus.

The UK and US Governments, health authorities and medical establishments behave as though the very concept of vaccine damage does not exist. But it does, and there have been a number of very serious problems with a variety of vaccines, including in recent years, as was recently pointed out by the Congressional Committee on Government Reform in the US:

“On three occasions in the last fifteen years, changes have been made to vaccine policies to reduce the risk of serious adverse effects. First, a transition from oral polio vaccine to injected polio was accomplished in the US to reduce the transmission of vaccine-induced polio. Second, an acellular pertussis vaccine was developed and a transition from DTP to DTaP was accomplished to reduce the risk of pertussis-induced seizures in children. And when the Rotashield vaccine for rotavirus was linked to a serious bowel condition (intersucception), it was removed from the US market” - quote from the report.

In the UK, there were to be serious problems with both Pluserix and Immravax versions of MMR. It took the UK Department of Health a full four years to identify these and to withdraw the two brands, in September 1992, due to an emerging link between the Urabe strain mumps virus and aseptic meningitis.

The vaccines use an attenuated (weakened) version of the virus to stimulate an immune-system response in the child. In a letter published on 9th February 2002 in The Times (UK), Dr. David Hall, President of the Royal College of Paediatrics and Child Health, stated: “Some children develop encephalitis (brain swelling) when they catch measles, mumps or rubella virus, and may be left with a variety of handicaps, including physical and mental impairment, deafness, internal organ damage and autism......”

So could an insufficiently-attenuated strain of these viruses, administered in the form of a vaccine, also cause autism?

20. Recognised Adverse Reactions to MMR

As a background to the controversy about MMR’s safety, it is important to make clear that there is already a range of adverse reactions to the vaccine that are recognised by the manufacturers themselves, if not by the UK Department of Health.

The latter insists that the vaccine is safe and has a good safety record worldwide. However, the February 2000 edition of the manufacturer’s notes, issued by Merck & Co., lists the following possible adverse reactions reported during clinical trials:

? (body as a whole) panniculitis, atypical measles, fever, syncope, headache, dizziness, malaise, irritability

? (cardiovascular system) vasculitis

? (digestive system) pancreatitis, diarrhoea, vomiting, parotitis, nausea

? (endocrine system) diabetes mellitus

? (hemic and lymphatic system) thromobocytopenia, purpura, regional lymphadenopathy, leukocytosis

? (immune system) anaphylaxis and anaphylactoid reactions, angioneurotic edema, bronchial spasm

? (musculoskeletal system) arthritis, arthralgia, myalgia

? (nervous system) encephalitis, encephalopathy, measles inclusion body encephalitis (MIBE), subacute sclerosing panencephalitis (SSPE), Guillain-Barre Syndrome, febrile convulsions, afebrile convulsions or seizures, ataxia, polyneuritis, polyneuropathy, ocular palsies, paresthesia. On encephalitis, the Merck notes state that “the data suggest the possibility that some of these (reported) cases may have been caused by measles vaccines.”

? (respiratory system) pneumonitis, sore throat, cough, rhinitis

? (skin) Stevens-Johnson syndrome, erythema multiforme, urticaria, rash, burning/stinging at injection site, wheal and flare, redness, swelling, induration, tenderness, vesiculation at injection site

? (special senses - ear) nerve deafness, otitis media

? (special senses - eye) retinitis, optic neuritis, papillitis, retrobulbar neuritis, conjunctivitis

? (urogenital system) orchitis

? (other) “death from various and in some cases unknown causes has been reported rarely following vaccination with MMR; however, a causal relationship has not been established”

The above, although qualified in Merck’s preamble as being “without regard to causality”, does suggest that rare or relatively rare serious adverse events are not unknown and are already recognised by the manufacturers of MMR. In this context, the possibility of an unrecognised adverse event such as autism - particularly if its onset is subtle, insidious and unresearched - becomes much more credible.

It is also interesting to see that numerous adverse reactions to MMR have actually been reported in the past, as well as adverse reactions (including rare serious reactions) to single vaccines. Although links between adverse events and vaccines are invariably routinely denied by medical and health bodies, it is stretching credibility to suggest that all reported adverse events are unconnected with prior vaccination. The Department of Health’s line seems to be “only good can come from vaccination”. The manufacturers’ own warnings contradict this stance.

21. US Vaccine Adverse Events Reporting System (VAERS)

The following statistics are taken from the US VAERS (vaccine adverse events reporting system) database, covering the period from 1st January 1990 to 6th March 2001.

The table below also includes some other vaccines, for comparison. It should also be noted that a very small percentage indeed - perhaps as low as 1% - of adverse events are actually reported to VAERS in practice, and the real numbers will therefore be very much higher. Many of these reactions are extremely minor and transitory, but a considerable number are also very serious, and some reactions are fatalities.

