Federal Document Clearing House
Copyright (c) 2002 EMediaMillWorks, Inc.
Testimony
June 19, 2002
House of Representatives
Government Reform
Vaccine Safety and Autism
Statement of Representative Dan Burton
Committee on House Government Reform
"The Status of Research into Vaccine Safety and Autism"
June 19, 2002 21.
Good afternoon, a Quorum being present, the Committee on
Government Reform will come to order. I ask unanimous consent
that all Members' and witnesses' written and opening statements
be included in the record. Without objection, so ordered.
I ask unanimous consent that all articles, exhibits, and
extraneous or tabular material referred to be included in the
record. Without objection, so ordered.
[Chairman's Opening Statement]
In April the Committee conducted a hearing reviewing the epidemic
of autism and the Department of Health and Human Service's (HHS)
response. Ten years ago, autism was thought to affect 1 in 10,000
individuals in the United States. When the Committee began its
oversight investigation in 1999, autism was thought to affect 1
in 500 children. Today, the National Institutes of Health (NIH)
estimates that autism affects 1 in 250 children.
In April we looked at the investment our Government has made into
autism as compared to other epidemics. We showed in that hearing
that the CDC and NIH have not provided adequate funding to
address the issues in the manner that our Public Health Service
agencies have used to address other epidemics.
After our hearing, I joined with my colleagues on the Coalition
on Autism Research and Education to request from our
appropriators that at least 120 million dollars be made available
in FY 2003 for autism research across the NIH and at that an
additional $8 million be added to the CDC's budget for autism
research.
Giving more money to research is not the only answer though.
Oversight is needed to make sure that research that is funded
will sufficiently answer the questions regarding the epidemic,
how to treat autism, and how to prevent the next ten years from
2002 WL 1335565 (F.D.C.H.) Page 2
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
seeing the statistic of 1 in 250 from becoming 1 in 25 children.
High quality clinical and laboratory research is needed now, not
five or ten years from now. Independent analysis of previous
epidemiological and case control studies is needed as well.
We have learned that a majority of parents whose children have
late-onset or acquired autism believe it is vaccine-related. They
deserve answers. We have also learned that the parents have been
our best investigators in looking for both causes of autism and
for treatments.
It has been parents who have formed non-profit organizations to
raise research dollars to conduct the research that the CDC, the
FDA, and the NIH have neglected to do. We have heard from many of
these parents in the past, Elizabeth Birt, Rick Rollens, Shelley
Reynolds, and .Jeanna Smith, to name just a few. Each of these
parents had healthy babies who became autistic after vaccination.
I might have been like many of theofficials within the public
health community - denying a connection - had I not witnessed
this tragedy in my own family. 1 might not have believed the
reports from parents like Scott and Laura Bono, Jeff Sell, Jeff
and Shelly Segal, and Ginger Brown, who came to me with pictures,
videos and medical records. I might have been like so many
pediatricians who discounted the correlation between vaccination
and the onset of fever, crying, and behavioral changes. Because
both of my grandchildren suffered adverse reactions to vaccines,
I could not ignore the parent's plea for help. I could not ignore
their evidence.
My only grandson became autistic right before my eyes - shortly
after receiving his federally recommended and state-mandated
vaccines.
Without a full explanation of what was in the shots being given,
my talkative, playful, outgoing healthy grandson Christian was
subjected to very high levels of mercury through his vaccines. He
also received the MMR vaccine. Within a few days he was showing
signs of autism.
As part of our investigation, the Committee has reviewed ongoing
concerns about vaccine safety, vaccine adverse events tracking,
the Vaccine Safety Datalink (VSD) Project, and the National
Vaccine Injury Compensation Program. I have joined with
Congressman Weldon, Congressman Waxman and 32 other members of
Congress in introducing HR 3741 , the National Vaccine Injury
Compensation Program Improvement Act of 2002 to realign the
compensation program with Congressional Intent.
In today's hearing, we will receive a research update from
several previous witnesses as well as new research findings that
further support a connection between autism and vaccine adverse
events. We will learn more about both the possible link between
the use of the mercury-containing preservative thimerosal in
vaccines and autism, as well as autistic entercolitis resulting
from the Measles-Mumps-Rubella (MMR) vaccine.
2002 WL 1335565 (F.D.C.H.) Page 3
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
Through a Congressional mandate to review thimerosal content in
medicines, the FDA learned that childhood vaccines, when given
according to the CDC's recommendations exposed over 8,000
children a day in the United States to levels of mercury that
exceeded Federal guidelines. Is there a connection between this
toxic exposure to mercury and the autism epidemic? We will hear
from Dr. James Bradstreet and Dr. Vera Stejskal [Stets Call] on
this issue.
We have twice received testimony from Dr. Andrew Wakefield
regarding his clinical research into autistic entercolitis.We
will learn today that not only has he continued to conduct
clinical research, but that this research is confirming the
presence of vaccine-related measles RNA in the biopsies from
autistic children. Dr. Wakefield - like many scientists who blaze
new trails - has been attacked by his own profession. He has been
forced out of his position at the Royal Free Hospital in England.
He and his colleagues have fought an uphill battle to continue
the research that has been a lone ray of hope for parents whose
children have autistic entercolitis. Dr. Arthur Krigsman is
joining us as well today to discuss his clinical findings of
inflammatory bowel disorder in autistic children. He will share
with us his initial findings as well as discuss his research
plans currently with his Institutional Review Board for approval.
Do the epidemiological and case control studies, which the CDC
has attempted to use to refute Dr. Wakefield's laboratory
results, answer the autism- vaccine questions honestly?
Epidemiologist Dr. Walter Spitzer is back today to answer this
question. What else is needed to prove or disprove a connection?
Unfortunately, rather than considering the preliminary clinical
findings of Dr. Wakefield as a newly documented adverse reaction
to a vaccine, the CDC attempted to refute these clinical findings
through an epidemiological review. While epidemiological research
is very important, it cannot be used to disprove laboratory and
clinical findings. Valuable time was lost in replicating this
research and determining whether the hypothesis was accurate.
Officials at HHS have aggressively denied any possible connection
between vaccines and autism. They have waged an information
campaign endorsing one conclusion on an issue where the science
is still out. This has significantly undermined public confidence
in the career public service professionals who are charged with
balancing the dual roles of assuring the safety of vaccines and
increasing immunization rates. Increasingly, parents come to us
with concerns that integrity and an honest public health response
to a crisis have been left by the wayside in lieu of protecting
the public health agenda to fully immunize children. Parents are
increasingly concerned that the Department may be inherently
conflicted in its multiple roles of promoting immunization,
regulating manufacturers, looking for adverse events, managing
the vaccine injury compensation program, and developing new
vaccines. Families share my concern that vaccine manufacturers
have too much influence as well. How will HHS restore the
2002 WL 1335565 (F.D.C.H.) Page 4
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
public's trust?
Access to the Vaccine Safety Datalink (VSD)
One of the primary topics to be discussed at this hearing is
access to the Vaccine Safety Datalink. (VSD). To help fill
scientific gaps, the CDC formed partnerships with eight large
health maintenance organizations through an agreement with the
American Association of Health Plans to continually evaluate
vaccine safety. This project is known as the Vaccine Safety
Datalink (VSD) and includes medical records on millions of
children and adults. Up until this year, access to data from the
VSD has been limited to researchers affiliated with the CDC and a
few of their handpicked friends. This .good old boy's network"
practice has predictably led to questions about the objectivity
of the research and the fairness of the results.
The VSD data should be made available to all legitimate
scientific researchers so that independent studies can be
conducted and results verified. This database contains a wealth
of data involving millions of patients over a ten-year period. If
properly utilized, it can help researchers study vitally
important questions about the safety of vaccines, the effects of
mercury-based preservatives in childhood vaccines, and many other
questions.
The Committee first raised this issue with the CDC two years ago.
For two years the CDC delayed. Six months ago, we were informed
that the CDC was developing a plan to expand access to the
database. Finally, in February of this year, after a great deal
of prompting from the Committee, Dr. Robert Chen, Chief of
Vaccine Safety and Development at the National Immunization
Program, informed Committee staff that the CDC had finalized its
plan and that it was poised to put it into effect. Under this
plan, any legitimate scientist could submit a proposal to the CDC
to conduct research using VSD data and access to the data would
be provided along with some basic safeguards.
In preparation for today's hearing, Committee staff asked the CDC
why the plan described to us in February had not yet been put
into effect. The staff was informed that the plan had been put
into effect. However, there had been no public announcement. How
are researchers supposed to know about the availability of the
data if there is no announcement? It took two years of prodding
by this Committee to get the CDC to open up access to the
database. For four months it appears that the CDC didn't inform
anybody but this Committee of the data's availability.
That doesn't make it appear that the CDC is making a good faith
effort to open up this database. It looks to me like the CDC is
trying to do the bare minimum that they have to do to get us off
their backs. That's not acceptable. That's why I insisted that
Dr. Chen be here today.I just want to ask him why they didn't
tell anyone about the database being available. I'd like to know
how he expects researchers to use this data if nobody tells them
it's available.
2002 WL 1335565 (F.D.C.H.) Page 5
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
Dr. Roger Bernier is here from the CDC to testify about these
issues. He is accompanied by both Dr. Chen, the creator of the
VSD Project and Dr. Frank DeStefano, the CDC official who is also
a co-author of the MMR - IBD study. They are here to address our
questions on the VSD project and the vaccineautism research. The
CDC employees are accompanied by Dr. Stephen Foote of the
National Institutes of Health and Dr. William Egan of the Food
and Drug Administration.
As representatives of the people, we have a responsibility to
ensure that our public health officials are adequately and
honestly addressing this epidemic and its possible links to
vaccine injury.
