Issues - Chemical Abuse of Children - MMR debate and autism

MMR and Acquired Autism (Autistic Enterocolitis)
A Briefing Note by David Thrower April 2002
Executive Summary
Part A: A Novel Syndrome
1. What Is Acquired Autism/Autistic Enterocolitis
2. The New Syndrome
3. Recognised Adverse Reactions to MMR
4. Contraindications To Receiving MMR
5. Families Taking Legal Action
6. The UK Department of Health’s Position
7. The Parents Have Seen What They’ve Seen.....
Part B: The Costs of Autism
8. The Financial Costs - Autism Is Costing Billions
9. Estimates
10. Failure to Monitor Increases In UK Autism Numbers
11. "Now Almost Everyone Knows Someone Who’s Autistic"
12. University of Cambridge Research
13. University of Sunderland Research
14. National Autistic Society Estimates
15. Report by Fiona Loynes for UK All Party Parliamentary Group, Dec. 2001
16. Is Autism Increasing? - Some Recent Official UK Pronouncements
17. Autism In The USA
18. California
19. New Jersey
Part C: Studies That Have Been Used To Disprove An MMR/Autism Link
20. Stokes et al paper, Journal of American Medical Association (JAMA), Oct. 1971
21. Study by Peltola and Heinonen, Lancet, April 1986
22. Paper by Miller, Miller et al, The Practitioner, January 1989
23. Gillberg Study, Sweden, British Journal of Psychiatry, 1991
24. Commentary by Gillberg and Heijbel, Autism, 1998
25. Letter by Fombonne, Pediatrics, March 1998
26. UK Committee on Safety of Medicines Study, June 1999
27. Paper By Taylor, Miller and Farrington, Lancet, June 1999
28. Paper by Miller & Farrington to US Government Reform Committee, April 2000
29. Patja, Peltola et al Study, Finland, Pediatric Infectious Disease Journal Dec. 2000
30. Kaye, Melero-Montez and Jick Study, British Medical Journal, 2000
31. Fombonne Paper, Pediatrics, January 2001
32. Dales, Hammer and Smith Study, JAMA, March 2001
33. De Wilde, Carey & Richards Study, Br. Journal of General Practice, March 2001
34. Davis et al study, Archive Pediatrics Adolescent Medicine, 2001
35. Further Paper by Farrington, Miller and Taylor, Vaccine Journal, 2001
36. Fombonne & Chakrabarti Study, Pediatrics, October 2001
37. Further Paper by Taylor, Miller et al, BMJ.com, February 2002
Part D: Reviews That Conclude There Is No Evidence Of A Link
38. Medical Research Council Ad-Hoc Review, March 1998
39. Presentation by Miller to UK All Party Parl. Group on Primary Health Care, 2000
40. Medical Research Council Sub-Committee Report, March 2000
41. Review by US Institute of Medicine, 2001
42. Elliman, Bedford and Miller Review, Arch. of Diseases in Childhood, Oct. 2001
43. Medical Research Council Review, July-December 2001
44. Further Review by US Institute of Medicine, February 2002
Part E: The MMR Original Safety Trials Debate
45. Wakefield & Montgomery "Through A Glass Darkly" MMR safety-studies paper
46. Dr. Peter Fletcher Commentary, Journal of Adverse Drug Reactions, 2001
47. Dr. Stephen Dealler Commentary, Journal of Adverse Drug Reactions, 2001
48. Dr. F. Edward Yazbak Commentary, Journal of Adverse Drug Reaction, 2001
49. The Wakefield/Watson/Shattock Rebuttals
50. The UK Department of Health’s Repudiation of "Through A Glass Darkly".
Part F: Studies/Papers That Point Towards An MMR Link
51. Paper by Eggers, Klinical Paediatrics, March 1976
52. Weizman, Weizmann, Szekely et al Study, Am. Journal of Psychiatry, Nov. 1982
53. Delgiudice-Asch and Hollander Study
54. Fudenberg paper
55. Paper by Dr. Reed Warren
56. Warren and Singh Study, Immunogenetics, 1992
57. Singh, Warren, Odell, Warren and Cole Paper, March 1993
58. Singh, Warren, Odell et al Study, Brain Behaviour, March 1993
59. Oleske and Zecca paper
60. Binstock paper
61. Anne-Marie Plesner Letter, Lancet, February 1995
62. Gupta, Aggarwal and Heads Study, Journal of Autism and Dev. Disorders, 1996
63. Montinari, Favoino and Roberto paper, Naples conference May 1996
64. Auwaerter and Griffin paper, Clinical Immunology and Immunopath., May 1996
65. Cook, Courchesne et al Paper, Molecular Psychiatry, May 1996
66. Griffin and Hussy Study, Journal of Infectious Diseases, June 1996
67. Martinez et al Study, Proceedings of National Academy of Sciences, 1997
68. Paper by Zecca, Graffino et al, Meeting of National Inst. of Health, Sept. 1997
69. Weibel, Caserta and Evans Study, March 1998
