[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]
TRUTH REVEALED: NEW SCIENTIFIC DISCOVERIES REGARDING MERCURY IN
MEDICINE AND AUTISM
=======================================================================
HEARING
before the
SUBCOMMITTEE ON HUMAN RIGHTS AND WELLNESS
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
SECOND SESSION
__________
SEPTEMBER 8, 2004
__________
Serial No. 108-262
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
______
U.S. GOVERNMENT PRINTING OFFICE
98-046 WASHINGTON : 2005
_____________________________________________________________________________
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COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
DAN BURTON, Indiana HENRY A. WAXMAN, California
CHRISTOPHER SHAYS, Connecticut TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania
MARK E. SOUDER, Indiana CAROLYN B. MALONEY, New York
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
DOUG OSE, California DENNIS J. KUCINICH, Ohio
RON LEWIS, Kentucky DANNY K. DAVIS, Illinois
TODD RUSSELL PLATTS, Pennsylvania JOHN F. TIERNEY, Massachusetts
CHRIS CANNON, Utah WM. LACY CLAY, Missouri
ADAM H. PUTNAM, Florida DIANE E. WATSON, California
EDWARD L. SCHROCK, Virginia STEPHEN F. LYNCH, Massachusetts
JOHN J. DUNCAN, Jr., Tennessee CHRIS VAN HOLLEN, Maryland
NATHAN DEAL, Georgia LINDA T. SANCHEZ, California
CANDICE S. MILLER, Michigan C.A. ``DUTCH'' RUPPERSBERGER,
TIM MURPHY, Pennsylvania Maryland
MICHAEL R. TURNER, Ohio ELEANOR HOLMES NORTON, District of
JOHN R. CARTER, Texas Columbia
MARSHA BLACKBURN, Tennessee JIM COOPER, Tennessee
PATRICK J. TIBERI, Ohio BETTY McCOLLUM, Minnesota
KATHERINE HARRIS, Florida ------
------ ------ BERNARD SANDERS, Vermont
(Independent)
Melissa Wojciak, Staff Director
David Marin, Deputy Staff Director/Communications Director
Rob Borden, Parliamentarian
Teresa Austin, Chief Clerk
Phil Barnet, Minority Chief of Staff/Chief Counsel
Subcommittee on Human Rights and Wellness
DAN BURTON, Indiana, Chairman
CHRIS CANNON, Utah DIANE E. WATSON, California
CHRISTOPHER SHAYS, Connecticut BERNARD SANDERS, Vermont
ILEANA ROS-LEHTINEN, Florida (Independent)
ELIJAH E. CUMMINGS, Maryland
Ex Officio
TOM DAVIS, Virginia HENRY A. WAXMAN, California
Mark Walker, Chief of Staff
Mindi Walker, Professional Staff Member
Danielle Perraut, Clerk
Sarah Despres, Minority Counsel
C O N T E N T S
----------
Page
Hearing held on September 8, 2004................................ 1
Statement of:
Deth, Richard, Ph.D., Bouve College of Health Sciences,
Department of Pharmaceutical Services, Northeastern
University................................................. 50
Egan, William, Ph.D., Acting Director, Office of Vaccines
Research and Review, Center for Biologics Evaluation and
Research, Food and Drug Administration, Department of
Health and Human Services.................................. 29
Fischer, Richard, D.D.S., International Academy of Oral
Medicine and Toxicology.................................... 138
Hornig, Mady, M.D., Ph.D., assistant professor of
epidemiology, Columbia University.......................... 194
Just, Marcel, Ph.D., professor of psychology, D.O. Hebb
Chair, Carnegie Mellon University.......................... 86
Redwood, Lyn, R.N., MSN, president, Coalition for Safeminds.. 95
Wharton, Melinda, M.D., M.P.H., Acting Deputy Director,
National Immunization Program, Centers for Disease Control
and Prevention, U.S. Department of Health and Human
Services, accompanied by Coleen Boyle, Associate Director
for Science and Public Health.............................. 14
Letters, statements, etc., submitted for the record by:
Burton, Hon. Dan, a Representative in Congress from the State
of Indiana, prepared statement of.......................... 5
Cummings, Hon. Elijah E., a Representative in Congress from
the State of Maryland, prepared statement of............... 204
Deth, Richard, Ph.D., Bouve College of Health Sciences,
Department of Pharmaceutical Services, Northeastern
University, prepared statement of.......................... 53
Egan, William, Ph.D., Acting Director, Office of Vaccines
Research and Review, Center for Biologics Evaluation and
Research, Food and Drug Administration, Department of
Health and Human Services, prepared statement of........... 32
Fischer, Richard, D.D.S., International Academy of Oral
Medicine and Toxicology, prepared statement of............. 140
Hornig, Mady, M.D., Ph.D., assistant professor of
epidemiology, Columbia University, prepared statement of... 196
Just, Marcel, Ph.D., professor of psychology, D.O. Hebb
Chair, Carnegie Mellon University, prepared statement of... 89
Redwood, Lyn, R.N., MSN, president, Coalition for Safeminds,
prepared statement of...................................... 100
Wharton, Melinda, M.D., M.P.H., Acting Deputy Director,
National Immunization Program, Centers for Disease Control
and Prevention, U.S. Department of Health and Human
Services, prepared statement of............................ 18
TRUTH REVEALED: NEW SCIENTIFIC DISCOVERIES REGARDING MERCURY IN
MEDICINE AND AUTISM
----------
WEDNESDAY, SEPTEMBER 8, 2004
House of Representatives,
Subcommittee on Human Rights and Wellness,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 10 a.m., in room
2154, Rayburn House Office Building, Hon. Dan Burton, (chairman
of the committee) presiding.
Present: Representatives Burton, Watson, Murphy, and
Cummings.
Staff present: Danielle Perraut, clerk; Mark Walker, staff
director; Mindi Walker, Dan Getz, and Brian Fauls, professional
staff members; Nick Mutton, press secretary; Sarah Despres,
minority counsel; and Cecelia Morton, minority office manager.
Mr. Burton. A quorum being present, the Subcommittee on
Human Rights and Wellness 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 materials referred to be included in the
record. Without objection, so ordered.
In the event of other Members attending the hearing, I ask
unanimous consent that they be permitted to serve as a member
of the subcommittee for today's hearing, and without objection,
so ordered.
We have with us from the 18th District of Pennsylvania
Representative Tim Murphy. Representative Murphy is very
interested in this issue and we really appreciate him being
here.
Representative Watson will be here in just a few minutes.
The subcommittee is convening today to discuss the latest
scientific research regarding the use of mercury in medicine in
the United States and the possible connection between these
products and autism spectrum disorders. The subcommittee will
also discuss the need for further research to determine the
biological basis of autism and how the Federal Government is
working to decrease the occurrences of this health epidemic in
the United States.
During my tenure as the chairman of the full Committee on
Government Reform and as the current chairman of this
subcommittee, I have convened no fewer than 20 hearings on the
topics of autism, vaccine safety and the detrimental health
effects of mercury-containing medical products. During these
investigations, numerous scientists from all around the world
have testified before this committee and the full committee.
They have presented credible, peer-reviewed research studies
that indicated a direct link between the exposure of mercury, a
widely known neurotoxin, and the increasing incidence of
autism.
Just recently we found that, I think the EPA was
complaining about the excessive amount of mercury in our
waterways in and around the central United States, the Great
Lakes and so forth, and how that's having an adverse impact on
neurological disorders across this country. It continues to
mystify me how we can say that it has to be taken out of the
environment and yet we continue to inject it into our children
and into adults and expect there not to be some kind of adverse
reaction.
Mercury has been present in medicines dispersed widely to
the public for decades. Unknown to most Americans, mercury is
still present in medicines that we use every day, including eye
drops, nasal spray, as well as many anti-fungal and anti-itch
creams, as well as vaccines. While the pharmaceutical industry
has found new ways to manufacture many medicines and
vaccinations that don't require the use of mercury, three
vaccines that currently remain on the mandatory pediatric
vaccine schedule still contain the mercury derivative
thimerosal, and those vaccines are the DTAP, which is called
the diphtheria, tetanus and pertussis vaccine, the flu vaccine
and hepatitis B.
We've been complaining about mercury in children's vaccines
now for about 4 or 5 years. And it's been removed from most
children's vaccines except those three.
My grandson, as I've said before, got nine shots in 1 day,
seven of which had mercury in them. Just a few days later, he
became autistic. This is a story that we've heard from many
parents who have testified before this committee over the
years. And yet, we continue to see mercury used as a
preservative.
Now, although it's been taken out of a lot of the
children's vaccines, the shelf life on many of those vaccines
is pretty long. Mercury-containing vaccines are still on the
shelf, even though they're not being produced. So in addition
to these three vaccines that are still being produced using
mercury, there are others that are on the shelf right now that
doctors are still using that children are being vaccinated
with. And I think it's a crying shame.
Although I applaud the benefits that many vaccines have
provided Americans over the years, I am perplexed as to why we
are administering shots containing poisonous toxins to our
children, when technology has ceased the need for this
otherwise harmful preservative. The debate over whether or not
there are linkages between mercury and neurodevelopmental
diseases has become more heated in recent times.
Six years ago, when I started an investigation into the
detrimental health effects of mercury, the science supporting
these claims was sparse. Recently, credible researchers from
many of our Nation's most highly regarded research universities
have published studies noting the possible associations between
mercury and health defects.
Dr. Richard Deth, professor at the College of
Pharmaceutical Studies at Northeastern University, was the lead
researcher in a collaboration between Johns Hopkins University,
Tufts University, the University of Nebraska and Northeastern
University on a groundbreaking study into the possible
correlation between increases in environmental toxins, such as
thimerosal, and the incidence of autism. Dr. Deth will testify
on the findings and future implications of his research.
Another innovative study was conducted at Columbia
University recently, released in June of this year. The
researchers exposed mice to thimerosal in doses and timing
which corresponds to the current pediatric immunization
schedule. The independent Columbia University study indicates
that subjects with a specific genetic susceptibility toward
autism are placed at a greater risk for neurodevelopmental
diseases when administered thimerosal-containing vaccine.
Unfortunately, Dr. Mady Hornig, the lead researcher on this
project, is unable to be with us this morning due to a personal
emergency. But in her place, Dr. Deth will present her oral
testimony.
In a partnership between the University of Pittsburgh,
Carnegie Mellon University and the University of Illinois,
funded by the National Institute of Child Health and
Development, participating scientists have begun looking at the
neural science of autism on a wide scale, multi-million dollar
project.
A brain scanning technique identified as FMRI, or
functional magnetic resonance imaging, was used in this
experiment to compare the brain activity of adults afflicted
with high functioning autism with non-autistic participants.
The researchers then specifically examined two regions of the
brain associated with language skills. To better explain the
findings of this study, the subcommittee has the pleasure of
receiving testimony from Dr. Marcel Just, one of the lead
researchers on this monumental study.
To discuss the implications of using mercury in medical
devices, the subcommittee will be hearing testimony from my
good friend, Dr. Richard Fischer, a practicing dentist and
representative of the International Academy of Oral Medicine
and Toxicology.
As many of us already know, the incidence of autism have
become increasingly prevalent in modern day society. Once
considered a rare disease, affecting roughly 1 in 10,000
children, autism now affects 1.5 million of our Nation's
children. And this problem continues to escalate rapidly.
According to a recent Autism Alarm released by the U.S.
Department of Health and Human Services, the Centers for
Disease Control and the American Academy of Pediatrics,
currently one out of every six children is diagnosed with a
developmental disorder and/or behavioral problem. Even more
alarming, 1 out of every 166 children in the United States is
being diagnosed with an autism spectrum disorder. From 1 in
10,000 to 1 in 166. This major health care crisis has clearly
reached epidemic proportions and will not simply go away.
To address the current CDC observations with regard to the
autism epidemic, the subcommittee will be receiving testimony
from Dr. Melinda Wharton, Medical Doctor, the Acting Deputy
Director of the National Immunization Program at CDC, who will
be speaking about information her office has collected
regarding the incidence and prevalence of autism in the United
States.
The FDA's Center for Biologics Evaluation and Research is
responsible for the regulation and oversight of vaccines
administered here in the United States. Dr. William Egan,
Acting Director of the Office of Vaccine Research and Review at
CBER will be testifying today on how the FDA has worked to
reduce the exposure of thimerosal to children in the United
States. I will be very interested in hearing that.
To give a perspective into the challenges facing the
families of autistic individuals, Lyn Redwood, a registered
nurse and mother of an autistic child, will be informing the
subcommittee on these issues. In addition to her professional
and personal obligations, Ms. Redwood is also the president and
founder of the Coalition for SafeMinds, Sensible Action for
Ending Mercury-Induced Neurological Disorders, an organization
founded to investigate and raise awareness about the autism
spectrum disorders.
While the science behind the causation of autism is being
deliberated, I firmly believe that we should take every
precaution to ensure the health and well-being of every
American. By eliminating mercury from medicine, we are taking a
vital first step. Even if there was not a lot of evidence, and
I believe conclusive evidence, that mercury in vaccines and in
other areas is causing neurological disorders, it seems to me
even if there is the most remote possibility, we would get it
out of there.
I mean, every time I talk to people who appear before the
committee, either privately or in public forum, I say to them,
would you mind if we just took the thimerosal, the mercury, and
injected it into you like they did our kids? And they will say
to you, well, I don't think I want mercury injected into our
bodies. And these are doctors who say there's no harm being
done. But they don't want mercury stuck in their bodies with a
needle.
Yet we do it to our kids every single day, and we do it to
adults. And we wonder why there's an increase in the rates of
autism, these epidemic increases, 1 out of 166. And we wonder
why we see more and more people coming down with Alzheimer's
disease. And we find out that mercury is in the environment and
they're saying we've got to get it out of the environment
because of the problems with the neurology of our population.
Yet we continue to put it into our bodies with needles. I just
don't understand it.
