MMR and Acquired Autism (Autistic Enterocolitis) - A Briefing Note
David Thrower February 2003

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. UK Families Taking Legal Action
6. UK Vaccine Damage Payment Scheme
7. Families Taking Legal Action in the US over Thiomersal and Autism
8. MMR Litigation in Japan
9. The UK Department of Health's Position over MMR
10. Position of the US Center For Disease Control on MMR/Autism
11. The Parents Have Seen What They've Seen.....

Part B: The Costs of Autism
12. The Financial Costs - Autism Is Costing Billions
13. Estimates
14. Failure to Monitor Increases In UK Autism Numbers
15. "Now Almost Everyone Knows Someone Who's Autistic"
16. University of Cambridge Research
17. University of Sunderland Research
18. UK National Autistic Society Estimates
19. Report by Fiona Loynes for UK All Party Parliamentary Group, Dec. 2001
20. Report for the National Autistic Society, Autism In Schools, May 2002
21. Is Autism Increasing? - Some Recent Official UK Pronouncements
22. Autism In The USA
23. Autism Elsewhere

Part C: Evidence That Increases Are Real
24. California
25. The MIND Study, California
26. New Jersey
27. Atlanta Study

Part D: Reviews Questioning the Autism Epidemic
28. Paper by Fombonne, UK Medical Research Council, Pediatrics, January 2001
29. Paper by Wing, Centre for Social & Communication Disorders, London 2002
30. Position of Dr. B. S. Siegal, University of California, 2002
31. Study by Croen et al, July 2002
32. Editorial by Fombonne, Journal of the American Medical Asscn., January 2003

Part E. Studies That Have Been Used To Disprove An MMR/Autism Link
33. Stokes et al paper, Journal of American Medical Association (JAMA), Oct. 1971
34. Study by Peltola and Heinonen, Lancet, April 1986
35. Paper by Miller, Miller et al, The Practitioner, January 1989
36. Gillberg Study, Sweden, British Journal of Psychiatry, 1991
37. Commentary by Gillberg and Heijbel, Autism, 1998
38. Letter by Fombonne, Pediatrics, March 1998
39. UK Committee on Safety of Medicines Study, June 1999
40. Paper By Taylor, Miller and Farrington, Lancet, June 1999
41. Paper by Miller & Farrington to US Government Reform Committee, April 2000
42. Patja, Peltola et al Study, Finland, Pediatric Infectious Disease Journal Dec. 2000
43. Kaye, Melero-Montez and Jick Study, British Medical Journal, 2000
44. Dales, Hammer and Smith Study, JAMA, March 2001
45. De Wilde, Carey & Richards Study, Br. Journal of General Practice, March 2001
46. Davis et al study, Archive Pediatrics Adolescent Medicine, 2001
47. Further Paper by Farrington, Miller and Taylor, Vaccine Journal, 2001
48. Fombonne & Chakrabarti Study, Pediatrics, October 2001
49. Further Paper by Taylor, Miller et al, BMJ.com, February 2002
50. Review by Donald and Muthu, Bazian Limited, pub British Medical Jnl June 2002
51. Study into Childhood Gastrointestinal Disorders and Autism, August 2002
52. Study, Madsen et al, Population-Based study, MMR/Autism, Denmark, Nov 2002
53. Paper, Neurologic Disorders after MMR Vaccination, Makela et al, Dec 2002

Part F: Reviews Concluding There Is No Evidence Of A Link
54. Medical Research Council Ad-Hoc Review, March 1998
55. Presentation by Miller to UK All Party Parl. Group on Primary Health Care, 2000
56. Medical Research Council Sub-Committee Report, March 2000
57. Review by US Institute of Medicine, 2001
58. Review by Strauss and Bigham, Health Canada/Un. Of British Columbia, 2001
59. Elliman, Bedford and Miller Review, Arch. of Diseases in Childhood, Oct. 2001
60. Medical Research Council Review, July-December 2001
61. Further Review by US Institute of Medicine, February 2002
62. Review of the Scottish Executive MMR Expert Group, April 2002

Part G: The MMR Original Safety Trials Debate
63. Wakefield & Montgomery "Through A Glass Darkly" MMR safety-studies paper
64. Dr. Peter Fletcher Commentary, Journal of Adverse Drug Reactions, 2001
65. Dr. Stephen Dealler Commentary, Journal of Adverse Drug Reactions, 2001
66. Dr. F. Edward Yazbak Commentary, Journal of Adverse Drug Reaction, 2001
67. The Wakefield/Watson/Shattock Rebuttals
68. The UK Department of Health's Repudiation of "Through A Glass Darkly".