I look forward to hearing from our witnesses today. Our hearing
record will remain open until duly 3.
I now recognize the ranking minority member, Mr. Waxman for his
opening statement.
DAN BURTON
Representative
2002 WL 1335565 (F.D.C.H.)
END OF DOCUMENT
2002 WL 1335565 (F.D.C.H.) Page 6
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
Federal Document Clearing House
Copyright (c) 2002 EMediaMillWorks, Inc.
Testimony
June 19, 2002
House of Representatives
Government Reform
Vaccine Safety and Autism
Statement of James Jeffrey Bradstreet,
MD, FAAFP, Clinical Director
The International Child Development Resource Center
Palm Bay
House Government Reform Committee
June 19, 2002
Mr. Chairman and Honorable Member of the Committee, much has
happened to forward our knowledge of autism spectrum disorders
(ASD) since I last spoke to you one year ago. To that end I am
encouraged. But there remains so much more to learn, and even
more to do for the families whose lives have been permanently
altered by this silent epidemic. I want to thank Chairman Burton
for his leadership. Your battle to bring the challenging issues
of autism before the Congress, poignantly demonstrate the power
of a grandfather's love for his family. I am equally impressed by
the efforts of Dr Dave Weldon. He remains a trusted friend,
fellow physician and Representative for my home district in
Florida.
Autism is clearly not any single entity, nor does it have
simplistic genetic or epidemiological characteristics. Rather, it
represents a rather broad spectrum of clinical disorders which
share behavioral and delayed-development features. Autism and its
related entities are characterized by_ delayed neurodevelopment,
lack or inappropriate use of language, stereotypical repetitive
behaviors, and social withdrawal. The various clinicians and
researchers associated or affiliated with ICDRC have been
involved in treating and/or describing this disorder from its
biological roots, as opposed to the genetic and psychiatric
perspectives. We have medically evaluated and treated over 1500
children with autism related disorders. Therefore, the insights
we have contribute primarily to an understanding of the
immunology and toxicology of this condition.
The changes since last year in the level of national attention
for autism are well reflected by events in my life during the
last few weeks. On June 4th, Congressman Weldon and I met with
the Deputy Secretary of HHS, Claude Allen in Chairman Burton's
office to discuss both recent clinical findings and the state of
the autism epidemic. Then ICDRC entered into collaboration
2002 WL 1335566 (F.D.C.H.) Page 7
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
agreements with Robert Wood Johnson Medical Center, Washington
University Medical School, and Wake Forrest University to further
define the immunological and toxicological disorders common in
autism. And last Tuesday an ABC news crew spent the entire day
filming at both my office and home. Those segments will air
tonight and tomorrow on the ABC evening news.
With this new public and academic awareness of the epidemic in
childhood developmental disorders in mind, where has the last
year's investigations taken our understanding of both Thimerosal
and MMR as they relate to autism? In July of 2001, I presented
the ICDRC data on mercury burden and autoimmunity to the IOM
(page 47, Immunization Safety Review: Thimerosal-Containing
Vaccines and Neurodevelopmental Disorders, 2001). It doesn't seem
the IOM understood my recommendations based on that data, so it
warrants some degree of explanation here.
First, however, there is a fundamental flaw in the analysis
process of vaccine safety. The IOM has undertaken the process of
drawing conclusions regarding separate pieces of the actual
schedule when they are an integrated event in an individual
child's life.
I presented 221 children with ASD who showed a significant - 500%
- on average greater mercury burden when compared to
neurologically normal controls. The study was based on routine
heavy metal provocation challenge testing similar to that
published in Environmental Health Perspectives that same year. I
did not try to infer a direct tie to thimerosal. Rather, it was
apparent some possible foundational problem in the metabolism of
heavy metals was present in the autistic population. This
observation could represent a significant predisposing factor in
their vulnerability to mercury when used as a perservative - a
point the IOM did not mention. It is also consistent with
research regarding sulfur depletion in the presence of persistent
viral infections. The literature is replete with reference in the
case of HIV* and specific to autism as published by Dr Rosemary
Waring. She has found marked renal loss of sulfur in autism.*
But most concerning to me in the Institute's treatment of the
mercury problems, was the almost complete absence of regard for
the compounding effect of thimerosal on preexisting mercury
levels. The NHANES study from CDC had already established perhaps
one in ten children is born to mothers with elevated mercury
burden.
Prevalence:
Various studies provide data that there are greater numbers of
children with autism than previous suspected. Recently, the
Congressional Reform Committee, held hearings where there was
broad consensus that autism spectrum disorders (ASD), now
represent an epidemic of neurodevelopmental problems for our
youth. Various recent studies place the prevalence at 57 to
67/10,000 children (Scott, 2002 & Bertrand, 2001), although
older. literature places the prevalence at 10/10,000 (1/1,000).
2002 WL 1335566 (F.D.C.H.) Page 8
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
However, this deceptively under estimates the problem for males.
Boys suffer from autism at a four to 10 fold greater frequency
than girls. So the actual problem for the male offspring in this
country is more accurately represented as 100/10,000 (or
greater). The 1997 US Census of disability reported 2.4% of
children ages five and under suffer from developmental delays -
clearly many of these are ASD related issues. Data from
California further reveals the rate of growth in ASD is doubling
every four years.
Using simple math - we appear to be on the Titanic of child
development:
RESULTS: The prevalence of all autism spectrum disorders combined
was 6.7 cases per 1000 children (1:149). The prevalence for
children whose condition met full diagnostic criteria for
autistic disorder was 4.0 cases per 1000 children, and the
prevalence for PDD-NOS and Asperger disorder was 2.7 cases per
1000 children. Characteristics of children with autism in this
study were similar to those in previous studies of autism.
CONCLUSIONS: The prevalence of autism in Brick Township seems to
be higher than that in other studies, particularly studies
conducted in the United States, but within the range of a few
recent studies in smaller populations that used more thorough
case-finding methods.
If the current epidemiology of autism is correct, then it will
affect approximately 1 % of boys under 18, or an estimated
364,540, and a further approximately 60,000 girls would be
affected. This is considerably less than the one million figure
reported in the recent Time Magazine cover story, but probably
far more accurate.
Economic Impact:
While no precise studies have attempted to look at the cost of
correcting the biological problems associated with ASD, at least
on report from England places the custodial costs of ASD in the
range of $3-4 million per child per lifetime, with a societal
cost that would likely be three times the individual cost.
Little is known about the economic impact of autism. This study
estimated the economic consequences of autism in the United
Kingdom, based on published evidence and on the reanalysis of
data holdings at the Centre for the Economics of Mental Health
(CEMH). With an assumed prevalence of 5 per 10,000 (a gross
underestimate), the annual societal cost for the UK was estimated
to exceed 11 billion (likely 110 billion). The lifetime cost for
a person with autism exceeded 2.4 million. The main costs were
for living support and day activities. Family costs account for
only 2.3 percent of the total cost, but a lack of relevant
information limited our ability to estimate these costs. Minor
improvements in life outcome for people with autism could
substantially reduce costs over the lifetime.
The cost of education, medical care, and therapies for behavioral
2002 WL 1335566 (F.D.C.H.) Page 9
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
and physical symptoms is staggering. Many of our families report
having paid $50,000 per year to care for their child. IDEA allows
up to $35,000/year for education of children with autism. So much
of this burden is already being carried by the Federal and State
programs which provide for disabled children. Custodial care for
autism can exceed $100,000/year. The public education system is
literally swamped with children. Any survey of public educators
will quickly reveal the suddenness and magnitude of the ASD
problem. They lack the therapists and trained special educators
to deal with the problem, so children with severe disorders
receive nominal meaningful intervention. The further loss of
potential earnings form the ASD children who will likely not be
self-supporting are impossibly large to calculate meaningfully.
Many parents must quit working to care for the child as well. We,
as a nation, are therefore paying and will continue to pay an
enormous price for this epidemic.
ICDRC estimates the minimal cost in present value, to care for
those 420,000 existing children with autism is $1,260,000,000,000
(based on $3million/lifetime and 420,000 children affected). So a
little over a $1 trillion in the next 50 years would be required
if we stopped creating new cases today. Because autism is
doubling every four years, this is likely an overly conservative
estimate. The societal cost could easily be $3-4 trillion.
Biological Evidence of Causality:
The data will show there is sufficient cause for concern and
abundant published findings that the causal relationship of MMR
to ASD does not represent a narrow view held by radical or
renegade physicians. Rather it is sound peer-reviewed science,
which, while currently not widely accepted, represents a
plausible hypothesis consistent with our observations and the
totality of the data. Unfortunately, the present objections to
the data are largely based on conclusions drawn from
epidemiological studies. The data must be evaluated in its
entirety, rather than critiqued bit by bit as it has been.
However, as a clinician treating hundreds of children with
specific & measurable biological disorders - I draw very little
comfort from the conclusions of epidemiologists. Nor does it help
me explain or treat the child's inflammatory bowel disease or the
autoimmunity to vital brain components. So what I will present
here today is a definable clinical disorder, in which children
present with antibodies to a variety of brain components,
inflammatory bowel disease, heavy metal burdens, often
accompanied by seizures, skeletal maturation delay and a variety
of significant biochemical abnormalities. The children I treat
have symptoms consistent with encephalopathy with autistic
features.
We are in the process of collecting data and analyzing the trends
in our patient population. The two cases I will present here
represent very early data. We have now accumulated simultaneous
autoimmune, immune studies and viral polymerase chain reaction
studies on blood, spinal fluid and intestinal biopsies. These are
2002 WL 1335566 (F.D.C.H.) Page 10
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
combined with comprehensive biological studies. As yet, there are
no controls for the viral spinal fluid data, but the
immunological data does have controls. What these two cases mean
for the rest of the population of children with autism will have
to wait for larger studies, reproducibility and necessary
controls.
