<DOC>
[108th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:98046.wais]




    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


                                 ______

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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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