Fwd: Part 3 - REGRESSIVE AUTISM AND MMR VACCINATION

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http://www.redflagsweekly.com/yazbak/2003_nov01_3.html

 

REGRESSIVE AUTISM AND MMR VACCINATION

 

By RFD Columnist, F. Edward Yazbak, MD, FAAP.

 

TL Autism Research

Falmouth, Massachusetts

 

E-mail: tlautstudy

 

Part Two here

 

The Anti-Wakefield Movement

Expensive and extensive campaigns have been mounted in the US and the UK in

defense of the MMR vaccine and against Andrew Wakefield and the parents who dare

question a vaccine connection. The anti-Wakefield fronts have repeatedly quoted

certain epidemiological studies in support of their argument. Not a single

parent was interviewed and not a single child examined in any of those studies;

most have been “supported” (funded) by the vaccine manufacturer and or

authorities.

 

Since 1998, the UK Government has spent immensely more money defending the MMR

vaccine and depicting Wakefield as a maverick, than it did on autism research.

 

As mentioned earlier, the message to the parents remains “We do not know what

caused your child’s autism …but we are absolutely sure that it is not the MMR or

another vaccine.”

The studies from Finland

Merck financed all studies and reports on MMR and autism by the Peltola group.

 

The first publication by Peltola, Patja et al. was published in Lancet in May

1998, just 3 months after Wakefield’s first paper on children with autism. It

was titled: No evidence for measles, mumps, and rubella vaccine-associated

inflammatory bowel disease or autism in a 14-year prospective study. (17)

 

The conclusion of the authors was that: “Over a decade's effort to detect all

severe adverse events associated with MMR vaccine could find no data supporting

the hypothesis that it would cause pervasive developmental disorder or

inflammatory bowel disease”

 

The second paper by Patja, Peltola et al. was published in the Pediatric

Infectious Disease Journal in December 2000 (18). It was titled: Serious adverse

events after measles-mumps-rubella vaccination during a fourteen-year

prospective follow-up.

 

The authors reported some of the adverse events pointing out that there were no

cases of autism and Inflammatory Bowel disease (IBD).

 

Those two studies (and others by the same groups) were based on a review of

adverse events reported following the administration of some 3 million doses of

MMR vaccine to about 1.8 million individuals during a “national immunization

campaign” in Finland between 1982 and 1996. During the campaign, children were

vaccinated between 14 and 18 months of age and again at 6. Also receiving the

vaccine were older children and selected groups of young adults, such as

military recruits and nursing students

 

The cases that were followed for 14 years were those that developed adverse

events within 3 weeks of vaccination, less than 200 in all. There was NO

follow-up on the rest of the 1.8 million vaccine-recipients in the Country.

 

..

 

Both autism and inflammatory bowel disease (IBD) are chronic illnesses, which

develop over months or years. Certainly no one ever claimed that they start

within 21 days of vaccination and Wakefield never contended that children who

develop diarrhea immediately after vaccination, a known and accepted reaction,

are those who will go on to develop IBD as young adults.

 

Peltola himself, when questioned on BBC Radio-4 on January 13, 2001, stated that

the main study was not designed to look at IBD and autism.

 

In summary, Peltola and Associates never looked for autism and IBD following MMR

vaccination. Neither did anyone else before 1998. In spite of that, the findings

of these studies from Finland were highly publicized for a long while and

interpreted in the Press, and over the Internet, as proving conclusively that

there was no increase in autism and IBD among the millions who received the MMR

vaccine during the national vaccination campaign and were followed for 14 years.

 

This is not true.

 

Autism & Inflammatory Bowel Disease have increased in Finland in recent years.

 

Autism: M. Kielinen et al, in a study published in 2000 (19), described a

significant rise in autism in the northern provinces of Oulu and Lapland, which

represent 1/8 of the total population of Finland. The Kielinen study included

all children born in the two provinces, between 1979 and 1994. Every single one

of those children was eligible and must have received the MMR vaccine. The

authors personally reviewed all records of children with autism to determine

that they fulfilled the criteria of ICD-10 and DSM-IV. The cumulative incidence

of autism was 12.2/10,000, a significant increase when compared to the

previously reported incidence of 4.75/10,000 by Vinni and Timonen. The increase

in the younger children, all born in the second half of the MMR campaign, was

even more striking. In the 5 to 7 age group, the cumulative incidence was

20.7/10,000 or more than 1 in 500. At the time, I predicted that the increase in

autism was not limited to the Northern Provinces and that it would

keep accelerating.

 

On November 11, 2002, a spokesperson for autismiliitto.fi informed me that she

did not have accurate figures but that “we are estimated to have 10,000 autistic

people in Finland and about 40,000 people with Asperger’s syndrome”.