Case Presentations:
Case 1. Matthew, my son, seems very typical of many children I
have examined over the past 5 years. He shares similar historical
events and laboratory data with as many as 80% of our 1500
patients. He presently is age 8 and went to term without
complication in pregnancy and had an uncomplicated labor and
delivery. He presented with an entirely normal first 7 months. At
the end of that period he self-weaned and standard formula was
tried. This resulted in reflux and vomiting, so he was changed to
predigested formulas with significant reduction in symptoms. The
pediatrician noted slight delay in ambulation at 12 months, but
in line with maternal developmental patterns. He had a protracted
otitis media which required tube placement by 10 months and
extended courses of antibiotics. The International Child
Development Resource Center
By 11 months he was seen in the ER for an acute febrile event not
accompanied by seizures. It responded to IV antibiotics and
outpatient treatments. Near 15 months he was seen for routine
care and vaccinations. He was noted to be on track and developing
normally. He received MMR, HIB and Varicella vaccinations at that
visit. Shortly after that he developed tantrums and bizarre
behaviors. Then he developed diarrhea and hyperactivity
accompanied by a new symptom - night terrors. With the
introduction of essential amino acids and taurine these symptoms
improved somewhat for about 8 to 12 months. He then began
slipping with increased hyperactivity and unusual language and
behaviors. By age three he was diagnosed as having pervasive
developmental delays and tested at the lowest percentile for
function in all areas. He was started in therapies and improved
somewhat. On his 4"' birthday the original Wakefield paper was
published and at nearly the same time, Matt received his MMR
booster. (He received the full recommendations of the AAP for
vaccinations during the mid to late 1990s). Shortly thereafter we
noted staring spells as did the special needs teacher in his
title H program. The neurologist diagnosed seizures and tried
several medications unsuccessfully. His diarrhea returned and his
behavior declined. Several months later we learned about gluten
and casein free diets, secretin and IVIG. After a variety of
studies confirmed autoimmunity to his brain, Matthew was begun on
IVIG at the suggestion of two department chairs of immunology at
different medical schools. The results were dramatic, with
improvement in behavior and bowel dysfunction which had become
explosive bouts with daily soiling past diapers.
The process of regression was not understood by Matthew's
pediatrician or any of us in his family. Typically, it was
2002 WL 1335566 (F.D.C.H.) Page 11
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
variously dismissed as the result of the terrible two's, having
an older sister, being a boy - "they are slower than girls you
know", several ear infections, food allergies, or an attention
deficit hyperactivity disorder.
Halsey, the eminent professor of vaccine safety, told the
listening audience of CNN that it was natural for me to want to
blame something for my son's autism, but MMR was unquestionably
not part of either the timing or autoimmune profile observed. I
believe, medicine lacks the luxury of such amazing confidence.
However, it seems extraordinarily improbable that his autoimmune
encephalopathy and seizures are not MMR related. A review of his
lab data paints an unmistakable picture, recognizable to any
skilled clinician. I choose to share the details of my son's
medical history, so that those who continue the refrain - "there
is no data" might know they are wrong - data exist - and it is
compelling.
Summary of Major Abnormalities in Matthew:
-Milk allergy early in life
-Multiple ear infections
-Transient gait abnormality up until about one year. Was this
mercury related?
-Rapid decline after each MMR or combination of vaccines with MMR
-Autoimmunity to Myelin Basic Protein (the insulation of the
central nervous system).
- Seizures
-Immune Deficiency with protracted low lymphocyte levels
-Inflammatory Bowel Disease
-Persistent Measles Virus genome in that inflammatory bowel
disease
-Persistent Measles Virus in circulating monocytes
-Persistent Measles Virus in genome in spinal fluid
-Antibodies to Measles Virus in spinal fluid
-Autoantibodies to Myelin Basic Protein in spinal fluid
-Elevated ammonia
-Low sulfate with resultant high mercury due to a loss of
glutathione and cysteine
So, in my child, what would a reasonable clinician conclude for
the medical diagnoses? Autism? Certainly not, unless they
believed the hypotheses of Wakefield, Singh and a handful of
2002 WL 1335566 (F.D.C.H.) Page 12
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
others who are arguing as I am, that what we have come to call
autism - in fact represents a new disorder of immune, viral and
toxic origin.
About the only question left to answer is - did the viral
persistence cause the condition or did the condition cause the
viral persistence? In part, we need to consider the toxicity of
thimerosal and Matthew's early gait disorder. Thimerosal becomes
a neurotoxin as soon as it dissociates and liberates
ethylmercury. The levels of mercury obtained in the vaccine -
likely combined with environmental mercury from various sources
to precipitate the early motor/coordination/gait problems.
Tiddelbaum and colleagues from the University of Florida have
published their findings regarding early movement disorders as a
predictor of future risk of autism. This may well be an
association with the subtle effects of mercury, although that was
not their conclusion. I believe we can the inherent "chicken or
egg question", but I want to present another case to establish
that my son's condition is not an isolated event.
Case 2. I presented this child to this committee last year. Scott
was born 7/25/95. For brevity sake I will comment only that
numerous documentations of his early development established no
abnormalities at all. Shortly after receiving the MMR vaccine
Scott became fussy and lost eye contact and then developed
diarrhea and behavioral and developmental regressions. On 2/20/99
we obtained a serum specimen from Scott for evaluation at the
University of Michigan, College of Pharmacy, Neuroimmunological
Research Laboratory of Dr. V.K. Singh. The 2/20/99 serum
underwent testing for autoantibodies to myelin basic protein (a
component of the central nervous system), which were found to be
positive at a dilution of 1:400 - (Strongly positive range).
Scott has had repeated spinal fluid analysis which will be
presented here. He has also had intestinal biopsies and blood
work for the detection of measles virus F gene - all of which are
positive. Scott's parents have filled a claim in the Federal
Court of Claims alleging the MMR vaccine precipitated their
child's autoimmune encephalopathy - which like my son's - has
autistic features. They, as parents, are also not reassured by
epidemiological studies or arguments from the public health
officials claiming MMR cannot cause the disorder their son has.
The implications of these findings could have incredible
potential impact on public health policy and the future
acceptance of voluntary vaccines by parents for their children.
We desire safer vaccines and safer administration of vaccines,
but we fear a lack of government response to the concerns of
researchers and parents will result in lowered overall immunity
to numerous preventable disorders, because parents will reject
some of the vaccines in their current forms. The request for a
safer MMR vaccine was also presented by Imani and colleagues at
the Division of Clinical Immunology, Department of Medicine, The
Johns Hopkins University School of Medicine, Asthma and Allergy
Center (Clip Immunol 2001 Sep;100(3):355-61). So, we do not feel
2002 WL 1335566 (F.D.C.H.) Page 13
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
alone in our understanding of the apparent immunological flaws of
the current trivalent vaccine.
These data are also public knowledge and have been presented at
numerous professional and public forums, as well as through
publication in mainstream medical literature, eg Pediatrics, The
Journal of Pediatric, The British Medical Journal - Molecular
Pathology, The American Journal of Gastroenterology, and recently
in a press release from the American Society of Microbiology.
Historically, high titer measles vaccine caused more mortality
than expected due to the induction of immune deficiency (Halsey
1993). This caused a reversal of policy and high titer MV
vaccines no longer exist. The nature of mass vaccination programs
are in effect an ongoing open-label experiment. No study can
predict the long-term and subtle effects of a vaccine adequately
prior to introduction to a group as large as most of the
population of our planet.
Unfortunately, and as true of many new discoveries in medicine,
the initial reactions are that of skepticism or rejection. We
have seen this historically with H.pylori and peptic ulcer
disease, as well as during the emerging literature on AIDS and
HIV. Eventually, the early observations in these disorders were
proven accurate, medicine adapted and acceptance became
universal. We believe the same is true for this literature which
will be summarized below, despite the present political
incorrectness of the findings.
What do we know so far:
1) MV wild type persists in seemingly normal individuals,
although I would have preferred a more in depth study of the
histories obtained from autopsy studies.
2) Therefore the mere presence of MV (even vaccine strain) is not
enough evidence for us to claim causality, although it is
definitely not reassuring to find it in the CSF of children with
encephalopathy, or in the intestines of f children with
inflammatory bowel disease. MV is known to cause encephalopathy
and as found in the study from the Mayo Clinic - it is also a
risk factor for inflammatory bowel disease.
3) We have shown - through Dr Singh's efforts that the children
are reacting to the virus (immune response) - which are not seen
in controls. The response is to Myelin Basic Protein as would be
typical in measles viral infections of the CNS. Other viruses are
known to do this as well, eg, Japanese Encephalitis, but we have
no evidence or history for any of the other candidate infections.
So, we see:
-Presence of the virus in 82% of regressed/bowel patients
compared to a very low number of controls. This represents a
documented unique inflammatory bowel disease in ASD children.
(Uhlmann 2002 & Wakefield 2000)
2002 WL 1335566 (F.D.C.H.) Page 14
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
-Autoimmunity in the presence of the virus (gut and brain -
published by Singh, et al & the group at Royal Free). Present in
cases not controls.
-Antibodies to the virus in the CSF - not seen in controls.
(Singh & Bradstreet 2002).
-Virus genome (F gene) in the CSF - no controls yet. High
correlation between MV in blood of cases (currently 100% of those
with suspected brain MV). (Presented here).
-Frequent seizures (typical of MV in the CNS, but not specific
for any one virus). -Depletion of cysteine and sulfur (Waring et
al 2000), consistent with a persistent viral infection, not
specific for MV - also seen in HIV patients.
-Resultant 500% higher levels of Hg in cases over controls.
(ICDRC - IOM presentation of Bradstreet, 2001).
