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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

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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.

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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

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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.

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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

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END OF DOCUMENT

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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

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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).

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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

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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

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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

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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

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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

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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)

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-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.

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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

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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.

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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)

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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

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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

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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

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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:

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(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

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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

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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

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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

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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

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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:

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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

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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

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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

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END OF DOCUMENT

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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)

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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

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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.

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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

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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 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. And that's something that we continue to look

into. How will HHS restore the public's trust?

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One of the primary topics to be discussed at this hearing is

access to the Vaccine Safety Datalink. 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 or 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 10-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 our

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

scientific or 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 beenput into effect.

And the staff was informed that the plan had been put into effect.

However, there had been no public announcement. They put it into

effect, but they didn't tell anybody.

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. And that's not acceptable.

That's why I insisted that Dr. Chen be here today. I just wanted

to ask him why they didn't tell anybody 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.

Dr. Roger Bernier is here from the CDC to testify about these

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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 coauthor

of the MMR-IBD study. They are here to address our questions

on the VSD project and the vaccine-autism research. The CDC employees

are accompanied by Dr. Stephen Foote from the National Institutes of

Health and Dr. William Egan of the FDA.

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. And our record,

the hearing record will remain open until July 3rd. And I now

recognize Mr. Waxman.

WAXMAN: Mr. Chairman, today you have convened a hearing about

the safety of vaccines. This is an important topic and also a

familiar one to this committee.

Over the last several years, you have held a series of hearings

raising questions about the safety of vaccines, questions that

undoubtedly have caused real concern among some parents. These

hearings have had some positive effects.

Your interest over the years has led to unprecedented attention

to vaccine safety. Since your first hearing on the topic, many

respected researchers have chosen to investigate whether vaccines are

associated with inflammatory bowel disease, autism, diabetes and other

assorted conditions among children. While rare side effects from

vaccines are always possible, these studies have not found that

vaccines are associated with any of these serious health problems.

Since your first vaccine safety hearing, a blue ribbon panel of

scientists convened by the Institute of Medicine has reviewed many of

the most widely disseminated theories alleging harm from vaccines.

This esteemed panel evaluated the allegations that the MMR vaccine

causes autism.

Such studies claim that thimerosal, a vaccine preservative, cause

development delay. It reviewed whether the Hepatitis B vaccine causes

neurological injury. It assessed the theory that multiple

vaccinations cause allergies and asthma.

In each case, the Institute of Medicine panel has found that

scientific evidence does not validate the theory. Expert panels in

other nations have reached similar conclusions.

Mr. Chairman, you have challenged the public health systemto

defend itself against numerous allegations that vaccines cause a wide

variety of problems. I am not aware of any allegation about the

safety of vaccines that you have not pursued.

So far, the subsequent investigations and expert reviews have

found vaccines to be safe. Because of your efforts in this area,

Americans can have more confidence today in the safety of the vaccine

supply than ever before.

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But there has also been a negative consequence to your approach.

You have repeatedly provided a forum for unsubstantiated allegations

about vaccine safety that has alarmed and confused parents. Although

the scientific evidence of vaccine safety has grown stronger, parental

concerns about vaccine safety have also increased since we started

these hearings. This is a potentially dangerous development because

it can lead to lower immunization rates and more disease.

I recently asked the Centers for Disease Control to describe what

would happen if MMR immunization rates dropped. According to CDC, if

immunization rates dropped to the levels they were in 1989, we could

see over 26,000 hospitalizations from measles, 8,500 cases of

pneumonia, 135 cases of encephalitis and 224 deaths.

According to the Centers for Disease Control, even a drop in

immunization rates of 10 percent could result in an additional two

million kids being susceptible to measles. It would also

significantly increase susceptibility to rubella and congenital

rubella syndrome, which can cause serious birth defects, such as

blindness, deafness and stillbirth.

Congenital rubella syndrome is also a well-known cause of autism,

a disease that we all want to prevent. How tragic it would be if an

unjustified vaccine scare caused some children to die and others to

have permanent brain deficits and still others to suffer from autism.

I ask that the information from the CDC be placed in the record at the

conclusion of my statement.

While I am strongly opposed to reckless allegations about vaccine

risk that scare parents and are not supported by the science, I also

recognize that questions about vaccines will always arise. That's why

I support efforts to fund additional research on vaccine safety.

Some of the theories on the agenda for today do require

additional research. And I am pleased that the government is

supporting such studies.

I also support making sure that the government does not lose the

ability to conduct valid vaccine safety studies. We must assure the

future of initiatives like the Vaccine Safety Datalink Project.

This is a unique collaboration between CDC and several large

health maintenance organizations that allows for valid and timely

research on vaccine safety. Indeed, this research has led to many

important policy changes over the years.

Today, we'll hear from scientists at CDC who work closely with

the Vaccine Safety Datalink Project. These scientists are quite

concerned about your threat to subpoena the raw data from this

database to pursue a vaccine-related allegation. Because the raw data

contain identifiable information from the medical reference records of

more than six million Americans, a congressional subpoena would

constitute a serious violation of medical privacy.

According to CDC, a subpoena could have the effect of driving

health maintenance organizations from the program and destroying CDC's

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ability to scientifically test hypotheses relating to adverse events

potentially associated with vaccines. So in other words, we're going

to end up causing more harm than doing good if we pursue this subpoena

approach.

You have an alternative to a subpoena, Mr. Chairman. The Centers

for Disease Control has worked with HMOs to create a process for

allowing independent researchers access to this data. And in continue

to urge you to accept this solution and renounce your subpoena threat.

Finally, I would like to address some allegations that Dr.

Wakefield makes in his written testimony. Dr. Wakefield implies that

a witness who testified here last year, Dr. Michael Gershon, either

perjured himself or was guilty of sloppy science by noting problems in

the lab that Dr. Wakefield used in his research. Dr. Gershon did not

lie to this committee. And this portion of his testimony did not

involve his scientific expertise and thus, was not sloppy.

Dr. Gershon related what he was told by Dr. Michael Oldstone of

the Scripps Institute, who had performed an evaluation of this lab.

Dr. Gershon continues to stand by his testimony.

Dr. Wakefield also is planning to make a needless attack on Dr.

Gershon's wife, who he alleges may have a financial interest in the

chickenpox vaccine. In fact, according to Dr. Gershon, while his wife

did conduct research relevant to a chickenpox vaccine patent, neither

he nor his wife has any financial interest in the vaccine or its

manufacturer.

Dr. Wakefield's allegation is therefore groundless, as well as

gratuitous.

Dr. Gershon's testimony last year was quite lengthy. And he

raised many scientific issues. But Dr. Wakefield has not refuted any

of them. Instead, he is resorting to name calling, which does not

move these scientific issues along and is unproductive.

I'm going to ask unanimous consent that the written testimony of

Dr. Elizabeth Miller (ph) of the Public Health Laboratory Service of

the United Kingdom be entered into the record. And I also alluded to

other information, which I would like to also attach to this opening

statement and make part of the record.

I thank the witnesses for coming today. I look forward to your

testimony. And I yield back my time.

BURTON: Regarding the unanimous consents you asked to put that

in the record, we'd like to review it. We'll probably have no

objection to it. We'd like to take a look at it. Do we have a copy

of that?

WAXMAN: Mr. Chairman, we'll make everything available to you and

your staff to put into the record. I did note that the chairman asked

unanimous consent at the beginning of the hearing for all submissions

of materials to be part of the record. And I would hope you would

come to the same conclusion with these articles.

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BURTON: We probably will. We just want to review it.

WAXMAN: Well, I have no problem with that.

BURTON: Mr. Weldon?

WELDON: I thank Chairman Burton for calling this hearing. As a

physician who continues to see patients, I have a very, very strong

interest in maintaining the safety and integrity of our national

immunization program. The response from the CDC and the NIH to the

growing concerns over the safety of the Measles, Mumps, Rubella or MMR

vaccine continues to baffle me.

While this vaccine may be safe for most children, there is

growing clinical evidence that a subset of children may be suffering

very severe reactions to the MMR. For too long, public health

officials and those with a vested interest in the status quo have

engaged in what I perceive to be a denial or simply viewed those who

suffer severe adverse reactions as a cost of doing business.

We have a moral imperative to look at the clinical evidence to

determine why some children may be suffering reactions to MMR. For

nearly three years, I have been urging the CDC and NIH to more

aggressively move to address these growing concerns. And I must say

that I have been disappointed by the failure of the CDC and NIH, since

these concerns were first raised in a study published in 1998, they

have not addressed this issue.

The CDC, in conjunction with public health officials in the

United Kingdom, have responded to each new clinical study raising

safety concerns about the MMR with an epidemiologic study, a

statistical study. They did this after the 1998 Wakefield study.

They did it with the study issued in January of this year by Olman et

al. (ph). And they did it again last week, in anticipation of the

release of a study identifying vaccine strain measles as the strain in

the affected children in the Olman (ph) study.

These statistical studies have been released with great fanfare

to the media. And the media, thus far, have given the expected

response of proclaiming the complete safety of the MMR vaccine.

Those who have been raising these questions and conducting

clinical research in this area have grown to expect the mantra, "Our

statistics say that this cannot be." I must say, if their purpose is

to preserve the status quo and succeed in a public relations campaign,

they have been successful; at least, to date.

However, if their purpose is to directly address the clinical

findings of persistent measles inspections in seriously affected

children, their efforts have been a dismal failure. They have not

produced one clinical study to directly address these concerns.

My message to the NIH, but particularly to the CDC, is put away

your statistics textbook and get out your microscope. The failure to

do so only breeds speculation and undermines public confidence and

ultimately makes the job of clinicians more difficult.

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Thank you. And I yield back.

(UNKNOWN): Thank you, Mr. Chairman, for this opportunity, and to

address some issues that have been of great concern to me for a while.

As you know, I am cosponsoring, with Congressman Burton, a bill that

would require informed consent on the part of patients at a dentist's

office when the dentist is getting ready to put in a filling. That's

an amalgam that contains mercury because, over the years, there has

been a connection between mercury in amalgam and an effect on not only

the brain cells of the mother, but going through the placenta into the

fetus.

I will listen very intently, in the time that I have, to hear

from CDC and to hear from the other witnesses about the connection of

vaccines and autism because we're thinking now that any kind of

foreign substance that is toxic that you put into any orifice of the

body has an effect. And certainly mercury in the teeth.

I've had dentists come to me and argue against our opposition,

from the standpoint of they're questioning the research. Well, this

morning, I put on a ring. And I can taste silver on my tongue.

This is nickel. And there is an effect that metals do have in

the body from things that we apply to it and ingest orput into these

orifices.

So I am hoping that CDC will support the work of Dr. Wakefield,

make the connection, report back to us. Then I'm going to start

looking into the use of nickel. And nickel is in most costume jewelry

-- in the earrings that we wear, in the ring that I have on and so on.

It does have an effect on the body.

So I want to thank the chair for having this hearing. And there

have been hearings before. I'm sure there will be hearings. And I am

listening very closely to see if we can, indeed, draw that linkage

from vaccines to autism and other conditions that face not only

children, but human beings as a whole.

Thank you, Mr. Chair. And forgive me for running out to my next

hearing before I can hear all the witnesses.

BURTON: Thank you very much.

The gentleman from Tennessee, Mr. Duncan?

DUNCAN: Thank you very much, Mr. Chairman. I don't have a

formal opening statement. I do want to say that I want to thank

Chairman Burton for calling this hearing and continuing to pay close

attention to what I think is a very, very important topic.

I mentioned at the last hearing that I've been getting interested

in this because I've talked to several parents who have told me very

sad, heartbreaking stories about the healthy children that they had

and then just terrible problems that occurred after taking some of

these vaccines.

So I think this is something that we really need to look at.

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I've been sitting here reading the testimony of the witnesses and

looking through the outstanding notebooks that the staff has prepared

for us.

And I think this is something that we need to have a hearing

about and we need to continue to do some research on and look into as

fully as we possibly can. And I thank you for calling this hearing.

BURTON: Thank you, Mr. Duncan.

Mr. Cummings?

CUMMINGS: Thank you very much, Mr. Chairman. And I want to

thank you for holding this hearing. And I want to thank you for your

tremendous interest in healthcare and for the recent hearing that you

held with regard to disparities in healthcare.

Our committee has held several hearings exploring vaccine safety

and the theories on the correlation between vaccinations and autism.

Let me say, first off, that vaccinations have played a very

significant role in this country and actually across the world. When

we think of diseases like polio and smallpox and many others, vaccines

have certainly allowed many people to live who probably would have

died and have helped them to live the best lives that they could, as

opposed to suffering.

Additionally, the committee initiated an investigation into the

dramatic rise in autism rates across the country. Autism is a

disorder that severely impairs development of a person's ability to

communicate, interact with other people and to maintain normal contact

with the outside world.

One of the most common development disabilities, autism affects

two to five out of every 10,000 children. And it usually appears

before the age of three.

The causes of autism are unknown. There are some effective

treatments for some children. But there is no cure.

In the past, autism was considered a rare disorder. However,

today, autism is being diagnosed much more frequently. There have

been approximately 2,800 cases of autism reported in my state of

Maryland. Additionally, there has been a rise in the number of autism

cases in California, New Jersey and other states.

Although at this time, it is unclear whether the rise in the

number of autism cases is due to increased reporting or demand for

services. Emerging data appears to support the theory that changes in

diagnosis explain the rise in autism cases.

Parents everywhere are anxious to learn more about the possible

link between common preservative in childhood vaccinations and

developmental problems whose symptoms resemble those of autism.

Symptoms of mercury toxicity in young children are extremely similar

to those of autism.

There is a growing awareness of the nature of autism and the

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kinds of approaches to diagnosis, treatment and care that are likely

to be effective in meeting the needs of autistic individuals and their

families. Diagnosing autism today requires specific training and

experience.

I would encourage medical schools to offer specialized training

to our nursing and medical students for autism. And as I have said in

the past hearings, I applaud the Centers for Disease Control and

Prevention, the National Institutes of Health, as well as the Kennedy

Krieger Institute Center for Development and Behavior Learning at the

University of Maryland School of Medicine in Baltimore and the many

other organizations for their continued research on autism.

Congress should allocate more money for autism research. I offer

my support to the families of autistic children who must continue to

look for the cause and the cure of autism.

I am convinced that with further research, a cause and cure will

be found. As such, I strongly believe that all theories for the cause

of autism must be objectively researched. I look forward to hearing

from today's witnesses and learning more about the Vaccine Safety

Datalink, a large linked database that the Centers for Disease Control

and Prevention uses to research vaccine safety.

Again, Mr. Chairman, I thank you for the hearing. And with that,

I yield back.

BURTON: Thank you, Mr. Cummings.

Mr. Horn?

HORN: I commend you, Mr. Chairman. I've sat through the

hearings. And we have really looked at this situation. And I look

forward later in the day -- I have to go to Transportation right now

and Infrastructure. But thank you for putting all this together.

BURTON: Thank you.

Mr. Tierney?

TIERNEY: Thank you, Mr. Chairman, for having these hearings. I

would like to get to our witnesses. And I'm pleased that we're going

to have testifying before us here today individuals and

representatives from the CDC and others who are actually conducting

the research into autism and its causes.

I really believe that affected children and their families

obviously can't afford to have us be complacent about this disorder.

So Mr. Chairman, I'd like to enter my more complete remarks on the

record, with unanimous consent, and look forward to hearing from these

witnesses today.

BURTON: Thank you, Mr. Tierney.

We'd like to have Dr. Bradstreet, Dr. Wakefield, Dr. Stejskal,

Dr. Krigsman and Dr. Spitzer come to the table.

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And while they're coming up there, let me just say that the

purpose of the Government Reform and Oversight Committee -- it's not

called oversight anymore, butthat's our responsibility is to conduct

oversight into every agency of government where we think there's a

problem.

And the minute that the Congress of the United States quits

asking questions, stops asking questions about very important issues

like vaccine safety, which affects every single person in this

country, then we will be guilty of dereliction of our

responsibilities. And as long as I'm chairman of this committee,

we're going to continue to ask these questions.

And I want to make one more real brief comment and that is that

we have gone from one in 10,000 children who are autistic to one in

250. Now somebody has got to start explaining why this horrible

tragedy is occurring, why we have this epidemic. And we're not

getting the answers.

I mean, we have an epidemic here. And we can't just close our

eyes and stick our head in the sand. We've got to find out why this

is going on. And the health agencies have not yet given us an

adequate answer.

Would all of you please rise so I can swear you in?

Do you swear to tell the whole truth and nothing but the truth,

so help you God? Be seated.

Dr. Bradstreet, do you have an opening statement?

BRADSTREET: Unfortunately, the nature of autism is so complex

that to do it in five minutes will be challenging. So I have

submitted, under tab five, a more complete review of the nature of our

research. I will try and get through my slides quickly, Mr. Chairman.

Thank you very much for the hearing and for an opportunity to

present this. Dr. Weldon and I previously met two weeks ago in your

office with the deputy secretary of health and human services, Claude

Allen, to present this data to him. So he has been made aware of it.

And it was a very encouraging and very positive meeting. I look

forward to the outcome of that over time.

With that, the next slide.

The prevalence may be both misunderstood and underestimated. Two

recent studies, one from England and one that was a CDC study with

Brick Township, indicated between 57 per 10,000 and 67 per 10,000

children. However, autism is primarily a boy-related disorder; four

to eight times as many boys suffer with this disorder. That means

that the prevalence is therefore in the order of one percent for boys.

Next slide.

The economic impact. We estimate that there are approximately

420,000 children with autism in this country at this time, based on

those studies, greatly less than what the "Time Magazine" article set

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at one million. However, that puts a price tag, over the next 50

years to take care of these children, in excess of $1 trillion.

That was a lot of zeroes. I had to go through that a couple

times on my calculator to make sure that that was correct. But that

is the real number. The lifetime costs could be $3 trillion to $4

trillion for the families and for society, with the lost wages and

other factors.

Next slide.

The biological evidence for causality is growing significantly.

And for those members of the committee who may not be familiar with

me, I am a physician. I am also a parent of a child with autism. And

I am a clinical researcher associated with studies currently ongoing

at 14 medical schools around the world.

