AUTISM: PRESENT CHALLENGES, FUTURE NEEDS—

WHY THE INCREASED RATES?

HEARING

BEFORE THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED SIXTH CONGRESS

SECOND SESSION

APRIL 6, 2000

Serial No. 106–180

Printed for the use of the Committee on Government Reform

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http://www.house.gov/reform

For sale by the Superintendent of Documents, U.S. Government Printing Office

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AUTISM: PRESENT CHALLENGES, FUTURE NEEDS

—WHY THE

INCREASED RATES?

U.S. GOVERNMENT PRINTING OFFICE

69–622 DTP WASHINGTON : 2001

AUTISM: PRESENT CHALLENGES, FUTURE NEEDS—

WHY THE INCREASED RATES?

HEARING

BEFORE THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED SIXTH CONGRESS

SECOND SESSION

APRIL 6, 2000

Serial No. 106–180

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

For sale by the Superintendent of Documents, U.S. Government Printing Office

Internet: bookstore.gpo.gov Phone: (202) 512–1800 Fax: (202) 512–2250

Mail: Stop SSOP, Washington, DC 20402–0001

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

DAVID M. MCINTOSH, Indiana

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

STEVEN C. LATOURETTE, Ohio

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

BOB BARR, Georgia

DAN MILLER, Florida

ASA HUTCHINSON, Arkansas

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

GREG WALDEN, Oregon

DOUG OSE, California

PAUL RYAN, Wisconsin

HELEN CHENOWETH-HAGE, Idaho

DAVID VITTER, Louisiana

HENRY A. WAXMAN, California

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, Washington,

DC

CHAKA FATTAH, Pennsylvania

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

HAROLD E. FORD, JR., Tennessee

JANICE D. SCHAKOWSKY, Illinois

———

BERNARD SANDERS, Vermont

(Independent)

KEVIN BINGER, Staff Director

DANIEL R. MOLL, Deputy Staff Director

DAVID A. KASS, Deputy Counsel and Parliamentarian

LISA SMITH ARAFUNE, Chief Clerk

PHIL SCHILIRO, Minority Staff Director

(III)

C O N T E N T S

Page

Hearing held on April 6, 2000 ................................................................................ 1

Statement of:

Curtis, Kenneth, Catonsville, MD; James Smythe, Carmel, IN; Shelley

Reynolds, Baton Rouge, LA; Jeana Smith, Denham Springs, LA; Scott

Bono, Durham, NC; and Dr. Wayne M. Dankner, San Diego, CA ............ 49

Rimland, Bernard, Ph.D., Autism Research Institute, San Diego, CA;

Dr. Michael J. Goldberg, Director, NIDS Medical Advisory Board,

Tarzana, CA; Dr. Mary N. Megson, Pediatric and Adolescent Abilities

Center, Richmond, VA; Dr. John E. Upledger, the Upledger Institute,

Clearwater, FL; Cathy L. Pratt, Indiana Resource Center for Autism;

Dr. Deborah G. Hirtz, National Institutes of Health; Dr. Edwin H.

Cook, Jr., University of Chicago .................................................................. 327

Spitzer, Dr. Walter O., professor emeritus of epidemiology, McGill University, and member, National Academy of Science of the United

States, Corpus Christi, TX ........................................................................... 187

Wakefield, Dr. Andrew, Royal Free and University College Medical

School, London, England; Dr. John O’Leary, Coombe Women’s Hospital,

Dublin, Ireland; Vijendra K. Singh, Utah State University; Coleen A.

Boyle, Centers for Disease Control and Prevention, U.S. Department

of Health and Human Services, accompanied by Dr. Ben Schwartz,

Acting Director, Epidemiology and Surveillance Division, CDC; Dr.

Paul A. Offit, University of Pennsylvania School of Medicine; and Dr.

Brent Taylor, Royal Free and University College Medical School, London, England ................................................................................................. 101

Letters, statements, et cetera, submitted for the record by:

Bono, Scott, Durham, NC, prepared statement of ......................................... 85

Boyle, Coleen A., Centers for Disease Control and Prevention, U.S. Department of Health and Human Services:

Prevalence of Autism report ..................................................................... 198

Prepared statement of ............................................................................... 148

Cook, Dr. Edwin H., Jr., University of Chicago, prepared statement of ...... 463

Curtis, Kenneth, Catonsville, MD, prepared statement of ........................... 52

Dankner, Dr. Wayne M., San Diego, CA, prepared statement of ................. 90

Goldberg, Dr. Michael J., Director, NIDS Medical Advisory Board,

Tarzana, CA, prepared statement of ........................................................... 339

Hirtz, Dr. Deborah G., National Institutes of Health, prepared statement

of ..................................................................................................................... 450

Megson, Dr. Mary N., Pediatric and Adolescent Abilities Center, Richmond, VA, prepared statement of ................................................................ 424

O’Leary, Dr. John, Coombe Women’s Hospital, Dublin, Ireland, prepared

statement of ................................................................................................... 128

Offit, Dr. Paul A., University of Pennsylvania School of Medicine, prepared statement of ........................................................................................ 165

Pratt, Cathy L., Indiana Resource Center for Autism, prepared statement

of ..................................................................................................................... 444

Reynolds, Shelley, Baton Rouge, LA, prepared statement of ....................... 70

Rimland, Bernard, Ph.D., Autism Research Institute, San Diego, CA,

prepared statement of ................................................................................... 331

Singh, Vijendra K., Utah State University, prepared statement of ............. 142

Smith, Jeana, Denham Springs, LA, prepared statement of ........................ 77

Smythe, James, Carmel, IN, prepared statement of ..................................... 58

Taylor, Dr. Brent, Royal Free and University College Medical School,

London, England, prepared statement of .................................................... 173

Page

IV

Letters, statements, et cetera, submitted for the record by—Continued

Upledger, Dr. John E., the Upledger Institute, Clearwater, FL, prepared

statement of ................................................................................................... 435

Wakefield, Dr. Andrew, Royal Free and University College Medical

School, London, England, prepared statement of ....................................... 107

Waxman, Hon. Henry A., a Representative in Congress from the State

of California:

Documents from the Autism Autoimmunity Project .............................. 230

Various prepared statements ................................................................... 8

(1)

AUTISM: PRESENT CHALLENGES, FUTURE

NEEDS—WHY THE INCREASED RATES?

THURSDAY, APRIL 6, 2000

HOUSE OF REPRESENTATIVES,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The committee met, pursuant to notice, at 10:37 a.m., in room

2154, Rayburn House Office Building, Hon. Dan Burton (chairman

of the committee) presiding.

Present: Representatives Burton, Morella, Ros-Lehtinen,

McHugh, Horn, LaTourette, Hutchinson, Terry, Biggert, Ose,

Chenoweth-Hage, Waxman, Norton, Kucinich, Tierney, and Turner.

Staff present: Kevin Binger, staff director; Daniel R. Moll, deputy

staff director; David A. Kass, deputy counsel and parliamentarian;

Mark Corallo, director of communications; S. Elizabeth Clay, Nicole

Petrosino, and Nat Weinecke, professional staff members; Robert

Briggs, deputy chief clerk; Robin Butler, office manager; Michael

Canty, legislative aide; Scott Fagan and John Sare staff assistants;

Toni Lightle, legislative assistant; Leneale Scott, computer systems

manager; Lisa Smith Arafune, chief clerk; Corinne Zaccagnini, systems administrator; Phil Schiliro, minority staff director; Sarah

Despres, minority counsel; Ellen Rayner, minority chief clerk; Teresa Coufal, minority staff assistant; Jean Gosa and Earley Green,

minority assistant clerks; and Andrew Su, minority research assistant.

Mr. BURTON. If I could have your attention, please. I know a lot

of people have cameras, and I hate to throw a wet blanket on those

of you who want to take some pictures, but unless you are a member of the media, I wish you would not take any pictures during

the hearing. We will try to get the people you want to take pictures

of together later; but please do not take a bunch of pictures during

the meeting because it will probably disrupt what we are trying to

accomplish.

Good morning. A quorum being present, the Committee on Government Reform will come to order.

I ask unanimous consent that all Members’ and witnesses opening statements be included in the record. Without objection, so ordered.

I also ask unanimous consent that all articles, exhibits, and extraneous or tabular material referred to be included in the record.

Without objection, so ordered.

We do have some Members who have opening statements, and

we will allow those, and if they do not choose to give an opening

2

statement and want to prepare one for the record, that will be fine

as well.

This morning we are here to talk about autism. As we learned

in our August hearing, the rates of autism have escalated dramatically in the last few years. What used to be considered a rare disorder has become a near epidemic. We have received hundreds of

letters from parents across the country. In fact, here are some notebooks, and each one of the pages represents a parent who has a

problem with a child with autism.

They have shared with us their pain and their challenges. My

staff tells me that some of them cried when they read some of these

letters—and I have a pretty hard-nosed staff.

I do not have to read a letter to experience the kind of heartbreak that is in these letters. I see it in my own family. I am very

proud of this picture. The one on the left is my grand-daughter,

who almost died after receiving a hepatitis B shot. Within a short

period of time, she quit breathing, and they had to rush her to the

hospital.

My grandson, Christian, whom you see there with his head on

her shoulder, according to the doctors was going to be about 6-foot10—we anticipated having him support the family by being an

NBA star—but unfortunately, after receiving nine shots in 1 day,

the MMR and the DTaP shot and the hepatitis B, within a very

short period of time, he quit speaking, ran around banging his

head against the wall, screaming, hollering, waving his hands, and

became a totally different child. We found out that he was autistic.

He was born healthy. He was beautiful and tall. He was outgoing

and talkative. He enjoyed company and going places. Then, he had

those shots, and our lives and his life changed.

I do not want to read all the things that happened to Christian,

because I am not sure I could get through it. But unfortunately,

what happened to Christian is not a rare, isolated event. Shelley

Reynolds will testify today. Her organization, Unlocking Autism,

will be displaying thousands of pictures of autistic children at the

‘‘Hear Their Silence’’ autism rally this Saturday.

Forty-seven percent of the parents who provided these pictures

feel that their children’s autism is linked to the immunizations—

almost half. We frequently hear about the children with chronic ear

infections and children who became autistic after spiking a fever

with their vaccinations. Liz Birt was one of the hundreds of parents who contacted us. Her 5-year-old son Matthew has been classified as autistic. He was developing normally. At age 15 months, following his MMR vaccine, he began to regress. Since the time of his

vaccination, he has had chronic diarrhea. This is his picture—a

good-looking kid.

This is very prevalent, this chronic diarrhea, in autistic children.

Matthew also did not sleep on a regular basis for over 3 years. Liz

took her son to numerous gastroenterologists in prominent medical

facilities in the United States with no resolution. Finally, this past

November, Liz took her son to London, to the Royal Free Hospital.

A team of medical experts there examined Matthew. They felt that

he had a bowel obstruction. To the family, this seemed impossible

since he had constant diarrhea. An x-ray indicated that Matthew

had a fecal mass in his colon the size of a cantaloupe. After the obVerDate 11-MAY-2000 09:13 Feb 26, 2001 Jkt 000000 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 C:\DOCS\69622.TXT HGOVREF1 PsN: HGOVREF1
3

struction was cleared with laxatives, Matthew underwent an endoscopy and colonoscopy. The lesions in Matthew’s bowel tested

positive for the measles virus.

Dr. Andrew Wakefield and Professor John O’Leary will be testifying today. Their research has uncovered a possible connection between inflammatory bowel disorder in children with autism who receive the MMR vaccine and have measles virus in their small intestines.

Since coming home from England and being treated for chronic

inflammatory bowel disorder, Matthew has finally begun to sleep

through the night. I know that is a welcome relief for his family.

Unfortunately, Matthew’s story is not that unusual in children

with autism. Our grandson has a similar problem. Unfortunately,

it is important that I make two things very clear today. I, and I

believe every Member of Congress, am not against vaccinations,

and I do not think that every autistic child acquires autism after

receiving childhood immunizations.

I think slide 3 shows a lot of children who have had autism— is that correct—those are before-and-after pictures of the children.

However, there is enough evidence emerging of some kind of connection for some children that we cannot close our eyes to it—we

have to learn more.

Dr. Mary Megson of Richmond, VA will testify about the correlation she has seen in children with autism and attention deficit disorder. She has seen a correlation between Vitamin A depletion and

immune suppression after receiving the MMR vaccination.

There are certainly children who are born with autism. They

have what can be called ‘‘classical autism.’’ There is, however, a

growing number of children who are growing normally and then acquire autism, or ‘‘atypical autism.’’ There most probably is a genetic component to autism, but genetics is not the only issue. Many children seem to have severe food

sensitivities, particularly to gluten and casein, ingredients in the

most common foods, dairy and wheat. Many of these children show

signs of autism shortly after receiving their immunizations. Some

of these children, as we will hear from Jeana Smith, have metal

toxicities, aluminum and mercury. What is the source of these toxic

substances?

Dr. Goldberg will testify that maybe what we are seeing is not

autism at all, but a neuro-immunologic dysfunction.

I am very concerned about the increased number of childhood

vaccines. I am concerned about the ingredients that are put in

these vaccines. I am concerned about the way they are given. We

have learned that most of the vaccines our children are given contain mercury, aluminum and formaldehyde. Last year, the FDA

added up the amount of mercury our babies are being given to

learn that in the first 6 months of life, they receive more mercury

than is considered safe. Think about that—in the first 6 months of

life, the FDA has said that children are receiving more mercury

than is considered safe, and most of that is from vaccinations. Why

is it that the FDA licenses vaccines that contain neurotoxins like

mercury and aluminum?

When asked about the increased rates of autism, many will immediately discount that there is even an increase—even though the

4

latest statistics from the Department of Education show increased

rate in every, single State. This slide shows you that every State

has seen a dramatic increase.

Others will say the increase is due to better diagnostic skills.

Others will say it is because the diagnostic category was expanded.

If we look at the slide showing California here, California has reported a 273 percent increase in children with autism since 1988.

From this increase, 21 percent of all autistic children in California

live in the 29th District, which is Henry Waxman’s district, who is

the ranking Democrat on our committee.

Florida has reported a 571 percent increase in autism. Maryland

has reported a 513 percent increase between 1993 and 1998. You

cannot attribute all of that to better diagnostic skills.

In 1999, there are 2,462 children ages 3 to 21 in Indiana diagnosed with autism. That is one-fourth of 1 percent of all the school

children in Indiana, or 1 out of every 400; 23 percent of these children live in my district, the 6th District of Indiana.

This increase is not just better counting. If we want to find a

cure, we must first look to the cause. We must do this now, before

our health and education systems are bankrupted, and before more

of our Nation’s children are locked inside themselves with this disease.

Kenneth Curtis, part of ‘‘Dave’s Morning Show’’ at Oldies 100

FM here in Washington, will set the stage by talking about being

the parent of an autistic child. He will be followed by James

Smythe, of Carmel, IN. He will share how, through properly looking at autism as an illness and addressing that illness, his son is

improving.

Scott Bono, from North Carolina, lives close to one of the finest

medical facilities in the world—Duke University. However, he has

been unable to find medical experts to properly address his autistic

son’s needs. He is forced to drive 12 hours every 4 weeks for his

son’s medical treatments.

Dr. William Dankner, the father of a 13-year-old daughter with

autism, and a scientist, will testify about the challenges of finding

therapies and treatments that have adequate research. He will also

talk about the battle of getting adequate education through the

public school system. I think all of us who have autistic children

or grandchildren know the problems that it involves.

We hear repeatedly that parents are not informed at the time of

diagnosis by their school system what educational options an autistic child is entitled to. It is only after hiring lawyers and going

through the legal process that many children have access to appropriate educational opportunities. We are learning that the earlier

autism is diagnosed and treatments are begun, the better it is for

the child. Indiana is fortunate to have the First Steps Early Intervention System, a nationally recognized system that provides early

intervention services for children up to 2 years of age.

Families are forced to spend huge sums of money out-of-pocket

even when they have good insurance, because autism is often specifically excluded. We need to talk to State legislators around this

country to tell them how important it is, with the explosion of autism, that these benefits be mandated by the States and be covered

by insurance.

5

California passed legislation recently to require insurance compa- nies to cover autism. Parents spend $20,000 to $30,000 a year.

What medical care is covered is often done after extensive struggles

with insurance companies.

We have a long hearing scheduled today with a broad spectrum

of ideas presented. We will have a variety of medical approaches

presented. We will hear about secretin, which gained a great deal

of media attention in the past year and from which many parents

have seen tremendous success.

Dr. John Upledger, a former adviser to the Office of Alternative

Medicine at the National Institutes of Health, will testify on the

use of craniosacral therapy. He is the director of the Upledger Institute in Palm Beach Gardens, FL. For more than 25 years, Dr.

Upledger has been treating autistic children and helping families

through this approach. Craniosacral therapy is a gentle, powerful

form of body work that directly influences the brain and spinal

cord. It is used to treat pain, discomfort, or trauma to the head or

face, including TMJ dysfunction and headaches. Craniosacral therapy can also relieve physical and emotional trauma.

In addition to his work with autism, Dr. Upledger has achieved

dramatic results in treating post-traumatic stress disorder in Vietnam veterans.

In addition to medical treatments for the physical symptoms of

autism, there are numerous therapies that are needed to help autistic children. Special educational approaches are needed that can

include intensive behavior modification, known as ABA, Lovass,

music therapy, speech therapy, auditory integration and sensory

integration, as well as play therapy.

We will hear from both the Centers for Disease Control and Prevention and the National Institutes of Health about ongoing research and future needs. Of particular interest is the Brick Township study which has been evaluating a cluster of autism in New

Jersey.

This hearing will raise more questions than we can answer

today. We owe it to our children and to our grandchildren to ensure

that we are being diligent in looking for the causes of autism. We

have to do everything humanly possible to determine if there is

something that can be done to unlock our children from the prison

that they are in as a result of autism. I think that as a top priority,

we have to do much more research on the potential connection between vaccines and autism. We cannot stick our heads in the sand

and ignore this possibility.

If we do not take action now, 10 years from now, it may be too

late, not only for this generation of children, but for our taxpayerfunded health and education systems, which could collapse from

trying to care for all of these children.

The hearing record will remain open for 2 weeks.

I now yield to my colleague from California, Mr. Waxman, for his

opening statement.

Mr. WAXMAN. Thank you very much, Mr. Chairman.

I am glad we are having this hearing today on autism. We still

have many questions about autism—what causes it; what are the

safest and most effective treatments; is there a way to prevent it;

how many people in the country suffer from autism?

6

We do know some things about autism. We know there is a genetic component to autism. There have been some dramatic discoveries recently in the genetics of autism like the discovery of the

Fragile X gene and the gene that causes Rett syndrome. We know

that autism most likely develops very early during fetal development. We also know that parents are not to blame for autism. We

have come a long way from the time when fathers and mothers

were led to believe that they had done something to cause their

children’s autism, leaving them with needless and destructive guilt.

But I also understand that this hearing was called to consider a

theory that certain vaccines cause autism. From my discussions

with medical experts, scientists, and the autism community, it is

clear that this is only a theory. As the American Medical Association concluded recently, ‘‘Scientific data does not support a causal

association between vaccination and autism.’’

I believe that we need to increase our efforts to understand the

causes of autism. In this search, no possible cause, including vaccines, should be off the table. That is why I am a cosponsor of H.R.

3301, which would provide additional funding at NIH for research

into what causes autism, how many people suffer from autism, and

how best to treat those who have autism.

But in this process, we must not get ahead of the science or raise

false alarms. At every hearing in this Congress that this committee

has held touching on childhood immunizations, I have made a point

of emphasizing the tremendous public health value of immunization. More Americans have been saved by vaccines than by any

other medical intervention. Across the globe, 2.5 million children

die every year from childhood diseases; another 750,000 are crippled by these diseases. But American children are shielded from

this death and misery by their vaccinations.

During my 25-year career in Congress, my focus has been on improving health care, especially for children. When I was chairman

of the Health and Environment Subcommittee of the Commerce

Committee from 1979 to 1994, we worked constantly to expand

NIH research into childhood diseases. I have continued to fight for

more research, better treatments, and coverage while I have been

in the minority. During countless hearings and many legislative

battles, I have heard over and over again about the pain of parents

whose children suffer from debilitating diseases.

So I sympathize with the parents who are here today. I know

how painful and how hard it must be for you as parents to have

children who appear to be developing normally and then, all of a

sudden, seemingly out of nowhere, stop communicating and stop

developing.

We need to do everything we can to give these parents here and

other parents around the country answers. There is still much to

learn. In medicine the best answers come from research that can

withstand the rigors of the scientific method. These standards have

been developed in order to find the truth. If research has been conducted with control groups, and the results have been independently validated, then that gives parents meaningful information

about what causes a disease or a condition and what the best treatments are.

7

Parents and doctors need the best possible information so that

they can make the best possible decisions regarding their children’s

health.

There are lots of experts and groups that are knowledgeable

about this issue but who were not invited to testify today. These

groups include Dr. Louis Sullivan, former Secretary of Health and

Human Services, and current president of the Morehouse School of

Medicine; Dr. Isabelle Rapin, from the Albert Einstein College of

Medicine; the American Public Health Association; the American

Medical Association, and the National Network for Immunization

Information. At this time I would ask unanimous consent that all

of their statements be entered into the record.

Mr. BURTON. Without objection, so ordered.

[The information referred to follows:]

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Mr. WAXMAN. I thank all the witnesses who are here today for

appearing. I know how difficult it is for some of them to be here,

how hard it is to share their pain, and how much they want their

testimony to be a way for us to understand that we in the Congress

must do everything we can, consider all theories, get to the truth

about autism, what causes it, what we can do to treat it, and how

we can prevent it. I see that as our job today, and I look forward

to the testimony and learning from the witnesses who are here to

share their perspectives with us.

Thank you, Mr. Chairman.

Mr. BURTON. Thank you, Mr. Waxman.

Mrs. Morella.

Mrs. MORELLA. Thank you, Mr. Chairman. I appreciate your effort to hold this important hearing on autism, and I look forward

to hearing the testimony of the witnesses.

I come to this hearing today with an open mind, ready to listen

carefully to the testimony of the witnesses. Autism and its associated behaviors have been estimated to occur in as many as 1 in 500

individuals. Over 500,000 people in the United States today have

some form of autism. The estimated prevalence rate of autism now

places it as the third most common developmental disability—more

commonly occurring than Down Syndrome.

Mr. Chairman, in your opening statements, you mentioned that

there was a 513 percent increase in my State of Maryland between

1993 and 1998, and I notice that the first witness on our first

panel, Mr. Curtis, is from Maryland.

Unfortunately, there is almost no existing data on causes or links

to causes of autism in children. I am very concerned with these

striking statistics. I am most concerned with the lack of information and the confusion surrounding the issue of vaccines and their

relationship to autism.

I hope that today we can come closer to discerning what the appropriate steps are for this committee and for Government to take.

I hope to learn from testimony that will make this committee better understand where we need to focus research dollars, be it

through vaccines, genetic or environmental factors, and the question of why is autism four times more prevalent in boys than in

girls. I hope to get some sense of what further studies are needed

so that we can accelerate research on autism.

There is no question in my mind that this is an issue of high priority and that more studies are needed. That is why I wrote to our

Representative John Porter, who chairs the House Subcommittee

on Appropriations for Labor and Health and Human Services, requesting an increase in funding for autism epidemiology research

at the National Center for Environmental Health within the Centers for Disease Control and Prevention, an appropriation of $1.5

million for the CDC to expand its epidemiology activities in autism

from two isolated studies to a more national scope.

An increase in funding for autism epidemiology research in 2001

will enable CDC to expand monitoring efforts to other parts of the

country. This will allow them to better understand the prevalence

of autism spectrum disorders—information which is necessary to

eventually discover prevention, treatment, and a cure for autism.

46

I think that the choice of this ribbon with its puzzle pieces as the

symbol of autism, with the heart in the center, is most appropriate.

I yield back and look forward to hearing from the witnesses.

Mr. BURTON. Thank you, Mrs. Morella.

Mrs. Chenoweth-Hage.

Mrs. CHENOWETH-HAGE. Thank you, Mr. Chairman.

I can hardly begin to thank you enough for holding this hearing.

It is astounding to see all of these people who have come from all

over the Nation, and I understand, Mr. Chairman, that you have

arranged for two overflow rooms, and I noticed that the hall was

packed when I came in.

I rarely ask to make an opening statement, but I am unable to

overstate the importance of this particular issue, and I look forward to hearing the testimony from the witnesses today and learning more.

Mr. Chairman, oftentimes, I focus on the larger issues at hand

when I address the committee, but I too am the grandparent of an

incredibly handsome autistic child—an incredible boy. I cannot

overemphasize how much autism affects education and family cohesiveness in the most loving of families. All of these are irretrievably

affected when autism is discovered in one’s own family.

Mr. Chairman, when Timmy was born, neither my daughter nor

my son-in-law knew that he was autistic. They did not have a clue.

He was the youngest of four children, so his parents thought they

knew what to expect in raising a baby. It was only later that they

realized that there was something very different about Timmy.

When he was diagnosed with autism, we were all worried and saddened. How would our family deal with this? How could he be educated, and how could we best provide for his future? How could,

how could how could? And it went on.

We had hundreds if not thousands of questions. We were shocked

and frightened and worried and relieved to know what it was, all

at the same time. At the same time, none of us knew what the future held, and the questions kept coming.

That is why I am so very grateful to you, Mr. Chairman, for your

courage and willingness to deal in areas that the Congress usually

is not willing to open its mind to.

Timmy is now 8 and is a beautiful young boy whom we are all

immensely proud of. However, I cannot understate the challenges

that our family still faces. Parents are desperate to find an answer

to their questions. They want so much for their children to have

integrative and communicative lives. Oftentimes, they feel at a

loss, almost desperate, in trying to find answers to their questions.

Many of my family’s questions still remain. Day after day, we still

search for answers. It is an overriding concern with all of us.

While our questions are not all easily answered, even the beginning of the questions, we do somehow manage to look toward a

brighter future for Timmy than we ever thought possible after his

initial diagnosis. He was a gifted child in a number of areas, particularly music. But we still want to learn how to unlock the full

potential of his future.

All too often, people will write off such potential, but it is there.

We are all sure of it. You can literally look in his eyes and see it.

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Mr. Chairman, autism is a very strange disorder. When Timmy

was diagnosed, we were told that medical science did not know the

cause of it. We were told that Timmy had about a 4 percent chance

of leading a normal life, depending on his IQ. They thought autism

was probably genetic, but they really just were not sure.

After much research, we discovered his current schooling program, which is based on extensive research done by Dr. Iver Lovass

of California. At first, quite simply, we encountered a vacuum of

knowledge when it came to autism, and that shocked me. However,

what shocked me even more was learning that the rate of autism

has increased over the past several years, and the statistics which

you show today, Mr. Chairman, are incredibly shocking.

I continue to be surprised when I discover that some studies

have found preliminary evidence of a link between autism and vaccines, and evidence linking dietary health to autism. Vaccines and

dietary health are issues that I have been very interested in for

some time now, and I look forward to hearing from the witnesses

who will address these links.

Mr. Chairman, we understand from the research that was the

foundation of Dr. Lovass’ program, ‘‘Ready, Set, Go,’’ that the

chances of Timmy leading a normal life rose from 4 percent to

nearly 20 percent, and this is based on the intensive behavioral

intervention program developed after decades of research by Dr.

Lovass. You can imagine the impact this program has had on

countless children and their families.

Research in this area changes lives, as I am sure research regarding vaccinations and dietary health has changed the lives of

numerous others. The astounding results of research into this terrible disorder have changed the lives of many families, and as a result of this research, I am aware of families that have literally upended their lives to move across the country in search of programs

like that of Dr. Lovass.

Mr. Chairman, there are some remarkable programs that have

developed over the years with regard to autism, in particular some

amazing advances in educating autistic children. But we still need

more answers.

Mr. Chairman, again, let me thank you and the committee and

the hard-working staff of the committee for holding this critically

important hearing. For better or for worse, we must deal with this

subject. This committee is taking a very important first step.

Thank you, Mr. Chairman.

Mr. BURTON. Thank you very much, Mrs. Chenoweth-Hage.

Mr. Kucinich.

Mr. KUCINICH. Thank you very much, Mr. Chairman.

I have to first inform you that I have a markup and votes in another committee, so I will not be able to stay. But I did want to

come here specifically to support the cause of this hearing and your

efforts in this regard.

While I agree with Mr. Waxman when he says the history of vaccinations has shown a lot of benefits, it is important for science to

take note of the increased reporting with respect to rates of autism

in recent years. If we have a higher incidence of autism, this is an

appropriate subject for a congressional inquiry, and I think it is

also appropriate for us to ask questions not only of the witnesses

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here today but of the industry producing these vaccines. I am particularly interested in what are their production protocols for the

vaccines which our children receive; how are the vaccines being

made; what is in the vaccines; are there any differences in how the

vaccines were made years ago and how they are made today; are

there any different products in there?

These are questions which could lend themselves to an understanding of why there is an increased rate today, and it seems to

be different than what it was years ago.

So I think that when you see the heartfelt concern which is expressed here, the witnesses who are appearing and are scheduled

to appear, and when you see that there are scientists who are willing to address the question of a causal link between autism and a

vaccine, and when you have a scientist who is ready to say maybe

there is not a causal link—the fact that this debate has begun here

suggests an important moment in this Congress and in this country

on the issue of autism. We need to find out if there is a link, and

if there is a link, we need to go right back to the way the vaccine

is made and what it is made of—because the problem may not be

in our children; the problem may be in what our children are being

given.

So I thank you very much for your diligence, Mr. Chairman, and

for your commitment and for your quality of heart on issues of public health importance.

Mr. BURTON. Thank you, Mr. Kucinich, and I want to thank you

for all the help you have given us on a whole host of issues relating

to the health of the people of this country.

Mr. KUCINICH. I want to say I would not be on this committee

if it were not for Mr. Waxman inviting me to be on this committee,

and I am on it because of my deep respect for Mr. Waxman, whom

I revere as not just our leader, but for me, he has been a personal

hero. But I think I am on a committee with two of the best people

in the House, so I am pretty fortunate.

Thanks.

Mr. BURTON. I hope everybody heard that. That was from the

other side of the aisle. [Laughter.]

Mr. BURTON. Mr. Ose has said he does not have an opening

statement.

Mr. Hutchinson, do you have an opening statement?

Mr. HUTCHINSON. No, Mr. Chairman.

Mr. BURTON. OK.

We will now proceed with our witnesses. As a practice, especially

since we are talking about something as important as the various

problems that have been occurring with you folks with autistic children, I would like to ask everybody to rise.

On our first panel, we have Mr. Kenneth Curtis, Mr. James

Smythe, Ms. Shelley Reynolds, Ms. Jeana Smith, Mr. Scott Bono,

and Dr. Wayne Dankner.

Would all of you raise your right hands, please?

[Witnesses sworn.]

Mr. BURTON. Please be seated.

Mr. Curtis, would you like to start? What I would like to ask, because we have 19 witnesses, and this is a very big hearing today,

is if you could try to confine your remarks to 5 minutes. Some of

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the doctors who have technical expertise that they want to express

will be allowed a little latitude, but if you could stick close to 5

minutes, we would really appreciate it.

Mr. Curtis, would you like to start?

STATEMENTS OF KENNETH CURTIS, CATONSVILLE, MD;

JAMES SMYTHE, CARMEL, IN; SHELLEY REYNOLDS, BATON

ROUGE, LA; JEANA SMITH, DENHAM SPRINGS, LA; SCOTT

BONO, DURHAM, NC; AND DR. WAYNE M. DANKNER, SAN

DIEGO, CA

Mr. CURTIS. Certainly. Mr. Chairman, all of you, first of all,

thank you for this opportunity to speak on behalf of my son—— Mr. BURTON. Would you pull the mic a little closer? The mics do

not pick up as well as we hope.

Mr. CURTIS. Sure. Leave it to the radio guy to mess up the microphone.

Thank you again for this opportunity to speak on behalf of my

son, my family, and children with autism nationwide; but mostly

I am speaking on behalf of my son, because this is really his story.

Autism does not announce itself in the delivery room. When our

son Morgan Scott was born, he looked like a Sharpei dog—he was

wrinkled from head to toe. Things were sort of storybook for us at

that time. We had a girl and a boy, a mom and a dad, and life was

kind of like a picnic. But the clouds were rolling in, as it were.

Slowly, little drops of doubt began to fall. We wondered about the

way he liked to watch Disney videos over and over, or how he

would spin around and make strange noises and look at things out

of the corner of his eye; the way he liked to line up his toys. Drop

after drop—we wondered, and we waited to see what would happen.

He did not talk, and most of the time, he did not even seem to

hear us. So we worried some more, and we wondered, until all of

these little drops were like a downpour—and of course, we had to

take cover.

Our doctor suggested a hearing test, but his ears were fine. He

just would not talk. We tried speech therapy, but he still would not

talk. Even with all of these odd behaviors, my son was a happy

enough kid. He was loving, affectionate, he was ticklish, stubborn—

just like any kid—but he would not talk.

Finally, when Morgan was a little more than 2 years old, we had

a word for it, and the word was more terrifying and confusing than

any of the things we were dealing with at the time. Of course, the

word was autism.