4) In that last several months, a senior investigator for the
Committee and I have conducted an informal poll of numerous
pediatricians, neurologists and immunologist. We have provided
laboratory results and histories. Then we asked them to give us
their best diagnosis for the cases. Every physician was unanimous
that the findings represent measles infection in the brain. They
differed somewhat on the nature of the infection, but only over
whether it represented acute infection or subacute sclerosising
panencephalitis (SSPE).
5) In Scott's situation, Dr John Menkes the esteemed professor of
pediatric neurology and author of the foundational textbook Child
Neurology, agrees that the findings can only be interpreted to
represent measles infection in the brain. He refers to this as
atypical SSPE, since it does not appear to be causing the typical
findings in SSPE. That may be somewhat confusing terminology. I
would prefer to call it autoimmune encephalopathy with measles
virus persistence. I believe Professor Menkes and I remain in
complete agreement about the disease process, and as with this
entire problem -just need to come to terms about the
nomenclature. Menkes would no doubt have an identical
interpretation of my son's case.
So who and what are we to believe. Everyone agrees the
epidemiology is not precise enough to detect rare events. But are
these two boys rare? Certainly the data of Singh , Uhlmann,
Wakefield, Bradstreet and others represent a much larger
population than just these two cases. Several hundred children
have been studied and published in the various papers. While we
need controls and confirmation for this most recent piece of the
puzzle (viral genome in the CSF), I think we should be more than
concerned about the findings. My impression from carefully
examining and investigating 1500 cases of autism is that these
boys are not isolated cases. I am terribly concerned they may
well represent the majority of cases of regressed autistic
encephalopathy children.
2002 WL 1335566 (F.D.C.H.) Page 15
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
Therefore, we as a society need ask and answer some important
questions:
-What if Wakefield, Singh, Bradstreet and Menkes are right about
these data.? -What then?
-Have we traded acute measles and occasional SSPE from the wild
disease for a 1 in 80 risk for boys to develop this new form of
measles disease?
-Can that be a justifiable risk benefit ratio?
-Do we have safer vaccines?
-If so, why aren't we using them? It appears Dr Bellanti at
Georgetown does have a safer measles vaccine that he cannot get
licensed.
-What has held up the approval of that measles vaccine?
-If we do not have safer vaccines, why don't we?
- How are we going to treat these two boys, or the potential
hundreds of thousands like them?
-Why doesn't the epidemiology agree with the biology? Have we
asked the right questions in the way the epidemiology studies
were constructed? Did they use reliable methods and databases?
-Is it only a reaction to MMR or are many things capable of
triggering the brain autoimmunity and gut disorders we are
seeing?
- Do, as I suspect thimerosal, aluminum, and the various vaccine
antigens prime the immune system to respond abnormally to live
virus injections?
-We suspended live polio vaccines for early life because of 9
cases of polio in susceptible individuals. How many persistent
measles autistic-like encephalopathies will it take to stop using
MMR and find a safer vaccine alternative? Are 10 enough? 100?
1000? OR do we need hundred's of thousands of cases?
-In a similar light, how many inflammatory bowel diseases must it
cause?
- Should live viruses be injected, thereby violating the normal
immune mechanisms, or should they always be provided through
natural route of infection means?
-Should live viruses ever be used, or is this playing with
immunological and virological fire?
I am only asking these questions to stimulate reasoned medical
debate and investigation. I am convinced about the nature of our
present autism epidemic, but I also recognize changing the course
2002 WL 1335566 (F.D.C.H.) Page 16
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
for vaccine policy is like changing the course for a large ocean
going vessel, hopefully it will not be like the Titanic.
Presently, my partner, Dr Kartzinel and I have a waiting list to
get on our waiting list. We hear from parents daily with newly
diagnosed children. I will once again remind the Congress of the
words of our Surgeon General:
"Growing numbers of children are suffering needlessly because
their emotional, behavioral, and developmental needs are not
being met by those very institutions, which were explicitly
created to take care ofthem." Surgeon General Sachet
(http://www.surgeongeneral.gov/cmh/childreport.htm)
Epidemiology (with the known flaws in the published studies) has
failed to find an association, although the data sources used are
suspect. The most difficult piece of data is the continued rise
in prevalence despite flat uptake of the vaccine. Our explanation
of that observation has to do with other priming events for MMR
which are not constant over the time in question.
So how is it the IOM and the various expert bodies looking at
this data come away saying there is NO evidence of a link between
MMR and ASD? They ignore all of these molecular viral data and
immunological findings and rely slavishly upon rather poor
epidemiology. Is ASD multi-factorial? It must be - humans are far
to complex to be The International Child Development Resource
Center reduced to simplistic & mechanistic processes when brain
development is involved. Is it just MMR? I doubt it for most
cases.
The better question is this: is it ultimately MMR? I certainly
see the evidence for that - again - in most cases. This, I
believe is the result of numerous antecedent priming events -
including the right genetic predisposition to certain
immunological events - such as autoimmunity.
There is even more reason for concern. The CDC was willing to
present data that Thimerosal vaccines were associated with a
statistically significant increased risk of Attention Deficit
Hyperactivity Disorder. Below I compare the chart prepared and
presented to the IOM by Mark Blaxil and the US data on stimulant
use for ADHD. It seems obvious there is a significant
relationship between the two - both start to rise abruptly around
1990.
VACCINE MERCURY BURDEN AND AUTIISM RISK: UNFTED STATES
This moves my discussion into: Legal Concerns Congress Must Keep
in Mind Last year I predicted that if there was not immediate
action to address the growing understanding of thimerosal
toxicity and MMR, that this country would face potentially
catastrophic legal consequences. I made several recommendations,
some of which are echoed in the proposed amendments to the
Vaccine Injury Compensation Fund, (VIC Fund) supported by both
sides of this Committee. But sending parents to the "Fund" for
compensation for their child's needs is literal purgatory.
2002 WL 1335566 (F.D.C.H.) Page 17
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
As we search for truth in determining the safety, or lack
thereof, for the many vaccine components, we must keep in
perspective there exists two separate systems for determining
medical truth in this country: 1) the realm scientific purity
which is largely impossible to obtain in pediatric research and
practice, and 2) the legal or tort system.
The requirements to satisfy the Institute of Medicine, from my
personal dealings with them, might be greater than 90% certainty
prior to affirming any casual relationship to vaccine components.
But the tort system defines things differently. While it will not
be my place to offer legal definitions to the committee, it
suffices to say that our courts and/or special masters will soon
answer the question regarding vaccine linkage to autism.
Having been an expert at several causation hearings for vaccine
"Fund" cases, it is clear this system will in no way benefit the
children affected by ASD, even if the table were amended. The
program is broken beyond repair and the use of the Justice
Department to try cases is unwise. They - by the nature of legal
practices - take an adversarial position against the parents -
whom are already suffer through tremendous financial and emotion
hardships. Presently 85% of our ASD families have ended in
divorce. Clearly then, a non-adversarial system must be created,
or again the thousands of children enrolled in class- action or
private suits against vaccine manufacturers and distributors will
quickly become hundred's of thousands.
A primer on causality from Attorneys Kenneth S Lewis and Ann-
Louise Kleper: "To the lawyer, "cause" includes not only that
which precipitates, initiates or produces, but also that which
accelerates, aggravates or worsens some medical condition. In
other words, the definition embraces elements which bring about
symptoms, disability, damages or death sooner than would have
ordinarily been expected in the normal course of the underlying
disease. Such a concept is inherently foreign to scientific
thinking, which considers the underlying reason for the entire
disorder After considering all of the factors underlying the
disorder and their inter-relationships, medicine seeks to
ascertain the cause - the single element responsible for the
condition of ill-being, the identity of which may be demonstrated
clearly and conclusively. In law, exclusivity may not be
demanded... The evidence necessary to establish causation in
medicine must be verifiable by objective diagnostic methods;
physicians demand scientific proof. The law is too pressed for
time to allow the parties the luxury of such certainty. If
disputes are to be resolved and if justice is to be done, a
decision cannot be postponed until medical science advances to
the point where all questions posed by a particular claim may be
unequivocally determined. "
And what ultimately determines "scientific proof' always seems to
be debatable amongst the experts themselves. So, while medical
types piously discuss the purity of research, the courts grind
on. Inaction by Congress and Administrations (current and past)
2002 WL 1335566 (F.D.C.H.) Page 18
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
has allowed a tragic epidemic to go unnoticed, except by those
directly involved. While there may be some hope based on recent
meetings I have had with HHS, government response to the crisis
is still painfully slow. As regrettable as our present reality is
- it does appear families will be turning to the courts to
resolve their grievances in huge numbers. And that will be, to
quote the Bard: "A pox on both your Houses."
Regardless of the ultimate legal outcome, everyone will loose
something.
-The child with autism will loose irreplaceable time as the cost
of required treatment goes unmet by both governmental and
insurance providers.
-The vaccine manufacturers will pay vast amounts in legal defense
and thereby loose money which might be used to generate safer
vaccines. If the courts find against the vaccine industry, the
losses could be staggering - beyond any prior tort awards given
the nature of ASD and the huge numbers of children affected. -
Parents have already lost their peace of mind regarding public
health policy, but the public legal battle will no doubt erode
remaining confidence in vaccines even further regardless of the
science - doubt will be fostered.
-Society will continue to loose the productive contribution of
parents and children consumed by ASD.
Again I ask Congress and the Administration to address the needs
for families and the appropriate funding for ASD treatment,
therapy and research. In any other clinical setting the
information we have gathered on children would be far more than
what would be needed to make a diagnosis. Is it enough evidence?
Most certainly! Is it proof? Well, I guess that depends on what
you call proof. Is it more than the 50% assurance as would be
required in a legal setting? Is it 100%? No, but things rarely
are in medicine - especially early in the evolution of knowledge
on a new finding.