The growing evidence is substantial that measles virus is still

the front runner with the viral etiology aspects of things. And not

all children suffer from measles virus-related disorders. But we'll

show you today some examples that are quite, I think, impacting.

Additionally, autoimmunity continues to be published by a variety

of researchers at multiple medical schools that there is a unique

disorder affecting the autoimmunity in these children where they

become immune to their gut and their brain. And that is a disaster

for them.

Mercury -- and, to a lesser extent, lead -- remain significant

toxic burdens. And we presented that data to the Institute of

Medicine in July of last year.

Next slide.

The first case -- I'm going to present two cases today. I'll try

and go through them briefly.

Matthew (ph), who was born in 1984 from an uncomplicated

pregnancy and an easy delivery, had a normal early development, except

he did develop some gait abnormalities that are very consistent with

what you might expect from Mercury. We'll see that data later on.

He had a rapid decline after each of two MMRs. He did receive

those in combination with other vaccines, however.

He developed autoimmunity to myelin basic protein, a critical

insulator of the brain. He suffered seizures shortly after the second

MMR. And he has consistent immune deficiency with protracted low

mythecide (ph) counts.

Next slide.

He has inflammatory bowel disease that has been documented on an

endoscopy and biopsy. He has persistent measles virus genome in that

inflammatory disease. He has persistent measles virus in circulating

white blood cells. He has persistent measles virus "F" gene in his

cerebral spinal fluid, which is the fluid that surrounds the brain,

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implying it is present in the brain as well.

He has auto-antibodies to measles virus in his spinal fluid. He

has auto-antibodies to myelin basic protein in his spinal fluid,

elevated a million, a very low serum sulfur level and cysteine level

and very high Mercury as a result of that.

Next slide.

And next. That is my son, who is also the, I think, inspiration

for our research and the work that we do. He was a very happy, wellconnected

child prior to his MMR. That's about approximately at 12

months of age. And that is Matthew (ph), completely lost, about two

months after his MMR vaccine.

Next slide. That is a copy of the laboratory result documenting

the presence of measles virus in his terminal ileum.

Next. Copy of the laboratory result from Utah State University

where Matthew (ph) had spinal fluid analyzed that showed antibodies to

myelin basic protein and to measles virus in his spinal fluid.

Next slide. This shows the presence of antibodies in his RBCs.

Excuse me, the presence of virus in his red blood cells. It is also

present in his cerebral spinal fluid.

Next slide. And this is his first mercury titer, showing marked

elevations of mercury. And if you can see for all those, essentially

the only thing that is truly abnormal is a significant increase in

Mercury.

Next slide. The first challenge to us to get Mercury out of his

body resulted in an extremely high titer. That number of dots

actually represents 24 micrograms for gram of creatne (ph). It would

take it well off the slide, perhaps into the next room.

Next? This is an interesting correlation. Mark Blacksill (ph)

presented this to the Institute of Medicine last year. And that shows

the rising titer of cumulativeMercury in the vaccine program in

California, compared to the prevalence of autism in California.

Next? And I want to superimpose on that a very interesting

graphic derived from the government website on the use of

methylphenidate, also known as Ritalin or Concerta. And look at the

time relationship between the rise in that.

Next? It's identical. In 1990, the rise in the mercury titer

started to go up. And in 1990, there is a striking and continuous

rise in the use of Ritalin in this country, which I think is rather

telling.

Next slide, please. This is the thimerosal versus autism

relative risk that was produced in the CDC confidential study that was

acquired under the Freedom of Information Act, showing that by the

time approximately 37 micrograms of Mercury is administered, there is

more than a doubling of the relative risk of autism.

Next. This is a copy of a transcript from the Simpson-Wood (ph)

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meetings. It is page 229, where Dr. Brent (ph) -- who is not employed

by the CDC; he is a public health official from one of the states --

said that the medical-legal findings in the study, causal or not, are

horrendous. If an allegation was made of a child's -- the behavioral

findings were caused by thimerosal-containing vaccines, you will not

find a scientist with any integrity who would say the reverse of the

data that is available.

So we are in a bad position, from the standpoint of defending any

lawsuits if they were initiated. And I am concerned.

I think that may set part of the tone for what we have seen

happen in the last several years.

Next slide. Additionally, there was a very good documentary on

this. Parents are aware. And I think it's very important for

Congress to be aware that the parents are receiving information from a

variety of outlets.

This is not just your doing or undoing a vaccine policy. Parents

are well educated. They are hungry for information. And they

currently don't believe many of the reassurances that are being

provided by CDC.

Next slide. Case two is very similar to my son. And I present

it so that you will realize that this is not -- my son was not an

isolated case. He had, again, normal developmental milestones. He

arrests shortly after his first MMR at 15 months. He again has

antibodies to many things in his brain and persistent measles virus in

places that it doesn't belong, including his cerebral spinal fluid.

Next. Lab slide. This indicates that, in fact, he has

antibodies to myelin basic protein and to measles virus in his spinal

fluid.

Next. He has this unique antibody. And this is the presence of

MMR antibody, which is actually the "H" protein or the hemogluten (ph)

protein from the measles virus of a special antibody titer that was

derived using MMR vaccine. And this was done in Dr. Singh's

laboratory at Utah State University. Also positive in spinal fluid.

Next. We presented this data, Dr. Singh and myself, at the

American Society of Microbiology last month, which indicates that 50

percent of children in our society had antibodies to this special

measles, mumps, rubella-derived protein in their cerebral spinal

fluid. Also, 86 percent have antibodies to myelin basic protein in

their spinal fluid. And again, a very high percentage, up to 100

percent, had antibodies to myelin basic protein in their blood.

This is not present in normal controls. This is a controlled

study. We now have significant controls. And we do not see these

present. This is not an antibody leakage phenomenon. This is real

disease in these children.

Next. Again, Scott (ph) has documented measles virus in his

terminal ileum in his blood, as well as the spinal fluid. These are

laboratory data.

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Next. And I want to include from Dr. Menkes (ph), his comments,

where he concludes that, in fact -- this is related to the MMR vaccine

in this particular child. Dr. Menkes (ph) wrote the textbook, "Child

Neurology." He is considered to be one of the foremost experts, both

on child neurology and on vaccine safety and has concluded that

measles, mumps, rubella vaccine is causing this syndrome.

Next. That's the child. I think it's always important to put a

face. This is impacting human lives.

Next slide. I would leave you with some questions. I think we

have some important things that we need to ask. These are in the

handout. But as we work through this, I think we need to know that

what if Dr. Wakefield, myself, Dr. Singh, Dr. O'Leary and Dr. Menkes

(ph) and others are right. What then? What would be the reaction to

public health officials if, in fact, this data is -- as we believe it

is -- verifiable?

In addition to that, what is the response to treating these kids?

How are we going to get this virus out of these kids and restore them

to good health? And have we traded a very rare occurrence of severe

side effects to natural measles infection for a very common occurrence

of autism?

With that, I will end because I think I went past my time.

BURTON: That's all right. I think it was very informative.

BRADSTREET: Thank you.

BURTON: Dr. Wakefield?

WAKEFIELD: Mr. Chairman, members, it's a great pleasure to be

back here again. Before bringing you up to date with the research

linking MMR vaccine to regressive autism, I would like to 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.

WAKEFIELD: 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 relating to this, all raw data have been provided

to both 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 in blinded studies.

Scientifically, Dr. Gerson's behavior was a disgrace. And I

stand by that.

I would level the same charge at anyone who relies on -- or has

relied on in any way -- upon his testimony. The disgrace is that he

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did not check the raw data before impugning the reputation of a fellow

scientist before the eyes of the world. I'm not surprised that Dr.

Gershon has turned down, on two occasions, the offer to appear before

this committee.

Let me turn now to the current state of the science. The

association between MMR vaccine autism and intestinal inflammation was

first suggested by my group on the inspiration of parents from the

Royal Free Hospital Medical School in 1998 in a paper published in the

"Lance" (ph). And this is well known to you.

The same research team, in collaboration with Professor John

O'Leary and Dr. Simon Mertz (ph) a pediatric gastroenterologist from

the Royal Free Hospital, have since shown in a comprehensive series of

what were eight and now 10 peer-reviewed scientific studies, that the

major findings of our original study were indeed correct. These

papers are listed in the appendix. The papers are here. And I will

make them available to anyone who wishes to read them.

The sum of the research of my group and our collaborators, taken

together with additional work by independent physicians and scientists

in the United States, has now confirmed the following facts. Children

with regressive autism and intestinal symptoms have a novel and

characteristic inflammatory bowel disease. This disease is not found

in developmentally normal control children.

This disease is entirely consistent with a viral cause. This

disease may be the source of a toxic or immune insult to the brain.

Measles virus has been identified in the diseased intestine in the

majority children with regressive autism studies, precisely where it

would be expected if it were the cause of the intestinal disease.

These children, who suffer the same pattern of regressive autism

and intestinal inflammation, come from many countries, including the

U.S. and Ireland, where they have been investigated. These barristers

(?) have been nowhere near my laboratory.

Measles virus has been found in only a small minority of

developmentally normal control children. The measles virus in the

diseased intestine of autistic children is from the vaccine. Children

with regressive autism appear to have an abnormal immune response to

measles virus, as you've heard from Dr. Bradstreet.

And these findings are entirely consistent with parental reports

that their normally developing child regressed into autism following

exposure to the MMR vaccine. As you will hear from my colleague on my

left, Dr. Stejskal, these findings are also entirely consistent with

an immune-mediated damage to the developing child by thimerosal.

Confirmation of the intestinal findings. Other researchers in

the U.S. have confirmed the presence of intestinal inflammation in

children with regressive autism. And we will hear testimony from Dr.

Krigsman to this effect and, independently, the link between measles

virus in children who were given the MMR vaccine and abnormal immune

responses,

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Measles virus sequencing has been performed. Most significantly,

a study due to be presented at the Pathological Society of Great

Britain in Ireland, in Dublin at the beginning of July has confirmed

that the measles vaccine virus is present in the diseased intestinal

tissues of these children.

The Dublin researchers, headed by Dr. John O'Leary, professor of

pathology at Trinity College-Dublin, examined viral genetic material

from intestinal biopsies taken from 12 children with gastrointestinal

disease and autistic spectrum disorder. The viral genetic material

had already been identified as coming from measles virus in a study

published in January in "Molecular Pathology."

Using state-of-the-art molecular science, the samples from these

12 children have now been characterized as from the vaccine strain

virus. This investigation continues. These data constitute a key

piece of evidence in the examination of the relationship between MMR

vaccine and regressive autism.

We heard last year about re-challenge phenomena, children who had

received more than one dose of the vaccine. A further key piece of

evidence comes from the examination of these re-challenged cases and

biological gradient effects. I will explain what I mean by that.

Re-challenged refers to a situation where an exposure of an

individual to an agent -- for example, a vaccine -- elicits a similar

adverse reaction to that seen following the initial exposure. The

secondary reaction associated with re-challenge may either reproduce

the feature associated with the primary challenge or lead to worsening

of the condition that was initially induced.

In other words, Mr. Chairman, I give you a drug; you develop a

rash. That could be coincidence. I give you the same drug again; you

develop the same rash. That is not coincidence until proven

otherwise.

During the course of our clinical investigations, we have

observed some children who receive a second dose of MMR or, in the

U.K., boosting with the combined measles-rubella vaccine, experience

further deterioration in their physical and/or behavioral symptoms, as

explained in Dr. Bradstreet's child.

In a report of April 2001, the Vaccine Safety Committee of the

Institute of Medicine said that in the context of MMR vaccine as a

possible cause of this syndrome, re-challenge would constitute strong

evidence of an association. In the context of adverse reactions, a

biological gradient refers to an increasing severity of the disease

upon repeated exposure.

We have undertaken a systematic evaluation of re-challenge and

biological gradient effects in children with regressive autism. We've

undergone investigation at the Royal Free Hospital.

We have compared exposed children, those who have received more

than one dose, with those who have only received one dose to ask: is

there a sequential deterioration in their behavior and development,

compared with the group who only received one dose? And is there

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worsening of the intestinal inflammation?

In analysis, based upon the exposed and unexposed children, we

find that secondary regression on the basis of three independent

analyses, including parental history alone, excluding those children

whose secondary deterioration appeared after the publication of our

first paper in 1998 or inclusion of only those children for whom we

can find independent corroborative evidence in their records, there is

a highly significant effect in terms of secondary deterioration in the

children who had two doses, compared to those who only had one.

Secondary physical symptoms -- for example, deterioration in

their bowel disease, their bowel symptoms -- is present. Severe

lymphoid hyperplasia. You will remember the swelling of the lymph

glands in the intestine is significantly worse in the children who

have had two doses than one.

And to me, as a pathologist, the most significant finding is that

the intestinal inflammation, a blinded observation made independently

of any knowledge of the child's deterioration or their vaccination

status, shows that it is much worse. It is worse in those children

who have received two doses than one.

This is something that you cannot confabulate. The quality of

records might not be good enough to make didactic decisions about

deterioration. But you cannot fake the state of a child's intestine

in terms of inflammation.

So these data identify re-challenge effects upon symptoms and the

biological gradient effect upon severity of intestinal inflammation

that provide evidence of a causal association between MMR and

regressive autism.

What about the political aspects of this, Mr. Chairman? I have

repeatedly requested a meeting with Selene Donaldson (ph), the U.K.'s

chief medical officer, in order to discuss this 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 analyze these samples. He may have a

PCR machine in his kitchen, for all I know. I do not know how he

intends to analyze them.

He has, as far as I'm aware, no ethical approval for analyzing

these samples. But he may be reassured to know that independent

testing is being conducted and that as part of a litigation process in

the U.K., the defendants are being provided with identical samples for

entirely independent analysis.

The last seven days have seen a report in the "Journal of

Clinical Evidence" from the U.K. publicized as new research,

disproving any links between autism and the MMR vaccines. The author

specifically excluded clinical research into the bowel disease; in

other words, everything that has been performed in my laboratory.

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They do not cite any of our publications, beyond the initial

study of 12 children in 1998. In fact, this paper does no more than

review the epidemiological studies that have already been deemed

irrelevant by the members of the IOM Committee.

In closing, Mr. Chairman, Dr. Bradstreet's data somewhat

underestimate the size of the problem. A recent study published by

the National Autistic Society in the U.K. show that in primary school

children -- that is those between four and 11 -- autism now affects

one in 86 children; not one in 86 boys, but one in 86 children.

This is a staggering level of a disease. It's unacceptable. And

no society can afford to sustain this attrition of its children.

Something has to be done. We have to de-politicize this process

and conduct the science that is necessary to answer the questions.

Thank you.

BURTON: Before we go to the next witness, I believe other

scientists who differed with the prevailing opinions have suffered

similar castigation as you have. And you may rest assured that

eventually, the truth will out. Louis Pasteur found that out after 17

years when he was knighted.

So eventually, the truth will out. And those who criticize and

continue to denigrate what you have done, they will be eating a hell

of a lot of humble pie.

(LAUGHTER)

Dr. Stejskal?

STEJSKAL: Mr. Chairman, ladies and gentlemen and dear

colleagues, I am honored to be here. And this is my first testimony.

STEJSKAL: And what I am going to do in this limited time is to

tell you why I'm here, what are my credentials. I have been working

for 20 years in pharmaceutical industry, directing a group of clinical

immunotoxicology. So I have been working with allergy to simple

chemicals, like for example mercury, for 20 years.

What I am going to tell you is the fact which has not been

mentioned here before, to my big surprise. And this is that

thimerosal in clinical testing is a strong allergen.

You can learn about it more looking on our website, which I will

show later, where I compile the studies from all over the world,

telling us that thimerosal, obviously due to vaccination, is number

one childhood allergen; meaning that if you are getting a special

testing, which I will tell, 10, 20, 30 percent of the children are

allergic.

I will tell you why this is risky to be allergic if you don't

know this. And I will also tell you how it goes together, opening

ways to out immunity. And at the end, to be constructive, I will tell

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you how to diagnose the causes, which are leading to autism, and what

studies should be conducted.

So if we can have my Power Point presentation first? I have been

also asked to see if it is plausible that there is a synergistic

reaction between thimerosal and MMR. And yes, it is. And I will tell

you why.

The next one. Again, you are well acquainted with the fact that

mercury -- and I am not talking about organic mercury only; I also

talk about inorganic mercury -- it will damage the brain, especially

organic mercury because it's lipophelic (ph). It will easily go to

brain.

There are some basically called a retrograde transport. Again,

if somebody wants, it's on our website.

So, in addition to toxicity, which is very important, which of

course can damage blood-brain barrier, you also have to worry about

allergy. And allergy is the thing which explains to us why not every

child is affected by vaccination.

This is something which is very important as, as you know, some

children cannot eat egg. Some other children cannot ride a horse

because they are allergic to a horse. And some don't eat fish.

People don't do either.

And then, which is also very important, the allergy affects the

brain. And as you know, in spring when there is a pollen around,

people become sleepy. They cannot concentrate. This is due to the

chronic inflammation which is affecting the brain.

This may be part of the answer why Dr. Wakefield sees

inflammation in the stomach in gut affecting the brain. This is

another reason why we can see that, in certain children and especially

the autistic ones, we see also other types of allergies like food

allergies, atopic in general, increase disintegration of the immune

system.

Next one. This is very simply showing you that we are not equal.

Genetic, we're determined our detoxification capacity. These were

explained to us that we have a subgroup of children and subgroup of

adults which will not handle properly the overload of toxins and

allergens.

Next one. Thimerosal is an allergen. It is worldwide known for

years, I think, since '70s, that if you are doing special testing for

a special type of allergy, which is lymphocyte-mediated allergy, socalled

"delay" type hypersensitivity or cellular hypersensitivity, you

do find that actually thimerosal is superceding nickel in the

frequency of sensitization worldwide.

If you're looking on few studies which has been done comparing,

for example, East Germany and West Germany and you see that in East

Germany, the allergy was very low and it started to rise up after

those two merged, you just wonder why is that so? And it may be more

strict regime of vaccination couldn't do something against this.

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How do you test for this quite important allergy to thimerosal

and other things? You do it by so-called patch testing.

Next one, please. And in patch testing, what you do is you put

this allergen, the things which you would like to see if you are

allergic against, on the skin in the back.