70. Wakefield et al "Early Report", Lancet, February 1998
71. Paper by Montgomery, Morris et al (publication date/details not yet known)
72. Sabra, Bellanti and Colon letter, Lancet, July 1998
73. Further Unpublished Paper by Singh and Yang, October 1998
74. Uhlmann, Sheils et al Paper
75. Bitnun et al Study, Clinical Infectious Diseases Journal, October 1999
76. Paper by Dr. Singh to the US Committee on Government Reform, April 2000
77. O’Leary Paper Presented to US Congressional Oversight Committee, April 2000
78. Kawashima, Takayuki et al Study, Digestive Diseases and Sciences, April 2000
79. Hagenbuch, Kullak-Ublick et al Study, Journal of Pharm. Exp. Ther., July 2000
80. Wakefield et al Paper, American Journal of Gastroenterology, September 2000
81. Statement by Professor Walter O. Spitzer, December 2000
82. Furlano, Anthony et al Study, Journal of Pediatrics, 2001
83. Study by Jyonouchi, Sun and Le, J. Allergy & Clinical Immunology, Feb. 2001
84. Study by Jyonouchi, Sun and Le, J of Neuroimmunology, 2001
85. Paper by Spitzer, Aitken et al, Journal of Adverse Drug Reactions & Tox., 2001
86. Paper by Dr. Ken Aitken to the Scottish Society for Autism, 2001
87. Paper by Imani and Kehoe, Clinical Immunology, September 2001
88. Paper by Dr. Timothy Buie, Oasis 2001 Conference for Autism, Portland, US
89. Paper by Uhlmann, Wakefield, O’Leary et al, J. of Clinical Pathology, Feb. 2002
90. Paper by Singh and Nelson, February 2002
Part G: Other Potentially Relevant Papers
91. US Developmental Delay Registry Report, 1994
92. Stratton et al Study, National Academy Press, 1994
93. Paper by Carbone.
94. Iizuka, Saito et al Study, Gut, May 2001 (Mumps Study)
95. Statement by Spitzer, US House of Repres. Govt Reform Committee, April 2001
Part H: Future Papers Investigating A Link
96. Fombonne et al Study, London
97. Charman et al Study, London
98. Study by Professor Andrew Hall, London
99. Study by Takahashi et al, Tokyo
100. Study by Byrd et al, M.I.N.D. Institute, University of California at Davis
Part J: The Thiomersal Issue
101. Thiomersal’s Possible Role
102. Thiomersal In Vaccines: Statement of US AAP/Public Health Service, July 1999
103. UK Vaccines With Thiomersal
104. Scientific Review by US Centre for Disease Control, Simpsonwood, June 2000
105. Press Release by Waters and Kraus, March 2002
106. UK Medicines Control Agency Position
Part K: Flawed UK Regulatory and Monitoring Systems
107. Fighting Measles, Missing Autism, Overlooking Damage?
108. Has the Medicines Control Agency Missed the Syndrome?
109. UK Department of Health Re-Launch of MMR, January 2001
Part L: UK and US Political Initiatives
110. UK House of Commons Health Committee, Westminster
111 UK All Party Parliamentary Group on Autism, Westminster
112. Scottish Parliament, Edinburgh
113. UK Liberal Democrats
114. UK Conservatives
115. US House of Representatives Government Reform Committee
Part M: Some Conclusions and Some Unanswered Questions
116. Some Broad Conclusions
117. Some Unanswered Questions
EXECUTIVE SUMMARY
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 measles vaccines.
It does not attempt to cover every single piece of the available scientific literature for or against an MMR/autism link, but it reviews about 70 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 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 whose parents are now taking action through the UK High Court?
The one study that has both claimed there is no MMR/autism link and also actually looked at a sub-set of the 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.
Parents who have scrutinised the studies quoted by the Department of Health as "proof" of there being no link have found that such studies crumble 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 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 later 2000 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.
In contrast, the parents find that there are a number of studies that suggest that MMR could be causing acquired autism (or "autistic enterocolitis") in significant numbers of children.
Not all of these studies originate from only one group of researchers, 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, offer further clues as to what may be happening, and are consistent with an MMR involvement.
