2. MMR and Late-Onset Autism -(Autistic Enterocolitis)

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2. MMR and Late-Onset Autism -(Autistic Enterocolitis)

A Briefing Note by Thrower

Continued from previous post.

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 an autism epidemic. Other countries may also

be becoming aware of increases (further details welcomed), including Finland

(400% increase in cases since MMR introduced?)

US has IDEA (Individuals with Disabilities Education Act). Picks up

numbers of schoolchildren with developmental problems. Autistic pupils up

from 12,222 to 53,561 between 1992-3 and 1998-9 (Source: US State data). So

for every 2 cases in 1993, by 1999 there were nearly 9. Numbers will have

risen since.

Huge increases in some States - up 421% in Connecticut, 509% in

Indiana, 663% in Iowa, 933% in Michigan, 548% in Pennsylvania, all in just

six years (Source: US State data)

Also very interesting that individual towns eg Round Rock Texas up

from 6 to 115 in 8 years - just like Wakefield Local Education Authority in

UK (up from 5 to 111 in seven years). So suggests UK increases may very

closely match USA.

Latest California increases (State with best database) showed autism

up 19% in 1999 and up nearly 16% in 2000

Brick Township (New Jersey) " autism cluster " . Some 40 of Brick

Township’s 6,000 3-10 year olds have autistic spectrum disorder. It has made

Brick Township the " autism capital of the USA " - but note, East Surrey rates

in UK are higher still. Federal investigators collected data on surface and

ground water, sites of industrial spillages and waste dumping, and ensured

that there had been correct diagnosis. They found nothing.

US clearly has autism epidemic. US similar to UK, so reasonable to

conclude UK probably has epidemic, too, but just hasn’t yet woken up to it.

Dr Bernard Rimland, Autism Research Institute, US: " Some supposed

experts will tell you that the increase reflects only greater awareness.

That is nonsense. Any paediatrician, teacher or school official with 20

years experience will confirm there is a real increase, and the numbers are

huge and growing " . (Source: Dr Bernard Rimland, ARI, 4182 Avenue, San

Diego, California CA 92116)

15. California

California has the best data in the world, going back about 25 years,

so trends there have a worldwide significance. [The older data is

problematic. -LS]

Latest California State Department of Developmental Services data

shows 566 new cases (all children age under 10) with

professionally-diagnosed DSM-IV criteria autism, entering the State system

in the previous quarter-year.

This does not include children with persistent developmental disorder,

non-specific (NOS) developmental delays, Asperger’s or and other autistic

spectrum disorder - it is therefore the tightest definition of the

severe-case numbers.

The 556 cases for the last quarter of 2000 compares with 667 cases for

the entire year in 1994.

It took 25 years from the establishment of the State developmental

services system in 1969, to 1994, to reach a total of the first 5,100. Yet

the second 5,100 was reached in just five years. In 1999, 200 and the first

half of 2001, a further 5,100 cases will be added. So this third cohort of

5,100 cases will have taken just two and a half years.

This will represent a 1000%+ increase in twenty years, and excludes

all cases other than full-blown DSM-IV diagnosis.

Originally, autism accounted for three per cent of the State system’s

overall caseload. It now accounts for between 30% and 34% of the caseload.

Part E - Inconclusive " Evidence " Against There Being A Link

16. The , 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 , et al study, 6/99:

Study (designed by Dr , Public Health Laboratory

Service, tel 0) 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.

, 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 0). 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 is

co-author of 1988 paper clearing safety of triple vaccines, is

described in Daily Express press reports of 1/01 as " a colleague of Dr

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 , 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, , 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 th

at 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, , Arguedas, Buynak and

Hilleman, has assumed more importance recently, see later

Wakefield//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, , Tedder, Ward, Wing, . 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

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).

Continued next post.

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