I have to say you again, I have read some witnesses from CDC and

other claiming that thimerosal is perfectly safe because the only

thing we can see if it's local reaction at the skin. These people do

not remember from the years at school that allergy is never a local

phenomenon.

Allergy is a systemic phenomenon. It's governed by special types

of white blood cells, which are circulating in the body and in the

lymph. So if somebody tells you that there is only local reaction,

this is a lie or incompetence. But this is not true.

Allergy is a systemic reaction. And anywhere in the body where

this foreign agent -- for example, thimerosal -- will be, the reaction

will occur. And this is inflammatory reaction.

So how -- we are doing patch testing. You read on my website.

There are thousands and thousands and thousands of people which we

are patch testing, telling you that especially children are very

strongly sensitized. And I think the data from Germany shows that

children eight years or less have actually sensitization rate in those

which are tested -- that means people with skin problems -- 20 to 30

percent, which is quite amazing.

The other test which can be used and especially should be used in

children because it's not so good to put the allergen on the skin

because you become resensitized, is so-called "blot test," or

lymphocyte proliferation test. This test has been used for years in

American for detection of people which are sensitized to different

occupational allergens; for example, beryllium.

This beryllium-specific stimulation test is used as a code and

standard in America to detect latent sensitization to beryllium prior

to clinical outcome. So pharmacological factories and those who are

using beryllium have realized that you can save a lot of suffering

like long-term sickness in sarcoidosis, to detect by biomarkers,

because now we are looking at the markers of susceptibility that

people or children which are susceptible to the agents, which other

people tolerate.

And this also save the money at the end. So with MELISA, you

take a blot test. MELISA stands now for optimized lymphocyte

proliferation test for memory lymphocytes. You take a blood sample

and you ask if the body has or stored the information of allergy to

certain substances.

If it's yes, there is a sensitization, then you can see it

objectively by increase in the volume of lymphocytes and you can

measure it objectively. If there is no (?), that means the person is

genetically not able to respond, there is no difference.

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I will, in the end, show some cases of this.

Next one. This please, if you forget everything from my hearing,

you remember this. Thimerosal and autoimmunity are the two sides of

the one coin. That means you can't never separate.

And why is this? Why is this?

Next one. This is because mercury -- but not only mercury;

nickel, as Chairman Diana (ph) said, and other metals -- will strongly

bind to certain amino acids in our bodies, which are containing SH

groups, sulfhydryl groups. And these sulfhydryl groups are

everywhere. They are in two amino acids which are called methionine

and cysteine, for example.

And they are especially rich in fat tissue. And as you know,

brain is full of fat.

So that's why mercury will go into the brain and it will bind

there; for example, in so-called myelin protein. And this is the

reason why this machine can measure increased antibodies -- again,

myelin -- in many of those children.

So since there are physical, chemical properties which are

indisputable, mercury will bind in the brain and elsewhere, where do

we find these things? So it will go there, it will bind there. And

then, your genetic susceptibility, if you can make it or not make it

will explain why some will be ill while not other ones.

Next one. Edema (ph) and thimerosal. There is no way I can

comprehend that there is a concern about synergistic adverse effects

upon the immune system of susceptible children if you put those things

together. So you can, by immunosuppression, which is other way how

mercury works, you can lower the threshold of protection against the

virus, meaning that in this time, there will be persistent viral

infection instead of the limited one.

There is a fact, which you may know or may not know, and this is

that in my country, in Sweden, thimerosal has been removed from

vaccines in 1998. And one of the reasons for it is a report on the

Pharmacovigilance Working Party of the European Agency for evaluation

of medical products. And what they basically say is that alteration

of the immune system due to mercury could have consequences on the

ability of the host to withstand viral attack.

So Swedish people make a lecture. And since I have been working

in toxicology laboratory for 20 years, I know that there is always

risk assessment. And they decided they don't want to take the risk.

Next one. Next please, could you move up? Conclusion for this

general part is yes. I really believe that there is a connection

between synergistic effect of thimerosal and MMR and that there is a

group of susceptible individuals which we may actually detect maybe

even prior. And they will be affected and they will be ill.

I will just finish up to show you a couple of cases. Some of

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them were published; some were not.

And just to show you how we work with this. And these are the

guys, the big guys, lymphocytes, which are now stimulated. This is of

course in culture outside the body. This test system is a blood test.

And the big guys are lymphoblasts and the small ones are the ones

which are not affected.

Next one. Since I was talking about patch testing as a device or

instrument to look on the special type of hypersensitivity which is

having no counterpart in the serum, I am as a start -- and we started

these studies in 1992 -- we have taken people which have patched as

positive and looked for their lymphocytes, just to prove that this is

not only back reactions. It's a systemic reaction, driven by

lymphocytes.

So this woman has a muscle inflammation. And she also --I have

to look here -- she has been susceptible to infections. And she had

chronic fatigue. She was patch tested in '91. And she was positive

to thimerosal.

As you see now, I am looking on different mercuries because this

part goes together with the dental mercury part completely.

Everything I say now, it can be actually applied to dental mercury

fillings. And you can look on our website again.

Since '92, she had thimerosal positive patch test. And in '92,

we did MELISA test.

Next one, please. Could you put another one? This is just

exposure. We are always looking into the exposure. From this point

of view, she had been occupationally exposed to inorganic mercury.

She had 17 amalgam fillings.

She was exposed to ointment which was containing thimerosal. And

she received gammagobulin and other vaccines at least 16 times.

And the next one? What you can see now is a diagram of her

lymphocytes' reactivity to different metal sorts. And this can be

difficult for you to follow, but the horizontal line shows you the

line of positivity. And the rest one is very, very strongly positive.

I just show -- you can go farther on. I don't think we have

time. This is from published paper, which you can download on

Internet.

Please go on. This is another patient. And this patient has

been treated by mercurochrome, which is another organic mercury. And

you can see showing extreme sensitization to mercurochrome, but not at

all sensitization to other mercury compounds, meaning that both in

patch testing and in lymphocyte testing, you can actually see no cross

reactivity between inorganic and organic mercury.

But there is one cross reactivity. And this is between

ethylmercury and methylmercury, meaning that we are very much afraid

that any sort of sensitization to one may cross react and deteriorate

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and heighten the response to other ones. And there are patch test

results on this.

BURTON: Doctor, could we submit the rest of your testimony for

the record?

STEJSKAL: Yes. You can do it.

BURTON: We'll get to the questions. We'll have questions for

you that you can elaborate on.

STEJSKAL: I just would like to finish up with the data on

autistic children, two of them?

BURTON: Okay.

STEJSKAL: And this part of study is done together with

scientists from Center for Pediatric Health in Belgium, Antwerpen,

from a group of Austrian researchers, from some American scientists

and from some Swedish scientists. Due to that reason, I am not going

into the study still continuing. So I'm just showing some case

reports.

This is an Austrian girl, 14 years old, with mild form of autism,

lactose-intolerance and vaccinations. And there is a causal

relationship of vaccines to his deterioration.

And next one. And this shows you the non-responsiveness to

inorganic mercury, strong reactivity to thimerosal, cross reaction to

methylmercury and no reaction to nickel and cadmium.

Next one. And this is a Belgium boy, five years old, from John

Kronenberg (ph), which is a pediatrician in Antwerpen. He was healthy

at birth. He got first symptoms of autism as a baby, strong

aggravation of symptoms at 15 to 18 months. He was diagnosed with

autism in '96 at 11 months of age.

He has digestive problems, food sensitivity, skin lesions,

eczema, rashes and irritation from metallic contact. Mother had

dental work during pregnancy.

Next one. This is the schedule of vaccination in Belgium. They

don't vaccinate at birth. You only one who do. At three months, four

months, five months, seven months, 12; at two years, several vaccines

at once.

Next one. And this is his reactivity. In this case, there is a

thimerosal and methylmercury; nothing on aluminum and zinc.

At conclusion, I would like to say that credible data show that

theory that thimerosal-containing vaccine may be a co-factor in the

development of autism in genetically susceptible children. And I

would like to tell you what I would like to have for future studies,

because there is no sense if you give millions and millions of dollars

to do and waste the time for nothing.

So the things what we learned about the reactivity, allergic

reactivity to simple compounds -- for example, mercury, regardless it

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it's inorganic or if it's organic -- is that rats and mice are not

suitable. One of the reasons is that they produce their own C

vitamin. So it's not a man. We don't do it. And C vitamin will

protect against metals.

The second thing is that you have to do a biomarker screening for

susceptible children. And there is a notion from a paper on our

website, published my daughter, which says that the increased

knowledge about individual sensitivity, based on genotype and

phenotype variability, together with the use of the mile markers for

the diagnosis of individual susceptibility seems to be the key in

elucidation of operative mechanisms of any autoimmune disease and also

autism.

Thank you.

BURTON: Thank you, doctor. We'll have questions for you later.

Dr. Krigsman?

KRIGSMAN: Mr. Burton, members of the committee, thank you for

having me today. The purpose of my appearance today is to report to

the committee the status of my findings regarding our research into

the intestinal inflammation in autistic children.

KRIGSMAN: What we have done is actually a retrospective survey.

And what we have done is we have collected intestinal biopsy specimens

from 43 patients. Now these 43 patients were mostly referred from

private practitioners who were caring for their overall autistic

medical issues; among them, their GI symptoms.

After chronic frustration and inability to control mainly

symptoms of diarrhea and constipation, these patients were referred to

me. Other patients came on their own, after again often years of

frustration with these symptoms.

Most of the GI symptoms that these children have been seen for,

mostly it's diarrhea. Many also have constipation. And a large

number have both diarrhea and constipation alternating.

The stools are severely malodorous. It's one of the most common

things we hear parents talk about is the entire house smelling when

these children have a bowel movement in the basement.

Abdominal pain -- very, very common symptom. Most of these kids

are non-communicative. And when they have pain, they either just

scream and wail, fall to the floor having tantrums, unexplainable

crying, could last for half an hour to an hour.

Problems sleeping at night. Waking up in the middle of the night

screaming. And parents intuitively feel that these symptoms are due

to pain.

Sometimes, there's an objective observation as such, holding

their belly. But more often than not, it's just unexplainable crying.

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Abdominal distention and poor growth. The growth is a very

interesting issue. What I've seen is that most of the children with

regressive autism fall in the bottom 10 percentile on the growth

charts in weight for age.

And we have not found that their height for age is similarly

affected. I don't have an explanation for that. But their weight for

age, most of these kids are skinny kids.

The male to female ratio of these 43 patients is seven to one.

Who said that these kids are autistic? Well, the diagnosis was

made either by a pediatric neurologist, a developmental pediatrician.

And, for the most part, parents have gone to both and even a third

opinion. And in no patient was the diagnosis in dispute.

Next slide. When I first meet with these patients, we do a

routine evaluation for what often is diarrhea, constipation. We get a

complete blood count, sedimentation rate, chemistries. To most of

you, these tests are meaningless. To a gastroenterologist or parents,

they're very, very meaningful.

What these tests look for are specific reasons, specific

diagnoses that can cause these GI symptoms that these kids complain

of. We do stool cultures. We look for parasites. We look for blood

in the stool.

We go over their diet. We make major revisions in their diet.

We remove carbohydrates. We remove sorbitol from their diet. We take

them off gluten and casein.

And pretty much without exception, none of these interventions

help. And none of these tests show anything that would explain why

these kids have chronic diarrhea, constipation and pain.

At that point, I perform a colonoscopy, along with biopsy. We

look at the entire colon -- and not just the colon, but more

importantly, the very end of the small bowel, which is the terminal

ileum, which is the area that Dr. Wakefield had described as involved

in these diseases.

And by the way, I should mention that, as recently as two years

ago, I would never have put a colonoscope in any of these children. I

didn't feel it was justified or appropriate. I didn't know what I'd

be looking for. And I wouldn't do it, even though I had seen quite a

number of them.

And it wasn't until I read Dr. Wakefield's article in September

2000, "American Journal of Gastroenterology," where he described the

biopsy findings in over 60 patients. And he described a pattern of

colonic inflammation that could explain their symptoms.

It wasn't until I read that article -- I read it about seven

times, actually, in one night, because I just couldn't believe it.

And after reading it over and over, I decided that I could not find

any valid criticism to the article. And I felt justified, at that

point, to perform these colonoscopies myself.

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And at the outset, I will say that our findings, which are

independent of Dr. Wakefield's findings, completely support his

explanation and his observations of the abnormalities that are found

in the bowels of these children.

I also performed an upper endoscopy, looking up the esophagus and

stomach. I performed that task in those children who, based upon the

histories as related by the parents, sounded as if the -- if those

histories contained abdominal pain, a story of pain, then we needed to

rule out any esophageal or esophagus problems, stomach problems,

intestinal inflammation, infection, et cetera.

Next slide. I'm going to be showing now a series of slides,

actual photographs that are taken during the colonoscopies, to give

you a visual idea of the extent of abnormality that we find. As

you'll see, these are not normal.

This first slide is normal. This is a terminal ileum, the area

at the end of the small bowel, in a normal patient. And what you can

see -- my laser pointer is not showing up.

In the photo on the right, if you look carefully, you'll see very

small bumps. They're almost indiscernible. Those are enlarged lymph

nodes. But those are normally enlarged lymph nodes. Those are the

kind of lymph node enlargement in normal small bowel.

Next slide. In contrast, the upper row of photographs -- could

we dim the lights here? Is that possible?

BURTON: You can't dim the lights with the cameras? She said it

would not be . . .

KRIGSMAN: Pity, because I think the effect would be greater.

The photographs would be . . .

BURTON: Just one second. You say we cannot dim the lights? The

TV cameras then can't pick up what you're doing. And I think that's

important that the American people get a chance to review all this.

KRIGSMAN: Absolutely.

The upper row, three across, show marked nodularity, marked

abnormality because of those numerous small lumps and bumps.

Next slide. Another patient, same exact finding.

Next slide. Another patient. You're looking down the tube of

the small bowel. On your right side, along the wall, those large

nodular bumps. This is not normal.

Next slide. I call your attention to the upper left. And those

large, bumpy nodules are the ileal tissue that Dr. Wakefield had first

described. On the right slide, same patient, a view from a different

way, upper right corner.

Next slide. Another patient, same finding.

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Next slide. Same finding, upper right corner on both those

pictures.

Next slide. Upper right corner on both the pictures, those

large, nodular bumps.

Next slide. Same thing, lower left half of the slide.

Next slide. Same thing from another patient, all over the --

mucosa of the ileum, there's nodularity.

Next slide. This particular patient didn't have as much

nodularity as they have swelling. The medical term is edema and it's

one of the byproducts of ongoing inflammation.

Next slide. Same thing.

Next slide. There's a very dramatic photograph. If you look in

the middle, downwards in both of those pictures, it's actually normal

mucosa. But on both sides of the midline, you see marked nodularity.

Next slide. Same thing.

Next slide. Again.

Next slide. These are all different patients.

Next slide. Same thing once again.

Next slide. And again.

Next slide. Next slide. This patient I included because the

lower two photographs show the same nodularity. The upper two

photographs are of the colon.

And if you look carefully, you'll see very small, minute nodules

scattered around the mucosa. So not only are these nodules present in

the ileum of these patients, they are also present, scattered

throughout the colon.

Next slide. Same thing.

Next slide. Same thing.

Next slide. Same thing.

Next slide. This patient, the inflammation was so bad in the

colon that he formed what's called a pseudo-polyp. And the polyp is

recognizable to all.

It's actually not really a polyp. What's happened in this

patient is that the surrounding tissue is so inflamed and eroded that

what's left is the polyp. Everything else has eroded around it.

Next slide. This patient I just saw yesterday. And I included

this -- this is the final patient I'll be showing you. This is the

oldest patient that I have done a colonoscopy on.

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He's 13 years old, autistic. The regression history is not

clear. It's been many years. Chronic history of one to two bowel

movements a day, always very loose, dismissed by the pediatrician.

Over the last three months, this child's diarrhea has become

uncontrollable, 10, 15 times per day. He's incontinent all of a

sudden. He never was incontinent. And his behavior has been

intolerable -- aggressive, throwing tables over. And his parents are

at the verge of institutionalizing him because of this recent

worsening over the last three or four months.

His mother found me out. And I do the colonoscopy just

yesterday. And this child has the absolute worst colitis I've ever

seen.

Most of these kids, when you put the scope up the colon, the

colon appears normal. It's only in biopsy that you find the

abnormalities. In this particular child, the inflammation was so bad

that it has attained the characteristics of classic inflammatory bowel

disease. If you saw this colon, you'd think this patient had

ulcerative colitis or Crohn's Disease.

Next slide. What's interesting about this patient -- and Dr.

Wakefield might be interested particularly in this slide -- is that

this is -- the photo on the left is the bottom of the esophagus. And

in the area at about 3:00, you see a wide little nodule. That is an

abscess ulcer, which is something you see in class inflammatory bowel

disease. And you find those ulcers anywhere in the GI tract.

The photo on the right is the upper esophagus, the upper

esophageal sphincter. And you can see, there are two nodules there

are well, two more abscess ulcerations as well.

And I'm wondering if this patient doesn't have just autistic

enterocolitis, but actual inflammatory bowel disease. And the

biopsies are still pending.

Next slide. I'm going to bypass these slides because -- but I

just want to point out that the areas, that big round ball on the

right is the microscopic view of those big nodules that you saw

grossly.

Next slide. Next slide. Okay, what you're seeing over here,

that circle in the middle is a crypt. And the intestine on the left

side of that crypt, you see what seems to be small, little black dots

infiltrating it.

This is a cryptitis. This is one of the classic findings of

bowel inflammation, which we have seen over and over and over again in

these patients, exactly as described by Dr. Wakefield.

Next slide. Same view, but the crypts are -- the crypt in the

middle in particular is being invaded by inflammatory cells. There's

a very heavy inflammatory exiting throughout the mucosa.

Next slide. Same thing over here.

One more slide.

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Okay. So looking at our 43 patients, what are our cumulative

results? Well, the percent of patients who have colitis, 65 percent.

And by colitis, I mean either active colitis or chronic colitis.

There is a difference.

Active colitis, 51 percent of the patients have that; chronic

colitis, 40 percent. Most patients have both, which is why the

overall colitis indicator is 65 percent.