But in any event, I look forward to hearing the testimony
from our witnesses. With that, Ms. Watson, it's nice to see
you. As usual, you look very fashionable today.
[The prepared statement of Hon. Dan Burton follows:]
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Ms. Watson. I want to thank our chairman very much for
pursuing this particular topic. I join him as a committed ally.
So over the last several years, our chairman has
investigated potential health problems associated with the use
of mercury in medicine, including the use of a mercury-
containing preservative in vaccines called thimerosal and the
use of mercury in dental amalgams. These are issues that I have
been involved with for a long time. I understand the paramount
importance of having vaccines and dental amalgams and dental
materials that work. Vaccines save thousands of lives every
year, and poor oral health is a major cause of suffering in
this country. But the question is, whether we can achieve these
goals without using mercury, a known neurotoxin.
Now, let me start with dental amalgam, an issue that has
been of major concern to me for years. Over the last century
and a half, mercury-containing amalgam has been the most widely
used dental device in the United States. Yet important studies
about the safety of amalgam, including some underway at the
National Institutes of Health, have not been completed? Why?
In 1992, I authored a bill that passed the California
Legislature, requiring disclosure of the risks and efficacies
of various types of dental materials. In the past month, the
California dental board is finally, is finally disseminating a
fact sheet to inform the public about these materials. This is
an important step forward, and I commend them. But more needs
to be done for the law to be fully implemented.
Chairman Burton and I have corresponded with the Food and
Drug Administration on the subject of dental amalgam. We are
trying to determine why the FDA has failed to put dental
amalgam into a particular class of medical devices. I am
pleased FDA is represented at this hearing today, and I would
hope that the representatives would address this issue.
I am also interested in hearing about progress in research
on dental amalgam, including studies that were discussed at
previous meetings this committee has held. In addition to
hearing from FDA, I look forward to Dr. Richard Fischer's
testimony on the regulatory status of dental amalgam.
Now, let me turn to the issue of vaccine. Since our last
meeting, the Institute of Medicine released a major report
investigating a potential link between thimerosal in vaccines
and autism. The Institute of Medicine reviewed published and
unpublished studies and concluded that available evidence
favors rejection of the theory that thimerosal in vaccine
causes autism. Some scientists and parents have expressed
concern about this report, and today we will hear from several
scientists who have conducted recent research on thimerosal and
autism.
Some of this research was considered by the Institute of
Medicine but did not figure prominently in its report. The
testimony today should be very enlightening and interesting. A
timely concern relates to the use of mercury in flu vaccines.
Flu kills tens of thousands of Americans every year, and
protecting infants, children and adults from this deadly virus
is essential. At the same time, I think we all can agree that
it would be ideal for the flu vaccine to be mercury-free.
So I'm interested in hearing from those who will be
presenters today. And I want to know why, particularly from our
CDC, why our Nation's leading public health authority has not
endorsed this idea.
And on a personal note, Mr. Chairman, I have been pursuing
the amalgam issue for over a decade. So I decided that I would
get the amalgam in my fillings that I have had since I was 9
years old removed. I had to go to Mexico to do it. My own
dentist didn't have a clue, and argued with me that it was
safe.
But as I gather information and I chaired the California
Health and Human Services Committee for 17 out of the 20 years
I was in the California State Senate, and I had an expert staff
that dug up the information and the research, enough that I
knew that my health would improve if I had it removed. I had it
removed, and my health improved immediately. Went back over the
border to the United States, had dental work, and I have a
temporary covering that has amalgam in it, and I can see the
difference in my complexion and my look. I was being poisoned,
Mr. Chairman, all of those years, by the amalgam vapors that
were escaping because the tooth next to it was pulled, and it
leaves exposure.
So I don't buy the argument the professional dental
community came to my office to give me in opposing my bill. And
they said, it's cheap, it's sealed and it will not hurt. Well,
kids chew hard balls, and dentures, dental teeth crack and the
vapors escape, and they go up to the meninges of the brain,
causing considerable damage. So I myself am a victim and I'm
going to pursue this issue until we can come to some agreement
about the best policy.
So thank you for coming, and I look forward to hearing from
you. Thank you, Mr. Chairman.
Mr. Burton. Thank you, Ms. Watson.
Representative Murphy.
Mr. Murphy. Thank you, Mr. Chairman. As you know, I am not
a member of this subcommittee, although I am a member of the
full committee, and I appreciate the opportunity to sit on this
subcommittee with you. Rather than take time now, I would like
to go on and listen to the witnesses today. Thank you, sir.
Mr. Burton. Very good, thank you.
Our first panel consists of William Egan, Ph.D., Acting
Director of the Office of Vaccines, Research and Review, Center
for Biologics Evaluation and Research, Food and Drug
Administration, Department of Health and Human Services, and
Melinda Wharton, M.D., MPH, Acting Deputy Director of the
National Immunization Program, Centers for Disease Control and
Prevention, U.S. Department of Health and Human Services. I
presume you have somebody there with you that you'd like to
introduce. Who else do we have there? Dr. Egan, Dr. Wharton and
Dr. Boyle?
Dr. Wharton. Yes, Dr. Coleen Boyle, from CDC.
Mr. Burton. OK. Will she be testifying as well?
Dr. Wharton. She is available to answer questions should
there be questions that fall into her area of expertise.
Mr. Burton. OK. Would you please rise to be sworn?
[Witnesses sworn.]
Mr. Burton. Thank you.
Dr. Wharton, would you like to start?
STATEMENT OF MELINDA WHARTON, M.D., M.P.H., ACTING DEPUTY
DIRECTOR, NATIONAL IMMUNIZATION PROGRAM, CENTERS FOR DISEASE
CONTROL AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN
SERVICES, ACCOMPANIED BY COLEEN BOYLE, ASSOCIATE DIRECTOR FOR
SCIENCE AND PUBLIC HEALTH
Dr. Wharton. Good morning. I'm Dr. Melinda Wharton, Acting
Deputy Director of the National Immunization Program at the
Centers for Disease Control and Prevention. Thank you for the
opportunity to testify today on CDC's vaccine safety research
activities, particularly those regarding thimerosal-containing
vaccines.
I am accompanied today by Dr. Colleen Boyle, Associate
Director for Science and Public Health with CDC's National
Center for Birth Defects and Developmental Disabilities, who is
here to help answer questions on CDC's autism related
activities.
CDC understands that autism can be a devastating illness
and impacts families and caregivers alike. CDC joins with other
Federal and State agencies and other partners in their
continued search to learn more about the causes. Autism
spectrum disorders are a group of lifelong developmental
disabilities caused by an abnormality of the brain. The most
recent data suggests that between two and six children per
thousand have autism spectrum disorders. However, one of CDC's
goals is to obtain better information on the incidence and
prevalence of these disorders.
The emotional, social and economic impact on families and
children diagnosed with autism spectrum disorders is often
devastating, and the cost to the Nation in human and economic
terms is substantial and needs to be better documented. The
Department of Health and Human Services is dedicated to finding
the answers to what causes autism and how it can be prevented.
There's a great deal of ongoing research throughout the
various public health agencies. But my focus today is on the
vaccine safety related issues. It should be noted that the
Department of Health and Human Services has established an
inter-agency action coordinating committee [IACC], composed of
representatives to various Federal agencies as well as four
members of the public. The IACC's mandate is to enhance
coordination of autism-related activities of these Federal
agencies from biomedical research to service delivery.
Immunizations are one of the great public health success
stories of the 20th century, having made once common diseases
like diphtheria, measles and mumps diseases of the past.
Vaccines are now available to protect children and adults
against 15 life-threatening or debilitating diseases. This has
reduced cases of all vaccine-preventable diseases for which
children are now routinely vaccinated by more than 97 percent,
from peak levels before the vaccines were available, saving
lives and treatment and hospitalization costs.
However, we know that parents, researchers and others have
expressed concerns about a potential link between autism and
vaccines containing thimerosal, a preservative used to reduce
the possibility of bacterial or fungal contamination of
vaccine. Other than minor effects, like swelling and redness at
the injectionsite due to sensitivity to thimerosal, there is no
definitive evidence of harm caused by the amounts of thimerosal
in vaccine.
After an FDA analysis of the potential mercury content of
the full recommended childhood vaccination schedule and concern
about health effects of mercury exposures from all sources in
mid-1999, the U.S. public health service agencies took
precautionary action, working collaboratively with the American
Academy of Pediatrics and the vaccine manufacturers to begin
the voluntary removal of thimerosal preservative from the
vaccine supply.
While the risk of harm from exposure to thimerosal in
vaccines is only theoretical, the decision was made as a
precautionary measure. The elimination of mercury from vaccines
was judged a feasible means of reducing an infant's total
exposure to mercury in a world where other environmental
sources of exposure are more difficult or impossible to
eliminate.
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, with the
exception of influenza vaccines. As of January 14, 2003, the
final lots of the routinely recommended infant vaccines that
contained thimerosal as a preservative, with the exception of
influenza vaccine, expired.
CDC is actively involved in detecting and investigating
vaccine safety concerns and in supporting a wide range of
vaccine safety research to address safety questions. CDC
developed the vaccine safety data link project in 1990 to
better enhance the understanding of rare adverse effects of
vaccines. This project was a collaborative effort utilizing the
data bases of large health maintenance organizations. The data
bank contains comprehensive medical and immunization histories
of approximately 7.5 million children and adults. The VSD
enables vaccine safety research studies comparing the incidence
of health problems in unvaccinated and vaccinated people.
CDC recognizes the importance of data sharing when
questions are raised regarding a particular study's designer
methodology. Therefore, CDC has worked with the participating
HMOs to determine how their clients' personal medical records
can be maintained confidentially while still allowing for
external researchers to re-analyze the data from studies which
have been conducted through the VSD. As a result, CDC has
developed a data sharing process operated by the National
Center for Health Statistics designed to allow independent
researchers 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 public
health service agencies, CDC requested the Institute of
Medicine, one of the world's preeminent medical organizations,
to conduct independent reviews by objective, highly qualified
scientific experts to determine whether the available
scientific information tends to show or does not tend to show
vaccines played a role in causation, the level of public health
priority that concern should receive and recommendations for
research.
As you have already noted, in May 2004, the IOM
Immunization Safety Review Committee updated its previous
report regarding vaccines and autism based on the additional
studies that have been done on the topic since its 2001 report.
The IOM concluded that thimerosal-containing vaccines are not
associated with autism, that hypotheses regarding the links
between autism and thimerosal-containing vaccines lacked
supporting evidence and were only theoretical, and that future
research to find the cause of autism should be directed toward
other promising lines of inquiry that are supported by current
knowledge and evidence and offer more promise for providing the
answer.
CDC takes the issue of vaccine safety very seriously and
has initiated several studies that address IOM recommendations
in its previous report. The first study, the thimerosal
screening analysis in the VSD was started in the fall of 1999.
The VSD was used to screen for possible associations between
exposure to thimerosal-containing vaccines and a variety of
outcomes. In a first phase of this study, the CDC used data
from the two VSD HMOs with automated outpatient data. An
association between cumulative exposure to thimerosal and tics
was found in one HMO. At the other HMO, slightly increased
risks of language delay were found, but there was no increased
risk of tics.
In the second phase of the investigation, CDC investigators
obtained data from a third HMO with similar, available
automated vaccination in outpatient data bases 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.
To determine if these associations are real or by chance,
the usual scientific approach is to conduct other studies to
confirm or not confirm the initial results. No statistically
significant relationship between autism and thimerosal was
found in any of CDC's analyses of the FSD data. The findings of
the study were published in Pediatrics in November.
CDC and VSD researchers remain committed to clarifying the
results encountered during the VSD screening analysis, and
therefore a followup study is being conducted. This study will
be designed to assess whether neurodevelopmental disorders
confirmed by uniform neuropsychologic testing are associated
with thimerosal exposure.
Approximately 1,100 children between the ages of 7 and 9
randomly selected from the 4 VSD HMOs, based on thimerosal
exposure during the first 7 months of life, are being
evaluated. All of the children will be assessed using a
standard set of neuropsychological test batteries. Data
collection is nearing completion and the testing has been
completed and medical records are now being reviewed.
Preliminary study results should be available in the spring of
2005.
The vaccine safety data link and autism study is a case
control study that will begin data collection this fall. Autism
cases identified through the review of automated medical
records from three VSD HMOs will be assessed using a standard
autism assessment tool. CDC is also funding a followup study of
a group of Italian children who participated in a prior DTAP
trial in the 1990's in which thimerosal exposure was randomly
allocated. The children will be evaluated similarly as we're
doing in the followup study. Testing of the children will begin
in the fall.
Though we remain vigilant to assure the safety of vaccines,
we also must remember that vaccines benefit the public by
protecting persons from infectious diseases and the
consequences. Continued high vaccination rates are crucial to
prevent the spread of diseases such as measles, pertussis and
rubella among U.S. children. From 1989 to 1991, a measles
epidemic in the United States led to more than 55,000 cases of
measles and more than 11,000 hospitalizations and 123 deaths.
The outbreak stopped only when vaccination coverage increased.
Thus, if preschool vaccine coverage drops substantially,
large measles outbreaks are likely to occur once again. The
threats posed by vaccine preventable diseases are known and
real. The viruses and bacteria that cause vaccine preventable
diseases still circulate in the United States 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 United States each
year and globally remain the leading causes of death.
CDC remains committed to collecting accurate data on the
prevalence of autism, conducting public health research on
autism and conducting studies on vaccine safety. Vaccines are
one of our most valuable weapons against disease and have
afforded to us one of our proudest achievements in public
health. Autism research and monitoring will continue to be high
priorities for CDC. Such efforts will be essential in answering
key questions about whether autism is increasing over time,
determining the causes of this condition and ultimately
developing prevention strategies.
In addition to these critical efforts, we also realize the
need to act on existing science to improve the lives of
children already living with this condition by providing
developmental screening and intervention. We want each child to
be born healthy and to grow and develop to their full
potential.