(vaccine)	Reported adverse events	Reported serious adverse events	Reported deaths	% of total events reported as serious**	% of adverse events reported as deaths**
Dipther Tet	1,492	189	15
DTAP	10,348	1,422	283
DipTetPert	21,163	3,286	794
DTPH	6,212	928	254
Flu	15,351	2,082	324
Hepatitus B	32,209	4,676	662
HibV	21,726	3,905	932
Measles	414	61	7	15%	2%
Measles M	34	25	2	74%	6%
MMR	20,974	2,586	132	12%	1%
Measles R	117	23	0	20%	0%
Mumps	54	19	3	35%	6%
Polio live or	24,702	3,541	970
Pneumococ	5,841	712	95
Rubella	685	100	1	15%	0%
Tetanus Dip	9,566	520	12
Varicella	12,635	590	31
TOTALS*	201,815	27,768	4,965	14%	2%

Notes: * totals include a number of other vaccines, not included in the table,

** percentages only calculated selectively for components of MMR. Full titles of those vaccines itemised in the table are (1) dipitheria tetanus, (2) diptheria tetanus acellular pertussis, (3) diptheria pertussis tetanus, (4) diptheria pertussis tetanus haemophilus B, (5) influenza, (6) hepatitus B, (7) haemophilus B, (8) measles virus live, (9) measles mumps virus live, (10) measles mumps rubella virus live, (11) measles rubella virus live, (12) mumps, (13) poliovirus live oral, (14) pneumococcal, (15) rubella virus live, (16) tetanus diptheria adult, (17) varicella.

It is noteworthy that MMR and the various other components of vaccines for measles, mumps and rubella appear to account for 2,814 reported serious adverse events and 145 deaths. This has to be set against the many millions of doses administered, but also against the likely levels of under-reporting. For the autism issue, under-reporting is likely to be very high indeed, perhaps even almost total, due to lack of knowledge on the part of both parents and health professionals.

More up-to-date information has been obtained in relation to years 1999-2002, covering adverse reactions, hospitalizations and deaths data on the US Vaccine Adverse Events Reporting System database:

(adverse reactions reported to VAERS 1999-2002 ages 0-6 years):

(vaccine)	(number of adverse events reported)
DTaP	16,544
Flu	419
HepB	13,363
Hib	22,463
MMR	18,680
OPV	22,915
Varc	11,246 (from 1995)

(hospitalizations reported to VAERS 1999-2002 ages 0-6 years)

(vaccine)	(number of adverse events reported)
DTaP	1,631
Flu	41
HepB	1,840
Hib	3,224
MMR	1,736
OPV	2,868
Varc	576 (from 1995)

(deaths reported to VAERS 1999-2002 ages 0-6 years)

(vaccine)	(number of adverse events reported)
DTaP	394 deaths
Flu	11 deaths
HepB	642 deaths
Hib	843 deaths
MMR	110 deaths
OPV	866 deaths
Varc	34 deaths (from 1995)

It is interesting to note that 20,526 adverse events were reported 1999-2002 for MMR, including 110 deaths. The VAERS data is regarded as a gross underestimate of the true number of adverse events.

22. Contraindications to Receiving MMR

This list of potential contraindications to receiving MMR, contained in the Merck manufacturer’s information sheets, is also lengthy. It is very questionable as to whether all parents of UK recipients of MMR during the late 1980s and the 1990s were questioned in detail by their healthcare professionals on these aspects before their child received MMR.

Department of Health leaflets are extremely uninformative about both adverse reactions and contraindications, barely mentioning them. The moral pressure is always to press ahead with giving the child MMR, and indeed, doctors receive a significant financial bonus for achieving takeup targets. The bonus is not on a pro-rata sliding scale - if you are just short of the target, you receive a nil bonus. The pressure is therefore considerable, particularly where takeup rates hover just around the target threshold.

Contraindications recognised by the manufacturers (but in almost all cases not passed on to the public by the Department of Health) include:

? Hypersensitivity to any component of MMR, including gelatine

? Anaphylactic or anaphylactoid reactions to neomycin

? Febrile respiratory illness or other active febrile infection

? Patients receiving immunosuppressive therapy

? Individuals with blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the bone marrow or lymphatic system

? Primary and acquired immunodeficiency states, including patients who are immunosuppressed in association with AIDS or other clinical manifestations of infection with human immunodeficiency viruses

? Patients with cellular immune deficiencies or hypogammaglobulinemic and dysgammaglobulinemic states. The Merck information sheets note that “Measles inclusion body encephalitis (MIBE), pneumonitis and death as a direct consequence of disseminated measles vaccine virus infection has been reported in immunocompromised individuals inadvertently vaccinated with measles-containing vaccine”

? Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated

Some of the above contraindications could be partly relevant to the MMR/autism issue. And clearly, if a hitherto-unrecognised syndrome such as the insidious onset of autism, should exist but go unreported, then the list of contraindications would remain too narrowly defined until the syndrome became recognised. Much therefore depends on the effectiveness of reporting systems and length of follow-up. These issues will be covered later.