A third type of colitis is the osinofilla (ph) colitis, also

described by Dr. Wakefield. We have that a seven percent number, very

similar to his number.

The percentage of patients who had those large nodularities of

the ileum, we found to be 90 percent; also very similar to Dr.

Wakefield's. Thirty-five percent of our patients had no form of

colitis. However, even though they did not have colitis or

inflammation on biopsy, all of them, without exception, had abnormal

lymph nodes. So they are not normal, even though there is no colitis.

Next slide. And this is my last slide. I'd just like to

conclude that our study is ongoing. We have a control group in place.

We are waiting for formal IRB approval to sit down with one designated

pathologist, a gastrointestinal pathology specialist, on pre-agreedupon

pro forma to define the exact grade of colitis, types of colitis.

And with one definition, to review all the slides that we've done from

all 43 patients, plus our control group and publish our results and

make them known.

The question I would like to explore in our publication is: if

you compare regressive autistic children with non-regressive autistic

children, is the incidence of colitis the same? OR will it be

different?

I would like to go over the growth of these children and compare

the growth of children, both in regressive groups and non-regressive

groups and see if we find a weight percentile difference when we

compare the two groups.

And finally, I would like -- because it is our hypothesis that

children with regressive autism will be those who are most likely to

exhibit growth failure. And it is our hypothesis also that if we

trace back their growth charts to early infancy, I suspect that we

will find that for the first year of life, they were growing normally

at closer to the median and that, somewhere near the onset of their

autistic symptoms, I suspect we're going to find that they began to

show evidence of growth failure, along with their autism, which

suggests that their autistic symptoms and their GI symptoms are

related.

Thank you very much for having me.

WELDON: Thank you very much, Dr. Krigsman. You essentially did

what I've been asking the NIH to do for several years.

Dr. Spitzer, you're recognized for five minutes to make the

presentation.

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SPITZER: Thank you, Dr. Weldon. I'd like to start by saying my

presentation will attempt to be as objective and as neutral as I can.

I would like in particular to say that despite disagreement on a

narrow set of issues, he CDC, in my experience of 35 years in

epidemiology, has been a great institution. I'm honored that some of

my students have been hired by them, that we've been able to recruit

their colleagues, graduates and people with work experience.

And it is not adhominim (ph). I do not know Dr. Davis (ph) or

any of the colleagues. I'm looking at the paper and what I find. And

I'd like that accepted.

Next slide, please.

So the focus of what I'm going to talk about is measlescontaining

vaccines and the risk of inflammatory bowel disease, as

published by Dr. Robert Davis (ph) and others in the publications

cited in the slide.

The purpose of the study published was to examine the risk of

inflammatory bowel disease following exposure to a measles-containing

vaccine. Unfortunately, as implied by other of my colleagues at the

table, the use of the results to demonstrate no link between MMR and

autism is what I respectfully consider to be a misuse of the study.

And I shall try to explain why.

Next. The fatal flaw of the study is that it is grossly

underpowered. With conventional programs of power calculation, the

calculation of power is somewhat complex but not controversial. And

we all do it similarly in various institutions.

The power we calculate is 12 percent. But normally accepted

power is on the order of 80 percent. And when you're looking at

trying to demonstrate no difference, you want the power to be higher

to avoid what is called a Type II error, as opposed to a Type I error,

which is what we worry about in clinical research.

Next, please. And as I say there in what I try to make nonjargon

English, a power of 12 percent means that one has a chance of

88 percent of declaring no increase in risk if, indeed, there was a

twofold increase.

Now just to explain that in a somewhat different way to a nonstatistical,

non-epidemiologic audience and to colleagues in the world

of politics. If you mandate a poll as you're facing reelection and so

on and you get a poll back with a figure, a point estimate, that 55

percent in your jurisdiction are in favor of reelection. In the

published newspapers, "Time Magazine" and so on and so forth, you'll

see that the error is about three percent. So whether you're on the

low side -- 52 percent or 58 percent -- you'll probably get elected.

But if it were 40 percent, your estimates go down to the 20's and

up to the 80's and 90's. And you have no way, from that poll which

had insufficient numbers, to predict whether you're going to get

elected or not. It's an underpowered poll, as I'm giving the example

from this paper.

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So the low power results in the wide confidence intervals you see

in almost every -- if not every -- estimate of the paper we're talking

about. And in this case, six percent of the exposed to needles

containing vaccines, in the population from which the sample was

drawn, were among the controls they picked. I think their choice of

controls was reasonable,

And that's what determines a low power. It's an imbalance, a

maldistribution with exposed and non-exposed in the controls. That

low six percent is what demonstrates the low power.

Next, please. Let me turn then to another issue. We can expand

with questions, Mr. Chairman.

A hallmark of science, as I've always taught and my colleagues

teach, is replication and/or verification. I think the replication

that Dr. Krigsman has done of the British work is an enormous

contribution to our understanding the validity of what went on before.

And it must be part of the practice in an evolving challenge like this

and other challenges.

And these temples of secrecy, it's more in academia in fact, I

would say, than in organizations like the CDC where, "this is our

data," and false issues such as confidentiality are brought up. We

worked that out decades ago.

Ten years ago, I went through the database in Saskatchewan. And

in four months, we sorted out the controversy of beta argones (ph) and

death in children due to asthma. It took four months; it took $4

million. It would have taken five years and $25 million to do it out

in the field.

And you can protect the identity of the patients easily in our

state of science today and computer skills and so on.

We should avoid adversarial challenges. There were those who

didn't believe this. We worked together in that.

And you know, I just hope we can get bast that in these

controversies. And as I say, temples of secrecy and adversarial

approaches have no room in population science and most other clinical

and related sciences.

Next slide, please. I would agree with what the chairman said

earlier, that the Datalink database should be opened to train

scientists with reasonable safeguards. I don't believe in fishing

expeditions. I'm sure colleagues in the CAT (ph) worry about that.

Advanced research plans . . .

BURTON: Can you speak into the microphone because we . . .

SPITZER: I'm sorry, sir.

BURTON: Pull the microphone a little closer to you.

SPITZER: Like I say, these occasional searches -- random

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searches -- to see if you can find some dirt, if you wish, didn't have

no place. This is done seriously, in a scientific way. But access

must be given to the legitimate concerned academic population

governmental organization that needs to look, especially if they're

funded through public funds like the Saskatchewan database in Canada.

Next. So I conclude, the Davis (ph) case control study from the

Vaccine Safety Datalink Project, cannot determine whether measlescontaining

vaccines do or not increase the risk that we are concerned

about. And in the three years that I've been looking at epidemiologic

literature from the entire world, scarcely any of it allows you to

rule out MMR; nor can it rule it in.

And part of the reason is in most jurisdictions where this is

being done, you can't get high power. That's why, in a case control

study that my colleagues and I have designed to sort out this problem.

And we can't do it in the U.S. and in the U.K.

The population has been penetrated to too much of a degree. It

has to be done in eight other countries. Just like the NIH supported

the WHO studies on oral contraceptives for exactly the same reasons --

and appropriately so.

And lastly, this study does not contribute to our understanding

of the relationships between MMR and MCV and autism.

Thank you for your attention.

BURTON: Thank you.

Do you want to start the questions? I'm going to yield to Dr.

Weldon because he is a physician and has some scientific background.

And I thought I'd let him start off the questions. And then I'll

chime in as we go through this.

WELDON: Thank you, Mr. Chairman. And I want to thank all of our

witnesses. You have provided us with a tremendous amount of

information. I wanted to focus on a couple of important points

initially.

If I understand you correctly, Dr. Bradstreet, you have two cases

where you have identified the measles virus in the cerebral spinal

fluid in two children with regressive autism?

BRADSTREET: We presented two cases out of the ongoing

investigation.

WELDON: So you have other cases?

BRADSTREET: Yes, sir. We do.

WELDON: Have you submitted this for peer review and publication?

BRADSTREET: No. At this point in time, the data is preliminary.

We are in the process of developing a control base and replicating the

science, at which time we will submit it for peer review.

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We intend to have, based on the current rate of acquisition of

cases, at least 30 cases to submit.

WELDON: This is fairly significant, what you presented. And has

anybody done this type of research where they've looked at kids with

regressive autism and done a spinal tap on them and checked their

spinal fluid for evidence of the antibodies to myelin basic protein,

as you've described, but more importantly, the viral particles in

their cerebral spinal fluid?

BRADSTREET: I believe we're the only people so far who have done

that research.

WELDON: So you did a research of the medical literature. And

you didn't find any evidence that this has been looked at previously?

BRADSTREET: Not at any point in time in the creation of the

vaccine, the introduction of the vaccine, development of the safety

issues of the vaccine or subsequent to that has anyone looked for

persistence of the measles virus from the vaccine or autoimmunity in

the sensors to the brain, as it relates to the vaccine strain. I'm

not aware of any data to that effect.

WELDON: Now my understanding of pathophysiology, for them to

have measles particles in their cerebral spinal fluid, that suggests

an ongoing encephalitis, basically, in these kids. Is that what

you're implying to the committee?

BRADSTREET: I think it's very early, in terms of drawing

conclusions. There is clearly a persistence of a detectable viral

genome in the brain in these children. There is the autoimmunity to

myelin basic protein and the presence of abnormal antibodies to

measles virus only in the children with autism. We do not see that in

controls.

Before we draw further conclusions, we would love to have those

controlled spinal fluid looking at the virus. We should have that

within two months.

WELDON: Now one of these children is your own child.

BRADSTREET: Correct.

WELDON: Have you tried antiviral therapy in treating these kids?

BRADSTREET: We have. And I would say, at this point in time,

it's unpredictable. And we clearly need a lot more research.

There is a risk of developing hemolytic anemia. In autism, it

seems to greatly exceed the risk of hemolytic anemia from antivirals

that's published in the literature. And I've been in contact with the

manufacturers of various antivirals.

And there is something unusual going on in autism that makes them

more susceptible to side effects to antivirals. So it would not be a

way to proceed, generally speaking, at this time, without some very

carefully observed research.

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WELDON: Now are you making any attempt -- I understand the

strain of measles that is in the vaccine has certain genetic markers

that enable researchers to distinguish it from so-called "wild" type

measles. Are you making an attempt to do the genetic mapping to see

whether this is wild type measles or the vaccine strain?

BRADSTREET: Certainly, that would be place. But the

collaborators for us that are at the various laboratories that are

analyzing the spinal fluid are going to be looking at strain

specificity. The history is consistent -- very consistent -- with

this being vaccine in onset, as opposed to a vaccine failure, where

wild virus is getting in and causing these persistent symptoms.

Again, we should know that within one to two months.

WELDON: And do these kids have seizures also?

BRADSTREET: A very high percentage have seizures. And again,

this is a select group of children with autism. I am not trying to

extend these conclusions to the entire population. These are children

that have a very well established history that's very consistent with

looking at measles virus or MMR as a cause of their symptoms.

WELDON: Thank you, Dr. Bradstreet.

Dr. Krigsman, Dr. Wakefield came under a lot of criticism when he

published his findings. A lot of professional derogatory statements

were made. I believe his credentials as a research professor have

been threatened.

Have you encountered anything like this in your research at all?

You're at Mount Sinai, is that correct?

KRIGSMAN: Lenox Hill Hospital.

WELDON: Lenox Hill. By the way, what is your background? Where

did you do your training?

KRIGSMAN: I trained at Mount Sinai. I did my pediatric

residency at Down State (ph) in Brooklyn and my fellowship in

pediatric gastroenterology at Mount Sinai in Manhattan.

WELDON: And you have published research articles previously?

KRIGSMAN: Yeah.

WELDON: And you're a professor of medicine?

KRIGSMAN: No. I have a position at NYU, which is the academic

affiliate of Lenox Hill Hospital.

WELDON: Okay. And have you come under any of the criticism

encountered . . .

KRIGSMAN: Not yet.

(LAUGHTER)

WELDON: Okay.

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Dr. Wakefield, I'm curious about just this issue of Dr. Gershon.

The ranking member brought it up. And I just want to clarify my

understanding of this issue because I was here when Dr. Gershon

testified. And according to Dr. Gershon's statement that measles

virus particles were detectable in the controls in Dr. O'Leary's lab

-- do I have that correct?

WAKEFIELD: That's correct.

WELDON: And you're contending that there was no evidence to

support the statement made by Dr. Gershon, that Dr. Gershon didn't

look at the data. He made that statement based on essentially

hearsay, what he had heard from somebody else. Is that correct?

WAKEFIELD: That is my understanding. And in fact, the written

data show quite the opposite, that there is substantial evidence that

there was no contamination or no presence of measles virus in those

tissues.

WELDON: Well, the reason I'm bringing this issue up -- and I

don't want to get too bogged down in the controversies between you and

Dr. Gershon. But as I understand it, Dr. O'Leary, who is a very well

respected viral pathologist -- I think he was the gentleman who first

identified herpes simplex type A as the causative agent for Kaposi's

Sarcoma -- that he came under a certain amount of criticism within --

he's in Dublin, correct? -- within the British Isles, Great Britain,

England, Ireland? And he actually lost some credibility and some

research grants. Is that correct, based on that testimony?

WAKEFIELD: Yes, within a week of that testimony, he had lost

five grants from the Irish Cancer Society.

WELDON: From the Irish Cancer Society? And I would assume that

was very costly to him and his research lab. Is that correct?

WAKEFIELD: Sorry, could you say that again?

WELDON: Was that very costly to him and his research lab?

WAKEFIELD: Extremely, both in terms of staff, research and

professional reputation.

WELDON: Is Dr. O'Leary litigating this issue?

WAKEFIELD: No. I think that what I simply want to do here is

put the record straight. And we do not wish to pursue it beyond that.

Let's get on with the science.

WELDON: Mr. Chairman, I yield back.

BURTON: I just wanted to add, I talked to Dr. O'Leary on the

phone. And he would have been here today to testify, but he's having

some health problems of his own. And he couldn't be with us.

But he, I think, stands by what Dr. Wakefield said.

WELDON: If you could just indulge me for another minute?

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Dr. Spitzer, I get the "Archives of Internal Medicine." And I,

like a lot of busy doctors, I just read the abstracts and I move on.

In the case of the Davis (ph) study, I just want to make sure I

understand this correctly.

I took medical statistics in medical school. And I also took it

in college. And I've looked at this study. And I'd like to -- do you

have the study?

SPITZER: Yes, I have it right in front of me, Dr. Weldon.

WELDON: I want to get at this issue of the power. Table three,

which is on page 357 in the study, they report all inflammatory bowel

disease. And they have the -- it's the fourth column -- and they have

it broken down by age. And they have these ranges for children who

receive the MMR before age 12 months. it's a .61 with a range of .15

to 2.45. And then they have all the different.

As I understand it, one basically means it's neutral. Correct?

SPITZER: Yeah.

WELDON: And then the range is -- let's take the less than 12

months. What they're saying is .61. So they're saying, I guess

there's a suggestion there's a reduction in risk of inflammatory bowel

disease. But the range is as low as .15, which would be a dramatic

reduction in risk, up to almost a two-and-a-half-fold increase?

SPITZER: Yes.

WELDON: That tells me this is garbage. I hate to say that. But

that's like my pollster telling me your chance of being reelected is

55 percent, with a range of 10 percent to 90 percent.

SPITZER: Well, I prefer not to use that word. But it just makes

it difficult. You can't rule a failure to reelect versus reelection

in or out on the basis of the poll.

WELDON: Well, I think my time has expired. And I'm sure the coauthors

of the study will take issue with some of this when they have

their opportunity to testify. So I yield back.

Thank you very much.

BURTON: If the gentleman would like, we'll come back for some

more questions for this panel.

Mr. Waxman?

WAXMAN: Thank you very much, Mr. Chairman.

I want to point out to the witnesses and the audience that I have

a conflict in the schedule because at the same time as this hearing,

there's a Commerce Committee markup, a vote on Medicare and Medicaid.

So I'm trying to go back and forth.

But I wanted to get on the record some points about Dr.

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Wakefield's testimony because Dr. Wakefield today testified about an

upcoming scientific presentation in Ireland by Dr. O'Leary. And in

this presentation, which is going to take place in July, scientists

are presumably going to claim to have found vaccine-strain measles in

the intestines of children with developmental disorder.

And I hope to have a copy of that abstract. Do I have a copy of

that? I do have a copy of the abstract. And I want to make it a part

of the record.

In the abstract, it states that the conclusion that the virus was

vaccine-strain, which means caused by the vaccine, is based on one

nucleic acid, position number 7901. Now according to the abstract, if

the chemical at position 7901 is adenine, then the strain is natural

measles virus. But if the chemical is guanine, then the strain is

from the vaccine.

According to this abstract, this difference can perfectly

distinguish between natural and vaccine strains of the measles.

However, according to the Gene Bank website run by the National

Institutes of Health, this isn't true. So what we see in this

abstract, from what we hear from Dr. Wakefield, there's a real

question.

Measles experts have told us that more than 10 natural measles

strains have a guanine at position 7901, even though the abstract says

that only happens in the vaccine strain. Well, if there are 10

natural measles strains that have that particular chemical

positioning, then this theory doesn't hold up. And I have the names

of some of those strains. And I expect to even receive other names,

which I want to add to the record later on.

I want to ask Dr. Wakefield, are you aware if Dr. O'Leary has

checked the NIH website thoroughly before writing his abstract? And

if it is true that position 7901 does not distinguish between natural

and vaccine strain measles, would it be fair to say that the

conclusion of the abstract remains unproven?

WAKEFIELD: The work was based upon a recent publication by Parks

(ph) and colleagues, which may well supercede what is published on the

website. And in that study, they make a clear distinction between

vaccine and wild types of strains based upon that mutation.

Other questions on this will have to be referred to Professor

O'Leary himself, who can't be here.

WAXMAN: Well, I want to ask you whether you know if Dr. O'Leary

checked the NIH website thoroughly before writing his abstract?

WAKEFIELD: I know for sure that he has checked the Gene Bank

website.

WAXMAN: Well, if it's true that this position 7901 does not

distinguish between natural and vaccine strain measles, if that's

true, would it be fair to say that the conclusion of the abstract

remains unproven?

