UPDATED [July 2004] MMR and Acquired Autism (Autistic Enterocolitis) - A Briefing Note by David Thrower

March 2001

Part A - Introduction
1. Summary
2. Late-onset Autism/Autistic Enterocolitis
3. The New Syndrome

Part B - The Parents, The Children, The Costs
4. UK Parents Taking Legal Action
5. The Parents’ Reports
6. Financial Costs

Part C - UK Autism Numbers
7. Failure to Monitor UK Increases
8. "Now Almost Everyone Knows Someone......"
9. University of Cambridge Research
10. University of Sunderland Research
11. National Autistic Society Estimates
12. UK Department of Health Views
13. Fombonne Paper

Part D - The USA
14. Autism In The USA
15. California

Part E - Inconclusive "Evidence" Against There Being An MMR/Autism Link
16. Taylor, Miller North London study
17. UK Committee on Safety of Medicines study
18. Gillberg study
19. Patja (Peltola) study
20. Kaye et al paper
21. Stokes et al paper
22. Medical Research Council Ad-Hoc Review, 1998
23. Medical Research Council Sub-Committee Report, 2000

Part F - Evidence To Suggest That There Is A Link/Other Papers
24. Weibel et al paper
25. Delgiudice-Asch et al paper
26. Fudenberg paper
27. Singh paper
28. Further Singh paper
29. Singh, Warren et al paper
30. Weizman et al paper
31. Gupta et al paper
32. Oleske and Zecca paper
33. Binstock paper
34. Griffin paper
35. Auwaerter and Griffin paper
36. Martinez paper
37. Wakefield et al "Early Report" paper,
38. Sabra, Bellanti and Colon letter
39. Cook et al paper
40. Warren paper
41. Warren and Singh studies
42. Kulman paper
43. US Developmental Delay Registry
44. Other Researchers
45. Professor Spitzer statement
46. Wakefield & Montgomery "Through A Glass Darkly" MMR safety-studies paper
47. Wakefield/Watson/Shattock Rebuttals
48. UK Department of Health Rebuttals
49. UK Department of Health Re-Launch of MMR

Part G - Flawed UK Regulatory and Monitoring Systems
50. Fighting Measles, Missing Vaccine Damage?
51. How the Medicines Control Agency Missed the Syndrome?
52. Subculture of the Regulatory Establishment
53. Independence of the Committee on Safety of Medicines?
54. Independence of the Joint Committee on Vaccination and Immunisation?
55. Lack of Public Scrutiny of CSM & JCVI
56. Monitoring of Medicines Control Agency and Public Health Laboratory Service
57. Monitoring of Department of Health

Part H - Various Experiences Elsewhere
58. Measles Outbreak, Republic of Ireland
59. MMR in Japan
60. Autism in Finland

Part J - Political Initiatives
61. UK All Party Parliamentary Group on Autism
62. Scottish Parliament
63. UK Liberal Democrats
64. UK Conservatives
65. US House of Representatives

Part K - Recent & Coming Events
66. Recent and Coming Events, UK
67. Ireland
68. USA
69. Just One More Question, Minister.........

David Thrower, 01925-264156, email David@ThrowerWarrington.freeserve.co.uk

1. Summary

This note sets out, in some detail, the concerns of parents whose children have become autistic after MMR or measles-containing vaccines.

• It does not attempt to cover all the available scientific literature, but it reviews a number of recent or frequently-quoted studies.
• It finds that there are studies that clearly point to MMR causing late-onset autism (or "autistic enterocolitis") in significant numbers of children.
• More importantly still, it finds that there are absolutely no other credible explanations for these children’s conditions, and that there has not been a single credible study that can refute the claims of the parents that their children’s autism has been caused by MMR or elated vaccines.
• It also investigates some of the surrounding issues - the numbers of children affected, whether there has been an increase, the flawed regulatory regime governing MMR and the failure to properly monitor adverse reactions.
• It also highlights the lack of independent public scrutiny of much of the UK immunisation programme, and of those who are employed within public bodies to oversee it.

2. What Is Late-Onset 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, affecting particularly 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 emerged, at first in the US in the late 1970s and then in the UK in the late 1980s and onwards. In this new-variant autism, children develop normally, passing all their developmental milestones, and then regress into an autistic-like state. They lose their previously-demonstrated speech, learned behaviour and social skills. In effect, they dissolve into a state of mental impairment, of varying severity.
• This late onset of autism typically occurs at an age of between fifteen months and two years, which is the period following receipt of MMR vaccination.
• This is described by the UK Department of Health as a coincidence of timing. However, very significantly, older children, aged four, five or six, have also degenerated into autism after MMR, implying that the link is not coincidental.
• Also, no cases are known to campaigning parents of any children who have become autistic just before MMR.
• The parents are also not aware of any children who missed MMR out altogether, but still degenerated into autism around age one to two years. This in itself is not scientific proof of a link, but it is very strongly suggestive of a connection.
• No credible alternative explanation for why a previously-healthy child should become severely autistic has been put forward.
• Undoubtedly there are other factors involved, pointing to a predisposition of certain children to be vulnerable to damage, of varying severity. Research is trying to pinpoint those factors.
• Coinciding with the late onset of autism (or other damage - autism is not the only manifestation of there being a problem), has come other symptoms. These include gastrointestinal problems such as alternating bouts of diarrhoea and constipation, chronic abdominal pains and bloating, hyperactivity, extremely poor sleep patterns, and particular intolerances to gluten and casein.
• 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 penetration of the blood-brain barrier.

3. The New Syndrome

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

• In a 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) are then able to attack the central nervous system

4. The UK Families Taking Legal Action

• Estimated 850 families taking legal action in the UK under Consumer Protection Act against MMR manufacturers Aventis Pasteur MSD, Merck and Company, SmithKline Beecham and SmithKline & French Laboratories
• Families convinced that MMR vaccination was trigger for child’s degeneration into autism or other serious condition, including deaths.
• Despite research pointing to original failure to properly conduct safety tests on MMR, and emerging research linking MMR with autism (autistic enterocolitis syndrome) and/or inflammatory bowel disease, UK Department of Health and other medical institutions continue to claim that MMR is safe
• This claim based upon advice of 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 have severe weaknesses or inconclusive outcomes. Details in text.

5. The Parents Have Seen What They’ve Seen

• Vaccines have saved millions of lives. Parents not anti-vaccination in principle. Parents all took children to be vaccinated. All recognise 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.
• Also felt by many parents that argument that "the benefits of vaccination outweigh the risks" has become increasingly skewed by overstating dangers of diseases (by citing experience from poor and underdeveloped countries, or UK experience from half a century ago), or grossly underplaying risks from vaccination. Latter aided by extremely poor monitoring of adverse outcomes, or by authorities refusing to accept that an adverse outcome was result of vaccine (= "cooking the numbers").
• All affected parents are in privileged position of having watched child degenerate. Powerful experience. Other parents report same experience.
• Usually gradual degeneration over many weeks and months, not acute event. More like eg onset of cancer than the rare acute reactions to vaccines seen in the past.
• Onset of gut/bowel problems and hyperactivity have accompanied onset of autism. Clearly these are connected with each other. Wakefield investigated bowel problems - and found autism. Concept of a link is therefore obvious, even without detailed research.
• An anecdote is an anecdote. A pattern is much more powerful. What we have a consistent detailed pattern of reports from parents. UK Department of Health (DoH) doesn’t appear to recognise difference.
• Likely that very few of the medical establishment spokespersons, commentators etc. have examined even single example of affected children, talked to the parents, or checked child’s records. Doubtful if most have even read any of the research available (as opposed to the DoH’s press releases and other second-hand material)

6. 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 taxpayer. 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
• 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 GDP

7. Failure To Monitor Increases In Autism Numbers

• Not just better recognition. Where data is available, increases are too steep, in far too short a timescale. These children wouldn’t all have been missed by their parents, doctors and teachers in the past
• Undoubtedly some better recognition and reclassification, following introduction of ICD-10 criteria in 1992 (international classification of diseases/disorders) and DSM-IV in 1995 (diagnostic statistics manual).
• DoH has failed to monitor autism, and is still failing to (despite 1997 recommendation of Westminster Health Committee). Afraid of what it might find?
• Health Boards/Authorities are also failing to monitor. Health Boards/Authorities have little clue, and no consistent approach. Very few have any data at all. Only 1 in 6 has any figures (despite 1997 HoC Backbench Health Committee recommendation that DoH collate centrally.), and some of these are wrong.
• Better data in Education, also Scottish schools census (1999 census showed 18% increase over 1998 census).
• Official figures vary wildly, by factor of 300-fold, i.e. 300-times (not 300%). Data is extraordinary mess.
• Little attempt being made to remedy. DoH clearly dragging feet over improving data monitoring. DoH also very keen to explain-away increases through better recognition (= self-comfort explanation).
• Other indications of real increases: Kaye et al paper (see later) found sevenfold increase 1988-99 in UK. Also unpublished 1999 paper by Dr. Fiona Scott, Autism Research Unit, Cambridge, indicated autism at eleven times the expected level (1 in 174) - see later.
• Some paediatricians convinced of new type of autism/real increases, but reluctant to go on the record. Other commentators agree, eg education professionals etc.

8. "Now Almost Everyone Knows Someone Who’s Autistic"

• Autism was very rare condition, but now almost commonplace. Very many cases now late-onset, whereas almost all used to be from birth. We have to ask why this is.
• Strongly believe new phenomena, autistic enterocolitis. Not the autism of the past.

Evidence of dramatic rates/ increases

• examples - East Surrey 1/69 rate amongst three year old boys, 1/139 rate amongst three year old boys+girls combined (source: letter of 10/6/99 from Caroline Clark, Commissioning Manager, Learning Disability Services, East Surrey Health Authority, tel 01372 731073, to David Thrower)
• Bromley Autistic Trust figures show 1990-94 increase of 280% over 1980-84 figure (source: letter of 16/9/99 from Miss CM Povey, Services Director, Bromley Autistic Trust, to David Thrower)
• Wakefield LEA autism pupils up from 5 to 111 in seven years (source: survey by David Brown, a specially-seconded headmaster from the Park School, Wakefield, on behalf of Wakefield Local Education Authority, 1999)
• Telford health data up from 4 new cases per year in 1990 to 17 per year 1998 and again 1999 (source: letter of 20/11/00 by Dr FRJ Hinde, Consultant Paediatrician, Princess Royal Hospital, Telford, tel 01952 641222, to David Thrower
• Scottish schools census up 18% in one year (source: Scottish Annual School Censuses, available from Scottish Education Office, tel 0131 556 8400)
• Potentially very significant that Shetland children were all age 12 or under (in 1999), ie post-date MMR introduction. Total of 13 cases (source: Mrs Gena Garson, Board Secretary, Shetland Health Board, tel 01595 696767, in letter of 10/2/00 to David Thrower). Understand Western Isles & Highland is similar (contact parent doing Scottish numbers research, Bill Welsh, 0141 638 2859).

9. Cambridge University Research

On 18/2/01, the UK "Sunday Telegraph" reported on research undertaken by Dr. Fiona Scott at the Autism Research Centre at the University of Cambridge. The research, undertaken across schools in Cambridgeshire, found that:

• One in 175 (58/10,000) children was autistic, whereas previous studies had pointed to a rate of 5/10,000
• Extrapolated across the UK, that would imply 30,000 primary school (age 5-11) children with autism
• The costs of education and care for sufferers could be as high as £5 BILLION per year, year after year.
• The figures were described as "if anything an under-estimate". They included only children with definite clinical diagnosis. Any child who had only been "statemented" (= educational needs-assessed) as autistic, but not yet clinically diagnosed, was not counted
• One in eight children with special educational needs was suffering from some form of autistic spectrum disorder
• The eleven-fold increase of actual numbers over previously-assumed numbers would have enormous cost implications for Government
• A year-2000 report for the UK Mental Health Foundation by Professor Martin Knapp for the UK Institute of Psychiatry used the earlier "textbook" rate of autism of 5/10,000 to put the total UK economic cost of autism at £1bn. The Knapp report estimated the lifetime cost of a severely-affected child at £3m, for a high-functioning autism child at £0.8m, and for an Asperger’s syndrome child at £0.5m. The revised £5bn per year estimate is based upon these costs.

10. University of Sunderland Research

A study to be published in April 2001 will show a tenfold increase in diagnosis of autism, during the years 1989-93.