Thank you, Mr. Chairman and members of the committee, for
the opportunity to testify before you today. Dr. Boyle and I
will be happy to answer any questions that you may have.
[The prepared statement of Dr. Wharton follows:]
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Mr. Burton. Thank you for your testimony. Everybody knows
the value of vaccinations. And every time you testify, you tell
us how valuable they've been. And we already know that.
We're not here to say that vaccinations aren't important.
They're very important. They've given us the highest quality of
life of any civilization in the history of mankind. That isn't
what we're talking about. We're talking about why they're
putting mercury in vaccinations and why it's never been tested
since 1929 when Lily developed it.
Mr. Egan.
STATEMENT OF WILLIAM EGAN, PH.D., ACTING DIRECTOR, OFFICE OF
VACCINES RESEARCH AND REVIEW, CENTER FOR BIOLOGICS EVALUATION
AND RESEARCH, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF
HEALTH AND HUMAN SERVICES
Mr. Egan. Mr. Chairman and members of the committee, I am
Dr. William Egan, the Acting Director for the Office of
Vaccines Research and Review of the Food and Drug
Administration Centers for Biologics Research and Review.
FDA's Office of Vaccine Research and Review is responsible
for the regulation and oversight of vaccines in the United
States. On behalf of the FDA, I appreciate the opportunity to
participate in this hearing as the committee explores the
hypothesized link between thimerosal in vaccines and autism. I
want to assure the committee, the public and the parents who
are here today that FDA takes this issue and their concerns
very seriously.
As you know, vaccines have contributed to a significant
reduction in many childhood diseases, such as diphtheria,
polio, measles and whooping cough. It is now rare for American
children to experience the devastating effects of these
illnesses, and infant deaths due to these diseases have
essentially disappeared in countries with high vaccination
coverage, such as the United States.
As a recent example, prior to the introduction of a vaccine
in 1985, an estimated 20,000 cases of invasive hemophilus
influenza type A disease, primarily meningitis, occurred each
year in the United States. Now because of widespread
vaccination, the number of cases of invasive HIB disease have
decreased by more than 98 percent. In the United States, HIB
disease had been the leading cause of acquired mental
retardation.
Although vaccines have contributed greatly to the health
and well-being of our children, we must nonetheless be vigilant
for any potential safety concerns that are related to these
vaccines. In response to Section 413 of the Food and Drug
Administration Modernization Act of 1997, FDA conducted a
review of, among other things, the use of thimerosal in
childhood vaccines. This review led to the realization that
some children, during the first 6 months of life, may receive
amounts of ethylmercury from the preservative thimerosal in
excess of EPA guidelines for methylmercury, while though not
the guidelines for either the ATSDR or the FDA.
Although there were no known risks from these levels of
thimerosal in vaccines, the Public Health Service, along with
the American Academy of Pediatrics and the American Academy of
Family Physicians, thought that it was prudent to reduce
childhood exposure to mercury from all sources, including
vaccines, whenever possible. Consistent with this goal, FDA has
encouraged and worked with manufacturers to develop new
vaccines and new vaccine formulations that are either
thimerosal-free or contain only trace amounts of thimerosal.
We are pleased to report that FDA actions have resulted in
a marked reduction in thimerosal exposure from vaccines. At
this time, with the exception of the influenza vaccine, and I
will address this vaccine in a moment, all of the routinely
recommended pediatric vaccines, DTAP, hepatitis B, the
pneumococcal conjugate vaccine, IPV, the HIB conjugate vaccine,
MMR and varicella that are currently manufactured for the U.S.
market are either thimerosal-free or contain only trace amounts
of residual thimerosal.
As just noted, the exception is the inactivated influenza
virus vaccine that has only recently been recommended for
routine use in a pediatric population 6 months through 23
months of age. FDA has approved two preservative-free
formulations of the inactivated influenza vaccine containing
only a trace of mercury from thimerosal. One of these
formulations is approved for use in the pediatric population.
The other is not, it's for children above the age of 4. The two
licensed manufacturers of the injectable form of the vaccine
also do market this product in a thimerosal preservative-
containing formulation.
The reduction or elimination of thimerosal was in principle
achievable because over time, it has been possible to replace
multi-dose vials with single dose vials which do not require a
preservative. Prior to this initiative to reduce or eliminate
thimerosal from childhood vaccines, the maximum cumulative
exposure to mercury as ethylmercury via the routine pediatric
vaccinations during the first 6 months of life was
approximately 187.5 micrograms. The vaccines with trace amounts
of thimerosal licensed to date contain less than 1 microgram of
mercury per dose.
With the newly formulated vaccine, the maximum cumulative
exposure during the first 6 months of life is less than 3
micrograms of mercury. This use of vaccines with no thimerosal
or only trace amounts of thimerosal represents a greater than
98 percent reduction from previous maximum exposure to young
infants. A table listing vaccines, preservative contents and
the manufacturers can be found on FDA's Web site.
Although not administered to children below the age of 6
months, the influenza vaccine could add an additional 25
micrograms of mercury during the first year of life if each of
the two doses that were administered both contain thimerosal as
a preservative. Since the FDA last appeared before the
committee to discuss this issue, we have approved several
vaccines, new vaccines that are either thimerosal-free or
contain only a trace amount of thimerosal.
These are Pediarix, which is a combination diphtheria,
tetanus, toxoid and acellular pertussis vaccine with hepatitis
B and inactivated polio vaccine. And this is manufactured by
GlaxoSmithKline. Decovax, a tetanus and diphtheria toxoid
absorbed vaccine, for adult use, mainly for ages 7 and up,
manufactured by Aventis Pasteur Inc. A diphtheria and tetanus
toxoids DP vaccine for pediatric use, this is also manufactured
by Aventis Pasteur Inc. And a tetanus and diphtheria absorbed
TB vaccine for adult use manufactured by Aventis Pasteur Ltd.
In addition, a live attenuated influenza virus vaccine that is
thimerosal-free, Flu Mist, that was manufactured by Metamune,
was licensed in 2003.
The Immunization Safety Committee of the Institute of
Medicine has completed two reviews of studies addressing a
potential link between thimerosal-containing vaccines and
autism that are relevant to this hearing today. The first IOM
review was conducted in 2001. In 2001, based on the data then
available, the IOM concluded that the body of data was
inadequate to either accept or reject a causal relationship
between thimerosal-containing vaccines and neurodevelopmental
disorders, including autism.
The committee, prompted by an accumulation of new data, re-
reviewed this issue of the potential causal relation between
thimerosal-containing vaccines and autism in 2004. Based on a
review of the full body of data, which included epidemiological
studies from the United States, Denmark, Sweden and the United
Kingdom, the committee concluded, ``Thus, based on this body of
evidence, the committee concludes that the evidence favors
rejection of a causal relationship between thimerosal-
containing vaccines and autism.''
The FDA has succeeded in reducing children's exposure to
mercury from vaccines during the first 6 months of life. It
continues toward reducing everyone's thimerosal exposure
through vaccines. With the exception of the inactivated
influenza vaccine, which just this year was added to the list
of routinely recommended pediatric vaccines, all routinely
recommended licensed pediatric vaccines that are currently
being manufactured in the United States now contain no
thimerosal or only trace amounts of thimerosal. FDA, together
with our colleagues within the other HHS agencies, will
continue to study data relating to the incidence and etiology
of autism.
I would be happy to respond to any questions from the
committee.
[The prepared statement of Dr. Egan follows:]
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Mr. Burton. Thank you, Dr. Egan.
You quoted the IOM study. I understand there were 14 or 15
studies that were included in that research that they did. One
was from Denmark. The government of Denmark, as I understand
it, administers these vaccines over there. And if they admitted
that there was a problem with the mercury in the vaccines, the
government could be held liable, is that not correct?
Mr. Egan. I don't know what the liability issue is.
Mr. Burton. Well, in any event, they have a vested interest
in it. There were five studies that were pretty much discounted
by reputable groups that said that there was a causal
relationship between the mercury in vaccines and autism that
were discounted by the IOM. It has been the opinion of not only
myself but other Members that the pharmaceutical industry has a
great deal of influence on a lot of these decisions.
And as a result, we continue to see reports come out
saying, oh, there's no relationship between the mercury in
vaccines and autism. And yet we've gone from 1 in 10,000
children that are autistic to, according to CDC, 1 in 166. Is
that not correct, Dr. Wharton?
Dr. Wharton. Yes, in our written testimony, it's 2 to 6 per
1,000 in our recent study in Atlanta.
Mr. Burton. Two to six per thousand, yes.
Dr. Wharton. Yes.
Mr. Burton. Well, it was 1 in 10,000 before. And according
to what we got from CDC, it's 1 in 166 now.
Dr. Wharton. That's for all autism spectrum disorders, for
autism, a report that was published last year was 3 per 1,000.
Mr. Burton. Would you find the difference between the 1 in
166 and the 2 in 1,000?
Dr. Wharton. Find the difference?
Mr. Burton. Yes, what's the difference?
Dr. Wharton. The one includes a much narrower definition of
autism. The other one includes pervasive developmental
disorders and other issues, such as Asperger's syndrome.
Mr. Burton. Sounds like to me you're mincing words. The
fact is, more and more kids are being damaged and becoming
autistic, is that not correct?
Dr. Wharton. The rate of autism does appear to be higher
than it was, as you mentioned earlier.
Mr. Burton. Is mercury considered a toxic substance?
Mr. Egan. Yes.
Mr. Burton. It is?
Mr. Egan. Yes.
Mr. Burton. Is it considered a toxic substance?
Dr. Wharton. Yes.
Mr. Burton. Do we still allow it to be put into
thermometers? Do we put it into thermometers any more? I
remember when we were kids, we didn't know better, we'd play
with that mercury. Is it available like that any more?
Mr. Egan. I actually don't know. I don't think I've seen
them.
Mr. Burton. The answer I think is no.
Mr. Egan. I think they're in the water pressure rises, but
I'm not sure.
Mr. Burton. Well, that may be. I know I have a friend that
works in the things that set the heat in your house, and
they're going to try to get the mercury out of those, because
it's toxic, and because they put it in landfills when they
don't work and it gets into the water system and the water
supply and it leaches into people through the water. And we
just got the report from the Great Lakes, I think, that there
are unsafe levels of mercury in our water.
So mercury is a toxic substance. And you keep talking about
thimerosal. We're talking about mercury. Mercury is a part of
the thimerosal. So when we talk about, when you give your
testimony, I'd just as soon you say mercury instead of
thimerosal. Thimerosal is a way to kind of cover up that it
contains mercury.
What level is safe? You gave us an amount, Dr. Egan. What
level is safe?
Mr. Egan. I can only quote the different guidelines that
have been put forth on the basis of the number of studies.
Mr. Burton. What studies?
Mr. Egan. That were conducted by the studies in the
Seychelles, studies that were in the Faroe Islands, estimates
from accidental mercury exposures.
Mr. Burton. So what level is safe?
Mr. Egan. Well, there are various levels for different
purposes.
Mr. Burton. Does it vary from person to person because of
their ability to reject or live with it?
Mr. Egan. Yes, there are certainly differences between
people and between a developing fetus and a child.
Mr. Burton. So there's really no real scientific evidence
that says, this amount of mercury in a person's body is safe
and this amount is not safe from person to person?
Mr. Egan. Well, I guess, yes, the guidelines that the EPA
got were 0.1 micrograms of mercury per kilogram of body weight
per day.
Mr. Burton. That's kind of subjective, though, isn't it? I
mean, I don't understand how they came up with that.
Mr. Egan. Well, from the studies that they did, looking for
abnormalities or where, developmental abnormalities or
behavioral abnormalities. And based on those ranging studies
that were unfortunately the result of accidents and looking for
what the damage of thimerosal was, they got this level which
they said was a level, their reference dose, which is the dose
that they felt----
Mr. Burton. They felt.
Mr. Egan [continuing]. Could be taken into the body every
day over a lifetime with no observed effect.
Mr. Burton. Has thimerosal ever really been tested? Has
thimerosal ever been tested by our health agencies?
Mr. Egan. Only in those early tests that you know of that
were done by Lily.
Mr. Burton. When was that? That was done in 1929. Let's
followup on that. In 1929, they tested this on 27 people that
were dying of meningitis. All of those people died of
meningitis, so they said there was no correlation between their
death and the mercury in the vaccines. That is the only test
that's ever been done on thimerosal that I know of. Can you
think of any other?
Mr. Egan. No, in people, no. Except for accidental
exposures over time.
Mr. Burton. So we have mercury that's being put into
people's bodies in the form of this preservative, and has been
since the 1930's, and it's never been tested by our health
agencies. And yet you folks come here and you testify that
there's no conclusive evidence, and the IOM says, they favor,
get this, they don't say they're sure, they say they favor
rejection of a causal relationship between mercury and autism
and other neurological disorders. Nobody ever gives a
categorical statement, that no, mercury does not cause this,
no, it doesn't. And that's because you can't do it.
So why in the world are we even putting a little bit of it
in vaccinations? Why are we doing that? Why? Can't we create
single shot vials of these various vaccinations that does not
require mercury being put in them? Can we come up with another
preservative, a way to preserve these vaccinations so they
don't put the toxic chemical mercury into our bodies?
Mr. Egan. I can't speak to finding another preservative.
That's a very, very difficult issue. And I don't know if it's
possible to find something that works as well to replace
thimerosal. Tuthemoxyethanol seems to work in some cases.
Mr. Burton. How about if you----
Mr. Egan. We are diligently working, as we have testified
today and previously, toward eliminating thimerosal mercury
from vaccines as quickly as can be done. But there are many
issues that are involved in doing this. If we were to say
tomorrow that all vaccines, for example, all flu vaccines could
only be administered in single dose syringes or single dose
vials, the capacity to fill those does not exist.
Mr. Burton. Well, you know, right now we have a new vaccine
that's being tested on people below the age of 50 that doesn't
contain thimerosal that you administer through your nose. It's
not even a shot. Are you familiar with that?
Mr. Egan. Yes, that's the vaccine that I spoke of.
