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THE AUTISM EPIDEMIC—IS THE NIH AND CDC

RESPONSE ADEQUATE?

HEARING

BEFORE THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED SEVENTH CONGRESS

SECOND SESSION

APRIL 18, 2002

Serial No. 107–74

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.gpo.gov/congress/house

http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

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

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

BOB BARR, Georgia

DAN MILLER, Florida

DOUG OSE, California

RON LEWIS, Kentucky

JO ANN DAVIS, Virginia

TODD RUSSELL PLATTS, Pennsylvania

DAVE WELDON, Florida

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

C.L. ‘‘BUTCH’’ OTTER, Idaho

EDWARD L. SCHROCK, Virginia

JOHN J. DUNCAN, JR., Tennessee

——— ———

HENRY A. WAXMAN, California

TOM LANTOS, California

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

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

JANICE D. SCHAKOWSKY, Illinois

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

———

BERNARD SANDERS, Vermont

(Independent)

KEVIN BINGER, Staff Director

DANIEL R. MOLL, Deputy Staff Director

JAMES C. WILSON, Chief Counsel

ROBERT A. BRIGGS, Chief Clerk

PHIL SCHILIRO, Minority Staff Director

(III)

C O N T E N T S

Page

Hearing held on April 18, 2002 .............................................................................. 1

Statement of:

Boyle, Coleen, Associate Director for Science and Public Health, National

Center on Birth Defects and Developmental Disabilities, Centers for

Disease Control and Prevention, U.S. Department of Health and

Human Services, accompanied by Melinda Wharton, Director, Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and Prevention; Stephen Foote, Director, Division of Neuroscience and Basic Behavioral Science, National Institute

of Mental Health, National Institutes of Health, U.S. Department of

Health and Human Services; and Ann Willoughby, Director, Center

for Research for Mothers and Children, National Institute of Child

Health and Human Development ................................................................ 85

Grossman, Lee, president, Autism Society of America, and an autism

parent, Honolulu, HI; Belinda Lerner, member, Autism Coalition, and

an autism parent, New York, NY; Stephen Shore, board member,

Unlocking Autism, Brookline, MA; and Doug Compton, scientific director, Cure Autism now Foundation, New Jersey ......................................... 27

Letters, statements, etc., submitted for the record by:

Burton, Hon. Dan, a Representative in Congress from the State of Indiana:

Information concerning thimerosal .......................................................... 76

Prepared statement of ............................................................................... 6

Boyle, Coleen, Associate Director for Science and Public Health, National

Center on Birth Defects and Developmental Disabilities, Centers for

Disease Control and Prevention, U.S. Department of Health and

Human Services, prepared statement of ..................................................... 88

Clay, Hon. Wm. Lacy, a Representative in Congress from the State of

Missouri, prepared statement of .................................................................. 146

Compton, Doug, scientific director, Cure Autism now Foundation, New

Jersey, prepared statement of ...................................................................... 59

Davis, Hon. Thomas M., a Representative in Congress from the State

of Virginia, prepared statement of .............................................................. 145

Foote, Stephen, Director, Division of Neuroscience and Basic Behavioral

Science, National Institute of Mental Health, National Institutes of

Health, U.S. Department of Health and Human Services, prepared

statement of ................................................................................................... 104

Grossman, Lee, president, Autism Society of America, and an autism

parent, Honolulu, HI, prepared statement of ............................................. 31

Horn, Hon. Stephen, a Representative in Congress from the State of

California, ‘‘For the Love of Zachary’’ ......................................................... 19

Lerner, Belinda, member, Autism Coalition, and an autism parent, New

York, NY, prepared statement of ................................................................. 41

Morella, Hon. Constance A., a Representative in Congress from the State

of Maryland, prepared statement of ............................................................ 68

Shore, Stephen, board member, Unlocking Autism, Brookline, MA, prepared statement of ........................................................................................ 50

Smith, Hon. Christopher H. Smith, a Representative in Congress from

the State of New Jersey, prepared statement of ........................................ 148

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

of California, prepared statement of ........................................................... 81

(1)

THE AUTISM EPIDEMIC—IS THE NIH AND

CDC RESPONSE ADEQUATE?

THURSDAY, APRIL 18, 2002

HOUSE OF REPRESENTATIVES,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The committee met, pursuant to notice, at 1 p.m., in room 2154,

Rayburn House Office Building, Hon. Dan Burton (chairman of the

committee) presiding.

Present: Representatives Burton, Gilman, Morella, Shays, Horn,

Jo Ann Davis of Virginia, Weldon, Waxman, Maloney, Norton,

Cummings, Kucinich, and Watson.

Staff present: James C. Wilson, chief counsel; S. Elizabeth Clay,

Scott Feeney, and John Rowe, professional staff members; Jennifer

Klute, counsel; Robert A. Briggs, chief clerk; Robin Butler, office

manager; Elizabeth Crane, legislative assistant; Elizabeth Frigola,

deputy communications director; Joshua Gillespie, deputy chief

clerk; Susie Schulte, staff assistant; Leneal Scott, computer systems manager; Corinne Zaccagnini, systems administrator; Sarah

Despres, minority counsel; Josh Sharfstein, minority professional

staff member; Jean Gosa and Earley Green, minority assistant

clerks; and Teresa Coufal, minority staff assistant.

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

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

so ordered.

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

Without objection, so ordered.

Today we are here to talk about the autism epidemic. I use the

word ‘‘epidemic’’ for a good reason. Typically, we think about

epidemics in terms of infectious diseases. However, a condition is

considered epidemic when it occurs suddenly in numbers that are

clearly higher than normal.

Ten years ago only 1 in 10,000 children were thought to be autistic. When we began our investigation in 1999, that number was estimated to be 1 in 500. That is a 20 times increase. However, the

number today appears to be even higher.

The Center for Disease Control [CDC], conducted two prevalence

studies. The study in Brick Township, NJ, found that 1 in 181 children between the ages of 3 and 10 were diagnosed with autism,

and 1 in 128 were diagnosed with autism spectrum disorders. An

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as yet unpublished study conducted in 1996 in Atlanta, GA, found

that 1 in 294 children ages 3 to 10 had autism.

The National Institutes of Health [NIH], places the estimate at

1 in 250 children, and boys are affected four times more often than

girls. That means that about 1 in every 156 boys in this country

between the ages of 1 and 10 are autistic.

Unfortunately, the unexpectedly high rates in Georgia and New

Jersey are not isolated examples. This school year there are 3,789

individuals with autism in Indiana schools. This is up from 116

just 12 years ago, 116 to 3,789.

A recent news article out of Thailand indicates that there are

100,000 children in Thailand with autism. In 1999, the East Surrey

Health Authority in the United Kingdom stated that the prevalence of autism in their district was 1 in every 69 boys.

In the 60 years since autism was first described, we have not yet

figured out what causes it. We do not know if classical autism and

late-onset autism are the same conditions or two different conditions with similar symptoms. We have come a long way in 60

years. Doctors no longer blame the condition on bad mothering. But

we have a lot more work to do before we can pat ourselves on the

back for our accomplishments.

Is our investment in research on autism on a comparable level

with other epidemics? This is very interesting. Are the CDC and

NIH funding studies that will help prevent or cure autism? Is their

research adequately addressing the medical issues associated with

autism such as food allergies, chemical sensitivities, and autistic

enterocolitis? Is the information about autism provided by our government adequate and useful to families? The CDC will testify today that they plan on spending $11.3 mil- lion on autism this year and $10.2 million on autism next year. We

compared that to two other conditions that have been declared

epidemics: diabetes and AIDS. Both of these conditions can be devastating. Both deserve sufficient research dollars to develop treatments and look for cures.

The CDC is spending over $932 million on the AIDS epidemic

this fiscal year. Compare that to $11 million for autism. AIDS deserves attention—don’t get me wrong—and so does diabetes, which

both Secretary Thompson and the former Surgeon General declared

an epidemic. CDC this year will spend just over $62 million on diabetes. The autism epidemic, just like the diabetes and AIDS

epidemics, is no less deserving. Yet, the CDC’s spending for autism

is almost 80 times less than that for AIDS. And CDC’s spending

for autism is five times less than that of diabetes. CDC should be

committing more research money for autism, and we are going to

work on that.

Now let’s look at the National Institutes of Health. We have got

some charts up there on the wall which you can look at. The NIH

is the premier biomedical research institution in the world. Congress has worked hard to double the NIH’s budget. Their total

budget this year is $27 billion. We are committed to funding research to help cure crippling diseases.

The NIH will testify today that their commitment to researching

autism has grown dramatically in the last few years. In fiscal year

1997, the NIH investment in autism research was only $22 million.

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Last year that number had grown to $56 million, in large part because of the Congress.

That’s good, but let’s put that into perspective. At the same time

the NIH is spending $56 million on autism, a condition that affects

1 in every 250 children in this country, they are investing over $2.2

billion in AIDS research. The rates of diabetes increased by 49 percent between 1990 and the year 2000. Diabetes is a devastating

condition in the Native American community and of increasing concern in the African American and pediatric populations. This year

the NIH investment for diabetes is $688 million, and compare that

to the $56 million that they are going to spend on autism, and compare that to the huge money that is being spent on the AIDS research.

I believe these numbers speak for themselves. Funding in basic

and clinical research into autism needs to be expanded dramatically. We have an epidemic on our hands, and we in Congress need

to make sure that the NIH and CDC treat this condition like an

epidemic and put their efforts into doing several things: First, to

find out the causes of the epidemic. Second, determine how to stop

the epidemic in its tracks. Third, to evaluate treatment options.

And, fourth, to look for a cure.

When we first began looking at this issue, we heard from thousands of families. Many told us their children were absolutely normal until they were vaccinated, and that just a few days or weeks

after they became vaccinated they became autistic. We also heard

about a dramatic similarity in these late-onset autism cases. Many

of these children have unusually high levels of heavy metals in

their systems. They have immune system irregularities. They have

unresolved yeast infections. Eating foods that contain wheat or

dairy may result in a rapid deterioration of behavior. Exposure to

many chemicals, even perfumes, can have the same adverse effect.

Many have chronic diarrhea. NIH and CDC need to fund research

to get answers to all these issues.

One of the things that concerns me is that it seems that many

of these children, if we tested hair samples, urine samples, blood

samples, could give us an idea of whether or not they have mercury

in their systems, and to what degree, and whether or not there are

other toxic chemicals that may be in their systems that could be

found through these tests.

Autism has personally affected my family, and many of you already know that. My grandson Christian was normal and healthy

until his second year of life. He walked, he talked, he made eye

contact, he enjoyed going to the mall, and all the other things that

2-year-olds do. And then suddenly, shortly after receiving his mandated immunizations, he became a different child. He no longer

spoke. He would not look anyone in the eye. He cried endlessly. He

banged his head against the wall. He began running around flapping his hands, and he had chronic diarrhea and severe bowel

problems. We now know that he was suffering from an adverse reaction to his vaccines. We also know that he may have received

more mercury in his vaccines than is considered safe, way more

than safe, by Federal standards. This mercury toxicity was contributing to the adverse reaction.

4

So far, the NIH and the CDC discount any potential connection.

The Institute of Medicine has stated that the available research

data is insufficient to prove or disprove a connection between autism and either the MMR vaccine or thimerosal, which is the preservative put in most children’s vaccines. But they say the link is

biologically plausible. The IOM called for more research in this

area. One of the reasons we are here today is to make sure that

research gets done, and gets done now rather than 10 years from

now, when many more thousands of children become autistic.

When you are a parent, whether your son or daughter is autistic

from birth, because of genetics, or because of some environmental

exposure such as vaccines or maybe something else, you are facing

a challenge more difficult than a 500-piece puzzle. You are faced

with putting the puzzle of your child’s life together one piece at a

time.

Do you put special locks on your doors and windows and add an

alarm system because you’re afraid the child will wander away

from your home? Do you need to put a lock on a cabinet in your

kitchen to keep the foods that set your children into a spiral out

of their reach? What medicines or dietary supplements will your

child need? How do you find services? Does your child need to learn

sign language? Do you need ABA or other behavioral therapy?

Where can you find a qualified speech therapist? How are you

going to pay for all of this? How are you going to get through the

school services maze? How will you find time for your other children?

What happens when the child grows up? And that’s something

our government needs to think about. One in 250 children are becoming autistic, and we are not doing a great deal of dealing with

that problem right now, but they are going to grow up and then

they are going to be adults with autism. Now if you have 1 in 250

people in this society that’s autistic down the road, because we

haven’t done our job now, how are we going to take care of it? How

are we going to take care of all the health care needs besides autism at the same time as taking care of the burden they are going

to be on society? And our medical and research people need to address that issue. These are all dilemmas that parents face now.

In addition to witnesses from the NIMH and CDC, I am pleased

that we have several autism organizations represented here today.

We were not able to have all of the organizations testify at the

table, but I hope that each will submit written statements for the

record.

Mr. Lee Grossman of Hawaii is our first witness. He is the president of the Autism Society of America and has a son with autism.

Ms. Belinda Lerner of New York is a member of the Autism Coalition and has a son with autism. While having a child with autism

may be her toughest battle, Ms. Lerner is not a stranger to tough

battles; she is the first female attorney to work for the National

Football League. Those are big guys. [Laughter.]

Mr. Stephen Shore of Brookline, MA, is a board member of

Unlocking Autism. Mr. Shore, who did not speak the first 4 years

of his life, has Asperger’s disease, a condition on the autism spectrum. Mr. Shore is a success story. Because of his mother’s drive

and dedication, Mr. Shore is a doctoral candidate at Boston UniverVerDate 11-MAY-2000 09:56 Jul 02, 2002 Jkt 000000 PO 00000 Frm 00008 Fmt 6633 Sfmt 6633 C:\DOCS\80356.TXT HGOVREF1 PsN: HGOVREF1
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sity. That’s very commendable. He gives all families with autistic

children hope.

Mr. Doug Compton is the science program director of Cure Autism Now and the father of an autistic child.

I look forward to hearing from our witnesses today. Our hearing

record will remain open until May 3rd.

[The prepared statement of Hon. Dan Burton follows:]

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Mr. BURTON. Mr. Waxman is not yet here.

Mr. Gilman, do you have a statement you would like to make?

Mr. GILMAN. I do. Thank you, Mr. Chairman. I want to thank

Chairman Burton for conducting this important hearing regarding

NIH and CDC’s response to the rising rate of autism in our Nation.

I recently met in my constituency with Jeanine Conklin, a mother to Daniel, her 5-year-old autistic son. Listening to her explain

the obstacles that her family must face each and every day reaffirmed by commitment to this issue. It is essential that there be

continued research of and funding for learning more about how this

affliction manifests itself and how it can be prevented, and how to

properly educate the public. It is important to understand how we

define autism, why the autism rate is increasing, and how we can

support effective research that will benefit those who are already

afflicted by autism.

Autism makes it difficult for an individual to interact with people

and their environment. In some cases those with the illness may

behave in an aggressive or self-injurious manner. It occurs in people of all races, ethnicities, and socioeconomic backgrounds. A better understanding of the origins of the disease is crucial to introducing new and effective treatments.

As Chairman Burton noted, autism has afflicted 1 in 500 children in the United States. However, the CDC shows that even

higher rates occur in some specific locales such as Atlanta, GA,

Brick Township, NJ, where the autism rates are 1 in 94 and 1 in

128, respectively.

These alarmingly high rates have lead to several inquiries into

the contributing factor of the disease, including, but not limited to,

childhood vaccines and some of the environmental factors. Many of

the symptoms of autism are the same as mercury toxicity. Through

an FDA review, it was learned that the amount of mercury in mandated vaccines that children were receiving in the first 6 months

of their lives exceeded guidelines that were established by the Environmental Protection Agency and validated through an Institute

of Medicine review.

We have convened here today to monitor whether NIH and the

CDC have satisfactorily responded to the challenge of autism research. More specifically, we would like to know if they made headway into IOM’s research recommendations, research to determine

how children metabolize and excrete metals, particularly mercury;

continued research on theoretical modeling of ethyl-mercury exposures and careful, rigorous, and scientific evaluations of chelation,

when used in children with neurodevelopmental disorders, especially autism.

Our committee’s oversight is an essential component to increasing communication. Autism is a disease that paralyzes communication. We cannot afford to paralyze the communication between our

medical community, our government sector, and those families who

have been affected by autism. We owe it to the American families

like the Conklins in my area to do everything in our power to ensure that the Federal Government continues its commitment to autism, to research and discovery.

As a member of our Congressional Caucus on Autism, I am extremely interested in the testimony that our witnesses will have to

18

present to us today. I want to thank Chairman Burton again for

his dedication to the health and safety of our Nation’s children.

Mr. BURTON. Thank you, Mr. Gilman.

Let’s see, Dr. Weldon.

Dr. WELDON. Hi, Mr. Chairman. I do not have an opening statement, but I just want to again thank you for bringing the spotlight

of congressional scrutiny onto this very critical issue of autism in

America. I believe it to be a forgotten and neglected disease for too

long. Thank you for your leadership on this.

Mr. BURTON. Thank you, Dr. Weldon. Mr. Shays.

Mr. SHAYS. Thank you, Mr. Chairman. Mr. Chairman, no prepared statement other than to thank you for having this hearing

and to say that, like a number of Members of Congress, I have a

very sizable number of autistic young and old in my district. It is

far more noticeable than in the past, and I am deeply concerned

about it. I can’t imagine what it must be like for a parent to hold

a child and just be hungry for some type of response of recognition.

So I just thank you.

I know we are all wrestling with this. I know nobody has the answers, but together I hope we are able to find some.

Mr. BURTON. Thank you, Mr. Shays. Ms. Davis. Mr. Horn.

Mr. HORN. Thank you, Mr. Chairman, for this continuing effort

to get at autism. I would like to have in the record a piece called

‘‘Medicine for the Love of Zachary,’’ which was Zach and Karen

London, and she affected 400,000 people nationwide with her crusade. I think you would find it very inspiring.

Mr. BURTON. Thank you, Mr. Horn. We will put that in the

record, without objection.

[The information referred to follows:]

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Mr. BURTON. Are any of the minority members going to be here?

[No response.]

Mr. BURTON. We will now ask the first panel to come forward.