Furthermore, many of the studies that suggest that there is an MMR/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 over the past five years, with repeated assurances being given to the public, but with these being based upon a lop-sided, partisan and 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 thiomersal-containing vaccines, though it is not yet clear whether these problems are directly interlinked biologically to the MMR/autism problems (MMR does not contain thiomersal). Class-action lawsuits are now under way in the US over thiomersal and autism, just as they are in the UK 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 five years or more - clues that all too often have been ignored, or, worse still, rejected out of hand, by the authorities.
The medical establishment has repeatedly asked itself the wrong question. It has asked itself "Is MMR safe?", hoping for an affirmative answer. In contrast, researchers and parents have asked two very different questions: "What 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 children that have been damaged have had their lives ruined. They were previously 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.
Finally, this briefing note poses a number of unanswered questions about MMR, and about the UK children that are believed to have been severely damaged by its administration
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.
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 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 is permanent.
This late onset of autism typically follows the receipt of MMR vaccination. It does not necessarily occur immediately afterwards - 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.
Crucially, the onset of this acquired form of autism is accompanied by other visible manifestations of problems. These include bright red ears and dark rings under the eyes after certain foods, gluten and casein intolerances, 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 is described by the UK Department of Health as a coincidence. Their argument is that it is "noticed" around this time, because this is a time when child development is most rapid, and any failure most noticeable.
However, very significantly, much older children have also degenerated into autism after MMR. 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 become autistic just before MMR.
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.
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.
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 is not. It is being held up by the refusal of the medical establishment in the UK to recognise the problem, or even to recognise the increase in autism.
Also coinciding with the late onset of autism in many of the children (or other 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 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. This research has not only come from the Royal Free Hospital, London, but also from other centres in 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).
2: The New Syndrome
This is a 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 its swollen and hyperplasic condition, 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 thiomersal, a mercury-based preservative that has been routinely used in a number of vaccines, may have played a role. Again, adequate research has not yet been done.
Damage may in the event be via a combination of these pathways.
3. 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 insidious - becomes rather more credible.
4. Contraindications to Receiving MMR
This list of potential contrainications 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 on these aspects before their child received MMR: Contraindications include:
Hypersensitivity to any component of MMR, including gelatine
Anaphylactic or anaphylactoid reactions to neomycin
Febrile respiratoty 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 virues
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.
5. Families Taking Legal Action
Between 2,000 and 3,000 families whose children became autistic or had other serious adverse events after MMR are believed to be now taking legal action, or actively seeking to take legal action, in the UK, against MMR manufacturers Aventis Pasteur MSD Ltd, Merck and Company Inc, SmithKline Beecham & French Laboratories Ltd and SmithKline Beecham Plc. The trial date is currently fixed for October 2003 in the High Court of Justice in London.
Leading UK legal firms involved are Alexander Harris, Freeth Cartwright Hunt, and Hodge Jones & Allen. The action is being brought under the European Union’s Product Liability Directive, the Consumer Protection Act.
Cases include children who received Aventis Pasteur MSD’s Immravax and Glaxo SmithKline’s Pluserix brands of MMR vaccine. These brands were withdrawn by the UK Department of Health in 1992, two years after a similar vaccine containing the Urabe strain of mumps virus was withdrawn in Canada, following reports of meningitis.
The UK lawyers Alexander Harris have stated that a clear pattern of events began to emerge when they were contacted by families, with children who had been developing well, both physically and intellectually, before the MMR vaccine, then acquired their autistic state after the vaccine. This condition was often accompanied by other symptoms, with sometimes only a gradual decline into autism. Many of these children are now chronically ill and mentally or physically disabled.
By 2002, the number of UK cases of alleged damage by MMR was growing rapidly, with an increase of well over a hundred cases in the space of a few weeks.
A class action over autism is now also under way in the US, led by a large consortium of specialist lawyers. This action is based upon autism and other damage being caused by thiomersal, a mercury-based preservative. This is used in some vaccines, but reportedly not MMR. However, as noted, it is possible that damage caused by MMR and damage caused by thiomersal may be interlinked biologically.
The initial US lawsuit was filed by Walters & Krauss (Long Beach, California). Other law firms taking action are Anderson & Krieger (Temecula, California), Dogan & Wilson ((Pascagoula, Mississippi), Doran & Murphy (Buffalo, New York), Evert & Weathersby (Atlanta, Georgia), Hendrickson & Long (Charleston, West Virginia), Jones, Martin, Parris & Tessener (Raleigh, North Carolina), Leach, Schwarz & Strassberg (Bala Cynwyd, Pennsylvania), Martzell & Bickford (New Orleans, Louisianna), and Wise & Julian (Alton, Illinois). More firms are expected to become involved.