Mr. Burton. Does it contain mercury?
Mr. Egan. No, that's thimerosal-free.
Mr. Burton. Yes. So you can do it. Now, let me ask you, do
we have a----
Mr. Egan. And other manufacturers are working toward that,
and have put out the vaccines that are thimerosal reduced.
Mr. Burton. The vaccines that we have in the marketplace
that are now thimerosal-free, do we have vaccines that were
made with thimerosal that does the same thing that's still on
the shelves that doctors are using?
Mr. Egan. If I understand your question----
Mr. Burton. In other words, there's a shelf life.
Mr. Egan. Yes, are there any of the routinely recommended
pediatric vaccines that should be on the shelf now, the answer
is no. To the best of my knowledge, they've all gone past their
expiration date.
Mr. Burton. They've all gone past it, so there's none on
the shelves?
Mr. Egan. I was actually somewhat surprised with your
opening comment, and I would certainly like to know----
Mr. Burton. I've been told that there are some children's
vaccines that are still being utilized that contain mercury
that now are being produced mercury-free. And you're saying
that's not so?
Mr. Egan. Unless you mean trace amounts of thimerosal.
Mr. Burton. Wait a minute, hold it. I don't want to
monopolize this, I want to let my colleagues answer questions
and we'll come back.
Mr. Egan. But I would appreciate----
Mr. Burton. What is a trace amount?
Mr. Egan. We define that as meaning less than 1 microgram
of mercury per dose.
Mr. Burton. OK. Now, my grandson got nine shots in 1 day,
seven of which contained mercury. So if he got the very small
amount, he'd be getting maybe 9 micrograms, right?
Mr. Egan. No, much less than that. Because the maximum that
we calculate that a child could receive now during the first 6
months of life is somewhat less than 3. A number of these
vaccines with defined trace as less than 1, some of them have
considerably less than 1.
Mr. Burton. But that amount of mercury would not do any
neurological damage to anybody?
Mr. Egan. Not according to any guideline.
Mr. Burton. No, no, no, no. I want you to say yes or no.
Mr. Egan. I do not believe so.
Mr. Burton. You do not believe so. I didn't say believe.
Can you say to me right now that amount of mercury being
injected into a baby will not hurt it?
Mr. Egan. It's impossible to make those categorical
statements with 100 percent----
Mr. Burton. That's right. So it is possible that the amount
of mercury that's being injected, even in trace amounts, could
damage a child neurologically, right?
Mr. Egan. I don't think it has that capacity, no. We can
argue.
Mr. Burton. I know, but you don't think it is, but you
can't say categorically, can you?
Mr. Egan. Do I have evidence for every single child, for
every possible dose, the answer is no.
Mr. Burton. There you go. Let me yield to Ms. Watson, and
I'd like to ask a few more questions after my colleagues ask
questions.
Ms. Watson. Thank you. In the State of California, we had
proposition 65 a decade ago that the kinds of toxins that are
available in the environment, and the goal of establishing the
list was to be sure we diminish the risks that citizens are
under by being exposed to these toxics. Mercury is at the top
of the list, and I understand that WHO had an international
ruling that mercury should come out of all thermometers.
Congressman Burton and I have sponsored H.R. 1618 to
phaseout mercury-based fillings and to ban their use
immediately for children and pregnant women. As far as can be
determined, based on scientific evidence at this point that
even trace elements can do harm in the fetus, and I understand
mercury is biocumulative. So what are the safe dosages are, the
safe amounts to use in dental amalgams or fillings? Can either
one of the three, any of you respond?
Mr. Egan. Unfortunately, we were not aware that this
hearing was also going to go into dental amalgams, or else it
would have been possible for us to have somebody from the
Center for Medical Devices.
Ms. Watson. Let's talk about mercury. Mercury's infusion
into the body, what are the safe amounts? Do you have any idea?
Mr. Egan. Well, the EPA guidelines where they said there
should be no adverse effect if continuously received over a
lifetime was 0.1 microgram per kilogram of body weight per day.
That was designed to protect the developing fetus, which they
felt, and I think rightly so, was much more sensitive to any
potential harm. The ATSDR and FDA standards, guidelines are
somewhat higher.
Ms. Watson. If we know and we have empirical evidence that
mercury is very toxic to the human body and to the environment,
the exposure of mercury creates a real challenge for us, why is
it that we don't eliminate it from all products that are
ingested or used internally? And we have a whole different set
of issues, the external, getting rid of mercury. Why is it that
we still use trace amounts or larger amounts, thimerosal, why
do we use it in other products? We'll just leave dental
amalgams on the table for the time being.
Mr. Egan. OK, thank you. Well, certainly for the vaccines
and the use of thimerosal, we have been working diligently to
remove thimerosal from these products as quickly as we can.
It's not possible to do these overnight. If one wants to
develop a process, a manufacturing process that's completely
preservative free, one has to develop a new manufacturing
process and validate it, present that data to FDA, have it
reviewed.
If we talk about removing the thimerosal at the end, or not
getting it, there are a number of issues about the quality of
the product and the nature and quality of the product having
done this. Data have to be generated and submitted to FDA and
these need to be reviewed.
All of this switchover takes time. Moreover, the primary
way that, you know, we haven't been able to find, or there
aren't very good alternative preservatives, the non-mercury
containing ones. So what people have done, the manufacturers
have done, is primarily switch to single dose files or
prefilled syringes, which do not require a preservative. The
preservative is needed because you go into the vial many times,
it can be bacterially contaminated and then you get bacterial
infections. So it's to prevent that, that the preservative is
there.
But switching over to these single dose vials,
preservative-free, again requires validating that these can be
filled aseptically. Because we don't want to create other
problems. Moreover, the capacity to put these many doses of
vaccines in these single does vials of syringes doesn't exist
at the moment, although manufacturers are working toward that.
So we do have some vaccine out there now that's thimerosal-
free. There was last year for the pediatric population. There
is this year for the pediatric population. Much of it goes
unsold. The uptake is not as high as I would like.
But we're working toward this goal in the face of these
number of studies that say that there are no effects of
thimerosal in vaccines on neurodevelopmental disorders. But
because, as you and Chairman Burton have pointed out, it is a
neurotoxin and we are, the public health service is committed
to removing it whenever possible. As you said, and California
has done----
Mr. Burton. If the gentlelady would yield, the IOM report
that was done that you quoted a while ago, weren't there five
studies that they discounted, five studies they discounted that
said that thimerosal was a contributing factor to neurological
disorders, including autism?
Mr. Egan. Well, they looked at all the studies that were--
--
Mr. Burton. I'm just asking, weren't there five that they
discounted from various sources that did conclude that autism
was caused by the mercury in vaccine?
Mr. Egan. I don't know if discounted is the right word to
use. They looked at all the studies, some they felt I think
were more credible than others. I think we'll need to have----
Mr. Burton. Let me just say that there were five studies
that did say there was a connection between the mercury and
neurological disorders, including autism. There were five, they
discounted those.
Thank you for yielding.
Ms. Watson. Do you remember mercurochrome?
Mr. Egan. Sure. We used it all the time.
Ms. Watson. Yes, I did too, as a child.
Mr. Egan. Every cut got it.
Ms. Watson. How long did it take to remove it from the
American market? I know you can get it in foreign countries.
How long did it take to declare that mercurochrome was toxic
and have it removed?
Mr. Egan. That's something regulated by our Center for
Drugs. I'll have to get back to you on the status of what that
was, when it was removed and for what reason.
Ms. Watson. We know the statutes, I just wanted to know the
length of time. You don't have the answer so let me move on.
Mr. Egan. Someone else would have to answer that for you.
Ms. Watson. I don't know why the process takes so long,
when we know, I mean, intellectual honesty tells us that
mercury, if it is ingested, has a negative effect on the body.
If we know that, why doesn't CDC or FDA move toward as quickly
as possible trying to remove it from use? Anyone want to
speculate on that?
Mr. Egan. I'd be happy to take a shot. I think we are. And
we, the CDC and the manufacturers----
Ms. Watson. That gives me some hope.
Mr. Egan. I think we've done pretty good with all the
pediatric vaccines and now we're talking about flu. But as was
mentioned before, this is a very devastating disease. Now----
Ms. Watson. We're not talking about the disease. Let me ask
the question. Can you respond why it's taking so long when we
know the level of toxicity of mercury to have our leading
agencies come out and say, our goal is to remove it from all
these products?
Mr. Egan. The first issue is, thimerosal is in there during
the manufacturing process. I'll just talk about one of the
companies. We need about 100 million doses of flu vaccine per
year in the United States. Now, when they take the thimerosal
out at the end, they lose about 30 percent of that, a third of
that. So that would mean that if we said we could only have the
thimerosal-reduced vaccine, containing a trace, we would have
much, much less vaccine available, maybe 70 million doses
instead of 100 million doses.
The second issue is even if we had all of this thimerosal-
reduced vaccine containing only the traces, they don't have the
capacity at this time to put it into the single dose vials and
syringes, so they couldn't get it out.
Ms. Watson. Who doesn't?
Mr. Egan. The manufacturers. They are addressing that, they
are building new plants, new manufacturing suites. They are
developing new manufacturing processes that don't require
thimerosal in them. And we do have some of them now, the
thimerosal-reduced vaccine out there. And as Mr. Burton just
noted, we also have the inactivated, I'm sorry, the live
attenuated vaccine, which has none.
And we are going there. But developing these processes and
validating and building the plants and building the filling
suites takes a considerable amount of time.
Ms. Watson. My final question, where are the various
agencies of Government that are involved in focusing on these
products, what is your goal? What would you like to see? What
would you like to promote, those of you that are involved? I
think there are a set of facts already known about mercury as
an ingredient in any substance, any product. What are you
aiming for, what would you like to see?
Mr. Egan. What I have been aiming for and what I would like
to see is only thimerosal-free products, both for children and
adults.
Ms. Watson. Very good. Because you see, that helps me in
terms of being a policymaker, knowing where we need to go. And
if I know that we have our various agencies of Government with
us, then it encourages us to continue down this same way. Thank
you very much, Mr. Chairman.
Mr. Burton. Thank you. Before I yield to my colleague, let
me just say that I was chairman of the full committee for 6
years. I have now been chairman of this subcommittee for 2
years. That's 8 years. We've been talking about this since I
first started as chairman, maybe 7 years ago.
All I can say is, I don't know how long it's going to take.
I hope it happens in my lifetime. You're saying, well, you need
to work toward that, for single shot vials, you need to work
toward getting thimerosal out of these products, or mercury out
of these products. We've been after this now for 8 years.
Now, progress is being made, but sometimes I feel like it's
pulling a wisdom tooth, where they get into your mouth with
both feet and both hands and they're in there jerking that
tooth out and it's just so hard to get it moving. Eight years,
7 years should be long enough. The manufacturers, with the
technology that we have today, the quantum leaps that are being
made in technology and industry, it seems to me they could have
made this changeover. I think the main reason is money and I
think the main reason is because they're concerned about the
liability factor.
Mr. Murphy.
Mr. Murphy. Thank you, Mr. Chairman.
A few questions on some of the issues that were raised. Dr.
Wharton, in your testimony you mentioned that for a period of
time, only 61 to 66 percent of children would have received a
vaccine for measles. Was that the whole MMR group that they
would have received?
Dr. Wharton. That was predominantly as MMR, that is
generally the vaccine that was administered.
Mr. Murphy. I'm sorry, I'm having trouble hearing you.
Dr. Wharton. Yes, it is predominantly with MMR.
Mr. Murphy. OK. Which means about a third of children did
not receive them then. Was there a subsequent study which
looked at that third that did not receive compared with the
two-thirds that did receive it to see if there was a difference
in incidence of autism related disorders?
Dr. Wharton. During the period of time in which preschool
immunization coverage was low in the United States, most
children did receive measles vaccine prior to school entry. So
it wasn't that the children remained unvaccinated forever, they
simply weren't vaccinated in a timely way.
There have been a couple of studies done which have looked
at differences in autism among MMR vaccinated and unvaccinated
populations. In a study in Denmark, no difference was found in
the rate of autism among children who received MMR vaccines
compared to those who hadn't. Our birth defect center also did
a study looking predominantly at the timing of administration
of MMR since again most children do receive the vaccine prior
to school entry. There was no association found, there was not
found to be a difference.
Mr. Murphy. Dr. Boyle and Dr. Egan, do you agree with that?
Dr. Boyle. Essentially the study that we did in our birth
defects center indicated that there was no relationship between
timing of the administration of MMR vaccine and autism.
Mr. Murphy. What I'm concerned about here is you have
groups here that, even if you have 90 percent of children
getting it, you open up the issue that some children did not
and some children did. Was there actually an epidemiological
study which looked at children who never received any of these
things? Is there a clinically, not just statistical, but
clinically significant difference in autism spectrum disorders?
Dr. Boyle. In our Denmark study, there were children who
were not vaccinated at the time of followup, and there was not.
So that's probably the closest one.
Mr. Murphy. The next question I have relates to maternal
exposure. If mother has had exposure to mercury herself, either
fillings or her vaccinations, etc., does that mercury
accumulate in her system and is that passed on to her fetus?
Mr. Egan. Maybe I can comment a little bit on what I know.
This is not complete. There is mercury that will go to the
developing fetus. That's why the EPA set their guidelines so
low, to protect the developing fetus.
The second thing is that mercury is excreted.
Mr. Murphy. So it does not remain--there are a couple of
things here and I understand EPA is looking at substances, fish
and other foods a mother may eat during pregnancy. But I'm
wondering, if she had been exposed when she was a child, and
things she ate, even if she stopped before pregnancy, does
mercury accumulate in her system and is that passed on, even if
that baby never was exposed to mercury, will the substance be
passed on through her, from her own childhood?
Mr. Egan. I don't know the whole pharmaco----
Mr. Murphy. I only want you to speak to what you
scientifically can verify.
Mr. Egan. I don't know, sir.