Mr. Grossman, Ms. Lerner, Mr. Shore, and Mr. Compton, would

you please approach the witness table and stand up so we can

swear you in?

[Witnesses sworn.]

Mr. BURTON. Be seated.

We will start with you, Mr. Grossman. I guess we will just go

right down the line. Do you have an opening statement?

STATEMENTS OF LEE GROSSMAN, PRESIDENT, AUTISM SOCIETY OF AMERICA, AND AN AUTISM PARENT, HONOLULU, HI;

BELINDA LERNER, MEMBER, AUTISM COALITION, AND AN

AUTISM PARENT, NEW YORK, NY; STEPHEN SHORE, BOARD

MEMBER, UNLOCKING AUTISM, BROOKLINE, MA; AND DOUG

COMPTON, SCIENTIFIC DIRECTOR, CURE AUTISM NOW

FOUNDATION, NEW JERSEY

Mr. GROSSMAN. Yes, I do, Mr. Chairman.

Mr. BURTON. If we could, we would like to try to keep our opening statements to 5 minutes, if we can, so we can get through everybody and have time for questions.

Mr. GROSSMAN. Good afternoon. My name is Lee Grossman and

I am president of the Autism Society of America, chair of the Autism Society of America Foundation, a member of the Federal Government’s Interagency Autism Coordinating Committee, a resident

of Honolulu, HI, a small business owner for over 20 years in the

medical industry, and, most importantly, a father of a child with

autism whose name is Vance.

Mr. Chairman, I would like to thank you and your colleagues on

the Committee on Government Reform for this opportunity to

present testimony on the issue of autism, the fastest-growing disability in our country today. As President of the Autism Society of

America, I can tell you that hearings such as this offer hope to

hundreds of thousands of individuals and families affected by autism.

I am going to deviate from my testimony a little bit to respond

to your opening statements. They’re very moving to me in that it

truly represents what all of the families are going through, our experiences, our frustrations in dealing with this dilemma that we’re

faced with.

I want to thank you very much for acknowledging for the first

time, that I am aware of, that the Federal Government is now acknowledging in this country that autism is an emergency, and it

is a national health crisis. It is something that has not evaded the

advocates and the families to this point. It is reassuring to all of

us to know that the government is finally recognizing this as an

epidemic.

There are a number of factors and figures that I would like to

present here before I get into what I believe that we need to do and

what ASA believes that we should do to correct this problem over

the near short-term. Currently, it is easy to say that this is a national health crisis. There are as few as a half million to perhaps

1.5 million people with autism in the United States today. EstiVerDate 11-MAY-2000 09:56 Jul 02, 2002 Jkt 000000 PO 00000 Frm 00031 Fmt 6633 Sfmt 6633 C:\DOCS\80356.TXT HGOVREF1 PsN: HGOVREF1
28

mates are as high as for every 1,000 children that are born today

6 will have autism.

The annual cost of treating autism in the United States is any- where from $20 billion to $60 billion every year. Autism is growing

at a rate of 10 to 17 percent each year. Based on these figures, in

10 years the annual costs associated with autism could be as much

as $50 to $300 billion per year. After 60 years of dealing with this

problem, the Federal Government is currently spending $75 million

on research when the problem is in actuality conservatively a $20

billion problem. After 60 years of this approach, we have no identified causes of autism or any proven treatments or therapies. Something substantially greater has to be done to address this national

emergency, and we have to spend substantially more money to find

causes and effective treatments.

The Autism Society of America believes there are four critical

areas that need to be addressed, and these four areas are in autism

research, early identification intervention, secondary school education, and adult issues. Here are our immediate recommendations.

Current funding levels in biomedical research at NIH are terribly

low in relation to the disorders population and economic impact.

We are recommending that the Federal Government increase the

funding available for research over the next 3 years to a level of

$500 million per year devoted to basic science, environmental

science, tissue and genetic collection, and all aspects of biomedical

research related to autism. When compared to the annual growing

rate of autism in our Nation, this is substantially below the funding to keep pace with the projected growth.

In the area of applied science, we must find new and innovative

ways to develop and implement therapeutic and clinic interventions

and effective treatments. There has been to date virtually no activity and support from Federal agencies in these vital areas. We recommend that applied research funding be increased over the next

5 years to a level of $100 million per year. This increase is needed

in the case of autism because we are building from a zero base.

ASA also recommends that there is a need to increase the number of scientists involved with research and treatment grants. We

request that NIH develop programs and encourage researchers to

enter into fields associated with autism research and to stimulate

new research protocols.

The CDC surveillance programs need to be implemented and

then expanded immediately so that more exact figures on the prevalence and population of those with autism are established. In our

discussions with CDC, we recognize that data from a substantial

number of State or other geographic areas will be needed to better

identify those who have autism and what scope of services will be

needed. We, therefore, recommend that the CDC budget in this

area be increased to $8 million to expand the number of regional

centers and State surveillance programs from 9 States to 20 States.

These 20 States should represent a statistically significant data

base to allow CDC to better identify those who have autism, and

then start looking for root causes and trends.

As we must find the causes and best treatments for those with

autism, there is also a need to fund areas which could identify possible causes of autism created by our society. A substantial number

29

of families within our autism community believe some forms of autism may be caused by some use of vaccines. While we do not know

this to be specifically proved at this time, we should not ignore the

body of evidence that calls into question the source of many children with autism. If causation is found, those injured must be provided recourse and compensation.

This is why ASA supports and asks for early adoption by Congress of the Burton-Waxman bill, H.R. 3741, which improves the

National Vaccine Injury Compensation Program by extending the

statute of limitations for individuals to file claims and provides a

2-year look-back provision for the families that are presently prevented from filing under the program, through no fault of their

own.

Now under early diagnosis and early intervention, ASA strongly

supports the general consensus that the most effective means for

a successful result in the life of an individual with autism is

through early diagnosis and early intense and appropriate intervention. Therefore, we recommend that a national awareness campaign be established through the U.S. Department of Health and

Human Services, national physician organizations, and community

health centers to provide education and identification programs to

pediatricians, child care providers, and to the population at large.

ASA has expressed its willingness to act in concert with the Department to make this happen by drawing upon its unique membership and chapter base with the entire autism community. ASA

also seeks increased funds for States to Early Head Start, or zero

to 3, programs administered by the Administration for Children

and Families to provide.

For education for children with autism, ASA recommends to the

committee that it supports and develops legislation to implement

the recommendations and plans detailed in the National Research

Council’s report, ‘‘Educating Children with Autism.’’ This report

precisely addresses the education interventional needs of secondary

school age children with autism.

ASA further recommends that Congress immediately reauthorize

the Individuals with Disabilities Education Act and fulfills the long

overdue commitment to the full funding of IDEA, and, last, support

services for adults with autism. The current availability of services,

support, employment, and residential options available to adults

with autism can only be described as almost non-existent. For too

long the service supports for these people has dramatically dropped

once the person passes through the secondary education system. A

comprehensive program must be developed and implemented to address the tremendous needs of this growing and immense population.

ASA has developed a white paper on this subject and has posted

it on our Web site to help develop interest in having it implemented. We have also joined with coalitions and formed coalitions

of adult service providers, and are now doing assessments of the

needs of the adults with autism community to formulate initiatives

and legislation to address this problem. We ask the Congress and

this committee to join in supporting the development of legislation

and funding that will be necessary to deal with this current and

ever-growing dilemma.

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In closing, Mr. Chairman, I would be terribly remiss if I did not

address the relevance and significance of this hearing. As I stated,

this is the first time that I am aware of that the U.S. Government

has acknowledged the autism epidemic and attendant national

health crisis. And with your acknowledgment, ASA stands firm and

ardent in requesting that this Nation take real and measurable actions today to stop this national economic, social, and health emergency.

I have described in my testimony what needs to be done now in

terms of money and autism. However, there is something just as

important to be added; that is hope. The autism community has endured 60 years of unfulfilled hope.

Congressman Burton, I know you have waited with hope for your

grandson over the last 5 years. I have waited and hoped for the

last 14 years, and the community has waited 60 years. If we will

take the actions I have offered to you today, all of our hopes can

be translated into fulfillment. Please let us help each other give

meaningful hope to the millions of people affected by autism.

Thank you, Mr. Chairman, and I will stand ready to answer any

questions you may have.

[The prepared statement of Mr. Grossman follows:]

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Mr. BURTON. Thank you for that statement, Mr. Grossman. Your

recommendations, along with the others that we will hear today,

will be given to the officials at NIH and CDC and the FDA. We

have some of them here who are going to be testifying in a little

bit, and they are, I am sure, taking all this in.

Ms. Lerner.

Ms. LERNER. Thank you, Chairman Burton and distinguished

members of the committee.

I am here to speak to you today about my personal experiences

with the heartbreak and frustrations of autism. By way of history,

you should know, and as Chairman Burton has already said, that

professionally I am an attorney with the National Football League.

My job has presented me with many interesting challenges, including cross examining 6-foot 5-inch, 300-plus pound professional football players. I was the first female attorney hired in that role, and

so my challenges were not limited to my interactions with football

players, but in winning the confidence and respect of my male colleagues in the league and at the NFL clubs. However, those challenges, while daunting at the time, pale in comparison to the challenges I have faced, and continue to face, as a mother of an autistic

son.

My son, Benjamin, was diagnosed when he was 2 years old, and

when I received the news, I was relieved—yes, relieved. Prior to his

diagnosis, I was the mother of a screaming, inconsolable, non-communicative little boy, who seemed to reject all my attempts to love

him and was incapable of demonstrating his love for me. At a time

when I should have been awash in feelings of love, I was overwhelmed by feelings of inadequacy, failure, and shame.

Now the enemy that had overtaken my son had a name—autism—and like any lawyer worth her salt, I was going to defeat my

adversary by researching and understanding its characteristics. I

remember bombarding the psychologist, who had diagnosed Ben,

with questions: What causes autism? No one knows. How prevalent

is it? Undetermined, last count, 1 in 500. What treatments are

most effective? It is unclear. There have been no reliable studies.

Most importantly, what are my son’s chances for a normal life?

Hard to say, but not particularly good.

I refused to be cowed, but little did I know at the time the journey I was embarking on. I was able to secure a spot for Ben in a

wonderful school dedicated to children with developmental disorders, where by the age of 3 he began to master basic language

and other life skills. Finally, the wonderful, charming little boy hidden beneath the disorder began to emerge, and so did this incredible bond between Ben and me.

Although Ben was making progress, he, nonetheless, still had

substantial and pervasive deficits. And so each time a new problem

arose that required additional therapy, we needed to get permission from the school district’s Committee on Pre-School Education

to amend his individual education plan [IEP], to address this problem. Although I had my share of battles with the CPSE to get appropriate services for Ben, it wasn’t until Ben turned 5 and was

transitioned from the CPSE to the CSE, Committee on Special

Education, that the hostilities elevated to an all-out war.

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At that point Ben was to graduate from his special education

school. So my husband and I evaluated the school district’s inclusion kindergarten program, and we both agreed that the curriculum and behavioral requirements were far too advanced for Ben at

that time. However, the school district refused to provide us with

any alternatives. So even though the law requires that a ‘‘free and

appropriate education in the least restrictive environment’’ be provided to each child, we were left with the choice of putting him in

the school district’s program or pay out of pocket for any alternative.

We knew that following the district’s mandate would be setting

Ben up for failure, in our experience a sure-fire recipe for disaster

and regression. If we sued the school district, it would cost us as

much as a year’s tuition. So we bit the bullet and sent Ben to a

private pre-kindergarten program at our expense.

This private school was initially a godsend for us, and Ben continued to make small, but steady progress. But as Ben went from

pre-K to the typical kindergarten program, it was clear that his developmental problems were too severe to be handled by a well-intentioned but untrained and underequipped staff.

Because the school district would not provide additional support

for Ben at his private school, his failure to get the appropriate

interventions resulted in his lashing out and shutting down. Once

again, the shadow of autism was eclipsing my sweet, charming little boy who had been showing so much promise.

My husband and I pulled Ben from the private school, obtained

additional therapy and additional evaluations at our own expense,

and put him in our only other alternative, the school district’s kindergarten program, which we had rejected 2 years earlier. Ben is

no longer regressing, but he is still significantly delayed in all developmental categories.

Our most recent round of evaluations have revealed that, unless

Ben receives intensive interventions this summer to make up for

the losses he experienced this school year, he has absolutely no

chance of surviving first grade. However, because the CSE has refused to classify Ben as a child who needs year-round services, the

job of securing the right therapists, as well as the financial burden

of providing them, will fall to us.

Based on my unwavering love for my little boy, I am determined

to do what is in his best interest so that he may have a chance for

a happy, independent life. However, I and similarly situated parents are faced with many obstacles, and it is time for the Federal

Government to share the burden and the shame that has dogged

the parents of the autistic, and the lack of government assistance

in autism to date is shameful. It is shameful that this country, the

greatest nation in the world, has conducted no concerted nationwide prevalence study.

Funding Centers of Excellence, pursuant to the Children’s Health

Care Act, would give us a vehicle to conduct a proper nationwide

tracking program. It is shameful that there has not been significant funding into biomedical research. Less than two generations

ago, the disorder was thought to be a mental illness caused by cold

and detached mothers. Although we now know it is a neurological

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disorder, we have yet to determine what causes the autism and

how it impairs the brain’s functioning.

It is shameful that this country has not conducted meaningful

and concerted applied research to determine what therapies are

most effective in countering the horrific effects of autism. Our

schools have been besieged by this growing population, and while

required by law to educate and treat the autistic, they lack funding

and training to handle this enormous responsibility. Fully funding

the IDEA statute would alleviate some of that burden.

Finally, it is shameful that our Nation, either through willful ignorance or benign neglect, has allowed this insidious and pervasive

health care crisis to rise to epidemic proportions.

I began my testimony by presenting to you the challenges I have

faced professionally and personally as a mother of an autistic son,

and I would like to conclude by asking that you adopt these challenges and support the funding for the five Centers of Excellence

and IDEA. Past generations were damned to institutionalization.

Let’s not condemn our present and future generations to the same

fate.

I speak on behalf of the exhausted, voiceless, and desperate parents of autistic children, the children that without the proper government intervention will become adults doomed to be a financial

burden rather than a contributing member of society. So please

give full force and effect to the Children’s Healthcare Act and the

IDEA statute. Thank you.

[The prepared statement of Ms. Lerner follows:]

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Mr. BURTON. Thank you for that statement. I would urge all of

you who are interested and who are leaders in the autistic community to write your Congressmen and to write the White House and

to tell them that you want these changes made and that there be

appropriate funding for all of these research programs that you

talked about, because the squeaky wheel in this town gets the oil.

You talk about the AIDS research, and I am taking a little liberty here, so forgive me. The AIDS research moneys that are being

spent are huge. I don’t fault them for giving that money to AIDS

research. I think it is important. But autism is equally important.

Because they have been very outspoken in the AIDS community,

they have gotten a great deal of results from the health officials of

this country, and from the Congress, and from the administrations,

$700 million; I believe it was pretty close to that. If we had that

kind of money being given for autism research, we could probably

get a lot more accomplished.

So write your Congressmen. Don’t write me. I am already on

board. [Laughter.]

But write your Congressman and write the White House and

Senators and tell them that you want something done.

Dr. WELDON. Mr. Chairman.

Mr. BURTON. Yes?

Dr. WELDON. Could you yield to me on this issue?

Mr. BURTON. I will be glad to yield.

Dr. WELDON. Just for a minute?

Mr. BURTON. Sure.

Dr. WELDON. I was going to say this in my question period. If

you add up—comparing to AIDS is a good thing because the prevalence is somewhat similar. It is estimated 500,000 to a million with

autism and there’s 500,000 people with AIDS, about 900,000 if you

add AIDS and HIV-positive status.

If you add up the money that is spent by NIH, CDC, Medicare,

Medicaid, the housing money, the drug money, the Federal Government is spending $12 billion on AIDS. That is why I refer to this

as a forgotten disease. You know, Mr. Grossman, you laid out a

really nice strategy. I mean it was great. I was really glad to hear

you do all that.

You’ve got a bunch of people here that are going to be foursquare

behind you, but you have got to develop a very sophisticated lobbying effort. You are a 600-pound gorilla that has been asleep for

years. I can tell you, if you get your act together and start working

this town aggressively—and you ought to meet with the AIDS people and just have them brief you on how they did it. I mean, we

are going to double the NIH budget, and everybody is going to be

out there to take a piece of it: the kidney people, the heart people,

the Parkinson’s people. But they’ve already got a big chunk, and

the time is really ripe. I apologize for rambling on here.

Mr. BURTON. No, that is all right.

Dr. WELDON. You brought it up, Mr. Chairman.

Mr. BURTON. It adds to the discussion.

Dr. WELDON. It is a two-way street. You know, you’ve got to work

this town, and you’ve got to be really slick and really sophisticated,

and you’ve got to put money into it, too. There are a lot of people,

NFL football players, businessmen with money who will write

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checks, and you’ve got to hire consultants. You’ve got to do a whole

9 yards, but you ought to do it because I think you can cure autism. I really do.

Mr. BURTON. Thank you, Dr. Weldon.

Mr. Shore.

Mr. SHORE. Chairman Burton, I thank you and your colleagues

on the Committee on Government Reform for this opportunity to

present testimony, this historic opportunity to present testimony on

the issue of autism.

I am Stephen Shore and reside in Brookline, MA with my wife

Leawee, where I am completing a doctoral degree in special education from Boston University with an emphasis on helping those

with autism reach their fullest potential. I am the author of ‘‘Beyond the Wall: Personal Experiences with Autism and Asperger’s

Syndrome,’’ consult internationally for autism-related issues, teach

college-level courses in special education at both Boston University

and Lesley University, as well as work with people that have autism. I am very fortunate to be leading a fulfilling and productive

life.

Most of us here today have involuntarily been inducted into this

community by the autism bug. What happens? A child is born and

develops typically until 18 to 24 months, suddenly hit with a bomb

that spreads its shrapnel from the child to the family, to education,

the community, and humanity at large. The child loses verbal ability; withdrawal from the environment occurs. We often see selfabusive and self-stimulatory behaviors, tantrums.