23. The UK Department of Health’s Position On MMR And Autism

? Despite research pointing to an original failure to properly conduct safety tests with adequate follow-up of MMR (see later), and emerging research linking MMR with autism (autistic enterocolitis syndrome) and/or inflammatory bowel disease, the UK Department of Health and other medical institutions continue to insist that MMR is safe.

? This claim is based upon advice of the UK Committee on Safety of Medicines and Joint Committee on Vaccination and Immunisation - both of which would suffer a catastrophic loss of public confidence, should such a link emerge - and a number of studies, all of which arguably have severe methodological weaknesses or inconclusive outcomes. Details follow later in the text.

? Much of the support for MMR, and denial of a link with autism, is based around a very small number of these studies, which the various sectors of the medical establishment have then endorsed.

? There have also been general reviews of the MMR/autism issue by the Medical Research Council, most recently in late 2001, and by other bodies. These reviews have failed to find a link between MMR & autism. The parents believe this failure was inevitable, given the past lack of funded research into causes, and the superficial nature of these reviews, which have accepted “absence of evidence” as “evidence of absence” of a link.

? The outcome of these reviews, and other published papers, has then been misrepresented or misinterpreted by the Department of Health as hard evidence that there is not a link.

? The DoH-sponsored impression of “a growing body of evidence” that there is no MMR/autism link is therefore illusory - the “house of cards”.

? The situation mirrors that in the US, where there is official Congressional recognition of it:

“To date, studies conducted or funded by the CDC (US Centers for Disease Control) that purportedly dispute any correlation between autism and vaccine injury have been of poor design, under-powered and fatally flawed. The CDC’s rush to support and promote such research is reflective of a philosophical conflict in looking fairly at emerging theories and clinical data related to adverse reactions from vaccinations” - quote from the conclusions of a report of the Subcommittee on Human Rights and Wellness, Committee on Government Reform, US House of Representatives, May 2003

? The UK Department of Health’s position on MMR has been endorsed by many of the major medical institutions, though it is questionable whether these institutions have themselves fully considered, in adequate detail, all the evidence on both sides of the argument.

? It is also unlikely that any of these bodies has met with parents or listened sufficiently attentively (or even at all) to their accounts of how their children degenerated. It is likely that some of the bodies, and spokespersons, backing MMR and refuting a link with autism are entirely basing their confidence upon a few selected studies, and that their knowledge of the actual children believed to have been damaged is very poor. Their detailed knowledge of the studies that point towards there being a problem may be weak and incomplete.

? The starting point should be to “listen to the patient”. Most of those giving reassurance have never even met the patient, nor the patient’s parents, nor examined the affected child, nor reviewed their medical case-notes.

24. Single Vaccines In The UK

? Despite the DoH’s position of “MMR or nothing” (and increasing numbers of parents seem to be choosing the latter), when MMR was introduced in 1988, the UK National Health Service advice to doctors was that single vaccines should be made available for any parents not wishing their child to have MMR.

? In the pamphlet, Immunisation Against Infectious Disease”, which accompanied the introduction of MMR to the UK, it stated: “For children whose parents refuse MMR vaccine, single antigen measles vaccine will be available” (source: Joint Committee on Vaccination and Immunisation, 1988). It is unclear when, or why, this advice was withdrawn by the DoH, but it may have followed discontinuation of the single vaccines as an economy measure. In the 1996 edition it states, page 135, 22.2.3, “single antigen measles mumps and rubella vaccines are available”, so perhaps it was dropped some time after this date as stocks of single vaccines were reduced.

25. Measles In The UK

? There have also been numerous spurious claims about measles deaths, aimed at frightening parents into having MMR. For example, the Chief Medical Officer for England, Professor Sir Liam Donaldson, told the BBC Today programme that Dr. Andrew Wakefield’s research had led to a loss of confidence in MMR, a vaccine “that had saved millions of children’s lives”. The implication was that a large proportion of these “saved” lives was in the UK.

? The truth was very different. Dr. F. Edward Yazbak, in a letter to the British Medical Journal in March 2004, pointed out that UK measles deaths had decreased precipitously before the introduction of measles vaccines, because of better nutrition and hygiene. “The following can be checked with the (UK) Department of Health. In 1901 there were 9,019 deaths attributed to measles, in a population of 32,612,000 in England and Wales, giving a mortality of 276.5 per million. In 1960 (before measles vaccination was introduced, using the single vaccine), there were 80 deaths and the total population was 45,775,000.

