1. New Round of MMR - Vaccine Media Reports/ Spitzer

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June 15, 2001 Search www.feat.org/search/news.asp

Also: * Two other MMR - Vaccine Reports

* Testimony on MMR - Vaccine connection by Walter O Spitzer,

Professor of Epidemiology at House Hearings Last April

New MMR Research Rules Out Autism Link

[“They still don’t get it,” observers skeptical newsletter reader

Miles, “regressive autism doesn’t get an ‘official’ diagnosis within

a certain time frame of receiving MMR. Dr , as one of the architects

of the introduction of MMR into The UK, has marked her own homework yet

again, reworking the data to suit her own agenda.” by Zoe .]

http://www.thisislondon.co.uk/dynamic/news/story.html?in_review_id=400399 & in

_review_text_id=347943 <-- address ends here

A London clinic has more than 14,000 children on a waiting list to

receive single measles, mumps and rubella jabs, despite new assurances that

the combined MMR vaccine is safe.

Research published today concludes there is no link between the MMR

jab and autism.

The suggestion of a link was first made by Royal Free consultant Dr

Wakefield, following a study of 12 children in 1998. Medical opinion

has been divided ever since.

The latest research, published in the journal Vaccine, concluded there

is " no causal link " between the jab and the onset of autism after studying

the diagnosis of the disorder in 357 children.

Researchers found no pattern in the time autism was diagnosed which

could be linked to receiving the jab.

Professor Brent , consultant in community child health at Royal

Free hospital and University College Medical School, said: " It is difficult

to prove a negative. We cannot say it is impossible for there to be an

occurrence of a child having an adverse reaction to MMR which might manifest

itself as an autistic disorder.”

However, he emphasised: " What we can say is there is no evidence that

MMR causes autism and that has been shown by four other studies.”

Liz , co-author of the study and head of the immunisation

division at Public Health Laboratory Service, said: " This evidence further

strengthens confidence in the safety of the vaccine. " Dr Elliman,

consultant community paediatrician and chairman of the London Consortium of

Immunisation Co-ordinators said: " It is difficult to understand how, in the

face of overwhelming evidence, anyone can believe there is a connection

between MMR and autism.”

A Department of Health spokeswoman said: " This is an important study

which looks to quantify the risk of autism at any time after MMR and whether

a second dose of MMR might increase the risk of autism. The authors results

do not support the theory that there might be a link between MMR and autism.

Parents should be reassured that, yet again, a study has failed to find a

link between MMR and autism.

" Unimmunised children can be protected today, by the NHS, by parents

taking their children to their own surgery. MMR is the safest way for

parents to immunise their children.”

In January, the Department of Health launched a campaign aimed at

persuading parents that MMR is safe, but the evidence from Direct Health

2000 clinic in Eltham, south London suggests many are unconvinced.

The clinic has been inundated with requests for single doses of the

vaccines ever since the Evening Standard first revealed they were available

in January.

Parents concerned about claims that the MMR jab is linked to autism

and bowel disorders are prepared to wait six months to get single vaccines

from the clinic. The waiting list includes hundreds of children from outside

London.

Dean, director of the clinic and former practice nurse, said

around 60 children a day are being given single vaccines at the London

clinic and demand has been relentless.

* * *

Study 'Refutes' MMR Link to Autism

[same story as above, different report. Boseley in The

Guardian.]

http://www.guardian.co.uk/uk_news/story/0,3604,507240,00.html

Immunisation against measles, mumps and rubella does not cause autism

in children, according to the findings of public health specialists which

they say should end the argument that has been raging for three years.

Their paper re-analyses the results of a study of all children

diagnosed with autism in the North Thames health region after the theory of

a link between the vaccine and autism caused a scare among parents of

babies.

The theory came from Wakefield, a consultant gastroenterologist

at the Royal Free hospital in London. His work, published in the Lancet and

other medical journals, explored the possibility that measles vaccine can

cause gut disorders such as Crohn's disease, and then link to autism.

When the number of babies taken for the MMR jab fell the Department of

Health commissioned various research studies, including the North Thames

study by Brent , professor of community child health, and

of the public health laboratory service.

This looked at 498 children born since 1979 in the region. It found no

link between the MMR, normally given when a child is 12-18 months old, and

autism, which tends to show itself in the same age range.

Dr Wakefield and his supporters, however, criticised the study because

it looked at autism that appeared within a short period - 24 hours to two

months - after the jab.

The re-analysis, published today in the journal Vaccine, did not

impose a cut-off period for autism to show itself, but the researchers found

that this made no difference.

Elliman, consultant community paediatrician and chairman of the

London Consortium of Immunisation Coordinators, said: " This last paper

should answer those critics who feel that autism was looked for too soon

after the vaccination. Hopefully this will reassure parents and health

professionals. "

* * *

Autism Link To Vaccine False: Docs

[This is a different story than that of the previous two articles.]

http://www.canoe.ca/OttawaNews/OS.OS-06-15-0014.html .