The US defendants are Aventis Pasteur Inc., Pfizer Inc., Glaxo SmithKline, Merck and Co., Abbott Laboratories, American Home Products, Baxter International Inc., Eli Lilly & Co., Sigma Chemical Co. and Aldrich Chemical Co.
It is also noteworthy that there is a legal precedent for autism being triggered by multiple vaccination, even if not by measles-containing vaccine. In the United States Court of Federal Claims, in the case of Eric Lassiter v. Secretary of the Department of Health and Human Services, in a judgement filed on December 17th 1996, a case of autism was successfully brought by the parents of Eric Lassiter. The decision of entitlement was as follows:
"This case arises under the National Vaccine Injury Compensation Program. Petitioner’s mother, Mrs. Mary Lassiter, filed this claim on behalf of her son on September 26th 1990, alleging that as a result of the administration of a diptheria-pertusis-tetanus (DPT) shot on April 19th 1972, the petitioner sustained an injury set forth on the Vaccine Injury Table (s14 of the Act), namely an encepalopathy, with permanent neurological damage. Respondent defends by arguing that because no contemporaneous medical records exist that document conclusively that the onset of the injury occurred within the requisite time frame, petitioner has not established a Table injury. Respondent argues further that petitioner’s condition, more likely than not, is due to autism and is unrelated to the DPT vaccine. Following a careful review of the record in its entirety, the Court concludes that Eric Lassiter is entitled to compensation."
The judgement also included the following paragraph:
"A careful interpretation of the literature indicates that autism can be mirrored by a condition that includes "autistic-like" signs or symptoms. Eric’s condition has never been diagnosed conclusively as autism according to the medical records. The predominating diagnosis refers instead to "static encepalopathy with autistic tendencies in addition to delayed development"".
The judgement concluded:
"In summary, respondent’s (Department of Health & Human Services) evidence and proffered explanations are weak, unconvincing and insufficient to support a finding of an underlying metabolic or genetic disorder as the cause of Eric’s affliction. Petitioner (Lassiter) has presented a better case in support of a Table injury. The Court concludes that a preponderance of the evidence requires a finding for the petitioner."
6. The UK Department of Health’s Position On MMR
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 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 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.
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.
During the years 1998-2002, 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")

(UK Department of Health’s "Top 10 Myths")

7: 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.
PART B
THE COSTS OF AUTISM
8: The Financial Costs - Autism Is Costing £$Billions
Quite apart from the immense social costs of autism, there are the huge financial costs. Autism effects every UK and US taxpayer. In the UK, the costs comprise:
Health costs - specialist hospital visits, GP visits, prescriptions, exclusion diet costs
Education costs - special schools, extra teachers, extra teaching assistants, extra training
Transport costs - taxis plus drivers and escorts, plus local authority management costs, plus environmental/congestion costs of extra traffic
Social Services costs - respite care costs, transport, management, inspection, reviews
Loss of earnings of parents acting as carers
Social Security costs - carers allowances, disability living allowances
Inland Revenue costs - loss of earnings of parent, loss of revenues from child when he/she reaches earning age
Wider economic costs - loss of gross domestic product to the national economy
It would be interesting to know if the UK 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 significant loss to the wider national economy. Is autism too important to be left to the Department of Health?
9: Estimates
In June 2000 a study for the Mental Health Foundation found that
the annual costs of autistic disorder in the UK were at least £1 billion
individual lifetime costs per child affected could run to £2.94 million each.
The full costs, taking into account wider economic costs, are probably considerably higher still.
10. 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, 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 DoH 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 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 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 1999 census showed 18% increase over the 1998 census. The 2000 census showed a 31% increase over the 1999 census. The 2001 census will report during mid-2002.
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 from a relatively-recent study in 1983.
Urging that the apparent increase is down to better recognition may therefore be little more than a counsel of complacency.
11. "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 in the past by parents, and recognised medically, and also reflected in much higher historic rates of prevalence/incidence.
In the parents’ view, there is clear evidence of recent dramatic rates/increases:
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)
Wakefield LEA autism pupils up 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 up 18% in one year (1999 vs. 1998), and then a further 31% in the next year (2000 vs. 1999); (source: Scottish Annual School Censuses, available from Scottish Education Office, tel 0131 556 8400)
12. 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. 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)
Extrapolated across the UK, that would imply 30,000 primary school (age 5-11) children with autism
Linking these rates to estimated costs of education and care for sufferers would give a figure of as high as £5 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 £1bn. The Knapp report estimated the lifetime cost of a severely-affected child at £3m, for a high-functioning autism child at £0.8m, and for an Asperger’s syndrome child at £0.5m. The revised £5bn per year estimate is based upon these costs.