? The measles mortality rate in England and Wales was therefore 1.75 per million in 1960. In other words, the mortality rate from measles had decreased by 99.12% before the introduction of the (single) measles vaccine.”

? It is also interesting to note that, bearing in mind that health officials routinely wave-away claims of potential damage from vaccines as being a “one in a million” chance, but that even as long ago as 1960, the actual recorded death rate from measles was barely much more than the proverbial “one in a million”.

26. Promotion Of MMR In The UK After The Wakefield “Early Report” Controversy

? During the years 1998-2004, a one-sided view of the MMR/autism issue has thus been adopted by the Department of Health and its satellite organisations, much of it aimed at restoring public confidence in immunisation, to fight communicable diseases, rather than rigorously searching-out the cause of the damage to the actual children. Fresh publicity issued during early 2002 took a one-sided view of the debate, and ignored some key scientific evidence such as the January 2002 research by Dr. Vijendra Singh (see later), despite the latter being widely available in advance of the date of the Department’s publicity.

? A similar denial process has occurred in the US, but its main roots lie in the UK, and based on (mainly statistical) advice stemming from only a very small number of sources.

? At the end of 2001, the UK Department of Health released a “Top 10 Truths/Top 10 Myths” leaflet about MMR, and this is summarised below, with a critique alongside:

(UK Department of Health’s “Top 10 Truths”)

*(Department of Health “Truth”)*	*(Critical Response of Parents)*
MMR is safest way to protect children	Does not address the alleged damage
Over 500m doses of MMR have been used in over 90 countries	Almost all those countries have no autism database. Only US has good data - and this shows a steep rise in autism
No country in the world recommends single vaccines	No country in the world has yet acknowledged that there may be an MMR/autism link, either, but that may yet follow in time. Some countries permit single vaccines as a choice.
Children who are not immunised with MMR increase the chance of infection in others.	True. But those children could still receive single vaccines. And there may yet be a massive loss of confidence in all vaccination, if the children win in the High Court. It would therefore be prudent to think of this possibility, and permit choice now.
The evidence is that MMR does not cause autism or IBD (a number of studies are quoted, but only those which suit the Department’s stance)	There is evidence that suggests that it may do. Every one of the quoted studies that “disproves” an MMR/autism link can be flawed (see elsewhere in this document).
Wakefield et al in 1998 said “We did not prove an association”.	True. The research is still unfolding. Time did not stop in 1998.
Single vaccines put children at risk	The Department’s argument is based upon a supposition that some children would not complete the full course of vaccines. But if the children win in the High Court, and the Department is shown to have misled the public (either unknowingly or knowingly), the damage will be far greater. And already, some children are avoiding any measles vaccine. The Department’s argument is already having a perverse consequence, and may eventually massively backfire..
MMR was thoroughly tested before introduction into the UK in 1988.	In the context of adverse outcomes with an insidious long-term onset, MMR was not properly tested. Advice at the time to explore possible adverse effects was not followed up. By disputing historical facts, the Department reveals its bias.
Two doses of MMR are needed to protect children.	The efficacy of MMR in terms of preventing measles is not the point at issue.
There are very few children with genuine contraindications.	This does not address the MMR/autism link. It also does not square with the manufacturer’s own information sheets, which imply a substantial number of possible adverse effects.

The Department of Health’s “Top 10 Truths” leaflet ends with the reassuring statement, “All of the above are correct”! The above critique suggests that the “truth” is nowhere near clear-cut, and the Department’s position is thus exposed as artificial and one-sided.

(UK Department of Health’s “Top 10 Myths”)

*(Department of Health “Myth”)*	*(Critical Response of Parents)*
Getting protection by catching the disease is better.	This is not the issue in dispute.
Three viruses given at the same time is too much for children.	It may yet prove to be. The Department has no evidence (in the context of the MMR/autism debate) to the contrary, in relation to live viruses.
Other countries recommend that MMR is given as separate vaccines.	Of course they don’t. Perhaps this is because no country has yet woken up to the problem. As yet, there is insufficient evidence to alter this position.
Measles, mumps and rubella are rare in the UK so there is no need to immunise.	This is not the issue in dispute.
MMR causes autism and bowel disease.	There is evidence pointing towards an MMR/autism/IBD connection. Until this area is thoroughly researched, it is scientifically untenable to rule it out.
There was a scientific paper that linked MMR and autism/IBD	There have now been a number of such papers. They form part of an unfolding story.
Giving MMR as separate vaccines reduces the risk of side effects.	It is not possible to prove/disprove this until proper clinical research has been funded and conducted.
The vaccine was not properly tested.	In the context of the MMR/autism debate, and the alleged link, this is factually true, and it is extraordinary for the Department to claim otherwise. Even the Department cannot re-write history.
My child has already received one dose, so does not need a second dose.	This is not the issue in dispute.
My son does not need protection against rubella, my daughter does not need protection against mumps.	This is not the issue in dispute.