Part H: Studies That Point Towards The Plausibility Of An MMR/Gut/Autism Link
69. Paper by Eggers, Klinical Paediatrics, March 1976
70. Weizman, Weizmann, Szekely et al Study, Am. Journal of Psychiatry, Nov. 1982
71. Delgiudice-Asch and Hollander Study
72. Paper by Dr. H. Fudenberg
73. Paper by Dr. Reed Warren
74. Warren and Singh Study, Immunogenetics, 1992
75. Singh, Warren, Odell, Warren and Cole Paper, March 1993
76. Singh, Warren, Odell et al Study, Brain Behaviour, March 1993
77. Oleske and Zecca paper
78. Binstock paper
79. Anne-Marie Plesner Letter, Lancet, February 1995
80. Paper by Thompson, Montgomery, Pounder & Wakefield, Lancet, April 1995
81. Gupta, Aggarwal and Heads Study, Journal of Autism and Dev. Disorders, 1996
82. Montinari, Favoino and Roberto paper, Naples conference May 1996
83. Auwaerter and Griffin paper, Clinical Immunology and Immunopath., May 1996
84. Cook, Courchesne et al Paper, Molecular Psychiatry, May 1996
85. Griffin and Hussy Study, Journal of Infectious Diseases, June 1996
86. Martinez et al Study, Proceedings of National Academy of Sciences, 1997
87. Paper by Zecca, Graffino et al, Meeting of National Inst. of Health, Sept. 1997
88. Weibel, Caserta and Evans Study, March 1998
89. Wakefield et al "Early Report", Lancet, February 1998
90. Paper by Montgomery, Morris et al (publication date/details not yet known)
91. Sabra, Bellanti and Colon letter, Lancet, July 1998
92. Further Paper by Singh and Yang, Pharmaceutical Journal, October 1998
93. Uhlmann, Sheils et al Paper
94. Bitnun et al Study, Clinical Infectious Diseases Journal, October 1999
95. Paper by Dr. Singh to the US Committee on Government Reform, April 2000
96. O'Leary Paper Presented to US Congressional Oversight Committee, April 2000
97. Kawashima, Takayuki et al Study, Digestive Diseases and Sciences, April 2000
98. Hagenbuch, Kullak-Ublick et al Study, Journal of Pharm. Exp. Ther., July 2000
99. Wakefield et al Paper, American Journal of Gastroenterology, September 2000
100. Statement by Professor Walter O. Spitzer, December 2000
101. Furlano, Anthony et al Study, Journal of Pediatrics, 2001
102. Study by Jyonouchi, Sun and Le, J. Allergy & Clinical Immunology, Feb. 2001
103. Study by Jyonouchi, Sun and Le, J of Neuroimmunology, 2001
104. Paper by Spitzer, Aitken et al, Journal of Adverse Drug Reactions & Tox., 2001
105. Paper by Dr. Ken Aitken to the Scottish Society for Autism, 2001
106. Paper by Imani and Kehoe, Clinical Immunology, September 2001
107. Paper by Dr. Timothy Buie, Oasis 2001 Conference for Autism, Portland, US
108. Paper by Uhlmann, Wakefield, O'Leary et al, J. of Clinical Pathology, Feb. 2002
109. Paper by Singh and Nelson, February 2002
110. Review by Wakefield, Puleston, Montgomery et al, Aliment Pharm. Ther. 2002
111. Report of Study by Comi et al, Johns Hopkins Hospital, Baltimore, April 2002
112. Paper by Torrente, Ashwood, Day et al, Lancet, May 2002.
113. Paper to 102nd GM of American Soc for Microbiology by Singh et al, May 2002
114. Study by O'Leary et al, to be presented to Path Soc of GB and Ireland July 2002
115. Wakefield Paper Presented to US Government Reform Committee, June 2002
116. Paper to US Government Reform Committee by Dr Krigsman, June 2002
117. Unpublished Research by Dr Paul Shattock, University of Sunderland, June 2002
118. Paper by Sheils, Smyth, Martin & O'Leary, Trinity College Dublin, 2002
119. Paper by Dr. Vijendra Singh, Utah State University, August 2002
120. Paper by Finegold, Molitoris, Song, J. Of Clinical Infectious Diseases, Sept 2002
121. Further paper by Jyonouchi, Sun & Itokazu, University of Minnesota, Oct 2002
122. Paper, Treatment of Late Onset Autism, Matarazzo, Univ. of Sao Paulo, Nov 2002
123. Unpublished letter by Dr. Wakefield to the New Eng. J. of Medicine, Nov 2002
124. Study by Croonenberghs et al, University of Antwerp, December 2002

