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Dan
Burton (R-IN)
Chairman, Committee on Government Reform
November 22, 2002
The Autism Epidemic and Its Possible Connection to Vaccines
Mr. Speaker, I am here today to clarify for my fellow legislators
why I have objected so vigorously to the inclusion of certain
provisions in the Homeland Security Act.
There is no one in Congress who more strongly supports the
need to protect the United States and its people from terrorist
attacks.
The fact remains that we weren't prepared to prevent what
happened on September 11, 2001. And we weren't prepared to
recover from a terrorist attack of that magnitude. We need
to have these agencies working together in a coordinated way
to prevent the next terrorist attack. By creating this new
department, we're going to improve that coordination.
I am a strong supporter of the President, our men and women
in uniform, and our law enforcement, first responder, and
intelligence communities.
I also am a strong supporter of the legislative process. It
is important to have a bipartisan process where every issue
is handled in a fair and open way.
Last week, the legislative process was hijacked and we ended
up with a fiasco of extreme proportions. That is what I am
here to talk about today.
At the eleventh hour, several sections were added to the final
version of the Homeland Security Act, which many members of
Congress, including myself, were not aware of.
My remarks today will focus on Sections 1714 through 1717.
These four sections were thrown in at the last minute-obviously
so as they are the last four paragraphs of the 484 page document.
My Family's Experience
Mr. Speaker, I have only two grandchildren-Alex and Christian.
While the so-called experts tell us that vaccines are safe
except in rare instances, both of my grandchildren suffered
serious adverse events from vaccines.
My granddaughter stopped breathing the day she received her
Hepatitis B vaccine and was hospitalized for three weeks.
We thought she was fine for years, however, this year she
was diagnosed with a seizure disorder and her doctor's tell
us that she likely was suffering small seizures for years
that went unnoticed.
My grandson Christian was absolutely normal as a baby. He
developed on time and healthy. He talked, walked, he was outgoing.
He made eye contact. He enjoyed being with people. We joked
that because he was expected to be very tall, that be would
take care of us in our retirement by being a professional
basketball player.
My daughter took Christian to receive the vaccinations that
our Centers for Disease Control and Prevention say children
are supposed to receive. And he got them all in one day-at
least six shots for nine different diseases…all in one
office visit. And in many of those shots was the mercury-containing
preservative, thimerosal.
We totaled up the amount of mercury he may have been exposed
to and it was over 40 times more than a safe exposure according
to Environmental Protection Agency's guidelines for methyl
mercury. (Which the Institute of Medicine validated as accurate)
Within days he lost all speech, he began banging his head,
ran around flapping his hands…he withdrew into himself,
and very soon after that was diagnosed with autism.
I want to specifically thank Dr. Cathy Pratt from the Indiana
Autism Resource Center at Indiana University for helping us
in those early days.
Autism
And Christian is not an isolated case. We have heard from
thousands of families across the country that this same thing
happened to their child.
What Is Autism? Autism is a complex neurobiological disorder,
resulting in developmental disability. It typically appears
in the first three years of life.
Autism is a spectrum disorder. The symptoms and characteristics
of autism can present themselves in a wide variety of combinations,
from mild to severe.
Although autism is defined by a certain set of behaviors,
children and adults can exhibit any combination of the behaviors
in any degree of severity. Two children, both with the same
diagnosis, can act very differently from one another and have
varying skills.
- People
with autism process and respond to information in unique
ways. In some cases, aggressive and/or self-injurious behavior
may be present.
- Forty
Percent of individuals with autism do not have speech.
- Persons
with autism may be resistant to change. They may have difficulty
expressing their needs, using gestures or pointing instead
of words. They may laugh or cry, showing distress for no
reason apparent to others.
- Persons
with autism often prefer to be alone. They may throw tantrums.
- They
often have difficulty interacting with others.
- Children
with autism may not want to cuddle or be cuddled. Imagine
having a child who does not want you to hug him. Imagine
a child who never spontaneously tells you that he loves
you.
- Persons
with autism frequently make little or no eye contact.
- They
will not respond to normal teaching methods, they may have
odd play habits, and frequently spin objects.
- Many
have sensory integration issues-over or under sensitivity
to pain. They may not understand the need to fear danger.