JAMES JEFFREY BRADSTREET
Clinical Director
The International Child Development Resource Center
2002 WL 1335566 (F.D.C.H.)
END OF DOCUMENT
2002 WL 1335566 (F.D.C.H.) Page 19
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
Federal Document Clearing House
Copyright (c) 2002 EMediaMillWorks, Inc.
Testimony
June 19, 2002
House of Representatives
Government Reform
Vaccine Safety and Autism
Statement of Doctor Andrew J Wakefield
MB MS FRCS
FRCPath
Committee on House Government Reform
June 2002
Mr Chairman and members of the Committee,
Before bringing you up to date with the research linking MMR
vaccine to regressive autism I will put the record straight with
respect to Dr Gershon's testimony last year on the molecular
detection of measles virus in the laboratory of Professor
O'Leary. Dr Gershon's testimony was false in relation to a number
of assertions, whether or not his testimony constituted perjury
or simply sloppy science. It is not my wish to take up valuable
time in this hearing with the details of Dr Gershon's
unacceptable errors. All correspondence and raw data have been
provided to the ranking majority and minority members. Merely by
way of illustration, he stated that tissues from experimental
animals not infected with measles virus were positive in
Professor O'Leary's lab. In fact they were all entirely and
consistently negative on repeat testing. Dr Gershon's behaviour
was a disgrace. I would level the same charge at anyone who
relies or has relied in any way upon this testimony. I am not
surprised that Dr Gershon turned down the offer to appear before
this committee. Had he done so, I am sure he would have
enlightened the Committee, somewhat belatedly, as to any
proprietary rights his wife might have in the Merck chickenpox
vaccine patent.
The current sate of the science:
The association between MMR vaccine, autism and intestinal
inflammation was first suggested by my group from the Royal Free
Medical School in 1998 in a paper published in the Lancet. The
same research team, in collaboration with Professor John O'Leary
and Dr Simon Murch from the Royal Free Hospital, has since shown
in a comprehensive series of eight peer-reviewed scientific
studies that the major findings of our original study were
correct. These papers are listed as an appendix.
The sum of the research by my group and our collaborators, taken
2002 WL 1335568 (F.D.C.H.) Page 20
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
together with additional work by independent physicians and
scientists in the United States has now confirmed the following
facts.
o Children with regressive autism and intestinal symptoms have a
novel and characteristic inflammatory disease of their intestine
(1-4).
oThis disease is not found in developmentally normal control
children (24).
oThis disease is entirely consistent with a viral cause (5-8).
oThis disease may be the source of toxic damage to the brain (9).
o Measles virus has been identified in the diseased intestine in
the majority of children with regressive autism studied,
precisely where it would be expected if were the cause of the
intestinal disease (5,8).
oThese children, who suffer the same pattern of regressive autism
and intestinal inflammation, come from many countries including
the US and Ireland where they have been investigated and biopsied
independently.
o Measles virus has been found in only a small minority of
developmentally normal children (5).
oThe measles virus in the diseased intestine of autistic children
is from the vaccine (11).
oChildren with regressive autism appear to have an abnormal
immune response to measles virus (1
o These findings are entirely consistent with parental reports
that their normally developing child regressed into autism
following exposure to MMR vaccine (1,11).
Confirmation of intestinal findings
Other researchers in the US have confirmed the presence of
intestinal inflammation in children with regressive autism (3a &
see testimony of Dr A.
Krigsman MD) and, independently, the link with measles virus in
children who were given the MMR vaccine (12,13).
Measles virus sequencing
Most significantly, a study due to be presented at the
Pathological Society of Great Britain and Ireland, in Dublin at
the beginning of July has confirmed that the measles vaccine
virus is present in the diseased intestinal tissues of children
with regressive autism.
The Dublin researchers headed by Dr John O'Leary, Professor of
Pathology at Trinity College Dublin, examined viral genetic
2002 WL 1335568 (F.D.C.H.) Page 21
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
material from intestinal biopsies taken from 12 children with
gastro-intestinal disease and an autistic spectrum disorder. The
viral genetic material had already been identified as measles in
a study published in January in Molecular Pathology. Using state
of the art molecular science the samples from these twelve
children have now been characterised as from vaccine strain
measles virus. This investigation continues. These data
constitute a key piece of evidence in the examination of the
relationship between MMR vaccine and regressive autism.
Re-challenge and biological gradient effects for MMRIMR vaccines
A further key piece of evidence comes from examination of "rechallenge"
and "biological gradient" effects for possible vaccinerelated
adverse events.
Re-challenge refers to a situation where re-exposure of an
individual to an agent (e.g. vaccine) elicits a similar adverse
reaction to that seen following the initial exposure. The
secondary reaction associated with re-challenge may either
reproduce the features associated with the primary challenge, or
may lead to worsening of the condition that was provoked or
induced by the initial exposure.
During the course of our clinical investigation we have observed
that some children who received a second dose of MMR, or boosting
with the combined measles rubella (MR) vaccine, experienced
further deterioration in their physical and/or behavioural
symptoms following re-exposure. In a report of April 2001, the
Vaccine Safety Committee of the US Institute of Medicine (IOM)
stated that, in the context of MMR vaccine as a possible cause of
this syndrome, "challenge re-challenge exposed would constitute
strong evidence of an association"'.
In the context of adverse vaccine reactions, a biological
gradient refers to an increasing severity of, or increased risk
of developing, a particular disease outcome. More severe bowel
disease in children with regressive autism who had received more
than one MMR/MR would be an example of this.
We have undertaken systematic evaluation of re-challenge and
biological gradient effects in children with regressive autism
who have undergone investigation at the Royal Free Hospital.
"Exposed" - children with normal early development & regressive
autism who had received more than one MMR/MR - were compared with
age and sex matched "unexposed" - children with normal early
development & with regressive autism who had received only one
MMR but otherwise similar baseline characteristics to the exposed
group. Comparisons included: secondary (2)
developmental/behavioural regression; 2 physical deterioration,
prospective, observer-blinded scores of endoscopic & microscopic
disease severity.
In a preliminary analysis exposed children scored significantly
higher than unexposed children for:
2002 WL 1335568 (F.D.C.H.) Page 22
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
(i)secondary regression on the basis of analyses performed at the
different levels, including
oparental history
oexcluding those whose secondary regression occurred following
publication of the 1St suggested MMR-autism link in 1998; and,
o inclusion of only those for whom independent corroborative
evidence of secondary regression was obtained from the records;
(ii)secondary physical symptoms;
(iii)presence of severe ileal lymphoid hyperplasia; and,
(iii)presence and severity of acute mucosal inflammation.
No measures of disease were worse in unexposed than exposed
children.
These data identify a re-challenge effect on symptoms and a
biological gradient effect on severity of intestinal inflammation
that provide evidence of a causal association between MMR and
regressive autism in these children.
I have repeatedly requested a meeting with Sir Liam Donaldson the
UK's Chief Medical Officer to discuss the situation. His response
has been to refuse to meet, but instead to demand that we send
him the children's samples. He has provided absolutely no
indication, in terms of scientific protocol, how he would proceed
to analyse these samples. He has, as far as I am aware, no
ethical approval for analysing these samples. He may be reassured
to know that independent testing is being conducted and that as
part of the litigation process in the UK, the Defendants are
being provided with identical samples for independent analysis.
The last seven days have seen a report, in the journal Clinical
Evidence, publicised as "new research" disproving any links
between autism and the MMR vaccine. The authors specifically
excluded clinical research into bowel disease, immune disorders
and other documented features of autism that may relate to a
viral cause. They do not cite any of our publications beyond the
initial study of 12 children in 1998. In fact, the Clinical
Evidence paper was no more than a review of the epidemiological
studies, including the Davis study that will be critically
reviewed during this hearing, that have already been dismissed as
irrelevant by an independent review commissioned by the Institute
of Medicine in the US.
ANDREW J WAKEFIELD
Doctor
Frcpath
2002 WL 1335568 (F.D.C.H.) Page 23
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
2002 WL 1335568 (F.D.C.H.)
END OF DOCUMENT
2002 WL 1335568 (F.D.C.H.) Page 24
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
Federal Document Clearing House
Copyright (c) 2002 EMediaMillWorks, Inc.
Testimony
June 19, 2002
House of Representatives
Government Reform
Vaccine Safety and Autism
Statement of Roger Bernier, Ph.D., M.P.H.
Associate Director for Science,National Immunization Program
Centers for Disease Control and Prevention,
U.S. Department of Health and Human Services
Committee on House Government Reform
June 19, 2002
Good afternoon Mr. Chairman, Congressman Waxman, and members of
the Committee. I am Dr. Roger Bernier, of the National
Immunization Program at the Centers for Disease Control and
Prevention (CDC). Thank you for the opportunity to testify today
on CDC's activities on vaccine safety research.
I am accompanied today by Dr. William Egan, Deputy Director,
Office of Vaccines Research and Review, Center for Biologics
Evaluation and Review, Food and Drug Administration, and Dr.
Stephen Foote, Director, Division of Neuroscience and Basic
Behavioral Science, National Institute of Mental Health, National
Institutes of Health.At your request, Dr. Robert Chen of CDC's
National Immunization Program and Dr. Frank DeStefano of CDC's
National Center on Birth Defects and Developmental Disabilities
are here to respond to questions.
AUTISM AND VACCINES
Autism spectrum disorders (ASD) are a group of life-long
developmental disabilities caused by an abnormality of the brain.