Part J: Other Relevant Papers
125 US Developmental Delay Registry Report, 1994
126 Stratton et al Study, National Academy Press, 1994
127. Paper by Carbone.
128. Iizuka, Saito et al Study, Gut, May 2001 (Mumps Study)
129. Statement by Spitzer, US House of Repres. Govt Reform Committee, April 2001
130. Statement by Dr. Jefferson, Cochrane Collaboration, Oxford, October 2002

Part K: Future Papers Investigating A Link/Prevalence
131. Fombonne et al Study, London
132. Charman et al Study, London
133. Study by Professor Andrew Hall, London
134. Study by Takahashi et al, Tokyo
135. Study by Rall, Fox Chase Cancer Center, US
136. Studies Commissioned by the US Center for Disease Control
137 UK National Institute for Biological Standards and Control Study
138. Study by University of California at Davis into Environmental Factors
139 Other UK Studies funded by the Medical Research Council
140 Study by Autism Center, University of Medicine & Dentistry, New Jersey, US
141. Study by Center for Disease Control, New Jersey, US
142. Study by Robert Wood Johnson Medical School, New Brunswick, US
143. Survey by New Jersey Answers for Autism

Part L: The Thiomersal Issue
144. Thiomersal's Possible Role
145. Thiomersal In Vaccines: Statement of US AAP/Public Health Service, July 1999
146. UK Vaccines With Thiomersal
147. Scientific Review by US Center for Disease Control, Simpsonwood, June 2000
148. Press Release by Waters and Kraus, March 2002
149. UK Medicines Control Agency Position
150. US CDC Thiomersal Studies
151. Pichichero et al Study into Mercury Concentrations, Lancet, November 2002.

Part M: Flawed UK Regulatory and Monitoring Systems
152. Fighting Measles, Missing Autism, Overlooking Damage?
153. Has the Medicines Control Agency Missed the Syndrome?
154. UK Department of Health Re-Launch of MMR, January 2001

Part N: UK and US Political Initiatives
155. UK House of Commons Health Committee, Westminster
156 UK All Party Parliamentary Group on Autism, Westminster
157. Scottish Parliament, Edinburgh
158. UK Liberal Democrats
159. UK Conservatives
160. US House of Representatives Government Reform Committee

Part P: Some Conclusions and Some Unanswered Questions
161. Some Broad Conclusions
162. 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. And - note - this was 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 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 (we are told that MMR in itself does not contain thiomersal). Class-action lawsuits are now under way in the US (see later sections) 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 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 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.

It is also interesting to see that numerous adverse reactions to MMR have actually been reported in the past, as well as adverse 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 of these reported adverse events are unconnected with prior vaccination.

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.

4. 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 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 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.

5. UK 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.

6. UK Vaccine Damage Payment Scheme

It is sometimes alleged that parents are all too ready to turn to litigation to seek damages for autism, as part of the "compensation culture". However, caring for a child with autism is expensive over a lifetime. It destroys or very severely damages the child's quality of life, and their opportunities for earnings. It also severely damages family quality of life, and frequently reduces family income dramatically.

The only recourse other than to litigation has been the UK Vaccine Damage Payments Scheme (VDPS). However, no cases of autism have succeeded in the VDPS to date, and indeed, the scheme has a history of rebutting claims of all kinds.

The VDPS was introduced in 1979 by the Callaghan Government as a response to the 19878 Pearson Report. One of the latter's conclusions had been that "the Government.....should be liable in tort for severe damage suffered by anyone (adult or child) as a result of vaccination which has been recommended in the interests of the community".

The VDPS is administered by the Vaccine Damage Payments Unit, which gives effect to the decisions of the "SEMA Group", a medical agency sub-contracted to the Government's Department of Work and Pensions. Any subsequent appeals on both fact and law are made to Vaccine Damage Appeal Tribunals, and there is no further appeal avenue, although the Secretary of State may reverse a Tribunal decision.

The VDPS does not provide compensation per se, but a "contribution" towards the expenses of bringing up a disabled child. VDPS payments are not admissions of negligence, nor are they the result of strict liability (I am grateful to researcher Dr. Stephanie Pywell, University of Hertford, UK, for this and subsequent information).