Imagine your child wandering away from school and walking
out on a highway-this happened just last year in the Washington
areas.
- Children
with autism may often first appear to be deaf because they
do not respond to verbal cues. In fact, the first diagnosis
a child with autism first receives is a speech or language
delay.
There
are certainly children who are born with autism.
- They
have what can be called "classical autism.''
- There
is, however, a growing number of children who are growing
normally and then acquire autism. It is sometimes called
"atypical autism'' or "late-onset" autism.
There
most probably is a genetic component to autism. But genetics
is not the only issue.
- Many
children seem to have severe food sensitivities, particularly
to gluten and casein, ingredients in the most common foods,
dairy and wheat.
- Many
of these children show signs of autism shortly after receiving
their immunizations.
- Some
of these children suffer from heavy metal toxicities. When
tested they have abnormally high amounts of aluminum and
in particular mercury. How did they get this overload of
mercury in their body, except through their vaccines?
How
Many People Are Affected?
In California the rates of the most serious form of autism
have tripled in the last decade. And as the researcher who
evaluated the California data stated, it is not because of
a broadening of the definition of autism.
What is being seen in California is being seen across the
country.
Once a rare condition, the National Institutes stated earlier
this year that autism is now seen in 1 in 250 children in
this country. It affects boys four times more often than girls.
This means that one in 156 boys in this country have autism.
And in some places the rate is higher. For instance, in Brick
Township, New Jersey the CDC determined that 1 in 150 children
is autistic.
And these are cases of the most severe forms of autism, not
the entire spectrum that would incorporate the less severely
affected often called "high functioning" autism.
The Autism Society of America estimates that autism is increasing
at a rate of 10 to 17 percent each year. This is faster than
any other disease or disability.
What is the Potential Burden to Society and to the Taxpayer?
A study published in California several years ago indicated
that it would cost the state at least $ 2 million for each
child with autism for the first 18 years of life.
The Autism Society of America estimates that the total cost
of autism is between $20 and 60 billion annually.
School districts are struggling to meet the needs of the huge
number of new cases.
While many individuals with autism, especially high functioning
autism, may grow up and be able to work, a vast majority of
those with the most severe forms of autism will not. Their
families are faced with finding long-term care solutions.
Much of the financial burden for the long-term care will fall
to the Government.
What we can't measure in dollars is the cost to families.
The divorce rate in autism is said to be about 85%. Siblings
in families with an autistic child must make do with less
attention from their parents. Many of the medical treatments
for autism are not covered by insurance. Children often need
one on one intensive speech and behavioral therapies. It is
often a constant struggle for families to help their child
and to stay financially solvent. Research In the sixty years
since autism was first described, we have not yet figured
out what causes it. We do not know if classical autism and
late-onset autism are the same conditions or two different
conditions with similar symptoms. We have come a long way
in sixty years. Doctors no longer blame the condition on bad
mothering. But we have a lot more work to do before we can
pat ourselves on the back for our accomplishments. In the
Committee, we looked at our investment in research on autism
on a comparable level with other epidemics?
We asked these questions:
- Are
the CDC and NIH funding studies that will help prevent or
cure autism?
- Is
their research adequately addressing the medical issues
associated with autism such as food allergies, chemical
sensitivities, and autistic entercolitis?
- Is
the information about autism provided by our Government
adequate and useful to families?
The
CDC:
- The
CDC will told us they plan on spending 11.3 million dollars
on autism this year and 10.2 million dollars next year.
- We
compared that to two other conditions that have been declared
epidemics-diabetes and AIDS.
- Both
of these conditions can be devastating. Both deserve sufficient
research dollars to develop treatments and look for cures.
- The
CDC is spending over 932 million dollars on the AIDS epidemic
this fiscal year. AIDS deserves attention-don't get me wrong.
And so does diabetes, which both Secretary Thompson and
the former Surgeon General declared an epidemic.
- CDC
this year will spend just over 62 million dollars on diabetes.
- The
autism epidemic just like the diabetes and AIDS epidemics,
is no less deserving.
- Yet,
CDC's spending for autism is almost 80 times less than that
for AIDS.
- And
CDC's spending for autism is 5 times less than that of diabetes.