The most recent data suggests that between 2 and 6 children per
1,000 have ASD. The impact on families of children diagnosed with
autism spectrum disorders is tremendous. We recognize that there
is considerable public interest and concern on this issue and we
are committed to addressing concerns of parents and families. The
Department of Health and Human Services (HHS) is dedicated to
finding the answer to what causes autism and how it can be
prevented. There is a great deal of ongoing research throughout
the various public health agencies. While my focus today is on
vaccine safety related issues, it should be noted that HHS has
implemented an Interagency Autism Coordinating Committee (IACC).
The IACC is composed of representatives from MIH (top which the
2002 WL 1335571 (F.D.C.H.) Page 25
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
Department has delegated a leadership role in organizing and
supporting the committee), CDC, FDA, the Health Resources and
Services Administration (HRSA), the Agency for Toxic Substances
and Disease Registry (ATSDR), the Substance Abuse and Mental
Health Services Administration (SAMHSA), the Department of
Education, and four public members appointed by the Secretary of
HHS. The IACC takes as its mandate enhanced coordination of the
autism-related activities of these federal agencies, from
biomedical research to services delivery. At the most recent IACC
meeting, topics included the progress being made on
implementation of autism research centers programs by NIH and
CDC; efforts to comprehensively map the autism research field in
order to analyze its strengths and weaknesses; information about
each of the individual grants that collectively constitute the
majority of the NIH autism research portfolio; strategies to
improve the coordination of gene and tissue banking, data
sharing, and federal interactions with voluntary organizations;
and, strategic planning for the development of treatments and
interventions for autism. The activities of this committee
highlight the large-scale, coordinated response that has been
launched by HHS in order to understand, prevent and treat autism.
Some parents, researchers and others have expressed concerns
about a potential link between autism and vaccines currently
being used in the United States, focusing primarily on
thimerosal, a preservative in some vaccines, and secondly, on
measles, mumps, and rubella (MMR) vaccine.
In mid-1999, the United States Public Health Service agencies,
including NIH, FDA, HRSA, and CDC took action, working
collaboratively with the American Academy of Pediatrics, the
American Academy of Family Physicians and the vaccine
manufacturers, to begin removing thimerosal preservative from the
vaccine supply. While the risk of harm was only theoretical, the
decision was made as a precautionary measure in order to reduce
overall mercury exposure of infants. As a result of this action,
all manufacturers are now producing only vaccines that are free
of thimerosal as a preservative for routine infant immunization.
The suggestion that MMR vaccine, which has never contained
thimerosal, triggers autism was initially based on some reports
of cases of autism in which parents noted the onset of autistic
behaviors shortly after MMR vaccination. Over the last few years,
a number of studies have been performed in countries around the
world to address this issue. Systematic scientific reviews by
some of the most prestigious medical bodies around the world
including the Medical Research Council in the United Kingdom, the
American Academy of Pediatrics, and the Institute of Medicine of
the National Academy of Sciences have unanimously concluded that
evidence does not support a relationship between MMR and autism.
The most recent review was conducted in the United Kingdom and
commissioned by the British Medical Association. British experts
reviewed five decades of research on the MMR vaccine and
concluded that there is no link to autism or bowel
disease.However, despite these findings and because of continued
2002 WL 1335571 (F.D.C.H.) Page 26
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
public concerns, CDC is committed to further scientific research
on this issue as detailed in this testimony.
CDC'S COMMITMENT TO VACCINE SAFETY
CDC is actively involved in detecting and investigating vaccine
safety concerns and supporting a wide range of vaccine safety
research to address safety questions.
In order to enhance the understanding of rare adverse effects of
vaccines, CDC developed the Vaccine Safety Datalink (VSD) project
in 1990. This project is a collaborative effort, which utilizes
the databases of eight large health maintenance organizations
(HMOs). The database contains comprehensive medical and
immunization histories of approximately 7.5 million children and
adults. The VSD enables vaccine safety research studies comparing
incidence of health problems between unvaccinated and vaccinated
people. Over the past decade, the VSD has been used to answer
many vaccine-related questions, and has been used to support
policy changes that have reduced adverse effects from vaccines.
CDC recognizes the importance of data sharing when questions are
raised regarding a particular study's design and methodology.
Therefore, CDC has been actively engaged with the participating
HMOs to determine how their clients' personal medical records can
be maintained confidentially and the proprietary interests of the
HMOs protected, while still allowing for external researchers to
reanalyze the data from studies which have been conducted through
the Vaccine Safety Datalink. As a result, CDC has developed a
data sharing process designed to allow an independent researcher
to replicate or conduct a modified analysis of a previous VSD
study, while maintaining the confidential nature of the data.
Another critical part of our vaccine safety effort is the
objective, scientific evaluation of safety concerns by
independent experts. In collaboration with NIH and other U. S.
Public Health Service agencies, CDC requested the Institute of
Medicine (IOM) to conduct independent reviews by independent
scientific experts to determine: 1) whether the available
scientific information favors, or does not favor, vaccines
playing a role in causation, 2) the level of public health
priority the concern should receive, and 3) recommendations for
research. The IOM Immunization Safety Review Committee has
released reports on MMR Vaccine and Autism, Thimerosal and
Neurodevelopmental Disorders, Hepatitis B and Neurological
Disorders and the Multiple Immunizations and Immune Dysfunction.
The IOM was asked to review the available scientific information
on these issues. CDC has initiated a broad range of studies to
address recommendations made by the IOM Immunization Safety
Review Committee.
MMR and Autism Studies
In its report regarding the association between the MMR vaccine
and autism spectrum disorder (ASD) in April 2001, the IOM
concluded "the evidence favors rejection of a causal relationship
at the population level between MMR vaccine and autism spectrum
2002 WL 1335571 (F.D.C.H.) Page 27
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
disorder." The IOM made several recommendations regarding future
research including the following epidemiological studies:
1.Explore whether exposure to MMR vaccine is a risk factor for
ASD in a small number of children;
2.Develop targeted investigations of whether or not measles
vaccine-strain virus is present in the intestines of some
children with ASD;
3.Study the possible effects of different MMR immunization
exposures; and
4.Conduct further clinical and epidemiological studies of
sufficient rigor to identify risk factors and biological markers
of ASD in order to better understand genetic or environmental
causes.
CDC takes this issue very seriously and therefore, is currently
funding five research studies that address the above four
recommendations from the IOM:
The first study, the Metropolitan Atlanta Developmental
Disabilities Surveillance Program (MADDSP) MMR/Autism Study, is a
large case-control study. The autism cases for the study were
identified through MADDSP. The control subjects were selected
from the same or similar schools in the Atlanta area and matched
to cases based on age and gender. The study is assessing the
relationship between the timing of receipt of thefirst MMR
vaccine and risk for developing autism. The analyses for this
study and a manuscript should be completed by early fall 2002.
The second study, the MMR/Regression Autism Study funded by CDC
and the National Institutes of Child Health and Human Development
(NICHD) is also a large case-control study that is using a sample
of autism cases identified as part of the NICHD and the National
Institute on Deafness and other Communication Disorders (NIDCD)
10 Collaborative Programs of Excellence in Autism (CPEA). This
study is specifically designed to examine the association between
regression autism and the timing of first receipt of the MMR
vaccine. The study is being carried out over a three-year period
and results from this study are expected in the spring of 2004.
The third study, the Denmark MMR/Autism Study, is a recent study
that was carried out in Denmark in collaboration with CDC. The
study was designed to follow-up on approximately 537,000 children
born in Denmark during the period from January 1, 1991 to
December 31, 1998. Of these, 82% received MMR vaccine. The cohort
was generated based on data obtained from the Danish Civil
Registration System and subsequently linked with other national
registries. This manuscript has been submitted for publication
this year.
The fourth study is a large epidemiological study to identify
risk factors and biological markers of ASD to better understand
genetic or environmental causes. The study is being planned in
2002 WL 1335571 (F.D.C.H.) Page 28
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
the four Centers for Autism and Developmental Disabilities
Research and Epidemiology (CADDRE), which are being supported by
CDC.
Additionally, CDC is in the early stages of planning a study to
investigate whether or not measles vaccine-strain virus is
present in the intestines of some children with ASD.
There have been a limited number of laboratory reports of the
finding of measles virus sequences in intestinal tissue and white
blood cells of children with ASD; therefore, there has been
speculation that MMR vaccine either precipitates or aggravates
ASD. However, other epidemiologic and laboratory studies do not
support this observation. To resolve differences in results from
previous studies that may have occurred due to differences in
study design, sampling biases, and differences in laboratory
asstesting procedures and their sensitivity, an independent,
multicenter study is being designed. The study plan is to
determine the prevalence of measles virus vaccine strain gene
sequences in bowel biopsy tissue from children with
gastrointestinal tract complaints with and without ASD. The study
will be designed to ensure use of standardized clinical and
laboratory protocols, appropriate enrollment of controls,
blinding of specimens, use of standardized laboratory reagents
and assays, and appropriate statistical evaluation.
Thimerosal and Neurodevelopmental Delay Studies
In October 2001, the IOM Immunization Safety Review Committee
published a report on the possible association between thimerosalcontaining
vaccines and neurodevelopmental disorders. In this
report, the IOM concluded "that the evidence is inadequate to
accept or reject a causal relationship between exposure to
thimerosal from childhood vaccines and the neurodevelopmental
disorders of autism, ADHD (attention deficit hyperactivitity
disorder), and speech or language delay." The IOM made several
recommendations regarding future research studies including
several epidemiological studies. They recommended:
A.Case-control studies examining the potential link between
neurodevelopmental disorders and thimerosal-containing vaccines;
B.Further analysis of neurodevelopmental outcomes in several
cohorts of children outside the U.S. who participated in a
clinical trial of DTaP vaccine; and,
C.Conducting epidemiological studies that compare the incidence
and prevalence of neurodevelopmental disorders before and after
the removal of thimerosal from vaccines.
