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

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

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

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

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

17. Committee On Safety of Medicines Study, June 1999

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

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

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

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

18. Gillberg Study, Sweden

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

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

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

Other awkward facts re Peltola:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

For autism, its recommendations included:

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