CDC should be committing more research money to autism.
The
National Institutes of Health has a total this year of 27
billion dollars.
The NIH told us their to researching autism has grown dramatically
in the last few years. In fiscal year 1997, the NIH investment
in autism research was only 22 million dollars. Last year
that number had grown to 56 million-in large part because
of Congress. Let's put that into perspective. At the same
time the NIH is spending 56 million dollars on autism-a condition
that affects 1 in 250 children in this country-they are investing
over 2.2 billion dollars in AIDs research. The rates of diabetes
increased by 49 percent between 1990 and 2000. Diabetes is
a devastating condition in the Native American community and
of increasing concern in the African American and pediatric
populations. This year, the NIH investment for diabetes is
688 million. I believe the numbers speak for themselves. Funding
into basic and clinical research into autism needs to grow.
We have an epidemic on our hands and we in Congress need to
make sure that the NIH and the CDC treat this condition like
an epidemic and put their efforts into doing several things:
- Find
out the cause(s) of the epidemic
- Determine
how to stop the epidemic in its tracks
- Evaluate
treatment options
- Look
for a cure
Thimerosal:
What is it?
- Thimerosal
is a preservative that has been used in some vaccines since
the 1930's.
- Thimerosal
is about 50 percent mercury and 50 percent thiosalicylic
acid.
- In
1999, the FDA recognized that some children could be exposed
to a cumulative level of mercury over the first 6 months
of life that exceed the federal guidelines on methyl mercury.
- Methyl
mercury is associated with neurotoxicity in high doses.
- According
to the FDA, a 6-month old baby that received all the vaccines
on schedule would receive 75 micrograms of mercury from
three doses of DTaP, 75 micrograms of mercury from three
doses of Hib and 37.5 micrograms from three doses of hepatitis
B vaccine. The total of 187.5 micrograms exceeds the suggested
safe limits published by the EPA.
- Some
of you may say that the Federal Guidelines are for methyl
mercury not ethyl mercury, however, there is no Federal
Guideline on safe dosing of ethyl mercury.
- In
fact, what we learned when we investigated was that the
Food and Drug Administration appeared to be asleep at the
switch on making sure that all the ingredients being injected
into our babies is safe. There appear never to have required
a safe human exposure of thimerosal to be established.
- In
1999, and after much debate they decided to ask the manufacturers
to start switching to thimerosal-free vaccines for children.
Many
of my colleagues have reported that thimerosal is no longer
being used. This is not true.
- The
flu vaccine given to children and to members of Congress
has thimerosal.
- Many
clinics and doctor's offices still have vaccines on the
shelves that contain thimerosal. Parents need to ask their
doctors for the package insert and look at the ingredient
list to assure that there is no thimerosal. We have received
reports where doctors were told by the pharmaceutical salesman
that the vaccine was thimerosal free, and yet, when the
parent looked at the package insert, they had been sold
vaccine with thimerosal.
- Many
adult vaccines still contain thimerosal. This could be problematic
especially to new recruits in the military who get a large
number of vaccines all at one time.
- Many
of the vaccines that we ship to Third World Countries to
be given to babies and young children still contain thimerosal.
An
internal HHS document produced to the House Government Reform
Committee during its investigation into vaccine safety described
what it referred to as a "weak signal" in its data
linking thimerosal to neurological disorders:
"Preliminary screening of ICD-9 codes for possible neurologic
and renal conditions following exposures to vaccines containing
thimerosal before 3 months of age showed a statistical association
for the overall category of neurological developmental disorders
and for two conditions within the category, speech delay and
attention deficit disorder."
If there were no concerns that scientific research would demonstrate
a connection between thimerosal and autism in court, Sections
1714-1717 would not have been tacked onto the Homeland Security
Act in the eleventh hour with no debate.
The Institute of Medicine
Much has been said about the Institute of Medicine's review
of thimerosal in vaccines. Many have said that the IOM concluded
that there was no connection between thimerosal and autism.
This is not exactly accurate.
In 2001, the Institute of Medicine concluded that a connection
between thimerosal and autism, while unproven, is "biologically
plausible."
The IOM called for further research, stating, "the evidence
is inadequate to accept or reject a causal relationship between
exposure to thimerosal from vaccines and neurological developmental
disorders of autism, ADHD, and speech and language delays."