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WAKEFIELD: Yes, it would.

WAXMAN: I want to point out that we have been in contact with

Dr. David W.G. Brown (ph), the laboratory director, and Dr. L. Gin

(ph), clinical scientist. They are the head of the World Health

Organization Collaborating Center for Measles in the United Kingdom.

And according to Dr. Brown (ph), he says the data presented

suggesting the presence of fragments of measles vaccine in these

tissue samples is not scientifically valid. The authors should have

reviewed the measles database fully. And there are a number of

questions that he believes should have been evaluated.

Now I guess we'll have to hear from Dr. O'Leary whether he did

the work that was required in order to come up with the conclusion

that would be beyond doubt the conclusion. OR whether it's simply a

conclusion that remains to be unproven.

But Dr. Brown (ph) says the approach described is scientifically

flawed and will not reliably discriminate between wild and vaccine

strains. He didn't know why the authors did not review available data

or discuss with other measles groups with experience in this field.

Sequencing is the definitive technique to discriminate between

wild and vaccine strains of measles. And he doesn't know why that

wasn't used.

So I want to just make the point here in the time that I have

available to me that what we have now presented to us is another

conclusion that's made, but it's based on some unproved information

from an abstract. And I'm looking at the abstract.

Based on the abstract that Dr. O'Leary is going to be submitting

and which Dr. Wakefield submits to us as establishing the point he

wants to make, according to the World Health Organization

Collaborating Center head, Dr. Brown (ph), it's another unproven

theory. And we need to have a lot more questions answered about that

particular scientific evaluation.

BURTON: Before you leave, Mr. Waxman, I think we have some later

information on that. And I'll yield to Mr. Weldon. Maybe he can

bring us up to date.

WELDON: I just want to clarify this issue here that Dr. Waxman

-- I almost promoted you, sorry.

WAXMAN: Well, I have a juris doctor.

WELDON: You do? I'm glad you shared that with me. I'll refer

to you as doctor.

The abstract that we're talking about is 12 biopsies. Is that

correct? OR you haven't seen it. It's not your publication, right?

So you're being asked to identify something that -- well, let me just

say for the record, I know a little bit about this issue of single

mutation of a single amino acid using it as a discriminator in

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determining whether a population -- in this case, it was 12 biopsies

-- are wild type versus their vaccine type.

And you get into the statistics of this -- and maybe Dr. Spitzer

may want to comment on this -- the statistical probability of all 12

of these being they happen to get wild type is extremely low.

Whereas, if that is indeed a marker that is used for the vaccine type,

then the statistical probability is much, much higher.

Now yes, you could say that some in that sample may have acquired

it through a wild type. But nonetheless, the statistically higher

probability is that this is vaccine-related measles.

BURTON: Would any of the witnesses care to comment on that?

SPITZER: Thank you. I would really have to look at the

specifics of the study, would have to look at comparison groups,

especially with a low sample of 12 of that sort, and have a bit better

understanding than you obviously have, Dr. Weldon, of the biology

under that.

So off the top of my head, I prefer not to give an opinion. I'll

have to look at the basic data and the design and some of the

biological issues before giving an opinion.

WELDON: Just for the record, so the ranking member understands,

when I was an undergraduate, I did molecular genetics research. And

specifically, we were looking at these kinds of issues in the research

that I did. So I'm somewhat familiar with the issue that they're

publishing on.

WAXMAN: Would the gentleman yield to me?

WELDON: Yeah, I'd be very happy to yield.

WAXMAN: It just seems to me that the question is either the test

reliably distinguishes vaccine and natural strain or it doesn't. And

that really goes to the very heart of this abstract because if the

test does establish that the measles in the gut or the bowel came from

a natural strain or it came from the vaccine strain, we want to know

whether that's established.

And I think what Dr. David W.G. Brown (ph), who is the head of

the World Health Organization Collaborating Center for Measles in the

United Kingdom is pointing out to us is that he thinks the conclusion

that they can distinguish the strain that was from the vaccine from

other natural sources of strain is not proved by this abstract because

that position of those genes can be the result of strains not from the

vaccine itself.

So that is the essential point that I think remains unsettled.

Either it is or it isn't. And Dr. Brown (ph) believes it hasn't been

established. Whether it's 12 or more, if in fact the chemical at

position 7901 is from a natural measles virus or from a strain from

the vaccine is the question that I think needs to be established and

addressed.

And I think we have enough question here to really feel that we

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don't have the conclusion in place.

BURTON: We have to leave for a vote. But we're not through with

this panel yet. But I'd just like to say that we've gone from one in

10,000 children who are autistic and have all these kinds of variables

and complications to one in 250; in some cases, more than that.

Something is causing it. And we've got to find out what it is.

And CDC and FDA and HHS had better get on the ball or else in 10

years, it may be one in 25.

I mean, something has to be done. We've got to get to the bottom

of this. And to sit here and just argue back and forth about one case

study or another begs the issue.

The issue is there is a problem and it has to be solved.

We stand in recess at the fall of the gavel. We'll be back in

about 15 or 20 minutes.

(RECESS)

BURTON: Is Dr. Krigsman coming back? While we're waiting, let

me talk to Dr. Stejskal.

How many people do you estimate are allergic to mercury?

STEJSKAL: Mr. Burton, what sort of mercury you mean? Because

there is a distinction when you talk about allergy, if you talk about

thimerosal or other mercury.

BURTON: Something like thimerosal.

STEJSKAL: Something like thimerosal?

BURTON: Right.

STEJSKAL: Then we have to go for patch testing, which is the

things that has been mostly looked at.

BURTON: I understand. But what . . .

STEJSKAL: And I can tell you the numbers are not insignificant.

In children, it seems to be especially often they do react to

thimerosal.

BURTON: Ten percent? Twenty percent? Thirty percent?

STEJSKAL: No. Twenty to 30 percent of those which are tested.

In unselected population, that means adolescents which are healthy,

not coming to dermatology clinics, the number which I remember from

Howard Miller (ph) in Sweden, it's about 15 percent.

BURTON: Fifteen percent?

STEJSKAL: Yes.

BURTON: So anywhere from 15 to 30 percent of the children are

allergic to thimerosal.

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STEJSKAL: Yes.

BURTON: Dr. Krigsman, you did how many endoscopies or

colonoscopies on those children?

KRIGSMAN: We have 43 results back from 43 patients. One patient

had to do a colonoscope twice because of unexplainable worsening

symptoms.

In addition to the 43 patients that we've seen, five have been

scoped already. And those biopsy results are still pending.

BURTON: I know that you can't make a categorical statement about

this. But in your opinion, do you think this was caused by just a

regular measles virus? OR do you think it was caused by the vaccines?

What's your theory on this?

KRIGSMAN: Well, I read the same papers that everyone else has

read. And what I'd like to do and what we plan on doing is to attempt

to replicate what Dr. Wakefield's group has published. And we have

everything in place.

We have our lab. We have been in contact with other laboratories

that have performed this test. We have the details of the ASA (ph).

We have the patients. All we're waiting for now is the hospital

approval. The day after we get that, we've started.

BURTON: So you prefer not to theorize until you get the actual

study?

KRIGSMAN: If I do it myself, I don't know.

BURTON: Okay. We would like to have that. If you would send

that to me for the record when you get it because we think that will

be not insignificant.

I think what you've done today by showing your results so far is

very significant. And I think finding the measles virus in the spinal

fluid is also a very significant finding. And I don't if I were over

to CDC or FDA, I think I'd want to start replicating those studies

right away over there before the private sector does it and they're

proven wrong.

It seems to me that our health agencies ought to be ahead of the

game instead of standing around waiting for the basketball game to be

over and then say, "Oh well, we better do something about that."

I think -- I don't think Dr. Weldon had any more questions for

this panel, did he? Do you know?

I think we've pretty much covered everything with you. You've

been a very good panel. You've been very patient. And we really

appreciate you being with us.

We have one more question. Let me get this real quick.

Do you believe -- and I'll address this to the whole panel -- do

you believe that the CDC statistical studies can dismiss the clinical

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findings? That's what the Associated Press has said and what Reuters

News Service has said. Do you believe that the CDC statistical

studies can dismiss the clinical findings?

BRADSTREET: If I might take that up, as a clinician treating

about 1,500 children with autism between myself and my partner, Dr.

Jerry Kartzenow (ph) who is a pediatrician. One of the disturbing

things for me in the way this has been handled by the media is that I

have a patient -- and I only take care of one patient at a time, even

though I may have 1,500 in my practice -- who has a definable,

biological problem I can measure.

I can get a laboratory test and measure autoimmunity to brain. I

can find excessive amounts of mercury. And I can send off biopsies

and find measles virus.

Now we could debate whether that's the vaccine strain or the wild

strain. But we don't seem to be debating the fact that it's measles

virus that is persistent in these children. So we have a definable

biological problem that must be addressed as a clinician.

The problem is that medicine has not yet given me, as a

clinician, the tools to deal with most of these problems. So we need

a lot more data that would allow me to treat.

Does it dismiss -- does the statistics somehow magically erase

the laboratory results and the clinical findings and the abdominal

pain and the history and the chronic diarrhea like my patients are

experiencing? Absolutely not.

BURTON: Anyone else want to comment? Dr. Wakefield?

WAKEFIELD: Just to say, Mr. Chairman, that the statistical

studies of the CDC and others have actually tested the wrong

hypothesis. And this point was made in the paper that was

commissioned by the Institute of Medicine for the review on MMR last

year. Until they set about testing the correct hypothesis for a

relationship between vaccines, be that thimerosal or MMR or both, and

autism, then they will continue to come up with ambiguous or negative

conclusions.

BURTON: Anyone else?

STEJSKAL: I would like you to put the overhead. And I would

like to stress again that I am sure that case control studies, when

you just pull up all autistic children against all controls, which may

be asymptomatic but still sensitized, will have a power to tell you

anything. So unfortunately -- no, not this one. The last one, which

I gave to you with quotations for reference.

Yes, that's it.

BURTON: Okay.

STEJSKAL: And just please read it, sir, carefully. The effect

of risk factor may be diluted. So if we are now talking about mercury

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sensitization or mercury -- weak mercury detoxification as a factor in

these which develop the disease, normal case control study will not

catch this.

So this is what this paper saying, the effect of risk factor may

be diluted if evaluated in heterogeneous population. So how you have

to study is that analysis has to be based on the clinical markers of

susceptibility either for toxicity or for allergy, but on the

biomarkers. These biomarkers can be enzymed for detoxification.

We have different methionines. And you have to select patients,

autistic children, for this. And then you have to do average to do

the studies.

So analysis based on clinical markers of susceptibility which are

phenyldicate (ph) markers, but also genetic markers, if they are

available. And this may be one way how to elucidate separate causes

best ways and identify specific environmental risk factors.

So I think this is very important that the new studies which

should be set up would be done so we can really measure and find the

causes. Thank you.

BURTON: Go ahead.

WELDON: I just have one quick follow-up question. And I'll just

offer it out to the whole committee. One of the issues that I've had

a little bit of a problem with over the years we've been looking at

this issue is we hear about mercury and we hear about MMR . . .

(AUDIO BREAK)

(UNKNOWN): . . . I believe that are thimerosal-related. There

is going to be an effort, led by CDC, to try to create a multicentered

laboratory study that will examine, I believe, some of the

same questions that Dr. Wakefield and others have looked at.

So yes, that effort is underway. And good progress has been made

in trying to organize this kind of multi-centered study. But we're

trying to do this in such a way that we can overcome some of the

shortcomings or limitations that may have existed on some of the

earlier work.

BURTON: So what you're saying is you're in the process of doing

it now, but you have not yet done it?

(UNKNOWN): Specifically relating to the work that Dr. Wakefield

and his colleagues have done, that's correct. But there is a lot of

other work that has been done and that has been reviewed by the IOM

and these other committees that I've talked about.

So I wouldn't want to leave the impression that there is a big

void of information. I wouldn't want to leave the impression that we

know everything we should know. But I certainly don't want to leave

the impression that there is a void either.

BURTON: How long have we been talking about this? How many

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times have I had people from HHS and FDA up here? It's been, what?

Couple of years, hasn't it?

(UNKNOWN): It's been often.

BURTON: Two to three years. Yeah, it's been often.

(UNKNOWN): Yes.

BURTON: And now you're staring to look into it. And I want to

tell you, we appreciate that. And I'm sorry ittook so much prodding

to get it started.

We were talking about the Vaccine Safety Datalink. For two years

now, we've tried to get that information so that other doctors and

scientists who are not connected to our health agencies who have

credentials could start using that information to do studies on their

own.

We were told in -- when was it? January or February? In January

or February that that was going to be made public. Before this

hearing, we asked why it had not yet been made available to

responsible people in the scientific community. And we were told,

"Oh, it has been made available."

I didn't know it. Did you make any kind of report to the public?

Did you announce this in a press release or anything?

CHEN: Off-mike.

BURTON: We can't hear you. Can you pull the microphone closer,

Dr. Chen? Have you got it turned on? There you go.

CHEN: I think several members of the audience were present at

the meeting. And we discussed several issues. The VSD Project is a

very important and unusual project that contains about 7.5 million

persons in the United States and their personal medical records.

And so with all the public concern in terms of data privacy, it

is very important to work out a process in which we could balance the

privacy of these individuals' medical records on the one hand, as well

as secondly, the desire for us to be able to look at independent data.

Now the two years that it has taken us to develop a process, in

fact I think we, number one, when we first approached the HMOs, there

were severe concerns on all of them that, in fact, they would not

agree to this and that they would, in fact, withdraw from the project.

And so we've had to take the time to work out a compromise in which

they would still be willing to participate in this partnership with

the government with our ability to look at data safety issues, as well

as meet the needs of the HMOs, in terms of protecting their privacy.

So I think that's the question in terms of why it has taken time.

And so we have, in fact, come from where each of the HMOs, not only

the principal investigators, but also their governing bodies, were

opposed to this idea. And we've kind of gone through each of them

and, in fact, convinced them to come around to the other way, to this

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research data center.

So that's what has taken considerable amount of time and

convincing.

Now in terms . . .

BURTON: Let me pursue this. So in February, you had a meeting

and other CDC employees were involved, with committee staff. And they

discussed the release of the Vaccine Safety Datalink raw data to

researchers. That was in February.

And at that meeting, CDC provided a draft proposal. Have we got

that exhibit? Exhibit number one is -- can we put that up on the

screen? Well, never mind. It's in your file there, exhibit number

one for researchers to access to the VSD data. At that time, the

staff was told that the project was ready to go.

Isn't that what we were told? It was ready to go at that time in

February?

CHEN: That's correct.

BURTON: And we did not receive, up to this meeting today, a

press release or an advertisement in any medical journal was seen or

on any CDC website regarding this new program. Now if you're going to

make an announcement, how do you propose to let anybody know unless

you tell us?

CHEN: As I mentioned at themeeting to the people that were

present, that this in fact is the first time that we have tried to

develop this mechanism with the National Center for Health Statistics.

It's a pilot project, using their research data center, which

historically have not put this type of personal medical records

available for public use.

It's really for kind of national health interview survey, where

people over the telephone are willing to answer those type of

questions about their health status. Those are the type of things that

are put on there.

So this is in fact a pilot process. And so until we work out all

the potential concerns through the first couple of test projects, if

you will, it is our sense that it will be premature to widely

advertise it.

BURTON: But I think, with the quantum leaps that we've seen in

technology, there's not any real risk if you don't want the

researchers from the outside to know who the individuals are that is

on the data. You can do that. You can protect the privacy of those

individuals. You can make sure that there is no public announcement

about that.

CHEN: Unfortunately, that turns out not to be really feasible in

this database. If you could imagine that for any vaccine safety

study, you need several parameters that are key to be able to make the

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analysis. You need to know the date of birth of that individual. You

need to know the date of vaccination of that person and any medical

visits and what diagnoses they had.

So you need all of those three elements in order to be able to do

your analysis. And it turns out that with the key variable on date of

birth -- so for example, this was actually one of the major concerns

expressed by one of HMOs in Colorado, the principal investigators, his

daughter in fact recently had a sprained ankle.

So he kind of posed hypothetically to his analyst that if you

attended a birthday party and knew my daughter's date of birth and you

also happened to find out that the child had a sprained ankle the

previous day or the previous week, can you find this child? And in

fact, he was very easily able to find that.

BURTON: I see where you're going. We're talking about how many

people? Six million?

CHEN: 7.5 million.

BURTON: 7.5 million. And you're concerned because there is a

sprained ankle and somebody goes to a party that they might be able to

tell by using the birth date who this person was.

BERNIER: Mr. Chairman, may I interject if I may? I want to put

on the record very clearly that CDC does support sharing information

and trying to work transparently, which I think is where you've been

trying to get us to go. So let me make clear . . .

BURTON: What I'm trying to find out right now is why, when we

were told in February they were going to release this -- you know,

every day is important to people who are going through these problems.

My grandson, my granddaughter, all these people out here who have kids

who are autistic, the people whose kids are becoming autistic today.

Every day is important to them.

And when we're told in February we're going to get information

and the information -- here we are, at the end of June, and we haven't

received it. And yet, it was supposed -- we've been told that, "Oh

yeah, it was made public a long time ago." But nobody knew it.

That's important.

And that's what I'm trying to get at here. Why if you made a

decision, why didn't you tell us? Why didn't we know about it? Why

didn't all these people in the scientific community that wanted to get

started on this, why weren't they told about it?

BERNIER: Well, first of all, we have been trying to strike the

right balance between the interests of all of the concerned parties,

so that's part of the reason. The other thing is that this is new for

us. We're not interested in highly publicizing something where it is

a pilot type of project.

When we can iron out the wrinkles, we potentially will be in a

position to make this more available. So part of this is that this is

a new pilot project and there have been efforts to try, as Dr. Chen

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alluded to, we have to try to protect the cooperation of the HMOs. We

have the proprietary interest of the HMOs and the privacy rights of

the patients.

So we are trying to strike a balance. And we are trying to make

this work as smoothly as possible. We don't know all of the issues

that we will confront when we do bring in these researchers to

reanalyze some of the studies that we have done.

So we are trying to move cautiously so that we can do so. But we

will get to where you're going for people who want to reanalyze

studies that CDC has done in the VSD.