The Department of Health’s leaflet ends, “All of the above are wrong”. In the view of the parents, of the “Top 10 Myths”, four are irrelevant to the debate about an MMR/autism link, one statement about a “Myth” is factually incorrect, and the remainder can readily be disputed because the research has not been completed, or in some cases even commissioned, to decide the issue either way.

The position in the US is no different. In summer 2002, the US Center for Disease Control (CDC) updated its “Frequently Asked Questions” (FAQs) on the MMR/autism issue. It asked the question: “What have studies found regarding MMR vaccine and autism?”.

Its answer was “Epidemiologic studies have shown no relationship between MMR vaccination in children and development of autism”. However, what it did not acknowledge, or discuss, was that “studies” in the original question should have included both clinical and epidemiological studies, with greatest weight being attached to clinical findings. Its answer ducked the issue of clinical studies, focussing solely on epidemiological studies (see later for a critical review of these).

The Department’s position on measles as a disease is also open to question. The Chief Medical Officer for England, Professor Sir Liam Donaldson, claimed during a BBC Radio 4 Today Programme interview that DR. Wakefield’s research had led to a loss of confidence in a vaccine that had claimed “millions” of children’s lives. But in a written response, Dr. F. Edward Yazbak has pointed out that measles deaths in the UK had declined precipitously before the introduction of the measles vaccine, because of better nutrition and improvements in hygiene.

According to the Department of Health’s own figures, in 1901 there were 9,019 deaths attributed to measles in England and Wales, amongst a total population including adults) of 32.6m, giving a mortality rate of 276.5 per million. In 1960, there were 80 deaths amongst a population of 45.8m, giving a mortality of 1.75 per million. In other words, mortality attributed to measles had declined by over 99% before the introduction of measles vaccine.

27. Position of US Center for Disease Control on MMR/Autism

The position of the US Center for Disease Control is summarised as follows (taken from their website in February 2002, but believed to be unchanged as at 2004):

? Is there any scientific evidence that provides a link between autism and vaccination? - To date there is no convincing evidence that any vaccine can cause autism or any kind of behavioural disorder. A suspected link between MMR vaccine and autism has been suggested (but this).......may simply be an.....unrelated chance occurrence.

? Is there a theoretical possibility that there is a connection between autism and MMR vaccine, or any other vaccine? - If measles vaccine or any other vaccine causes autism, then it would have to be a very rare occurrence, since millions of children have received vaccines without ill effects.

? What are the known side-effects associated with MMR? - About 5-15% of vaccinees may develop a fever 5-12 days after MMR, and 5% may develop a rash (comment - not clear if this means 5% within the 15% or 5% plus the 15%). Central nervous system conditions, including encephalitis and encephalopathy, have been reported with a frequency of less than one per million doses administered

? What is the federal government doing to protect the health of persons who receive MMR? - There are no proven data to suggest that measles vaccine will increase the risk of developing autism or other behavioural disorders.

Comment: the above is neither comprehensive nor balanced, and its one-sided reassurance is therefore unhelpful. The details of the above could even be challenged on the grounds of factual accuracy. Point one is particularly threadbare.

The position of the US health authorities on thimerosal is equally evasive. There is no admission of potential harm. The thimerosal issue is covered elsewhere in this Briefing Note.

28: The Parents Have Seen What They’ve Seen.......

It is not in dispute that vaccines have saved millions of lives. The MMR/autism parents are not anti-vaccination in principle. These parents all took children to be vaccinated. We all recognise the need to protect children from diseases.

But saving lives from diseases doesn’t justify ruining significant numbers of lives from unrecognised and unmonitored vaccine damage.

It is also felt by many parents that the mantra “the benefits of vaccination outweigh the risks” has become increasingly skewed by

? (a) occasionally overstating the dangers of diseases, citing experience of diseases from poor and underdeveloped countries, or UK experiences from half a century ago, or pointing to recent deaths (e.g. Ireland) where other factors played a major part, or

? (b) grossly underplaying or dismissing outright any risks from vaccination. This latter has been aided by the extremely poor monitoring of adverse outcomes, and by the authorities strenuously refusing to accept that an adverse outcome was the result of a vaccine.