11. National Autistic Society Estimates

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

• People with Kanner syndrome (IQ less than 70) 5/10,000, or 1 in 2,000
• Other spectrum disorders (IQ less than 70) 15/10,000, or 1 in 666
• Asperger’s (IQ 70 or above) 36/10,000, or 1 in 278
• Other spectrum disorders (IQ 70 or above) 35/10,000, or 1 in 286
• Combined total of above four groups 91/10,000, or 1 in 110

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

12. Is Autism Increasing? - The Department of Health’s View

• "There is no good evidence that the frequency of autism has increased since the introduction of MMR" - Tessa Jowell, Minister for Public Health Oct 1997 (in letter to David Thrower)
• "The true incidence of autism is uncertain" - Kenneth Calman, Chief Medical Officer, March 1998
• The apparent rise in autism in the UK began more than ten years before the introduction of MMR" - Tessa Jowell, in June 1998
• "Rates of autism are rising, but not because of MMR" (Committee on Safety of Medicines, June 1999)
• "There is no robust data on the prevalence of autism before and after MMR’s introduction" - Brent Taylor, June 1999 study
• "Numbers of cases of autism are rising, but the reason for this is unclear" - John Hutton, Minister for Public Health, December 2000

• At the end of January 2001, a paper, "Is There An Epidemic of Autism?" was published by Dr. Eric Fombonne, of the Medical Research Council Child Psychiatry Unit and Institute of Psychiatry, Denmark Hill, London, in the journal Paediatrics. The paper sought to deny that autism had really increased, and criticised the "poor research methodology" of Dr. Andrew Wakefield, and said "There is no need to raise false alarms on putative epidemics nor to practice poor science....."
• Fombonne criticises the California increase on the basis of in-migration, possible changes within the population make-up, the change from DSM-III to DSM-IIIR in 1987, the introduction of diagnostic categories for Asperger, Rett and childhood disintegrative disorder in DSM-IV in 1994, the effects of earlier diagnosis adding to the totals, and other factors.
• His most useful conclusion is that "we simply lack good data". He raises doubt about the apparent epidemic, but is then unable to refute it.
• In an excellent FEAT (parents’ group) critique (8th Feb 2001), Mark Blaxil goes carefully through Fombonne’s previous work and argues that Fombonne has now become confused and inconsistent. He points out key flaws in Fombonne’s previous work, and criticises his inconsequential criticisms of the California data, his "counsel of complacency" and his scientifically-unsupported assertions

14. Autism In The USA

• DoH fond of saying how MMR is used safely in 32 countries, inc USA. But USA has clear evidence of autism epidemic. Other countries may also be becoming aware of increases (further details welcomed), including Finland (400% increase in cases since MMR introduced?)
• US has IDEA (Individuals with Disabilities Education Act). Picks up numbers of schoolchildren with developmental problems. Autistic pupils up from 12,222 to 53,561 between 1992-3 and 1998-9 (Source: US State data). So for every 2 cases in 1993, by 1999 there were nearly 9. Numbers will have risen since.
• Huge increases in some States - up 421% in Connecticut, 509% in Indiana, 663% in Iowa, 933% in Michigan, 548% in Pennsylvania, all in just six years (Source: US State data)
• Also very interesting that individual towns eg Round Rock Texas up from 6 to 115 in 8 years - just like Wakefield Local Education Authority in UK (up from 5 to 111 in seven years). So suggests UK increases may very closely match USA.
• Latest California increases (State with best database) showed autism up 19% in 1999 and up nearly 16% in 2000
• Brick Township (New Jersey) "autism cluster". Some 40 of Brick Township’s 6,000 3-10 year olds have autistic spectrum disorder. It has made Brick Township the "autism capital of the USA" - but note, East Surrey rates in UK are higher still. Federal investigators collected data on surface and ground water, sites of industrial spillages and waste dumping, and ensured that there had been correct diagnosis. They found nothing.
• US clearly has autism epidemic. US similar to UK, so reasonable to conclude UK probably has epidemic, too, but just hasn’t yet woken up to it.
• Dr Bernard Rimland, Autism Research Institute, US: "Some supposed experts will tell you that the increase reflects only greater awareness. That is nonsense. Any paediatrician, teacher or school official with 20 years experience will confirm there is a real increase, and the numbers are huge and growing". (Source: Dr Bernard Rimland, ARI, 4182 Adams Avenue, San Diego, California CA 92116)

• California has the best data in the world, going back about 25 years, so trends there have a worldwide significance.
• Latest California State Department of Developmental Services data shows 566 new cases (all children age under 10) with professionally-diagnosed DSM-IV criteria autism, entering the State system in the previous quarter-year.
• This does not include children with persistent developmental disorder, non-specific (NOS) developmental delays, Asperger’s or and other autistic spectrum disorder - it is therefore the tightest definition of the severe-case numbers.
• The 556 cases for the last quarter of 2000 compares with 667 cases for the entire year in 1994.
• It took 25 years from the establishment of the State developmental services system in 1969, to 1994, to reach a total of the first 5,100. Yet the second 5,100 was reached in just five years. In 1999, 200 and the first half of 2001, a further 5,100 cases will be added. So this third cohort of 5,100 cases will have taken just two and a half years.
• This will represent a 1000%+ increase in twenty years, and excludes all cases other than full-blown DSM-IV diagnosis.
• Originally, autism accounted for three per cent of the State system’s overall caseload. It now accounts for between 30% and 34% of the caseload.

16. The Taylor, Miller et al North London Study, June 1999

The Government’s advice on MMR and autism comes from the DoH, the Medicines Control Agency (MCA), the Committee on Safety of Medicines (CSM) and the Joint Committee on Vaccination and Immunisation (JCVI).

But these bodies are closely intertwined, and have staked everything on a tiny handful of very small studies that have completely failed to get at the truth (this failure is obvious to anyone reading these studies, but most media and the medical establishment has probably relied on prepared "summaries" and press releases).

First, the Taylor, Miller et al study, 6/99:

• Study (designed by Dr Elizabeth Miller, Public Health Laboratory Service, tel 0208 200 6868) wholly inconclusive
• Only looked at 498 cases, far too small a sample for robust statistical (case-series analysis) test. Study attempted to track-down children through special schools and LA special needs registers - open to question. Study describes itself as "a large regional sample", but it was actually very small, and probably missed many cases.
• Taylor, Miller study found steep increase in autism, ("There was a steady increase in cases by year of birth"), but did not explain it.
• Also, study looked for clustering of parental concern six months after MMR, found it, dismissed it unconvincingly by saying it was "related to the difficulty of defining precisely the onset of symptoms". But this identifying a date was the very basis of their study.....
• Also, study did not include in post-MMR numbers those children born 1986-87 who later received it, nor those 2/3/4 year olds who had MMR at this older age. Also missed children who had single vacc then MMR later. Not only misses these from "post-MMR" numbers, but (worse) adds them to pre-MMR numbers. Whole study thereby compromised. Authors have since sought to clarify (Lancet) but unconvincingly.
• Autism sometimes not diagnosed for years after. Very difficult to pin down actual "date" of diagnosis, and many children don’t receive formal diagnosis anyway (contact National Autistic Society, which did study on this, tel 0207 833 2299). Taylor Miller study doesn’t recognise this.
• Therefore study seems to have been designed to clear MMR, not test whether link. Study struggles to do this, and fails.
• The study is described by the DoH as "independent". But Taylor is co-author of 1988 paper clearing safety of triple vaccines, Miller is described in Daily Express press reports of 1/01 as "a colleague of Dr David Salisbury" (head of the DoH Immunisation & Communicable Diseases Branch), and study was funded by Medicines Control Agency.
• The authors have been repeatedly challenged by other researchers to release their raw data but have refused. Yvette Cooper, Minister for Pub Health, has backed up their refusal.

17. Committee On Safety of Medicines Study, June 1999

In the words of the study report......

• Information was extremely variable in quality and completeness
• Difficult to draw conclusions about causal association (quote: "the information evaluated has important intrinsic limitations as regards assessing whether the vaccines are or are not causally associated with the adverse effects")
• Not feasible to review less common side effects

Study run as knockout competition: each case had to pass 4 hurdles (all four) to be counted as being caused by MMR. The four hurdles were: (1) have either the diagnosis or clinically relevant signs/symptoms been confirmed medically? (2) was the onset of the possible adverse effect within six weeks of immunisation with MMR? (3) was there history prior to immunisation relevant to the possible adverse effect? (4) was there evidence of other causes for the possible adverse effect?

• Six weeks after immunisation was chosen as a cut-off point for a close temporal association because (quote) "this is the maximum period in which viral replication can be detected after immunisation". But this probably missed many cases.
• At every stage, the study looked for other "causes" to explain-away the cases, and took every opportunity to ascribe cases to these "causes". In most cases, it was assumed at every stage without scientific justification that autism was caused by other factor rather than MMR, when not known what causes autism - therefore gross study bias, and unscientific. The other "causes" were previous medical history, parent/sibling with speech or behavioural problems, obstetric history of pregnancy complications (these, alone, were not considered as "causes"), signs/symptoms of encephalopathy, head circumferences larger than the 97th percentile, unspecified viral illnesses, bronchiolitis, rubella, measles, minor head injury.
• It eventually only looked at 92 cases of autism in detail (plus 15 Crohn’s), and was left with a residue of 8 autism cases and four of the Crohn’s it could not explain away - these were then just set aside without explanation.
• The study team comprised Messrs. Langman, Wilson, Appleton, Verity, Boon, Baird, Tantam and Sullivan. Professor Langman has been vocal in condemning the Royal Free research and appeared at the DoH re-launch of MMR in 1/01. At the time of the study, he had a consultancy with Roche (pharmaceuticals mfr) and had a declared non-personal non-current interest with Merck Sharpe Dohme, makers of MMR, plus three other non-personal declared interests (Astra-Zeneca, Norvatis, Boots).
• What the study did was to introduce so many extraneous considerations that hardly any case remained, with sufficiently-clear documentation, to survive the appraisal process. This eliminated almost all cases. They then simply set aside the residue.
• Commented that (quote) "it was impossible to prove or refute the suggested associations between MMR vaccine and autism or inflammatory bowel disease because of the nature of the information.". But final conclusion of the study did not properly reflect this sentence.
• The wording of the final conclusion left a small exit-route for any possible future U-turn: ""On the basis of all the available evidence, the demonstrated benefits of MMR or MR vaccines far outweigh any possible risks" (my emphasis).
• The DoH press release 0342 of 1999 spun this further - "Two New Independent Studies Have Not Found A Link Between MMR Vaccination And Autism"

18. Gillberg Study, Sweden

• The paper was "Is Autism More Common Than Ten Years Ago?" By Gillberg et al, British Journal of Psychiatry, 1991, 158 403-409. It has been partially updated since.
• Gillberg looked at tiny sample of autistic children (55 typical autism, just 19 atypical autism), in Goteburg and Bohuslan. The study, actually three studies with differing criteria, does not mention vaccination, does not state coverage of MMR, does not include data on uptake or demographic factors, and is therefore irrelevant to the MMR/autism debate.
• It had tracked down cases of autism unscientifically, by word of mouth, doctors etc., then allocated them by d.o.b. to "pre-MMR" and "post-MMR" eras
• being a few cases out either way would neutralise or completely reverse the findings of the study.
• The paper does acknowledge that the rate of autism has increased but "explains" this through changes in population structure and better diagnosis

19. Patja et al Study (Peltola Study), Finland, December 2000

• Peltola admitted on R4 on 13/1/01 that Finnish study was not designed to look at either autism or inflammatory bowel disease. Said study was not specifically designed to look for autism, as no-one had ever raised this issue.
• Peltola study simply identified 173 children out of 1.8m who had acute reactions to MMR, then followed just these children up. The study followed up the wrong children.
• No-one has ever suggested that autism follows an acute reaction.
• There would almost certainly have been potential cases amongst the remainder of the 1.8m, but these were missed, because they were excluded from the study, as it had a 3-week cut-off for reporting reactions. After that point, the remaining (1,799,827) children were ignored.
• Peltola relied on referrals from health workers out in the field, who would never have connected autism months after MMR with the vaccine being a potential causational factor. Syndrome not known of by health-workers at that time.
• DoH interpretation, widely trumpeted 1/2001, is that Peltola clears MMR of a link with autism/IBD. Wholly unfounded conclusion. Looks as though DoH "conclusions" have been retrospectively bolted-onto an old and irrelevant study

Other awkward facts re Peltola:

• study part-funded by Merck Sharp Dohme (MMR manufacturers),
• very old study designed long before link with autism even suspected. Study barely refers to autism or IBD,
• recent reviews of study (eg December 2000 Medscape) do not even mention autism/IBD (obviously not seen by reviewers as central conclusion of study)

UK DoH also said in correspondence, speaking of all the various studies: "the follow-up time (three weeks) was based on knowledge of the replication rates of the vaccine viral components.....it is recognised that such a study could not establish a causal relationship with extremely rare events..... millions of children have received MMR in other countries such as Finland and the USA; no serious long-term complications have been identified...."