Dr. Marie McCormick, IOM Committee Chair made the following
statement:
"Because mercury at high doses is known to pose risks,
some parents and researchers are concerned that thimerosal
in vaccines puts children at increased risk for developmental
disorders such as autism. Preliminary data from a few studies
have suggested that thimerosal-containing vaccines could possibly-very
minimally-affect some measures of normal child development.
But the data are inconclusive….Our committee has reviewed
the limited body of toxicological, clinical, and epidemiological
literature on ethyl mercury and the more exposures are associated
with neurological damage."
She also stated:
"There is also toxicological and epidemiological literature
suggesting that methyl mercury is a toxicant to the developing
nervous system. Some children who received the maximum number
of thimerosal-containing vaccines on the recommended childhood
immunization schedule had exposures to ethyl mercury that
exceeded some safe exposure guidelines for methyl mercury.
In addition, some children could be particularly vulnerable
or susceptible to mercury exposures because of genetic or
other differences…. It was viewed as feasible as well
as consistent with the public health goal of decreasing mercury
exposures in general, as much as possible. Mathematical calculations
also suggested that some infants received a total amount of
mercury from vaccines that exceeded some federal agency guidelines
for safe mercury exposure. … Based on information from
these sources, our study has come to the following conclusion:
The hypothesis that thimerosal exposure through the recommended
childhood immunization schedule causes neurodevelopmental
disorders is not supported by clinical or experimental evidence.
Existing epidemiological evidence is inadequate to either
accept or reject a causal relationship between exposure to
thimerosal from vaccines and the neurodevelopmental disorders
of autism, ADHD, and speech or language delay. However, there
are some indirect associations concerning biological plausibility,
which refers to a theoretical but unproven possibility. For
example, high-dose thimerosal.
Vaccine Injury Research
It is important to remember that the absence of proof of a
correlation between vaccines and autism is far different than
no proof of a correlation. Each time the Institute of Medicine
has evaluated vaccine safety issues, they conclude that there
is inadequate research to reach firm conclusions.
We found that all too often the right research questions have
not been asked. In fact, very little research has been done.
When Dr. Andrew Wakefield reported that in a small population
of late-onset autism cases, in which there was chronic bowel
dysfunction, that he found measles in the guts of these children,
the CDC's response was to fund epidemiological research to
try to disprove his hypothesis. In the four years since this
first was made public, our health officials have yet to conduct
one clinical study to replicate the Wakefield work. Instead,
we get large-scale population based reviews of medical charts,
rather than actual clinical research with children looking
at their specific medical issues.
This is the case for the Danish Study recently published in
the New England Journal of Medicine.
- While
the news media reported that the case is now closed on a
correlation between MMR and autism, nothing could be further
from the truth. Comparing epidemiology with clinical research
is like comparing apples and oranges.
- This
study found that there was a five-fold increase in autism
over the ten years they looked.
- This
study in no way can be considered a conclusive study. Much
more research needs to be done-and the research we need
to do needs to be biomedical research that will result in
understanding what is going on with each child and how best
we can help them.
The
Homeland Security Act: Section 1714-1717 affects the National
Vaccine Injury Compensation Act.
They do not protect Americans from a terrorist threat, or
affect the Department of Homeland Security. Rather they protect
large domestic pharmaceutical companies who manufacture the
components of campaigns. They protect them from potential
civil liability from vaccine injured children.
Amending the Vaccine Act through this legislation is inappropriate.
These sections were intentionally insert to protect the manufacturers
of thimerosal.
If, as some Senators were told, the desire was to protect
manufacturers of the components of any smallpox vaccine, the
date of enactment would not have suspended the currently filed
cases. None of the current cases are related to smallpox.
What Will This Mean for Families? These provisions will some
families have no legal recourse.
For instance, Scott Bono of Durham, North Carolina testified
before our committee a few years ago. His son, Jackson Bono
is one of those children who were adversely affected by thimerosal.
He has autism; he has documented to have toxic levels of mercury
in his body. He is now 13 years old. It is likely that the
case his family has filed in the Vaccine Injury Compensation
Program will be kicked out because of the short three-year
statute of limitations. Unless his family can seek compensation
through civil litigation, they will likely never be compensated
for their child's vaccine injury.