BURTON: I have more questions. But I'll yield to my colleagues.

As I said before, as I yield to Dr. Weldon, we all want you to be

cautious. We don't want to make mistakes. We all support

vaccinations that's done in a responsible way because it has protected

the health of this country.

But you've got people every day that are starting to suffer.

There's huge quantities of people who have children now that are

suffering from these diseases.

And the quicker we move, the better. And the more people that

get involved in the research, the better. So having outside

responsible scientists having this data so they can get started on it

quickly is very, very important.

Mr. Weldon? Dr. Weldon?

WELDON: Thank you, Mr. Chairman.

Let me just start out by saying to you, Dr. Bernier, we . . .

BERNIER: Sorry, I'm getting a lot of notes.

WELDON: Yeah, this is very technical and complicated. We all

support the vaccine program, okay? I'm a physician. And I vaccinated

hundreds and hundreds of people every year in my practice. And we all

recognize the tremendous accomplishment of the vaccine program in

preventing death and morbidity in the United States, world over.

Okay?

And I'm just saying that because we've had a lot of hearings on

this issue over the years. And a lot of people from the vaccine

community come forward and they point out all of that over and over

again.

And we don't really question any of that. Our concern is that

there has been clinical evidence that there are some very serious

problems with our vaccine program and that officials in the United

States and officials in Great Britain have been trying to avoid

addressing them straight up.

I mean, just to cite one teeny, little example. This doctor over

here, Bradstreet, did a culation on his kid and culated out a mountain

of mercury from this kid. We had, in other panels, we had physicians

with autistic kids who did hair analysis on their kids and discovered

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they had toxic mercury levels.

Now I'm very glad you're getting around to the studies now. And

I'm very, very pleased. You said you have six studies going on.

But I just want to underscore that we all support the vaccine

program. We all know it saves millions of lives. We all want to see

it continue.

But credibility is also one of the other issues at stake here.

It's not just the science of the matter. It's the credibility of our

vaccine program. The last thing I personally want to see is that

public confidence get undermined -- like it has been undermined in

Great Britain -- and you've got thousands of families refusing to

vaccine now.

And as I understand it, you have outbreaks of measles going on

over there. And I would like to see us handle it better.

And let me just say -- and you can take this back to your bosses

-- one of the things I continue to be very, very disappointed about is

the amount of money that's being thrown at this issue. We have, I

think, about a million people with HIV/AIDS. The CDC budget for

HIV/AIDS is $932 million, almost $1 billion for HIV/AIDS for a million

people.

We have about a half a million people -- kids mainly -- with

autism. And the CDC budget is about $10 million or $11 million. And

we have to start putting the resources to this problem to address this

issue.

And the access to the data, you guys have to work through that

problem and you have to allow skeptical people to look at the data.

Because the impression is being generated that there is a cover up

going on. And I want to say that this study lends credence to the

concern of their being a cover up.

This archive study -- and Dr. Chen, I'd love for you to respond

to my question. You have got a claim in here in your conclusions,

"Vaccinations with MMR and other measles-containing viruses or the

timing of the vaccination early in life does not increase the risk of

inflammatory bowel disease."

Now you weren't the principal author. It was Robert Davis (ph).

And there is 10 different authors here, so maybe you didn't write that

conclusion.

But the statisticians are telling us that you don't have the

power in this study to make that sort of a claim. And what's really

disturbing to me is now in clinical evidence, which this is sort of

the Bible in medicine, this study is being quoted in clinical evidence

that there is no relationship. But the statisticians that I've talked

to tell me that the data doesn't support the claim at all.

And this suggests again that you guys are -- it's like you're

circling the wagons and you're not really addressing the issue

straight on, straight up, honestly.

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CHEN: Dr. Weldon, let me address some of the points that you

addressed. I think if you take a look at my record over the years,

I've done everything I can to build the infrastructure that's needed

for us to address some of these issues. I started the Vaccine Adverse

Event Reporting System. I started the Vaccine Safety Datalink

project.

And I think part, in retrospect, part of our challenge, if you

will, in the field of vaccinology is that, in fact, there is one

additional missing piece of the infrastructure which, in part, has

created an unnecessary gulf, if you will, between the clinicians and

the population scientists. And if you think about it, adverse events

obviously occur rarely, so that any particular doctor reporting to

VAERS will be pretty much doing so for the very first time.

And so our difficulty has been finding a way in which these type

of cases can be assessed in a standardized way. The analogy would be

that, for example, we do not expect the average primary care physician

to be able to diagnose and treat a rare type of leukemia on their own.

We create, in fact, a sub-specialty, a hematology oncology, which over

time then as a sub-specialty, is able to make progress on these rare

outcomes.

And now this situation with vaccine safety is that, by and large,

these events are rare. And so we, in fact, need a tertiary

infrastructure to be able to study them. And we have just started the

Clinical Immunization Safety Assessment Centers in this current fiscal

year. So I think we will have a mechanism, I think, to bridge the

type of research between population and the individual level.

WELDON: Well, let's talk technical stuff here. The issue is

power. And the problem with the power in this study, the power

calculation renders this study invalid because you do not have enough

people in your control group who were not vaccinated. And the only

way that we can get a statistically valid study, because the

penetration of this vaccine is so extremely high, is that we would

literally have to have a multi-national effort to try to address the

question that you attempted to answer in this study, which you really

didn't answer.

CHEN: And I agree that more studies -- this is one study. And

with all evidence, the more studies the better that are replicated.

(UNKNOWN): If I may?

WELDON: Yeah.

(UNKNOWN): I'm a co-author of this paper.

WELDON: You're on this too. Please.

(UNKNOWN): . . . strongly criticized. I just want to put my

viewpoints and put it into context.

WELDON: Can you move the microphone up a little bit closer,

please?

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(UNKNOWN): I think this paper and the low power that was alluded

to earlier, I think kind of missed the main point of this paper. It

combined all measles vaccine into one group. And therefore, we found

that 94 percent were vaccinated.

By the time of this study, the hypothesis with IDD and measles

vaccine had shifted to the MMR vaccine as the culprit. Before that,

there have been studies done looking at single antigen measles

vaccine, one done by Montgomery (ph), which Dr. Wakefield is a coauthor;

the cohort study of a 1970 British birth cohort. They did not

find any association with single antigen measles vaccine.

Similarly, a case control study by FINI (ph) could not find

association with single antigen measles vaccine. Subsequently, the

study by Montgomery was the one in which there were two cases in which

the individuals -- again, this long-term follow up. They were

followed up to about age 26. It think it was about two cases that the

individuals had wild type measles disease and mumps disease in the

same year. And I think it was part of that. And those two cases had

a high relative risk.

I think it was their finding that the sort of theory, the

hypothesis that having the two antigens exposure at the same time may

be more detrimental. From there, I think they have part of the

evidence that it's combined measles-mumps-rubella vaccine that's

really the more dangerous combination and calls for a single antigen

vaccine.

So by the time of this study, really the main new information to

address or issue to address is MMR vaccine. And if you'll look in

this study, the proportion vaccinated with MMR was 66 percent. I

think the relevant table is table two, where we're looking at ever

vaccinated with MMR vaccine. And you'll see that the upper end of the

95 percent confidence interval for inflammatory bowel disease is 1.69.

We can be fairly confident. We can be over 95 percent confident

that the relative risk for inflammatory bowel disease in this

population associated with MMR is well below two.

WELDON: We've got a range of .21 to 1.69.

(UNKNOWN): This is a range. But this isn't a flat range. You

have to look at the odds ratio. That .59 says that's our best

estimate. It's almost like if you would repeat this study, it would

be statistically like a bell-shaped curve. Most of the results would

be around .69.

You may have a few out there around 1.6, maybe a few down by .2.

But they're more mainly going to cluster around. So this is our best

estimate is .6. And it's for MMR. It's a lot better than focusing --

I mean, I'll agree that we were much more limited at looking at table

three with specific ages of vaccination. They were more limited in

looking specifically at Crohn's Disease or ulcerative colitis.

But I don't think our power -- I'd say our power was reasonable

or at least, as the confidence intervals would suggest, address the

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main issue that was expended at the time.

WELDON: Well, let me just reclaim my time here. The issue is

this is a relatively low probability event. I mean, the data suggests

that the vast majority of girls can take this vaccine and it's

probably less than one percent are having -- this hypothesis is

correct, that MMR alone or MMR somehow interacting with mercury is

causing regressive autism associated with inflammatory bowel disease

or autistic enterocolitis.

The data is that it's maybe one percent of boys and it's well

below one percent of girls. It may be on the order of .2 percent or

less of girls. So even an odds ratio that you're putting forward here

in table two, I'll give you credit, of 1.69 doesn't answer the

question.

And you cannot, on the basis of the data that you've provided

here, substantiate the conclusion. And frankly, I've been reading the

annals -- or excuse me, the archives for years, not the "Archives of

Pediatric and Adolescent Medicine," the "Archives of Internal

Medicine." But it's published by the same publisher, AMA.

And I'm surprised this would be accepted for publication. And

I'm even more disturbed that the data is being cited in other

publications as further evidence that there is no relationship.

Meanwhile, we have more and more clinical studies. We heard from

another researcher here, totally unaffiliated with Dr. Wakefield,

basically substantiating Dr. Wakefield's findings. And now we have

even the more disturbing development of a researcher telling us he's

finding measles in the cerebral spinal fluid in these kids.

Now perhaps maybe the CDC is the wrong agency to be addressing

these questions. None of you are with NIH, correct? You're with NIH?

I mean, the NIH budget, I think is even more disturbing.

You've got in '03, $2.7 billion on AIDS-related research,

HIV/AIDS, which I don't quibble with. It's a terrible problem. But

$70 million? You've got 500,000 people with autism and a million

people with AIDS. Why don't we just apply the dollars now?

Now I've heard you say you've got to get quality research and

that you just can't throw money out. You want quality.

But I know enough about research. If you dangle the money in

front of them, the quality research will start coming forward.

There's a lot of researchers who will say, "I can do that." Why don't

we get answers to some of these questions?

(UNKNOWN): As we discussed several weeks ago when I last

testified before this committee, but I think even in that time, for

example, we've made strides toward funding our first large autism

research centers. And there will be a formal announcement about that

in several weeks.

And in those centers, for example, is where a there's kind of

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training will occur that will allow young investigators to develop

skills, to develop quality grant applications, to design very rigorous

experiments to undertake these issues.

Your message is well taken that there is a need for biomarkers

for this disorder. There is a need for more clinical investigation.

And we have put the money on the table.

We are working with investigators with a great deal of technical

assistance to them about how to prepare grant applications and so on.

WELDON: I want to just underscore a very, very important point

in all this. And I don't mean to keep picking on AIDS. But you know,

you're going to have another dramatic increase in the funding. The

president wants it. The House and the Senate all want it.

You're going to get hundreds of millions of dollars more.

Keeping this kind of a ratio, you have to start applying

disproportionately more money to autism so we can get answers to some

of these questions. And one of the reasons I feel so strongly about

this is, unlike AIDS, where it's clearly a behaviorally-related

disease, these kids may be getting this from a government-mandated

vaccination.

And that if we get answers to some of these questions, we may be

able to prevent it; whereas, in the case of AIDS, we can't really

prevent it because it's behaviorally related. It's not something

mandated by the government that has caused it.

So a shift in priorities can have a dramatic impact.

I'm going to yield back. I just want an answer for the record.

The issue brought up by the ranking member on using various

coding regions in the RNA and in the proteins as biomarkers to

determine whether or not there is a wild type version of the vaccine

strain, I want to introduce into the record a research article

published by a Dr. Christopher L. Parks (ph). And it's entitled

"Analysis of Non-Coding Regents of Measles Virus Strains in the

Edmonton (ph) Vaccine Lineage."

I yield back.

BURTON: Without objection, we'll submit that for the record. We

also have an article which we'll also put those in the record.

Ms. Morella, do you have some questions?

MORELLA: Thank you, Mr. Chairman. I thank you for this hearing

and continuation of the series.

Dr. Weldon made some exceedingly great points, by virtue of his

experience and knowledge. I also, I agree with him that we should not

be acquainting HIV and AIDS with the money that's going into this

research either. Let's just contribute the money to all of the

research. I know he doesn't mean to say we take away from one or the

other.

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But I'm going to ask a series of questions to Dr. Chen.

Dr. Chen, sir, in the U.S. medical community, studies that have

been done by CDC researchers are given a great deal of credence,

aren't they?

CHEN: I hope so.

MORELLA: Right. And internationally, such studies tend to be

viewed as the opinion of the government, correct?

CHEN: You have to ask those people. Again, we try to do the

best science possible.

MORELLA: Right. Generally, medical authorities, particularly

those in the international community, tend not to distinguish between

CDC employees publishing research and the CDC's official position.

Correct?

CHEN: Again, you have to ask -- I have not done a survey to look

at that.

MORELLA: Generally, you would agree with this? Isn't it true

then that HHS requires or perhaps should require that CDC ensure that

its research regarding vaccines, for example, is of the highest

caliber, is not misleading and that a published study actually answers

the question being asked.

CHEN: I think all studies have their strengths and weaknesses,

as has been seen by the discussion this morning. And all we can do

is, for any particular study, do our best to see what we can answer

with the particular study design and address the kind of the strengths

and weaknesses in the discussion.

MORELLA: So if a given CDC study can't reach a conclusion, the

CDC in the article needs to explicitly say so. Correct?

CHEN: Again, in any particular discussion, hopefully we discuss

both the strengths and the weaknesses. And in the weaknesses,

obviously that would be -- no single study on its own, very rarely, is

able to definitively arrive at a single conclusion. What you do is

you add to the weight of the evidence on a particular issue.

MORELLA: Right. It's also our understanding that the Vaccine

Safety Datalink project was your idea, your concept. Is that true?

CHEN: Well, I don't know if it's unique. I think there were

several other predecessors who actually did smaller projects, versions

of these large linked databases. In fact, the drug safety folks

actually came up with the early versions of these linking up automated

pharmacy files, if you will, with automated outcome files.

MORELLA: But you were a critical part of that process.

CHEN: So we were building on those other -- like science, we're

always building on others' ideas.

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MORELLA: Yeah, you're being pretty modest about it. Was the

project originally designed for a specific length of time? OR was it

designed to go into perpetuity?

CHEN: Well, I think the thought would be that we will continue

to vaccinate. And presumably, there will continue to be vaccine

safety issues.

Our initial contract, I think, was for five years because that's

the extent of how long government contracts could be. So I don't know

if we actually ever thought about it in terms of how long it would

run. But it was definitely ran for at least five years.

MORELLA: So about five years was the original intent.

Why was the project extended past the original five-year plan?

Who made the decision?

CHEN: Well, I think the main reason is there continued to be new

vaccines added. And there are continuing new vaccine safety issues

that arose. The main impetus, back in around early 1990 when we got

started, the Institute of Medicine reviewed the evidence available on

the safety issues as part of the Vaccine Injury Compensation Act.

And for about two-thirds of the issue that they looked at, they

had to take the agnostic position that there was inadequate events to

accept or reject a causal relationship. So there was a large number

of research issues that, in fact, was a backlog, if you will, from

even before.

MORELLA: But who was it who made the decision? And as a matter

of fact, who at CDC determines what studies will be conducted?

CHEN: Well, it's actually a decision like any multi-center

research project. It's done collaboratively through the principal

investigators, so we have a monthly conference call among the PIs to

kind of look at potential new study ideas.

We take into account a whole variety of potential study ideas, be

it from the Institute of Medicine, be it from VAERS, be it from case

reports in the literature. And then on an annual meeting, face-toface

meeting, we try to even do further prioritization among our

ongoing studies.

MORELLA: So it's collaborative?

CHEN: It's very much unusual. It really is a partnership. It's

the largest collaborative project between CDC and managed care

organizations. And so we have the public health interest to do the

vaccine safety monitoring.

The HMOs -- and I should mention that this is perhaps an aspect

that is different than Canada and Saskatchewa, where there is national

health insurance -- the HMOs kind of have their own internal

administrative databases as part of their regular internal insurance

organization, if you will. And so we piggyback the VSD project onto

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data that's really collected for routine medical care.

MORELLA: May I just ask one more question related to that, Mr.

Chairman? In February of this year, I understand that you and other

CDC employees met with committee staff to discuss the release of the

Vaccine Safety Datalink raw data to researchers. Is that correct?

CHEN: It was not the raw data. I think there is some confusion

here. What we had talked about is that in terms of the completed

studies of the VSD, in which individuals would wish to do independent

validation of our findings, we would make that available through the

research data center.

MORELLA: And at this meeting, CDC provided a draft proposal for

researchers to access the VSD data. And at the time, again I

understand that the staff was told that the project was ready to go.

Is this project now up and running?

CHEN: In fact, I think someone contacted me yesterday in terms

of the proposal process and we're in discussions with him.

MORELLA: And so again, I understand that no one has seen a press

release. Have you released a press release or an advertisement in any

of the medical journals or on the CDC website?

CHEN: Generally, we do not publicize or issue a press release on

matters like this. That is really handled by the department.

We pursued this issue at the urging of the committee and made

your staff aware of the availability of this new policy, so that other

researchers who may wish to replicate the findings, we make it

available.

MORELLA: You can see what I'm getting at. I mean, the idea that

I think it's important that you make the announcement; otherwise, how

do you propose that people are going to even know that the program

does exist?

The committee was sent an email message last week saying that

applicants could send their applications to you? Do you have the

procedures and the timeline for people to respond?

CHEN: Again, as I mentioned earlier to an earlier question, this

is a pilot process that we're working out. And we are going to accept

those requests. And we'll just work it through and see how it goes.

Because I think this is very much an experiment in terms of seeing

whether, in fact, we are able to maintain this very valuable

infrastructure for vaccine safety monitoring to the extent that the

HMOs are still willing to continue to participate.

We cannot mandate them to participate. It's really their

patients, their database and their institutional review boards who

have oversight over the access to these data.

MORELLA: Can outside researchers contact the HMOs who

participate in the VSD directly with specific research proposals?

CHEN: If they wish, sure. In fact, currently for example, the

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infrastructure that the VSD has built has permitted a number of other

folks who are interested in research, predominantly folks interested

in doing vaccine-related research, to work directly with the HMOs.