But what did that mean? Of course, we thought of ‘‘Rain Man,’’

but we also thought of all the horrible stories you hear about kids

who repeatedly bang their heads against the wall, or bite, scratch,

and sit in a corner, rocking and hugging themselves. Is it possible

that this could be our little boy? It did not seem real—but obviously, it was.

Morgan was diagnosed as ‘‘moderately autistic,’’ a term I have always thought to be a bit like being ‘‘moderately pregnant.’’ So we

began to immerse ourselves in information. We were determined to

learn everything possible about autism—and when I say ‘‘we,’’ I

really mean my wife Kimberly. You have never seen a woman on

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a mission until you have seen a mother determined to save her

child. There is no match for a mother’s love. She read, she researched, she investigated, while I tried to come to terms with the

idea that I might never be able to shoot hoops with my son.

Before long, we had a plan. We opted for the one-to-one intensive

ABA therapy program developed by Dr. Lovass at UCLA. We spent

thousands of dollars, wrangled with the school system, hired lawyers, lived in my grandmother’s house to save on rent, and we

began teaching our son in-home.

For 5 years, Morgan had between 30 and 40 hours a week of oneon-one therapy. At age 4, my son had more college friends than

most fraternity brothers. He learned to read a little, to spell a little, to use the toilet—and most importantly, he learned how to listen to people, and he even began to talk a little bit.

I am a radio guy—I talk for a living—and the irony of having a

son who does not know how to communicate with words is not lost

on me. I know there are things that my son wants to say to me,

and as he gets older, I can look into his eyes and see the frustration and the confusion. There is a little boy inside of him somewhere, and it is as if he is lost.

This is really what it is like. It is like being in the mall with your

child, and you look down and discover he is not there anymore— that sickening feeling you get in the pit of your stomach. Except

that every once in a while, I catch a glimpse of the real boy—the

way his eyes light up when you bring the Christmas tree home; the

way he smiles when he jumps into the pool, or the way he sits perfectly still, enraptured, when he got to see the symphony. He loves

music, he loves animals, he loves trains, books, swings, ice cream,

and even his family, of course.

But he cannot tell me his favorite color, or how his day at school

was, or what hurts when he falls off the swing set. He still has not

figured out how to express or reveal himself. And he does not seem

to understand why this is so important to us.

I want to know why my son is locked inside himself. Is there a

genetic disposition? Is it environmental? Is it something in the

water? Do pesticides cause it—preservatives; antibiotics; immunizations; Nutrasweet; the time he fell and hit his head? It sounds

crazy, but these are the things we have all heard and thought

about, and the truth is we have no idea why our son is autistic,

and we have to accept that.

But we love our son so much that we can never give up hope that

he will 1 day carry on a conversation with us or even just say, ‘‘Hi,

Dad,’’ when I come home from work.

Morgan is a truly beautiful person in his own right just as he

is right now. I have never met anyone, and I doubt I ever will, who

lives more in the moment than my son. He is affectionate, imaginative, and even humorous sometimes. And I have learned more from

him than I have from any other single person in my entire life. He

is autistic, and that is just the way he is.

But not everybody is as lucky as we are. Morgan is not aggressive or self-injurious like a lot of individuals with autism. He is 8

years old. I have had a lot of time to come to terms with this. Even

so, the frustration of dealing with autism is nearly eclipsed by the

frustration and the lack of concrete information about this disorder.

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Autism used to be considered rare, the kind of thing you see in

movies or read about in books, but it never actually happened to

anyone you knew. In January of this year, the Autism Society of

America estimated that autism had increased from 15 out of every

10,000 individuals to 1 in 500. And the repercussions of this increase are so far-reaching.

These children will need specialized education and appropriate

care for the rest of their lives. Are we honestly ready for this? Are

our schools equipped to handle this increase? This overwhelming

surge in this disorder is not just going to affect individual families.

This is going to impact our community and the entire world in

which we live.

My son is a beautifully colored thread in the fabric of my family.

But even so, 1 in every 500 families should not have to live with

this disorder. And what if these numbers keep increasing?

So here I am today, wearing the only suit that I own, discussing

my son before the legislative arm of the ruling body of the greatest

Nation in the world. Believe me, testifying here today is one of the

most important things I have ever done, and with all due respect

to the tremendous body of work before each of you, I would like to

think that it is a very important day for you as well.

Thank you.

Mr. BURTON. Thank you very much, Mr. Curtis.

Mr. Smythe.

[The prepared statement of Mr. Curtis follows:]

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Mr. SMYTHE. Thank you very much, Congressman Burton, Congressman Waxman, and other Members of Congress, for this opportunity to speak here for my son and for the tens of thousands of

autistic children around this country and the millions of people

who are affected by this, literally—parents, brothers and sisters,

aunts and uncles, grandparents, and so on.

I will keep my remarks to 5 minutes, but I would like to make

three points here, and I would like you to write these down.

The first is that living with these children can be hell. They can

destroy your entire home. You cannot keep anything nice around.

They will ruin your rugs. They will jump off the furniture. They

will move the furniture around the room, push it over, break

things, clear counters with one sweep of the arm. And they do all

of these things with no malice whatsoever.

One cannot take them to friends’ homes. One cannot stay overnight at friends’ homes. When one is at a friend’s or a relative’s

home, they will be worse there because it is a strange environment.

The second point is that no one to my knowledge is consistently

measuring acquired autism. And Congressman Waxman, you mentioned that there is no causal connection between autism and vaccines.

Mr. WAXMAN. I did not say that.

Mr. SMYTHE. That there is no measurable causal connection.

Mr. WAXMAN. I said there is a theory, and that theory is still

controversial.

Mr. SMYTHE. Is unproven. And I would suggest to you that we

are now defining autism behaviorally; that certain activity, certain

behaviors on the part of these children cause them to be classified

as autistic, and then, most of the medical community gives up. And

there is a difference between classical autism, a child who is born

autistic, that one knows is autistic, and most doctors have been

trained about autism because that is the way they were born, and

they show up that way; and this late-onset autism that we are seeing, this acquired autism, if you will. There is a tremendous difference, and there may be many different medical causes. But because, in our language, we are not making that distinction, we are

not able to follow medical cures or even medical causation. So that

is an important distinction which I think needs to be made for all

of us and by the NIH.

If you look at the insurance companies, if a child is labeled autistic, they will not cover it. It does not matter what the cause of that

behavior is. If you look at the educational models, if you speak to

the professionals in education, they do not have a distinction to my

knowledge in the way that children who are acquired autistic are

trained, compared with children who are classically autistic, how

they are educated. The end result is that our educational models

are not recognizing that some of these children may in fact just

simply be sick; they may just simply be diseased. As a result, we

are letting them down, and they are going through the educational

system basically being warehoused, without any treatment, either

medically or educationally.

From a financial standpoint, the stresses are huge. When one

has an autistic child, suddenly, a whole new world of potential

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trauma has opened up, and there is very little known on this subject with regard to treatment.

We have followed a number of different treatment programs—auditory integration therapy, vision therapy, speech therapy, occupational therapy, and sensory integration therapy. We have participated in swimming and horseback riding, had CAT-scans, allergy

testing, stool analysis and urine analysis, and all kinds of blood

analysis. What we have noticed is that there is often kind of an

uncaring attitude by the providers of many of these services, that

‘‘Maybe we will find out what is going on.’’ But their house is not

being destroyed. They do not have the motivation or the drive, it

seems, to research this process. But it is very important to research.

Our school system is so overwhelmed that a recent Indianapolis

Star article said that the State of Indiana has now changed the

rules, so that a special education teacher can include anyone who

has a college degree. What kind of special education is that? There

is such a need out there, and the burdens are only going to become

much greater.

The waiting list for Indiana’s Medicaid waiver in order for a parent to get some financial assistance here is 3 years, and as I understand, it is growing—it has to grow—with the increase in the numbers of these children.

The ignorance in the insurance industry is phenomenal. I noticed

that Secretary Shalala and the First Lady spoke about the use of

ritalin in children, and I have heard that 10 to 20 percent of children are now on ritalin. Has it occurred to anyone that there may

very well be and almost certainly is a causal connection that is related between ADD and this increase in autism; that they may be

all part of one spectrum? I suggest that this needs to be looked at.

But we have to make distinctions in language in order to do that.

Mr. BURTON. Mr. Smythe, if you could summarize, please, we

would appreciate it. I know that you have a lot to cover, and we

do appreciate your testimony.

Mr. SMYTHE. Thank you, Congressman.

The bottom line is that there are ways to measure how at least

some of what is now showing up as autistic behavior, seems to be

immune-related is affecting the brain differently from most of us,

how it can be treated and then cured, and how the treatment itself

can be seen to produce results in the return of blood flow to the

brain.

I sincerely request that the members of this panel, the National

Institute of Mental Health, and the Secretary of Health and

Human Services look very carefully into this process and support

the healing of these children—at least the subset which is probably

responsible for this large increase.

Thank you very much.

Mr. BURTON. Thank you, Mr. Smythe. We appreciate you being

here.

Ms. Reynolds.

[The prepared statement of Mr. Smythe follows:]

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Ms. REYNOLDS. Mr. Chairman and Members, my name is Shelley

Reynolds. I live in Baton Rouge, LA with Aidan, my husband of 8

years, and my children, Liam, who is 4, and Mairin, who is 2. I

would like to thank you both for holding this hearing and allowing

me to testify before you today.

I met Aidan in the 10th grade. We were in love with each other

from day one. We dated all through college, and we got married as

soon as we graduated. We had our own house, two cars, two careers, and two dogs. We were living the American dream.

Right after we were married, Hurricane Andrew, one of the most

destructive hurricanes to ever hit the United States, slammed

through Baton Rouge. Sustained winds of 100 miles an hour ripped

off our roof, and 8 days without electricity left us with very little

food or water. We promised each other we would never again be

unprepared for such a disaster.

But 6 years later, hurricane-force winds blew into our home

again. This time, the disaster was the diagnosis of autism for our

first born son Liam. It completely tore our home apart, and the effects have lasted much longer than 8 days. No amount of preparedness can ready you for a storm such as this.

Liam was a normally developing baby until June 27, 1997, when

he received his MMR and Hib vaccines. He did everything he was

supposed to do. He cooed, rolled over, crept, crawled, pulled up and

walked on time. He said ‘‘Mamma,’’ he said ‘‘Daddy,’’ he said ‘‘Love

you.’’ He learned how to sing ‘‘Itsy Bitsy Spider.’’ He played finger

games with us. He loved to interact, and he especially loved to

show off for his grandparents.

We did all the well-baby checkups on time. I breast-fed him until

he was 8 months old. I did not start solid foods until he was 4

months old. We did everything completely by the book.

But when he was 17 months old, shortly after he had received

the shots, he started exhibiting some different behaviors. He was

constantly taking off his shoes; he screamed if we dressed or undressed him; he would stare for hours in front of the television and

would not move if you blocked the view. He could not tolerate playing in the sandbox anymore. He did not want to sing any of his favorite songs; he would cover his ears and scream ‘‘No.’’

We assumed he was just asserting his independence, since he

was almost 2. And somewhere along the way, he developed chronic,

nonspecific diarrhea, sometimes 8 to 10 times a day, and still suffers from that 3 years later.

By April 1998, I realized that Liam was no longer saying

‘‘Mamma’’ or ‘‘Daddy’’ or ‘‘Love you,’’ so I took him for a speech and

language evaluation. They told me that my 27-month-old child had

the language capacity of an 8-month-old. This was a child who only

months before would chime in ‘‘Ee-i-ee-i-o’’ at the appropriate moment when singing ‘‘Old MacDonald.’’

What had happened to our beautiful baby boy, and how could we

help him? My husband and I decided to become advocates and

work for increased funding for autism research and awareness. The

answers may not come in time to help our son, but we are hopeful

that we can persuade you to see the need for intensive research regarding this disorder which is affecting more and more children

every year.

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In Liam’s case, we have no doubt that he developed his autism

as a direct result of an adverse vaccine reaction. And personally,

if I could strike the belief that my son’s autism sprang from a routine childhood vaccination, that I held him down on the table for

and had to go back to the Russian roulette of genetics, I would take

it in a heartbeat, because the pain of knowing that I inadvertently

caused him harm due to blind trust in the medical community, or

a matter of inconvenience of yet another office visit taking time

away from my job is nearly unbearable.

Many in the medical community continue to dismiss this as mere

happenstance because autism often coincides with the time of vaccination, and state that there is no scientific evidence to back this

up. My question to you is: How long does it take for a coincidence

to surface time and time and time again, case after case after case,

before it can become a viable hypothesis, especially when the solution to solving the problem seems so apparent? How can pharmaceutical companies concoct substances with mercury, formaldehyde,

antifreeze, lead, aluminum, aborted fetal tissue and live viruses

and not expect that as they continue to pour these highly toxic and

reactive substances into children, increasing dose after dose, all on

the same day, that it will not alter their minds and bodies?

Why would it be so completely impossible for a child to contract

a chronic form of the disease rather than to have the ‘‘proper

immunologic response,’’ especially if their immune systems are not

up to par? And where is their scientific evidence to back up the

claim that this cannot happen, when it is published in the very

package inserts, in their writing, that they have not studied the effects of these vaccines for more than a few weeks, or longer than

the incubation of this disease itself?

What happens when you give multiple doses in 1 day or combine

different diseases into one hypodermic needle?

I need someone to explain to me why it is acceptable to have

products on the market that exposed my son to 37.5 micrograms

of mercury in 1 day at a time when he should not have been exposed to more than .59 micrograms of mercury given his body

weight. I should not be exposed to more than 5 micrograms, and

I have 31 years of an immune history behind me. It is completely

unacceptable. One size does not fit all when it comes to vaccines.

Through our organization, Unlocking Autism, we have talked

with thousands and thousands of parents from across the country,

and their story is the same: Child is normal; child gets vaccine;

child disappears within days or weeks into the abyss of autism.

If you doubt me, I invite you to come to the ‘‘Hear Their Silence’’

rally on April 8th on the Mall, where the ‘‘Open Your Eyes’’ project

will be displayed and view the thousands of pictures that we have

called and realize that 47 percent of those people who participated

believe that vaccines contributed in some way to the development

of their child’s autism.

Parents like me are relying on you to demand that the pharmaceutical companies retrace their steps once again and that the public health community look at the possibility that these things might

indeed not just be a coincidence. They obviously have a forced market. They manufacture products that are required for every child

in this country. We fear that it is possible that while seeking greatVerDate 11-MAY-2000 09:13 Feb 26, 2001 Jkt 000000 PO 00000 Frm 00076 Fmt 6633 Sfmt 6633 C:\DOCS\69622.TXT HGOVREF1 PsN: HGOVREF1
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er monetary profits, there may be some who have lost sight of the

medical community’s original goal regarding vaccinations—to protect children from harm.

I know my children, and I know what happened to my son. As

far as I am concerned, the needle that silently slipped into my

baby’s leg that day became the shot heard around the world.

Thank you.

Mr. BURTON. Thank you, Ms. Reynolds.

Ms. Smith.

[The prepared statement of Ms. Reynolds follows:]

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Ms. SMITH. Mr. Chairman and Members, I am Jeana Smith. I

live in Denham Springs, LA with my husband Darrell and our four

small children—5-year-old genetically identical twins, Jesse and

Jacob, 3-year-old Garrett, and 16-month-old Julianna.

Darrell and I have always loved children, and we tried for over

6 years to have a child. We simply gave up on the idea that it was

possible, and then I discovered I was pregnant with not one but

two babies. I was completely overwhelmed.

Perhaps because I had tried so hard to have a child, I took especially good care of my body while I was pregnant with the twins.

Our identical twins were born right on time and were completely

healthy. We were absolutely thrilled. Our family was perfect.

One month later, we found dark blood mixed in with Jacob’s diarrhea. Jacob had never had diarrhea before. We immediately took

him to the doctor, who assured us that there was no problem. He

mentioned that in the chaos that generally follows the birth of

twins, we had been released from the hospital without them receiving their hepatitis B vaccine and wanted to give it to Jacob that

day.

I questioned him, because it did not seem right to give a potentially ill child a vaccine, but he convinced me that it was routine

and safe and not to worry.

Two months later, Jacob received his second hepatitis B vaccine

and Jesse his first. On the same day, Jacob and Jesse both received

their first DPT, polio, and Hib vaccination. From that day on,

Jacob was constantly coming down with one ear, respiratory, or

sinus infection after another. Jacob was constantly on antibiotics.

As his mother, I was heartbroken to see him sick or in pain practically all the time. As a new mom, I was embarrassed and frustrated to have a child who was always ill. I knew I was doing everything I could for him, and I could not understand why he was

constantly ill.

Jacob met every developmental milestone that first year, right

along with Jesse. They were two little peas in a pod and went everywhere together. At only 16 months of age, Jacob and Jesse received their first MMR vaccine. On this same day, they also received their fourth DPT, their fourth Hib, and their third hepatitis

B. The following 24 hours, both twins slept most of the time, with

over 100-degree temperatures, in spite of receiving the recommended Tylenol dosage every 6 hours. Immediately following

that, Jacob began exhibiting strange behaviors. He was no longer

excited or responsive when Daddy would come home from work. He

began to become preoccupied with certain toys. He would spend

long periods of time studying the way their wheels would spin or

whether or not they were lined up just right. Any attempt to interrupt or distract him was met with great resistance and an eventual

fit. During this time, Jesse continued to progress, starting to talk

and interact with all the children around him.

Back to the doctor we went again, but this time with even bigger

concerns about the growing developmental difference between Jesse

and Jacob. And once again we were met with the ‘‘dominant twin’’

theory, that Jacob would probably be more quiet, Jacob would probably want to play by himself more often, and Jacob is fine, stop

worrying.

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Finally, we would not stand the undeniable difference between

their language and communication skills. Something was most definitely wrong with Jacob. He could not express even the most simplest needs or wants. He could not ask for juice or something to

eat. Jesse was chattering constantly. And at times, Jacob was so

withdrawn that we could absolutely not reach him.

On days when Jacob is overloaded from sounds, colors, or lights,

we cannot go anywhere. Autism not only isolates the individual

whom it affects; it isolates the entire family. My husband and I

have to go to the grocery store independently. When our other children have programs at school or birthday parties, one of us has to

stay home, because Jacob cannot stand the outside stimulation.

Our vacations have changed to only being able to go to the beach— no amusement parks, no baseball games, no family outings.

Unlike most parents of an autistic child, I do not have to wonder

what Jacob would have been like. I know what he would have been

like. I see what he would have been like every day in Jesse’s eyes.

I see Jesse excelling in school and in social activities. I see Jesse

excited about T-ball; I know that Jacob will probably never play Tball and that he cannot attend birthday parties.

For us, there is no denying that in Jacob’s case of autism, the

answer does not lie in genetics, but in a catalyst. The thousands

of hours of research that we have spent searching and retracing his

regression continue to point to the fact that the road of Jacob’s autism began when his immune system was damaged by the hepatitis

B vaccine he received when he was ill. The final blow was the adverse reaction to the host of vaccines he received 16 months later.

We are certain that for Jacob, the catalyst was his vaccine.

I cannot bear the thought that after waiting so long and being

so careful carrying my twins, I was so easily persuaded to immunize Jacob without knowing all that I should. I should have taken

the time to find out what his risk of contracting hepatitis B at only

1 month old was. I did not do that. I should have found out about

all the toxic metals that are used to manufacture the vaccines. I

did not do that. I should have known back then what I do today.

I did not. I trusted his pediatrician. I trusted the CDC. I was persuaded to believe that I was doing the best thing I could to protect

my child.

No scientist, doctor, researcher or parent looking for answers or

resources should never have to question where the funding will

come from. It has to be here, and it has to be here now. I implore

you to act now. Please—we do not have the time to wait for another hearing and another panel of parents and experts to advise

us that this epidemic is waiting in the wings. We are swiftly and

silently losing a generation of children to this disease that possibly

could have been avoided. Please let this country be the leader in

seeing the percentages of autism decrease and not increase.

Every night, Darrell and I tuck two beautiful little boys into bed.

On the outside, they look the same. Their pajamas are the same;

their bed covers are the same. Everything on them is the same.

They have the same ears, and they have matching toes. As Darrell

and I sit in between their beds, we talk to Jesse about his day. He

gives us all the details of his day at school and tells us everything

he did with his friends. He talks about how excited he is for the

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next birthday party that will come this weekend. He talks to Darrell about working on his batting swing to prepare for T-ball in the

summer.

As he drifts off to sleep, we turn and look at Jacob. We know

that even at only 5 years old, Jacob will never be able to enjoy the

simple pleasures of childhood the way Jesse does. He will never be

on a sports team. He cannot enjoy the fulfillment of a birthday

party or friends. This difference is real. We know that Jacob’s autism will not go away.

When they fall asleep, we once again see two beautiful, matching

faces. We know what should have been. It is the only time that

their faces match. Even though they are identical, Jacob’s countenance left when he was 16 months old. The light behind his eyes

was replaced with a blank, lost, bewildered stare.

Thank you.

Mr. BURTON. Thank you, Ms. Smith.

[The prepared statement of Ms. Smith follows:]

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Mr. BONO. Before I begin, I would like to give you the perspective

of an autistic parent.

Right now, I am more nervous about where my son is, because

I do not see him, than I am about being before you today. That is

a constant worry in the mind of a parent of an autistic child.

My name is Scott Bono, and I live in Durham, NC with my wife

Laura and my children, Dylan, Ashley, and Jackson. I have read

the testimony and heard the stories of other parents in similar circumstances—change that to ‘‘identical circumstances.’’ Our story is

not much different.

We had a perfectly normal pregnancy and birth of our son. In the

first 16 months of life, he learned language, played with toys, appropriately began pretending skills, initiated contact with his twin

sisters, and could light up a room with his wonderful personality.

He was brighter than most, and he could even tell the difference

between a Concord jet and a 727 at such an early age.

On August 9, 1990, Jackson would begin a journey into silence,

bewilderment, and a medical enigma. That was the day he received

his MMR immunization. He would not sleep that night. In the days

to follow, he would develop unexplained rashes and horrible constipation and diarrhea. After eating, he would experience projectile

vomiting that would scare him.

His normally very healthy body was being ravaged by an invader. Over the next weeks, he would slip away, unable to listen

or speak. He retreated into what we now know as autism. He became allergic to everything in his world. His immune markers skyrocketed.

What was the reason for this change? It is my sincerest believe

that it was that shot.

The single biggest challenge in raising an autistic child is getting

appropriate, informed, and competent medical services. As I sit before you today, autism is, as it has been for decades, viewed as a

psychological disorder. I cannot help but wonder about and get

frustrated by the lack of medical and physiological intervention for

all of these children.

I live just 3 miles from Duke University Medical Center, yet for

one of the most effective treatments for Jackson’s gastrointestinal

problems, I drive 12 hours for a procedure that takes 5 minutes.

I have been doing this for the past 21⁄2 years and will be making

this trip 13 times this year alone.

To dismiss Jackson’s acidic diarrhea for 7 years because ‘‘autistic

children sometimes do that’’ is just what happened. That is just unacceptable. As my son’s advocate, I know that he is not receiving

the medical treatment he needs, and I believe that as long as autism is regarded as a psychological disorder, this will always be the

case. We need and seek responsible, effective and caring physicians

who do not dismiss the patient’s ailments as ‘‘behaviors,’’ but look

at them as treatable medical conditions with appropriate medical

intervention.

This is what I believe to be the single biggest problem in getting

group insurers to pay for medical services. Insurers must pay according to their contract. It is the law. But if a doctor says the visit

to his office is for the treatment of autism when the autistic child

is being seen for gastrointestinal distress, the insurer will not pay

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the claim. If, however, the diagnostic code for the visit shows that

it is for gastrointestinal distress, the bill will be paid. The diagnosis of autism is used as a shield by some insurers to deflect the

responsibility of paying for medical and remedial treatment for

these children’s medical problems.

The expenses of seeing Jackson’s needs are overwhelming—hundreds of thousands of dollars over the past 8 years. After going

through all of our savings and retirement, we continue to accumulate debt to meet his educational and therapeutic needs and his

medical needs.

Our priority right now is to get him well. There are other costs

besides financial. Jackson is on a very strict diet that takes time

and money. If he eats offending foods, he gets a rash, has diarrhea,

and we will not sleep for the next 5 nights. His behaviors will worsen.

How do I put a cost on not sleeping for 6 years? How do I put

a cost on attention not paid to my daughters because I am seeing

to the needs of my son? How do I put a cost on locking every door

and window at all times for fear of him wandering out of the

house?

Financial burden is only part of it. It is only part of the picture

that families with autistic children face. If the price of eradicating

measles, mumps, rubella, or any other illness is thousands of autistic children or health-impaired children, is it worth it? Have we

simply traded acute illness for chronic disease? Is that worth the

price?

Autism has reached epidemic proportions, and the numbers are

still growing. We must allocate funds to find the cause and the

cure. The U.S. Department of Education indicates the increase in

autism is 900 percent in the 8 years since 1992. If tooth decay went

up 900 percent, we would be scrambling for answers.

The statistics can no longer be ignored. Thousands of parents

who claim their children were developing normally until the MMR

vaccine should no longer be ignored. We all cannot be wrong.

As elected officials, you hold the public trust, the essence of faith

in Government. Your challenge is to uphold that trust.

Thank you.

Mr. BURTON. Thank you very much, Mr. Bono.

Dr. Dankner.

[The prepared statement of Mr. Bono follows:]

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Dr. DANKNER. Honored committee members, fellow panel participants and members of the audience, I feel privileged today to appear before this committee to share my perspectives on autism,

foremost as a parent but also from the additional perspectives as

a pediatric infectious disease specialist and a scientist engaged in

clinical research and evidence-based medicine.

My daughter Natalie, who is over there, is now nearly 13 years

old, has autism, and has taught my family and me a lot about ourselves and how the world around us deals with individuals who appear different from the norm. She has been both a joy and a real

challenge to live with, and we continue to live through these experiences every day, and I want to emphasize that.

We have weathered this storm by rejoicing in her triumphs and

finding humor in past events, even when those events may have

seemed unbearable at that time. And I should add that my wife,

unfortunately, is the one who has to bear most of these unpleasant

experiences.

We have found that our daughter’s greatest needs have been in

the area of education and for a highly structured environment to

allow her some control over the events of her life. It is in the area

of education that we have experienced our greatest challenge and

have been labeled by our local school district administrators as the

most difficult parents they have had to deal with. In the context

of that meeting, we found this statement an insult, and there were

other personal comments made to my wife that essentially have

put her in a position where she will not talk to the school district

administrators any longer.

But we have been convinced by our friends and family that we

should wear this as a badge of honor. If anything, it highlights the

advocacy that we have championed for our daughter’s right to an

appropriate education that addresses her individual needs and the

manner in which she learns best. I should point out that probably

every parent on this panel is his or her own child’s best advocate.

My greatest hope today is that members of this committee and

the audience will gain a better understanding of the unique nature

of autism, the challenges and demands placed upon families caring

for autistic children and adults, the significant emotional, financial,

and community resources required to prepare and involve these individuals in everyday life, and to accept and respect these individuals for who they are.

However, as previously mentioned, I also come to this committee

as a trained infectious disease specialist and clinical scientist and,

therefore, feel compelled to comment on two other areas of importance to me. In the area of medical and other treatments intended

to help autistic children function to the best of their ability, I would

hope to see more funding to allow for appropriately controlled and

conducted studies to rapidly determine the true effectiveness of

these interventions so that families can make informed decisions

regarding the best use of their limited resources, as we have heard

from a number of the panel participants already. Without these

studies, I and other parents of autistic children are forced to make

decisions which may at times prove disadvantageous to all involved, without the benefits of real data.

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I would also wish to comment on the current concerns regarding

the potential causes for the perceived increase in autism. I implore

the committee to be cautious in its statements and conclusions with

regard to possible links to environmental factors and medical factors, especially immunizations. Recognizing that there are other

parents on this panel who may feel otherwise—in fact, definitively

feel otherwise—as a pediatric infectious disease specialist, I have

seen no sound evidence linking autism to the MMR or any other

vaccine, yet there is considerable evidence proving that the MMR

vaccine is safe and highly effective in protecting children from serious diseases.

In closure, no matter what conclusions are formed today or

where the activities of these hearings may lead, I would like to

share an axiom of medicine I have learned, practice daily, and continue to teach to future doctors: Above all, do no harm.

Thank you.

Mr. BURTON. Thank you, Dr. Dankner.

[The prepared statement of Dr. Dankner follows:]

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Mr. BURTON. First of all, I’ll start with you, Dr. Dankner. Your

daughter—whom I see sitting over there and is a lovely young

lady—acquired her autistic condition—was this from birth?

Dr. DANKNER. No. She had the typical description that has been

more commonly described of showing behaviors that became more

and more obvious from about 14 to 18 months of age.

Mr. BURTON. When she was 14 months or thereabouts, did she

receive any shots?

Dr. DANKNER. She received the normal vaccine schedule of immunizations as recommended by the American Academic of Pediatrics and the—— Mr. BURTON. What shots were those?

Dr. DANKNER. She received her MMR at about 151⁄2 months of

age.

Mr. BURTON. And when did she manifest or change?

Dr. DANKNER. She was manifesting subtle changes before that.

It was obvious to us; we just did not know what to attribute it to

at that time or what the issues were. We used to joke that compared to our older son, she seemed to be on an ‘‘independent study

program.’’ Mr. BURTON. Did she receive any other shots when you started

seeing the manifestation of autism?

Dr. DANKNER. She had received her previous shots at about 6

months of age.

Mr. BURTON. And had she received any others close to the time

she started developing autism?

Dr. DANKNER. Not at that time, no.

Mr. BURTON. There were no other shots?

Dr. DANKNER. No, because at 12 months, essentially, you just get

your PPD to screen for tuberculosis, which in California is potentially prevalent.

Mr. BURTON. When she started manifesting these signs, did she

get worse after the MMR shot, or did it have any effect at all?

Dr. DANKNER. We did not notice any difference in her behavior;

in fact, she got her second dose of MMR at about 5 years of age,

and there was definitively no change in her behavior after that.

She pretty much continued on in her mode of autistic behavior that

required, in our opinion, a definitive educational approach to address her needs.

Mr. BURTON. Thank you, Doctor.

Mr. Bono, when did your child start manifesting signs of autism?

Mr. BONO. Within about 30 days of the MMR.

Mr. BURTON. So when did——

Mr. BONO. Quite honestly, when my wife had said, ‘‘Don’t you

see?’’ I think mothers have a much keener sense of behaviors with

their infants.

Mr. BURTON. I understand, but what I am trying to find out is

she received the MMR shot, and you and your wife started noticing

a change—— Mr. BONO. Indeed; exactly.

Mr. BURTON [continuing]. In 30 days, you said?

Mr. BONO. Well, within hours of the shot, we went home, and

there was no sleeping that night, and he had rashes on his

body——

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Mr. BURTON. And it got progressively worse?

Mr. BONO [continuing]. And over the next week, there were gastrointestinal problems, and finally, full blown behaviors that were

odd.

Mr. BURTON. And how old was your child when that started?

Mr. BONO. I think it was right at 16 months.

Mr. BURTON. Sixteen months.

Ms. Smith, when did your child start manifesting a change in behavior?

Ms. SMITH. Well, at 16 months when they received the host of

multiple vaccines, including the—— Mr. BURTON. Which were what? What were all those shots?

Ms. SMITH. The DPT, the Hib—it was their fourth DPT, their

fourth Hib, their third hepatitis B, and their first MMR on that

day—they came home, they slept for 24 hours, most of that time,

did not eat a whole lot, long periods of sleep, had over 100-degree

temperatures in spite of giving them Tylenol before the vaccine and

during the entire 24 hours.

After that time, I figured, well, Jacob is sick again, because he

was just kind of out of it and did not seem real interested in

much—— Mr. BURTON. But this was at about 16 months—— Ms. SMITH. Right, right.

Mr. BURTON [continuing]. That you started seeing the manifest

change in the child with autism.

Ms. SMITH. Right. And when we did go to the pediatrician, they

just passed it off as his asserting his independence.

Mr. BURTON. OK.

Ms. Reynolds.

Ms. REYNOLDS. Liam got his shot on June 27, 1997. That is when

he got his MMR and his Hib. That was the day before he turned

17 months old. A week later, I went to visit my parents in Maryville, TN for July 4th, and we started seeing some very strange, different behaviors showing up then. He would not come when we

called his name. He was doing weird pattern movements up

against the wall—but it was within a week.

Mr. BURTON. So it was right after he received the MMR shot.

Ms. REYNOLDS. Yes, sir.

Mr. BURTON. OK.

Mr. Smythe.

Mr. SMYTHE. At about 20 months, our son—I included in the

record his vaccine schedule and my other children’s, and interestingly, he was given hepatitis B the day he was born and then received the other two shots, one of them 30 days later, and another

about 8 months later. He received 12 vaccines in the first 6

months, as the record shows, as compared to our other children

who did not, in fact, receive the hepatitis B until a year after he

received his third shot.

Mr. BURTON. When did he start—— Mr. SMYTHE. Right after the MMR, at 20 months.

Mr. BURTON. At 20 months, right after the MMR.

So you four people right here are all in concert that right after

the MMR shot, you started seeing the manifest change in your children. Is that correct?

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Ms. SMITH. Yes.

Mr. SMYTHE. Yes.

Ms. REYNOLDS. Yes.