In June 2000, substantial changes to the VDPS were announced, in response to heavy public criticism and press campaigns. Three changes were proposed:

• Increasing the £40,000 (formerly £30,000) statutory payment to £100,000. This was effected from July 2000
• Increasing the absolute six-year time limit for claims to any time up until a claimant's 21st birthday
• Lowering the disability threshold (level of damage) from 80% to 60%

However, the scheme remains deeply adversarial, and very few payments are made, not surprisingly as the process involves ordinary members of the public taking on the medical establishment, without funding for studies or access to advocacy resources. The award rate data for the VDPS is as follows (1978-2000):

• Over the 21 years, 4,111 claims were submitted
• Of these, just 415 were given initial awards. Of these 415, almost all were in the first seven years of the scheme. In the first seven years, between 1978-79 and 1984-85, 3,085 claims were submitted and 390 awards were made, an initial-award rate of about 13%
• In the second seven years of the scheme, 1985-86 to 1991-92 inclusive, 370 claims were submitted but only 15 awards were made, an initial-award rate of just 4%
• In the most recent seven years for which data is to hand, 1992-93 to 1998-99 inclusive, 656 claims were submitted (note the increase) but only 10 awards were made, an initial-award rate of about one and a half per cent. This represents a quite extraordinary rate of rejection.

• Even with Section 4 awards (subsequent to a review of the medical reasons by an independent tribunal) and Section 5 awards (subsequent to an appeal to the Secretary of State), the award rates remain very low. Although 479 Section 4 awards were made - a greater number than the 415 initial awards over the 21 years - after appeal, the number of awards in recent years remains very low, only a handful of Section 4 awards succeeding. Only one Section 5 award to the Secretary of State has succeeded in 21 years.

A survey of the scheme was undertaken by the UK parents' group JABS. It found that rejection rates were especially high in MMR cases. Just six out of 93 claims succeeded. Three of these related to the early Urabe strain of MMR vaccine, which was very hurriedly withdrawn by the UK Department of Health in 1992.

7. Families Taking Legal Action in the US over Thiomersal and Autism

• 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 thiomersal issue is considered in detail in a later section of this Briefing Note).

• The initial US lawsuit was filed by Walters & Kraus (Dallas, Texas, contact C. Andrew Waters). Other law firms taking action are Anderson & Krieger (Temecula, California), Dogan & Wilson ((Pascagoula, Mississippi), Doran & Murphy (Buffalo, New York), Evert & Weathersby (Atlanta, Georgia), Gallagher, Lewis, Downey & Kim (Houston, Texas, contact Michael Gallagher), Hendrickson & Long (Charleston, West Virginia), Jones, Martin, Parris & Tessener (Raleigh, North Carolina), Leach, Schwarz & Strassberg (Bala Cynwyd, Pennsylvania), Martzell & Bickford (New Orleans, Louisiana), Miller and Associates (Alexandria Virginia, lead partner Michael J. Miller), Williams Dailey (Portland Oregon, contact Michael Williams) and Wise & Julian (Alton, Illinois). The above list is not exhaustive, and more firms are also expected to become involved.

• A large number of parents have contacted US lawyers. Lewis, Downey & Kim reports that it has been contacted by several thousand families and (as at March 2002) was considering nearly one thousand cases, with about 50 filed at that time. The claims include product liability, conspiracy and fraud. Waters & Kraus have indicated that the potential scale of the claims is immense. An individual claim could run to $10m-30m for a life-care plan alone, plus damages reflecting emotional distress and pain.

• 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., Johnson & Johnson, Sigma Chemical Co., Lederle Inc., Wyeth Pharmaceuticals Inc., Parke-Davis & Company, American International & Chemical Spectrum and Aldrich Chemical Co. The lawyers employed by Eli Lilly are Shook, Hardy & Bacon (Kansas City).

• In June 2002, notice was given by the PR Newswire service that all defendants had now been served in a lawsuit filed on 3rd April 2002 in the United States District Court for the Eastern District of New York on behalf of three groups, against the manufacturers of thiomersal, and against the vaccine manufacturers that use or used thiomersal in manufacturing or distributing childhood vaccines

• Plaintiffs and the plaintiff class defined as Sub Class One have been diagnosed with autism or neurodevelopmental disorders, as well as other severe and permanent health consequences claimed to be the result of exposure to high levels of mercury contained in thiomersal.

• Plaintiffs and the plaintiff class defined as Sub Class Two claim an increased risk of developing autism, other serious neurological disorders, or other severe and permanent health consequences as a result of exposure to high levels of mercury contained in thiomersal

• Plaintiffs and the plaintiff class defined as Sub Class Three have claims based upon the injuries to their children as well as claims for medical monitoring of their children who have not yet manifested an injury, but who must be continuously monitored due to their exposure to the high levels of mercury contained in childhood vaccines.
• By July 2002 it was reported in the Indianapolis Star that Eli Lilly was facing at least 45 lawsuits over its role in developing and selling (for more than 40 years) the thiomersal vaccine preservative. By this time, nationally, the manufacturers in the US faced over 60 lawsuits.