Dr. Wharton. I know that we are doing some work in our
National Center for Environmental Health on this issue in terms
of looking at actual exposures from elemental mercury, which
would be mercury from amalgams.
Mr. Murphy. OK. And this is where we raise the question, if
there was a link between mercury, that if there was some that
she has from amalgams or from her own childhood, too, that
could be important for us to find out if there are links there.
Is it safe to say we don't know this yet?
Dr. Wharton. I would say it's safe to say we don't know.
We're conducting a very large study in a number of areas in the
country and that would be one of the issues to address, those
environmental sources of mercury, as well as medical sources.
Mr. Murphy. Would that then confuse or confound any ability
to draw conclusions then from what I mentioned before, that if
there were children that did not receive MMRs and those that
did, I'm wondering if it would confuse the results, being able
to clearly delineate distinctions between those children who
did or did not have autism spectrum disorders based upon
exposure to mercury during immunizations?
Dr. Wharton. Well, it is true that in many epidemiologic
studies you're unable to completely account for these other
sources of exposures, because they're very difficult to
quantify or estimate, things that happened previously. But in
order for it to influence the results of the study, the
exposure needs to be different in the vaccinated and the
unvaccinated group, if it's randomly allocated it really
shouldn't affect the results much. And there is not any
particular reason to think that those exposures would have been
different among for instance, those families who vaccinated or
did not vaccinate their child.
Mr. Egan. You've all testified to the point that mercury is
being removed from many vaccinations, so now there are more and
more children being vaccinated with virtually no immunization
exposure to that. That's only a couple of years old now? How
long has it been, in 2003 I think it was?
Mr. Egan. Well, this started in 1999, when Merck produced
the hepatitis B vaccine that's given at birth, that they came
out with their thimerosal-free version. Then in March 2000,
GlaxoSmithKline, their versions of thimerosal-reduced. And
these have been phasing in since 1999. You're correct, it's
been the last couple of years where it's been completely free.
But it started decreasing in 1999, 2000, 2001.
Mr. Murphy. I know from my own clinical practice as a
psychologist sometimes you can begin to detect autism spectrum
disorders very early in a child's life, one and a half or two
in some cases, even younger. And some children you need to do
it at later ages, 4, 5, 6, etc., for the higher functioning
Asperger's types. Is someone conducting these studies now,
following up these children, and do we have any preliminary
results?
Dr. Boyle. I would testify to the actual studies that we've
done specifically to address vaccines in the center that I'm
in, which is the National Center for Birth Defects and
Developmental Disabilities, where we're doing, as I mentioned
before, a very large study to look at a number of different
exposures. It would be vaccines but also maternal and other
early life exposures.
Mr. Murphy. We'll be waiting for those results, then.
Thank you, Mr. Chairman.
Mr. Burton. Thank you, Representative Murphy. I just want
to ask a couple more questions, then I'll let you go. First of
all, I'm sure you read the Wall Street Journal article
yesterday.
Mr. Egan. Yes, I actually did see that.
Mr. Burton. Did you get a chance to read that?
Mr. Egan. I saw the article.
Mr. Burton. That's good. We have people who will be
testifying today that worked on those studies, which show
problems with mercury in mice, administered in similar doses to
human beings in a relatively consistent way. You said mercury
is excreted?
Mr. Egan. Yes.
Mr. Burton. A lot? Because we were told by scientists who
have been before this committee from around the world that
mercury has a cumulative effect in the brain, it gets into the
fatty tissues in the brain and it is difficult for it to be
excreted once it gets into the brain and it has a cumulative
effect.
Mr. Egan. Yes, there is some accumulation, some----
Mr. Burton. So it isn't all excreted. So if you get a whole
bunch of shots, like if children get as many as, or were
getting as many as 25 to 30 shots before they started to
school, the mercury would accumulate even though some of it is
excreted, right?
Mr. Egan. You know, in the absence of any additional
exposures, I don't know that it's not actually all excreted.
The study the people did showed half times for ethylmercury, it
was around 7, 8 days, and for methylmercury it was around 30,
40 days. Those are the times at which half are eliminated. If
there is some fraction that remains, I don't know.
Mr. Burton. Some others that we've had, other scientists
from around the world who testified before the committee, it's
not a fraction, it's a substantial amount. The Denmark study,
you keep referring to that Denmark study. The Denmark study,
according to many of the experts that we've had before the
committee, not you folks, but many of the experts say that is a
flawed study, and there were 14 different studies that the IOM
used to come up with their last analysis. Five of the studies,
not of the 14, but 5 additional studies were discounted.
But one they laid an awful lot of the interest in was the
Denmark study. And scientists that we've had before this
committee say that that Denmark study is very, very flawed for
a number of reasons. So referring to that over and over again I
don't think really proves much.
I do want to ask, if you get a chance, I know you have busy
schedules, we're going to have the people testify here at the
next panel who have worked on these new studies. I think it
would be beneficial, if you had the time, to hear some of their
testimony. Would you have the time to listen to those folks, or
do you folks have to leave?
Mr. Egan. I think we have to get back.
Mr. Burton. Do you really? Gosh.
Mr. Egan. But certainly we can read the testimony. We're
reading the papers.
Mr. Burton. I know. I realize that their studies are really
not that significant or important.
Mr. Egan. No, that's not true.
Mr. Burton. That's not so?
Mr. Egan. No.
Mr. Burton. Well, they're not so significant that you guys
can't stay around here like we do and listen to them and glean
from them some of the information. But I'll make sure that you
get copies of them. And I'll send you, if you don't mind, a
raft of questions about their studies that I hope you'll
answer. Would you be willing to answer those questions for us
when we send those to you?
Mr. Egan. Yes.
Dr. Wharton. We will be happy to do that.
Mr. Burton. Would you be happy to do that? Then I have one
more question and I'll let you go. The hepatitis B vaccination
is given to children at birth. And this has nothing to do with
the mercury content. As I understand it, you can only get
hepatitis B from blood, needles or some direct contact with a
person that has hepatitis B, is that correct?
Mr. Egan. Yes. To the best of my knowledge.
Mr. Burton. Why are we giving hepatitis B vaccination to a
child the minute they come out of the womb? They're not exposed
to needles from drugs. They're not exposed to blood products,
other than from the mother and other bodily fluids from the
mother. So why do we do that? I'm not saying that you shouldn't
give that hepatitis B vaccination, I just wonder why you're
doing it at birth.
Mr. Egan. I'm going to have to let CDC answer.
Mr. Burton. Why is that?
Dr. Wharton. There's a couple of reasons for it. Perhaps
the most salient is that we have an imperfect system for
ensuring that we can protect newborn children from transmission
of hepatitis B virus from the mother at the time of birth. Some
women are not tested during pregnancy to determine whether or
not in fact they are contagious to their child for hepatitis B
virus. In some events you are tested, the results are not
communicated to the birth hospital.
We know we can prevent perinatal transmission of the
hepatitis B virus by timely vaccination and administration of
hepatitis B immunoglobulin. In the absence of knowledge of the
mother's status, we can still prevent many cases by that
newborn immunization. Children who are infected with hepatitis
B virus at birth have a high risk of establishing chronic
infection, permanent hepatitis B disease, or should they
survive, long term risk of liver cancer. In order to, because
we are not able to assure that every child who is born to a
hepatitis B surface antigen mother is known at the time of
birth, the routine hepatitis B immunization program provides a
safety net.
Mr. Burton. Well, I understand what you said, it just seems
to me that between the time they're born and the time they go
to school might be a good time to give it. I just never have
understood why they do it at birth. And it does include mercury
still, hepatitis B still does contain mercury?
Mr. Egan. The vaccine that's produced by Merck, the
Combivax HB, that is completely free of mercury. The Comvax,
which is the hepatitis B-HIB conjugate comvaxes vaccine, is
also completely free of mercury thimerosal. The InterexB, which
is manufactured by GlaxoSmithKline, does contain a residual
trace of mercury and it's somewhere on the order of about 0.05
micrograms----
Mr. Burton. If you have some that don't include it, why not
get the mercury out of all of them? Anyhow, that's something
that you can look into later.
Mr. Egan. They actually are trying to develop those.
Mr. Burton. OK. We have a vote on the floor, Representative
Murphy, so we will stand in recess until the fall of the gavel.
We'll be back here in about 10 minutes. Thank you very much for
your testimony. And I will send you copies of the testimony of
the people that are going to be testifying on these other
studies. I really hope you will respond to the questions we'll
ask along with those studies.
We stand in recess until the fall of the gavel.
[Recess.]
Mr. Burton. The subcommittee will come to order.
Our next panel consists of Richard Deth, Ph.D, from Bouve
College of Health Sciences, Department of Pharmaceutical
Services, Northeastern University; Marcelle Joust, Ph.D., D.O.,
health professor of psychology, director of the Center for
Cognitive Brain Imaging at Carnegie Mellon University; Richard
Fischer, DDS, International Academy of Oral Medicine and
Toxicology, Annandale, VA, my good buddy who takes care of my
teeth and makes me look halfway decent, which isn't easy; and
Lynn Redwood, R.N., MSN, president of SafeMinds.
Would you please stand so you can be sworn?
[Witnesses sworn.]
Mr. Burton. Thank you. According to my expert here, he says
we should start with Richard Deth. So Dr. Deth, would you like
to start? And if we could, I know that you're probably going to
go over, but if you could keep your comments close to 5
minutes, I'd really appreciate it.
STATEMENT OF RICHARD DETH, PH.D., BOUVE COLLEGE OF HEALTH
SCIENCES, DEPARTMENT OF PHARMACEUTICAL SERVICES, NORTHEASTERN
UNIVERSITY
Mr. Deth. I'll do my best, thank you. And thanks to you,
Chairman Burton, for the opportunity to testify today about our
thimerosal-related research that we do at Northeastern and its
significance for autism and understanding autism.
At the outset, I have to say that there is indeed a
molecular cause for autism. As a result of it being molecular,
you're going to have to tolerate my talking about molecules for
the next 5 minutes here. I trust you'll forgive me for that.
The primary goal of my research, that of my close
collaborative colleagues, is to find the cause of autism so
that we can use this information to identify effective
treatments for autistic children. I'm pleased to say that we've
made progress on understanding the disease and also on the
treatment.
The molecular problem at the heart of autism appears to be
a process known as methylation. Methylation means the transfer
of single carbon atoms or methyl groups between molecules. And
this process is highly sensitive, as it turns out, to heavy
metals, and it also turns out to be particularly sensitive to
thimerosal.
At the heart of the methylation process is the methionine
cycle shown in this slide here. Our lab has been studying the
role of methylation in mental illnesses. Methyl groups are
brought to this methionine cycle that is at the bottom of this
slide by the folate pathway, that's shown at the top of the
slide. The key enzyme that brings the methyl groups to the
pathway is called methinionine synthase. A methionine synthase
requires vitamin B12 to bring the methyl groups, and as it
turns out, thimerosal potently inhibits methionine synthase. We
published this this past April in the Journal of Molecular
Psychiatry.
The inhibition by thimerosal occurs at concentrations
easily produced in the blood of children after even a single
vaccination, as shown in this slide by the arrow. Now, we now
know that thimerosal inhibits this enzyme, methionine synthase,
by blocking the formation of the active form of vitamin B12,
which is known as methylB12 or also as a methylcobalimin.
The next slide just outlines the pathway here and what it
shows is that cobalamin or B12 forms that we take in either by
the diet or from vitamin pills have to first be converted to
active methylB12 before they can be used. And as summarized in
my written testimony more extensively, thimerosal blocks the
first step in this synthesis of methylB12, and as a result, it
inhibits methylation.
In neuronal cells, methylation can be stimulated by the
neurotransmitter dopamine. This appears to be important for
normal attention and the capability for normal attention. Thus,
ADHD, attention deficit hyperactivity disorder, and autism are
manifestations of what happens when methylation is impaired in
the brain.
Recently, Dr. Jill James measured the blood levels of
methionine cycle metabolites in children with autism. As
illustrated in this table, all the levels of these metabolites
were abnormal, confirming that methylation is indeed impaired
in autism. Her work will be published shortly in the American
Journal of Clinical Nutrition.
During the last year, researchers that I collaborate with
have examined genes that regulate methylation, and they have
found that autistic children have a significantly higher
frequency of so-called disabling polymorphism or mutations in
these genes. The next slide summarizes some of these genes.
Thus it appears that a sub-population of children who carry
these genetic risk factors are more sensitive to the toxic
effects of thimerosal and therefore are at greater risk of
developing autism.
The next slide shows some data that we recently obtained in
what I call a Timmy and Tommy study. That is in the same
family, two siblings, Timmy and Tommy, one developed autism and
one didn't. We had the opportunity to study the cells from such
individuals, and what we have found is that the individual that
developed autism is the one that was more sensitive to
thimerosal as shown in this illustration.
The good news that goes along with the knowledge of this
mechanism is that metabolic interventions which augment
methylation are proving to be effective treatment for autism.
These treatments include methylB12 itself, which can produce
dramatic improvements in some kids, as first reported by Dr.
James Neubrander. In other words, thimerosal is a toxin that
inhibits methylB12 synthesis. This lists some of the
treatments. Thimerosal is a toxin that inhibits methylB12
synthesis, and giving methylb12 turns out to be an antidote for
this toxin.
While further work is needed to identify the optimum
treatment for autism, these early clinical findings are
encouraging.
In conclusion, it appears that thimerosal causes autism and
ADHD by interfering with folate dependent methylation by the
enzyme methionine synthase. And it does this by blocking the
synthesis of methylB12, the active form of B12. Genetic risks
in the form of polymorphism and methylation related genes
increases thimerosal toxicity in some children. And the fact
that methylation enhancing metabolic treatments improves autism
provides strong evidence that impaired methylation does indeed
cause autism and that increased thimerosal exposure has been
the critical factor in this so-called autism epidemic.
So what caused the autism epidemic would be, the 1 in
10,000 frequency that was observed in 1970 is now, as we've
heard today, 1 in 162. That difference is not due to changes in
genetic risks, but due to an increase in exposure to
thimerosal.