Mr. BONO. Yes.

Mr. BURTON. And your child, Mr. Curtis?

Mr. CURTIS. I guess I have to be the dissenting opinion on this

end of the table. I do not really remember the specific day of Morgan’s MMR shots or any of his immunizations. He did not really

exhibit any behaviors—it was not anything that he did—it was

what he never did. It was the fact that he never talked. And again,

as I mentioned, it was a very gradual process. I think his idiosyncratic behaviors of lining up his toys and the self-stimulatory behavior, the flapping of the hands, the spinning, all really started

after he was 2 years old. It seemed like once we had a word for

it, then it almost got worse.

We have thought about this a lot, because this is a very common

theory. You read about it on the net, and you talk with other parents, and my wife and I have both discussed it at length, and we

really do not see any correlation between the time of his immunizations and the onset of any specific or more intense behaviors.

Mr. BURTON. OK. My last question, then, would be did you notice

shortly after his birth, as he was progressing, some problems then?

Mr. CURTIS. I think, yes. The reason I say ‘‘I think’’ is because

we wanted to believe that he was a late talker, a late developer.

The only thing we noticed was that he was not speaking and that

he did not seem to react to the things that we did with him—but

otherwise, he was a very normal, happy baby. He played, he

interacted, he made lots of noises. He just never formed words and

almost did not seem to react to our speech.

For a long time, we were very concerned about his hearing, that

maybe he did not hear properly. In fact, when his hearing was tested, in the first test, they said he was deaf, and once they did the

brainstem test that was conclusive, it turned out that his hearing

was absolutely fine; it was just that he was not reacting to sound

or voice.

Mr. BURTON. Thank you, Mr. Curtis, very much.

I want to yield—go ahead.

Mr. SMYTHE. I am sorry. I also noticed that my son was given

the DPT vaccines the same day he was given the MMR. So he got

six vaccines on the same day.

Ms. SMITH. So did mine.

Mr. SMYTHE. Yours did, also? OK.

Mr. BURTON. Thank you.

Mr. Waxman.

Mr. WAXMAN. It takes a lot of courage for all of you to be here,

and I want you to know how much I appreciate it, especially when

you are talking about something personal and painful. And, I know

you are here to try to help us understand what you are going

through so that we can try to find out about autism, and so that

we can spare others from going through what you are going

through.

There is legislation—this committee does not have legislative authority; it has the ability to hold hearings and get information. But

the committee that has legislative jurisdiction, which I am also on,

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is the Commerce Committee, and there, we have a bill, H.R. 3301,

which incorporates legislation by Congressman Greenwood, Congressman Bilirakis. Both Mr. Burton and I are on that bill, and it

would do a lot to research more about the prevalence and ways to

deal with autism. I hope that will give us some of these answers

that we so desperately want.

Dr. Dankner, you are in a unique position. You are the father of

an autistic child, and you are also a pediatrician and an expert on

infectious diseases. But your testimony, is that you do not think

there is sound evidence linking autism to the MMR vaccine. How

can you say that when the other parents have given us evidence

that, in their view, their children developed autism after the vaccine? Isn’t that sound evidence? As a scientist, how do you think

we should consider it, and what do we need to prove that there is

a connection, if there is one?

Dr. DANKNER. One thing is that I am not here to invalidate the

testimony of the other individuals. I know that from their heart,

they feel that these events occurred in relation to a specific time

and place, and it would be wrong for me to make a challenge to

anyone on this panel. This is a personal issue for a number of these

individuals.

However, as a clinical scientist, when we do research—I take

care of HIV-infected children—it is important to identify causal

events so that we do not do, as I mentioned, harm on either side

of the fence of any of these issues. And I think it is important that

if this committee or the scientific world feels that there is not

enough evidence to generate a causal link between vaccinations

and autism or any other disorder, those studies need to be done

and that people then should look at those studies in a critical view,

with appropriate peer review, and all individuals who are purporting one position versus another should be able to stand under the

light of appropriate peer review to ensure that the scientific information is collected appropriately, analyzed appropriately, and discussed in an open forum and not in closed sessions, to ensure that

the best information is provided to everyone so that, again, best decisions can be made by individuals.

I would like to bring a personal perspective as an infectious disease doctor. Unlike the other panel members, I have been on the

other side of the fence and have seen children who have been

harmed by vaccine-preventable diseases. I live close to the border,

where the vaccination rate in Mexico is not the same as in the

United States. I have seen children who have developed congenital

rubella, a lifelong disabling condition. I have seen children die of

measles during a measles epidemic in San Diego 10 years ago, even

with the pretty reasonable vaccine rates for a highly transmissible

disease. I have seen children suffer from pertussis, hospitalized at

significant rates.

That position puts me in a position of being cautious about making any links, because if the vaccine rates fall in the United States,

I can almost guarantee from my own personal experience that

there will be individuals who will suffer on the other side of the

fence, and those are the individuals that this committee usually

does not hear about.

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Mr. WAXMAN. I am not a scientist. I studied science at different

levels of my education, and when I studied science, I was told that

there is a scientific method to try to get answers, and the scientific

method sometimes took a theory or a hypothesis and then tested

it, and you had trials and control groups, and you tried to find out

whether that theory is correct or not. Sometimes, theories turn out

to be widely believed, but then they are discarded. We all studied

the fact that in the past, people did not know about hygiene in connection with hospitals, which used to be among the most dangerous

places to be because of the lack of hygiene.

But you are a scientist—the others on this panel are parents—

but from a scientific method, are you saying the theory is absolutely incorrect, or are you saying that we just do not know enough

to say that it is correct?

Dr. DANKNER. There are other people who will testify today who

I think can probably better answer that. I was asked to come on

the panel both as a parent and as a scientist.

My reading of what has been correlated to date does not appear

to indicate a causal link. I think that debate has not been settled

and probably needs to be, so that we do not continue to move down

avenues that may be less productive in terms of the resources that

are necessary to identify other potential links to autism, what the

needs are in the community, which I can tell you are great——

Mr. WAXMAN. Let me interrupt you because my time is up. Are

you saying to us, in other words, that we should not be alarmed

about vaccinations and have parents refrain from having their kids

vaccinated because of this theory, which, at this point, you do not

think has gone through a scientific evaluation to be established as

scientific fact?

Dr. DANKNER. I think an alarmist view is always of concern. I

am a cautious individual, and I think we just need to be cautious

in how we approach this issue.

Mr. BURTON. Thank you, Mr. Waxman.

Dr. Dankner, I hope that you will have the ability to stay and

hear some of the other scientists’ positions just for your own information.

Dr. DANKNER. I planned on it.

Mr. BURTON. Thank you very much.

Mrs. Morella.

Mrs. MORELLA. Thank you, Mr. Chairman.

I am very moved by the testimony that I have heard and read

today. You are indeed the heroes, and we see you as role models,

and your children are very fortunate to have you as parents. So

thank you for being here.

I think the only question I want to ask is to Mr. Bono. When you

said that you had to travel 12 hours for a 5-minute treatment—I

do not know enough about the background to know what that

treatment is, why you have to travel 12 hours for it, and how you

found out about it.

Mr. BONO. I have to travel 12 hours, but that is deceiving, and

first let me apologize. It is 6 hours up and 6 hours back in 1 day,

so it is 12 hours.

Mrs. MORELLA. It is significant.

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Mr. BONO. I have to travel because the treatment is not recognized as helping my son, and it is not approved. It is secretin, and

they call it a slow push, or an infusion of sorts. We found that

going up about every 28 days is a real good cycle for Jackson. Without it, he will not have a normal bowel movement; he will have

acidic diarrhea, and he will not digest food properly, he will have

unexplained rashes.

Mrs. MORELLA. Who advised you that this would help him in

that area? Is there another doctor who made the suggestion?

Mr. BONO. At the press conference, one of the doctors said that

the parents have really been the ones in the forefront of finding

treatment options for their children, and this was a parent, too.

Her name is Victoria Beck, and she serendipitously discovered secretin working for her child as the result of an endoscopy.

Laura and I had always thought there was some connection between the gut and the brain that needed to be bridged, and when

we heard about Victoria’s experience, we were rather fascinated,

and we began to read about it, and that is how we arrived at that

treatment.

Mrs. MORELLA. Dr. Dankner, I just want to briefly ask you—it

is your daughter who is autistic, but in general, as I mentioned in

my opening statement, there is a prevalence among males with regard to autism—are there some unique challenges that you face

with a female rather than a male with autism?

Dr. DANKNER. Oh, yes, and those challenges are becoming more

apparent now that she has achieved puberty. Luckily, she responds

very well to sequenced pictures. One of the social stories that was

provided to her through her school at my wife’s insistence—and I

have to admit that she has taken the forefront on this—is how to

deal with menstruation. If you allow our daughter to do her own

thing, she gets into a pattern, and that pattern becomes very difficult to break. And we have several holes in our wall for which we

could probably pay a drywall person a pretty sum of money to repair when she gets mad at things, she will kick holes here and

there. Luckily, we are having a room addition put on very soon, so

that will take care of the last patch jobs that we did. That is one

issue that came up.

Another issue that my wife and I feel very concerned about is the

risk for her to be sexually abused as she gets older because of her

inability to really indicate or express interactions with other individuals, as a number of the other panel discussants talked about

with older children. Our daughter comes home from school, and

you can ask her how her day went, and she will say ‘‘Fine,’’ but

you will not be able to—unless we are given a set of things that

went on at school, she is not there to carry on small talk; that is

not a major impetus in her life. She will interact with us because

she has needs, and she will seek us out for those, but if left to her

own devices, she will stay in her garage room, watch her TV, whatever video she finds the most appealing that day, and she loves to

play with the reverse and replay buttons on a regular basis.

So, yes, I think there are some special challenges, but I think

there are challenges for males growing up with autism also. There

are things that they are going to have to face as they get older, and

as they get older, I think the challenges become different. And I

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think all of the parents have to deal with the issue of what is going

to happen to their children as they get older, who is going to take

care of them when the parents are beyond an age when they can

no longer take care of these children.

Mrs. MORELLA. The toll on parents is immeasurable, obviously.

Thank you.

Thank you, Mr. Chairman.

Mr. BURTON. Thank you, Mrs. Morella.

Mr. Turner, do you have any questions?

Mr. TURNER. Thank you, Mr. Chairman.

Doctor, I just have one question for you, and I know this hearing

centers on the problem of autism. The chairman has had personal

experience with it in his family, and I know that he has also had

some experience with a granddaughter with the hepatitis B vaccine.

I just wonder—is there any reason to question the age at which

some of these vaccines are administered? I have always had the

feeling that the younger the child, the more fragile, and therefore,

the negative impact, if it be there, the potential is certainly greater

when those vaccines are administered at an early age.

I have, of course, had particular interest in the hepatitis B vaccine which is administered, I think, in most States now at birth,

routinely. In fact, I was in the home of a family in my district this

weekend who have a 2-year-old child who is severely disabled, and

basically, this family spends most of their waking hours tending to

the child, and they strongly suspect that the problem is the result

of a hepatitis B vaccination. That is administered at birth, and I

have been told that there is really no logical argument for trying

to vaccinate a newborn, because the threat of hepatitis B does not

exist at that early an age, but it might be a more appropriate vaccine for later in childhood or approaching the teenage years.

Is there any reason to question the timing of some of these vaccines? One of our witnesses today talked about the large number

of vaccines administered at one time.

Dr. DANKNER. Again, I was not called to the panel, I think, to

give a long explanation of vaccine policy. There are lots of other individuals who have been involved in those policymaking decisions

over the years. But I can give you my perspective once again from

the diseases that we see in these age groups.

Albeit hepatitis B is an uncommon disease process that children

may or may not get exposed to, the more likely exposure is going

to occur when they reach sexual debut, as we call it, when they can

easily be exposed to hepatitis B from a partner. That is one of the

major concerns, and hepatitis B is a major cause of chronic liver

disease in the United States and has reached a rate where vaccination would definitely have an impact on that disease in terms of

its prevention.

The reason for giving some vaccines earlier is just to ensure that

the vaccination gets performed. Rubella is a perfect example. When

congenital rubella was identified in the United States, Australia

and Europe as a devastating disease linked definitively to the acquisition of rubella by mothers who were previously uninfected,

with no previous immunity to rubella, the approach was taken differently by different nations. If you look at the United States, they

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focused on giving the rubella vaccine early in life so that you would

eliminate the pool of individuals who were exposing adults to rubella, whereas England took the approach of trying to vaccinate adolescent females primarily, because they were the, ‘‘at-risk population’’ who could transmit rubella to their unborn fetus. The experience in England was that it took them a lot longer to eliminate

congenital rubella from their population, and the experience in the

United States was an enormous success, because even though you

had women who were susceptible to rubella, they were not being

exposed, and as those children who got the rubella vaccine early in

life aged up into their childbearing years, they were no longer at

risk of developing congenital rubella. The result is that the United

States sees probably about two, four, five cases of congenital rubella a year, and most of those are from individuals who have either

not received vaccination or come from a foreign country where the

vaccine rates are much lower.

Additionally, the hemophilus influenza B vaccine, the vast majority of H-flu meningitis that we see occurred in children less than

24 months of age. If you wait until they are 2 years of age to give

the vaccine, you have missed the peak period. We used to see at

our Children’s Hospital in San Diego 60 to 70 cases of hemophilus

influenza meningitis per year. That is a pretty devastating disease

for most of the children. We see essentially one case about every

2 or 3 years now, and the last case we saw was in a mother who

had her fourth child and just did not get to the doctor to get the

H-flu vaccine.

I think that if you want to ask about the policies, you will need

to talk to the policymakers for their conclusions. I can only give

you my viewpoint from the standpoint of how I see infectious disease and the impact that I have seen in our local community, and

the diseases that I no longer see, which some doctors in practice

now may never see again, I think to the advantage of those particular children who are not suffering from those particular diseases.

To be fair to the other panel participants, I recognize that I am

a physician and I bring certain issues to the table, but I think the

other individuals also have a lot to say that needs to be heard, and

I do not want to monopolize everyone’s time.

Mr. TURNER. I appreciate your comments. I guess the only point

I was trying to make, and perhaps the witnesses on our second

panel will help us with it, is that there are obviously good public

policy reasons to have the vaccines given, but at a minimum, if the

timing of those vaccines could be later in life for children, it seems

that at least we owe the public that information, because particularly in the case of hepatitis B, if the threat of hepatitis B only occurs at the time when the child has the potential of becoming sexually active, it does not make a lot of sense to have a public policy

that says we administer it on the second day of life; and if there

is a risk, I as a parent certainly would not want that vaccine administered to my child at that point in time. People need to have

that information.

Thank you so much, Doctor.

Mr. BURTON. The gentleman’s time has expired.

Mr. TURNER. Thank you, Mr. Chairman.

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Mr. BURTON. Thank you very much, Mr. Turner.

Mr. LaTourette.

Mr. LATOURETTE. Thank you, Mr. Chairman, and thank you, Mr.

Waxman.

I want to thank each of you for sharing your families’ experiences

with us today. Ms. Smith, my wife and I are the parents of 8-yearold twins, and we always said that if the twins had been first, they

would have been last, because raising twins is enough of a challenge all by itself.

I was not going to talk about what my friend from Texas was

talking about, but it always amazed me—and I am not smart

enough to know the connection between vaccines and what brings

you here today—but it always amazed me that after these vaccines,

you would bring your baby home, and he would turn bright red and

have a horrible fever, and they would say, ‘‘Well, you just have to

hang on for a little while, and everything is going to be OK,’’ and

this was a drug which was going to prevent some horrible childhood disease in the future. But why they were being exposed to

these vaccines within the first couple days of being born, or even

the first few months of being born, is something that I do think we

need to get a handle on.

But Ms. Smith, I want to talk to you about a portion of your testimony, and Ms. Reynolds also, because if I understand it, you may

be following similar paths. That is, you have had Jacob screened

and tested for the presence of heavy metals and fungi and other

foreign substances within his system, and he is currently undergoing some nutritional therapy and so on. I wonder if you could

share those experiences with us. And I think it was you, Ms.

Smith, who wrote that the results of that screening were shocking

and that it was amazing—was it you who had Dr. Stephanie

Cave—— Ms. SMITH. Yes. We both——

Mr. LATOURETTE. You both had Dr. Stephanie Cave.

Ms. SMITH. Right.

Mr. LATOURETTE. OK. Then, maybe one at a time or in tandem,

you could tell us a little bit about Dr. Cave’s work and what about

the results of these screenings was shocking, and what sorts of

things now Liam and Jacob are going through that give you hope

and point in the direction that this is a biomedical condition rather

than a neurological condition.

Ms. SMITH. In my case, it is clearly not a genetic issue, considering that they are identical. The other reason I do not feel that it

was a neurological disorder that he was born with is because his

descent into autism happened so rapidly. He was completely with

me, and he descended into autism so rapidly, and to me, that is not

a neurological disorder that he had at birth.

Also, I feel that it was not a neurological disorder that he was

born with because when he was 21⁄2, we had several professionals

recommend that we put him on medications. I do not know what

medications they said, such as Ritalin—I never pursued that avenue, because I felt like medicating a 21⁄2 child was simply not good

enough when I did not know what his body was already doing.

I went to see Dr. Cave, and she ran blood and urine tests and

took stool samples to see what deficiencies he had, the areas that

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he was lacking in, his amino acids and so on. We found that he had

10 food allergies. Because he had been on repeated antibiotics, he

had extremely high—out of 23 fungal and yeast infections, he was

high in 20. He was chromium, zinc, magnesium and copper deficient. He was B5-deficient. So, basically, what we did was we immediately started taking out what was bad and putting back what

was good and taking him off the foods that he was allergic to. And

within 5 days, my son, who had only a couple of words in his language and was very lost, said a full, appropriate sentence and

started speaking again.

So the rapid improvement also shows me that this was not a

neurological disorder in his case.

Mr. LATOURETTE. OK. And Ms. Reynolds, is Liam also undergoing similar therapy?

Ms. REYNOLDS. Yes, he is. When he was diagnosed in May 1998,

we put him on a strict, gluten-free, casein-free diet that Dr. Cave

prescribed, where he was not allowed to eat any of the substances,

because his body was taking those things and actually manufacturing morphine, which was what was making him just sit and stare

and not respond appropriately to things.

Since that time, he has undergone an MRI, EEGs, all the normal

things that they run on autistic children, and those all point to normal things. But when you start doing blood work and stool work

and urinalysis, and they measured for toxic metals in his hair, she

suggested that we give him a medication that would help pull out

the heavy metals that he had been exposed to, and my husband

and I were so gun-shy at this point from dealing with doctors that

we pulled out the PDR and read through it, and we were, like, ‘‘I

do not know, this sounds a little weird to me; I do not think we

are going to try this.’’ And we took Liam to an environmental toxicologist who did some blood work and told us that the shape of

Liam’s blood—he had stippled cells that would be the same as a

plant worker who had had serious toxic heavy metal exposure and

that our son’s blood cells were malformed as a result of heavy

metal exposure that he had received.

We have given him this medication several times. We were able

in December to get a good urine sample, which is a little challenging around our house, and we were finally able to test that. The

normal range—and I am probably going to mess this up—but the

normal range for anything to show up in their bodies is between

zero and six, and his lead and mercury had reduced down to normal ranges, but his levels of tin were completely off the charts.

They were not even measurable. They were up around 250.

Mr. LATOURETTE. Did you say tin?

Ms. REYNOLDS. Tin.

Mr. LATOURETTE. If I could just beg the chairman’s indulgence,

is he likewise receiving, aside from the medication that you are

talking about, a nutritional program?

Ms. REYNOLDS. He receives a number of nutritional supplements

every day. He is on an antifungal medication, because we have

been dealing with a yeast infection that just will not go away for

3 years, that makes him just a real mess. He is just a walking biological nightmare. And he looks as healthy as a horse. He has great

skin, he has great teeth and cheeks. He is a beautiful, beautiful litVerDate 11-MAY-2000 09:13 Feb 26, 2001 Jkt 000000 PO 00000 Frm 00108 Fmt 6633 Sfmt 6633 C:\DOCS\69622.TXT HGOVREF1 PsN: HGOVREF1
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tle boy, but if you take it down to the cellular and the molecular

level, you can see that this child is a total mess.

Mr. LATOURETTE. Thank you very much.

Thank you, Mr. Chairman.

Ms. REYNOLDS. You are welcome.

Mr. BURTON. Thank you very much, Mr. LaTourette.

Ms. Biggert, did you have any questions?

Ms. BIGGERT. No questions, Mr. Chairman.

Mr. BURTON. Well, let me thank this panel. I just want to say

to the four of you who have experienced this change right after the

MMR shot that my daughter is sitting back there, and I and my

daughter experienced exactly the same things that you did, and I

believe what you are saying, and we are going to pursue that as

diligently as possible, because I cannot believe that it is just a coincidence that the shot is given, and within a very short time—he got

nine shots in 1 day, the MMR and DPAT, HIB and oral polio—and

within a matter of just a few days, instead of being the normal

child that we played with and talked to and everything else, he

was running around, banging his head against the wall and flailing

his arms.

When people tell me that that was a genetic problem, I am telling you they are just nuts. That is not the way it was.

With that, I want to thank this panel very much. We will now

go to our next panel.

Thank you very much.

We now welcome our second panel to the witness table. This

panel consists of: Dr. Andrew Wakefield, who came all the way

from merry old England, and we appreciate him being here; Professor John O’Leary, whom I am sure you will notice after he starts

talking is from Ireland; Dr. Vijendra Singh, I appreciate you being

here; Dr. Coleen Boyle, Dr. Paul Offit, and Dr. Brent Taylor.

Would you all please rise and be sworn?

[Witnesses sworn.]

Mr. BURTON. Please have a seat.

Dr. Wakefield, would you like to start this panel?

STATEMENTS OF DR. ANDREW WAKEFIELD, ROYAL FREE AND

UNIVERSITY COLLEGE MEDICAL SCHOOL, LONDON, ENGLAND; DR. JOHN O’LEARY, COOMBE WOMEN’S HOSPITAL,

DUBLIN, IRELAND; VIJENDRA K. SINGH, UTAH STATE UNIVERSITY; COLEEN A. BOYLE, CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND

HUMAN SERVICES, ACCOMPANIED BY DR. BEN SCHWARTZ,

ACTING DIRECTOR, EPIDEMIOLOGY AND SURVEILLANCE DIVISION, CDC; DR. PAUL A. OFFIT, UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE; AND DR. BRENT TAYLOR,

ROYAL FREE AND UNIVERSITY COLLEGE MEDICAL SCHOOL,

LONDON, ENGLAND

Dr. WAKEFIELD. Yes, thank you, Mr. Chairman, members of the

committee. It is a great privilege to be here.

The purpose of my testimony is to report the results of the clinical and scientific investigation of a series of children with autism.

Nothing in this testimony should be construed as anti-vaccine;

rather, I advocate the safest vaccination strategies for the protecVerDate 11-MAY-2000 09:13 Feb 26, 2001 Jkt 000000 PO 00000 Frm 00109 Fmt 6633 Sfmt 6633 C:\DOCS\69622.TXT HGOVREF1 PsN: HGOVREF1
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tion of children and the control of communicable disease. I am also

here on my behalf representing the children who have come to me

for investigation.

I would like you to look at the screen if you would, please, and

I will take you through the presentation.

Next slide, please.

Just as a little bit of background, this represents 12 years of intensive clinical and scientific research, collaborative research, into

the causes and mechanisms of bowel inflammation. I am a gastroenterologist.

The principal authors of this work have contributed to over 1,500

peer-reviewed and published scientific papers and abstracts. Again,

these represent my views.

Next slide, please.

I want to report the results today from the first 60 children that

we have investigated. We have now investigated over 150 children,

and the results that I am going to describe are pertinent to all

those children bar about four.

As far as the range of psychiatric assessments, the great majority

had autism, but there was a spectrum of neuropsychiatric problems

including Asperger’s Syndrome and Attention Deficit Disorder. By

far and away the most important investigation has been direct visualization of the bowel and taking biopsies by the procedure of

ileocolonoscopy. This is a flexible instrument introduced into the

bottom end to take a biopsy.

Next slide, please.

What you have heard this morning is a classical description of

two different types of autism from the parents. You have heard

about the children that we have seen, those who have gone off after

a period of normal development, many of them in the face of multiple vaccine exposures with severe gastrointestinal symptoms.

The other type, described very articulately, was of an insidious

failure to acquire skills at an extremely important point. The essence of what I am going to present today is based upon conventional clinical medicine. It is listening to the patient.

Here is a child who was entirely normal for the first year of life

and went off a week after receiving his MMR vaccine. He is exactly

as the four children were described earlier.

Next slide, please.

The classical features in these children are pain—there is a

radiograph here of the abdomen, and there is fecal impaction.

When these children came to us, the feature was of diarrhea, but

in fact this turned out to be what we call spurious or overflow diarrhea. There was soiling, loss of contents, fastidious eating habits,

reflux and nighttime wakening. They get heartburn, and they wake

up very distressed. These symptoms are the same wherever you go.

If I listen to parents from Canada, from the States, from Europe,

and from Australia, the story is the same.

Next slide, please.

The associated features that we have in these children are of

atopy—asthma, eczema, and hay fever. There are refractory upper

respiratory tract infections. They do not deal well with common

childhood infections, colds, and there is a very high level of autoVerDate 11-MAY-2000 09:13 Feb 26, 2001 Jkt 000000 PO 00000 Frm 00110 Fmt 6633 Sfmt 6633 C:\DOCS\69622.TXT HGOVREF1 PsN: HGOVREF1
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immune disease in the family—thyroid disease, diabetes, for example.

Next slide, please.

This is the insider’s view of the small intestine. The panel on the

top left is of what it should look like in a child. The bottom left

of is lymphoid nodular hyperplasia. There is a swelling of the

lymph glands in the bowel. These are rather like tonsils, and when

they swell, they cause pain and symptoms.

Mr. Waxman asked about the reproducibility. He is absolutely

right. Up on the top right-hand panel, you see a child who was

scoped in the United States with exactly the same symptoms. So

this is reproducible in two different continents. We have compared

it with controls, and the graph on the bottom right shows that even

children who come to us with gastrointestinal symptoms who are

scoped, the finding of lymphoid nodular hyperplasia is relatively

uncommon. In the bar on the left, 85 percent of them show no evidence of it, but virtually all of our autistic children show evidence

of lymphoid hyperplasia, either mild, moderate, or severe.

Next slide, please.

There are histological changes under microscopy which show

there is a definite disease. The top left-hand panel is normal; the

bottom right-hand panel, for example, shows what is called a crypt

abscess, that is, puss in the bowel wall, and this is a feature that

we see in children and adults with ulcerative colitis. There is a

clear and demonstrable, albeit subtle, pathology.

Next slide, please.

A further paper that is due to be published soon has taken this

to one further level and asked is this disease distinct from classical

inflammatory bowel disease, Crohn’s and colitis, or is it something

new. And the data, at least, so far, suggest that it is something

new.

Next slide, please.

We have described this feature in the gut, lymphoid hyperplasia,

and colitis in children with autism. From this same city, from

Georgetown University, Professor Joe Bellanti has described it in

children with attention deficit disorder, coming back to the question, is this a spectrum of disorders which have at their heart some

gastrointestinal abnormality.

Next slide, please.

Lymphoid nodular hyperplasia classically occurs in the presence

of immunodeficiency. We do see it during acute infection, but it is

classically associated with immunodeficiency. Are our children

immunodeficient? As a group, the answer is yes, they are.

This graph just shows you a particular count of a certain type

of immune cell in the blood. The green line is the upper limit for

normal, the red line is the lower limit for normal, and each blue

dot represents a child. You can see that the great majority sit at

or below the lower limit of normal. Not only are they numerically

deficient, their immune system does not respond appropriately to

common recall antigens when compared with normal age-matched

children. In other words, if you give them a skin-prick test for pertussis or diphtheria, they mount no response.

Next slide, please.

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So the key features of the syndrome are developmental regression, ileocolonic lymphoid hyperplasia, swelling of these tonsil tissues, enterocolitis—that means inflammation of the small and

large intestines—and immunodeficiency.

Next slide, please.

So it is a real syndrome, there is a remarkably consistent pattern

of bowel inflammation, and it provides us with vital clues. What

are those clues?

Next slide, please.

The story as told to us and which we have an obligation to report

is that the majority of children regressed following a period of normal development in the face of MMR vaccination. That does not

mean it is the cause of the disease.

We also had two children who regressed after classical measles

infection—one after the monovalent measles vaccine and one after

a rare vasculitic rash. Thirty-six percent of parents could contemporaneously identify no particular environmental hit.

Next slide, please.

Have measles and common childhood infections been linked to

autism before? Is there a reason to go into this and look at it? The

answer is yes, there is. There is a paper that came from the Harvard School of Public Health, and it showed that atypical patterns

of exposure to common childhood infections—measles, mumps,

chicken pox, rubella—were a risk for autism in the child. By ‘‘atypical,’’ I mean maternal exposure when pregnant or neonatal exposure.

What was intriguing about this, which we may come to later, is

that if you were a pregnant mother who was exposed to more than

one of these common infections at the same time, or indeed, an infant child, then your risk of autism was both greater, and the severity of the autism was greater. Question: Was there a compound

effect of more than one infection?

It has also been shown that children born in and around

epidemics of measles and rubella have higher rates of this disease.

Next slide, please.

What about vaccines? There is a paper from the Vaccine Damage

Compensation Board in the United States—acute encephalopathy

followed by permanent brain injury or death associated with further attenuated measles vaccine. What was intriguing in this cohort of children who fulfilled rather strict criteria was that 43 out

of 48 underwent developmental regression as part of their syndrome. So we have this other pattern of exposure to measles as the

further attenuated vaccine children undergoing developmental regression.

Next slide, please.

To summarize, unusual patterns of exposure to common childhood infections are associated with autism and developmental regression.

Next slide, please.

Here is the clue. This is the important image, and here, you see

the insider’s view again—these swollen tonsilar tissues. If you are

looking for an infection, this is where you should be looking.

Next slide, please.

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When you look down the microscope, this is what that swollen

tonsil tissue looks like, and you are looking in the center of that

for the infection. This is a response to a foreign agent, a foreign

antigen, usually an infection. So if you are looking for the cause of

that, that is where you are looking.

Next slide, please.

This is a very high-powered micrograph of a single cell called a

follicular dendritic cell, and this is crucial, because if you are looking for the source of that infection, not only are you looking in that

lymphoid follicle, not only in the center of the lymphoid follicle, but

in this specific cell.

Next slide, please.

When we look in that specific cell using an antibody which picks

up measles protein and only measles protein, we find it in that cell.

We do not find it in other cells or other tissue, we find it in that

cell.

Next slide, please.

You look for other viruses. You ask the question: Is this just a

nonspecific response? Do we find other viruses in there? So you

look for adenovirus, herpes simplex I and II, rubella, mumps, HIV,

and other crucial controls that Mr. Waxman referred to early, and

you do not find them. They are not there.

So at least within the context of this study, this appears to be

specific for measles virus.

Next slide, please.

The next question: Is there an antibody; is there an immune response to the virus in these children? The mere presence does not

make it the cause. Is there an immune response?

We take the autistic children, and we compare them with agematched controls, and we look at measles antibody titers. We also

look at controls of mumps, rubella, and cytomegalur virus, or other

common childhood infections. The only one for which there is a statistically significant difference between the cases and the controls

is for the measles virus.

Next slide, please.

We had failed completely to identify this virus by molecular amplification technology. In my laboratory, we had a reaction that was

sensitive to about 10,000 copies. Anything less, we could not find

it.

The Japanese had succeeded, so we sent nine blood samples from

our children to the Japanese laboratory, and we also sent 21 other

patients. We mixed them up. We did not tell them what they were

getting. They just had a control label. And they identified measles

virus in three of those nine children in the peripheral blood. That

is an intriguing finding. This is consistent with; but not definitely,

vaccine strain. One can only say that this is consistent with, but

there it is, and this was a blinded control study.

Next slide, please.

Very briefly, to finish up, what is the link between the gut and

the brain? This is one of the most difficult things for people to understand. How can the gut influence the brain? I come from a liver

unit where we see patients with chronic liver failure, acute liver

failure, all the time, and one of the classical manifestations of

that—next slide, please—is hepatic encephalopathy. This is where

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the liver is damaged, is diseased, and fails to degrade the chemical

constituents of the bowel that come through. It fails to mop them

up and clear them out; they impact upon the brain. This is largely

reversible. If you are hit with these for long enough, it becomes irreversible.

The question is, therefore—at least we have biologically a plausible hypothesis, a testable hypothesis that elements from the gut,

undegraded chemicals from the gut, including the opiods that were

referred to by Shelley Reynolds, may be getting through, may not

be metabolized, may be impacting upon the rapidly developing

brain during the first few years of life and producing residual cognitive deficit, which we recognize as autism.

Next slide, please.

So finally, in summary, we have an environmental insult in perhaps a genetically susceptible child. The problem is that if you go

to Sweden now, autism affects over 1.2 percent of the pediatric population. So if there is a genetic background, it is clearly widely distributed within the population. We believe that in many children,

clearly, the subset of autistics, it leads to gut infection and damage;

that leads to an ingress, an impaired metabolism, degradation of

these chemicals from the gut which then get through and impact

upon the brain. And the disregulated immune system which measles classically can produce also encourages immune diseases,

atopic diseases, and immuno disregulation.