All affected parents are in the privileged position of having watched their child degenerate. It is a powerful first-hand experience. Comparing notes results in finding that other parents have undergone extremely similar experiences. Unfortunately, such experiences are not part of a scientifically-controlled study, so are routinely dismissed by the Department of Health as anecdotal.

? Usually there appears to be a very gradual degeneration over many weeks and months, not an acute event, more akin to (eg) the onset of cancer than the rare acute reactions to vaccines seen in the past.

? But all the attention of the past upon possible adverse reactions to vaccines has focussed upon acute near-immediate events.

? The onset of gut/bowel problems and hyperactivity have accompanied the onset of autism. Some link between them is therefore likely, even without detailed research.

? An anecdote is an anecdote. A consistent pattern of anecdotes is much more powerful. What we have is a consistent detailed pattern of reports from parents. The importance of this pattern has been ignored by the Department of Health.

The view of affected parents can be summed up by two quotes from Canada:

“Basically, I haven’t met a single person with autism who can’t trace it to the shots. Our stories are all the same. My kid had the DPT and he started getting sick. He had the MMR and we thought he went deaf. We gave him antibiotics for an ear infection.....and suddenly he’s going spinning and twirling and laughing for no reason. You’d have to be an idiot not to see the connection.” (Cynthia Stark, Canadian parent)

“How is it possible that (the medical establishment) can ignore it? They keep talking about environmental factors. What is this mysterious environmental factor? I hear the same stories over and over again. A few months after an MMR shot, a child begins to regress and to lose milestones. That’s the repeated “broken record” that keeps being told over and over. I see the MMR as the straw that breaks the child’s health.” (Edda West, of the Vaccine Risk Awareness Network, Canada)

PART D

THE THIMEROSAL/THIOMERSAL ISSUE

29. Thiomersal’s Possible Role

This section commences with some quotes:

“My grandson received vaccines for nine different diseases in one day. He might have been exposed to 62.5 micrograms of mercury in one day through his (US Food and Drug Administration-approved) vaccines. According to his weight, the maximum safe level that he should be exposed to in one day (according to the US Environmental Protection Agency) is 1.51 micrograms. This is (therefore) 41 times the amount at which harm can be caused” - letter from Rep. Dan Burton, then Chairman of the House of Representatives’ Committee on Government Reform, to the then US Department of Health and Human Services Secretary Donna Shalala, October 2000

and.....

“In 2001, the Institute of Medicine stated that it is “unclear whether ethylmercury (from vaccines) passes readily through the blood-brain barrier. Th IoM recommended several biological and clinical studies to answer this question.....These studies were in a large part never done.....Even today, the IoM cannot tell you with any degree of certainty what happens to ethylmercury once injected into an infant. Does it go to the brain? Does it cause developmental problems?” - Press Release by Representative David Weldon, US House of Representatives, May 2004

and.....

In 2003, the staff of Rep. Dan Burton, member of the US House of Representatives for Indiana, obtained a confidential internal US Government email written in June 1999 by former Food and Drug Administration scientist Peter Patriarca, offering an assessment of the impending statement in July 1999 by the US Public Health Service urging manufacturers of vaccines to reduce or eliminate thimerosal: “(This) will raise questions about the FDA being asleep at the switch for decades, by allowing a potentially hazardous compound to remain in many childhood vaccines, and not forcing manufacturers to exclude it from new products. Will also raise questions about various advisory bodies about aggressive recommendations for use. We must keep in mind that the dose of ethylmercury was not generated by rocket science - conversion of the percentage of thimerosal to actual (micrograms) of mercury involves 9th grade algebra. What took the FDA so long to do the calculations? Why didn’t the Centers for Disease Control and the advisory bodies do these calculations while rapidly expanding the childhood immunisation schedule?”

The currently-stalled UK litigation regarding autism and vaccination were proceeding on the basis of autism following MMR (or MR) vaccination. In contrast, in the US, cases are taking legal action over the link between autism and thiomersal, the mercury-based preservative used in many vaccines for several decades, both in the UK and US.

It is understood that thiomersal, a mercury-based preservative, has been used in a number of UK and US vaccines over many years. It is believed that it is not used in MMR itself, but it may yet prove to have been used in the manufacturing process. If this is the case, it is believed that no declaration has to be made on the manufacturer’s information sheet, as it is not an actual MMR constituent.

In the US, in the 70 years since thimerosal/thiomersal/merthiolate preservative was developed, the Food and Drug Administration never required manufacturers Eli Lilly to conduct clinical studies of its safety. Even in 2004, the FDA still referred to the original 1931 Powell and Jamieson study (which offered no proof of thimerosal’s safety) as an indication of its “safety and effectiveness as a preservative.

