2004] MMR and Acquired Autism
(Autistic Enterocolitis) - A Briefing Note
David ThrowerMMR and Late-Onset Autism
-(Autistic Enterocolitis) - A Briefing Note by David Thrower
Part A - Introduction
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
- 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
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
69. Just One More Question, Minister.........
David Thrower, 01925-264156, email David@ThrowerWarrington.freeserve.co.uk
Part A - Introduction
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 childrens conditions, and that there has not been a single
credible study that can refute the claims of the parents that their childrens 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
- 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
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
- 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
Part B - The Parents &
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 childs 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 Theyve 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
- But saving lives from diseases doesnt 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) doesnt
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
childs records. Doubtful if most have even read any of the research available (as
opposed to the DoHs 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
- Education costs - special schools, extra teachers, extra teaching assistants, extra
- 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
In June 2000 a study for the Mental Health Foundation found that the annual
costs of autistic disorder in the UK were at least £1 billion, and that individual
lifetime costs per child affected could run to £2.94 million.
Part C - Autism Numbers
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 wouldnt 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 (=
- 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
- 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 Whos 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
- 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
- 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 Aspergers 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
- Aspergers (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 Healths 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 MMRs
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
13. The Fombonne Paper, January 2001
- 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
- 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 Fombonnes previous work and argues that Fombonne has now become
confused and inconsistent. He points out key flaws in Fombonnes previous work, and
criticises his inconsequential criticisms of the California data, his "counsel of
complacency" and his scientifically-unsupported assertions
Part D - The USA
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
- 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 Townships
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 hasnt 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, Aspergers 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
- 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 systems overall
caseload. It now accounts for between 30% and 34% of the caseload.
E - Inconclusive "Evidence" Against There Being A Link
16. The Taylor, Miller et al North London Study, June 1999
The Governments 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 dont receive formal diagnosis
anyway (contact National Autistic Society, which did study on this, tel 0207 833 2299).
Taylor Miller study doesnt 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
- 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
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 Crohns), and
was left with a residue of 8 autism cases and four of the Crohns 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
- 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
- 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 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
- 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
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 MMRs 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
MMRs introduction and autisms 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?
Couldnt the continuing rise in diagnosed cases in 1995-97 be due to Operation
- 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 todays UK MMR recipients. Some 64% were
also not from Western social/health backgrounds.
- The 30 childrens 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
22. Ad-Hoc Medical Research Council "Committee of 37 Independent
This was held as a one-off in March 1998 to examine the Wakefield teams
"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 Councils 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
Despite the above, which implied continued vigilance, the chairman was openly
dismissive of even the possibility of a link emerging, Professor Alan McGregor telling
Reuters "We see this as the end of the story" (Reuters, 3/4/00).
PART F - EVIDENCE
TO SUGGEST THAT THERE IS A LINK
24. Paper By Weibel, Caserta, Benor and Evans, "Acute Encephalopathy
Followed By Permanent Brain Injury Or Death Associated With Further Attenuated Measles
Vaccines: A Review of Claims Submitted to the National Vaccine Injury Compensation Program",
Pediatrics, Vol 101 No. 3 March 1998.
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
25. US paper, by Drs. Delgiudice-Asch (clinical
instructor in psychiatry, Mount Sinai School of Medicine) and Hollander
(Seaver Autism Research Centre)
- 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 Singhs 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
- reference to Todd and Ciaranellos detection of circulating antibodies in seven out
of thirteen children with autism
26. Paper, Dialysable Lymphocyte Extract In Infantile Onset Autism: A Pilot Study,
has been published (journal not identified) by Dr. H. H. Fudenburg of the
NeuroImmuno-Therapeutics Research Foundation, Spartanburg, South Carolina.
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
- 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
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
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
- 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
- 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
- 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
33. US paper by Teresa
Binstock, Researcher in Developmental
and Behavioural Neuroanatomy, IMI, Denver
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, Tourettes, 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
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
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
- 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
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
- 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 childs 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
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,
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 Peyers 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
- 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
- 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
- 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
- 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
- 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
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
- 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
- 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
- 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
- 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
- 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
- "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
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 Watsons 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
- 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 Wakefields 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 havent they been quoted by DoH, why cant
anyone find them?
Other "facts" quoted by Watson in "Aventis Pasteur MSD - Vaccines For
- Watson: "national safety regulators require all side effects to be reported".
But this doesnt mean they actually are, especially novel syndrome with (up till
1998) no publicity, delayed onset, and official refusal to count as "adverse
- 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
- Watson: "As anyone in clinical trials knows, all participants or their parents
are very carefully informed and consented". Yes, but this wouldnt 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 DoHs 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
- 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" doesnt 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 "its safe because its used in the
- "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
Governments 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
- "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 DoHs 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 Healths 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 Departments
actions seem to have not countenanced this potential scenario.