20. The Kaye, Melero-Montes and Jick Paper, BMJ, February 2001

This paper attempted to prove that there was no link between MMR and autism because although autism increased when MMR was introduced, it has carried on increasing since, when MMR’s coverage reached near-saturation almost immediately after introduction.

• The study looked at 305 children aged 12 or under with autism diagnosed in the years 1988-99. It also looked at 114 boys aged 2 to 5 years born in 1988-93. It used the UK General Practice Research Database.
• The study found that autism had increased sevenfold from 0.3 per 10,000 in 1988 to 2.1 per 10,000 in 1999
• In the 114 boys born 1988-93, it found autism increased fourfold, from 8 per 10,000 (1 in 1250) for boys born in 1988 to 29 per 10,000 (1 in 345) for boys born in 1993
• The study concluded that no correlation existed between MMR and autism, and that the explanation for increased autism remained uncertain
• However, the authors acknowledge that their methods were a "second-best", because what they really wanted to do was compare vaccinated and unvaccinated cohorts of children. They said that this was impossible because only 3% of cases and controls did not receive MMR. Given the small numbers of autism cases they actually looked at, this seems an unconvincing argument for abandoning their preferred approach
• The authors then argue that if MMR was a major cause, then the risk of autism should have stopped rising within a few years.
• However, they admit that the diagnosis of autism was not confirmed from original records, but conclude that "differential misclassification of the diagnosis in vaccinated and unvaccinated children is unlikely to vary over the period of the study", though no evidence is offered to back this claim.
• They also acknowledge that time trend analysis is a "relatively crude method". One consequently suspects that, had their analysis confirmed a direct parallel between MMR’s introduction and autism’s increase, this would have been met with a fusillade of caveats and "ifs and buts". The study approach might therefore be seen as a "heads we win, tails you lose" stance.
• The study authors go on to speculate that the increase in autism found "could be due to increased awareness of the condition among parents and GPs, changing diagnostic criteria or environmental factors", without subjecting these "explanations" to any detailed scrutiny.
• The authors also acknowledge the limitation that they have not yet obtained and evaluated full clinical record information from GPs to describe more fully the characteristics of children diagnosed with autism and to explore other possible explanations. Yet they still dismiss MMR, despite this shortcoming.
• It might be the case that the increase in autism that the authors find, over the period 1988 to 1997 (note - not 1999 - the figures fall away after 1997) could be due to a hybrid explanation, with increases in the early years due to MMR and then continuing further increases in the later years due to better awareness. There is nothing in the study to refute this criticism
• It is also unclear how the issue of re-vaccination has been dealt with. What of the seven million children vaccinated or re-vaccinated in 1994 in Operation Catch-Up? Couldn’t the continuing rise in diagnosed cases in 1995-97 be due to Operation Catch-Up?
• It is interesting that the Finland study team (Patja et al) said "Causality between immunisation and a subsequent untoward event cannot be estimated solely on the basis of a temporal relation." Yet the Kaye et al study uses a basically similar approach to "prove" there is no link, comparing temporally-linked trends in MMR take-up and autism increases. (= heads we win, tails you lose)
• There is also a question over the use of mercury-based preservative (thimerosal) in vaccines. This was used in the late 1980s and early 1990s, but has been since phased-out. Autistic enterocolitis may involve thimerosal as part of the damage sequence. If it did, and following a change in formulation, then this might well explain continued rises in autism through the 1990s, then a fall-away in increases at the end of the decade, as was actually found by Kaye et al. Did the industry change the preservative formulation as public concern grew?

21. The Stokes et al Paper, Trivalent Combined Measles Mumps Rubella Vaccine, Journal of the American Medical Association, 4th October 1971

This paper, by Stokes, Weibel, Villarejos, Jorge, Arguedas, Buynak and Hilleman, has assumed more importance recently, see later Wakefield/Watson/Shattock debate section.

• The paper stated that triple vaccines were desirable TO SIMPLIFY ADMINISTRATION, REDUCE COSTS AND MINIMIZE VISITS. There was no mention of greater effectiveness, or inherent drawbacks with single vaccines.
• There were three trials, of 30 children in Philadelphia, then of 214 children in Philadelphia, then of 440 children in rural Costa Rica and San Salvador, total 684 but (note) of very different economic and geographical backgrounds.
• The mean ages of children in the three trials was 1.1, 1.5 and 3.0 years. Note that the present age of receiving MMR is about 14 months, and therefore the vast majority of the trial children were significantly older than today’s UK MMR recipients. Some 64% were also not from Western social/health backgrounds.
• The 30 children’s parents were given report cards for recording temperatures for 28 days, and queried at six to nine weeks. For the 214 child-cohort and the 440 child-cohort trials, follow-up was 28 days. The parents were instructed to notify any significant illnesses during the 28-day period, and were queried at the second bleeding, six to nine weeks after vaccination - but the implication is that this query may have covered the 28-day interval, not longer.
• The study noted that "the fifth to twelfth day after vaccination is the critical time period for occurrence of the expected low incidence of febrile reaction", also that the significance of the difference between vaccinees and controls in terms of miscellaneous subsequent complaints (gastroenteritis included) was "doubtful" (though it was actually very marked in the study tables, up to 18/228 of vaccinees with gastroenteritis, compared with at most 3/106 of controls)
• At no point in the study was autism mentioned as a risk-factor or an actual outcome. Clearly, the possibility was not even considered. The study noted the lack of arthritis and arthralgia.

22. Ad-Hoc Medical Research Council "Committee of 37 Independent Experts"

This was held as a one-off in March 1998 to examine the Wakefield team’s "Early Report" published in 2/98 in The Lancet

• Concluded that there was no current evidence linking bowel disease or autism with MMR, and there was thus no reason, arising from the work considered, for a change in the current MMR vaccination policy" (my emphasis - note the careful wording)

23. The Medical Research Council’s Report ("Report of the Strategy Development Group Sub-Group on Research into Inflammatory Bowel Disorders and Autism", March 2000

This was yet another review group which, upon failing to prove that there was a link, then drew the illogical and unproven conclusion that MMR therefore was safe.

• Membership of the group was messrs. McGregor (chairman), Driscoll, Frith, Jewell, Meade, Sewell, Smith, Tedder, Ward, Wing, Wright. Only known gastroenterologist was Jewell. Sub-group met four times, 1998-99.
• The group was to develop a strategy for further research, monitor and steer future MRC support and report at least annually.
• The subgroup recognised that the level of MRC support, particularly for IBD (not autism???) was "relatively weak".
• due to wider definitions and increasing awareness".
• It concluded that much remained unknown about autism and IBD, MRC support for research was weak and that "between March 1998 and September 1999 there had been no new evidence to suggest a causal link" (again, note careful wording).

For autism, its recommendations included:

• Investigation of risk factors, large-scale epidemiological studies concentrating on late-onset cases (this led directly to the Professor Andrew Hall three-year study at London School of Hygiene & Tropical Medicine)
• Development of tests to investigate gastrointestinal involvement in autism
• Maintaining a watching brief for further evidence of any link

• The purpose of this study was to determine any causal relationship between acute encephalopathy and subsequent permanent brain injury or death, following measles vaccine, mumps vaccine, rubella vaccine, MR or MMR. The conclusion was that a causal relationship may exist as a rare complication.
• The study looked at children who received the first dose of these vaccines 1970-93 and who then developed an encephalopathy with no determined cause within 15 days
• A total of 48 children (out of 403 claims submitted) aged 10-49 months met the criteria. Eight had died, the remainder had mental regression and retardation, chronic seizures, motor and sensory deficits and movement disorders. Symptoms were clustered on days 8 and 9 after vaccination. The clustering was accepted as suggesting a rare complication of measles immunisation.
• Of the 48, 1 child had MR, 30 had MMR, 2 had MMR plus DTP, 2 had MMR plus haemophilus influenzae type b (Hib), 4 had MMR plus DTP plus oral polio vaccine (OPV), 1 had MMR plus DTP plus OPV plus Hib
• Two of the deaths were in previously apparently normal healthy children, who then received MMR. Three deaths occurred 3 months to 4 years later. One non-fatal case reviewed had eventual hyperactivity and aggressive behaviour at age 5 years.
• The authors thought that (1) the 48 cases represented under-reporting from a passive system, but (2) most serious cases had been captured by the system - a self-comforting point?

25. US paper, by Drs. Delgiudice-Asch (clinical instructor in psychiatry, Mount Sinai School of Medicine) and Hollander (Seaver Autism Research Centre)

This includes:

• the noting of the potential relevance of antimyelin autoantibodies
• reference to the work of Stubbs in the USA and the suggestion that an inflammatory reaction in the brain may contribute to the development of autism
• references to indirect evidence of immune activation in autism
• the reference to Singh’s finding, also in the USA, that identified serum antibodies to myelin basic protein in 19 out of 33 autistic children, compared with only 9% in a control group
• reference to Todd and Ciaranello’s detection of circulating antibodies in seven out of thirteen children with autism

This studied 40 infantile autistic patients ranging from 6-15 years, of which 22 were classical infantile autism ("true autism", or TA) and 18 lacking one or more defects associated with infantile autism and were therefore termed "pseudo-autism syndrome" (PAS). Medical histories focused on possible viral infection in the mother, especially during second trimester, whether the child had multiple infections, especially otitis media, in the first to fifteenth month of life, and the relation of onset of symptoms to immunisation. Results were:

• antibodies to myelin basic protein were present in 20 out of 22 TA and 4 out of 18 PAS children
• 12/22 TA and 6/18 PAS children had a decreased response to ConA and negative LIF response to PHA and a decrease in suppressor functional assay (later studies showed a good correlation of the above with low levels of CD8/CD28 and CD8/CD38 T-cells)
• 6/22 TA and 12/18 PAS children had increased toxic metal levels, usually aluminium) and decreased levels of trace minerals necessary for a normal immune response
• 10/22 TA and 6/18 PAS children had elevated thyroid stimulating immunoglobin values
• titers to rubella were ten times normal in 11/22 TA and 5/18 PAS children
• several of the children had elevated IgM levels to measles, indicating a defect in immune regulation

Fudenberg states that:

• the very low IL-2 receptor/positive lymphocytes and the decrease in DR+, but not IL-2 receptor+ lymphocytes, suggests incomplete activation in the TA children, a finding seen in other autoimmune diseases; this suggests that TA may be an autoimmune disease
• it is possible that "auto-antibodies" are directed against various viruses and that the reaction to myelin basic protein, neuron axone filaments, one or other receptors for neurotransmitters, represent molecular mimicry
• TA is probably due to adverse reactions to live virus or live virus vaccine in a genetically-predisposed individual, one whose cell-mediated arm of his/her immune system is not yet mature, or, in a very young infant, by transplacental IgG antibodies from a mother with high titers of antibodies to one of the vaccine constituents, e.g. diptheria toxin

27. Unpublished paper by Dr. Vijendra Singh at the College of Pharmacy, University of Michigan, Ann Arbor, jointly with the late Professor Reed Warren, Professor of Biology at the Centre for Persons with Disabilities, Utah State University in Logan and Adjunct Professor of Psychiatry at the University of Utah, and also Dennis Odell

This studied the immune responses to myelin basic protein, which is a protein component of myelin. Defects in myelin would dramatically affect brain activity. The study of 33 autistic children at or over ten years old was compared with eighteen age-matched normal children. twenty children with unknown-cause mental retardation and twelve children with Down syndrome were also studied as controls, and testing for serum antibodies to MBP undertaken:

• antibodies were found in nineteen of the 33 (58%) of autistic children
• the corresponding level for controls was 7%, or over eight times higher
• testing of the autistic children showed features also found in patients with autoimmune diseases such as rheumatoid arthritis, insulin-dependent diabetes and multiple sclerosis

The features above included genetic predisposition, gender imbalance (four or five times higher frequency in boys than girls), major histocompatibility association, and immune activation.

