MMR and                     Acquired Autism

  (Autistic Enterocolitis)

    -   A Briefing Note

             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”)

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”)

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.

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.

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