Thank you, Mr. Chairman.

Mr. BURTON. Thank you, Doctor.

Professor O’Leary.

[The prepared statement of Dr. Wakefield follows:]

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Dr. O’LEARY. Mr. Chairman and members of the committee, the

purpose of my testimony is to report the scientific results in a series of children with autistic enterocolitis that has just been described to you. Nothing in my testimony should or must be construed as anti-vaccine; rather, it encourages safe vaccination strategies. The opinions that I am expressing in the text and in my

presentation are those of my own.

These studies were undertaken following an approach made to

me by Dr. Andrew Wakefield, who has just submitted independent

testimony. The studies represent a transnational, multidisciplinary

research program aimed at elucidating the causes and pathogenesis

of inflammatory bowel diseases in association with developmental

disorders of childhood.

Next slide.

Dr. Wakefield has alluded to measles virus as a potential associated factor in the pathogenesis of autistic enterocolitis, and he

came to our laboratory to seek molecular confirmation.

Next slide, please.

He posed some questions. The first question: Was measles virus

present in gut biopsies from these children?

Next slide, please.

Where was it located? How much was there? Could it be

sequenced—could we actually confirm there was measles virus?

And finally, could different molecular technologies actually independently confirm the presence of measles virus?

May I inform you that I am a pathologist and a molecular biologist. My area of diagnostic expertise is histopathology, which is understanding and examining the cellular basis of disease.

Next slide, please.

The blinded study included 46 cases; 25 children had a diagnosis

of autistic enterocolitis, and 21 controls were included in the study,

including 15 normal children who did not have a developmental

disorder, four children with Crohn’s disease, which is a chronic inflammatory bowel disease condition, and two children with ulcerative colitis, a very similar condition but one which is histologically

different.

We examined terminal ileal biopsies, and from the blocks of tissue that were given to us, we looked at four to six serial sections

on the one case. What we wanted to do was to see if we could identify the virus; could we replicate it on multiple sections from one

patient. Where available, fresh tissue was examined.

Next slide.

The positive control materials in this study were transvected

measles virus-infected viral cells which contained measles virus genome, and measles virus-infected brain tissue. As negative controls,

we screened a panel of other virally infected cells lines.

Next slide.

To confirm the presence of measles virus, we adopt a five-hit

strategy. The first was to localize and identify the presence of measles virus RNA in the tissue sections from these patients.

The second was to quantify using a technology called TaqMan

real-time quantitative PCR. I have worked in this technology for

the last 6 years, and it is approximately 1,000 times more sensitive

than existing PCR-based technologies.

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Finally, we wanted to confirm the sequence of the virus, so we

employed capillary fluorescent-based sequencing.

Next slide.

Let me summarize what in-cell PCR is. I know this is technical,

but I think it is extremely important. Measles virus is an RNA

virus, and RNA when it is removed from the body is extremely easily degradable. PCR basically is like a photocopying reaction. We

can make multiple copies of a particular gene that we are interested in looking for.

In-cell PCR allows us to demonstrate these genetic sequences in

cells and without cells, looking down the microscope.

Next slide.

TaqMan quantitative PCR basically is a revolutionary PCR-based

technology which is sequence detection-specific. You will only get a

positive result in this assay if the desired gene of interest that you

are looking for is present in the tissue section.

Next slide.

In our laboratory, we are one of the few laboratories in the world

that actually perform RNA inhibition assays. This is effectively to

test how degraded the RNA in our samples is, and No. 2, is there

anything in the environment of the laboratory that is contributing

to the breakdown of RNA in tissue samples of cells.

Next slide.

I think it is extremely important in relation to the detection of

low-copy viral infections, and I think our laboratory has a reputation for the detection of low-viral copy numbers, that we have strict

anti-contamination measures. What I mean here is that we do not

want to generate false-positive results.

So we have separate, isolated extraction and PCR areas. This is

in a newly built, custom-designed molecular biology facility. We

have two independent laboratory sites, and for the purpose of this

investigation, we employed in situ hybridization, which is basically

a way of taking a cloned or a fragment of DNA or RNA that you

have in your laboratory and looking for the presence of that in a

tissue section or cell. We can use the technology of in-cell PCR that

I have described, solution phase PCR, and TaqMan PCR, which are

complementary technologies, but TaqMan PCR is 1,000 times more

sensitive than standard solution phase PCR technologies, and then

sequencing.

Next slide, please.

Just to reiterate again the point: Our laboratories go to desperate

lengths, No. 1, to prove that we do not have RNA inhibition, but

second to prove that we do not have contamination. We purposely

in all of our plates set up contamination. This is effectively to

outrule the possible generation of false-positive results.

Again, I would appeal to the non-scientific members of the committee that this is an extremely important control that must be included if you are looking for low-copy viral gene detections.

Next slide, please.

And of course, to confirm the presence of measles virus, the gold

standard is to confirm the sequence of the virus, to say yes, this

is measles virus RNA that we have got in the tissue sections.

Next slide, please.

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Let us look at the results now. We carry out an extensive set of

optimization reactions where we had measles virus clones, looking

at several regions of the measles virus genome, F, N, and H. The

technical detail of this is not important, but just to show you that

we could look at several genes within the measles virus genome,

and we could reproducibly make copies of these or amplify them.

The bottom panel shows you an experiment which allows us to

detect the measles virus in viral cells, showing what the optimal

concentration of the probe that we require to detect the virus is,

and you can see clearly that the optimum concentration is 1 to 1.5

micrograms per ml.

Next slide, please.

This slide shows the results of in-cell PCR by two different technologies. One is in-cell solution phase PCR, the other is in-cell

TaqMan PCR, which produces a green signal in the right-hand

panels, top and bottom. Again it demonstrates that we can clearly

identify measles virus in these transvected cells.

Next slide, please.

This is a patient with subacute sclerosing panencephalitis. Measles virus is the cause of this condition. So of course, if we are to

reliably detect measles virus in biopsies of the children that Dr.

Wakefield provided to us, we should of course be able to identify

measles virus in brain biopsies from patients with SSPE.

The left panel and the middle panel show measles virus presence

in these biopsies, and the right-hand panel is the negative control.

Next slide, please.

This is a case of an autistic child No. 1. You can see the top lefthand panel is a microscopic appearance of what the gut looks

like—and this is not normal gut epithelium from a child; it is heavily inflamed. The bottom left-hand panel show a spidery, black deposit, outer width of the cells that are in green. This is actually

measles virus RNA. The top right-hand panel again in a different

field shows a heavier deposit of black, which again is measles

virus, and again, I need to point out to you that this is outer width

of the cells that are surrounding it.

Measles virus was located in the tonsils, in the lymphoid

hyperplastic areas that Dr. Wakefield described on endoscopy. And

the negative control is absolutely clean.

Next slide, please.

This is another case, a second autistic child, again showing a

very similar findings—a black deposit, which is measles virus, outside of inflammatory cells, associating the fibrillary matrix, and the

negative controls here for mumps are absolutely clean.

Next slide, please.

I think this slide is extremely important. If you look at the lefthand panel, this is measles virus for the nucleocapsid gene. It is

a black signal. It again is the outer width of the cells, but it has

a spidery, cobwebby morphology. There are little processes and tentacles coming out of this region. If you look at the top right-hand

panel, the follicular dendritic cell has processes, dendrites, which

form the cell matrix, which is very, very similar to what we see on

the left-hand panel. And the immunocytic chemical staining analysis which Dr. Wakefield alluded to gives exactly the same results.

Next slide, please.

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By solution phase PCR, by what we call fairly standard laboratory protocols, we can detect the measles virus in gut biopsies from

these children, and the negative controls are appropriately negative.

Next slide, please.

Even in a paraffin-embedded tissue section that has probably

been sitting around in wax for 4 to 5 years, we can detect measles

virus. That is an astounding finding in view of the fact that wax

and fixation by itself breaks down RNA. This graph shows in real

time, we can look at the accumulation of the PCR product that we

are making, confirming that measles virus is actually present in

this biopsy.

Next slide.

And of course, we can sequence it, and we can say that this is

measles virus RNA present in the biopsies of these children.

To do this properly, you need to do it in a forward and negative

strand. I started off by saying that measles virus is an RNA virus.

When we make copies of the RNA virus, we make copies in twostrand forms. So if we are to sequence it, we should sequence in

a forward and reverse strand.

Looking at that electrophoretogram, the sequences in both directions are exactly the same.

Next slide, please.

In summary, then, in terms of the association that Andrew

Wakefield alluded to, I can confirm that his hypothesis is correct— 24 out of 25 children—that is 96 percent of the children’s biopsies

that he sent to my laboratory, blinded—children with autistic

enterocolitis harbor measles virus genomes.

Three out of four patients with Crohn’s disease—these are children with Crohn’s disease—and one out of two children with ulcerative colitis also contain measles virus. That is an interesting biological fact.

Finally, 1 of 15, 6.6 percent, of control children harbored measles

virus genome. I think it does not take greater statistical analysis

to work out that there is a significant difference between 24 out of

25 and 1 out of 15.

Next slide.

Solution phase RT-PCR, which is standard laboratory-based technology, was positive in all children with autistic enterocolitis for

different regions of the measles virus genome. That is extremely

important. And we can sequence measles virus isolates from these

children.

Final slide, please.

However, the infection that is present in these children is at extremely low copy, at about 5 to 30 transcripts per approximately

2,000 cells.

Now, again, I want to add some technical overlay on this. The

way that we quantify RNA in our laboratory is by a method called

copy RNA. Again, we are one of the few laboratories worldwide

that would do this as the most accurate way of actually measuring

RNA. Indeed, industry now is accepting this as a standard way of

quantifying RNA in cells of tissue sections.

Finally, the presence of measles virus was identified by in situ

hybridization, by solution phase PCR, by TaqMan PCR, by in-cell

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PCR, by sequencing. This really, in terms of technology, is as good

as it gets right now.

I hope that I have given you evidence here which is compelling

in relation to the presence of measles virus in children with autistic enterocolitis.

Thank you for your time and attention.

Mr. BURTON. Thank you, Professor, and when we get to the question-and-answer phase, I am sure that we will try to ask questions

in layman’s terms and try to get some answers so that we can understand everything that both you and Dr. Wakefield said—but I

think we got the gist of it.

Dr. Singh.

[The prepared statement of Dr. O’Leary follows:]

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Mr. SINGH. Thank you very much, Mr. Chairman.

I did not realize that I could have shown a couple of slides as

well to make the point much more in layman’s language, but I will

try to explain the results of the research that I am involved in.

It has been nearly 25 years that I have been involved in so-called

childhood diseases, from the immunology side as well as the pediatric neurology side. I was working at Children’s Hospital in Vancouver, Canada, which is where I began my career in childhood diseases, and early on, I saw a few examples of autism mentioned in

congenital rubella syndrome. It was a fascinating observation, because at that time, I was very excited about the research on virus

infections and nervous system disorders. That really led me to kind

of work back and forth between nervous system disorders and virus

infections and immunology.

So the whole thing here is that we need to consider combination

of these disciplines that we talk about. We are not going to be able

to answer any questions as far as I am concerned about nervous

system diseases simply by studying psychology or simply by looking

at the epidemiology data. We need to come together as a team to

focus histories of nervous system, immune system, and whatever

else comes into the picture. That is one major focus of attention

that at least I am taking for my future research.

On autism as an immune disorder, I think I am probably one of

the earlier investigators who started working on the immunity and

autism connection. Followed by that was my theory that

autoimmunity is a very important process in autism. That is partly

because I was studying autoimmunity in nervous system disorders

like multiple sclerosis and Alzheimer’s disease. Quite frankly, some

of my earlier work in Alzheimer’s disease has opened the way, and

today, people are actually using immunology as a platform to design treatment for Alzheimer’s disease.

It was funny to see on the news last night that some doctor has

a new approach; he says he is going to use immunology as a means

of activating the nervous system in order to correct the Alzheimer’s

problem. That is a fascinating stuff, at least to me.

So I started to pay more and more attention to autism, and the

results that I am going to share with you are actually quite unique

to autism. They are part of the nervous system, but they are being

analyzed by the immune system research.

I know there are people, especially who are funded by NIH or by

CDC, who continue to make no mention at all of this so-called immunology research or autoimmunity research in autism. I have

been invited by the NIH panel; I have made two trips to NIH panels. I made a visit to the Institute of Medicine and the National

Academy of Sciences about 11⁄2 or 2 years ago. And if you hear

those people who have been funded by these agencies, when they

go out and present, they do not even mention anything about

autoimmunity in autism. NIH people prepared a document of that

meeting. It was designed for updating the screening and diagnostic

criteria. If you read that document, there is virtually no mention

of this sort of research. To me, this is simply mind-boggling.

Is it because people out there in the scientific community do not

want to buy the argument, or are they just being naive about what

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is already coming out in the way of solid, decent, experimentally

proven research?

Now, having given that background, let me show you some of the

results. First of all, I started looking at autism as an autoimmune

disorder, as I mentioned. And what we have found is over the last

5 or 6 years of research—and I think now, the number of cases I

have studied is approaching about 400 cases—very early on, I

wanted to study the myelination problem in the brain. You will ask

what is myelination. It is one of the most critical events in the

nervous system development. So when a child is actually growing,

this myelination process is very important. It is really more or less

like a mother will feed a child and perhaps nurse in such a way

that this process has to be nurtured very, very carefully.

Having said that, what we are finding is auto-antibodies. Autoantibodies are the hallmark of the autoimmune process. If you

have an autoimmune process, you are going to have auto-antibodies, but if you have those antibodies against an organ which is

affected in a disease—in autism, what would that be—that would

be the brain. So we are finding brain auto-antibodies in autobodies.

What I am trying to illustrate in this chart is that we had a

number of normal children, normal adults, patients with other disorders, Down syndrome, and none of those seemed to show these

auto-antibodies, but on a rare occasion, 1 or 2 percent positive in

the normal or control population.

Here, we have a scientific observation which anybody can go out

there and repeat. I do not think I need to use any difficult thing

to illustrate that point. It is a consistently reproducible result, and

it is happening now in children all over the world. I am getting

specimens from overseas as well, not just the nationwide specimens

alone. So this is a very important thing.

Furthermore, I find that particular protein marker is selective,

because I have now studied two additional markers of the same

structure in the brain, and I do not find these auto-antibodies in

autism.

Let me move on to the next issue. What happens is, assuming

there is an autoimmune process, most autoimmune diseases are

triggered by virus infections. So I started to think about looking at

viruses. I was not thinking of the vaccine issue at all. I was thinking of virus infection. And, quite surprisingly, when I started to do

antibody measurements to viruses which are out there or temporarily associated, what I found was that the measles virus stands

out as statistically significant in terms of its antibodies, significantly much higher in autistic children. So these children have

what is so-called hyperimmune response to the measles virus—not

other viruses. We studied rubella virus, HHV–6 virus,

cytomegalovirus, and none of those three viruses showed this

hyperimmune antibody response.

Furthermore, the important thing is the measles antibodies

which we have now measured by two different methods, and the

result is the same—a statistically significant increase.

The next thing I wanted to see was if anything correlated between these two parameters. Quite strongly, I found that brain

auto-antibody-positive patients also had measles antibody levels

which were very high. So the higher the antibody level to measles

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virus, the higher the chance of brain auto-antibody. It does not

take too much intelligence to make some sense here now.

Over the years, some of these families have been sending me

written notes or telephone calls and so on, and every time I was

going out to make my presentation, people would tell me about the

vaccine connection with autism.

Early on, I was not sure what was happening. So I tried to put

together their own reports, and the report looks like this in the pie

chart. Nearly 53 percent of the families reported that their child

got autism because of MMR. The remaining 30 percent said it was

because of the DPT shot. And about 15 percent—this was a critical

category for two reasons—about 7 percent said they were not sure

whether it was measles or DPT, but the remaining 7 percent had

no history of vaccination connection, or at least they did not make

the connection. I wonder if that 7 or 8 percent category is where

Dr. Dankner’s child might fit in.

The last point I want to make is that of a very recent research

finding of my own, not yet published, but something quite important. About which I showed a slide in my presentation in a meeting

last year which was held in Orlando, FL. This is an observation of

antibodies to measles, mumps, rubella (MMR) itself. I decided to

start with measles, mumps, rubella, because that is the largest

population which was reported to me as being affected by the measles vaccine.

We took the vaccine preparation itself, and we decided to examine antibodies in these children. Normal children do not show any

antibody to a protein that I will point out in a second, but in children with autism, nearly 65 percent of them showed that antibody.

Actually, I can illustrate that point a little more if we just imagine that I am a molecule, or a preparation of measles, mumps, rubella. This protein, this antibody that I am detecting will be something like detecting this coat pin. In other words, antibodies to this

protein which is present in the measles, mumps, rubella vaccine

preparation were found in autistic children, but not in the normal

children. I think this is a very, very important laboratory-based research evidence. If anybody wants to make a criticism of that, of

course, they are at liberty to do so. However, I find this is a scientifically very, very important observation, telling us that perhaps

there is a good connection, there is something happening with this

measles, mumps, rubella vaccine in these children, something is

unusual.

So basically, after having illustrated some of these points, I want

to make a final comment. That is, if you really look at the literature reported on the vaccine adverse reactions, I do not think

you will need a crystal ball to see that vaccines have adverse reactions. The literature is full of those reports. What is not there or

is it has never been reported, or at least, the officials from the CDC

continue not to mention anything about it. What they mention is

that vaccines are good. Every week, you read about it in the newspaper, and you hear about it on the television. And I do not dispute

that information because I know vaccines are very, very important.

My concern as a researcher now, more so than ever before, is that

we must pay attention to the safety of these vaccines. It is missing;

it has not been disclosed publicly, and I do not think it exists in

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the literature, and therefore, I urge the Government Reform Committee to look into particular new policies concerning the vaccine

safety issue.

Thank you very much.

Mr. BURTON. Thank you, Dr. Singh.

Dr. Boyle.

[The prepared statement of Mr. Singh follows:]

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Ms. BOYLE. Good afternoon, Mr. Chairman and members of the

committee. I am Dr. Coleen Boyle, Chief of the Developmental Disabilities Branch at the Centers for Disease Control and Prevention.

I am presenting the agency’s testimony, and I am accompanied by

Dr. Ben Schwartz, who is the Acting Director of the Epidemiology

and Surveillance Division at the National Immunization Program

at CDC.

I am pleased to discuss our work at CDC to prevent developmental disabilities including autism. I want to begin by assuring

the parents that we have heard from today that CDC is concerned

about autism, and that we are working hard to find the causes of

autism and other developmental disabilities so that all children

will have the opportunity to have a healthy and productive future.

Autism is a serious developmental disability which can have profound impact on children and their families. It is characterized by

qualitative impairments in social interactions and communication

and a pattern of restrictive, repetitive, and stereotypic behaviors,

interests, and activities. Autism may require long-term special education and care at a cost of more than $30,000 per year. Costs for

residential care can be $80,000 to $100,000 per year.

CDC’s role in preventing developmental disabilities including autism is to track the disease rates in the population and to identify

causes of this condition. CDC can then establish prevention programs and then evaluate how well these programs work.

We do not know if autism rates are going up. Early studies found

autism rates in the range of 4 to 6 per 10,000 children, using a

narrow set of criteria. More recent studies have reported rates

averaging 12 per 10,000 children, but these studies have used different criteria than the earlier studies.

CDC is not certain how much of the reported increase is due to

changes in the definition of autism or an improved recognition of

this condition over time. We also do not know if other factors have

contributed to the larger numbers of children seeking treatment.

CDC is currently developing ways to better measure autism. In

1998, we added autism to our Metropolitan Atlanta Development

Disabilities Surveillance Program. This program, which also monitors other serious developmental disabilities such as mental retardation and cerebral palsy among school-age children in Atlanta, is

the only community-wide study in the United States. CDC has just

funded Marshall University in West Virginia to start tracking autism in six countries in that State.

At this point, I want to briefly describe our activities in Brick

Township, NJ and in investigating the alleged association between

autism and the MMR vaccination.

In early 1998, the CDC and the Agency for Toxic Substances and

Disease Registry [ATSDR], were contacted by the New Jersey

Health Department, Senator Robert Torricelli, and U.S. Representative Christopher Smith, requesting the CDC investigate autism

rates in Brick Township. They were concerned that the number of

children with autism was too high.

In response, CDC conducted a study of children with autism living in Brick Township during 1998. ATSDR investigated sources of

environmental pollution and exposure routes in Brick Township.

All the data have been collected, and the results are currently unVerDate 11-MAY-2000 09:13 Feb 26, 2001 Jkt 000000 PO 00000 Frm 00153 Fmt 6633 Sfmt 6633 C:\DOCS\69622.TXT HGOVREF1 PsN: HGOVREF1
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dergoing scientific review. Once this review is completed, we will

provide the report first to the parents of the affected children, the

community, and then the local and State health departments. We

would be pleased to brief interested Members or their staffs on the

results of this work at the time we make them available to the

community.

As the committee is aware, a theory links the MMR vaccine and

autism, which has generated public interest and some controversy.

CDC believes that the current scientific evidence does not support

the hypothesis that MMR or any combination of vaccines cause the

development of autism. Initial case series reports have not been

substantiated by more focused reviews or by more in-depth followup research.

It should be pointed out that factors known to be associated with

autism include genetic factors and events that occur before birth.

CDC recognizes how important it is to identify the causes of autism as well as to ensure the safety of vaccines. CDC is currently

undertaking three studies related to autism or about hypotheses

related to vaccines and autism.

First, CDC is using its Autism Surveillance Program in Atlanta

to examine the possibility of a link between the MMR vaccine and

autism.

Second, we are working with the National Institutes of Health to

conduct a study that will evaluate whether vaccination is linked

with developmental regression which occurs in some children with

autism.

Third, CDC is using the Vaccine Safety Datalink, in collaboration

with several HMOs, to study inflammatory bowel disease and the

MMR vaccination.

Through these studies, CDC is working to assure the safety of

the vaccination program and to identify preventable causes of autism.

Mr. Chairman, in the past 4 years, public health has made significant advances in preventing developmental disabilities. Prevention of congenital syphilis and congenital rubella syndrome have

spared lives and prevented disability for thousands of children.

Newborn screening programs have prevented lifelong mental retardation in children with hyperthyroidism and sickle cell disease.

However, given these strides, we still do not know what causes

many developmental disabilities, including autism. While additional scientific research is being completed, it is important to also

consider the broader context of public health, including the vaccination program, which is one of the most successful public health

achievements of the 20th century.

Given the weight of the scientific data and the known seriousness and ongoing risk of vaccine-preventable diseases, in CDC’s

judgment, the best public policy is to continue vaccination unchanged while aggressively working to try to identify causes of developmental disabilities.

CDC agrees with the committee and the parents who have testified today that autism has a significant and profound adverse impact on the lives of children and families and communities where

it occurs. We must track this disorder, we must identify the preVerDate 11-MAY-2000 09:13 Feb 26, 2001 Jkt 000000 PO 00000 Frm 00154 Fmt 6633 Sfmt 6633 C:\DOCS\69622.TXT HGOVREF1 PsN: HGOVREF1
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ventable causes, and we must institute effective prevention programs.

It is my hope that our efforts, combined with those of the NIH

and the academic community, will lead to a way to prevent developmental disabilities of autism, enabling those children to live full

and productive lives.

Thank you, Mr. Chairman and members of the committee.

Mr. BURTON. Thank you, Dr. Boyle.

Dr. Offit.

[The prepared statement of Ms. Boyle follows:]

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Dr. OFFIT. First, I would like to recognize the courage of the parents who have testified her today, as well as the two grandparents

on the committee, including you, Mr. Chairman. As I share my testimony, I also deeply share their feelings and concerns.

My name is Paul Offit. I am pediatrician, and I am also the chief

of infectious diseases and the Henle professor of immunologic and

infectious diseases at the Children’s Hospital of Philadelphia and

the University of Pennsylvania School of Medicine. In addition, I

am a member of the Advisory Committee on Immunization Practices to the CDC. I have 20 years of experience in the areas of virology and immunology.

My role in these proceedings is to explore the theories that have

arisen due to concerns by the public that autism might be caused

by the combination of measles, mumps, and rubella vaccines known

as MMR.

No evidence exists which proves this association. However, three

theories have been used to explain it. In the time that I have been

given, I would like to explain why I think that these theories are

not valid.

The first theory is that children who get the measles vaccine

make an immune response not only to the vaccine, but also to their

own nervous system. This kind of reaction is called autoimmunity.

To understand why this theory is invalid, we must first understand

differences between natural measles infection and measles vaccination.

During natural measles infection, the measles virus reproduces

itself many times in the body and causes disease. In contrast, following measles vaccination, the vaccine virus reproduces itself

much less and does not cause disease. Because more measles proteins are made during natural infection than after immunization,

the immune response to natural infection is greater than the immune response to immunization. If the immune response is greater

after natural infection, then the autoimmune response would also

be greater. If this were the case, then autoimmunity should occur

more frequently after natural infection than after vaccination. Or,

said another way, if measles virus caused autism, then measles

vaccination would lower, not raise, the incidence of autism.

The second theory is that the child’s immune system is simply

overwhelmed by seeing three viruses in a vaccine at the same time.

Some have gone so far as to suggest that it may be of benefit to

divide the MMR vaccine into three separate vaccines. The rationale

behind this theory is that children do not normally encounter such

an assault on their immune system.

From the birth canal and beyond, infants are confronted by a

host of different challenges to their immune system. Their intestines encounter foreign proteins in milk and formula. Their lungs

encounter bacteria inhaled on the surface of dust in the air. And

literally thousands of different bacteria immediately start to live on

the skin as well as on the lining of the nose, throat, and intestines.

Here is how infants deal with this immediate confrontation to

their immune system. Babies have a tremendous capacity to respond to their environment from the minute they are born. The

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ing an immune response to bacteria that live on the surface of their

intestines, babies keep these bacteria from invading their bloodstream and causing serious disease.

Therefore, the combination of the three vaccines contained in

MMR, or even the 10 vaccines given in the first 2 years of life, is

literally a raindrop in the ocean of what infants successfully encounter in their environment every day.

The third theory is that the MMR vaccine is given by an unnatural route. The rationale behind this theory is that children do not

normally encounter viruses or bacteria under their skin or in their

muscles. But infants and children frequently encounter viruses and

bacteria in many places throughout the body. Our species survives

because from the minute we are born, we are capable of meeting

challenges at all sites.

To review, here are the medical facts. First, if autism is a consequence of autoimmunity, the incidence of autism would have decreased, not increased, after vaccination.

Second, children from birth are confronted with and manage an

enormous array of different challenges to their immune system at

the same time.

Third, challenges to their immune system occur by a variety of

routes.

The parents we have heard testify here today are asking a scientific question: Does the MMR vaccine cause autism? Questions of

science are best answered by scientific studies, and the answer to

this question is already available. Dr. Brent Taylor and his coworkers in London have conducted a large, meticulously designed, wellcontrolled study that disproves an association between MMR vaccine and autism. I believe other studies will confirm Dr. Taylor’s

results, because it is important to have confirmatory studies.

What is really at stake here? In the early 1990’s, our immunization rates against measles dropped only about 10 percent. Measles

outbreaks swept across the country. About 11,000 people were hospitalized, and 123 died from measles—died from a disease which is

easily and safely prevented by a vaccine.

My concern, Mr. Chairman, is that parents listening to or reading about this hearing might incorrectly conclude that vaccines

cause autism. This is not the case. Vaccines are extremely safe and

highly effective. I encourage this committee to make that fact clear

to every parent in America.

If, as a result of reading about this hearing, some parents choose

to withhold or delay vaccines for their children, their tragedy could

be profound. If many parents choose to withhold vaccines, the tragedy all across America could be devastating.

Let us proceed cautiously, carefully, and scientifically.

Thank you.

Mr. BURTON. Thank you.

Dr. Taylor.

[The prepared statement of Dr. Offit follows:]

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Dr. TAYLOR. Hello. I am Brent Taylor. I am the professor of community and child health at the Royal Free and University College

School of Medicine and the head of the Department of Pediatrics

and Child Health on the Royal Free campus of University College

London.

I am honored to have the opportunity to testify today. I am here

as a clinical scientist, but I am also a practicing pediatrician. My

clinical work involves children with disabilities including autism.

I know how desperate families can be to understand the cause

of their child’s often devastating condition. I also know that if we

are to avoid families being led astray by false hopes, advances in

understanding and treatment must be based on high-quality and

rigorous science.

Mr. Wakefield and Professor O’Leary’s testimony notwithstanding, the belief that MMR is the cause of autism is a false hope.

I have four main points. We do not fully understand the reasons

why autism has recently increased. We do know that there is no

evidence that immunizations are involved.

Second, there is no evidence that MMR vaccine causes autism.

Third, there is no conspiracy to suppress information about the

side effects of vaccines—completely the reverse. Fourth, because of

poor science, uptake of MMR vaccine has fallen to dangerously low

levels in the United Kingdom, putting children’s lives at risk from

a resurgence of the damaging and occasionally killing of preventable diseases, measles, mumps, and rubella. The same thing could

happen in the United States of America.

If I could have the first overhead, please.

Here are some figures from the United Kingdom. You can see at

the top, in the black closed circles, MMR uptake, which has fallen

from about 90 percent in 1995 to 75 percent in April 1999. There

is almost an exact parallel fall—shown in the open circles—in

mothers’ confidence in the safety of MMR vaccine.

Could we have the next overhead on top of this one, please?

The reason for this loss of confidence relates mainly to two papers produced by Mr. Wakefield and colleagues. The first, which incorrectly related measles vaccine to Crohn’s disease, one form of inflammatory bowel disease, has subsequently been completely undermined. There is no evidence that measles or measles vaccine

play any part in inflammatory bowel disease.

The second arrow shows the timing of a paper produced by Mr.

Wakefield and colleagues describing a small group of inadequately

described children with a range of autism-related disorders.

Following each of these papers, there was a major effect on mothers’ confidence and a resultant further decline in MMR uptake.

I will now discuss the results of an epidemiological study I led

to test Mr. Wakefield’s hypothesis that MMR causes autism. My

two senior colleagues, Dr. Elizabeth Miller and Dr. Patty

Farrington, have submitted testimony to this committee with details of our methods and the background of our study.

We identified all known cases of autism—498 in total—living a

defined area of North London and compared details of the onset

and recognition of their condition with independently collected data

on exactly when they received MMR and other measles-containing

vaccines. The study involved a large amount of work, and we anaVerDate 11-MAY-2000 09:13 Feb 26, 2001 Jkt 000000 PO 00000 Frm 00178 Fmt 6633 Sfmt 6633 C:\DOCS\69622.TXT HGOVREF1 PsN: HGOVREF1
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lyzed the data in considerable depth. There are lots of results

which have been published in the Lancet.

In summary, all of our analyses were negative. We concluded

that MMR vaccine is not causally related to autism. In particular,

we looked at the clustering after MMR of regression where it occurred, the timing of parents’ concern about the child’s development, and the age at diagnosis. There were no significant relationships.

Our results are supported by other studies from Sweden, from

Finland, and from France.

Our particular interest in this hearing is the rise with time we

identified from the late 1970’s to 1992.

Could we have the next overhead, please?

Mr. Wakefield has compared our results with those reported in

California. This is the overhead. It is important to remember that

the authors of the California report clearly stated that theirs was

not incidence data.

The overhead, which is downloaded from the Lancet Web page,

is of rather poor quality, and so is Mr. Wakefield’s content. He has

fiddled with the data regarding the dates of the introduction of autism, and to demonstrate other problems he has with time relationships, it is worthwhile just looking at the bottom line, where it goes

from 1987 to 1960 to 1990. What is actually going on?

I have included two additional arrows, the red arrows, which perhaps more accurately identifies the acceleration in cases in the

rates at which autism is increasing. These, one can see, occurred

at least 2 years before autism was introduced into the United Kingdom and at least 2 years after in California—hardly a convincing

causal relationship.

There is another problem for the MMR theory. Could we have

the next overhead, please?

Here is our data from our study up until 1992, which is what we

published. The rise in autism can be seen there as clearly occurring

long before MMR was introduced, and I must say, contrary to what

Mr. Wakefield and some of the groups he is associated with say,

that we included all cases in our analysis, including those involved

in the MMR Catch-Up Campaign.

After 1992, the numbers fell. We did not include these data in

our analysis because we felt that there might be too many missing

cases not yet diagnosed, and by leaving the left-hand side, it really

gave the hypothesis that MMR causes autism the best chance of

being confirmed.

The parallel line in red is data from two of the larger districts,

and this is important, because we have preliminary data as part

of the further study on the same population to see what has happened. Is autism still going up, or is it flattening out?

What our early results in these two districts show—if we could

have the final overhead—is that rates are going down. There is an

overall increase of numbers, reflecting continuing better recognition

of autism, and immigration. The fall is seen in both studies, suggesting it is a real fall. Cases appear in this population to have

peaked in about 1992, for reasons which are quite unclear.

This finding alone must exclude MMR as a cause of autism.

MMR had a rapid uptake in our population from 1988; then, rates

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plateaued, certainly until 1995, while autism rates were rising and

then falling.

We need more research on autism and its treatment, but Mr.