 

Better diagnosis may have led to the identification of some of these cases, but

the increase in the prevalence of autism is clearly as real in Finland as it is

elsewhere, even if Peltola does not think so. The above figures show that in

Finland 1 of every 100 individuals may have an autistic spectrum disorder

(50,000 cases in a population of slightly over 5 million). This would translate,

in the US, to 2.88 million individuals with Autistic Spectral Disorder (ASD).

Taking into account the fact that the incidence is higher in children and

younger adults and the well-known gender difference, one can only guess the

affliction in young Finnish males. The high ratio of Asperger’s Syndrome (AS) is

also relevant. Kielinen pointed out in the study mentioned above, that in the

Northern Provinces, there were more children recently with IQs above 70 than had

been reported in earlier studies. Other investigators have reported a similar

trend worldwide.

 

Children affected since birth and in early infancy, are usually more profoundly

brain damaged than those who develop normally until their first birthday and

then sink into autism in the second year of life, some reportedly after

receiving the MMR vaccine.

 

Inflammatory Bowel Disease: According to figures obtained from the Statistical

Branch of the Social Insurance Institution of Finland, the number of patients

entitled for special refunds because of Crohn’s and Ulcerative Colitis more than

doubled between 1992 and 2001, from 9,737 to 20,807. In the same period, the

prevalence rate per thousand of the two conditions also doubled while the

population of Finland only increased by 3%. Also of concern is the fact that,

not only did the number of patients with IBD reporting to Social Services

increase yearly, but that the rate of increase is accelerating, with more

patients having registered in the last five years than in the previous five.

 

Inflammatory Bowel Disease is most often diagnosed between the ages of 15 and

35. The older children, adolescents, nursing students and army recruits who

received the MMR vaccine in Finland starting in 1982, reached that vulnerable

age in the last ten years and figure in all likelihood, in the increasing

statistics.

 

There are obviously many other factors causing IBD. Nevertheless when the rates

of Crohn’s Disease and Ulcerative Colitis continue to increase and accelerate in

Finland in the next few years as the younger vaccinees reach adulthood, it will

become increasingly difficult for Peltola and his group to prove to everyone

that such increases are NOT related to vaccination.

 

The third study from Finland is more recent (2002). It is also based on the data

of passive reporting from the “National Campaign” and is titled Neurologic

Disorders After Measles-Mumps-Rubella Vaccination. The authors Makela, Peltola

et al. compared the numbers of events of encephalitis and aseptic meningitis,

within a 3-month risk interval after vaccination with the expected numbers

estimated on the basis of occurrence of encephalitis and aseptic meningitis

during the subsequent 3-month intervals. Examining the incidence of encephalitis

and aseptic meningitis in the two weeks following vaccination would have been

much better, because cases occurring during that period, would be considered

ipso facto vaccine complications.

 

Again in this study, although no one in Finland was looking for autism before

1986, the authors went ahead and included it. Interestingly, by stating: “The

aim of this study was to assess whether an association prevails between MMR

vaccination and encephalitis, aseptic meningitis, and autism” in an article

titled “Neurologic Disorders after Measles-Mumps-Rubella Vaccination” the

authors in fact imply that autism is a neurological complication of MMR

vaccination.

 

Of interest, though not directly related to the topic of this study is the fact

that Finland has the highest incidence of childhood Type 1 (insulin-dependent)

diabetes mellitus in the world. (20) According to Tuomilehto: “During

1987-1989, the overall incidence of Type 1 diabetes was about 35.2 per 100,000

per year. It was higher in boys (38.4) than in girls (32.2). There was no clear

geographic variation in incidence among the 12 provinces of Finland. Of the

1,014 cases during these 3 years only six cases were diagnosed before their

first birthday. The incidence was high already in the age group 1-4-years old:

33.2 in boys and 29.5 in girls.”

 

It has been suggested that a possible connection between MMR vaccination and

juvenile diabetes exists. The sudden increase in the incidence of diabetes after

age 1 during a national campaign (1982-1996), during which a vaccine is

administered at 15 months of age, deserves attention.

 

Our vaccine authorities have denied any connection between vaccination and the

present steep increase in Juvenile Diabetes in the United States. Obesity and

increased intake of junk food / sweets, increased television watching and

computer games plus lack of exercise are believed to be responsible for the

present record high incidence of the disease.

 

It is important to stress that juvenile diabetes remains a serious problem in

Finland. According to the Social Welfare and Health Report 2000 of the Ministry

of Social Affairs and Health “Finland has the highest incidence of juvenile

onset or insulin-dependent diabetes in the world and it is continuing to grow.”