Yes.

MORELLA: My time has expired. I would yield back. I thank you

for your response, Dr. Chen. And you can see we're looking at what

that streamlined procedure will be -- the openness timeline.

Thank you, Mr. Chairman.

BURTON: Thank you, Ms. Morella. We certainly want to see this

opened up as quickly as possible so that other researchers can check

on all these things that we're talking about today.

Dr. Egan, one thing that's bothered me for a long, long time, do

you know when thimerosal was checked for its safety initially?

EGAN: I guess the first study that I'm aware of, I guess, was in

the late 1920s when some researchers from Eli Lilly first evaluated

the . . .

BURTON: Do you know of any safety studies after that one? OR is

that the only one?

EGAN: I'm trying to think. That's probably the only direct.

BURTON: Okay. Well, let me ask you a question. Do you know

anything about the study? Have you ever looked at that study?

EGAN: Yes, the original publication of it. Yes.

BURTON: Do you know that everybody, from what I've been told,

everybody in that study was suffering from some kind of meningitis.

And it was a fatal disease and that every one of them died? And so

there was no way to know if the thimerosal was safe or not because

every one of the people that were injected with it died? And they

died from the meningitis. Did you know that?

EGAN: I'll have to go back and look at that. No.

BURTON: Do you mean to tell me, since 1929, we've been using

thimerosal and the only test that you know of is the one that was done

in '29? And every one of those people had meningitis and they all

died?

EGAN: I guess there are other reports about the use of

thimerosal in various products.

BURTON: Like methiolate? We took that off the market.

EGAN: Yes, as a topical. Yes.

BURTON: But you don't know of any other study, thorough study,

that showed the safety of thimerosal?

EGAN: No, other than those studies that were done using it in

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products and at whatever doses that they had where they did see some

safety-related issues.

BURTON: But the point is, before you put a product on the

market, before you start using it and injecting it into children or

putting it into the products that people can put on their skin that

might be toxic, shouldn't there be a very thorough test to make sure

it's safe?

EGAN: Well, the product itself, the final formulation of the

vaccine is studied. And these studies were done. The limitation of

those studies, of course, is that they would only find the more acute,

the more rapid adverse events that might occur.

BURTON: But you're not familiar with any study that specifically

deals with thimerosal?

EGAN: There were animal-based studies, but not in humans, other

than those studies where it was in products where either people

received too much by accident or what else and they could get ideas of

what the toxic doses were. And then the other studies that are

environmental, trying to get estimates of the toxicity of mercury.

BURTON: So the way you found out if there was too much given

thimerosal given was from the person who got the shot?

EGAN: Yes.

BURTON: So they, in effect, were guinea pigs because you really

didn't know how much thimerosal was going to be tolerable in a human

being?

EGAN: Well, these weren't studies that were done directly like

that.

BURTON: How did you know how much thimerosal could be given?

EGAN: Excuse me?

BURTON: How did you know how much thimerosal could be given? Or

be put into a vaccine or a product?

EGAN: They started off with the amounts of thimerosal that were

needed as preservatives. There were animal-based tests. The amounts

were certainly much, much less than the amounts that came out of those

Lilly studies. And then during the investigational drug phase,

adverse events were monitored. And none were seen.

BURTON: You testified before this committee on July 18, 2000

that the FDA's major concern regarding thimerosal in vaccines started

around May of 1999. And it's on page 282 of the mercury hearing

transcript.

And we'd like for you to see this FDA email sent by Dr. Peter

Patiarka (ph), a CBER employee, to Roger Bernier and Jose Cadaro (ph)

regarding an FDA plan in place for many years to remove thimerosal

from vaccines. And it's exhibit number 15. Do you have that before

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you, sir?

EGAN: No, I don't. I'm sorry.

BURTON: Can you see exhibit 15?

Dr. Chen, can you give him exhibit 15, please?

BURTON: Let me read directly from exhibit 15. It says -- and

this is the email that I just referred to. It says, "The fact of the

matter is that an interim plan for potential removal of thimerosal has

already been in place for many years. We just need to speed up the

existing plan and not create a new interim plan. We are proactive,

not reactive. Thanks, Peter P."

Why wasn't thimerosal taken out of all these vaccinations? If

the plan had been in place for many years, according to this email?

And why didn't this committee get a copy of that email? We didn't get

a copy of the interim plan, excuse me.

EGAN: I'm not aware of any interim plan.

BURTON: What's he talking about?

EGAN: I'm not sure what he's talking about. There was probably

some discussion.

BURTON: Have you read that? It says again, "The fact of the

matter is that an interim plan for potential removal of thimerosal has

already been in place for many years." They already had an interim

plan. And you're not aware of that?

EGAN: No, other than . . .

BURTON: And then it goes on to say, "We just need to speed up

the existing plan." So there was a plan to get this mercury product

out of vaccines for many years. But you don't know about it?

EGAN: No, I know that there have been some discussions with some

of the manufacturers as they were developing vaccines to caution them

not to add additional thimerosal.

BURTON: Why wouldn't you want to add additional thimerosal?

EGAN: Well, not to add additional thimerosal or to add

thimerosal as a preservative if it could be avoided.

BURTON: You know, I think to anybody who is paying attention to

this discussion probably gets the impression -- very strong impression

-- that the scientific community and our health agencies knew that the

mercury was a dangerous thing to have in those vaccines. And yet, for

some reason, even though it had been discussed time and again to

remove it from these vaccines, they kept putting it in there.

And the only conclusion that I can come to is it was money, that

there was some kind of money involved, that this was a product

produced by pharmaceutical companies and used by pharmaceutical

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companies. And to expeditiously take it off the market was going to

cost them a lot of money. And that brings us to the possible

conclusion that there is undue influence being exerted on our health

agencies by pharmaceutical industries, the pharmaceutical industry.

Now what do you think about that?

EGAN: Well, from my own experience, I would say no, that that

wasn't the case.

BURTON: Then why is thimerosal still in there? Why is it, if

this was an interim plan that had been discussed years before, why

wasn't it taken out?

EGAN: As I said, I'm not aware of this interim plan that was

existing that Dr. Patiarka (ph) is referring to. I can only speak to

my own personal involvement in this in the late '90s. I guess in

1999, at around the summer when the issue arose . . .

BURTON: Well, doctor . . .

EGAN: And we did work with the vaccine manufacturers to remove

and reduce thimerosal from their products.

BURTON: I know, because we've been raising so much Cain about

it, there's a lot of heat being generated.

This email was to you, Dr. Bernier, was it not?

BERNIER: I don't recall . . .

BURTON: Can you turn the microphone on?

BERNIER: I don't specifically recall the email. But if I can

look at the exhibit?

BURTON: Sure, go ahead. It's to RHB2 (ph). Is that your

website? Is that your email address?

BERNIER: Yes, Mr. Chairman.

BURTON: So it was to you? Do you recall getting that?

BERNIER: I think, looking at the date, this is late June 1999.

BURTON: About three years ago.

BERNIER: This is in the early days when we were pulling together

the joint statement, the first joint statement on thimerosal. And it

looks like we were expressing, exchanging views about the pros and

cons of moving forward with that joint policy statement. And it looks

like Dr. Patiarka (ph) was commenting on some of the pros and cons of

moving forward in the direction that we were moving.

So yes, I did get this email.

BURTON: Let's see, Dr. Egan, let me see, here's an email. On

July 2nd, 1999, Dr. Robert Ples (ph) sent Dr. Ben Schwartz (ph), then

of the NIP Office, an email regarding thimerosal in the drafting of

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answers to possible questions that would arise from the release of a

statement. In this message, it states:

"You mean the FDA does not already know? How could they approve

a product without knowing how much mercury it contains? What else is

lurking that nobody knows about?"

That's exhibit 13. Are you familiar with that email?

This is from Dr. Ples (ph) of the FDA and it was to who? To Ben

Schwartz (ph), who is the acting commissioner. Are you familiar with

that?

EGAN: No, I haven't seen this. But we certainly did know the

amount of thimerosal that was in each vaccine. So I don't know what

this means.

I mean, FDA did already know. And the amount of mercury that's

in every product is published . . .

BURTON: Who is Dr. Ples (ph)? Do you know who Dr. Ples (ph) is?

EGAN: He worked for the Bureau of Biologics in Canada. And he

currently works for the Centers for Disease Control.

BURTON: And he is the one that sent this. "You mean the FDA

does not already know?" You say they did know?

EGAN: But we do know.

BURTON: But did you know then?

EGAN: Yeah. And the amount of mercury that's in each product is

in the accompanying package insert. So we know. And it's publicly

available.

BURTON: Dr. Ples (ph) also made the statement, "It is also no

longer going to wash that there is no data to suggest a risk."

Did anybody see that memo, any of you? And it went to the acting

director of the -- he's the acting commissioner now? But it said, and

this is in 1999, it is also no longer going to wash that -- quote --

"there is no data to suggest a risk." That's three years ago. Three

years ago, a memo was sent saying it's not going to wash. I mean, it

isn't going to wash that you don't know that there's a risk there.

And yet, we continue to have thimerosal in vaccines. And when I

asked at previous meetings like this one, previous hearings, I said,

"Why don't you just recall everything with thimerosal in it right now

and put out there single doses of measles vaccine or whatever, which

doesn't contain this possible toxic substance, and get it over with?"

And nobody had an answer.

And the only answer that I could figure out was that there was

money involved. The pharmaceutical companies were going to lose some

money if you pulled this stuff off the market.

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Is that assumption incorrect?

EGAN: I would disagree with it.

BURTON: What do you think about what this doctor said?

EGAN: I'm not sure exactly what he's referring to. This is

around the time that people were saying that yes, there is no data

that suggests that there is a risk. In other words, there's no

positive data showing any risk.

But whether or not it's sufficient to just say that or whether

one has to go out and generate data to show that there is no risk, one

is going to have to do something else.

BURTON: Here's the crux of the problem, Dr. Egan. If there is a

risk when you're injecting something into a child, should not we err

on the side of caution? And if you get a memo, an email that says,

"It's not going to wash that there's no risk," it's not going to wash.

And if I were -- and I'm not a scientist or a doctor -- but if I

were in an agency and I knew there was going to be a risk to human

beings, I would say, "Hey listen, we've got to get on with this right

away. We've got to get this stuff taken care of."

EGAN: Well again, I'm not sure what he meant by that statement.

I never had a chance to discuss it with him. This wasn't sent to me.

BURTON: Well, let's read it again. "It is also no longer going

to wash that there is no data to suggest a risk. I mean, I don't

know, it doesn't take a rocket scientist to understand that.

EGAN: Well, I don't know whether he meant that what we've got to

do is go out and do studies to positively demonstrate that there is no

risk or that there is a risk, rather than just simply say that there

is no evidence saying that there is no risk. That may not be good

enough.

BURTON: Do you think that injecting mercury into a human being

poses any kind of risk whatsoever?

EGAN: At the doses that were used, that have been used in the

vaccines, no there was no evidence that that was posing a risk.

BURTON: Does mercury being injected into a human being have a

cumulative effect? In other words, if you get eight or nine shots

with mercury in it, would it have a cumulative effect in your brain?

EGAN: There may be some effect. That has to be looked at more,

finding out what the rates of excretion are versus what the rates of

deposition into various tissues are and what those rates of clearance

are.

But one thing I would like to stress is that as this issue came

to the floor, that the public health service and the FDA did state

that they wanted to reduce levels of mercury from all sources whenever

possible. And that we did very, very actively work with manufacturers

to eliminate and reduce mercury from all of the routinely recommended

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pediatric vaccines.

It was not a very, very simple or straightforward process, doing

that.

BURTON: Well, let me just say that according to -- quote,

unquote -- "experts," my grandson got nine shots in one day that

contained about 40 times or 45 times the amount of mercury that's

tolerable in an adult in one day. And within just a few days, he

became autistic.

And I imagine a lot of these people in the audience and people

around the country who are dealing with this sort of a problem right

now feel the same way. And to have our health agencies continue to

put this thing, what appears to be on the back burner, really bothers

me.

Let me ask a couple more questions of Dr. Chen.

Dr. Chen, have you received any requests to date for the data?

CHEN: On Monday, when I came back from some travels, there was a

voice mail from, I believe, one of the consumer groups on autism who

asked us to work with them to make the data available.

BURTON: So you've only had one so far?

CHEN: Yes.

BURTON: Do you recall the name of the organization?

CHEN: I think it was Elizabeth Birt, but I don't remember the

agency that she represents.

BURTON: But at this time, no one outside the CDC or HMO has had

access to the VSD data so far. Right?

CHEN: In terms of this new research data center, that's correct.

BURTON: Okay. Now you attended a staff briefing in late

February with the committee, which we've already established. At the

end of the meeting, the secretary's representative informed the

committee staff that prior to the committee request, about 18 months

ago, that no one had ever suggested to the CDC that the VSD data

should be made available.

Isn't that true? Eighteen months ago, no one had ever said that

that material should be made available?

CHEN: I don't know if that's true or not. Obviously, people out

there can say things without me being knowledgeable. OR people may

have mentioned it.

BURTON: You don't know of any, though?

CHEN: I don't know at this point, no. I don't recall, at least.

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BURTON: Well, the office of the secretary not having been a part

of this program since its inception, had to rely on you and your staff

for their briefing, didn't they?

CHEN: I presume so.

BURTON: Do you agree with the statement that prior to our

committee's request to make the VSD data available, that no one had

made such a suggestion?

CHEN: Again, being a human being, there may be. To my best

recall, that's the case.

BURTON: Can you give me a yes or no answer? Did anybody or any

organization or scientist request this data from you prior to that?

CHEN: To the best of recall, I don't remember anyone making that

request.

BURTON: Do you know, when I was having my investigation into the

previous administration, we had what we called an epidemic of memory

loss.

(LAUGHTER)

And the reason that that epidemic of memory loss occurred was

because people were afraid that they would be nailed for perjury.

That's not the case with you, I hope?

CHEN: I hope not.

(LAUGHTER)

BURTON: Okay. Okay.

Isn't it true, Dr. Chen, that as early as 1993, that CDC was

getting requests to make the VSD available to other researchers?

1993?

CHEN: Again, if you could . . .

BURTON: Take a look at exhibit three, bottom of page six, top of

page seven. I mean, you're the guy in charge of this. And this is

1993. You just said you didn't recall whether there had been any

requests. And here we are, going back to 1993. Would you take a look

at that?

CHEN: And where is it on there?

BURTON: It's on the bottom of page six and the top of page

seven. And I'll read this quote to you. It's in fact in the minutes

of a meeting from a CDC-sponsored meeting that took place on January

12, 1993, the Large Linked Database Data Managers Meeting, a part of

the VSD's annual meetings. Here is the reference to this.

It said -- quote -- "Guidelines to using the LLDB files. Data

managers indicated that a growing number of people are expressing

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interest in using LLDB files for specific vaccine safety and other

types of studies. Because the files are so complex, it is important

to develop written guidelines, write model programs and provide SAS

and/or consultation for other uses in order to ensure the files are

used correctly. This may become very resource-intensive, especially

as the data sets grow and LLDB results are presented."

Now doesn't this mean then that almost from the beginning, the

CDC was being prompted to allow access to the database?

CHEN: This is a meeting back from January 12, 1993, among data

managers. And I was not present at that data managers' meeting.

BURTON: So you weren't aware of any of this?

CHEN: I was not aware of this discussion, no, because I was not

present.

BURTON: Would you not have received these minutes of this

meeting?

CHEN: Well, I may have received it. But as most of us know, we

don't always read every single minutes of the meetings we were not at.

So I don't recall reading this.

(LAUGHTER)

BURTON: Well, this is pretty important stuff. We're talking

about release of some of this data so that other research scientists

can go out and look into this stuff. And you got this memo and didn't

even read it?

CHEN: It looks like it's about 10, 15 pages of very detailed

discussion about different aspects of data management. And I don't

recall having read this one.

BURTON: Why in the world do they even . . .

BERNIER: Chairman, can I . . .

BURTON: Just a minute. Why do they even have these meetings and

give you the minutes if you're in charge of this if nobody's going to

do anything with it? I mean, here you have requests. It says, "Data

managers indicated that a growing number of people are expressing

interest in using LLDB files for specific vaccine safety and other

types of studies." That's pretty important.

Outside groups wanted to start doing this nine years ago. And

you didn't know about it?

CHEN: Well, as I mentioned, in all the discussions with the

HMOs, their major concern is the protection of the privacy of their

patients.

BURTON: But that's not the point. You said you didn't know that

there was a request. Now did you know there was a request for this or

not?

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CHEN: Again, I was unaware of this discussion at this meeting.

BURTON: Well, how about any time since then, in the last nine

years? Were you aware that outside groups wanted this information?

CHEN: No, until the recent discussion from a couple of years

ago, no one has really kind of approached us.

BURTON: Okay. In the last two years, are you aware of anybody

asking for this information?

CHEN: There has been some Freedom of Information Act requests.

Yes.

BURTON: So you did get some requests from outside groups in the

last couple of years?

CHEN: Yes, that's right.

BURTON: OH, so you remember that.

And did you have something you wanted to say, Dr. Bernier?

BERNIER: Mr. Chairman, I just wanted to suggest to Dr. Chen that

he might want to talk a little bit about some of the collaborations

that have occurred over the years. I don't want to leave the

impression that this was a totally closed system. And there are

others who have made use of the system.

Dr. Chen is in a much better position than I am to say that.

They may not have been requests coming in under the Freedom of

Information Act.

But again, I think the question was asked earlier this morning:

can people collaborate with the HMOs? And yes, it's my understanding

-- and again, I'll let Dr. Chen comment -- that the HMOs are open to

collaboration if people want to approach them.

BURTON: One of the things that Dr. Weldon stressed was that

credibility is extremely important. People have to trust their

government. If they don't, man, you've got a real mess on your hands.

We currently have problems with some people who don't trust the

FBI. They don't trust the CIA. They don't trust other agencies.

And one of the agencies that they really should have to trust and

be able to trust is the people who are prescribing needles being stuck

into their kids' arms for vaccinations. And you talk about a

collaboration, a collaboration. Well, what's the difference in you

having a closed study just inside the CDC or HHS and doing a

collaborative study with somebody else that you might be able to

control?

