Harvey v. Fineberg | Autism PDD

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Dear TAAP members,  

As you know, F. Edward Yazbak, MD, FAAP, a Member of the TAAP Scientific Board wrote
to President Harvey V. Fineberg of the Institute of Medicine on May 11, 2005 and
requested from the President that the report of the Immunization Safety Review Committee
Meeting of February 9, 2004 be retracted, that a new committee under a new Chairperson
be formed and that the new committee meet as soon as possible to examine all the
evidence without bias. http://www.TAAP.info/Fineberg.pdf 

Less than a week ago, Dr. Yazbak published an investigative report, in which he 
examined the recent Danish studies on autism and the role of the CDC. http://www.TAAP.info/DanishStudy2005.pdf

President Fineberg did not respond to Dr. Yazbak as yet, but has published the following
statement on the IOM Web site.  

I invite you to read it carefully and make up your own mind.  

I will keep you informed as things develop. 

Sincerely 

 

April Oakes, President 

http://www.iom.edu/news.asp?id=27733

Statement by Dr. Harvey Fineberg, President of the Institute of Medicine of the 
National Academies, on the Immunization Safety Review Committee 

Questions have been raised about the work and integrity of one of the committees
of the Institute of Medicine (IOM) and its staff.  The Immunization Safety Review
Committee, which was convened in January 2001 and completed its work in 2004, continued
a long history of work related to vaccine safety at the IOM. This document offers
information about the established processes and policies of the National Academies
that ensure the impartiality and integrity of all IOM studies. 

The Immunization Safety Review Committee produced eight reports over the course 
of 3.5 years on vaccine safety-related topics.  A list of the topics is available
online at: http://www.iom.edu/imsafety.  The IOM conducted this work at the request
of the Centers for Disease Control and Prevention and the National Institutes of
Health.  The scope and sponsorship of the committee is, and has always been, a matter
of public record.  Other than publicly posing the scope of study to the committee
and delineating the specific hypotheses to be explored, the sponsoring agencies 
had no relationship with the committee other than when invited to present scientific
information to the committee, either in public sessions or in written submissions
that were placed in a publicly available file.  

The public sessions of this committee were attended by many scientists and the public.
Audiofiles and transcripts of the public sessions are posted on the IOM Web site.
Print material provided by the federal agencies or any other party are available
through the National Academies' Public Access Records Office.  Allegations that 
the Centers for Disease Control and Prevention had any control over the committee's
findings are false. 

The Immunization Safety Review Committee operated at all times in adherence with
National Academies' policies to assure openness and scientific integrity, which 
are outlined in a brochure available online at: http://www.nationalacademies.org/studyprocess.
The members of the committee underwent a stringent review process that ensured all
were free of financial conflicts of interest and were not biased for or against 
any vaccine safety hypothesis.  The general criteria by which this impartiality 
was assured has been a matter of public record and is discussed by the president
of the IOM in the foreword of each of the eight reports issued by this committee.

Specifically, members of Immunization Safety Review Committee had no ties to vaccine
manufacturers, had not made policy statements regarding vaccines; had not served
as expert witnesses--paid or unpaid--in any vaccine-related litigation; and had 
not worked for nor received recent funding for research on vaccine safety from the
agencies that sponsored the study.  As is the case with all IOM projects, their 
service was entirely voluntary; they received no compensation. 

As with all IOM projects, the Immunization Safety Review Committee operated under
a scope of work that was requested by the sponsoring organization.  The committee
was asked to provide an assessment of the scientific and societal significance of
specific vaccine safety hypotheses and make recommendations for appropriate public
health responses.  The scientific assessment included conclusions about whether 
there exists a cause-and-effect relationship between particular vaccines and certain
serious health problems and about the plausibility of any biological means by which
a vaccine might adversely affect health.  The recommendations address the need for
policy review, research and surveillance, and communication. 

The charge to the committee was discussed at length in a public session in January
2001 prior to the start of its review of the extensive body of research related 
to its first report on vaccine safety.  The committee continued its discussions 
of its charge and its work plans in a closed session.  The discussions during this
closed session focused on the committee members' efforts to make sure that they 
fully understood their charge and reached agreement on the best way to conduct their
study.  Part of the discussions focused on the concerns, interests, and stakes held
by various parties, including both CDC and parents.  Some individuals have taken
words and phrases from a transcript of this closed session out of context, combined
these fragments, and misrepresented them as direct quotes designed to suggest that
committee members had biases.  

It has also been suggested that the committee reached its conclusions about thimerosal's
possible associations with autism based on just a few scientific papers.  On the
contrary, IOM committees review all relevant literature, data, and other information
when conducting their studies.  The Immunization Safety Review Committee reviewed
vast amounts of information for each of its eight reports and deliberated thoroughly
and independently before issuing each report.  More than 215 references are cited
in the 2004 report on vaccines and autism.  The committee members' detailed analysis
of the strengths and weaknesses of the scientific papers they reviewed is included
in their report, which is a public document available to anyone who wishes to read
it.  

The value of IOM studies is that they provide evidence-based guidance.  IOM committee
members can state only conclusions and recommendations that are supported by evidence.
This is illustrated by the conclusions of the Immunization Safety Review Committee's
2001 report on thimerosal and neurodevelopmental disorders and its 2004 report on
vaccines and autism.  

In 2001, the little evidence that was available provided only weak and inconclusive
information about an association between thimerosal and neurodevelopmental disorders,
including autism.  Because the committee could say only what the evidence enabled
them to deduce--not what any individual or organization wished that they could conjecture
from it--the committee concluded that the evidence was insufficient to either accept
or reject an association between thimerosal and neurological disorders.  

When the committee looked at the topic of thimerosal and autism in 2004, data from
a number of studies was then available.  The committee members had much more evidence
to consider.  Their finding that the evidence favored rejection of an association
between thimerosal and autism was based on the totality of the available evidence.

Every report written by IOM committees must go through an extensive peer-review 
process and committees must respond to any questions and comments raised about their
work before any report is approved for publication.  Since the Immunization Safety
Review Committee's reports have been published, their findings and conclusions have
not been challenged or questioned by any major medical or public health association.

The Institute of Medicine and the National Academies have full confidence that the
Immunization Safety Review Committee operated independently, impartially, and in
accordance with the highest scientific standards.  

 

 


DEFINITION * TREATMENT * PREVENTION
Autism is 1 in 150 children today, 1 in 68 families!  TAAP (The Autism Autoimmunity
Project) is a non-profit charity dedicated to obtaining funding for independent 
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disorders.  Please visit our new website at http://www.TAAP.info and "TAAP 
into the Truth!"




I thought the autism rate was down to 1 in 122 children.

Tammy


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