There are hundreds of Jackson's out there who need Congress
to keep their legal options available to them.
The Vaccine Injury Compensation Program: History of the Program
The National Vaccine Injury Compensation Program was created
in the late 1980's as a no-fault compensation program. The
trust fund comes from an excise tax from the sale of vaccines.
The companies who make thimerosal and who will now be protected
under the new law make no financial contribution to the trust
fund. They are being given a free ride.
Sections 1714-1717 will have a devastating effect on the families
of children who were injured from their thimerosal-containing
vaccines and suffered damage to their central nervous system,
resulting in diagnosis of autism spectrum disorder, speech
and language delays, or neurodevelopmental delays. Vaccine
Injury Compensation Program Investigation and Proposed Legislation
The Committee on Government Reform, over the last two years
has conducted an extensive investigation into the Vaccine
Injury Compensation Program. After six months of negotiations,
on February 13, Chairman Dan Burton and Ranking Minority Member
Henry Waxman in collaboration with Congressman (and physician)
Dave Weldon, and broad bipartisan group of Congressmen introduced,
HR 3471, the National Vaccine Injury Compensation Program
Improvement Act of 2002.
This Bill would:
- Increase
compensation for future lost earnings for injured children.
Under current law, compensation is based o the average weekly
earnings of full and part-time workers as determined by
the Bureau of Labor Statistics. This bill would specify
that only full-time workers should be used in the calculation.
- Increase
the level of compensation to a family after a vaccine-related
death from $250,000 to $300,000. The death benefit has remained
unchanged since the program's inception in 1986.
oAllow families of vaccine-injured children to be compensated
for the costs of family counseling and creating and maintaining
a guardianship to administer the funds.
- Allow
for the payment of interim attorneys fees and legal costs
while a petition is being adjudicated. The costs of assembling
the necessary medical records and obtaining expert witnesses
are substantial. Under current law, these costs, as will
as attorney's fees, are not reimbursed until a case is fully
resolved, which oftentimes takes years..
- Extend
the statute of limitations for seeking compensation to six
years from the date of injury. Under current law, families
must file within two years of a child's death or three years
of a child's injury.
oProvide a one-time, two-year period for families to file
a petition if they were previously excluded from doing so
because they missed the statute of limitations.
Other
bills were also introduced.
However, the other bills also appear to protect industry,
while whittling down families opportunities to receive compensation
through the program. These provisions include the ones inserted
we have talked about here. These bills also included a provision
to Federalize a state ruling, which found individuals who
missed the statue of limitations in the Federal program would
loose their ability to file in the state courts of New Jersey.
This in essence prevents tolling for minors, and prevents
cases from being filed for individuals who did not know about
the program in time to file in the Federal program. While
these Bills appear to have the Administration's support, they
do not have the support of the vaccine injured.
Conclusion
We have a promise from both the Senate and House leadership
that Sections 1714 through 1717 will be modified to allow
for the existing thimerosal cases that would not fit within
the vaccine program's statute of limitation to go forward
in the civil court system. This means that as soon as we come
back in the 108th Congress, we must make this our first course
of action. We owe this much to the families of the 1 in 250
children who are now autistic. And we especially owe this
to those families whose children may be autistic as a result
of thimerosal in their vaccines.
Yesterday, I sent a letter to the President urging him to
host a White House conference on autism.
- I
have asked him to begin a national effort to determine why
autism has reached epidemic proportions in the United States.
- I
believe we must try to determine what is causing this outbreak
and how it can be stopped. President Bush is in a unique
position to provide the leadership that this issue needs.
- He
could bring together parents of autistic children and the
best minds from the scientific community to chart a course
of scientific research to uncover the underlying causes
of this alarming epidemic.
Mr.
Speaker I have provided three documents I would like put into
the Congressional Record.
The first is an outline of what we know from the published
literature about thimerosal's safety. The second is a report
submitted to the Committee that outlines through the scientific
literature the similarities between mercury poisoning and
the symptoms of autism. And the third is testimony submitted
to the Committee last April by the Autism Society of America,
which outlines the economic implications of autism, and the
research needs.
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