• The authors suggest that autoimmunity may be a critical factor in the cause of autism.
• They note that an essential part of the autoimmune mechanism should involve antibody-mediated immune responses or antibodies against the brain, and that other recent studies have found evidence of antibodies to brain tissue antigens, such as myelin basic protein, neurofilament proteins and serotonin receptor.
• They also note that antibodies to MBP may have some pathological relevance since abnormal cell-mediated immune response involving a soluble factor but not antibodies to this protein has been detected by other researchers, suggesting that autistic children develop inappropriate immune responses to this brain protein.
• They conclude that at present (1992) the relationship between antibodies to MBP and autism was not understood, but they hypothesised that the development of the immune response could be the basis of autoimmune pathogenesis in some cases of autism. It was conceivable that if an immunological assault was to occur before birth or during infancy or early childhood, it could lead to poor myelin development or abnormal function of the nerve fibre myelin.

28. Further unpublished US paper, from Dr. Vijendra Singh

This suggests that:

• a significant number of autistic children have positive titers of measles and/or MMR autoantibody which is associated with the presence of myelin basic protein autoantibody
• a measles-related triggered autoimmune response to myelin may play a pathogenesis role in the cause of autism in at least a subset of cases

29. Paper by Singh, Warren, Odell, Warren and Cole, published in Brain Behaviour 1993 March 7(1) 97-103

This investigated the possible pathological relationship between autoimmunity and autism, reported that:

• antibodies reactive with myelin basic protein (anti-MBP) had been investigated in the sera of autistic children
• nineteen out of 33 (58%) of sera of autistic children under or equal to age ten were found to be positive for anti-MBP
• in controls, only eight out of 88 (9%) were positive; controls were age-matched and included normal children and children with mental retardation or Downs Syndrome, as well as normal adults aged 20-40.

30. Paper by Weizman, Weizman, Szekely, Livni and Wijsenbeek, published in the American Journal of Psychiatry 1982 Nov 139 (11) 1462-5

This reported a study by macrophage migration inhibition factor test, in seventeen autistic patients and a control group of eleven patients suffering from other mental diseases, of cell mediated immune response to human myelin basic protein. It found:

• of the seventeen autistic patients, thirteen demonstrated inhibition of macrophage migration
• none of the non-autistic patients showed such a response
• the results therefore indicate the existence of a cell-mediated immune response to brain tissues in autism

31. Paper by Drs. Gupta, Aggarwal and Heads, titled Dysregulated Immune System in Children with Autism - Beneficial Effects of Intravenous Immune Globulin on Autistic Characteristics, published in the Journal of Autism and Developmental Disorders, vol. 26 no. 4 1996

This suggested a theory that high titers of rubella antibody present in mothers of children with autism could be transplacentally transferred and could persist in the child, and that when the child received MMR, rubella antigen may complex with pre-existing antibodies, thereby possibly playing a role in the pathogenesis of autistic features

32. Unpublished US paper, by Dr. Oleske and Assistant Professor Zecca, New Jersey Medical School

This found that:

• among 16 children diagnosed with autism, there was a threefold increase in their serum rubeola titers over the expected normal range
• the unusually high and persistent titers of anti-measles antibodies in autistic children was statistically significant when compared with a similar group of non-autistic subjects
• it is suggested in the paper that MMR may play a role in the pathogenesis of autism because elevated titers of anti-measles antibodies may signify a chronic over-activation of the immune system

This found that

• brain regions whose pre-vaccination neuronal damage had been relatively insignificant may, via vaccine-induced clonal expansions, suffer additional damage.......resulting in vaccination-enhanced neuropathy presenting clinically as autism
• recent research findings are instructive regarding autistic children for whom.......medical records show a history of infections, antibiotic treatments, vaccinations and temporally-associated onset of autistic traits.........
• nearly any vaccine may have the potential for inducing neuronal damage in persons with NdEs." (Source: Hypothesis: Infection, Antibiotics, Vaccination-Induced Neuropathies; Mechanism Of Pathogenesis In Some Cases Of Autism, ADHD, Tourette’s, by Theresa C. Binstock, bit.listserv.autism 3rd January 1997)
• although presented as a hypothesis, a route is offered that demonstrates how a small subset of susceptible infants could be affected, that a variety of vaccines could be involved for this subset of cases, and that prior treatment with antibiotics may play a critical role

34. Paper by Diane E. Griffin, D. E. Hussy et al, John Hopkins University, US, has established (source: Journal of Infectious Diseases, 173 (6), 1320-26, June 1996)

This found that:

• measles virus and measles vaccinations impair cell-mediated immunity
• they also increase the likelihood of other viral infections

These researchers found that:

• of 88 children immunised at six or nine moths with Edmonston-Zagreb or Schwarz SW6 or SW9 strain of measles vaccine, mitogen-induced lymphoproliferation was decreased at 2 weeks in the SW9 group and at 3 months in all groups
• this was negatively correlated with measles antibody level at 3 months
• CD8 T-cells, soluble CD8, neopterin and beta2-microglobulin were increased at 2 weeks in the SW9 group
• soluble CD8 and beta2-microglobulin remained elevated at three months
• therefore measles immunisation resulted in suppression of lymphoproliferation, which was most evident in infants with the highest antibody responses and most immune activation

35. Paper by P. G. Auwaerter and Diane Griffin, (source: Clinical Immunolgy and Immunopathology, 79(2): 163-70, May 1996):

This found that:

• measles produces immune suppression which contributes to an increased susceptibility to other infections
• high-titred measles vaccines have been linked to increased long-term mortality among some female recipients
• vaccines can impair cell-mediated immunity by shifting cytokines release into a Th2 pattern, thereby allowing intracellular pathogens (e.g. many viruses) to be more successful

36. Paper by Martinez et al, (source: Proceedings of the National Academy of Sciences, 94.8726-31 1997):

This found that:

• relative deficiency of T-helper type 1 (Th1) and cytotoxic T lymphocyte (CTL) responses in early life is associated with an increased susceptibility to infections by intracellular microorganisms
• this is likely to reflect a preferential polarisation of immature CD4 T-cells towards a Th2 rather than a Th1 pattern upon immunisation with conventional vaccines

37. Early Report by Dr. Andrew Wakefield and team, Inflammatory Bowel Disease Study Group at the Royal Free Hospital, London

Dr. Wakefield suggested in early 1998 that there could be the possibility of a linkage between vaccination and autism and other disorders. Although he was not in a position at that time to present the published evidence of comprehensive studies, his initial findings suggested that his hypothesis was plausible. The Royal Free Hospital study found:

• that there was patchy inflammation of the colon and swelling of the lymph glands in the last part of the small intestine in 39 out of 40 children studied that had developmental disorders. All the children had previously gone through periods of normal development, ad most had acquired words and social skills which were subsequently lost
• most children had suffered either diarrhoea or alternating periods of diarrhoea or constipation, frequently associated with bloating, abdominal pain and poor appetite, and occasionally the passing of blood
• parents reported in some cases that certain foods made their child’s symptoms worse, and witholding those foods improved behaviour
• this implied that there could be a syndrome that linked intestinal inflammation with developmental disorders of the autistic spectrum, and could offer a vital clue in understanding the origins of some forms of childhood autism

Dr. Wakefield also speculated that if the bowel was damaged during a critical period of brain growth, an excess of peptides could gain access to the developing brain, where these peptides may not only influence behaviour but also brain growth and development. The disease pathway was described as "speculative but biologically plausible".

No evidence to contradict this hypothesis has been offered to date by the UK Department of Health, and the Department has yet to offer evidence of its own that degeneration into autism or the onset of inflammatory bowel disease following vaccination is caused by some other source.

38. Letter published in The Lancet, Vol. 352, July 18th 1998, from Drs. Sabra, Bellanti and Colon of the International Centre for Interdisciplinary Studies of Immunology and the Department of Paediatrics, Georgetown University Medical Centre, Washington DC

This stated that:

• in support of the findings of Dr. Andrew Wakefield are several behavioural and clinical features known to be related to the central nervous system, such as infantile colic and attention-deficit hyperactivity disorder, which have been related to food allergy
• the US researchers had noted a striking appearance of ileal-lymphoid nodular hyperplasia in patients with non-IgE-mediated food allergy who had presented a range of conditions including asthma and attention-deficit-hyperactivity disorder
• examination of two cases with hyperactive disorders who were intolerant to various foods, by colonoscopy of their terminal ileum, had produced findings match those of Wakefield et al
• ileal-lymphoid nodular hyperplasia lesions of the gastrointestinal tract allowed the entry of antigens across the inflamed mucosa of the bowel as a result of the reactive inflammatory response in the adjacent lymphoid tissue of Peyer’s patches in patients with non-IgE-mediated food allergies
• the researchers proposed that similar mechanism(s) may be involved in the pathogenesis of the central nervous system dysfunction in the patients described by Wakefield et al

39. Dr. Edwin Cook, Director of the Laboratory of Developmental Neuroscience, university of Chicago, in a joint paper with Courchesne, Lord, Cox, Yan, Lincoln Haas, Courchesne and Leventhal, published in the May 1996 edition of Molecular Psychiatry

This noted that:

• it was a well-established finding that a significant number of people with autism have elevated levels of blood serotonin, and the successful use of medications (potent serotonin transporter inhibitors, or PSTIs) suggest the possibility that serotonin plays a role in autism
• the authors studied 86 people with autism and their parents to examine whether the gene for the serotonin transporter may contribute to the risk of autism. They found evidence of a significant relationship
• it was possible that the serotonin transporter gene HTT was serving as a marker in linkage disequilibrium with a genomic variant which was contributing to susceptibility to autistic disorder
• several lines of evidence suggested the serotonin transporter as the most logical candidate gene, based on existing evidence, but many other candidates could be considered on only slightly weaker evidence
• the short variant at the serotonin transporter locus was found to be preferentially transmitted from parents to children with autistic disorder, and this provides preliminary evidence that the serotonin transporter may serve as a susceptibility locus in autistic disorder. This finding may contribute to identification of other factors which add additively or in a multiplicative manner

40. The late Dr. Reed Warren, formerly Professor of Biology at Utah State University in Logan, set out a pathogen-autoimmune hypothesis for autism:

• some children are susceptible to an environmental pathogen, probably a virus or bacterium, resulting from an inherited deficiency of their immune system
• unable to clear the pathogen, the child is at higher risk for the pathogen to damage the developing brain or trigger an autoimmune response
• the pathogen would not necessarily create gross neuronal damage, but have more subtle effects on portions of the brain controlling behaviour
• although not a requirement, the pathogen might persist and replicate slowly or be maintained in homeostasis by the immune system

Dr. Warren outlined the possibility of several key factors, which included:

• exposure to a certain pathogen at a vulnerable time, i.e. at the time the central nervous system is undergoing rapid development
• the existence of an immune susceptibility or deficiency that would allow a pathogen to persist
• a genetic constitution that allowed certain T cells to react to the pathogen in such a way as to cause reactivity against the central nervous system or products of the central nervous system such as neurotransmitters
• in some cases an immune susceptibility or deficiency in the immune system of the mother that may permit a pathogen to be present in utero or allow an immune response within the foetus
• in some cases, a purported immune mechanism may have not caused irreversible damage to the central nervous system but is only interfering with brain function such as by binding to various neurotransmitters or their receptors

41. Warren and Singh studies

In his own studies, jointly with Singh et al, published in the journal Immunogenetics 36:203-207 of 1992, he noted that:

• of the 46 chromosones of 23 patients, 27 chromosones (58.7%) had an extended haplotype as compared to an unrelated control group in which 33/128 (only 25.8%) of chromosones carried an extended haplotype
• the frequency of extended haplotypes on chromosones of autistic children was much greater than that on family-parent normal chromosones, the latter being only 30.7%
• in the initial and later studies, only eight out of 45 autistic subjects did not have an extended haplotype, and fifteen autistic subjects carried an extended haplotype on each of their chromosones
• also, the mothers but not the fathers of the autistic children had an increased representation of extended haplotypes
• an additional control group of subjects with general severe learning difficulties had a haplotype frequency of 26%, similar to that of the earlier-mentioned unrelated controls

He noted that many normal individuals possess one or more of the above factors, but it would only be those children that possessed all of these, plus probably others, simultaneously, where autism would occur. He also noted that four season-of-birth studies had found an excess of births in the month of March, and that, if a pathogen was involved in autism, it was conceivable that it was more prevalent during early winter so as to affect March babies. He also noted that four to five times more boys than girls were affected by autism, but that autoimmune diseases were often more common in one sex, with the influence of sex hormones on immune functions well-established. He further noted the link between genetic background and frequency of infections:

• the products of the C4A and C4B genes are crucial to the activation of the other vital components of complement involved in protection against viruses, bacteria and other infectious agents
• C4A proteins bind avidly to amino-rich surfaces and C4B proteins form linkages with hydroxyl-containing carbohydrate surfaces
• deficiency in the C4 proteins especially C4B has been associated with increased viral and bacterial infection
• inherited abnormalities of the complement C4 proteins are linked to certain autoimmune diseases

42. Paper by Kulman, Neri, Rovelli, Roselli, Lissoni and Bertolini, Divisione di Neuropsichiatria Infantile, Ospedale S. Gerardo, Monza, Italy

This examined the role of the pineal hormone melatonin (MLT) in the pathogenesis of autism. The study included 14 children affected by autism, median age seven years, mostly suffering sleep disorders, and found that:

• no patients exhibited physiological MLT increase during the night
• mean serum levels of MLT observed during the night were significantly lower in patients than controls
• there was therefore an indication of severe pineal function damage
• the absolute lack of MLT increase during the night would justify exogenous administration of MLT as replacement hormonal therapy

43. A USA parents’ group, the Developmental Delay Registry, has reported that of nearly 700 children aged between one and twelve that had been surveyed in 1994:

• those that had taken more than 20 cycles of antibiotics in their lifetime were more than 50% more likely to suffer developmental delays
• nearly 75% of the developmentally-delayed children had been reported as developing normally in their first year of life
• developmentally-delayed children were 37% more likely to have had three or more ear infections than non-developmentally delayed children
• developmentally-affected children were nearly four times as likely to have had adverse reactions to immunisations

44. Other Researchers Who Believe Link Possible

• Published evidence by Stratton et al ("Adverse Events Associated With Childhood Vaccines", National Academy Press 1994, 64-65) states "In the course of its review the committee encountered many gaps and limitations in knowledge.......(including) inadequate understanding of biological mechanisms underlying adverse events, insufficient information from case reports and case series, inadequate size or length of follow-up of many population-based epidemiologic studies".
• A paper published by Bitnun et al, Clinical Infectious Diseases Journal, October 1999, confirmed the presence of measles virus in the brain tissue of a previously-healthy 21-month-old boy, 8.5 months after he received MMR. The child had no history of exposure to measles or if immune deficiency. The nucleotide sequence in the nucleoprotein and fusion gene regions was identical to that of the Moraten and Schwartz vaccine strains. The fusion gene differed from known genotype A wild-type viruses.

45. Statement by Professor Walter O. Spitzer

Although not a study, the statement by Professor Spitzer deserves a high profile. Professor Walter O. Spitzer, Emeritus Professor of Epidemiology, McGill University, Montreal, stated on December 6th 2000:

• "The safety of MMR has been brought into question, both in the United Kingdom and in California. It is not possible to rule out the possibility that excessive rates of autism occur among children immunised with MMR"
• "The early epidemiological findings are worrisome. The clinical and laboratory data strongly suggest the biological plausibility of a link between MMR and autistic disorders"
• He "......strongly endorses immunisation as a pillar of public health strategy for most diseases. But one should never surrender caution".

46. Wakefield & Montgomery "Through A Glass Darkly" Paper (Look Back At MMR Safety Trials), Journal of Adverse Drug Reactions, 2000 19(4), 265-283)

Wakefield & Montgomery reviewed following safety studies: Buynak et al 1969, Stokes et al 1971, Minekawa et al 1974, Schwartz et al 1975, Crawford and Gremillion 1981, Miller et al 1987.

• Buynak study identified viral "interference". Follow-up only 12 days
• Stokes study revealed persistent gastrointestinal problems in US trial children. Follow-up only 28 days. Stokes compared 228 MMR children with 106 unvaccinated controls. Data, from Philadelphia and Costa Rica and San Salvador, was combined - serious methodological error.
• Gastroenteritis significantly more common in Philadelphia vaccinees (24%) compared with unvaccinated Philadelphia controls (5.6%). No significant difference between vaccinated and unvaccinated in Costa Rica and San Salvador because of high levels of gastroenteritis anyway (50% in vaccinees, 44% in controls). Combining all the data masked these instructive differences.
• Also significant "unrelated" illness in 39% of Philadelphia vaccinees (otitis, allergy, viral infection, abdominal pain), compared with 12.2% controls. Relevance not seen at time.
• Minekawa study confirmed viral interference. Follow-up only 15 days.
• Schwartz study also merged its data, so provided insufficient insight. Follow-up only 21 days. Looked at two different populations, 282 children in Ohio and 926 children in Santo Domingo, Dominican Republic. Merging of data from different countries again a serious error. No data provided to permit analysis of adverse events.
• Crawford and Gremillion study of USAF recruits confirmed viral interference. Follow-up only 19 days. Some 512 vaccinees were compared with 835 unvaccinated controls. Study noted increased fever and diarrhoea in those that received measles and rubella vaccines simultaneously. Effect not ADDITIVE but SYNERGISTIC - key point.
• Eddes study (small UK study) 1991 compared reactions to MMR with monovalent measles vaccine. High rates of gastrointestinal disorders (41.9% and 37.8%). Authors dismissed these as normal background illness.
• Miller study noted diarrhoea common (26% of vaccinees). Follow-up only 21 days. Major missed opportunity of following up large cohort. (NB Dr. Elizabeth Miller, who has been so vociferous in criticising the Wakefield findings and in defending MMR, including presentations to MP groups, was co-author, and designed the poor 1999 Taylor, Miller North London study)
• Stokes, Schwartz, Miller and Eddes studies were all too small or too superficial to pick up uncommon adverse events.
• Plesner et al study of gait disturbance following MMR (Acta Paediatrica, 2000, 89, 58-63) confirmed association and indicated more severe cerebellar ataxias following MMR may be associated with residual cognitive deficits.

Peer review comments on Wakefield & Montgomery paper very powerful. Peer reviewers included Dr Peter Fletcher, former Principal Medical Officer in Medicines Division (now MCA), who was medical assessor to Committee on Safety of Medicines. His comments:

• "Evidence on safety very thin", and "Too few followed for sufficient time"
• "Big numbers were necessary, and computerised databases already in place to permit this, but was not done"
• "Caution should have ruled the day", and "Should have been strong encouragement to conduct 12-month observational study on 10,000-15,000 children" (not done)
• "Granting of product licence was premature"

Wakefield paper is actually argument for vaccination - but not using triple measles-containing vaccines. Wakefield not anti vaccination per se. Duty is to patient. He is investigating children brought to him, not campaigning against DoH for its own sake. He is simply relating what he is finding.

Other background points relevant to paper:

• Is already accepted by Medical Research Council that concurrent exposure to natural (or vaccine) measles and natural mumps is a risk-factor for inflammatory bowel disease
• Also is legal precedent for triple vaccine causing autism (Lassiter case, US, 1996). This was a DPT vaccine, but established important ruling on probability of causation.
• MCA has left itself an escape route for later: "The numbers included in the trials, even if they were all followed up long term, would not be sufficient to detect rare problems.....". But what is "rare"?

47. The Wakefield/Watson/Shattock Rebuttals - "Anything You Can Rebut, I Can Rebut Better"

Through A Glass Darkly safety paper by Wakefield and Montgomery has been criticised by Mike Watson, Medical Director of Aventis Pasteur MSD, the manufacturers of MMR.

But Watson’s criticisms do not themselves stand up to scrutiny, as demonstrated below by Paul Shattock of Sunderland University Autism Research Unit (tel 0191 515 2000). The only aspects that cannot be bottomed-out by Shattock are where the studies themselves have not been published.

• Watson maintains that observation period in trials (as reported in paper by Stokes et al, 1971) was up to 63 days, not up to 28 as reported by Wakefield. However, Shattock quotes Stokes study as saying "Joint involvement was noticeably absent during six to nine week follow-up....Present studies with queries at six to nine weeks following vaccination did not reveal any occurrence of arthritis or arthralgia beyond the 28-day period for close observation". Trial therefore was 28 days, with only queries for arthritis etc beyond this. Wakefield version therefore correct.
• Watson maintains that "MMR I" safety was investigated in four studies prior to licensing in US 1971 and UK 1972. Also, "MMR II" investigated by seven studies, two of which published. Immruvax also tested in seven studies. But Shattock: unclear whether studies are published or secret. (Please publish?) Wakefield can only comment on what is published.
• Watson states that virologists generally accept wild measles virus only causes persistent disease in central nervous system, as subacute sclerosing panencephalitis (SSPE) or measles inclusion body encephalitis (MIBE). Wakefield maintains potential for delayed intestinal pathology has been borne out by Fournier et al, 1968. Shattock: technology has failed to isolate measles virus RNA in affected children, but further progress expected.
• Watson states that mutant measles virus genetic material can persist in tissues of apparently healthy people without causing disease (Katayama et al, 1998). Shattock: so mutant measles can persist but vaccine strains cannot? - challenge for evidence to substantiate this claim.
• Shattock also makes points that (a) MMR test group in Stokes 1971 paper had way more GI problems than controls, (b) that in Schwartz et al paper 1975 the results of 282 children from Daytona Ohio and the 1192 from Santo Domingo and Panama were pooled (unscientific), and (c) why was gastroenteritis completely omitted from list of side effects when difference of incidence between groups so blatant?
• Watson: "gold standard" in safety studies was placebo-controlled crossover study of 1162 twins in Finland 1982. More detail published by Virtanen, Peltola et al 2000. Shattock: was 1982 study published?/where? The 2000 paper was actually only published after Wakefield & Montgomery paper submitted.
• Wakefield: follow-up interval reduced from 4 weeks in initial controlled trial to 3 weeks in subsequent trials. Watson: insists follow-up was up to 63 days. Shattock: observations were for 28 days. At up to 63 days, parents asked about any significant illness - side effects listed in paper apparently excluded. No doubt Wakefield’s 28 days is right.
• Watson: later MMR II studies had observation period of 42 days. Priorix studies had periods of 42-60 days. Shattock: where are publication details?
• Watson: numerous post-marketing studies of MMR have been conducted and published. Shattock: references please? Why haven’t they been quoted by DoH, why can’t anyone find them?

Other "facts" quoted by Watson in "Aventis Pasteur MSD - Vaccines For Life" paper:

• Watson: "national safety regulators require all side effects to be reported". But this doesn’t mean they actually are, especially novel syndrome with (up till 1998) no publicity, delayed onset, and official refusal to count as "adverse reaction"
• Watson: "there have been over 500m doses given worldwide". But there are also many hundreds of thousands of cases of autism worldwide, and none of these has been admitted by authorities to be consequence of MMR, keeping its safety record clean.......
• Watson: "As anyone in clinical trials knows, all participants or their parents are very carefully informed and consented". Yes, but this wouldn’t have covered a warning to watch out for subsequent delayed degeneration into autism!
• Watson: "Any unusual event that occurs in that child at any time after trial should be reported to MCA". But this would almost certainly never have included autism pre-1997, when very first publicity was given in Pulse magazine and BBC Newsnight. (In Oliver Thrower case, Newsnight report 8/97 was first clue, nine years after vaccination. In his case, vaccination never previously mentioned or considered as possibility by health professionals. He was added to MCA database 11 years after vaccination. So much for the value of even a 63-day trial follow-up!)
• Watson: "An unimmunised child is the infectious equivalent of a drunk driver". This comment is a revealing insight.
• Watson: "Giving vaccines separately would be more expensive". More expensive than all the extra health costs, care costs, special education costs, special needs transport costs, lost earnings of victim, lost tax revenues, parents’ lost earnings and taxes?
• Quote from MSD product insert on MMR: "Clinical studies of 279 triple seronegative children, 11 mths to 7 years of age, demonstrate that MMR is highly immunogenic and generally well tolerated." (So is just 279 the number?)

48. UK Department of Health Repudiation of Wakefield & Montgomery "Through A Glass Darkly" Paper

The UK DoH’s response was summarised in its press release of 21st January 2001. The main points are set out below, with the DoH in italics, and with my own responses following.