13. 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.
14. 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.
15. 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.
16. Is Autism Increasing? - Some Recent Official 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
17. Autism In The USA
The UK DoH 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. 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 are up from 12,222 to 65,396 between 1992-1993 and 1999-2000 (Source: US IDEA State data). So for every 2 cases there were in 1993, by 2000 there were nearly 11. Numbers will have risen even further since.
To the above total also has to be added a further 15,581 cases of autism amongst children aged 3-5 years, as at year 2000.
There have been huge increases in some States between 1992-1993 and 1999-2000 - up 885% in Alabama, 529% in Connecticut, 435% in Florida, 513% in Idaho, 636% in Kansas, 561% in Minnesota, all in just seven years (Source: US State data, Individuals with Disabilities Education Act)
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 the UK (up from 5 to 111 in seven years). On the face of it, this suggests that UK increases may very closely match those in the USA.
The latest California increases (the State with the best database) showed autism up 19% in 1999 and up again nearly 16% in 2000.
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 latest 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 are as follows:.
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 eight years between 1992-93 and 2000-01:

(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 two cases there were in 1993, there are now thirteen. And the latest 2000-2001 figures represent a single-year increase of 20% over 1999-2000
The current estimate for the year-end of 2002 is 94,000-95,000.
It seems obvious that the US has an autism epidemic. The UK is a similar health environment 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".
18. California
California has probably the most useful autism data in the world, going back to 1970. Trends monitored there have a potential worldwide significance.
The rise in autism was first highlighted by a report Changes in the Population of Persons With Autism and Pervasive Developmental Disorders in California’s Developmental Services System, 1987 through 1998 - A Report to the Legislature, tabled on March 1st 1998 by the Department of Developmental Services, Sacramento, California Health and Human Services Agency.
The latest Department of Developmental Services data, released at the start of 2002, shows that a record number of professionally-diagnosed DSM-IV criteria autism cases, 2,725 cases, entered the State system during 2001.
This year-2001 number represents a 20% increase over the year 2000, itself a record.
In 2001, there were more cases of level-one autism in California than in 1994, 1995 and 1996 combined.
Historically, autism made up 3% of childhood disability in the State Developmental Services system. It now comprises 35% of the total.
Two out of three persons with autism in California’s child-developmental system are now young children between the ages of 3 and 13. Eight out of ten persons with autism have been born since 1980 (1980 was the year that California mandated the full complement of childhood vaccines as a condition of school entry. MMR was also introduced in California 1979-80).
California now has 16,802 persons with level-one autism in its Developmental Services system.
The total intake for the three years 1999-2001 was 6,596. This compares with a total intake for the twenty-five years 1970-1995 of 6,527 cases.
This does not include children with persistent developmental disorder, non-specific (NOS) developmental delays, Asperger’s or and other autistic spectrum disorder - it is therefore the tightest definition of the severe-case numbers.
19. New Jersey
Data on autism in New Jersey, recorded by the IDEA system for individuals with disabilities who require special education, suggest that there is a vast preponderance of cases amongst children/young people ages 6-21 amongst the youngest ages. The following figures relate to the position as at 1st January 2002:
age 6 7 8 9 10 11 12 13
nos 514 505 465 439 360 257 208 165
age 14 15 16 17 18 19 20 21
nos 145 124 81 73 58 63 30 14
The total number of cases is 3,501. This equates to an average of 219 for each age-year. For ages 11 and under, the number exceeds this average, and for ages 12 and over, it is less than this average.
The youngest three years average out at 495 cases. The oldest three years average out at 36 cases. The average of the youngest years is about 14 times that of the oldest three years.
PART C
STUDIES THAT HAVE BEEN USED TO DENY AN MMR/AUTISM LINK
This section deals with the numerous recent official studies and reviews, many in the UK but some in the US or elsewhere, that "prove" there is no connection between autism and vaccination.
As will be seen, all when scrutinised critically are actually either irrelevant, inconclusive, or are seriously methodologically questionable.
The UK Government’s advice on MMR and autism comes from the DoH, the Medicines Control Agency (MCA), the Committee on Safety of Medicines (CSM) and the Joint Committee on Vaccination and Immunisation (JCVI). These bodies are closely intertwined, and have based their position on a barely more than a handful of studies. Further advice has come from the Medical Research Council.