While there have been no vaccines being produced for routine
childhood immunization for over a year that contain thimerosal as
a preservative, CDC takes this issue very seriously and
therefore, has undertaken several studies that address the above
IOM recommendations:
2002 WL 1335571 (F.D.C.H.) Page 29
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
The first study, the Thimerosal Screening Analysis in the Vaccine
Safety Datalink (VSD) project, was started in the fall of 1999.
The VSD, described earlier, was used to screen for possible
associations between exposure to thimerosal-containing vaccines
and a variety of renal, neurologic and developmental problems. In
the first phase of this study, the CDC used data from the 2 VSD
HMOs with automated outpatient data (where more subtle effects of
mercury toxicity might be seen). The CDC and VSD researchers
found statistically significant associations between thimerosal
and neurodevelopmental disorders, such as language and speech
delays, ADHD, stuttering, and tics. No association was shown with
autism. However, the associations were weak and were not
consistent between the two HMOs. In the second phase of the
investigation, CDC investigators examined data from a third HMO
with similar available automated vaccination and outpatient
databases to see if these findings could be replicated. Analyses
of these data using the same methods as the first study did not
confirm results seen in the first phase. A statistically
significant relationship between autism and thimerosal was not
found in either the preliminary study or the later, larger
analysis. Due to the methodological limitations of the screening
analysis using automated data and the difference between the
preliminary study and the later analyses, the results required
further examination.
CDC and VSD researchers are committed to clarifying the results
encountered during the VSD Screening Analysis; therefore, a
Thimerosal Follow-Up Study will be conducted. This second study
will be designed to assess whether preliminary results from
automated data used in the Thimerosal Screening Analysis can be
confirmed using objective neuropsychological testing. The study
will focus on the conditions found in the first screening
analyses, including language and speech delays and ADHD. The
design of the new study will address the main drawback of the
Thimerosal Screening Analysis, which was that children were not
objectively assessed on the neurodevelopmental disorders of
interest. The various VSD HMOs categorize neurodevelopmental
disabilities in different ways, provide different services for
these disorders, and often refer children out of the health care
network when they are identified with these particular disorders.
The Thimerosal Follow-Up Study is planned to examine
approximately 1200 children between the ages of 7 and 9 years of
age randomly selected from four VSD HMOs based on thimerosal
exposure during the first 3 months of life. All 1200 children
will be brought into their respective HMOs and will be assessed
using a standardized set of neuropsychological test batteries.
The preliminary proposal for this study was presented to a panel
of external consultants including a consumer representative in
March of 2001. In September of 2001, CDC awarded a contract to
Abt Associates Inc. to carry out the planning phase of the study.
The panel of external consultants continues to provide individual
input into the study design and the planning phase should be
completed by June 2002. Data collection is expected to begin in
the latter half of 2002. Abt Associates Inc. is expected to
2002 WL 1335571 (F.D.C.H.) Page 30
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
present the results of the study by the end of 2003.
Several additional studies are being planned to address
additional issues raised by the IOM. These include:
The Thimerosal/Autism Study will be a case-control study to be
conducted simultaneously with the Thimerosal Follow-up Study.
Autism cases identified through review of automated medical
records will be assessed objectively by using a standardized
autism assessment tool. Controls will be selected from the
Thimerosal Follow-up Study and matched to cases by age and sex.
CDC has developed a proposal for a pilot study to conduct further
analyses of a group of Italian children who had participated in a
prior DTaP trial in which thimerosal exposure was randomly
allocated. CDC is pursuing this to determine the feasibility of
recruiting these participates for a follow-up study of
neurodevelopmental outcomes.
Two other studies being planned will examine changes over time in
the diagnosis of neurodevelopmental delays including autism.
These studies will use inpatient and outpatient discharge
diagnoses to compare rates of these conditions over time with
changes in levels of thimerosal in recommended childhood
vaccines. Because recommendations for the removal of thimerosal
from vaccines did not occur until 1999, several years of data
following the removal of thimerosal will be necessary before
these comparisons can be made. Thus, results will not be
available until 2005 or later.
BENEFITS OF VACCINES
We remain vigilant to assure the safety of vaccines. We must also
remember that vaccines benefit the public by protecting persons
from the consequences of infectious diseases. Continued high U.S.
vaccination rates are crucial to prevent the spread of diseases
such as measles, pertussis (whooping cough) and rubella among
U.S. children. Current measles coverage is approximately 91% in
children 19-35 months old and about 97% at school entry, and only
about 100 cases of measles have been reported per year; many of
the cases are imported; and ongoing indigenous transmission of
measles no longer occurs. From 1989-91, a measles epidemic in the
United States led to more than 55,000 cases of measles and more
than 11,000 hospitalizations, with 123 deaths in three years.
Before this epidemic, vaccination coverage was estimated at 61-
66% nationally and at 51-79% in 15 major cities. These outbreaks
stopped only when vaccination coverage increased. Thus, if preschool
coverage dropped by 25-30% below the current level, large
measles outbreaks are likely to occur once again. Additionally,
pertussis has continued to be a public health threat. For
example, in 1999, there were 7297 cases of pertussis in the
United States, with 15 reported deaths.
Vaccines are cited as one of the greatest achievements of
biomedical science and public health in the 20th century. We can
point to the remarkable success we have had in controlling
2002 WL 1335571 (F.D.C.H.) Page 31
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
numerous infectious diseases which used to be widely prevalent in
the United States, including polio, measles, and pertussis. In
fact, several of these vaccine-preventable infectious diseases
are known to cause developmental disabilities, including
Haemophilus influenzae type b (Hib) and congenital rubella
syndrome (CRS), one of the few known causes of autism. Rubella
vaccine, by preventing CRS, thus prevents some cases of autism.
Prior to routine immunization with Hib vaccine, of young children
who developed Hib meningitis, 5 percent died and another 15 to 30
percent were left with residual brain damage leading to language
disorders and mental retardation.
While we have made great progress to reduce the number of cases
of vaccine-preventable diseases, the threats posed by vaccinepreventable
diseases are known and real. The viruses and bacteria
that cause vaccine-preventable diseases still circulate in the
U.S. and around the world. Maintaining vaccination coverage and
high levels of immunity are crucial to protect the U.S.
population and to continue progress toward elimination of
diseases that, at one time, caused millions of infections in the
U.S. each year and that globally remain the leading causes of
death and of preventable birth defects.
CONCLUSION
CDC remains committed to collecting accurate data on prevalence
of autism and conducting studies on vaccine safety. Research is
already underway, and more is planned, to look at the
relationship between the MMR vaccine and autism. We want each
child to be born healthy and to grow and develop normally, so
that they are able to lead productive lives. Vaccines are one of
our most valuable weapons against disease and have afforded us
one of our proudest achievements in public health.
Thank you, Mr. Chairman and members of the Committee, for the
opportunity to testify before you today. I would be happy to
answer any questions that you may have.
ROGER BERNIER
Associate Director
U.S. Department of Health and Human Services
2002 WL 1335571 (F.D.C.H.)
END OF DOCUMENT
2002 WL 1335571 (F.D.C.H.) Page 32
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
Federal Document Clearing House
Copyright (c) 2002 eMediaMillWorks, Inc.
Verbatim Transcript
June 19, 2002
House of Representatives
Government Reform Committee
Committee Hearing
U.S. Representative Dan Burton (R-In) Holds Hearing on Vaccines and Autism
U.S. HOUSE OF REPRESENTATIVES, GOVERNMENT REFORM COMMITTEE
HOLDS A HEARING ON THE STATUS OF RESEARCH INTO VACCINE SAFETY
AND AUTISM.
WEDNESDAY, JUNE 19, 2002
SPEAKERS:
U.S. REPRESENTATIVE DAN BURTON (R-IN)
CHAIRMAN
U.S. REPRESENTATIVE BENJAMIN GILMAN (R-NY)
U.S. REPRESENTATIVE CONSTANCE MORELLA (R-MD)
U.S. REPRESENTATIVE CHRISTOPHER SHAYS (R-CT)
U.S. REPRESENTATIVE ILEANA ROS-LEHTINEN (R-FL)
U.S. REPRESENTATIVE JOHN MCHUGH (R-NY)
U.S. REPRESENTATIVE STEPHEN HORN (R-CA)
U.S. REPRESENTATIVE JOHN MICA (R-FL)
U.S. REPRESENTATIVE THOMAS DAVIS III (R-VA)
U.S. REPRESENTATIVE MARK SOUDER (R-IN)
U.S. REPRESENTATIVE STEVEN LATOURETTE (R-OH)
U.S. REPRESENTATIVE BOB BARR (R-GA)
U.S. REPRESENTATIVE DAN MILLER (R-FL)
U.S. REPRESENTATIVE DOUG OSE (R-CA)
U.S. REPRESENTATIVE RON LEWIS (R-KY)
U.S. REPRESENTATIVE JO ANN DAVIS (R-VA)
U.S. REPRESENTATIVE TODD RUSSELL PLATTS (R-PA)
U.S. REPRESENTATIVE DAVE WELDON (R-FL)
U.S. REPRESENTATIVE CHRIS CANNON (R-UT)
U.S. REPRESENTATIVE ADAM PUTNAM (R-FL)
U.S. REPRESENTATIVE BUTCH OTTER (R-ID)
U.S. REPRESENTATIVE ED SCHROCK (R-VA)
U.S. REPRESENTATIVE JOHN DUNCAN (R-TN)
U.S. REPRESENTATIVE HENRY WAXMAN (D-CA)
RANKING MEMBER
U.S. REPRESENTATIVE TOM LANTOS (D-CA)
U.S. REPRESENTATIVE MAJOR OWENS (D-NY)
U.S. REPRESENTATIVE EDOLPHUS TOWNS (D-NY)
U.S. REPRESENTATIVE PAUL KANJORSKI (D-PA)
U.S. REPRESENTATIVE PATSY MINK (D-HI)
U.S. REPRESENTATIVE CAROLYN MALONEY (D-NY)
U.S. REPRESENTATIVE ELEANOR HOLMES NORTON (D-DC)
U.S. REPRESENTATIVE ELIJAH CUMMINGS (D-MD)
U.S. REPRESENTATIVE DENNIS KUCINICH (D-OH)
2002 WL 1341099 (F.D.C.H.) Page 33
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
U.S. REPRESENTATIVE ROD BLAGOJEVICH (D-IL)
U.S. REPRESENTATIVE DANNY DAVIS (D-IL)
U.S. REPRESENTATIVE JOHN TIERNEY (D-MA)
U.S. REPRESENTATIVE JIM TURNER (D-TX)
U.S. REPRESENTATIVE THOMAS ALLEN (D-ME)
U.S. REPRESENTATIVE JANICE SCHAKOWSKY (D-IL)
U.S. REPRESENTATIVE WM. LACY CLAY (D-MO)
U.S. REPRESENTATIVE DIANE WATSON (D-CA)
U.S. REPRESENTATIVE STEPHEN LYNCH (DU.