I was hit with that very same bomb at age 18 months with all

those wonderful characteristics that we see going with it. Despite

the claim of being too sick to work with and recommendations for

institutionalization by diagnosing professionals, it was my parents

that were left to provide the needed early intervention, and this

was at a time when that term had yet to be conceived. We are talking about the early mid-sixties. My parents had no support.

However, fortunately, my mother was able to stay home all day

and provide the equivalent of what is known today, or would be

known today, as a home-based early intervention with an emphasis

on music, movement, sensory integration, narration, and imitation—to at first make me aware of her presence, and then to coax

me out into her world. I was very lucky. Parents and educators, we

need to listen to the parents. They are the experts on their children.

At this time I am before you as I continue my quest to help those

with autism and Asperger’s disorder lead fulfilling and productive

lives. I continue to struggle with the residuals of autism. While the

uniform of a suit and tie that we find in government and business

may be a mere inconvenience to most people, it is a major sensory

violation for me. However, helping my peers on the autism spectrum is way more important than my discomfort.

I am very lucky and the rare exception of a child with an early

autism spectrum diagnosis. Here in the United States of America,

the wealthiest, most powerful Nation on Earth, everyone on the autism spectrum has a right under IDEA to receive critical services

throughout their lifespan tailored to their needs. This should not

be a matter of luck or debate, but it is a question of how.

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These are some of my observations. As board president of the

Asperger’s Association of New England, board member of the Autism Society of America, Unlocking Autism, and other national autism-related organizations, I see many others with autism spectrum disorder who are vastly underserved: toddlers not receiving

vitally needed early intervention and school age children in need

of professionals educated in how to interact with those on the autism spectrum.

We desperately need more educational research. Today we know

very little about the interventions that are effective with individuals with high-functioning autism and Asperger’s syndrome. The

implications are enormous. So many of my peers living far below

their potential, homelessness, other substandard living conditions,

unemployment, and serious underemployment are all too common.

People with high-functioning autism and Asperger’s syndrome

need to be taught more how to interact successfully with the environment and people around them. Until medical terminology can

answer the questions it is pursuing, we have thousands of individuals who are exposed to educational interventions that are not validated or, perhaps even more tragic, not exposed at all because the

educational community doesn’t know what to do.

We have some literature that supports best practice for people

with moderate to severe autism spectrum disorders, but the same

cannot be said for individuals with high-functioning autism and

Asperger’s syndrome. We need to look at the academic, cognitive,

developmental, behavioral, social, sensory, and other interventions.

As was mentioned before, the CDC estimates that 1 out of 250

children have autism right now. What are we going to do in 10 to

15 years when they become adults? This number, 1 in 250, is actually much greater if we look at the people that are affected by autism. What do I mean by that? We are talking about the family.

One child has autism. We have other siblings. We have parents,

grandparents, other relations, friends. Funds devoted to research

and early intervention now will pay huge dividends later.

But what about the adults? There is very little literature on this

population also. What happens in the Commonwealth of Massachusetts where I live is we see people with high-functioning autism not

being served by the Department of Mental Retardation because

they have an IQ over 70; thus, they are not considered as having

retardation. The Department of Mental Health says autism is not

a psychiatric disorder, so they don’t get services from the Department of Mental Health. As a result, they fall in the crack, a big

crack, and don’t receive services at all, and similar situations exist

in many other States also.

What I have described, and what has been talked about by you,

by Lee, by Ms. Lerner, is a national emergency. They were talking

about up to 1.5 million individuals in the United States having autism, and the numbers are rising. The U.S. Department of Education, the California Department of Developmental Services, and

others, ASA, estimates autism is growing at a rate of 10 to 17 percent annually. We are talking about a rate of 100 to 400 percent

over the next 10 years.

If we look at the Mind Institute, they estimate that the conservative cost of a lifetime of care, and here we are talking only transVerDate 11-MAY-2000 09:56 Jul 02, 2002 Jkt 000000 PO 00000 Frm 00052 Fmt 6633 Sfmt 6633 C:\DOCS\80356.TXT HGOVREF1 PsN: HGOVREF1
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portation, day services, and residential care, for every person with

autism is $2 million. Multiply that by 1 million and 1.5 million,

and that doesn’t even begin to express the opportunity cost of lost

wages and other contributions to society such as charitable work

and even playing in musical ensembles. Every one of these persons

must be given the same chance that only a select few, often due

to luck, have had to succeed in life.

I would like to close with several concrete recommendations. One

is let’s work with the Autism Society of America by supporting

their funding request and in developing legislation regarding the

autism spectrum, including implementation of the National Research Council’s Educating Children with Autism Report recommendations.

Two, immediate and abundant funding for research and education of those who work with people having autism.

Three, fund fellowships to increase the number of skilled medical

doctors, teachers, and other professionals in working with people in

the autism spectrum.

Four, mainstream autism as it relates to insurance payments.

We are dealing with a medical neurobiological condition, and not

a psychiatric one, and, thus, should not be constrained by policy

limits that we see on mental health coverage.

Five, standardized payments for recognized methods of interventions across the country. It is unfair that some families are placed

on long waiting lists, perhaps a year or two, to access coverage.

No one particular approach can be required because different

children respond to different methodologies. According to IDEA, we

have to provide the child what they need in order to get the education they need. Some sound approaches include, but are not limited to, the Miller Method, Floor Time, Hagashi, Teach, and applied

behavioral analysis.

In summary, it is clear that we have some good interventions

and treatments for autism in place at this time, but it is a travesty

that the quantity and quality of these services are lacking. The

NIH needs to work with organizations such as the Autism Society

of America in developing national policy for people within the autism community, so that all those having autism have a fair shot

at leading fulfilling, productive, and independent lives to the limits

of their capacities.

Mr. Chairman and members of the Committee on Government

Reform, your providing this historic opportunity to present testimony on this issue of autism today is very much appreciated. I

know you will do the right thing. Thank you, and I am here to

serve you.

[The prepared statement of Mr. Shore follows:]

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Mr. BURTON. Thank you, Mr. Shore. Mr. Compton.

Mr. COMPTON. Good afternoon, Chairman Burton and members

of the committee. My name is Doug Compton, and I have been an

advocate for the autism community for 6 years while I was a career

scientist studying heart disease. I have recently become the science

program director for the Cure Autism Now Foundation. My son,

Daniel, who is now 9 years old, has autism.

I won’t restate the prevalence estimates. As we all know, they

are high, and scientists are debating why these numbers are

changing, the extent to which the environmental factors are playing, whether diagnosis is playing a role in the rise, or whether genetics are playing a role in the rise with its interaction with environmental factors.

What I will say is that we still do have hope. Four years ago my

family and I came from New Jersey to the Capital to help introduce

the Children’s Health Act. We came with enthusiasm, and it was

a bright day. My son stood at a microphone such as this and repeated his favorite script over and over, and he is still doing that

to this day.

During the years between the introduction of the bill and its passage, groups such as Cure Autism Now, the National Alliance for

Autism Research, and the ASA formed partnerships to establish genetic resources, brain resources, and alliances with the NIH and

other organizations studying autism. Together, we funded research

to try to identify the causes from genetics to environment. We have

funded brain imaging studies. We have funded animal models and

treatment trials. We have closed no doors, as there is still no conclusive evidence as to what causes this thing we call autism, nor

are there any universally effective treatments.

We continue to push the research agenda from the private sector,

but we need our government to push harder. While there has been

a large increase in funding from the Federal Government from $5

million to $30 million a year, this is far from sufficient. It is not

commensurate with or ambitious enough to address the depth of

the human suffering and of the economic hardship which the disorder is placing on affected individuals.

The formula by which specific funding is allocated by the NIH is

a mystery to us. Far more money is spent on diseases, as you said,

which affect fewer people. We understand that the NIH has to follow the scientific opportunity, but we ask that decisions be linked

directly to the real costs to society. We invest vastly more money

in Alzheimer’s research, for example, which has a much shorter

course between diagnosis and death than autism.

Autism is a lifelong disorder which has no apparent inherent impact on longevity. Children diagnosed today with autism will be an

economic and emotional burden to the country for the next 70

years.

Nearly 2 years after the passage of the Children’s Health Act, its

conditions and goals are far from being met. A recent report prepared by the National Institute of Mental Health in February of

this year contains what we consider to be several inaccuracies. It

reports that $56 million is spent each year on autism, and we believe that these numbers are slightly exaggerated due to accounting numbers of dollars that are spent from related activities. We

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would like to see those numbers put specifically toward direct research dollars that are focused on autism.

We would also ask our friends at the NIH, when they put out

these reports, to show us where the numbers are coming from, so

that we continue to maintain a relationship of trust and accountability between the public and the Federal Government. We have

been told by the NIH to anticipate the designation of two of the five

clinical centers mandated by the act this year. Even this small step

took a lot of effort on the advocacy groups’ part. The casual attitude of the NIH toward autism does not reflect sufficient urgency

in our minds. While it was stated in an NIH report to Congress

that there would be an increase to $15 million per year for these

centers, it became clear that is not going to be happening in the

near-term.

We would like to request that more than two Centers of Excellence be designated in this cycle of funding and three to four more

in the next cycle, as the law provides for a minimum of five centers. Time is of the essence. We realize that scientific and medical

research moves forward slowly, and I know that from my own experience at the bench. We could double or triple the pace if the NIH

were to designate more centers in this cycle now and then an additional number in the next cycle.

I know that there are qualified applicants and centers who are

anxious to get started. There have been minor activities by the

Federal Government in brain and gene banking, as required by the

act, but we expect a larger concerted effort, as described in the legislation.

These brain and gene repositories are vital resources to be able

to understand all aspects of the disorder, including the environmental interactions with these factors. The advocacy groups have

invested substantial dollars in these resources, and we expect a

larger effort from the government.

The NIH also needs to increase its intramural programs in autism. We have been trying, since the beginning at CAN, to develop

field-building in which we recruit heavily at major national neuroscience meetings to try to bring people to the field of autism. I

know that the NIH recognizes this and is supporting intramural

programs, but we believe that it is very important that be one of

the goals of the NIH, to develop scientists who are maybe working

in labs alongside with the NIH, who are actually working on autism and don’t realize that they are because this is a complex disorder that affects many biological systems in the body, including

the GI tract and the immune systems.

The Children’s Health Act mandated that physician and public

education programs be developed to allow for earlier diagnosis and

intervention. It is well established that this is currently the most

effective means of changing a child’s course on the catastrophic

course and possibly creating a productive, independent person. The

Department of Health and Human Services has failed to move

these programs forward.

In New Jersey the advocate groups came together and funded a

program called First Signs, which we launched last year at the Autism Caucus. It has been piloted in New Jersey and seems to be

successful in training doctors.

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It is unacceptable that 49 States do not have a formal mandated

training and education program for doctors and the public. People

are losing precious time. We lost lots of time with my son because

no one knew what he had.

Finally, we have heard that the CDC, also as part of the Children’s Health Act, has been prevented from fulfilling its prevalence

research studies due to the Family Education Rights and Privacy

Act. They have been working with the Department of Education for

over a year to allow access to the education records that hold diagnostic information. We think that should be able to be resolved so

that the CDC can be allowed to do their job.

The passage of the Children’s Health Act was an incredible first

step in changing the course of this disease, and the parents want

to thank Congress for this. There is great momentum, but it will

take much more effort and money than the not-for-profit advocacy

groups could ever hope to sustain. We ask Congress to continue to

lead us forward and for the NIH and CDC to show leadership in

autism.

My son still has autism, of course, and so do hundreds of thousands of other Americans. They need our government agencies to

be responsive.

I would like to close by thanking the members of the committee

for listening to us and for acting on our requests.

[The prepared statement of Mr. Compton follows:]

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Mr. BURTON. Members of the committee, we are going to have a

vote in about 10 minutes. So what I will do is I will yield to you

right now for questions, and then I will stay here. Then I guess,

Dr. Weldon, if you can come back and take the Chair, so I can rush

over and vote, and then we will keep the hearing going, if that’s

all right with the vice chair.

So let’s start with you, Mrs. Morella. Do you have any questions?

I will ask my questions while you guys are running over to vote.

Mrs. MORELLA. I was not the first to arrive here, if you want me

to yield to Mr. Horn.

Mr. BURTON. Let’s see, I think Dr. Weldon was the first to arrive.

So we will start with Dr. Weldon then. Then we will go to you, Mr.

Horn. Is that all right?

Dr. WELDON. Thank you, Mr. Chairman.

Mr. Grossman, the agenda that you put together, could you just

tell me a little bit about how you came to those recommendations?

You had some figures in there. Did you have a committee that

helped you work on that?

Mr. GROSSMAN. These figures were actually put together inhouse at ASA. We have been inundated recently by numerous

media in the United States, as well as in Europe, to support the

data about explosion in the prevalence of autism. We were challenged to find any good studies or any information out there. We

reviewed extensively all the literature that we had available. We

put it out to many people that are on our panel of professional advisors, other consultants that we know, professionals in the field,

to provide us with information that would support the data, show

some meaning to the statistics that we feel we need to support

showing this increase.

Frankly, there is nothing out there. There are no good studies.

This is all anecdotal evidence. So basing what we know on the

ranges that exist that are commonly being bantered about and accepted, we put together a formula of approximately what it would

take to fund at this point the research.

If you are specifically addressing the research and like the $500

million, for example, we are looking at the cost of autism, which

is, we conservatively say, $20 billion annually. That is based on

what we figure is the prevailing—the numbers, conservative numbers, of a half million times about $40,000 per person for treatments per year, which is actually a low figure.

Dr. WELDON. Did you have any professionals help you put this

together? Tell me a little bit about ASA. How many members do

you have and how many staff?

Mr. GROSSMAN. There’s 200 chapters throughout the United

States. We have approximately 25,000 members throughout the

United States. We have a panel of professional advisors made up

of about 20 experts in the field. Our membership extends beyond

the 24,000. We don’t exclude anybody that has an interest in it.

Our office here is located in Bethesda, MD. We have a staff of, I

believe, seven people.

The committee was made up of staff and people on our board, as

well as professionals that we were consulting with. We would gather the information, extend it out through conversations, and then

come back to put that information together.

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The $500 million, it is, to be frank with you, a drop in the bucket

compared to really what needs to be done to address this. It is

what we felt was a conservative number to approach the government with.

We feel also that much has to be done. That is why there is a

3-year ramping up of those figures, because the infrastructure of

what is available today in America to support autism research is

not there. It needs to be developed to get us to that point.

Dr. WELDON. I am glad you raised that point because this is one

of the issues I have gotten into with the NIH. I was very pleased

that Mr.—is it ‘‘Mr.’’ or ‘‘Dr.’’ Compton—Mr. Compton, he alluded

to this issue, that if we were somehow able to get an appropriation

through this year for $500 million, the NIH would be really hardpressed to find a way to spend that much money. There are not a

lot of people prepared to do the research studies.

I don’t recall, did you say anything in your recommendations

about behavioral treatment at all? I know we need to do a lot of

basic science treatments in terms of the pathophysiology and preventions, but dealing with all of these older kids and adults, it

seems to me there is really not a good body of knowledge. Some of

it seems to be emerging.

Mr. GROSSMAN. Yes, I mentioned in my testimony that virtually

it is nonexistent today, the research that is going on on the therapeutic aspect or the treatment aspect of autism, and we specifically

ask for a ramping-up over the next 5 years to a level of about $100

million, based specifically on the behavioral treatment, therapeutic,

clinical aspects of autism.

Dr. WELDON. I am running out of time. I have one more question.

Your health insurance policies cover virtually nothing, correct? You

get a diagnosis of autism. Your typical Blue Cross/Blue Shield,

whatever, they will not cover any types of therapies, treatments

whatsoever, correct? So these families are literally on their own? It

is all out of pocket?

Mr. GROSSMAN. Yes, essentially, it is all out of pocket. The only

avenue that is available to us is services provided to us by the educational system.

It is funny that you brought this up because that is an important

issue that we are grappling with on the insurance that would require a full hearing on its own. Recently, California was able to

pass legislation mandating that developmental disabilities, and

specifically autism, be covered under the medical insurance plans

in that State.

Dr. WELDON. Thank you, Mr. Chairman.

Mr. BURTON. Mr. Horn.

Mr. HORN. Thank you, Mr. Chairman.

I have been very interested in what you had to say, and there

is a few simple things I need to know. Is it Asperger’s? What is this

disease?

Mr. SHORE. Asperger’s syndrome.

Mr. HORN. Asperger’s. Could you tell me the difference between

autism and that? I see in our lists here that, after Mr. Shore’s bit,

that he is a doctoral candidate at Boston and also has Asperger’s

disease, sometimes known as high-functioning autism. I would like

to just get a feel for what is that particular part of this.

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Mr. SHORE. Well, the major difference between autism and

Asperger’s syndrome, we talked about the autism spectrum, ranging from severe to light. At the severe end that is what we consider

the classical canner’s autism. That is what most of society thinks

of children with autism. These are the children that we see being

nonverbal, having tantrums whenever there is a change in the environment, perhaps being self-abusive, a strong, you might say, or

severe lack of body-to-environmental awareness.

As we move to, say, the moderate part of the spectrum, we have

more environmental awareness. These children have more receptive language abilities. So they understand more than they can

speak. They may be considered being limited verbal, perhaps having one or two-word phrases and not very many of them.

At the high-functioning end, and Asperger portion of the spectrum, that is the lightest end of the spectrum, and we actually see

more people over there than at the severe end. These children, particularly with Asperger’s syndrome, according to the DSM–4 revised, they don’t have any delay in communication, but the issues

of socialization—I should say verbal ability. There are still difficulties in communication. So we see major issues in communication,

socialization, restricted interests, and repetitive motions.

Now when we move to Asperger’s syndrome, these are the children that strictly, according to the DSM–4, have never lost their

verbal ability. Applied a little bit more loosely, these are children,

to need to be specific, who had have verbal ability until 18 months,

the bomb hits; we lost verbal ability and we get it back. So usually

by around the age of 4 or 5 or so, maybe 6, the verbal ability is

back. It is pretty much at the level of most other people, but the

language is used, you might say, in a unique way and there is often

difficulties with dealing with abstract subjects, you might say reading between the lines, which translates to difficulties in being able

to determine what other people’s intents are, if it is not spoken in

a very concrete, clear way.