Eli Lilly ceased manufacture of thimerosal-containing products in the mid-1980s, but thimerosal remained in widespread common use, including in vaccines, into the 21st century. Eli Lilly still has revenue from licensing agreements with other pharmaceuticals companies using thimerosal all around the world.

The key point about thimerosal is that no-one thought to check that, as more and more vaccines were recommended for infants, whether this produced a cumulative total that was in excess of safety guidelines.

The two suspected causes, MMR and thimerosal, are not mutually exclusive. It has never been suggested that MMR causes all autism, and the two factors may in any case be working in concert.

? The thimerosal issue emerged when the 1997 US Food & Drugs Administration Bill was passed, a re-authorisation bill that required the FDA to compile a list of drugs and foods that contained intentionally-introduced mercury compounds. In June 1999, the FDA issued a report indicating that “infants who receive thimerosal-containing vaccines at several visits may be exposed to more mercury than recommended by Federal guidelines for total mercury exposure”.

? Despite the FDA’s report, there was no ordered recall of the vaccines. However, the FDA asked the manufacturers to reduce the mercury content, and they complied.

? Worldwide, thimerosal has been used for about the past 60 years. Ethyl mercury constitutes about 49.6% of its weight, and mediates the antimicrobial effects. Thimerosal has been used to prevent bacterial contamination during the vaccine manufacturing process, as well as in vials where repeated puncture may allow contamination to occur.

? It is believed that levels of thimerosal have been reduced over the years in vaccines, and removed altogether in some cases. In April 2001, the US Food & Drug Administration announced that they supported the reduction of mercury exposure from any source. The FDA then encouraged vaccine manufacturers to develop new vaccines without thimerosal. In the US, in 2001, a free exchange system was instigated by the manufacturers, to remove stocks.

? In the UK, the Department of Health has refused to acknowledge that there might be a problem with thimerosal, and no free exchange system has been offered, or sought. Thimerosal continues in use in a number of vaccines, not just those for children. As recently as January 2003, press reports in The Scotsman newspaper indicated that four out of the seven influenza vaccines in use in the UK contained thimerosal, and this was not refuted by the Department of Health.

? In the US, a September 2001 survey of 65,909 vaccines at provider centres found that 5.5% still contained thimerosal. Some 36% of these were DtaP-Hib for the fourth dose. A depot survey of 837,174 vaccine doses found that 1% still contained thimerosal. Of these, 80% were for DtaP.

? In early 2003, calls for all thimerosal to be removed from vaccine use were renewed. Michael Bender, Director of the Mercury Policy Project, stated that continued use was irresponsible and not worth the risk. Sallie Bernard, Director of the Safe Minds charity, said that there was no “safe” level for mercury in vaccines, and that use should cease unequivocally and without delay. Barbara Loe Fisher, President of the National Vaccine Information Center, said that all vaccines should be mercury-free.

30. Joint Statement of American Academy of Pediatrics and Public Health Service, Thiomersal In Vaccines, July 1999

In 1999, researchers calculated that a low-birthweight baby could receive a cumulative dose of mercury (187ug) that would have exceeded the safety recommendations of the US Environmental Protection Agency.

In July 1999 the AAP and the PHS issued a joint statement on thimerosal in vaccines, noting that the US Food & Drug Administration Modernization Act of 1997 called for the FDA to review and assess the risk of all mercury-containing food and drugs.

The joint statement was generous in its self-reassurance:

? “Thiomersal has been used as an additive......since the 1930s......”

? “There is a significant safety margin incorporated into all the acceptable mercury exposure limits”

? “There are no data or evidence of any harm caused by the level of exposure that some children may have encountered” (Comment - but this may reflect lack of studies or lack of monitoring, not lack of harm)

? “Infants and children who have received thiomersal-containing vaccines do not need to be tested for mercury exposure” (Comment - as an example of complacency, this statement is in a class of its own).

? “The recognition that some children could be exposed to a cumulative level of mercury over the first six months of life that exceeds one of the federal guidelines on methyl mercury now requires a weighing of two different types of risk.....The large risks of not vaccinating children far outweigh the unknown and probably much smaller risk, if any, of cumulative exposure to thiomersal-containing vaccines” (Comment - this is an tautological statement, and is revealing. What the AAP/PHS are saying is, the risks from thiomersal are unknown, are probably small, and are far outweighed by another risk - which of course is an impossible deduction to draw if the risks from thiomersal are unknown. One cannot say for certain that A is larger than B if there is no way of determining the size of B, or if the size of B is unknown because it has been historically overlooked, and thus not measured).

? “Nevertheless, because any potential risk is of concern, the PHS, the AAP and the vaccine manufacturers agree that thiomersal-containing vaccines should be removed as soon as possible”.