Much of the focus has been upon the need maintain public confidence in MMR to prevent communicable diseases, rather than the need to investigate specific cases of alleged damage.
The studies are also of random groups of children, but not of the actual children reported by parents as damaged by MMR.
Finally, the Department of Health has implied in the past that the evidence for a link between MMR and regressive autism has come from only one team of researchers, which is not factually correct. However, the very same criticism can be levelled at the "anti-link" camp. A significant proportion of the studies below only comes from a very small number of sources, some very close to the Department of Health itself.
20. Stokes et al Paper, Trivalent Combined Measles Mumps Rubella Vaccine, Journal of the American Medical Association, 4th October 1971
This paper, by Stokes, Weibel, Villarejos, Jorge, Arguedas, Buynak and Hilleman, has assumed more importance recently (see later Wakefield/Watson/Shattock debate section).
The paper stated that triple vaccines were desirable to simplify administration, reduce costs and minimise visits (my emphasis). There was no mention of greater effectiveness, or inherent drawbacks with single vaccines.
There were three trials, firstly of 30 children in Philadelphia, then of 214 children in Philadelphia, then of 440 children in rural Costa Rica and San Salvador, total 684 but (note) of very different economic and geographical backgrounds.
The mean ages of children in the three trials was 1.1, 1.5 and 3.0 years. Note that the present age of receiving MMR is about 14 months, and therefore the vast majority of the trial children were significantly older than today’s UK MMR recipients. Some 64% were also not from Western social/health backgrounds.
The 30 children’s parents were given report cards for recording temperatures for 28 days, and queried at six to nine weeks. For the 214 child-cohort and the 440 child-cohort trials, follow-up was 28 days. The parents were instructed to notify any significant illnesses during the 28-day period, and were queried at the second bleeding, six to nine weeks after vaccination - but the implication is that this query may have covered the 28-day interval, not longer.
The study noted that "the fifth to twelfth day after vaccination is the critical time period for occurrence of the expected low incidence of febrile reaction", also that the significance of the difference between vaccinees and controls in terms of miscellaneous subsequent complaints (gastroenteritis included) was "doubtful" (though it was actually very marked in the study tables, up to 18/228 of vaccinees with gastroenteritis, compared with at most 3/106 of controls)
At no point in the study was autism mentioned as a risk-factor or an actual outcome. Clearly, the possibility was not even considered. The study noted the lack of arthritis and arthralgia.
Overall verdict: this study is not relevant to disproving an MMR/autism link
21: Study of Twins By Peltola and Heinonen, Frequency of True Adverse Reactions to MMR Vaccine; A Double-Blind Placebo-Controlled Trial in Twins, National Public Health Institute and Children’s Hospital, University of Helsinki, Finland, published Lancet, April 26th 1986
This study sought to check levels of adverse reactions following MMR. MMR was introduced into Finland in 1982, being administered at 14-18 months and at 6 years, using Merck Sharp Dohme Viravac.
The study was a double-blind crossover study involving 581 twins. The vaccines were administered blind, but one twin of each pair first received active MMR, then three weeks later, received a placebo. The other twin was given the placebo first, then three weeks later received MMR.
Each twin was given a colour coded questionnaire to be completed daily by parents, for 21 days after the injections.
In theory, this should have provided a foolproof test of how reactive MMR was. However, the study completely founders on:
the issue of the potential time-delay between receipt of MMR and any possible gradual degeneration into autism. If such a delay could exceed 21 days, then the study would have missed it as an adverse reaction
Secondly, the linking of autism/developmental delays with MMR, or indeed any other vaccine. Parents in 1982, or indeed until about mid-1997, were not linking MMR with autism. It is extremely unlikely that regressive autism would have been connected, in the minds of either parents or the study authors, with MMR back in 1982. Virtually no literature or press reports had appeared on the issue.
As with the original safety trials of MMR (see later papers), this study was not designed to verify whether rare and complex adverse events might follow months or years after MMR.
The study only looked at one brand of MMR. As subsequently transpired, some brands of MMR used in the UK and elsewhere had a less satisfactory safety record than others, and (in the UK) were withdrawn at very short notice in 1992. A study with Viravac cannot be used to give safety clearance to other brands if the brands are found to have been variable.
A further criticism is that the study is still quite small in relation to rare events. It involved 581 twins. All other things being equal, if a rare adverse outcome occurred at a rate of 1 in 2 x 582, or less frequently, this study would not have found it.
The authors did actually acknowledge this, stating:
"The study was designed to explore relatively common symptoms and signs occurring after the vaccination" (they mean, "within 21 days of"), and
"Rare reactions due to the MMR vaccine cannot be studied with this small sample".