The important thing to keep in mind, though, is that with both

autism and Asperger’s syndrome the issues are coming from the

same place. You are still dealing with the communication issues in

one way or another. The most severe end, lack of verbal ability; the

lighter end, Asperger end, verbal ability, but difficulties in dealing

with pragmatics or what is between the words, you might say.

You still have restricted interests, special interests they are

called, as Tony Oustwich talks about them, interests that are so

strong that they actually interfere with daily functioning. What the

current educational—what people are beginning to learn in education is to use these special interests in order to facilitate learning.

Repetitive motions, that is often the self-stimulatory behavior

that we see, and an issue that the DSM–4 doesn’t cover that I find

present throughout the autism spectrum, sensory integration

issues. In that case what we are talking about is some of the

senses are turned up too high, way too high. I know people on the

spectrum that if they were in a room like this, I would see their

eyes vibrating like this, and they would say, ‘‘We’ve got to get out

of here.’’ Because they actually see the cycling of the fluorescent

lights above that screen there. Some senses are up too high, some

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are too low, and other senses, information that comes in from the

senses is distorted or unable to use the information, you might say,

in a typical manner that other people would.

Mr. HORN. Mr. Compton, is there anything you want to add to

this definition?

Mr. COMPTON. No, I think that Stephen described it fairly well.

Mr. HORN. So I would be curious about what type of either biochemical, chemical, or whatever, to work on some of these things.

Would you work with autism as well as Asperger’s approach or are

there certain other ways that would call for a different type of scientific approach?

Mr. COMPTON. Well, I would like to address one of the aspects

that Stephen brought up, which would be that, obviously, people

with Asperger’s who have more communication are more readily, I

believe, have their symptoms remediated by behavioral teaching

and interventions.

In the area of I think what you are referring to as

pharmacotherapy, I would say that we are in the infancy of that.

I just returned from an autism clinical trial task force that our

foundation held in Los Angeles last week, and I believe to this day

there have only been seven well-controlled, double-blind, placebocontrol clinical trials in autism. Because we don’t know what the

underlying neuroanatomical substrates are that are aberrant or the

biochemical pathways that are aberrant across the spectrum, it is

very difficult at this point to design targeted therapeutics for the

disease.

We are still not certain how many disorders are represented

under the umbrella of the autism spectrum. I would be certain

from the data that I heard last week that certain treatments will

actually give serious adverse effects to some patients, increase

their hyperactivity and motor stereotypies, cause restlessness, decreased sleep, whereas in another subset of patients we may see

improvements with these types of therapies. So I would say that

it is too early in the field to generalize about any of this.

When we think about treatments that go beyond the brain to the

GI tract or to immune dysfunction, they we have opened up an

even wider area that we need to study. All of this reflects back on

the fact that we need to cast a wide net and we need more money,

and we need more intramural programs, because despite the fact

that we have made tremendous progress in the past 5 years

through a lot of the advocacy groups funding research and the

NIH’s efforts with the CPEA programs and the newly funded research, we are far from having any clue as to how to develop effective therapies.

Mr. HORN. Do you feel like the report to Congress is an accurate

representation of what is happening in autism research?

Mr. COMPTON. Well, I would say, I was talking with Dr. Foote

before this, and we don’t have a line-by-line itemization of each dollar that is spent, but when we look at the directed programs, which

we are very happy that money is being spent there, we don’t see

it add up to $56 million. Now that can be due to something that

as a scientist I firmly agree that we need to field-build and we need

to fund research in other areas, but in the autism community I believe that we need to focus on autism. When there are basic reVerDate 11-MAY-2000 09:56 Jul 02, 2002 Jkt 000000 PO 00000 Frm 00069 Fmt 6633 Sfmt 6633 C:\DOCS\80356.TXT HGOVREF1 PsN: HGOVREF1
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search questions being addressed which could include development

of brain imaging techniques or genetic techniques, or what have

you, for those to be lumped under the category of spending on autism, if in fact that is being done, I’m not certain if that is being

done, but we do see an inconsistency that could be explained by

this phenomenon. That is acceptable in the sense that the intramural researcher, if it is being claimed as being money spent on

autism, that the intramural researcher is actually doing autism research or at least collaborating with a researcher who is doing autism.

I would suggest, if possible, that there be a detailed report from

the Public Information Officers, so that we would feel as a community that there was an open dialog on this issue.

Mr. BURTON. Mr. Horn, can we go to Mrs. Morella, and we’ll

come back to you in just a moment? We are going to have a vote

here, and I want to make sure she has an opportunity.

Mr. HORN. I have got to dump some stuff off for later things, so

I will try to come back.

Mr. BURTON. That would be fine.

Mr. HORN. OK.

Mr. BURTON. Mrs. Morella.

Mrs. MORELLA. Thank you, Mr. Chairman.

I think as people who are here assembled probably know, you

have had a real commitment to try to unlock those secrets of autism. Had I thought about it earlier today, I would have worn my

autism ribbon, which is puzzle pieces, you know, seeking to come

together, but they have yet to do that. But we on this committee

have been seeking the data, wanting to know more about what

studies are being conducted, and are rather frustrated about the

fact that so much needs to be done and has not been done yet. That

is the purpose of the meeting. So I thank you for this hearing, Mr.

Chairman, and for your commitment.

Mr. Grossman, you probably know that I represent Bethesda,

MD, where ASA is located, very proud of the fact that is your national headquarters.

Mr. Shore, I am a graduate, as is my husband and a couple of

my kids, of Boston University. I congratulate you on pursuing doctoral studies, and I thank Mr. Compton and Ms. Lerner for being

here.

Also, I represent the National Institutes of Health, and I am very

proud of the work that they do, and I am very proud of the fact

that in the budget that we approved on the House side, and the

President submitted, there is like a 16 percent increase for NIH,

which is going to bring it to that 5-year plan of having doubled the

budget of NIH during that 5 years, by 2003.

Now the question I want to ask all of you, or however time will

allow, is: NIH is going to be at the table right after you. If you had

a chance to ask them a question or if you had a chance to say to

them, ‘‘How do we work together’’—I mean, are they providing information? Is there a partnership? Does there need to be more of

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a partnership? I know their intent is very good. So it could be that

you want to say something for the record and that you would like

to ask them something or make a suggestion.

I would like to start off with you, Mr. Grossman.

[The prepared statement of Hon. Constance A. Morella follows:]

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Mr. GROSSMAN. The relationship that ASA has developed with

NIH over the last year has been very, very positive. The communication has been—— Mrs. MORELLA. I would add CDC, too.

Mr. GROSSMAN. Right, and the CDC has been very, very positive.

There’s been much communication between us in terms of us addressing our concerns with them, and them providing us answers

to those issues.

I am the representative on the Interagency Autism Coordinating

Committee also, which is a forum which started, our first meeting

was in November, which summarizes at that first meeting all the

activities of the Federal agencies and will be an organization or

committee going forward that, hopefully, will be coming forward

with more suggestions.

In looking at the report to Congress, for example, which describes in detail what NIH and CDC is doing, it is pretty much I

believe they have been mandated at this point to do. What we

would need to do, and I don’t have any specific suggestions for

them at this point, is that we need collectively, the autism community, as well as the legislative branch and the administration,

needs to provide them with the resources that they need specified

for autism to expand their research efforts, to expand the service

delivery.

This incorporates a much broader base than just those two agencies, NIH and CDC. This is a national emergency. It has reached

epidemic proportions. It is not only a two-Federal agency issue. It

is a national issue, and we need to bring it forward as such.

Mrs. MORELLA. Would any of the other panelists like to respond

to that? Yes, Mr. Compton?

Mr. COMPTON. Yes, I would like to respond. Despite the fact that

I may have sounded critical about the NIH, I am absolutely thrilled

with what has been going on since my son was diagnosed. When

I first went to my first meeting and I saw Dr. Bristol Powers

speak, I was very impressed, and I still maintain tremendous hope.

I think that the NIH and its subdivisions, the NIMH and

NICHD, etc., and the CDC need more money. It may sound ridiculous, but $56 million is not very much money when you look at the

vast number of systems that are affected in autistic individuals.

Beyond the medical research, at a biological level, there is a

need, for instance, to develop protocols, to measure outcomes in

clinical trials, and it does not just mean clinical trials of pharmaceuticals or interventions. It means clinical trials of educational

interventions, which need to be held to the same degree of scrutiny.

A lot of families are wasting money on therapies that are not biologically based, which are probably also not helping their children.

I would like the NIH to break down any of the barriers among

the agencies and try to promote as much collaboration as possible.

When it comes down to it, I think it is all about money and the

prioritization and, as we talked about earlier, the way that decisions are made to weigh the cost of the disease to society versus

the cost of investment. I think that needs to be looked at critically,

and to develop the intramural programs such that there is true

focus of related fields to this disease. It not only gets you more

bang for your buck, but creates the cross-talk and the collaborative

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environment that I think is going to be necessary to correct the situation.

Mr. SHORE. I have something to add. I think it is a great start.

We need more. We need more work on collaborating, and I see a

lot of in-fighting between the autistic community. If we just look

at educational interventions, like some of the ones that I have

named, there is no—I haven’t found any study where anyone who

has taken a serious look at comparative methodology. What I find

in looking at the different methodologies such as the ones I have

listed, a lot of them are doing similar things, but they are calling

them different names.

Also, because of such wide differences in people with autism, it

is a wide spectrum. There are some children where a particular

method works much better than another method. I would like more

research. Actually, that is going to be part of my doctoral dissertation, but that is just a start. I am just going to validate the instrument.

What I am talking about is something that will be able to allow

us to match the child to the method, because at this time it is a

bit like the Keystone Cops: ‘‘Oh, this method is the greatest; that’s

all there is. The other methods aren’t worth even thinking about.’’ We should be kind of ashamed of that. We should all be working

together and corroborating.

Mr. Compton’s suggestion of outcome studies, they are very, very

important, longitudinal studies, hard to do, but we need them.

Mrs. MORELLA. Thank you. You have all been very helpful in responding to that question. Thank you, Mr. Chairman.

Mr. BURTON. Thank you, Mrs. Morella.

One of the things that has concerned me has been the large incidence of autism being created, I believe, by things like thimerosal,

which includes mercury in that preservative. In Russia, in the

1980’s, they recognized problems. As a matter of fact, we just got

a letter that we received this week from a professor of medicine at

the Academy of Medical-Social Management in Russia, and this letter details the history of concern about thimerosal in vaccines and

injury. This is a concern, as I said, that reaches back to the

eighties.

I would like to specifically note that Dr. Krashenyuk states,

‘‘starting vaccination against hepatitis B of premature infants at

age 2 months . . . when they reach a weight of 4 kilograms is recommended in the U.S. From our point of view, this practice is undoubtedly harmful, since it does not take elementary notions of the

infant’s immunity into account—up to 1.5 years of age the infant

does not have its own immune protection, and is protected only by

the mother’s passive immunity.’’ And then he goes on to say, ‘‘It is

impossible today to deny the fact that this preservative,’’ thimerosal, ‘‘can cause severe post-vaccination complications in children.’’

[The information referred to follows:]

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Mr. BURTON. That same conclusion has been reached in countries

like Norway, Sweden, and Denmark has not allowed any thimerosal in any of their vaccinations since 1990.

Was there any connection when your children became vaccinated

and the onset of the autism? Did you notice it in close proximity?

Any of you at the table?

Ms. LERNER. Not me personally, but I can tell you that, because

of the controversies surrounding the MMR, I was very concerned

when my son had to get his second round of vaccinations. So in

New York State they allow you to get a titers test to determine

what the immunization level is for the child and whether or not it

necessitates a second vaccination. As a result of that blood test, it

showed my son still had very high levels of the immunity in his

system, which led me to believe that, for whatever reason, based

on his neurology, he was not able to properly metabolize the original vaccination that he got. Now Ben’s symptoms date back to, I

think, infancy, but there is demonstration that obviously, based on

their compromised neurology, that they can’t process these vaccinations in the same way.

Mr. BURTON. In the audience, how many have noticed a change

in your child after the vaccinations?

[Significant show of hands.]

Mr. BURTON. OK, I just wanted to know that from the audience.

Mr. GROSSMAN. Mr. Chairman, if I can comment on that?

Mr. BURTON. Yes, sure.

Mr. GROSSMAN. Personally, I didn’t recognize any change in my

son. We knew something was wrong, and it was about at the time

that he would have received his vaccination, but it took us a while

before we figured things out. It actually was my sister, who is a

practicing psychologist in Philadelphia, that took a trip with him

to the mainland, and she noticed that I had to get some interventions for him, something was terribly wrong, and she threatened to

take my son away from me unless I did.

But I think the stories that I have heard that many of our members tell, that many of these people in the audience will tell you,

is that they believe that there is evidence that there is a direct

linkage, a direct causation of vaccines causing their child’s autism.

I think it is imperative for us, the advocates in the room, for ASA,

and for Congress, for the lay public, to stand together to get this

question answered, answered immediately.

We are perhaps creating generations of children that are severely

getting injured through vaccinations. We don’t know that, but there

is a growing body of evidence such as what you are reporting from

Europe that really draws into question what is going on. So whatever is necessary from you to give us direction on what we need

to do, we will support that.

Mr. BURTON. How many members? You said you had 25,000

members in your organization?

Mr. GROSSMAN. 25,000 members, and we have an extended membership of people that are signed up as advocates that actually

don’t pay a membership. Our reach, we believe, extends into certainly 50,000 to 60,000 people at any one time.

Mr. BURTON. Now the organization that you are connected with,

Ms. Lerner, how many members do you have? Do you know?

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Ms. LERNER. It is hard to actually quantify that because we are

an umbrella organization, and organizations like ASA, CAN, NAR,

they are all part of our group. So we would be collectively whatever

their membership—— Mr. BURTON. So it would be kind of included in the same?

Ms. LERNER. Yes.

Mr. BURTON. How about you, Mr. Shore?

Mr. SHORE. Yes, the Asperger’s Syndrome Coalition of the United

States, I believe we have a reach of probably 2,000 to 3,000 by the

time the mailing that is rebound all over the place.

Mr. BURTON. OK, and your organization?

Mr. COMPTON. CAN’s membership, I am not sure if the membership is completely autistic, for autistic families, runs at about

35,000.

Mr. BURTON. Around 35,000? Well, somewhere between 60,000

and 100,000 people can be reached by your organizations, and I am

sure there are other organizations here that I am familiar with. I

would like to just restate one more time what I said earlier. That

is that the squeaky wheel gets the oil in this town.

I cited the amount of money that is being spent for the various

research projects including AIDS and diabetes, and so forth, and

the comparison of that with the money that is being used for autism research. We are going to be funding at a much higher level

research at NIH in the coming years, and this is the time for you

to be proactive.

I cannot stress enough how important it is, and I will be doing

my part here as well, and other Members will, to contact your Congressman, your Senators. Don’t just write to one; write to them all,

if you can, in your State, and make sure and tell your members,

make sure to tell them how important it is that there be an increase and an adequate amount of funding and the proper research

into rehabilitation for children and prevention, to make sure that

we find out what is causing this, not just possibly things like mercury in vaccines, but other things, maybe other toxic substances

that may be in the vaccines, maybe mixing too many at one time.

The immune system might not be able to handle that much. Maybe

it is the MMR vaccine. I don’t know what all the circumstances are,

but that research needs to be done, and it is going to cost money.

It is going to take pressure to be exerted from folks like you folks.

Yes, go ahead.

Mr. WAXMAN. I want to join you in supporting more research because there is still so much we don’t know about autism. We do not

know how prevalent it is. We need to do the research in order to

understand what the actual prevalence of autism is and whether

the increases in cases is due to better diagnosis or to environmental causes that can be prevented, or some combination of factors.

We also don’t understand the causes of autism, nor do we have

a cure. That is why Congress enacted the Children’s Health Act of

2000. This act, which I strongly supported, increased funding for

autism research. But we need to do more than wait for the research. The National Academy of Sciences has made it very clear

in a report last year that early intervention is critical for educating

and treating autistic children. It is incumbent on the medical and

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educational communities to identify children in need of services as

early as possible, and it must be a high priority for Congress to assure that all children with developmental delays, including autism,

have access to scientifically proven treatment and educational services that can maximize their potential.

I appreciate the contribution of all the witnesses who have testified at these hearings and educated us about what it is like to live

with a child with autism or to live with autism themselves. I want

you to know that the experiences you have recounted are part of

the record. They will be shared with our colleagues, and they are

going to have a genuine impact.

Thank you, Mr. Chairman.

[The prepared statement of Hon. Henry A. Waxman follows:]

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Mr. BURTON. Thank you, Mr. Waxman. We do appreciate what

you have done in the past to help in this area.

Let me just say to this panel that we really appreciate your testimony. We hope you stick around to hear what the NIH people have

to say and the people from our health agencies.

We are going to take a brief recess here. Dr. Weldon will start

the hearing, and I will be back as soon as I get a chance to vote

on the floor.

We stand in recess at the fall of the gavel.

[Recess.]

Dr. WELDON [assuming Chair]. Chairman Burton asked me to reconvene the hearing.

So I would like to again convey his thanks to the first panel, and

I would like to ask our next panel to come forward and take their

seats.

The committee will now resume. On the second panel we have

Dr. Steven Foote, Director, Division of Neuroscience and Basic Behavioral Science, National Institute of Mental Health, at the National Institute of Health, and Dr. Coleen Boyle, Associate Director

of Science and Public Health, National Center on Birth Defects and

Developmental Disabilities. And we have a third panelist, is that

right? You are going to accompany Dr. Boyle, OK. And your name

is?

Ms. WHARTON. Melinda Wharton.

Dr. WELDON. OK, could you all please rise?

[Witnesses sworn.]

Dr. WELDON. Let the record indicate that the witnesses indicated

in the affirmative.

I want to thank the panelists for being here. I would ask you to

try your best to summarize your comments to approximately 5 minutes, and we will begin with you, Dr. Boyle. Please proceed.