PART G - Flawed
Regulatory & Monitoring Systems
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
- 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 MMRs safety, eg original safety trials, Peltola
- 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
- 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
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 wasnt 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
- 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
- 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 -
- 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)
- MCAs 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
- Similar situation in USA - "On the basis of Vaccine Adverse Event Reporting
System alone, we dont 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 Clarkes 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
- DoH, Medicines Control Agency etc very remote from parents (parents still havent
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
- 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
- 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
- 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
- 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
- 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 (organisations) members 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,
- 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
- 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
- "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
- "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
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 Unions 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 theyd 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
- 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
- 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 publics 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
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
servants 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
Once again, the problem is that there is no external-to-the-department scrutiny of such
interests, or of the degree of departmental enforcement in practice. Given the major
increases in the value of pharmaceuticals shares during the 1990s, this appears to be
unsatisfactory, particularly in relation to the key sections of the Department of Health.
Part H - Various Experiences
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
59. MMR In Japan
The DoH has asserted that Japan doesnt 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
- 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
- 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 childrens
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.
Part J - Political Initiatives
61. UK All Party Parliamentary Group On Autism (APPGA), Westminster
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).
62. Scottish Parliament, Edinburgh
- 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
63. UK Liberal Democrats
- 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.
Wakefields 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
64. UK Conservatives
- 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 Members 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
- 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 FDAs Vaccines & Related Biological
Products Advisory Committee and the CDCs 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
- 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
- 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
- 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
Citizens 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
- 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.
Part K - Coming Events?
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 email@example.com , or AIA, Rosemary
Kessick, 01733 331771 email Rosie@Kessick.demon.co.uk
- 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
OKeefe stated that a recommendation will be made to the Dail on the odds for/against
MMR. Contact: Batt OKeefe, Chairman of Committee, Joint Cttee on Health &
Children, Leinster House, Dublin email firstname.lastname@example.org
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
69. "Just One More Question, Minister....."
Some sample questions for the media are offered here...
- (Q1) Does DoH/Minister/whoever accept that parents reports are consistent pattern?
- (Q2) why was autism rare a couple of decades ago but now very much more common?
- (Q3) why were most cases in the past of children who failed to develop in very
early infancy, whereas very many cases nowadays - when there is better recognition of
the condition (ie much less likely to be missed in infancy) are now of late-onset
autism, after normal infancy?
- (Q4) does DoH etc accept that alleged new syndrome involves slow degeneration
over many weeks/several months/many months, rather than acute event inside of three
or four week time-band vaccination?
- (Q5) does DoH etc accept that many late-onset autistic children have extreme multiple
food allergies, and that the onset of these coincided with the onset of their autism?
- (Q6) ditto question for bowel conditions
- (Q7) related question: does DoH etc accept that simultaneous or sequential onset of
gut/bowel/autism problems could be interlinked causationally?
- (Q8) is DoH monitoring autism numbers centrally?
- (Q9) are health authorities/Boards monitoring autism locally, to consistent degree?
- (Q10) is UK DoH aware of huge increase in autistic pupils in US, 1993-99 up from 12k to
53k? (DoH likes to quote that MMR is safely used in US)
- (Q11) what research has the DoH etc commissioned into possible causes (NOT
genetic susceptibility aspect) of autism, and what is £ value over how many years?
- (Q12) has DoH (or anyone in Government?) made any estimate of the national cost of
autism? (health, education, social services care, etc multiplied by numbers of cases
multiplied by years of life expectancy)?
- (Q13) was Medicines Division in disarray in 1988, year MMR was licensed? (see BSE
Inquiry evidence, Draft Factual Account 17, pp 31-33)
- (Q14) did the Taylor Miller North London study find that autism was increasing?
- (Q15) did the 1999 Committee on Safety of Medicines study include the admission
that "it was impossible to prove or refute the suggested association" ?
(it did, their exact words, page 12 para. 5.5 of the Study Teams report)
- (Q16) did the same study, whenever it found any other factor in the infancy of the 537
cases of autism it reviewed, ascribe the autism to that other factor, even when there is
no evidence to link autism to such other factors?
- (Q17) is it admitted that the Peltola (Finland) study only followed up 173 of the 1.8m
- (Q18) is it true that all these 173 cases were only those with acute
gastrointestinal or other problems (vomiting etc), not slow long-term degenerative
- (Q19) was the study designed to look at autism? (Peltola has publicly admitted it
- (Q20) would local paediatricians in Finland have connected autism with vaccination at
all at that time? (they certainly wouldnt, no-one had ever suggested it then, 15
- (Q21) are there members of the Committee on Safety of Medicines with declared personal
interests linking them to the manufacturers of MMR? (see earlier section)
- (Q22) does the DoH even admit to the concept of vaccine damage?
- (Q23) does DoH etc concede that long-term (six months plus) follow-up was not undertaken
of a sufficiently convincingly large sample (10,000-plus) children prior to MMR licensing,
and UK was in effect trusting to safety because MMR already widely used elsewhere, eg US?
(theyll never admit this, but keep trying)
- (Q24) is autism now recognised and recorded even as a potential adverse
reaction, nowadays, by the Medicines Control Agency as part of the Yellow Card warning
scheme? (very important question)
- (Q25) are doctors now asked to look out for degeneration as a potential adverse
consequence? Has there been any guidance on this?
- (Q26) will (Chief Medical Officer, whoever) resign if MMR children win in forthcoming UK
High Court cases?
[Vaccination] [MMR] [Autism &
vaccination] [David Thrower]