• The claim by Wakefield & Montgomery that there was insufficient research "is factually incorrect, as many studies recorded safety data up to six weeks, which is standard for vaccines, and some studies recorded data for longer - up to a year in some cases". Yes, but autism did not form part of this surveillance, the importance of gastrointestinal problems was not appreciated, the reference to six weeks being "standard for vaccines" doesn’t address the autism/gut syndrome, and very few cases indeed, in very few studies indeed, followed up for longer than a few weeks. The syndrome was missed.
• "Combined MMR vaccines had been extensively tried and tested in Scandinavia and the USA before they were introduced in the UK in 1988". As a statement, this proves nothing. The new syndrome of autistic enterocolitis was not suspected in these countries, either, and again was missed.
• "Now MMR is successfully used in over 30 European countries as well as the USA, Canada, Australia and New Zealand". Same comments apply. Presumably, these other Governments are claiming that "it’s safe because it’s used in the UK"?
• "A publication in 1988 lists 30 published studies where combined MMR vaccines were studied and follow-up extended up to ten years". Same comments again apply. (See also the Wakefield/Watson/Shattock rebuttals section)
• "The safety of combined MMR vaccines has been reviewed repeatedly by the Government’s independent expert scientific advisory committees including the Committee on Safety of Medicines and the Joint Committee on Vaccination and Immunisation". This is true in a literal sense, but the reviews have been mis-designed and halfhearted or inconclusive ("It was impossible to prove or refute the suggested association between MMR vaccine and autism/pervasive development disorder or inflammatory bowel disease because of the nature of the information, the self-selection of cases and the lack of comparators" - Committee on Safety of Medicines Report of the Working Party on MMR Vaccine, page 12, paragraph 5.5).
• One can also argue that the Committees quoted are neither independent (see other references) nor expert in the field of gastroenterology, as opposed to immunology. They stand to lose a great deal by a link being exposed, both corporately and individually, and possibly financially.
• "The use of MMR vaccine is also endorsed by the World Health Organisation, the British Medical Association, the Royal College of General Practitioners and the Royal College of Nursing." This in itself proves little in the context of an intense scientific debate about a new discovery in gastroenterology. The latter institutions may come to regret their endorsement in the fullness of time. Have their advisers read all the evidence, on both sides, first-hand?
• "By 2000, several hundred million doses will have been given wordwide". Yes, and there will also be several tens, or hundreds, of thousands of cases of autism worldwide, some of which may have been precipitated by MMR.

In short, the DoH’s rebuttal was a "non-denial denial". It sought to refute the Wakefield/Montgomery paper, but was almost entirely couched in generalities. The devil is in the detail of the Wakefield/Montgomery paper. And the DoH was unable to refute this detail - indeed, it largely avoided addressing it at all.

49. Department of Health Re-Launch of MMR, 22/1/01

On 22/1/01, DoH launched £3m publicity campaign for MMR and rejected Wakefield "Through A Glass Darkly" MMR safety-test paper, without:

• Announcing any investigation into affected children
• Any additional funding for research into causes of autism (however, see later DoH/MRC announcement of 5th March 2001)
• Any explanation as to why autism is rising so steeply in UK and around the developed world (again, see DoH/MRC announcement of 5th March)
• DoH also released 15-page paper, "Combined MMR Vaccines: Response of the Medicines Control Agency and DoH" to attempt to refute Wakefield paper. However, paper merely re-assembles previous studies quoted by DoH, and adds nothing new of note.
• The Chairman of the Committee on Safety of Medicines, Professor Alasdair Breckenridge, said "MMR vaccination is very safe. There is no question-mark whatever over its licensing". (Breckenridge is one of the 10 - out of 37 - members of the CSM to have no declared interests whatever).
• Professor Michael Langman, chairman of the JCVI, said "My Committee has independently (sic) considered all the issues and reached the same position as the Committee on Safety of Medicines". Langman has non-current non-personal declared links with Merck Sharpe Dohme.
• The Chief Medical Officer, Professor Liam Donaldson, said "We are very pleased to have this further confirmation from the two independent expert committees".
• Some parents feel that, in the absence of conclusive evidence, either way, and taking all the surrounding factors into account, the re-launch of MMR was a serious error, leaving the authorities no escape should the test cases win in the High Court. The Department of Health’s high-risk strategy would, if this was the outcome, severely damage public confidence, probably in all forms of immunisation. The repercussions for the Department, and for child health generally, would be significant. The Department’s actions seem to have not countenanced this potential scenario.

50. Fighting Measles, Missing Vaccine Damage

• DoH has traditionally failed to commission research into causes of autism (prefers uncontroversial research into detailed behavioural manifestations, or genetic research that offers little insight into triggers). This position has only changed in March 2001 (see later).
• Medicines Control Agency (MCA) has failed to properly monitor adverse reactions to all vaccines, inc MMR
• Department repeatedly demonstrates entrenched bias in favour of maintaining public confidence in vaccination programme
• DoH has dual standards re robustness of evidence for/against link, and repeatedly shows this in its embracing of irrelevant studies/findings
• The studies that DoH quotes (Taylor, Miller, the Committee on Safety of Medicines study, Gillberg, Peltola) are virtually worthless in terms of disproving MMR/autism link, and some of the authors of the studies are part of the DoH "constellation of influence".
• Adverse reaction system never heavily reformed, because it would probably greatly increase adverse reaction statistics, and cause political pressures
• Autism never recognised as adverse reaction, so not reported (thereby potentially giving false assurance about safety record)
• Failure to understand that slow descent into autism takes place - it is not an acute adverse reaction, like other alleged adverse drug reactions. DoH is determined to continue to ignore this, because acknowledging it would invalidate many of the studies it quotes as "proof" of MMR’s safety, eg original safety trials, Peltola study.
• Repeated DoH bias in way it reviews evidence for and evidence against a link. Inability to acknowledge uncertainty, unable to adopt this publicly because of risk of loss of confidence, loss of face and increase in political pressure.
• Medical establishment welcomes "research" that "proves" there is no link between MMR and autism, whereas research to the contrary attracts hostility, critical "leaders", labels such as "controversial", slurs such as "poor science".
• failure to rigorously investigate the cases now making their way to the High Court. (the Committee on Safety of Medicines’ study of 6/99 of these was flawed in methodology, severely biased in its "explaining away" of each case, and self-confessedly inconclusive)

51. Has The Medicines Control Agency Missed The Syndrome?

• Medicines Division was admitted by its then management to have been in chaos in 1988, year that MMR was licensed in UK (for details, see Draft Factual Account 17 of Evidence to BSE Inquiry, pp 31-33).
• Had no effective method of finding files, and severe staff shortages in key areas
• Product licence renewals were handled purely administratively without scientific input. MMR wasn’t a renewal, but may have been treated as little more than one, as singles already licensed, and long-term complications not foreseen. Therefore highly likely that MMR went through "on the nod"
• Follow-up of trial children was only three weeks (chicken & egg situation, with autism being missed, MMR then being declared safe, then safety record used to repudiate autism connection - a circular argument)
• DoH uses circular argument, "MMR has good safety record", therefore no problem. But slow degeneration into autism not recognised as consequence, and no figures being kept by MCA on this. Therefore autism numbers not added in, and safety record remains "good".
• The Medicines Control Agency’ adverse reaction warning system, known as the Yellow Card system, by their own admission only picks up 10-15% of even serious adverse reactions (source: Guidance on Interpretation of Yellow Card Data, MCA, 1997). System woefully weak.
• Yellow Card unable to identify problem because it must be shown that adverse event occurs more frequently in vaccinated than unvaccinated population - very difficult to do when almost all children vaccinated. (source: letter of MCA of 21/8/98 to David Thrower)
• Yellow Card depends on doctors, dentists, coroners and hospital pharmacists to file reports (source: MCA). But these are unlikely to be able to make the link between autism and MMR.
• Adverse reaction reports are added to the ADROIT database, introduced in 1991. However, the database can only deal with the data it actually receives. If a syndrome is missed completely, then there will be no data in the database.
• Yellow Card is voluntary for health professionals, but compulsory for pharmaceuticals manufacturers. But this depends on adverse reactions being reported to manufacturers - again, unlikely.
• Parents must also be able to make link between MMR/autism. This was not possible pre-1998, as publicity had never been given to connection between vaccination and later degeneration into autism
• In any case, "it has been estimated.....that only 10-15% of serious ADRs (adverse drug reactions) are reported" (1997 Guidance Sheet issued by MCA), and "....it is accepted that spontaneous reporting schemes have limitations" (source: MCA letter of 29/3/99 to David Thrower).
• And worse still, "Autism has been very rarely reported as an adverse drug reaction.....These figures are unsurprising since autism is not a recognised ADR to any particular medicinal substance" (Source: letter of MCA of 29/3/99 to David Thrower). The chicken-and-egg argument again.
• And a potentially-significant admission, "Evidence from the Yellow Card scheme is unlikely to resolve the issue as to whether or not autism could be causally associated with MMR vaccine" (Source: letter of MCA of 29/3/99 to David Thrower)
• MCA’s estimate of only 10-15% of ADRs being reported may even itself be optimistic - West Midlands Centre for Adverse Drug Reactions Reporting did survey and found rate of only 6.3% of all ADRs reported.
• All recent improvements to Yellow Card have been irrelevant to autism detection (extension of system to hospital pharmacists, GP prescribing systems, community pharmacists, nurses)
• Similar situation in USA - "On the basis of Vaccine Adverse Event Reporting System alone, we don’t have proof that vaccines are not contributing to (vaccine-related problems)(source: Caveats to Interpretation of VAERS Data, Centre for Biologics Evaluation & Research, VAERS, 1998)
• Whole monitoring system is therefore passive, and irrelevant to autism - like smoke-alarm with no battery.

52. The Subculture of the Regulatory Establishment

All this makes more sense if you study the subculture:

• Poor monitoring of all child health, not computerised (GP records are often scraps of paper bearing unreadable handwriting). By comparison, the DVLC computerised in 1977, 30m vehicles, 35m drivers, but DoH still in data Dark Ages
• Very "establishment" culture within Committee on Safety of Medicines, Medicines Control Agency, DoH Immunisation & Communicable Diseases Branch, PHLS, un-self-critical, not proactive in controversial areas
• No-one questions vaccine safety (like asking group of Bishops to question existence of God). Fear of loss of public confidence. See Rt. Hon. Kenneth Clarke’s evidence to the Phillips BSE Inquiry for further insight.
• Culture of secrecy, lack of openness, taboo subject. Joint Committee on Vaccination & Immunisation fulfils just ONE of the seventeen criteria of DoH for openness (this is the declared interests of members, which it is forced to publish, and even this is almost unobtainable).
• DoH, Medicines Control Agency etc very remote from parents (parents still haven’t even been approached)
• Senior civil servants lack specialist knowledge, Ministers even more so - yet Ministers nominally in charge (as per BSE). Minister "on a hook".
• Too many agencies involved, scope for muddle and messages not "getting through" (as BSE), and too many members with closely-parallel views. Dissent not encouraged.
• Licensing body (Committee on Safety of Medicines) far too close to industry (see list of declared interests, below). Also lack of independent regulator. Health Ombudsman cannot investigate DoH.
• Joint Committee on Vaccination & Immunisation so preoccupied with preventing diseases that it cannot see wider picture
• Long history of "denial culture" to maintain public confidence (eg mild reactions might be connected with vaccines, serious reactions always put down to some other event
• No part of DoH responsible for autism (repeated attempts to find out which part of DoH is responsible for autism monitoring have failed).
• Bizarre contrasts with DoH approach to other health concerns - mobile phones, surgical instruments. Precautionary principle used on these, even when no evidence.
• Have built "house of cards". If children win High Court cases, end of the line for Chief Medical Officer, Deputy,, Minister for Public Health, etc etc. Effect with be cataclysmic. Massive repercussions for institutions that have backed DoH line on MMR. More dramatic implications than even BSE.
• Also, immense damage to public confidence would follow, with massive drop in immunisation, and real risk of return of diseases we all want to avoid.

53. Independence of the Committee On Safety Of Medicines?

• Currently, 37 members of the CSM have a total of 188 separate financial links with the pharmaceuticals industry, inc the vacc manufacturers, including 82 separate personal declared links. These include shares, fees, consultancies, research grants and non-executive directorships. Also further 106 non-personal declared links. Source: Neill Committee on Standards in Public Life).
• Vaccine companies directly linked to members of CSM through personal declared financial links include SmithKline Beecham (NB), Merck Sharpe Dohme (NB), Lilly Industries, Pfizer, Glaxo Wellcome (NB), Bayer, Proctor 7 Gamble, British Biotech, Medeva Pharma. Members with personal financial links with MMR manufacturers are Messrs Blenkinsopp, Dargie, Donaghy, Evans, Forfar, MacGowan, Smyth, Wilkie. (Source: Neill Committee on Standards in Public Life).