STATEMENTS OF COLEEN BOYLE, ASSOCIATE DIRECTOR FOR

SCIENCE AND PUBLIC HEALTH, NATIONAL CENTER ON

BIRTH DEFECTS AND DEVELOPMENTAL DISABILITIES, CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, ACCOMPANIED BY MELINDA WHARTON, DIRECTOR, EPIDEMIOLOGY

AND SURVEILLANCE DIVISION, NATIONAL IMMUNIZATION

PROGRAM, CENTERS FOR DISEASE CONTROL AND PREVENTION; STEPHEN FOOTE, DIRECTOR, DIVISION OF NEUROSCIENCE AND BASIC BEHAVIORAL SCIENCE, NATIONAL INSTITUTE OF MENTAL HEALTH, NATIONAL INSTITUTES OF

HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND ANN WILLOUGHBY, DIRECTOR, CENTER FOR RESEARCH FOR MOTHERS AND CHILDREN, NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

Dr. BOYLE. Good afternoon, Congressman Weldon and members

of the committee. I am Dr. Coleen Boyle, Associate Director for

Science at the National Center on Birth Defects and Developmental

Disabilities at the CDC, and I am accompanied by Dr. Melinda

Wharton, who is the Director of the Epidemiology and Surveillance

Division at the National Immunization Program at CDC.

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First, I would like to thank you for the opportunity to update you

today on CDC’s activities related to autism that have occurred during the year since your last hearing. I would also like to thank the

parents, the autism advocacy groups, and Mr. Shore for sharing

their concerns with us about autism.

The committee requested that CDC testify about the problems of

autism and what we know about the apparent increase in rates.

We were also asked to discuss the timeline for implementation of

the research recommendations from the IOM evaluation of the autism vaccine-related issues as well as CDC’s funding for autism research. We are prepared to discuss these issues.

The committee also requested that we address research efforts

conducted by the CDC into treatments for autism spectrum disorder. CDC has not conducted research into the treatment of autism spectrum disorders since the NIH is the agency responsible

for such clinical research.

Last year I told you about the report of a prevalence study that

has already been mentioned today in Brick Township, NJ. That investigation found rates of 6.7 and 4.0 per thousand children for autism spectrum disorder and for autistic disorder, respectively.

This year we can report on the prevalence of autism spectrum

disorder in the metropolitan Atlanta Disabilities Program. This report shows a prevalence of autism spectrum disorder of 3.4 per

thousand children, as you have already heard. We believe this to

be a minimum prevalence and that most of the cases that we have

included are actually autistic disorder. In general, the Atlanta rate

is similar to that which we found in Brick Township. We cannot

determine whether the rates are increasing or not because we don’t

have comparable data from earlier years, but we will continue to

monitor the current rate closely.

We can also not yet generalize for a prevalence for the U.S. population. The population in Brick Township was very small, about

9,000 children, and the population monitored in metropolitan Atlanta is much larger, close to 300,000 children, but we cannot assume that is representative of the U.S. population. Determining if

there are regional differences in autism prevalence really requires

data from other regions of the country.

To address this need, we have implemented a State autism monitoring program. In fiscal year 2000 we funded five States to track

autism. In fiscal year 2001 we funded four Centers on Autism and

Developmental Disabilities Research and Epidemiology for the purpose of not only collecting prevalence data, but for conducting collaborative epidemiologic studies to try to begin to identify causes

and preventable risk factors for autism.

With these programs, plus the one that CDC runs in Atlanta, we

have now nine States involved in monitoring the prevalence of autism. With the new funding that we have received in fiscal year

2002, we expect to add at least three programs, bringing the total

up to 12 States that will be tracking autism prevalence.

Monitoring the prevalence of developmental disabilities such as

autism provides a number of challenges, including identifying proper sources for case information. Unlike birth defects that are more

easily identified in the first year of life, developmental disabilities

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are diagnosed later in childhood and may require nontraditional

sources for public health monitoring.

Collecting data from these sources has proved challenging. CDC

will continue to work with colleagues in other agencies to try to address this important issue.

In 2000, CDC and NIH contracted with the Institute of Medicine

to establish an independent expert committee to review the

hypotheses about existing and emerging immunization safety concerns. Some researchers have suggested that the receipt of either

the MMR vaccine or thimerosal-containing vaccines has been associated with various neurodevelopmental disabilities, including autism.

The IOM was asked to review the available information on these

issues. In the March 2001 IOM report regarding the association between MMR vaccine and autism spectrum disorder, the committee

concluded that the evidence favors rejection of a causal relationship

at the population level between the MMR vaccine and ASD.

In October 2001 the IOM Immunization Safety Committee published a report on the possible association between thimerosal-containing vaccines and neurodevelopmental disorders. In this report

the IOM concluded that the evidence is inadequate to accept or reject a causal relationship between exposure to thimerosal vaccines

and the neurodevelopmental disorders of autism, ADHD, and

speech and language delay.

In these reports IOM also made specific recommendations for a

number of epidemiologic studies. The CDC has initiated a broad

range of studies to better assess these findings as well as to address recommendations by the IOM Immunization Safety Review

Committee. These studies are discussed and detailed in my written

summary.

CDC remains committed to collecting accurate data on the prevalence of autism and to conducting studies to find its causes. We

want every child to be born healthy and to grow and develop normally, so that they are able to lead productive lives. We are dedicated to continuing our work to identify what causes autism and

how it can be prevented.

We appreciate your attention to this problem and we look forward to working with you, Dr. Weldon, and other members of the

committee.

[The prepared statement of Dr. Boyle follows:]

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Dr. WELDON. Thank you very much, Dr. Boyle. We will now hear

from Dr. Foote. You may proceed.

Dr. FOOTE. Dr. Weldon, members of the committee, I am Dr.

Steve Foote, Director of the National Institute of Mental Health’s

Division of Neuroscience and Basic Behavioral Science. Entering on

cue is Dr. Ann Willoughby, Director of the Center for Research for

Mothers and Children at the National Institute of Child Health

and Human Development, who is accompanying me today.

The sustained attention that this committee has directed to the

issue of autism research has helped to focus and accelerate our efforts at NIH. I appreciate the opportunity to talk with you about

NIH support of research on autism. I am a neuroscientist who has

been interested in the brain and its disorders throughout my career. Like others, I have found autism to be a particularly challenging mystery.

My view of this disorder has been broadened and deepened recently by my continuing interactions with family members of children and adults with autism. I feel their urgency. An affected child

cannot wait for research before growing up. Each day, each potential improvement is crucial.

I would like to acknowledge the important role of family and advocacy groups in our efforts. They have not only raised the visibility of autism and challenged assumptions, they have pushed for

accelerated and expanded research activities.

Today I would like to report on progress that has been made at

NIH. Only a few years ago research on pervasive developmental

disorders, the autism spectrum disorders, was fragmented and distributed across NIH institutes and other agencies with little coordination. Today a more integrated, but still appropriately specialized

approach is in place.

The basic research on autism that is sorely needed is moving forward at an accelerated pace, as is continued genetic research and

studies of the etiology of various symptoms, such as communication

disorders. I am a witness today because I play several roles in this

integration and overall comprehensive planning. I am the Interim

Executive Secretary of the Department of Health and Human Services’ Interagency Autism Coordinating Committee that was created

under a provision of the Children’s Health Act of 2000. In addition,

I serve as a scientific program staff member of the NIH Autism Coordinating Committee, a longstanding body that serves to coordinate research efforts within the NIH.

We have made much progress in implementing the provisions of

the Children’s Health Act of 2000 that focused on NIH research activities. The act authorized augmentation of autism research activities at the National Institutes of Health and the CDC.

First, with regard to the Interagency Autism Coordinating Committee, the Secretary of the Department of Health and Human

Services delegated to NIH the authority to organize the IACC, and

NIMH was asked to lead this effort. The IACC has already begun

to enhance communication and effective interaction among the several agencies that support or conduct autism-related research, service, or educational activities, and it will engage family and advocacy groups.

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The NIH Autism Coordinating Committee has continued to act

within NIH to allow program scientists and directors of the relevant institutes to come together to plan and conduct research, and

it communicates closely with the IACC. The inaugural meeting of

the IACC was held in November 2001 on the NIH campus, and it

included the public members selected by the Secretary. Lee Grossman, for example, was one of the founding public members of that

committee. The date of the second meeting has been set for next

month, and we are on schedule, as stipulated in the Children’s

Health Act, to have twice-a-year meetings of that committee.

In terms of accelerated and expanded research activities, NIH

issued a Request for Applications to implement on a fast track the

requirement for new Centers of Excellence Programs for autism research as specified in the Children’s Health Act. An RFA is a clear

statement to the field, setting aside funds, that NIH invites research applications in a particular area. These comprehensive centers are to be called STAART Centers, which stands for Studies to

Advance Autism Research and Treatment.

A number of applications were received in response to this initial

RFA. They were reviewed last month, and the successful applicants

will be funded this summer. A second round of competition has already been posted. It will close in August of this year, and those

successful applicants will be funded in 2003. At that time the full

network of at least five centers stipulated by the law will be in

place. The five participating NIH institutes have established a

funding pool of $12 million per year.

This past year the NIH ACC also endorsed two other RFAs, one

for groups planning to submit center applications this year in order

to allow them to undertake planning activities, and one for innovative research into treatments for autism.

In addition to these activities, NICHD and NIDCD will competitively renew their longstanding Cooperative Program for Excellence

in Autism. This program will expand to be essentially the same

size as the STAART program. And in yet another enhancement of

the NIH autism research portfolio, NIEHS, in collaboration with

the EPA, has funded two new centers focused on autism research.

We at NIH are in a heightened state of awareness concerning the

need for more research on autism, due to the clear magnitude of

this major public health problem and due to the work of many people within and outside this room, and we have been making

progress. As mentioned earlier, our budget for autism research has

expanded rapidly over the past few years, more than doubling. The

research now in this portfolio, and to be included in the near future, holds the promise of answers not only for children with autism, but also for unlocking the secrets of brain development, what

its possibilities are, how it goes wrong, and when to intervene,

which will help all children realize their potential.

In summary, NIH is on schedule in terms of implementing the

letter and the spirit of all aspects of Title I of the Children’s Health

Act, including a broadly based increase in autism research support,

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the initiation of a new Centers of Excellence Program, the extension of the CPEA Program, the enhancement of genetic and other

resources, and the establishment of the Interagency Autism Coordinating Committee.

I would be happy to answer any questions.

[The prepared statement of Dr. Foote follows:]

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Mr. BURTON. Thank you, Dr. Foote. Dr. Willoughby, does she

have any comments?

Dr. WILLOUGHBY. No, sir.

Mr. BURTON. You are just there to hold him up if he falls down.

[Laughter.]

Dr. WILLOUGHBY. He doesn’t need it.

Mr. BURTON. OK. I would like to put a chart up there. Maybe

you can explain this to me. The chart on the comparisons, please,

the NIH one. Yes.

I don’t know if you can see that. Do you have a slide that you

can put it on the slide machine, so that they can maybe see it

clearly?

What that says is that, for diabetes, the yellow line on diabetes

shows for fiscal year 2003 there’s $845 million; in fiscal year 2002, the blue line, it is $781.3 million, and in fiscal year 2001, it is

$688.1 million.

If you look at the middle set of lines, that concerns HIV and AIDS. There is $2,770,000,000 in fiscal year 2003; $2,000,515,000

in fiscal year 2002, and $2,247,000,000 in fiscal year 2001.

Then that very last part that is very difficult to see, that shows autism. In 2003 it will be $70 million, and in 2002 it will be $65

million, and in fiscal year 2001 it is $56 million.

Now, according to the statistical data we have, there is about the

same number of people who are autistic estimated as there are

HIV, and yet the amount of money that is projected to be spent for

HIV is going to be almost $3 billion as opposed to $70 million for

research. Can you explain that to me? Any of you?

Dr. FOOTE. Well, I think you know better than I do that these

budget figures result from a complex state of affairs that involves

not only NIH, but Congress, public health issues, and history. I

don’t think that I could adequately explain exactly how those numbers came about.

Mr. BURTON. Well, NIH, as I understand, they come up to the

Hill and they propose to the appropriators, the Appropriations subcommittees, ‘‘The College of Cardinals’’ we call them up here, they

propose various amounts of spending or spending levels for various

things. Can you tell me, in the last 2 or 3 years, how much money

has been requested for AIDS research or for diabetes research or

for autism research?

Dr. FOOTE. The short answer is no.

Mr. BURTON. Well, could you get that for me?

Dr. FOOTE. Yes.

Mr. BURTON. I would like to know what NIH is asking for.

Dr. FOOTE. We can obtain that information for you.

Mr. BURTON. Now NIH receives unprogrammed, unallocated

funds for research, and I don’t, how much is that? Do you know

how much money that is? Well, it is in the billions of dollars. Can

you tell us how the research spending levels are decided over there,

the unspecified, unprogrammed moneys?

Dr. FOOTE. Yes. NIH has several approaches to funding research.

One of the largest is to accept investigator-initiated grant proposals, which are subjected to peer review. Priority scores are assigned, and then program officials like myself make final funding

decisions and budgetary decisions.

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There’s a distribution of funds among basic research funding

pools, basic research that is applicable to biomedical research. This

issue has come up earlier today. For example, as one of the earlier

witnesses pointed out, in an area that is relevant to autism, we

support a number of studies of brain development, imaging the

brain in children, activities that are relevant to understanding

childhood disorders like autism or attention deficit hyperactivity

disorder. A certain fraction of our funds goes into those basic research efforts. There are other funds that are dedicated, in the case

of clinical neuroscience, to efforts to understand specifically brain

development in individuals affected with autism, and so forth.

Mr. BURTON. Let me interrupt just a minute here. The NIH estimates that now 1 in 250 children born will become autistic between

the ages of 3 and 8, I believe. Now that is your estimate. That is

NIH’s estimate. That is an epidemic. That is a major, major problem, and yet only $70 million is going to be allocated for research

in this area in 2003, and only—what did I say—$65 million this fiscal year. I would suggest that it might be wise to take a look at

those unallocated funds and see if more of that couldn’t be appropriated or utilized for autism research.

The other thing I want to point out to you, and you were here,

you have been here for the whole hearing. I am sorry you had to

wait so long, but they always take longer than we anticipate, especially when we have votes.

I want you to look around. Everybody that has a child who became autistic shortly after being vaccinated, hold your hands up,

please. I want you to look at that. Do you see that? I didn’t put

them up to that. But every time we have a hearing—and, incidentally, I will hold my hand up, too, because my grandson was a perfectly normal child, was going to be 6-foot 10. I was planning on

him in the NBA to take care of me in my old age. Within just days

after getting nine shots in 1 day he was banging his head against

the wall and running around the wall.

And all these people tell you pretty much the same thing. Yet,

when we have people from NIH and CDC up here, they continue

to tell us, well, we don’t have any information or evidence that

these vaccines have anything to do with it. Hold your hands up

again, will you, please?

[Significant show of hands.]

Mr. BURTON. I want you to look at that. Now I don’t know what

you want for evidence, but that ought to be enough to make sure

that there is very comprehensive studies done on thimerosal, which

has mercury in it, that is going into so many children’s vaccines.

Now, granted, you are taking it out.

You have been up here before, I believe, but I have also mentioned that every Congressman who gets a flu shot gets thimerosal,

too. I told the doctor today, Dr. Eisold, the physician here on Capitol Hill, that I am going to inform every single Congressman and

Congresswoman and Senator before the next shots are given for flu

vaccine that they have mercury being injected into their bodies.

Now we all want to get the flu shot, obviously, because we don’t

want to have that confused with anthrax and maybe die or something, because the anthrax scare was a real one, and the symptoms

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are similar. But we want to make sure that everybody is informed

about it.

I tell you, most people who had their children vaccinated did not

know that they were being injected with mercury. I mentioned earlier I think five or six countries that have stopped using thimerosal

in their vaccines, and I read a letter from this Russian doctor who

says there is no doubt that it has a bad effect on children who are

being vaccinated. Yet, we continue to put mercury into these children, not in one vaccine, but in my grandson’s case, I think it was

seven or eight of the nine in 1 day.

So I would urge you, and you will be getting a letter from me

and the head of the Autism Conference. We will be sending you letters signed by probably 50 or 100 Congressman urging you to do

more extensive research into the vaccines and into the causes of

autism in the coming years. We’re also going to be contacting the

members of the Appropriations Committee to try to earmark funds

for that, and the people in the audience are going to be contacting

everybody they know that lives and breathes to write to their Congressmen and Senators about it as well.

[Applause.]

Mr. BURTON. Thank you. Thank you. I didn’t request that, either.

Dr. Weldon, do you have any questions you would like to ask?

Dr. WELDON. Yes, thank you, Mr. Chairman. I have some questions for Dr. Boyle.

Dr. Boyle, you mentioned several studies that the CDC is undertaking in response to the recommendations of the recent IOM. I

have several questions regarding those studies.

First of all, as you know, many Americans are suspect over the

ability of the CDC to conduct an unbiased study. Rightly or wrongly, these are legitimate concerns. Well, they are concerns, whether

you feel it is right or wrong. I certainly hope that those concerns

are being taken into account.

If the research you are doing is to have any real effect on public

perceptions, you must make every effort to ensure independence.

Otherwise, the CDC will have not achieved its desired goal of restoring public confidence in the vaccine program.

Specifically, to get to my questions, the first study you mentioned

using the MADDSP data appears to be an epidemiologic study. Is

that right? There are no biopsies done as part of that study to look

at the presence of measles in the intestinal tracts of these children,

correct?

Dr. BOYLE. That is correct.

Dr. WELDON. The second study you mentioned is designed to determine whether or not the timing of the MMR has any association

with the onset of regressive autism. Again, this is another epidemiologic study, correct?

Dr. BOYLE. Yes, and, actually, that one is being conducted in conjunction with NIH.

Dr. WELDON. It is? OK. So, again, no biopsy specimens, no tend

to look at the gastrointestinal tract.

Dr. FOOTE. There are blood samples to examine questions of excretion and blood levels of mercury and immune parameters.

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Dr. WELDON. The third study, I think it is a study out of Denmark, again, an epidemiologic study, but then you mentioned a

fourth study?

Dr. BOYLE. Actually, that one also has biological markers in it as

well.

Dr. WELDON. The third one?

Dr. BOYLE. The Denmark study.

Dr. WELDON. The Denmark study? Is it serum specimens?

Dr. BOYLE. This is done in collaboration with the Danish National Research Study, and it actually looks at some particular biomarkers.

Dr. WELDON. What are those biomarkers?