It is therefore suggested that this study, regarded as the "gold standard" by the exponents of MMR, offers no evidence for or against an MMR/autism link; it is clearly irrelevant. Overall verdict: this study is not relevant to disproving an MMR/autism link
22: Study by Miller, Miller, Rowe et al, Surveillance of Symptoms Following MMR Vaccine in Children, The Practitioner, Vol 233, 8th January 1989
This paper was to report the incidence and severity of clinical reactions before the start of the UK national MMR programme. MMR was offered to 10,000 children in three districts in the UK, with a post-vaccination follow-up of every child.
Two types of MMR were introduced, Immravax in Somerset, England, and Pluserix in Fife, Scotland, and North Hertfordshire, near London. Both vaccines contained Schwarz measles and Urabe 9 mumps vaccine, and both later had to be withdrawn in 1992 for safety reasons, in connection with risks of aseptic meningitis. These risks were not detected by this study.
The study found that:
Of the 7,247 children aged 1-2 years, 38% had either no symptoms or symptoms for only one day
18 had convulsions. Fifteen were admitted to hospital.
Of the children aged 4-5 years, 61% had either no symptoms or symptoms for one day. There were no convulsions and no hospital admissions.
Follow up was for 21 days. However, 114 children were followed up through diary records for a further 21 days, total 42 days.
Comparison of symptoms of children after MMR was made against symptoms of children after measles vaccination - not unvaccinated children.
The study concluded that symptoms reported after MMR appeared to be similar in nature, frequency, time of onset, and duration, to those recorded in earlier studies after monovalent measles vaccine
Comment: as with the original safety trials of MMR, follow-up was extremely short and only immediate/near-immediate reactions noted. The study did not look at autism, but effectively cleared the way for MMR’s general introduction into the UK. It is noteworthy that the study was co-authored by Dr. Elizabeth Miller, who subsequently authored or co-authored several of the studies that have been used as "proof" that there is no MMR/autism link. It is also noteworthy that, as noted, this study missed the aseptic meningitis problem of MMR, and that the brands of MMR with Urabe strain mumps virus subsequently had to be withdrawn, in 1992, at extremely short notice.
Overall verdict: this study fails to disprove an MMR/autism link
23. Gillberg Study, Sweden, Is Autism More Common Than Ten Years Ago?, British Journal of Psychiatry, 1991, 158; 403-409
The paper reported a study in Sweden by Gillberg et al, 1991. It has been partially updated since (see below).
Gillberg looked at tiny sample of autistic children (55 of typical autism, just 19 of atypical autism), in Goteburg and Bohuslan. The study, actually a mish-mash of three studies with differing criteria, does not mention vaccination, does not state the coverage of MMR, does not include data on uptake or demographic factors, and is therefore irrelevant to the MMR/autism debate.
It had tracked down cases of autism unscientifically, by word of mouth, doctors etc., then allocated them by d.o.b. to "pre-MMR" and "post-MMR" eras
The study’s case-selection being a few cases out either way would neutralise or completely reverse the findings of the study.
The paper does acknowledge that the rate of autism has increased but "explains" this through changes in population structure and "better diagnosis".
Overall verdict: this study offers little evidence that MMR does not cause autism, particularly as it is so small.
24. Paper by Gillberg and Heijbel, Commentaries, Autism, Vol 2 (4) 423-430, 1998
This further paper by Gillberg was published following the appearance of the Wakefield et al "Early Report" paper in The Lancet in early 1998.
Gillberg and Heijbel stated that they had re-analysed the data from their population study of autism performed in the late 1980s and published in 1991 (as above). The children in that study (n = 55) had been born in the ten-year period 1975-84. The authors claimed that as MMR was introduced in Sweden for 18-month-old children in 1982, with coverage increasing rapidly to 90%. The authors then argued that if there was an MMR/autism link, then children born from July 1980 onwards (i.e. The post-MMR generation) would be expected to be at increased risk. The 55 children were therefore divided into 34 (62%) pre-MMR and 21 (38%) post-MMR.
The authors then argued that had there been a strong effect of MMR, they could have expected more than 45% of the 55 cases of autistic children to have fallen into the post-MMR group. As this was not the case, then their study did not support the hypothesis of an association between MMR and autism
The authors also again claimed that in their parallel study of 19 atypical autism cases, there would have been a similar effect, and therefore that again there was no support for an association.