 

The following from the same report is also of interest: “Asthma has become more

common among children and adolescents and in the past 10 years, its prevalence

among the under-20s has increased threefold.”

 

“International comparisons show that Finnish school-age girls head the

intoxication statistics and that boys are near the top. The number of

non-drinkers has declined among all 12-18 year-olds in the past ten years. The

combined use of alcohol and medicines affecting the central nervous system is

still common”.

 

“Thanks to vaccinations and other preventive measures, the frequency of the most

common dangerous infectious diseases has plummeted in Finland. This is not to

say however, that such diseases are a thing of the past. On the contrary, they

are still a major single cause of short- term absences from work among people of

working age and account for the bulk of children’s outpatient visits.”

 

The Autism and MMR IOM Committee Report

 

The Institute of Medicine (IOM) convened a special Committee to study Autism and

MMR. The committee met in early March 2001. The Chairperson rushed to publish

its findings by April 23rd, a historical record for any IOM special committee

report.

 

In addition, the Chairperson reportedly “shared” the committee’s findings and

conclusions with certain interested parties prior to publication and played an

active and very vocal role in promptly and widely publicizing its results. Her

statement: “It [MMR] is as safe as a vaccine can get” was immediately construed

as a seal of approval and translated in the lay press to: “Vaccine is off the

hook” [Actual words].

 

The “conclusive report by the Institute of Medicine” is widely quoted.

 

The vaccine authorities (and lobby) like to state that the special committee

found that the “…evidence favors rejection of a causal relationship at the

population level, between MMR vaccine and autistic spectrum disorders “. They

are careful not to mention that the Committee actually “did not exclude the

possibility that MMR vaccine could contribute to ASD in a small number of

children”.

 

The committee also recommended that more research be done.

 

Andrew Wakefield also said that MMR vaccination could contribute to autism and

pervasive disorders in a small number of children and he also said that more

research was needed; for that, he was forced to resign.

 

Historically, the IOM Committees’ conclusions are based on epidemiological data

and therefore need large numbers of cases to justify one of the following

classifications:

 

1. No evidence bearing on a causal relation.

 

2. The evidence is inadequate to accept or reject a causal relation.

 

3. The evidence favors rejection of a causal relation.

 

4. The evidence favors acceptance of a causal relation.

 

5. The evidence establishes a causal relation.

 

Clearly the possible MMR-Autism connection was placed beyond the third group

somewhat closer to the fourth. This is traditionally unusual for a first

examination. The criticism that was heaped on the report is almost sure to lead

to a review in the not too-distant future.

 

One can best understand the nuances of the MMR-Autism IOM study by having a look

at the special report published immediately before it, on April 19, 2001.

 

That special report on “Agent Orange” was commissioned in 1991 & completed nine

years later, in April 2000, a whole year before it was published (23). In that

report, Diabetes Mellitus & Children’s Myelogenous Leukemia were moved from a

lower category to Category 4: “The evidence favors acceptance of a causal

relation”.

 

The undeniable fact is that since the Vietnam War, hundreds of veterans and a

multitude of VA physicians have been thoroughly convinced that Diabetes and this

particular form of Leukemia belong not in Category 4 but actually in Category 5

“The evidence establishes a causal relation”.

 

The following remarks (24) on the IOM MMR report, by Walter O. Spitzer, MD,

Emeritus Professor of Epidemiology at McGill University are sobering: “As an

epidemiologist who has been a Member of the IOM since 1986, I have been proud of

IOM reports in my field that I have examined or co-authored. I am embarrassed by

the process of this latest Report and would urge President Shine of the IOM to

retract the Report until the message has been clarified. What was released, the

IOM Report or the

 

McCormick Position?”

 

 

 

Other IOM Committee reports on vaccines have also been questionable. The trust

all citizens should have in the august Institute of Medicine will certainly be

eroded by the continued bias of vaccine reports. It is imperative that the

committee members insist on receiving TOTAL information prior to making a final

decision. They are responsible to the people of the United States, not only to

the CDC because it funds the studies.

 

The Studies by Brent Taylor

 

“Autism and measles, mumps, and rubella vaccine: no epidemiological evidence for

a causal association” (21) was the first Taylor publication on the subject

(1999). The Medicines Control Agency and the Public Health Laboratory Service

(somewhat the equivalents of the FDA and the CDC, financed the study. Any

incrimination of the MMR vaccine therefore would have been unlikely, regardless

of the findings.

 

Taylor reported on 498 cases of autism (261 of core autism, 166 of atypical

autism, and 71 of Asperger's syndrome).