Vancouver - Anxious parents concerned that a vaccine against measles,

mumps and rubella causes autism should continue getting their children

immunized because there's no truth to the theory, the Canadian Pediatric

Society affirmed yesterday. .

The association between the MMR vaccine and autism has created

worldwide controversy since a British researcher published a study in 1998.

But research in several countries, including the United States, the

United Kingdom, Sweden and Canada, has debunked the claim that raised alarm

bells among parents and health professionals.

Still, the issue has continued to raise anxiety levels, especially in

the U.S. and the U.K., where parents have pushed for more research into the

matter.

Flawed Study

Speaking at the annual meeting of the Canadian Pediatrics Society,

doctors said that while there's overall consensus that the 1998 study was

flawed, they want to alleviate concern because they fear parents will stop

getting their children immunized.

That in turn could lead to cases of measles, mumps and rubella,

diseases that have virtually been eradicated in developed countries such as

Canada, said Dr. Joanne Embree, professor of pediatrics at the University of

Manitoba.

It's difficult to know how many parents concerned about the MMR-autism

link have opted not to get their children immunized because there's no

national immunization registry, Embree said.

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* * *

Spitzer: Is MMR Linked To Autism? Epidemiological Perspectives

Testimony to the Congress of the United States of America

House Committee on Government Reform

April 25, 2001

Walter O Spitzer, M.D., M.P.H., F.R.C.P.C.

Emeritus Professor of Epidemiology, McGill University, Montreal, Canada

15305 Isabella Court, Corpus Christi, Texas, 78418

In a briefing paper for the Institute of Medicine of the National

Academy of Sciences of the USA, Soto and colleagues concluded: “… based on

the epidemiological evidence to date and the opinion of the authors…, the

evidence is inadequate to accept or reject a causal relationship between MMR

and autism.” [Reference: Soto MA, Cleary SD, and VB, Commissioned

Backround Paper, Institute of Medicine Immunization Safety Review Committee,

2001] As summarized in this document, submitted to the House Committee on

Government Reform of Congress, on April 25, 2001, I reached the same

conclusion independently. My views were peer reviewed shortly before the

release of the I.O.M.’s briefing document and will be published by Oxford

University Press this month. [Reference: Adverse Drug Reactions and

Toxicological Reviews, in press].

At the turn of this millennium (December ’00 and January ’01), the

public debate about the safety of trivalent measles-mumps-rubella (MMR)

vaccine has been intense. A handful of papers with strong views have been

published in the medical press. Extensive coverage in the lay press and

electronic media has now brought the controversy to the center of the public

’s attention. I refer to only one example of lay press coverage, a headline

in The Time of London, “Biggest study clears MMR” [12-XII-2000, p.1].

A cluster of articles in the most recent issue of Adverse Drug

Reactions and Toxicological Reviews (2000, 19(3) 1-19) has been welcome to

those of us who are agnostic about MMR as a possible determinant of autistic

syndromes (AuS) with attendant complications. The lead paper of the cluster

is a review of the ‘state of science’ as reflected in part by pre-licensing

studies of the safety of MMR vaccine. In it, Wakefield and Montgomery

distilled and underscored viewpoints that have characterized their published

and ongoing research. To publish anything about MMR/AuS that does not

necessarily support “official” mainstream policies or governmental

interpretation of evidence is a difficult decision for editors of any

journal. I commend the editorial integrity of Adverse Drug Reactions and

Toxicological Reviews in publishing such controversial articles. It was very

wise to publish the evaluations of the four distinguished peer reviewers of

the Wakefield-Montgomery article in the same issue. Disquiet among those

four British opinion leaders about the evidence on safety of MMR is betrayed

by their comments. Nevertheless, the absence of stridor in their written

opinions, their objectivity and their willingness to consider all sides of

the continuing debate is a refreshing stance and should be a role model. One

arresting statement was made by Fletcher and merits prominence: The granting

of a Product License was premature. [Emphasis mine.]

There were three important points made by Wakefield and Montgomery

that have a bearing on pharmacoepidemiological considerations. Paraphrased,

these are the key assertions:

· Studies that assure safety of MMR in reference to autism and AuS

cannot be found.

· The length of follow up of immunized children in reported

evaluations of the safety of MMR is inadequately short for complications of

delayed onset, typically 3 to 6 weeks.

· Regulators and public health authorities have proscribed products

other than trivalent MMR in some countries. [Many of us are concerned that

parents who believe in immunization but mistrust trivalent MMR must take

their children outside the UK for protection, notably against measles.].