Overall verdict: as with the original study, these numbers were so small as to render this study, and its conclusions, as virtually without value in the context of proving/disproving an MMR/autism link. Statistical/epidemiological studies based upon cohorts numbering 55 and 19 cases are far too small. It is extraordinary that the UK Department of Health was using this study in the late 1990s to "disprove" the suggested association.
25. Letter by Dr. Eric Fombonne, Inflammatory Bowel Disease and Autism, Pediatrics, March 28th 1998
This letter set out two studies that attempted to prove that there was no connection between inflammatory bowel disease/Crohn’s disease and autism. The first study looked at UK clinical data collected by the Child & Adolescent Psychiatric Services of the Maudslay Hospital, London.
For ASD, three diagnostic groups were examined, autism, atypical autism including disintegrative disorder, and pervasive developmental disorder
Medical disorders were coded for a 25-year period, including Crohn’s and ulcerative colitis, for 8889 patients.
Of the 8889 patients, 987 were born in 1987 or later, and were therefore most likely to have been exposed to MMR. Of these, 201 had ASD.
Of the 8889 children, only two had Crohn’s, and both were non-autistic. None had ulcerative colitis.
For the second study, a similar approach was undertaken. Fombonne surveyed medical, behavioural and intellectual disabilities amongst 6100 French children.
He found 174 cases with autism.
One child of the 6100 had Crohn’s, and one had ulcerative colitis. Neither were autistic
The conclusion that Fombonne drew was that these data provide no support for the hypothesis of an association between IBD and autism.
Overall verdict: neither of these studies offer any evidence to disprove an MMR/autism link.
26. UK Committee On Safety of Medicines Study, Report of the Working Party on MMR Vaccine, Committee on Safety of Medicines, June 1999
This study looked at the medical records of some of the children who are now taking High Court action. Their details were provided by their lawyers.
The study admitted:
Information on the children was extremely variable in quality and completeness
It was "difficult" to draw conclusions about any causal association (verbatim quote: "the information evaluated has important intrinsic limitations as regards assessing whether the vaccines are or are not causally associated with the adverse effects")
It was not feasible to review the less common adverse side effects
The study was effectively run as knockout competition. Each case had to pass four hurdles (all four) to be counted as being caused by MMR. The four hurdles were: (1) have either the diagnosis or clinically relevant signs/symptoms been confirmed medically? (2) was the onset of the possible adverse effect within six weeks of immunisation with MMR? (3) was there history prior to immunisation relevant to the possible adverse effect? (4) was there evidence of other causes for the possible adverse effect?
Six weeks after immunisation was chosen as a cut-off point for a close temporal association because (quote) "this is the maximum period in which viral replication can be detected after immunisation". But this probably missed many cases, and is arbitrary. The Spitzer, Aitken et al study (see later) renders this six-week limit as irrelevant.
At every stage, the study looked for other "causes" to explain-away the cases, and took every opportunity to ascribe cases to these "causes". In most cases, it was assumed at every stage without scientific justification that autism was "caused" by other factor rather than MMR. But it is not known what causes autism. Therefore there is a gross study bias, and the study rests upon unscientific assumptions.
The other assumed "causes" were the child’s previous medical history, comprising having a parent/sibling with speech or behavioural problems, an obstetric history of pregnancy complications (these, alone, were not considered as "causes"), signs/symptoms of encephalopathy, a head circumferences larger than the 97th percentile, or history of unspecified viral illnesses, bronchiolitis, rubella, measles, or a minor head injury.
The study eventually only looked at 92 cases of autism in detail (plus 15 Crohn’s), and was left with a residue of 8 autism cases and four of the Crohn’s it could not "explain" away. These were then just set aside, without explanation.
What the study did was to introduce so many extraneous considerations, and accord these such an importance, that hardly any case with sufficiently-clear documentation remained to survive the appraisal process. This eliminated almost all cases. The study then appears to have then simply set aside the residue.
The study text commented that (quote) "it was impossible to prove or refute the suggested associations between MMR vaccine and autism or inflammatory bowel disease because of the nature of the information.". This would seem to inevitably render the study as inconclusive. But the study’s conclusions did not reflect this sentence.
The wording of the final conclusion left a small exit-route for any possible future U-turn: ""On the basis of all the available evidence, the demonstrated benefits of MMR or MR vaccines far outweigh any possible risks" (my emphasis).
The DoH’s press release 0342 of 1999 spun the study’s conclusions further - "Two New Independent Studies Have Not Found A Link Between MMR Vaccination And Autism"
Note: this is the only study to date to have both looked at the actual children reported to have been damaged and to have "cleared" MMR. But as the above criticisms show, the study was actually self-admittedly inconclusive. It also failed to medically examine the actual children. <