Key action agreed was:

? A formal request to manufacturers for a clear commitment and a plan to eliminate or reduce mercury content of vaccines

? A review of data

? Expedited FDA review of manufacturers’ supplements to their product license applications, to eliminate or reduce mercury content

? Studies to better-understand the risks and benefits of this safety assessment

31. Removal of Thimerosal

The following is quoted from a paper, Vaccination - An Analysis of the Health Risks, Part 1, by Gary Null PhD and Martin Feldman MD: published in Townsend Letter for Doctors & Patients, October 2003

“Use of thimerosal - In July 1999, the American Academy of Pediatrics issued a statement urging the removal of the mercury-containing preservative thimerosal from vaccines. The Centers for Disease Control and Prevention (reported) that as of April 2001, all seven of the vaccines recommended for use in all children contain either no thimerosal or trace elements only. These vaccines include Hepatitis B, Haemophilus influenza B, and DTaP (Diphtheria tetanus acellular Pertussis) which formerly contained thimerosal as a preservative, and MMR, polio, varicella and pneumococcal (which have never contained thimerosal).

The FDA explained that the vaccines were now being produced as either thimerosal-free or thimerosal-reduced products. The term “thimerosal-reduced” indicated that trace amounts of mercury - less than 0.5mcg per 0.5ml vaccine dose - may remain from the use of thimerosal in the manufacturing process, but that thimerosal was no longer added as a preservative. The term “thimerosal-free” means that a vaccine does not have a preservative but, again, that trace amounts may remain from the manufacturing process”.

What this report did not make clear, as is explained later in the papers by Geier and Geier, was that large stocks of thimerosal-containing vaccines, some with expiry dates of 2005, remained in use, and were not recalled, but were being used up in children.

32. Waters & Kraus Press Release of March 17th 2002

In March 2002, the lawyers Waters and Kraus, acting on behalf of US children in the thiomersal/autism class action, stated that their discovery process in their case of Counter v. Eli Lilly (manufacturers of thiomersal) had demonstrated that thiomersal was known by Lilly as early as April 1930 to be dangerous. These included the following studies/warnings deposited with Lilly:

? (1947) “It may be dangerous to inject a serum containing merthiolate into a patient sensitive to merthiolate”

? (1963) “It seems advisable to use a preservative other than merthiolate for injections into merthiolate-sensitive people”

? (1972) Merthiolate in vaccines caused six deaths - “The symptoms and clinical course of the six patients suggest subacute mercury poisoning”

? (1982) The (FDA) Panel concludes that thimerosal is not safe for OTC topical use because of its potential for cell damage if applied to broken skin, and its allergy potential”.

? (1991) Lilly ceases manufacture or sale of thimerosal. Licensing agreements demonstrate continued profits from the product until at least 2010

? (1999) Lilly advice on thimerosal: “Mercury poisoning may occurr.....Exposure in children may cause mild to severe mental retardation”.

In July 2002, the Indianapolis Star newspaper quoted the lawyers Waters and Kraus as saying that “Lilly flim-flammed scientists for years with a 1931 study that concluded thiomersal wasn’t harmful to humans”. The Star went on: “The study, published in the American Journal of Hygiene, reported that merthiolate has a very low order of toxicity......for man”.

Digging further, Waters found out that the study’s toxicity data came from experimental use of thimerosal by doctors from Lilly and Indianapolis City Hospital on meningitis patients during a severe outbreak in 1929-30. ‘The 1931 study on a cohort of severely ill people (who all died) ended up being quoted in Lilly brochures into the 1980s’, Waters said. ‘It very clearly demonstrates an effort to do an unethical study and then paint the results in a certain way that helps them sell this product’. Lilly ignored or covered up later evidence that thimerosal, which contains 50 per cent mercury by weight, can be dangerous to humans”, Waters said.

The detailed sequence uncovered by Waters (the wording is taken directly from their press release) is as follows:

? September 1930, Lilly secretly sponsor a “human toxicity” study on patients dying of meningococcal meningitis. Waters then states: “Lilly then cited this study repeatedly as proof that thimerosal was of low toxicity and harmless to humans. They never revealed to the scientific community or the public the highly questionable nature of the original research.”

? Numerous articles since the 1930s indicated concerns about thiomersal and its potential hazard to humans. The evidence clearly demonstrates (according to Waters & Kraus) that Eli Lilly was advised repeatedly that their conclusions on low toxicity were not warranted, and they failed to pass the information on to appropriate Federal and public health authorities.

? 1947, article received by Lilly states: “No eruptions or reactions have been observed or reported to merthiolate internally, but it may be dangerous to inject a serum containing merthiolate into a patient sensitive to merthiolate”