Specific members of CSM linked with MMR manufacturers are:

• Blenkinsopp (personal consultancy with Johnson & Johnson/Merck Sharpe Dohme),
• Chipman (non-personal research grants from Glaxo-Wellcome and from SmithKline Beecham),
• Darbyshire (non-personal support for clinical trials, including salaries, expenses consultancy finance, from Glaxo-Wellcome, SmithKline Beecham),
• Dargie (personal consultancy with Merck and another with SmithKline Beecham, and non-personal trials grant from Merck and SmithKline Beecham),
• Donaghy (personal shareholder in Glaxo-Wellcome and in SmithKline Beecham),
• Duff (non-personal support from Glaxo-Wellcome),
• Evans (personal fees from and shares in SmithKline Beecham, shares in Glaxo-Wellcome, fees from Medeva Pharma, and non-personal research grant from Medeva Pharma),
• Forfar (personal shares in Glaxo-Wellcome),
• Gordon-Smith (non-personal research grant from Pasteur Merieux),
• Langman (non-personal support for research from Merck Sharpe Dohme),
• MacGowan (personal consultancy with Glaxo-Wellcome, and another with SmithKline Beecham, plus non-personal research studentships or fellowships with Merck Sharpe Dohme, Glaxo-Wellcome, SmithKline Beecham),
• Park (non-personal support for studentships or fellowships from Glaxo-Wellcome and from SmithKline Beecham),
• Smyth (personal fees for meetings from SmithKline Beecham, non-personal support for clinical trials from SmithKline Beecham),
• Weller (non-personal support for trials/studies from Glaxo-Wellcome, SmithKline Beecham),
• Wilkie (personal fees from Consumer Health Info Centre, which is supported by Merck Sharpe Dohme and DoH),
• Woodhouse (non-personal support for clinical research from SmithKline Beecham and from Merck Sharpe Dohme).

(total 16 members)

54. Independence of the Joint Committee on Vaccination and Immunisation?

A Parliamentary Written Question by Mrs. Ann Winterton MP in May 1999 confirmed the following declared interests within the JCVI membership (NB - the PWQ related only to a limited range of pharmaceuticals companies, so the full list will be greater than this):

• Professor Lewis Ritchie (Glaxo Wellcome)
• Dr. Barbara Bannister (Glaxo Wellcome and SmithKline Beecham)
• Dr. David Goldblatt (SmithKline Beecham)
• Dr. Diana Walford (Glaxo Wellcome and SmithKline Beecham)
• Professor Roy Anderson (Glaxo Wellcome and SmithKline Beecham)
• Dr. Karl Nicholson (Glaxo Wellcome)

(total 6 members)

55. Lack of Public Scrutiny of the Committee on Safety of Medicines, the Joint Committee on Vaccination and Immunisation, and the Standing Medical Advisory Committee

In its Memorandum 9 of 24th November 1999 to the Select Committee of the House of Commons, the UK Department of Health sets out how its Non-Departmental Public Bodies (NDPBs) have provided information on openness of government. This was a response to the consultation document "Quangos - Opening The Doors", about improving the scrutiny of Quangos (a "Quango" is a quasi-autonomous non-governmental organisation, such as the Committee on Safety of Medicines or the Medicines Control Agency).

• The Department of Health sets out sixteen different measures of whether a Quango or Non-Departmental Public Body is open to public scrutiny:

1 Required to publish an annual report
2 Required to publish an annual account
3 Subject to a full audit by the National Audit Office or equivalent
4 Comes under scrutiny of the Parliamentary Ombudsman/other ombudsman
5 Has its own complaints procedure
6 Has to observe code of practice on access to Government information
7 Allows public to inspect register of (organisation’s) member’s interests
8 Has public right to attend Board or Committee meetings
9 Is obliged to release reports of above meetings
10 Has public right to inspect agendas of above meetings
11 Has public right to inspect minutes of above meetings
12 Is required to hold public meetings
13 Has Register of Members’ Interests
14 Maintains internet site
15 Is considering developing internet site
16 Has been recently (in last year) subject to "Quinquennial Review"

• The Committee on Safety of Medicines fulfils just six of the sixteen criteria (items 1, 5, 6, 7, 13 and 14, which are annual report, complaints procedure, code of practice on access to information, public inspection of register of interests, register of interests, internet site).
• The Joint Committee on Vaccination and Immunisation fulfils just ONE of the sixteen criteria (the register of members’ interests).
• The Department of Health concluded: "Our assessment is that......(there has been) a cultural change for Non-Government Departmental Bodies.......All the bodies have taken the proposals (from "Quangos-Opening The Doors") on board wherever possible and practicable with the aims of increasing public accountability, (and) commanding greater public confidence".

It is not clear what role the Standing Medical Advisory Committee (SMAC) has in relation to MMR. Its Register of Members’ Interests is published on the Internet, but does not give details as to the pharmaceuticals companies involved, annotating each member as having "consultancies, directorships and similar positions", "fee-paid work", shareholdings, "fellowships", "industrial support" and "other".

• Of the 14 ex-officio members, six (Messrs Bogle, Alberti, McEwen, Strunlin, Armstrong and Shaw) have between them twelve declared "types" of interests, though the actual number of specific links to specific companies may considerably exceed this
• Of the 15 appointed members, nine (Dr. Diana Walford, Dr John Chisholm, Dr Judith Gilley, Dr Richard Home, Dr Sheila Willatts, Professor Alan Johnson, Professor Raymond Tallis, Professor Brian Jarman and Professor Sir Cyril Chandler) have between them 17 "types" of interests; again the real number may be much higher

The failure to specify what these actual links are, how many companies are involved or the value of significant financial interests is wholly unsatisfactory.

56. Monitoring Declared Conflicts of Interests Within Medicines Control Agency and the Public Health Laboratory Service

These two bodies are executive non-departmental public bodies (NDPBs). Conflicts of interest are handled by the Guidance on Codes of Practice for Board Members of Public Bodies. This states (with my own comments following):

• "The Chairman and other Board members should declare any personal or business interests which may conflict with their responsibilities as Board members......Rules of conduct....(should) ensure that such conflicts are identified.....and that appropriate action can be taken to resolve them". The problem is, "appropriate action" is not clearly defined, and there is no means for members of the public to verify such action, or to ascertain what "personal or business interests" might exist.
• "The rules should include the keeping of a register of interests......(including) interests of close family members and persons living in the same household....". This latter implies a fairly strict interpretation of the code?
• "Public bodies should make registers of interests open to the public". Yet the register in relation to the MCA and PHLS is apparently not published for public scrutiny, nor is it available on the Internet.
• "When an interest in not of a direct pecuniary kind, members should consider whether participation in the discussion or determination of a matter would suggest a real danger of bias". This principle may possibly have been breached by the PHLS during the MMR/autism issue, but there is no way of verifying the matter.

A Parliamentary Written Question by Mrs. Ann Winterton MP in May 1999 confirmed that, of the PHLS:

• Professor Banatvala had a declared interest with Glaxo Wellcome
• Mr. J. Quin had declared interests with Glaxo Wellcome and with SmithKline Beecham
• Dr. D. Scales had a declared interest with Glaxo Wellcome

In February 2001, the Committee on Standards in Public Life confirmed that the Guidance on Codes of Practice for Board members of Non-Departmental Public Bodies is published by the Central Secretariat in the Cabinet Office. Anyone researching this further should approach that office.

The Committee also confirmed that:

• There is no requirement for NDPBs to publish registers of interests on the Internet
• There is a requirement that registers should be publicly available on request
• There is no requirement that registers should be deposited with the Committee on Standards in Public Life

The Office of the Commissioner for Public Appointments (tel 020 7276 2625) confirmed the following in February 2001:

• Guidelines covering the appointment of persons to public bodies, in relation to conflicts of interest, apply beyond the date of appointment
• Responsibility for conflicts of interest issues after an appointment is made lies entirely within the Government department concerned (i.e. There is no outside scrutiny, nor scrutiny by the Commissioner)
• The Commissioner emphasises the need for departments to monitor conflicts of interest throughout the lifetime of any appointment
• Possible conflicts must be explored with appointees in advance, to assess whether such conflicts are significant enough to prevent an appointee to a body from carrying out the duties of the post
• Appointees must be made aware by departments of the need to update them of any changes in their situation

Again, there seems to be no outside scrutiny whatever of these measures in practice.

57. Conflicts of Interest/Declared Personal Interests Within UK Department of Health

Is the management of the key sections of the Department of Health truly 100% independent over the MMR/autism issue? There is no evidence whatever to suggest that pecuniary or other non-legitimate interests or considerations have in practice influenced civil servants’ judgement, but the question is a legitimate one purely in principle, and therefore the monitoring of such potential conflicts of interest is briefly reviewed here, for completeness.

The background to this section is the following text from a health campaigner, Dr. Vera Shreibner, but the origins of the details are items from the Bulletin of Medical Ethics, published in London in 1994-95, particularly the August 1995 issue:

"The Bulletin of Medical Ethics.....in......the October 1994 article, "Is Your Measles Jab Really Necessary?", stated that during November 1994 the UK Government would be running a mass campaign of measles vaccination with the intention of reaching every child between the ages of five and sixteen......The purpose.....was to prevent an epidemic that would otherwise occur in 1995, with up to 200,000 cases and up to 50 deaths.....(but) between May and August 1994 the notification rate in England and Wales dropped sharply, so there was nothing that clearly suggested an imminent epidemic.....Based on the epidemiology of measles, there was never going to be a measles epidemic in 1995, and there was certainly no justification for concomitant rubella vaccination. The mass campaign was planned as an experimental alternative to a two-dose schedule of MMR. The UK Government knowingly misled parents about the need for the campaign and about the relative risks of measles and measles vaccination. The UK Department of Health broke the European Union’s law about contracts and tendering to ensure that specific pharmaceutical companies were awarded the contracts......Al this must have been extremely fortunate for the drug companies in question, since the supplies of MR (measles and rubella) vaccines, which they’d been left with in 1992 (when two brands of MMR had been hastily withdrawn after a press leak) and for which there was virtually no demand, were soon to go out of date".

(The Bulletin also pointed out that the whole concept of a mass campaign was questionable. The World Health Organisation had indicated such a strategy, but not specifically for developed countries).

The Civil Service Code gives some principles (with my commentary added):

• "The Civil Service must assist Government "with integrity, honesty, impartiality and objectivity". (The Phillips Inquiry into the BSE scandal demonstrated that this is not always the case in practice).
• The Code "should be seen in the context of the duties and responsibilities set out for Ministers.....which include.....the duty to give fair consideration and due weight to informed and impartial advice from civil servants, as well as to other considerations and advice, in reaching decisions". (There are strong grounds for believing that this may not have been fully carried out, in the light of Ministers’ decisions to continue to endorse the safety of MMR, and this suggests that Ministers have not been kept fully informed).
• The Code states: "Civil servants.....should give honest and impartial advice to the Minister......and make all information relevant to a decision available to them. They should not deceive or knowingly mislead Minister, Parliament, the National Assembly (of Wales) or the public". (There are a number of grounds for questioning whether this has been observed over MMR/autism, for example over the December 2000 Peltola (Finland) study).
• Also, "Civil servants should endeavour to deal with the affairs of the public........without bias". (There are grounds for questioning whether to repeatedly defend the record of MMR, in order to sustain the public’s confidence in vaccine safety, and failing to investigate specific problems such as MMR/autism with sufficient determination, represents "bias").
• Finally, "Civil servants should not misuse their official position or information acquired in the course of their official duties to further their private interests or those of others. They should not receive benefits of any kind from a third party which might reasonably be seen to compromise their personal judgement or integrity". (This would seem to rule out civil servants involved in the immunisation programme having shareholdings in the manufacturers of vaccines. Yet no formal debarment appears to be in place.

Although there is no evidence whatsoever to suggest any impropriety in this area, it remains a source of concern that, as there is no register of civil servants’ interests, there is no way that the public can verify the matter, one way or the other. This is important when the ordering of all UK vaccine supplies is now centralised in the Department of Health, when major campaigns such as the 1994 "Operation Catch-Up" anti-measles campaign involve major contracts for over seven million doses of vaccine, and if EU competitive tendering rules are reported to have been side-stepped).