Dr. BOYLE. Various neurotropins. There is a study that was reported last year at the hearing by Dr. Cary Nelson at the NIH that

looked at some specific neurotropins that may, in fact, be predictors

of autism. So what we’re trying to do with that study is essentially

look at whether or not these particular children may be more vulnerable.

Dr. WELDON. What I really wanted to get though is in the fourth

study, you say you are in the early stages of planning this study

to investigate whether or not measles vaccine strain virus is

present in the intestines of some children with ASD. So is that the

one where you are going to try to look at the issues raised by Dr.

Wakefield in his reports and Dr. O’Leary?

Ms. WHARTON. There is a study that is still in development. No

word has made yet to an investigator to do the study, but, yes,

there is a plan to look for the presence of measles virus geno-menotestinal tissue.

Dr. WELDON. One of the concerns that I have is that the biological markers is a competent lab. As I understand it, the standards

and the techniques that Dr. O’Leary uses are not in common use

in most labs. They are relatively unique and there are only a small

handful of labs that are capable of duplicating that work. Is that

correct?

Ms. WHARTON. Yes, similar methods to what Dr. O’Leary used

were being put in the study, and laboratory work will be done simultaneously on blinded specimens by a number of different independent laboratories.

Dr. WELDON. OK. The question I have for you, are you making

every effort to make sure that the virology sampling and analysis

is of the same quality and caliber as the work that is done by Dr.

O’Leary? I am saying this because, if you publish something and

if other scientists can nitpick it and say they didn’t use this technique and didn’t use that technique, and the techniques were

faulty, then we are not going to restore public confidence in the

system and we are going to be back to square one.

Ms. WHARTON. Yes, I appreciate that, Dr. Weldon, and thank you

for making that point. There will be an effort made in this study

to use the best virologic techniques available, as well as having

specimens obtained from patients whose clinical systems are wellcharacterized, whose vaccinations and disease histories are

ascertained with appropriate blinding of the specimens.

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Dr. WELDON. Thank you very much. I would like to be notified

as soon as possible when you are ready to—I guess you do Request

for Proposals associated with that study?

Ms. WHARTON. Yes, as far as I know, no specific funding mechanism has yet been identified, but we hope to be able to make an

award this fiscal year.

Dr. WELDON. Thank you. Well, please keep my office informed.

Dr. Boyle, the epidemiologic study on thimerosal, the preliminary

data, as you know, did not show any link with autism, but did

show a statistically significant link with speech development disorder, and then the final analysis that statistically significant link

disappeared.

There have been a number of people who have wanted to look at

that data, and the CDC has not released the datasets. Could you

explain to me why the CDC has not released the datasets on that

information? There is some concern that the sampling techniques

used may have diluted down the information.

Ms. WHARTON. With your permission, Dr. Weldon, I will respond

to that question. There has been a lot of discussion about the differences in the preliminary analyses of the screening data from the

Vaccine Safety Data Link with the subsequent studies done.

The major differences between the preliminary analyses were

that they included followup through 1997. Because of the way the

Vaccine Safety Data Link works, we receive additional information

each year regarding subsequent followup on patients. So what has

happened since then is we now have several years of additional followup on the children who were initially part of the study cohort,

which actually should greatly enhance our ability to detect

neurodevelopmental problems which may not be diagnosed until

the children are older.

With extension of the study 2 years, from 1997 through 1999,

there is an average increase in followup of 23 months. So it is not

that we have diluted it out by including younger children, but we

have extended followup, and that accounts primarily for the differences in findings between the preliminary analyses and the subsequent analyses.

Regarding your question about access to the information, as you

know, the Vaccine Safety Data Link essentially is electronic medical information of a large number of individuals. There is a strong

obligation to maintain the confidentiality of those data. That need

has greatly complicated the ability to make the information, the

dataset, available for independent review.

However, we appreciate this request and have worked very hard

with the individual health maintenance organizations that participate in the Vaccine Safety Link Data Project to identify mechanisms through which independent researchers can repeat analyses

from these sorts of vaccine safety studies while maintaining the

confidential nature of these private medical records, as well as the

proprietary interests of the health maintenance organizations that

participate in the project.

We have been able to develop a process that is quite comparable

to that used by the National Center for Health Statistics, using

their Research Data Center, so that a dataset can be made available for re-analysis using a protocol that could be developed by

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independent researchers. We have shared this plan with Chairman

Burton’s staff. So, in fact, we have been able to solve, I think, the

most serious problems related to re-analysis and will be prepared

to receive protocols to—— Dr. WELDON. To release the data?

Ms. WHARTON. It is making the data available for analysis using

a protocol that has been written. We can’t release the data because

these are confidential medical records, but the data can be made

available in a secure setting, so that analyses can be performed by

independent researchers.

Dr. BOYLE. I just may add as well, this is a prototype that the

National Center on Health Statistics has developed for other types

of confidential information, allowing people access, allowing them

to have availability of the resources to actually analyze the data.

Dr. WELDON. Well, what I would like to see is the data made

available as soon as possible, so that an independent review—so

that the committee can look at the data. Certainly, I understand

the need to maintain patient confidentiality.

One other question I have: Dr. Boyle, you were in my office about

2 years ago. We talked about incidence, and you talked about the

Atlanta study. It was just getting underway. So, based on the information you have recently released, the incidence rates that were

being spoken of, 1 in 250, 1 in 500, and many scientists were questioning that 2 years ago and 3 years ago, you are saying now, yea,

verily, at least in Atlanta that it is that high, and it is reasonable

to speculate it may be that high throughout the Nation? I know

you are scientists and you are going to say we have no proof of

that, but I have been in Atlanta and I have been to lots of other

cities. I find it hard to believe that this would be exclusive to Brick

Township and Atlanta. So the rates are really high?

Dr. BOYLE. Based on what we found in Atlanta, they are very

comparable to what we found in New Jersey. The important part

of what we found in Atlanta is that most of, even though we call

it autism spectrum disorder, the way we find cases is through access to school records, and we know that most of those children are

children who are in special education. Higher-functioning children,

children with Asperger’s disorder, or children with higher-functioning autism may not be captured by those methods. So, in fact, the

rate, if you look at the whole spectrum, might be a little higher.

Dr. WELDON. Well, I know you are scientists and you won’t believe it is going to rain unless the weather balloons go up and

measure the humidity in the clouds and the barometric pressure,

etc., but, and I think I have said this before at previous hearings,

when I started medical school in the seventies, I didn’t know anybody with autism. I never saw any kids with autism. I didn’t know

anybody on the faculty with autism. I didn’t know, I never saw a

case as I went through all the rotations. The thing that has really

dramatically struck me is I am starting to hear everywhere so-andso’s got a child with autism. I think it is one of these things where

the scientists are the last to find out what is going on.

I am certainly glad your data verified what everybody has been

saying, that we’ve got a crisis, and I certainly would encourage you

to duplicate the analysis in other locations and try to refine the

data as much as possible, and then continue to track it to see if

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the rate is increasing even further. I certainly appreciate all the

work you are doing.

I yield back to the gentleman from Connecticut.

Thank you very much. Thank you for your testimony.

Mr. SHAYS [assuming Chair]. I thank the gentleman.

I want to apologize. I don’t usually take the Chair when I haven’t

heard the testimony, but Mr. Burton is on the floor of the House

on an issue that he also cares deeply about, and as we know, he

is a very passionate person, thank goodness.

I want to ask you a question, Mr. Foote. ‘‘Doctor,’’ I’m sorry. I

just want to ask you, do you think the title of this hearing is appropriate in terms of its being an epidemic or would you qualify it in

a certain way, and if you would qualify it, how would you qualify

it? It is not a trick question. It sounds like it, but, honestly, it isn’t.

Dr. FOOTE. I think it is clear, as Dr. Weldon was saying, that

there has been a change. It has been a change that has involved

a substantial increase, as in Chairman Burton’s definition of an

epidemic as an unexpected large increase in the prevalence of a

disorder. Given that definition, I think it is fair for him to use that

term. I would call it a large increase, and our response, I believe,

has been appropriate; that is, that we are mobilizing and we are

assembling the structure, and putting it in place, that will provide

resources for investigators to undertake large-scale studies that

would not previously have been possible that are necessary to address a disorder that is occurring this commonly. That is our goal,

and that is what our actions have been: to establish centers where

young investigators who are interested in autism can be trained to

go on and develop the science that is going to be necessary to have

rational treatments for this disorder.

There is only so much we can do in a short period of time.

Science is an endeavor that takes a lot of training and a certain

amount of ramping-up to be able to use funding in an appropriate

and very high-quality way. So we are hoping that we are putting

in place the infrastructure that will allow that to happen.

Mr. SHAYS. Thank you. That is a very helpful answer.

Dr. Boyle, how would you respond to that question?

Dr. BOYLE. Well, I guess, rather than sort of fooling with the semantics of it, I feel, based on the work that we have done, the work

that many other people have done, that the prevalence of autism

is clearly much higher than what we previously thought, and that

we need to have a concerted response to that issue.

I think at CDC we have strived over the last 5 years to do that,

both in terms of trying to understand the magnitude of the problem, who’s affected, and then by actually setting up sort of the research, epidemiologic capacity, to begin to address why this is happening.

It is clearly hard to look retrospectively and say, what was the

rate 30 years ago, what was the rate 15 years ago. We don’t have

that data assembled. But I think it really shows us that in this

country we need to understand that developmental disabilities, including autism, are extremely important conditions, and conditions

that we all must take seriously.

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Mr. SHAYS. Let me understand. It is my understanding that CDC

is going to actually be reducing its spending next year on autism.

Is this accurate, and if so, why would that be happening?

Dr. BOYLE. Well, actually, we were appropriated $9.7 million for

autism in 2002. We also included additional funding for autism-related activities from the Vaccine Safety Program. I can actually let

Melinda talk. We are still going to be expending the $9.7 million

for autism that is specifically appropriated by Congress for those

activities.

Mr. SHAYS. Let me just say something, just so I can put this on

the record. I don’t fault administrators when we in Congress don’t

appropriate the money, but where administrators become responsible is when they see a need and they can fill a need, they don’t

request the money, and then we in Congress don’t respond.

I am getting the sense that in the last years this has been mostly

generated by Congress kind of pushing NIH and others to treat

this as a more important effort. I may be wrong, and I am happy

to be corrected.

But, I’m sorry, you wanted to make your response?

Ms. WHARTON. Well, I was going to elaborate on what Dr. Boyle

just said—— Mr. SHAYS. Sure.

Ms. WHARTON [continuing]. About the small reduction that you

see in the projected CDC numbers for fiscal year 2003. As Dr.

Boyle said, there has been a certain amount of money appropriated

for autism activities, and that has been supplemented by vaccine

safety appropriations. There have been a number of studies

launched in response to different issues that have come up related

to autism that have been initiated in the last couple of years. Some

of those studies, the final funding cycle is in fiscal year 2002. So

that accounts for the apparent reduction. In the fiscal year 2003

spending we have only reported to you what we currently anticipate spending based on the President’s budget, but, of course, if additional issues arise that require additional studies, those might

very well be the studies we would end up doing in fiscal year 2003,

in response to new concerns or problems that arise.

Mr. SHAYS. When a President submits a budget, and I don’t pretend to be a big spender, and I voted against spending, so I am not

suggesting where blame lies here, but what I am interested in

knowing, though, is if the President and the Budget Director are

not suggesting enough funds for either of your agencies as it relates to this effort, have you gone on record as saying you need

more money, not just with Congress? Let me start with the Budget

Director, or are you basically just accepting whatever has been allocated?

Dr. BOYLE. This is really not done at my level. I clearly feel like

this is an important issue, but it is really done at levels above me.

Mr. SHAYS. OK, Dr. Foote.

Dr. FOOTE. Well, the same is true for me, but, once again, to

point out the way NIH does business, we have to have scientists

who have the skills and the motivation to propose to us, even if we

publicize an RFA, the kind of science that is necessary to address

the issues. So we need to cultivate fields and we need to develop

the competence and the expertise and the people and the resources

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to make the research possible. More often, that is a matter of sustained investment over a period of at least a few years to get fields

really ready to take advantage of opportunities. So, yes, we have

consistently, I think, advocated for that approach to biomedical research.

Mr. SHAYS. I used to chair the Human Resources Subcommittee

of Government Reform and for 4 years had oversight of NIH and

CDC, and so on, and FDA as well, and HHS. I am very familiar

with the point you are mentioning. I think it is important to put

on the record.

But would it be fair to say that you have a pretty good comfort

level that if the field was hearing your testimony, that we wouldn’t

be flooded with people who say, ‘‘I’ve come in with proposals and

I’ve been told there isn’t the money’’? Are you pretty comfortable

in suggesting to this committee that there aren’t a lot of people out

there looking to do research in this area, and that you have to cultivate this group? Is this kind of what you are suggesting?

Dr. FOOTE. I think if there is appropriate training offered and if

the structure that we are establishing and that other institutes at

NIH have long supported, such as NICHD and NIDCD with their

CPEA Program, the field expands because this is an interesting

problem. This is a problem that scientists are motivated to get into

and to try to help. There will be growth. As you know, once the

seed is there, then sometimes growth can be quite rapid. So I think

that is the scenario we are looking at, that in a few years, over the

next few years, there will be investigators coming in with applications, and so on, and we will need to plan for some sustained

growth in this area, so that people don’t get disappointed. So that

is the scenario we will be trying to plan for, sustained growth.

Mr. SHAYS. In our public life, just in our private life, we may

come in contact with families and friends who have children that

have different challenges, and autism being one of them, but in our

public life, we’re obviously exposed to more families. I find myself

thinking, what if I was the parent? I would find myself somewhat

frustrated with traditional medicine, given that it sometimes does

seem to prod, traditional research. I would be very fearful that

there weren’t things that I was doing to my child, or had done, that

may have contributed; in other words, if they were allergic to certain things, and so on.

So I have tremendous empathy as to why people don’t want to

wait too long, because wouldn’t it be amazing to think that, when

we discover something 5 or 10 years from now, we will learn that

there were things we were doing for our kids, thinking we were

helping them, when we were actually hurting them, and there were

things that we could have done at a younger age that would have

made them well, but at an older age may not have the same impact. I know you all have to have that sense as well.

I want to ask a few questions that the staff has prepared. So I

will be reading a few of these, but I would like to put them on the

record, and I would like the synergy of both of you responding and

making comment.

But, Dr. Foote, this is to you. It relates to Dr. Ruth Kirchstein

of NIH. I guess she is the Deputy Director, is that correct?

Dr. FOOTE. She is currently the Acting Director of NIH.

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Mr. SHAYS. She published research she conducted in the 1960’s

on thermara—— Dr. FOOTE. Thimerosal.

Mr. SHAYS [continuing]. Thimerosal, yes.

Dr. FOOTE. Yes.

Mr. SHAYS. Our staff has been seeking to speak to her about this

research and what other research she conducted relative to this. I

am interested if you or anyone else at NIH is looking at this issue,

and whether she will be getting back in touch with our staff. We

need some cooperation from her, frankly.

Dr. FOOTE. I can carry that message back.

[Applause.]

Mr. SHAYS. Let me just say something to our guests. In this

hearing it is truly a hearing, and so I want to respect your interests, but it is important that we have decorum.

Dr. FOOTE. My understanding is that was an FDA research effort. So I think probably it is also appropriate to request of FDA

whatever documentation they have.

Mr. SHAYS. Can we, given that you are before our committee, can

we anticipate that you will certainly try to help us in this regard?

Dr. FOOTE. You can anticipate that we have heard what you have

said, and that we will carry the message back, yes. Thank you, Mr.

Chairman.

Mr. SHAYS. Isn’t it going to be important to evaluate the realworld treatment approach in autism and not just one therapy at a

time? Let me just repeat the whole question. And don’t you think

it would be important to find a practice-based research center that

is providing care for individuals with autism, so that we can track

cutting-edge treatments in real-world situations?

Dr. FOOTE. Well, the issue of treatment, obviously is a primary

one for families faced with an affected individual. As we were just

discussing, it may be some time before there is a treatment founded and based on the pathophysiology of the disorder and derived

in some rational way that really has a silver bullet approach to this

disorder. In the meantime, people, of course, need to be trying to

help their children, and doing it in as timely a way as possible, and

in a way that is guided as much as possible by reliable information.

So NIH has in place several research programs focused on treatment. The CPEA networks have strong treatment components utilizing treatments that families are making use of right now, aimed

at evaluation of their effectiveness and, as has been mentioned

many times, which subset of affected individuals that treatment

might be most appropriate for.

When we issued the RFA for the new STAART centers, the one

requirement, absolute requirement, we had was that each application had to include a treatment component, a treatment study, and

for a center to be considered to be fundable it had to have at least

one treatment study that got strong ratings from the Peer Review

Committee. So it has been our intention all the way along that in

this major new effort treatment would be an inherent and major

part of the overall effort.

Then I might note, finally, that this past year the NIH Autism

Coordinating Committee issued an RFA as the result of which we

funded seven applications having to do with new approaches to

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treatment, and we have funded those seven grants to get them

going. So we are trying to undertake an effort where we are developing basic science for long-term treatment, but we are also doing

these very much more immediate efforts where people have to find

treatments; they have to use treatments now. People look for evidence. They say, ‘‘I want to use the kind of treatment that has the

best evidence supporting it,’’ and they often find that they go and

look and the evidence base is very fragmentary, anecdotal, highly

variable. It is not clear to them what to do when faced with this

entire array of possible treatments. So we have undertaken efforts

to try to help to deal with that as well.

Mr. SHAYS. Thank you. I am going to have the staff ask these

questions, and ask as many as you want. I am going to listen to

them. I might jump in, but I think that we might cover this more

quickly to do it that way, given that they are going to be a little

more familiar with your responses as well.

Ms. CLAY. Dr. Foote, when can we expect the NIH intramural

program to replicate Dr. Wakefield’s research?

Dr. FOOTE. I’m sorry, there was a distraction. When can we expect the intramural research program? I’m sorry, is that what you

said?

Ms. CLAY. Yes. When can we expect children to be able to be

seen at the NIH Clinical Center who have autism and who also

have gastrointestinal issues to be investigated in the same manner

that Dr. Wakefield did?

Dr. FOOTE. I don’t know the answer to that. I would be glad to

find out the answer to that and furnish it to you.