Chairman and members of the committee, present evidence does

not support a causal relationship between MMR vaccine and autism. As a result of adverse publicity on this topic, many clients in

the UK are now at risk from the dangerous diseases of measles,

mumps, and rubella. I urge this committee to strongly support the

continued MMR program to avoid putting America children’s lives

at risk.

As a result of my work and clear study of the evidence on this

topic, I believe I can say with confidence that MMR vaccine is not

a cause of autism.

[The prepared statement of Dr. Taylor follows:]

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Mr. BURTON. I want to thank the panel. We will now go to our

questions.

Dr. Offit, you talk about collaboration, I guess, with the Merck

Pharmaceutical Co.?

Dr. OFFIT. Yes. As I disclosed in my written report, I have been

in collaboration with Merck and Company on the development of

a rotavirus vaccine since 1992.

Mr. BURTON. Do you do any traveling around, speaking on behalf

of Merck or Merck products?

Dr. OFFIT. I travel and speak about vaccines, and those talks are

supported by unrestricted educational grants from either pharmaceutical companies or from universities.

Mr. BURTON. So they pay for your expenses and that sort of

thing?

Dr. OFFIT. They have an interest in educating physicians about

vaccines, and it is good that they do, because physicians need to

be educated about vaccines.

Mr. BURTON. I understand. And they produce the MMR vaccine,

don’t they?

Dr. OFFIT. Yes, they do, yes.

Mr. BURTON. Thank you.

Dr. Taylor, in your Lancet paper, you omitted to mention the

Catch-Up Campaign. That is the vaccination of children over 1 year

of age when the vaccination was introduced. Yet you appear to

have included these Catch-Up children in your analysis of the stepup hypothesis. So you consider that to be methodologically—do you

think that is a correct analysis?

Dr. TAYLOR. Basically, that statement is not true, Mr. Chairman.

We did include the children involved in the Catch-Up Campaign in

our analysis, as is clearly stated. To suggest otherwise—and I suspect the suggestion comes from Mr. Wakefield—is malicious.

Mr. BURTON. Well, was it included—was it not omitted in the

original paper that you submitted?

Dr. TAYLOR. No. All cases were included who received MMR vaccine. All cases—we will submit additional analysis with all cases

who received any measles-containing vaccine——

Mr. BURTON. Didn’t some of those 36 children receive the MMR

vaccine after the—— Dr. TAYLOR. I think what you are referring to is the reply which

we put to Mr. Wakefield’s criticism of our paper in the Lancet. I

have to say that his is the only criticism of our paper which we

have received on a scientific basis. All other reports have been constructive and supportive.

Mr. BURTON. Well——

Dr. TAYLOR. What we looked for there were the children who had

received MMR vaccine, which we had included in our analysis.

There were 36 such children, and in 29 of them, there was evidence

regarding when the parents became concerned about their child’s

development. In all cases, this was before they received the MMR

vaccine.

Mr. BURTON. We have an epidemiologist in the audience, and—

where is he?

Would you mind coming up? I would like to have you sworn in

real quickly.

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Dr. SPITZER. Yes.

[Witness sworn.]

Mr. BURTON. Thank you.

Can you explain the importance of properly counting these children born before 1988 who were given the Catch-Up vaccines?

STATEMENT OF DR. WALTER O. SPITZER, PROFESSOR EMERITUS OF EPIDEMIOLOGY, MCGILL UNIVERSITY, AND MEMBER, NATIONAL ACADEMY OF SCIENCE OF THE UNITED

STATES, CORPUS CHRISTI, TX

Dr. SPITZER. Well, as implied by Professor—— Mr. WAXMAN. Point of order, Mr. Chairman. Point of order, if you

will suspend your answer to that question. I want to make a point

of order.

Mr. BURTON. The gentleman will state his point of order.

Mr. WAXMAN. The rules of this committee require that ‘‘Witnesses appearing before the committee shall, so far as practicable,

submit written statements at least 24 hours before their appearance, and, when appearing in a nongovernmental capacity, provide

a curriculum vitae and a listing of any Federal Government grants

and contracts received in the previous fiscal year. Identification of

witnesses are to be provided to members of the committee.’’ Suddenly, we have a witness being called forward, and Rule 2

says ‘‘Every member of the committee or the appropriate subcommittee, unless prevented by unusual circumstances, shall be

provided with a memorandum at least 3 calendar days before each

meeting or hearing explaining 1) the purpose of the meeting or the

hearing, 2) the names, titles, background and reason for appearance of any witness. The ranking minority member shall be responsible for providing the same information on witnesses whom the

minority requests.’’ Suddenly, we have a witness being called forward. We have all

of these people testifying, and we have now a witness coming up— I do not know who he is. It just seems to me that this is in violation of the rules.

Mr. BURTON. I think as you were reading there, where there are

‘‘unusual circumstances’’—and I believe you can go back and read

that again—or whenever ‘‘practicable’’ was another term that was

used in there—so the chair—excuse me, let us suspend for one moment. [Pause.]

Mr. WAXMAN. Mr. Chairman, if I might be heard——

Mr. BURTON. No——

Mr. WAXMAN [continuing]. And I am going to withdraw my point

of order—but I do want to say that there are procedures for the

conduct of hearings which provide for opportunities for all points

of view to be expressed. And for a witness to be brought out of the

audience because the witnesses before you did not give you testimony that fit with your preconceived theory seems to me to turn

a congressional hearing more into a circus than a genuine fact-finding opportunity.

But I will not object if you want to call this witness. I do want

to also point out that we have rules on the time allocated to members, and I would insist that that time be observed or that all

members be given the same open-endedness that I see about to

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come in your questioning, because the clock that usually keeps

time for our questioning has been deliberately stopped.

I will not object, but I do think it is inconsistent with the rules

of this committee to bring witnesses out of the audience when you

have a panel here that just testified, with whom we ought to pursue our questions.

Mr. BURTON. The parliamentarian has just informed me that

where there are extenuating circumstances, the chair has the ability to bring a witness forward—and this is not the first time this

has happened.

[Applause.]

Mr. BURTON. That is the first thing. The second thing is that this

is one of the most important hearings I think we have had, because

we are talking about an epidemic of autism that is taking place in

this country, and if there is information that is being given to the

committee that is going to be in the Congressional Record that is

not accurate, it needs to be corrected as quickly as possible so the

American people and people from around the world who may want

to look at the record of this committee have the facts.

Now, if we have an epidemiologist here who has expertise about

a report and can cite that information about this report where

there might be an error, then we ought to correct it right now, instead of waiting until a report is filed, goes out to the American

people, and then try to correct it where there might be a misunderstanding. So—— Mr. WAXMAN. Well, we do have an epidemiologist on this panel,

and perhaps you ought to question her, or this other witness

should have been asked to testify. No one would have objected to

having anybody who had anything pertinent to say to us to have

an opportunity to present what they have to say.

Mr. Chairman, let us proceed, and let us keep the rules on time,

or acknowledge the open-endedness of questions, because we will

have a lot of questions as well.

Mr. BURTON. Dr. Spitzer.

Dr. SPITZER. Very briefly, Congressman Waxman, your points are

well-taken, and I respect them. I will say now to Professor Taylor

that those additional cases in the Catch-Up Campaign may well

have been included in the paper but were not clearly segregated or

identified or enabled peers to evaluate the possible impact of including them or not, so the findings may have been misleading

until we reanalyze them taking that into account.

Moreover, the use of the case series strategy of analysis is unconventional, not accepted by mainstream scientists, and leaves the

paper at best as a hypothesis-generating study and not something

with which he or anyone can categorically say this proves that

there is no relationship. It just shows and emphasizes what he said

himself, that we need to study it further.

So we have a compelling reason to have a blue panel, an international panel, to go back to that data base, look at the raw data,

and be able to come up with a second assessment that is verifiable

by the scientific community and the relevant community.

Thank you, Mr. Waxman, Mr. Chairman.

Mr. BURTON. Thank you very much.

Mr. TIERNEY. Point of order, Mr. Chairman.

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Dr. TAYLOR. Mr. chairman, can I comment on that?

Mr. BURTON. Stop the clock.

The gentleman will state his point of order.

Mr. TIERNEY. Is Mr. Taylor going to be given an opportunity to

respond at this point in time?

Dr. TAYLOR. May I comment?

Mr. TIERNEY. I think it might be helpful to those of us who are

sort of surprised by this new witness. I would like to hear what Mr.

Taylor has to say in response to that. I think it would be educational.

Mr. BURTON. I have no objection to him responding, but I have

some more questions of Dr. Wakefield, so——

Mr. TIERNEY. Well, Mr. Chairman, my point of order is can we

have them nearer in time to each other so we can get the full benefit of it, rather than go back and forth.

Mr. BURTON. I will yield to the gentleman next. He can have the

time next, or Mr. Waxman can, and he can yield to Dr. Taylor.

Dr. Wakefield, would you come back up, please? Dr. Wakefield,

would you clarify the difference of opinion that you have from your

colleague?

Dr. Wakefield. My anxiety, Mr. Chairman, is that if you test a

step-up hypothesis—that is, those children who should be the first

to receive the vaccine at the age of 1 year, born in 1987, because

the vaccine was introduced in the UK in 1988, and therefore they

would have been 1 year old, then the take-off, if there were a relationship between MMR and the vaccine, should have occurred at

that point.

The paper illustrated the point that the take-off occurred before

those born in 1985 and 1986. What took place when the MMR was

introduced was the Catch-Up Campaign, where all children of 1 to

4 years of age were targeted. It was an aggressive campaign—I

know that, because one of the authors on the paper that we published in the Lancet was in charge of that campaign for Hackmey

in Northeast London. If you give the vaccine to children over the

age of 2, then it will cause the take-off to occur before 1987, and

that is exactly what occurred.

Now, at the very least, those cases should have been mentioned,

because the reviewers, in the absence of those data, cannot give a

valid interpretation of the paper when they make a recommendation for it to be published or not, and they should have been excluded from the analysis so we could see how the graph looked

without them, and that did not occur, and that is a major anxiety.

Mr. BURTON. Dr. Taylor, do you want to respond now?

Dr. TAYLOR. It does seem slightly surprising that at one moment,

we are accused of excluding them and therefore that upsets the results, and now we are accused of including them, and that upsets

the results.

I have to say the time relationships, the step-up part of our

paper is the least important part of our findings. The direct findings, the time series analysis, is much more important, which is

the direct evidence that the individual children did not develop

symptoms of autism within various defined periods after they received the MMR vaccine.

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If I could just comment on Dr. Spitzer’s comment, he describes

our analysis as unorthodox. We used the highest standards of epidemiological and statistical analysis in our handling of this data,

and this data has been reviewed by numerous experts, both prior

to publication and since.

Last week, our research was the basis of a detailed debate at the

Royal Statistical Society, where there was no criticism of the statistical techniques that we used, and the conclusions of our paper

were accepted by this very expert group.

The testimony which you received from Dr. Elizabeth Miller, who

is an epidemiologist, and Dr. Patty Farrington, who is an expert

statistician, is tabled for the committee’s consideration.

Mr. BURTON. Would you mind, since there is a strong difference

of opinion between you and Dr. Wakefield, and I presume some

others, providing the data for your study to the committee, the

complete data?

Dr. TAYLOR. I will have to take advice on that from both my colleagues and the others. I would be required to decide whether the

committee is an appropriate body for this information, which was

collected, as you know, by the Medicines Control Agency, which is

a branch of the Department of Health in the UK. In principle, I

have no problem, but in practice, I would need to check—— Mr. BURTON. Well, we would be very happy to write to the Department of Health in the UK and ask that you be able to release

that information to the committee in total so that we could have

somebody who is totally nonbiased, hopefully, on this issue to analyze it.

Dr. TAYLOR. Yes. I think it would need to be done by more than

a selected statistician. If it is to be reanalyzed, it should be reanalyzed by independent individuals—which, of course, is the problem

with much of Mr. Wakefield’s research, that it has never been independently verified. No one anywhere in the world has been able to

reproduce any of his studies, and it seems possible, and it is only

going to be a matter of time before this most recent information is

also found to be inadequate.

Mr. BURTON. Well, my time has expired, but let me just say that

I believe that Dr. Wakefield and Professor O’Leary and others

would be willing to give us the documentation in the study that

they did, and we would like to have yours as well so we can look

at all of that.

Mr. Waxman.

Mr. WAXMAN. Mr. Chairman, because I believe autism is such a

serious problem, I am troubled by this hearing. This hearing was

called and structured to establish a point of view, and it is the

point of view of the chairman. The chairman believes a particular

point of view, and that is the connection between autism and vaccinations.

You can look at it by the first panel, where we had five parents,

all of whom believed the same thing that the chairman believed,

and the way we just had the handling of the questions a minute

ago.

What also bothered me was when we asked that we have the

American Medical Association or the American Public Health Association or the National Network for Immunization Information or

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the former Secretary of HHS, Dr. Louis Sullivan—real experts in

addition to those we have before us—we were told no, they cannot

fit in.

I think hearings like this have a real danger because if you sensationalize the idea that there is a connection between immunization and autism, immunization rates will drop. That is what happened in Great Britain after Dr. Wakefield published his first

study. Immunizations dropped. Autism rates did not drop, but measles rates increased.

I was impressed by the statement that we had a drop of just 10

percent in measles immunizations in 1990, and then we had 11,000

people hospitalized from measles. This can cause brain retardation

and death. We know we can prevent that. Why should we then

scare people about immunizations until we know the facts?

I fear that what we have in this hearing is a sensationalization

by the chairman in order to get all these cameras to report to the

American people that there is this connection because he believes

it, and many other people believe it, and therefore a lot of others

who watch this will think, ‘‘I will not immunize my children.’’ Dr. Wakefield came out with a report in England, and the first

group that examined his claims was the Medical Research Council,

which is the British equivalent of the NIH, and they found no evidence to indicate any link between the MMR vaccine and bowel

disease and autism.

After they did their work, the Chief Medical Officer of the United

Kingdom issued a letter to doctors in 1998, stating, ‘‘Based on the

previous material that I have seen and on the opinion of experts

present at the Medical Research Council, I have concluded there is

no link between measles, measles vaccine, or MMR immunization,’’ etc.

Then, the World Health Organization looked at his study, and

they came up with the following statement: ‘‘Given our view, the

previous scientific claims made by Dr. Wakefield and colleagues

lack scientific credibility, and his present study does not meet the

requirements for establishing such a causal relationship.’’

I do not know whether that is true or not, but that is what the

scientists in England said when they evaluated it, as did Dr. Taylor

when he evaluated Dr. Wakefield’s study.

Now, Dr. Wakefield has testified he has some new information.

Fine. Let us get the new information out there. Let us let the epidemiologists evaluate it. Let us let scientists explore where the

truth may be. But to put this out in a congressional hearing and

scare people from getting immunizations—we know that without

immunizations, dreaded diseases will occur, deaths and mental retardation and disability will occur among our children, and we can

prevent that.

What we do not know, and we have a lot of information to the

contrary, is that autism will result from that immunization.

Dr. Taylor—well, let me ask Dr. Boyle. You are an epidemiologist. Suddenly, we had to pull out of the audience an epidemiologist. But you are an epidemiologist. What do you have to say about

this debate that we are seeing back and forth? Have you evaluated

any of this information that is now being presented as if it were

fact?

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Ms. BOYLE. I think that the scientific data currently does not

show an association between the MMR vaccine and autism. We

have heard from Dr. Taylor. We also know that there is a study

in Sweden by Dr. Gilberg and associates, who have been monitoring—Sweden is actually the only country that has been monitoring

the rate of autism over time—and they looked at pre-MMR immunizations and post-MMR immunizations and found no changes in

the rates of autism.

Mr. WAXMAN. Well, I cannot tell you what is true or not, but I

do not think our chairman can tell you what is true or not either,

and I feel that when we had the hearings on whether there were

campaign abuses by Democrats, a lot of people’s reputations were

ruined, and I thought the hearings were unfair. But those were political. The consequences of an unfair hearing on autism connected

to vaccinations can cause people to die, and I worry about that, and

I think we should get the facts before we make the assertions and

not make the assertions and then throw out the witnesses who tell

us information that does not fit those allegations.

I yield back the balance of my time.

Mr. BURTON. The gentleman’s time has expired.

Does the gentlelady from Florida wish to question the panel?

Ms. ROS-LEHTINEN. Thank you so much, Mr. Chairman, and I

thank you for holding this hearing.

Rather than asking questions, because I am needed for a caucus

in my other subcommittee, I want to thank you, Mr. Chairman, for

holding this important hearing and for highlighting the need for

further research as we explore the possible causes, interventions,

strategies, counseling and other services to help families who are

living with autism. We need to keep in mind that a person with

autism is indeed a person first and not a behavior.

These posters, which I would like to have the audience and the

panelists see, show constituents from my Congressional District,

Bonnie and Willis Flick, two beautiful children in my district who

are living with autism, and, indeed, the whole family lives with autism.

Bonnie and Willis are fortunate to be able to afford treatment

and therapy, but so many other families are not as fortunate.

So I thank you for the opportunity to hear from researchers and

from parents and people who cope daily with this disease, and I

commend you for your initiative, Mr. Chairman, in seeking answers to help those individuals with autism and for the opportunity

to learn from experts and researchers.

I especially want to thank you for allowing Dr. Cathy Pratt, the

director of the Indiana Resource Center for Autism to come today

and share her expertise on what we as policymakers can do to help

families deal with autism.

Approximately 50 percent of Florida’s children with autism reside in my community in south Florida, so I am delighted to have

you take this leadership role, Mr. Chairman, and have your committee address this issue so that 1 day, we can find prevention and

methods and a cure to help us all cope with this rising curse of autism.

I thank you very much, Mr. Chairman.

Mr. BURTON. Will the gentlelady yield to me?

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Ms. ROS-LEHTINEN. Yes, Mr. Chairman.

Mr. BURTON. Let me just ask Dr. Wakefield, because I want to

conclude with this panel and move on—would you be willing to give

us all of the information on your study so it can be reviewed?

Dr. WAKEFIELD. Certainly.

Mr. BURTON. You will?

Dr. WAKEFIELD. Yes.

Mr. BURTON. Thank you very much.

Professor O’Leary, would you be willing to give us all the information on your study so that we can review it?

Dr. O’LEARY. Yes, sir; no problem.

Mr. BURTON. I cannot hear you.

Dr. O’LEARY. Yes, sir.

Mr. BURTON. OK.

Dr. Singh, would you be willing to give us all the information on

your study so we can review it thoroughly?

Mr. SINGH. Yes, absolutely, without any hesitation.

Mr. Chairman, if there is a moment, if I may have a chance, I

would like to raise some interesting points later on.

Mr. BURTON. Yes, but just 1 second.

Mr. SINGH. Yes. Thank you very much.

Mr. BURTON. Now, then, Dr. Taylor, will you give us all the information on your study so we can review it along with the others?

Dr. TAYLOR. In principle, I have no problem, but I would need

to discuss that with my employing authority, University College

London, and with the Department of Health, who funded this

study.

Mr. BURTON. Who funded your study, Dr. Wakefield?

Dr. WAKEFIELD. We did. We have a small charitable contribution,

but——

Mr. BURTON. A charitable organization did; I see.

Dr. WAKEFIELD. We found it a little difficult to get funding——

Mr. BURTON. And yours was done by the Government?

Dr. TAYLOR. It was funded by the Medicine Control Agency,

which is the body charged with responsibility for the safety of vaccines and other treatments.

Mr. BURTON. Well, I would be happy to work with the ranking

Democrat, Mr. Waxman, to get an independent group of doctors/scientists that we mutually agree upon to review all of your work to

come to some kind of a conclusion if that is possible.

So, since Dr. Wakefield and Professor O’Leary and Dr. Singh

have all agreed, we would sure like to have yours, and I will be

happy to write a letter, as I said before, to the authorities in England asking for your report, and hopefully, we will get that along

with the others so we can review them side-by-side.

Mr. WAXMAN. Mr. Chairman, on that point—and I want to agree

with you.

Mr. BURTON. Sure. Mr. Waxman.

Mr. WAXMAN. I drafted a letter, and I am going to share it with

you, and I hope you will join with me on this letter to Secretary

Shalala. We say in this letter: ‘‘Because of the vital public health

importance of childhood immunization as well as the growing concerns over the prevalence of autism in the United States, we urge

you to convene, under the auspices of the National Institutes of

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Health, the Centers for Disease Control and Prevention, and the

Food and Drug Administration, an expert panel of leading scientists and clinicians to review whether there is any causal association between vaccines and autism. Given the grave possibility

that immunizations against life-threatening childhood diseases

may decline is a result of unsubstantiated allegation of vaccine-induced autism, I would want her to act as expeditiously as possible.’’ Perhaps you will join me in this letter because I think the only

proper thing to do is to get the experts to evaluate all of these conflicting claims. I would not want the American people as a result

of this hearing to stop being immunized if these claims are not—— Mr. BURTON. Let me reclaim my time and say nor would I, but

one of the concerns—the time is right there; it is on the clock—let

me just say that the Department of Health and Human Services

and Donna Shalala and the others have some very competent people over there. We have been checking into all the financial records

of the people at FDA, HHS, and CDC, and we are finding that

some of those people, even on the advisory panels, do have some

possible financial conflicts, as was expressed in the New England

Journal of Medicine just recently, on their front page.

As a result, I will join with you to get an independent panel to

review all of these studies, but I want to make sure they are not

controlled by the health agencies of this country that may have

some people who have some possible conflicts of interest. It has already been expressed in the New England Journal of Medicine, and

we believe that that also possibly exists with some of the agencies

of our health services here in the United States. So I will join with

you, and we will pick them together, and we will try to make sure

that we have some people who are totally unbiased.

Mr. WAXMAN. Well, ‘‘independent’’ means no conflict of interest.

I would not want a panel that had people with a conflict of interest,

but I do want a panel of experts, and I think that the NIH and

the CDC and the FDA can give us a panel that can do this evaluation. [Laughter.]

I do not know why some people find that amusing, but I

think——

Mr. BURTON. So long as we find there is no conflict of interest,

we would not have any problem with that.

Mr. Tierney.

Mr. TIERNEY. Thank you, Mr. Chairman.

I have to say that I am a bit disturbed with the nature of this

hearing and the direction that it has gone, only because I have a

considerable number of people in my district who have not only

children with autism, and they deal with it every day, but we have

a number of institutions that have been working hard to give people the kind of support they need to deal with this situation, and

I find this hearing taking on a lot different tone than a hearing

that would like to look at some solutions and work together in a

cooperative way to find out just what we can do.

I do note that Representative Michael Bilirakis from Florida has

some legislation filed, and one of the provisions would authorize

funding for the NIH to establish Centers of Excellence that would

conduct basic and clinical research into the causes, diagnosis, detection, prevention and treatment of autism. I congratulate the

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members of this panel who are cosponsors on that legislation and

hope that that is the direction in which we will proceed, because

I think we need to find out what the causes are.

First, Dr. Boyle, you are an epidemiologist. Given your background, have you examined the evidence that autism is increasing

in the United States?

Ms. BOYLE. We do know that the rates of autism appear to be

higher than previously thought. As I said in my testimony, they

range from 10 to 15 per 10,000. But that is really from studies

from other countries. We have not had prevalence studies conducted in the United States. There were two done in the eighties

that found very low rates, with perhaps methodologic reasons for

that.

At CDC, we have begun to develop a monitoring program at CDC

which is only for the Atlanta area. We have our first year of data

collected, and we are in the process of reviewing the information

on the children with autism, and we hope to have a rate fairly

soon. And we would like to see similar activities in many other locations. We have a wonderful model on birth defects. They are

many years ahead of us in terms of trying to understand the causes

of birth defects, and there are about 35 States that monitor birth

defects on an ongoing basis. That does not happen for developmental disabilities, and we need to make that happen.

Mr. TIERNEY. There are people in my district, particularly in the

Merrimac Valley area, who seem to have at least acknowledged an

increased number of reported cases, if not of autism itself, of one

of the related diagnoses. Have you heard of—— Ms. BOYLE. It is a difficult issue because the diagnosis for autism

has changed considerably. The first studies were based on fairly

narrow criteria from the way it was originally described. The more

recent studies have actually used criteria that are much broader,

and there is increased recognition. So we really do not know. There

have been a number of investigators who have tried to see whether

the increase in rates over time, or the higher rates in more recent

years, is really due to a real increase or sort of a redefinition and

better awareness. It is not an easy question to answer.

Mr. TIERNEY. I bring that up only because in one instance, at

least, a group of very active parents of children with autism

worked with the school system and some other researchers and

heightened the awareness of identification and found a marked increase in the number of cases that were beginning to be identified

in the area, so people had not really appreciated these symptoms,

including some doctors, pediatricians, who looked at it.

Does that sound right to you?

Ms. BOYLE. The one study that has addressed this is the study

by Gilberg which I mentioned earlier, which looked at trends over

time. If you look at the range of functioning of those children over

time, it appeared that the increase was in children who were higher-functioning as well as children who were lower-functioning. So

the classic group seemed to remain constant. Now, why that is happening, we do not know. That is what we hope to do the research

to understand.

Mr. TIERNEY. Well, I agree that we ought to do this research and

do it soon. I am a little bit concerned about what might be the mesVerDate 11-MAY-2000 09:13 Feb 26, 2001 Jkt 000000 PO 00000 Frm 00203 Fmt 6633 Sfmt 6633 C:\DOCS\69622.TXT HGOVREF1 PsN: HGOVREF1
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sage taken from this hearing by people and what we want to take

on this.

Dr. Boyle, if you had young children today, would you vaccinate

them?

Ms. BOYLE. I do have children, and they are both fully vaccinated, and I would vaccinate them again.

Mr. TIERNEY. Dr. Offit, how about you?

Dr. OFFIT. Yes. I have a 7-year-old son, Will, and a 5-year-old

daughter, Emily, and they are both fully vaccinated.

Mr. TIERNEY. And you would do it again?

Dr. OFFIT. Of course. I want them to be protected against the viruses and bacteria that can cause serious disability and death. I

am fortunate, actually—I was a little boy in the early 1950’s, and

when I was a little boy, there were four vaccines—diphtheria, pertussis, tetanus and smallpox. I was fortunate that I was not killed

by measles or paralyzed by polio. My son, hopefully, did not have

to be as lucky, but hopefully, as we move into the 21st century and

can develop vaccines against respiratory virus and para flu, children will not have to die from those diseases.

Mr. TIERNEY. Dr. Boyle, you wanted to add something.

Ms. BOYLE. I did want to mention one thing. We do monitor the

trend of other serious developmental disabilities in Atlanta, and

just based on my own experience over the last 10 or 15 years, we

used to see children who were deaf due to congenital rubella or

who had mental retardation due to hemophilus influenza Type B.

We no longer see those children in our program.

Mr. BURTON. The gentleman’s time has expired.

Mr. TIERNEY. Thank you, Mr. Chairman.

Mr. BURTON. I just have a few more questions, and then we will

go to the next panel—I think Mr. Waxman has a few as well.

Dr. Boyle, why did the CDC ignore the pleas of the parents of

Brick Township when they begged CDC to look at the vaccine

issue?

Ms. BOYLE. Actually, the study of Brick Township is sort of our

first step, which is to look at the prevalence of——

Mr. BURTON. Did you check into the vaccine issue, though? The

parents there wanted the vaccines looked into as well. Did

CDC—— Ms. BOYLE. The concern with the parents from Brick Township

in a number of meetings that we had with parents was related to

environmental concerns.

Mr. BURTON. They did not——

Ms. BOYLE. We have been working with the Agency for Toxic

Substances and Disease Registration——

Mr. BURTON. But didn’t they also ask that the vaccines that had

been given to their children also be investigated?

Ms. BOYLE. That is not my understanding. My understanding is

that their initial concern was to answer the question, is the rate

of autism in their community higher than what they thought—— Mr. BURTON. Well, the information that we have is that the parents of Brick Township were very adamant that they wanted the

vaccines checked because so many of their children had become autistic. And evidently, that is not one of the things that CDC is looking into, and I would like to pose the question to you and have you

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answer it in writing—why? Why didn’t CDC include as one of the

things they were investigating the possibility that some of these

vaccinations may have caused the autism increase? Would you

check that out and let me know?

Ms. BOYLE. I would be happy to.

Mr. BURTON. OK.

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Mr. BURTON. Dr. Taylor, you have shown the measles virus in

the intestine, and you have in your laboratory—or ‘‘laboratory,’’ as

they call it in your country—you have gone through and checked

those samples that were sent to you by Dr. Wakefield that show

that there definitely was measles in the gut of these children who

became autistic. I think Dr. Singh verified the same thing.

Did you check any of that, Dr. Taylor, why there was measles in

the guts of those children? Did you take a look at any of that?

Dr. TAYLOR. I am sorry, I have not had a chance to look at this

paper. It is interesting information. However, in terms of Mr.

Wakefield’s history, in all of his initial results, he has found the

cure for, first of all, Crohn’s disease, and he has found the cure

for——

Mr. BURTON. Let me just ask you this—I do not want to go into

those other things—Dr. Wakefield showed us on his slides that

there was measles in the guts of these children who were vaccinated with the MMR shot. Professor O’Leary verified it in a separate laboratory——

Dr. TAYLOR. Not in a separate laboratory; that was the same laboratory. That, I think, is the critical point.

Mr. BURTON. Well, it was——

Dr. TAYLOR. This information does have to be verified by an independent laboratory.

Mr. BURTON [continuing]. It was sent to him—and Dr. Singh, I

think, verified it as well. You have not, though, looked into the

problem with the measles in the gut of these children, though?

Dr. TAYLOR. I do not know quite what you mean. That is not my

area.

Mr. BURTON. You have not checked into that; OK.

Professor O’Leary, did you want to say something?

Dr. O’LEARY. Sir, can I make a comment, please? What I presented is evidence, direct evidence, cell-based and tube-based. It

was done at a separate laboratory from Dr. Wakefield’s.

If Professor Taylor has a beef with me, he should say that. My

work is completely independent. I stand over it. I have come here

to tell the truth. There is nothing for me to be gained in not telling

the truth.

Mr. BURTON. Dr. Singh, you had some more comments, and I

want to yield the balance of my time to you to respond.

Mr. SINGH. Yes, just a couple of things. Basically, I want to raise

the issue that when we think about epidemiological studies, what

are these individuals really looking at. All they do is they take

numbers from previous, old records of what-have-you. They do not

even pay any attention to the fact that old-time vaccines were

made based on old immunology. Today, immunology is so different;

it is almost a difference of day and night. So we need to take into

account that new research should really be evaluated by so-called

expert epidemiologists.

The second thing——

Mr. BURTON. Well, let me just say one more thing. I want to ask

Dr. Boyle one last question, and that is do you believe anybody who

is getting funds from Merck or any of the other pharmaceutical

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ments about pharmaceuticals coming from those companies, or do

you believe that that is a conflict of interest?

Ms. BOYLE. I think that is a difficult question to answer.

Mr. BURTON. Wait a minute. Let me get this straight. You think

it is a difficult question to answer. If somebody is getting funding

of some type from a pharmaceutical company, for them to sit on an

advisory panel that is approving or giving their approval to a new

drug that is coming on the market, you do not see that as a conflict?

Dr. SCHWARTZ. Mr. Chairman, I am Dr. Schwartz. I am a colleague of Dr. Boyle and am the acting director of the Epidemiology

and Surveillance Division in the National Immunization Program,

and we appreciate your indulgence in allowing me to testify and to

help with answering questions about immunization.

The Advisory Committee on Immunization Practices is a chartered advisory committee under the FACA regulations. There are

very strict guidelines regarding the participation in votes of members who may have conflicts of interest that will help assure that

those potential conflicts of interest, those potential financial conflicts, do not affect the votes and the decisions of the advisory committee.

The reason why individuals who may potentially have conflicts

are included in the committee is to assure that we get the best expert advice possible so that we can make the best vaccine recommendations possible, and frequently, the best experts are those

who may have done research or may have provided information to

some of the vaccine manufacturers—but their role in the committee

and in the voting process is very strictly defined.

It is also important to point out that recommendations for vaccination are made independently by the American Academy of Pediatrics and the American Academy of Family Physicians, and

those recommendations are virtually always in harmony with the

recommendations from the Advisory Committee on Immunization

Practices.

Mr. BURTON. Well, I am going to go ahead—my time is expired,

but I am going to come back to you on that. I will take another

round on that.

Mr. Waxman.

Mr. WAXMAN. I want to say to the parents in the audience and

to others, family members, who are here that I do not want you

to think that I am in any way trying to minimize what you have

gone through or to in any way challenge the depth and sincerity

of your feelings. I think that is a separate question from the scientific question of whether there is a causal link. And because it

is so important, it is essential that through sound science, we determine this fact—not through emotionalism and not through sensationalism.

I did not come here to say one side is right or one side is wrong,

but I want us to have the best scientific information we can have.

Now, Dr. Offit’s integrity has been challenged, presumably because he has a point of view that does not quite fit with the chairman’s point of view. Dr. Schwartz started to indicate why he

thought your situation, even though you have a relationship with

Merck, did not put you in a conflict.

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Let me ask you directly, Dr. Offit, do you have a conflict of interest, and if ‘‘No,’’ why not?

Dr. OFFIT. No, I have no conflict of interest. What I have is an

apparent conflict of interest, and that is why I disclosed that at the

beginning of every ACIP meeting, and that is why I disclosed it in

my written report.