• In May 2002 it was also reported that a class action had commenced in the Canadian courts. A lawsuit was filed on 8th May 2002 in Ontario Superior Court on behalf of children who became autistic after receiving vaccines containing thiomersal. The action is being brought by lawyers Klein Lyons against Aventis Pasteur.

It is also noteworthy that there is a legal precedent in the US courts 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 judgment 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 judgment 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 judgment 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."

However, the progression of the US litigation over vaccines and autism has been made very much more uncertain by the insertion of four clauses in the US Homeland Security bill in December 2002, debarring families from filing lawsuits against Eli Lilly & company over thiomersal. The inclusion of these clauses has been strongly criticised by a range of US politicians, including Rep. Dan Burton (R-Indiana), Sen. Debbie Stabenow (D-Michigan), and Sen. Patrick Leahy (D-Vermont).

A move to seal all documents was also made, then withdrawn in December 2002, by the US Department of Justice.

In January 2003, a Bill was to be introduced in Congress which would focus solely upon the reversal of clauses 1714/15/16/17 of the December 2002 Homeland Security Bill, which were the clauses that protected Eli Lilly from lawsuits. This bill was introduced by Sen. Debbie Stabenow, and co-sponsored by Sen. Barbara Boxer (D-California), Sen. Tom Daschle (D-South Dakota), Sen. Mark Dayton (D-Minnesota), Sen. Christopher Dodd (D-Connecticut, Sen. Byron Dorgan (D-North Dakota), Sen. Richard Dunbin (D-Illinois), Sen. Dianne Feinstein (D-California), Sen. Mary Landrieu (D-Los Angeles), Sen. Frank Lautenberg, Sen. Patrick Leahy (D-Vermont), Sen. Carl Levin (D-Michigan) and Sen. Paul Sarbanes (D-Maryland).

Documents relating to thiomersal's original testing by Eli Lilly have been subpoenaed by the House of Representatives Committee on Government Reform (see also later sections on thiomersal and on the US Congress and Government Reform Committee). Thiomersal is believed to have only ever been tested on 27 people (who were dying from meningitis) in 1929. Eli Lilly maintain that, although all 27 died, it was not due to the thiomersal. Further details are in the later sections.

8. MMR Litigation in Japan

Only limited information has been obtained on litigation under way in Japan. This information is based upon a press report in the Yomiuri Shimbun (Daily Yomiuri).

• The Japanese Government was forced in April 2002 to release documents on MMR after a group of plaintiffs invoked a new public information disclosure law.
• The group intends to use these documents as evidence in a lawsuit that claims that MMR caused the deaths of their children. It has been alleged that there has also been a cover-up over the earlier delay in banning the vaccine in Japan. MMR was introduced into Japan in 1989 (one year after the UK), but was discontinued in 1993 after it had caused numerous cases of aseptic meningitis, a side-effect of mumps
• The documents disclosed include records of Japanese Health Ministry research carried out on the frequency of side-effects, during the six months following MMR's introduction. According to the documents, the October 1989 interim report of the research includes data indicating that 1 in every 637 children in Gunma Prefecture and one in every 706 children in Miyazaki Prefecture suffered side-effects. The vaccination committee, however, did not discuss these figures at a meeting held on October 25th 1989, but instead focussed on the lowest figure obtained from Aichi Prefecture, in which 1 in every 28,477 children suffered side-effects. The committee then announced that the frequency of side-effects was "1 in every several thousand to 30,000".
• The final calculation revealed that 311 of 630,157 children who took the vaccine suffered side-effects, and the committee on December 25th that year revised the figures in the data to "1 in several thousand", whereas it was in fact one in several hundred.
• The adverse event data also included data on the number of inpatients, which was 39 as at December 1989. The committee, however, reported publicly that symptoms of aseptic meningitis were only slight, and that all of the victims had recovered. The children's lawyer, Tatsuro Shigemura, commented that the released documents clearly revealed that the Health Department had hidden uncomfortable data and had then delayed the discontinuation of MMR.
• Litigation is also known to be under way in Canada and in Sweden

9. 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")

(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).

10. 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 February 2003):

• 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.

11: 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

12: 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?

13: 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.

14. 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.

The repeated official line that the apparent increase is down to better recognition may therefore be 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 be 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.

15. "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.