Mr. SHAYS. That would be helpful. Thank you.

Ms. CLAY. Yes.

Isn’t it going to be important for the program at the NIH Clinical

Center to be expanded for autism?

Dr. FOOTE. It sounds to me like that is addressing basically the

same issue of what is happening on the NIH campus in terms of

the ability of people to access that facility and get advice and potentially care, or enter into clinical trials, through that particular

facility. I am afraid I don’t know the answer to that. I will have

to find out, but we will try to provide an answer that encompasses

both of those questions.

Ms. CLAY. Dr. Boyle, we have talked about the CDC’s Vaccine

Safety Data Link project today. You have been tracking for 10

years vaccine adverse events through several HMOs. The committee asked for the raw data a couple of years ago, and we were told

we could not have it because the HMOs were threatening to pull

out of the project. We have learned that at least one pharmaceutical company has had access to the data through one of the

HMOs and that other individuals have tried to receive this data

through Freedom of Information Act and been denied.

Why has the pharmaceutical industry been given preferential

treatment?

Ms. WHARTON. The study in question was actually done by one

of the participating HMOs and was not a Vaccine Safety Data Link

project. These individual HMOs each have their own research organizations which make their own arrangements with outside entities, including universities, pharmaceutical companies, vaccine

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manufacturers, and others, to do research using their patient population.

The particular study you are referring to, which I believe was

initially on the list of VSD studies actually shouldn’t have been on

that list because it wasn’t a VSD study. It was a study engaged in

by one of the individual organizations in corroboration with a manufacturer, which they do many studies in terms of post-licensure

safety studies, for example, these individual organizations.

Ms. CLAY. So your position is that no pharmaceutical company

has had access to the Vaccine Safety Data Link project tapes at all?

Ms. WHARTON. That is my understanding.

Mr. SHAYS. Could you verify that? In other words, would you

check that out?

Ms. WHARTON. Yes, we can get back to you on that, but that is

my understanding.

Mr. SHAYS. And would you, in getting back, confirm yes or no?

In other words, if your answer is the same, don’t not get back to

us; say that you have confirmed your answers.

Ms. WHARTON. Yes, I will do that. Thank you.

Mr. SHAYS. Thank you very much.

Ms. CLAY. In reviewing the publications that were provided to us

from the CDC from this project, it appeared that an equal or more

number of these projects were not looking at vaccine safety issues,

but were looking at ways to increase immunization rates. Is that

an accurate assessment?

Ms. WHARTON. I’m sorry, I can’t answer your specific question.

Ms. CLAY. We were given about 45 published studies. Fourteen

of them were looking at potential adverse event correlations doing

vaccines. Another 14 or more were specific studies looking at how

to improve immunization rates. So, in other words, how we were

going to have increased uptake of vaccine usage within the HMOs,

not at all about vaccine safety.

Ms. WHARTON. Well, the Vaccine Safety Data Link is used by the

participating investigators to answer a variety of questions, including disease incidence, other issues beyond those related to vaccine

safety, but it is still done within the same constraints of the system; that is, maintaining confidentiality of the patient records.

Ms. CLAY. Well, given the need to find out the issues of vaccine

safety and the lack of research looking at adverse events, and that

the creation of this project was specifically to look at adverse

events, wouldn’t it be important to put our focus there first?

Ms. WHARTON. Well, I appreciate your comments, and I can assure you that the people who are directly involved with the VSD

project share your concern that the primary focus of the project has

to be vaccine safety. The other projects that have been done

through the system have really been, in general, smaller projects

that have not required use of substantial resources. This system

was created for vaccine safety, and vaccine safety continues to be

its primary focus.

Ms. CLAY. And who at the CDC makes the decision of what

projects can and cannot be conducted with the access to this data?

Ms. WHARTON. It actually is not CDC’s decision. It is a collaborative project involving a number of health maintenance organizations, which, as I noted earlier, have their own research structures

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and their own principal investigators. This group collaboratively reviews protocols and makes decisions about what are appropriate

uses of VSD resources.

Ms. CLAY. And as we move forward in having protocol established for outside experts to have access to this data, can we be assured that the data will be available fairly, and that there will be

no reduction of access to the projects that they are requesting the

data for?

Ms. WHARTON. Well, clearly, it is our intent to make the dataset

available for re-analysis. A protocol will need to be developed and

will need to be approved by the institutional review boards of the

participating health maintenance organizations, but, yes, the

dataset will be made available, the appropriate dataset will be

made available for the re-analysis.

Ms. CLAY. Can we be assured then that if a researcher wants to

conduct an independent analysis of Dr. Verstraeten’s study, that

can be done without bias?

Ms. WHARTON. You have asked a difficult question, and I may

not be giving you quite the answer you are anticipating. Actually,

I think there are some real issues with Dr. Verstraeten’s study,

and the epidemiological term for that is ‘‘bias.’’ But, yes, what

needs to be done is a protocol developed that will specify what data

are needed for analysis, and those data will be provided in this confidential, in this secure setting of the Research Data Center at the

National Center for Health Statistics using the existing model, following IRB approval.

Mr. SHAYS. Does the gentlelady, Ms. Watson, have questions that

she would like to ask? We are having staff just pursue some questions, but if you have some questions or comments, I would love to

recognize you.

Ms. WATSON. Let me just first thank the committee for holding

this hearing. Since I am so late, I am wondering if there was a connection made between the fumes and the toxicity from mercury in

the amalgams and autism. All right, we had kind of reached and

bridged a gap. We thought there was some kind of connection.

Mr. SHAYS. If you would like to just ask a question or two about

that, we would be happy to have you do that.

Ms. WATSON. Yes. Let me ask those from CDC, I’m carrying a

piece of legislation that will prohibit the use of mercury in dental

fillings. Fifty percent of that silver that they call silver is really

mercury. The bill will outlaw eventually the use of it at all, but we

want people very well informed when they go in to have fillings.

Can someone comment on whether there has been a connection

made between mercury fillings and autism? Does that ring a bell

with anyone?

Dr. BOYLE. I’m Dr. Boyle from CDC.

Ms. WATSON. Yes.

Dr. BOYLE. As far as I know, there has been no study that specifically addressed that issue in terms of dental fillings and autism.

Ms. WATSON. Yes.

Dr. BOYLE. No, there has not been a connection, but also there

has not been specific studies.

Ms. WATSON. In my literature that we have collected around the

bill, there has been some reference to not only autism, but serious

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conditions of brain deterioration suspected coming from that toxic

substance that is emanating from the fillings. So I would like to let

you know that my door and mail is open. If there is anything that

you find in the literature that you could share with our office, it

would certainly help us.

My staff is just handing me a note that is saying in some of the

vaccines thimerosal contains mercury, and it is a kind of preservative, and it goes into the filling. So what we are looking for is any

research, evidence, that would indicate a connection. Thank you.

Mr. SHAYS. Does the gentlelady from California have any other

questions she would like to make?

Ms. WATSON. No, Mr. Chairman.

Mr. SHAYS. I am going to have the staff continue to ask questions. If you are still here and want to jump in, you could do that.

Ms. WATSON. Let me just ask one more question.

Mr. SHAYS. Sure. No, you have the floor.

Ms. WATSON. In your research, is it true that autism continues

throughout a lifetime or can autism come to some point where the

person comes back to very normal growth? Can someone comment

on that?

Dr. FOOTE. Well, I think the observations are that it is a lifetime

disorder with sometimes quite striking remission in certain symptom domains. The communication disorder, the communication

problems, for example, can improve substantially. People have

striking luck with certain kinds of treatments for parts of the disorder in certain children. But these tend to be sporadic, partial alleviation of the disorder rather than a sustained and total remission.

Ms. WATSON. Can the disorder be affected, say, for the good

through a change in nutrition? Is there any evidence?

Dr. FOOTE. There have been reports—we were just talking a little bit earlier about the fact that the number of appropriately

blinded, placebo-controlled studies in autism are several, literally

several studies in the entire literature that have been very well

done. Nutritional changes haven’t been one of the domains in

which there have been really careful studies.

So there are examples of alleviation of symptoms with dietary

changes or nutritional supplements, but those tend to be anecdotal;

that is, stories about a few to several people rather than carefully

controlled clinical trials.

Ms. WATSON. Are autism patients treated individually? The condition can change for the better, but it still stays with them for the

rest of their life? So my question is, can they be treated individually or is there a protocol?

Dr. FOOTE. Well, because we do not have broadly effective, standardized, rigorously demonstrated treatments, and people are confronted with serious difficulties in day-to-day life with an autistic

child, people search for treatments. So, given that the typical story

is that a given child will be exposed to several different treatment

regimes over a period of time, the most broadly used treatments

tend to be behavioral treatments rather than drug or other kinds

of treatments. There are certain behavioral treatments, educational

treatments, that with sustained large investments of time and efVerDate 11-MAY-2000 09:56 Jul 02, 2002 Jkt 000000 PO 00000 Frm 00137 Fmt 6633 Sfmt 6633 C:\DOCS\80356.TXT HGOVREF1 PsN: HGOVREF1
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fort can show substantial improvement in a large fraction of children. I think that is a fair statement.

Ms. WATSON. Institutionalization is one way to deal with this

disorder. What percentage of those identified during their school

years go into institutions, or do you have that information?

Dr. FOOTE. I don’t have that information.

Ms. WATSON. Anyone?

Dr. BOYLE. From our work in Atlanta and Brick, there were no

children who were currently institutionalized.

Ms. WATSON. There are no children in Atlanta or no children in

your studies in the children that you know of?

Dr. BOYLE. In our studies of trying to establish the prevalence

of autism, there are no children who were institutionalized. However, the whole issue of institutionalization in children, I mean

there is clearly very few children who are currently institutionalized.

Ms. WATSON. Throughout the country?

Dr. BOYLE. Again, this is just in Atlanta and New Jersey.

Ms. WATSON. Just in Atlanta. So you don’t have any information

countrywise? That is something I would like to know. I know in

California they do institutionalize. I know in Massachusetts they

institutionalize. I am just wondering how prevalent it is across the

country. Thank you.

Mr. SHAYS. Dr. Foote and Dr. Boyle, let me just say it is our intention to let you get out pretty soon. You haven’t had a break or

anything. Do you have 20 more minutes in you? Are you OK?

I am going to do something that may seem a little unusual, and

I may have to just cut it off if it is not a good idea. But, Dr. Foote

and Dr. Boyle, if you can trust me in terms of my ability to control

a meeting, it is not lost on me that we have a lot of people in the

audience who have a keen direct interest. There may be a question

or two that none of us on the panel here have asked that we should

have. I am going to ask if there is someone in the audience who

may have a question that says we should have addressed this. I

will allow you to stand up and tell the committee, and then we may

choose, our committee may choose to ask that question.

My motivation is that it would be a shame to have people leave

without you having the opportunity to respond and maybe clear

something up. Both of you have such a nice, friendly smile. I figured I could get away with it. So we are going to try it out, but

I have the counsel—excuse me, the minority counsel would like to

ask you a few questions, the majority professional staff would just

like to ask a few more, and then I am going to just throw it out

to the audience, pick two or three of you and ask you to stand and

tell me if there is a question you think we should have asked, loud

enough so I can repeat it to our witnesses.

There you go. So I will recognize the minority counsel. Yes? Mrs.

Morella, I had asked if there was any question, and I had been told

you didn’t have any. Would you like the floor?

Mrs. MORELLA. I would love it.

Mr. SHAYS. You have the floor as long as you would like.

Mrs. MORELLA. Particularly because I represent the National Institutes of Health, and, Dr. Foote, I am glad you are here, and I

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work very closely with CDC, and I am glad you are here, Dr. Boyle,

too.

I was here for the first panel and heard the kinds of questions

or the points that they brought out. I think one of the notes that

I had jotted down was they felt there was a need to develop a national policy, that we needed more collaboration, that we needed to

match the child to the method.

We pointed out the fact that there are just so many questions

that are still unanswered. Funding was stressed by I think every

member of that first panel. I am not sure—if you would kind of

comment on whether you see, what do you see is really necessary?

Is it the need for further collaboration? Will funding alone do it?

How do we get some of these questions answered, particularly also

with regard to vaccines and what their connection is to autism? If

any of you would like to comment on that just general area? Dr.

Boyle.

Dr. BOYLE. I will start. I took some notes, too, during the last

panel. I would applaud the issue of collaboration. I think we have

made a good start across not just NIH and CDC, but all the agencies involved. The Department of Education, the Health Services

and Resources Administration, all of these agencies need to work

together to address this issue.

Mrs. MORELLA. Should we do something about that? I mean, is

there direction we should be offering?

Dr. BOYLE. I think the direction from Congress from the Child

Health Act clearly directed collaborations. It directed, I think, to

CDC and NIH, but other partners have clearly been pulled into

that. I think that we need to continue to make that happen, as well

as work with all of the parent groups that are seated behind us

here.

I applaud the effort of hearing from the parents at the end of the

committee hearing today. So I would definitely second that notion.

The other thing I heard about was, though, the issue of training.

Mrs. MORELLA. Yes.

Dr. BOYLE. And this is training across the board. I think a lot

has happened in the last 5 years in terms of both epidemiology researchers, diagnosticians, treatment issues. I think that we have

made clear progress, but I do think this is an area that we need

to put concerted energies into.

There is a lot of interest in autism and other neurodevelopmental

disorders, and we want to continue to have that momentum happening it and growth in positive ways.

Mrs. MORELLA. Dr. Foote, I would love to give you an opportunity to respond to any of those facets.

Dr. FOOTE. Well, the Children’s Health Act called for the establishment of an Interagency Autism Coordinating Committee. We

now have that up and running. There is, of course, always a big

distance between sitting down in the same room and talking and

converting that into something that resembles a national policy or

even a coherent picture of what it is that is being done, which, of

course, helps you identify what isn’t being done.

But I think at our first meeting, and I think on the agenda for

our second meeting of that committee, those are exactly the jobs

that we are taking on. I think we have the appropriate representaVerDate 11-MAY-2000 09:56 Jul 02, 2002 Jkt 000000 PO 00000 Frm 00139 Fmt 6633 Sfmt 6633 C:\DOCS\80356.TXT HGOVREF1 PsN: HGOVREF1
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tion on the committee to be able to do that in a realistic way. So

I think if there is going to be a national agenda about autism, I

think that there is a kernel for starting that with the Interagency

Autism Coordinating Committee.

Mrs. MORELLA. Maybe this committee hearing will help to spur

that on.

Thank you, Mr. Chairman. I am pleased also to note your new

concept of involving the audience, involving the parents.

Mr. SHAYS. Well, we have done it before and it has worked, but

it does take cooperation.

Mrs. MORELLA. Right.

Mr. SHAYS. We will give it a try in a second. Excuse me for not

calling on you; I apologize. I think it was the nervousness of thinking how we were going to do the latter. [Laughter.]

I recognize minority counsel.

Ms. DESPRES. Thank you. I have just a couple of questions regarding that request for the Vaccine Safety Data Link data. I was

wondering if you could explain to us why the privacy concerns are

so important. I am particularly interested in what could happen to

the VSD if the participating HMOs didn’t believe that there was

adequate control over patient confidentiality.

Ms. WHARTON. Well, in fact, I think just the fact that this discussion has been ongoing for so long has convinced all of them that

there is no longer assurance that the data can be maintained in a

private way at CDC. The individual participating organizations are

no longer sending master datasets to CDC. I think that unless

these issues can be resolved, the project is likely to no longer be

possible to continue.

What we have tried to do is develop a new way of doing studies

where, in fact, the data won’t reside at CDC, but the analyses will

be done in a distributed way among the participating organizations. This is something which is theoretically possible to do, but

operationally would clearly require much more in the way of data

management and statistical support of the individual sites, as well

as at CDC. So I think, in effect, it will reduce the amount of work

that will be possible for us to accomplish within the VSD with existing resources.

Ms. DESPRES. Can you explain to us, if the VSD is not able to

continue, what would be the implications for vaccine safety research in the future? I am also curious about the implications of

the fact that the data currently is not at CDC. What present implications on vaccine safety research has that had and what implications could it have in the future.

Ms. WHARTON. Well, at the moment we, as I understand it, have

not yet received any of the year 2000 data because none of the organizations are currently willing to send it to us. So we are not

currently able to perform any studies easily in terms of screening

analysis that requires access to the year 2000 data. Now, again,

the data do reside at the individual sites and can be accessed in

this distributed way, but it is far more laborious.

Should the project cease to exist, I think it would dramatically

change—it would be a great loss for us. The VSD has provided a

mechanism through which vaccine safety concerns could be rapidly

addressed, and often reassurance provided in a very prompt way

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when something comes up. Now many issues are complex and do

require more detailed investigation beyond what can get from analyzing the automated data tape, and do require chart review, and

so forth. Those studies are more complicated and take longer to

perform, but the VSD has really been one of the bedrocks of our

vaccine safety system. I think its loss would be a great one.

Dr. BOYLE. Can I add a comment to that as well? I think that

this actually has had a ripple effect with the HMOs. We are dealing with other issues where we would like to have a rapid response

and work with the HMOs because they are a wealth of information

and data, and they are reluctant to participate because of these privacy issues.

Ms. DESPRES. So without having VSD data now and the possibility that you won’t have it at all in the future, would that mean that

it could take longer to detect vaccine adverse effects?

Ms. WHARTON. It clearly would take longer. It would clearly be

more laborious. It clearly would be more resource intensive, and we

would be unable to accomplish as much.

Ms. DESPRES. I don’t have any more questions. Thank you.

Mr. SHAYS. I thank you very much. It is important to get on the

record. I appreciate it.

I recognize the majority professional staff.

Ms. CLAY. Aren’t some of the privacy concerns as a result of the

HIPAA regulations that are about to be implemented?

Ms. WHARTON. Some of the privacy concerns do overlap with

HIPAA issues. There are additional State requirements in some of

the States in which these organizations persist. But it is a general

issue that we have to assure the confidentiality of these data.

Ms. CLAY. And is their not providing the tapes to you a violation

of the contract that you have with the association that oversees

these HMOs?

Ms. WHARTON. We are in the process of trying to develop a new

procurement mechanism that will allow development of this distributed model.