If I could just explain this a little bit, I have been doing research

for 20 years on rotaviruses. What I have done in my laboratories

is try, with my colleagues, to understand what the genes are that

cause diarrhea and what the genes are that help the body fight infection. That led to a patent on a vaccine for rotavirus. Rotaviruses

kill 13 children a day in this world, and rotaviruses cause 1 out of

every 75 children born in this country to be hospitalized. It is a serious, and in developing countries often a deadly, infection.

It would be an advance if we could prevent that disease. Merck

and Company has made a commitment to developing that vaccine,

and hopefully, if we can develop a safe and effective vaccine, we

can prevent a lot of disease and death.

Mr. WAXMAN. I think that everyone here should agree that we

want a safe vaccine, or a vaccine that is as safe as possible. Merck

did not hire you to come up with a particular position, did they?

Did they tell you they wanted your research to have a certain outcome?

Dr. OFFIT. No. This work was all done—frankly, it was funded

by the National Institutes of Health, and it was funded by research

that we did as a basic—I am an immunologist—that is my expertise.

Mr. WAXMAN. There is an organization—and I am going to put

this in the record—called the Autism Autoimmunity Project. I have

a letter from its president urging people to give money to it, because this project is going to fund research that is going to show

the connection between vaccines and autism and other diseases.

And they proudly say they fund Dr. Wakefield and Dr. Singh. Is

that true?

Mr. SINGH. Yes.

Mr. WAXMAN. Is that true, Dr. Singh?

Mr. SINGH. Yes. I just received some money from that foundation, oh, about 2 months ago. My research has been going on on

this issue for the last 15 years.

Mr. WAXMAN. Yes—and I am not saying there is anything wrong

with it——

Mr. SINGH. I just wanted to make a point on that.

Mr. WAXMAN [continuing]. Although this organization seems to

have a particular point of view. How would you think they would

feel if your research came up with a different conclusion from what

they wanted to achieve in their—because they have a position——

Mr. SINGH. Mr. Waxman, I am a very honest, decent human

being—unlike, perhaps, some other people that you might know

of—and I can tell you that if I found a connection which was not

existent or if my results did not support what this foundation

wanted, I would even return the money to that foundation.

Mr. WAXMAN. Even though they want a particular point of

view—— Mr. SINGH. They never asked me to do any research——

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Mr. WAXMAN [continuing]. You are an independent scientist, and

you have integrity.

Mr. SINGH. What I am—— Mr. WAXMAN. Just answer yes or no, because I do want to

ask——

Mr. SINGH. I beg your pardon?

Mr. WAXMAN. My question to you is they have a point of view,

but they fund you, you have integrity, and you are going to do your

work based on science. Is that your answer?

Mr. SINGH. My answer is that I am getting funds from private

sources because national agencies continue to decline my research

grant proposals when I submit. Where else am I going to go to get

the funding?

Mr. WAXMAN. Have you been turned down by NIH?

Mr. SINGH. I am trying to raise funding independently, on my

own, not necessarily—— Mr. WAXMAN. Have you been turned down by NIH?

Mr. SINGH. Three times, I have attempted—three times, I have

written grants, and NIH has not given me a single dime.

Mr. WAXMAN. I want Dr. Wakefield to be able to answer the

same question very briefly.

Dr. Wakefield, you acknowledge you have received money. Do

you feel that that in any way raises expectations that your research come out with a result that this organization wants?

Dr. WAKEFIELD. We are funded to test hypotheses, and we

present the data whether the hypothesis is correct or not. And we

have done that, we have gone on record as doing it. We publish

negative studies in association with measles and Crohn’s disease.

That does not mean it is not there; it means that our hypothesis

was wrong in terms that we could not find it using the technology.

So we have gone on record as publishing both positive and negative

data.

Mr. WAXMAN. I ask unanimous consent that those documents

from the Autism Autoimmunity Project be put in the record, and

I would note, Mr. Chairman, that you are also associated on the

board of this group.

Mr. BURTON. Without objection. That is no problem.

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Mr. BURTON. I see this as a little bit different situation. The

pharmaceutical companies who are producing jobs—and they do a

great job for the country—but they have a financial interest in getting things approved.

The New England Journal of Medicine has recognized this in a

recent publication, on the front page. They said that they had some

people on their advisory committees who had made some comments

and made some recommendations that had financial interest, and

they had not scrutinized them properly, and they apologized for it

and said it would not happen again.

So what I asked Dr. Boyle and what I am inferring here today

is that there can be a bias if people are being paid or reimbursed

by pharmaceutical companies when they start making a decision or

a recommendation on an advisory panel.

Now, you said that if they represent Merck or Bristol Meyers or

some other laboratory, they will probably excuse themselves from

voting, and there may be a requirement for that. That does not

alter the fact that they are sitting on that panel, and they are talking to everybody else on that panel, and they have influence on

that panel, and they do have a tremendous impact on whether or

not certain things are approved or disapproved. And I think that

that is a conflict of interest. I do not see why we cannot have people on advisory panels who have no financial interest whatsoever

with pharmaceutical companies when they are approving those, because we are talking about the health of the Nation. And that is

something which ought to be investigated very thoroughly by this

Congress.

We are talking today about autism, but there is something of as

great stake here as the autism question and whether or not the

MMR vaccine and other vaccines may be contributing to autism,

and that is are we letting pharmaceutical companies have too great

an influence on the decisionmaking process that affects very one of

our lives?

Right now, we are talking about the anthrax vaccine. They are

going to inoculate every one of our military personnel, and there

are all kinds of questions about the anthrax vaccine, all kinds of

them. We have had all kinds of side effects that we have talked

about, and I have talked to people who have had them. And the

former chairman of the Joint Chiefs of Staff is on the board of that

company that makes the anthrax vaccine. They are manufacturing

millions of doses of this vaccine, and every member of the service

will have to get six shots of that. If the decisionmaking process involves people who have a financial interest in it, and that outweighs the potential side effects of any drug, then I think there is

something amiss.

So I have great concerns about that, and I would just say to you

that HHS and CDC and FDA and all of them ought to take a hard

look at whether or not they have people on their advisory panels

who have a potential conflict of interest by getting money or something else from a pharmaceutical company that they represent.

Now, I was not trying to impugn the integrity of Dr. Offit, but

I did want to point out that he does get money from Merck and

gets some benefits from Merck. So for anybody to say that he can

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be totally unbiased is questionable. Maybe he would be totally unbiased, but it is questionable.

So I think that this whole issue of whether or not the MMR vaccine is a problem—the measles vaccine has been found in the gut,

it has been verified, and we still have this problem, and the question was whether or not it goes from the gut up to the brain and

is a contributing factor to autism—but the companies that make

the MMR vaccine have people on the advisory boards who are participating in the decisionmaking process.

So it makes me wonder whether we are going to really get to the

bottom of it unless we go to outside entities—and that is not questioning anybody’s integrity. It is just saying that if I am paying

somebody money for some product or something, and there is something else that I am going to make money off of, and they are on

a board that is going to participate in a decisionmaking process, to

say that they do not at least think about me and think about where

the money is coming from just boggles my mind, and I think it

would most people.

With that, do I have any further questions? Let us see what else

we have here.

[Pause.]

Mr. BURTON. OK. Dr. Boyle, for your information, at a public

meeting in Brick Township in January 1997—and you should know

this—with CDC and others present, several audience members

asked about the vaccines and the possible autism link, and they

asked that vaccines be checked. That is from Andy Napoli, the legislative director of Representative Chris Smith.

So, I again want to stress that we want to have an answer from

CDC. If parents from that township were wondering about the possible connection between these vaccinations and autism, why didn’t

CDC check on it? Why not? You are checking on everything else,

the other environmental concerns around there. Why not check on

the vaccine?

And I submit that maybe, just maybe, it is because the pharmaceutical company that manufactures it had some influence on the

people who were in that meeting, and they said, Hey, we do not

want to get into that. And if that is the case, that is damned near

criminal.

With that, I will be happy to yield back the balance of my time

and let Mr. Waxman have his 5 minutes. Then we will go to the

next panel.

Mr. WAXMAN. Thank you, Mr. Chairman.

I would like to have Dr. Spiker come forward, if he would.

Dr. SPITZER. Spitzer. S-p-i-t-z-e-r.

Mr. WAXMAN. Oh. I am sorry. Dr. Spitzer, where are you——

Dr. SPITZER. I am a professor of epidemiology with the Faculty

of Medicine at McGill University in Montreal.

Mr. WAXMAN. When you came forward a moment ago, you appeared to be reading from a prepared statement. Did you have a

statement written out that you read from?

Dr. SPITZER. Yes, I did. The circumstances are that I personally

learned of this hearing, and of related activities very late in the

game. I have been an honorary assistant to 2,100 families in the

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United Kingdom who have great difficulty getting scientific help

and cannot afford it. I have chosen on this issue——

Mr. WAXMAN. Excuse me. Did you prepare that statement yourself before the hearing?

Dr. SPITZER. Yes, I did.

Mr. WAXMAN. OK. And were you contacted or did you contact

Chairman Burton’s staff before your testimony?

Dr. SPITZER. I did so indirectly, to the best of my knowledge,

through a person named Ms. Barbara Fisher.

Mr. WAXMAN. And could you identify Barbara Fisher? Is she

here?

Dr. SPITZER. She is here in the audience.

Mr. WAXMAN. Is she a staffperson for the committee?

Dr. SPITZER. No. She is in the vaccination——

Mr. WAXMAN. When did you talk to her? Was it today or earlier

than today?

Dr. SPITZER. I spoke to her yesterday and the day before yesterday by telephone and met her here——

Mr. WAXMAN. And you met her here?

Dr. SPITZER. I met her this morning.

Mr. WAXMAN. But you talked to her yesterday and the day before

about coming here to testify?

Dr. SPITZER. Yes.

Mr. WAXMAN. Thank you very much.

Dr. Offit——

Dr. SPITZER. I am sorry. It was primarily for the press conference, but with the possibility of being able to testify as well.

Mr. WAXMAN. Yes—some extenuating circumstances for which

the rules did not have to be observed.

Dr. Offit, the chairman says he is not impugning your reputation, but it sounds to me like your reputation has been impugned.

You get money from Merck. They make the vaccine. You are on an

advisory committee for the CDC about vaccines. That is an apparent conflict of interest. Again, why isn’t it a conflict of interest?

Dr. OFFIT. Because as I sit on the Advisory Committee on Immunization Practices and make recommendations for children in this

country, the only thing I consider is exactly how I would treat my

own children. I mean, I take the job very seriously. So the recommendations that I make are based solely on a careful review of

the data that are presented to us, period. I do not have any conflict

with regard to that decisionmaking process. It is simple in that

sense.

Mr. WAXMAN. Dr. Boyle and Dr. Schwartz, what would happen

if you excluded people from your advisory committee who worked

in the area of research on vaccines or in some other area for a

pharmaceutical company?

Dr. SCHWARTZ. Those with the greatest expertise on vaccines and

those who are best able to make recommendations that will protect

the health of American children have frequently done research in

vaccines. They are the ones who know the issues best and who can

make the best recommendations. By including them on the advisory committee, but implementing appropriate controls to make

sure there are no apparent conflicts of interest, the CDC feels that

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they get the best advice to make the best public health recommendations.

Mr. WAXMAN. How about people who are funded by the Autism

Autoimmunity Project—have you ever heard of that group?

Dr. SCHWARTZ. The ACIP meetings are all open public meetings.

They are all—— Mr. WAXMAN. What is ‘‘ACIP?’’ Dr. SCHWARTZ. The Advisory Committee on Immunization Practices meetings are all open meetings and are announced in the Federal Register. If someone from that particular institute wanted to

come and share information or present to the ACIP, they would

certainly be welcome to do so.

Mr. WAXMAN. And would you feel they have a conflict of interest

if they are funded by an organization that wants to have scientists

establish a certain conclusion?

Dr. SCHWARTZ. I think the most important thing that we need to

consider is the quality of the scientific data and whether those data

have been peer-reviewed, whether they have been considered by

other scientists, and whether they have been replicated in other

laboratories.

Mr. WAXMAN. So you think the most important thing is that Dr.

Wakefield and Dr. Singh ought to disclose if they are funded by

this group, and Dr. Offit ought to disclose if he is funded by Merck.

Dr. SCHWARTZ. I think disclosure is important, yes.

Mr. WAXMAN. And then you evaluate their science?

Dr. SCHWARTZ. Yes.

Mr. WAXMAN. Because ultimately what is at stake are the scientific questions that we want answered.

Dr. SCHWARTZ. That is exactly correct, and preserving the health

of American children.

Mr. WAXMAN. Well, that, it seems to me, should be the goal of

all of us, and I hope that hearings like this are to try to get to that

result and not simply to further a particular point of view which

could well be wrong, and if it is wrong, as I fear it may be, by advertising this particular point of view and scaring the public, we

could see a drop in immunization rates. And we do not know if autism will drop—in fact, we have evidence from Great Britain that

it did not drop when immunizations did——

Mr. BURTON. I am allowing you extra time because I have one

more question. I am allowing you extra time.

Mr. WAXMAN [continuing]. I am getting extra time—for good behavior—that when we do have an example in the real world of sensational press about the link between autism and vaccinations, vaccination rates dropped, and we knew that caused an increase in

measles, but we saw no decrease in autism.

It is troubling to me. I appreciate all of the views that have been

expressed here, and I hope that we can get an independent group

to look at this, because I do not think this committee is an independent group trying to reach an honest conclusion.

I yield back the balance of my time to the chairman.

Mr. BURTON. Let me just make one final comment, and that is

that the people who are doing the independent studies here do not

sit on any advisory boards that are making decisions on what kinds

of vaccinations we are going to be giving to the people of the

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United States of America. The people who represent the pharmaceutical companies and sit on those boards do. That is the difference.

And let me just conclude by saying that I really appreciate all

of you being here. This is a very difficult issue. I think it was unavoidable that there would be this kind of contention today because

we have a lot of parents and grandparents, like myself, who feel

very strongly about the life that our kids and grandkids are going

to have to lead; and on the other side of the issue are the people

who are saying there is no impact from the shots that are being

given to our kids.

So the bottom line is that there are going to be strong differences

of opinion, and we want to get all those differences of opinion on

the record, and then we will all go out and have a cup of coffee together and debate it in private.

The American people need to know the facts. Lincoln said, ‘‘Let

the people know the facts, and the country will be saved,’’ and I

think that is just as true today as it was at the beginning of this

Republic. So that has been our goal—not to fight with everybody,

but to get the facts out. And we are all for vaccinations. It is just

do we want to give a child nine vaccinations in 1 day; do we want

to give them 31 or 32 or 33 vaccinations between the time they are

born and age 6? Isn’t that maybe a little bit of overload? That is

the whole question.

I want to thank this panel. We have one more panel. I really appreciate all of you being here, even though we may have some differences with some of you.

Thank you.

I apologize to the next panel for having to sit there for so long.

While the next panel is coming up, we will take a couple-minute

break. The next panel consists of Dr. Bernard Rimland, Dr. Michael Goldberg, Dr. Mary Megson, Dr. John Upledger, Dr. Catherine Pratt, Dr. Deborah Hirtz, and Dr. Edward Cook.

We will start in just 1 minute.

[Recess.]

Mr. BURTON. The committee will reconvene.

Would everybody please take their seats and shut the doors,

please?

I appreciate very much your patience today. Would the panel

please rise?

[Witnesses sworn.]

Mr. BURTON. Have a seat, please.

We will start with you, Dr. Rimland.

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STATEMENTS OF BERNARD RIMLAND, Ph.D., AUTISM RESEARCH INSTITUTE, SAN DIEGO, CA; DR. MICHAEL J. GOLDBERG, DIRECTOR, NIDS MEDICAL ADVISORY BOARD,

TARZANA, CA; DR. MARY N. MEGSON, PEDIATRIC AND ADOLESCENT ABILITIES CENTER, RICHMOND, VA; DR. JOHN E.

UPLEDGER, THE UPLEDGER INSTITUTE, CLEARWATER, FL;

CATHY L. PRATT, INDIANA RESOURCE CENTER FOR AUTISM;

DR. DEBORAH G. HIRTZ, NATIONAL INSTITUTES OF HEALTH;

DR. EDWIN H. COOK, JR., UNIVERSITY OF CHICAGO

Mr. RIMLAND. Thank you very much for the opportunity to be

here. It is a great honor and a great privilege.

I want to start by commenting that there has been a lot of discussion during the past few hours about the supposedly unproven

hypothesis that vaccines may cause autism. There is another

unproven hypothesis which has been unchallenged and unquestioned, at least relatively so, and it is really a very important hypothesis, and that hypothesis is that vaccines are safe.

The real hypothesis which should have been tested years and

years and years ago by much more scientific research than has

ever been devoted to it is the proposition that vaccines do not cause

damage. The Vaccine Information Adverse Reaction Reporting System has not been studied; it has not been looked at at all carefully,

and therefore, the assumption that many people are making is that

the vaccines have been looked at carefully for adverse reactions,

and they have not been.

The other point I want to make has to do with the testimony of

Dr. Brent Taylor, who spoke here on the last panel. I was very

bothered by the lack of information and the confusing information

in his paper. My entire life has been spent as a professional researcher—almost 50 years of my life has been as a full-time professional researcher. I am a fellow of the division of statistics, measurement and evaluation of the American Psychological Association.

I wrote a friendly letter to Dr. Taylor indicating that I would

very much like to take a look at his data, because I did not understand part of it, and there were some questions that I wanted to

raise. He ignored my first letter. I sent a second letter, and he responded to that by saying no, I could not have a look at his data.

I then wrote to the editor of the Lancet urging that a blue-ribbon

committee be appointed to take a very close look at the data of Dr.

Taylor. So I am delighted that you have asked for it as well.

My own son Mark was born in 1956 as a severely autistic child

from birth. Our pediatrician, who had been in practice for 35 years

at that time, had never seen such a child or heard of such a child.

When Mark was 2, my wife and I found the word ‘‘autism’’ for

the first time in a textbook. I was at that point 5 years beyond my

Ph.D. in psychology, never having heard of or seen the word ‘‘autism’’ before. It obviously was a very rare disorder, extremely rare.

None of us had heard of it.

Today it is extremely common. There is hardly a high school kid

in the country who has not heard of autism. It is a household word

now, and that is not because of the movie ‘‘Rain Man,’’ but because

it is extremely prevalent.

Despite denials from some experts, there is a terrible worldwide

epidemic of autism. In the mid-1960’s, after my book ‘‘Infantile AuVerDate 11-MAY-2000 09:13 Feb 26, 2001 Jkt 000000 PO 00000 Frm 00335 Fmt 6633 Sfmt 6633 C:\DOCS\69622.TXT HGOVREF1 PsN: HGOVREF1
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tism’’ was published, I began hearing from parents throughout the

world whose children had been normal until given the DPT shot.

I began to make note of it and ask questions about it in the form

letters I sent out to parents seeking information about autism.

In the past few years, the Autism Research Institute, which I direct in San Diego, has been flooded with letters and faxes about

children whose parents say and can prove very well with videotapes and photos that their kids were normal until getting another

triple vaccine, the MMR shot. In my view, the evidence is overwhelming that vaccines, especially the triple vaccines, and among

the triple vaccines especially the MMR, can and do cause many

cases of autism.

It is also alarming but true that 90 to 99 percent of adverse reactions to vaccines are never reported. There is no penalty for a doctor’s failure to report a bad vaccine reaction, so they simply do not

do it. Why should they engage themselves in paperwork if there is

no requirement that they do it and no penalty for not doing it?

This being so, how can the authorities claim that the vaccines

are safe, given that only 1 to 10 percent of adverse events are ever

reported? Doctors must be trained to recognize, and required, not

just requested, to report adverse events.

With regard to the question of genetics, they say that autism has

a large genetic component, and therefore, vaccines must play a

minimal role. My book, ‘‘Infantile Autism,’’ published in 1964 was

the first systematic attempt to marshal the evidence for a genetic

relationship to autism, so I am certainly not hostile to that idea.

However, genes do not begin to account for the huge increase in the

incidence of autism. There is no such thing as an epidemic due to

gene problems. The increase ranges from 250 to 500 percent in various places, as other people have pointed out here.

As the editor of the Autism Research Review International, I

have just reviewed a very large number of studies on the genetics

of autism. The next issue of the Autism Research Review is going

to contain our review study. The results of our review are spectacularly inconsistent. The best guess is that there are at least 20 different genes that may be involved in the causation of autism.

Genes are not the answer to the question, even though, at one

time, I was very much in favor of looking at that hypothesis. I am

still interested in the hypothesis, but it is certainly not responsible

for the increase in autism.

The people who claim that the vaccines are safe claim that autism naturally occurs at about 18 months, when the measles/

mumps/rubella vaccine is routinely given, so the association is

merely coincidental and not causal. But the onset of autism at 18

months is a recent development. Autism starting at 18 months rose

very sharply in the mid-1980’s, when the MMR vaccine was introduced. For the previous 30 years—we have been collecting information from children born in the fifties, sixties, seventies, and so

forth—there were twice as many kids reported with the autism

started at birth as there were kids whose parents reported that the

autism started at 18 months.

Starting in about the 1980’s, when the MMR vaccine was introduced, those two curves converged. Over a period of several years,

the number of kids whose autism started at 18 months rose to

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twice as high as the number starting at birth. On the last page of

my handout, I have a graph that shows those curves based on the

records of over 31,000 children in our San Diego institute. So that

particular argument against the MMR hypothesis is obviously a

very poor one.

Autism is not the only severe chronic illness which has reached

epidemic proportions, as the number of very profitable vaccines has

rapidly increased. Children now receive 33 vaccines before they

enter school—a huge increase. The vaccines contain not only live

viruses, but also very significant amounts of highly toxic substances such as mercury, aluminum and formaldehyde. Could this

be the reason for the upsurge in ADHD, asthma, arthritis, Crohn’s

disease, lupus, and other chronic disorders? It seems as though we

are trading protection against acute diseases such as measles and

mumps for a huge epidemic of chronic diseases like autism, asthma, and the others I mentioned.

As a parent and a full-time professional researcher, I am bitterly

disappointed with the medical establishment’s dismal record with

regard to autism over the past 60 years. The medical schools as

well as the Government agencies have consistently supported outmoded, unproven and even disproven ideas, including the one that

autism was caused by ‘‘refrigerator mothers’’ who did not love their

children, thus causing autism. The medical establishment was opposed to behavior modification, or what is now called the ABA approach. They said that this was not a way to treat autism, because

autism was based on deepseated emotional problems, so a technique that is used to train animals cannot be used to improve autistic children. That was untrue. They have ignored and continue

to ignore the long series of studies conducted both in the United

States and Europe showing that the elimination of foods containing

gluten and casein from the diet brings about marked improvement

in many autistic children. They have consistently ignored the series

of 18 consecutive studies conducted by researchers in six countries

which show that almost half of all autistic children and adults respond favorably to high doses of Vitamin B6 and magnesium, with

no adverse reports from any of these studies. Eleven of these studies were double-blind placebo-crossover experiments. There is no

drug which comes even close to B6/magnesium in terms of safety,

efficacy, and positive research findings, yet it is not being explored

at all.

Tens of millions of dollars have been spent on nonproductive

lines of research while virtually no money at all has been given to

research on methods of alternative medicine which are far more

promising in terms of both safety and efficacy.

The most interesting questions are not being asked. Why does

the majority of any population survive such epidemics as autism,

the bubonic plague, Legionnaire’s disease, polio and AIDS, while

relatively few succumb?

The very obvious answer and the most probable answer is that

the survivors have healthy, effective immune systems. Would enhancing the immune system decrease the likelihood of adverse reactions to vaccines—including, by the way, the anthrax vaccine. I

hope that DOD will pay some attention to that. There is good reason to think about anthrax in this context.

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It is well-known that the immune system must be adequately

supplied with many nutrients if it is to function properly, including

especially Vitamins A, C, E, B6, and a number of minerals, including zinc, magnesium, and selenium. Nutritional levels of these substances are not only harmless, but they are essential to good

health.

Since people do not change their diets readily, I believe that

foods should be fortified with these nutrients, especially foods

which will be consumed by infants and children. Research along

these lines, as well as on the safety of the vaccines, is desperately

needed.

Recently, Professor Clementson published a paper—he is the author of a three-volume treatise on Vitamin C—reviewing the evidence showing that individuals who are vaccinated without having

adequate supplies of Vitamin C in their bodies are far more likely

to suffer an adverse reaction to the vaccine than those who have

higher levels of Vitamin C.

Dr. Archie Kalokerinos of Australia, a pediatrician assigned by

the Government to the outback people there, found an infant death

rate of 50 percent among the children he cared for. They died soon

after the vaccines. He found that they were extremely Vitamin Cdeficient, and he learned that by giving them some extra Vitamin

C, he could prevent their deaths. The death rate went from 50 percent to zero in a very short time. Dr. Kalokerinos was given a

medal by the Australian Government.

We should be giving our children Vitamin C as well as other nutrients to make sure that their immune systems are well-fed and

function well. I think we would see a lot fewer of the problems that

we are experiencing today.

As a parent and as a researcher, I believe there should be a

marked redirection of effort and funding along the lines suggested

above.

Thank you.

Mr. BURTON. Thank you, Dr. Rimland. I appreciate your comments.

Dr. Goldberg.

[The prepared statement of Dr. Rimland follows:]

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Dr. GOLDBERG. Mr. Chairman and members of this committee,

thank you for allowing me the opportunity to speak here today. I

wish to take a moment to examine the urgency of this epidemic.

I am Dr. Michael Goldberg, a practicing pediatrician for over 20

years in Los Angeles, and I am on the clinical teaching staff of

UCLA. I am also the founding member of the NIDS Research Institute, a parent-physician partnership developed to expedite research

on behalf of children with special needs.

Out of necessity and a desire to help, my practice is comprised

primarily of children with autism, ADD, and other special needs.

I am here before you today to share my frontline, everyday experience with these children, experience that has overwhelmingly convinced me and my colleagues that this is a disease that can be

treated.

In turn, I hope to propose a unique medical research model that

combines the tenets of basic science and strong academics with an

unprecedented sense of clinical urgency.

To understand this new autism that everyone keeps speaking

about, one must actually step back and look at the increased understanding and incidence of autoimmune diseases across the

board from the mid-1970’s to the present date. All that one has to

do is look at the medical literature to realize that every disorder

we have associated as an immune-connected, immune-mediated defect of the immune system—lymphomas, multiple sclerosis, Alzheimer’s, lupus, ulcerative colitis, irritable bowel syndrome, rheumatoid disease, and even aging—have all become recognized as in

part an autoimmune process or illness. As Dr. Galpin, an authority

in infectious disease immunology and a pioneer in the application

of immune-modulators and a member of the NIDS Medical Board

likes to say: The friendly fire of our own bodies causes the damage.

We either have to assume that the increase in these disorders in

the human population is mass hysteria, mass psychosis, schizophrenia and/or behavioral-developmental disorders, as was thought

in the old days, or we need to step back and realize that maybe

we have a large number of adults and children suffering a disease

process that is affecting how their brain and nervous system functions. I have family after family within my new practice in which

there is a mother or a father with chronic fatigue syndrome, an

older child with ADD/ADHD, and a young child or two with autism/PDD.

Unless we assume that this is all random, unfortunately, there

is a logical connection between the above disorders and the rapid

emergence of this crisis. We must rapidly realize that almost all of

these disorders result from a treatable disease process.

When you look at the factors among the children that I am seeing, many of them have low natural killer cells. These are part of

the findings being reported in many of those other disorders. Another frequent finding is the presence of active HHV–6 virus and

other related herpes viruses in some of these children. Similar findings are being reported for various adult autoimmune disorders,

and recently, even the Centers for Disease Control published an article focusing on our emerging knowledge of HHV–6 and related

disorders.

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Fortunately, while people talk about the unknown entity of autism, I can show you picture after picture after picture that has allowed me with the help of researchers, Dr. Ismael Mena and Dr.

Bruce Miller, to look at NeuroSPECT scans and understand what

is going on in the brains of these children. For the majority, there

is a decrease of blood flow and function of the temporal lobe of the

brain, areas that are consistent with that predicted by neuro-anatomists.

We have a large collection of scans that show a decrease in blood

flow that is reproducible, quantifiable. Blood flow corresponds directly to function. When compared to MRIs and CAT-scans, they

help to confirm no pre-existing damage but rather point toward a

neuro-immune direction etiology. In fact, as we learn more through

imaging and scans and technology about the brain, in a recent New

England Journal of Medicine article a year ago, they discussed the

immune-brain-endocrine connection in the hippocampus, a system

that, with the CA1 and CA2 nuclei and neuron, affects cognitive

function, fatigue, and memory.

Today I have come to look upon this as a reversible condition.

Thankfully, many children return to normal/above normal functioning by combining steps reflecting diet control, a combination of

antivirals, antifungal, and low-dose SSRIs.

Parents who are told that their children will never be independent, will never be able to earn a living, will 1 day might have to

be placed in an institution, have seen their children become top of

their class academically. I have children within the practice scoring

in the 97th and even the 99th percentile in California and Illinois

State testing. This past week, a mother came to me with her 5-

year-old child, who has been with me in the practice for about 8

months. She related an instance where the child said, ‘‘Mom, do

you want me to pretend I cannot talk? Remember when I could not

talk?’’ We have so misunderstood and misjudged these children. What

harm are we doing to these children as a result?

Hopefully, tomorrow, we will see new agents which will let us

work better with the immune system. If we can focus a unified effort to identify a subspecialized set of immune markers, that will

let us understand which patient is the most likely candidate for

which immune agent, separate out this mixed group of children

into logical subgroups.

In my written submission to the committee, the NIDS Medical

Board outlines a hypothesis which is supported by over 60 journal

references on children with autism and the neuro-immune disease

process that is potentially reversible.

It is interesting to note that that hypothesis has been reviewed

by at least four pharmaceutical companies, and there are no holes

or deficits in that hypothesis.

Within the NIDS Institute, our researchers are all heavily

credentialed, and many are involved in current NIH projects and

other activities at the NIH and the FDA. Using this technology,

their past experience, and a computerized data base, we can unify

researchers in institutions across the country. We can literally pick

and choose top physicians and researchers around this country and

around the world to focus on the crisis it has become.

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For instance, I am pleased to announce that members of the

Mind Institute are hopefully looking at joining and combining efforts, and my hope would be that many independent groups can

focus in a scientific manner on answering the questions being

raised by this committee today.

Another significant benefit of exploring this disease process with

a sense of urgency would be the unprecedented ability to screen

children who might be susceptible to vaccines or any other factors

which have been implicated as potential roles in subsets of these

children. Any injury or loss of a child that could have been prevented remains unacceptable. There is no way to adequately console the parent of a lost or damaged child.

If focused correctly, we do have the ability to accelerate understanding and identification of potentially high-risk children. If we

can identify these children, adjust their vaccine schedule appropriately, we have begun the process of stemming this epidemic and

will have created a preventive health policy which would be part

of a collective legacy for generations to come.

In 1996, I was a speaker at the Autism Society of America, attended by over 2,000 parents and professionals. My wife made the

comment: ‘‘Where are the M.D.s?’’ The medical community had essentially abandoned these children once they became labelled as

autistic.

The NIDS Medical Board is designed to help logically, academically, scientifically circumvent the expected learning curve as we

see physicians coming back into this field make a radical shift in

direction and orientation from what we might have been taught as

physicians.

I plead with you, Mr. Chairman and members of the committee.

These children are supposed to be a productive part of this country’s future, not a health cost and burden. These children have the

potential for full, productive, intelligent lives. Contrary to the old

idea, their genetics are not the determining factor. A child cannot

develop normally, develop some language, and lose it all, except in

a disease process. We can apply good, sound science and logic to

help solve the crisis now.

We must embrace what is literally a paradigm shift in the world

of medicine and begin to view autism and other related classifications like we do Alzheimer’s disease, cystic fibrosis, childhood cancer, and multiples sclerosis. Tragically, if we accept the status quo,

we will be sacrificing millions of kids and will likely lose more in

subsequent generations.

I implore you to investigate the concepts I have introduced,

evaluate them, test them—do whatever it takes to convince you

that we have a crisis for which inaction is politically and medically

more risky than action.

I am extremely fortunate to have three healthy children and one

healthy grandchild. I selfishly want the rest of my future grandchildren, all of yours, and others out there to have the same

chance.

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Thank you.

Mr. BURTON. Thank you, Dr. Goldberg. As I think you can probably guess, we are going to pursue this for a long time.

Dr. GOLDBERG. I hope so.

[The prepared statement of Dr. Goldberg follows:]

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Mr. BURTON. Dr. Megson.

Dr. MEGSON. Mr. Chairman, members of the committee, my

name is Mary Megson. I am a board-certified pediatrician, fellowship-trained in child development, a member of the American Academy of Pediatrics and on the clinical faculty at the Medical College

of Virginia.

I have practiced pediatrics for 22 years, and the last 15 years,

I have worked only with children with developmental disabilities,

which include learning disabilities, attention deficit hyperactivity

disorder, mental retardation, cerebral palsy, and autism.

In 1978, as a resident at Boston Floating Hospital, I learned that

the incidence of autism was 1 in 10,000 children. Recent surveys

have suggested an incidence in several parts of the country of between 1 in 300 and 1 in 600 children.