I have not found scientifically sound safety studies. I shall present

new data supporting the view that British evaluations on safety of MMR in

respect to autism invoked inappropriately short lengths of follow up. The

intrusion of the authorities in the legitimate freedom of choice of

responsible parents by proscribing monovalent products is self evident.

Although the data about biological plausibility of an MMR /autism link

has gradually become more persuasive, my experience and expertise is neither

in the laboratory nor the clinic.

I will comment specifically on other papers that appeared in recent

debate pursuing a better understanding of the epidemiological evedence and

the related public health issues.

Fombonne.

Fombonne has written a letter seeking to debunk the very existence of

an epidemic of autism. [Fombonne E. “Is there an epidemic of autism?”

Pediatrics 2001; 107(2):411-12]. He is of the view that the prevalence of

autism “had clearly been underestimated in the past”. He writes, further,

that “the debate on the hypothesis of a secular increase in rates of autism

would benefit from a clear recognition of the methodological limitations of

existing data”. I agree with him about methods. Until now, most of the

studies measuring the frequency of occurrence of autism in a defined

population estimate prevalence. That includes Fombonne’s earlier work. The

existence of an epidemic of AuS can only be confirmed with age-specific

incidence. Declaring a non-epidemic flies in the face of official statistics

in governmental files and several published papers.

For instance, in California, there was a 15.6% increase of AuS in 2000

compared to 1999. For 1999 compared to 1998 there had been a 19.0 % rise.

This is in a period when there was no change to the diagnostic criteria

being used. [Kleffman S. Contra Costa Times Feb 9, 2001] From 1984 to 1998,

the increase of persons accrued to the state’s AuS system was 273%.

[Reference: California Department of Developmental Services. Changes in the

population of persons with autism and pervasive developmental disorders in

California’s Developmental Services System: 1987-1998. A Report to the

Legislature; Dept. of Dev.: 1987-1998. A Report to the Legislature; Dept. of

Dev. Services, Sacramento, March 1999.]

A report released this month by the California Department of

Developmental Services documents a continuing remarkable rising rate of

occurrence of full-blown level one DSM IV for autism in the state

developmental services system. From January 4, 2001 to April 3, 2001, 700

new children were professionally diagnosed with DSM IV autism, which means a

rate of eight new children per day seven days a week. The 700 new children

represent the largest quarterly increase in the history of California’s

system. It also represents an increase of 107 more children than reported in

the previous record highest quarter. Autism now accounts for 37 percent of

all new cases coming into California’s developmental services system. In the

period of January 1994 to April 1994, 173 new children had been added to the

system. The increase seven years later, i.e. 700 cases for the same quarter

of the year, is a 404 percent increase. The figures do not include any

component of the autism spectrum of disorders such as pervasive

disintegrative disorders (PDD) and disorders not otherwise specified (NOS),

Asperger’s syndrome, Rett’s syndrome or any other spectrum disorder. .

[Reference: California Department of Developmental Services. Report to

Department of Developmental Services, Sacramento, April 2001.] I cannot

categorize the California phenomenon or the British phenomenon described by

Kaye as anything other than a true epidemic

Such changes and other major increases in several countries over a

period of less than two decades, even when reflected indirectly by

prevalence rates, are strongly suggestive evidence. Fombonne’s arguments do

not explain away such steep rises in occurrence of AuS anywhere. He does not

change my opinion mainly because his letter gives inadequate attention to

the rate changes of subsets of AuS, such as regressive autism. A worldwide

epidemic of autism is in progress. That demands serious scientifically

admissible inquiries about possible determinants. Epidemiology has been

challenged and epidemiology should respond with the highest attainable

rigour.

Kaye, Melero-Montes and Jick. The Boston Collaborative Drug

Surveillance programme may have done the first correctly designed study to

measure changes in population frequency of autism. [Kaye J, Melero-Montes M,

Jick H. Mumps, measles and rubella vaccine and the incidence of autism

recorded by general practitioners: a time trend analysis. BMJ

2001;322:460-463]. The key estimates are annual, age-adjusted incidences.

From 1988 to 1993 the adjusted annual incidence (based on birth cohorts)

rose from 0.3/10,000 to 2.1/10,000 per year in the General Research Practice

Database of the U.K., a seven-fold increase. A lack of correlation of those

incidence figures with the prevalence of coverage with MMR in the same

cohorts of children is sobering to anyone already fully persuaded that MMR

causes AuS.

Nevertheless, observing a key tenet of epidemiology, such an

ecological correlation cannot and should not be invoked to test any

hypothesis. Further in-depth assessments of the Kaye findings must focus on

the diagnostic subcategories of the children affected, the validity of the

clinical data and the short span between vaccination date and the date of

diagnosis. The Kaye-Jick study is the best published descriptive

epidemiological study to date demonstrating that an epidemic of autism

exists.

+ Continued Next Post

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