The Commissioner for Public Appointments does not cover civil servants within a department. This issue is only covered by a management code within each department. The code stipulates that:

• Permission must be sought before accepting outside employment which might affect a civil servant’s work either directly or indirectly
• Civil servants may freely invest in shareholdings and other securities unless the nature of their work is such as to require constraints on this. They must not be involved in taking any decision which could affect the value of their private investments
• Civil servants must declare to their department or agency any business interests or holdings of shares or other securities which they or members of their immediate family hold, and which they would be able to further as a result of their official position. They must comply with any subsequent instructions from their department regarding retention, disposal or management of such interests

58. Measles Outbreak In The Republic of Ireland

It has been reported by the UK DoH that there has been an epidemic of measles in the Dublin area, and that two children have died:

• One child suffering from malnutrition, other had other complications, so probably spurious to automatically link deaths to lack of vaccination. Details of cause of death not known. Also 6 intensive care cases, same lack of information - but see below.
• According to the PHLS of Ireland, the Informed Immunisation Network Dublin and Eurosurveillance Weekly, the year-2000 outbreak grew thus: by Feb 2000 there were 16 hospitalisations, but 9 were under age of vaccination and 4 vaccinated. Only 3 out of 16 cases were therefore children who had avoided vaccination.
• By June 2000, there were 844 cases, of which 101 were hospitalised. The highest attack rate was in ages 6-14 months, i.e. under the age of MMR. By end September 2000 there were 1523 cases
• What the UK DoH does not quote about Ireland is numbers of deaths following vaccination. Any recorded numbers also likely to be underestimate because paediatricians do not always link with MMR.

Autism is reported as rising sharply in Ireland. A survey of Cork found 33 cases in a population of just 13,000 (source: Ms. Miriam Twomey, Chairwoman of the Hope Project, Cork). The children had generally become autistic before the age of two years, and following vaccination.

59. MMR In Japan

The DoH has asserted that Japan doesn’t use MMR and the consequence has been 69 deaths from measles. The UK Channel 4 News and the UK Daily Mail checked out the facts, on 29/01/01 and 7/2/01 respectively:

• In 1989, for four years, MMR was recommended. Then evidence of side effects built up (research done by Sunshuke Fuji?). More than 1000 children suffered side-effects. Of 3,969 medical claims for damage, over 30 years, 25% were for MMR in these 4 years. By 1993, 1.8m children had received MMR. Adverse reactions included non-viral meningitis, damaged hearing, blindness, loss of control of limbs, death (3), but no info on autism (link not suspected at that time)
• Doctors now give separate injections, and no boosters. Public confidence badly damaged, vaccination rates lowered as consequence.
• Sunshuke accepts that between 1994 and 1998 there were 4,500 cases of measles and 69 deaths, but such levels of deaths were the case in MMR era too. Daily Mail quotes 94 deaths from measles in 5 years. Measles cases 1994-98 were mainly in the under-ones, and these would not have had MMR anyway, as they were too young.
• Analysis of MMR over three months showed 1/900 children having problems. Japan then switched to another make of MMR, but adverse reaction rate remained high at 1/1755.
• UK DoH quoting Japan case as "dire warning of what happens if you shun MMR" is irrelevant and inaccurate. Real warning is that Japan shows what happens if you betray trust of parents, by using unsafe product, and take-up (even of single vaccines) falls as consequence.
• Government reconsidered MMR in 1999, but decided against it. Quoted that three single vaccines costs twice as much as one MMR, but considers price worth paying (this implies that re-licensing single vaccines and switching over from MMR, if adopted in the UK, would involve a doubling of expenditure).

60. Autism In Finland

(See also Patja et al study)

• A study paper, Autism In Northern Finland, was published by Kielinen, Linna and Moilanen in European Child & Adult Psychiatry, Volume 9 No. 3, 2000. The stated purpose of the study was to estimate the prevalence of autism in the two northernmost provinces of Finland, Oulu and Lapland.
• The study showed the cumulative incidence in 15-18 year olds to be 6.1/10,000, and in 5-7 year olds to be 20.7/10,000, almost three and a half times the rate for the older children.
• The study population comprised those born 1979-94, representing the age group 3-18 years, and totalling 152,732. The criteria used was ICD-10 and DSM-IV. The children’s records were reviewed against these criteria. The original criteria had varied over the years. The population of autistic children and adults was found to be 212.
• In the youngest age group, 5-7, the cumulative incidence was 20.7/10,000. The previously-reported rate in a study by Vinni and Timonen in 1991 was 4.75/10,000. The Kielinen rate for this age group was therefore nearly four and a half times higher. The cumulative incidence rate for the entire Kielinen study population was 12.2/10,000, still over two and a half times higher
• The explanation of the Kielinen study team was better recognition,, improved sensitivity of case-finding, greater healthcare consciousness and possible changes in diagnostic practices or in-migration - all of which might be expected to have only marginal impact. The huge increase is therefore largely unexplained.

• An All Party Parliamentary Group on Autism has been formed at Westminster. It is currently looking at diagnosis, education, care and causation issues. The Chair is Dr. Stephen Ladyman MP (Labour, Thanet South). Vice-Chairs are Lord Clement-Jones (LibDem), Stephen Hesford MP (Labour), and Tim Loughton MP (Conservative). The Treasurer is Brian Cotter MP (Labour).

• The Health Committee of the Scottish Parliament appointed a Reporter, Mary Scanlon MSP, in Autumn 2000, to examine the issues surrounding the MMR/autism link and to report back to the Committee
• The Scottish National Party and Tommy Sheridan MSP of the Scottish Socialist Party have called for the re-introduction of single (monvalent) vaccines in Scotland

• In February 2002, Nick Harvey MP, Liberal Democrat health spokesperson, stated in correspondence to David Thrower that "We do not doubt the integrity with which (Dr. Wakefield) approaches his work, which is still at an interim stage, we note that Dr. Wakefield’s opinions are not currently shared by the vast majority (of the medical establishment). However, there are also a number of parents who are convinced that the MMR vaccine has been the cause of their children developing autism......Liberal Democrats......respect the right of parents to choose to have the vaccinations administered separately, this being preferable to children slipping through the net entirely".

• The Conservative health spokesman, Dr. Liam Fox, has expressed his support for MMR but has also expressed his view that the provision of single vaccines would be preferable to children being unimmunised at all, and would reflect the wishes of parents for being offered a choice.
• A Conservative MP, Ms. Julie Kirkbride, has promoted a Private Member’s Bill to bring about the re-introduction of single vaccines.

65. US House of Representatives

• In April 2000, Rep. Dan Burton, Chairman of the US House of Representatives Committee on Government Reform, initiated a series of hearings into the relationship between vaccination and autism.
• Burton concluded that "conflict of interest rules employed by the Food and Drug Administration and the Centre for Disease Control have been weak, enforcement has been lax, and committee members with substantial ties to pharmaceutical companies have been given waivers to participate in committee meetings".
• The Committee on Government Reform found that the majority of members of both the FDA and CDC committees had financial ties to vaccine manufacturers or held patents on vaccines under development.
• The Committee Chairman, Rep. Dan Burton, said: "For the public to have confidence in the decisions made by their government, they must be assured that those decisions are not being affected by conflict of interest. It has become clear over the course of this investigation that the FDA’s Vaccines & Related Biological Products Advisory Committee and the CDC’s Advisory Committee on Immunisation Practices are dominated by individuals with close working relationships with the vaccine producers. This was never the intent of the Federal Advisory Committee Act, which requires that a diversity of views be represented on advisory committees" (my emphasis).
• Parents giving evidence to the Committee on Government Reform told repeatedly-similar stories of how their child had developed normally, then received triple vaccines (MMR or DPT) and had gradually become autistic.
• A number of researchers in the field gave detailed evidence on autism incidence and its steep climb to near-epidemic (for a supposedly-rare condition) proportions
• The cause of autism could not be explained away by genetics, because genetics do not cause epidemics within only two decades - the two decades that multiple vaccines have become standard
• The US agencies defending MMR made poor presentations. Some acknowledged financial links with vaccine manufacturers. Others said they were "looking into" the MMR/autism connection, but their stance suggested an entrenched hostility to the concept of any link. Overall, these agency representatives displayed indifference and an unconvincing grasp of the facts. (Note: an entire industry of "looking into it" has developed, both in the US and the UK (in the US, this has reported to have consumed $100m in two decades of lack of progress). Controversial areas of research are avoided, in favour of more abstract genetic-background research. Key leads are not followed up, so progress is understandably very poor. At every turn, the researchers try to prove that MMR and DPT are not involved. Obvious approaches, such as comparing significant-size cohorts of triple-vaccine-immunised and unimmunised children - the most promising line of any scientific exploration - are not taken.)
• Further hearings by the Committee are planned.

Other relevant points:

• There has been strong criticism of the US regulatory mechanisms for drugs and adverse drug reactions by the Committee on Government Reform, and by others. The consumer group Public Citizen found that only 13% of 88 follow-up studies required as a condition for the licensing of drugs launched in the early 1990s were actually completed. Public Citizen’s Health research Group said that the neglect of follow-up studies could mean that side effects are going undetected.
• A "USA Today" investigation of FDA advisory committees between 1/1/98 and 30/6/00 found that at 55% of meetings, half or more of the FDA advisors present had conflicts of interest. At some meetings, over 90% of advisors present had conflicts of interest.
• Federal law generally prohibits the FDA from using experts with financial conflicts of interest, but this has been side-stepped by using waivers. The FDA issued more than 800 waivers between 1998 and late 2000. Some 300 advisors serve on 18 advisory committees.

66. Recent and Coming Events - UK

• High Court proceedings (several hundred cases in class action).
• Scottish Parliament Health Committee currently considering calls for re-introduction of single vaccines in Scotland. Debating in March.
• Susan Deacon, Scottish Health Minister, has said issue is "reserved matter", ie power remains in Whitehall, but Scottish MPs at Westminster no longer cover health. So Scottish democratic representation is in Edinburgh, but power is in London. Likely to cause constitutional problem. Contact: Scottish Parliament, tel 0131 348 5786.
• House of Commons Health Committee Chairman, David Hinchliffe MP, says he still has questions over MMR issue, serious concerns raised in own constituency, need to look for answers, is to team up with members of Scottish Health Committee to further investigate (report in D Express 21/1/01) Contact: Clerk to the Committee, Dr. John Benger, Committee Office, via HoC switchboard 0207 219 3000
• £350,000 three-year study into GP records of several hundred autistic cases is now being undertaken by Prof Andrew Hall at London School of Hygiene & Tropical Medicine. Contact Prof Andy Hall, 0207 636 8636
• UK Department of Health and Medical Research Council jointly announced on 5th March 2001 that the DoH has asked the MRC to conduct a detailed review of the current state of knowledge about autism and to suggest possible areas for further research development, including obtaining a clear and comprehensive picture of what is currently known about the incidence, prevalence and causes of autism, and how strong the evidence is which underpins that knowledge. The review is to be chaired by Professor Eve Johnstone of the University of Edinburgh and Royal Edinburgh Hospital, who is chair of the MRC Neurosciences and Mental Health Board. The review meetings will take place Spring/Summer 2001, and report in Autumn 2001. MRC contacts Dawn Duncan/Marion Irving 0207 637 6011.
• Medicines Control Agency has attempted to prevent single vaccines from being administered, banning the importing of further supplies and threatening any GP who administers single vaccines with prosecution for breaching laws on importation, sale or supply of unlicensed vaccines
• Continuing fight by parents’ groups. Contacts: JABS, Jackie Fletcher, 01942 713565 email jabs@argonet.co.uk , or AIA, Rosemary Kessick, 01733 331771 email Rosie@Kessick.demon.co.uk

67. Ireland

• In Dublin, the Health Committee of Dail is also considering issue. The Committee has held hearings to consider the evidence, but has not heard evidence from key Royal Free Hospital researchers. Over 80 written submissions have been received. Chairman Batt O’Keefe stated that a recommendation will be made to the Dail on the odds for/against MMR. Contact: Batt O’Keefe, Chairman of Committee, Joint Cttee on Health & Children, Leinster House, Dublin email health@oireachtas.irlgo

68. United States

• Congress has also ordered the Institute of Medicine (IoM) to investigate the autism/MMR link, or identify another cause(s). The IoM is a division of the National Academy of Sciences, whose members serve as advisers to Congress. The IoM met on 11/1/01, will meet three times in 2001, will look at eight other vaccine-related safety concerns and make a recommendation. Project funded by National Institutes of Health and Centre for Disease Control.

69. "Just One More Question, Minister....."