What we're talking about is giving the information to scientists

on the outside who can verify and make absolutely sure that the

information is correct, that the vaccines are safe, that there is no

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problem with things like thimerosal. And that's why these independent

studies are important.

And it appears as though there has been a circling of the wagons,

as Dr. Weldon said, to keep everybody else out. And that's got to

change if there's going to be a belief that our health agencies are

shooting straight with the American people.

Now Dr. Chen, isn't it true that Dr. Harold Guess (ph), an

employee of Merck who has been invited repeatedly into the VSD

planning meetings, also suggested to you in 1995 that CDC needed to

make the data available to outside researchers, such as industry

researchers? Did Dr. Guess (ph), an employee of Merck, say that to

you in 1995?

CHEN: He is also a professor at the University of North

Carolina, in terms of his status. But again, I think in terms of the

discussion, that is a sensitive issue at the HMOs. We have worked

with them. And I think we now have a research data center . . .

BURTON: That isn't the question.

CHEN: . . . to work that out.

BURTON: That isn't the question. You said first that you don't

remember anybody asking for this data. First you said you didn't

remember.

Then you said, "Well, yeah. There was a couple of years ago,

some people talked to me." So you got that far.

Now we're going back to 1995. Dr. Harold Guess (ph), an employee

of Merck, who has been invited repeatedly into VSD meetings, also

suggested to you in 1995, seven years ago, that CDC needed to make

this data available.

Do you recall that?

CHEN: I must admit, I don't recall that.

BURTON: You don't recall that.

Dr. Chen, please go to exhibit 10, January 1995. Exhibit 10,

it's the annual VSD meetings. And I'd like for you to turn to page

four, the section titled, "Priorities."

See that?

CHEN: Okay.

BURTON: Would you read to the committee the two sentences

beginning with, "There was consensus. . .?"

CHEN: In the first paragraph, second paragraph, after

priorities?

BURTON: Yeah. It says, "There was consensus . . ." Well, if

you want me to, I'll read it.

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CHEN: OH, I'm sorry. There it is.

BURTON: "There was consensus that -- quote -- 'nothing focuses

the mind like writing a paper.' End quote. And the highest priority

for the project was in publishing the results of the studies; thereby,

garnering visibility and hopefully continued support and funding."

Is this taxpayer-funded project simply to keep a bunch of

scientists employed and to pad your curriculum vitae with

publications? OR is it to actively look for adverse events related to

vaccines and to protect our children?

CHEN: No, I think it's both. I mean, you hope to be able to do

both good vaccine safety monitoring. But those results need to be

shared with the public in peer review research. And as part of the

scientific process, hopefully by demonstrating that productivity,

you're also able to continue to get additional resources.

BURTON: Well, let me ask just one or two more questions and then

we'll call it a day. It's been a long day.

Dr. Bernier, as you know, there has been a great deal of concern

aboutthe changing of the definition of encephalopathy in the Vaccine

Injury Compensation Program. This change resulted in many cases being

ruled "off table" and thus harder to be compensated.

We have repeatedly been told that the department adopted an

existing scientific definition. I'm going to read to you verbatim

from January 12th, 1994, VSD annual meeting, summary written by and

approved by the CDC employees.

Quote: "Encephalopathy, the definition developed by Jerry Inichel

(ph) for revision of the vaccine injury table and published in the

Federal Registry, should be adapted."

Dr. Bernier, it appears that Congress and the public have been

misled about this definition. I'm going to ask that you take back to

the secretary a request to revert to Congress' definition immediately.

Exhibit five, do you have that? Exhibit five, page two, paragraph

six?

BERNIER: Mr. Chairman, I don't know if this is the appropriate

time or you want to finish this, but I would like to recommend or

suggest that we defer questions about the compensation program to

representatives from HRSA. There is not a HRSA representative here

today. And we were asked, if any questions did come up, could we ask

for them to be sent to HRSA so they could respond for the record.

BURTON: Well, I think that the secretary should be made aware of

the definition that is currently being used. And it should be

changed. And I'd like for you to go back. And I'll be glad to send a

memo to him as well and ask him to review that, along with you to see

if that's not in order.

BERNIER: We'd be happy to do that, Mr. Chairman.

BURTON: Okay. We'll prepare a memo to that effect.

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I think we have some more questions I'd like to submit for the

record. But I'm tired and I'm sure that you're tired. And we don't

want to keep beating on this ad infinitum.

What? All right. All right.

Dr. DeStefano -- am I pronouncing that right? DeStefano?

DESTEFANO: DeStefano.

BURTON: DeStefano, excuse me. I'm sorry.

You worked with Dr. Verstraten (ph)?

DESTEFANO: Verstraten (ph), yes.

BURTON: Verstraten (ph). On the thimerosal study, didn't you?

DESTEFANO: Yes.

BURTON: Would you turn to exhibit 14 and read the results and

conclusions section, please? It's in exhibit 14.

DESTEFANO: "Results. We identified 3,517 children with

neurologic disorders and 106 with renal disorders. We found a

statistically significant, positive correlation between the following

measures of exposure and outcome: the cumulative exposure at two

months of age and unspecified developmental delay; the cumulative

exposure at three months of age and tics; the cumulative exposure at

six months of age and attention deficit disorder; the cumulative

exposure at one, three and six months of age and language and speech

delay; the cumulative exposure at one, three and six months of age and

neurodevelopmental delays in general."

"In conclusion, this analysis suggests that in our study

population, the risks of tics, ADD, language and speech delays and

developmental delays in general may be increased by exposures to

mercury from thimerosal-containing vaccine during the first six months

of life. Confirmation of these findings in a different population and

further quantification of the dolce (ph) response effect are needed."

BURTON: Do you recall the date of that? We don't have the date

here.

DESTEFANO: It must have been like probably winter, late winter,

early spring of 2000.

BURTON: So has that study been published?

DESTEFANO: This was presented, I believe, at the Epidemic

Intelligence Service Conference in April of that year.

BURTON: Was it published?

DESTEFANO: No, those are not published proceedings.

BURTON: They're not?

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DESTEFANO: This was a training program. And this is usually the

conference where the Epidemic Intelligence Service officers in

training present their research. But they are not published.

BURTON: But it showed that there was a problem, didn't it?

DESTEFANO: Well, I think this is the analysis that's been that

figure from the autism figure is come from that was displayed earlier.

BURTON: Okay. Well, what was Dr. Verstraten's role at the CDC

when this study was conducted?

DESTEFANO: He was an Epidemic Intelligence Service officer.

This was one of his -- so he was there to obtain training and applied

epidemiology.

BURTON: And he's no longer with the CDC, correct?

DESTEFANO: No, he's not.

BURTON: Isn't it true that shortly after this study, Dr.

Verstraten left the CDC and took a job with a vaccine manufacturer?

DESTEFANO: Yes.

BURTON: In June of 2000, the VSD project held a meeting. This

is exhibit 16. Could you look at exhibit 16? You have it there?

DESTEFANO: Yeah.

BURTON: In June of 2000, the VSD project held a meeting at the

Simpson-Wood (ph) retreat center. Is that correct?

DESTEFANO: Yes.

BURTON: Would you explain the purpose of that meeting?

DESTEFANO: I could explain the purpose. But Dr. Bernier, I

think he organized it and he'd be better able to explain it.

BURTON: Well, it was to discuss the thimerosal study, was it

not?

DESTEFANO: Right.

BURTON: Was that correct?

BERNIER: That's correct.

BURTON: Okay. As you can see, exhibit 16 is an internal memo

from Dr. Harold Guess (ph) at Merck to Merck employees, distributing

the thimerosal information from the Simpson-Wood meeting. Isn't it

correct that all the vaccine manufacturers had representatives at that

meeting?

BERNIER: I can't say that all of them did. But they were

invited.

BURTON: But most of them were there.

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BERNIER: I believe that's correct.

BURTON: Okay. Well, what were the industry's recommendations or

concerns about the study? And we're going to find out, so I hope

you'll give us the whole story here.

What was the industry's concerns about that study?

BERNIER: I'm not sure that I can characterize industry's

concerns separate from the concerns of epidemiologists or other

members of the group that were there. We didn't segregate out

people's views by their affiliations.

BURTON: So the views of CDC or the FDA or the health agency

would be incorporated right in with the pharmaceutical representatives

that were there?

BERNIER: No, the pharmaceutical representatives were not there

as consultants. The Simpson-Wood (ph) meeting was called together on

short notice by CDC because of these results had caused concern on our

part. And we wanted to consult with expert opinion outside the

agency. And as a result, we invited somewhere in the neighborhood of

a dozen or 15 individuals, I believe.

BURTON: Where were they all from?

BERNIER: They came from academia. They came from -- I'm not

exactly sure. We did it more by expertise. We were looking for

pediatricians, neurologists, epidemiologists, that kind of thing.

BURTON: Were most of them from the pharmaceutical companies?

BERNIER: OH, no. They were just a minority. The members from

the vaccine companies were not there as consultants. They were there

as observers because their products were being -- were the subject of

the conversation. And so CDC felt it was appropriate for them to be

aware of these data so that they could have an opportunity to assess

them, along with others who were looking at them.

BURTON: Did any of the industry representatives make any

recommendations or anything while they were there? Did they say

anything about, you know, "Hey, we have a problem with this report?"

BERNIER: It's difficult to deal with things on two sides. They

were free to talk, Mr. Chairman. If they were at the meeting, they

were observers in the sense that they were not the consultants, per

se. But if they had an opinion about the data or about anything that

was going on, I'm sure that the chairman of the group would have

recognized them and would have allowed them to express their views.

BURTON: Were there minutes taken at the meeting?

BERNIER: Yes, there were. I don't know about minutes. But I

believe there's a transcript and report that was written.

BURTON: I would like to have that transcript post-haste. And if

need be, I'll give you a subpoena for it. I want a transcript of

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that. I want to read it. I want to find out if the pharmaceutical

industry had any influence over the decision making process of our

health agencies. Because if that is the case, there is going to be a

big, big problem.

How soon can I have that transcript?

BERNIER: I believe the transcript is available. Should not take

a long time. I would think a matter of days, if we can put our hands

on it.

BURTON: Well, I sure hope you can put your hands on it.

BERNIER: Shouldn't be a problem, Mr. Chairman.

BURTON: Okay.

Why haven't you submitted that information that I read to you a

few minutes ago, Dr. DeStefano, for peer review?

DESTEFANO: Well, that is part of the manuscript that's being --

it was developed from this. I think its current status, perhaps Dr.

Chen could -- I'm no longer involved.

BURTON: Dr. Chen?

CHEN: Unusual to most scientific studies; in fact, because of

the importance of this finding of this study, if you will, the

analysis of the VSD, in fact, have been shared publicly in multiple

forms -- at the Simpson-Wood (ph), at the ACIP, at the ION. And at

each of the meetings, several interested parties on both sides of the

equation if you will, have raised many concerns about how they want

the study improved or analyzed. And we've been trying to address

those concerns.

And so we, in fact, have finished that. And we expect to submit

the paper for peer review shortly.

BURTON: Well, I think I'll let you fellows go for the time

being. I'm sure we'll be together again before long. But I

appreciate you being here.

And with that, could I have the first panel, if you're still

here, come back to the table? I have a few more questions that I'd

like to ask you.

I don't have to swear you in again, so you can just -- and I

really don't have any questions for you. I just want each one of you

to, as people who have been working on this subject for a long time,

I'd like to have any of your thoughts on what you just heard regarding

all this questioning.

Because you've been working on this a long time. We're talking

about kids who have been harmed. So if you have any response or any

comments you'd like to make, I'd like to hear them for the record.

And if you don't, that's fine as well.

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BRADSTREET: As a parent of a child with autism, as a physician,

it would have been wonderful, absolutely grand, to have the

information that has been kept largely behind closed doors for years,

available to me, both as a parent and as a physician to guide my

decision making about vaccine administration.

BURTON: Amen.

BRADSTREET: I think it's actually appalling that some of the

answers were clearly evasive and fly in the face of reality, where we

just received evidence that, in fact, there was abundant information

that thimerosal associated itself with a variety of different

problems, all of which, for the most part, would be associated with

neurodevelopmental disorders typical of autism, whether it's speechlanguage

delay, general overall neurodevelopmental disorders.

To then take that data and say that there is no relationship to

autism, where most of those constituents are part of the spectrum of

autism, seems hypothetically almost impossible, statistically almost

impossible. But I think that we have been done a disservice in the

way in which this data has been withheld for two, three, four years.

I think that it has and should have been the cause of a recall of

thimerosal immediately. I think we've seen some of the concerns that

they were concerned about. Whether or not we would continue to have

uptake of vaccines, if the parents would continue to submit to

voluntary vaccination programs. And I realize some of the driving

forces behind that.

The problem is, in the process of attempting to cover this up,

they haven't done a very good job. And parents have found out the

truth. They have multiple access, whether it's through freedom of

information or through various other resources, to find out the

toxicology of mercury and to find out the problems with persistent

viral infections.

So I think it's incredibly valuable for this committee to

continue its work, trying to expose the truth. And I thank you very

much.

BURTON: You don't have any doubt about that, do you?

(LAUGHTER)

BRADSTREET: No, I don't. I don't have any doubt that you . . .

BURTON: There's a lot of reasons I'm concerned about the health

and safety of the entire population of America, number one. But I'm

so ticked off about my grandson and my granddaughter, just like you

are, that I can't see. And to find that our health agencies have, as

Dr. Weldon said, circled the wagons, trying to keep us from knowing

the facts, just makes me want to vomit.

BRADSTREET: Do you think it's any coincidence that the rise in

the use of Ritalin, which we all -- in fact, I think you've had or

various other government agencies have had hearings on the use of

Ritalin, absolutely corresponds to the rise in the use of mercury?

And that they find a statistically significant increase in ADHD?

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BURTON: Well, those are things that we'll continue to beat on

and try to get to the bottom of, with your help and others.

Anybody else have any more comments?

WAKEFIELD: One comment, Mr. Chairman, and that is . . .

BURTON: Dr. Wakefield?

WAKEFIELD: Sorry. This is my third occasion here. It

underscores for me the overwhelming need to dissociate those who

mandate and endorse vaccines from those who monitor safety. You

cannot referee your own soccer matches. It's like asking the Italians

to -- an Italian referee to take over the game of Italy between South

Korea. It doesn't work. Can't do it.

You have to separate those agencies that endorse and mandate

vaccines and those who monitor safety. One needs to be on the back of

the other all the time in order to check on safety.

It also underscores the value of your Freedom of Information Act,

which we do not have in the United Kingdom. And it's enormously to

this committee's credit that it's got as far as it has. But the work

clearly must continue.

BURTON: You know, AL Jolson used to sing and they'd bring the

curtain down. And the audience would be up pounding the floor and

just clapping because he was such a great entertainer. And he'd get

down on one knee and say, "You ain't seen nothing yet."

(LAUGHTER)

Any other comments? Dr. Spitzer?

SPITZER: Chairman Burton, I'd like to say, as a Canadian

epidemiologist, I'm also a member of the Institute of Medicine of the

USA, that if one had to make a choice between epidemiology and the

clinical and laboratory disciplines. Looking at all of this, one sets

epidemiology aside. One goes to the clinic. One goes to the labs.

And some of the work that has been in Britain, in here and that we've

heard about today.

Nevertheless, having said that, I would urge proper responsible

colleagues, such as those on the committee and the leadership in this

country and elsewhere, that we need to push the answers in parallel in

three or four areas: the biological mechanisms, such as have been done

by Dr. Krigsman and Dr. Wakefield and Professor O'Leary; the

epidemiology, which so far has been non-contributory. The Institute

of Medicine says there is no evidence. That's different, very

different than saying the evidence demonstrates that there is no

relationship.

And you can see the study we saw today. And that's the kind of

epidemiology that we find when we go and look. And we really need to

do serious work.

We were talking about sample size, the study we designed

internationally to get some answers has 3,500 cases and 7,000

controls. Why? Suppose 10 percent of the children are affected by

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one product -- say thimerosal or MMR? That subset also has to be

statistically significant or we're going to have to use another five

years.

I would make that my only example.

And I want to thank you, as one who benefits from the fact that I

have no family members involved or anything like that, that the

support by this committee, its staff, to those trying to look at this

seriously in various countries. And I think this hearing was

extremely important to many of us involved.

BURTON: Why don't we go ladies first, Dr. Krigsman?

STEJSKAL: Mr. Chairman, you've got one admirer in Sweden for

your work with this issue of chemical toxicity. As an immunologist

working for a long time in pharmaceutical industry at toxicology

laboratory, I am still shocked because regarding risk-benefit

assessment of this additive bactericidal agent thimerosal, I just

don't see the reason why it wasn't changed and replaced by other

additives, like for example basal chromium chloride.

So for me, this is astonishing and shocking. And I just think

your explanation of money, it's the right one.

I also hope you will continue with your work to remove really all

mercury out of the body and out of the dental fillings. And I just

want to tell you that in Europe, the nickel is already banished and

prohibited as a part of metal alloys used in dentistry. While

unfortunately, here in America, you still have high nickel for each

metal for each metal alloys allowed. And the nickel is another

mutagen and carcinogen and so on and so on.

So I hope -- and we will help you any ways we can -- you will go

on with your work.

Thank you.

BURTON: Thank you, doctor.

Dr. Krigsman?

KRIGSMAN: Thank you. I'd like to just to conclude by saying that

what has happened in the past and what this committee is interested in

looking into, is one issue. From where I sit, I want to project into

the future. And I would invite the governmental agencies to show and

to demonstrate their commitment to research into this area by

providing funding for those people who are pursuing those answers.

Thank you.

BURTON: Thank you very much. I want to thank all of you for

being so patient. You've been here since what time? 10:00 this

morning. I really appreciate that.

You're doing the good Lord's work. Hopefully, there will be a

lot of children and people that will grow up a little bit safer

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because you're willing to come and testify.

And Dr. Wakefield, hang in there, buddy.

(LAUGHTER)

Thank you very much.

(APPLAUSE)

END

U.S. REPRESENTATIVE DAN BURTON (R-IN)

Chairman

Washington, D.C.

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END OF DOCUMENT

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