S. REPRESENTATIVE BERNARD SANDERS (I-VT)
WITNESSES:
PANEL I
DR. JEFF BRADSTREET, MD, FAAFP,
MEDICAL DOCTOR AND FOUNDER OF THE INTERNATIONAL CHILD
DEVELOPMENT RESOURCE CENTER AND AN AUTISM PARENT
DR. ANDREW WAKEFIELD, MD
RESEARCH DIRECTOR
INTERNATIONAL CHILD DEVELOPMENT RESOURCE CENTER
DR. ARTHUR KRIGSMAN, MD
PEDIATRIC GASTROINTESTINAL CONSULTANT
LENOX HILL HOSPITAL
CLINICAL ASSISTANT PROFESSOR
DEPARTMENT OF PEDIATRICS
NEW YORK UNIVERSITY SCHOOL OF MEDICINE
DR. VERA STEJSKAL
ASSOCIATE PROFESSOR OF IMMUNOLOGY
UNIVERSITY OF STOCKHOLM AND
MELISA MEDICA FOUNDATION
DR. WALTER SPITZER, MD, MPH, FRCPC
EMERITUS PROFESSOR OF EPIDEMIOLOGY
MCGILL UNIVERSITY
PANEL II
DR. ROGER BERNIER
ASSOCIATE DIRECTOR FOR SCIENCE
OFFICE OF THE DIRECTOR
CENTER FOR DISEASE CONTROL AND PREVENTION
DR. ROBERT CHEN
CHIEF OF VACCINE SAFETY AND DEVELOPMENT
NATIONAL IMMUNIZATION PROGRAM AND
ASSOCIATE DIRECTOR FOR SCIENCE AND PUBLIC HEALTH
NATIONAL CENTER ON BIRTH DEFECTS AND DEVELOPMENTAL
DISABILITIES
CENTER FOR DISEASE CONTROL AND PREVENTION
DR. FRANK DESTEFANO
MEDICAL EPIDEMIOLOGIST
2002 WL 1341099 (F.D.C.H.) Page 34
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
NATIONAL CENTER ON BIRTH DEFECTS AND DEVELOPMENTAL
DISABILITIES
CENTER FOR DISEASE CONTROL AND PREVENTION
DR. STEPHEN FOOTE
NATIONAL INSTITUTES OF HEALTH
DR. WILLIAM EGAN
FOOD AND DRUG ADMINISTRATION
BURTON: Good afternoon. I'm sorry we're getting started just a
little bit late. It's my fault and I apologize.
A quorum being present, the Committee on Government Reform will
come to order. And I ask unanimous consent that all members' and
witnesses' written and opening statements be included in the record.
Without objection, so ordered.
I ask unanimous consent that all articles, exhibits and
extraneous or tabular materials referred to be included in the record.
And without objection, so ordered.
In April, the committee conducted a hearing reviewing the
epidemic of autism and the Department of Health and Human Service's
response. Ten years ago, autism was thought to affect one in 10,000
children in the United States. When the committee began its oversight
investigation in 1999, it was thought to affect one in 500 children.
Today, the National Institutes of Health estimates that autism affects
one in 250 children.
Now think about that. It's gone from one in 10,000 to one in
250. We have an absolute epidemic.
In April, we looked at the investment our government has made
into autism as compared to other epidemics. We showed in that hearing
that the CDC and NIH have not provided adequate funding to address the
issues in the manner that our public health service agencies have used
to address other epidemics. And we have some charts that I think
you're going to put up there on the screen to show this.
After our hearing, I joined with my colleagues on the Coalition
on Autism Research and Education to request from our appropriators
that at least $120 million be made available in fiscal year 2003 for
autism research across the NIH and at that an additional $8 million be
added to the CDC's budget for autism research.
Giving more money to research is not the only answer though.
Oversight is needed to make sure that research that is funded will
sufficiently answer the questions regarding the epidemic: how to treat
autism and how to prevent the next 10 years from seeing the statistic
of one in 250 children go to one in 25 children.
High quality clinical and laboratory research is needed now, not
five or 10 years from now. Independent analysis of previous
epidemiological and case control studies is needed as well.
2002 WL 1341099 (F.D.C.H.) Page 35
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
We have learned that a majority of parents whose children have
late-onset or acquired autism believe it is vaccine-related. They
deserve answers. We have also learned that the parents have been our
best investigators in looking for both causes of autism and for
treatments.
It has been parents who have formed non-profit organizations to
raise research dollars to conduct the research that the CDC, the FDA
and NIH have neglected to do. We have heard from many of these
parents in the past: Elizabeth Birt, Rick Rollens, Shelley Reynolds
and Jeanna Smith, just to name just a few. Each of these parents had
healthy babies who became autistic after vaccination.
I might have been like many of the officials within the public
health community -- denying a connection -- had I not witnessed this
tragedy in my own family. I might not have believed the reports from
parents like Scott and Laura Bono, Jeff Sell, Jeff and Shelly Segal
and Ginger Brown, who came to me with pictures, videos and medical
records. I might have been like so many pediatricians who discounted
the correlation between vaccination and the onset of fever, crying and
behavioral changes.
Because both of my grandchildren -- not one, but both of my
grandchildren -- suffered adverse reactions to vaccines, I could not
ignore the parents' plea for help. I could not ignore their evidence.
My only grandson became autistic right before my eyes, shortly
after receiving his federally recommended and state-mandated vaccines.
Without a full explanation of what was in the shots being given, my
talkative, playful, outgoing healthy grandson Christian was subjected
to very high levels of mercury through his vaccines. He also received
the MMR vaccine. And within a few days -- and I'm telling you, within
a few days -- he was showing signs of autism.
I won't go into the details. Those of you who have autistic
children know what I'm talking about.
As a part of our investigation, the committee has reviewed
ongoing concerns about vaccine safety, vaccine adverse events
tracking, the Vaccine Safety Datalink (VSD) Project and the National
Vaccine Injury Compensation Program. I have joined with Congressman
Weldon, Congressman Waxman and 32 other members of Congress in
introducing HR 3741, the National Vaccine Injury Compensation Program
Improvement Act of 2002, to realign the compensation program with
congressional intent.
In today's hearing, we will receive a research update from
several previous witnesses, as well as new research findings that
further support a connection between autism and vaccine adverse
events. We will learn more about both the possible link between the
use of the mercury-containing preservative thimerosal in vaccines and
autism, as well as autistic entercolitis resulting from the Measles-
Mumps-Rubella vaccine, MMR vaccine.
Through a congressional mandate to review thimerosal content in
medicines, the FDA learned that childhood vaccines, when given
2002 WL 1341099 (F.D.C.H.) Page 36
Copr. © West 2002 No Claim to Orig. U.S. Govt. Works
according to the CDC's recommendations, exposed over 8,000 children a
day -- 8,000 a day -- in the United States to levels of mercury that
exceed federal guidelines. Is there a connection between this toxic
exposure to mercury and the autism epidemic? We will hear from Dr.
James Bradstreet and Dr. Vera Stejskal on this issue.
We have twice received testimony from Dr. Andrew Wakefield
regarding his clinical research into autistic enterocolitis. We will
learn today that not only has he continued to conduct clinical
research, but that this research is confirming the presence of
vaccine-related measles RNA in the biopsies from autistic children.
Dr. Wakefield, like many scientists who blaze new trails, has
been attacked by his own profession. He has been forced out of his
position at the Royal Free Hospital in England. He and his colleagues
have fought an uphill battle to continue the research that has been a
lone ray of hope for parents whose children have autistic
enterocolitis.
Dr. Arthur Krigsman is joining us as well today to discuss his
clinical findings of inflammatory bowel disorder in autistic children.
He will share with us his initial findings, as well as discuss his
research plans currently with his institutional review board for
approval.
Do the epidemiological and case control studies, which the CDC
has attempted to use to refute Dr. Wakefield's laboratory results,
answer the autism-vaccine questions honestly? Epidemiologist Dr.
Walter Spitzer is back today to answer this question. What else is
needed to prove or disprove a connection?
Unfortunately, rather than considering the preliminary clinical
findings of Dr. Wakefield as a newly documented adverse reaction to a
vaccine, the CDC attempted to refute these clinical findings through
an epidemiological review. While epidemiological research is very
important, it cannot be used to disprove laboratory and clinical
findings. Valuable time was lost in replicating this research and
determining whether the hypothesis was accurate.
Officials at HHS have aggressively denied any possible connection
between vaccines and autism. They have waged an information campaign
endorsing one conclusion on this issue where the science is still out.
This has significantly undermined public confidence in the career
public service professionals who