I thank the chairman and others for their attention and
look forward to your questions. Thank you.
[The prepared statement of Dr. Deth follows:]
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Mr. Burton. I want to ask you a question right now, but
this is pretty conclusive scientific evidence, in your opinion?
Mr. Deth. The combination of both molecular studies from
our lab and the results of blood measurements in autistic
children and the genetic profiles of autistic children showing
the presence of genetic risk factors in the same area, and the
fact that treatments directed toward this same area improved
clinically autistic children, in some cases making them non-
autistic, seems to me, in my personal and professional opinion,
to be overwhelming evidence that this is the area from which
autism arises, and that thimerosal's insult to this area has
produced the dramatic increase in autism that we've observed.
Mr. Burton. Thank you. I will have some more questions for
you.
Dr. Just.
STATEMENT OF MARCEL JUST, PH.D., PROFESSOR OF PSYCHOLOGY, D.O.
HEBB CHAIR, CARNEGIE MELLON UNIVERSITY
Mr. Just. Mr. Chairman, members of the subcommittee, it is
such a pleasure for me, Mr. Chairman and members of the
subcommittee, to be here today, because I think in trying to
get at the causes of autism, you have to know what the end
state is, to understand the nature of autism. It is after all
something, a disease of the brain.
And we, my colleagues and I at Carnegie Mellon, other
universities, have with considerable Federal funding through
NICHD and the centers, the collaborative programs for
excellence in autism have been working on this for 5, 6, 7
years. I think we have something new to tell you today.
Let me show you, I want to start a little bit and tell you
that brain imaging science that has just taken off in the past
10 years has given us a new view of how the brain works. One of
the important things bears on autism. You see pictures in
Newsweek and Time of some lit-up brain area. I have some of
those, too. But really, that doesn't tell the right story.
The story is that any kind of thinking, your listening to
my sentences right now, entails the use of a group of areas, a
team of areas in the brain working together, 10, 12, depending
how you count, say 5 to 20 areas of the brain, work together.
It's a team effort. That wasn't very clear, but now with brain
science, we do know that is absolutely the case.
I want to say something about autism. As you know, it's
very enigmatic. Here you have people who are sort of nice,
decent and smart people and yet you know that their thinking is
somewhat disordered. Many of us have seen the movie Rain Man,
many people have met people with autism. And it's hard to put
it together.
There's an enigma. The fact that you know that there's an
overall kind of not adequately coping with the world and yet at
the same time being good at some specific tasks, some narrowly
focused tasks. We wanted to look at this in brain imaging, and
let me tell you a sort of a microcosm, a little micro-world
where this is true, and it's in the area of language.
Do you know that people, high functioning people with
autism do pretty well at spelling bees? They can spell words
better than average. They can read words better than average.
At the same time, they have more difficulty in understanding a
complex sentence. How do you put that together? They're good at
the pieces and not good at the puzzle.
That's what we went after, and we did a brain imaging study
that asked people, control participants and mainly adult
people, high functioning people, normal i.q. range. We gave
them sentences like the farmer was followed by the parent who
was following, they're lying in an MRI scanner, they're looking
at a little screen, they're reading on a little screen and they
press buttons saying whether it's the farmer or the parent.
And while they're doing this, through the magic of MRI, and
particularly FMRI, we measure where the blood, where the oxygen
in their brain is flowing. We measure it on a second by second
basis, so we get a movie of the brain activity while they're
doing the sentence comprehension.
Here's the result. And it's so interesting, I don't want to
get too technical, but I have pictures of, I see my pointer
isn't showing up. There are two areas lit up there. The one to
the left is Broca's area, it's in the front. It kind of does
sentence processing. It's a gross oversimplification, but it
does sentence processing. And the one to the right behind is
Wernicke's area. And another oversimplification is that it does
word processing.
If you look at the brain activation in the autistic
population, that's a group image up above, there's relatively
more activation in the area on the right, Wernicke's, in the
word area, and relatively less in the sentence area, compared
to the control subjects down below. For these sentences, the
people with autism can work their way through it by focusing on
the individual words, working really hard with the individual
words.
But the way they differ from the control subjects is the
control subjects are putting the pieces together of the
individual words to make up the sentence in Broca's area, by
looking at the grammatical relations between the words, the
syntactic relations.
Now, I want to make a very important point here. I don't
think that Broca's area is broken, I don't think it's at fault.
I don't want to point the finger at Broca's area. I don't think
autism lives in one place in the brain, certainly not in
Broca's area. I think it's a neural systems disorder that's
caused by a lack of adequate communication among areas. How
could the area that puts the pieces together put the pieces
together if it doesn't get adequate information about the
pieces?
So that's just the first part of the story, the integrating
area works less well than the individual pieces area. So that's
one piece of the puzzle.
Here's another one. As we measure the activity in these
various areas, it's not a photograph, it's a movie. We measure
the activity every few seconds. We can see, we measure the
activity in one area, the activity in another area, we can see
how well it's synchronized. Are the two areas marching to the
same drum?
The finding is that the degree of synchronization is lower
in the people with autism. And you know, we've done this in
lots of studies, it's a robust finding. I illustrated here in
this graph, the upper graph is from a person who has autism and
the two lines show the level of activity in the two brain
areas. And the two areas you can kind of see track each other
decently.
But if you look at the person without autism down below,
they track each other much better. So there's lower
synchronization, just the activity level is marching to the
same drum in the case of people without autism.
We measured one of the main white matter tracks in these
people. The corpus callosum is the main cable, so to speak,
connecting the left and the right hemisphere. And in general,
it was smaller in the people with autism. So think about it,
the cable that provides the communication is smaller. That's
got to impact bandwidth, how much information you can put
through it per unit time. That's the third piece of the puzzle.
Differences in white matter. Now, I should say, we're not
the leading laboratory in measurement of white matter. But
there are wonderful findings, I want to mention Dr. Martha
Herbert, who had a paper on this recently that precisely
measured white matter throughout the brain of people with
autism, finding reliable and systematic differences. But we
focused here on the corpus callosum.
And one more, here's the fourth piece of the puzzle, and I
think this for me nails it. The size of the relevant piece of
the corpus callosum, it's called the posterior midbody, but
don't worry about that, the size, the diameter of that area
predicted how well we're synchronized, the two brain regions
that cable connected. That's the scatter plot here.
The smaller the posterior midbody was in these people with
autism, the worse was their synchronization. If you look at
this plot, I don't have it here for the people without autism,
there's no relation, because the corpus callosum doesn't
constrain, doesn't limit how that synchronization goes.
Mr. Burton. The one thing that we were interested in is the
mercury impact on these areas. You haven't mentioned anything
about that. Is that a part of this?
Mr. Just. I'm afraid not, Chairman Burton. This is an end
stage, if you're going to look for causes, you need to have a
precise description of the causes. I believe that this is a
large step forward in improving the precision of the
description of autism, of what it is, how it affects people.
Mr. Burton. OK, that's fine. We'll get back to that in
questions. We'll maybe ask you questions about how these things
correlate with one another.
[The prepared statement of Mr. Just follows:]
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Mr. Burton. OK. Ms. Redwood.
STATEMENT OF LYN REDWOOD, R.N., MSN, PRESIDENT, COALITION FOR
SAFEMINDS
Ms. Redwood. Good morning, Chairman Burton and members of
the subcommittee. My name is Lyn Redwood. As president of the
Coalition for SafeMinds and parent of a child with mercury-
induced autism, I want to thank you on behalf of the entire
autism community for holding this important hearing today.
Given the prescribed time to take my comments, I am
providing a copy of the newly released report from SafeMinds
entitled A Brief Analysis of Recent Efforts in Mercury Medical
Induced Neurological and Autism Spectrum Disorder, and ask that
it along with my full written testimony be entered into the
hearing record.
Since the scientists present here will be testifying
regarding their research telling the connection between
thimerosal and autism, I have chosen to limit my oral testimony
to the response of our Federal agencies to this issue.
How I came to this discussion, I'm here today because of my
son Will. These pictures show you a healthy, alert, happy, non-
autistic boy. This is my son after he received toxic levels of
mercury, 125 times his allowable EPA exposures. He was just a
shell of his former self. I share this personal information
with you to bring to you the reality of Government policy. What
we discuss here today is not just a theoretical risk, but
actual injury.
It has been 5 years since the Public Health Service and the
American Academy of Pediatrics first announced that thimerosal
should be removed from vaccines. And at that time, taking the
appropriate position of caution, they announced to the public
and practitioners, ``Because of any potential risk or concern
the Public Health Service, the American Academy of Pediatrics
and vaccine manufacturers agree that thimerosal-containing
vaccines should be removed as soon as possible.
This next slide, on the left is a picture of a boy from the
1930's who suffered from acrodynia, which was a form of mercury
toxicity resulting from exposure to mercury in teething
powders. On the right is my son after developing mercury
toxicity.
In July 2000, when SafeMinds presented to the Government
Reform Committee a paper, Autism: A Novel Form of Mercury
Poisoning, publishing the evidence pointing to the synonymous
nature of the symptoms of mercury poisoning and autism spectrum
disorders, we could not have imagined that in 2004, thimerosal
would still be in vaccines and that the Government agencies
tasked with protecting the public would have failed to take
aggressive action to get the mercury out. We could not have
imagined that the Department of Health and Human Services would
instead have focused their energies on avoiding the truth
that's before them, and in doing so, undercut the public's
trust in vaccine programs, and continuing to put babies at
risk.
The first in a series of regulatory failures of our
Government agencies belongs to the Food and Drug Administration
for failing to remain open minded and objective about the
possibility that vaccines might at times be harmful, and
requiring valid scientific evidence from manufacturers to prove
safety of vaccines, their preservatives and adjutants. Over the
course of 70 years since thimerosal was first introduced into
the marketplace, FDA has repeatedly failed to ask tough
questions and require proof of safety, while allowing its
increased use in vaccines.
But worse than this initial series of failures is that
which has occurred since the July 1999 announcement. The
Coalition for SafeMinds asked the FDA to immediately conduct a
recall and protect every child from potential mercury injury.
The FDA denied this request as they denied your request,
Chairman Burton, citing their fear that industry would sue
because they had ``no proof of harm.''
Since then, two citizens' petitions have also been
submitted to the FDA asking for recall and ban on thimerosal-
containing vaccines, one by the National Vaccine Information
Center in 2002 and just recently another by the Coalition for
Mercury-Free Drugs in July 2004. These petitions seek to make
the FDA enforce its own regulations that unless a component of
a drug has been proven safe it must be removed. Neither of
these petitions have been responded to or acted upon at this
time.
I and many of my medical colleagues remain astonished that
we even have to ask the FDA to stop allowing mercury to be
injected into babies. We've trusted that the FDA was doing its
job and assuring the safety of all drugs and biologics it
regulates, and that trust has been proven under-served in this
instance.
CDC failures are even more egregious. At every turn when
the CDC could have alerted the public and taken a strong stand
against the use of thimerosal, they instead have promoted
flawed epidemiological studies as proof that no evidence of
harm has existed. If the uninformed public takes the statements
on the CDC Web site at face value, they could conclude that
rigorous evaluations have been conducted and that no risks are
associated with the use of thimerosal in vaccines. Nothing
could be further from the truth.
In July 2000, when you had the CDC before you, your
committee, they made no mention of their own research looking
at the link between thimerosal and autism. SafeMinds obtained
relevant documentation through a Freedom of Information Act
request which showed that by December 1999 the CDC knew
thimerosal could be linked to the increased incidence of
neurodevelopmental disorders.
Using taxpayer resources and ready access to the vaccine
safety data link sets, CDC researcher Dr. Tom Verstraeten and
his team looked at the medical records of children in a number
of HMOs to see if there was any truth to the thimerosal autism
hypothesis. Their results were so striking and deserving that
they would next call for a private meeting away from the CDC
complex and away from the public eye to discuss. This is the
now infamous Simpsonwood meeting where Dr. Verstraeten
presented his findings to a closed group of CDC and HHS
officials and selected outside experts, many of whom were
academic scientists with close ties to vaccine manufacturers.
The Simpsonwood meeting, ostensibly designed to be a
careful review of the CDC analysis on the impact of thimerosal-
containing vaccines on child development instead became a
vehicle for making numerous deliberate choices that took
positive findings in a single direction toward insignificance.
Between February 2000 and November 2003, Dr. Verstraeten and
his supervisors at the National Immunization Program produced
four separate generations of an analysis designed to assess the
impact of vaccine mercury exposure on neurodevelopmental
disorders in children. With each generation, elevated and
statistically significant risks were reduced or eliminated.
But before these four generations of study were produced,
Verstraeten conducted an earlier analysis of these issue in
November and December 1999. He never prepared a formal report
of the work, but statistic tables obtained by SafeMinds in a
FOIA request not previously analyzed demonstrate large and
statistically significant mercury exposure effects that in many
cases exceeded the findings of their later reports.
The results of the generation zero analysis are striking
and more supportive of a causal relationship between vaccine
mercury exposures and childhood developmental disorders,
especially autism, than any other results reported later. The
elevated risk of autism for the highest exposure level of
mercury at 1 month of age ranged from 7.4 to 11.4 times the
zero exposure level. This increased risk level corresponds to a
tenfold increase in autism rates seen since vaccine mercury
exposures increased starting in 1990.
It's also interesting to note than in August 1999, with
increasing pressure for scientists and researchers to gain
access to this data base, a CDC employee, Dr. Chen, went to a
meeting in Europe and created an organization which he named
the Brighton Collaboration. The mission is to facilitate the
development, evaluation and dissemination of high quality
information about safety of human vaccines.
Their aim is to develop globally accepted and implemented
standardized case definitions of adverse events following
immunization. While on the surface this may seem like a worthy
cause, a number of legitimate concerns need to be fully
addressed, including how CDC employees are gaining CDC funding
for their outside activities. I have outlined some of these
concerns in my written testimony and ask for your assistance in
gaining full disclosure from CDC on these issues.