Over the last 9 months, I have charts now in an office that I

opened last June on 1,900 patients, well over 1,200 of whom have

fullblown criteria for autism. I have 70 autistic children in a clinical trial and I am beginning a second clinical trial to look at treatment on these children.

At the same time, the State Department of Education says there

are only 1,522 children with the diagnosis of autism in the State

of Virginia.

Mental health and mental retardation agencies have scrambled

to set up infant intervention programs and have had a hard time

keeping up with the numbers of delayed infants and toddlers. I

have served as an advisor for the city of Richmond and the surrounding counties as they set up these infant programs and also

set up special education programs for children with autism. Now

there are autistic classes in each county and several classes in several schools. There has been a very rapid rise over the last several

years, The segment of children with ‘‘regressive autism’’—who develop normally and then regress usually between 18 and 24

months—has increased dramatically. This past week, I was involved in four cases of children who were perfectly normal in their

development until they had their school-age shots at age 5—DPT,

hepatitis vaccine, MMR. Within weeks, they were autistic. In the

past, this was unheard of.

In the vast majority of cases, I have discovered that one parent

or another reports night blindness or other rare disorders associated with a defect in something called a G protein. G proteins are

proteins inside the cell that join receptors that sit in the cell membrane. They are cellular proteins that upgrade or downgrade signals in their sensory systems all over the body that regulate touch,

taste, smell, hearing, and vision. They are important also in turning on or off multiple metabolic pathways, including those for glucose, lipid, protein metabolism. They also turn on and off pathways

for cell growth differentiation and survival.

Close to the age of autistic regression, we are adding a second

defect to the G protein—namely, pertussis toxin—which completely

disrupts these G protein pathways. The opposite G protein pathways are on without the off switch.

In my research, I have discovered that some children are protected if they have the lipid-soluble form of Vitamin A, that’s found

in natural sources. Those children, especially those who are breastVerDate 11-MAY-2000 09:13 Feb 26, 2001 Jkt 000000 PO 00000 Frm 00426 Fmt 6633 Sfmt 6633 C:\DOCS\69622.TXT HGOVREF1 PsN: HGOVREF1
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fed—get the early vaccines in spite of having the genetic defect and

do fine. However, the measles/mumps/rubella vaccine at 15 months

of age depletes the body of all Vitamin A. When they get the DPT

the same day or several months later, many of these children disconnect.

There are several metabolic problems that I am seeing repeatedly in these children. The pathway to break down the storage

form of glucose in the body is on without opposition. These children

have elevated blood sugars. In the past week, I have been made

aware of four cases of autistic children who developed juvenile

onset diabetes. There is a 68 percent incidence of diabetes in the

parents or grandparents.

Lipid breakdown is turned on without opposition. I have diagnosed many 21⁄2-year-old children with autism who have serum

cholesterol of 240 and above. There is an incidence in one of three

of these families of heart attack of a parent or grandparent under

age 55 and diagnosed with hyperlipidemia.

Of great concern, cell growth, differentiation, and survival is

turned on, which leads to uncontrolled cell growth. In the first 60

families I examined, there were 62 cases of malignancies associated

with the RAS oncogene.

I have also discovered that the measles antibody that the body

makes, once they are exposed to the measles vaccine, cross-reacts

with intermediate filaments. Intermediate filaments are the glue

that hold the cells that line the gut wall together, so when they get

that MMR vaccine, they develop a leaky gut. Intermediate filaments are also important in areas of high stress. One of the areas

of highest stress in the human body is the upper small intestine

right below the stomach. They develop a chronic autoimmune disorder at that point.

The loss of the cell-to-cell connection also occurs in the bloodbrain barrier and in the cells that surround the bite annicul: where

toxins are excreted from the body. So any toxins that they are exposed to, leak through the gut wall, and they cannot pump them

out of the body.

The loss of cell-to-cell connection interrupts another process in

the body which is very important called aproptosis, or the ability

of neighborhooding cells to get rid of abnormal cells. The MMR vaccine at 15 months precedes the DPT vaccine, which turns on uncontrolled cell growth differentiation and survival.

Most families have reported cancers in parents or grandparents.

The genetic defect found in 30 to 50 percent of adult cancers is a

cancer gene, the RAS oncogene. This is the same defect that is the

defect for congenital stationary night blindness.

In Harrison’s Textbook of Internal Medicine, which is the standard textbook in medical schools all across this country, it is stated

that it is absolutely contraindicated to give the MMR vaccine or a

measles vaccine in the face of Vitamin A deficiency. I am afraid

that some of these children are facing that vaccine when they are

already deficient in their Vitamin A stores, and then they cannot

reconnect pathways.

Most of us in our current diets have the lipid-soluble form of Vitamin A taken out. This lipid-soluble form is found in liver, kidney,

milk fat and cod liver oil. In lowfat milk products, however, it is

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taken out, and another, water-soluble form is added which they are

unable to absorb.

Mr. BURTON. Pardon me, Dr. Megson.

You heard all those buzzers. That means that I have to run to

the floor and vote or else I will be voted out of office, which I do

not want to happen.

Dr. MEGSON. OK.

Mr. BURTON. So if you will please bear with me, I will get over

there and vote and get back just as quickly as I possibly can, because I am very interested in everything that you folks are saying,

and I do want to get answers to a number of questions.

We have two votes, and I will be back just as quickly as possible,

so we will stand in recess—there are how many votes—I think everybody had better get a cup of coffee, because there are four votes.

It is probably going to be half an hour before I get back. I apologize.

We stand in recess.

[Recess.]

Mr. BURTON. I really want to apologize to those of you who have

been so patient today hearing all the debate. It must have been difficult for you, but I am sure it has also been entertaining.

Would you close the doors in the back after everyone comes in?

OK. We left off with Dr. Megson in a very impassioned moment

of her talk.

Dr. MEGSON. Briefly, I was saying that in the vast majority of

these children, I get a history from one parent or another of a disorder associated with a defect in these major signalling proteins,

the G proteins.

As I approached my research, I looked through the eyes of these

children and tried to figure out what their world was like. Now

that I have talked with them and know what questions to ask

these children, I understand how these G protein defects affect

their perception.

They have a severe loss of rod function in their eyes. There are

four beautiful studies that have been published and out there for

several years that show this. They are then left with cone function

in which to see their world. Cones give us color and shape in our

environment. The only situations I could imagine having only color

and shape to organize my world are those ‘‘magic eye puzzles,’’

where you look beyond and back up, and then you get a box of 3D.

That is the only place in their visual field where they get a 3D impression of objects.

Mr. BURTON. Everything else is flat?

Dr. MEGSON. Correct.

Only then, when they look at a box, like television or a computer,

or a therapist who is sitting right in front of them, do they consistently hear the right words for what they are looking at. So that

most of the day, they are not hearing the right words for what they

are looking at, because they only have one area of their visual field

where they see 3D.

I have treated some adults, and one adult I am treating in Alabama calls me every week and gives me the measurement of his

‘‘box’’ as it grows, and he gets better, which is really fun.

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The other areas of perception and sensory perception are controlled by G protein pathways as well, and adding a second defect

to these children, who on a genetic basis probably have a first defect, changes multiple sensations. Their avoidance of eye contact is

an attempt to have light land off-center in the retina, where they

have some rod function. So when they look away from Mom, they

are actually looking at Mom. When we make them force their pupils directly in front of us, we are making them look away from us.

With this form of natural Vitamin A treatment, within days, they

look right at you.

The other things that happen in these children—suddenly,

Mom’s touch starts to feel like sandpaper on their skin because of

modulation of touch; common sounds sound like nails scraped on

a blackboard. These are words that autistic children have given me

as they have gotten better.

We think these children cannot abstract, when actually, we are

sinking them into the middle of an abstract painting at 18 months

of age, and they are left trying to figure out if the language they

are hearing is connected to what they are looking at at the same

time.

This defect for congenital stationary night blindness is on the

short arm of the X chromosome, which explains the male-to-female

ratio autism, and it affects cell membrane calcium channels that

Dr. Goldberg just referred to in the hippocampus. These are the

NMDA/glutamate receptors in the hippocampus. These pathways

are where major pathways processing language cross from the left

side of the brain to the right. The pathways then go back through

the hippocampus. The frontal lobe is where attention is added, executive function, inhibition of impulse, and all social judgment.

When stimulated, these NMDA receptors through their G proteins stimulate other receptors in the nucleus of the cell, right

there at the hippocampus. These receptors were discovered by Ron

Evans in December 1998. In the animal model, when they are

blocked, the mice are unable to learn or to remember changes in

their environment; they act like they have significant visual perceptual problems, and they have significant spatial learning deficits.

Of great concern to me is that when the hepatitis B virus was

initially isolated, the protein sequences were isolated and inserted

into the gene for one of these Vitamin A receptors, RAR beta. This

is the critical receptor important for plasticity and retinoid signaling in the hippocampus in this area of major pathway intersection.

We will have to look at the vaccine and see if there is any defect

being produced by that related to the recent increase in autistic

spectrum disorders.

What I am treating these children with is the natural, lipid-soluble form of Vitamin A. I am giving them their recommended daily

allowance only of Vitamin A in the form of cod liver oil to bypass

these blocked G protein pathways and turn on these central

retinoid receptors.

In a few days, a lot of these children look at me, focus, they regain eye contact, and they talk about their box of vision growing.

After 2 months on this Vitamin A treatment, I give them a single

dose of a medicine called bethanechol, which stimulates pathways

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in the parasympathetic system in the gut. What I have discovered

is that there are nerve receptors in the gut called acetylcholine receptors, or muscarinic receptors which are blocked in these children. This medication mimics acetylcholine. It does not cross the

blood-brain barrier. I give it to these children in the office, and

sometimes, 30 to 40 minutes after the initial dose, after having

pathways corrected for several months of Vitamin A, when I bring

them in and give them this medicine and observe them, they connect in the office. I have had children look at me, talk, act out, talk

back to their mothers, and use vocabulary above their chronological

age. This is a disconnect, and I have seen this again and again and

again. Bill Walsh in Chicago has seen it; Woody McAinnis in Arizona has seen this change.

In one child I have treated beginning last April, her IQ score has

gone up 105 points, from 60 to 165.

This treatment improves cognition, but these children are still

really physically ill. Their Vitamin A stores are depleted, oftentimes before and if not before, at the time of the MMR vaccine, and

they cannot compensate for these blocked pathways.

Vitamin A has been called the anti-infective agent. It leaves

them immunosuppressed when they are depleted. They lack cellmediated immunity. Adding a second defect to this GI alpha protein blocks a very important pathway in the body where you convert retinol into something called 14-hydroxy retro-retinol. 14-HRR

is needed to turn on T-cells.

I give these children cod liver oil—cold water fish oil is the only

natural source of 14-HRR—and the children get well.

The parasympathetic nervous system which is blocked in the gut

is part of what I call the peripheral nervous system. We think of

the nervous system as having two major parts. The central nervous

system is the brain and spinal cord. The peripheral system is divided into two parts. The sympathetic nervous system is your fightor-flight response—everything that happens to your body when you

run away from danger—you dilate your pupils, increase your heart

rate, and increase your blood pressure. The parasympathetic side

of the peripheral nervous system allows us to sit back, relax, focus,

and digest our food. We are blocking the parasympathetic side of

the nervous system, and these children are in fright or flight all

the time.

I have asked someone to bring these panels out so you can look

at these children and see their faces.

I live in a small middle-class neighborhood with 23 houses. I recently counted 30 children who were on stimulants for attention

deficit hyperactivity disorder. One week ago, my oldest son, who is

gifted but dyslexic, had 12 neighborhood friends over for dinner. As

I looked around the table, all of these children but one had dilated

pupils. After 21⁄2 months of taking his recommended daily allowance of Vitamin A and D in cod liver oil, my son announced: ‘‘I can

read now. The letters do not jump around the page anymore.’’ He

can focus, and his handwriting has improved dramatically.

In a survey in his private high school for dyslexic students who

are bright enough to go to college, 68 out of 70 of those children

reported night blindness. They see headlights like starbursts, and

they get a whiteout when their picture is taken.

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I think we are staring a national disaster in the face which is

affecting thousands of American children. The children with autism, ADD, dyslexia are lucky in a way, because they are identified. There are many other children out there who are not identified and who have just been disconnected.

We must direct all of our resources and efforts to establish multidisciplinary centers to treat these children. Insurance companies

should pay for evaluations, both medical and psychiatric, and treatment.

For over a year, I have been paying for speech therapy for these

children. They are able to talk, but they do not know what to do

with their mouths. I have had 10-year-olds wake up and talk. Insurance companies do not pay for rehabilitative services for these

children. These children are physically ill, immunosuppressed,

have a chronic autoimmune disorder affecting multiple organ systems. We must get funding to look at the etiology of autism and

identify these children prior to autistic regression and prevent this

disorder. Implementing vaccine policies which are safe for all children should be our first priority.

Mothers from all over the country have brought pictures of their

autistic children to Washington this weekend. Most of these children were born normal and lost to ‘‘autistic regression.’’ Look into

their eyes, and you will hear their silence.

Mr. BURTON. Thank you very much. We are going to read the

text of your comments very thoroughly.

Dr. MEGSON. Thanks.

Mr. BURTON. Dr. Upledger.

[The prepared statement of Dr. Megson follows:]

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Dr. UPLEDGER. Thank you.

I am John Upledger. I am an osteopathic physician, and I thank

you for inviting me to come and present today.

I should probably tell you a little bit about my background first,

because you will understand that I am coming at autism not in disagreement with anyone but by adding another parameter to it.

First of all, I used to teach biochemistry, so the molecular things

are not new to me. I practiced general medicine and surgery for

about 11 years in Clearwater, FL and then got into the rather

avant garde things, and they invited me up to Michigan State University, where I became a clinician researcher in the Department

of Biomechanics.

Being a researcher in biomechanics, I was researching a system

which ultimately became called the craniosacral system. The

craniosacral system is simply a semi-closed hydraulic system. The

boundary of the hydraulic system is the dural membrane which encases the brain and spinal cord and provides sleeves for all of the

cranial nerves and for the spinal nerve roots. The fluid inside it is

cerebrospinal fluid, essentially. Of course, there is blood flowing

and so on and so forth within vasculature, but it is not really part

of the system. And it is called ‘‘semi-closed’’ because the inflow of

the volume is controlled, and it is rhythmical, and the outflow is

rather constant and reabsorbs the fluid; so you have a circulation

of fluid with a rhythmical rise and fall of fluid volume and pressure

within the system.

If one looks at advances as we go along, we used to think that

cerebrospinal fluid bathed the surface of the brain, and that is

what it did. About 8 years ago, it was very definitely shown using

radioactive tracers that cerebrospinal fluid is formed in the ventricles of the brain, and within seconds of its formation, it not only

bathes the surface but it penetrates all the spaces between all the

cells that form the brain; it also goes down the spinal cord internally as well as externally.

More recently, in a symposium called ‘‘Neuroprotective Agents’’

by the New York Academy of Science, I came across a piece that

had just been discovered, that is, that cerebrospinal fluid not only

circulates nutrients and carries away waste products, but it also

has chelating agents in it, so it cleanses the brain of metallic deposits, which would be the mercury, the aluminum and that kind

of thing.

So it is very important, and if you look at it this way, it is extremely important, that cerebrospinal fluid flow be kept moving.

Stagnation of cerebrospinal fluid is going to lead to brain dysfunction.

In my work at Michigan State in developing this department, developing this whole system, what happened was that it was decided

that I would be working with brain-dysfunctioning children to see

the applications. Autism happened to be one of the things that I

was assigned to, so for 3 years, I spent 2 days a week at the

Genessee County Center for Autism, and I went in there not even

understanding the first thing about what autism was.

We did work with what was called hyperkinesis in those days,

and we found out on a structural level that the hyperkinetic child

could be relieved of his hyperkinetic activity if we released a comVerDate 11-MAY-2000 09:13 Feb 26, 2001 Jkt 000000 PO 00000 Frm 00438 Fmt 6633 Sfmt 6633 C:\DOCS\69622.TXT HGOVREF1 PsN: HGOVREF1
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pression at the base of his skull between the first cervical vertebra

and the occiputal base. Tracing this backward, this happens a lot

during delivery. The baby is face down, the obstetrician assists the

baby coming out under the pubic bone, the head comes base or forward, and the cervical vertebra goes that way, and they jam together. You release that jamming, and you get rid of your hyperkinesis in a matter of minutes many times.

That is not the only cause for hyperkinesis, but when it is there,

and you release it, it is very definitely going to show you clinically

that it is over.

We also found out that in newborns we could treat colic this way.

When I got into looking at autistic behaviors, there were several

things that we noticed, and being a novice, I was not about to accept anybody’s word for anything. I went over there with a

neurophysiologist and another fellow who was a generalist in

science, a design specialist, and we started going every week,

Thursday and Friday.

Our observations showed first of all that a lot of the kids were

banging their heads. There were 28 kids in that first year we went

there. I noticed their head-banging, and they were chewing on their

wrists; they would get all the way down to the tendons sometimes.

We were also told they sucked on their thumbs, and I saw that, but

they were not making an airtight things with their lips; what they

were really doing was pushing up on the base of their skulls.

So we thought about this a lot, and one would say, OK, they are

banging their heads, and this happened at a behavior modification

center that we were working at, so I had them take the helmets

off, and we let them bang their heads and watched very carefully,

and it looked like they were trying to knock something loose in

their heads, as if something was jammed together.

When we started looking at their wrists and everything, I

thought, OK, maybe they are inducing a controlled pain for a pain

they have in their head that is uncontrolled, because I think anybody here would agree that sometimes when something hurts, and

you just cannot get to it, you will give yourself a pain somewhere

else, and it at least gives you some sense of comfort. And the other

thing that might be happening is when they are chewing, they are

inducing endorphin production and getting that natural analgesia,

because endorphins are like a natural morphine.

The thumb-sucking clearly, to the point where it was causing the

teeth to protrude forward over a period of time, the thumb-sucking

clearly was an attempt to mobilize the base of their skull.

Anatomically—and now I am in biomechanics, so I am thinking

anatomically, and what I am doing a lot of on the other days off

is getting very fresh cadavers, dissecting them, studying membranes and all of that kind of thing on the inside of the head, so

I am tying these two things together. So we began to get the idea

that the cranial rhythm or the movement inside that head was not

giving the amplitude that we were looking for in other children.

The autistic head just did not have the craniosacral rhythm, the activity, so it was not pumping cerebrospinal fluid.

Hence, you would get an accumulation of toxic metals. You would

also get a deficit in the delivery of fluid carrying nutritional agents

and carrying away metabolic byproducts. You would also get a

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thing that we began to understand clearly, and this became the

model we put forth after about the second year, and that is that

something occurred to denature the membrane biochemically so

that it would not expand and accommodate the normal growth pattern of the skull as it was trying to expand in the brain and trying

to grow. If the brain is trying to grow against the resistance of a

membrane that is having difficulty expanding, you are going to cut

down cerebrospinal fluid exchange and you are going to cut down

blood flow.

We finally got into it and started decompressing heads forward

to backward in this direction—forehead forward, back of the head

backward. We would just sit there and hold it, a small force over

a long period of time, and ultimately, the head would begin to expand in that direction. When it did, those things that looked like

they were trying to create their own pain—the thumb-sucking

stopped, the head-banging stopped, and the wrist-chewing and that

kind of thing stopped—they stopped spontaneously after we released that particular forward-to-backward compression.

That was probably very close to 100 percent response. Now, you

had to spend a lot of time to get an autistic kid to lie on a table

in an autistic center and let you work on them and have them be

quiet, but after we saw them three or four times, they would actually come in, lie down on the table, take your hands and place

them on their head where they wanted them. And I would go along

with that.

The next thing I wanted to do was expand the head side-to-side.

I had a lot of graduate students with me all the time and did not

know what to do with them, so I would put one student on each

leg and one student on each arm, and I would just start expanding

the head laterally. Well, we found out that after we got that expansion done laterally, first of all, the child would very, very much

relax, and the body would go into all kinds of contorted positions

and stay there. As they stayed in that contorted position, you could

feel energetic changes going on throughout their body, and when

they finished that particular thing, they were very liable to turn

around and kiss you and give you a hug. And after that, they became sociable.

So what I am looking at is a model here that says, OK, decompress these membranes. What caused the membranes not to expand? And then, historically, we started looking at it. Febrile episodes were extremely common. The fever could be due to a vaccine

reaction, it could be due to a viral infection, it could be something

in utero that occurred when Mom had a little fever when she was

still pregnant. And it seemed as though it was taking about 2 to

3 weeks historically for most parents to discover the signs of the

changes occurring which were later called ‘‘autism’’—after the febrile episode.

So we chalked up the idea that most likely febrile episodes could

cause a change in the biochemistry of the membrane so that it did

not accommodate the growth process as readily as it could. Now,

that does not fly in the face of genes at all, because I am sure that

genes control some of the accommodative process of the dural membrane, and therefore, if they have a genetic predisposition to a

membrane that is vulnerable, it takes a smaller shock to make the

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membrane become less accommodative. That does not bother me at

all.

We also found—after I got this going, I was invited to London to

start an autistic treatment program for children in a craniosacral

therapy clinic, and again, in Brussels. And in London, I have to tell

you that I wound up evaluating children that I thought were autistic from a craniosacral evaluation perspective—I wound up with 42

children in that clinic, and I was there for about 4 days evaluating

them—and 38 of the parents out of the 42 said the febrile episodes

were subsequent to a vaccine. And most incriminating—and this

would be in the late seventies—the vaccine most incriminated by

the parents in their opinion was pertussis.

When I went to Brussels, it was an entirely different thing. The

feel of the head, the energy patterns in the head, everything was

different. Almost all of the autistic kids I picked up there had been

delivered by vacuum extraction—that is where they put the suction

cup on the head and just pull. If you consider a plumber’s tool, and

you clamp it on the top of the head and pull, what you are going

to do is extravasate a lot of capillary blood, and when blood breaks

down and deteriorates, it becomes bile in one of its stages, which

is extremely irritating, so the tissue that has these red blood cells

that are deteriorating begins to contract and cause scarring and

lose its accommodative ability. In Belgium, that was the main

cause we came across.

In this country, there is a great variation. At the autistic center

where I spent the first 3 years of my experience, I would have to

say that two-thirds of those kids were in foster homes, so we did

not know much about their backgrounds. But when I finished the

contract for autism at the Genessee County Center in Flint, we

opened a clinic at the university, and there, I have to say that

probably 50 percent of the parents were totally convinced that the

autism was secondary to a febrile episode which more often than

not, they related to a vaccine reaction. And I do not say that that

is yes or no, but I say it certainly does deserve a healthy look.

Some of the things that I would like to share with you that we

did—and it is interesting that Dr. Megson talked about parasympathetic, because one of the pieces of research we did on our autistic

children was to monitor with a thermograph the hand as we were

stretching the membranes in the head. And as we got some releases, the temperature of the hand would go up 2 or 3 degrees

Fahrenheit, which indicates that the blood vessels in the hand are

relaxing; you are getting better blood flow. And in order to get better blood flow, you have to reduce the activity level of the sympathetic nervous system which she was referring to, and that is the

flight-or-fight system.

So we were able to reduce their sympathetic activity by working

on their head and stretching their membranes.

Now, the whole thing begins to make a lot of sense if you consider, then, the things that we were watching happen. If we got a

child’s membrane stretched in all directions, and he was feeling

pretty good, he would take on a lot of good behaviors; and if we

got that to happen and then—our research was always held up

from June until September when school was out, getting the contract renewed and all that kind of thing, so we had a lot of children

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who did not receive treatment for 2 or 3 months, and they would

regress. I look at it this way—their head is trying to grow, and

their brain is trying to grow, but they need a mechanical stretching

activity which is craniosacral work to keep the membrane spreading enough so that it will accommodate that intended growth process. And if you do not have that for a while, then you begin to regress because the pressure on the brain and the reduction of fluid

activity, the reduction of blood flow, all begin to recur.

So the next thing we try to do—and we have done this successfully I would say with 30 percent or so of our parent groups, and

I did not have the opportunity to do it the way I would really like

to—but we taught them to do this treatment process once a week

and maybe see a therapist every 6 weeks or so. That seemed to

work if the parents were willing and able to learn how to do it. It

is not hard once you get the initial job done; then it is a question

of maintenance, which is not too difficult. And that is one of the

things we look for.

I left the university in 1983 and took time out to develop a prototype for a holistic health center for Unity Churches, and then we

started our own institute in 1985, at the end of 1985. Since that

time, the way we handle the problems is, first of all, we do not always focus on autism, because the kind of difficulties we have with

the craniosacral system can involve anything from autism to hyperkinesis to chronic pain—seizure activity is a big one we work

with—and all those kinds of things, but about four times a year,

we will have a special intensive program for just autistic children.

That is what we do, and we try to help the parents learn how to

work with it. And when I say ‘‘intensive,’’ it is a week, and it is

from 10 a.m., until 6 p.m., and it is hands-on work almost all the

time. During that week, we get things pretty well taken care of.

And I do not think we have had a child yet who did not show at

least 50 percent improvement during that period of time, and most

of them do significantly better than that.

That is about where I am.

Mr. BURTON. Very good. That was a very good lecture. I enjoyed

that, and we will have some questions about whether or not any

of our health agencies have picked up on your procedures.

Dr. UPLEDGER. Thank you.

Mr. BURTON. Dr. Pratt.

[The prepared statement of Dr. Upledger follows:]

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Ms. PRATT. Mr. Chairman, thank you for the opportunity to

present testimony today concerning autism treatment options and

research. I am here today kind of in multiple roles, first as director

of the Indiana Resource Center for Autism, located at Indiana University’s Indiana Institute on Disability and Community, and as a

board member of the Autism Society of America.

I would like to commend you and thank you for holding this

hearing. I think that for too many years, the voices of some of the

children you see on the posters have not been heard; this gives

them a wonderful opportunity to be heard.

While I have your attention, I would encourage you to do two

things. One is to continue funding the Centers for Disease Prevention and Control in terms of looking at the incidence and prevalence of autism. As I was working with your office on providing testimony for today, it is clear that we do not have a true idea of the

incidence and prevalence of autism across the United States.

The other thing that I would encourage you to do is to work with

your colleagues on supporting H.R. 3301, which is the omnibus

children’s health bill, which would provide clear direction to the

CDC and the National Institutes of Health.

I am probably the oddity on this panel. I am not a physician. I

spend a lot of time in classrooms and in homes and around the

State of Indiana, visiting children and their families and their educators and other professionals who support them. And while I know

that there is broad disagreement about whether there really is an

increasing incidence of autism, I know that we are incredibly busy.

I know that I hear from professionals out in the field and from

family members that they truly are seeing many more children

than they ever saw in the past. So I have to listen to their words.

In terms of the potential causes of autism, I hope you realize

that autism is referred to as a ‘‘spectrum disorder,’’ and along with

that, that probably reflects the idea that there is a spectrum of reasons why children do develop the characteristics associated with

autism and that each of the professionals and family members who

are here today are painting just a piece of that picture for you. I

would really encourage you to propose legislation and funding that

will look at the possible multiple causes of autism, and along with

the vaccination issue, the issues around environmental situations

and other issues which parents keep reporting as being possibly related to the occurrence of autism.

I have never heard from any of the families an issue about

whether they want to vaccinate their children or not. I think the

issue is in terms of safe vaccinations. As a professional in the State

of Indiana, I know there is broad disagreement about whether

there is a link between autism and vaccinations.

As a professional who works with families every day, here is my

position. If I could have helped those four families who are here

today to avoid having a child diagnosed with autism by giving

them accurate information, I would have done so in a heartbeat regardless of what the research tells us. I think that is the issue that

all of us face, that when the research may not be proving it, when

we hear the stories, we want to avoid further stories being told.

In addition to looking at the research behind causes, I would also

encourage us not to forget about the 500,000 other individuals and

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their families who currently have a diagnosis of autism and the

needs that they have. The families and several of the panelists

today have talked about some of those needs.

The first one is in terms of early intervention. I really applaud

the National Academy of Sciences and the National Institutes of

Health for starting to look at the essential components of early

intervention programs that are most effective. I think we have focused a lot of effort on looking at specific programs, and while

there is some broad disagreement about which of those specific programs is most effective, I think there is some general agreement

arising about the components of those programs, and I hope that

those things will really be looked at.

Based on the testimony that I have heard during the National

Academy of Sciences meetings, it is very clear that additional research is needed to try to really build a case for the various components of effective programming.

The next issue that I would like to cover is full funding for IDEA

and the professional development efforts. In a recent report, it was

noted that 44 out of 50 States are not in compliance with the ‘‘free

and appropriate education’’ mandate of the Individuals with Disabilities Education Act. While those reasons may differ from State

to State, I believe part of the reason is due to funding.

In addition to that, there is a tremendous need for trained professionals in the field. Sometimes, professionals are placed in the

role of supporting challenging individuals, and they do not receive

any training or guidance or assistance in being able to do so. So

I would really encourage that we look at providing funding support

to States for continued professional development.

In addition to that, you have heard from many of the parents

about the need for accurate information to pediatricians and other

physicians who play a critical role. They are oftentimes the first

people that parents talk to when they think their children may

have a diagnosis of autism. The information that they can provide

to families can help to set them on either the right track or the

wrong track. So I really encourage education for them.

Another issue that I hear a lot from families is in terms of insurance coverage and funding sources. In my written testimony, I provide the example of a family in Indiana that was denied coverage

for their child’s appendectomy because he had a diagnosis of autism. Autism is considered a pre-existing condition by some insurance companies, so these children are excluded from insurance coverage.

I hope you realize the tremendous accommodations that the families that you saw today have had to make to be here today, and

in their lives on a daily basis. The tremendous financial devastation that many of them face, the stresses on their marriages—and

I am so glad to see that many of them are here, fathers and mothers together—the stress on their entire lives is just unbelievable.

You know first-hand as a grandparent how tremendous the stress

can be.

I also need to tell you that your support is greatly appreciated

by the autism community. Your support is even more greatly appreciated by your daughter today.

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I also hope you realize that when insurance companies turn families away, they look to other funding sources, whether State or

local agencies, and in many cases, that money, that funding, is

nonexistent or is inadequate for the family support needs. Families

are told that they have a window of opportunity for their children,

and at that point, they have run to get those services and supports

that they need; and when they are denied the funding they need

to be able to provide those services, they will do anything and risk

tremendous devastation to be able to reach those goals.

A population that I hope we will not forget is the adults who

have autism. We have a high percentage of individuals who remain

unemployed, who are very competent, talented individuals with autism; others who are underemployed or in jobs which really do not

match their talents and skills and interests.

In addition, many of them choose living options that are only a

far-off dream—to live in a community, to have access to the same

rights and privileges as every other citizen of the United States.

While progress has been made in this area, much is still left to do.

While I commend the committee for taking this opportunity to

listen to families today, I also urge you to support authorizing legislation and appropriation provisions that will further the state of

autism research. While much progress has been made, remember

that there is still much to do.

Thank you.

Mr. BURTON. Thank you very much, Dr. Pratt.

Dr. Hirtz.

[The prepared statement of Ms. Pratt follows:]

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Dr. HIRTZ. Mr. Chairman, I am Deborah Hirtz of the National

Institute of Neurological Disorders and Stroke [NINDS], at the National Institutes of Health.

I have been asked to appear before you today to give the committee and the families of autistic individuals who are here a sense of

what we have learned from research, what we hope to achieve, and

I want to explain that we at the NIH share the sense of urgency

that autistic individuals and their families and advocates feel with

regard to unlocking the mysteries of this devastating disorder.

As a physician who takes care of children with neurological disorders including autism, this urgency has a particular intensity for

me as well. By presenting information about a broad array of NIH

autism research activities, I will try to convey to you the strong

commitment of the NIH to increasing our knowledge about autism,

what causes it, how best to diagnose and treat it, and we hope not

too far in the future, perhaps even how to prevent it.

I would also like to tell you that over the last 5 years, the total

NIH funding for autism research has nearly quadrupled. It was

$10.5 million in fiscal year 1995 and $40 million in fiscal year

1999.

We now know that autism is much more common than we previously thought. Estimates vary widely, but recent studies suggest

that as many as 1 in 500 people may be affected by some form of

autism. Recent reports suggest that the number of children with

autism may be increasing substantially. It is not clear whether the

reported increases can be accounted for by improved or expanded

diagnosis, or by the increasing availability of services for autism

and it would be necessary to study the trends of that prevalence

over time.

The NIH recognizes the pressing need to look into these issues

and to do this work and is actively working to design studies that

can give us knowledge in these areas. Accurate and consistent diagnosis of autism is one of these difficult areas. To address this

problem and in response to the requests of concerned parents, the

NIH sponsored a 1998 meeting of major medical and professional

societies, parent advocacy groups and Federal agencies to review

existing evidence for autism screening and diagnosis. Based on the

assembled research and evidence, a consensus statement is near

completion as a practice parameter, which is a professional guideline for recommended procedures, criteria and timing for screening

and diagnosis in autism. This will be the first time that such a

multidisciplinary group has reached consensus on screening and diagnostic procedures in the area of autism. The specific practice parameters or clinical recommendations, once approved, which we expect to be shortly, by the boards of various relevant professional societies, will be published in widely read medical journals.

