Part 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/Other Papers
MMR and Late-Onset Autism -(Autistic Enterocolitis) - A
Briefing Note by David Thrower