In 2001, the CDC contracted with the Institute of Medicine
to create an immunization safety review committee, in order to
review the scientific evidence regarding a number of vaccine
injury hypotheses, including the correlation between
thimerosal-containing vaccines and the onset of
neurodevelopmental disorders, including autism. The IOM's first
report on thimerosal was issued in October 2001, and concluded
that the evidence was inadequate to either accept or reject
this hypothesis.
But they went on to find the hypothesis biologically
plausible and called for a clear and scientifically sound path
for research necessary to find these answers. That path include
epidemiology but it also called for animal models, clinical,
case study and other relevant research in keeping with the
tenets of good science. The committee went even further to
recommend that infants, children and pregnant women not be
exposed to thimerosal-containing vaccines, a recommendation
that was not embraced by our Federal agencies.
On May 18th, the Institute of Medicine Immunization Safety
Review Committee issued their final report, which found that
the biological mechanisms presented to their committee,
including thimerosal's ability to induce DNA damage and
apoptosis in neurons, disrupt methionine synthase pathways, a
model of autism induced with vaccine level exposure to
thimerosal in an autoimmune mouse, elevated levels of mercury
in children with autism after challenge with a chelating agent
in comparison to controls, along with data that children with
autism are not able to effectively excrete mercury were only
theoretical at best. They concluded that the body of
epidemiological evidence favors a rejection of a causal
relationship between vaccine thimerosal exposure and autism.
A causal relationship between autism and vaccinations
cannot be proved or rejected based solely on the evidence from
population-based epidemiological studies. Epidemiological
studies are by definition not designed to prove causality, they
can only provide statistical associations. Therefore, the
committee's conclusion that the body of epidemiological
evidence favors rejection of a causal relationship has no
scientific meaning.
The committee admits in their report that population-based
studies would not be able to detect sub-populations that could
be genetically more vulnerable to mercury at lower doses than
normal. By their own admission, an untested plausible
biological explanation for the causal association is the
genetic susceptibility theory. Why was this not emphasized as a
worthy hypothesis to explore?
Access to data is important, but access means nothing if
you do not have the resources to conduct research. The very
reason taxpayers support significant resources, $27 billion, to
be provided by the National Institutes of Health, is to conduct
research free of industry or other outside influence, to get
timely answers to important health related questions. Since the
mid 1980's, we've seen the epidemic increase in the rates of
autism, yet NIH and other health agencies have been slow to
respond. Autism research in 1977 was only $22 million. Although
that's increased over the last few years, it remains woefully
inadequate.
The NIH's efforts to conduct and fund studies evaluating
thimerosal have been at time misdirected and continue to be
inadequate given the severity and the potential risks
associated with the discovery in 1999 that 8,000 children a day
were being exposed to potentially dangerous levels of mercury.
While the entire research portfolio on autism spectrum
disorders remains inadequate, the investment on thimerosal
research is even more minuscule.
In previous hearings, HHS staff testified to you that they
had nominated thimerosal to the National Tox Program managed by
the NIH's National Institute of Environmental Health Services.
But after more than 3 years of waiting, thimerosal has yet to
hit the radar screen of the National Tox Program. There are 31
chemicals with a project leader assigned and a study designed,
but thimerosal is not among them.
So is there scientific evidence to support a parent's claim
that receiving thimerosal-laden vaccines caused their children
to become ill? Is there evidence to validate that the presence
of mercury in the bodies of young children who also happen to
be autistic is of concern? To those who remain open minded,
there is ample evidence to support these concerns. When NIH has
failed to fund studies, the IOM asked for non-profit
organizations, such as SafeMinds to fund or supplement research
at some of our country's most respected academic institutes.
While the NIH spends less than $59 per autistic child on
research, families are paying tens of thousands out of pocket
for therapeutic care for their thimerosal injured children.
They have been forced to devote energy and resources to raise
money for research from art auctions, dinners, tee-shirt sales
for 5 years because NIH and HHS have chosen not to make this a
priority.
The Office of Special Counsel, an independent investigative
and prosecutorial agency operates as a secure channel for
disclosure of whistleblower complaints and abuse of authority.
I only point this out to let you know right now the Office of
Special Counsel is currently investigating the issues with
thimerosal.
I know I've gone over time. I will cut through this real
quickly and go to Cautious Hope for California.
Mr. Burton. You're talking about the bill that's on
Governor Schwarzenegger's desk?
Ms. Redwood. Yes, sir.
Mr. Burton. Well, we'll all be pushing to try to make sure
that he signs that. I've already got a call in to him.
If you could summarize, though.
Ms. Redwood. I am. I have just a quick few more notes.
Although the reduction of thimerosal in medical products,
including vaccines, has taken over 5 years to accomplish, we
may be starting to see some of the effects of this policy
decision. According to information released in July 2004 by the
California State Department of Developmental Services,
California has experienced the first ever 9 month sustained
reduction in the numbers of professionally diagnosed new cases
of full syndrome autism being added to California's
developmental disability service system.
What makes this historic reduction in new cases of autism
so important is that those children come from the birth cohort
years of 1999 and 2000, which Dr. Egan mentioned earlier. These
are the years when serious efforts began to substantially
reduce the amount of mercury-containing thimerosal from
vaccines.
Vaccine safety is an important public health issue.
Concerns voiced by parents, physicians and the scientific
community regarding vaccine safety must be addressed with
thoughtful, complete and unbiased investigations. I showed you
pictures earlier of my son Will. Unfortunately, his mercury-
induced autism was not an isolated incident. Last April,
Unlocking Autism brought photos of autistic children that
spanned the length of three football fields on the Capitol
grounds. I must ask how many children were thimerosal injured
because the FDA and CDC chose not to act aggressively in 1999
and how many more are at risk because mercury continues to
remain in vaccines and other medical products.
Thank you.
[The prepared statement of Ms. Redwood follows:]
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Mr. Burton. Thank you, Ms. Redwood. I understand your deep
concern about this, since you as well as my family have
suffered from having an autistic child in the family. We
appreciate your comments.
Dr. Fischer.
STATEMENT OF RICHARD FISCHER, D.D.S., INTERNATIONAL ACADEMY OF
ORAL MEDICINE AND TOXICOLOGY
Dr. Fischer. Good afternoon, Mr. Chairman and members of
the committee and guests. My name is Rich Fischer, I'm a
dentist.
Dental amalgam or silver mercury fillings contain 50
percent mercury, which is more toxic than lead, cadmium or even
arsenic. These dental fillings contribute more mercury to body
burden in humans than all other sources combined. In fact, the
amount of mercury contained in one average size filling exceeds
the U.S. EPA standard for human exposure for over 100 years.
Mercury vapor which escapes from these fillings is readily
absorbed into the body, accumulates within all body tissues and
has been shown to cause pathophysiology. In the case of
pregnant women with mercury fillings, the mercury readily
passes from her fillings into her lungs through her bloodstream
through the placental barrier and into the developing child,
whose central nervous system and immune system are especially
vulnerable to this poison.
The fetus developing in the average American mother will be
born into this world with more mercury from its mother's dental
fillings alone than it will receive from all the vaccinations
it receives during its first 5 years of childhood. And I would
add, those vaccines, without the trace, that was with the full
load of thimerosal.
Scientists around the world have come to realize that even
minute amounts of mercury can cause permanent neurological harm
to young children and developing fetuses. The EPA recently
announced that 630,000 babies are born each year with too much
mercury in their bodies, and that one woman of childbearing age
in 12 has enough mercury in her system to put her at risk to
giving birth to a retarded child.
In response, the FDA has issued advisories to pregnant
women and women of childbearing age to reduce their dietary
intake of those fish which are known to contain elevated levels
of mercury, such as tuna, swordfish and shark. But according to
leading toxicologists, including the World Health Organization,
only 20 percent of mercury body burden in adults is derived
from diet. In contrast, 80 percent is derived from dental
fillings.
As of today, the FDA has yet to advise these same women
whom they warned against eating fish to avoid having mercury
fillings placed in their mouth. If 20 percent is a problem, why
isn't 80 percent a bigger problem?
In 1976, the President and Congress directed the FDA to
evaluate all medical devices intended for human use and to
classify them according to safety and effectiveness. The FDA
was also directed to ``assure the safety and effectiveness of
medical devices intended for human use.'' Dental amalgam has
been the most widely used dental device for over 150 years. Yet
to date, the FDA has never accepted or classified mixed dental
amalgam. I ask why.
In 1987, upon the advice of the FDA dental device panel,
the FDA accepted not dental amalgam but its premixed and
separate components, amalgam alloy as class 2 and dental
mercury as class 1. Class 1 is for devices that present no risk
of harm and therefore are subject only to general controls for
good manufacturing procedures. That's right, the FDA classifies
mercury, the most neurotoxic element on the planet, to be of
equal risk to humans as toothbrushes and dental floss.
Neither amalgam alloy nor dental mercury can be placed into
a tooth until they have been first mixed together. Forgetting
the safety issue for a moment, why does the FDA classify them
as devices when neither is effective? They cannot be an
effective device until mixed together. One cannot put mercury
into a cavity, it will just drip right out. Similarly, you
can't put the amalgam alloy powder into a cavity, because it
immediately washes out.
In 1991, the FDA director of dental devices declared that
the reason the FDA cannot regulate mixed dental amalgam is
because it is prepared by the dental clinician. Yet at the same
time they do classify dental resins and dental cements, which
also must be prepared by the clinician.
In 1998, the FDA ruled that mercury is not generally
recognized as safe. However, it left dental mercury as a safe
and effective class 1 dental device. Since all other medical
uses of mercury have been banned, why should we assume that the
only safe to implant it is in the human mouth?
Scrap amalgam, that unused portion of the filling material
remaining after the filling material remaining after the
filling is placed into a patient's tooth, must be handled as a
toxic waste disposal hazard. It cannot be thrown in the trash
or buried in the ground or incinerated. It must be stored in an
airtight vessel until properly disposed of. How can we justify
storing this same mixture inches from a child's brain stem and
declare it harmless?
The International Academy of Oral Medicine and Toxicology
applauds the efforts of this subcommittee in urging the dental
profession to join the rest of the medical profession and
abandon the use of mercury. Thank you.
[The prepared statement of Dr. Fischer follows:]
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Mr. Burton. Thank you, Dr. Fischer. You've been doing
yeoman's service in this area, and I really appreciate it.
Dr. Deth, you were supposed to also bring testimony from
this recent study. Could you quickly go into that?
STATEMENT OF MADY HORNIG, M.D., PH.D., ASSISTANT PROFESSOR OF
EPIDEMIOLOGY, COLUMBIA UNIVERSITY
Mr. Deth. Yes, thank you. I was asked by Dr. Mady Hornig to
provide her summary, and I'll do that now.
Mr. Burton. OK.
Mr. Deth. Chairman Burton, Congresswoman Watson and members
of the subcommittee, thank you for the opportunity to submit
for the record this statement regarding our new animal model of
the toxicity of thimerosal and its implications for human
health. I regret that I am unable to personally present this
testimony due to a family medical emergency.
Our work addresses whether genes are important in
determining if mercury exposures akin to those in childhood
immunizations can disrupt brain development and function. I
also submit for the record an electronic copy of the first
paper published on this animal model in the Nature Publishing
Group Journal Molecular Psychiatry.
The premise of our research is that if mercury in vaccines
creates risks for neurodevelopmental disorders such as autism,
genetic differences are likely to contribute to that risk. We
built upon an extensive existing literature on toxicity of
other forms of mercury in in-bred mouse strains that affirmed
the importance of specific genes controlling immune responses
in determining mercury-induced autoimmune outcomes in mice.
Earlier studies, however, did not use the form of mercury
present in vaccines known as thimerosal, and did not consider
whether intramuscular repetitive administration during early
post-natal development, when the brain and immune systems are
still maturing, might intensify toxicity. Based on reports of
immune disturbances and family history of autoimmune disease in
a subset of children with autism, we hypothesize that immune
response genes linked to mercury immunotoxicity in mice would
predict damage following low dose vaccine based mercury in our
mouse model.
Our predictions were confirmed. Using thimerosal dosages
and timing that approximated the childhood immunization
schedule, our model of post-natal thimerosal neural toxicity
demonstrated that the genes in mice that predict mercury-
related immunotoxicity also predicted neurodevelopmental
damage.
Features reminiscent of those observed in autism occurred
in the mice of the genetically sensitive strain, including
generalized behavioral impoverishment and abnormal reaction to
novel environments, enlargement of the hippocampus, a region of
the brain involved in learning and memory, correlation of
hippocampal enlargement with abnormalities in exploration and
anxiety, increased packing density of neurons in hippocampus
and disturbances in glutamate receptors and transporters.
Only mice carrying the H2 susceptibility gene showed these
autism-like effects. Two mouse strains with different H2 genes
did not demonstrate adverse consequences following thimerosal
exposure.
It's important to empathize that these animal model studies
do not provide conclusive evidence regarding a link between
mercury exposure and human autism. Nonetheless, the finding
that a specific genetic constraint profoundly alters the brains
and behavior of thimerosal-exposed mice confirms the biological
plausibility of thimerosal neurotoxicity, provides critical
guidance for the interpretation of existing epidemiologic
investigations into the potential association of thimerosal
with neurodevelopmental disorders, and suggests important new
avenues for future research.
Our work implies that if genetic factors are operative in
mediating a link between thimerosal and autism in humans, then
studies that fail to consider genetic susceptibility factors
will be compromised in their ability to detect a statistical
significant effect, even if one exists.
Recent findings presented at scientific meetings but as yet
unpublished suggest that thimerosal neurotoxicity in
susceptible mice involves the generation of auto-antibodies
targeting brain components. This autoimmune response persists
long after the presence of mercury can no longer be detected.