Ms. CLAY. One of the correlations that we have looked at between the issue of mercury in medicine and exposure for our children is the same process that we went through in the 20th century

looking at lead in paint and its effect on children. How does this

issue correlate, the CDC and the NIH response correlate for mercury as it did to lead in the paint 50 years ago?

Dr. BOYLE. Well, I will start first. One of the things that we are

hoping to be able to do with our State-based program is to be able

to monitor, and we call it, from an ecological standpoint. The implications you have had were in terms of looking at lead. But we are

hoping to be able to look over time at the prevalence of autism

based on our State-based monitoring program and how that prevalence may have been impacted based on the removal of thimerosal

from vaccines.

Dr. FOOTE. I think the NIH response to the thimerosal issues has

been to undertake a series of research projects looking at metabolism, and distribution of ethyl-mercury in the body, rates of clearance, and potential toxic effects. There are several such research efforts now underway, some of which, as we discussed earlier, and

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in collaboration with CDC. So I think this is a serious and appropriate response to those issues.

Ms. CLAY. And, Dr. Foote, if a parent, when they have a newly

diagnosed child, goes to the NIH Web site and looks for information

on therapies for the child, will they find adequate information?

Dr. FOOTE. Well, we have a joint linkage with the National Library of Medicine in which there are large amounts of data available. The real problem is one of the underlying science and the underlying science not being adequately developed. Anybody would be

daunted right now in attempting to sift through that information.

I don’t think it is as much a matter of organizing the information

as it is of literally developing the information, and that is the effort

that we have underway. So, yes, we have taken seriously the task

of having an interface with the public that makes information accessible to them, but our real job and the real effort that is going

to solve this problem is to have better information available.

Mr. SHAYS. Now let me state what I would like to do. I would

like to let our witnesses leave soon. I would like to just say that

this is a hearing of the House of Representatives, of Congress, so

the decorum needs to be done well.

I am going to first ask how many people would like to ask the

question. I am going to invite five people to take each of those five

seats. I am going to invite you, Ma’am, in the front row to come

up to that seat up there, yes. I am going to invite you in the very

back to come up, the very back there. I am going to invite you, sir,

to come up. I am going to invite you, Ma’am, in the middle, and

I am going to invite you in the very back there.

I am going to have you each take a seat. What I am going to invite each of you to do, the committee is going to invite each of you,

you are just going to go down and you are going to identify your

name, as you ask the question, where you live. If you have a loved

one who is impacted, we are happy to have you share the name of

your child, but this is primarily for an opportunity to ask a question. We will just see how it goes. OK?

You all are nice—thank you—to let us do this.

Just turn the mic on, start at the very end, and ask your question.

Ms. MINTZ. Hi. My name is Sandy Mintz. I am from Anchorage,

AK. I am lucky enough not to have a child who has been injured

by a vaccine.

My question is, is NIH ever planning on doing a study using the

only proper control group, that is, never vaccinated children?

Dr. FOOTE. I am not aware of—but note carefully what I said,

that I am not aware of—a proposed study to use a suitably constructed group of never vaccinated children. Now CDC would be

more likely perhaps to be aware of such an opportunity.

Dr. BOYLE. The study that I mentioned earlier that we are doing

in collaboration with Denmark compares children who received the

MMR vaccine versus children who did not receive MMR.

Ms. MINTZ. But I am saying never vaccinated with any vaccine.

That assumes that other vaccines don’t cause autism, which is

what needs to be studied, not assumed.

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Mr. SHAYS. Let me just say that if you would turn off your mic,

I am happy to have you do the followup, if you would respond to

it.

Ms. MINTZ. I’m sorry.

Mr. SHAYS. No, you don’t need to apologize. And we will go to the

next. Do you have any other comment based on that? The point

that is being made, any vaccination. Could we just suggest that you

take this under advisement?

Ms. WHARTON. The difficulty with doing such a study in the

United States, of course, is that a very small portion of children

have never received any vaccines, and these children probably differ in other ways from vaccinated children. So performing such a

study would, in fact, be quite difficult.

The Denmark study was a study that, in fact, could not have

been done in the United States, although, of course, these children

did potentially receive some other vaccines, but simply hadn’t received MMR.

Mr. SHAYS. I will invite anyone who is here to speak to staff or

me afterwards if they want to augment a comment.

Let’s go to the second person. I am sorry, I don’t know your

name. So I can’t call you by name. So you are going to be a number

to me.

Ms. STEWART. OK.

Mr. SHAYS. You are No. 2.

Ms. STEWART. OK. My name is Dr. Linda Stewart. I am from

New York. I am coming from Switzerland. I have been working in

Switzerland for 30 years in the political and internal affairs international arena. I am also a mother of a son, my No. 2 son, who

has been recently diagnosed with autism spectrum disorder.

Mr. SHAYS. How old is your son now?

Ms. STEWART. He is 8.

Mr. SHAYS. OK.

Ms. STEWART. We returned to the United States, as he was born

and vaccinated in Florida. We had been to four or five neurologists

in Europe, the highest doctors we could find in France, Switzerland, Italy, and we came to the United States to find out if we

could find any help for the boy since he was born and vaccinated

here.

All the tests, MRIs——

Mr. SHAYS. Let me ask you, can you do your question, if you

could, yes?

Ms. STEWART. Yes. All our tests showed normal, and we were

able to find a program by residents from NASA that showed the

child was full of mercury. My question to you, respectfully, as scientists and researchers, what results, with all the millions that I

hear you mention back and forth today, what have been your results in a pragmatic and functional level for the millions of research that you have received in biological autism?

Dr. FOOTE. The types of studies that happened and are underway

are studies about the levels of mercury that result from vaccination

and are about the timing of the onset of autism symptoms in regressive and/or non-regressive autism and how those may be or

may not be systematically related to the time of vaccination.

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Some of those data are in; some of those studies are currently

being conducted, and some of those studies are still being organized. The data are not yet in. But the money is on the table. The

studies have been funded and they are underway.

Ms. STEWART. Thank you.

Mr. SHAYS. No. 3.

Ms. WEDEWER. Hi. My name is L.D. Wedewer. I am the U.S. Autism Ambassador, and I have more titles than my arms, so I will

leave it at that.

But I have a two-part question actually. My daughter received a

hepatitis B shot at 2 days old, which I truly feel was too young,

but I was never given any information on the cause and effect,

what could happen to her. Do you feel that there is a need to ensure that parents have the knowledge of what the mercury could

do to the individual, and how would we assure that?

Ms. WHARTON. Well, clearly, we do try to inform parents of the

known risks and benefits of vaccination through vaccine information statements, which are required by the National Vaccine Injury

Compensation Act passed by Congress some time ago.

The mercury is no longer contained in any of the hepatitis B vaccines administered to infants or thimerosal is not, and thimerosal—the vaccines now being routinely administered to children, in

fact, none of them contain thimerosal at this point.

There are not data to—there are no established harms associated

with this. I know this is a subject of great concern, and a number

of studies are underway, but we do not have data that support

known hazards associated with thimerosal contained in vaccines at

this point.

Ms. WEDEWER. OK, and my second part to the question is I have,

as the U.S. Ambassador, I have been receiving over the last year

numerous information and different amounts of proof on the thimerosal connection, Ma’am, as my daughter is one of them. I had

found a recent CDC report that had never been released that had

birth to 6 months, and yet the release that you released to the public and congressional hearings omitted birth to 6 months. Is there

a reason why the original report and the second report do not

match?

Ms. WHARTON. Well, this is an issue that was addressed earlier.

I believe the study you are referring to is Dr. Thomas Verstraeten’s

analysis of the VSD screening data.

Ms. WEDEWER. I actually have it here today, if you would like

to have it in front of you, so you know——

Mr. SHAYS. No, but she is on target, right? She got the study.

Ms. WEDEWER. OK, go ahead.

Mr. SHAYS. Yes.

Ms. WHARTON. And as I mentioned earlier, the initial studies focused on a limited followup period. Since that time, there has been

more extensive followup which should actually enhance the finding

of children whose subsequent developmental abnormalities were diagnosed later in life. So more extensive followup should help us do

a better study.

Ms. WEDEWER. OK, my final, this is the final part to it, and I

promise I will let Mr. Horowitz go on. My last concern—and, reVerDate 11-MAY-2000 09:56 Jul 02, 2002 Jkt 000000 PO 00000 Frm 00144 Fmt 6633 Sfmt 6633 C:\DOCS\80356.TXT HGOVREF1 PsN: HGOVREF1
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member, I receive e-mails from many, many parents; I was inducted by more than 245,000 people, so I—— Mr. SHAYS. Ask your question. Why don’t you ask it.

Ms. WEDEWER. I have U.S. knowledge. May I ask, why, then, if

you are so worried about releasing the statistics from the parents

to a congressional hearing, as I do work with Democrats, etc., in

Iowa, do you really think—as a parent of a child with autism, I

don’t think that I would have a problem with you releasing the information for someone else to look at. Do you really think that

other parents would have problem with that, when everybody they

see——

Mr. SHAYS. OK, you have asked your question. Now I am going

to have you move the mic, so I know you are not going to have a

fourth followup.

Ms. WEDEWER. OK. [Laughter.]

Mr. SHAYS. OK.

Ms. WHARTON. Well, it is not just parents of children who have

neurodevelopmental abnormalities. It is all the patients participating in these health maintenance organizations, which is a measurable proportion of the U.S. population, have data on every medical

encounter and every diagnosis they have received. I think these are

data which have to be maintained confidentially. We have no choice

about that.

Mr. SHAYS. Thank you. We have two more to go, and you all have

been wonderful. Yes, sir, you are No. 4. Turn the mic on, if you

would.

Mr. HOROWITZ. Thank you. My name is Dr. Len Horowitz. I am

here representing an organization nationwide called Vaccination

Liberation, as well as I am an Honorary Autism Ambassador, and

I appreciate this opportunity.

My question is not simply for the good representatives here, but

also for all of us to consider. We have currently in the last several

years particularly become very aware of the tobacco industry and

its infusion into what amounts to cancer sticks, a variety of ingredients that the industry itself knew was totally toxic. The evidence

before this committee, I understand, including the Verstraeten report, indicates clearly the Centers for Disease Control and other industry officials knew well in advance that mercury, as well as potentially aluminum, formaldehyde, formalin derivatives, as well as

foreign species DNA, RNA, proteins, cause a horrific number of injuries.

The question that I have is, how, as we begin to spend millions

of dollars and give to these same organizations who have this

knowledge, how can we assure that putting virtually the fox in

charge of the hen house do we expect this autism pandemic or epidemic here in the United States to stop without a full housecleaning within the NIH, CDC, NAID, NIMH, and FDA, freeing

this bureaucracy from special pharmaceutical industry biases and

influences, especially since the lives of our children, our Nation’s

future is at great and grave risk?

Mr. SHAYS. OK, let me say, you are not going to have a followup

on that one because that was such a long question, and it did have

a sense of bias as well as a statement, but it is an important question to put on the record.

142

I don’t know if you all want to address it. It was thrown out to

all of us. Do you want to just make any response? I mean, Dr.

Foote, can you—let me try to narrow it down a little bit.

Given that we did know that there are a lot of things that we

have allowed to happen where we knew they shouldn’t, how do we

sort that out? In other words, in Congress, in the private sector as

well, I mean we could say with hindsight we know it shouldn’t

have happened. We can say, well, some people in a company may

have known, but maybe not everyone. Just he deserves some type

of response.

Ms. WHARTON. Well, I would call into question the initial statement that we know that all these additives are in vaccines and we

know that they cause harm.

Mr. SHAYS. Right.

Ms. WHARTON. In fact, that is not known. The Institute of Medicine has reviewed the data regarding IOM and autism and has

found that the evidence favors rejection of a connection between

MMR vaccine and autism. As far as the thimerosal issue is concerned, the evidence is too incomplete and fragmentary to make

any decisions about causation.

Of course, many substances are known to be dangerous when administered in high concentrations, but the additives that are included in vaccines are present in trace amounts, and even when

multiple vaccines are given, these are still very small amounts of

products. It is not established even that thimerosal is associated

with any harm as a vaccine additive.

That said, we have committed a large amount of staff time and

funding to try to further elaborate these issues and have designed

a whole series of studies that have been described in our written

testimony that we believe will help address these issues and are responsive to the specific research recommendations made to us by

the Institute of Medicine.

Mr. SHAYS. Thank you. I am going to respond and say that some

of our most dedicated employees are in the very institutions you

have mentioned. So I would dispute that we need a cleaning of the

house, but I do think——

Mr. HOROWITZ. Just in terms of those biases by special interests,

currently, the waivers bother me, the fact that we have CDC officials and ASIP officials in the vaccine—— Mr. SHAYS. You know what we are going to do——

Mr. HOROWITZ [continuing]. That get these waivers——

Mr. SHAYS [continuing]. We are going to allow you to have dialog

directly with the staff about this afterwards, and the staff will stay.

Let me just go to No. 5, and then you all have been very trustworthy, and I thank you, and I know it is tempting to jump in, but

you won’t be given an opportunity. We are going to five, and then

you all are going to get home.

Ms. BIGELOW. Hi. I am Rita Bigelow. I have an 11-year-old boy

with autism. I just want to say thank you to the Congressmen and

women who are here helping us with this cause, and also to the

people from the NIH. Thank you for listening to us, answering our

questions.

Mr. SHAYS. And CDC.

Ms. BIGELOW. And CDC. Sorry.

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Mr. SHAYS. Yes.

Ms. BIGELOW. I am with the Autism Coalition and with other

groups. I see many of my friends who are here, too. So thanks to

all of them for making the trip down.

I have a question that is a little bit taking a different tack, but

I worked with several researchers in autism, tried to raise money

for them, and worked with them. It seems that most scientists believe that autism is caused by a combination of genetic and environmental triggers.

My specific question, and I don’t have a part B, but, what types

of steps has the NIH taken to promote genetic studies? You know,

the genes may perhaps interact with environmental triggers, with

psycho-pharmacologic agents, things like that.

Dr. FOOTE. So the CPEA network that has been funded for the

past several years by NICHD and NIDCD has a coordinated genetics program, their Centers of Excellence in Neurobiologic and Genetics of Autism, where they have multiple sites at which they collect genetic data from subjects. The advantage of having multiple

sites being that you can collect from them a much larger cohort

than you could ever do having individual investigators operating

just within their own spheres. So it provides power to genetic analyses that couldn’t otherwise be obtained.

In the new STAART Centers Program, we will be doing the same

kind of thing, where there will be standardized diagnostic protocols

across all of the sites, standardized instruments, so that then you

can collect genetic data from a large number of subjects distributed

at various sites and have the numerical power to do genetic analyses that wouldn’t otherwise be possible.

We have at NIMH a genetics repository where we collect large

amounts of genetic data and make it available to any responsible

investigator who applies to us to receive genetic materials from rigorously diagnosed subjects about whom we have large amounts of

information.

So this is the future. This is what we are actively implementing.

We recently just gave a multimillion dollar grant to the AGRE data

base, which you may have heard of, which has originated from advocacy groups, and really the grassroots, generating genetic samples. So now we feel like we are in the position where we can have

a very large data base of genetic information combined with very

detailed behavioral and clinical information from subjects, so that

we can do powerful genetic analyses.

Then just one final note, and then I will be quiet, because you

hit one of my buttons here, obviously. The other issue is that some

of these questions that come up, ‘‘Why did my child respond so dramatically to a particular vaccine when all the other kids on the

block didn’t respond the same way?’’ Well, the genetics may well

be a clue to that. The way we are going to get the answer eventually is through these combined genetics efforts where we have a

large number of subjects, thorough clinical histories, standardized

genetic information, freely available to a number of investigators

who may well want to look at exactly this question. So that is

where we are going. We are getting there.

Mr. SHAYS. Dr. Boyle.

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Dr. BOYLE. I was just going to be very brief. In our centers’ studies, these are epidemiologic studies that are done collaboratively,

sort of what we call gene environment interaction. This is a very

important issue, and it is clearly one that is the basis for the studies, and that is what we are addressing.

Mr. SHAYS. I thank all five of our——

Mrs. MORELLA. Mr. Chairman, may I just add something to that?

Mr. SHAYS. Sure.

Mrs. MORELLA. That is where you are going to need the passage

of the Genetic Non-Discrimination in Employment and Health Act,

which has about 260 co-sponsors here on the House side.

Mr. SHAYS. I hope I am on that bill. Good grief.

Mrs. MORELLA. I think you are, yes. [Laughter.]

Mr. SHAYS. Ms. Watson, do you have any last comments you

would like to make?

Ms. WATSON. No, I don’t except to thank the panel.

Mr. SHAYS. Yes. I am going to ask this question. I have one other

question.

Mrs. Morella, any comments?

Mrs. MORELLA. No, Mr. Chairman.

Mr. SHAYS. I had a question that I was asked to give, and I think

by the response to one that we are doing this. But the question

was, do the CDC and NIH recommend that the removal of thimerosal from childhood vaccines—it appears that is the case, that we

are removing them from childhood vaccines? Is that the case?

Ms. WHARTON. That recommendation was actually made in 1999.

Mr. SHAYS. Great.

Ms. WHARTON. And the vaccine manufacturers moved very quickly to reformulate and relicensed all the routinely administered

childhood vaccines, so that they are now available only in thimerosal—they are now marketed only in thimerosal—in formulations

that do not contain thimerosal as a preservative.

Mr. SHAYS. Got you. Let me ask you this now: Is there any question that you had prepared to answer that we never thought to ask

that you want to answer? [Laughter.]

[No response.]

Mr. SHAYS. I think that our guests would recognize that you all

have been very patient, and I think our witnesses would recognize

that you all, those of us who are our guests at this hearing are

dealing with some really tough issues. We want to be helpful to you

and want you to stay in touch with our committee. Our committee

record will be open until the 3rd, and you are invited to submit

anything in writing to the committee that you would like to submit.

But I do thank all of you for participating here, and I thank No.

1, 2, 3, 4, and 5 for being here and your patience in not having the

sixth or seventh followup.

This hearing is now adjourned. Thank you.

[Whereupon, at 5:10 p.m., the committee was adjourned, to reconvene at the call of the Chair.]

[The prepared statements of Hon. Thomas M. Davis, Hon. Wm.

Lacy Clay, Hon. Christopher H. Smith, and additional information

submitted for the hearing record follow:]

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