 

“In 293 cases the diagnosis could be confirmed: 214 [82%] core

autism, 52 [31%] atypical autism, 27 [38%] Asperger's syndrome. There was a

steady increase in cases by year of birth with no sudden " step-up " or change in

the trend line after the introduction of MMR vaccination. There was no

difference in age at diagnosis between the cases vaccinated before or after 18

months of age and those never vaccinated. There was no temporal association

between onset of autism within 1 or 2 years after vaccination with

MMR…Developmental regression was not clustered in the months after vaccination …

No significant temporal clustering for age at onset of parental concern was seen

for cases of core autism or atypical autism with the exception of a single

interval within 6 months of MMR vaccination This appeared to be an artifact

related to the difficulty of defining precisely the onset of symptoms in this

disorder.”

 

Interpretation: Our analyses do not support a causal association between MMR

vaccine and autism. If such an association occurs, it is so rare that it could

not be identified in this large regional sample.”

 

Though this study was somewhat better than subsequent Taylor studies, it still

had many weaknesses, the small number of cases evaluated being one.

 

Taylor himself stated: “The study has some limitations: two of these [meaning

there are more] are that we could not verify the diagnosis according to ICD 10

criteria in some cases, and that the ascertainment may have been incomplete.

The clinical notes were of variable quality and many did not contain systematic

or regularly updated information, which would have allowed independent

validation of the diagnosis, particularly in the children with atypical autism

or Asperger’s syndrome.

 

Later he goes on to say: “ There is uncertainty about whether the prevalence of

autism is increasing” and then adds: “Our study is consistent with an increase

in the incidence of autism in recent birth cohorts”

 

He then inserts Figure 1 showing the sudden and acute rise in the number of

cases of core autism starting in 1991.

 

Two pages later, Taylor states: For age at first parental concern, no

significant temporal clustering was seen for cases of core autism and atypical

autism, with the exception of a single interval within 6 months of MMR vaccine

associated with a peak in reported age of parental concern at 18 months” and

then, unashamedly adds: “Our results do not support the hypothesis that MMR

vaccination is causally related to autism...”

 

Taylor has consistently refused to reveal, share or discuss the study’s raw

data. Two requests from Dr. Bernard Rimland (ARI), two from Dr. Jane Orient,

Executive Director, The Association of American Physicians and Surgeons and one

from US Congressman Daniel Burton, Chairman of the House Government Reform

Committee at the April 6, 2000 meeting, were turned down. Interestingly, Yvette

Cooper, the UK Minister for Public Health, defended Taylor’s stand. Just as odd

was the fact that the Lancet, a prestigious medical journal, published the

article without insisting that raw data be available on request. Taylor’s excuse

was that the clinic records were confidential.

 

There were several critiques of that particular Taylor study. Those by Dr.

Andrew Wakefield and Dr. James Roger, an expert on medical statistics stand out.

 

Dr. Andrew Wakefield wrote: “A case-series analysis is unlikely to identify a

relation between exposure and disease, in which the onset is insidious and in

which, very often, there is diagnostic delay” and later: “However, it pales into

insignificance compared with their failure to declare the fact of an MMR

catch-up campaign that was initiated in 1988 with the introduction of this

vaccine. This campaign was targeted at children, whatever their age, who

presumably had not received monovalent mumps or rubella vaccine whatever their

exposure status. As such it was a novel and, in terms of safety, untested

policy. On the basis of Taylor and colleagues’ inclusion criteria, and taking

account of the catch-up campaign, then those first birth cohorts who actually

received MMR (circa 1986) were precisely those in whom a doubling of the numbers

of cases of autism were seen”.

 

Dr. James Roger in a letter to the Editor of The Lancet (July 8, 2000) stated:

 

Sir--Rather than clarify the measles, MMR, and autism confusion with your

editorial, you perpetuated the myth that good scientific evidence rejects a link

between MMR vaccination and autism.

 

You quote Taylor and colleagues as publishing " epidemiological evidence

contradicting this alleged association. " On March 28, 2000, I presented a talk

to the Royal Statistical Society, in which I showed how the currently published

data, including that from this study, are consistent with an appreciable number

of autism cases being triggered by MMR vaccination. In short, Taylor and

colleagues used the wrong study design to detect an association between

immunisation and a disease with chronic onset, such as autism. Rather than use a

conventional case-control approach, the study used a case-series design. The

case-series approach is appropriate for investigating acute adverse events such

as febrile convulsion but is not suitable for long-term effects of vaccination.

 

As stated, the above underlined statement was made at a Royal Statistical

Society meeting. Dr. C.P. Farrington, the statistician who co-authored the

article, participated in the debate.

 

Taylor and Associates published two other studies on autism, gut pathology and

MMR.

 

These were never given the publicity that the above paper received and for the

sake of brevity, they will not be discussed here.

 

 

 

 

 

 

 

 

 

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