If confirmed, these findings will enable us to develop a
human diagnostic test to determine whether some individuals
with autism have similar autoantibodies present in their
peripheral blood. Such work would not only bring us a step
closer to identifying the genes associated with thimerosal
neurotoxicity in humans, facilitating prevention programs, it
would also validate the utility of this animal model for the
development of safe and effective modes of intervention.
It is highly likely that the neurotoxic effects of
cumulative mercury burden, including exposure to other sources
or forms of mercury, follow similar patterns of genetic
restriction. It's also likely that similar genetic factors
influence the neurotoxicity observed following exposure to
xenobiotics other than mercury. Age, developmental status and
the time of exposure, nutritional factors and gender are known
to influence outcomes.
We have limited ability to explain the interplay of such
factors in humans. Consider the example of the disparate
cognitive outcomes reported in children in the Faroe Islands
and the Seychelles after similar prenatal methylmercury
exposures. The reasons for this divergence remain unclear. The
design of future epidemiologic studies must take into account
the possibility of multiple xenobiotic exposures as well as the
influence of factors that modulate risk. Our studies have
important implications for understanding the role of gene-
environment interactions in the pathogenesis of autism and
related neurodevelopmental disorders.
I refer subcommittee members to our recent publication in
Molecular Psychiatry where experimental findings and their
implications are discussed in more detail. Thank you for your
attention, Mady Hornig, New York, NY.
[The prepared statement of Dr. Hornig follows:]
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Mr. Burton. Thank you, Dr. Deth. And thank her for her
research. We really appreciate that.
Mr. Deth. Thank you.
Mr. Burton. So what she's saying is, if there's a genetic
possibility that the mercury in these mice can cause autistic
like symptoms?
Mr. Deth. That's right. The theme of her work, which
parallels the theme of part of what I mentioned as well, is
that genetic factors that are probably exclusively or highly
over-represented in autistic children are in fact giving them a
higher vulnerability to thimerosal, as they were in her mouse
model. And her mouse had certain genetic factors, autistic
children no doubt have their own genetic factors that bring
risk to their metal exposure.
Mr. Burton. In the charts that you showed earlier, it
showed two children from the same family. One had evidently
genetic risk factors that the other one didn't, and as a result
they suffered autism while the other one didn't. So that's, you
think, pretty common among the population?
Mr. Deth. At this point, we've only analyzed about half a
dozen such paired siblings, that is, siblings of the same sex
that either did or didn't develop autism. So far we have found
a correlation with thimerosal sensitivity, a higher thimerosal
sensitivity and the occurrence of autism.
At the same time, in that same larger set that we hope to
eventually get data on, a bigger data set, we can see the
presence of these genetic risk factors as polymorphisms in the
very same genes that affect this methylation process that
thimerosal inhibits. So we are able now in a small number of
families to show that genes do make a difference and where they
do affect the outcome has to do with the methylation and
thimerosal sensitive methylation pathways.
Mr. Burton. You said B12 administered in a certain way does
help cure or clean out the autistic problem in children?
Mr. Deth. A remarkable finding presented about a year and a
half ago by Dr. James Neubrander at a meeting of Defeat Autism
Now, or DAN meeting, was that when he administered methylB12
injections to children in his autism practice, that a
significant number of them, that he estimated to be at least 75
percent, experienced significant improvement in their autism
symptoms. In a followup presentation, he indicated that there
was again a significant number of those who were so well
benefited that the independent neurologists' evaluation
concluded that they no longer had autism.
Now, this is not a large proportion that in fact were off
the autism spectrum. But it is significant that even the
numbers that he found were able to be so significantly improved
that they could be thought to be autism-free. But they were
still under treatment with methylB12.
Mr. Burton. So some children can be helped, but it's not a
cure-all?
Mr. Deth. That's easily said. It's unfortunate that it
isn't even effective for a larger number of children. But it is
effective for many.
Mr. Burton. If thimerosal, or the mercury, is indeed the
culprit for causing some of this autism, and from Dr. Just
obviously, it's not the only cause of autism, why do you think
the IOM committee gave it a clean bill of health?
Mr. Deth. As has been reviewed here, the IOM report very
clearly says that their conclusion was based simply on a subset
of the epidemiologic studies that they valued at a higher level
than other studies, as you pointed out earlier. The hypotheses
or the scientific data, in fact, that they did not include in
their consideration they branded as speculative.
I suppose it is speculative in that this information has
not been out in the literature for more than a year or a year
and a half. But in fact, it is not speculative, it's hard
science. Their conclusions were simply based upon epidemiologic
studies that they selected.
Mr. Burton. They were very selective in their findings?
Mr. Deth. It appears to me personally that they had a
mission to preserve vaccine reputation and that they were
willing to turn a blind eye to the body of information
indicating that thimerosal could have caused autism in a sub-
population for the greater benefit.
Mr. Burton. You're being very diplomatic.
Mr. Deth. I'm trying to be subjective on that matter.
Mr. Burton. In other words, they would listen to the ones
that were going to benefit certain people that they wanted to
benefit, and they turned their eyes away from the five studies
that showed that there was a correlation.
Dr. Just, you were talking about this under-connectivity in
the brains of autistic individuals. Do you think, and this has
nothing to do with the mercury in vaccines, but it is
interesting, do you think that they will be able to correct
that in people in the future?
Mr. Just. Yes, in two ways. First of all, in the short run,
I think we can design therapies, and test them of course, that
might be more effective than current therapies. It's not going
to be the cure-all. But I think there are ways to promote the
kind of thinking to get those key players to work together in
the face of and in spite of the under-connectivity.
As you say, I don't know the exact number of people who
have autism now. They need to have the most effective treatment
possible given them. I think that's one possible outcome of
this kind of research.
But in the slightly longer run, can we hope to cure it? I
think not next year but in the long run, I think we can. And I
think the way to do it is through a science called converging
methods. Many, many kinds of evidence that point to the same
thing, that's how you can be most sure, I think.
Mr. Burton. If you have somebody who has had their brain
cells killed, in part, by mercury, could that be one of the
reasons why you have this non-connectivity between the two
portions?
Mr. Just. There are definitely abnormalities in brain cells
in people with autism.
Mr. Burton. The causes we're not sure of.
Mr. Just. That's right. But let me tell you one of the
remarkable things about the brain. It has tremendous
plasticity. People have a stroke and you can just visibly see
an enormous number of brain cells being killed right then and
there. And you see sometimes, not in everybody, sometimes you
see a remarkable recovery.
Mr. Burton. Regeneration.
Mr. Just. I don't know about regeneration. Other parts of
the brain taking over. I've seen this in my own research in
stroke recovery, and I think you can promote some of this. So I
think there is tremendous potential there for that kind of
therapy.
Mr. Burton. Ms. Redwood, we appreciate your being with us
again. You provided the subcommittee a newly released report
from SafeMinds, outlining the last 5 years of research. In your
opinion, did the CDC take this possible thimerosal-autism
connection seriously? Did they pay any attention to that? Did
they look at it?
Ms. Redwood. Mr. Chairman, they did look at the issue. My
concern is that what they saw was so disturbing to them, it was
an unthinkable thought that a program that had been so
successful that it could have possibly caused injury. I think
it was an unthinkable thought for CDC. And when they saw this
initial data, it was so disturbing to them that they
purposefully went about devising methods for that data to no
longer be significant.
There's a number of manipulations that they did to that
data along the 3 years or 4 years that they had it that made
those highly statistically significant dose dependent
relationships between exposure to thimerosal and adverse
neurodevelopmental outcomes slowly go away with each new
generation. So I think in my personal opinion they didn't want
to find the truth.
Mr. Burton. Well, I think they're aware of the problem to a
much greater degree than any of us would like to believe. When
we passed the Homeland Security Bill, and I've brought this up
at committee hearings before, at the 11th hour, this committee
wrote most of the Homeland Security Bill, and at the 11th hour
late at night, they put a provision in the bill which would
protect pharmaceutical companies from lawsuits pending from a
component part of a vaccination, i.e. thimerosal, which was a
preservative. And that, had it been passed into law, would have
protected them from any type of legal remedy from these people
who have been damaged, like your son or my grandson.
And we were able to get that out in the Senate and it's not
the law. So there is still a liability exposure there, and it's
more of, if Congress and the people in the industry that are
doing this research, and come up with a compromise that would
protect them from large class action lawsuits which could put
some of them out of business if this is ever proven beyond a
reasonable doubt, and a solution that would help the people who
have been damaged like your son and my grandson, by giving them
restitution.
We passed what we called the Vaccine Injury Compensation
Fund back in the 1980's, which was designed to help people who
were damaged. That fund now has probably $3 billion in it. That
may not be enough to be able to take care of all the children
who have been damaged, or the people who have been damaged by
vaccines.
But when, and I'm not saying if, but I believe when it's
proven that the mercury in vaccines has been a major
contributing factor to these damaged kids, then there's going
to be a tremendous amount of liability exposure for these
pharmaceutical companies and then they're going to be out there
all by themselves. That's why I suggested to them that we try
to beef up the Vaccine Injury Compensation Fund and at the same
time that we could protect them from class action lawsuits, as
long as they took care of the people that were damaged.
And then finally, get the mercury out of everything. Get it
out of all vaccinations so that future generations of kids
aren't going to be damaged.
We're not there yet, but with the body of evidence that's
being developed by you, Dr. Deth, and the doctor that did the
mice study, the body of evidence is growing. It's going to be,
in my opinion, conclusive enough in the not too distant future
that they're going to be put in this position.
So I'd just like to say, and I'm sure there's nobody from
the pharmaceutical industry here today, well, maybe there is,
it's time for them to sit down with the Members of Congress and
people who are working in this area, and try to work out a way
to beef up the Vaccine Injury Compensation Fund, No. 1, No. 2,
get mercury out of all vaccinations or anything that goes into
the human body, and third, we would be willing then to protect
them from these class action lawsuits.
And Dr. Fischer, you and I have been friends and worked on
this for a long, long time. That would include, I believe,
getting mercury out of anything that goes into the body,
including amalgams. It seems to me unbelievable that when you
can't take the refuse from a mercury filling and flush it down
the drain because it's so toxic, and you don't want to get it
into the groundwater supply, that you have to put it into a
container to protect the people from the contamination, that
they put it in our mouths and say that if the filling cracks or
if the vapors from it, that they are not going to damage the
human brain. It just doesn't make sense to me.
In any event, do any of you have any last comments you'd
like to make before we call this hearing closed? What's that?
Do we have that?
For the media and anybody else, we have a video that we got
from a research group in Canada. I'd like to show that one last
time, because this may be the last hearing we'll have this year
on this subject. So could we play that? It shows what happens
when a minute amount of mercury is put in close proximity to a
brain cell. So if we could run that real quickly.
[Video presented.]
Mr. Burton. I think that shows pretty clearly, and that was
in 1999, that's been 5 years ago, and we showed that to the CDC
and the FDA and HHS, and they have paid virtually no attention
to it.
Dr. Fischer, I'll let you make a final comment then we'll
adjourn.
Dr. Fischer. Thank you. I wanted to make one brief comment
about that video. That's a study that our Academy helped fund.
Dr. Fritz Larshager, the lead investigator on that, told us
actually at a hearing here about a year ago when he testified
before this committee that the amount of mercury that was used
in that experiment was 1 million times less than the amount of
mercury that is entranced the body on a daily basis from dental
fillings. One million times less.
Mr. Burton. Anybody else have any final comments you'd like
to make? Yes, Dr. Deth.
Mr. Deth. In relation to Dr. Just's presentation, even
though it didn't include thimerosal, I would like to just point
out that the synchronization of brain waves seems to be a
process that this methylation pathway involving dopamine
receptors is also involved in. So it's interesting to me, and I
didn't actually know Dr. Just before this morning, that you
would see impairment of the synchronized brain activity that
fits very well with impairment of methylation.
The other aspect that also makes his work link to ours is
the fact that the synthesis of myelin, the white matter that
was lower in autism in his study, and the corpus callosum is
also dependent upon methylation. So an insult to that system
could account for reduced white matter, as well as reduced
synchronization of brain activity that would contribute to
autism.
Mr. Burton. Thank you, Dr. Deth. Dr. Just.
Mr. Just. I'd like to take the opportunity to express our
tremendous appreciation of the individuals with autism and
their families who have participated in our studies and others.
This is just a critical contribution to understanding autism,
treating it effectively, finding a cure. We want to encourage
others to do so. The pace of progress is only as fast as the
number of individuals who volunteer increases. That can't be
over-emphasized.
Mr. Burton. Well, we would encourage anybody who has an
autistic child or who has autism in their family to participate
in those kinds of studies. They're not dangerous, there's no
danger involved, but it is going to be helpful long term.
Ms. Redwood, do you have any last comments?
Ms. Redwood. Yes, and again I apologize for going over my
presentation. It's just impossible----
Mr. Burton. That's all right. We understand your
enthusiasm.
Ms. Redwood [continuing]. To sum up 5 years in 5 minutes.
But one of the things that concerns us at SafeMinds is the
creation of the Brighton Collaboration. We would ask for your
help in contacting CDC to look into this further.
Mr. Burton. We will. In fact, the reports that we have, all
this is going to be sent over to the CDC along with a number of
questions, and to FDA. And we're going to ask them to respond.
I'm not optimistic we're going to get any big change in their
attitudes, but as the scientific research continues, I think
it's going to become very evident that mercury is a major
contributing factor to these neurological disorders, including
autism.
Like I said before, I just don't understand the
pharmaceutical industry, when we've already reached out to them
to try to find a solution to this problem, getting mercury out
of all vaccines, getting it out of amalgams, creating a fund,
increasing the fund so we can take care of these people who
have been damaged, and then finally, if they do that,
protecting them from class action lawsuits, I just don't
understand the down side to any of that. Nevertheless, we're
not getting much response from them.
But we will continue working on this, and I thank you all
for your diligence and your hard work. We stand adjourned.
[Whereupon, at 1:10 p.m., the subcommittee was adjourned.]
[The prepared statement of Hon. Elijah E. Cummings and
additional information submitted for the hearing record
follow:]
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