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98–046 PDF 2004

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

(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

DAN BURTON, Indiana

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

DOUG OSE, California

RON LEWIS, Kentucky

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

EDWARD L. SCHROCK, Virginia

JOHN J. DUNCAN, JR., Tennessee

NATHAN DEAL, Georgia

CANDICE S. MILLER, Michigan

TIM MURPHY, Pennsylvania

MICHAEL R. TURNER, Ohio

JOHN R. CARTER, Texas

MARSHA BLACKBURN, Tennessee

PATRICK J. TIBERI, Ohio

KATHERINE HARRIS, Florida

——— ———

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. ‘‘DUTCH’’ RUPPERSBERGER, Maryland

ELEANOR HOLMES NORTON, District of

Columbia

JIM COOPER, Tennessee

BETTY MCCOLLUM, Minnesota

———

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

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

DIANE E. WATSON, California

BERNARD SANDERS, Vermont

(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

(III)

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

(1)

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,

2

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, peerreviewed 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.

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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

4

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.

13

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?

14

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.

15

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 mid1999, 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 reanalyze 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

16

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 thimerosalcontaining 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.

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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 expoVerDate 11-MAY-2000 10:55 Feb 11, 2005 Jkt 000000 PO 00000 Frm 00033 Fmt 6633 Sfmt 6633 D:\DOCS\98046.TXT HGOVREF1 PsN: HGOVREF1
30

sure 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 thimerosalfree 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 multidose 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

31

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.

40

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?

41

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——

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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?

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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

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cines 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,

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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.

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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

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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

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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.

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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

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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

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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.

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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.

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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 studVerDate 11-MAY-2000 10:55 Feb 11, 2005 Jkt 000000 PO 00000 Frm 00091 Fmt 6633 Sfmt 6633 D:\DOCS\98046.TXT HGOVREF1 PsN: HGOVREF1
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ies, 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 preVerDate 11-MAY-2000 10:55 Feb 11, 2005 Jkt 000000 PO 00000 Frm 00099 Fmt 6633 Sfmt 6633 D:\DOCS\98046.TXT HGOVREF1 PsN: HGOVREF1
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servatives 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

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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.

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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 populationbased 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

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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

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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

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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 cureall?

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

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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 cureall. 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.

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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

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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.

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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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