In the vast majority of cases, no specific underlying cause of autism can be identified. A variety of genetic, metabolic, infectious

and unknown factors may be important. The NIH supports research directed at exploring the possible role of these various factors and is exploring the feasibility of a very large, multi-agency,

prospective study that could shed light on some of these questions.

A working group convened by NIH in 1995 reached a consensus

that for at least a significant subgroup of people with autism, there

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appears to be a genetic susceptibility that most likely involves multiple genes, and the NIH has conducted two major meetings on the

genetics of autism.

An exciting development this past year has been the identification of the gene for Rett syndrome, an autism spectrum disorder.

In addition, genetic ‘‘hot spots,’’ potential chromosomal locations,

for more classic forms of autism have been identified. In another

area, NIH is supporting a major pediatric brain imaging initiative

to learn how the brain develops in normal infants, children and

adolescents. This will provide important data for comparison in

studies of developmental disorders such as autism.

Although there is currently no known cure or treatment which

can reverse all the symptoms of autism, interventions designed to

alleviate specific symptoms are available. In November 1999, the

NIH held a workshop in conjunction with the Department of Education on treatments for people with autism and other pervasive

developmental disorders. The purpose of this workshop was to

evaluate the current biological, behavioral, psychopharmacological

and biomedical treatments in autism and to identify critical research needs in autism treatment. The written reports and recommendations from the working groups at this meeting have recently been assembled and are currently being reviewed by the

members of the NIH Autism Coordinating Committee, which is a

group from various institutes involved that coordinates the NIH research activities, and also by the representatives of autism advocacy groups to see where we go from here in pursuing various avenues of treatment research.

I have just very briefly described some of the NIH autism research activities. There are several more presented in my written

testimony.

I would like to add that autism research is a major priority for

the NIH, and we are committed to continuing to work to expand

our efforts.

I have tried to stick as closely as I could to the 5-minute limit,

Mr. Chairman, so that concludes my prepared statement, but I

would be pleased to respond to any questions you might have.

Mr. BURTON. And your full statement will appear in the record.

Dr. Cook.

[The prepared statement of Dr. Hirtz follows:]

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Dr. COOK. Thank you, Mr. Chairman, for the opportunity to testify on the topic of autism. I am, as some have before, speaking as

someone wearing three hats—actually, first, as the brother of the

late Kenneth Wade Cook, who had many of the problems of children and adults with autism; I am also speaking as a child and adolescent psychiatrist who cares for many patients with autism, and

as a biomedical researcher trying to increase our knowledge of the

causes of autism and, above all, to try to increase our ability to

treat this devastating disorder.

It starts with me recalling being an 8-year-old boy with a 2-yearold brother who my family had just realized was not developing

normally. I remember vividly the pain of my parents. I further recall that we went to a meeting where, to my recollection—I will not

speak for my parents—we were told that it was known from theory

about what was known of the brain at that point that ‘‘patterning,’’

a way of moving the arms and legs, a special diet, re-breathing

through a mask, and related methods still practiced today in various forms, would cure his problems.

I remember our family being skeptical from the beginning of that

meeting. However, by the end of the meeting, we and the other

families in the group were sold on this treatment because it was

too painful to accept what we knew was happening.

If there is anything I have not forgotten, it is that hope is something essential in working with children with severe challenges—

for the children, for the families, and for all of us.

I am very thankful to those who were interested enough that far

back in children with developmental problems to have spent so

much time with my brother and my family and to be with us. They

knew that providing us the tools to work to teach my brother the

basics of communication and motor skills was very helpful, and I

suspect that many of them were practicing this method for the

same reason we were—they simply had to try.

I could complain about the 5 a.m. mornings in which as a child,

it was physically exhausting to perform the patterning, but I am

sure it was good training for being a physician-scientist, or perhaps

a Congressperson.

However, I am not pleased that there was not more time spent

teaching me to play with my brother instead of trying to teach him

to read just to show that their method was working, when it was

not even close to being an appropriate next step.

Our family learned to accept and love my brother deeply. I would

like to add that at this time, the preferred professional response

was to tell you to put your child away at birth. And some of our

increased awareness, I am afraid, actually positively, is that we do

not simply ship the kids away. We felt sort of like we were going

against advice to keep him in our home, which we did for 10 years.

I am very thankful that children today have more opportunities

for education due to congressional legislation. Excellent community

support and model community support in St. Louis was vital to my

family during my brother’s last year. Mostly, I miss him deeply,

since his death remains as unexplained as his original problem, although the two are certainly related. It reminds me that not only

is there much suffering, there is also death with this disorder.

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Obviously, I am also a physician-scientist because I cannot accept

this, even after he is gone. Having several hats, as brother, physician and scientist can be extremely painful. I recall my anger as

a child when investigators found that patterning was not effective.

As it turns out, I collaborate with people at the same institution

at Yale today—but I wondered how could they do such a thing, and

how could I now be in their shoes, now that I have studied secretin

and have failed to find that it is working as much as initially

claimed.

The only thing in my defense, frankly, fighting myself here, is to

say that I actually shed a tear when the data were analyzed for

secretin, because even though at the bottom of it, there is not a lot

of plausibility, I do not care—I deeply wanted this to work. And

that is probably what my anger is, that all these things have not

provided what they say they will, and I am the first one who wants

them to work.

So our laboratory, not being satisfied with the status quo, has

worked on neurochemistry, neuroendocrinology, neuroimaging and

neurogenetics of autism. The reason for our current focus on genetics is the data, not our impressions or our wishes, show it to be the

most powerful influence on the etiology of autism—and many have

been studied carefully—maybe not carefully enough.

It is not the only influence—I would agree with what has been

said several times—it is certainly not the only influence in autism,

and it is certainly not a simple, single-gene disorder. If it were, we

would know for sure what that single gene was.

However—and this is very important—it is a rare event in my

lifetime to realize that suddenly, molecular-genetic study of autism

spectrum disorders provides one of the best scientific opportunities

in medicine. I must say that usually throughout my career, I have

had my passion, and my colleagues say, yes, it is very important,

but there is no scientific opportunity; we cannot learn anything

there. In genetics, we are actually ahead of most other medical disorders when we study autism.

In terms of why study genetics of autism, I think it is unlikely—

and I would have said this before recent events—that gene therapy

will be the result of genetic research in autism. It is also unlikely

that genetics of autism will explain a relatively recent increase in

measured autism prevalence.

The point of genetic research is to develop treatments that will

correct the missing or abnormal signals for a small set of nerve

cells in the amygdala, hippocampus and cerebellum so that the

nerve cells mature. I very much agree with those who are optimistic on this point. These are not children who have brains that cannot further develop. That is my view, but it is a view as a scientist.

You do not see the kinds of changes in the brain that would make

things not able to move forward.

If we knew the signals, what has long been a too complicated

puzzle of autism would become simple enough for us to understand.

We are all challenged in a sense in trying to make sense of this.

So although the simple idea is to provide gene therapy, oral delivery of more traditional small molecules, which we usually refer to

as ‘‘medications,’’ is likely to be more feasible and preferable, partly

because there are few treatments that we have not wanted to take

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back. That is certainly something that I have learned as a physician—I try things, and they make sense, but if they do not work,

it is time to stop them.

Two recent developments in the broader field of developmental

disorders show that complex situation may be better understood

through molecular genetics. The first is the finding of the gene for

FRAXA, or Fragile XA mental retardation. This is very relevant to

autism since a substantial proportion of children with FRAXA have

autism spectrum disorders. Although one wishes knowledge of a

gene will lead to new treatment sooner, the results of a decade of

research in FRAXA to understand the mechanism of this disorder

is leading to an almost exponential growth in understanding complex interactions of molecules in the process of learning.

Mentioned earlier, which is actually quite historic, was the recent finding of the gene for Rett syndrome, because this is actually

finding a specific gene for an autism spectrum disorder. It is notable that it is caused by a single gene, MECP2, but that it has a

course of regression in social behavior and communication between

the first and second birthdays. Knowing the gene has led to a

breakthrough in the systematic approach to investigation of Rett

syndrome in terms of how it affects the development of the brain,

and this is already moving us forward.

Although we do not know the specific genes involved—and I

would agree with that, and it is definitely something that is personally frustrating today—several groups have been finding evidence that an extra part of chromosome 15 leads to a high risk for

autism, especially if inherited from the mother. Believe me, based

on the history of autism, if I could have it come out another way,

I would; but this is simply the origin of the chromosome and has

nothing to do with the mother’s behavior, as the theory went in the

past.

Although this is responsible for less than 4 percent of cases of

autism, these 15q11-q13 duplications, like Rett syndrome and

FRAXA, are helping us understand autism with regression, because all three of these often have this as a component, more generally.

Several laboratories including our own are searching for a gene

in this region. As an example of our concern in genetics about not

wanting to waste precious resources, the probability at this point

of there not being a gene in this region is about 5 in 100,000 with

the most rigorous blinded studies. But we are not sure yet, and

that is just the way it has to be, because we may expend our resources in the wrong direction. We are close to sure at that level.

Of course, the problem is that we will have to get beyond regions

with likely autism genes to actually finding the specific changes

and then getting on with the work of using the information to improve treatment, because that is the point.

So it is a good thing there are people doing excellent clinical research and trying to improve educational and other interventions

while we are working out the fundamental causes, with many others. However, it is important not to think we have more of an effect

than we can back with controlled data.

The history of autism teaches that zeal without skepticism may

have negative consequences. The first was blaming mothers, and

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the second was false accusation of fathers of children with autism

of abuse when their children were undergoing facilitated communication. That was probably the biggest problem that we had last

decade in terms of things that, on their face, should not have bad

consequences but did.

The challenges of autism research are obvious. In terms of needs,

I mostly want to thank Congress for the appropriation of increased

funds for biomedical research generally. All of the pertinent NIH

institutes are now actively engaged in the support of autism research.

A simple statement of needs is that there are many important

and feasible questions about autism not able to be asked with current resources. There are not enough well-trained researchers in

the field, partly because, in spite of the figures that they have increased, I question that it was much more than zero 5 years ago.

Most importantly, questions that are being asked efficiently, such

as in the area of molecular genetics and others, are not being answered at an optimal rate given current funding in this area. That

is not OK for me, because my patients are aging with me, and

more are being born. Again, I am not criticizing the funding but appointing a statement of scientific opportunity that we do not want

to miss.

I thank you for the opportunity to communicate.

[The prepared statement of Dr. Cook, Jr., follows:]

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Mr. BURTON. Thank you, Dr. Cook.

Let me start the question with you. Do you subscribe to the theory that part of the problems of kids getting autism is caused by

the vaccine?

Dr. COOK. I guess that is a direct question to me, having evaded

that.

Mr. BURTON. Yes.

Dr. COOK. I have heard more today than I knew before I came.

I did not specifically address that because I have not directly studied the question.

As I see the data at this point, the data do not support the idea

that vaccines cause autism. As someone who studied secretin as an

example, I realize that I cannot prove the absence of something.

For example, on secretin, all I can say is that I have proved the

absence of it for myself; if someone else wants to come and only

treat a certain kind of child in a certain kind of setting, then perhaps our work will have helped them.

Mr. BURTON. What would you think, Doctor, of taking a hard

look at the conclusions that Dr. Wakefield and Professor O’Leary

and Dr. Singh came to with their research? I know you work on

genetics, but what would you think about looking at their research?

Dr. COOK. Well, in some ways, I work in the area of clinical

trials, so I can comment on why they fail to convince me that there

is a connection. They have raised the possibility of a connection,

but there are several areas in their logic that do not come together.

It may be that if they were up here, they would say, yes, those are

gaps that we have to fill—but I am concerned that in the presentations, starting with the original paper and today, they have not

sufficiently highlighted where the gaps are, so the logic falls apart

in a few places.

First of all, if we know that we have prevented a lot of autism

by preventing rubella-caused autism, which was a prevalent cause

20 or 30 years ago, as Dr. Chess showed, then why is it now MMR,

and all of a sudden, it is measles?

Now, if someone is so pleased—and I must say it is fairly fancy

methodology in terms of pulling the measles virus out—why not

show that they can pull the measles virus out from the vaccine, differentiated genetically from the measles virus that would occur

without the vaccine?

These are holes, and my main thing is what I hear from the positive side is an almost total lack of self-criticism, OK? That is a key

point——

Mr. BURTON. But——

Dr. COOK [continuing]. That is a key point of the scientific method.

Mr. BURTON. But you do not think that their research is worth

taking a look at?

Dr. COOK. Oh, I think their research is very interesting, and I

think it is particularly interesting to what I think—and this is an

interesting epidemiological question—if there is autistic

enterocolitis—and I think they have interesting data—how much of

the total group of autism is it? From what I have seen, it would

not be nearly enough of autism to account for an increase in prevalence.

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Mr. BURTON. You heard the—and I am going to go down the line

with the rest of you in just a minute——

Dr. COOK. If I have a child who is vomiting, I very much agree

with the——

Mr. BURTON [continuing]. You heard the testimony of the four

parents as well as the testimony I gave about our grandson; and

within just a day of their getting these shots, their temperatures

went up, and they started the violent reactions, and it got worse.

How would you account for that? Is that just a coincidence, or

what?

Dr. COOK. Well, if I am to take that as a reason for their autism

to be caused, then I will agree with the parents who told me their

child had autism because they took a 2-day trip, leaving the child

with very good grandparents; they came back, and the child had

autism suddenly. Am I supposed to now tell them, yes, you are

right, because you see the connection—because of a potential coincidence—you are right and caused it by taking 2 days off and leaving your child in very loving hands?

I think we have got to be very careful and use careful epidemiological approaches. Dr. Taylor has done the best epidemiological

study. There is not another one on the other side. If there were,

I would weight it—in fact, I would give more weight to a positive,

well-done epidemiological study. We have only got one.

Mr. BURTON. Well, I am not a doctor, but it just seems to me that

the scientific community ought to have their minds open to all possibilities as far as the causes of autism are concerned. From your

testimony, you sounded like it is a gene problem, and the vaccines

could not possibly be a contributing factor.

Dr. COOK. No. They could, but the people who think they could,

the people who want to raise the hypothesis—and I am someone

who has spent a lot of effort testing other people’s hypotheses—I

think there is a lot of duty when people raise a hypothesis, including Dr. Wakefield, from GI studies, who raise an epidemiological

hypothesis, I think it is his responsibility to test the hypothesis

carefully. I have thrown out hypotheses that I quite loved, and they

were great—they were not all genetic; some were immunological—

but you have to go with the data. If I have the data, I will go with

it.

Mr. BURTON. When you studied secretin, did you study more

than one dose?

Dr. COOK. No. As a matter of fact, before we did the study, there

was a meeting which included people who were convinced that secretin worked who said it was one dose, and we used the dose it

was supposed to be; we used porcine-derived secretin—and now, all

of a sudden, the hypothesis shifts. Now, the hypothesis shifted to

multiple doses—that is fine. The people who think it is multiple

doses and single doses now have to test it. And if we have helped

to refine the hypothesis so they can do a better study and show

that it works, then I am fine with that.

I recognize that basically, science cannot disprove anything. It is

really meant to—you have to actually set up a hypothesis to tear

apart to accept the other one. That is what I mean by part of the

self-criticism of the scientific method.

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So absolutely—if this gets turned around in particularly children

with projectile vomiting—that is a very rare group of autism—but

somebody with projectile vomiting, maybe 30 kids like that, secretin would work wonderfully.

Mr. BURTON. Dr. Hirtz, we were talking about the study at Brick

Township, NJ. I do not know if you heard me ask the question of

the doctor from the CDC earlier. Why would you think that the National Institutes of Health and CDC and others would go into Brick

Township, NJ and look at all the environmental problems that may

have caused the autism epidemic they have had there, and when

the parents asked that they check to see if any of the vaccines had

anything to do with it, why would you think the health agencies

did not check that as well?

Dr. HIRTZ. I am sorry, Mr. Chairman, I am not at all familiar

with the study at Brick Township; that was conducted by the CDC,

not the NIH, and I am afraid you will have to ask them questions

about it.

I would be glad to tell you about activities that the NIH is doing

in this area, however, if you would like to hear some of them.

Mr. BURTON. What would you say about the NIH taking a hard

look at the studies done by Dr. Wakefield, Dr. O’Leary, and Dr.

Singh, and some of the theses that Dr. Megson espoused earlier?

Dr. HIRTZ. I think that examining scientific evidence is always

a useful thing to do; there is nothing wrong with that. In terms of

the vaccine issue, I would just like to say that you are right—we

do need to keep our minds open. I do feel that at this time, the

available, valid scientific evidence does not support that vaccine is

a cause of autism.

However—— Mr. BURTON. What bothers me about a lot of this is Dr. Cook and

you say if there is a hypothesis that says this, it has to be proven

before we will even take a hard look at it.

Dr. HIRTZ. No—— Mr. BURTON. Well, that is the impression that I am getting,

and——

Dr. HIRTZ. May I finish?

Mr. BURTON [continuing]. Let me just finish. The problem is that

there are a large number of children who have acquired this problem shortly after getting these vaccines, and when scientists and

doctors from other parts of the world come up with a thesis, I think

it is irresponsible to out-of-hand just discard that and say, well,

that is something they have to further prove, because their hypothesis has not yet been proven. It seems to me that you say, hey, if

there is a positive result there, if it looks like there may be something there, why don’t we take a look at it, too, instead of keeping

yourselves confined to one area?

Dr. HIRTZ. If you will let me finish, Mr. Chairman, I was going

to tell you about all the efforts we are making to look at that. What

I was going to say when I continued was that even though that is

the case at the moment, we do take this very seriously, we take

the concerns of the parents very seriously, and when we have reports like this and concerns like this, we do address them.

We are taking three steps at the NIH, and we are undertaking

three projects to look at the relationship of vaccines and autism.

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One of them is very immediate and is going to be done in the centers that now exist. The Child Health Network has Centers of Excellence in autism, and they have about 1,000 children enrolled. In

conjunction with the Deafness and Communicative Disorders Institute and the CDC, they are going to look at the children who have

regressed and look at their vaccine histories and study this issue,

compare them to other children. That is going to be done as soon

as possible, hopefully, this fiscal year.

In addition to that study, something I have been working on, we

are planning at the NIH to look at the very important issue of not

only vaccines but risk factors for development of autism as well——

Mr. BURTON. I have had a number of people today testify from

the health agencies that there is no scientific evidence that autism

is related to vaccines. How do they know that?

Dr. HIRTZ. They do not.

Mr. BURTON. How do you know that? A vaccine is put out on the

market, children all take it——

Dr. HIRTZ. On the——

Mr. BURTON [continuing]. Let me just finish—and there is an increase from 1 in 10,000 to 1 in 400 or 500, so we have an epidemic

on our hands; and yet the health agencies of this country are telling us there is no connection between these vaccinations and autism. How do you know?

Dr. HIRTZ. I do not know that there is no connection. What I

know is that the evidence that has been reviewed by the British

Medical Research Council and the epidemiologic evidence does not

support a large-scale causation. But I still think——

Mr. BURTON. How do you know that?

Dr. HIRTZ [continuing]. But I still think that there are and there

may be certain children who are susceptible, and that is what we

have to go after. It is very important that we look for why children

develop autism and whether there might be a small minority of

children who have some susceptibility, and we are not ruling that

out.

Mr. BURTON. Yes. One of the things that concerns me—and pharmaceutical companies are extremely important; they employ an

awful lot of people in my district and in Indiana; we have some

great pharmaceutical companies that have saved a lot of lives and

probably kept epidemics from happening around the world, there

is no question about that—but there are so many people who work

at CDC, HHS, NIH, and the other health agencies who have some

kind of connection to the pharmaceutical companies and are on

these advisory boards, that it causes one to wonder whether there

is thorough research going into these things before they are approved.

Does that concern you at all?

Dr. HIRTZ. At the NIH, we do not really deal with the approval

process of the vaccines. Other agencies can tell you more about how

they deal with that.

What I am really concerned about—it is hard for me to convey

to you that we really—there is nothing I would not do to stop autism from occurring and to stop children from developing this

order, but I——

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Mr. BURTON. Well, then, what I would suggest is that we are

going to get all of these studies—I am going to get them—and we

are going to send them to all the health agencies, and I want the

health agencies to write back and tell me, after they do some research, whether or not they feel there is any merit to these arguments. And I want them to look at—and I will get other Members

of Congress to join me if necessary—I want them to look at Dr.

Wakefield, Dr. O’Leary, Dr. Singh, Dr. Megson—all of the doctors

who have come here today with various solutions that have

worked—Dr. Upledger with his cranial manipulation. Those things

should all be looked at, because we are giving the health agencies

in this country billions and billions and billions of dollars, and for

them not to look at every avenue for possible treatment for these

things I think would be wrong.

Let me just go down to the end of the table and give all of you

a question—Drs. Rimland, Goldberg, Megson, Upledger, and Ms.

Pratt.

Do you think from what you have heard today and seen in your

scientific research that there is a possibility that the vaccines are

contributing to the increase in autism?

Mr. RIMLAND. There is not only a possibility, there is an extremely high likelihood.

Mr. BURTON. Would you pull the mic closer?

Mr. RIMLAND. There is not only the possibility, there is an extremely high likelihood from all the evidence available, including

the so-called anecdotal evidence that people like to snicker at, but

which is really very important evidence, from the kind of evidence

that Dr. Wakefield submitted, from the rise in autism at the time

of initiation of the MMR, the time of the rise of the epidemic, the

data that I provided in my handout which shows that late-onset

autism started at just about the same time that the MMR was initiated. There is just a world of evidence that leads me to think that

it is extremely likely that when the final answer is known, if it is

ever known, the MMR will be strongly implicated as an important

cause of autism.

Mr. BURTON. Dr. Goldberg.

Dr. GOLDBERG. With caution as I say this, as a practicing pediatrician, I have vaccinated children in my practice whom I considered high-risk—I have literally had a godchild with one foot in autism and one foot out and vaccinated her along the way. As I stated

this morning, I however try to practice vaccination policies that I

was taught 20, 30 years ago—you do not vaccinate an ill child; you

use certain plans; I never gave a child a hepatitis B shot in the

nursery yet. But I think that the effort to solve autism gets distracted by the fact that we do have a lot of children triggered off

by some time correlation to the vaccine.

As I mentioned in my testimony, I think that if we are going to

understand this, we need to step back and figure out why there is

a wealth of science that says, hey, the vaccines do not create this

or cause it, and then we suddenly have this epidemic going on, and

I really believe the way it will come out in the end, whether we

do it in the next 6 or 8 months or in 10 years, is going to be that

this will all tie in from the eighties and nineties with what is going

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on in our population and it is not specifically the vaccines, but the

vaccines are playing a role in it.

Mr. BURTON. Would play a role in it.

Dr. GOLDBERG. Pardon?

Mr. BURTON. The vaccine would play a role.

Dr. GOLDBERG. Yes, the vaccines would play a role. But we need

to understand why, suddenly, a population has become susceptible

to those when they did so much good along the way.

Mr. BURTON. Dr. Megson.

Dr. MEGSON. I am seeing more and more families that are completely devastated. I know one mother who has been very active in

the parent support group in our local community has had three

children. The oldest has severe dyslexia/ADD; the second one died

of SIDS within 24 hours of DPT; and the third one is autistic.

If my theories are correct, there is an organ in the neck at the

base of the main artery to the brain called the carotid body, and

we are disconnecting the pathway. When the oxygen-level in the

blood decreases in the carotid body, there is a signal sent to the

respiratory center in the brainstem to increase breathing rates, and

we are disconnecting that pathway.

Recently they discovered that, oh, if you put children down to

sleep on their backs, they do not die of SIDS. I think we really

need to look at this.

I do not want to be here. I have never gone against the grain.

I am not a vaccine researcher. But once I discovered some of these

connections, I do not think any of us can turn our backs. So many

families are devastated.

Mr. BURTON. Thank you.

Dr. Upledger.

Dr. UPLEDGER. I have to say yes, I do. As I stated earlier, I think

there is a group of autistic children—and by no means do I say all

autistic children—whose problems are due to membrane dysfunction. But I have learned to understand that a significant number

of them do, and I can easily differentiate autism from childhood

schizophrenia just based on the feel of the membranes.

I think that the membrane is a place where several factors may

go, and it can be, as I said, a fever due to a virus, it can be a vaccine reaction, it can be a traumatic delivery—it can be anything

that creates a change in the membrane flexibility and growth accommodation.

From the histories I have taken—and I have taken histories with

autistic parents since 1975—it is more than coincidence as far as

I am concerned. I do not know how many cases of anecdotes we

need to consider that the anecdote has some validity, but it would

appear to be that it is infinite. We still will not believe the anecdote. I happen to subscribe to the idea that if you study the anecdote, you might learn something.

So I would go very strongly in favor of the idea that vaccines are

potentially able to cause autism in terms of their effect on membranes. I think that membrane condition is probably largely influenced by genetic factors along with nutritional factors, along with

toxic factors, and so on, so you have a susceptible membrane.

I have opened up enough human heads that are not embalmed,

that are maybe 4 or 5 hours old, and I can see the difference in

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the membranes, and when you look at the diagnoses, you begin to

put 2 and 2 together.

I think one of the major things that has happened in medicine

is the meningeal membrane system has been given a very short

shrift. It is a very important system. It has just come out recently—I cannot think of his name now, but a fellow from California, UC San Diego, I think, came out with evidence, very strong

evidence, that 1 gram of dura mater membrane, which is a very

small quantity of that membrane, carries 100 million single-domain

magnetic crystals that are ferric.

What does it take to change that? The brain itself has 5 million

per gram. Anything that interferes with electrical conduction or

magnetic fields is going to screw up that brain function. When we

stretch that base membrane laterally, why does the kid get better

in terms of his emotion? Because I think we are improving the conditions under which his temporal lobes have to live. That is why.

You can tear it all apart, and if you study temporal lobes, you can

say, OK, temporal lobes cause autism. But what caused the temporal lobe, and what caused the membrane to not accommodate the

temporal lobe? When you start looking at it that way, you start

looking at multiple factors any one of which can be causal—and I

put vaccine in that category.

Mr. BURTON. Thank you, Doctor.

Dr. Pratt, do you have a comment?

Ms. PRATT. I think it is a very hard issue, and from both the autism side of America and the Indiana Resource Center for Autism,

our job is really to provide information for families. And it is very

hard when you listen to very well-respected scientists and researchers like Dr. Cook, whom I have tremendous respect for—and

I point him out because he is in Illinois, the State neighboring Indiana—it is very hard when you hear the testimony and the research

that says there does not seem to be a link, and then, when you

hear from the families their stories. Balancing that out is a very

difficult thing, and I struggle with that, because I do not want all

of us running down one path, hoping that, yes, at the end of that

path is going to be a cure or the reason or whatever.

I hope we can all keep our minds open to all possibilities. Again,

to be an ethical and decent professional, I have to say to families

that I am hearing some stories, and there is a possibility for it.

Those families and the families that you have heard from today

really cannot wait for the research to tell them conclusively that

there is a relationship.

I would say that in all likelihood, Congressman Burton, if your

daughter had another child, she would take a very serious look at

the usage of vaccinations with her third child, regardless of what

the research tells her. That is the complexity of the issue.

So, what you have heard over the last several hours today is a

lot of different testimony and sometimes conflicting testimony, and

I hope that what we will all focus on is trying to uncover the complex nature and perhaps the complex causes behind autism.

Mr. BURTON. Thank you.

Let me just ask Dr. Cook one more question, and then I want

to make a couple of announcements before we conclude.

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Dr. Cook, how do you account for these parents and these doctors

finding the measles virus in the guts of these kids who have had

the MMR shot?

Dr. COOK. I am very interested in that finding because I think

it is a fascinating finding even if it applies to one in 1,000 kids

with autism. Each child is very valuable. So first of all, realize that

Dr. Wakefield is talking about a very small group of autism, with

documented pathology, with vomiting—which, as I said, is quite

rare in autism. I think that is an interesting finding that needs to

be followed up.

The next step of that may not be a link with vaccines and autism; it may be something quite more important in understanding

what is happening with autism. So that some of what was presented today, it was very good to see data ahead of time; it is rare,

and it is nice of them to share it. There is something about their

work, particularly seeing more controlled data than I have seen before, that is very interesting, and I will be paying quite a bit of attention to, because we need every clue that we can get.

Thank you.

Mr. BURTON. Very good; 1 second.

[Pause.]

Mr. BURTON. Let me just ask you a couple more questions, Dr.

Cook. Where do you see the autism rates in the next 10 years? Do

you see them pretty close to where they are now, or do you see

them increasing?

Dr. COOK. I think if we are talking about from the perspective

of school districts, they will continue to rise, because I think we are

still underestimating across all school districts.

In terms of the actual prevalence, meaning all the children who

have always been out there suffering from this, I do not see it

going up that high. What I see is appropriately—and this is a very

important, I think almost civil rights movement—these kids and

families are being heard now. But I do not see this as an epidemic

in the sense of prevalence. I see it as an epidemic in terms of a

wake-up call that lots of kids and families have been suffering for

a long time.

Mr. BURTON. So you are saying the 1 in 10,000——

Dr. COOK. It was never—I do not know——

Mr. BURTON [continuing]. It was always a lot higher than that?

Dr. COOK. I do not know of a 1 in 10,000. I know that 2 to 4 per

10,000 is what DSM3 said, which was 1980 to 1987. And 1987 has

been referred to as around the time of an increase. That is when

we went from DSM3 to DSM3R. The reason is DSM3 said the child

had to have a pervasive lack of responsiveness. Now, I do not know

who these kids were who had autism then, because every child

with autism is related; they are just not related in the same ways.

So now you have increased the definition as of 1987—and I think

I have lost the question. I am sorry.

Mr. BURTON. It was about the projected increase in the next 10

years.

Dr. COOK. Right. So the most important thing about the 2 to 4

per 10,000 estimates is that they were often done by, well, let us

say someone has come in to a university clinic, and you estimate

476

that against the population. What has happened, which is better

epidemiology since then, is you go knocking on every door.

So I have heard 1 in 500 referred to more than just autism, but

the best study where they knocked on every door, half a million in

Japan, found 1 in 500 for autism. So I do not think we are estimating it yet in terms of its impact.

Mr. BURTON. Do any of the rest of you have any projections or

guesses on that?

Mr. RIMLAND. In California, the increase started in 1977 before

the diagnostic changes were made, so the switch from DSM3 to

DSM4 cannot even begin to account for that.

Dr. GOLDBERG. If I can tie in a projection, unfortunately, I can

remember discussions back, literally, in the mid-eighties with clinicians, and at that time, the CDC, the NIH and everyone was saying this new entity out there that we were calling ‘‘chronic fatigue

syndrome’’ or whatever it was supposed to be did not exist, or was

not in any big numbers, and as clinicians, we were saying we were

going to see 1 to 3 percent of the population. Well, now we are in

the late nineties, the numbers are getting very close to that, and

we are now talking 5 or 10 percent.

I think that if this is the same crossover to the children as was

seen in adults, you can make a prediction that in the next 5 to 10

years, you may hit 5 or 10 percent of our population or more.

One of the most scary moments in my life recently, literally, was

coming back on a flight from giving talks in Australia. I remember

there was literally not a family who did not know a family who did

not know a family that either had chronic fatigue syndrome, ADD,

or autism. My thoughts on the flight coming back were, well, where

is Australia—near the ozone hole—but my big concern was that

that was going to be our country 5 or 10 years later. In the last

month, I have literally had three families in—this is only a year

and a half from that flight—telling me they do not know a family

that does not know a family that does not know a family. This is

a major crisis.

Mr. BURTON. Any other comments?

[No response.]

Mr. BURTON. Let me just end by thanking all of you. I really appreciate your being here. I have two grandchildren—one got a hepatitis B shot and stopped breathing within an hour; the other one

got nine shots in 1 day and had a temperature of about 105 and

became autistic, slamming his head against the wall, running

around screaming. That is two for two. I guess maybe I am just one

of those unfortunate statistics. But I have got to tell you, I think

the problem is much greater than we believe, and I do believe, I

personally do believe the vaccines have something to do with it.

Now, my position, since I am not a scientist, is really not one

that most people are going to pay much attention to, or the parents

who testified here today. But, what I do want to do is take all the

scientific information that we have acquired today from you, from

all the other doctors, and submit that to the health agencies of this

country and ask them to do a thorough study of all of them to see

if there is any validity to what we think the problem is. If they do

that and do it thoroughly, and they report back to the Congress,

it will be a real service to the American people.

477

Yes, Dr. Rimland.

Mr. RIMLAND. I think it is rather interesting that most of the official authorities are taking the position that the increase in autism

is unrelated to the vaccine use.

One of my favorite expressions—I do not know who said it; I

heard it one time, and I have tried to find out who said it, because

I think it is extremely true—is ‘‘The chronicle of man’s progress is

the history of authority refuted.’’ Mr. BURTON. Well, thank you very much.

Thank you, ladies and gentlemen.

I have two very quick announcements. The NIH is having a

meeting for parents of children with autism tomorrow morning

from 10 a.m. to noon at the Natcher Auditorium on the NIH campus in Bethesda. If you would like to attend, you are welcome to

attend that.

And we need to announce that the Unlocking Autism group is

having a reception in HC–5 in the Capitol immediately after the

hearing.

Thank you very much. I appreciate your being here. We stand

adjourned.

[Whereupon, at 5:25 p.m., the committee was adjourned.]

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